Byannli

Package leaflet: Information for the user

BYANNLI 700 mg prolonged-release injectable suspension in pre-filled syringe, 1 000 mg prolonged-release injectable suspension in pre-filled syringe

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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What BYANNLI is and what it is used for

BYANNLI contains the active substance paliperidone, which belongs to the class of medicines known as antipsychotics.
BYANNLI is used as maintenance treatment for the symptoms of schizophrenia in adult patients.
If you have responded well to treatment with monthly or every-three-month paliperidone palmitate injections, your doctor may start you on BYANNLI.
Schizophrenia is a condition characterized by both "positive" and "negative" symptoms. "Positive" symptoms refer to an excess of symptoms that are not normally present. For example, a person with schizophrenia may hear voices or see things that are not there (called hallucinations), believe things that are not true (called delusions), or feel 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 For example, a person with schizophrenia may appear withdrawn and may show no emotional response at all, or may have difficulty speaking clearly and logically. People with this condition may also feel depressed, anxious, guilty, or tense.
BYANNLI can help relieve the symptoms of the illness and reduce the risk of symptoms returning.

2. What you need to know before using BYANNLI

Do not use BYANNLI

• if you are allergic to paliperidone or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to risperidone.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using BYANNLI.
This medicine has not been studied in elderly patients with dementia. However, elderly patients with dementia treated with other types of similar medicines may have an increased risk of stroke or death (see section 4).
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 to inform your doctor about any of the following conditions, as they may potentially worsen during treatment with this medicine:

• if you have Parkinson’s disease
• if you have a type of dementia called “dementia with Lewy bodies”
• 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 experienced uncontrollable contractions or jerking movements of the face, tongue, or other parts of the body (Tardive Dyskinesia)
• if you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines)
• if you have diabetes or are at risk for diabetes
• if you have had a breast tumor or a pituitary tumor in the brain
• if you have heart disease or are being treated for heart conditions that make you prone to low blood pressure
• if you have low blood pressure when standing up or sitting down suddenly
• if you have a history of seizures
• if you have kidney problems
• if you have liver problems
• if you have prolonged and/or painful erection
• if you have problems with body temperature regulation or conditions involving hyperthermia
• if you have abnormally high levels of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumor
• 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, discuss them with your doctor, as they may need to adjust your dose or monitor you for a period of time.
Since a dangerously low number of a certain type of white blood cells needed 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 risperidone or paliperidone, allergic reactions may rarely occur after receiving BYANNLI injections. Contact your doctor immediately if you experience a skin rash, throat swelling, itching, or breathing difficulties, as these may be signs of a serious allergic reaction.
This medicine may cause weight gain or weight loss. Significant changes in weight may be harmful to your health. Your doctor should regularly monitor your body weight.
Since type 2 diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine, your doctor should check for signs of high blood sugar levels. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Since 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.

Cataract surgery
If you are planning eye surgery, make sure to inform your ophthalmologist that you are taking this medicine, because during cataract surgery due to lens clouding:

• the pupil (the black circle in the center of the eye) may not dilate as required
• the iris (the colored part of the eye) may become flaccid during surgery, which could lead to eye damage.

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. It is not known whether it is safe and effective in these patients.

Other medicines and BYANNLI
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 a dose adjustment of this medicine.
Since this medicine acts mainly on the brain, using other medicines that act on the brain may increase side effects such as drowsiness or other brain-related effects, such as those caused by other psychiatric medicines, opioids, antihistamines, and sleeping pills.
Inform your doctor if you are taking this medicine while also taking risperidone or paliperidone orally for long periods. You may need to adjust the dose of BYANNLI.
Since this medicine can lower blood pressure, caution is needed when using it with other medicines that 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), showing a prolonged interval before an electrical impulse travels through a certain part of the heart (known as “QT prolongation”). Other medicines that have this effect include certain medicines used to treat heart rhythm or infections, and other antipsychotics.
If you have a history of seizures, this medicine may increase the risk of having them. Other medicines that have this effect include certain medicines used to treat depression or infections, and other antipsychotics.
BYANNLI should be used with caution with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

BYANNLI and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Women of childbearing potential
A single dose of this medicine is expected to remain in the body for up to 4 years, which could pose a risk to a baby. Therefore, BYANNLI should only be used in women who intend to become pregnant if strictly necessary.
Pregnancy
Do not use this medicine during pregnancy unless discussed with your doctor. Newborns of mothers who used paliperidone during the third trimester (last three months of pregnancy) may experience symptoms such as tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. Newborns should be closely monitored, and if the baby shows any of these symptoms, contact your doctor.
Breastfeeding
This medicine may pass from mother to baby through breast milk. It may harm the baby, even long after the last dose. Therefore, you must not breastfeed if you are using or have used this medicine within the last 4 years.

Driving and using machines
While being treated with this medicine, dizziness, extreme tiredness, and vision problems may occur (see section 4). This should be taken into account in situations requiring full alertness, such as driving a car or operating machinery.

BYANNLI contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to use BYANNLI

This medicine will be administered by your doctor or another healthcare professional. Your doctor will
determine when you will need the next injection. It is important not to miss your scheduled dose.
If you think you will be unable to attend your appointment, contact your doctor immediately to reschedule
as soon as possible.
You will receive a BYANNLI injection into the buttocks once every 6 months.
Depending on your symptoms, your doctor may increase or decrease the amount of medicine you receive
at your next scheduled injection.

Patients with kidney problems
If you have mild kidney problems, your doctor will decide whether BYANNLI is appropriate based on the dose of
monthly or quarterly injectable paliperidone palmitate you have received. The 1,000 mg dose of
BYANNLI is not recommended.
If you have moderate to severe kidney problems, this medicine must not be used.

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

If you receive more BYANNLI than you should
Since this medicine is administered under medical supervision, it is unlikely that you will receive an overdose.
However, patients who have received an excessive dose of paliperidone may experience the following
symptoms: drowsiness or sedation, rapid heartbeat, low blood pressure, abnormal electrocardiogram (ECG;
recording of the heart's electrical activity), or slowed or abnormal movements of the face, body, arms, or legs.

If you stop treatment with BYANNLI
If you stop receiving the injections, your schizophrenia symptoms may worsen. Do not stop treatment
with this medicine unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

If you experience any of the following serious side effects, you may need immediate medical treatment; inform your doctor immediately or go immediately to the nearest hospital:

• Blood clots in the veins, especially in the legs. This is rare (may affect up to 1 in 1,000 people). Symptoms include:
  o swelling, pain and redness of the leg (deep vein thrombosis) or
  o chest pain and breathing difficulties caused by blood clots travelling through blood vessels to the lungs (pulmonary embolism)

• Stroke symptoms; frequency is unknown (cannot be estimated from available data). Symptoms include:
  o sudden change in mental state, or
  o sudden weakness or numbness of the face, arms or legs, particularly on one side of the body, or
  o slurred or incoherent speech, even if only for a short time.

• Neuroleptic malignant syndrome. This is rare (may affect up to 1 in 1,000 people). Symptoms include:
  o fever, muscle stiffness, sweating or decreased level of consciousness.

• Prolonged and possibly painful erection (priapism). This is rare (may affect up to 1 in 1,000 people).

• Involuntary jerking movements or contractions that you cannot control, affecting the tongue, mouth and face, or other parts of the body (tardive dyskinesia). This is uncommon (may affect up to 1 in 100 people).

• Severe allergic reaction (anaphylactic reaction), frequency unknown (cannot be estimated from available data). Symptoms include:
  o fever,
  o swelling of the mouth, face, lips or tongue,
  o shortness of breath,
  o itching, rash and, sometimes, a sudden drop in blood pressure.
  Even if you previously tolerated risperidone or paliperidone taken orally, allergic reactions may rarely occur after receiving paliperidone injections.

• Floppy iris syndrome, in which the iris (the coloured part of the eye) becomes floppy during cataract eye surgery. This may cause eye damage (see also “Cataract surgery” in section 2). Frequency is unknown (cannot be determined from available data).

• Stevens-Johnson syndrome or toxic epidermal necrolysis. A severe or potentially life-threatening skin rash with blisters and peeling of the skin, which may start inside and around the mouth, nose, eyes and genitals and may spread to other areas of the body. Frequency is unknown (cannot be estimated from available data).

Inform your doctor immediately or go immediately to the nearest hospital if you notice any of the serious side effects described above.

• Agranulocytosis, a dangerously low count of a certain type of white blood cells in the blood needed to fight infections. Frequency is unknown (cannot be estimated from available data).

Other side effects

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

• Difficulty falling asleep or staying asleep.

Common side effects: may affect up to 1 in 10 people

• Common cold symptoms, urinary tract infection, flu-like symptoms.
• BYANNLI may increase levels of a hormone called “prolactin” detected in a blood test (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, loss of menstrual periods or other menstrual cycle problems.
• Elevated 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 movements), and sometimes a sensation of movement freezing and then restarting. Other signs of parkinsonism include shuffling gait with dragging feet, resting tremor, increased saliva and/or drooling, and loss of facial expression.
• Restlessness, drowsiness or reduced alertness.
• Dystonia: this is a condition involving slow or prolonged involuntary muscle contractions. Although it may affect any part of the body (which may result in abnormal posture), dystonia often affects 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 (shakiness).
• Headache.
• Increased heart rate.
• High blood pressure.
• Cough, stuffy nose.
• Abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache.
• Increased liver transaminases in the blood.
• Bone or muscle pain, back pain, joint pain.
• Loss of menstrual periods.
• Fever, weakness, fatigue (tiredness).
• Injection site reaction, including itching, pain or swelling.

Uncommon side effects: may affect up to 1 in 100 people

• Pneumonia, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, tonsillitis, fungal nail infection, skin infection.

• Decreased white blood cell count.

• Anaemia.

• Allergic reaction.

• Diabetes or worsening of diabetes, increased levels of insulin in the blood (the hormone that controls blood sugar levels).

• Increased appetite.

• Loss of appetite, resulting in malnutrition and low body weight.

• Elevated triglyceride levels (a type of fat), increased cholesterol in the blood.

• Sleep disorders, elevated mood (mania), reduced sexual drive, nervousness, nightmares.

• Fainting, urgent need to move certain body parts, dizziness upon standing, attention disturbances, speech problems, loss or abnormal sense of taste, reduced skin sensitivity to pain and touch, tingling, prickling or numbness of the skin.

• Blurred vision, eye infection or “conjunctivitis”, dry eyes.

• Dizziness (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 of the heart, increased heart rate upon standing, slow heart rate, abnormal tracing of the heart's electrical activity (electrocardiogram or ECG), sensation of rapid heartbeat or pounding in the chest (palpitations).

• Low blood pressure, low blood pressure upon standing (as a result, some people taking this medicine may feel faint, dizzy or may faint when suddenly standing up or sitting up).

• Shortness of breath, sore throat, nosebleeds.

• Abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth, excessive passage of air or gas.

• Increased levels of GGT (a liver enzyme called gamma-glutamyl transferase) in the blood, increased liver enzymes in the blood.

• Rash (or “hives”), itching, skin rash, hair loss, eczema, dry skin, skin redness, acne, skin abscess, skin peeling, scalp or skin itching.

• Increased levels of CPK (creatine phosphokinase), an enzyme in the blood.

• Muscle spasms, joint stiffness, muscle weakness.

• Urinary incontinence (lack of control), frequent urination, painful urination.

• Erectile dysfunction, ejaculation disorders, absence of menstrual periods or other menstrual cycle problems (in female subjects), breast development in male subjects, sexual dysfunction, breast pain, milk discharge from the breasts.

• Swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs.

• Increased body temperature.

• Change in walking pattern.

• Chest pain, chest discomfort, feeling of malaise.

• Hardening of the skin.

• Falls.

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

• Eye infection.
• Skin inflammation caused by mites.
• Increased eosinophils (a type of white blood cells) in the blood.
• Reduced platelets (blood cells that help stop bleeding).
• Inappropriate secretion of a hormone that controls urine volume.
• Sugar in the urine.
• Potentially life-threatening complications from uncontrolled diabetes.
• Low blood sugar levels.
• Excessive water intake.
• Confusion.
• Absence of movement or response while awake (catatonia).
• Sleepwalking.
• Lack of emotions.
• Inability to reach orgasm.
• Lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (fits), balance disorders.
• Abnormal coordination.
• Glaucoma (increased pressure inside the eyeball).
• Problems with eye movements, eye rolling, light sensitivity, increased tearing, eye redness.
• Uncontrollable head shaking.
• Atrial fibrillation (an abnormal heart rhythm), irregular heartbeat.
• Hot flushes.
• Breathing difficulties during sleep (sleep apnoea).
• Pulmonary congestion, respiratory congestion.
• Pulmonary crackles.
• Wheezing.
• Pancreatitis (inflammation of the pancreas).
• Swelling of the tongue.
• Faecal incontinence, very hard stools, intestinal blockage.
• Chapped lips.
• Drug-related skin erythema, skin thickening, dandruff.
• Joint swelling.
• Muscle tissue breakdown (“rhabdomyolysis”).
• Inability to urinate.
• Breast discomfort, enlargement of breast glands, breast enlargement.
• Vaginal discharge.
• Very low body temperature, chills, feeling of thirst.
• Drug withdrawal symptoms.
• Pus accumulation due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.

Not known: frequency cannot be estimated from available data

• Dangerously excessive water intake.
• Sleep-related eating disorder.
• Coma due to uncontrolled diabetes.
• Rapid and shallow breathing, pneumonia caused by food aspiration, voice disorder.
• Reduced oxygen levels in parts of the body (due to reduced blood flow).
• Lack of intestinal movement causing blockage.
• Yellowing of the skin or eyes (jaundice).
• Change in skin colour.
• Abnormal posture.
• Newborns born to mothers who took BYANNLI during pregnancy may experience side effects due to the medicine and/or withdrawal symptoms, such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems.
• Decreased body temperature.
• Dead skin cells at injection site, an ulcer at injection site.

Reporting of side effects

If you experience any side effect, 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 BYANNLI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Ship and store in a horizontal position. See the arrows on the product carton for correct orientation.
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 BYANNLI contains
The active substance is paliperidone.
Each pre-filled syringe of BYANNLI 700 mg contains 1092 mg of paliperidone palmitate
equivalent to 700 mg of paliperidone in 3.5 mL.
Each pre-filled syringe of BYANNLI 1,000 mg contains 1560 mg of paliperidone palmitate
equivalent to 1,000 mg of paliperidone in 5 mL.
The other components are:
Polysorbate 20
Polyethylene glycol 4,000
Monohydrate citric acid
Monohydrate sodium dihydrogen phosphate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of the appearance of BYANNLI and contents of the pack
BYANNLI is a white to off-white prolonged-release injectable suspension in a pre-filled syringe. The pH is approximately 7.0. The doctor or nurse will shake the syringe very rapidly to re-suspend the suspension before administering the injection.
Each pack contains 1 pre-filled syringe and 1 needle.

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

Manufacturer
Janssen Pharmaceutica NV
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
[email protected] [email protected]

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

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

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf.: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

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

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
[email protected]

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

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

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

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

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Tηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija United Kingdom (Northern Ireland)
UAB "JOHNSON & JOHNSON" filiāle Latvijā Janssen Sciences Ireland UC
Tel: +371 678 93561 Tel: +44 1 494 567 444
[email protected] [email protected]

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

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

Important safety summary

Shake the syringe with the
syringe cap pointing upwards
VERY RAPIDLY for at least
15 seconds, allow to rest briefly,
then shake again for 15 seconds.

Shipping and storage
Shipping and storing the
box in a horizontal position
improves the resuspendability
of this highly concentrated
product.
BYANNLI (semi-annual prolonged-release injectable suspension of paliperidone palmitate) requires longer and more vigorous shaking compared to the monthly prolonged-release injectable suspension of paliperidone palmitate.
BYANNLI must be administered by a healthcare professional as a single
Preparation
injection.

• Do not divide the dose into multiple injections. BYANNLI is intended for intramuscular use only, administered in the gluteal site.
• Inject slowly and deeply into the muscle, taking care to avoid injecting into a blood vessel. Administer BYANNLI once every Dosage 6 months. It is important to use only the 0.9 mm x Thin-wall safety needle 38 mm (20 gauge, 1.5 inches) safety needle provided in the kit. It is designed for use with BYANNLI only.

Pack contents
Pre-filled syringe
containing the dose

Syringe cap
Luer connection

Flange
Plunger

Thin-wall safety needle

1. Preparation of the Injection

This highly concentrated product requires specific steps for resuspension.

Always hold the syringe with the
closure cap pointing upwards.

To ensure complete resuspension,
shake the syringe with:

• Short, up-and-down movements, VERY FAST
• Loose wrist
  Shake the syringe VERY VIGOROUSLY for at least 15 seconds, let it rest briefly, then shake again for 15 seconds. If more than 5 minutes pass before injection, shake the syringe VERY FAST with the tip cap pointing up again for at least 30 seconds to resuspend the medication.

Not well mixed

Check the Well mixed
suspension for the

presence of solid particles

• Uniform white, thick and milky appearance – STOP
• Presence of solid material on the sides and upper part of the syringe
• Air bubbles are normal
• Fluid liquid
  The product may clump. If this occurs, shake the syringe with the closure cap pointing upwards VERY VIGOROUSLY for at least 15 seconds, let it rest briefly, then shake again for 15 seconds.

Open the needle container
Peel back the cover from the container.
Place the container with the needle inside on a clean surface.
Remove the closure cap from the syringe and attach
the needle

1. Hold the syringe with the closure cap pointing upwards.
2. Twist and remove the cap.
3. Attach the safety needle to the syringe using a gentle twisting motion to avoid breakage or damage at the needle hub. Always check for any signs of damage or leakage before administration.

Use only the needle provided in this kit.

1. Pull back the plunger
2. Hold the syringe in an upright position.
3. Gently pull back the plunger to clear the syringe tip of any solid material. This will make it easier to push the plunger during injection.

Remove air bubbles
Carefully push the plunger until a drop of liquid appears at the needle tip.

2. Slowly inject the entire contents and check

Select and clean an injection site in the
upper outer quadrant of the buttock.
Do not administer via other routes.
Clean the injection site with an alcohol swab and
allow to dry.
Do not touch, fan, or blow on the injection site after
cleaning.
Remove the needle cover
Remove the needle cover with a straight motion.
Do not rotate the cover, as this may loosen
the needle from the syringe.

Inject slowly and check
Apply slow and steady pressure to push the
plunger completely in. This should take
approximately 30–60 seconds.
Continue to push the plunger if resistance is felt.
This is normal.
While the needle is in the muscle,
confirm that the entire content of the syringe has been injected.
Remove the needle from the muscle.

3. After the injection

Engage the safety needle
After completing the injection, use your thumb or a flat surface to engage the needle into the safety device.
The needle is secured when you hear a "click" sound.
Dispose properly and check the injection site
Dispose of the syringe in an approved sharps container.
There may be a small amount of blood or fluid at the injection site. Apply pressure to the skin using a cotton ball or gauze until bleeding stops.
Do not rub the injection site.
If needed, cover the injection site with a bandage.