Psylipax

Package leaflet: Information for the user

Psylipax, 25 mg, prolonged-release injection suspension in pre-filled pen-syringe
Psylipax, 50 mg, prolonged-release injection suspension in pre-filled pen-syringe
Psylipax, 75 mg, prolonged-release injection suspension in pre-filled pen-syringe
Psylipax, 100 mg, prolonged-release injection suspension in pre-filled pen-syringe
Psylipax, 150 mg, prolonged-release injection suspension in pre-filled pen-syringe
Psylipax, 100 mg/150 mg, prolonged-release injection suspension in pre-filled pen-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, as 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.
For patients who previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, your doctor may initiate treatment with Psylipax without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a condition with "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 usual behaviours or emotions. A person with schizophrenia may, for example, seem withdrawn, emotionally unresponsive, or have difficulty speaking clearly and logically. People affected by this condition 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 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 characterized by 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 a breast tumor 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 experiences 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 family members have a history of blood clots in blood vessels, as antipsychotic medicines may increase the risk of developing clots.

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 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 well, allergic reactions may rarely occur after Psylipax injections. Seek immediate medical help if the patient develops rash, throat swelling, itching, or breathing difficulties, as these may be symptoms of a severe allergic reaction.

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

The treating doctor 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. Patients with pre-existing diabetes should have their blood glucose levels monitored regularly.

Since 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 surgery due to 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 the procedure, potentially leading 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

Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.

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, concomitant use with other medicines acting on 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 prolongation of the electrical impulse through a specific part of the heart (known as "QT interval prolongation"). Other medicines with this effect include certain drugs used to treat heart rhythm disorders or infections, as well as other antipsychotics.

If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with this effect include certain antidepressants or antimicrobials, 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 plans 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 symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact your doctor.

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

Driving and operating machinery

Dizziness, extreme tiredness, and vision disturbances may occur during treatment with this medicine (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 polisorbate

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 polisorbate 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 a 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 must inform your doctor immediately 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 you 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 in the upper arm or buttock on the day the next scheduled injection is due. 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 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 based on kidney function. If you have mild kidney impairment, your doctor may reduce the dose. This medicine should not be used in patients with moderate or severe kidney impairment.

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

Overdose of Psylipax
This medicine will be administered under medical supervision, so 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 treatment with Psylipax
If you stop receiving the injections, the medicine will stop working. 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 difficulty breathing. If such symptoms occur, seek immediate medical help.
• the patient with dementia experiences 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 signs of stroke.
• fever, muscle stiffness, sweating or decreased level of consciousness occurs (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary.
• the male patient experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be required.
• involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs, characterized by fever, swelling of the lips, face, tongue or throat, breathing difficulties, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or paliperidone taken orally, allergic reactions may rarely occur after paliperidone injections.
• the patient is scheduled for eye surgery, inform the ophthalmologist about taking this medicine. During cataract surgery (clouding of the lens), the iris (the colored part of the eye) may become floppy (so-called "intraoperative floppy iris syndrome"), which may lead to eye damage.
• the patient develops dangerously low levels of certain white blood cells essential for fighting 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-like symptoms, urinary tract infection, flu-like symptoms
• the medicine Psylipax may increase the level of prolactin hormone in the blood (which may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include breast swelling in men, 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 "freezing" of movement followed by sudden release. Other symptoms of parkinsonism include slow shuffling gait, resting tremor, increased saliva production 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 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, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased activity of liver enzymes known as transaminases in the blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• reaction at injection site, 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 (twitching or jerking uncontrolled movements of the face, tongue or other body parts). Inform your doctor immediately if involuntary rhythmic movements of the tongue, mouth 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 sensitivity 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
• heart conduction block between upper and lower chambers, 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 passing of gas
• increased activity of GGTP enzyme (liver enzyme known as gamma-glutamyltransferase) in blood, increased liver enzyme activity in blood
• skin rash, itching, hives, hair loss, skin rash, dry skin, skin redness, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) enzyme 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 face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling unwell
• skin hardening
• fall.

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

• eye infection
• skin inflammation caused by mites, peeling and itching of scalp or body skin
• increased number of eosinophils (a type of white blood cells) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• head tremors
• abnormal secretion of 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, low level of consciousness, seizures, balance disturbances
• abnormal motor coordination
• glaucoma (increased pressure inside the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity, excessive tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• blood clot in the lungs causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help.
• blood clots in veins, especially in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, seek immediate medical help.
• 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, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, feeling 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 estimated 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, tongue or throat, 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 disturbances
• absence of intestinal peristalsis leading to obstruction
• yellowing of skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes, genital organs 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
• newborns whose mothers used Psylipax during pregnancy may experience drug-related adverse reactions and (or) withdrawal symptoms such as irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• decreased body temperature
• skin necrosis at injection site and ulcer at injection site.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 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 the 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 pack and other information

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

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

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

What Psylipax 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, 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 carton.

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.
ul. Szamocka 8
01-748 Warszawa
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 must be read together with the full product information (Summary of Product Characteristics).
The injectable suspension is 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 DELTOID MUSCLE needle. 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 DELTOID MUSCLE needle.

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 on the day of the next scheduled injection into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle.

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 layer of the blister packaging of the safety needle. Hold the base of the needle without touching the safety device. Attach the Luer-lock tip of the safety needle to the pre-filled syringe by gently screwing it clockwise.

5. Slide the needle safety 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 the deltoid or gluteal muscle. Do not administer the medicinal product intravenously or subcutaneously.

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

9a

9b

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