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
Risperidonum
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.

• Keep this leaflet as you may need to read it again.
• 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 the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Rispolept Consta is and what it is used for
2. Important information before using 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 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 tablets should be used first before starting treatment with Rispolept Consta.

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

• if the patient has heart problems, such as irregular heartbeat, or if the patient is prone to low blood pressure, or is taking medicines to control blood pressure. Rispolept Consta may cause a drop in blood pressure. A dose adjustment may be necessary
• if the patient has any risk factors for stroke, such as high blood pressure, cardiovascular 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 characterised 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 a man who has experienced prolonged or painful erection
• if the patient has problems regulating body temperature or is overheating
• if the patient has kidney problems
• if the patient has liver problems
• if the patient has abnormally high levels of the hormone prolactin in the blood or a suspected prolactin-dependent tumour
• if the patient or a family member has a history of blood clots, as use of medicines such as Rispolept Consta has been associated with blood clot formation.

If the patient is unsure whether any of the symptoms described above apply, they should
consult their doctor or pharmacist before using Rispolept or Rispolept Consta.
The treating doctor may order a white blood cell count, as very rarely, patients receiving Rispolept Consta have developed a dangerously low number of a certain type of white blood cells essential for fighting infections.
Even if the patient previously tolerated orally administered risperidone well, 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 difficulty breathing, as these may be symptoms of a severe allergic reaction.
Rispolept Consta may cause weight gain. Significant weight gain may negatively 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 has been observed in patients treated with Rispolept, and existing diabetes may worsen. 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, or breast enlargement in men (see: Possible side effects). If such adverse effects occur, measurement of blood prolactin levels is recommended.
During cataract surgery, the pupil may not dilate sufficiently. Also, the iris of the eye may be flaccid during surgery, which may result in eye damage. If the patient has planned eye surgery, inform the ophthalmologist about use of this medicine.
Elderly patients with dementia
Rispolept Consta must not be given to elderly patients with dementia.
Seek immediate medical help if the patient or caregiver observes sudden changes in mental status, sudden muscle weakness or numbness, especially on one side of the body, or speech disturbances, even if they last only briefly. These symptoms may indicate a stroke.
Patients with kidney or liver problems
Studies have been conducted on oral administration of risperidone in patients with kidney or liver problems, but no studies have been conducted on the use of Rispolept Consta. In this patient group, Rispolept Consta should be used with caution.
Rispolept Consta and other medicines
Inform your 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 their doctor or pharmacist if they are taking
any of the following medicines:

• sedative medicines acting on the brain (benzodiazepines) or certain painkillers (opioids), antiallergy medicines (some antihistamines), as risperidone may enhance their sedative effect
• medicines that may cause changes in the heart's electrical activity, 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), or 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 reduce swelling 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 (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 enhance 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 in 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 their doctor or pharmacist before using Rispolept Consta.
Rispolept Consta with food, drink and alcohol
Alcohol should not be consumed during treatment with Rispolept Consta.
Pregnancy, breastfeeding and fertility

• if the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether the patient may use Rispolept Consta
• in newborns whose mothers used Rispolept Consta during the third trimester (last 3 months of pregnancy), the following symptoms may occur: tremors, muscle stiffness and (or) weakness, drowsiness, restlessness, 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 which may affect fertility (see section "Possible side effects").

Driving and using machines
Dizziness, tiredness and vision disturbances may occur during treatment with Rispolept Consta. Therefore, without consulting a doctor, do not drive, use tools or operate any machinery.
Rispolept Consta contains sodium
The medicine contains less than 1 mmol of sodium (23 mg), i.e. the medicine is considered "sodium-free".

3. How to use Rispolept Consta

This medicine should always be used exactly as prescribed by the doctor. In case of 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 and
the next time on the left side. Intravenous administration is not allowed.
Recommended dose:
Adults
Initial dose
If the oral daily dose of risperidone taken during the previous 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 previous 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 patient's individual 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 patient's individual needs
• the doctor may also recommend taking Rispolept orally 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, feeling of fatigue, abnormal body movements, difficulties with 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.

Stopping treatment with Rispolept Consta
The effect of the medicine will cease if the patient stops taking it. Therefore, do not discontinue
treatment without explicit instruction from the doctor, as symptoms may return.
Always attend scheduled biweekly appointments at the doctor's office to receive the next dose.
If the patient is unable to attend an appointment, they should notify the doctor immediately 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 effects

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

Immediately inform the doctor if the patient experiences any of the following uncommon adverse effects (may occur in less than 1 in 100 people):

• sudden change in mental state or sudden weakness or numbness of the face, limbs—particularly on one side—or speech disturbances, even if brief. These symptoms may indicate a stroke
• tardive dyskinesia (involuntary, jerking or twitching movements of the face, tongue, or other parts of the body). Immediately 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 effects (may occur in less than 1 in 1000 people):

• blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness of the leg); these clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. 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 Rispolept Consta injections.

Other adverse effects may also occur:

Very common adverse effects (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 shuffling gait, resting tremor, increased salivation and/or drooling, and expressionless face
• headache.

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

• pneumonia, respiratory tract infection (bronchitis), sinus infection
• urinary tract infection, flu-like symptoms, anemia
• 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, decreased libido, or other sexual disturbances. In women, symptoms may include breast discomfort, milk discharge from the breasts, absence of menstruation, 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. They may affect any part of the body (possibly resulting in abnormal 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 (dyspnea), sore throat, cough, nasal congestion
• abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, 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 effects (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 due to 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 glucose in urine, onset of diabetes or worsening of existing diabetes
• loss of appetite leading to malnutrition and low body weight
• increased blood triglyceride (fat) levels, 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, imbalance, poor coordination, dizziness upon standing, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, pricking, or numbness of the skin
• eye infection or conjunctivitis, dry eyes, excessive tearing, red eyes
• dizziness, tinnitus (ringing in the ears), 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 ECG reading, 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, wheezing, nosebleeds
• fecal incontinence, difficulty swallowing, excessive gas
• itching, hair loss, rash, dry skin, redness of the skin, skin discoloration, acne, scaly and itchy scalp or body skin
• 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 gait
• thirst, malaise, chest discomfort, feeling unwell
• skin hardening
• increased liver enzyme activity in blood
• pain related to medical procedures.

Rare adverse effects (may occur in less than 1 in 1000 people):

• decreased number of certain white blood cells responsible for fighting infections
• abnormal secretion of the hormone regulating urine production
• low blood sugar levels
• excessive water drinking
• sleepwalking (somnambulism)
• sleep-related eating disorders
• 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, Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is currently or previously treated with Rispolept Consta. If the patient has planned 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 apnea)
• aspiration pneumonia (caused by food entering the airways), pulmonary congestion, crackles, speech difficulties, respiratory tract disturbances
• pancreatitis, intestinal obstruction
• very hard stools
• drug-induced rash
• urticaria (hives), skin thickening, seborrheic dermatitis, 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 intraocular pressure), eyelid margin ulcers (with crust formation)
• flushing attacks, tongue swelling
• dry lips
• breast gland enlargement
• low body temperature, cold hands and feet
• withdrawal symptoms.

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

• life-threatening complications associated with uncontrolled diabetes
• severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties
• lack of intestinal activity, leading to obstruction.

Adverse effects 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 areas, and around these sites, and may spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

An adverse effect observed with another medicine—paliperidone—very similar to risperidone, which may also occur with Rispolept Consta: rapid heartbeat upon standing.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder.

Reporting adverse effects helps provide more information on the safety of this 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 stored outside the refrigerator at a temperature below 25°C for a maximum of 7 days prior to administration. The prepared suspension must be used within 6 hours (if stored at a temperature 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 in use. This 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 components 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 pack

• 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-protected needle for deltoid muscle injection;
  • One 20G TW 2-inch (0.9 mm x 51 mm) safety-protected needle for gluteal muscle injection.

Rispolept Consta is available in packs containing 1 set or in a carton 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 for deltoid muscle injection, 2-inch 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, 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 for sale in the European Economic Area countries 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 Rispolept Consta, carefully read the “Instructions for Use” (step by step).
Use only components provided in the kit
The components of this kit are specifically intended for use with Rispolept Consta. Only the solvent provided in the package must be used to prepare the Rispolept Consta suspension.
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 Rispolept Consta.
Single-use device
Do not reuse: Medical devices are designed to function properly only when used once. Their material properties have been validated solely for single use. Any attempt to reuse the device may lead to device damage or impaired performance.

Contents of the package

Step 1: Assembling the kit
Remove packaging Connect vial to adapter

Wait Remove cap Prepare adapter Connect adapter
30 minutes from vial
from vial to vial
Before preparing the suspension, remove the product from the refrigerator and leave at room temperature for at least 30 minutes.
Do not remove the vial from its blister.
Peel off and remove the coloured blister as shown.
Wipe the top of the vial’s grey rubber stopper with an alcohol-impregnated swab.
Do not touch the stopper. This may contaminate it.
Do not remove the grey rubber stopper.
Do not heat the product in any way.
Leave to dry.
Place the sterile hard surface on a flat, stable surface.
Place the vial upright on the surface.
Position the adapter centrally over the grey rubber stopper.
Push the adapter straight down until it clicks securely onto the vial.
Do not attach the adapter at an angle, as this may cause leakage of solvent when introduced into the vial.

Connecting the pre-filled syringe to the adapter

Click!
Remove sterile Correctly Remove cap Connect
blister hold Hold the white flange and snap off the white cap. pre-filled syringe
pre-filled syringe to adapter

Hold the pre-filled syringe by the white flange at the end of the syringe.
Do not touch the tip of the pre-filled syringe. This may contaminate it.
Do not unscrew or cut the white cap.
Hold the vial during connection.
Hold the vial upright to prevent leakage.
Do not shake.
Remove the sterile blister.
Do not touch the exposed white flange.
Do not hold the glass barrel of the pre-filled syringe. This may cause loosening or disconnection.
Hold the adapter by the protective cover.
Hold the pre-filled syringe by the white flange.
Insert the end of the pre-filled syringe into the luer port of the adapter.
Do not touch the luer port in the adapter. This may contaminate it.
Connect the pre-filled syringe to the adapter by screwing it clockwise until firmly secured.
Do not overtighten. Excessive force may damage the syringe tip.

Step 2: Preparing the suspension

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

Step 3: Attaching the needle

Re-mix suspension
Select appropriate needle Attach needle
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, re-shake the syringe, as sedimentation may have occurred.
Holding the syringe by the white flange, connect it to the luer port of the needle by screwing clockwise until firmly secured.
Do not touch the luer port of the needle. This may contaminate it.

Step 4: Administering the dose

Remove Remove air Inject Dispose of
Needle safety
transparent cap bubbles Immediately properly
Hold the syringe in one hand,
cap from needle
Hold the syringe with the needle pointing upwards, and gently tap to move air bubbles to the top.
Remove air by slowly and carefully depressing the plunger.
Ensure the entire contents of the syringe are administered.
Inject rapidly and decisively into the selected muscle (gluteal or deltoid) intramuscularly (i.m.).
For gluteal injection, administer into the upper outer quadrant of the buttock.
Do not inject intravenously.
Avoid needlestick injury:
Do not use two hands.
Do not deliberately disengage the needle safety mechanism or handle it improperly.
Do not attempt to straighten or recap a bent or damaged needle.
Press the needle safety mechanism against a flat, hard surface at a 45-degree angle.
Push the syringe forward until the safety mechanism clicks and fully covers the needle.
Dispose of the used syringe and needle in a designated container for used medical devices.
Also dispose of the second unused needle provided in the pack.