Paliperidone +pharma

Package leaflet: Information for the user

Paliperidone +pharma, 25 mg, prolonged-release suspension for injection
in pre-filled syringe
Paliperidone +pharma, 50 mg, prolonged-release suspension for injection
in pre-filled syringe
Paliperidone +pharma, 75 mg, prolonged-release suspension for injection
in pre-filled syringe
Paliperidone +pharma, 100 mg, prolonged-release suspension for injection
in pre-filled syringe
Paliperidone +pharma, 150 mg, prolonged-release suspension for injection
in pre-filled syringe
Starting package
Paliperidone +pharma, 100 mg + 150 mg, prolonged-release suspension for injection
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, so that you can read it again if necessary.
• 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 previously responded to paliperidone or risperidone, and who currently have mild to moderate psychotic symptoms, 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 symptoms that normally do not occur. For example, a person suffering from schizophrenia may hear voices or see things that do not exist (hallucinations), believe in things that are not true (delusions), or be excessively suspicious of others. Negative symptoms refer to the absence of behaviors or emotions that are normally present. For example, a person with schizophrenia may appear withdrawn, isolated, emotionally unresponsive, or may have difficulty speaking in a coherent and logical manner. Individuals 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, please 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, there may be an increased risk of stroke or death (see section 4, "Possible side effects").
All medicines can cause side effects. Some of the side effects of this medicine may worsen symptoms of other medical conditions. Therefore, it is important to discuss with your doctor any of the following conditions that could potentially worsen during treatment with this medicine:

• if the patient has Parkinson's disease
• if the patient has ever been diagnosed with a condition characterized by symptoms such as high fever and muscle stiffness (also known as neuroleptic malignant syndrome)
• if the patient has ever experienced 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 may predispose to low blood pressure
• if the patient experiences low blood pressure upon sudden change to an 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 regulating body temperature or is prone to overheating
• if the patient has abnormally high levels of the hormone prolactin in the blood 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 development

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 for fighting infections have been observed in patients taking paliperidone.
Even if the patient previously tolerated oral paliperidone or risperidone well, 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 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 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 reduce the vomiting reflex, there is a risk that it may mask the body's normal response to ingesting toxic substances or other medical conditions.
During cataract surgery, the pupil (black circle in the center of the eye) may not dilate sufficiently. Also, the iris of the eye (coloured part) may be floppy during surgery, which may lead to 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 with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
Taking this medicine together with carbamazepine (an antiepileptic and mood stabilizer) 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 the risk of 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 for 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 certain part of the heart (known as "QT interval prolongation"). Other medicines known to have this effect include certain medicines used to regulate heart rhythm or treat infections, as well as other antipsychotics.
If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines known to have this effect include certain antidepressants or antimicrobials, as well as other antipsychotics.
Caution is advised 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 plans to become pregnant, 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 child, contact your doctor immediately.
This medicine may pass from the mother's body into her breast milk and harm the baby. Therefore, breastfeeding should 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). These effects should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Paliperidone +pharma contains sodium and polysorbate
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".
This medicine contains 12 mg of polysorbate per 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 Paliperidone +pharma

The medicine is administered by a doctor or other medical personnel. It will be injected intramuscularly. 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 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, monthly injections (at a dose ranging from 25 mg to 150 mg) will be given into the upper arm or buttock.

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

Patients with renal impairment
The doctor will adjust the dose of the medicine based on kidney function. If you have mild renal impairment, your doctor may reduce the dose. This medicine should not be used in patients with moderate or severe renal impairment.

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

Taking more Paliperidone +pharma than prescribed
This medicine will be administered under medical supervision, so overdosing 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 you stop receiving the injections, the medicine will no longer be effective. 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 effects

Like all medicines, this medicine can cause adverse effects, 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, immediate medical help must 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 lasting only briefly. These symptoms may indicate a stroke.
• the patient develops fever, muscle stiffness, sweating or reduced 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, tongue or throat, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or oral paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient has planned eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract removal surgery, floppy iris syndrome may occur, which may lead to eye damage.
• the patient has dangerously low levels of certain white blood cells essential for fighting infections.

The following adverse effects 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 (this may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection or other sexual disturbances. In women, they may include: breast discomfort, milk 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 drowsy or reduced alertness

• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements

• dizziness

• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks

• tremor

• headache

• rapid heartbeat

• high blood pressure

• cough, stuffy nose

• 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 insulin levels in blood (hormone regulating blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high triglyceride levels (fats) in blood, increased cholesterol levels in blood
• 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 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 up, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, pricking or numbness sensations in the skin
• blurred vision, eye infection or conjunctivitis, dry eyes
• dizziness, ringing in the ears, ear pain
• heart conduction block, abnormal electrical conduction in the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heart rate, abnormal electrocardiogram (ECG), 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 - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood
• skin rash, 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, 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, galactorrhea
• swelling of 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 1000 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
• sugar 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
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, reduced or loss of consciousness, high fever and severe muscle rigidity), cerebral vascular 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 in the eyeball)
• eye movement disorders, rotational eye movements, light sensitivity, excessive tearing, red eyes
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• blood clot in the lungs causing chest pain and breathing difficulties. If such symptoms occur, immediate medical help must be sought.
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, immediate medical help must be sought.
• facial flushing
• breathing disturbances during sleep (sleep apnoea)
• pulmonary congestion, respiratory tract hyperaemia
• crackling sounds in 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, feeling 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 low 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 disorders
• absence of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes, genital 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 effects 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 181 C, 02 - 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects 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 pre-filled syringe and carton after "EXP:". The expiry date refers to the last day of the specified 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. Proper disposal helps protect the environment.

6. Contents of the package 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, monohydrate citric acid, disodium phosphate, monohydrate sodium dihydrogen phosphate, 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 stopper, lock and needle cap, with a 22G 1½ inch needle with safety device and a 23G 1 inch needle with safety device. All 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 injectable suspension is for single use only. Before administration, inspect visually 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 x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular injection. 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 initiation dose of the medicinal product Paliperidone +pharm (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE using the needle for DELTOID MUSCLE injection.
The second initiation 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 for DELTOID MUSCLE injection.

When switching from long-acting risperidone injections to the medicinal product Paliperidone +pharma, the first injection of Paliperidone +pharma (in a dose range from 25 mg to 150 mg) may be administered into the DELTOID MUSCLE or 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 GLUTEAL MUSCLE using the appropriate needle.

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

For injections into the GLUTEAL MUSCLE, use the 1½-inch, 22G needle (38.1 mm x 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 syringe tip.

4. Peel open the outer blister package of the safety needle. 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 slightly clockwise.

5. Pull back the protective needle shield at the angle shown, away from the syringe barrel.

6. Remove the needle cap with a straight pull. Do not twist the cap, as this 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 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 needle protection. Dispose of the prefilled syringe with attached needle appropriately.

9a

9b

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