Egoropal

Leaflet attached to the packaging: information for the user

Egoropal, 25 mg, prolonged-release suspension for injection

In a pre-filled syringe

Egoropal, 50 mg, prolonged-release suspension for injection in a pre-filled syringe

Egoropal, 75 mg, prolonged-release suspension for injection in a pre-filled syringe

Egoropal, 100 mg, prolonged-release suspension for injection in a pre-filled syringe

Egoropal, 150 mg, prolonged-release suspension for injection in a pre-filled syringe

Paliperidone

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, pharmacist, or nurse.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Egoropal and what is it used for

Egoropal contains the active substance paliperidone, which belongs to a group of antipsychotic medicines and is used to treat schizophrenia in adult patients who have been stabilized on paliperidone or risperidone.
If the patient has previously responded to paliperidone or risperidone and has mild or moderate symptoms, the doctor may start treatment with Egoropal without prior stabilization on paliperidone or risperidone.
Schizophrenia is a disease with "positive" and "negative" symptoms. Positive symptoms mean an accumulation of symptoms that usually do not occur. A person suffering from schizophrenia may, for example, hear voices or see things that do not exist (these are hallucinations), believe in untrue things (these are delusions), or be overly suspicious of others. Negative symptoms mean a lack of usually occurring behaviors or feelings. A person suffering from schizophrenia may, for example, seem withdrawn, closed off, and not respond emotionally at all, or may have difficulty speaking clearly and logically. People with this disease may also experience depression, anxiety, guilt, or tension.
Egoropal may help alleviate the symptoms of the disease 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, you should discuss it with your doctor, pharmacist, or nurse.
The use of this medicine has not been studied in elderly patients with dementia. However, in such patients treated with other similar medicines, there may be an increased risk of stroke or death (see section 4, Possible side effects).
All medicines have side effects. Some side effects of this medicine may worsen the 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 whose symptoms include high fever and muscle stiffness (also known as malignant neuroleptic syndrome)
• if the patient has ever experienced abnormal movements of the tongue or facial muscles (late dyskinesia)
• if the patient has had a low white blood cell count in the past (which may or may not have been caused by the action of other medicines)
• if the patient has diabetes or is prone to it
• if the patient has breast cancer or a pituitary tumor
• if the patient has heart disease or is being treated for heart disease that predisposes to low blood pressure
• if the patient has low blood pressure when changing position from lying down to standing or sitting
• if the patient has epilepsy
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient experiences prolonged or painful erections
• if the patient has a problem with body temperature regulation or overheating
• if the patient has an abnormal, elevated level of the hormone prolactin in the blood or a suspected prolactin-dependent tumor
• if the patient or their family members have had cases of blood clots in blood vessels, as antipsychotic medicines are associated with their formation.

If the patient has any of the above conditions, they should consult their doctor, who may adjust the dose or periodically monitor the patient.
The doctor may order a white blood cell count test, as very rare cases of a dangerously low number of a certain type of white blood cell necessary for fighting infections have been reported in patients taking this medicine.
Even if the patient has previously tolerated oral paliperidone or risperidone, rare allergic reactions may occur after injections of paliperidone. The patient should seek medical help immediately if they experience a 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 can have a negative impact on the patient's health. The doctor will regularly check the patient's weight.
The doctor will check if the patient has symptoms of high blood sugar levels, as new cases of diabetes or worsening of existing diabetes have been reported in patients taking this medicine. In patients with existing diabetes, blood glucose levels should be regularly checked.
Since this medicine can suppress vomiting, it may mask the body's normal response to swallowing toxic substances or other medical conditions.
During eye surgery for cataracts, the pupil (the black part of the eye) may not dilate sufficiently. The iris (the colored part of the eye) may also be flaccid during the procedure, which can result in eye damage. If the patient is scheduled for eye surgery, they should tell their ophthalmologist about taking this medicine.

Children and adolescents

This medicine is not used in people under 18 years of age.

Egoropal and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Taking this medicine with carbamazepine (an antiepileptic and mood stabilizer) may require a change in the dose of this medicine.
Due to the fact that this medicine acts primarily in the brain, interactions with other medicines such as other psychotropic medicines, opioids, antihistamines, and sedatives that act in the brain may cause an increase in side effects such as drowsiness or other effects on the brain.
This medicine may cause a decrease in blood pressure, so caution should be exercised when taking this medicine with other medicines that lower blood pressure.
This medicine may weaken the effect of medicines used to treat Parkinson's disease and restless legs syndrome (e.g., levodopa).
This medicine may cause abnormalities in the electrocardiogram (ECG) characterized by prolongation of the time it takes for the electrical impulse to pass through a certain part of the heart (known as "prolongation of the QT interval"). Other medicines with this effect include those used to regulate heart rhythm or treat infections, as well as other antipsychotic medicines.
If the patient has a tendency to seizures, this medicine may increase the risk of their occurrence. Other medicines with this effect include certain medicines used to treat depression or infections, as well as other antipsychotic medicines.
Care should be taken when using Egoropal with medicines that increase the activity of the central nervous system (psychostimulant medicines such as methylphenidate).

Using Egoropal with alcohol

Alcohol should be avoided.

Pregnancy and breastfeeding

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.
This medicine should not be used during pregnancy, unless discussed with a doctor.
In newborns whose mothers used paliperidone 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 feeding difficulties. If such symptoms are observed in the patient's child, they should contact their doctor.
This medicine may pass from the mother's body into her breast milk and harm the baby.
Therefore, breastfeeding should be avoided while using this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness, extreme fatigue, and vision disturbances (see section 4) may occur. This should be taken into account in situations where full alertness is required, such as driving a vehicle or operating machinery.

Egoropal contains sodium

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

3. How to use Egoropal

This medicine is administered by a doctor or other medical staff. The doctor will inform the patient when the next injection is due. It is essential not to miss a scheduled dose.
If it is not possible to keep the appointment with the doctor, the patient should contact them immediately to schedule another appointment as soon as possible.
The patient will receive the first (150 mg) and second (100 mg) injections of this medicine in the upper arm with an approximate 1-week interval. Then, the patient will receive an injection (in a dose ranging from 25 mg to 150 mg) in the upper arm or buttock once a month.
If the doctor decides to switch from using 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 in the upper arm or buttock on the day of the next scheduled injection. Then, an injection (in a dose ranging from 25 mg to 150 mg) will be administered in the upper arm or buttock once a month.
Depending on the symptoms that occur in the patient, the doctor may increase or decrease the administered dose of the medicine by one level of strength during the scheduled monthly injection.
Patients with kidney function disorders
The doctor will adjust the dose of the medicine, taking into account the patient's kidney function. If the patient has mild kidney function disorders, the doctor may decrease the dose. This medicine should not be used in cases of moderate or severe kidney function disorders.
Elderly patients
The doctor may decrease the dose of the medicine if the patient has impaired kidney function.

Using a higher than recommended dose of Egoropal

This medicine will be administered under medical supervision, so administering too high a dose is unlikely.
In patients who have received too high a dose of paliperidone, the following symptoms may occur: drowsiness and sedation, rapid heart rate, low blood pressure, abnormal ECG (electrocardiogram), or slow or abnormal movements of the facial muscles, body, arms, or legs.

Stopping the use of Egoropal

If the patient stops taking the injections, the medicine will stop working. The patient should not stop taking the medicine unless their doctor decides to do so, as the symptoms of the disease may return.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

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 blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek medical help immediately.
• they have dementia and experience a sudden change in mental state or sudden weakness or numbness of the face, arms, or legs, especially on one side, or speech disturbances, even if only for a short time. These symptoms may indicate a stroke.
• they experience fever, muscle stiffness, sweating, or decreased level of consciousness (a condition known as malignant neuroleptic syndrome). Immediate treatment may be necessary.
• they experience prolonged or painful erections. This condition is known as priapism. Immediate treatment may be necessary.
• they experience involuntary rhythmic movements of the tongue, lips, or face. It may be necessary to discontinue treatment with paliperidone.
• they experience a severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure (known as anaphylactic reaction). Even if the patient has previously tolerated risperidone or paliperidone taken orally, rare allergic reactions may occur after injections of paliperidone.
• they are scheduled for eye surgery, they should inform their ophthalmologist about taking this medicine. During eye surgery for cataracts, the iris (the colored part of the eye) may become flaccid (a condition known as "floppy iris syndrome"), which can lead to eye damage.
• they have a dangerously low number of certain white blood cells necessary for fighting infections.

The following side effects may occur:

Very common side effects: may occur in more than 1 in 10 patients

• difficulty falling asleep or maintaining sleep continuity.

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

• cold symptoms, urinary tract infections, flu-like symptoms
• Egoropal may increase the level of the hormone prolactin in the blood (which may or may not cause symptoms). If symptoms of elevated prolactin levels occur, they may include in men: breast swelling, difficulty achieving or maintaining an erection, or other sexual disturbances. In women, they may include discomfort in the breast area, milk secretion from the breasts, absence of menstrual periods, or other disturbances of the menstrual cycle
• high blood sugar levels, weight gain, weight loss, decreased appetite
• irritability, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or muscle tension (which can cause the patient's movements to be uneven, jerky), and sometimes even a feeling of "freezing" of movements, followed by unlocking. Other symptoms of parkinsonism include a slow, shuffling gait, tremors at rest, increased saliva production, and a face without expression
• psychomotor agitation, drowsiness, or decreased alertness
• dystonia: this condition includes slow or sustained involuntary muscle contractions. Although it can affect any part of the body (which can result in an abnormal posture), dystonia most commonly affects the facial muscles, including abnormal movements of the eyes, lips, tongue, or jaw
• dizziness
• dyskinesia: this condition includes involuntary muscle movements and can take the form of repetitive, spasmodic, or twisting movements or jerks
• tremors
• headaches
• rapid heart rate
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased activity of liver enzymes in the blood
• bone or muscle pain, back pain, joint pain
• absence of menstruation
• fever, weakness, fatigue
• reaction at the injection site, including itching, pain, or swelling.

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

• pneumonia, bronchitis, respiratory tract infections, sinusitis, urinary tract infections, ear infections, fungal nail infections, tonsillitis, skin infections
• decreased white blood cell count, decreased number of certain white blood cells that protect against infections, anemia
• allergic reaction
• onset of diabetes and worsening of existing diabetes, increased insulin levels in the blood (a hormone that regulates blood sugar levels)
• increased appetite
• loss of appetite leading to malnutrition and low body weight
• high levels of triglycerides (fats) in the blood, increased cholesterol levels in the blood
• sleep disturbances, elevated mood (mania), decreased libido, nervousness, nightmares
• late dyskinesia (involuntary, rhythmic 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, lips, or face. It may be necessary to discontinue treatment with this medicine
• fainting, need to move limbs, dizziness when changing position from lying down to standing, concentration disorders, speech difficulties, loss of taste, decreased sensitivity to pain and touch on the skin, feeling of tingling, pricking, or numbness of the skin
• blurred vision, eye infection or conjunctivitis, dry eye
• feeling of dizziness, ringing in the ears, ear pain
• heart block, abnormal conduction of electrical impulses in the heart, prolongation of the QT interval in the heart, rapid heart rate when changing position from lying down to standing, slow heart rate, abnormal electrocardiogram (ECG), feeling of palpitations
• low blood pressure, low blood pressure when changing position from lying down to standing (which can cause some patients taking this medicine to faint, feel dizzy, or lose consciousness when standing up or getting up)
• shallow breathing, sore throat, nosebleeds
• discomfort in the abdominal cavity, stomach or intestinal infection, difficulty swallowing, dry mouth
• passing gas
• increased activity of the enzyme GGTP (a liver enzyme - gamma-glutamyltransferase) in the blood, increased activity of liver enzymes in the blood

Increased activity of the enzyme CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released from damaged muscles

• hives, itching, rash, hair loss, eczema, dry skin, redness of the skin, acne, boils
• muscle cramps, joint stiffness, muscle weakness
• urinary incontinence, frequent urination, painful urination
• erectile dysfunction, ejaculation disorders, absence of menstruation, and other menstrual cycle disorders (in women), breast enlargement in men, sexual disturbances, breast pain, galactorrhea
• swelling of the face, lips, eyes, or tongue, swelling of the body, arms, or legs
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• scleroderma
• falls

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

• eye infection
• skin rash caused by mites, scaling, and itching of the skin of the head or body
• increased number of eosinophils (a type of white blood cell) in the blood
• decreased number of platelets (blood cells responsible for stopping bleeding)
• head tremors
• abnormal secretion of the hormone that regulates the amount of urine
• sugar in the urine
• life-threatening complications of untreated diabetes
• low blood sugar levels
• excessive water drinking
• lack of movement and reaction to stimuli in a patient who is not sleeping (catatonia)
• confusion
• sleepwalking (walking while sleeping)
• lack of emotions
• inability to achieve orgasm
• malignant neuroleptic syndrome (confusion, decreased or lost consciousness, high fever, and severe muscle stiffness), cerebral vascular disorders including sudden cessation of blood flow to the brain (stroke or "mini" stroke), lack of reaction to stimuli, loss of consciousness, low level of consciousness, seizures, balance disorders
• abnormal coordination
• glaucoma (increased pressure in the eyeball)
• eye movement disorders, rotational eye movements, hypersensitivity of the eyes to light, increased tearing, redness of the eyes
• atrial fibrillation (abnormal heart rhythm), irregular heart rhythm - blood clot in the lungs causing chest pain and difficulty breathing. If such symptoms occur, the patient should seek medical help immediately
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs). If such symptoms occur, the patient should seek medical help immediately
• flushing
• sleep apnea (breathing disturbances during sleep)
• pulmonary congestion, respiratory tract congestion
• wheezing, whistling breathing sounds
• pancreatitis, tongue swelling, fecal incontinence, very hard stools
• intestinal obstruction
• chapped lips
• skin rash related to medicine use, skin thickening, dandruff
• muscle fiber breakdown and muscle pain (rhabdomyolysis)
• joint swelling
• urinary incontinence
• breast discomfort, breast enlargement, gynecomastia
• vaginal discharge
• priapism (prolonged erection that may require surgical intervention)
• very low body temperature, chills, feeling of thirst
• withdrawal symptoms
• abscess at the injection site and ulcer at the injection site

Side effects with unknown frequency: cannot be determined from available data

• dangerously low number of certain white blood cells necessary for fighting infections
• severe allergic reaction characterized by fever, swelling of the lips, face, tongue, or throat, difficulty breathing, itching, skin rash, and sometimes a drop in blood pressure
• dangerously excessive water drinking - water intoxication
• eating disorders related to sleep
• coma due to uncontrolled diabetes
• decreased oxygenation of various parts of the body (due to decreased blood flow)
• rapid, shallow breathing, aspiration pneumonia, voice disorders
• lack of intestinal peristalsis leading to obstruction
• jaundice (yellowing of the skin and eyes)
• 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)
• severe allergic reaction with swelling that can involve the throat and lead to difficulty breathing
• skin discoloration
• abnormal posture
• in newborns whose mothers used Egoropal during pregnancy, the following side effects of the medicine and/or withdrawal symptoms may occur: irritability, slow or sustained muscle contractions, trembling, drowsiness, difficulty breathing, and feeding difficulties
• low body temperature
• necrosis at the injection site and ulcer at the injection site

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 will help gather more information on the safety of the medicine.

5. How to store Egoropal

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and pre-filled syringe.
The expiry date refers to the last day of the month stated.
Do not store above 30°C.
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. Contents of the packaging and other information

What Egoropal contains

• The active substance of the medicine is paliperidone. Each pre-filled syringe of Egoropal 25 mg contains 39 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 50 mg contains 78 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 75 mg contains 117 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 100 mg contains 156 mg of paliperidone palmitate. Each pre-filled syringe of Egoropal 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 packaging

Egoropal is a white or off-white prolonged-release suspension for injection in a pre-filled syringe.
Each cardboard box contains 1 pre-filled syringe and 2 needles.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Denmark
Egoropal
Poland
Egoropal
Hungary
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe
Czech Republic
Egoropal
Bulgaria
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe
Lithuania
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe
Latvia
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe
Slovakia
Egoropal 25mg, 50mg, 75mg, 100mg, 150mg, prolonged-release suspension for injection in a pre-filled syringe

In order to obtain more detailed information, the patient should contact the representative of the marketing authorization holder.
EGIS Polska sp. z o.o.:
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone number: +48 22 417 92 00
Date of last revision of the leaflet:16.12.2023

Information intended for healthcare professionals only and should be read in conjunction with the full product information (Summary of Product Characteristics).

The suspension for injection is intended for single use only. Before administration, the suspension should be inspected for foreign particles. If foreign particles are visible in the pre-filled syringe, the medicinal product should not be used.
The packaging contains a pre-filled syringe and 2 needles with a safety device [22G 1.5 inches (38.1 mm x 0.72 mm) and 23G 1 inch (25.4 mm x 0.64 mm)] for intramuscular injection.

• 1. Shake the pre-filled syringe vigorously for at least 10 seconds to ensure the suspension is homogeneous.

• 2. Choose the appropriate needle.

The first initiating dose of the medicinal product Egoropal (150 mg) should be administered on Day 1 in the DELTOID MUSCLE using the 22G 1.5-inch needle. The second initiating dose of the medicinal product Egoropal (100 mg) should be administered in the DELTOID MUSCLE 1 week later (Day 8), using the 22G 1.5-inch needle.
In the event of a switch from risperidone long-acting injections or other paliperidone long-acting injections to Egoropal, the first injection of Egoropal (in a dose ranging from 25 mg to 150 mg) should be administered in the DELTOID MUSCLE or GLUTEAL MUSCLE on the day of the next scheduled injection, using the appropriate needle. Subsequent injections of Egoropal (in a dose ranging from 25 mg to 150 mg) should be administered in the DELTOID MUSCLE or GLUTEAL MUSCLE once a month.
For intramuscular injections in the DELTOID MUSCLE in patients weighing less than 90 kg, the 23G 1-inch needle (with a blue hub) should be used. If the patient weighs 90 kg or more, the 22G 1.5-inch needle (with a gray hub) should be used.
For intramuscular injections in the GLUTEAL MUSCLE, the 22G 1.5-inch needle (with a gray hub) should be used.

• 3. Hold the pre-filled syringe with the needle facing upwards and remove the rubber cap from the end of the pre-filled syringe by a gentle twisting motion.

• 4. Tear off the outer part of the needle packaging halfway. Grasp the needle shield by the plastic packaging. Hold the pre-filled syringe with the needle facing upwards. Mount the needle with a safety device onto the pre-filled syringe by gently screwing to avoid breaking or damaging the needle tip. Before administration, always check for signs of damage or leakage.

• 5. Remove the needle shield by a straight pull. Do not rotate the needle shield, as this may cause the needle to loosen from the pre-filled syringe.

• 6. Hold the pre-filled syringe with the attached needle in a vertical position to remove any air bubbles. Expel any air bubbles by gently pushing the plunger upwards.

• 7. Administer the entire contents of the pre-filled syringe intramuscularly, slowly, and deeply into the selected muscle of the patient - deltoideus or gluteus. 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. The clicking sound confirms that the needle is properly secured. Dispose of the pre-filled syringe with the needle in an appropriate manner.

8a

8b

8c