ABADINE 600/300 Abacavir (as sulfate) and Lamivudine 600 mg/300 mg tablets 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: microcrystalline cellulose; sodium starch glycollate; magnesium stearate; 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:

ABADINE 600/300 tablets are a combinaton of two nucleoside analogues (abacavir and lamivudine). ABADINE 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: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-12-13

Patient Information leaflet

ABADINE 600/300/08112018/V2
1
ABADINE 600/300 TABLETS
_abacavir (as sulfate) and lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABADINE 600/300, WHICH CONTAINS ABACAVIR, MAY DEVELOP
A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH ABADINE 600/300 IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR
ADVICE ON
WHETHER YOU SHOULD STOP TAKING ABADINE 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 ABADINE
600/300 TABLETS,
NEVER TAKE
ABADINE 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 ABADINE 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
ABADINE 600/300.
ABADINE 600/300/08112018/V2
2
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start ABADINE 600/300
tablets.
This leaflet answers some common
questions about ABADINE 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
ABADINE 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 ABADINE
600/300 TABLETS ARE
USED FOR
ABADINE 600/300 tablets contain
abacavir and lamivudine which
belong to a group of medicines
called antiretrovira