ABACAVIR/LAMIVUDINE 600/300 APOTEX abacavir 600mg (as sulfate) and lamivudine 300mg tablets bottle

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

lamivudine, Quantity: 300 mg; abacavir sulfate, Quantity: 702.76 mg (Equivalent: abacavir, Qty 600 mg)

Prieinama:

Arrotex Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

Abacavir sulfate,Lamivudine

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: hypromellose; titanium dioxide; sunset yellow FCF aluminium lake; macrogol 8000; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose

Vartojimo būdas:

Oral

Vienetai pakuotėje:

30

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

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

Produkto santrauka:

Visual Identification: Orange coloured, modified capsule-shaped, biconvex film-coated tablets with engraved "APO" on one side and "600/300" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2016-08-03

Pakuotės lapelis

ABACAVIR/LAMIVUDINE
600/300 APOTEX TABLET
_Contains the active ingredients abacavir (as sulfate) and lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, WHICH
CONTAINS
ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC
REACTION) WHICH
CAN BE LIFE-THREATENING IF TREATMENT WITH THIS MEDICINE IS CONTINUED.
CONTACT YOUR
DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING
ABACAVIR AND
LAMIVUDINE COMBINATION TABLETS 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 GENERAL ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR AND
LAMIVUDINE
COMBINATION TABLETS, NEVER TAKE ABACAVIR AND LAMIVUDINE, OR ANY OTHER
MEDICINAL
PRODUCT CONTAINING ABACAVIR, AS YOU MAY DEVELOP A LIFE THREATENING
REACTION WHICH
CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR AND LAMIVUDINE 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
ABACAVIR AND LAMIVUDINE.
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about abacavir and
lamivudine combination tablets. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apo

Prekės savybės

1
AUSTRALIAN PRODUCT INFORMATION
ABACAVIR/LAMIVUDINE 600/300 APOTEX
(ABACAVIR SULFATE AND LAMIVUDINE) TABLET
WARNING:
ABACAVIR,
A
COMPONENT
OF
ABACAVIR
AND
LAMIVUDINE
COMBINATION
TABLETS,
IS
ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE
LIFE-THREATENING, AND IN RARE CASES FATAL.
ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, OR ANY OTHER MEDICINAL
PRODUCT CONTAINING
ABACAVIR, MUST NEVER BE RESTARTED FOLLOWING A HYPERSENSITIVITY
REACTION (SEE SECTIONS 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS
(UNDESIRABLE EFFECTS)).
1
NAME OF THE MEDICINE
Abacavir (as sulfate) and lamivudine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg abacavir (as sulfate) and 300 mg
lamivudine as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Orange coloured, modified capsule-shaped, biconvex film-coated tablet
with engraved “APO”
on one side and “600/300” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir and lamivudine combination tablets are a combination of two
nucleoside analogues
(abacavir and lamivudine).
Abacavir and lamivudine combination tablets are 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
Abacavir/Lamivudine 600/300 APOTEX tablets are intended for oral
administration.
DOSAGE
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Abacavir
and
lamivudine combination 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.
Abacavir and lamivudine combination tablets can be taken with or
without food.
2
Abacavir and lamivudine combination tablets should not be prescribed
for patients requiring
dosage
adjustments,
such
as
those
with
creatinine
clearance
< 50
mL/min.
Separate
preparations of abaca