Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
RIBAVIRIN
MERCK SHARP & DOHME ISRAEL LTD
J05AB04
CAPSULES
RIBAVIRIN 200 MG
PER OS
Required
SCHERING-PLOUGH LABO. N.V , BELGIUM
RIBAVIRIN
RIBAVIRIN
Tritherapy:Rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis C (CHC) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.Bitherapy:Rebetol is indicated for the treatment of chronic hepatitis C virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b .Rebetol monotherapy must not be used. There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b).Previously untreated (naïve) patientsAdult patients (18 years of age or older): Rebetol is indicated for:• tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis C genotype1 infection with compensated liver disease.• bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, fo
2014-10-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine can be sold under doctor's prescription only REBETOL ® 200 MG CAPSULES Each capsule contains: Ribavirin 200 mg For a list of inactive ingredients see section 6.1 "What REBETOL contains". See also section 2.7 “Important information about some of the ingredients of REBETOL". READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. This leaflet contains concise information about REBETOL. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. This medicine is intended for adult patients. This medicine is not intended for children and adolescents under 18 years of age. 1. WHAT REBETOL IS AND WHAT IT IS USED FOR? REBETOL capsules contain the active substance ribavirin. This medicine stops the multiplication of many types of viruses, including hepatitis C virus. REBETOL capsules are intended to treat patients 18 years of age or older who have chronic hepatitis C. This medicine must not be used without peginterferon alfa-2b or interferon alfa-2b, i.e. REBETOL must not be used alone. Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with boceprevir and peginterferon alfa-2b (tritherapy). Adult patients without genotype 1, can only use peginterferon alfa-2b or interferon alfa-2b and this medicine (bitherapy). There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection. Your doctor will recommend the best course of therapy. The combination of this medicine and peginterferon alfa-2b is used to treat previously untreated adult patients who have chronic hepatitis C (HCV) infection and who are co-infected with clinically stable HIV. There is no safety or efficacy information on the use Przeczytaj cały dokument
1 _ _ 1. NAME OF THE MEDICINAL PRODUCT Rebetol ® 200 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 200 mg of ribavirin. Excipient with known effect: Each capsule contains 40 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule White, opaque and imprinted with blue ink. 4. CLINICAL PARTICULARS _ _ 4.1 THERAPEUTIC INDICATIONS Tritherapy: Rebetol in combination with boceprevir and peginterferon alfa-2b is indicated for the treatment of chronic hepatitis C (CHC) genotype1 infection in adults patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. Please refer to peginterferon alfa -2b and boceprevir Summary of Product Characteristics (SmPCs) when using Rebetol in combination with these medicines. Bitherapy: Rebetol is indicated for the treatment of chronic hepatitis C virus infection in adults and must only be used as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b. Rebetol monotherapy must not be used. Please refer to interferon alfa-2b and peginterferon alfa-2b Summary of Product Characteristics (SmPCs) when using Rebetol in combination with these medicines. There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i.e., not alfa-2b). Previously untreated (naïve) patients _Adult patients_ _(18 years of age or older): _Rebetol is indicated for: tritherapy- in combination with peginterferon alfa-2b and boceprevir for the treatment of adult patients with chronic hepatitis C genotype1 infection with compensated liver disease bitherapy- in combination with interferon alfa-2b or peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid (HCV-RNA). bitherapy- for the treatment of CHC infection in co Przeczytaj cały dokument