瑞比達膠囊

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

有效成分:

RIBAVIRIN

可用日期:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

药物剂型:

膠囊劑

组成:

RIBAVIRIN (0818000800) MG

每包单位数:

鋁箔盒裝

类:

製　劑

处方类型:

須由醫師處方使用

厂商:

MSD International GmbH (Puerto Rico Branch) LLC PRIDCO INDUSTRIAL PARK, STATE ROAD #183, LAS PIEDRAS, PUERTO RICO 00771 PR

疗效迹象:

1.與Peginterferon Alfa或Interferon Alfa併用治療於：（1）曾經使用Interferon Alfa單一療法治療後又復發的慢性C型 肝炎。 （2）首次接受治療的慢性C型肝炎。 （3）合併感染臨床穩定HIV的慢性C型肝炎。2.與Peginterferon Alfa併用治療於曾以Interferon Alfa併用 Ribavirin治療無效或復發之慢性C型肝炎。

產品總結:

註銷日期: 2019/02/12; 註銷理由: 自請註銷; 有效日期: 2021/06/18; 英文品名: REBETOL CAPSULE

授权状态:

已註銷

授权日期:

2001-06-18

资料单张

S-CCDS-MK89008-MTL-082014
MK-8908-TWN-2014-009672-PC-MTL
REBETOL
® (RIBAVIRIN) CAPSULES
PRESCTIPTION, FOR ORAL ADMINISTRATION
DESCRIPTION
: Rebetol Capsules consist of a white, crystalline powder, which is
freely soluble in water and slightly soluble in dehydrated
alcohol, in a white opaque gelatin capsule. Each Rebetol Capsule
contains ribavirin 200 mg. Inactive ingredients including
microcrystalline
cellulose, lactose monohydrate, croscarmellose sodium and magnesium
stearate
。
ACTIONS
: Ribavirin is a synthetic nucleoside analogue that has shown_ in
vitro_ activity against some RNA and DNA viruses. Oral formulations
of ribavirin monotherapy have been investigated as therapy for chronic
hepatitis C in several clinical trials. Results of these
investigations
showed that ribavirin monotherapy had no effect on eliminating
hepatitis virus (HCV-RNA) or improving hepatic histology after 6 to 12
months
of therapy and 6 months of follow-up. However, clinical trials
combining ribavirin with peginterferon alfa-2b or interferon alfa-2b
resulted in an
increased response rate over treatment with pegylated interferon or
interferon alfa-2b alone. The mechanism by which ribavirin in
combination
with peginterferon alfa 2b or interferon alfa-2b exerts its effects
against HCV is unknown.
PRECLINICAL PHARMACOLOGY AND TOXICOLOGY
: Rat pups dosed from postnatal day 7 through 63 demonstrated a minor,
dose-related decrease in overall growth, which was subsequently
manifested as slight decreases in body weight, crown-rump length and
bone length. These effects showed evidence of reversibility, and no
histopathological effects on bone were observed. No ribavirin effects
were observed regarding neurobehavioral or reproductive development.
Similar to other preclinical studies in adult animals, plasma
concentrations achieved in rat pups at the maximally tolerated dose
were below human plasma concentrations at the therapeutic dose and no
safety margin could be established for pediatric use.
INDICATIONS AND USAGE
: Rebetol Capsules are indi