TRIZIVIR abacavir sulfate with lamivudine and zidovudine tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

abacavir sulfate, Quantity: 351 mg (Equivalent: abacavir, Qty 300 mg); zidovudine, Quantity: 300 mg; lamivudine, Quantity: 150 mg

Dostupno od:

ViiV Healthcare Pty Ltd

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: magnesium stearate; sodium starch glycollate type A; microcrystalline cellulose; purified water; titanium dioxide; hypromellose; indigo carmine; iron oxide yellow; macrogol 400

Administracija rute:

Oral

Jedinice u paketu:

60 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Trizivir is indicated in antiretroviral therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents over the age of 12 years. Trizivir should not be administered to adults and adolescents who weigh less than 40kg because it is a fixed dose tablet, and the dose cannot be adjusted for this patient population.

Proizvod sažetak:

Visual Identification: Blue-green film coated modified capsule-shaped tablet, engraved with 'GX LL1' on one side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2001-06-06

Uputa o lijeku

TRIZIVIR
FILM COATED TABLETS
_abacavir (as sulfate), lamivudine and zidovudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING TRIZIVIR, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH TRIZIVIR IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON WHETHER
YOU SHOULD STOP TAKING TRIZIVIR 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 TRIZIVIR
TABLETS, NEVER TAKE
TRIZIVIR, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA,
TRIUMEQ,
ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN
BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE TRIZIVIR 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
TRIZIVIR.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start TRIZIVIR tablets.
This leaflet answers some common
questions about TRIZIVIR 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 risks and
benefits. Your doctor has weighed
the expected benefits of you taking
TRIZIVIR 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 MEDICINE.
You may need to read it again.
_HYPERSENSITIVITY_
_REACTION_
PATIENTS TAKING TRIZIVIR MAY
DEVELOP A HYPERSENSITIVITY REACTION
(SERIOUS ALLERGIC REACTION) WHICH
CAN BE LIFE-THREATENING IF YOU
CONTINUE TO TAKE TRIZIVIR. IT IS
IMPORTANT YOU READ THE
INFORMATION ON THIS REACTION IN THE
SECTION "SPECIAL WARNING"

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION
TRIZIVIR (ABACAVIR, LAMIVUDINE AND ZIDOVUDINE) FILM-COATED TABLETS
ABACAVIR, A COMPONENT OF TRIZIVIR TABLETS, IS ASSOCIATED WITH
HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL.
TRIZIVIR, OR ANY OTHER
MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, ZIAGEN AND TRIUMEQ),
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 sulfate), lamivudine and zidovudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIZIVIR tablets are a fixed combination product containing abacavir
(as sulfate) 300 mg,
lamivudine 150 mg and zidovudine 300 mg in each tablet. Product
information for ZIAGEN
(abacavir (as sulfate) tablets and oral solution), 3TC (lamivudine
tablets and oral solution)
and RETROVIR (zidovudine capsules and syrup) contain additional
information.
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.
Zidovudine is a white to off-white, odourless, crystalline solid.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TRIZIVIR tablets are blue/green capsule-shaped film-coated tablets,
engraved with “GX LL1”
on one tablet face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRIZIVIR is indicated in antiretroviral therapy for the treatment of
Human Immunodeficiency
Virus (HIV) infected adults and adolescents over the age of 12 years.
TRIZIVIR should not
be administered to adults and adolescents who weigh less than 40 kg
because it is a fixed-
dose tablet, and the dose cannot be adjusted for this patient
population.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS
The recommended dose of TRIZIVIR in adults is one tablet twice daily,
giving a total daily
2
dose of 600 mg abacavir, 300 mg lamivudine a