ABALAMID HETERO 600/300 Abacavir (as sulfate) and Lamivudine 600mg/300mg tablets, PVC/PVdC-Alu blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamivudine, Quantity: 300 mg; abacavir sulfate, Quantity: 702.762 mg (Equivalent: abacavir, Qty 600 mg)

Available from:

Hetero Australia Pty Ltd

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sodium starch glycollate; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; sunset yellow FCF; polysorbate 80; macrogol 400

Administration route:

Oral

Units in package:

30's

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ABALAMID HETERO 600/300 tablets are a combinaton of two nucleoside analogues (abacavir and lamivudine). ABALAMID HETERO 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.

Product summary:

Visual Identification: Orange modified capsule shaped, biconvex film-coated tablets debossed with 'H' on one side and 'A1' on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-12-13

Patient Information leaflet

ABALAMID HETERO 600/300/06112018/V3
1
ABALAMID HETERO 600/300
TABLETS
_abacavir (as sulfate) and lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABALAMID HETERO 600/300, WHICH CONTAINS ABACAVIR, MAY
DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH ABALAMID HETERO 600/300 IS CONTINUED. CONTACT YOUR DOCTOR
IMMEDIATELY FOR
ADVICE ON WHETHER YOU SHOULD STOP TAKING ABALAMID HETERO 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 ABALAMID
HETERO 600/300
TABLETS, NEVER TAKE
ABALAMID HETERO 600/300, OR ANY OTHER MEDICINAL PRODUCT CONTAINING
ABACAVIR (KIVEXA,
TRIUMEQ, TRIZIVIR &
ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN
BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABALAMID HETERO 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 UNDER BEFORE
YOU TAKE
ABALAMID HETERO 600/300.
ABALAMID HETERO 600/300/06112018/V3
2
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start ABALAMID
HETERO 600/300 tablets.
This leaflet answers some common
questions about ABALAMID
HETERO 600/300 tablets. 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
ABALAMID HETERO 600/300
tablets 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 ABALAMID
HETERO 600/300
TABLETS ARE USED FOR
A