Viread

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

tenofovir disoproxil fumarate

Tillgänglig från:

Gilead Sciences Ireland UC

ATC-kod:

J05AF07

INN (International namn):

tenofovir disoproxil

Terapeutisk grupp:

Antivirals for systemic use

Terapiområde:

Hepatitis B, Chronic; HIV Infections

Terapeutiska indikationer:

HIV 1 infectionViread 123 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 17 kg to less than 22 kg.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 infectionViread 123 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg, withcompensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.HIV 1 infectionViread 163 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 22 kg to less than 28 kg.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 infectionViread 163 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 22 kg to less than 28 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.HIV 1 infectionViread 204 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, aged 6 to < 12 years who weigh from 28 kg to less than 35 kg.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 infectionViread 204 mg film coated tablets are indicated for the treatment of chronic hepatitis B in paediatric patients aged 6 to < 12 years who weigh from 28 kg to less than 35 kg, with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.HIV 1 infectionViread 245 mg film coated tablets are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults.In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).Viread 245 mg film coated tablets are also indicated for the treatment of HIV 1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.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 infectionViread 245 mg film coated tablets are 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).evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).Viread 245 mg film coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with:compensated liver disease and evidence of immune active disease, i.e. active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.HIV 1 infectionViread 33 mg/g granules are indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected paediatric patients, with NRTI resistance or toxicities precluding the use of first line agents, from 2 to < 6 years of age, and above 6 years of age for whom a solid dosage form is not appropriate.Viread 33 mg/g granules are also indicated in combination with other antiretroviral medicinal products for the treatment of HIV 1 infected adults for whom a solid dosage form is not appropriate.In adults, the demonstration of the benefit of Viread in HIV 1 infection is based on results of one study in treatment naïve patients, including patients with a high viral load (> 100,000 copies/ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ml, with the majority of patients having < 5,000 copies/ml).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 infectionViread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate 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).evidence of lamivudine resistant hepatitis B virus (see sections 4.8 and 5.1).decompensated liver disease (see sections 4.4, 4.8 and 5.1).Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in paediatric patients2 to < 18 years of age for whom a solid dosage form is not appropriate with:compensated liver disease and evidence of immune active disease, i.e. active viral replication, and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.  With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, 4.8 and 5.1.

Produktsammanfattning:

Revision: 58

Bemyndigande status:

Authorised

Tillstånd datum:

2002-02-04

Bipacksedel

220
B. PACKAGE LEAFLET
221
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIREAD 123 MG FILM-COATED TABLETS
tenofovir disoproxil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS 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 child’s doctor or
pharmacist.
-
This medicine has been prescribed for your child only. Do not pass it
on to others. It may harm
them, even if their signs of illness are the same as your child’s.
-
If your child gets any side effects, talk to your child’s doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Viread is and what it is used for
2.
What you need to know before your child takes Viread
3.
How to take Viread
4.
Possible side effects
5.
How to store Viread
6.
Contents of the pack and other information
1.
WHAT VIREAD IS AND WHAT IT IS USED FOR
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
working of an enzyme (in HIV
_reverse transcriptase_
, in hepatitis B
_DNA polymerase_
) that are
essential for the viruses to reproduce themselves. In HIV Viread
should always be used combined
with other medicines to treat HIV infection.
VIREAD 123 MG TABLETS ARE A TREATMENT FOR HIV
(Human Immunodeficiency Virus) infection.
Viread 123 mg tablets are for use in children. They are only suitable
for:
•
CHILDREN AGED 6 TO LESS THAN 12 YEARS
•
WHO WEIGH FROM 17 KG TO LESS THAN 22 KG
•
WHO HAVE ALREADY BEEN TREATED
with other HIV medicines which are no longer fully effective
due to development of resistance, or have caused side effects.
VIREAD 123 MG TABLETS ARE ALSO A TREATMENT FOR CHRONIC HEPATITIS B, AN
INFECTION WITH H

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Viread 123 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 123 mg of tenofovir disoproxil (as
fumarate).
Excipient with known effect
Each tablet contains 78 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White, triangle-shaped, film-coated tablets, 8.5 mm in diameter,
debossed on one side with “GSI” and
on the other side with “150”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_HIV-1 infection _
Viread 123 mg film-coated tablets are indicated in combination with
other antiretroviral medicinal
products for the treatment of HIV-1 infected paediatric patients, with
NRTI resistance or toxicities
precluding the use of first line agents, aged 6 to < 12 years who
weigh from 17 kg to less than 22 kg.
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 123 mg film-coated tablets are indicated for the treatment of
chronic hepatitis B in paediatric
patients aged 6 to < 12 years who weigh from 17 kg to less than 22 kg,
with:
•
compensated liver disease and evidence of immune active disease, i.e.
active viral replication
and persistently elevated serum ALT levels, or histological evidence
of moderate to severe
inflammation and/or fibrosis. With respect to the decision to initiate
treatment in paediatric
patients, see sections 4.2, 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.
Posology
_HIV-1 and Chronic hepatitis B _
The recommended dose for the treatment of HIV-1 infection and chronic
hepatitis B in paediatric
patients aged 6 to < 12 years weighing 17 kg to < 22 kg who are able
to swallow film-coat