Xeplion

Package leaflet: Information for the user

Xeplion 25 mg prolonged-release injectable suspension, 50 mg prolonged-release injectable suspension, 75 mg prolonged-release injectable suspension, 100 mg prolonged-release injectable suspension, 150 mg prolonged-release injectable suspension

Paliperidone
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Xeplion is and what it is used for

Xeplion 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 stabilised with paliperidone or risperidone.
If you have previously responded to paliperidone or risperidone and have mild to moderate symptoms, your doctor may start treatment with Xeplion without prior stabilisation with paliperidone or risperidone.
Schizophrenia is a condition characterised by “positive” and “negative” symptoms. Positive symptoms refer to an excess of symptoms that are normally not present. For example, a person with schizophrenia may hear voices or see things that do not actually exist (called hallucinations), believe things that are not true (called delusions), or be unusually suspicious of others. Negative symptoms refer to a lack of behaviours or feelings that are normally present. For example, a person with schizophrenia may tend to withdraw socially, may not respond emotionally, or may have difficulty speaking clearly and logically. People with this condition may also feel depressed, anxious, guilty, or tense.
Xeplion can help relieve the symptoms of your illness and help prevent them from returning.

2. What you should know before using Xeplion

Do not use Xeplion

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Xeplion.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia 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 medical conditions. For this reason, it is important that you discuss with your doctor if you have any of the following conditions, which could potentially worsen during treatment with this medicine:

• if you have Parkinson’s disease
• if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you know you have previously had low levels of white blood cells in the blood (whether or not caused by other medicines)
• if you have diabetes or are predisposed to diabetes
• if you have been diagnosed with breast cancer or a tumour of the pituitary gland in the brain
• if you have heart disease or are taking treatment for heart disease that tends to lower your blood pressure
• if you have low blood pressure when standing up or when changing suddenly from lying down to sitting position
• if you suffer from epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty controlling your internal body temperature or are exposed to excessive heat
• if you have abnormally high levels of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour
• if you or someone in your family has a history of blood clots (thrombosis), as antipsychotics have been associated with blood clot formation.

If you have any of these conditions, talk to your doctor so they can assess whether it is necessary to adjust your dose or monitor you closely for a period of time.
Since a dangerously low number of a certain type of white blood cells necessary to fight infections in the blood has been observed very rarely in patients taking this medicine, your doctor may check your white blood cell count.
Even if you previously tolerated oral paliperidone or oral risperidone, allergic reactions may rarely occur after receiving Xeplion injections. Contact your doctor immediately if you develop a 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 may negatively affect your health. Your doctor should weigh you regularly.
Since diabetes mellitus has been observed or worsening of pre-existing diabetes mellitus has occurred in patients taking this medicine, your doctor should check for high blood sugar levels. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Since this medicine may reduce the vomiting reflex, it may mask the body's normal response to ingesting toxic substances or other medical conditions.
During cataract surgery (an operation to remove clouding of the lens), the pupil (the black circle in the centre of your eye) may not dilate as required. In addition, the iris (the coloured part of the eye) may become floppy during surgery, which could lead to eye damage. If you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.

Other medicines and Xeplion
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Taking this medicine with carbamazepine (an antiepileptic and mood stabilizer) may require adjustment of the dose of this medicine.
Since this medicine acts mainly on the brain, interactions with other medicines that act on the brain—such as other psychiatric medicines, opioids, antihistamines, and sleep disorder medications—may lead to an increased risk of side effects such as drowsiness or other brain-related effects.
Since this medicine may lower blood pressure, be cautious when using it together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used to treat Parkinson’s disease and restless legs syndrome (e.g., levodopa).
This medicine may cause an abnormality in the electrocardiogram (ECG), characterized by a prolonged duration of electrical impulse conduction through a specific 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, and other antipsychotics.
If you are predisposed to seizures, this medicine may increase the likelihood of experiencing them. Other medicines with this effect include certain antidepressants, antibiotics, and other antipsychotics.
Xeplion should be used with caution together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Xeplion and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. You must not use this medicine during pregnancy unless you have discussed it with your doctor. The following symptoms may occur in newborns of mothers who have used paliperidone during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
This medicine may pass from mother to child through breast milk and may harm the baby. Therefore, do not breastfeed while using 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 in situations requiring full alertness, such as driving a car or operating machinery.

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

3. How to use Xeplion

This medicine will be administered by your doctor or another healthcare professional. Your doctor will determine when you need your next injection. It is important not to miss your scheduled dose. If you think you will not be able to attend your appointment, contact your doctor immediately to arrange a new appointment as soon as possible. You will receive a first injection (150 mg) and a second injection (100 mg) of this medicine in the upper arm, approximately one week apart. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock once every month.

If your doctor is switching you from long-acting risperidone to this medicine, you will receive the first injection of this medicine (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock on the date already scheduled for your next injection. Afterwards, you will receive an injection (ranging from 25 mg to 150 mg) either in the upper arm or in the buttock once every month.

Depending on your symptoms, your doctor may increase or decrease by one dose level the amount of medicine you receive at your scheduled monthly injection.

Patients with kidney problems
Your doctor may adjust the dose of this medicine depending on kidney function. If you have mild kidney problems, your doctor may prescribe a lower dose. If you have moderate to severe kidney problems, this medicine must not be used.

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

If you take more Xeplion than you should
This medicine will be administered under medical supervision, so it is unlikely that you will receive an overdose.
In patients who have received an overdose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, low blood pressure, abnormal electrocardiogram (electrical activity trace of the heart), or slow or abnormal movements of the face, body, arms, or legs.

If you stop using Xeplion
If you stop receiving your injections, you will lose the medicine's effects. You must not stop using this medicine unless instructed by your doctor, as your symptoms may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if:

• you suspect you have blood clots in your veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• you have dementia and notice a sudden change in your mental state, sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech becomes incomprehensible, even briefly. These may be signs of a stroke.
• you develop fever, muscle stiffness, sweating, or reduced level of consciousness (a condition called "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• you are male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• you experience involuntary, rhythmic movements of the tongue, mouth or face. Discontinuation of paliperidone may be necessary.
• you develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash, and sometimes a sudden drop in blood pressure (consistent with an 'anaphylactic reaction'). Although you may previously have tolerated oral risperidone or oral paliperidone, allergic reactions may rarely occur after receiving paliperidone injections.
• you are planning to undergo eye surgery, make sure to inform your ophthalmologist that you are taking this medicine. During cataract surgery (lens clouding), the iris (the colored part of the eye) may become floppy during the procedure (known as "intraoperative floppy iris syndrome"), which may cause eye damage.
• you know you have a dangerously low count of a certain type of white blood cells in your blood needed to fight infections.

The following side effects may occur:
Very common: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep.

Common: may affect up to 1 in 10 people

• symptoms of the common cold, urinary tract infection, feeling as if you have the flu
• Xeplion may increase levels of a hormone called "prolactin" found in blood tests (which may or may not cause symptoms). When symptoms due to high prolactin levels occur, they may include (in men) breast enlargement, difficulty achieving or maintaining erections, or other sexual dysfunction; (in women) breast discomfort, milk discharge from the breasts, loss of menstrual periods, or other menstrual problems
• high blood sugar levels, weight gain, weight loss, decreased appetite
• agitation, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or muscle tension (making movements jerky), and sometimes a sensation of movement starting and stopping. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased or decreased saliva, and loss of facial expression
• restlessness, drowsiness or reduced alertness
• dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. While it may affect any part of the body (resulting in abnormal posture), dystonia often involves facial muscles, including abnormal eye, mouth, tongue or jaw movements.
• dizziness
• dyskinesia: this is a condition involving involuntary muscle movements and may include repetitive, jerky or twisting movements, or spasms.
• tremor
• headache
• rapid heartbeat
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in the blood
• bone or muscle pain, back pain, joint pain
• loss of menstrual period
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• lung infection, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased white blood cell count, decreased levels of a certain type of white blood cells in the blood that help protect the body from infections, anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin in the blood (a hormone that controls blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• increased triglycerides (a fat) in the blood, increased cholesterol in the blood
• sleep disorders, elevated mood (mania), reduced sexual drive, nervousness, nightmares
• tardive dyskinesia (spasms or uncontrolled jerky movements of the face, tongue or other body parts). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. Discontinuation of this medicine may be necessary.
• fainting, an urgent need to move a body part, dizziness when standing up, attention disturbances, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, a tingling, prickling or numbness sensation of the skin
• blurred vision, eye infection or "slightly red" eyes, dry eyes
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption in conduction between upper and lower parts of the heart, abnormal electrical conduction of the heart, QT interval prolongation, rapid heartbeat when standing up, slow heartbeat, abnormal heart electrical pattern (electrocardiogram or ECG), sensation of rapid heartbeat or chest pulsations (palpitations)
• low blood pressure, drop in blood pressure when standing up (as a result, some people taking this medicine may feel faint, dizzy, or may faint when standing or sitting up suddenly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passage of gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyl transferase), increased liver enzymes in the blood
• skin rash (or hives), itching, rash, hair loss, eczema, dry skin, red skin, acne, subcutaneous abscess
• increased CPK (creatine phosphokinase) in the blood, an enzyme sometimes released when muscle damage occurs, muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (lack of control), frequent urination, pain during urination
• erectile dysfunction, ejaculation disorders, absence of menstruation or other menstrual problems (females), breast development in males, sexual dysfunction, breast pain, milk discharge from the breasts
• swelling of the face, mouth, eyes or lips, body swelling, swelling of arms or legs
• increased body temperature
• change in walking pattern
• chest pain, chest discomfort, feeling unwell
• skin hardening
• falls.

Rare: may affect up to 1 in 1,000 people

• eye infection
• skin inflammation caused by mites, scalp or skin flaking and itching
• increased eosinophils (a type of white blood cells) in your blood
• decreased platelets (blood cells that help stop bleeding)
• head tremor
• inappropriate secretion of a hormone controlling urine volume
• sugar in the urine
• complications leading to life-threatening uncontrolled diabetes
• low blood sugar
• excessive water intake
• absence of movement or response while awake (catatonia)
• confusion
• sleepwalking
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, reduced or lost consciousness, high fever, severe muscle rigidity), vascular problems in the brain including sudden loss of blood supply to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (fits), balance disorders
• abnormal coordination
• glaucoma (increased pressure within the eyeball)
• eye movement problems, eyes rolling back, light sensitivity, increased tearing, red eyes
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs which may cause chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs). If you notice any of these symptoms, consult your doctor immediately.
• hot flushes
• breathing problems during sleep (sleep apnea), lung congestion, respiratory congestion
• lung crackles, wheezing
• pancreatitis (inflammation of the pancreas), tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• chapped lips
• drug-related rash, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of breast glands, breast enlargement
• vaginal discharge
• priapism (a prolonged penile erection which may require surgical treatment)
• very low body temperature, chills, feeling thirsty
• drug withdrawal symptoms
• pus accumulation due to infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site.

Not known: frequency cannot be estimated from available data

• dangerous decrease in a certain type of white blood cells in the blood that helps protect the body from infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash, and sometimes a sudden drop in blood pressure
• dangerous and excessive water intake
• sleep-related eating disorder
• coma due to uncontrolled diabetes
• reduced oxygen supply to parts of your body (due to reduced blood flow)
• rapid and shallow breathing, infection due to inhalation of food, voice disorder
• lack of intestinal muscle movement causing blockage
• 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 / toxic epidermal necrolysis)
• severe allergic reaction with swelling that may affect the throat causing breathing difficulties
• skin discoloration
• abnormal posture
• babies born to mothers who took Xeplion during pregnancy may have experienced drug-related adverse events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• reduced body temperature
• death of skin cells at the injection site and ulceration at the injection site

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Xeplion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard carton. The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xeplion contains
The active substance is paliperidone.
Each pre-filled syringe of Xeplion 25 mg contains 39 mg of paliperidone palmitate in 0.25 mL.
Each pre-filled syringe of Xeplion 50 mg contains 78 mg of paliperidone palmitate in 0.5 mL.
Each pre-filled syringe of Xeplion 75 mg contains 117 mg of paliperidone palmitate in 0.75 mL.
Each pre-filled syringe of Xeplion 100 mg contains 156 mg of paliperidone palmitate in 1 mL.
Each pre-filled syringe of Xeplion 150 mg contains 234 mg of paliperidone palmitate in 1.5 mL.

The other ingredients are:
Polysorbate 20
Polyethylene glycol 4000
Monohydrate citric acid
Anhydrous disodium hydrogen phosphate
Monohydrate sodium dihydrogen phosphate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of the appearance of Xeplion and contents of the pack
Xeplion is a white to off-white prolonged-release suspension for injection in a pre-filled syringe.
Each pack contains 1 pre-filled syringe and 2 needles.

Initiation pack:
Each pack contains 1 pack of Xeplion 150 mg and 1 pack of Xeplion 100 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB “JOHNSON & JOHNSON”
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88

България Luxembourg/Luxemburg
”Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.:+359 2 489 94 00 Tél/Tel: +32 14 64 94 11

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel:+420 227 012 227 Tel.:+36 1 884 2858

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD.
Tlf: +45 45 94 82 82 Tel: +356 2397 6000

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: +49 2137-955-955 Tel: +31 76 711 1111

Eesti Norge
UAB “JOHNSON & JOHNSON” Eesti filiaal Janssen-Cilag AS
Tel.: +372 617 7410 Tlf: +47 24 12 65 00

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε Janssen-Cilag Pharma GmbH
Tηλ: +30 210 80 90 000 Tel: +43 1 610 300

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tel: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson s.r.o.
C/o Vistor hf Tel: +421 232 408 400
Sími: +354 535 7000

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tel: +46 8 626 50 00

Latvija United Kingdom (Northern Ireland)
UAB “JOHNSON & JOHNSON” filiāle Latvijā Janssen Sciences Ireland UC
Tel: +371 6789 3561 Tel: +44 1 494 567 444
[email protected]

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/

The following information is intended exclusively for physicians or healthcare professionals and must be read by physicians or healthcare professionals together with the complete prescribing information (Summary of Product Characteristics):

The injectable suspension is for single use only. A visual inspection must be performed to exclude the presence of particulate matter before administration. Do not use if the syringe is not visually free of particulate matter.

The pack contains one pre-filled syringe and two safety needles (one 1½-inch, 22 G [38.1 mm x 0.72 mm] and one 1-inch, 23 G [25.4 mm x 0.64 mm]) for intramuscular injection. Xeplion is also available in a treatment initiation pack containing two pre-filled syringes (150 mg + 100 mg) and two additional safety needles.

(A) 22 G x 1” (grey hub)
(B) 23 G x 1” (blue hub)
(C) Pre-filled syringe
(D) Hub
(E) Closure cap

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

2. Select the appropriate needle. The first initial dose of Xeplion (150 mg) must be administered on Day 1 into the DELTOID muscle using the needle for DELTOID injection. The second initial dose of Xeplion (100 mg) must also be administered into the DELTOID muscle one week later (Day 8) using the needle for DELTOID injection.

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

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

For DELTOID injection:

• If the patient weighs < 90 kg, use the 1-inch, 23 G (25.4 mm x 0.64 mm) needle (the needle with the blue hub).
• If the patient weighs ≥ 90 kg, use the 1½-inch, 22 G (38.1 mm x 0.72 mm) needle (the needle with the grey hub).

For GLUTEAL injection: use the 1½-inch, 22 G (38.1 mm x 0.72 mm) needle (the needle with the grey hub).

3. Holding the syringe with the closure cap facing upwards, remove the rubber closure cap with a slight twisting motion.

4. Open the safety needle blister pack halfway. Grasp the needle cap using the open plastic wrapper. Hold the syringe upright. Attach the safety needle to the syringe with a slight twisting motion to avoid breakage or damage at the needle hub. Always check for any signs of damage or leakage before administration.

5. Remove the needle protective cap with a straight pulling motion. Do not rotate the cap, as the needle may loosen from the syringe.

6. Hold the syringe with the attached needle in an upright position to expel air. Carefully push the plunger forward to remove air from the syringe.

7. Inject the entire content slowly and deeply into the selected deltoid or gluteal muscle by intramuscular route. Do not administer by intravenous or subcutaneous route.

8. After completing the injection, use the thumb or another finger (8a, 8b), or a flat surface (8c) to activate the needle safety device. The safety mechanism is fully activated when a clicking sound (“click”) is heard. Dispose of the syringe with the needle appropriately.

8a

8b

8c

Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.