Rispolept consta

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any 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 them even if their symptoms are the same.
• If you experience any side effects, 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 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 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 to 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 treatment with 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 low 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, mouth 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 male and 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 previously had blood clots, as treatment with medicines such as Rispolept Consta may be 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 taking Rispolept Consta
have developed dangerously low levels of a certain type of white blood cells, which are essential for
fighting infections.
Even if the patient previously tolerated orally administered risperidone, allergic reactions may
rarely occur after Rispolept Consta injections. 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 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
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, or breast swelling in men (see:
Possible side effects). If such adverse effects occur, measuring prolactin levels in the blood is
recommended.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be floppy during the
procedure, which may lead to eye damage. If the patient has planned eye surgery, they should inform
the ophthalmologist that they are 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 observes sudden changes in
mental status, sudden muscle weakness or numbness, especially on one side of the body, or speech
difficulties, even if they are brief. 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
impairment, 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines they plan 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 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 slow down 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 relieve swelling due to fluid accumulation (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 risperidone dose 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 risperidone dose may be necessary.
If the patient is unsure whether they are taking or have taken 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 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 her doctor or pharmacist before using this medicine. The doctor will decide whether the patient may use Rispolept Consta
• newborns whose mothers have taken Rispolept Consta during the third trimester (last 3 months of pregnancy) may experience the following symptoms: 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 that may affect fertility (see section "Possible side effects").

Driving and operating machinery
While taking Rispolept Consta, dizziness, tiredness and vision disturbances may occur. Therefore,
without consulting a doctor, patients should not drive, use tools or operate machinery.
Rispolept Consta contains sodium
This medicine contains less than 1 mmol of sodium (23 mg), meaning it is considered "sodium-free".

3. How to use Rispolept Consta

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.

Rispolept Consta is administered as an intramuscular injection into the arm or buttock every two weeks by a doctor or nurse. Injections should be alternated, one time on the right side and the next on the left side. Intravenous administration is not permitted.

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 physician will decide and prescribe Rispolept Consta at a dose of either 25 mg or 37.5 mg.

The physician will adjust the dose of Rispolept Consta according to the individual needs of the patient.

Maintenance dose:

• The usual maintenance 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 physician will adjust the dose of Rispolept Consta according to the patient's needs.
• The physician 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, 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.
• In such cases, seek immediate medical attention.

Discontinuation of Rispolept Consta

The effect of the medicine will cease if the patient stops using it. Therefore, do not discontinue treatment without explicit instruction from the physician, as this may lead to relapse of the illness. Always attend scheduled biweekly appointments for administration of the next dose. If the patient is unable to attend an appointment, they should inform the physician immediately to arrange an alternative date.

If you have any further questions regarding 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 any medicine, this medicine can cause adverse effects, although not everyone will experience 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 status or sudden weakness or numbness of the face, 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 twitching movements of the face, tongue or other body parts). 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 1,000 people):

• blood clots in the 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 breathing difficulties. If such symptoms occur, seek immediate medical help
• fever, muscle stiffness, sweating or reduced 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 necessary
• severe allergic reaction characterized by fever, swelling of the lips, face, tongue or throat, 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 movement 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 sexual desire or other sexual disturbances. In women, they 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. They may affect any body part (possibly leading to 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 aminotransferase activity, increased blood GGT enzyme activity (liver enzyme - gamma-glutamyl transferase)
• falls.

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

• respiratory tract infection, urinary 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 glucose in urine, onset of diabetes or worsening of existing diabetes
• loss of appetite leading to malnutrition and low body weight
• increased blood triglyceride levels (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, concentration difficulties, speech difficulties, loss or altered sense of taste, reduced sensitivity to pain and touch on the skin, tingling, pricking or numbness sensations
• 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 up suddenly)
• rapid, shallow breathing, respiratory congestion, rales, nosebleeds
• fecal incontinence, difficulty swallowing, excessive flatulence
• itching, hair loss, rash, dry skin, skin redness, skin discoloration, acne, scaly and itchy scalp or other body parts
• increased blood creatine kinase activity, 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 induration
• increased liver enzyme activity in blood
• pain related to medical procedures.

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

• decreased number of certain types 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)
• sleep-related eating disorders
• reduced motor activity or lack of response in a conscious patient (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 taking Rispolept Consta. If cataract surgery is planned, 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 disorders
• pancreatitis, intestinal obstruction
• very hard stools
• drug-induced rash
• urticaria, skin thickening, psoriasis, 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)
• episodes of flushing, 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 related to uncontrolled diabetes
• severe allergic reaction with swelling, which may involve the throat and lead to breathing difficulties
• loss of intestinal function, 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 areas, and may spread to other body parts (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 up.

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 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 stored outside the refrigerator at a temperature below 25°C for up to 7 days prior to administration. The prepared suspension should be used within 6 hours (if stored at a temperature up to 25°C).
Store in the original packaging to protect from light.
Medicines should 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.
The 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 containing 2 ml of clear, colourless solvent for Rispolept Consta, used to reconstitute the powder into a prolonged-release injectable suspension;
• One vial adapter to facilitate the preparation of 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 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 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 further 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 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 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 reconstitute the Rispolept Consta suspension.
DO NOT substitute ANY of the components included in the package.

Do Not Store the Suspension After Reconstitution
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 their material properties meet specific requirements. 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: Assembling the Kit
Remove the Package Connect the Vial to the Adapter

Wait Remove the cap Prepare the adapter Connect the adapter
30 minutes from the vial
from the vial to the vial
Before preparing the Remove the coloured Peel off the sterile Place the vial on a
suspension, remove the blister as shown. protective paper sealing hard surface
package of Rispolept the grey rubber stopper
Consta from the with a gauze pad
refrigerator and leave moistened with
at room temperature alcohol.
for less than 30 minutes.
Do not remove the
grey rubber stopper.
Do not warm the
product in any way.
Never touch the
spike—this may
contaminate it.
Do not attach the adapter
at an angle, as this may
cause leakage of the
solvent when it is
introduced into the vial.

Connecting the Pre-filled Syringe to the Adapter

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

Hold by the white cap. Hold the adapter
Hold the pre-filled syringe by the white collar. securely by the protective
Hold the vial during connection. Do not unscrew or cut off shield.
Do not touch the tip of the white cap. Hold the
the pre-filled syringe—this pre-filled syringe
Do not hold the glass may contaminate it. by the white collar
cylinder of the pre-filled
Hold the vial vertically to
syringe. prevent leakage. Do not hold
Do not shake. the glass cylinder or
Snap off cap and discard. the pre-filled syringe
Do not touch the exposed white collar. body. This may loosen
Do not touch the luer lock or disconnect the
connection in the adapter—this may connection.
contaminate it. Connect the pre-filled
Connect the pre-filled syringe to the adapter
syringe to the adapter by screwing it
by inserting its tip into clockwise until the
the luer lock of the adapter. connection is secure.
Do not overtighten.
Excessive force may
damage the tip of the
pre-filled syringe.

Step 2: Preparing the Suspension

Inject Disperse the powder Transfer the suspension Remove the adapter
the solvent into the solvent into the
into the vial
Inject all the solvent contained Shake pre-filled syringe Remove the adapter
in the pre-filled syringe vigorously for at least 10 seconds, Rotate the vial upside down. Slowly pull the plunger of the
into the vial, keeping the while holding it down. pre-filled syringe back by holding the plunger to draw the
plunger depressed as shown. entire volume of suspension from the vial 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 prevent sedimentation.
Peel off the part of the label from the vial at the perforation and affix the label to the pre-filled syringe for identification purposes.
Remove both the vial and adapter properly.

Step 3: Attaching the Needle

Re-mix the suspension
Select the appropriate needle Attach the 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, shake the pre-filled syringe again, as sedimentation may have occurred.
Holding the pre-filled syringe by the white collar, connect it to the luer lock of the needle by screwing it clockwise until the connection is secure.
Do not touch the luer lock of the needle—this may contaminate it.

Step 4: Administering the Dose

Remove Remove air bubbles Inject Dispose of
the needle shield
the transparent Inject the full immediately in the
Hold the pre-filled syringe protective cap Hold the pre-filled syringe dose proper manner
with one hand, rest the with the needle pointing the entire contents Check that the needle
protective cap of the needle upwards, gently tap the barrel into the selected muscle is fully enclosed
against a flat hard surface at to dislodge air bubbles, (gluteal or deltoid) in the protective
a 45-degree angle. and slowly depress the plunger to expel air. intramuscularly (i.m.). cap.
Press the needle into the
Hold the pre-filled syringe by the white collar, remove the transparent protective cap from the needle.
Do not twist the cap, as the luer lock connection could loosen.
Do not administer intravenously.
For gluteal injection, inject into the upper outer quadrant of the buttock.
Do not use two hands.
Do not intentionally remove the needle safety device or handle it improperly.
Do not attempt to straighten or recap a bent or damaged needle.
Dispose of used medical devices in a designated sharps container.
Also dispose of the second unused needle supplied in the package.