RIBAVIRIN capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K)

から入手可能:

Zydus Lifesciences Limited

INN（国際名）:

RIBAVIRIN

構図:

RIBAVIRIN 200 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Ribavirin capsules in combination with interferon alfa-2b (pegylated and nonpegylated) is indicated for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease [see Warnings and Precautions (5.9, 5.10), and Use in Specific Populations (8.4)]. The following points should be considered when initiating ribavirin capsules combination therapy with PegIntron® or INTRON A® : - Combination therapy with ribavirin /PegIntron is preferred over ribavirin /INTRON A as this combination provides substantially better response rates [see Clinical Studies (14) ]. - Patients with the following characteristics are less likely to benefit from retreatment after failing a course of therapy: previous nonresponse, previous pegylated interferon treatment, significant bridging fibrosis or cirrhosis, and genotype 1 infection [see Clinical Studies (14) ]. - No safety and efficacy data are available for treatment duration lasting longer than one year. Ribavirin capsules combination

製品概要:

Ribavirin capsules USP, 200 mg are white to off-white granular powder filled in size '0' hard gelatin capsules with white colored cap printed with "ZA-12" in black ink and white colored body printed with "200mg" in black ink and are supplied as follows: NDC 65841-260-04 in bottle of 42 capsules NDC 65841-260-07 in bottle of 56 capsules NDC 65841-260-09 in bottle of 70 capsules NDC 65841-260-12 in bottle of 84 capsules NDC 65841-260-13 in bottle of 140 capsules NDC 65841-260-03 in bottle of 168 capsules NDC 65841-260-28 in bottle of 180 capsules NDC 65841-260-10 in bottle of 1000 capsules NDC 65841-260-30 in unit-dose blister cartons of 100 (10 x 10) unit-dose capsules Dispense in a tight container. Storage Conditions: Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled  Room Temperature].

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 81e414f0-8bbc-4bfa-98a6-067f2bd0c1ab
34391-3
Set id: b97cd49c-9e19-4a35-987c-06e62bb25b6b
Version: 8
Effective Time: 20230927
Zydus Lifesciences Limited

製品の特徴

RIBAVIRIN- RIBAVIRIN CAPSULE
ZYDUS LIFESCIENCES LIMITED
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RIBAVIRIN CAPSULES
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-260-12 in bottle of 84 capsules
Ribavirin Capsules USP, 200 mg
R only
84 capsules
RIBAVIRIN
ribavirin capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-260
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
x
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
RIBAVIRIN (UNII: 49717AWG6K) (RIBAVIRIN - UNII:49717AWG6K)
RIBAVIRIN
200 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
22mm
FLAVOR
IMPRINT CODE
Z A;12;200mg
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
260-30
10 in 1 CARTON
01/25/2006
1
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
2
NDC:65841-
260-04
42 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
3
NDC:65841-
260-07
56 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
4
NDC:65841-
260-09
70 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
5
NDC:65841-
260-12
84 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
6
NDC:65841-
260-13
140 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
7
NDC:65841-
260-03
168 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
8
NDC:65841-
260-28
180 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
9
NDC:65841-
260-10
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
01/25/2006
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA077224
01/25/2006
Zydus Lifesciences Limited
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Z