NiaPelf 150 mg prolonged-release injection suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Niapelf 25 mg prolonged-release injectable suspension

Niapelf 50 mg prolonged-release injectable suspension

Niapelf 75 mg prolonged-release injectable suspension

Niapelf 100 mg prolonged-release injectable suspension

Niapelf 150 mg prolonged-release injectable suspension

Paliperidone

Read all of this leaflet carefully before you start 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 questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Niapelf is and what it is used for

Niapelf contains the active substance paliperidone, which belongs to the class of antipsychotic medicines. It is used as maintenance treatment for the symptoms of schizophrenia in adult patients who have been stabilized with paliperidone or risperidone.

If you have previously responded to paliperidone or risperidona and have mild to moderate symptoms, your doctor may start treatment with Niapelf without prior stabilization with paliperidone or risperidona.

Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive means an excess of symptoms that are not normally present. For example, a person with schizophrenia may hear voices or see things that do not exist (called hallucinations), have false beliefs (called delusions), or have unusual mistrust of others. Negative refers to the absence of behaviours or emotions that are normally present. For instance, a person with schizophrenia may become withdrawn and unresponsive to emotional stimuli, or may have difficulty speaking in a clear and logical way. People with this disorder may also feel depressed, anxious, guilty, or tense.

Paliperidona can help relieve the symptoms of your illness and prevent them from returning.

2. What you need to know before using Niapelf

Do not use Niapelf

• if you are allergic to paliperidone or to any of the other components of this medicine (listed in section 6).
• if you are allergic to any other antipsychotic medicine, including risperidone.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Niapelf.

This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with similar medicines may have 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 conditions. Therefore, it is important that you discuss with your doctor if you have any of the following conditions, which could worsen during treatment with this medicine:

• if you have Parkinson's disease
• if you have ever been diagnosed with an illness involving high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you have previously had low levels of white blood cells in the blood (which may or may not have been caused by other medicines)
• if you are diabetic or have a tendency towards diabetes
• if you have had breast cancer or a tumor in the pituitary gland of the brain
• if you have heart disease or are receiving treatment for heart conditions that may make you more prone to low blood pressure
• if you have low blood pressure when standing up or getting up suddenly
• if you have epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty regulating body temperature or feel overheated
• if you have abnormally high levels of the hormone prolactin in the blood or have a tumor that may be prolactin-dependent
• if you or someone in your family has a history of blood clots, as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, please consult your doctor, as you may require a dose adjustment or monitoring during treatment.

Because, very rarely, patients treated with this medicine have developed a dangerously low number of a type of white blood cell needed to fight infections in the blood, your doctor may check your white blood cell count.

Even if you have previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after receiving paliperidone injections. Seek immediate medical help if you experience a skin rash, swelling of the throat, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.

This medicine may cause weight gain. Significant weight gain can negatively affect your health. Your doctor will regularly monitor your weight.

Diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients treated with this medicine. Your doctor should check for signs of increased blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Because this medicine may reduce the urge to vomit, it may mask the body's normal response to ingestion of toxic substances or other medical conditions.

During eye surgery for lens clouding (cataracts), the pupil (the black circle in the middle of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents

Do not use this medicine in individuals under 18 years of age.

Other medicines and Niapelf

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Taking this medicine together with carbamazepine (an antiepileptic and mood stabilizer) may require a change in your dose of this medicine.

Since this medicine acts mainly in the brain, interactions with other medicines that also act on the brain may increase side effects such as drowsiness or other brain-related effects, including psychiatric medicines, opioids, antihistamines, and sleeping medicines.

Because this medicine may lower blood pressure, caution is advised if you take it together with other medicines that also lower blood pressure.

This medicine may reduce the effect of medicines used for Parkinson's disease and restless legs syndrome (e.g., levodopa).

This medicine may cause an abnormality in the electrocardiogram (ECG) indicating a prolonged time for an electrical impulse to travel through a certain part of the heart (known as "QT interval prolongation"). Other medicines that have this effect include certain medicines used to treat heart rhythm disorders or infections, as well as other antipsychotics.

If you are prone to seizures, this medicine may increase your risk of experiencing them. Other medicines that have this effect include certain antidepressants and antimicrobials, as well as other antipsychotics.

Niapelf should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Niapelf and alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You should not use this medicine during pregnancy unless discussed with your doctor. The following symptoms may occur in newborn babies of mothers who have been treated with paliperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

This medicine may pass into breast milk and may harm the baby. Therefore, you should not breastfeed while taking this medicine.

Driving and using machines

Dizziness, extreme tiredness, and vision problems may occur during treatment with this medicine (see section 4). This should be taken into account when maximum attention is required, e.g., when driving or operating machinery.

Niapelf contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".

3. How to use Niapelf

This medicine will be administered by your doctor or another healthcare professional. Your doctor will inform you when the next injection should be given. It is important not to miss any of the scheduled doses. If you are unable to attend your appointment, make sure to contact your doctor immediately to reschedule as soon as possible.

You will receive the first injection (150 mg) and the second injection (100 mg) of this medicine in the upper arm approximately one week apart. After that, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

If your doctor is switching you from long-acting injectable risperidone to this medicine, you will receive the first injection of this medicine (between 25 mg and 150 mg) in the upper arm or buttocks at your next scheduled injection. After that, you will receive an injection (between 25 mg and 150 mg) in the upper arm or buttocks once a month.

Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive to a different dose level at the time of your scheduled monthly injection.

Patients with kidney problems

Your doctor may adjust the dose of this medicine according to your kidney function. If you have mild kidney problems, your doctor may give you a lower dose. You must not use this medicine if you have moderate or severe kidney problems.

Elderly patients

Your doctor may reduce the dose of this medicine if your kidney function is reduced.

If you receive more Niapelf than you should

You will receive this medicine under medical supervision, so it is unlikely that you will receive an overdose.

Patients who have received an overdose of paliperidone may experience the following symptoms: drowsiness or sedation, rapid heartbeat, low blood pressure, abnormalities in the electrocardiogram (electrical tracing of the heart), or slow or abnormal movements of the face, body, arms, or legs.

If you stop using Niapelf

If you stop receiving your injections, the effects of the medicine will be lost. You should not stop using this medicine unless instructed by your doctor, as your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Tell your doctor immediately if:

• you develop 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 you notice any of these symptoms, seek medical advice immediately.
• you have dementia and experience a sudden change in mental status or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking, even for a short period. These may be signs of a stroke.
• you develop fever, muscle stiffness, sweating, or decreased level of consciousness (a disorder known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• you are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be needed.
• you develop involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of paliperidone may be necessary.
• you experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (i.e., an "anaphylactic reaction"). Even if you have previously tolerated oral risperidone or oral paliperidone, severe allergic reactions have rarely occurred after receiving paliperidone injections.
• you are scheduled for eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery, the iris (the colored part of the eye) may become floppy during surgery (known as "floppy iris syndrome"), which may cause eye damage.
• you have a dangerously low number of a type of white blood cells needed to fight blood infections.

The following adverse effects may occur:

Very common adverse effects: may affect more than 1 in 10 patients

• difficulty falling or staying asleep.

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

• symptoms of common cold, urinary tract infection, feeling as if you have the flu
• paliperidone may increase levels of a hormone called "prolactin" detectable in blood tests (which may or may not cause symptoms). When symptoms of elevated prolactin occur, they may include (in men) breast swelling, difficulty achieving or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems
• increased blood sugar, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: This condition may include slow or impaired movement, a feeling of stiffness or tightness in the muscles (causing jerky movements), and sometimes a sensation of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and loss of facial expressiveness
• restlessness, drowsiness, or reduced alertness
• dystonia: A disorder involving involuntary, slow, or sustained muscle contractions. Although any part of the body may be affected (and may lead to abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements
• dizziness
• dyskinesia: This disorder involves involuntary muscle movements and may include repetitive, spasmodic, or twisting movements, or spasms
• tremor (shakiness)
• headache
• rapid heartbeat
• increased blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain, or swelling

Uncommon adverse effects: may affect up to 1 in 100 patients

• pneumonia, chest infection (bronchitis), respiratory tract infection, nasal infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased number of white blood cells, decreased number of a type of white blood cells that help fight infections, anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin (a hormone that controls blood sugar levels) in blood
• increased appetite
• loss of appetite leading to malnutrition and decreased body weight
• increased blood triglycerides (fat), increased blood cholesterol
• sleep disorder, euphoria (mania), decreased sex drive, nervousness, nightmares
• tardive dyskinesia (involuntary spasms or spasmodic movements of the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of this medicine may be necessary.
• fainting, restlessness causing movement of body parts, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin
• blurred vision, eye infection, or "red eye," dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• conduction block between upper and lower parts of the heart, abnormal heart electrical activity, QT interval prolongation on the electrocardiogram (ECG), rapid heartbeat upon standing, slow heartbeat, abnormalities in the heart's electrical tracing (ECG), sensation of fluttering or pounding in the chest (palpitations)
• decreased blood pressure, low blood pressure upon standing (thus, some people taking this medicine may feel weak, dizzy, or may faint when standing or sitting up suddenly)
• shortness of breath, sore throat, nosebleeds
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excess gas or flatulence
• increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood, increased liver enzymes in blood
• hives (or "urticaria"), itching, rash, hair loss, eczema, dry skin, skin redness, acne, abscess under the skin
• increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
• muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (loss of bladder control), frequent urination, painful urination
• erectile dysfunction, ejaculation disorder, absence of menstrual periods or other menstrual cycle problems (women), breast development in men, sexual dysfunction, breast pain, milk secretion from breasts
• swelling of the face, mouth, eyes, or lips, body swelling, arms or legs swelling
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling of unease
• skin hardening
• falls

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

• eye infection
• skin inflammation caused by mites, scaly and itchy skin or scalp
• increased eosinophils (a type of white blood cell) in blood
• decreased platelets (blood cells that help stop bleeding)
• head agitation
• inappropriate secretion of the hormone controlling urine volume
• sugar in urine
• potentially life-threatening complications of uncontrolled diabetes
• decreased blood sugar
• excessive water intake
• lack of movement or response while awake (catatonia)
• confusion
• sleepwalking
• absence of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever, and severe muscle rigidity), problems with brain blood vessels, including sudden loss of blood supply to the brain (stroke or "mini" stroke), unresponsiveness to stimuli
• loss of consciousness, decreased level of consciousness, seizures (epileptic fits), balance disorder
• abnormal coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, eye rolling, light sensitivity of the eyes, increased tearing, eye redness
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs causing chest pain and breathing difficulty. If you experience any of these symptoms, see a doctor immediately.
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg). If you experience any of these symptoms, seek immediate medical help
• flushing
• difficulty breathing during sleep (sleep apnea)
• pulmonary congestion, respiratory congestion
• crackling lung sounds, wheezing
• pancreatitis (inflammation of the pancreas), tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• cracked lips
• drug-related skin rash, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of breast glands, breast growth
• vaginal discharge
• priapism (a prolonged erection that may require surgical treatment)
• very low body temperature, chills, sensation of thirst
• medication withdrawal symptoms
• pus accumulation due to infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site.

Frequency not known: cannot be estimated from available data

• dangerously low number of a type of white blood cells needed to fight infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, breathing difficulty, itching, skin rash, and sometimes drop in blood pressure
• dangerously excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• decreased oxygen in parts of the body (due to reduced blood flow)
• rapid, shallow breathing, aspiration pneumonia (pneumonia caused by inhaling food), voice disorder
• absence of intestinal movement causing obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening skin rash with blisters and skin peeling that may start inside and around the mouth, nose, eyes, and genitals and spread to other body areas (Stevens-Johnson Syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling that may affect the throat, causing breathing difficulty
• skin discoloration
• abnormal posture
• newborn babies of mothers who were treated with paliperidone during pregnancy may experience adverse effects from the medicine and/or withdrawal symptoms such as irritability, weak or sustained muscle contractions, restlessness, drowsiness, breathing problems, or feeding difficulties
• decreased body temperature
• dead skin cells at the injection site and ulceration at the injection site

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Niapelf

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Niapelf

The active substance is paliperidone.

Each pre-filled syringe of Niapelf 25 mg contains 39 mg of paliperidone palmitate.

Each pre-filled syringe of Niapelf 50 mg contains 78 mg of paliperidone palmitate.

Each pre-filled syringe of Niapelf 75 mg contains 117 mg of paliperidone palmitate.

Each pre-filled syringe of Niapelf 100 mg contains 156 mg of paliperidone palmitate.

Each pre-filled syringe of Niapelf 150 mg contains 234 mg of paliperidone palmitate.

The other components are:

Polysorbate 20

Macrogol

Monohydrate citric acid (E-330)

Disodium phosphate

Sodium dihydrogen phosphate dihydrate

Sodium hydroxide (E-524)

Water for injections

Nature of the product and contents of the pack

Niapelf is a white to off-white prolonged-release injectable suspension supplied in a pre-filled syringe.

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

Treatment initiation pack:

Each pack contains 1 pack of Niapelf 150 mg and 1 pack of Niapelf 100 mg.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona

Spain

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

Richrath, Langenfeld (Rheinland)

40764 Germany

More information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Belgium/Belgium/Belgium Neuraxpharm Belgium Tel/Tel: +32 (0)2 732 56 95	Lithuania Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00
Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00	Luxembourg/Luxembourg Neuraxpharm France Tel/Tel: +32 474 62 24 24
Czech Republic Neuraxpharm Bohemia s.r.o. Tel: +420 739 232 258	Hungary Neuraxpharm Hungary Kft. Tel.: +36 (30) 542 2071
Denmark Neuraxpharm Sweden AB Tlf: +46 (0)8 30 91 41 (Sweden)	Malta Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00
Germany neuraxpharm Arzneimittel GmbH Tel: +49 2173 1060 0	Netherlands Neuraxpharm Netherlands B.V Tel: +31 70 208 5211
Estonia Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00	Norway Neuraxpharm Sweden AB Tlf: +46 (0)8 30 91 41
Greece Brain Therapeutics IKE Tel: +302109931458	Austria Neuraxpharm Austria GmbH Tel.: +43 2236 320038
Spain Neuraxpharm Spain, S.L.U. Tel: +34 93 475 96 00	Poland Neuraxpharm Polska Sp. z.o.o. Tel.: +48 783 423 453
France Neuraxpharm France Tél: +33 1.53.62.42.90	Portugal Neuraxpharm Portugal, Unipessoal Lda Tel: +351 910 259 536
Croatia Neuraxpharm Pharmaceuticals, S.L. T: +34 93 602 24 21	Romania Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00
Ireland Neuraxpharm Ireland Ltd. Tel: +353 1 428 7777	Slovenia Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00
Iceland Neuraxpharm Sweden AB Sími: +46 (0)8 30 91 41 (Sweden)	Slovakia Neuraxpharm Slovakia a.s Tel: +421 255 425 562
Italy Neuraxpharm Italy S.p.A. Tel: +39 0736 980619	Finland Neuraxpharm Sweden AB Puh/ Tel: +46 (0)8 30 91 41 (Sweden/Sweden)
Cyprus Brain Therapeutics ΙΚΕ Tel: +302109931458	Sweden Neuraxpharm Sweden AB Tel: +46 (0)8 30 91 41
Latvia Neuraxpharm Pharmaceuticals, S.L. Tel: +34 93 475 96 00	United Kingdom (Northern Ireland) Neuraxpharm Ireland Ltd. Tel: +353 1 428 7777

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

This information is intended for healthcare professionals only and should be read together with the complete prescribing information (Summary of Product Characteristics).

The injectable suspension is for single use only. It should be visually inspected for any foreign particles before administration. Do not use the product if the syringe is not visually free from foreign particles.

The package contains a prefilled syringe and two safety needles (one 22-gauge 1½-inch [38.1 mm x 0.72 mm] needle and one 23-gauge 1-inch [25.4 mm x 0.64 mm] needle) for intramuscular injection. Niapelf is also available as a Treatment Initiation Kit containing two prefilled syringes (150 mg + 100 mg) and two additional safety needles.

1. Shake the syringe vigorously for at least 10 seconds to ensure a homogeneous suspension.

1. Select the appropriate needle.

The first initiation dose of Niapelf (150 mg) is administered on Day 1 into the DELTOID muscle using the needle intended for injection into the DELTOID. The second initiation dose of Niapelf (100 mg) is also administered into the DELTOID muscle one week later (Day 8) using the needle intended for injection into the DELTOID.

If a patient is being switched from long-acting injectable risperidone to Niapelf, the first injection of Niapelf (dose range 25 mg to 150 mg) may be administered into either the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site, at the time of the next scheduled injection.

Subsequently, monthly maintenance injections may be administered into either the DELTOID or GLUTEAL muscle, using the appropriate needle for the injection site.

For injection into the DELTOID: if the patient weighs < 90 kg, use the 23-gauge 1-inch needle (25.4 mm x 0.64 mm) (needle with blue hub); if the patient weighs ≥ 90 kg, use the 22-gauge 1½-inch needle (38.1 mm x 0.72 mm) (needle with gray hub).

For injection into the GLUTEAL muscle, use the 22-gauge 1½-inch needle (38.1 mm x 0.72 mm) (needle with gray hub).

1. While holding the syringe upright, remove the rubber cap from the tip with a twisting motion.

1. Open the safety needle pouch halfway. Hold the needle cover using the peelable pouch. Attach the safety needle to the luer connection of the syringe with an easy clockwise twisting motion.

1. Pull the cover straight off to separate it from the needle. Do not twist the cover, as the needle may detach from the syringe.

1. Position the syringe with attached needle upright to proceed with air removal. Remove air from the syringe by carefully pushing the plunger forward.

1. Inject the entire contents slowly and deeply into the selected deltoid or gluteal muscle by intramuscular route. Must not be administered intravascularly or subcutaneously.

2. After completing the injection, use the thumb or another finger of the hand (8a, 8b) or a flat surface (8c) to activate the needle safety system. The system is fully activated when a click is heard. Dispose of the syringe with the needle properly.

Any unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations.