PegIntron 80 mcg. 1 ampoule
The active ingredient in said medicament is a protein called peginterferon alfa-Zb, which belongs to the group of medicines called interferons. Interferons are produced by your immune system to help fight infection and severe illness. This medicine is injected into your body to work with your immune system. This drug is used to treat chronic hepatitis C - a viral infection of the liver.
The combination of this drug, ribavirin and boceprevir are recommended for use in certain types of infection with chronic hepatitis C (also called HCV infection) in adults aged 18 years and over. It can also be used in adults who were not previously treated for HCV infection or who have previously used drugs called interferons or pegylated interferons.
The combination of this medicine and ribavirin is recommended for adults 18 and older who have not previously treated with these drugs. It also includes adults with clinically stable HIV infection (human immunodeficiency virus). The combination can also be used to treat adults who have not responded to treatment with interferon alfa or peginterferon alpha in combination with ribavirin or interferon alpha alone.
If you have a disease that makes use of ribavirin dangerous or if you have reception problems, it is likely your doctor may prescribe this medicine alone.
If you have 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 aged 3 years and older who have not previously treated for chronic hepatitis C.
2. What you should know before using PegIntron
Do not use PegIntron
Before starting treatment, tell your doctor if you or the child you are caring for:
you are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6);
you are allergic to any interferon;
you have serious heart problems;
you have heart disease that has not been well controlled during the past 6 months;
have severe medical conditions as a result of which you have fallen;
have autoimmune hepatitis or any other problem with your immune system;
taking medicines that suppress (weaken) your immune system;
have advanced, uncontrolled liver disease (other than hepatitis C);
you have thyroid disease that is not well controlled;
have epilepsy - a disease resulting in getting seizures (convulsions, "fits");
if you are being treated with telbivudine (see section "Other medicines and PegIntron").
You should not use PegIntron, if any of the above conditions apply to you or the child you are caring for.
In addition, children and adolescents who have had severe neurological or psychiatric problems, such as severe depression or thoughts of suicide, should not use this medicine.
Reminder: Please also read the section "Do not take" in the package leaflet of ribavirin and boceprevir before you start to use them in combination with this medicine.
Warnings and Precautions
Seek immediate medical care in case of a severe allergic reaction (such as difficulty breathing, wheezing or hives).
Talk with your doctor before using this medicine if you or the child you are caring for:
have had serious neurological or psychiatric disease or have a history of substance use (eg. alcohol or drugs). The use of this medicine in children and adolescents with existing severe mental illness or evidence of such is not permitted (see section "Do not use PegIntron" above);
ever suffered from depression or have had symptoms of depression (eg feeling of sadness, fatigue, etc.) during treatment with this medicine (see section 4 "Possible side effects");
you have ever been treated for depression or any other mental or neurological disease;
you had a heart attack or have had other heart problem;
have kidney disease, your doctor may prescribe treatment at a dose lower than usual, and periodically during treatment to do blood tests to assess your kidney function. If you are taking this medicine in combination with ribavirin, your doctor should closely monitor you or the child you are caring for a possible reduction in the number of red blood cells;
you have ever had liver problems (other than hepatitis C);
when you develop symptoms such as a cold or other respiratory infection such as fever, cough or difficulty breathing;
you are diabetic or have high blood pressure, your doctor may prescribe eye examination you or the child in your care;
have suffered from serious diseases affecting the respiratory system or blood;
have skin diseases, psoriasis or sarcoidosis that during administration of this drug may worsen;
planning to become pregnant, talk to your doctor before you start being treated with this medicine;
Your organ transplant, kidney or liver, interferon may increase the risk of rejection. You should discuss with your doctor;
you are being treated for HIV (see section "Other medicines and PegIntron").
Reminder: Please also read the point "Warnings and Precautions" in the package leaflet of ribavirin before you begin combination treatment with this drug.
Problems with teeth and gums have been reported in patients treated with this drug in combination with ribavirin. When you can occur gum disease, which can lead to loss of teeth. May appear dry mouth or vomiting, both of which can lead to tooth decay. It is very important to better brush your teeth twice a day to rinse your mouth if you vomit and regular dental examinations.
During treatment, some patients may experience eye problems, or in rare cases, loss of vision. Your doctor should do a complete eye examination before starting treatment. In the event of any changes in your vision, tell your doctor and make a prompt and complete eye examination. If you have a disease which can lead to further problems with eyes (eg. Diabetes or hypertension) during treatment will have periodic eye exams. If violations of your eyes get worse or develop new offenses, your treatment will be discontinued.
During treatment with PegIntron Your doctor may advise you to take more fluids than usual to not drop your blood pressure.
To ensure that the treatment you receive is safe and effective, your doctor will do a blood test before you start treatment and during the entire treatment.
Children and adolescents
This medicine is not recommended for use in patients under the age of 3 years.
Other medicines and PegIntron
Please tell your doctor or pharmacist if you or the child you are caring for:
taking or have recently taken any other medicines or vitamins / nutritional supplements, including medicines obtained without a prescription;
are co-infected with human immunodeficiency virus (HIV-positive), and hepatitis C virus (HCV) and are treated with drug (s) against HIV [nucleoside reverse transcriptase inhibitors (NRTI) and / or highly active antiretroviral therapy (HAART)]. Your doctor will monitor you for signs and symptoms of these conditions;
The use of this medicine in combination with ribavirin and anti-HIV drug (s) product (s) may increase the risk of lactic acidosis, liver failure and abnormal blood tests: reducing the number of red blood cells, white blood cells and blood cells involved in blood clotting, called platelets. Patients with advanced liver disease receiving HAART, may have an increased risk of worsening liver function, so the addition of this drug, alone or in combination with ribavirin may increase their risk;
In zidovudine or stavudine, it is not certain if ribavirin will affect the way these drugs. Therefore, you will have regular blood tests to make sure that the HIV infection progresses. If it gets worse, your doctor will decide whether you need to change your treatment with ribavirin. Moreover, patients treated with this drug in combination with ribavirin and zidovudine could be at increased risk of developing anemia (low red blood cells). Therefore the use of zidovudine and this medicine in combination with ribavirin is not recommended.
Reminder: Please also read the section "Other drugs" in the Package Leaflet for ribavirin before you begin combination treatment with this medicine.
if you accept telbivudine. If you take telbivudine with this medicine or some kind of injectable interferon product, the risk of developing peripheral neuropathy (numbness, tingling and / or burning sensation in the arms and / or legs) is higher. These events may also be more severe. Therefore, you should not take this medicine at the same time with telbivudine.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
In studies in pregnant animals have been reported cases of abortion caused by administration of interferon. The effect of this drug on pregnancy in humans is not known. Girls or women of childbearing potential should use effective birth control during treatment with this medicine.
Ribavirin may cause fetal harm. Therefore, you and your partner must take special precautions in sexual activity if there is any possibility of pregnancy:
when you are a girl or a woman of childbearing age and taking Ribavirin: treatment can be started only after obtaining a negative result from a pregnancy test, as during treatment and for four months after treatment every month should be tested Pregnancy, which is negative. You should use effective methods to control pregnancy during your treatment with ribavirin and four months after the end of treatment. You should discuss with your doctor;
if you are a man who is taking ribavirin: sexual contact with a pregnant woman must use a condom. If your partner is not pregnant now but is of childbearing age, during treatment and for seven months after the end of each month, it must be tested for pregnancy. You or your partner must use an effective control of pregnancy during your treatment with ribavirin and for seven months after treatment. You should discuss this with your doctor.
It is not known whether this medication passes into breast milk. Therefore, if you are taking this medication should not breastfeed. Ask your doctor for advice.
Reminder: Please also read the section "Pregnancy and lactation" in the Package Leaflet for ribavirin before you begin combination treatment with this medicine.
Driving and using machines
If you feel tired, sleepy or confused while being treated with PegIntron, do not drive or operate machinery.
Important information about some of the ingredients of PegIntron
This medication contains sucrose. If you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This product contains less than 1 mmol sodium (23 mg) of 0,7 ml, ie contains virtually no sodium.
3. How to use PegIntron
Always use this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
General information on how to use this medicine
Your doctor has determined the correct dose of this medicine based on your body weight or weight of the child you are caring for. If necessary, in the course of treatment, the dose may be changed.
This medicine is intended for subcutaneous administration. This means to inject short injection needle into fat under the skin. If you inject yourself you will be instructed how to prepare and give the injection. Detailed instructions for subcutaneous administration are given at the end of this leaflet (see section "How to inject Pegintron").
Water for injections and PegIntron powder provided in separate vials. Prepare the dose by adding water for injections to the PegIntron powder immediately before the injection and use immediately. Before use, carefully inspect the solution you've prepared. The solution should be clear and colorless. Do not use if the solution is cloudy (discolored to the original) or contains particles. After the injection, discard the vial with the remaining solution in it. For instructions on disposal, see section 5 "How to store PegIntron".
Inject this medicine once a week on the same day. Injected at the same time of day each week will help you not to forget about the injection.
Always use this medicine exactly as prescribed by your doctor. Do not apply more than the recommended dosage and do not use the drug for longer than the prescribed time.
If your doctor prescribes this medicine with ribavirin or with ribavirin and boceprevir, please read the package leaflet of ribavirin and boceprevir before you begin combination treatment.
Use in adults - PegIntron in combination therapy
This medication is usually administered in a dose of 1.5 microgram per kg once a week. If you have kidney disease, your dose may be lower depending on your kidney function.
Use in adults - single treatment with PegIntron
When administered alone, the usual dose of this medication is 0.5 or 1.0 micrograms per kilogram of body weight once a week for 6 months to 1 year. You have kidney problems, your dose may be lower depending on your kidney function. Your doctor will determine the correct dose for you.
Use in children aged 3 years and adolescents
PegIntron is to be administered in combination with ribavirin. The dose of PegIntron is determined by calculation using height and weight. Your doctor will determine the correct dose for you or the child you are caring for. Treatment can last up to one year on medical advice for you or the child you are caring for.
For all patients,
If we inject this medicine, make sure that the packages you received, containing the prescribed dose.
If you use more PegIntron dose
Tell your doctor or healthcare professional about this or your doctor or healthcare professional of the child you are caring for.
If you forget to take PegIntron
Accept / dose of this medication as soon as you remember, but not later than 1-2 days after the missed dose. If it is almost time for your next injection, do not take a double dose to make up for the missed dose and continue your treatment as usual.
If you are unsure, 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 effects may occur, if this happens, you may need medical intervention. When this medicine is used alone, the possibility that some of these reactions occur is small and some may not appear at all.
Psychiatric and central nervous system:
During the self-treatment with this drug or in combination with ribavirin, some people develop depression, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behavior (sometimes directed against others). Some patients have actually committed suicide. If you become depressed, you start thinking about suicide or notice a change in their behavior, seek emergency medical care. Ask a family member or close friend to stay alert to signs of depression or changes in your behavior.
Children and adolescents are particularly prone to develop depression during treatment with this medicine and ribavirin. Immediately contact your doctor or seek emergency medical attention if your child has unusual behavioral symptoms, feel depressed, or want to harm themselves or others.
Growth and development (children and adolescents):
During treatment with this medicine in combination with ribavirin for up to one year, some children and adolescents did not grow or gain weight as expected. Some children did not reach their projected height within 1-5 years after completing treatment.