TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

07-07-2021

Summary of Product characteristics (SPC)

12-11-2021

Public Assessment Report (PAR)

18-10-2017

Active ingredient:

abacavir sulfate, Quantity: 702 mg (Equivalent: abacavir, Qty 600 mg); lamivudine, Quantity: 300 mg; dolutegravir, Quantity: 50 mg

Available from:

ViiV Healthcare Pty Ltd

INN (International Name):

Abacavir sulfate,Dolutegravir,Lamivudine

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; purified water; mannitol; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in TRIUMEQ.

Product summary:

Visual Identification: Purple, biconvex, film coated oval tablets (approximately 22 x 11 mm), debossed with 572 Tri on one face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2015-01-14

Patient Information leaflet

TRIUMEQ
FILM-COATED TABLETS
_50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as
abacavir sulfate) / 300mg lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON WHETHER
YOU SHOULD STOP TAKING TRIUMEQ 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 TRIUMEQ
TABLETS, NEVER TAKE
TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA,
TRIZIVIR &
ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN
BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ 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
TRIUMEQ.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take TRIUMEQ. This
leaflet answers some common
questions about TRIUMEQ
(dolutegravir/abacavir/lamivudine). It
does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
TRIUMEQ 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 MEDICINE.
You may need to read it again.
WHAT IS TRIUMEQ
USED FOR?
TRIUMEQ contains three active
ingredients that are used to treat HIV
infection in adults and children over
12 years old: dolutegravir, abacavir,
and lamivudine. Dolutegravir
belongs to a group of anti-retroviral
medicines c

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
TRIUMEQ (DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE)
FILM-COATED TABLETS
ABACAVIR, A COMPONENT OF TRIUMEQ TABLETS, IS ASSOCIATED WITH
HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL.
TRIUMEQ TABLETS, OR
ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA
[ABACAVIR/LAMIVUDINE],
TRIZIVIR [ABACAVIR/LAMIVUDINE/ZIDOVUDINE] AND ZIAGEN [ABACAVIR]) 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
Dolutegravir (as sodium), abacavir (as sulfate) and lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIUMEQ film-coated tablets contain 50 mg of dolutegravir
(as dolutegravir sodium),
600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine.
Product Information for
TIVICAY (dolutegravir), ZIAGEN (abacavir), 3TC (lamivudine) and KIVEXA
(abacavir and
lamivudine) contain additional information.
Dolutegravir sodium is a white to light yellow powder and is slightly
soluble in water.
Abacavir sulfate is a white to off-white crystalline powder with a
solubility of approximately 77
mg/mL in water at 25°C.
Lamivudine is a white to off-white crystalline solid which is highly
soluble in water.
TRIUMEQ tablets also contain mannitol. For the full list of
excipients, see Section 6.1 LIST
OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Purple, film-coated, oval, biconvex tablets, debossed with ‘572
Trı’ on one side. Each film-
coated tablet contains 50 mg of dolutegravir (as dolutegravir sodium),
600 mg of abacavir
(as abacavir sulphate) and 300 mg of lamivudine.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus
(HIV) infection in
adults and adolescents from 12 years of age who are antiretroviral
treatment-naïve or are
infected with HIV without documented or clinically suspected
resistance to any of the three
antiretroviral agents (dolutegravir, abaca

Read the complete document