Tenofovirdisoproxil DOC Generici 245 mg filmomhulde tabletten

Pajjiż: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Disponibbli minn:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

Kodiċi ATC:

J05AF07

INN (Isem Internazzjonali):

TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TITAANDIOXIDE (E 171), 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 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; TITAANDIOXIDE (E 171),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Tenofovir Disoproxil

Sommarju tal-prodott:

Hulpstoffen: 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 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; TITAANDIOXIDE (E 171);

Data ta 'l-awtorizzazzjoni:

2016-04-28

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENOFOVIRDISOPROXIL DOC GENERICI 245 MG, FILMOMHULDE TABLETTEN
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
IF 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 AND WHAT IT IS USED FOR
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
enzymes (in HIV _reverse transcriptase_; in hepatitis B _DNA
polymerase_) that are essential for the viruses to
reproduce themselves. In HIV should always be used
combined with other medicines to treat
HIV infection.
245 MG TABLETS ARE A TREATMENT FOR HIV (Human
Immunodeficiency Virus) infection. The
tablets are suitable for:
•
ADULTS
•
ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO HAVE ALREADY BEEN
TREATED with other HIV medicines
which are no longer fully effective due to develop

Karatteristiċi tal-prodott

NL/H/3437/001/IA/009: Mar2020 - NL/H/3437/001/IB/010: Apr2020 -
NL/H/3437/001/R/001: Jan21; NL/H/3437/001/IA/014:
Mar21 – NL/H/3437/001/IB/017: Dec2022 – NL/H/3437/001/IB/019:
Mar24 – proposed var 20 PSUSA
1.
NAME OF THE MEDICINAL PRODUCT
Tenofovirdisoproxil DOC Generici 245 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
succinate).
Excipient with known effect:
Each tablet contains 105 mg lactose and 5,2 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light blue, almond-shaped, film-coated tablets, with dimensions of
approximately 17.0 mm x 10.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_HIV-1 infection_
TENOFOVIRDISOPROXIL DOC Generici 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 tenofovir 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
tenofovir 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).
TENOFOVIRDISOPROXIL DOC Generici 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 TENOFOVIRDISOPROXIL DOC Generici 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_
TENOFOVIRDISOPROXIL DOC Generici 245 mg film-coated tablets are
indicated for the treatment of
chronic hepatitis B in adults with:
•
compensated liver disease, with evidence