ViraferonPeg - patient leaflet, side effects, dosage

1. What ViraferonPeg is and what it is used for

The active substance in this medicine is a protein called peginterferon alfa-2b, which belongs to the class of medicines called interferons. Interferons are made by your body’s immune system to help fight infections and severe diseases. This medicine is injected into your body to work with your immune system. This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.

Adults

The combination of this medicine, ribavirin and boceprevir is recommended for use for some types of chronic hepatitis C virus infection (also called HCV infection) in adults 18 years of age and older. It may be used in adults who have not been previously treated for HCV infection or who have previously used medicines called interferons and pegylated interferons.

The combination of this medicine and ribavirin is recommended for adults 18 years of age and older who have not previously been treated with these medicines. This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus). The combination can also be used to treat adults who have already failed treatment with an interferon alpha or peginterferon alpha in combination with ribavirin or interferon alpha alone.

If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.

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

Children and adolescents

This medicine is used in combination with ribavirin in children 3 years of age and older and adolescents who have not been treated previously for chronic hepatitis C.

2. What you need to know before you use ViraferonPeg

Do not use ViraferonPeg

You should tell your doctor before starting treatment if you, or the child you are caring for:

• – are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in

section 6).

• – are allergic to any interferon.

• – have had severe heart problems.

• – have heart disease that has not been well controlled during the past 6 months.

• – have severe medical conditions that leave you very weak.

• – have autoimmune hepatitis or any other problem with your immune system.

• – are taking medicine that suppresses (weakens) your immune system.

• – have advanced, uncontrolled liver disease (other than hepatitis C).

• – have thyroid disease that is not well controlled with medicines.

• – have epilepsy , a condition that causes convulsions (seizures, or “fits”).

• – are being treated with telbivudine (see section “Other medicines and ViraferonPeg”).

You must not use ViraferonPeg if any of the conditions above should apply to you, or the child you are caring for.

In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.

Reminder: Please also read the “Do not take” section of the Package Leaflet for ribavirin and boceprevir before using them in combination with this medicine.

Warnings and precautions

Seek medical help immediately in case of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives).

Talk to your doctor before taking this medicine if you, or the child you are caring for:

• – have had a severe nervous or mental disorder or have a history of substance abuse (e.g.

alcohol or drugs).

The use of this medicine in children and adolescents with existence of or history of severe psychiatric conditions is not allowed (see section “Do not use ViraferonPeg” above).

• – are being treated for a mental illness or had treatment in the past for any other nervous or mental

disorder, including depression (such as feelings of sadness, dejection) or suicidal or homicidal behaviour (see section 4 “Possible side effects”).

• – have ever had a heart attack or a heart problem.

• – have kidney disease , your doctor may prescribe a lower than usual dose and monitor your kidney

blood values regularly during treatment. If this medicine is used in combination with ribavirin, your doctor should monitor you, or the child you are caring for more carefully for a decrease in red blood cell count.

• – have cirrhosis or other liver problems (other than hepatitis C).

• – develop symptoms associated with a cold or other respiratory infection, such as fever , cough , or

any difficulty in breathing.

• – are diabetic or have high blood pressure , your doctor may ask you, or the child you are caring for

to have an eye examination.

• – have had any serious illness affecting breathing or blood.

• – have the skin disorders, psoriasis or sarcoidosis , which may become worse while you are using

this medicine.

• – are planning to become pregnant , discuss this with your doctor before starting to use this medicine.

• – have received an organ transplant , either kidney or liver, interferon treatment may increase the

risk of rejection. Be sure to discuss this with your doctor.

• – If you are also being treated for HIV (see section “Other medicines and ViraferonPeg”).

• – have a current or previous infection with the hepatitis B virus, since your doctor may want to

monitor you more closely.

Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for ribavirin before using it in combination with this medicine.

Teeth and mouth problems have been reported in patients receiving this medicine in combination with ribavirin. You may develop gum disease, which could lead to loss of teeth. You may develop a dry mouth or vomiting, both of which can damage your teeth. It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.

During treatment, some patients may experience eye problems, or loss of vision in rare instances. Your doctor should carry out an eye examination before starting your treatment. In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination. If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy. If your eye disorder becomes more severe or if you develop new eye disorders, your treatment will be discontinued.

While being treated with ViraferonPeg, your doctor may advise to drink extra fluids to help prevent low blood pressure.

Your doctor will test your blood before you begin therapy and throughout the treatment to make sure that the therapy you are getting is safe and effective.

Children and adolescents

This medicine is not recommended for use in patients under the age of 3 years.

Other medicines and ViraferonPeg

Please tell your doctor or pharmacist if you, or the child you are caring for:

• – are taking or have recently taken any other medicines or vitamins/nutri­tional supplements,

including medicines obtained without a prescription.

• – are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C

Virus (HCV) and are being treated with an anti-HIV medicine(s) – [nucleoside reverse transcriptase inhibitor (NRTI ), and/or highly active anti-retroviral therapy (HAART )]. Your doctor will monitor you for signs and symptoms of these conditions.

o Taking this medicine in combination with ribavirin and an anti-HIV medicine(s) may increase the risk of lactic acidosis, liver failure, and blood abnormalities: reduction in number of red blood cells, white blood cells and blood clotting cells called platelets. Patients with advanced liver disease receiving HAART may be at increased risk of worsening liver function, therefore adding treatment with this medicine alone or in combination with ribavirin may increase their risk.

o With zidovudine or stavudine , it is not certain if ribavirin will change the way these medicines work. Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse. If it gets worse, your doctor will decide whether or not your ribavirin treatment needs to be changed. Additionally, patients treated with this medicine and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia (low number of red blood cells). Therefore the use of zidovudine with this medicine and ribavirin combination therapy is not recommended.

Reminder: Please read the “Other medicines” section of the Package Leaflet for ribavirin before using it in combination with this medicine.

• – are taking telbivudine. If you take telbivudine with this medicine or any type of injectable

interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher. These events may also be more severe. Therefore, you must not take this medicine at the same time as telbivudine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

In studies in pregnant animals, interferons have sometimes caused miscarriage. The effect of this medicine on human pregnancy is not known. Girls or women of childbearing potential need to use effective birth control during the treatment with this medicine.

Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur:

• – if you are a girl or a woman of childbearing age who is taking ribavirin:

you must have a negative pregnancy test before treatment, each month during treatment, and for the

4 months after treatment is stopped. You must use an effective birth control during the time you are taking ribavirin and for 4 months after stopping treatment. This should be discussed with your doctor. – if you are a man who is taking ribavirin:

do not have sex with a pregnant woman unless you use a condom. If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment. This should be discussed with your doctor.

Breast-feeding

It is not known whether this medicine is present in human milk. Therefore, you should not breast-feed an infant if you are taking this medicine. Ask your doctor for advice.

Reminder: Please read the “Pregnancy and breast-feeding” section of the Package Leaflet for ribavirin before using it in combination with this medicine.

Driving and using machines

Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking this medicine.

ViraferonPeg contains sucrose

This medicine contains sucrose. If you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per 0.7 ml, i.e., essentially „sodium-free“.

3. How to use ViraferonPeg

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

General information about taking this medicine

Your doctor has determined the correct dose of this medicine based on how much you, or the child you are caring for weighs. If necessary, the dose may be changed during treatment.

This medicine is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under the skin. If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection. Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject ViraferonPeg”).

Water for injection and ViraferonPeg powder are provided in separate ampoules. Prepare the dose by adding water for injection to ViraferonPeg powder just before you intend to inject it and use it immediately. Look carefully at the solution you prepared before you use it. The solution should be clear and colourless. Do not use the solution if it is discoloured (changed its colour from the original) or if there are bits of particles in the solution. Discard any solution that is left in the vial after you give yourself the injection. For disposal instructions, see section 5 “How to store ViraferonPeg”.

Inject this medicine once each week on the same day. Injecting it at the same time of day each week will help you not to forget to take it.

Always use this medicine exactly as your doctor has told you. Do not exceed the recommended dosage, and take it for as long as prescribed.

If your doctor prescribes this medicine with ribavirin or with ribavirin and boceprevir, please read the Package Leaflets of ribavirin and boceprevir before you begin combination treatment.

Use in adults – ViraferonPeg in combination treatment

This medicine, when given with ribavirin capsules, is usually given at a dose of 1.5 microgram per kilogram of body weight once a week. If you have kidney disease, your dose may be lower, depending upon your kidney function.

Use in adults – ViraferonPeg alone

This medicine, when given alone, is usually given at a dose of 0.5 or 1.0 microgram per kilogram of body weight once a week, for 6 months to 1 year. If you have kidney disease, your dose may be lower, depending upon your kidney function. Your doctor will determine the correct dose for you.

Use in children 3 years of age and older and adolescents

ViraferonPeg will be given in combination with ribavirin.The dose of ViraferonPeg is determined by a calculation accounting for both height and weight. Your doctor will determine the correct dose for you, or the child you are caring for. The duration of treatment is up to 1 year based on the doctor’s judgement for you, or the child you are caring for.

All patients

If you are injecting this medicine yourself, please be sure that the dose that has been prescribed is clearly provided on the package of medicine you receive.

If you use more ViraferonPeg than you should

Tell your doctor or healthcare professional or the doctor or healthcare professional of the child you are caring for as soon as possible.

If you forget to take ViraferonPeg

Take/administer the dose of this medicine as soon as you remember, but only if within 1–2 days after the forgotten dose. If it is very close to your next injection, do not double the dose to make up for the forgotten dose, but continue your treatment as usual.

If you are uncertain, contact your doctor or pharmacist or the doctor or pharmacist of the child you are caring for.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although not all of these side effects may occur, they may need medical attention if they do. When this medicine is used alone, some of these effects are less likely to occur, and some have not occurred at all.

Psychiatric and central nervous system:

Some people get depressed when taking this medicine alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. Ask a family member or close friend to help you stay alertto signs of depression or changes in your behaviour.

Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin. Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.

Growth and development (children and adolescents):

With up to one year of treatment with this medicine in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected. Some children did not reach their projected height within 1–5.5 years after completing treatment.

Contact your doctor immediately if you notice any of the following serious side effects occurring during treatment:

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

• – breathing problems (including shortness of breath),

• – feeling depressed

• – trouble sleeping, thinking or concentrating, dizziness,

• – severe stomach pain or cramps,

• – fever or chills beginning after a few weeks of treatment,

• – painful or inflamed muscles (sometimes severe),

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

• – chest pain, changes in the way your heart beats,

• – confusion,

• – difficulty remaining alert, numbness or tingling feeling,

• – pain in your lower back or side, difficulty or inability to pass urine,

• – problems with your eyes or your eyesight or hearing,

• – severe or painful reddening of your skin or mucous membrane,

• – severe bleeding from your nose, gums or any other part of your body.

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

• – wanting to harm yourself,

• – hallucinations,

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

• – convulsion (“fit”),

• – blood or clots in stool (or black, tarry stool),

Unknown frequency side effects (frequency cannot be estimated from the available data):

• – Wanting to harm others.

Other side effects that have been reported in adults include:

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

• – feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or

nervous, difficulty concentrating, mood swings,

• – headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection,

weakness,

• – difficult breathing, pharyngitis (sore throat), coughing,

• – stomach pain, vomiting, nausea, diarrhoea, loss of appetite, loss of weight, dry mouth,

• – hair loss, itching, dry skin, rash, irritation or redness (and rarely, skin damage) at the site of

injection,

• – decreases in the number of red blood cells (that may cause fatigue, shortness of breath,

dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections),

• – pain in joints and muscles, muscle and bone pain.

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

• – decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous

bleeding, excess of uric acid (as in gout) in the blood, low calcium level in the blood,

• – decrease in thyroid gland activity (which may make you feel tired, depressed, increase your

sensitivity to cold and other symptoms), increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors), swollen glands (swollen lymph nodes), thirst,

• – changed behaviour or aggressive behaviour (sometimes directed against others), agitation,

nervousness, feeling sleepy, trouble sleeping, unusual dreams, lack of interest in activities, lack of interest in sex, erectile problem, increased appetite, confusion, shaky hands, poor coordination, vertigo (spinning feeling), numbness, pain or tingling feeling, increased or decreased sensitivity to touch, tense muscles, limb pain, arthritis, migraine, increased sweating,

• – eye pain or infection, blurred vision, dry or teary eyes, changes in hearing/loss of hearing,

ringing in ears,

• – sinusitis, respiratory infections, stuffy or runny nose, difficulty in speaking, nosebleed, cold

sores (herpes simplex), fungal or bacterial infections, ear infection/earache,

• – indigestion (stomach upset), heartburn, redness or sores in mouth, burning sensation on tongue,

red or bleeding gums, constipation, intestinal gas (flatus), bloating, hemorrhoids, sore tongue, change in taste, tooth problem, excessive loss of body water, enlarged liver,

• – psoriasis, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin

disorders, puffy face, puffy hands or feet, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), acne, hives, abnormal hair texture, nail disorder, pain at the site of injection,

• – difficult, irregular or no menstrual period, abnormally heavy and prolonged menstrual period,

problem affecting ovary or vagina, pain in breast, sexual problem, irritation of prostate gland, increased need to pass urine,

• – chest pain, pain on the right side around your ribs, feeling unwell, low or high blood pressure,

feeling faint, flushing, palpitations (pounding heart beat), rapid heart rate.

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

• – suicide, attempted suicide, thoughts about threatening the life of yourself, panic attack,

delusions, hallucination,

• – hypersensitivity reaction to the medication, heart attack, inflammation of the pancreas, pain in

bone and diabetes mellitus,

• – cotton wool spots (white deposits on the retina).

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

• – diabetic ketoacidosis (medical emergency due to build-up of ketone bodies in the blood as a

result of out-of-control diabetes),

• – seizures (convulsions) and bipolar disorders (mood disorders characterized by alternating

episodes of sadness and excitement),

• – eye problems including changes in vision, damage to the retina, obstruction of the retinal artery,

inflammation of the optic nerve, swelling of the eye,

• – congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the

heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems,

• – sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin

lesions and swollen glands).

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

• – aplastic anaemia, stroke (cerebrovascular events), toxic epidermal necrolysis/Stevens Johnson

Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin).

• – loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients

treated at high doses.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• – pure red cell aplasia (a condition where the body stopped or reduced the production of red blood

cells). This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.

• – facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as

angioedema (an allergic skin disease characterized by patches of swelling involving the skin and its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania (excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), change in colour of the tongue.

• – thoughts about threatening the life of others.

• – pulmonary fibrosis (scarring of the lungs).

• – pulmonary arterial hypertension – a disease of severe narrowing of the blood vessels in the

lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs. This may occur in particular in patients with risk factors such as HIV infection or severe liver problems (cirrhosis). The side effect may develop at various time points during treatment, typically several months after starting treatment with ViraferonPeg.

• – hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).

If you are an HCV/HIV co-infected adult patient receiving HAART , the addition of this medicine and ribavirin may increase your risk of lactic acidosis, liver failure, and development of blood abnormalities (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).

The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART: – oral candidiasis (oral thrush),

• – defective metabolism of fat,

• – CD4 lymphocytes decreased,

• – appetite decreased,

• – back pain,

• – hepatitis,

• – limb pain,

• – and various laboratory blood values abnormalities.

Side effects in children and adolescents

The following effects have occurred in children and adolescents:

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

• – loss of appetite, dizziness, headache, vomiting, nausea, stomach pain,

• – hair loss, dry skin, pain in joints and muscles, redness at the site of injection,

• – feeling irritable, tired feeling, feeling unwell, pain, chills, fever, flu-like symptoms, weakness,

decrease in rate of growth (height and weight for age),

• – decreases in red blood cells that may cause fatigue, shortness of breath, dizziness.

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

• – fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection,

coughing, throat pain, feeling cold, eye pain,

• – decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous

bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms,

• – wanting or attempting to harm yourself aggressive behaviour, agitation, anger, mood changes,

nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.

• – changes in taste, diarrhoea, stomach upset, oral pain,

• – fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed,

• – sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,

eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), acne,

• – back pain, muscle and bone pain, limb pain, dryness, pain, rash, irritation or itching at the site of

injection.

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

• – painful or difficult urination, urinary frequency, the presence of excess protein in the urine,

painful menstruation,

• – itchy anal area (pinworms or ascarids), inflammation of the lining membrane of the stomach and

the intestines, inflamed gums, enlarged liver,

• – abnormal behaviour, emotional disorder, fear, nightmare, tremor, decreased sensitivity to touch,

numbness or tingling feeling, pain radiating along the course of one or more nerves, drowsiness,

• – bleeding of the mucous membrane that lines the inner surface of the eyelids, itchy eyes, eye

pain, blurred vision, intolerance to light,

• – low blood pressure, paleness, nasal discomfort, runny nose, wheezing, difficult breathing, chest

pain or discomfort,

• – redness, swelling, pain of skin, shingles, skin sensitive to sunlight, rash with raised spotted

lesions, skin discolouration, peeling of skin, shortening of muscle tissue, muscle twitching, facial pain, bruising.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects, you can also help provide more information on the safety of this medicine.

Reminder to adult patients prescribed combination therapy of this medicine, boceprevir and ribavirin: Please read the “Possible side effects” section of these Package Leaflets.

5. How to store ViraferonPeg

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

Do not use this medicine after the expiry date which is stated on the carton, after EXP.

Store in a refrigerator (2°C – 8°C).

Use the reconstituted solution (solution you prepared by adding water for injection to the ViraferonPeg powder) immediately or within 24 hours when stored in a refrigerator (2°C – 8°C).

Do not use this medicine if you notice discolouration of the powder, which should be white.

The reconstituted solution should be clear and colourless. Do not use if it is discoloured or if bits of particles are present. ViraferonPeg vials are for single use only. Discard any unused material.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ViraferonPeg contains

• – The active substance is peginterferon alfa-2b.

ViraferonPeg 50 micrograms powder and solvent for solution for injection

Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 50 micrograms/0­.5 ml of solution when reconstituted as recommended.

ViraferonPeg 80 micrograms powder and solvent for solution for injection

Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 80 micrograms/0­.5 ml of solution when reconstituted as recommended.

ViraferonPeg 100 micrograms powder and solvent for solution for injection

Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 100 microgram­s/0.5 ml of solution when reconstituted as recommended.

ViraferonPeg 120 micrograms powder and solvent for solution for injection

Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 120 microgram­s/0.5 ml of solution when reconstituted as recommended.

ViraferonPeg 150 micrograms powder and solvent for solution for injection

Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 150 microgram­s/0.5 ml of solution when reconstituted as recommended.

• – The other ingredients are:

Powder: disodium phosphate; anhydrous, sodium dihydrogen phosphate dihydrate; sucrose and polysorbate 80.

Solvent: water for injections.

What ViraferonPeg looks like and contents of the pack

This medicine is a powder and solvent (liquid) for solution for injection.

The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.

ViraferonPeg is available in different pack sizes:

• – 1 vial of powder for solution for injection and 1 ampoule of solvent for injection;

• – 1 vial of powder for solution for injection, 1 ampoule of solvent for injection, 1 injection syringe,

• 2 injection needles and 1 cleansing swab;

• – 4 vials of powder for solution for injection and 4 ampoules of solvent for injection;

• – 4 vials of powder for solution for injection, 4 ampoules of solvent for injection, 4 injection syringes,

• 8 injection needles and 4 cleansing swabs;

• – 6 vials of powder for solution for injection and 6 ampoules of solvent for injection;

• – 12 vials of powder for solution for injection, 12 ampoules of solvent for injection, 12 injection

syringes, 24 injection needles and 12 cleansing swabs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

SP Labo N.V.

Industriepark, 30

B-2220 Heist-op-den-Berg

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

This leaflet was last revised in MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency website:.

How to self-inject ViraferonPeg?

Your healthcare provider will instruct you how to self-inject this medicine. Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection. The following instructions explain how to inject this medicine yourself. Please read the instructions carefully and follow them step by step.

Preparation

Collect the necessary items before you begin:

• – a vial of ViraferonPeg powder for injection;

• – an ampoule of water for injections solvent to prepare ViraferonPeg injection;

• – a 1 ml syringe;

• – a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water for

injections to the ViraferonPeg powder vial;

• – a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous injection;

• – a cleansing swab.

Wash your hands carefully.

Reconstituting ViraferonPeg powder for injection

Before reconstitution, this medicine may appear either as a white tablet-shaped solid that is whole or in pieces, or as a white powder.

When the total amount of solvent is combined with the full amount of ViraferonPeg powder, the solution will be at the correct concentration to measure your dose (i.e., the labelled amount is contained in 0.5 ml).

A small volume is lost during preparation of this medicine for injection and when the dose is measured and injected. Therefore, each vial contains an extra amount of solvent and ViraferonPeg powder to ensure delivery of the labeled dose in 0.5 ml of ViraferonPeg, solution for injection.

• – Remove the protective cap from the ViraferonPeg vial.

• – Clean the rubber top of the vial with a cleansing swab. You can save the swab to clean the skin area

where you will inject the dose.

• – Remove the syringe from the wrapping and do not touch the tip of the syringe.

• – Take the long needle and place it firmly on to the tip of the syringe.

• – Remove the needle guard without touching the needle and keep the syringe with the needle in your

hand.

• – Tap the top of the ampoule of solvent gently to make sure that all the liquid is at the bottom of the

ampoule.

• – Break off the top of the ampoule of solvent.

• – Insert the needle in the ampoule of solvent and withdraw the total amount of solvent.

• – Then insert the needle through the rubber top of the ViraferonPeg vial. Gently place the needle tip

against the glass wall of the vial without touching the cleaned top of the vial with your hands.

• – Inject the solvent SLOWLY, aiming the stream of liquid at the glass wall of the vial. Do not aim

the stream directly at the white solid or powder, or inject the liquid quickly, as this causes a greater amount of bubbles. The solution may appear cloudy or bubbly for a few minutes. This is to be expected and is not a cause for concern.

• – Dissolve the entire contents by swirling the ViraferonPeg vial with a gentle rotary motion leaving

the needle and attached syringe in the vial.

• - Do not shake , but gently turn the vial upside down until any powder at the top of the vial is

dissolved.

• – The contents should now be completely dissolved.

• – Stand the vial upright and let any bubbles present in the solution rise to the top of the solution.