Egoropal

Package leaflet: Information for the user

Egoropal, 25 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 50 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 75 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 100 mg, prolonged-release injection suspension
in pre-filled syringe
Egoropal, 150 mg, prolonged-release injection suspension
in pre-filled syringe
Paliperidone
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Table of contents

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

1. What Egoropal is and what it is used for

Egoropal contains the active substance paliperidone, which belongs to a group of medicines
called antipsychotics. It is used for the maintenance treatment of symptoms of schizophrenia
in adult patients stabilized on paliperidone or risperidone.
If you have previously responded to paliperidone or risperidone and have mild or moderate
symptoms, your doctor may initiate treatment with Egoropal without prior stabilization
on paliperidone or risperidone.
Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive symptoms
refer to the presence of symptoms that are not normally experienced. For example, a person
with schizophrenia may hear voices or see things that are not there (hallucinations), believe
in things that are not true (delusions), or be excessively suspicious of others. Negative symptoms
refer to the absence of usual behaviors or emotions. A person with schizophrenia may, for example,
seem withdrawn, emotionally unresponsive, or have difficulty speaking in a clear and logical way.
People with this condition may also experience depression, anxiety, feelings of guilt, or tension.
Egoropal may help reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Egoropal

When not to use Egoropal

• if the patient is allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to another antipsychotic medicine, including the substance risperidone.

Warnings and precautions
Before starting treatment with Egoropal, discuss this with your doctor, pharmacist, or nurse.
The use of this medicine in elderly patients with dementia has not been studied. However, in such
patients treated with other similar medicines, an increased risk of stroke or death may occur (see section 4, Possible side effects).
All medicines have side effects. Some of the side effects of this medicine may worsen symptoms of other medical conditions. For this reason, during treatment with this medicine, you should discuss with your doctor any of the following conditions that may potentially worsen during treatment with this medicine:

• if the patient has Parkinson's disease;
• if the patient has ever been diagnosed with a condition characterized by symptoms such as high fever and muscle stiffness (also known as neuroleptic malignant syndrome);
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (tardive dyskinesia);
• 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 or is predisposed to developing diabetes;
• if the patient has breast cancer or a pituitary gland tumor;
• if the patient has heart disease or is being treated for heart disease that predisposes to hypotension;
• if the patient has low blood pressure upon sudden change to upright or sitting position;
• if the patient has epilepsy;
• if the patient has been diagnosed with impaired kidney function;
• if the patient has been diagnosed with impaired liver function;
• if the patient experiences prolonged and (or) painful erection;
• if the patient has problems with body temperature regulation or overheating of the body;
• if the patient has abnormally high levels of the hormone prolactin in the blood or suspicion of a prolactin-dependent tumor;
• if the patient or a family member has a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient has any of the above conditions, they should consult their doctor, who may adjust the dose or monitor the patient periodically.
The treating doctor may order a white blood cell count test, as very rarely, dangerously low levels of certain types of white blood cells necessary for fighting infections have been observed in patients using this medicine.
Even if the patient previously tolerated oral paliperidone or risperidone, allergic reactions may rarely occur after paliperidone injections. Seek immediate medical help if the patient develops rash, throat swelling, itching, or difficulty breathing, as these may be symptoms of a severe allergic reaction.
This medicine may cause weight gain. Significant weight gain may negatively affect the patient's health. The treating doctor will regularly monitor the patient's body weight.
The treating doctor will check whether the patient shows symptoms of elevated blood sugar levels, as new-onset diabetes or worsening of pre-existing diabetes has been observed in patients taking this medicine. In patients with pre-existing diabetes, blood glucose levels should be monitored regularly.
Since this medicine may suppress vomiting, it may mask the body's normal response to ingestion of toxic substances or other medical conditions.
During cataract surgery (clouding of the eye lens), the pupil (black part of the eye) may not dilate sufficiently. Also, the iris (colored part of the eye) may be floppy during surgery, which may result in eye damage. If the patient has planned eye surgery, inform the ophthalmologist about taking this medicine.
Children and adolescents
This medicine is not used in individuals under 18 years of age.
Egoropal with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilizing medicine) may require adjustment of the dose of this medicine.
Since this medicine acts primarily in the brain, concomitant use with other medicines acting on the brain, such as other psychotropic medicines, opioids, antihistamines, and sedatives, may increase side effects such as drowsiness or other effects on the brain.
This medicine may cause low blood pressure; therefore, caution is advised when using this medicine together with other medicines that lower blood pressure.
This medicine may reduce the effectiveness of medicines used in Parkinson's disease and restless legs syndrome (e.g., levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG), manifested by prolongation of the electrical impulse through a specific part of the heart (known as "QT interval prolongation"). Other medicines with such effects include those used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
If the patient is prone to seizures, this medicine may increase the risk of their occurrence. Other medicines with such effects include certain antidepressants or medicines used to treat infections, as well as other antipsychotic medicines.
Caution is advised when using Egoropal together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).
Use of Egoropal with alcohol
Alcohol consumption should be avoided.
Pregnancy and breastfeeding
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.
This medicine should not be used during pregnancy unless discussed with the doctor.
Newborns whose mothers used paliperidone during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact your doctor.
This medicine may pass from the mother's body into breast milk and harm the child. Therefore, breastfeeding should not be performed while using this medicine.
Driving and operating machinery
During treatment with this medicine, dizziness, extreme fatigue, and visual disturbances may occur (see section 4). This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.
Egoropal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free."

3. How to use Egoropal

This medicine will be administered by a doctor or other medical personnel. The doctor will inform the patient when the next injection should be given. It is important not to miss a scheduled dose. If it is not possible to keep the appointment, the patient should immediately contact the doctor by telephone to arrange another visit as soon as possible.

The patient will receive the first (150 mg) and second (100 mg) injections of this medicine into the upper arm, approximately one week apart. After that, the patient will receive an injection (in a dose ranging from 25 mg to 150 mg) into the upper arm or buttock once a month.

If the doctor decides to switch from long-acting risperidone injections or other long-acting paliperidone injections to this medicine, the first injection of this medicine (in a dose ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock on the day of the next scheduled injection. After that, an injection (in a dose ranging from 25 mg to 150 mg) will be given into the upper arm or buttock once a month.

Depending on the patient's symptoms, the doctor may increase or decrease the dose by one dose level during the scheduled monthly injection.

Patients with kidney function disorders

The doctor will adjust the dose of the medicine based on kidney function. If the patient has mild kidney function impairment, the doctor may reduce the dose. This medicine should not be used in patients with moderate or severe kidney function impairment.

Elderly patients

The doctor may reduce the dose if the patient has impaired kidney function.

Overdose of Egoropal

This medicine will be administered under medical supervision, so overdose is unlikely.

In patients who have received an excessive dose of paliperidone, the following symptoms may occur: drowsiness and sedation, increased heart rate, low blood pressure, abnormal ECG (electrocardiogram) findings, or slowed or abnormal movements of the facial muscles, body, arms, or legs.

Discontinuing treatment with Egoropal

If the patient stops receiving injections, the medicine will cease to be effective. Do not discontinue treatment unless instructed by the doctor, as symptoms of the illness may return.

If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately inform your doctor if:

• the patient develops blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, seek immediate medical help.
• the patient with dementia experiences a sudden change in mental status or sudden weakness or numbness of the face, arms or legs, particularly on one side, or speech disturbances, even if brief. These symptoms may indicate a stroke.
• fever, muscle stiffness, sweating or decreased level of consciousness occur (a condition known as neuroleptic malignant syndrome). Immediate treatment may be necessary.
• a man experiences prolonged or painful erection. This condition is called priapism. Immediate treatment may be required.
• involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of paliperidone treatment may be necessary.
• a severe allergic reaction occurs, characterised by: fever, swelling of the lips, face, tongue or throat, breathing difficulties, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated oral risperidone or paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient is scheduled for eye surgery, the ophthalmologist should be informed about taking this medicine. During cataract surgery (clouding of the lens), the iris (coloured part of the eye) may become floppy (so-called "floppy iris syndrome"), which may lead to eye damage.
• the patient has a dangerously low number of certain white blood cells essential for fighting infections.

The following adverse effects may occur:
Very common adverse effects: may occur in more than 1 in 10 patients

• difficulty falling asleep or maintaining sleep.

Common adverse effects: may occur in up to 1 in 10 patients

• cold-like symptoms, urinary tract infection, flu-like symptoms
• the medicine Egoropal may increase the level of prolactin hormone in the blood (this may, but does not necessarily, cause symptoms). If symptoms of increased prolactin occur, they may include in men: breast swelling, difficulty achieving or maintaining erection or other sexual disturbances. In women, they may include breast discomfort, milk leakage from the breasts, absence of menstrual bleeding or other menstrual cycle disturbances
• high blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, feelings of stiffness or muscle tension (causing uneven, jerky movements), and sometimes even a sensation of "freezing" of movements followed by sudden release. Other symptoms of parkinsonism include: slow gait, resting tremor, increased salivation/drooling, and expressionless face
• psychomotor restlessness, drowsiness or reduced alertness
• dystonia: this condition involves slow or sustained involuntary muscle contractions. Although it may affect any part of the body (possibly resulting in abnormal posture), dystonia most commonly affects facial muscles, including abnormal eye, mouth, tongue or jaw movements
• dizziness
• dyskinesia: this condition involves involuntary muscle movements and may present as repetitive, spasmodic or twisting movements or jerks
• tremor
• headache
• rapid heartbeat
• high blood pressure
• cough, nasal congestion
• abdominal pain, vomiting, nausea, constipation, diarrhoea, indigestion, toothache
• increased liver enzyme activity in blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• injection site reaction, including itching, pain or swelling.

Uncommon adverse effects: may occur in up to 1 in 100 patients

• pneumonia, bronchitis, respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection

• decreased number of white blood cells, decreased number of certain white blood cells protecting against infections, anaemia

• allergic reaction

• onset of diabetes or worsening of pre-existing diabetes, increased blood insulin levels (hormone regulating blood sugar levels)

• increased appetite

• loss of appetite leading to malnutrition and low body weight

• high blood triglyceride (fat) levels, increased blood cholesterol levels

• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares

• tardive dyskinesia (twitching or jerking uncontrolled movements of the face, tongue or other body parts). Inform your doctor immediately if involuntary rhythmic movements of the tongue, lips or face occur. Discontinuation of this medicine may be necessary

• fainting, need to move body parts, dizziness upon changing to upright position, difficulty concentrating, speech difficulties, loss or altered sense of taste, reduced sensation to pain and touch on the skin, tingling, pricking or numbness of the skin

• blurred vision, eye infection or conjunctivitis, dry eyes

• sensation of dizziness, ringing in the ears, ear pain

• conduction block of impulses between heart chambers, abnormal electrical conduction in the heart, QT interval prolongation in the heart, rapid heartbeat upon changing to upright position, slow heart rate, abnormal electrocardiogram (ECG), palpitations

• low blood pressure, low blood pressure upon standing (as a result, some patients taking this medicine may faint, feel dizzy or lose consciousness when standing up suddenly)

• shallow breathing, sore throat, nosebleed

• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth

• excessive passing of gas

• increased activity of GGTP enzyme (liver enzyme - gamma-glutamyl transferase) in blood, increased liver enzyme activity in blood

• urticaria, itching, rash, hair loss, acne, subcutaneous abscess

• increased CPK (creatine phosphokinase) enzyme activity in blood, an enzyme sometimes released from damaged muscles

• muscle cramps, joint stiffness, muscle weakness

• urinary incontinence, frequent urination, painful urination

• erectile dysfunction, ejaculation disorders, absence of menstruation and other menstrual cycle disturbances (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhoea

• swelling of the face, lips, eyes or eyelids, body swelling, swelling of upper or lower limbs

• increased body temperature

• change in gait

• chest pain, chest discomfort, malaise

• skin hardening

• falls.

Rare adverse effects: may occur in up to 1 in 1,000 patients

• eye infection
• skin inflammation caused by mites, peeling and itching of the scalp or body skin
• increased number of eosinophils (a type of white blood cell) in blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• tremulous head movements
• abnormal secretion of the hormone regulating urine output
• sugar in urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement and response to stimuli in a patient who is not asleep (catatonia)
• confusion
• sleepwalking
• lack of emotions
• inability to achieve orgasm
• neuroleptic malignant syndrome (confusion, decreased or loss of consciousness, high fever and severe muscle rigidity), cerebrovascular disorders including sudden interruption of blood flow to the brain (stroke or "mini" stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures, balance disturbances
• abnormal motor coordination
• glaucoma (increased pressure inside the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity, increased tearing, eye redness
• atrial fibrillation (irregular heartbeat), irregular heartbeat - blood clot in the lungs causing chest pain and breathing difficulties. If such symptoms occur, seek immediate medical help.
• blood clots in veins, especially in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, seek immediate medical help
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• blood congestion in the lungs, congestion of the airways
• respiratory sounds, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• chapped lips
• drug-related skin rash, skin thickening, dandruff
• breakdown of muscle fibres and muscle pain (rhabdomyolysis)
• joint swelling
• inability to urinate
• breast discomfort, enlargement of mammary glands, breast enlargement
• vaginal discharge
• priapism (prolonged erection which may require surgical intervention)
• very low body temperature, chills, thirst sensation
• withdrawal symptoms
• abscess due to infection at injection site, deep skin infection, cyst at injection site, bruising at injection site.

Adverse effects with unknown frequency: frequency cannot be estimated based on available data

• dangerously low number of certain white blood cells responsible for fighting infections
• severe allergic reaction characterised by fever, swelling of lips, face, eyelids or tongue, shallow breathing, itching, skin rash, and sometimes low blood pressure
• dangerously excessive water drinking - water intoxication
• feeding disorders related to sleep
• coma due to uncontrolled diabetes
• reduced oxygenation of various body parts (due to reduced blood flow)
• rapid, shallow breathing, pneumonia caused by food aspiration, voice disturbances
• lack of intestinal peristalsis leading to obstruction
• yellowing of the skin and eyes (jaundice)
• severe or life-threatening blistering rash with skin peeling, which may appear in the mouth, nose, eyes, genital organs and around these areas and may also spread to other parts of the body (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling which may involve the throat and lead to breathing difficulties
• skin depigmentation
• abnormal posture
• in newborns whose mothers used Egoropal during pregnancy, adverse effects of the drug and/or withdrawal symptoms may occur, such as: irritability, slow or sustained muscle contractions, tremor, drowsiness, breathing difficulties and feeding problems
• low body temperature
• necrosis at injection site and ulceration at injection site.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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 authorisation holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Egoropal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and syringe-pre-filled ampoule.
The expiry date refers to the last day of the stated month.
Do not store above 30 ° C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Egoropal contains

• The active substance is paliperidone. Each Egoropal pre-filled syringe, 25 mg contains 39 mg of paliperidone palmitate. Each Egoropal pre-filled syringe, 50 mg contains 78 mg of paliperidone palmitate. Each Egoropal pre-filled syringe, 75 mg contains 117 mg of paliperidone palmitate. Each Egoropal pre-filled syringe, 100 mg contains 156 mg of paliperidone palmitate. Each Egoropal pre-filled syringe, 150 mg contains 234 mg of paliperidone palmitate.
• Other ingredients are: Polysorbate 20, Macrogol 4000, Citric acid monohydrate, Disodium phosphate, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide (for pH adjustment), Water for injections.

What Egoropal looks like and contents of the pack
Egoropal is a white or almost white prolonged-release injectable suspension in a pre-filled syringe.
Each cardboard box contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38
1106 Budapest
Hungary

Manufacturer
PHARMATHEN INTERNATIONAL S.A
Industrial Park Sapes
Rodopi Prefecture, Block No 5
69300 Rodopi
Greece
Pharmathen S.A
Dervenakion 6
15351 Pallini Attiki
Greece

This medicinal product is authorised for sale in the European Economic Area under the following names:
Denmark Egoropal
Poland Egoropal
Hungary Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, retardszuszpenziós injekció előretöltött fecskendőben
Czech Republic Egoropal
Bulgaria Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, инжекционна суспензия с удължено освобождаване в предварително напълнена спринцовка
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection
Lithuania Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, pailginto atpalaidavimo injekcinė suspensija užpildytame švirkšte
Latvia Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, ilgstošas darbības suspensija injekcijām pilnšļircē
Slovakia Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, injekčná suspenzia s predĺženým uvoľňovaním v naplnenej injekčnej striekačke

For further information, please contact the representative of the Marketing Authorisation Holder.
EGIS Polska sp. z o.o.:
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Telephone number: +48 22 417 92 00

Information intended exclusively for medical personnel or healthcare professionals and should be read together with the full product information (Summary of Product Characteristics).

The suspension for injection is for single use only. Before administration, inspect the suspension for foreign particles. If foreign particles are visible in the prefilled syringe, do not use the medicinal product.

The package contains a prefilled syringe and 2 needles with safety device [22G 1.5 inch (38.1 mm x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular administration.

1. Shake the prefilled syringe vigorously for at least 10 seconds to ensure homogeneity of the suspension.

2. Select the appropriate needle.

The first initiating dose of the medicinal product Egoropal (150 mg) should be administered on Day 1 into the DELTOID MUSCLE using a needle suitable for deltoid injections. The second initiating dose of the medicinal product Egoropal (100 mg) should be administered one week later (Day 8) into the DELTOID MUSCLE using a needle suitable for deltoid injections.

When switching from long-acting risperidone injections to the medicinal product Egoropal, the first injection of Egoropal (at a dose ranging from 25 mg to 150 mg) may be administered on the day of the next scheduled injection into either the DELTOID MUSCLE or the GLUTEAL MUSCLE, using the appropriate needle.

Monthly maintenance doses may be administered into either the DELTOID MUSCLE or the GLUTEAL MUSCLE using the appropriate needle.

For injections into the DELTOID MUSCLE in patients with body weight < 90 kg, use a 1-inch, 23G needle (25.4 mm x 0.64 mm) (needle with blue hub). If the patient’s body weight is ≥ 90 kg, use a 1.5-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

For injections into the GLUTEAL MUSCLE, use a 1.5-inch, 22G needle (38.1 mm x 0.72 mm) (needle with gray hub).

3. Holding the prefilled syringe with the tip pointing upward, remove the rubber cap from the tip by gently twisting.

4. Partially peel back the outer layer of the blister packaging of the safety needle. Grasp the needle shield through the plastic packaging. Hold the prefilled syringe upright. Attach the safety needle to the syringe by gently screwing it on to avoid breakage or damage to the tip. Before administration, always check for any signs of damage or leakage.

5. Remove the needle shield by pulling it straight off. Do not twist the shield, as this may cause the needle to become loose on the prefilled syringe.

6. Position the prefilled syringe with attached needle vertically to expel air. Expel air from the syringe by gently pushing the plunger forward.

7. Inject the entire contents of the prefilled syringe intramuscularly, slowly and deeply, into the selected patient muscle—either deltoid or gluteal. Do not administer the medicinal product intravenously or subcutaneously.

8. After completing the injection, use the thumb or finger of one hand (8a, 8b) or a flat surface (8c) to activate the needle safety device. A clicking sound indicates successful activation of the needle protection. Dispose of the prefilled syringe with needle appropriately.

8a

8b

8c