PegIntron
peginterferon alfa-2b
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What PegIntron is and what it is used for
What you need to know before you use PegIntron
How to use PegIntron
Possible side effects
How to store PegIntron
Contents of the pack and other information
Medicinal product no longer authorised
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.
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 PegIntron”).
You must not use PegIntron 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
Medicinal product no longer authorised
Seek medical help immediately in case of a severe allergic reaction (such as difficulty in breathing, wheezing, or hives).
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 PegIntron” 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 PegIntron”).
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.
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 PegIntron, 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.
This medicine is not recommended for use in patients under the age of 3 years.
Medicinal product no longer authorised
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.
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.
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.
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
Medicinal product no longer authorised
Do not drive or operate any tools or machines if you feel tired, sleepy or confused while taking this medicine.
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".
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 PegIntron”).
Water for injection and PegIntron powder are provided in separate ampoules. Prepare the dose by adding water for injection to PegIntron 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 PegIntron”.
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 – PegIntron 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 – PegIntron 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
Medicinal product no longer authorised
PegIntron will be given in combination with ribavirin. The dose of PegIntron 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.
Tell your doctor or healthcare professional or the doctor or healthcare professional of the child you are caring for as soon as possible.
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.
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.
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 alert to 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.
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.
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),
chest pain, changes in the way your heart beats,
confusion,
Medicinal product no longer authorised
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.
wanting to harm yourself,
hallucinations,
convulsion (“fit”),
blood or clots in stool (or black, tarry stool),
Wanting to harm others.
Other side effects that have been reported inadults include:
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.
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,
Medicinal product no longer authorised
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.
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).
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).
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.
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 PegIntron.
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).
Medicinal product no longer authorised
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.
The following effects have occurred inchildrenandadolescents:
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.
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.
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.
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
Medicinal product no longer authorised
in Appendix V. 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.
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 PegIntron 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. PegIntron 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.
The active substance is peginterferon alfa-2b.
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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.
PegIntron 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.
Medicinal product no longer authorised
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.
PegIntron 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.
2031 BN Haarlem The Netherlands
B-2220 Heist-op-den-Berg Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium BVBA/SPRL
Tel: 0800 38 693 (+32(0)27766211)
UAB Merck Sharp & Dohme
Tel. +370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
Merck Sharp & Dohme s.r.o.
Tel: +420 233 010 111
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300
MSD Danmark ApS
Tlf: + 45 4482 4000
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
MSD SHARP & DOHME GMBH
Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Merck Sharp & Dohme BV
Tel: 0800 9999000 (+31 23 5153153)
Medicinal product no longer authorised
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel: +48 22 549 51 00
MSD France
Tél: + 33-(0)1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 2900
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 5204 201
Vistor hf.
Sími: + 354 535 7000
Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija
Tel: +371 67364224
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272
medicalinformationuk@merck.com
Medicinal product no longer authorised
Preparation
a vial of PegIntron powder for injection;
an ampoule of water for injections solvent to prepare PegIntron 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 PegIntron 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 PegIntron 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 PegIntron 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 PegIntron powder to ensure
Medicinal product no longer authorised
delivery of the labeled dose in 0.5 ml of PegIntron, solution for injection.
Remove the protective cap from the PegIntron 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 PegIntron 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 PegIntron vial with a gentle rotary motion leaving the needle and attached syringe in the vial.
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.
Once all bubbles have risen to the top of the solution, you should have a clear solution with a small ring of tiny bubbles around the top. Use this solution immediately. If it cannot be used immediately,
the solution may be refrigerated for up to 24 hours.
Measuring the dose of PegIntron from the reconstituted powder for injection
Turn the vial and the syringe upside down in one hand. Be sure the tip of needle is in the PegIntron reconstituted solution. Your other hand will be free to move the plunger. Pull back on the plunger slowly to draw just more than the dose prescribed by your doctor into the syringe.
Hold the syringe with the needle in the vial pointing up. Remove the syringe from the long needle leaving the needle in the vial and without touching the tip of the syringe. Take the short needle and
place it firmly on to the tip of the syringe. Remove the needle guard from the syringe needle and check
for air bubbles in the syringe. If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing upwards, until the bubbles disappear. Push up the plunger slowly back
to the correct dose. Replace the needle guard and place the syringe with the needle on a flat surface.
Be sure the solution is at room temperature up to 25°C. If the solution is cold, warm the syringe between your palms. Inspect visually the reconstituted solution prior to administration: do not use if discolouration (change in the original colour of the solution) or particulate matter is present. You are now ready to inject the dose.
Injecting the solution
Select the injection site. The best sites for injection are tissues with a layer of fat between skin and muscle. These are thigh, outer surface of the upper arm (you may need the assistance of another person to use this
site) and abdomen (except the navel or waistline). If you are exceptionally thin, use only the thigh or outer
surface of the arm for injection.
Medicinal product no longer authorised
Cleanse and disinfect the skin where the injection is to be made. Wait for the area to dry. Remove the needle guard. With one hand, pinch a fold of loose skin. With your other hand, hold the syringe as you would a pencil. Insert the needle into the pinched skin at an angle of approximately 45°. After the needle is inserted, remove the hand used to pinch the skin and use it to hold the syringe barrel. Pull back the plunger very slightly with one hand. If blood comes into the syringe, the needle has entered a blood vessel. Do not inject into this site; withdraw the needle and repeat the procedure. Inject the solution by pushing the plunger all the way down gently.
Pull the needle straight out of the skin. Press the injection site with a small bandage or sterile gauze if necessary for several seconds. Do not massage the injection site. If there is bleeding, cover with an adhesive bandage.
The vial, ampoule and injection materials intended for single use must be discarded. Dispose of the syringe and needles safely in a closed container.