Страна: Нідерланди
мова: голландська
Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
RIBAVIRINE 200 mg/stuk
Ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM (DUITSLAND)
J05AP01
RIBAVIRINE 200 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Ribavirin
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
1900-01-01
Ribavirin NL/H/2092/001, 15.07.2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT _ _ RIBAVIRINE RATIOPHARM 200 MG, FILMOMHULDE TABLETTEN ribavirin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. [Product name] 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 other medicines. 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 [Product name] and other medicines is used to treat adult patients who have chronic hepatitis C (HCV). [Product name] may be used in paediatric patients (children 3 years of age and older and adolescents) who are not previously treated and without severe liver disease. For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation may be available. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFOR Прочитайте повний документ
Ribavirin NL/H/2092/001-002, 15.07.2021 1 SUMMARY OF PRODUCT CHARACTERISTICS Ribavirin NL/H/2092/001-002, 15.07.2021 2 1. NAME OF THE MEDICINAL PRODUCT Ribavirine ratiopharm 200 mg filmomhulde tabletten Ribavirine ratiopharm 400 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of ribavirin. 400 mg Each film-coated tablet contains 400 mg of ribavirin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Oval, biconvex, ivory film-coated tablets of 14 mm length and 7 mm width. 400 mg Oval, biconvex, yellow film-coated tablets of 18 mm length and 9 mm width. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Product name] is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1). [Product name] is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated, and monitored, by a physician experienced in the management of chronic hepatitis C. Posology [Product name] must be used in combination therapy as described in section 4.1. Please refer to the corresponding Summary of Product Characteristics (SmPC) of medicinal products used in combination with ribavirin for additional prescribing information particular to that product and for further dosage recommendations on co-administration with [Product name]. [Product name] film-coated tablets are to be administered orally each day in two divided doses (morning and evening) with food. _Adults _ The recommended dose and duration of [Product name] depends on patient’s weight and on the medicinal product that is used in combination. Please refer to the corresponding SmPC of medicinal products used in combination w Прочитайте повний документ