Truvada

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

emtricitabine, tenofovir disoproxil fumarate

Διαθέσιμο από:

Gilead Sciences Ireland UC

Φαρμακολογική κατηγορία (ATC):

J05AR03

INN (Διεθνής Όνομα):

emtricitabine, tenofovir disoproxil

Θεραπευτική ομάδα:

Antivirals for systemic use

Θεραπευτική περιοχή:

HIV Infections

Θεραπευτικές ενδείξεις:

Treatment of HIV-1 infection: , Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults., Truvada is 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. , Pre-exposure prophylaxis (PrEP): , Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Περίληψη προϊόντος:

Revision: 46

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2005-02-20

Φύλλο οδηγιών χρήσης

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRUVADA 200 MG/245 MG FILM-COATED TABLETS
emtricitabine/tenofovir disoproxil
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 Truvada is and what it is used for
2.
What you need to know before you take Truvada
3.
How to take Truvada
4.
Possible side effects
5.
How to store Truvada
6.
Contents of the pack and other information
1.
WHAT TRUVADA IS AND WHAT IT IS USED FOR
TRUVADA CONTAINS TWO ACTIVE SUBSTANCES, _emtricitabine _
and
_tenofovir disoproxil_
. Both of these
active substances are
_antiretroviral_
medicines which are used to treat HIV infection. Emtricitabine is
a
_nucleoside reverse transcriptase inhibitor _
and tenofovir is a
_nucleotide reverse transcriptase _
_inhibitor._
However, both are generally known as NRTIs and they work by
interfering with the normal
working of an enzyme (reverse transcriptase) that is essential for the
virus to reproduce itself.
•
TRUVADA IS USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1)
INFECTION IN ADULTS
•
IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18
YEARS WHO WEIGH AT LEAST
35 KG,
and who have already been treated with other HIV medicines that are no
longer effective
or have caused side effects.
−
Truvada should always be used combined with other medicines to treat
HIV infection.
−
Truvada can be administered in place of emtricitabine and tenofovir
disoproxil used
separately at the same doses.
THIS MEDICINE IS NOT A CURE FOR HIV INFECTION.
While taking T

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Truvada 200 mg/245 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil
(equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of
tenofovir).
Excipient with known effect
Each tablet contains 91 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule-shaped, film-coated tablet, of dimensions 19 mm x 8.5
mm, debossed on one side with
“GILEAD” and on the other side with “701”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection: _
Truvada is indicated in antiretroviral combination therapy for the
treatment of HIV-1 infected adults
(see section 5.1).
Truvada is also indicated for the treatment of HIV-1 infected
adolescents, with NRTI resistance or
toxicities precluding the use of first line agents (see sections 4.2,
4.4 and 5.1).
_Pre-exposure prophylaxis (PrEP): _
Truvada is indicated in combination with safer sex practices for
pre-exposure prophylaxis to reduce
the risk of sexually acquired HIV-1 infection in adults and
adolescents at high risk (see sections 4.2,
4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Truvada should be initiated by a physician experienced in the
management of HIV infection.
Posology
Treatment
_of HIV in adults and adolescents aged 12 years and older, weighing at
least 35 kg:_
One
tablet, once daily.
_Prevention of HIV in adults and adolescents aged 12 years and older,
weighing at least 35 kg:_
One
tablet, once daily.
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of HIV-1
infection if it becomes necessary to discontinue or modify the dose of
one of the components of
Truvada. Please refer to the Summary of Product Characteristics for
these medicinal products.
3
If a dose of Truvada is missed within 12 hours of the time it is
usual