Viropil tablets film-coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

dolutegravir (dolutegravir sodium), lamivudine, tenofovir disoproxil fumarate

Tersedia dari:

Emcure Pharmaceuticals Ltd.

Kode ATC:

J05AR27

INN (Nama Internasional):

dolutegravir (dolutegravir sodium), lamivudine, tenofovir disoproxil fumarate

Dosis:

50mg+ 300mg+ 300mg

Bentuk farmasi:

tablets film-coated

Unit dalam paket:

(30) in plastic container, (90) in plastic container

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-12-07

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER
VIROPIL
50mg+300mg+300mg; film-coated tablets
_dolutegravir+tenofovir disoproxil fumarate + lamivudine _
READ THIS ENTIRE 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, pharmacist, or
nurse.
•
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, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What VIROPIL is and what it is used for
2. What you need to know before you take VIROPIL
3. How to take VIROPIL
4. Possible side effects
5. How to store VIROPIL
6. Contents of the pack and other information
1. WHAT VIROPIL IS AND WHAT IT IS USED FOR
Viropil is a medicine that contains three active ingredients:
dolutegravir, tenofovir disoproxil and
lamivudine. Dolutegravir belongs to a group of anti-retroviral
medicines called integrase inhibitors.
Tenofovir is a nucleotide reverse transcriptase inhibitor, while
lamivudine belongs to the group of the
nucleoside analogue reverse transcriptase inhibitors.
Viropil is used to treat HIV (human immunodeficiency virus) infection
in adults and young
people who weigh at least 30 kg.
Viropil does not cure HIV infection; it reduces the amount of virus in
your body and keeps it at a low
level. Reducing the amount of virus helps to increase number of white
blood cells, called CD4 cells, that
are important for fighting infection.
Viropil does not work equally well in everybody. Your health care
provider will check how
well your treatment is working.
To control your HIV infection, and to stop your illness from getting
worse, you must take all your HIV
medicines regularly, unless your health care provider tells you to
stop taking any.
2. WHAT YOU NEED TO KNO

Karakteristik produk

_SUMMARY OF PRODUCT CHARACTERISTICS _
_ _
VIROPIL
SUMMARY OF PRODUCT CHARACTERISTICS
VIROPIL
(DOLUTEGRAVIR 50 MG, TENOFOVIR DISOPROXIL FUMARATE 300 MG +
LAMIVUDINE 300 MG)
_SUMMARY OF PRODUCT CHARACTERISTICS _
_ _
VIROPIL
1. NAME OF THE MEDICINAL PRODUCT
Viropil
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCRIPTION:
White to off white, capsule shaped, film coated tablets, debossed with
“HP553”
on one side and plain on the other side
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredients are
_dolutegravir, lamivudine and tenofovir disoproxil fumarate_
.
Each film coated tablet contains:
Dolutegravir Sodium equivalent to Dolutegravir…... 50 mg
Lamivudine........ 300 mg
Tenofovir Disoproxil Fumarate 300 mg equivalent to Tenofovir
Disoproxil.............245 mg
For full list of excipients please see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Viropil is indicated for the treatment of human immunodeficiency virus
(HIV) infection in
adults and adolescents weighing at least 30 kg. Consideration should
be given to official
treatment guidelines for HIV-1 infection.
For use of antiretroviral agents for post-exposure prophylaxis the
most recent official
guidelines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Viropil should be prescribed by a health care provider experienced in
the management of
HIV infection.
_ _
_Posology _
_ _
_Adults _
The dose of Viropil is one tablet once daily.
_Dose adjustments _
Where discontinuation of therapy with one of the components of Viropil
is indicated or where
dose modification is necessary, separate preparations of dolutegravir,
lamivudine and tenofovir
disoproxil should be used. Please refer to the individual product
information for these
medicinal products.
_SUMMARY OF PRODUCT CHARACTERISTICS _
_ _
VIROPIL
When the patient’s HIV-1 infection is known or suspected to be
resistant to integrase inhibitors,
additional doses of dolutegravir are necessary. Please refer to the
product information of
dolutegravir for