PSYLIPAX

Package leaflet: Information for the user

Psylipax, 25 mg, prolonged-release injection suspension in prefilled syringe
Psylipax, 50 mg, prolonged-release injection suspension in prefilled syringe
Psylipax, 75 mg, prolonged-release injection suspension in prefilled syringe
Psylipax, 100 mg, prolonged-release injection suspension in prefilled syringe
Psylipax, 150 mg, prolonged-release injection suspension in prefilled syringe
Psylipax, 100 mg/150 mg, prolonged-release injection suspension in prefilled syringe: initiation pack
Paliperidone
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Psylipax is and what it is used for

Psylipax contains the active substance paliperidone, which belongs to a group of medicines called antipsychotics. It is used for the maintenance treatment of symptoms of schizophrenia in stable adult patients who have been previously treated with paliperidone or risperidone.
For patients who have previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, the doctor may initiate treatment with Psylipax without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a disorder characterised by “positive” and “negative” symptoms. Positive symptoms mean the presence of symptoms that normally do not occur. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe things that are not true (delusions), or be excessively suspicious of others. Negative symptoms mean the absence of behaviours or emotions that are usually present. For example, a person with schizophrenia may appear withdrawn, emotionally flat or unresponsive, or may have difficulty speaking clearly and logically. People affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.
Psylipax helps to reduce the symptoms of the illness and helps prevent their recurrence.

2. Important information before using Psylipax

When not to use Psylipax

• if the patient is allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to another antipsychotic medicine, including the substance risperidone.

Warnings and precautions

Before starting treatment with Psylipax, discuss this with your doctor, pharmacist, or nurse.

The use of this medicine in elderly patients with dementia has not been studied. However, in such patients treated with other similar medicines, there may be an increased risk of stroke or death (see section 4, "Possible side effects").

All medicines can cause side effects. Some of the side effects of this medicine may worsen symptoms of other medical conditions. For this reason, during treatment with this medicine, discuss with your doctor if any of the following conditions apply:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterized by symptoms such as high fever and muscle stiffness (also known as neuroleptic malignant syndrome)
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia)
• if the patient has previously had a low white blood cell count (whether or not caused by other medicines)
• if the patient has diabetes or is predisposed to developing diabetes
• if the patient has breast cancer or a pituitary gland tumor
• if the patient has heart disease or is being treated for a heart condition that predisposes to low blood pressure
• if the patient has low blood pressure upon sudden change to standing or sitting position
• if the patient has epilepsy
• if the patient has impaired kidney function
• if the patient has impaired liver function
• if the patient experiences prolonged and/or painful erection
• if the patient has problems with body temperature regulation or overheating
• if the patient has abnormally high levels of prolactin hormone in the blood or suspicion of a prolactin-dependent tumor
• if the patient or a family member has a history of blood clots in blood vessels, as antipsychotic medicines may increase the risk of developing clots.

If any of the above criteria apply, the patient should consult a doctor, who may adjust the dose or monitor the patient periodically. The treating physician may order regular white blood cell counts, as very rarely, this medicine has been associated with dangerously low levels of certain white blood cells essential for fighting infections.

Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after Psylipax injections. Seek immediate medical help if the patient develops rash, throat swelling, itching, or difficulty breathing, as these may be signs of a severe allergic reaction.

This medicine may cause weight gain. Significant weight gain may adversely affect the patient's health. The treating physician will regularly monitor the patient's body weight.

The treating physician will monitor for symptoms of increased blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.

Because this medicine may suppress vomiting, it may mask the body's normal response to ingestion of toxic substances or other medical conditions.

During cataract surgery (eye lens clouding), the pupil (black circle in the center of the eye) may not dilate sufficiently. Also, the iris (colored part of the eye) may be floppy during surgery, which could lead to eye damage. If the patient is scheduled for eye surgery, inform the ophthalmologist about taking this medicine.

Children and adolescents

This medicine is not intended for use in individuals under 18 years of age.

Psylipax and other medicines

Inform the doctor about all medicines currently used, recently used, or planned for use.

Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilizing agent) may require adjustment of the dose of this medicine.

Since this medicine acts primarily in the brain, combining it with other medicines that act on the brain—such as other psychiatric medicines, opioids, antihistamines, and sedatives—may intensify side effects such as drowsiness or other central nervous system effects.

This medicine may lower blood pressure; therefore, caution is advised when using it together with other medicines that lower blood pressure.

This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g., levodopa).

This medicine may cause abnormalities in the electrocardiogram (ECG), manifesting as prolonged conduction of electrical impulses through a specific part of the heart (known as "QT interval prolongation"). Other medicines with this effect include certain antiarrhythmic drugs or antibiotics, as well as other antipsychotics.

If the patient is prone to seizures, this medicine may increase the risk of seizure occurrence. Other medicines with this effect include certain antidepressants or antibiotics, as well as other antipsychotics.

Exercise caution when using Psylipax together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Psylipax and alcohol

Alcohol consumption should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy unless discussed with a doctor.

Newborns whose mothers used paliperidone during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact a doctor immediately.

This medicine may pass from the mother's body into breast milk and may harm the infant. Therefore, breastfeeding must not be undertaken during treatment with this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness, extreme tiredness, and visual disturbances may occur (see section 4). These effects should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Psylipax contains sodium and polysorbate

This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning it is considered "sodium-free."

This medicine contains 12 mg of polysorbate 20 in each mL, equivalent to 12 mg/mL. Polysorbates may cause allergic reactions. Inform the doctor if the patient has known allergic reactions.

3. How to use Psylipax

This medicine is administered by a doctor or other medical personnel. The medicine will be injected into the muscle. Your doctor will inform you when the next injection is due. It is important not to miss a scheduled dose. If you are unable to keep the scheduled appointment, you should contact your doctor immediately to arrange another appointment as soon as possible.

The first (150 mg) and second (100 mg) injections of this medicine will be given in the upper arm, approximately one week apart. Afterwards, an injection (in a dose ranging from 25 mg to 150 mg) will be administered once a month into the upper arm or buttock.

If your doctor decides to switch from long-acting risperidone injections to this medicine, the first injection of this medicine (in a dose ranging from 25 mg to 150 mg) will be given on the day of your next scheduled injection, into the upper arm or buttock. Afterwards, an injection (in a dose ranging from 25 mg to 150 mg) will be administered once a month into the upper arm or buttock.

Depending on your symptoms, your doctor may increase or decrease the dose by one level during the scheduled monthly injection.

Patients with kidney function disorders

Your doctor will adjust the dose of the medicine according to your kidney function. If you have mild kidney function impairment, your doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney function impairment.

Elderly patients

Your doctor may reduce the dose of the medicine if you have impaired kidney function.

Use of a higher than recommended dose of Psylipax

This medicine will be administered under medical supervision, so overdose is unlikely.

In patients who have received too high a dose of paliperidone, the following symptoms may occur: drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram, recording of the heart's electrical activity), or slowed or abnormal movements of the face, body, arms, or legs.

Stopping treatment with Psylipax

If you stop receiving the injections, the medicine will no longer work. Do not discontinue treatment unless instructed by your doctor, as your symptoms may return.

If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
You should immediately inform your doctor if:

• the patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, immediate medical help must be sought.
• in a patient with dementia, there is a sudden change in mental state or sudden weakness or numbness of the face, arms or legs, particularly on one side, or speech disturbances, even if brief. These may be symptoms of stroke.
• fever, muscle stiffness, sweating or decreased level of consciousness occurs (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary.
• a man experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be necessary.
• involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs, characterized by fever, swelling of the lips, face, mouth or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or oral paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient is scheduled for eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract surgery (clouding of the lens), the iris (colored part of the eye) may become floppy (so-called "intraoperative floppy iris syndrome"), which may lead to eye damage.
• the patient has a dangerously low number of certain white blood cells essential for fighting infections. The following adverse reactions may occur:

Very common adverse reactions (may affect more than 1 in 10 people)

• difficulty falling asleep or waking up.

Common adverse reactions (may affect up to 1 in 10 people)

• cold symptoms, urinary tract infection, flu-like symptoms
• the medicine Psylipax may increase the level of the hormone prolactin in the blood (this may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection, or other sexual disturbances. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual bleeding, or other menstrual cycle disturbances.
• high blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include slow shuffling gait, resting tremor, increased salivation and (or) drooling, and expressionless face
• psychomotor restlessness, feeling of drowsiness or reduced alertness
• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• dizziness
• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks
• tremor
• headache
• rapid heartbeat
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased activity of liver enzymes called transaminases in the blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• reaction at the injection site, including itching, pain or swelling.

Uncommon adverse reactions (may affect up to 1 in 100 people)

• pneumonia, bronchial infection (bronchitis), respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of certain white blood cells protecting against infections, anemia
• allergic reaction
• development of diabetes and worsening of pre-existing diabetes, increased blood insulin levels (hormone regulating blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high blood triglyceride (fat) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• tardive dyskinesia (involuntary twitching or jerking movements of the face, tongue or other body parts). You should inform your doctor immediately if rhythmic involuntary movements of the tongue, lips or face occur. Discontinuation of this medicine may be necessary.
• fainting, need to move body parts, dizziness upon standing, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• conduction block between upper and lower parts of the heart, abnormal electrical conduction in the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heartbeat, abnormal electrocardiogram (ECG) reading, sensation of heart pounding (palpitations)
• low blood pressure, low blood pressure upon standing (as a result, some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive flatulence
• increased activity of GGTP enzyme (liver enzyme known as gamma-glutamyltransferase) in blood, increased liver enzyme activity in blood
• hives, itching, rash, hair loss, skin eruption, dry skin, redness of the skin, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) activity in blood – an enzyme sometimes released from damaged muscles
• muscle cramps, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhea
• swelling of the face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• skin induration
• fall.

Rare adverse reactions (may affect up to 1 in 1000 people)

• eye infection
• skin inflammation caused by mites, scaling and itching of the scalp or body
• increased number of eosinophils (a type of white blood cell) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• head tremors
• abnormal secretion of the hormone regulating urine output
• sugar in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement or response to stimuli in a patient who is not asleep (catatonia)
• disorientation
• sleepwalking (somnambulism)
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, decreased or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, decreased level of consciousness, seizures, balance disturbances
• impaired motor coordination
• glaucoma (increased pressure inside the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity, increased tearing, redness of the eyes
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• pulmonary embolism causing chest pain and breathing difficulties. In case of such symptoms, immediate medical help must be sought.
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). In case of such symptoms, immediate medical help must be sought.
• flushing attacks
• breathing disturbances during sleep (sleep apnea)
• pulmonary congestion, respiratory tract hyperemia
• abnormal breath sounds, wheezing
• pancreatitis, tongue swelling, fecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• skin rash related to medicine use, skin thickening, psoriasis
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, breast gland enlargement, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, sensation of thirst
• withdrawal symptoms
• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.

Adverse reactions with unknown frequency: frequency cannot be determined from available data

• dangerously low number of certain white blood cells responsible for fighting infections
• severe allergic reaction characterized by fever, swelling of lips, face, mouth or tongue, shallow breathing, itching, skin rash, and sometimes drop in blood pressure
• dangerously excessive water drinking
• sleep-related eating disorders
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, aspiration pneumonia, voice disturbances
• absence of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes, genital areas and around these areas and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling which may involve the larynx and lead to breathing difficulties
• skin depigmentation
• abnormal body posture
• in newborns whose mothers used Psylipax during pregnancy, adverse drug reactions and (or) withdrawal symptoms may occur, such as irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• low body temperature
• skin necrosis at injection site and ulcer at injection site.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Psylipax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule-syringe and outer carton.
The expiry date refers to the last day of the stated month.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine contains
The active substance is paliperidone.
Each Psylipax 25 mg pre-filled syringe contains paliperidone palmitate equivalent to 25 mg of paliperidone.
Each Psylipax 50 mg pre-filled syringe contains paliperidone palmitate equivalent to 50 mg of paliperidone.
Each Psylipax 75 mg pre-filled syringe contains paliperidone palmitate equivalent to 75 mg of paliperidone.
Each Psylipax 100 mg pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of paliperidone.
Each Psylipax 150 mg pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of paliperidone.

Initiation pack
Each Psylipax 100 mg pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of paliperidone.
Each Psylipax 150 mg pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of paliperidone.

Other ingredients are: polysorbate 20, macrogol 4000, monohydrate citric acid, disodium phosphate, monosodium dihydrogen phosphate monohydrate, sodium hydroxide (for pH adjustment), water for injections.

What the medicine looks like and contents of the pack
Psylipax is a white or off-white injectable suspension in a pre-filled syringe.
Each single pack contains:
1 pre-filled syringe (made of colourless type I glass) with plunger, lock and "tip cap" (made of bromobutyl rubber), 1 needle with safety device (22 G 1½ inch) and 1 needle with safety device (23 G 1 inch). All packed in a cardboard box.

Each initiation pack contains:
1 pack of Psylipax 150 mg, 1 pre-filled syringe and 2 needles (administered on day 1 of treatment)
1 pack of Psylipax 100 mg, 1 pre-filled syringe and 2 needles (administered on day 8 of treatment).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Poland Sp. z o.o.
Szamocka 8 Street
01-748 Warsaw
e-mail: [email protected]

Manufacturer/Importer
Universal Farma, S.L
Polígono Industrial Miralcampo
C/ El Tejido 2
19200 Azuqueca de Henares – Guadalajara
Spain

Pharmascience International Limited
1st Floor Jacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus

This medicine is authorised in the European Economic Area countries under the following names:
Sweden: Psylipax
Finland: Psylipax
Spain: Psylipax
Portugal: Psylipax
Slovenia: Psylipax
Austria: Psylipax
Belgium: Psylipax
Luxembourg: Psylipax
Czech Republic: Psylipax
Hungary: Psylipax
Poland: Psylipax
Italy: Palbran
Slovakia: Psylipax
Estonia: Psylipax
Latvia: Psylipax

Information intended exclusively for medical personnel or healthcare professionals

and should be read together with the full product information (Summary of Product Characteristics).
The suspension for injection is intended for single use only. Before administration, inspect visually for foreign particles. If foreign particles are visible in the pre-filled syringe, do not use the medicinal product.

The package contains a pre-filled syringe and 2 needles with safety device [1½ inch 22 G (38.1 mm x 0.72 mm) and 1 inch 23 G (25.4 mm x 0.64 mm)] for intramuscular administration. The starter pack for initiating treatment contains two pre-filled syringes (150 mg + 100 mg) and 4 needles.

1. Shake the pre-filled syringe vigorously for at least 10 seconds to ensure homogeneity of the suspension.

2. Select the appropriate needle.

The first initiating dose of the medicinal product Psylipax (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE, using the needle for DELTOID MUSCLE injection. The second initiating dose of the medicinal product Psylipax (100 mg) should be administered one week later (day 8), also into the DELTOID MUSCLE, using the needle for DELTOID MUSCLE injection.

If switching from long-acting risperidone injections to the medicinal product Psylipax, the first injection of Psylipax (at a dose between 25 mg and 150 mg) may be administered into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle, on the day of the next scheduled injection.

Subsequently, monthly maintenance doses may be administered into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle.

For injections into the DELTOID MUSCLE in patients with body weight < 90 kg, use the 1 inch, 23 G (25.4 mm x 0.64 mm) needle (blue hub). If the patient's body weight is ≥ 90 kg, use the 1½ inch, 22 G (38.1 mm x 0.72 mm) needle (gray hub).

For injections into the GLUTEAL MUSCLE, use the 1½ inch, 22 G (38.1 mm x 0.72 mm) needle (gray hub).

3. Holding the pre-filled syringe vertically upright, remove the rubber cap by twisting it off.

4. Peel off the outer part of the blister packaging of the safety needle. Hold the base of the needle without touching the safety device. Attach the Luer tip of the safety needle to the pre-filled syringe by gently screwing it on in a clockwise direction.

5. Push the safety needle shield toward the syringe barrel at the indicated angle.

6. Pull the needle cap straight down to remove it. Do not rotate the cap, as this may loosen the needle from the pre-filled syringe.

7. Holding the pre-filled syringe in an upright vertical position, expel air by gently pressing the plunger rod of the pre-filled syringe.

8. Administer the entire content of the pre-filled syringe intramuscularly, slowly and deeply, into the selected muscle of the patient — either deltoid or gluteal. Do not administer the medicinal product intravenously or subcutaneously.

9. After completing the injection, activate the needle safety mechanism by pressing the safety shield with one finger (9a) or against a flat surface (9b). A clicking sound indicates successful needle safety activation. Dispose of the pre-filled syringe with attached needle appropriately.

9a

9b

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.