Pegasys 135 micrograms solution for injection in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pegasys 90 micrograms solution for injection in pre-filled syringe

Pegasys 135 micrograms solution for injection in pre-filled syringe

Pegasys 180 micrograms solution for injection in pre-filled syringe

peginterferon alfa-2a

Read all of this 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pegasys is and what it is used for

Pegasys contains the active substance peginterferon alfa-2a, which is a long-acting interferon. Interferon is a protein that modifies the immune system's response to help fight infections and serious diseases, and to prevent the growth of cancer cells.

Pegasys is used to treat polycythaemia vera and essential thrombocythaemia in adults.

Polycythaemia vera and essential thrombocythaemia are rare types of cancer in which the bone marrow produces too many red blood cells, white blood cells, and platelets (cells that help blood to clot).

Polycythaemia vera and essential thrombocythaemia: Pegasys is used alone.

Pegasys is also used to treat chronic hepatitis B or chronic hepatitis C in adults. It is also used to treat chronic hepatitis B in children and adolescents from 3 years of age and chronic hepatitis C in children and adolescents from 5 years of age who have not been previously treated. Both hepatitis B and hepatitis C are viral infections affecting the liver.

Chronic hepatitis B: Pegasys is usually used alone.

Chronic hepatitis C: Pegasys is used in combination with other medicines for the treatment of chronic hepatitis C (CHC).

You should also read the package leaflet of the medicines used in combination with Pegasys.

2. What you need to know before using Pegasys

Do not use Pegasys

• if you are allergic to peginterferon alfa-2a, any interferon, or any of the other components of this medicine (listed in section 6).
• if you have ever had a heart attack or have been hospitalized due to severe chest pain in the last six months.
• if you have or have ever had an autoimmune disease (such as rheumatoid arthritis, psoriasis, or inflammatory bowel disease).
• if you have a thyroid disorder that is not controlled by medication.
• if you have advanced liver disease and your liver is not functioning properly (e.g., your skin has turned yellow).
• if the patient is under 3 years of age.
• if the patient is a child who has ever had serious psychiatric disorders such as severe depression or suicidal thoughts.
• if you are infected with both hepatitis C virus and human immunodeficiency virus (HIV), and your liver is not functioning properly (e.g., your skin has turned yellow).
• if you are being treated with telbivudine, a medicine for hepatitis B virus infection (see “Other medicines and Pegasys”).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Pegasys

• if you have had a serious neurological or mental disorder.
• if you have ever had depression or symptoms related to depression (e.g., feeling sad, hopeless, etc.).
• if you are an adult who has or has had a history of substance abuse (e.g., alcohol or drugs).
• if you have psoriasis, as it may worsen during treatment with Pegasys.
• if you have other liver problems apart from hepatitis B or C.
• if you have diabetes or high blood pressure, your doctor may recommend an eye examination.
• if you have been diagnosed with VKH syndrome.
• if you have a thyroid disorder that is not adequately controlled with medication.
• if you have ever had anemia.
• if you have had an organ transplant (liver or kidney) or have one planned in the near future.
• if you are co-infected with human immunodeficiency virus (HIV) and are being treated with anti-HIV medicines.
• if a previous treatment for hepatitis C was discontinued due to anemia or low blood cell counts.

Once you have started treatment with Pegasys, speak to your doctor, nurse, or pharmacist:

• if you develop symptoms related to depression (e.g., feeling sad, hopeless, etc.) (see section 4).
• if you notice any changes in vision.
• if you experience symptoms of a cold or other respiratory infection (such as cough, fever, or any difficulty breathing).
• if you think you are developing an infection (such as pneumonia), as you may temporarily have an increased risk of infections while being treated with Pegasys.
• if you have any signs of bleeding or unusual bruising, consult your doctor immediately.
• if you experience symptoms of a severe allergic reaction (such as difficulty breathing, wheezing, or hives) while taking this medicine, seek immediate medical help.
• if you develop symptoms of Vogt-Koyanagi-Harada syndrome; a combination of symptoms such as neck stiffness, headache, loss of skin or hair color, eye problems (such as blurred vision), and/or hearing problems (such as ringing in the ears).

During treatment, your doctor will periodically take blood samples to monitor changes in your white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets (cells that help blood clot), liver function, glucose (blood sugar levels), or other laboratory values.

Dental and gum disorders, which may lead to tooth loss, have been reported in patients treated with Pegasys in combination with ribavirin. In addition, dry mouth may have harmful effects on teeth and oral mucosa during long-term treatment with Pegasys in combination with ribavirin. Teeth should be brushed properly twice daily, and regular dental check-ups are recommended. Some patients may also experience vomiting. If you have this reaction, you should rinse your mouth thoroughly afterward.

Children and adolescents

Indication for polycythemia vera and essential thrombocythemia:

Pegasys should not be administered to children and adolescents, as there is no information available on the use of Pegasys in this age group for these indications.

Indication for chronic hepatitis B and chronic hepatitis C:

Pegasys is limited to children and adolescents with chronic hepatitis C from 5 years of age, or children and adolescents with chronic hepatitis B from 3 years of age. Pegasys must not be given to children under 3 years of age because it contains benzyl alcohol, which may cause toxic and allergic reactions in these children.

• If your child has or has ever had a psychiatric disorder, consult your doctor, who will monitor your child for signs and symptoms of depression (see section 4).
• While receiving Pegasys, your child may experience slower growth and development (see section 4).

Other medicines and Pegasys

Do not use Pegasys if you are taking telbivudine (see “Do not use Pegasys”) because the combination of these medicines increases the risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs). Therefore, the combination of Pegasys with telbivudine is contraindicated. Inform your doctor or pharmacist if you are receiving treatment with telbivudine.

Tell your doctor if you are taking any medicine for asthma, as the dose of your asthma medication may need to be adjusted.

Patients who also have HIV infection: Inform your doctor if you are taking anti-HIV treatment. Lactic acidosis and worsening liver function are adverse effects associated with highly active antiretroviral therapy (HAART), an HIV treatment. If you are receiving HAART, adding Pegasys + ribavirina may increase the risk of lactic acidosis or liver failure. Your doctor will monitor you for signs and symptoms of these conditions. Patients who have received zidovudine in combination with ribavirin and alpha interferons may have an increased risk of developing anemia. Patients receiving azathioprine in combination with ribavirin and peginterferon have a higher risk of developing severe blood disorders. Please also read the ribavirin package leaflet.

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

When Pegasys is used in combination with ribavirin, both male and female patients must take special precautions regarding sexual activity if there is any risk of pregnancy, as ribavirin can be very harmful to the unborn baby.

• If you are a woman of childbearing potential and are taking Pegasys in combination with ribavirin, you must have a pregnancy test that is negative before starting treatment, each month during treatment, and for 4 months after stopping treatment. You must use effective contraception during treatment and for 4 months after stopping treatment. You should discuss this with your doctor.
• If you are a man and are taking Pegasys in combination with ribavirin, you must not have unprotected sex with a pregnant woman. Using a condom will reduce the chance of ribavirin being transferred to the woman’s body. If your partner is not pregnant but is of childbearing potential, she must have a pregnancy test each month during your treatment and for 7 months after you stop treatment. You or your partner must use effective contraception during the time you are receiving treatment and for 7 months after stopping treatment. You should discuss this with your doctor.

Consult your doctor or pharmacist before taking this medicine. It is unknown whether this product is present in human milk. Therefore, you must not breast-feed while being treated with Pegasys. In combination therapy with ribavirin, pay attention to the information provided in the leaflets of medicines containing ribavirin.

Also consult the package leaflets of medicines used in combination with Pegasys.

Driving and using machines

Do not drive or operate machinery if you feel drowsy, tired, or confused while being treated with Pegasys.

Pegasys contains benzyl alcohol, polysorbate 80, and sodium

This medicine contains 5 mg of benzyl alcohol in each pre-filled syringe, equivalent to 10 mg/ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (known as “gasping syndrome”) in young children. Pegasys must not be administered to premature infants, full-term newborns, or children up to 3 years of age.

Ask your doctor or pharmacist if you are pregnant or breast-feeding, or if you have any liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (known as “metabolic acidosis”).

This medicine contains 0.025 mg of polysorbate 80 in each pre-filled syringe, equivalent to 0.05 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to use Pegasys

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

Pegasys dosage

Your doctor has determined the exact dose of Pegasys and will tell you how often you should use it. If necessary, your doctor may adjust the dose during treatment. Do not exceed the recommended dose.

Polycythaemia vera and essential thrombocythaemia in adults

Pegasys for the treatment of polycythaemia vera and essential thrombocythaemia is administered with an initial recommended dose of 45 micrograms once weekly by subcutaneous injection, and is usually adjusted in increments of 45 micrograms once monthly up to a maximum of 180 micrograms once weekly by subcutaneous injection.

Your doctor may adapt the dose and/or prolong the administration interval.

Hepatitis B and hepatitis C in adults

Pegasys is used alone (as monotherapy) only if for some reason you cannot take ribavirin.

Pegasys, either alone or in combination with ribavirin, is usually administered at a dose of 180 micrograms once weekly. See also the sections below regarding combination therapies.

The duration of combination treatment varies from 4 to 18 months, depending on the type of virus you are infected with, your response during treatment, and whether you have been previously treated.

Please consult your doctor and follow the recommended treatment duration.

Pegasys injection is usually administered at bedtime.

Use in children and adolescents

Hepatitis B (from 3 years of age) and hepatitis C (from 5 years of age)

Your doctor has determined the exact dose of Pegasys for your child and will inform you how often it should be used. The usual dose of Pegasys is based on your child's height and weight. If necessary, the dose may be changed during treatment. For children and adolescents, Pegasys prefilled syringes are recommended, as they allow dose adjustment. Do not exceed the recommended dose.

The duration of combination treatment in children with chronic hepatitis C varies from 6 to 12 months, depending on the type of virus your child is infected with and their response to treatment. The duration of Pegasys treatment in chronic hepatitis B is 48 weeks. Consult your doctor and follow the recommended treatment duration. Pegasys injection is usually administered at bedtime.

Pegasys is administered by subcutaneous injection (under the skin). This means that Pegasys is injected with a short needle into the fatty tissue beneath the skin of the abdomen or thigh. If you are going to self-inject this medicine, you must be properly trained on how to do so. Detailed instructions are included at the end of this leaflet (see “How to inject Pegasys”).

Use Pegasys exactly as your doctor has instructed and for the duration specified. If you think that the effect of Pegasys is too strong or too weak, inform your doctor or pharmacist.

Combination treatment with ribavirine in chronic hepatitis C (all patients from 5 years of age)

In the case of combination therapy with Pegasys and ribavirin, please follow the dosing regimen recommended by your doctor.

Combination treatment with other medicines in chronic hepatitis C (all patients from 5 years of age)

In the case of combination therapy with Pegasys, please follow the dosing regimen recommended by your doctor, and also read the package leaflet of the medicines used in combination with Pegasys.

If you use more Pegasys than you should

Contact your doctor or pharmacist as soon as possible.

If you forget to use Pegasys

If you realize you missed the injection 1 or 2 days after the scheduled time, inject the recommended dose as soon as possible. Continue with the next injection according to the original schedule.

If you realize you missed the injection 3 to 5 days after the scheduled time, inject the recommended dose as soon as possible, then administer subsequent doses at 5-day intervals until the weekly rhythm is restored.

Example: You usually inject Pegasys every Monday. However, on Friday you realize you missed the injection scheduled for the previous Monday (a 4-day delay). You should immediately administer the regular dose on Friday, then the next dose on the following Wednesday (5 days after the Friday dose). The next injection should then be on Monday, 5 days after Wednesday. You have now recovered the original weekly schedule and can continue injecting every Monday.

If you realize you missed the injection 6 days after the scheduled time, wait and administer the dose the next day to maintain the usual rhythm.

Consult your doctor or pharmacist if you need further information in case you miss a dose of Pegasys.

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

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

Contact your doctor immediately if you experience any of the following adverse reactions: severe chest pain, persistent cough, irregular heartbeat, difficulty breathing, confusion, depression, severe stomach pain, blood in stools (or black, tarry stools), severe nosebleeds, fever or chills, or vision problems. These adverse effects may be serious and may require urgent medical attention.

Very common adverse effects of Pegasys in combination with ribavirin (may affect more than 1 in 10 people) are:

Metabolic disorders: loss of appetite

Psychiatric and nervous system disorders: depressive mood (feeling of sadness, low mood, pessimism), anxiety, insomnia, headache, difficulty concentrating, and dizziness

Respiratory disorders: cough, difficulty breathing

Gastrointestinal disorders: diarrhea, nausea, abdominal pain

Skin disorders: hair loss and skin reactions (including itching, dermatitis, and dry skin)

Musculoskeletal disorders: joint pain and muscle pain

General disorders: fever, weakness, fatigue, tremors, chills, pain, irritation at the injection site, and irritability (easily irritable)

Common adverse effects of Pegasys in combination with ribavirin (may affect up to 1 in 10 people) are:

Infections: fungal, viral, and bacterial infections. Upper respiratory tract infections, bronchitis, oral fungal infections, and herpes (a common and recurrent viral infection affecting lips and mouth)

Blood disorders: low platelet count (affects blood clotting ability), anemia (low red blood cell count), and swollen lymph nodes

Endocrine disorders: overactivity or underactivity of the thyroid gland

Psychiatric and nervous system disorders: mood/emotional changes, aggressiveness, nervousness, decreased libido, memory loss, fainting, decreased muscle tone, migraine, numbness, tingling, sensation of heat, tremor, altered sense of taste, nightmares, somnolence

Eye disorders: blurred vision, eye pain, eye inflammation, and dry eyes

Ear disorders: ear pain

Cardiac and vascular disorders: rapid heartbeat, palpitations, swelling of extremities, flushing

Respiratory disorders: shortness of breath during exercise, nosebleeds, nasal and throat inflammation, nasal and sinus infections (air-filled cavities in the bones of the head and face), nasal discharge, sore throat

Gastrointestinal disorders: vomiting, indigestion, difficulty swallowing, mouth ulcers, bleeding gums, inflammation of the tongue and mouth, flatulence (excess air or gas), dry mouth, and weight loss

Skin disorders: rash, increased sweating, psoriasis, redness and itching of the skin (urticaria), eczema, photosensitivity, night sweats

Musculoskeletal disorders: back pain, joint swelling, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps

Reproductive system disorders: impotence (inability to maintain an erection)

General disorders: chest pain, flu-like symptoms, malaise, lethargy, hot flushes, thirst

Uncommon adverse effects of Pegasys in combination with ribavirin (may affect up to 1 in 100 people) are:

Infections: lung infection, skin infections

Benign and malignant neoplasms: liver tumor

Immune system disorders: sarcoidosis (inflamed tissue areas throughout the body), thyroid inflammation

Endocrine disorders: diabetes (high blood sugar levels)

Metabolic disorders: dehydration

Psychiatric and nervous system disorders: suicidal thoughts, hallucinations, peripheral neuropathy (nerve disorders affecting the limbs)

Eye disorders: retinal hemorrhage (bleeding at the back of the eye)

Ear disorders: hearing loss

Cardiac and vascular disorders: high blood pressure

Respiratory disorders: wheezing (whistling sounds when breathing)

Gastrointestinal disorders: gastrointestinal bleeding

Hepatic disorders: liver dysfunction

Rare adverse effects of Pegasys in combination with ribavirin (may affect up to 1 in 1,000 people) are:

Infections: heart infection, external ear infection

Blood disorders: severe reduction in red blood cells, white blood cells, and platelets

Immune system disorders: severe allergic reactions, systemic lupus erythematosus (body attacks its own cells), rheumatoid arthritis (an autoimmune disease)

Endocrine disorders: diabetic ketoacidosis, a complication of uncontrolled diabetes

Psychiatric and nervous system disorders: suicide, psychotic disorders (severe personality problems and deterioration in normal social functioning), coma (deep and prolonged unconsciousness), seizures, facial paralysis (weakness of facial muscles)

Eye disorders: optic neuritis (inflammation of the optic nerve), retinal inflammation, corneal ulcer

Cardiac and vascular disorders: heart attack, heart failure, cardiac pain, rapid heartbeat, heart rhythm disturbances, inflammation of the lining of the heart and heart muscle, cerebral hemorrhage, and inflammation of blood vessels

Respiratory disorders: interstitial pneumonia (lung inflammation including fatal outcomes), blood clots in the lungs

Gastrointestinal disorders: gastric ulcer, pancreatitis (inflammation of the pancreas)

Hepatic disorders: liver failure, bile duct inflammation, fatty liver

Musculoskeletal disorders: muscle inflammation

Renal disorders: kidney failure

Injuries, poisonings, or trauma: overdose

Very rare adverse effects of Pegasys in combination with ribavirin (may affect up to 1 in 10,000 people) are:

Blood disorders: aplastic anemia (failure of the bone marrow to produce red blood cells, white blood cells, and platelets)

Immune system disorders: idiopathic or thrombotic thrombocytopenic purpura (increased bruising, bleeding, low platelet count, anemia, and extreme weakness)

Eye disorders: vision loss

Skin disorders: toxic epidermal necrolysis / Stevens-Johnson syndrome / erythema multiforme (a range of rashes with varying severity, including death, which may be associated with blisters in the mouth, nose, eyes, and other mucous membranes, and peeling of affected skin areas), angioedema (swelling of skin and mucous membranes)

Adverse effects of unknown frequency:

Blood disorders: pure red cell aplasia (a severe type of anemia in which production of red blood cells is reduced or absent), which may cause symptoms such as feeling extremely tired and lacking energy

Immune system disorders: Vogt-Koyanagi-Harada disease, a rare condition characterized by loss of vision, hearing, and skin pigmentation; rejection of liver and kidney transplants

Psychiatric and nervous system disorders: mania (episodes of exaggerated mood elevation) and bipolar disorders (episodes of exaggerated mood elevation alternating with sadness and hopelessness); thoughts of threatening others' lives, stroke (lack of blood supply to the brain)

Eye disorders: rare form of retinal detachment with fluid accumulation in the retina

Cardiac and vascular disorders: peripheral ischemia (inadequate blood supply to the limbs)

Gastrointestinal disorders: ischemic colitis (inadequate blood supply to the intestine), changes in tongue color

Musculoskeletal disorders: severe muscle damage and pain

Pulmonary arterial hypertension is a disease in which there is severe narrowing of the blood vessels in the lungs, leading to increased pressure in the blood vessels carrying blood from the heart to the lungs. This may occur particularly in patients with risk factors such as HIV infection or severe liver problems (cirrhosis). Cases have been reported at various times, even several months after starting treatment with Pegasys.

If Pegasys is administered alone in patients with hepatitis B or C, the likelihood of these effects is reduced.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pegasys

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). Do not freeze.

Keep the pre-filled syringe in its original packaging to protect it from light.

Do not use this medicine if you notice that the syringe or the needle cap is damaged, if the solution is cloudy, contains floating particles, or has a colour other than colourless to pale yellow.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pegasys

• The active substance is peginterferon alfa-2a. Each 0.5 ml pre-filled syringe of solution contains 90, 135 or 180 micrograms of peginterferon alfa-2a.
• The other components are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate, acetic acid and water for injections.

Appearance of the product and contents of the pack

Pegasys is presented as a solution for injection contained in a pre-filled syringe (0.5 ml) with a separate injection needle.

Pegasys 90 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 90 micrograms (µg), 65 µg, 45 µg, 30 µg, 20 µg and 10 µg. It is available in packs of 1 pre-filled syringe.

Pegasys 135 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 135 micrograms (µg), 90 µg and 45 µg. It is available in packs of 1, 4 or multiple pack containing 12 (2 packs of 6) pre-filled syringes. Only certain pack sizes may be marketed.

Pegasys 180 micrograms solution for injection in pre-filled syringe

The syringe has graduation marks corresponding to 180 micrograms (µg), 135 µg and 90 µg. It is available in packs of 1, 4 or multiple pack containing 12 (2 packs of 6) pre-filled syringes. Only certain pack sizes may be marketed.

Marketing Authorization Holder

pharmaand GmbH

Taborstrasse 1

1020 Wien

Austria

Manufacturer

Loba biotech GmbH

Fehrgasse 7

2401 Fischamend

Austria

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

How to inject Pegasys

The following instructions explain how to use the Pegasys pre-filled syringes to self-inject or inject your child. Please read the instructions carefully and follow them step by step. Your doctor or other healthcare professional will provide you with guidance on how to administer the injections.

Initial preparation

Wash your hands thoroughly before handling any of the materials.

Have all necessary items ready before starting:

Included in the pack:

• one Pegasys pre-filled syringe
• one injection needle

Not included in the pack:

• cotton wool for cleaning
• small plaster or sterile gauze
• adhesive bandage
• container for disposal of waste materials

Preparing the syringe and needle for injection

• Remove the protective cap covering the end of the needle (1-2).

• Remove the rubber cap from the syringe (3). Do not touch the tip of the syringe.

• Firmly attach the needle to the tip of the syringe (4).

• Remove the needle cap (5).

• To remove air bubbles from the syringe, hold it vertically with the needle pointing upwards. Tap the syringe several times with your finger to allow any air bubbles to rise to the top of the liquid. Slowly push the plunger until the correct dose is reached, where the edge of the plunger aligns with the syringe mark. Replace the needle cap and lay the syringe horizontally until ready for use.
• Allow the solution to reach room temperature before injection, or warm the syringe by holding it in your hands.
• Visually inspect the solution before administration: do not use if there are changes in colour or if particles are visible.

You are now ready to inject the dose.

Injecting the solution

• Select an injection site on the abdomen or thigh (avoiding the area around the navel or waistband). Change the injection site each time the medicine is administered.
• Clean and disinfect the skin at the injection site using cotton wool.
• Allow the area to dry.
• Remove the needle cap.
• With one hand, pinch the skin, and with the other hand, hold the syringe like a pen.
• Insert the needle fully at an angle of 45º to 90º into the pinched skin (6).

• Inject the solution by pushing the plunger down from the appropriate graduation mark.
• Remove the needle from the skin.
• If necessary, press the injection site gently with a small plaster or sterile gauze for a few seconds.

Do not massage the injection site. If bleeding occurs, cover it with an adhesive bandage.

Disposal of injection materials

The syringe, needle and all injection materials are for single use only and must be discarded after injection. Dispose of the syringe and needle safely in a closed container. Ask your doctor, hospital or pharmacist for an appropriate disposal container.