Abacavir/Lamivudine Hetero 600 mg/300 mg, filmomhulde tabletten

Ülke: Hollanda

Dil: Hollandaca

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

Aktif bileşen:

ABACAVIRSULFAAT SAMENSTELLING overeenkomend met ; ABACAVIR ; LAMIVUDINE 0-WATER

Mevcut itibaren:

Hetero Europe S.L.

ATC kodu:

J05AR02

INN (International Adı):

ABACAVIRSULFAAT COMPOSITION corresponding to ; ABACAVIR ; LAMIVUDINE 0-WATER

Farmasötik formu:

Filmomhulde tablet

Kompozisyon:

CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; 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) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

Uygulama yolu:

Oraal gebruik

Terapötik alanı:

Lamivudine And Abacavir

Ürün özeti:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Yetkilendirme tarihi:

2018-06-04

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
Abacavir/Lamivudine Hetero 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 HETERO CONTAINS ABACAVIR (which is also an active
substance in medicines
such as ABACAVIR, ABACAVIR/LAMIVUDINE/ZIDOVUDINE and
ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE). 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 Hetero 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 Hetero is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine Hetero
3.
How to take Abacavir/Lamivudine Hetero
4.
Possible side effects
5.
How to store Abacavir/Lamivudine Hetero
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE HETERO IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE HETERO IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION IN
ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG.
Abacavir/Lamivudine Hetero contains two active ingredients that are
used to treat HIV infection:
abacavir and lamivudine. These belong to a group of anti-retro

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine Hetero 600 mg/300 mg,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg lamivudine.
Excipient(s) with known effect: sunset yellow FCF (E110) 1.14 mg per
tablet.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange, modified capsule shaped, biconvex film-coated tablet
(approximately 20.6 x 8.6 mm),
debossed with “H” on one side and “A1” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir/Lamivudine Hetero 600 mg/300 mg film-coated tablets 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 Hetero 600 mg/300 mg
film-coated tablets is one
tablet once daily.
_Children Under 25 kg: _
Abacavir/Lamivudine Hetero 600 mg/300 mg film-coated tablets 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 Hetero 600 mg/300 mg film-coated tablets 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
indicated. In these cases the phy