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 experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Psylipax is and what it is used for
2. What you need to know before using 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 previously treated with paliperidone or risperidone.
In patients who 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 disease with "positive" and "negative" symptoms. Positive symptoms mean the presence of symptoms that usually do not occur. For example, a person with schizophrenia may hear voices or see things that are not there (hallucinations), believe in things that are not true (delusions), or be excessively suspicious of others. Negative symptoms mean the absence of behaviours or emotions that are normally present. For example, a person with schizophrenia may appear withdrawn, emotionally unresponsive, or have difficulty speaking clearly and logically. People affected by this illness may also experience depression, anxiety, feelings of guilt, or tension.
Psylipax helps to reduce the symptoms of the illness and 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 has not been studied in elderly patients with dementia. However, in such patients treated with similar types of medicines, an increased risk of stroke or death has been observed (see section 4, "Possible side effects").

All medicines have side effects. Some of the side effects of this medicine may worsen symptoms of other medical conditions. Therefore, during treatment with this medicine, discuss with your doctor any of the following conditions:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterised by, among others, high fever and muscle stiffness (also known as neuroleptic malignant syndrome)
• if the patient has ever experienced involuntary movements of the tongue or facial muscles (tardive dyskinesia)
• if the patient has previously had a low white blood cell count (which may or may not have been 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 tumour
• if the patient has heart disease or is being treated for heart disease 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 of the body
• if the patient has abnormally increased levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumour
• if the patient or a family member has had blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient meets any of the above criteria, consult a doctor who may adjust the dose or monitor the patient periodically. The treating doctor may order a white blood cell count test, as very rarely, this medicine has been associated with a dangerously low number of certain types of white blood cells essential for fighting infections.

Even if the patient previously tolerated orally administered 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 symptoms of a severe allergic reaction.

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

The treating doctor will check 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.

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

During cataract surgery (eye surgery due to clouding of the lens), the pupil (the black circle in the centre of the eye) may not dilate sufficiently. Also, the iris (the coloured part of the eye) may be floppy during the procedure, which may lead to eye damage. If the patient has planned eye surgery, inform the ophthalmologist about taking this medicine.

Children and adolescents
This medicine is not used in individuals under 18 years of age.

Psylipax with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Taking this medicine together with carbamazepine (an anticonvulsant and mood-stabilizing medicine) may require a dose adjustment of this medicine.

Since this medicine acts primarily in the brain, interactions with other medicines acting in the brain, such as other psychiatric medicines, opioids, antihistamines, and sedatives, may increase 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 such an effect include those used to normalize heart rhythm or treat infections, as well as other antipsychotic medicines.

If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with such an effect include certain antidepressants or medicines used to treat infections, as well as other antipsychotics.

Caution is advised 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 baby, 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 took 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 your baby, contact your doctor immediately.

This medicine may pass from the mother's body into breast milk and may harm the baby. Therefore, breastfeeding must not be undertaken while taking this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness, extreme tiredness, and vision disturbances may occur (see section 4). This 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, i.e. the medicine 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 will be administered by a doctor or other healthcare professional. 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 immediately inform your doctor so that a new appointment can be arranged 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 monthly 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 monthly into the upper arm or buttock.

Depending on the symptoms present, 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 based on kidney function. If you have mild kidney impairment, your doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney impairment.

Elderly patients
Your doctor may reduce the dose if you have impaired kidney function.

Overdose of Psylipax
Since this medicine is administered under medical supervision, overdose is unlikely.

In patients who have received an excessive 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 Psylipax treatment
If you stop receiving the injections, the medicine will no longer work. Do not discontinue treatment unless instructed by your doctor, as symptoms of the illness may return.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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. In case of such symptoms, immediate medical help should be sought.
• a patient with dementia experiences sudden changes in mental status or sudden weakness or numbness of the face, arms or legs, especially on one side of the body, or speech disturbances, even if brief. These may be symptoms of stroke.
• fever, muscle stiffness, sweating or decreased level of consciousness occur (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 lips, face, mouth or tongue, shortness of breath, itching, skin rash, and sometimes low blood pressure (referred to as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or oral paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient has planned eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract surgery (clouding of the lens), the iris (the colored part of the eye) may become floppy (so-called "floppy iris syndrome"), which may lead to eye damage.
• the patient has a dangerously low number of certain white blood cells necessary to fight infections. The following adverse reactions may occur:

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

• difficulty falling asleep or waking up.

Common adverse reactions (may occur in 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 levels 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 discharge 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 involve 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 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 (which may result in abnormal body 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
• injection site reaction, including itching, pain or swelling.

Uncommon adverse reactions (may occur in 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 levels of insulin (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, jerking or writhing movements of the face, tongue or other body parts). You should immediately inform your doctor 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 changing to upright position, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness sensations in 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 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 passing of gas
• increased activity of GGTP enzyme (liver enzyme known as gamma-glutamyltransferase) in the blood, increased liver enzyme activity in the blood
• hives, itching, rash, hair loss, acne, dry skin, skin redness, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) activity in the 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 hardening
• fall.

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

• eye infection
• skin inflammation caused by mites, skin scaling and itching of the scalp or body
• increased number of eosinophils (a type of white blood cell) in the blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• tremulous head movements
• abnormal secretion of the hormone regulating urine production
• 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
• abnormal motor coordination
• glaucoma (increased pressure within the eyeball)
• eye movement disorders, rotational eye movements, light sensitivity, excessive tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heartbeat
• pulmonary embolism causing chest pain and breathing difficulties. In case of such symptoms, immediate medical help should be sought.
• blood clots in veins, especially in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). In case of such symptoms, immediate medical help should be sought.
• flushing attacks
• breathing disturbances during sleep (sleep apnea)
• pulmonary congestion, respiratory tract hyperemia
• respiratory sounds, wheezing
• pancreatitis, tongue swelling, fecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, psoriasis
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• chest 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 low 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 disorders
• lack 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, genitals and around these areas and may also 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 the medicine 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warsaw, tel.: + 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 provide more information on the safety of the medicine.

5. How to store Psylipax

Keep this medicine out of the 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. This will help protect the environment.

6. Contents of the package and other information

What Psylipax 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 treatment 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: polysorbate 20, macrogol 4000, citric acid monohydrate, disodium phosphate, sodium dihydrogen phosphate monohydrate, sodium hydroxide (for pH adjustment), water for injections.

What Psylipax looks like and contents of the pack
Psylipax is a white or almost 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 treatment 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 medicinal product is authorised in the European Economic Area under the following trade 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 must 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 the suspension visually for foreign particles. If foreign particles are visible in the prefilled syringe, do not use the medicinal product.
The pack contains a prefilled 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 treatment initiation pack contains two prefilled syringes (150 mg + 100 mg) and 4 needles.

1. Shake the prefilled 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 the DELTOID MUSCLE. 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 the DELTOID MUSCLE.
If switching from long-acting risperidone injections to the medicinal product Psylipax, the first injection of Psylipax (at a dose ranging from 25 mg to 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 a 1-inch, 23 G (25.4 mm x 0.64 mm) needle (with blue hub). If the patient's body weight is ≥ 90 kg, use a 1½-inch, 22 G (38.1 mm x 0.72 mm) needle (with grey hub).
For injections into the GLUTEAL MUSCLE, use a 1½-inch, 22 G (38.1 mm x 0.72 mm) needle (with grey hub).

3. Holding the prefilled syringe vertically with the tip pointing upwards, 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 prefilled syringe by gently screwing it on in a clockwise direction.

5. Slide the needle safety shield towards the syringe barrel at the indicated angle.

6. Pull the needle cap straight down to remove it. Do not twist the cap, as this may loosen the needle from the prefilled syringe.

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

8. Administer the entire content of the prefilled 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 device by using either one hand to press with the thumb (9a) or a flat surface (9b). A clicking sound indicates successful activation of the needle safety. Dispose of the prefilled syringe with the needle properly. 9a

9b

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