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

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

ABACAVIR ; LAMIVUDINE 0-WATER

Dostupno od:

Pharos Pharmaceutical Oriented Services Ltd

ATC koda:

J05AR02

INN (International ime):

ABACAVIR ; LAMIVUDINE 0-WATER

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

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),

Administracija rute:

Oraal gebruik

Područje terapije:

Lamivudine And Abacavir

Proizvod sažetak:

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);

Datum autorizacije:

2016-04-07

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ABACAVIR/LAMIVUDINE PHAROS, 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
IMPORTANT — HYPERSENSITIVITY REACTIONS
ABACAVIR/LAMIVUDINE PHAROS CONTAINS ABACAVIR
(which is also an active substance in
other related medicines). 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 PharOS 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 PharOS is and what it is used for
2.
What you need to know before you take Abacavir/Lamivudine PharOS
3.
How to take Abacavir/Lamivudine PharOS
4.
Possible side effects
5.
How to store Abacavir/Lamivudine PharOS
6.
Contents of the pack and other information
1.
WHAT ABACAVIR/LAMIVUDINE PHAROS IS AND WHAT IT IS USED FOR
ABACAVIR/LAMIVUDINE PHAROS IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25
KG
.
Abacavir/Lamivudine PharOS contains two active ingredients that are
used to treat HIV
infection: abacavir and lamivudine. These belong to a group of
anti-retroviral medicines
called
_nucleoside

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Abacavir/Lamivudine PharOS 600 mg/300 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg abacavir and 300 mg lamivudine
Excipient 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.
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 PharOS 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 PharOS is one tablet once
daily.
2
_Children Under 25 kg: _
Abacavir/Lamivudine PharOS 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 PharOS 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 physician should refer to
the individual
product information for these medicinal products.
_Special Populations _
_Elderly:_
No pharmacokinetic data are currently available in patients over 65
years of age