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

Country: Netherlands

Language: Dutch

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

Active ingredient:

ABACAVIR 600 mg/stuk ; LAMIVUDINE 0-WATER 300 mg/stuk

Available from:

Accord Healthcare B.V. Winthontlaan 200 3526 KV UTRECHT

ATC code:

J05AR02

INN (International Name):

ABACAVIR 600 mg/stuk ; LAMIVUDINE 0-WATER 300 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

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),

Administration route:

Oraal gebruik

Therapeutic area:

Lamivudine And Abacavir

Product summary:

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);

Authorization date:

2016-04-07

Patient Information leaflet

1
BIJSLUITER; INFORMATIE VOOR DE GEBRUIKER
ABACAVIR/LAMIVUDINE ACCORD 600MG/300MG, 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
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 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 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
1.
WHAT IS AND WHAT IT IS USED FOR
IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS)
INFECTION IN
ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST 25 KG
.
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 _
_analogue reverse transcriptase inhibitors (NRTIs)_
.
does not completely cure HIV infection; it reduces the
a

Summary of Product characteristics

Abacavir_lamivudine, NL/H/3488/001, 29.09.20
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAAM VAN HET GENEESMIDDEL
Abacavir/Lamivudine Accord 600mg/300mg, filmomhulde tabletten
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
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 is one tablet once daily.
_Children Under 25 kg_
should not be administered to children who weigh less
than 25 kg because it is a
fixed-dose tablet that cannot be dose reduced.

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.
Abacavir_lamivudine, NL/H/3488/001, 29.09.20
Special Populations
_Elderly_
No pharmacokinetic data are currently available in pat