Abacavir/Lamivudine DOC Generici, 600 mg/300 mg filmomhulde tabletten

Maa: Alankomaat

Kieli: hollanti

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

Aktiivinen ainesosa:

ABACAVIR ; LAMIVUDINE 0-WATER

Saatavilla:

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

ATC-koodi:

J05AR02

INN (Kansainvälinen yleisnimi):

ABACAVIR ; LAMIVUDINE 0-WATER

Lääkemuoto:

Filmomhulde tablet

Koostumus:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 90 (E 1201) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 90 (E 1201) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

Antoreitti:

Oraal gebruik

Terapeuttinen alue:

Lamivudine And Abacavir

Tuoteyhteenveto:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 90 (E 1201); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Valtuutus päivämäärä:

2016-04-07

Pakkausseloste

Apr 2016: MA in NL; Dec 2016: approval var. 03; proposed var. 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ABACAVIR/LAMIVUDINE DOC GENERICI 600 MG/300 MG FILMOMHULDE TABLETTEN
abacavir/lamivudine
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.
_ _
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE DOC GENERICI CONTAINS ABACAVIR (which is also an
active substance in medicines
such as TRIZIVIR, TRIUMEQ AND ZIAGEN). Some people who take abacavir
may develop a HYPERSENSITIVITY
REACTION (a serious allergic reaction), which can be life-threatening
if they continue to take abacavir
containing products.
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE PANEL IN SECTION
4.
The Abacavir/Lamivudine DOC Generici pack includes an ALERT CARD, to
remind you and medical staff
about abacavir hypersensitivity. DETACH THIS CARD AND KEEP IT WITH YOU
AT ALL TIMES._ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Abacavir/Lamivudine DOC Generici is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine DOC Generici
3.
How to take Abacavir/Lamivudine DOC Generici
4.
Possible side effects
5.
How to store Abacavir/Lamivudine DOC Generici
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE DOC GENERICI IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE DOC GENERICI IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG.
Abacavir/Lamivudine DOC Generici contains two active ingredients that
are us

Valmisteyhteenveto

Apr 2016: MA in NL; Dec 2016: approval var. 03; Set 2017: approval
var. 06; proposed var. 11
1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine DOC Generici, 600 mg/300 mg filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir and 300 mg
lamivudine
Excipient(s) with known effect:
Sunset Yellow FCF Aluminium Lake (E110) 1.86 mg per tablet.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange, film-coated, modified capsule shaped tablets. The dimensions
of the tablets are 19.4
mm x 10.4 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir/Lamivudine DOC Generici is indicated in antiretroviral
combination therapy for the
treatment of Human Immunodeficiency Virus (HIV) infection in adults,
adolescents and
children weighing at least 25 kg (see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele
should be performed in any HIV-infected patient, irrespective of
racial origin (see section
4.4). Abacavir should not be used in patients known to carry the
HLA-B*5701 allele.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV
infection.
Posology
_Adults, adolescents and children weighing at least 25 kg: _
The recommended dose of Abacavir/Lamivudine DOC Generici is one tablet
once daily.
_Children Under 25 kg: _
Abacavir/Lamivudine DOC Generici should not be administered to
children who weigh less
than 25 kg because it is a fixed-dose tablet that cannot be dose
reduced.
Abacavir/Lamivudine DOC Generici is a fixed-dose tablet and should not
be prescribed for
patients requiring dose adjustments. Separate preparations of abacavir
or lamivudine are
available in cases where discontinuation or dose adjustment of one of
the active substances is
Apr 2016: MA in NL; Dec 2016: approval var. 03; Set 2017: approval
var. 06; proposed var. 11
2
in