Rispolept Consta

Leaflet accompanying the packaging: information for the user

Rispolept Consta, 25 mg, powder and solvent for prolonged-release suspension for injection

with prolonged release

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

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Rispolept Consta and what is it 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. Package contents and other information

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

Rispolept Consta belongs to a group of antipsychotic medicines.
Rispolept Consta is used to treat schizophrenia, a condition where the patient sees, hears, or feels things that do not exist, believes in things that are not true, feels unusually suspicious or confused.
Rispolept Consta is intended for patients currently being treated with oral antipsychotic medications (e.g., tablets, capsules).
Rispolept Consta may help alleviate symptoms of the disease 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 used Rispolept before in any form, they should first use Rispolept orally before starting treatment with Rispolept Consta.

Before starting to use Rispolept Consta, the patient should discuss the following with their doctor or pharmacist:

• if the patient has heart rhythm disorders, such as an irregular heartbeat, or if the patient has a tendency to low blood pressure, or is taking blood pressure medications. Rispolept Consta may cause a decrease in blood pressure. It may be necessary to adjust the dose of the medicine
• if the patient is aware of any factors that may contribute to their risk of stroke, such as high blood pressure, cardiovascular disease, or cerebral vessel disorders
• if the patient has ever experienced involuntary movements of the tongue, mouth, or face
• if the patient has ever experienced a condition characterized by fever, severe muscle stiffness, sweating, or decreased level of consciousness (also known as malignant neuroleptic syndrome)
• if the patient has Parkinson's disease or dementia
• if the patient has had a low white blood cell count in the past (which may or may not have been caused by the use of other medications)
• if the patient has diabetes
• if the patient has epilepsy
• if the patient is a man and has experienced a prolonged or painful erection
• if the patient has temperature regulation disorders or overheats
• if the patient has kidney or liver function disorders
• if the patient has an abnormally high level of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• if the patient or any of their relatives have had blood clots in the past, as the use of such medicines as Rispolept Consta is associated with the formation of blood clots.

If the patient is unsure whether any of the above symptoms apply to them, they should consult their doctor or pharmacist before using Rispolept or Rispolept Consta.
The attending physician may order a white blood cell count test, as very rarely, patients taking Rispolept Consta have been observed to have a dangerously low white blood cell count necessary to fight infections.
Even if the patient has previously tolerated risperidone orally, rare allergic reactions may occur after Rispolept Consta injections. Medical help should be sought immediately if the patient experiences: 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 can have a negative impact on health. The attending physician will regularly monitor the patient's weight.
The doctor should check if the patient has symptoms of high blood sugar levels, as patients taking Rispolept have been observed to develop diabetes and exacerbate existing diabetes. In patients with existing diabetes, blood sugar levels should be regularly monitored.
Rispolept Consta often increases the level of the hormone prolactin in the blood, which can affect fertility (see "Possible side effects"). If such side effects occur, it is recommended to perform a blood prolactin level test.
During cataract surgery, the pupil may not dilate sufficiently. The iris may also be flaccid during the procedure, which can result in eye damage. If the patient is scheduled for eye surgery, they should inform their ophthalmologist about their use of this medicine.

Elderly patients with dementia

Rispolept Consta should not be administered to elderly patients with dementia.
Medical help should be sought immediately if the patient or their caregiver notices a sudden change in the patient's mental state, sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke.

Patients with kidney or liver function disorders

Studies have been conducted on the oral use 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have 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:

• sedatives acting on the brain (benzodiazepines) or certain painkillers (opioids), antihistamines, as risperidone may enhance their sedative effect
• medicines that may cause a change in the electrical activity of the heart, such as anti-malarial medicines, anti-arrhythmic medicines, antihistamines, or certain antidepressants
• medicines that slow down the heart rate
• medicines that lower potassium levels in the blood (e.g., certain diuretics)
• medicines used to treat Parkinson's disease (e.g., levodopa) or medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate)
• medicines used to treat high blood pressure. Rispolept Consta may lower blood pressure
• diuretics (used in patients with heart disease or to relieve swelling in areas where there is excessive fluid accumulation, e.g., furosemide or chlorthiazide). 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 weaken the effect of risperidone:

• rifampicin (a medicine used to treat certain infections)
• carbamazepine, phenytoin (anti-epileptic medicines)
• phenobarbital. When starting or stopping these medicines, it may be necessary to adjust the dose of risperidone.

The following medicines may enhance the effect of risperidone:

• quinidine (used in certain heart diseases)
• antidepressants, such as paroxetine, fluoxetine, tricyclic antidepressants
• beta-blockers (used to treat high blood pressure)
• phenothiazines (e.g., used to treat psychoses or to sedate)
• 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, it may be necessary to adjust the dose of risperidone.
If the patient is unsure whether they have taken or are taking any of the above medicines, they should consult their doctor or pharmacist before using Rispolept Consta.

Rispolept Consta with food, drink, and alcohol

Alcohol should not be consumed while using Rispolept Consta.

Pregnancy, breastfeeding, and fertility

• if the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. The doctor will decide whether the patient can use Rispolept Consta
• in newborns whose mothers used Rispolept Consta in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, difficulty breathing, and difficulty feeding. If such symptoms are observed in the child, the doctor should be contacted
• Rispolept Consta may increase the level of prolactin in the blood - a hormone that can affect fertility (see "Possible side effects").

Driving and using machines

While using Rispolept Consta, dizziness, fatigue, and vision disturbances may occur. Therefore, without consulting a doctor, the patient should not drive vehicles, use any tools, or operate any machines.

Rispolept Consta contains sodium

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

3. How to use Rispolept Consta

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Rispolept Consta is administered by intramuscular injection into the arm or buttock every 2 weeks by a doctor or nurse. Injections should be given alternately, once from the right and once from the left side. It should not be administered intravenously.

Recommended dose:

Initial dose
If the patient has been taking risperidone orally (e.g., in tablet form) at a daily dose of 4 mg or less in the last 2 weeks, the initial dose of Rispolept Consta should be 25 mg.
If the patient has been taking risperidone orally (e.g., in tablet form) at a daily dose greater than 4 mg in the last 2 weeks, the initial dose of Rispolept Consta may be 37.5 mg.
If the patient is currently being treated with an antipsychotic medicine other than risperidone, the initial dose of Rispolept Consta will depend on their current therapy. The doctor will choose and prescribe Rispolept Consta at a dose of 25 mg or 37.5 mg.
The doctor will adjust the dose of Rispolept Consta according to the patient's needs.
Maintenance dose:

• usually, a dose of 25 mg is administered by injection every 2 weeks
• if necessary, a higher dose of 37.5 mg or 50 mg is administered. The doctor will adjust the dose of Rispolept Consta according to the patient's needs
• the doctor may also recommend taking Rispolept orally for 3 weeks after the first injection.

Using a higher dose of Rispolept Consta than recommended

• in patients who have taken a higher dose of Rispolept Consta than they should have, the following symptoms have been observed: drowsiness, fatigue, abnormal body movements, difficulty maintaining balance and walking, dizziness due to low blood pressure, and abnormal heart rhythm. There have also been reports of abnormal heart conduction and seizures
• the patient should seek medical attention immediately.

Stopping the use of Rispolept Consta

The effect of the medicine will disappear if the patient stops using it. Therefore, without explicit instructions from the doctor, the patient should not stop using the medicine, as this may lead to a recurrence of the disease.
The patient should always attend follow-up appointments at the doctor's office every 2 weeks to receive the next dose of the medicine. If the patient cannot attend an appointment, they should immediately notify the doctor to arrange an alternative appointment.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

Use in children and adolescents

Rispolept Consta is not intended for persons under 18 years of age.

4. Possible side effects

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

The patient should immediately inform their doctor if they experience any of the following, not very common side effects (may occur in less than 1 in 100 people):

• 100):
• in a patient with dementia, a sudden change in mental state or sudden weakness or numbness of the face, limbs, especially one-sided, or speech disorders, even if they occur for a short time. These symptoms may signal a stroke
• late dyskinesia (trembling or jerking uncontrollable movements of the face, tongue, or other parts of the body). The patient should immediately inform their doctor if they experience involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Rispolept Consta.

The patient should immediately inform their doctor if they experience any of the following, rare side effects (may occur in less than 1 in 1000 people):

• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg); these clots can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek medical attention immediately
• fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary
• a man experiences a prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary
• a severe allergic reaction characterized by fever, swelling of the lips, face, or tongue, difficulty breathing, itching, rash, or low blood pressure. Even if the patient has previously tolerated risperidone orally, rare allergic reactions may occur after Rispolept Consta injections.

Other side effects may also occur:

Very common side effects (may occur in more than 1 in 10 people):

• cold symptoms
• difficulty falling asleep or waking up
• depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or tension in the muscles (which can cause the patient's movements to be uneven), and sometimes even a feeling of "freezing" of movements, followed by a release. Other symptoms of parkinsonism include: slow, shuffling gait, tremors, increased saliva production, and (or) drooling, and a face without expression
• headache.

Common side 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 prolactin levels in the blood (with or without symptoms). Symptoms of increased prolactin levels may include: in men, breast swelling, difficulty achieving or maintaining an erection, decreased sex drive, or other sexual disorders. In women, they may include: breast discomfort, milk leakage from the breasts, absence of menstruation, or other menstrual cycle disorders
• high blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• sleep disturbances, irritability, decreased sex drive, restlessness, drowsiness or decreased alertness
• dystonia: this condition involves slow or sustained involuntary muscle contractions. It can affect any part of the body (which can result in an abnormal posture), but dystonia most commonly affects the muscles of the face, including abnormal eye movements, mouth, tongue, or jaw
• dizziness
• dyskinesia: this condition involves involuntary muscle movements, including repetitive, spasmodic, or twisting movements or jerks
• tremors
• blurred vision
• rapid heartbeat
• low blood pressure, chest pain, high blood pressure
• shortness of breath (dyspnea), sore throat, cough, stuffy nose
• abdominal pain, discomfort in the abdominal cavity, vomiting, nausea, gastrointestinal 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 leakage from the breasts
• swelling of the body, arms, or legs, fever, weakness, fatigue (exhaustion)
• pain
• reaction at the injection site, including itching, pain, or swelling
• increased liver enzyme activity in the blood, increased activity of the enzyme GGT (liver enzyme - gamma-glutamyltransferase) in the blood
• fall.

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

• respiratory tract infection, urinary tract infection, ear infection, eye infection, tonsillitis, fungal infection of the nails, skin infection, skin infection limited to one area or part of the body, viral infection, skin rash caused by mites, subcutaneous abscess
• decreased white blood cell count, decreased platelet count (blood cells that help stop bleeding), decreased red blood cell count
• allergic reaction
• presence of sugar in the urine, development of diabetes, or worsening of existing diabetes
• loss of appetite leading to malnutrition and low body weight
• increased triglyceride levels (fats) in the blood, increased cholesterol levels in the blood
• elevated mood (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• loss of consciousness, seizures, fainting
• uncontrollable movement of body parts, balance disorders, lack of coordination, dizziness when changing position to standing, concentration disorders, speech difficulties, loss or abnormal taste, decreased sensation of pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin
• eye infection or conjunctivitis, dry eye, increased tearing, redness of the eyes
• feeling of dizziness, ringing in the ears, ear pain
• atrial fibrillation (irregular heart rhythm), blockage of impulse conduction between the heart chambers, abnormal conduction of electrical impulses in the heart, prolonged QT interval in the heart, slow heart rhythm, abnormal electrocardiogram (ECG), feeling of heartbeat
• low blood pressure when changing position to standing (which can cause some patients taking Rispolept Consta to faint, feel dizzy, or lose consciousness)
• rapid, shallow breathing, congestion of the airways, wheezing, nosebleeds
• fecal incontinence, difficulty swallowing, excessive gas
• itching, hair loss, rash, dry skin, redness of the skin, skin discoloration, acne, flaky, itchy skin on the head or body
• increased creatine kinase activity in the blood, an enzyme that is sometimes released from damaged muscles
• stiffness of the joints, swelling of the joints, muscle weakness, neck pain
• frequent urination, inability to urinate, painful urination
• ejaculation disorders, delayed menstruation, absence of menstruation, and other menstrual cycle disorders (in women), breast enlargement in men, sexual disorders, breast pain, discomfort in the breasts, vaginal discharge
• swelling of the face, lips, eyes, or tongue
• chills, increased body temperature
• change in gait
• feeling of thirst, malaise, chest discomfort, feeling "unwell"
• skin thickening
• increased liver enzyme activity in the blood
• pain related to medical procedures.

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

• decreased count of a certain type of white blood cell responsible for fighting infections
• abnormal secretion of the hormone regulating urine volume
• low blood sugar
• excessive water drinking
• sleepwalking (sleepwalking)
• eating disorders related to sleep
• decreased motor activity or lack of response in a patient with preserved consciousness (catatonia)
• lack of emotions
• low level of consciousness
• trembling or jerking head movements
• eye movement disorders, rotational eye movements, hypersensitivity to light
• complications related to the eye during cataract surgery. During this procedure, a condition known as Intraoperative Floppy Iris Syndrome (IFIS) may occur if the patient is taking or has taken Rispolept Consta. If the patient is scheduled for cataract surgery, they should inform their ophthalmologist about their use of this medicine
• irregular heart rhythm
• dangerously low count of certain white blood cells responsible for fighting infections, increased count of eosinophils (a type of white blood cell) in the blood
• sleep apnea (sleep apnea)
• aspiration pneumonia (caused by food entering the airways), pulmonary congestion, wheezing, speech difficulties, respiratory disorders
• pancreatitis, intestinal obstruction
• very hard stools
• drug rash
• hives, skin thickening, dandruff, skin disorders, skin damage
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• abnormal posture
• breast enlargement, milk leakage from the breasts
• low body temperature, discomfort
• jaundice (yellowing of the skin and eyes)
• dangerously excessive water drinking
• increased insulin levels in the blood (a hormone that regulates blood sugar levels)
• cerebrovascular disorders
• lack of response to stimuli
• diabetic coma due to uncontrolled diabetes
• sudden loss of vision or blindness
• glaucoma (increased pressure in the eye), eyelid margin ulcers (with crust formation)
• flushing, tongue swelling
• dry lips
• breast enlargement
• low body temperature, cooling of the hands and feet
• withdrawal symptoms.

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

• life-threatening complications related to uncontrolled diabetes
• severe allergic reaction with swelling, which can affect the throat and lead to difficulty breathing
• intestinal obstruction, which can lead to bowel obstruction.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• severe or life-threatening rash with blisters and peeling skin, which can occur in the mouth, nose, eyes, and genitals, as well as around these areas, and can also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis).

A side effect observed in the use of another medicine - paliperidone, which is very similar to risperidone, and which may also occur when using Rispolept Consta:
rapid heartbeat when changing position to standing.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Rispolept Consta

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store in a refrigerator (2°C - 8°C). The medicine can be stored outside the refrigerator at a temperature below 25°C for a maximum of 7 days before 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Rispolept Consta contains

The active substance of the medicine is risperidone.
Each vial of powder for prolonged-release suspension for injection 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 carmellose 40 mPas, disodium phosphate dihydrate, anhydrous citric acid, sodium chloride, sodium hydroxide, water for injections.

What Rispolept Consta looks like and what the package contains

• one vial containing the powder (the powder contains the active substance risperidone);
• one ampoule syringe with a clear, colorless solvent (2 ml) for Rispolept Consta to be added to the powder for prolonged-release suspension for injection;
• one vial adapter to prepare the suspension;
• two Terumo SurGuard 3 needles for intramuscular injection:
• one 21G UTW 1-cal (0.8 mm x 25 mm) needle with a safety device for injection into the deltoid muscle;
• one 20G TW 2-cal (0.9 mm x 51 mm) needle with a safety device for injection into the gluteal muscle.

Rispolept Consta is available in a package containing 1 set or a multipack containing 5 sets.
In Poland, the following package sizes are available:
Package containing 1 set: 1 vial + 1 ampoule syringe + 1 device for preparing the suspension + 2 needles for intramuscular injection (1-cal for injection into the deltoid muscle, 2-cal for injection into the gluteal muscle).
Not all package sizes may be marketed.

Marketing authorization 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
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Janssen-Cilag Polska sp. z o.o.
phone: +48 22 237 60 00

This medicinal product is authorized 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

Date of last revision of the leaflet: 04/2021

IMPORTANT INFORMATION INTENDED FOR HEALTHCARE PROFESSIONALS

Important information

To ensure the successful administration of the Rispolept Consta medicinal product, the "Instructions for use of the device" should be carefully read (step by step).

Use only the components of the set

The components of this set are specifically designed for use with the Rispolept Consta medicinal product. Only the solvent contained in the packaging should be used to prepare the Rispolept Consta suspension.
Noneof the components of the set contained in the packaging should be replaced.

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 that the patient receives the correct dose of Rispolept Consta.
Do notreuse: Medical devices are designed to work properly when they have specific material properties. These properties have only been tested for single use. Any attempt to reuse the device may cause it to malfunction or fail.

Single-use device

Package contents

Step 1 Assembling the set

Remove the packaging Combine the vial with the adapter

Remove the cap from the vial

Remove the colored cap from the vial.
Wipe the top of the gray rubber stopper with a swab moistened with alcohol.
Let it dry.
Do notremove the gray rubber stopper.

Connect the adapter to the vial

Place the vial on a hard surface and hold it at the base.
Position the adapter centrally over the gray rubber stopper.
Push the adapter straight down until it is securely attached to the top of the vial.
Do notput the adapter on the vial at an angle, as this may cause the solvent to leak during injection.

Wait

30 minutes

Before preparing the suspension, remove the Rispolept Consta packaging from the refrigerator and let it stand for at least 30 minutes. Do notheat it in any way.

Prepare the vial adapter

Hold the sterile blister as shown.
Remove and discard the paper covering the blister.
Do notremove the adapter from the blister.
Nevertouch the needle. This will cause it to become contaminated.

Connect the ampoule syringe to the adapter

SNAP!

Remove the sterile blister

Properly hold the ampoule syringe

Hold the ampoule syringe by the white collar at the end.
Do nothold the glass cylinder during connection.

Remove the cap

Hold the ampoule syringe by the white collar and break off the white cap.
Do notunscrew or cut off the white cap.
Do nottouch the tip of the ampoule syringe. This will cause it to become contaminated.

Connect the ampoule syringe to the adapter

Hold the adapter firmly by the shield.

Holding the ampoule syringe by the white collar

insert the tip into the luer socket in the adapter.
Do nothold the glass cylinder of the ampoule syringe.
This may cause the white collar to loosen or detach.
Connect the ampoule syringe to the adapter by screwing it clockwiseuntil the connection is secure.

Do not overtighten

forcibly. Over-tightening may damage the tip of the ampoule syringe.

Hold the vial upright to prevent leakage.
Hold the vial at the base and pull and remove the sterile blister.
Do notshake.
Do nottouch the exposed luer socket in the adapter. This will cause it to become contaminated.

The broken cap can be discarded.

Step 2 Preparing the suspension

Inject the solvent

Inject all the solvent from the ampoule syringe into the vial.

Dissolve the powder in the solvent

Shake vigorously for at least 10 seconds

holding the plunger depressed, as shown.
Inspect the suspension. A properly mixed suspension will be homogeneous, thick, and milky in color.
The powder will be visible in the liquid.
Immediately proceed to the next step to avoid sedimentation of the suspension.

Transfer the suspension

to
the ampoule syringe
Turn the vial upside down. Slowly pull back on the plunger to draw the entire volume of the suspension from the vial into the ampoule syringe.

Remove the vial adapter

Holding the ampoule syringe by the white collar, unscrew it from the adapter.
Remove the part of the label from the vial at the perforation and attach the removed label to the ampoule syringe for identification purposes.
Dispose of the vial and adapter properly.

Step 3 Attaching the Needle

Resuspend the Suspension Again

Completely remove the blister.
Immediately before
injection, the syringe
should be shaken again,
as sediment may appear.

Attach the Needle

Tear off the blister partially
and grasp the base of the needle, as
shown.

Holding the Syringe by

the white collar,connect it
to the Luer lock on the needle
screwing in the direction
of the clock hands,until the connection is
secure.
Do nottouch the Luer lock
on the needle.
This will cause
contamination.

Choose the Right Needle

Choose a needle depending on
the injection site (in the gluteal or
deltoid muscle).

Step 4 Injecting the Dose

Remove the Transparent Needle Shield

Bend the needle guard
towards the syringe,
as shown.
Holding the syringe
by the white collar,

Remove Air Bubbles

Holding the syringe
with the needle upwards,
gently tap to make
the air bubbles move to
the tip of the syringe.

Inject

Immediately inject the entire
contents of the syringe into the chosen muscle (gluteal or deltoid)
of the patient (intramuscularly – im).

Dispose of Properly

Check if the needle is
completely enclosed in the needle guard.
Dispose of it in a special
waste container for

Secure the Needle

Holding the syringe with one hand, press the needle guard against a flat hard surface at a 45-degree angle.
Push the needle into the guard and remove the transparent needle shield.
Do nottwist the shield, as the Luer connection may loosen.
Remove the air by carefully and slowly pressing the plunger.
Injections into the gluteal muscle should be performed in the upper outer quadrant of the buttock.

Do Not Administer Intravenously.

With a quick, decisive movement, so that it is completely hidden in it.

Avoid Needlestick Injuries:

Do notuse two hands.
Do notintentionally detach the needle guard or handle it improperly.
Do notattempt to straighten the needle or put the guard on it when the needle is bent or damaged.
Dispose of used medical devices.
Also, dispose of the second, unused needle provided in the packaging.