VIREAD

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

TENOFOVIR DISOPROXIL AS FUMARATE

থেকে পাওয়া:

GILEAD SCIENCES ISRAEL LTD

এটিসি কোড:

J05AF07

ফার্মাসিউটিকাল ফর্ম:

FILM COATED TABLETS

রচনা:

TENOFOVIR DISOPROXIL AS FUMARATE 245 MG

প্রশাসন রুট:

PER OS

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

GILEAD SCIENCES IRELAND UC, IRELAND

Therapeutic group:

TENOFOVIR DISOPROXIL

Therapeutic area:

TENOFOVIR DISOPROXIL

থেরাপিউটিক ইঙ্গিত:

Viread is indicated for the treatment of :1. HIV 1 infected adults and pediatric patients 12 years of age and older in combination with other antiretroviral medicinal products for the treatment of HIV. 2. Chronic hepatitis B in adults with: • Compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. • Decompensated liver disease

অনুমোদন তারিখ:

2014-02-28

তথ্য লিফলেট

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed according to a doctor’s prescription only
VIREAD
®
Film-coated tablets
ACTIVE INGREDIENT: each film-coated tablet contains -
Tenofovir disoproxil
245 mg (as fumarate)
Inactive ingredients and allergens: See section 6: "_Additional
Information_".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU. This leaflet contains
essential information
about this medicine. If you have any further questions, ask your
doctor or pharmacist.
Keep this leaflet. You may need to read it again. This medicine has
been prescribed
for you only. Do not pass it on to others. It may harm them, even if
it seems to you that
their illness is similar to yours. If you experience any side effects,
talk to your doctor or
pharmacist. Even if you experience any side effects that are not
listed in this leaflet
(see section 4).
The medicine is not intended for children under the age of 12 years.
IF VIREAD HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE
INFORMATION
IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ
“YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT IS VIREAD INTENDED FOR?
•
Viread is used to treat HIV (Human Immunodeficiency Virus) in adults
and
paediatric patients 12 years of age and older.
•
Viread is also used to treat chronic hepatitis B, an infection with
hepatitis B virus
(HBV), in adults. It is not known if Viread is safe and effective for
treatment of
HBV in children under the age of 18 years.
THERAPEUTIC GROUP: Antiviral for systemic use; nucleoside and
nucleotide reverse
transcriptase inhibitors.
Viread contains the active substance _tenofovir disoproxil_. This
active substance is an
_antiretroviral_ or antiviral medicine which is used to treat HIV or
HBV infection or both.
Tenofovir is a _nucleotide reverse transcriptase inhibitor_, generally
known as an NRTI
and works by interfering with the normal workin

পণ্য বৈশিষ্ট্য

1
VIREAD
®
Tenofovir disoproxil (as fumarate)
Film-coated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Viread
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
fumarate).
Excipient with known effect
Each tablet contains 156 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm
x 10.3 mm, debossed on one
side with “GILEAD” and “4331” and on the other side with
“300”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_HIV-1 infection _
Viread is indicated in combination with other antiretroviral medicinal
products for the treatment of
HIV-1 infected adults and paediatric patients 12 years of age and
older.
The choice of Viread to treat antiretroviral experienced patients with
HIV-1 infection should be based
on individual viral resistance testing and/or treatment history of
patients.
_Hepatitis B infection_
Viread is indicated for the treatment of chronic hepatitis B in adults
with:
•
compensated liver disease, with evidence of active viral replication,
persistently elevated serum
alanine aminotransferase (ALT) levels and histological evidence of
active inflammation and/or
fibrosis (see section 5.1).
•
decompensated liver disease (see sections 4.4, 4.8 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection and/or
treatment of chronic hepatitis B.
2
Posology
_HIV-1 _
_Adults and adolescents aged 12 to < 18 years and weighing ≥ 35 kg:
_
The recommended dose of Viread for the treatment of HIV or for the
treatment of chronic hepatitis B
is 245 mg (one tablet) once daily taken orally with food.
_Chronic hepatitis B_
_Adults_
The recommended dose of Viread for the treatment of HIV or for the
treatment of chronic hepatitis B
is 245 mg (one tablet) once daily taken orally with food.
Duration of therapy in adults w