OKEDI

Package leaflet: Information for the user

OKEDI 75 mg powder and solvent for prolonged-release injectable suspension

risperidone
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What OKEDI is and what it is used for
2. What you need to know before using OKEDI
3. How to use OKEDI
4. Possible side effects
5. How to store OKEDI
6. Contents of the pack and other information

1. What OKEDI is and what it is used for

OKEDI contains the active substance risperidone, which belongs to a group of medicines called
"antipsychotics".
OKEDI is used in adult patients for the treatment of schizophrenia, a condition in which patients
may see, hear, or feel things that do not exist, believe things that are not true, and feel unusually
suspicious or confused.
OKEDI is indicated for use in patients in whom tolerability and efficacy of treatment with oral
risperidone (e.g. tablets) have been established.
OKEDI can help relieve the symptoms of the illness and prevent their recurrence.

2. What you should know before using OKEDI

Do not use OKEDI

• if you are allergic (hypersensitive) to risperidone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking OKEDI if:

• you have a heart condition. For example, if you have an irregular heartbeat, are prone to low blood pressure, or are taking medicines for blood pressure. OKEDI can cause low blood pressure. Your dose may need to be adjusted;
• you are aware of risk factors that may predispose you to stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain;
• you have experienced involuntary movements of the tongue, mouth, or face;
• you have had an illness with symptoms including high temperature, muscle stiffness, sweating, or reduced level of consciousness (also known as neuroleptic malignant syndrome);
• you suffer from Parkinson's disease;
• you have dementia;
• you know you have previously had low levels of white blood cells (with or without being caused by other medicines);
• you are diabetic;
• you suffer from epilepsy;
• you are a man who has experienced prolonged or painful erection;
• you have problems controlling your body temperature or feel excessive heat;
• you have kidney problems;
• you have liver problems;
• you have unusually high levels of the hormone prolactin in your blood or have a tumour potentially dependent on prolactin;
• you or someone in your family has a history of blood clots, as antipsychotics have been associated with such events.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before using oral risperidone or OKEDI.
During treatment
Very rarely, patients taking risperidone have developed a dangerously low count of a certain type of white blood cells needed to fight infections in the blood. Therefore, your doctor may monitor your white blood cell count before and during treatment.
Even if you have previously tolerated oral risperidone, rare allergic reactions may occur after administration of OKEDI injections. Contact your doctor immediately if you develop a skin rash, throat swelling, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.
OKEDI may cause weight gain. Significant weight gain may have negative effects on your health. Your doctor should regularly monitor your body weight.
Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking OKEDI. Therefore, your doctor should check for signs of high blood sugar levels. Blood glucose should be regularly monitored in patients with pre-existing diabetes mellitus.
OKEDI generally increases levels of a hormone called "prolactin", which may cause unwanted effects such as menstrual disorders, fertility problems in women, or breast enlargement in men (see section 4, Possible side effects). If any of these side effects occur, assessment of prolactin levels in the blood is recommended.
During cataract surgery, for clouding of the lens, complications may arise that could potentially damage the eye. If you are planning such a procedure, make sure to inform your ophthalmologist that you are taking this medicine.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and OKEDI
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that you inform your doctor or pharmacist if you are taking any of the following medicines

• Medicines acting on the brain, such as sedatives (benzodiazepines), painkillers (opioids), or allergy medicines (some antihistamines), as OKEDI may enhance their sedative effect.
• Medicines that can alter the electrical activity of the heart, such as medicines for malaria, heart rhythm disorders, allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that slow down the heartbeat.
• Medicines that lower potassium levels in the blood (such as certain diuretics).
• Medicines for high blood pressure. OKEDI may lower blood pressure.
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate).
• Medicines that promote fluid secretion (diuretics) used for heart problems or swelling in certain body parts due to excessive fluid accumulation (such as furosemide or chlorothiazide). OKEDI alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine used to treat certain infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

If you start or stop taking these medicines, your risperidone dose may need to be changed.
The following medicines may increase the effect of risperidone

• Quinidine (used in certain types of heart disease)
• Antidepressants (such as paroxetine, fluoxetine, tricyclic antidepressants)
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for fungal infections)
• Some medicines used in the treatment of HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking these medicines, your risperidone dose may need to be changed.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before using OKEDI.
OKEDI with food, drinks and alcohol
You should avoid alcoholic beverages while using OKEDI.
Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborns whose mothers used risperidone during the last three months of pregnancy: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
• OKEDI may increase levels of a hormone called "prolactin", which may affect fertility (see section 4, Possible side effects).

Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with OKEDI. Do not drive or operate tools or machinery without first discussing it with your doctor.

3. How to use OKEDI

OKEDI will be administered as an intramuscular injection in the upper arm or buttock every 28 days by a healthcare professional. Injections must be alternated between the right and left side.
The recommended dose is 75 mg every 28 days, but a higher dose of 100 mg every 28 days may be required. Your doctor will decide the appropriate dose of OKEDI for you.
If you are currently being treated with antipsychotics other than risperidone, but have previously taken risperidone, you must start taking oral risperidone at least 6 days before starting treatment with OKEDI.
If you have never taken any form of risperidone before, you must start taking oral risperidone at least 14 days before starting treatment with OKEDI. The duration of the oral risperidone treatment period will be determined by your doctor.

If you have kidney problems
Treatment with OKEDI is not recommended in patients with moderate to severe renal impairment.

If you are given more OKEDI than you should

• Seek immediate medical advice.
• In case of overdose, you may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, or abnormal heartbeats or seizures.

If you stop treatment with OKEDI
You will lose the medicine’s effects. Do not stop using this medicine unless your doctor has instructed you to do so, as symptoms may return.
It is important that you attend all scheduled appointments for administration of this medicine every 28 days. If you are unable to attend an appointment, inform your doctor immediately to arrange another date.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact a doctor or go to the nearest emergency room immediately if you experience the following uncommon side effect (may affect up to 1 in 100 people):

• tardive dyskinesia (involuntary, jerky movements that you cannot control in the face, tongue or other parts of the body);

Contact a doctor or go to the nearest emergency room immediately if you experience any of the following rare side effects (may affect up to 1 in 1,000 people):

• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing;
• fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "neuroleptic malignant syndrome");
• if you are a man and experience a prolonged or painful erection, known as priapism;
• a severe allergic reaction, characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or low blood pressure (anaphylactic reaction or angioedema). Even if you have previously tolerated oral risperidone, in rare cases allergic reactions may occur after administration of OKEDI injections;
• dark red or brown urine or a significant reduction in urine output together with muscle weakness or difficulty moving arms and legs. These could be signs of rhabdomyolysis (rapid muscle breakdown);
• weakness or mental dullness, fever, chills or mouth ulcers. These could be signs of a very low granulocyte count (a type of white blood cell that helps fight infections).

Other side effects may also occur:

Very common side effects (may affect more than 1 in 10 people):

• Difficulty falling asleep or staying asleep
• Parkinsonism: movement disorders that may include slow or impaired movements, feeling of stiffness or muscle tension, and sometimes even a sensation that movement "freezes" and then resumes. Other signs include slow, shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression
• Headache

Common side effects (may affect up to 1 in 10 people):

• Pneumonia (lung infection), bronchitis (infection of the main airways of the lungs), sinus infection, urinary tract infection, ear infection, influenza, flu-like symptoms, sore throat, cough, nasal congestion, fever, eye infection or eye redness
• Increased levels of a hormone called "prolactin", detected in a blood test. Symptoms of elevated prolactin occur rarely and may include, in men, breast enlargement, difficulty achieving or maintaining erection, decreased sexual desire. In women, they may include milk production from the breasts, sexual dysfunction, missed menstrual periods, lack of ovulation, fertility problems
• Weight gain, increased or decreased appetite
• Sleep disturbance, irritability, depression, anxiety, feeling drowsy or less alert
• Dystonia (involuntary muscle contractions causing slow, repetitive movements or abnormal postures), dyskinesia (another medical condition affecting muscle movements, including repetitive, spasmodic or twisting movements or muscle contractions)
• Tremor, muscle spasms, bone or muscle pain, back pain, joint pain, fall
• Blurred vision
• Urinary incontinence (involuntary loss of urine)
• Rapid heart rate, high blood pressure, shortness of breath
• Abdominal pain, abdominal discomfort, vomiting, nausea, dizziness, constipation, diarrhea, indigestion, dry mouth, toothache

Uncommon side effects (may affect up to 1 in 100 people):

• Bladder infection, tonsillitis, fungal nail infection, deep skin infection, viral infection, skin inflammation caused by mites
• Decreased or increased white blood cell count in blood, decreased platelets (blood cells that help stop bleeding), anemia or decreased hematocrit (reduction in red blood cells), increased creatine phosphokinase enzyme in blood, increased liver enzymes in blood
• Low blood pressure, drop in blood pressure upon standing, flushing, cerebral ischemia (inadequate blood flow to the brain)
• Diabetes, high blood sugar levels, excessive need to drink water, increased cholesterol in blood, weight loss, anorexia, high triglyceride levels (a type of fat) in blood
• Mania (euphoric mood), confusion, decreased sexual desire, nervousness, nightmares
• Fainting, seizures (convulsive fits), sensation of spinning (vertigo), tinnitus, ear pain
• Irresistible urge to move parts of the body, balance disorder, abnormal coordination, poor attention, language problems, loss or change in sense of taste, reduced skin sensation to pain and touch, tingling, prickling or numbness of the skin
• Irregular and often rapid heart rate, slow heart rate, abnormal electrocardiogram (test measuring electrical activity of the heartbeat), palpitations (sensation of pounding or fluttering in the chest), interruption of conduction between upper and lower parts of the heart
• Respiratory congestion, wheezing (harsh, whistling sound during breathing), nosebleed
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain, gait abnormalities, thirst, feeling unwell, chest discomfort or general discomfort, feeling "low"
• Stomach or intestinal infection or irritation, fecal incontinence, difficulty swallowing, excessive passing of gas, frequent need to urinate, inability to urinate, pain when urinating
• Absence of menstruation or other menstrual cycle problems, milk production from the breasts, sexual dysfunction, breast pain or discomfort, vaginal discharge, erectile dysfunction, ejaculation disorder, breast enlargement in men
• Hives, skin thickening, skin disease, intense skin itching, hair loss, eczema, dry skin, skin color changes, acne, seborrheic dermatitis (red, scaly, greasy, itchy and inflamed skin), skin lesion
• Excessive sensitivity of eyes to light, dry eyes, increased tearing
• Allergic reaction, chills

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Unusual secretion of a hormone controlling urine volume, dangerously high water intake, excess sugar in urine, low blood sugar levels, increased insulin in blood (a hormone that controls blood sugar levels)
• Lack of responsiveness to stimuli, catatonia (immobility and lack of reactions while awake), low level of consciousness, sleepwalking, sleep-related eating disorder, breathing difficulties during sleep (sleep apnea), rapid and shallow breathing, lung infection caused by inhaling food into the airways, lung congestion, respiratory tract disorder, voice disorder, lung crackles, lack of emotion, inability to reach orgasm
• Problems with blood vessels in the brain, coma caused by uncontrolled diabetes, involuntary head tremor
• Glaucoma (increased pressure inside the eye), eye movement problems, rolling eye, eyelid margin crusting/inflammation, eye problems during cataract surgery
• Pancreatitis (inflammation of the pancreas), intestinal obstruction
• Swollen tongue, chapped lips, dandruff, jaundice (yellowing of the skin and eyes), skin hardening
• Breast enlargement, breast engorgement (hard, swollen, painful breasts due to excessive milk production)
• Decreased body temperature, feeling cold in arms and legs
• Substance abuse withdrawal symptoms (also in newborns)

Very rare side effects (may affect up to 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes
• Absence of intestinal muscle movement causing obstruction

Side effects with unknown frequency: cannot be estimated from available data:

• Severe or life-threatening skin rash with blisters and peeling of the skin, which may start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OKEDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium sachets, and syringe labels after "Exp" or "EXP". The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the original packaging to protect the medicine from moisture.
Use OKEDI immediately after reconstitution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OKEDI contains
The active substance is risperidone.
Only the powder syringe contains the active substance. After reconstitution, the amount of risperidone administered is 75 mg.
The other components are:
Powder pre-filled syringe: copolymer (D,L-lactic acid and glycolic acid).
Solvent pre-filled syringe: dimethyl sulfoxide.

Description of the appearance of OKEDI and contents of the pack
Each pack of the OKEDI powder and solvent for prolonged-release injectable suspension kit contains:

• an aluminium pouch containing a pre-filled syringe with powder (this powder contains the active substance risperidone) and a silica gel desiccant sachet. The powder is white to off-white, non-aggregated;
• an aluminium pouch containing a pre-filled syringe with solvent and a silica gel desiccant sachet. The solvent pre-filled syringe contains a clear solution and has a RED finger-flange;
• a sterile 2-inch (0.90 x 51 mm [20G]) intramuscular injection needle with safety shield, for administration into the gluteal muscle;
• a sterile 1-inch (0.80 x 25 mm [21G]) intramuscular injection needle with safety shield, for administration into the deltoid muscle.

Marketing Authorisation Holder and Manufacturer
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Espagne/Spanje Ispanija
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

България Luxembourg/Luxemburg
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Испания Espagne/Spanien
Teл.: +34 91 375 62 30 Tel: +34 91 375 62 30

Česká republika Magyarország
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Španělsko Spanyolország
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Danmark Malta
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spanien Spanja
Tlf: +34 91 375 62 30 Tel: +34 91 375 62 30

Deutschland Nederland
Rovi GmbH Laboratorios Farmacéuticos Rovi, S.A.
Rudolf-Diesel-Ring 6 Julián Camarillo, 35
83607 Holzkirchen 28037 Madrid
Tel: +49 8024 4782955 Spanje
Tel: +34 91 375 62 30

Eesti Norge
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Hispaania Spania
Tel: +34 91 375 62 30 Tlf: +34 91 375 62 30

Ελλάδα Österreich
BIANEΞ Α.Ε. Rovi GmbH
Οδός Βαρυμπόμπης 8, Rudolf-Diesel-Ring 6
14671 Ν. Ερυθραία, Κηφισιά 83607 Holzkirchen
Tηλ. 210 8009111 Deutschland
Tel: +43 664 1340471

España Polska
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Tel: +34 91 375 62 30 Hiszpania
Tel: +34 91 375 62 30

France Portugal
ROVI Laboratorios Farmacéuticos Rovi, S.A.
24, Rue Du Drac Julián Camarillo, 35
38180 Seyssins 28037 Madrid
Tél: +33 (0)4 76 968 969 Espanha
Tel: +34 91 375 62 30

Hrvatska România
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Španija Spania
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Ireland Slovenija
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spain Španija
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Ísland Slovenská republika
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spánn Španielsko
Sími: +34 91 375 62 30 Tel: +34 91 375 62 30

Italia Suomi/Finland
Rovi Biotech, S.R.L. Laboratorios Farmacéuticos Rovi, S.A.
Viale Achille Papa, 30 Julián Camarillo, 35
20149 Milano 28037 Madrid
Tel: +39 02 366 877 10 Espanja/Spanien
Puh/Tel: +34 91 375 62 30

Κύπρος Sverige
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Ισπανία Spanien
Τηλ: +34 91 375 62 30 Tel: +34 91 375 62 30

Latvija United Kingdom (Northern Ireland)
Laboratorios Farmacéuticos Rovi, S.A. Rovi Biotech Limited
Julián Camarillo, 35 Davis House 4th Floor Suite 425
28037 Madrid Robert Street Croydon CR0 1QQ - UK
Spānija Tel: +44 (0) 203 642 06 77
Tel: +34 91 375 62 30

The following information is intended exclusively for healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
OKEDI 75 mg powder and solvent for prolonged-release injectable suspension

Important information
OKEDI requires careful attention to each step of these Instructions for Use to ensure correct administration.

Use the supplied components
The components provided with the kit pack are specifically designed for use with OKEDI.
OKEDI must be reconstituted exclusively with the solvent supplied in the kit pack.
Do not substitute ANY component of the kit pack.
Administer the dose immediately after reconstitution. For intramuscular use only after reconstitution.

Administer the correct dose
To ensure delivery of the intended dose of OKEDI, the entire content of the reconstituted syringe must be administered.

Single-use device

1. CHECK THE CONTENTS

On a clean surface, open the pouches and discard the desiccant packets.
Each OKEDI kit package contains:

• one aluminum foil pouch with a pre-filled syringe of OKEDI with a plunger rod

WHITE and a WHITE finger flange. The syringe is labeled with ;

• one aluminum foil pouch with a pre-filled syringe of SOLVENT for OKEDI with a plunger rod

TRANSPARENT and a RED finger flange. The syringe is labeled with ;

• two administration needles (21G, 1 inch for deltoid [green cap] and 20G, 2 inches for gluteal [yellow cap]).

Discard the kit if any component is damaged.
If foreign particles are observed and/or changes in physical appearance are noticed, do not
administer OKEDI.
1.1 Inspect the solvent syringe
ENSURE that the content of the SOLVENT syringe flows normally as a liquid.
The solvent freezes below 19°C.
If frozen or partially frozen, thaw it by warming with hands or leave at room temperature until completely liquid before proceeding.

1.2 Loosen the powder in the syringe
TAP the OKEDI syringe gently to loosen any powder that may have become compacted near the cap.

2. CONNECT THE SYRINGES

2.1 Remove the caps from the syringes while holding them vertically
Hold both syringes in an upright position to avoid loss of the product.

PULL the cap off the Solvent syringe.

TWIST and PULL the cap off the Powder syringe.

2.2 Connect the syringes
Grasp the Solvent syringe S by its colored finger flange and position it ABOVE the
Powder syringe R, or tilt it slightly during connection.
ROTATE the syringes together until slight resistance is felt.
Make sure the Powder syringe R remains in an upright position to avoid loss of the
product.

3. MIXING THE CONTENTS

STOP AND READ THIS PARAGRAPH BEFORE STARTING, OTHERWISE THE
RECONSTITUTION OF THE MEDICINAL PRODUCT MAY NOT BE PERFORMED
CORRECTLY.

• FIRMLY PUSH the Solvent content into the Powder syringe.
• DO NOT WAIT for the powder to become wet; instead, begin IMMEDIATELY mixing the contents by pushing the plungers RAPIDLY in an alternating rhythm for 100 pushes (2 pushes per second, approximately 1 minute).
• For proper mixing, ENSURE that the medicinal product passes from one syringe to the other: the medicinal product is viscous, therefore considerable pressure must be applied to the plungers.

Mix by performing at least 100 pushes, alternating

Ensure that the medicinal product passes from one syringe to the other.
When the medicinal product is properly mixed, it will appear as a uniform suspension of whitish to yellowish color and have a thick consistency.

Once reconstitution is complete, proceed immediately to prepare the syringe for administration to avoid loss of homogeneity.

4. PREPARING THE SYRINGE FOR INJECTION

4.1 Transfer the medicinal product
Press down on the plunger R and transfer the entire contents into the syringe S equipped with the coloured finger flange.
Make sure all the contents have been transferred.

4.2 Disconnect the syringes
After completely transferring the medicinal product, separate the two syringes by rotating them in opposite directions.
OKEDI must be administered immediately to avoid loss of homogeneity.

4.3 Attach the sterile needle with safety shield
Select the correct needle:

• Deltoid: 21G, 1 inch for deltoid (green cap).
• Gluteal: 20G, 2 inches for gluteal (yellow cap).

Attach the needle with a clockwise rotating motion. Do not overtighten.

4.4 Remove excess air
Remove the needle cap and gently push the plunger to expel excess air (only large bubbles) from the syringe barrel.
DO NOT expel any drops of the medicinal product.
If medicinal product is visible at the needle tip, slightly pull back the plunger to prevent leakage.

5. ADMINISTERING AND DISPOSAL

5.1 Injecting the medicine
Insert the needle fully into the muscle. DO NOT ADMINISTER BY OTHER ROUTES.

THICK MEDICINE – INJECT SLOWLY AND STEADILY. ENSURE COMPLETE INJECTION.
Due to the viscosity of the medicine, the injection will take longer than usual.
Wait a few seconds before removing the needle.
Avoid accidental injection into a blood vessel.

5.2 Disposal of the medicine
Cover the needle by pressing the dedicated safety cap with a finger or against a flat surface, then
dispose of it immediately in a secure sharps and puncture-resistant waste container.

Package leaflet: Information for the user

OKEDI 100 mg powder and solvent for prolonged-release injectable suspension

risperidone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor. See section 4.

Contents of this leaflet

1. What OKEDI is and what it is used for
2. What you need to know before using OKEDI
3. How to use OKEDI
4. Possible side effects
5. How to store OKEDI
6. Contents of the pack and other information

1. What OKEDI is and what it is used for

OKEDI contains the active substance risperidone, which belongs to a group of medicines called "antipsychotics".
OKEDI is used in adult patients for the treatment of schizophrenia, a disorder in which patients may see, hear, or feel things that do not exist, believe things that are not true, and feel unusually suspicious or confused.
OKEDI is indicated for use in patients in whom the tolerability and efficacy of treatment with oral risperidone (e.g. tablets) have been established.
OKEDI can help relieve the symptoms of the illness and prevent their recurrence.

2. What you need to know before using OKEDI

Do not use OKEDI

• if you are allergic (hypersensitive) to risperidone or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking OKEDI if:

• you have a heart condition. For example, if you have an irregular heartbeat, are prone to low blood pressure, or are taking medicines for blood pressure. OKEDI may cause low blood pressure. Your dose may need to be adjusted;
• you are aware of risk factors for stroke, such as high blood pressure, cardiovascular disease, or problems with blood vessels in the brain;
• you have experienced involuntary movements of the tongue, mouth, or face;
• you have had an illness with symptoms such as high body temperature, muscle stiffness, sweating, or reduced level of consciousness (also known as neuroleptic malignant syndrome);
• you have Parkinson’s disease;
• you have dementia;
• you know you have previously had low levels of white blood cells (with or without being caused by other medicines);
• you have diabetes;
• you have epilepsy;
• you are a man who has experienced prolonged or painful erection;
• you have problems regulating your body temperature or feel excessive heat;
• you have kidney problems;
• you have liver problems;
• you have unusually high levels of the hormone prolactin in your blood or have a tumour that may be prolactin-dependent;
• you or someone in your family has a history of blood clots, as antipsychotics have been associated with such events.

If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using oral risperidone or OKEDI.
During treatment
Very rarely, patients taking risperidone have developed a dangerously low number of a specific type of white blood cells needed to fight infections in the blood. Therefore, your doctor may monitor your white blood cell count before and during treatment.
Even if you have previously tolerated oral risperidone, rare allergic reactions may occur after OKEDI injections. Contact your doctor immediately if you develop a skin rash, throat swelling, itching, or breathing difficulties, as these could be signs of a serious allergic reaction.
OKEDI may cause weight gain. Significant weight gain may have negative effects on your health. Your doctor should regularly monitor your body weight.
Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients taking OKEDI. Therefore, your doctor should check for signs of high blood sugar levels. Blood glucose should be monitored regularly in patients with pre-existing diabetes.
OKEDI generally increases levels of a hormone called "prolactin", which may cause unwanted effects such as menstrual disorders, fertility problems in women, or breast enlargement in men (see section 4, Possible side effects). If these side effects occur, assessment of prolactin levels in the blood is recommended.
During cataract surgery, for clouding of the lens, complications may arise that could lead to eye damage. If you are planning such a procedure, make sure to inform your ophthalmologist that you are taking this medicine.
Children and adolescents
This medicine must not be given to children and adolescents under 18 years of age.
Other medicines and OKEDI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that you inform your doctor or pharmacist if you are taking any of the following medicines

• Medicines acting on the brain, such as sedatives (benzodiazepines), painkillers (opioids), or antihistamines for allergies, as OKEDI may enhance their sedative effect.
• Medicines that alter the heart's electrical activity, such as antimalarials, medicines for heart rhythm disorders, antihistamines, certain antidepressants, or other medicines for mental disorders.
• Medicines that slow down the heartbeat.
• Medicines that lower potassium levels in the blood (such as certain diuretics).
• Medicines for high blood pressure. OKEDI may lower blood pressure.
• Medicines for Parkinson’s disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Diuretics (medicines that increase water secretion) used for heart problems or swelling in parts of the body due to excessive fluid accumulation (such as furosemide or chlorothiazide). OKEDI, alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone

• Rifampicin (a medicine used to treat certain infections)
• Carbamazepine, phenytoin (medicines for epilepsy)
• Phenobarbital

If you start or stop taking these medicines, your risperidone dose may need to be changed.
The following medicines may increase the effect of risperidone

• Quinidine (used in certain types of heart disease)
• Antidepressants (such as paroxetine, fluoxetine, tricyclic antidepressants)
• Medicines known as beta-blockers (used to treat high blood pressure)
• Phenothiazines (such as medicines used to treat psychosis or as sedatives)
• Cimetidine, ranitidine (stomach acid blockers)
• Itraconazole and ketoconazole (medicines for fungal infections)
• Certain medicines used in the treatment of HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders

If you start or stop taking these medicines, your risperidone dose may need to be changed.
If you are unsure whether any of the conditions listed above apply to you, talk to your doctor or pharmacist before using OKEDI.
OKEDI with food, drinks and alcohol
You should avoid alcoholic beverages while using OKEDI.
Pregnancy, breastfeeding and fertility

• If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborns of mothers who have used risperidone during the last three months of pregnancy: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
• OKEDI may increase levels of a hormone called "prolactin", which may affect fertility (see section 4, Possible side effects).

Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment with OKEDI. Do not drive or operate tools or machinery without first discussing it with your doctor.

3. How to use OKEDI

OKEDI will be administered as an intramuscular injection in the upper arm or buttock every 28 days by a healthcare professional. Injections must be alternated between the right and left side.
The recommended dose is 75 mg every 28 days, but a higher dose of 100 mg every 28 days may be required. Your doctor will decide the appropriate dose of OKEDI for you.
If you are currently being treated with antipsychotics other than risperidone, but have previously taken risperidone, you must start taking risperidone at least 6 days before beginning treatment with OKEDI.
If you have never taken any form of risperidone, you must start taking oral risperidone at least 14 days before starting treatment with OKEDI. The duration of the oral risperidone treatment period will be determined by your doctor.

If you have kidney problems
Treatment with OKEDI is not recommended in patients with moderate to severe renal impairment.

If you are given more OKEDI than you should

• Contact your doctor immediately.
• In case of overdose, you may experience drowsiness or fatigue, abnormal body movements, difficulty standing or walking, dizziness due to low blood pressure, or abnormal heartbeats or seizures.

If you stop using OKEDI
You will lose the beneficial effects of the medicine. Do not stop using this medicine unless your doctor has instructed you to do so, as your symptoms may return.
It is important that you attend all scheduled appointments for administration of this medicine every 28 days. If you are unable to attend an appointment, inform your doctor immediately to arrange another date.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor or go to the nearest emergency room immediately if you experience the
following uncommon side effect (may affect up to 1 in 100 people):

• tardive dyskinesia (involuntary, jerky movements that you cannot control in the face, tongue or other parts of the body);

Contact a doctor or go to the nearest emergency room immediately if you experience
any of the following rare side effects (may affect up to 1 in 1,000 people):

• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing;
• fever, muscle stiffness, sweating or reduced level of consciousness (a condition called "neuroleptic malignant syndrome");
• if you are a man and experience a prolonged or painful erection, known as priapism;
• a severe allergic reaction, characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, rash or low blood pressure (anaphylactic reaction or angioedema). Even if you have previously tolerated oral risperidone, in rare cases allergic reactions may occur after OKEDI injections;
• dark red or brown urine or a significant decrease in urine output together with muscle weakness or difficulty moving arms and legs. These could be signs of rhabdomyolysis (rapid muscle breakdown);
• weakness or mental dullness, fever, chills or mouth ulcers. These could be signs of a very low granulocyte count (a type of white blood cell that helps fight infections).

Other side effects may also occur:
Very common side effects (may affect more than 1 in 10 people):

• Difficulty falling or staying asleep
• Parkinsonism: movement disorders which may include slow or impaired movements, feeling of stiffness or muscle tension, and sometimes even a sensation that movement "freezes" and then resumes. Other signs include slow, shuffling gait, resting tremor, increased salivation and/or drooling, and loss of facial expression
• Headache

Common side effects (may affect up to 1 in 10 people):

• Pneumonia (lung infection), bronchitis (infection of the main airways of the lungs), sinus infection, urinary tract infection, ear infection, influenza, flu-like symptoms, sore throat, cough, nasal congestion, fever, eye infection or eye redness
• Increased levels of a hormone called "prolactin", detected in a blood test. Symptoms of elevated prolactin occur rarely and may include, in men, breast enlargement, difficulty achieving or maintaining erection, decreased sexual desire. In women, they may include milk discharge from the breasts, sexual disturbances, missed menstrual cycles, lack of ovulation, fertility problems
• Weight gain, increased or decreased appetite
• Sleep disturbance, irritability, depression, anxiety, feeling drowsy or less alert
• Dystonia (involuntary muscle contractions causing slow, repetitive movements or abnormal postures), dyskinesia (another medical condition affecting muscle movements, including repetitive, spasmodic or writhing movements or muscle contractions)
• Tremor, muscle spasms, bone or muscle pain, back pain, joint pain, fall
• Blurred vision
• Urinary incontinence (involuntary loss of urine)
• Rapid heart rate, high blood pressure, shortness of breath
• Abdominal pain, abdominal discomfort, vomiting, nausea, dizziness, constipation, diarrhea, indigestion, dry mouth, toothache
• Rash, skin redness, injection site reaction (including discomfort, pain, redness or swelling), swelling of the body, arms or legs, chest pain, lack of energy and strength, fatigue, pain

Uncommon side effects (may affect up to 1 in 100 people):

• Bladder infection, tonsillitis, fungal nail infection, deep skin infection, viral infection, skin inflammation caused by mites
• Decreased or increased white blood cells in the blood, decreased platelets (blood cells that help stop bleeding), anemia or decreased hematocrit (reduction in red blood cells), increased blood creatine phosphokinase enzyme, increased liver enzymes in the blood
• Low blood pressure, drop in blood pressure upon standing, flushing, cerebral ischemia (inadequate blood flow to the brain)
• Diabetes, high blood sugar level, excessive need to drink water, increased blood cholesterol, weight loss, anorexia, high levels of triglycerides (a type of fat) in the blood
• Mania (euphoric mood), confusion, decreased sexual desire, nervousness, nightmares
• Fainting, seizures (convulsive fits), dizziness (spinning sensation), tinnitus, ear pain
• Irresistible urge to move parts of the body, balance disorder, abnormal coordination, poor attention, language problems, loss or change in taste sensation, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin
• Irregular and often rapid heart rate, slow heart rate, abnormal electrocardiogram (test measuring the electrical activity of the heartbeat), palpitations (sensation of pounding or fluttering in the chest), interruption in conduction between upper and lower parts of the heart
• Respiratory congestion, wheezing (harsh, whistling sound during breathing), nosebleeds
• Abnormal posture, joint stiffness, joint swelling, muscle weakness, neck pain, abnormal gait, thirst, feeling unwell, chest discomfort or general discomfort, feeling "low"
• Stomach or intestinal infection or irritation, fecal incontinence, difficulty swallowing, excessive gas release from the body, frequent need to urinate, inability to urinate, pain when urinating
• Absence of menstruation or other menstrual cycle problems, milk discharge from the breasts, sexual dysfunction, breast pain or discomfort, vaginal discharge, erectile dysfunction, ejaculation disorder, breast enlargement in men
• Hives, skin thickening, skin disease, intense skin itching, hair loss, eczema, dry skin, change in skin color, acne, seborrheic dermatitis (red, scaly, oily, itchy and inflamed skin), skin lesion
• Excessive sensitivity of the eyes to light, dry eyes, increased tearing
• Allergic reaction, chills

Rare side effects (may affect up to 1 in 1,000 people):

• Infection
• Unusual secretion of a hormone controlling urine volume, dangerously high water intake, excess sugar in urine, low blood sugar, increased insulin in blood (a hormone that controls blood sugar levels)
• Lack of responsiveness to stimuli, catatonia (immobility and lack of reaction while awake), low levels of consciousness, sleepwalking, sleep-related eating disorder, breathing difficulties during sleep (sleep apnea), rapid and shallow breathing, lung infection caused by inhalation of food into the airways, pulmonary congestion, respiratory tract disorder, voice disorder, lung crackles, lack of emotion, inability to reach orgasm
• Problems with blood vessels in the brain, coma caused by uncontrolled diabetes, involuntary head tremor
• Glaucoma (increased pressure inside the eye), problems with eye movement, eye rolling, crusts/inflammation of the eyelid margin, eye problems during cataract surgery
• Pancreatitis (inflammation of the pancreas), intestinal obstruction
• Swollen tongue, chapped lips, dandruff, jaundice (yellowing of the skin and eyes), skin hardening
• Breast enlargement, breast engorgement (hard, swollen, painful breasts due to excessive milk production)
• Decreased body temperature, feeling cold in arms and legs
• Withdrawal symptoms from substance abuse (also in newborns)

Very rare side effects (may affect up to 1 in 10,000 people):

• Life-threatening complications of uncontrolled diabetes
• Absence of intestinal muscle movement causing obstruction

Side effects with unknown frequency: cannot be estimated from available data:

• Severe or life-threatening skin rash with blisters and peeling of the skin, which may start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You may also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OKEDI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, aluminium sachets, and syringe labels after "Exp" or "EXP". The expiry date refers to the last day of that month.
Store below 30 °C. Keep in the original packaging to protect the medicine from moisture.
Use OKEDI immediately after reconstitution.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OKEDI contains
The active substance is risperidone.
Only the powder syringe contains the active substance. After reconstitution, the amount of risperidone administered is 100 mg.
The other components are:
Pre-filled syringe of powder: copolymer (D,L-lactic acid and glycolic acid).
Pre-filled syringe of solvent: dimethyl sulfoxide.

Description of the appearance of OKEDI and contents of the pack
Each pack of the OKEDI powder and solvent kit for prolonged-release injectable suspension contains:

• an aluminium pouch containing a pre-filled syringe with powder (this powder contains the active substance risperidone) and a silica gel desiccant packet. The powder is white to off-white, non-aggregated;
• an aluminium pouch containing a pre-filled syringe with solvent and a silica gel desiccant packet. The pre-filled solvent syringe contains a clear solution and has a BLUE finger flange;
• one sterile 2-inch (0.90 x 51 mm [20G]) intramuscular injection needle with safety protection, for administration into the gluteal muscle;
• one sterile 1-inch (0.80 x 25 mm [21G]) intramuscular injection needle with safety protection, for administration into the deltoid muscle.

Marketing Authorisation Holder and Manufacturer
Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35
28037 Madrid
Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Espagne/Spanje Ispanija
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

България Luxembourg/Luxemburg
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Испания Espagne/Spanien
Teл.: +34 91 375 62 30 Tel: +34 91 375 62 30

Česká republika Magyarország
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Španělsko Spanyolország
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Danmark Malta
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spanien Spanja
Tlf: +34 91 375 62 30 Tel: +34 91 375 62 30

Deutschland Nederland
Rovi GmbH Laboratorios Farmacéuticos Rovi, S.A.
Rudolf-Diesel-Ring 6 Julián Camarillo, 35
83607 Holzkirchen 28037 Madrid
Tel: +49 8024 4782955 Spanje
Tel: +34 91 375 62 30

Eesti Norge
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Hispaania Spania
Tel: +34 91 375 62 30 Tlf: +34 91 375 62 30

Ελλάδα Österreich
BIANEΞ Α.Ε. Rovi GmbH
Οδός Βαρυμπόμπης 8, Rudolf-Diesel-Ring 6
14671 Ν. Ερυθραία, Κηφισιά 83607 Holzkirchen
Tηλ. 210 8009111 Deutschland
Tel: +43 664 1340471

España Polska
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Tel: +34 91 375 62 30 Hiszpania
Tel: +34 91 375 62 30

France Portugal
ROVI Laboratorios Farmacéuticos Rovi, S.A.
24, Rue Du Drac Julián Camarillo, 35
38180 Seyssins 28037 Madrid
Tél: +33 (0)4 76 968 969 Espanha
Tel: +34 91 375 62 30

Hrvatska România
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Španija Spania
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Ireland Slovenija
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spain Španija
Tel: +34 91 375 62 30 Tel: +34 91 375 62 30

Ísland Slovenská republika
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Spánn Španielsko
Sími: +34 91 375 62 30 Tel: +34 91 375 62 30

Italia Suomi/Finland
Rovi Biotech, S.R.L. Laboratorios Farmacéuticos Rovi, S.A.
Viale Achille Papa, 30 Julián Camarillo, 35
20149 Milano 28037 Madrid
Tel: +39 02 366 877 10 Espanja/Spanien
Puh/Tel: +34 91 375 62 30

Κύπρος Sverige
Laboratorios Farmacéuticos Rovi, S.A. Laboratorios Farmacéuticos Rovi, S.A.
Julián Camarillo, 35 Julián Camarillo, 35
28037 Madrid 28037 Madrid
Ισπανία Spanien
Τηλ: +34 91 375 62 30 Tel: +34 91 375 62 30

Latvija United Kingdom (Northern Ireland)
Laboratorios Farmacéuticos Rovi, S.A. Rovi Biotech Limited
Julián Camarillo, 35 Davis House 4th Floor Suite 425
28037 Madrid Robert Street Croydon CR0 1QQ - UK
Spānija Tel: + 44 (0) 203 642 06 77
Tel: +34 91 375 62 30

The following information is intended exclusively for healthcare professionals:
INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
OKEDI 100 mg powder and solvent for prolonged-release injectable suspension
Important information
OKEDI requires careful attention at every step of these Instructions for Use to ensure correct administration.
Use only the supplied components
The components provided with the kit are specifically designed for use with OKEDI.
OKEDI must be reconstituted exclusively with the solvent supplied in the kit.
Do not substitute ANY component of the kit.
Administer the dose immediately after reconstitution. For intramuscular use only after reconstitution.
Administer the correct dose
To ensure delivery of the intended dose of OKEDI, the entire contents of the reconstituted syringe must be administered.
Single-use device

1. CHECK CONTENTS

On a clean surface, open the pouches and discard the desiccant packets.
Each OKEDI kit package contains:

• one aluminum foil pouch containing a pre-filled syringe of OKEDI with a WHITE plunger rod

and a WHITE finger flange. The syringe is marked with ;

• one aluminum foil pouch containing a pre-filled syringe of SOLVENT for OKEDI with a TRANSPARENT

plunger rod and a BLUE finger flange. The syringe is marked with ;

• two administration needles (21G, 1 inch for deltoid [green cap] and 20G, 2 inches for gluteal [yellow cap]).

Discard the kit if any component is damaged.
If particulate matter or any change in physical appearance is observed, do not
administer OKEDI.
1.1 Inspect the solvent syringe
ENSURE that the content of the SOLVENT syringe flows freely as a liquid.
The solvent freezes below 19°C.
If it is frozen or partially frozen, thaw it by warming with hands or leave it at room temperature until completely liquid before continuing.

1.2 Dislodge powder from the syringe
TAP the OKEDI syringe gently to dislodge any powder that may be compacted near the cap.

2. CONNECT THE SYRINGES

2.1 Remove the caps from the syringes while holding them upright
Hold both syringes upright to prevent loss of the product.

PULL the cap off the solvent syringe to remove it.

TWIST and PULL the cap off the powder syringe to remove it.

2.2 Connect the syringes
Grasp the solvent syringe S by the colored finger flange and place it on top of the powder syringe R, or slightly tilt it during connection.
ROTATE the syringes together until slight resistance is felt.
Ensure that the powder syringe R remains in an upright position to prevent loss of the product.

3. MIXING THE CONTENTS

STOP AND READ THIS PARAGRAPH BEFORE STARTING, OTHERWISE THE
RECONSTITUTION OF THE MEDICINAL PRODUCT MAY NOT BE PERFORMED
CORRECTLY.

• FIRMLY PUSH the Solvent contents into the Powder syringe.
• DO NOT WAIT for the powder to become wetted, but begin IMMEDIATELY mixing the contents by pushing the plungers RAPIDLY in an alternating rhythm for 100 pushes (2 pushes per second, approximately 1 minute).
• For proper mixing, ENSURE THAT THE MEDICINAL PRODUCT PASSES FROM ONE SYRINGE TO THE OTHER : the medicinal product is viscous ; therefore, considerable pressure must be applied to the plungers.

Mix by performing at least 100 alternating strokes

Ensure that the medicinal product passes from one syringe to the other.
When the medicinal product is properly mixed, it will appear as a uniform suspension,
whitish to slightly yellow in color, with a thick consistency.

After reconstitution is complete, immediately proceed to prepare the syringe for administration
to avoid loss of homogeneity.

4. PREPARE THE SYRINGE FOR INJECTION

4.1 Transfer the medicinal product
Press down on the plunger rod R and transfer all the contents into the syringe S equipped with the colored finger flange.
Make sure all the contents have been transferred.

4.2 Disconnect the syringes
After completely transferring the medicinal product, separate the two syringes by rotating them in opposite directions.
OKEDI must be administered immediately to avoid loss of homogeneity.

4.3 Attach the sterile needle with safety shield
Select the correct needle:

• Deltoid: 21G, 1 inch for deltoid (green cap).
• Gluteal: 20G, 2 inches for gluteal (yellow cap).

Attach the needle with a clockwise rotating motion. Do not overtighten.
4.4 Remove excess air
Remove the needle shield and gently push the plunger to expel excess air (only large bubbles) from the syringe barrel.
DO NOT expel any drops of the medicinal product.
If medicinal product is visible at the needle tip, slightly withdraw the plunger to prevent leakage.

5. ADMINISTERING AND DISPOSAL

5.1 Injecting the medicine
Insert the needle completely into the muscle. DO NOT INJECT BY OTHER ROUTES.

THE MEDICINE IS VISCOUS; INJECT SLOWLY AND CONTINUOUSLY. ENSURE THAT THE
ENTIRE DOSE IS INJECTED.
Due to the viscosity of the medicine, the injection will take longer than usual.
Wait a few seconds before removing the needle.
Avoid accidental injection into a blood vessel.
5.2 Disposal of the medicine
Cover the needle by pressing the dedicated safety shield with one finger or against a flat surface, then
dispose of it immediately in a safe sharps and puncture-resistant waste container.