KIVEXA abacavir 600 mg (as sulfate) and lamivudine 300 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

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

Boleh didapati daripada:

ViiV Healthcare Pty Ltd

Borang farmaseutikal:

Tablet, film coated

Komposisi:

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

Laluan pentadbiran:

Oral

Unit dalam pakej:

30 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

KIVEXA tablets are a combination of two nucleoside analogues (abacavir and lamivudine). KIVEXA is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age.

Ringkasan produk:

Visual Identification: Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2005-03-24

Risalah maklumat

KIVEXA
KIVEXA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
Important safety information on KIVEXA hypersensitivity reaction is
provided in the full CMI. Read before using this medicine.
1.
WHY AM I USING KIVEXA?
KIVEXA contains the active ingredients abacavir and lamivudine. KIVEXA
is used together with other antiretrovirals to slow down the
progression of human immunodeficiency virus (HIV) infection, which can
lead to Acquired Immune Deficiency Syndrome (AIDS) and
other related illnesses (eg AIDS-related Complex or ARC).
For more information, see Section 1. Why am I using KIVEXA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KIVEXA?
Do not use if you have ever had an allergic reaction to abacavir or
lamivudine or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
KIVEXA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with KIVEXA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE KIVEXA?
•
The normal dose for adults and adolescents is one tablet, once a day.
•
KIVEXA tablets should be swallowed whole with water.
•
KIVEXA tablets do not have to be taken with food.
More instructions can be found in Section 4. How do I use KIVEXA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KIVEXA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
KIVEXA.
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you are taking this medicine.
•
For as long as you're taking KIVEXA, your doctor will arrange regular
blood tests to check for side effects.
•
Keep in contact with your

Ciri produk

1
AUSTRALIAN PRODUCT INFORMATION
KIVEXA (ABACAVIR AND LAMIVUDINE)
FILM-COATED TABLETS
ABACAVIR, A COMPONENT OF KIVEXA TABLETS, IS ASSOCIATED WITH
HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL.
KIVEXA TABLETS, OR
ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (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 sulfate) and lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KIVEXA is supplied as film-coated tablets each containing 600 mg of
abacavir as abacavir
sulfate and 300 mg lamivudine.
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.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Orange, film-coated, modified capsule shaped tablets, debossed with GS
FC2 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KIVEXA tablets are a combination of two nucleoside analogues (abacavir
and lamivudine).
KIVEXA 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.
KIVEXA tablets 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.
KIVEXA tablets can be taken with or without food.
KIVEXA tablets should not be prescribed for patients requiring dosage
adjustments, such as
those with creatinine clearance < 30 mL/min. Separate preparations of
abacavir (ZIAGEN) or
2
lamivudine (3TC) should be administered in cases where discontinuation
or dose adjustment
is indicate