Risperidone Teva 37.5 mg powder and solvent for prolonged-release injectable suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risperidone Teva 25 mg powder and solvent for prolonged-release injectable suspension EFG

Risperidone Teva 37.5 mg powder and solvent for prolonged-release injectable suspension EFG

Risperidone Teva 50 mg powder and solvent for prolonged-release injectable suspension EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Risperidone Teva is and what it is used for

Risperidone belongs to a group of medicines called "antipsychotics".

Risperidone is used for the maintenance treatment of schizophrenia, which is characterized by seeing, hearing, or feeling things that are not present, believing things that are not true, or having unusual feelings of distrust or confusion.

Risperidone is intended for patients who are currently being treated with oral antipsychotics (e.g., tablets, capsules).

Risperidone can help reduce the symptoms of your illness and help prevent them from returning.

2. What you need to know before using Risperidone Teva

Do not use Risperidone Teva

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

Warnings and precautions

• If you have never taken risperidone in any of its forms before, you should start with oral risperidone before beginning this medicine.

Consult your doctor or pharmacist before starting to use Risperidone Teva if:

• You have a heart condition, for example an irregular heartbeat, or if you are prone to low blood pressure, or if you are taking medicines for blood pressure. Risperidone may lower blood pressure. Your dose may need to be adjusted.
• You know you have risk factors for stroke, such as high blood pressure (hypertension), cardiovascular disorders, or cerebral circulation disorders.
• You have ever experienced involuntary movements of the tongue, mouth, or face.
• You have ever had symptoms including fever, muscle stiffness, sweating, or decreased level of consciousness (also known as Neuroleptic Malignant Syndrome).
• You have Parkinson's disease or dementia.
• You have previously had low levels of white blood cells in your blood (which may or may not have been caused by other medicines).
• You are diabetic.
• You have epilepsy.
• You are a man who has ever had a prolonged or painful erection.
• You have difficulty regulating body temperature or feel excessive heat.
• You have kidney problems.
• You have liver problems.
• You have abnormally high levels of the hormone called prolactin in your blood, or if you have a tumor that may be prolactin-dependent.
• You or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before using risperidone or Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG.

Because a dangerously low number of a type of white blood cell needed to fight infections has been observed very rarely in patients treated with risperidone, your doctor may check your white blood cell count.

Allergic reactions rarely occur after receiving risperidone injections, even if you have previously tolerated oral risperidone. Seek immediate medical attention if you experience hives, throat swelling, itching, or breathing difficulties, as these may be symptoms of a serious allergic reaction.

Risperidone may cause weight gain. A significant weight gain may negatively affect your health. Your doctor will regularly monitor your weight.

Because diabetes mellitus has been reported or pre-existing diabetes mellitus has worsened in patients taking risperidone, your doctor should check for signs of elevated blood sugar. In patients with pre-existing diabetes mellitus, blood sugar should be monitored regularly.

Risperidone frequently increases levels of a hormone called "prolactin." This may cause adverse effects such as menstrual disorders or fertility problems in women, or breast enlargement in men (see Possible side effects). If these adverse effects occur, assessment of prolactin levels in the blood is recommended.

During eye surgery for clouding of the lens (cataracts), the pupil (the black circle in the center of the eye) may not dilate as needed. In addition, the iris (the colored part of the eye) may become floppy during surgery, which could cause eye damage. If you are considering eye surgery, make sure to inform your ophthalmologist that you are using this medicine.

Elderly patients with dementia

Risperidone is not used in elderly patients with dementia.

If you or your caregiver notice a sudden change in your mental state, or sudden weakness or numbness of the face, arms, or legs—especially on one side—or confused speech, even if brief, seek immediate medical treatment. These may be signs of a stroke.

Patients with kidney or liver problems

Although oral risperidone has been studied, Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG has not been studied in patients with kidney or liver problems. Risperidone should be administered with caution in this group of patients.

Using Risperidone Teva with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important that you speak with your doctor or pharmacist if you are taking any of the following:

• Medicines that act on the brain used to calm you (benzodiazepines) or certain pain medicines (opioids), or allergy medicines (some antihistamines), as risperidone may increase the sedative effect of these.
• Medicines capable of altering the electrical activity of your heart, such as those used for malaria, heart rhythm disorders, allergies (antihistamines), certain antidepressants, or other medicines for mental disorders.
• Medicines that may cause a decrease in heart rate.
• Medicines that may cause low potassium levels in the blood (such as certain diuretics).
• Medicines for Parkinson's disease (such as levodopa).
• Medicines that increase central nervous system activity (psychostimulants, such as methylphenidate).
• Medicines for high blood pressure. Risperidone may lower blood pressure.
• Diuretics used for heart problems or to treat swelling in certain body parts due to fluid retention (such as furosemide or chlorothiazide). Risperidone, taken alone or with furosemide, may increase the risk of stroke or death in elderly patients with dementia.

The following medicines may reduce the effect of risperidone:

• Rifampicin (a medicine used to treat certain infections).
• Carbamazepine, phenytoin (medicines used to treat epilepsy).
• Phenobarbital.

If you start or stop taking these medicines, you may need a different dose of risperidone.

The following medicines may increase the effect of risperidone:

• Quinidine (a medicine used to treat certain types of heart problems).
• Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants.
• Medicines known as beta-blockers (used to treat high blood pressure).
• Phenothiazines (such as medicines used to treat psychosis or for sedation).
• Cimetidine, ranitidine (medicines used to treat stomach acidity).
• Itraconazole and ketoconazole (medicines used to treat fungal infections).
• Certain medicines used to treat HIV/AIDS, such as ritonavir.
• Verapamil, a medicine used to treat high blood pressure and/or abnormal heart rhythm.
• Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders.

If you start or stop taking these medicines, you may need a different dose of risperidone.

If you are unsure whether any of the above applies to you, speak with your doctor or pharmacist before using risperidone.

Using Risperidone Teva with food, drinks, and alcohol

You should avoid consuming alcohol while using risperidone.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can use it.
• The following symptoms may occur in newborn babies of mothers who have been treated with risperidone during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
• Risperidone may increase levels of a hormone called "prolactin," which could affect your fertility (see Possible side effects).

Driving and using machines

Dizziness, fatigue, and vision problems have been observed during treatment with risperidone. Do not drive or operate tools or machinery without first consulting your doctor.

Risperidone Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially "sodium-free."

3. How to use Risperidone Teva

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Risperidone Teva is administered by intramuscular injection in the arm or buttock every two weeks by a healthcare professional. Injections should be alternated between the left and right side and must not be administered intravenously.

Recommended dosage:

Adults

Initial dose

If your daily oral risperidone dose (e.g., tablets) was 4 milligrams or less during the previous two weeks, your starting dose should be 25 milligrams of Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG.

If your daily oral risperidone dose (e.g., tablets) was more than 4 milligrams during the previous two weeks, you may be given the 37.5 milligram dose of Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG as the starting dose.

If you are currently being treated with another oral antipsychotic other than risperidone, your starting dose of Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG will depend on your current treatment. Your doctor will choose either Risperidone Teva 25 mg or 37.5 mg.

Your doctor will decide whether this risperidone dose is appropriate for you.

Maintenance dose

• The usual dose is one 25-milligram injection every two weeks.
• A higher dose of 37.5 or 50 mg may be required. Your doctor will determine the most appropriate risperidone dose for you.
• Your doctor may prescribe oral risperidone for the first three weeks after the initial injection.

If you use more Risperidone Teva than you should

• People who have used more risperidone than they should have experienced the following symptoms: drowsiness, fatigue, abnormal body movements, difficulty standing and walking, dizziness due to low blood pressure, and abnormal heartbeats. Cases of abnormalities in the heart's electrical conduction and seizures have been reported.
• Contact your doctor immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you stop treatment with Risperidone Teva

The effects of this medicine will be lost. You must not stop using this medicine unless instructed by your doctor, as your symptoms may return. Make sure to receive your injections every two weeks. If you are unable to attend your appointments, contact your doctor immediately to schedule another appointment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years of age must not receive risperidone.

4. Possible adverse effects

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

Immediately inform your doctor if you experience any of the following uncommon adverse effects (may affect up to 1 in 100 patients):

• You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or have difficulty speaking even for a short period. These may be signs of a stroke.
• You develop tardive dyskinesia (uncontrollable spasms or twitching movements of the face, tongue, or other body parts). Inform your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth, or face. Discontinuation of risperidone may be necessary.

Immediately inform your doctor if you experience any of the following rare adverse effects (may affect up to 1 in 1,000 patients):

• You develop blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately.
• You develop fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as "Neuroleptic Malignant Syndrome"). Immediate medical treatment may be required.
• You are a man and experience a prolonged or painful erection. This is known as priapism. Immediate medical treatment may be required.
• You develop a severe allergic reaction characterized by fever, swelling of the mouth, face, lips, or tongue, difficulty breathing, itching, skin rash, or low blood pressure. Even if you previously tolerated oral risperidone, allergic reactions may rarely occur after receiving risperidone injections.

The following adverse effects may also occur:

Very common adverse effects (may affect more than 1 in 10 people)

• Symptoms of common cold
• Difficulty falling or staying asleep
• Depression, anxiety
• Parkinsonism: This condition may include slow or impaired movement, sensation of muscle stiffness or tightness (causing jerky movements), and sometimes a feeling of "freezing" of movement that then restarts. Other signs of parkinsonism include slow shuffling gait, resting tremor, increased saliva and/or drooling, and reduced facial expression.
• Headache

Common adverse effects (may affect up to 1 in 10 people)

• Pneumonia, chest infection (bronchitis), sinusitis
• Urinary tract infection, feeling as if you have the flu, anemia
• Increased levels of a hormone called "prolactin" detected in blood tests (which may or may not cause symptoms). Symptoms of elevated prolactin rarely occur and in men may include breast enlargement, difficulty achieving or maintaining erections, decreased sexual desire, or other sexual dysfunctions. In women, they may include breast discomfort, milk secretion from the breasts, loss of menstrual periods, or other menstrual cycle problems or fertility issues
• Increased blood sugar, weight gain, increased appetite, weight loss, decreased appetite
• Sleep disorder, irritability, decreased sexual desire, restlessness, feeling drowsy or less alert
• Dystonia: This condition involves involuntary, slow, or continuous muscle contractions. Although any part of the body may be affected (and may result in abnormal postures), dystonia frequently affects facial muscles, including abnormal eye, mouth, tongue, or jaw movements
• Dizziness
• Dyskinesia: This condition involves involuntary muscle movements and may include repetitive, twitching, twisting, or spasmodic movements
• Tremor (agitation)
• Blurred vision
• Rapid heartbeat
• Low blood pressure, chest pain, increased blood pressure
• Shortness of breath, sore throat, cough, nasal congestion
• Abdominal pain, abdominal discomfort, vomiting, nausea, stomach or intestinal infection, constipation, diarrhea, indigestion, dry mouth, toothache
• Skin rash
• Muscle spasms, bone or muscle pain, back pain, joint pain
• Urinary incontinence (loss of bladder control)
• Erectile dysfunction
• Loss of menstrual periods
• Milk secretion from the breasts
• Swelling of the body, arms, or legs, fever, weakness, fatigue (tiredness)
• Pain
• Reaction at the injection site, including itching, pain, or swelling
• Increased liver transaminases in blood, increased GGT (a liver enzyme called gamma-glutamyltransferase) in blood
• Falls

Uncommon adverse effects (may affect up to 1 in 100 people)

• Respiratory tract infection, bladder infection, ear infection, eye infection, tonsillitis, fungal nail infection, skin infection, localized infection in a single area of the skin or body part, viral infection, skin inflammation caused by mites, subcutaneous abscess
• Decreased number of white blood cells, decreased platelets (blood cells that help stop bleeding), decreased red blood cells
• Allergic reaction
• Sugar in urine, diabetes or worsening of diabetes
• Loss of appetite leading to malnutrition and reduced body weight
• Increased triglycerides in blood (fat), increased blood cholesterol
• Euphoria (mania), confusion, inability to achieve orgasm, nervousness, nightmares
• Loss of consciousness, seizures (epileptic fits), fainting
• Restlessness causing movement of body parts, balance disorder, abnormal coordination, dizziness upon standing, attention disturbance, speech problems, loss or changes in taste, decreased skin sensitivity to pain or touch, tingling, prickling, or numbness of the skin
• Eye infection or "red eye", dry eyes, increased tearing, eye redness
• Sensation of spinning (vertigo), ringing in the ears, ear pain
• Atrial fibrillation (abnormal heart rhythm), interruption of conduction between upper and lower parts of the heart, abnormal electrical activity of the heart, QT interval prolongation in the heart, slow heartbeat, abnormal electrical conduction of the heart (electrocardiogram or ECG), sensation of fluttering or pounding in the chest (palpitations)
• Decreased blood pressure upon standing (as a result, some people taking risperidone may feel weakness, dizziness, or loss of consciousness when standing or sitting up suddenly)
• Rapid, shallow breathing, respiratory congestion, gasping, nosebleeds
• Fecal incontinence, difficulty swallowing, excess gas or flatulence
• Itching, hair loss, eczema, dry skin, skin redness, skin discoloration, acne, scaly or itchy skin or scalp
• Increased CPK (creatine phosphokinase) in blood, an enzyme sometimes released during muscle breakdown
• Joint stiffness, joint swelling, muscle weakness, neck pain
• Frequent urination, inability to urinate, painful urination
• Ejaculation disorder, delayed menstruation, loss of menstrual periods or other menstrual cycle problems (women), breast development in men, sexual dysfunction, breast pain, breast discomfort, vaginal discharge
• Swelling of the face, mouth, eyes, or lips
• Chills, increased body temperature
• Change in walking pattern
• Feeling of thirst, feeling unwell, chest discomfort, feeling "under the weather"
• Skin hardening
• Increased liver enzymes in blood
• Procedure-related pain

Rare adverse effects (may affect up to 1 in 1,000 people)

• Decrease in a type of white blood cell that helps fight infections
• Inappropriate secretion of a hormone that controls urine volume
• Low blood sugar level
• Excessive water intake
• Sleepwalking
• Sleep-related eating disorder
• Lack of movement or response while awake (catatonia)
• Absence of emotions
• Decreased level of consciousness
• Head agitation
• Eye movement problems, eye rolling, light sensitivity of the eyes
• Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may occur if you are taking or have taken risperidone. If you need cataract surgery, make sure to inform your ophthalmologist if you are taking or have taken this medicine
• Irregular heartbeat
• Dangerously low number of a type of white blood cell needed to fight infections in the blood, increased eosinophils (a type of white blood cell) in blood
• Breathing difficulty during sleep (sleep apnea)
• Pneumonia caused by aspiration of food, lung congestion, crackling lung sounds, voice disorder, respiratory tract disorder
• Pancreatitis, intestinal obstruction
• Very hard stools
• Drug-related skin rash
• Hives (or "urticaria"), skin thickening, dandruff, skin disorder, skin lesion
• Muscle fiber breakdown and muscle pain (rhabdomyolysis)
• Postural abnormality
• Breast enlargement, milk secretion
• Decreased body temperature, malaise
• Yellowing of the skin and eyes (jaundice)
• Dangerously excessive water intake
• Increased insulin (a hormone that controls blood sugar levels) in blood
• Problems with blood vessels in the brain
• No response to stimuli
• Coma due to uncontrolled diabetes
• Sudden vision loss or blindness
• Glaucoma (increased pressure in the eyeball), crusts at the edge of the eyelid
• Flushing, tongue swelling
• Cracked lips
• Enlargement of mammary glands
• Decreased body temperature, coldness in arms and legs
• Medication withdrawal symptoms

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Life-threatening complications of uncontrolled diabetes
• Severe allergic reaction with swelling, which may affect the throat causing breathing difficulty
• Lack of movement in intestinal muscles causing obstruction

The following adverse effect has been reported with the use of another medicine called paliperidone, which is very similar to risperidone; therefore, it is also expected to occur with risperidone: Rapid heartbeat upon standing.

Frequency not known: (cannot be estimated from available data)

• Severe or life-threatening blistering and peeling rash that may start around the mouth, nose, eyes, genitals, and spread to other areas of the body (Stevens-Johnson Syndrome or toxic epidermal necrolysis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risperidone Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). If refrigeration is not available, the container may be stored below 25°C for a maximum of 7 days prior to administration.

Keep in the original packaging to protect from light.

After reconstitution:

Physical and chemical stability in use has been demonstrated for 24 hours at 25°C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the conditions and duration of storage in use before administration are the responsibility of the user and should normally not exceed 6 hours at 25°C, unless reconstitution has been carried out under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Risperidone Teva

• The active substance is risperidone.
• Each Risperidone Teva powder and solvent for prolonged-release injectable suspension EFG contains 25 mg, 37.5 mg or 50 mg of risperidone.
• The other ingredients are:

Powder for injection suspension:

Poly-(D, L-lactide-co-glycolide)

Solvent (solution):

Polysorbate 20, sodium carmellose, disodium hydrogen phosphate dihydrate, citric acid, sodium chloride, sodium hydroxide, water for injections.

Appearance of the product and contents of the pack

Risperidone 25 mg:

Each pack contains the following components grouped in a plastic tray:

• One small vial with a grey stopper, sealed with a pink aluminium cap, containing the powder (the active substance, risperidone, is in this powder).
• One pre-filled syringe with 2 ml of clear, colourless liquid for addition to the powder for prolonged-release injectable suspension.
• One vial adapter for reconstitution.
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW safety needle, 1 inch (0.8 mm x 25 mm) with needle protection device for administration in the deltoid, and one 20G TW safety needle, 2 inches (0.9 mm x 51 mm) with needle protection device for administration in the gluteal muscle.

Risperidone 37.5 mg:

Each pack contains the following components grouped in a plastic tray:

• One small vial with a grey stopper, sealed with a green aluminium cap, containing the powder (the active substance, risperidone, is in this powder).
• One pre-filled syringe with 2 ml of clear, colourless liquid for addition to the powder for prolonged-release injectable suspension.
• One vial adapter for reconstitution.
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW safety needle, 1 inch (0.8 mm x 25 mm) with needle protection device for administration in the deltoid, and one 20G TW safety needle, 2 inches (0.9 mm x 51 mm) with needle protection device for administration in the gluteal muscle.

Risperidone 50 mg:

Each pack contains the following components grouped in a plastic tray:

• One small vial with a grey stopper, sealed with a blue aluminium cap, containing the powder (the active substance, risperidone, is in this powder).
• One pre-filled syringe with 2 ml of clear, colourless liquid for addition to the powder for prolonged-release injectable suspension.
• One vial adapter for reconstitution.
• Two Terumo SurGuard®3 needles for intramuscular injection: one 21G UTW safety needle, 1 inch (0.8 mm x 25 mm) with needle protection device for administration in the deltoid, and one 20G TW safety needle, 2 inches (0.9 mm x 51 mm) with needle protection device for administration in the gluteal muscle.

Risperidone Teva is available in packs containing 1, 2 or 5 single-dose packs.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Manufacturer

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25

10000 Zagreb

Croatia

or

Pharmathen International S.A

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

or

Pharmathen S.A

Dervenakion 6,

Pallini Attiki,

15351, Greece

Date of the most recent revision of this package leaflet: March 2022

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended for healthcare professionals only:

Important information

Risperidone Teva requires careful attention at every step of the "Instructions for Use" to help ensure successful administration.

Use of provided components

The components in the pack are specifically designed for use with Risperidone Teva.

Risperidone Teva must only be reconstituted with the solvent supplied in the pack.

Do NOT substitute ANY of the components in this pack.

Do not store the suspension after reconstitution

Administer the dose as soon as possible after reconstitution to avoid sedimentation.

Correct dosing

The entire content of the vial must be administered to ensure the correct dose of Risperidone Teva is delivered.

Do not reuse

Medical devices require materials with specific characteristics to function properly. These characteristics have been validated for single use only. Any attempt to reprocess the device for subsequent reuse may negatively affect the device's integrity or lead to impaired performance.

Pack components

Step 1	Assemble the components
Remove the dose container	Attach the vial adapter to the vial
Wait 30 minutes Remove the dose container from the refrigerator and allow it to reach room temperature for at least 30 minutes before reconstitution. Do not heat in any other way.	Remove the vial cap Remove the colored cap from the vial. Clean the top of the grey rubber stopper with an alcohol swab. Allow to air dry. Do not remove the grey rubber stopper.	Prepare the vial adapter Open the blister pack and remove the vial adapter by holding it at the white luer cap and the rim. Do not touch the puncture tip or the luer connection point at any time. This may cause contamination.	Attach the vial adapter to the vial Place the vial on a hard surface and hold it by the base. Center the vial adapter over the grey rubber stopper. Press the vial adapter straight down until it clicks securely into place on the vial. Do not place the vial adapter at an angle, as this may result in solvent loss during transfer to the vial.
Attach the pre-filled syringe to the vial adapter
Clean the connection point Keep the vial upright to prevent leakage. Hold the base of the vial and clean the luer connection point (blue circle) of the vial adapter with an alcohol swab; allow it to dry before attaching the syringe. Do not shake. Do not touch the luer connection point on the vial adapter. This may cause contamination.	Use the correct gripping area Hold the syringe by the white ring at the tip. Do not hold the syringe by the glass during assembly.	Remove the cap Holding the white ring, break off the white cap. Do not twist or cut the white cap. Do not touch the syringe tip. This may cause contamination. The broken cap can be discarded.	Attach the syringe to the vial adapter Hold the vial adapter by the rim to keep it steady. Hold the syringe by the white ring, then insert and press the syringe tip into the blue circle of the vial adapter, and turn clockwise to secure the connection between the syringe and the vial adapter (avoid over-tightening). Do not hold the syringe by the glass barrel. This may cause the white ring to loosen or detach.

Step 2	Reconstitute the microspheres
Inject solvent Inject the entire amount of solvent from the syringe into the vial.	Suspend the microspheres in the solvent Continue pushing down on the plunger with your thumb and shake vigorously, as shown, for at least 10 seconds. Inspect the suspension. When properly mixed, the suspension will appear uniform, dense, and milky in color. The microspheres will be visible in the liquid. Proceed immediately to the next step to prevent sedimentation of the suspension.	Transfer the suspension to the syringe Completely invert the vial. Slowly pull down the plunger rod to draw all the contents of the vial into the syringe.	Remove the vial adapter Hold the syringe by the white ring and unscrew it from the vial adapter. Properly dispose of both the vial and the vial adapter.

Step 3	Attach the needle
Select the appropriate needle Select the needle according to the injection site (gluteal or deltoid).	Attach the needle Open the blister pack at the partially peeled area and use it to hold the base of the needle, as shown. Holding the white ring of the syringe, attach the syringe to the luer needle with a firm clockwise rotating motion until securely fastened. Do not touch the opening of the luer needle. This may cause contamination.	Resuspend the microspheres Completely remove the blister pack. Immediately before injection, shake the syringe vigorously again, in case any sedimentation has occurred.

Step 4	Inject the dose
Remove the transparent needle protector Move the needle safety device toward the syringe, as shown. Then, hold the white ring of the syringe and carefully remove the transparent needle protector. Do not twist the transparent needle protector, as this may disconnect the luer attachment.	Remove air bubbles Hold the syringe upright and gently tap to allow air bubbles to rise to the top. Slowly and carefully, push the plunger rod to expel the air.	Inject Immediately inject the entire contents of the syringe intramuscularly (IM) into the patient's gluteal or deltoid muscle. The gluteal injection should be administered into the upper outer quadrant of the buttock. Do not administer intravenously.	Engage the needle into the safety device Using one hand, place the needle safety device at a 45-degree angle onto a flat, hard surface. Press down firmly and quickly until the needle is fully enclosed within the safety device. To prevent needlestick injury: Do not use two hands. Do not deliberately disengage or misuse the needle safety device. Do not attempt to straighten the needle or activate the safety device if the needle is bent or damaged.	Dispose of needles properly Check that the needle safety device is fully engaged. Dispose of it in a sharps container. Also dispose of the provided needle and any unused dose in the sharps container.