ABACAVIR/LAMIVUDINE GH 600/300 abacavir (as hydrochloride) 600 mg and lamivudine 300 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

abacavir hydrochloride monohydrate,lamivudine

Available from:

Lupin Australia Pty Limited

INN (International Name):

abacavir hydrochloride monohydrate,Lamivudine

Authorization status:

Registered

Patient Information leaflet

                                CONSUMER MEDICINE INFORMATION
ABACAVIR/LAMIVUDINE GH 600/300
(ABACAVIR HYDROCHLORIDE MONOHYDRATE AND LAMIVUDINE) FILM-COATED TABLET
PATIENTS TAKING ABACAVIR/LAMIVUDINE GH 600/300, WHICH CONTAINS
ABACAVIR, MAY
DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH
CAN BE LIFE-
THREATENING IF TREATMENT WITH ABACAVIR/LAMIVUDINE GH 600/300 IS
CONTINUED.
CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP
TAKING
ABACAVIR/LAMIVUDINE GH 600/300 IF:
1. YOU GET A SKIN RASH; OR
2. YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING
GROUPS:
-
FEVER;
-
SHORTNESS OF BREATH, SORE THROAT OR COUGH;
-
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN;
-
SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING.
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO
ABACAVIR/LAMIVUDINE GH
600/300, NEVER TAKE ABACAVIR/LAMIVUDINE GH 600/300, OR ANY OTHER
MEDICINAL PRODUCT
CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR OR ZIAGEN) AGAIN AS YOU MAY
DEVELOP A LIFE-
THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE GH 600/300
PACK, TO
REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS
CARD SHOULD
BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE
DETAILS BELOW
BEFORE YOU TAKE ABACAVIR/LAMIVUDINE GH 600/300.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start
Abacavir/Lamivudine GH
600/300.
This leaflet answers some
common questions about
Abacavir/Lamivudine GH
600/300. It does not contain all
of the available information.
It does not take the place of
talking to your doctor or
pharmacist (also known as a
chemist).
All medicines have benefits and
risks. Your doctor has weighed
the expected benefits of you
taking Abacavir/Lamivudine GH
600/300 against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
TABLETS.
You may need to read it again.
WHAT ABACAVIR/
LAMIVUDINE GH 600/300
IS USED FOR
Abacavir/L
                                
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Summary of Product characteristics

                                AUSTRALIAN PRODUCT INFORMATION –
ABACAVIR/LAMIVUDINE GH 600/300
(ABACAVIR (AS HYDROCHLORIDE MONOHYDRATE) AND LAMIVUDINE) TABLET, FILM
COATED
Abacavir, a component of ABACAVIR/LAMIVUDINE GH 600/300 (abacavir 600
mg and lamivudine 300
mg) tablet, is associated with hypersensitivity reactions, which can
be life-threatening, and in rare cases
fatal. ABACAVIR/LAMIVUDINE GH 600/300 (abacavir 600 mg and lamivudine
300 mg) tablets, or any
other medicinal product containing abacavir (KIVEXA®, TRIUMEQ®,
TRIZIVIR® and ZIAGEN®), MUST
NEVER be restarted following a hypersensitivity reaction (see SECTION
4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE and SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE
EFFECTS)).
1
NAME OF THE MEDICINE
Abacavir (as hydrochloride monohydrate) and lamivudine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABACAVIR/LAMIVUDINE GH 600/300 is supplied as film-coated tablets each
containing 600 mg of
abacavir as abacavir hydrochloride monohydrate and 300 mg lamivudine.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ABACAVIR/LAMIVUDINE GH 600/300 is an orange coloured, modified capsule
shaped, biconvex, film-
coated tablet debossed with “300” on one side and “600” on the
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ABACAVIR/LAMIVUDINE GH 600/300 is a combination of two nucleoside
analogues (abacavir and
lamivudine).
ABACAVIR/LAMIVUDINE
GH
600/300
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 GH 600/300 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 GH 600/300 v2.0
Page 2 of 21
(abacavir (as hydrochloride monohydrate) and lamivudine) tablet, film
coated
ABACAVIR/LAMI
                                
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