COMBIVIR (lamivudine 150mg and zidovudine 300mg) tablet bottle

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

lamivudine, Quantity: 150 mg; zidovudine, Quantity: 300 mg

Saadav alates:

ViiV Healthcare Pty Ltd

Ravimvorm:

Tablet, film coated

Koostis:

Excipient Ingredients: magnesium stearate; sodium starch glycollate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; macrogol 4000

Manustamisviis:

Oral

Ühikuid pakis:

60 tablets

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Combivir is indicated for use alone or in combination with other antiretroviral therapies in the treatment of HIV infection.

Toote kokkuvõte:

Visual Identification: White to off-white film-coated, capsule-shaped, scored tablet engraved with "GXFC3" on both tablet face. Each tablet contains lamivudine 150 mg and zidovudine 300 mg; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

1998-01-23

Toote omadused

1
AUSTRALIAN PRODUCT INFORMATION
COMBIVIR (LAMIVUDINE AND ZIDOVUDINE)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Lamivudine and zidovudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMBIVIR Tablets are a fixed combination product containing lamivudine
150 mg and
zidovudine 300 mg in each tablet. Product information for 3TC (tablets
and oral solution) and
RETROVIR (capsules and syrup) contain additional information specific
for lamivudine and
zidovudine, respectively.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
COMBIVIR tablets are available as both scored and unscored tablets.
COMBIVIR unscored tablets are white to off-white capsule-shaped
film-coated tablets,
engraved with “GXFC3” on one tablet face.
COMBIVIR scored tablets are white to off-white capsule-shaped
film-coated tablets,
engraved with “GXFC3” on both tablet faces.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COMBIVIR is indicated for use alone or in combination with other
antiretroviral therapies in
the treatment of HIV infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
COMBIVIR may be administered with or without food. Food reduces the C
max
and extends
the T
max
of lamivudine but the amount of drug absorbed is not reduced. The
clinical
significance of this is not known (see Section 5.2 PHARMACOKINETIC
PROPERTIES).
For situations where discontinuation of therapy with one of the active
constituents of
COMBIVIR, or dose reduction is necessary, separate preparations of
lamivudine (3TC
tablets and oral solution) and zidovudine (RETROVIR Capsules and
Syrup) are available.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, the
tablet(s) may be crushed and
100% of the crushed tablet could be added to a small amount of
semi-solid food or liquid, all
of which should be consumed immediately (see Section 5.2
PHARMACOKINETIC
PROPERTIES).
2
The dosing regimens for paediatric patients weighing 14-30 kg is