Pratyria

Package leaflet: Information for the user

Pratyria, 75 mg, prolonged-release injection suspension in pre-filled syringe
Pratyria, 100 mg, prolonged-release injection suspension in pre-filled syringe
Pratyria, 150 mg, prolonged-release injection suspension in pre-filled syringe
Initiation treatment pack
Pratyria, 150 mg, prolonged-release injection suspension in pre-filled syringe
Pratyria, 100 mg, prolonged-release injection suspension in pre-filled syringe
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, please ask your doctor, pharmacist, or nurse.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Pratyria is and what it is used for

Pratyria 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 adult patients who have already been stabilised on paliperidone or risperidone.
In patients who have previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, the doctor may initiate treatment with Pratyria without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive symptoms mean the presence of symptoms that are not normally experienced. 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 refer to the absence of usual behaviours or emotions. A person with schizophrenia may appear withdrawn, emotionally flat, or unable to speak in a clear and logical way. People with this condition may also experience depression, anxiety, feelings of guilt, or tension.
Pratyria helps to reduce the symptoms of the illness and helps prevent their recurrence.

2. Important information before using Pratyria

When NOT to use Pratyria

• 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 Pratyria, 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 have side effects, and 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 if any of the following conditions apply:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterised 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 (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 a breast tumour or a pituitary gland tumour
• if the patient has heart disease or is being treated for heart conditions that predispose to hypotension
• if the patient has low blood pressure upon sudden change to a 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 tumour
• if the patient or their family members have a history of 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 in rare cases, 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 oral paliperidone or risperidone, allergic reactions may rarely occur after Pratyria 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 check for symptoms of elevated 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, 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 surgery, which could 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.
Pratyria and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilising medicine) may require adjustment of the Pratyria dose.
• Since this medicine acts primarily in the brain, combining it with other medicines that act in the brain, such as other psychotropic medicines, opioids, antihistamines, and sedatives, may increase side effects such as drowsiness or other brain-related 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 such effects include medicines used to regulate 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 effects include some medicines used to treat depression or infections, as well as other antipsychotic medicines.
• Caution is advised when using Pratyria together with medicines that increase central nervous system activity ( psychostimulants such as methylphenidate ). Using Pratyria with alcohol Avoid consuming alcohol.

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.
Pregnancy
This medicine should not be used during pregnancy unless discussed with a doctor.
Newborns whose mothers have taken paliperidone during the third trimester (last three 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.
Breastfeeding
This medicine may pass from the mother's body into breast milk and harm the baby. Therefore, breastfeeding should not be performed during treatment with this medicine.
Driving and operating machinery
During treatment with this medicine, dizziness, extreme tiredness, and vision disturbances may occur (see section 4). These effects should be considered in situations requiring full alertness, such as driving or operating machinery.
Pratyria contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".

3. How to use Pratyria

The medicine will be administered by a doctor or other medical personnel. 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 a new appointment as soon as possible.

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

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

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 impairment
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 Pratyria
This medicine will be administered under medical supervision, so an 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), or slowed or abnormal muscle movements of the face, body, arms, or legs.

Stopping Pratyria 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, please 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 in 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 symptoms may indicate a stroke.
• fever, muscle stiffness, sweating or decreased level of consciousness occur (a condition known as 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, lips or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs, characterised by: fever, swelling of the lips, face, tongue or throat, shortness of breath, itching, skin rash, and sometimes a drop in 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 has planned eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract removal, floppy iris syndrome may occur, 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 patients

• difficulty falling asleep or waking up

Common adverse reactions: may affect up to 1 in 10 patients

• cold symptoms, urinary tract infection, flu-like symptoms

• the medicine Pratyria 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 (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 periods 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 movements), and sometimes even a feeling 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 (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 heart rate

• high blood pressure

• cough, nasal congestion

• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache

• increased liver enzyme activity in 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 affect up to 1 in 100 patients

• pneumonia, bronchitis, respiratory tract infections, sinusitis, 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, anaemia
• allergic reaction
• onset 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 (fats) levels, increased blood cholesterol levels
• sleep disturbances, elevated mood (mania), decreased libido, restlessness, 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, lips or face occur. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon standing, concentration disturbances, 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 dizziness, ringing in the ears, ear pain
• conduction block between heart chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, rapid heartbeat upon standing, slow heart rate, abnormal ECG reading, 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 or rising)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas
• increased GGTP enzyme activity (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• hives, itching, rash, hair loss, skin eruption, 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 (uncontrolled), frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (women), breast enlargement in men, sexual disturbances, breast pain, milk leakage from the breasts
• swelling of the face, lips, eyes or limbs, body swelling, upper or lower limb swelling
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• skin hardening
• fall

Rare adverse reactions: may affect up to 1 in 1,000 patients

• eye infection
• skin inflammation caused by mites, scaly, itchy skin of the head or other body parts
• increased number of eosinophils (a type of white blood cell) in blood
• decreased number of platelets (blood cells that help stop bleeding)
• head tremor
• abnormal secretion of the hormone regulating urine production
• glucose in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement and response to stimuli in a patient who is not asleep (catatonia)
• confusion
• sleepwalking (somnambulism)
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, 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, reduced level of consciousness, seizures, balance disturbances
• impaired motor coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotational eye movements, light sensitivity, increased tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• blood clot in the lungs causing chest pain and difficulty breathing. If any of these symptoms occur, contact your doctor immediately
• blood clots in the veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, contact your doctor immediately
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• pulmonary congestion, respiratory tract hyperaemia
• crackling sounds in the lungs, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, psoriasis
• muscle fibre breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, thirst sensation
• withdrawal symptoms
• pus accumulation 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 characterised by fever, swelling of lips, face, tongue or throat, shortness of breath, 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
• 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 and genital areas and around these sites and may also spread to other body parts (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 Pratyria during pregnancy, adverse reactions to the medicine and (or) withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• low body temperature
• 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, 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 authorisation holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Pratyria

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
pre-filled syringe. The expiry date (EXP) refers to the last day of the specified month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. Such measures will help protect the
environment.

6. Contents of the pack and other information

What Pratyria contains
The active substance is paliperidone.
Each 75 mg pre-filled syringe of Pratyria contains paliperidone palmitate equivalent to 75 mg of paliperidone.
Each 100 mg pre-filled syringe of Pratyria contains paliperidone palmitate equivalent to 100 mg of paliperidone.
Each 150 mg pre-filled syringe of Pratyria contains paliperidone palmitate equivalent to 150 mg of paliperidone.

The other ingredients are:
Polysorbate 20 (E 432)
Macrogol 4000
Citric acid monohydrate (E330)
Disodium hydrogen phosphate anhydrous (E 339)
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (E 542) (for pH adjustment)
Water for injections

What Pratyria looks like and contents of the pack
Pratyria is a white to off-white suspension for injection with prolonged release, supplied in a pre-filled syringe.
The pre-filled syringe is made of cycloolefinic copolymer, with a bromobutyl rubber stopper (plunger tip), safety lock, and a "tip-cap" needle shield.

Each single pack contains: 1 pre-filled syringe and 2 needles.

Each initiation pack contains:

• 1 pack of Pratyria 150 mg, 1 pre-filled syringe and 2 needles (administered on day 1 of treatment)
• 1 pack of Pratyria 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
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany

Manufacturer/Importer
STADA Arzneimittel AG,
Stadastrasse 2-18,
61118 Bad Vilbel,
Germany
Stada Arzneimittel GmbH
Muthgasse 36/2, Doebling
1190 Vienna,
Austria

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw, Poland
Tel. +48 22 737 79 20

Pack with needle featuring Magellan safety protection

Information intended exclusively for healthcare professionals or healthcare workers, 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 the presence of foreign particles. If foreign particles are observed in the prefilled syringe, do not use the medicinal product.

The package contains a prefilled syringe and two safety needles (22G x 1½ inches [38 mm x 0.7 mm] and 23G x 1 inch [25 mm x 0.6 mm]) for intramuscular administration.

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

2. Select the appropriate needle.

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

If switching from long-acting risperidone injections to the medicinal product Pratyria, the first injection of Pratyria (at a dose between 25 mg and 150 mg) may be administered either into 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 intramuscular injections into the DELTOID MUSCLE in patients with body weight <90 kg, use a 1-inch, 23G needle (25 mm x 0.6 mm) (needle with blue hub). If the patient’s body weight is ≥90 kg, use a 1½-inch, 22G needle (38 mm x 0.7 mm) (needle with gray hub).

For intramuscular injections into the GLUTEAL MUSCLE, use a 1½-inch, 22G needle (38 mm x 0.7 mm) (needle with gray hub).

3. Hold the syringe with the tip pointing upward and remove the rubber cap with a gentle twisting motion.

4. Partially peel back the outer part of the blister packaging of the safety needle. Hold the needle shield through the plastic packaging. Keep the syringe upright. Attach the safety needle to the syringe by gently screwing it on to avoid breakage or damage to the needle tip. Before administration, always check for signs of damage or leakage.

5. Remove the needle shield with a straight pull. Do not twist the shield, as this may loosen the needle from the prefilled syringe.

6. Remove air from the prefilled syringe by gently pressing the plunger while holding the syringe in an upright position.

7. Administer the entire content of the prefilled 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.

8. After completing the injection, activate the needle safety mechanism by pressing the thumb or finger of one hand against the shield (8a, 8b) or against a flat surface (8c). A clicking sound indicates successful activation of the safety mechanism. Dispose of the prefilled syringe with the needle properly.

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

Packaging with Terumo safety needle

Information intended exclusively for medical or healthcare personnel, which must be read together with the full product information (Summary of Product Characteristics).

The injection suspension is for single use only. Before administration, inspect the suspension for foreign particles. Do not use the medicinal product if foreign particles are visible in the prefilled syringe.

The package contains a prefilled syringe and two safety needles (22G x 1½ inches [38 mm x 0.7 mm] and 23G x 1 inch [25 mm x 0.6 mm]) for intramuscular administration.

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

2. Select the appropriate needle.

For injections into the DELTOID MUSCLE:

• In patients with body weight <90 kg, use the 1-inch, 23G needle (needle with blue hub).
• In patients with body weight ≥90 kg, use the 1½-inch, 22G needle (needle with gray hub).

For injections into the GLUTEAL MUSCLE:
Use the 1½-inch, 22G needle (needle with gray hub), regardless of patient body weight.

3. Hold the syringe with the tip pointing upward and remove the rubber cap by gently twisting it off.

4. Partially peel back the outer layer of the safety needle packaging. Grasp the needle shield through the packaging. Attach the safety needle to the syringe and gently screw it on clockwise.

5. 1. Slide the needle safety guard toward the syringe. 2) Remove the needle shield with a straight pull. Do not twist the shield, as this may loosen the needle from the prefilled syringe.

6. Remove air from the prefilled syringe by gently pressing the plunger while holding the syringe in an upright position.

7. Inject the entire contents of the prefilled syringe intramuscularly, slowly and deeply, into the selected muscle—deltoid or gluteal. Do not administer the medicinal product intravenously or subcutaneously.

8. After completing the injection, activate the needle safety mechanism by pressing the thumb or finger of one hand against the safety shield (8a, 8b), or against a flat surface (8c). A clicking sound indicates successful needle shielding. Dispose of the prefilled syringe with the needle properly.

Keep out of reach of children.
Any unused portions or waste material should be disposed of in accordance with local regulations.