Nevirapine Teva
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
21-03-2023
Svojstava lijeka
(SPC)
21-03-2023
Izvješće o ocjeni javnog
(PAR)
21-03-2023
Aktivni sastojci:
nevirapine
Dostupno od:
Teva B.V.
ATC koda:
J05AG01
INN (International ime):
nevirapine
Terapijska grupa:
Antivirals for systemic use
Područje terapije:
HIV Infections
Terapijske indikacije:
Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age.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.
Proizvod sažetak:
Revision: 11
Status autorizacije:
Withdrawn
Datum autorizacije:
2009-11-30
Uputa o lijeku
34
B. PACKAGE LEAFLET
Medicinal product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NEVIRAPINE TEVA 200 MG TABLETS
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 Nevirapine Teva is and what it is used for
2.
What you need to know before you take Nevirapine Teva
3.
How to take Nevirapine Teva
4.
Possible side effects
5.
How to store Nevirapine Teva
6.
Contents of the pack and other information
1.
WHAT NEVIRAPINE TEVA IS AND WHAT IT IS USED FOR
Nevirapine Teva 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, Nevirapine Teva helps
control HIV-1 infection.
Nevirapine Teva is indicated for the treatment of HIV-1 infected
adults, adolescents, and children of
any age. You must take Nevirapine Teva together with other
antiretroviral medicines. Your doctor will
recommend the best medicines for you.
IF NEVIRAPINE TEVA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE
THAT ALL INFORMATION IN THIS
LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR
CHILD” INSTEAD OF “YOU”).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEVIRAPINE TEV
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Nevirapine Teva 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of nevirapine (as anhydrous).
Excipient with known effect: Each tablet contains 168 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, oval, biconvex tablets. One side is debossed with "N", a
scoreline and "200". The opposite side
is debossed with a scoreline. The score line is only to facilitate
breaking for ease of swallowing and
not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nevirapine Teva is indicated in combination with other anti-retroviral
medicinal products for the
treatment of HIV-1 infected adults, adolescents, and children of any
age (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
Nevirapine Teva should be administered by physicians who are
experienced in the treatment of HIV
infection.
Posology
_Patients 16 years and older _
The recommended dose of Nevirapine Teva is one 200 mg 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
200 mg tablet twice daily, in combination with at least two additional
antiretroviral agents.
For patients who are unable to swallow tablets or who weigh less than
50 kg or whose body surface
area is below 1.25 m
2
according to the Mosteller formula, other nevirapine containing oral
formulations are available and should be used if appropriate.
If a dose is recognized as missed within 8 hours of when it was due,
the patient should take the missed
dose as soon as possible. If a dose is missed and it is more
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