ABACAVIR/LAMIVUDINE MYLAN abacavir (as sulfate)/lamivudine 600 mg/300 mg film-coated tablet bottle

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

abacavir sulfate,lamivudine

Dostępny od:

Alphapharm Pty Ltd

Status autoryzacji:

Registered

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION
ABACAVIR/LAMIVUDINE MYLAN
_abacavir (as sulfate)/lamivudine film-coated tablets _
1
NAME OF THE MEDICINE
Abacavir sulfate and lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABACAVIR/LAMIVUDINE MYLAN is supplied as film-coated tablets each
containing 600 mg of abacavir
as abacavir sulfate and 300 mg lamivudine.
Excipients with known effect: sorbates
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ABACAVIR/LAMIVUDINE MYLAN is a white, film-coated, modified capsule
shaped, biconvex tablet
debossed with AL12 on one side of the tablet and M on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ABACAVIR/LAMIVUDINE MYLAN tablets are a combination of two nucleoside
analogues (abacavir and
lamivudine). ABACAVIR/LAMIVUDINE MYLAN is indicated in antiretroviral
combination therapy for the
treatment of Human Immunodeficiency Virus (HIV) infection in adults
and adolescents from 12 years of age.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
ABACAVIR/LAMIVUDINE MYLAN tablets should not be administered to adults
or adolescents who weigh
less than 40 kg because it is a fixed-dose tablet that cannot be dose
reduced.
ABACAVIR/LAMIVUDINE MYLAN tablets can be taken with or without food.
ABACAVIR/LAMIVUDINE
MYLAN
tablets
should
not
be
prescribed
for
patients
requiring
dosage
adjustments, such as those with creatinine clearance <50mL/min.
Separate preparations of abacavir or
lamivudine should be administered in cases where discontinuation or
dose adjustment is indicated. In these cases
the physician should refer to the individual product information for
these medicinal products.
ADULTS AND ADOLESCENTS
The recommended dose of ABACAVIR/LAMIVUDINE MYLAN tablets in adults
and adolescents is one tablet
once daily.
ABACAVIR, A COMPONENT OF ABACAVIR/LAMIVUDINE MYLAN TABLETS, IS
ASSOCIATED WITH HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CAS