Viramune
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
21-04-2023
Vara einkenni
(SPC)
21-04-2023
Opinber matsskýrsla
(PAR)
27-10-2011
Virkt innihaldsefni:
nevirapine
Fáanlegur frá:
Boehringer Ingelheim International GmbH
ATC númer:
J05AG01
INN (Alþjóðlegt nafn):
nevirapine
Meðferðarhópur:
Antivirals for systemic use
Lækningarsvæði:
HIV Infections
Ábendingar:
Tablets and oral suspensionViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.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 should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.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 should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.
Vörulýsing:
Revision: 44
Leyfisstaða:
Authorised
Leyfisdagur:
1998-02-04
Upplýsingar fylgiseðill
99
B. PACKAGE LEAFLET
100
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRAMUNE 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 further questions, please 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 Viramune is and what it is used for
2.
What you need to know before you take Viramune
3.
How to take Viramune
4.
Possible side effects
5.
How to store Viramune
6.
Contents of the pack and other information
1.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
Viramune 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, Viramune helps control
HIV-1 infection.
Viramune is indicated for the treatment of HIV-1 infected adults,
adolescents, and children of any age.
You must take Viramune together with other antiretroviral medicines.
Your doctor will recommend
the best medicines for you.
IF VIRAMUNE 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 VIRAMUNE
DO NOT TAKE VIRAMUNE
-
if you are allergic to nevirapine or any of the other ingredients of
this medicine (listed in sect
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Viramune 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of nevirapine (as anhydrous).
Excipients with known effect
Each tablet contains 318 mg of lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), that is to say
essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, oval, biconvex tablets. One side is embossed with the code
“54 193”, with a single bisect
separating the “54” and “193”. The opposite side is marked
with the company symbol. The score line
is not intended for breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Viramune 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 Viramune is in combination with nucleoside
reverse transcriptase
inhibitors (NRTIs). The choice of a subsequent therapy after Viramune
should be based on clinical
experience and resistance testing (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Viramune should be administered by physicians who are experienced in
the treatment of HIV
infection.
Posology
_Patients 16 years and older_
The recommended dose of Viramune 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.
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 than 8
hours later, the patient should only
take the next dose at the usual time.
_Dose management considerations_
Patients experiencing rash during the 14-day lead-in period of 200
mg/day should not have their
V
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