Abacavir Hexal 300 mg, filmomhulde tabletten

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

ABACAVIR 300 mg/stuk

Verfügbar ab:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-Code:

J05AF06

INN (Internationale Bezeichnung):

ABACAVIR 300 mg/stuk

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Abacavir

Produktbesonderheiten:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

Sandoz B.V.
Page 1/10
Abacavir Hexal 300 mg, filmomhulde tabletten
RVG 117143
1311-V8
1.3.1.3 Bijsluiter
November 2023
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABACAVIR HEXAL
® 300 MG, FILMOMHULDE TABLETTEN
abacavir
_ _
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
[NATIONALLY COMPLETED NAME] CONTAINS ABACAVIR
(which is also an active substance in medicines
such as
KIVEXA, TRIUMEQ
and
TRIZIVIR
). 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 [Nationally completed name] 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 [Nationally completed name]
is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION.
[NATIONALLY COMPLETED NAME]
contains the active ingredient abacavir. Abacavir belongs to a group
of
anti-retroviral medicines called
_nucleoside

Fachinformation

Sandoz B.V.
Page 1/21
Abacavir Hexal 300 mg, filmomhulde tabletten
RVG 117143
1311-V10
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abacavir Hexal 300 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of abacavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, capsule shaped, film-coated, biconvex tablets de bossed with
'H' on one side with score line
and 'A and 26' separated by score line on other side. (18.50 mm x 7.30
mm)
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated in antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infection in adults, adolescents
and children (see sections 4.4
and 5.1).
The demonstration of the benefit of abacavir is mainly based on
results of studies performed with a
twice daily regimen, in treatment-naïve adult patients on combination
therapy (see section 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
[Nationally completed name
]
should be prescribed by physicians experienced in the management of
HIV infection. [Nationally completed name] can be taken with or
without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
Sandoz B.V.
Page 2/21
Abacavir Hexal 300 mg, filmomhulde tabletten
RVG 117143
1311-V10
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
Abacavir may also be available as an oral solution for use in children
over three months of age and
weighing less than 14 kg and for those patients for whom the tablets
are inappropriate