ABACAVIR/LAMIVUDINE VIATRIS abacavir (as sulfate)/lamivudine 600 mg/300 mg film-coated tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

lamivudine, Quantity: 300 mg; abacavir sulfate, Quantity: 702.78 mg

Inapatikana kutoka:

Alphapharm Pty Ltd

Dawa fomu:

Tablet, film coated

Tungo:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate; silicified microcrystalline cellulose; purified talc; crospovidone; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

30

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

Visual Identification: A white, film-coated, modified capsule shaped, biconvex tablet debossed with AL12 on one side of the tablet and M on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2017-11-17

Taarifa za kipeperushi

ABACAVIR/LAMIVUDINE
MYLAN
_abacavir (as sulfate) and lamivudine_
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ABACAVIR/LAMIVUDINE MYLAN, WHICH CONTAINS ABACAVIR,
MAY DEVELOP A
HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE
LIFE-THREATENING
IF TREATMENT WITH ABACAVIR/LAMIVUDINE MYLAN IS CONTINUED. CONTACT YOUR
DOCTOR
IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING
ABACAVIR/LAMIVUDINE
MYLAN 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
ABACAVIR/LAMIVUDINE MYLAN
TABLETS, NEVER TAKE ABACAVIR/LAMIVUDINE MYLAN, OR ANY OTHER MEDICINAL
PRODUCT
CONTAINING ABACAVIR AGAIN AS YOU MAY DEVELOP A LIFE THREATENING
REACTION WHICH CAN
BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE MYLAN 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/LAMIVUDINE MYLAN.
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start ABACAVIR/
LAMIVUDINE MYLAN tablets.
This leaflet answers some common
questions about ABACAVIR/
LAMIVUDINE MYLAN 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 benefits and
risks. Your doctor has weighed the
expected benefits of you taking
ABACAVIR/LAMIVUDINE
MYLAN 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 TABLETS.
You may need to read it again.
WHAT ABACAVIR/
LAMIVUDINE MYLAN
TABLETS ARE USED FOR
ABACAVIR/LAMIVUDINE
MYLAN tablets contain abacavir and
lamivudine which belong to a group
of med

Tabia za bidhaa

AUSTRALIAN PRODUCT INFORMATION
ABACAVIR/LAMIVUDINE MYLAN
_abacavir (as sulfate)/lamivudine film-coated tablets _
1
NAME OF THE MEDICINE
Abacavir sulfate and lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ABACAVIR/LAMIVUDINE MYLAN is supplied as film-coated tablets each
containing 600 mg of abacavir
as abacavir sulfate and 300 mg lamivudine.
Excipients with known effect: sorbates
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ABACAVIR/LAMIVUDINE MYLAN is a white, film-coated, modified capsule
shaped, biconvex tablet
debossed with AL12 on one side of the tablet and M on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ABACAVIR/LAMIVUDINE MYLAN tablets are a combination of two nucleoside
analogues (abacavir and
lamivudine). ABACAVIR/LAMIVUDINE MYLAN 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.
ABACAVIR/LAMIVUDINE MYLAN 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/LAMIVUDINE MYLAN tablets can be taken with or without food.
ABACAVIR/LAMIVUDINE
MYLAN
tablets
should
not
be
prescribed
for
patients
requiring
dosage
adjustments, such as those with creatinine clearance <50mL/min.
Separate preparations of abacavir or
lamivudine should be administered in cases where discontinuation or
dose adjustment is indicated. In these cases
the physician should refer to the individual product information for
these medicinal products.
ADULTS AND ADOLESCENTS
The recommended dose of ABACAVIR/LAMIVUDINE MYLAN tablets in adults
and adolescents is one tablet
once daily.
ABACAVIR, A COMPONENT OF ABACAVIR/LAMIVUDINE MYLAN TABLETS, IS
ASSOCIATED WITH HYPERSENSITIVITY
REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CAS