Neviran 400 mg tabletten met verlengde afgifte

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

NEVIRAPINE 0-WATER 400 mg/stuk

から入手可能:

Medicopharm AG Stangenreiterstraße 4 83131 NUßDORF AM INN (DUITSLAND)

ATCコード:

J05AG01

INN（国際名）:

NEVIRAPINE 0-WATER 400 mg/stuk

医薬品形態:

Tablet met verlengde afgifte

構図:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b),

投与経路:

Oraal gebruik

治療領域:

Nevirapine

製品概要:

Hulpstoffen: HYPROMELLOSE, type 2208 (Release controlling polymer), K4M (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b);

承認日:

1900-01-01

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEVIRAN 400 MG TABLETTEN MET VERLENGDE AFGIFTE
nevirapine
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neviran is and what it is used for
2.
What you need to know before you take Neviran
3.
How to take Neviran
4.
Possible side effects
5.
How to store Neviran
6.
Contents of the pack and other information
1.
WHAT NEVIRAN IS AND WHAT IT IS USED FOR
Neviran belongs to a group of medicines called antiretrovirals, used
in the treatment of Human
Immunodeficiency Virus (HIV-1) infection.
The active substance of your medicine is called nevirapine. Nevirapine
belongs to a class of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). Reverse transcriptase is an
enzyme that HIV needs in order to multiply. Nevirapine stops reverse
transcriptase from working. By
stopping reverse transcriptase from working, Neviran helps control
HIV-1 infection.
Nevirapine is indicated for the treatment of HIV-1 infected adults,
adolescents and children three years and
above and able to swallow tablets. You must take nevirapine together
with other antiretroviral medicines.
Your doctor will recommend the best medicines for you.
Neviran prolonged-release tablets should only be used after a two-week
treatment with another type of
nevirapine medicine (immediate-release tablets or suspension), unless
you are currently on these medicines
and are switching to the prolonged-release form.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEVIRAN
DO NOT TAKE NEVIRAN
-

製品の特徴

1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Neviran 400 mg tabletten met verlengde afgifte
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 400 mg of nevirapine (as
anhydrous).
Excipient with known effect: each prolonged-release tablet contains
375 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
White to off-white oval shaped, approx. 9.3 x 19.2 mm, biconvex
tablets debossed with ‘H’ on one side and
‘N1’ on other side. The prolonged release tablet should not be
divided.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nevirapine is indicated in combination with other anti-retroviral
medicinal products for the treatment of
HIV-1 infected adults, adolescents, and children three years and above
and able to swallow tablets (see
section 4.2).
Neviran 400 mg prolonged-release tablets are not suitable for the
14-day lead-in phase for patients starting
nevirapine.
Other nevirapine formulations, such as immediate-release tablets or
oral suspension, may be checked for
their availability and used accordingly (see section 4.2).
Most of the experience with nevirapine is in combination with
nucleoside reverse transcriptase inhibitors
(NRTIs). The choice of a subsequent therapy after nevirapine should be
based on clinical experience and
resistance testing (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Neviran 400 mg should be administered by physicians who are
experienced in the treatment of HIV
infection.
Posology
_Adults_
The recommended dose of nevirapine for patients initiating nevirapine
therapy is one 200 mg immediate-
release tablet daily for the first 14 days (this lead-in period should
be used because it has been found to
lessen the frequency of rash), followed by one 400 mg
prolonged-release tablet once daily, in combination
with at least two additional antiretroviral agents.
Patients currently on a nevirapine immediate-release twice daily
regimen:
2
P