Paliperidone +pharm

Package leaflet: Information for the user

Paliperidone +pharma, 25 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone +pharma, 50 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone +pharma, 75 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone +pharma, 100 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone +pharma, 150 mg, prolonged-release injection suspension
in pre-filled syringe
Starting dose pack
Paliperidone +pharma, 100 mg + 150 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidonum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

1. What Paliperidone +pharma is and what it is used for

Paliperidone +pharma 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 been stabilized on paliperidone or risperidone therapy.
For patients who have previously responded to paliperidone or risperidone and whose current psychotic symptoms are mild to moderate, the doctor may initiate treatment with Paliperidone +pharma without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive symptoms refer to the presence of abnormal experiences that do not normally 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 refer to the absence of normal behaviors or emotions. For example, a person with schizophrenia may appear withdrawn, isolated, emotionally unresponsive, or may have difficulty speaking in a clear and logical manner. People affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.
Paliperidone +pharma helps to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Paliperidone +pharma

When not to use Paliperidone +pharma

• 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 Paliperidone +pharma, discuss this with your doctor, pharmacist or
nurse.
The use of paliperidone has not been studied in elderly patients with dementia. However, in such
patients treated with other similar medicines, an increased risk of stroke or death may occur (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. For this reason, it is important to discuss with your doctor any of the following conditions which may potentially worsen during treatment with this medicine:

• 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 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 breast cancer or a pituitary gland tumour
• if the patient has heart disease or is being treated for heart disease which may predispose to low blood pressure
• if the patient experiences low blood pressure upon sudden change to upright 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 increased blood levels of prolactin hormone or suspicion of a prolactin-dependent tumour
• if the patient or a family member has a history of blood clots in blood vessels, as antipsychotic medicines are associated with their formation

If the patient meets any of the above criteria, they should consult their 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, dangerously low levels of a certain type of white blood cells necessary to fight infections have been observed in patients taking paliperidone.
Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after injections of Paliperidone +pharma. Immediate medical help should be sought 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 elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been reported in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Since this medicine may reduce the vomiting reflex, there is a risk that 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 middle of the eye) may not dilate sufficiently. Also, the iris of the eye (the coloured part of the eye) may be floppy during surgery, which may result in eye damage. If the patient is scheduled for eye surgery, they should inform the ophthalmologist about taking this medicine.
Children and adolescents
This medicine is not intended for use in individuals under 18 years of age.
Paliperidone +pharma and 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 antiepileptic and mood-stabilizing medicine) may require a dose adjustment of this medicine.
Since this medicine acts mainly on the brain, interactions with other medicines that also affect the brain, such as other psychiatric medicines, opioids, antihistamines and sleeping medicines, may increase side effects such as drowsiness or other brain-related effects.
This medicine may lower blood pressure; therefore, caution should be exercised when using this medicine together with other medicines that lower blood pressure.
This medicine may weaken the effect 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 time it takes for an electrical impulse to pass through a specific part of the heart (known as “QT interval prolongation”). Other medicines with such effects include those 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 certain antidepressants or medicines used to treat infections, as well as other antipsychotic medicines.
Caution should be exercised when using Paliperidone +pharma together with medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
Paliperidone +pharma 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 have taken 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 child, contact your doctor.
This medicine may pass from the mother's body into breast milk and harm the baby. Therefore, breastfeeding should not be performed while taking this medicine.
Driving and operating machinery
During treatment with this medicine, dizziness, extreme tiredness and visual disturbances may occur (see section 4). This should be taken into account in situations requiring full alertness, such as when driving a vehicle or operating machinery.
Paliperidone +pharma contains sodium and polysorbate
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
The medicine contains 12 mg of polysorbate per ml, equivalent to 12 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if the patient has known allergic reactions.

3. How to use Paliperidone +pharma

The medicine is administered by a doctor or other healthcare professional. It will be given as an intramuscular injection. Your doctor will inform you when the next injection should be given. 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 another appointment can be arranged as soon as possible.

The first (150 mg) and second (100 mg) injections of this medicine will be given into the upper arm, approximately one week apart. After that, an injection will be given once a month (at a dose ranging from 25 mg to 150 mg) 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 (at a dose ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock on the day your next scheduled risperidone injection is due. After that, an injection will be given once a month (at a dose ranging from 25 mg to 150 mg) into the upper arm or buttock.

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

Patients with kidney function disorders
The doctor will adjust the dose of the medicine based on kidney function. If the patient has mild kidney function impairment, the doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney function impairment.

Elderly patients
The doctor may reduce the dose if the patient has impaired kidney function.

Taking more than the recommended dose of Paliperidone +pharma
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) findings, or slowed or abnormal muscle movements of the face, body, arms, or legs.

Stopping Paliperidone +pharma treatment
If the patient stops receiving the injections, the medicine will no longer be effective. Do not discontinue treatment unless instructed by the 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 in the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If such symptoms occur, immediate medical help should be sought.
• 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.
• the patient develops fever, muscle stiffness, sweating or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate treatment may be required.
• the male patient experiences prolonged or painful erection. This condition is known as "priapism". Immediate treatment may be necessary.
• involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of paliperidone treatment may be necessary.
• the patient develops a severe allergic reaction characterised by: fever, swelling of the lips, face, eyelids, 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 is scheduled for eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract removal surgery, floppy iris syndrome may occur, which can lead to eye damage.
• the patient has dangerously low levels of certain white blood cells essential for fighting infections.

The following adverse reactions may occur:
Very common (may affect more than 1 in 10 people)

• difficulty falling asleep or waking up

Common (may affect up to 1 in 10 people)

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

• Paliperidone +pharma 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 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 include slow or abnormal movements, feelings of stiffness or muscle tension (causing jerky, abrupt movements), and sometimes even a feeling of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include:
  slow shuffling gait, resting tremor, increased salivation/drooling, and lack of facial expression

• psychomotor restlessness, feeling of drowsiness or reduced alertness

• dystonia: this condition includes 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 includes 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, 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 (may affect up to 1 in 100 people)

• pneumonia, 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, anaemia
• allergic reaction
• onset or 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, restlessness, nightmares
• tardive dyskinesia (twitching or jerking, uncontrolled 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 standing, concentration difficulties, 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 dizziness, ringing in the ears, ear pain
• heart conduction block between chambers, abnormal conduction of electrical impulses in the heart, QT interval prolongation on ECG, rapid heartbeat upon standing, slow heart rate, abnormal electrocardiogram (ECG), palpitations
• low blood pressure, low blood pressure upon standing (as a result of which some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly)
• shortness of breath, sore throat, nosebleeds
• 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, 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 or other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhoea
• swelling of the face, lips, eyes or eyelids, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, malaise
• skin hardening
• falls

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

• 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 responsible for stopping bleeding)
• tremulous head movements
• abnormal secretion of the hormone regulating urine production
• glucose in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive thirst
• lack of movement and 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
• impaired motor coordination
• glaucoma (increased pressure inside the eye)
• eye movement disorders, rotational eye movements, light sensitivity, excessive tearing, redness of the eyes
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• pulmonary embolism causing chest pain and breathing difficulties. If such symptoms occur, immediate medical help should be sought.
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, immediate medical help should be sought.
• facial flushing
• breathing disturbances during sleep (sleep apnoea)
• pulmonary congestion, respiratory tract hyperaemia
• crackling sounds in the lungs, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stools
• 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, sensation of thirst
• withdrawal symptoms
• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site

Frequency not known (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, eyelids or tongue, shortness of breath, itching, skin rash, and sometimes drop in blood pressure
• dangerously excessive water drinking
• eating disorders related to sleep
• 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, 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
• in newborns whose mothers used paliperidone 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
• decreased body temperature
• necrosis at injection site and ulceration at injection site

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 181 C, 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 or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Paliperidone +pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the prefilled syringe and carton after "EXP:". The expiry date refers to the last day of the stated month.
Do not freeze.
Medicines must 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 Paliperidone +pharma contains

• The active substance is paliperidone.

Paliperidone +pharma, 25 mg
Each pre-filled syringe contains paliperidone palmitate equivalent to 25 mg of paliperidone.
Paliperidone +pharma, 50 mg
Each pre-filled syringe contains paliperidone palmitate equivalent to 50 mg of paliperidone.
Paliperidone +pharma, 75 mg
Each pre-filled syringe contains paliperidone palmitate equivalent to 75 mg of paliperidone.
Paliperidone +pharma, 100 mg
Each pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of paliperidone.
Paliperidone +pharma, 150 mg
Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of paliperidone.
Initiation pack
Each pre-filled syringe contains paliperidone palmitate equivalent to 100 mg of paliperidone.
Each pre-filled syringe contains paliperidone palmitate equivalent to 150 mg of paliperidone.

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

What Paliperidone +pharma looks like and contents of the pack
Paliperidone +pharma is a white or almost white injectable suspension in a pre-filled syringe (injectable suspension).
Each single pack contains:

• 1 pre-filled syringe (clear glass, type I) with a plunger, lock, and needle cap, together with a 22G 1½ inch needle with safety device and a 23G 1 inch needle with safety device. All packed in a cardboard box.

Each initiation pack contains:

• 1 pack of Paliperidone +pharma, 150 mg: 1 pre-filled syringe and 2 needles (for administration on day 1 of treatment)
• 1 pack of Paliperidone +pharma, 100 mg: 1 pre-filled syringe and 2 needles (for administration on day 8 of treatment)

Not all pack sizes may be marketed.

Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstrasse 211
8054 Graz
Austria

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 Member States of the European Economic Area under the following names:
Austria Paliperidon Genericon 25 mg, 50 mg, 75 mg, 100 mg, 150 mg Depot-
Injektionssuspension in einer Fertigspritze
Paliperidon Genericon Starterpackung 150 mg + 100 mg Depot-Injektionssuspension in
einer Fertigspritze
Poland Paliperidone +pharma
Sweden Paliperidone Genericon

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel.: +48 12 262 32 36
e-mail: [email protected]

Information intended solely for medical personnel or healthcare professionals and should be read together with the full product information (Summary of Product Characteristics).

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

The package contains one prefilled syringe and two safety needles [22G 1½ inch (38.1 mm × 0.72 mm) and 23G 1 inch (25.4 mm × 0.64 mm)] for intramuscular administration. The medicinal product Paliperidone +pharma is also available in a starter pack containing two prefilled syringes (150 mg + 100 mg) and four safety 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 Paliperidone +pharma (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE using the needle intended for the DELTOID MUSCLE.
The second initiating dose of the medicinal product Paliperidone +pharma (100 mg) should be administered one week later (day 8), also into the DELTOID MUSCLE using the needle intended for the DELTOID MUSCLE.
When switching from long-acting risperidone injections to the medicinal product Paliperidone +pharma, the first injection of Paliperidone +pharma (in a dose range of 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 intramuscular injections into the DELTOID MUSCLE:

• In patients with body weight <90 kg, use a 1-inch, 23G needle (25.4 mm × 0.64 mm) (needle with blue hub).
• In patients with body weight ≥90 kg, use a 1½-inch, 22G needle (38.1 mm × 0.72 mm) (needle with grey hub).

For intramuscular injections into the GLUTEAL MUSCLE: use a 1½-inch, 22G needle (38.1 mm × 0.72 mm) (needle with grey hub).

3. Hold the prefilled syringe with the tip pointing upward. Gently twist and remove the rubber cap from the tip of the prefilled syringe.

4. Peel off the outer layer of the safety needle blister package. Grasp the base of the needle, not the safety mechanism. Attach the needle to the Luer-lock connector of the prefilled syringe by pressing and turning it gently clockwise.

5. Pull the protective needle shield away from the needle at the angle shown, moving it toward the body of the prefilled syringe.

6. Remove the needle cap straight off without twisting, as twisting may loosen the needle from the prefilled syringe.

7. Hold the prefilled syringe with attached needle in an upright vertical position to remove air. Expel air from the syringe by gently pressing the plunger forward.

8. Administer the entire content of the prefilled syringe slowly and deeply by intramuscular injection into the selected deltoid or gluteal muscle of the patient. Do not administer intravenously or subcutaneously.

9. After completing the injection, use either the fingers of one hand (9a) or a flat surface (9b) to activate the needle safety mechanism. A clicking sound indicates successful activation and secure locking of the needle safety system. Dispose of the prefilled syringe with needle appropriately.

9a

9b

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