Valdevon 200 mg/245 mg filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

Lähde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktiivinen ainesosa:

EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFUMARAAT 300 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk ; SAMENSTELLING overeenkomend met TENOFOVIR 136 mg/stuk

Saatavilla:

Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)

INN (Kansainvälinen yleisnimi):

EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFUMARAAT 300 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk ; SAMENSTELLING overeenkomend met TENOFOVIR 136 mg/stuk

Lääkemuoto:

Filmomhulde tablet

Koostumus:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171) ; ZETMEEL, GEPREGELATINEERD

Antoreitti:

Oraal gebruik

Valtuutus päivämäärä:

1900-01-01

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALDEVON 200 MG/245 MG FILMOMHULDE TABLETTEN
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 Valdevon is and what it is used for
2.
What you need to know before you take Valdevon
3.
How to take Valdevon
4.
Possible side effects
5.
How to store Valdevon
6.
Contents of the pack and other information
1.
WHAT VALDEVON IS AND WHAT IT IS USED FOR
VALDEVON 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.
•
VALDEVON 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.
_ _
•
This medicine should always be used combined with other medicines to
treat HIV infection.
•
This medicine can be administered in place of emtricitabine and
tenofovir disoproxil used
separately at the same doses.
PEOPLE WHO ARE HIV POSITIVE CAN STILL PASS ON HIV
whe

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valdevon 200 mg/245 mg filmomhulde tabletten
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 162 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 approx. 19 mm x9 mm debossed on
one side with 'H' and 'E44' on the other side with 'E44'.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Treatment of HIV-1 infection: _
Valdevon is indicated in antiretroviral combination therapy for the
treatment of HIV-1
infected adults (see section 5.1).
Valdevon 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):_
Valdevon 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
Valdevon 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 Valdevon. Please refer to the Summary of Product
Characteristics for these
medicinal products.
If a dose of emtricitabine/tenofovir disoproxil is missed within 1