衛滋錠２００毫克

Страна: Тайвань

Язык: китайский

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

Активный ингредиент:

NEVIRAPINE

Доступна с:

台灣百靈佳殷格翰股份有限公司 台北市中山區民生東路三段2號12樓 (12469866)

код АТС:

J05AG01

Фармацевтическая форма:

錠劑

состав:

NEVIRAPINE (0818001500) MG

Штук в упаковке:

盒裝

класс:

製　劑

Тип рецепта:

須由醫師處方使用

Производитель:

BOEHRINGER INGELHEIM ELLAS A.E. 5TH KM,PAIANIA-MARKOPOULO,194 00 KOROPI, GREECE GR

Терапевтические области:

nevirapine

Терапевтические показания :

與其他藥物併用、治療免疫缺陷逐漸惡化或嚴重ＨＩＶ－１感染之成年病患。

Обзор продуктов:

註銷日期: 2022/05/13; 註銷理由: 自請註銷; 有效日期: 2024/01/26; 英文品名: VIRAMUNE TABLETS 200MG

Статус Авторизация:

已註銷

Дата Авторизация:

1999-01-26

тонкая брошюра

COMPOSITION
1 tablet contains: 200 mg
11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido
[3,2-b:2’,3’-e][1,4]diazepin-6-one (= nevirapine anhydrous)
Excipients
cellulose, lactose monohydrate, povidone K 25, sodium starch
glycolate, silicia colloidal,
magnesium stearate
PHARMACOLOGICAL PROPERTIES
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
of HIV-1.
Nevirapine binds directly to reverse transcriptase and blocks the
RNA-dependent
and DNA-dependent DNA polymerase activities by causing disruption of
the enzyme’s
catalytic site. The activity of nevirapine does not compete with
template or nucleoside
triphosphates. HIV-2 reverse transcriptase and eukaryotic DNA
polymerases (such as
human DNA polymerases α, β, γ, or δ) are not inhibited by
nevirapine.
In clinical studies, VIRAMUNE has been associated with an increase in
HDL- cholesterol
and an overall improvement in the total to HDL-cholesterol ratio,
which in the general
population would be considered to be associated with a lower
cardiovascular risk.
However, in the absence of specific studies with VIRAMUNE on modifying
the
cardiovascular risk in HIV infected patients, the clinical impact of
these findings is not
known. The selection of antiretroviral drugs must be guided primarily
by their antiviral
efficacy.
_IN VITRO HIV SUSCEPTIBILITY: _
The in vitro antiviral activity of nevirapine has been measured in a
variety of cell
lines
including peripheral blood mononuclear cells, monocyte derived
macrophages,
and
lymphoblastoid cell lines. In recent studies using human cord blood
lymphocytes
and
human embryonic kidney 293 cells, EC50 values (50% inhibitory
concentration) ranged
from 14 – 302 nM against laboratory and clinical isolates of HIV-1.
Nevirapine exhibited antiviral activity in vitro against group M HIV-1
isolates from clades
A, B, C, D, F, G, and H, and circulating recombinant forms (CRF),
CRF01_AE, CRF02_AG
and CRF12_BF (median EC50 value of 63 nM). Nevirapine had no antiviral
activity in
vitro against isolates from group O H