Denepra

Package leaflet: Information for the user

Denepra, 25 mg, prolonged-release injection suspension in prefilled syringe
Denepra, 50 mg, prolonged-release injection suspension in prefilled syringe
Denepra, 75 mg, prolonged-release injection suspension in prefilled syringe
Denepra, 100 mg, prolonged-release injection suspension in prefilled syringe
Denepra, 150 mg, prolonged-release injection suspension in prefilled syringe
Denepra, 150 mg and 100 mg, prolonged-release injection suspension in prefilled 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.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Denepra is and what it is used for

Denepra contains the active substance paliperidone, which belongs to a group of medicines called antipsychotics. It is used for maintenance treatment of symptoms of schizophrenia in stable adult patients who are being treated with paliperidone or risperidone.
In patients who previously responded to oral paliperidone or risperidone and whose psychotic symptoms are mild to moderate, the doctor may initiate treatment with Denepra without prior stabilization with paliperidone or risperidone.
Schizophrenia is a disorder with "positive" and "negative" symptoms. Positive symptoms mean the presence of symptoms that usually do not occur. For example, a person suffering from 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 mean the absence of usual behaviors or emotions. A person suffering from schizophrenia may, for example, appear withdrawn, isolated, emotionally unresponsive, or may have difficulty speaking clearly and logically. People affected by this disorder may also experience depression, anxiety, feelings of guilt, or tension.
Denepra helps to reduce the symptoms of the illness and prevent their recurrence.

2. Important information before using Denepra

When not to use Denepra

• 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 Denepra, 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 medicines of similar type, there may be an increased risk of stroke or death (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. Therefore, during treatment with this medicine, discuss with your doctor if any of the following conditions apply:

• 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 low white blood cell count (whether or not 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 conditions that predispose to hypotension
• if the patient has low blood pressure upon sudden change to standing or sitting position
• if the patient has epilepsy
• if the patient has kidney function disorders
• if the patient has liver function disorders
• if the patient experiences prolonged and/or painful erection
• if the patient has problems with body temperature regulation or overheating
• if the patient has abnormally increased levels of the hormone prolactin in the blood or suspected prolactin-dependent tumor
• if the patient or their family members have a history of blood clots in blood vessels, as antipsychotic medicines are associated with their development.

If the patient meets any of the above criteria, 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 taking this medicine.
Even if the patient previously tolerated orally administered paliperidone or risperidone well, allergic reactions may rarely occur after Denepra 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 monitor for 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, the pupil may not dilate sufficiently.
Also, the iris of the eye may become 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.

Denepra and other medicines
Inform your doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Taking this medicine together with carbamazepine (an antiepileptic and mood-stabilizing medicine) may require dose adjustment of this medicine.
Since this medicine acts primarily in the brain, interaction with other medicines such as other psychotropic medicines, opioids, antihistamines, and sedatives that act on the brain may increase side effects such as drowsiness or other central nervous system effects.
This medicine may lower blood pressure; therefore, caution is advised when using this medicine concomitantly 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 electrocardiogram (ECG) abnormalities manifested by prolongation of the time it takes for an electrical impulse to pass through a specific part of the heart (known as "QT interval prolongation"). Other medicines with such an effect include certain medicines 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 an effect include certain antidepressants or medicines used to treat infections, as well as other antipsychotic medicines.
Caution is advised when using Denepra together with medicines that increase central nervous system activity (psychostimulants such as methylphenidate).

Denepra and alcohol
Alcohol consumption should be avoided.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 the child through breast milk and may harm the child.
Therefore, breastfeeding should not be performed during treatment with this medicine.

Driving and operating machinery
During treatment with this medicine, dizziness, extreme fatigue, and visual disturbances (see section 4) may occur. These effects should be taken into account in situations requiring full alertness, such as driving or operating machinery.

Denepra contains sodium and polysorbate
This medicine contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
This medicine contains 12.0 mg of polysorbate 20 in each mL of paliperidone injection.
Polysorbates may cause allergic reactions. Inform your doctor of any known allergies.

3. How to use Denepra

The medicine is administered by a doctor or other medical personnel. Your doctor will inform you when the next injection is due. It is important not to miss a scheduled dose. If you are unable to keep the scheduled appointment, you should contact your doctor immediately to arrange another appointment as soon as possible.

The first (150 mg) and second (100 mg) injections of this medicine will be given into the upper arm, approximately one week apart. After that, monthly injections (at a dose ranging from 25 mg to 150 mg) will be administered into the upper arm or buttock.

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

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

Patients with kidney function impairment
Your doctor will adjust the dose of the medicine according to kidney function. If you have mild kidney impairment, your doctor may reduce the dose. This medicine should not be used in cases of moderate or severe kidney impairment.

Elderly patients
Your doctor may reduce the dose if you have impaired kidney function.

Use of a higher than recommended dose of Denepra
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), or slowed or abnormal muscle movements of the face, body, arms, or legs.

Stopping treatment with Denepra
If you stop receiving the injections, the medicine will no longer work. Do not discontinue treatment unless instructed by your doctor, as symptoms of the illness may return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 the blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, immediate medical help should be sought.
• the patient with dementia experiences a sudden change in mental state 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.
• the patient develops fever, muscle stiffness, sweating or reduced level of consciousness (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary.
• a man experiences prolonged or painful erection. This condition is known as priapism. Immediate treatment may be necessary.
• involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of paliperidone treatment may be necessary.
• the patient develops a severe allergic reaction characterized by: fever, swelling of the lips, face, tongue or throat, shortness of breath, itching, skin rash, and sometimes low blood pressure (known as "anaphylactic reaction"). Even if the patient previously tolerated risperidone or orally administered paliperidone, allergic reactions may rarely occur after paliperidone injections.
• the patient is scheduled for eye surgery. Inform the ophthalmologist that the patient is taking this medicine. During cataract removal, floppy iris syndrome may occur, which could lead to eye damage.
• the patient has a dangerously low count of certain white blood cells essential 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 waking up

Common side effects (may occur in less than 1 in 10 patients)

• cold symptoms, urinary tract infection, flu-like symptoms
• the medicine Denepra may increase the level of prolactin hormone in the blood (which may, but does not necessarily, cause symptoms). If symptoms of elevated 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 discharge 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 involve 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 release. Other symptoms of parkinsonism include: slow shuffling gait, resting tremor, increased salivation/drooling, and expressionless face
• psychomotor restlessness, feeling of 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 body 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 side effects (may occur in less than 1 in 100 patients)

• pneumonia, bronchitis, respiratory tract infections, sinus infection, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased white blood cell count, decreased count 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 (fats) 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 the doctor immediately if involuntary rhythmic movements of the tongue, mouth or face occur. Discontinuation of this medicine may be necessary
• fainting, need to move body parts, dizziness upon standing, 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 conduction of electrical impulses in the heart, QT interval prolongation in the heart, rapid heartbeat upon standing, slow heart rate, abnormal electrocardiogram (ECG), sensation of heart 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 or rising)
• shortness of breath, 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
• hives, 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 menstrual bleeding and other menstrual cycle disturbances (women), breast enlargement in men, sexual disturbances, breast pain, galactorrhea
• swelling of the face, lips, eyes or mouth, body swelling, swelling of upper or lower limbs
• increased body temperature
• change in gait
• chest pain, chest discomfort, malaise
• skin hardening
• fall

Rare side effects (may occur in less than 1 in 1,000 patients)

• eye infection
• skin inflammation caused by mites, scaly and itchy scalp or other body parts
• increased number of eosinophils (a type of white blood cells) in blood
• decreased platelet count (blood cells responsible for stopping bleeding)
• head tremors
• 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)
• disorientation
• sleepwalking
• lack of emotion
• inability to achieve orgasm
• neuroleptic malignant syndrome (disorientation, reduced 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 in the eyeball)
• eye movement disorders, rotary eye movements, light sensitivity, increased tearing, red eyes
• atrial fibrillation (irregular heartbeat), irregular heart rhythm
• pulmonary embolism causing chest pain and difficulty breathing. If such symptoms occur, immediate medical help should be sought
• blood clots in veins, particularly in the lower limbs (symptoms include swelling, pain and redness of the lower limbs). If such symptoms occur, immediate medical help should be sought
• flushing attacks
• breathing disturbances during sleep (sleep apnoea)
• blood congestion in the lungs, congestion of the airways
• crackling sounds in the lungs, wheezing
• pancreatitis, tongue swelling, faecal incontinence, very hard stool
• intestinal obstruction
• dry lips
• drug-related skin rash, skin thickening, psoriasis
• breakdown of muscle fibers 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, sensation of thirst
• withdrawal symptoms
• abscess due to infection at the injection site, deep skin infection, cyst at the injection site, bruising at the injection site

Side effects of unknown frequency (frequency cannot be determined from available data)

• dangerously low count of certain white blood cells responsible for fighting infections;
• severe allergic reaction characterized by fever, swelling of lips, face, tongue or throat, shallow breathing, itching, skin rash, and sometimes low blood pressure
• dangerously excessive water drinking - water intoxication
• sleep-related eating disorders
• 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, genitals and around these areas and may also spread to other body parts (Stevens-Johnson syndrome or toxic epidermal necrolysis)
• severe allergic reaction with swelling, which may involve the larynx and lead to breathing difficulties
• skin depigmentation
• abnormal body posture
• in newborns whose mothers used Denepra 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 the injection site and ulcer at the injection site

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Side 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Denepra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton
and on the pre-filled syringe.
The expiry date refers to the last day of the stated month.
Do not freeze.
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 Denepra contains
25 mg: Each pre-filled syringe contains 39 mg of paliperidone palmitate in 0.25 mL of suspension,
equivalent to 25 mg of paliperidone.
50 mg: Each pre-filled syringe contains 78 mg of paliperidone palmitate in 0.5 mL of suspension,
equivalent to 50 mg of paliperidone.
75 mg: Each pre-filled syringe contains 117 mg of paliperidone palmitate in 0.75 mL of suspension,
equivalent to 75 mg of paliperidone.
100 mg: Each pre-filled syringe contains 156 mg of paliperidone palmitate in 1 mL of suspension,
equivalent to 100 mg of paliperidone.
150 mg: Each pre-filled syringe contains 234 mg of paliperidone palmitate in 1.5 mL of suspension,
equivalent to 150 mg of paliperidone.
Initiating treatment pack
Each 100 mg pre-filled syringe: contains 156 mg of paliperidone palmitate in 1 mL of suspension,
equivalent to 100 mg of paliperidone.
Each 150 mg pre-filled syringe: contains 234 mg of paliperidone palmitate in 1.5 mL of suspension,
equivalent to 150 mg of paliperidone.
Other ingredients:
polysorbate 20, macrogol 4000, citric acid monohydrate, disodium phosphate, sodium dihydrogen phosphate monohydrate, sodium hydroxide (for pH adjustment), water for injections.

What Denepra looks like and contents of the pack
Denepra is a white to off-white extended-release suspension for injection in a pre-filled syringe.
The pre-filled syringe (colourless Type I glass) with a bromobutyl rubber stopper (plunger tip), lock, and "tip-cap" made of bromobutyl rubber, together with two needles: 22G 1½ inch (35.5–39.5 mm) and 23G 1 inch (22.5–26.5 mm). Outer packaging: PET blister packed in a cardboard box.
Each pack contains 1 pre-filled syringe and 2 needles.
Each initiating treatment pack contains:

• 1 pack of Denepra 150 mg, 1 pre-filled syringe and 2 needles (for administration on day 1 of treatment)
• 1 pack of Denepra 100 mg, 1 pre-filled syringe and 2 needles (for administration on day 8 of treatment).

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warsaw
Poland
tel. 22 209 70 00

Manufacturer/Importer
Pharmascience International Limited
1st Floor Jacovides Tower
81-83 Griva Digeni Avenue
1090 Nicosia
Cyprus
Lek Pharmaceuticals d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Denepra 25 mg - Depot-Injektionssuspension
Denepra 50 mg - Depot-Injektionssuspension
Denepra 75 mg - Depot-Injektionssuspension
Denepra 100 mg - Depot-Injektionssuspension
Denepra 150 mg - Depot-Injektionssuspension
Denepra Starterpackung 100 mg + 150 mg - Depot-Injektionssuspension
Czech Republic Denepra
Spain Denepra 50 mg suspensión inyectable de liberación prolongada EFG
Denepra 75 mg suspensión inyectable de liberación prolongada EFG
Denepra 100 mg suspensión inyectable de liberación prolongada EFG
Denepra 150 mg suspensión inyectable de liberación prolongada EFG
Denepra 100 mg + Denepra 150 mg suspensión inyectable de liberación prolongada EFG (starterpack)
Croatia Denepra 50 mg suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki
Denepra 75 mg suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki
Denepra 100 mg suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki
Denepra 150 mg suspenzija za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki
Poland Denepra
Sweden Denepra

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

The injectable suspension is intended for single use only. Before administration, inspect visually 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 safety needles [22G 1.5 inches (35.5–39.5 mm) and 23G 1 inch (22.5–26.5 mm)] for intramuscular administration. The medicinal product Denepra is also available in a starter pack containing two prefilled syringes (150 mg + 100 mg) and 2 additional safety needles.

(A) 22 G x 1 inch (gray hub)
(B) 23 G x 1 inch (blue hub)
(C) Prefilled syringe
(D) Hub
(E) Tip cap

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 Denepra (150 mg) should be administered on day 1 of treatment into the DELTOID MUSCLE using the DELTOID MUSCLE needle. The second initiating dose of the medicinal product Denepra (100 mg) should be administered one week later (day 8), also into the DELTOID MUSCLE, using the DELTOID MUSCLE needle.

If switching from long-acting risperidone injections to the medicinal product Denepra, the first injection of Denepra (at a dose between 25 mg and 150 mg) may be administered either into the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle on the day of the next scheduled injection. Subsequently, monthly maintenance doses may be administered into either the DELTOID MUSCLE or GLUTEAL MUSCLE using the appropriate needle.

For DELTOID MUSCLE injections in patients with body weight <90 kg, use a 1-inch, 23G needle (22.5–26.5 mm) (blue hub). If the patient's body weight is ≥90 kg, use a 1.5-inch, 22G needle (35.5–39.5 mm) (gray hub).

For GLUTEAL MUSCLE injections, use a 1.5-inch, 22G needle (gray hub).

3. Hold the syringe vertically with the tip pointing upward. Remove the rubber tip cap with a gentle twisting motion.

4. Peel off the needle safety shield. Grasp the base of the needle, not the safety shield. Attach the safety needle to the syringe’s Luer lock connector by pressing and turning clockwise.

5. Remove the needle cover with a straight pull. Do not rotate the cover, as this may loosen the needle from the prefilled syringe.

6. Expel air from the prefilled syringe by gently pressing the plunger while holding the syringe vertically.

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

8. After completing the injection, activate the needle safety feature by pressing the thumb or finger of one hand against the safety shield (8a, 8b), or against a flat surface (8c). A clicking sound indicates successful needle protection. Dispose of the prefilled syringe with the attached needle properly.

8a

8b

8c

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.