Rispolept consta

Package leaflet: Information for the user

Rispolept Consta, 25 mg, powder and solvent for suspension for injection
prolonged-release
Rispolept Consta, 37.5 mg, powder and solvent for suspension for injection
prolonged-release
Rispolept Consta, 50 mg, powder and solvent for suspension for injection
prolonged-release
Risperidone
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Rispolept Consta is and what it is used for

Rispolept Consta belongs to a group of medicines called antipsychotics.
Rispolept Consta is used for the maintenance treatment of schizophrenia, a condition in which the patient
sees, hears or feels things that do not exist, believes in things that are not true, or experiences unusual
suspiciousness or confusion.
Rispolept Consta is intended for patients currently being treated with oral antipsychotic medicines
(e.g. tablets, capsules).
Rispolept Consta may help relieve the symptoms of the illness and prevent their recurrence.

2. Important information before using Rispolept Consta

When not to use Rispolept Consta

• if the patient is allergic to risperidone or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

• if the patient has never previously taken Rispolept in any form, Rispolept in oral form should be used first before starting treatment with Rispolept Consta.

Before starting treatment with Rispolept Consta, discuss the following with the doctor or pharmacist:

• if the patient has heart function disorders, for example irregular heartbeat, or if the patient is prone to low blood pressure, or is taking medicines to regulate blood pressure. Rispolept Consta may cause a drop in blood pressure. Dose adjustment may be necessary
• if the patient is aware of any factors that may predispose them to stroke, such as high blood pressure, cardiovascular disorders, or cerebrovascular disorders
• if the patient has ever experienced involuntary movements of the tongue, lips, or face
• if the patient has ever had a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as neuroleptic malignant syndrome)
• if the patient has Parkinson's disease or dementia
• 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
• if the patient has epilepsy
• if the patient is male and has experienced prolonged or painful erection
• if the patient has disorders of body temperature regulation or is overheating
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• if the patient or a family member has previously experienced blood clots, as use of medicines such as Rispolept Consta is associated with an increased risk of thrombosis.

If the patient is unsure whether any of the symptoms described above apply, they should consult a doctor or pharmacist before using Rispolept or Rispolept Consta.
The treating doctor may order a white blood cell count test, as very rarely, patients taking Rispolept Consta have developed dangerously low levels of a certain type of white blood cells essential for fighting infections.
Even if the patient previously tolerated orally administered risperidone, allergic reactions may rarely occur after injections of Rispolept Consta. Immediate medical help should be sought if the patient develops: rash, throat swelling, itching, or breathing difficulties, as these may be symptoms of a severe allergic reaction.
Rispolept Consta may cause weight gain. Significant weight gain may adversely affect health. The treating doctor will regularly monitor the patient's body weight.
The doctor should check whether the patient has symptoms of high blood glucose levels, as diabetes and worsening of pre-existing diabetes have been observed in patients taking Rispolept. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Rispolept Consta often increases the level of a hormone called prolactin. This may cause adverse effects such as: menstrual disorders, fertility problems in women, breast enlargement in men (see: Possible side effects). If such adverse effects occur, blood prolactin level testing is recommended.
During cataract removal surgery, the pupil may not dilate sufficiently. Also, the iris of the eye may be flaccid during the procedure, which may lead to eye damage. If the patient has planned eye surgery, they should inform the ophthalmologist about taking this medicine.

Elderly patients with dementia
Rispolept Consta should not be given to elderly patients with dementia.
Immediate medical help should be sought if the patient or caregiver notices sudden changes in mental status, sudden muscle weakness or numbness, especially on one side of the body, or speech disturbances, even if they are brief. These symptoms may indicate a stroke.

Patients with kidney or liver function disorders
Studies have been conducted on oral administration of risperidone in patients with kidney or liver function disorders, but no studies have been conducted on the use of Rispolept Consta. In this group of patients, Rispolept Consta should be used with caution.

Rispolept Consta and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Patients should especially inform the doctor or pharmacist if they are taking
any of the following medicines:

• sedatives acting on the brain (benzodiazepines) or certain painkillers (opioids), antiallergic medicines (some antihistamines), as risperidone may enhance their sedative effect
• medicines that may cause changes in the electrical activity of the heart, such as antimalarial drugs, antiarrhythmics, antiallergic medicines (antihistamines), certain antidepressants, or other medicines used to treat other mental disorders
• medicines that cause slowing of the heart rate
• medicines that reduce potassium levels in the blood (e.g. certain diuretics)
• medicines used to treat Parkinson's disease (e.g. levodopa), medicines that increase central nervous system activity (psychostimulants such as methylphenidate)
• medicines used for high blood pressure. Rispolept Consta may lower blood pressure
• diuretics used in patients with heart disease or to relieve swelling in areas where excess fluid has accumulated (e.g. furosemide or chlorothiazide). Rispolept Consta, used alone or in combination with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• rifampicin (a medicine used to treat certain infections)
• carbamazepine, phenytoin (antiepileptic medicines)
• phenobarbital. When starting or stopping these medicines, a change in the dose of risperidone may be necessary.

The following medicines may increase the effect of risperidone:

• quinidine (used in certain heart conditions)
• antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants
• beta-blockers (used to treat high blood pressure)
• phenothiazines (e.g. used to treat psychosis or for sedation)
• cimetidine, ranitidine (reducing stomach acid)
• itraconazole and ketoconazole (used to treat fungal infections)
• certain medicines used to treat HIV/AIDS, such as ritonavir
• verapamil, used to treat high blood pressure and (or) heart rhythm disorders
• sertraline and fluvoxamine, used to treat depression and other mental disorders.

When starting or stopping these medicines, a change in the dose of risperidone may be necessary.
If the patient is unsure whether they have taken or are taking any of the medicines listed above, they should consult a doctor or pharmacist before using Rispolept Consta.

Rispolept Consta with food, drink and alcohol
Do not drink alcohol while taking Rispolept Consta.

Pregnancy, breastfeeding and effects on fertility

• if the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient may use Rispolept Consta
• in newborns whose mothers took Rispolept Consta during the third trimester (last 3 months of pregnancy), the following symptoms may occur: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the baby, contact a doctor
• Rispolept Consta may increase the level of prolactin in the blood – a hormone that may affect fertility (see section "Possible side effects").

Driving and using machines
While taking Rispolept Consta, dizziness, tiredness, and vision disturbances may occur. Therefore, without consulting a doctor, do not drive, use any tools, or operate any machinery.

Rispolept Consta contains sodium
The medicine contains less than 1 mmol of sodium (23 mg), meaning the medicine is considered "sodium-free".

3. How to use Rispolept Consta

This medicine should always be used as directed by the doctor. If in doubt, consult
your doctor or pharmacist.
Rispolept Consta is administered as an intramuscular injection into the arm or buttock every
2 weeks by a doctor or nurse. Injections should be alternated, one time on the right side,
then on the left. Intravenous administration is not allowed.
Recommended dose:
Adults
Initial dose
If the oral daily dose of risperidone taken during the last 2 weeks was 4 mg or less,
the initial dose of Rispolept Consta should be 25 mg.
If the oral daily dose of risperidone taken during the last 2 weeks was greater than 4 mg,
the initial dose of Rispolept Consta may be 37.5 mg.
If the patient is currently being treated with an oral antipsychotic other than risperidone,
the initial dose of Rispolept Consta will depend on the previous therapy. The doctor will
determine and prescribe Rispolept Consta at a dose of either 25 mg or 37.5 mg.
The doctor will adjust the dose of Rispolept Consta according to the individual patient's needs.
Maintenance dose:

• the usual dose is 25 mg administered as an injection every two weeks
• if necessary, a higher dose of 37.5 mg or 50 mg may be given. The doctor will adjust the dose of Rispolept Consta according to the individual patient's needs
• the doctor may also recommend concomitant use of oral Rispolept for three weeks following the first injection.

Use of a higher than recommended dose of Rispolept Consta

• in patients who received a higher than recommended dose of Rispolept Consta, the following symptoms have been observed: drowsiness, fatigue, abnormal body movements, difficulty maintaining balance and walking, dizziness due to low blood pressure, and irregular heartbeat. Cases of abnormal electrical conduction in the heart and seizures have also been reported
• seek immediate medical attention.

Discontinuation of Rispolept Consta
The effect of the medicine will wear off if the patient stops using it. Therefore, do not discontinue
treatment without explicit instructions from the doctor, as this may lead to relapse of the illness.
Always attend scheduled biweekly appointments at the doctor's office for the next injection.
If the patient cannot attend an appointment, they should immediately notify the doctor to arrange
an alternative date.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Use in children and adolescents
Rispolept Consta is not intended for use in individuals under 18 years of age.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediately inform the doctor if the patient experiences any of the following
uncommon adverse reactions (may occur in less than 1 in 100 people):

• sudden change in mental state or sudden weakness or numbness of the face or limbs, especially on one side, or speech disturbances, even if brief, in a patient with dementia. These symptoms may indicate a stroke
• tardive dyskinesia (involuntary, jerking or writhing movements of the face, tongue or other body parts). Promptly inform the doctor if rhythmic involuntary movements of the tongue, mouth or face occur. Discontinuation of Rispolept Consta may be necessary.

Immediately inform the doctor if the patient experiences any of the following
rare adverse reactions (may occur in less than 1 in 1,000 people):

• blood clots in veins, especially in the legs (symptoms include swelling, pain and redness in the leg); these clots may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help
• fever, muscle stiffness, sweating or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be required
• prolonged or painful erection in men. This condition is known as priapism. Immediate treatment may be required
• severe allergic reaction characterized by fever, swelling of the lips, face, tongue or mouth, breathing difficulties, skin itching, rash or low blood pressure. Even if

the patient previously tolerated orally administered risperidone, allergic reactions may rarely occur after injections of Rispolept Consta.
Other adverse reactions may also occur:
Very common adverse reactions (may occur in more than 1 in 10 people):

• cold-like symptoms
• difficulty falling asleep or waking up
• depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation and (or) drooling, and expressionless face
• headache.

Common adverse reactions (may occur in less than 1 in 10 people):

• pneumonia, respiratory tract infection (bronchitis), sinus infection
• urinary tract infection, flu-like symptoms, anaemia
• increased blood levels of prolactin hormone (with or without symptoms). Symptoms of elevated prolactin occur uncommonly and may include in men: breast swelling, difficulty achieving or maintaining erection, reduced sexual drive or other sexual disturbances. In women, these may include breast discomfort, milk discharge from the breasts, absence of menstrual bleeding, other menstrual cycle disturbances or fertility problems
• high blood sugar levels, weight gain, increased appetite, weight loss, decreased appetite
• sleep disturbances, irritability, decreased libido, restlessness, drowsiness or reduced alertness
• dystonia: in this condition, slow or sustained involuntary muscle contractions occur. These may affect any part of the body (possibly resulting in abnormal body posture), but dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• dizziness
• dyskinesia: in this condition, involuntary muscle movements occur, including repetitive, spasmodic or twisting movements or jerks
• tremor
• blurred vision
• rapid heartbeat
• low blood pressure, chest pain, high blood pressure
• shortness of breath (dyspnoea), sore throat, cough, nasal congestion
• abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, stomach or intestinal infection, constipation, diarrhoea, indigestion, dry mouth, toothache
• rash
• muscle cramps, bone or muscle pain, back pain, joint pain
• urinary incontinence
• erectile dysfunction
• absence of menstruation
• milk discharge from the breasts
• swelling of the body, upper or lower limbs, fever, weakness, fatigue (tiredness)
• pain
• injection site reaction, including itching, pain or swelling
• increased blood levels of aminotransferase enzymes, increased blood levels of GGT enzyme (liver enzyme - gamma-glutamyl transferase)
• falls.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

• respiratory tract infection, bladder infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized skin infection, viral infection, skin inflammation caused by mites, subcutaneous abscess
• decreased number of white blood cells, decreased number of platelets (blood cells that help stop bleeding), decreased number of red blood cells
• allergic reaction
• presence of sugar in urine, onset of diabetes or worsening of existing diabetes
• loss of appetite leading to malnutrition and low body weight
• increased blood levels of triglycerides (fats), increased blood cholesterol levels
• elevated mood (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• loss of consciousness, seizures, fainting
• irresistible urge to move body parts, balance disturbances, abnormal coordination, dizziness upon standing, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, prickling or numbness of the skin
• eye infection or conjunctivitis, dry eyes, excessive tearing, red eyes
• dizziness, tinnitus, ear pain
• atrial fibrillation (irregular heartbeat), conduction block between heart chambers, abnormal electrical conduction in the heart, QT interval prolongation on ECG, slow heart rate, abnormal electrocardiogram (ECG), palpitations
• low blood pressure upon standing (as a result, some patients taking Rispolept Consta may faint, feel dizzy or lose consciousness when standing up or sitting down suddenly)
• rapid, shallow breathing, respiratory congestion, rattling sounds, nosebleeds
• faecal incontinence, difficulty swallowing, excessive passing of gas
• itching, hair loss, rash, dry skin, skin redness, skin depigmentation, acne, scaly and itchy skin on the scalp or other body parts
• increased blood levels of creatine kinase, an enzyme sometimes released from damaged muscles
• joint stiffness, joint swelling, muscle weakness, neck pain
• frequent urination, inability to urinate, painful urination
• ejaculation disorders, delayed menstruation, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, breast discomfort, vaginal discharge
• swelling of the face, lips, eyes or mouth
• chills, increased body temperature
• change in walking pattern
• thirst, malaise, chest discomfort, feeling unwell
• skin hardening
• increased liver enzyme activity in blood
• pain related to medical procedures.

Rare adverse reactions (may occur in less than 1 in 1,000 people):

• decreased number of a certain type of white blood cells responsible for fighting infections
• abnormal secretion of the hormone regulating urine production
• low blood sugar levels
• excessive water drinking
• sleepwalking (somnambulism)
• eating disorders related to sleep
• reduced motor activity or lack of response in a patient with preserved consciousness (catatonia)
• lack of emotion
• low level of consciousness
• tremulous, nodding head movements
• eye movement disorders, rotary eye movements, light sensitivity
• eye complications during cataract surgery. During this procedure, floppy iris syndrome (Intraoperative Floppy Iris Syndrome, IFIS) may occur if the patient is currently or previously taking Rispolept Consta. If the patient is scheduled for cataract surgery, the ophthalmologist must be informed about current or past use of this medicine
• irregular heartbeat
• dangerously low number of certain white blood cells responsible for fighting infections, increased number of eosinophils (a type of white blood cell) in blood
• breathing disturbances during sleep (sleep apnoea)
• aspiration pneumonia (caused by food entering the airways), pulmonary congestion, crackles, speech difficulties, respiratory tract disturbances
• pancreatitis, intestinal obstruction
• very hard stools
• drug rash
• urticaria, skin thickening, dandruff, skin disorders, skin damage
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• abnormal posture
• breast enlargement, nipple discharge
• low body temperature, discomfort
• yellowing of the skin and eyes (jaundice)
• dangerously excessive water drinking
• increased blood insulin levels (hormone regulating blood sugar)
• cerebral vascular disorders
• lack of response to stimuli
• coma due to uncontrolled diabetes
• sudden vision loss or blindness
• glaucoma (increased pressure in the eyeball), eyelid margin ulcers (with crust formation)
• episodes of flushing, tongue swelling
• dry lips
• enlargement of mammary glands
• low body temperature, cold hands and feet
• withdrawal symptoms.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

• life-threatening complications related to uncontrolled diabetes
• severe allergic reaction with swelling that may involve the throat and lead to breathing difficulties
• loss of intestinal function leading to obstruction.

Adverse reactions with unknown frequency: frequency cannot be estimated from available data

• severe or life-threatening rash with blisters and peeling skin, which may appear in the mouth, nose, eyes, genital organs and around these areas, and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

An adverse reaction observed during use of another medicine – paliperidone – very similar to risperidone, which may also occur during use of Rispolept Consta:
rapid heartbeat upon standing up.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform the doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Rispolept Consta

Keep this medicine out of 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 stated month.
Store in a refrigerator (2°C - 8°C). Rispolept Consta may be kept outside the refrigerator at a temperature below 25°C for up to 7 days prior to administration. The prepared suspension must be used within 6 hours (if stored at temperatures up to 25°C).
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Rispolept Consta Contains
The active substance is risperidone.
Each vial of powder for the preparation of a prolonged-release injectable suspension
Rispolept Consta contains 25 mg, 37.5 mg, or 50 mg of risperidone.
Other ingredients are:

• Powder: 7525 DL JN1 [poly (D,L-lactide-co-glycolide)],
• Solvent: polysorbate 20, sodium carboxymethylcellulose 40 mPas, disodium hydrogen phosphate dihydrate, anhydrous citric acid, sodium chloride, sodium hydroxide, water for injections.

What Rispolept Consta Looks Like and Contents of the Package

• One vial containing powder (the powder contains the active substance risperidone);
• One pre-filled syringe with 2 ml of clear, colourless solvent for Rispolept Consta, to be added to the powder for the preparation of a prolonged-release injectable suspension;
• One vial adapter for preparing the suspension;
• Two Terumo SurGuard 3 needles for intramuscular injection:
  • One 21G UTW 1-inch (0.8 mm x 25 mm) safety needle for deltoid muscle injection;
  • One 20G TW 2-inch (0.9 mm x 51 mm) safety needle for gluteal muscle injection.

Rispolept Consta is available in packages containing 1 set or in a multipack
containing 5 sets.
In Poland, the following pack sizes are available:
Pack containing 1 set: 1 vial + 1 pre-filled syringe + 1 device for
preparing the suspension + 2 intramuscular injection needles (1-inch needle for deltoid muscle injection, 2-inch needle for gluteal muscle injection).
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse,
Belgium
Manufacturer:
Janssen Pharmaceutica NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
CAP Pharmacy Line
179 Giannos Kranidiotis Avenue
Latsia, 2235 Nicosia
Cyprus
For more detailed information, please contact the local representative of the marketing authorisation holder:
Janssen-Cilag Polska sp. z o.o.
tel.: + 48 22 237 60 00
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria/Belgium/Cyprus/Czech Republic/Denmark/Finland/Greece/Spain/Netherlands/Iceland/Ireland/
Liechtenstein/Luxembourg/Malta/Norway/Portugal/Slovakia/Slovenia/Sweden/Hungary/United
Kingdom: RISPERDAL CONSTA
Estonia/Lithuania/Latvia/Poland/Romania: RISPOLEPT CONSTA
France: RISPERDAL CONSTA LP
Germany: RISPERDAL CONSTA 25 mg, 37.5 mg, 50 mg
Italy: RISPERDAL
IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS
Important Information
To ensure successful administration of the medicinal product Rispolept Consta, carefully read the “Instructions for Use of the Device” (step by step).
Use only components of the kit
The components of this kit are specifically intended for use with the medicinal product Rispolept Consta. Only the solvent provided in the package must be used to prepare the suspension of Rispolept Consta.
DO NOT substitute ANY of the components included in the package.
Do not store the suspension after preparation
The suspension should be administered as soon as possible after preparation to avoid sedimentation.
Proper administration
The entire contents of the vial must be administered to ensure the patient receives the correct dose of the medicinal product Rispolept Consta.
Single-use device
Do not reuse: Medical devices are designed to function as intended only when specific material properties are maintained. These properties have been validated only for single use. Any attempt to reuse the device may lead to device damage or impaired performance.
Contents of the Package

Step 1 Assembly of the Kit
Remove the packaging Connect the vial to the adapter

Wait Remove cap Prepare adapter Connect adapter
30 minutes from vial
from vial to vial
Before preparing the Remove the coloured Remove the paper seal Covering the vial.
suspension, remove the blister as shown. Sterilize the top of the Place the vial on a
package of Rispolept hard surface
Consta from the fridge and rubber stopper with a gauze pad
and leave at room temperature for at least 30 minutes. soaked in alcohol.
Do not remove the rubber stopper from the vial.
Do not heat in any way.
Never touch the spike. This may contaminate it.
Do not place the adapter on the vial at an angle, as this may cause leakage of the solvent when adding it to the vial.

Connecting the pre-filled syringe to the adapter

Click!
Remove sterile Correctly Remove cap Connect
blister hold Hold the white collar and snap off the white pre-filled syringe
pre-filled syringe cap

Hold by the white cap. Hold the adapter firmly Hold the vial vertically to prevent leakage.
Hold the pre-filled syringe by the white collar at the end of the pre-filled syringe.
Do not unscrew or cut the white cap.
Do not touch the tip of the pre-filled syringe. This may contaminate it.
Do not hold the glass cylinder of the pre-filled syringe.
Hold the vial at the base and pull off the sterile blister.
Do not shake.
The broken cap can be discarded.
Do not touch the exposed white collar.
Do not touch the luer lock on the adapter. This may contaminate it.
Connect the pre-filled syringe to the adapter by screwing it clockwise until firmly attached.
Do not overtighten. Excessive force may damage the tip of the pre-filled syringe.

Step 2 Preparation of the Suspension

Inject Disperse powder Transfer suspension Remove adapter
solvent in solvent to
into vial
Inject the entire solvent contained in the pre-filled syringe into the vial, while pressing the plunger as shown.
Shake vigorously for at least 10 seconds.
Turn the vial upside down. Slowly pull back the plunger of the pre-filled syringe to draw the entire volume of suspension into the pre-filled syringe.
Inspect the suspension. A properly mixed suspension will be uniform, thick, and milky in appearance. The powder will be visible in the liquid.
Proceed immediately to the next step to avoid sedimentation.
Peel off the label portion from the vial at the perforation and affix it to the pre-filled syringe for identification purposes.
Remove both the vial and adapter properly.

Step 3 Attaching the Needle

Re-mix
Select the appropriate needle Attach the needle the suspension
Select the needle depending on the injection site (gluteal or deltoid muscle). Partially open the blister and grasp the base of the needle as shown. Remove the blister completely.
Immediately before injection, shake the pre-filled syringe again, as sedimentation may have occurred.
Hold the pre-filled syringe by the white collar and connect it to the luer lock of the needle by screwing it clockwise until firmly attached.
Do not touch the luer lock of the needle. This may cause contamination.

Step 4 Administration of the Dose

Remove Remove air bubbles Inject Dispose of
Protect the needle
transparent Inject immediately properly
Hold the pre-filled syringe with one hand, rest the needle safety device against a flat hard surface at a 45-degree angle.
Remove the transparent
needle shield
safety device
from the needle
Hold the pre-filled syringe with the needle pointing upwards. Gently tap the syringe to move air bubbles to the tip.
Slowly press the plunger to expel air.
Ensure the entire contents of the pre-filled syringe are completely expelled into the selected muscle (gluteal or deltoid) (intramuscularly – i.m.).
For gluteal injection, administer into the upper outer quadrant of the buttock.
Do not twist the shield, as the luer lock connection may loosen.
Do not use two hands.
Do not intentionally detach the needle safety device or handle it improperly.
Do not attempt to straighten or recap a bent or damaged needle.
Dispose of used medical materials in a designated container for used medical devices.
Also dispose of the second unused needle supplied in the package.