ABACAVIR LAMIVUDINE TARO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ABACAVIR; LAMIVUDINE

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

J05AR02

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LAMIVUDINE 300 MG; ABACAVIR 600 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

REMEDICA LTD., CYPRUS

Therapeutic area:

LAMIVUDINE AND ABACAVIR

Therapeutic indications:

ABACAVIR LAMIVUDINE TARO is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.

Authorization date:

2020-06-14

Patient Information leaflet

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Abacavir Lamivudine Taro – ENG
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
The medicine is dispensed according to a physician’s prescription
only
Abacavir-Lamivudine Taro
Film-coated tablets
Active ingredients:
Each film-coated tablet contains:
600 mg abacavir
300 mg lamivudine
Inactive ingredients and allergens: see section 2 under ‘Important
information
about some of the ingredients of the medicine’ and section 6
‘Additional
information’.
Read the entire leaflet carefully before using the medicine. This
leaflet
contains concise information about the medicine. If you have any other
questions,
consult your physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar to yours.
IMPORTANT - Hypersensitivity reactions
Abacavir-Lamivudine Taro contains abacavir (which is also an active
ingredient in medicines such as Trizivir, Triumeq and Ziagen).
Some people who take abacavir may develop a hypersensitivity reaction
(a
serious allergic reaction), which can be life-threatening, if they
continue to take
products containing abacavir.
You must carefully read al l the information under ‘Hypersensitivity
reactions’ in the panel in section 4.
The Abacavir-Lamivudine Taro pack includes an alert card, to remind
you
and the medical staff about abacavir hypersensitivity. Detach this
card and
keep it with you at all times. This card contains important safety
information
that you must know and abide by before starting treatment and during
the
course of treatment with Abacavir-Lamivudine Taro. Read the alert card
and
patient leaflet before starting to use the medicine.
1.
What is the medicine intended for?
Abacavir-Lamivudine Taro is used to treat HIV (human immunodeficiency
syndrome) infection in adults, adolescents and in children weighing at
least 25 kg.
Therapeutic group:
Abacavir-Lamivudine Taro contains two active ingredients that are us

Summary of Product characteristics

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1.
NAME OF THE MEDICINAL PRODUCT
ABACAVIR LAMIVUDINE TARO
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg lamivudine.
Excipient(s) with known effect:
Each 600 mg/300 mg tablet contains 1.86 mg sunset yellow FCF (E110)
and 2.02 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange, film-coated, modified capsule shaped tablets.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
ABACAVIR LAMIVUDINE TARO is indicated in antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infection in adults, adolescents
and children weighing at least 25 kg
(see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be
performed in any HIV-infected patient, irrespective of racial origin
(see section 4.4). Abacavir should
not be used in patients known to carry the HLA-B*5701 allele.
4.2
Posology and method of administration
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children weighing at least 25 kg _
The recommended dose of ABACAVIR LAMIVUDINE TARO is one tablet once
daily.
_Children Under 25 kg _
ABACAVIR LAMIVUDINE TARO should not be administered to children who
weigh less than 25
kg because it is a fixed-dose tablet that cannot be dose reduced.
ABACAVIR LAMIVUDINE TARO is a fixed-dose tablet and should not be
prescribed for patients
requiring dose adjustments. Separate preparations of abacavir or
lamivudine are available in cases
where discontinuation or dose adjustment of one of the active
substances is indicated. In these cases,
the physician should refer to the individual product information for
these medicinal products.
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Special Populations
_Elderly _
No pharmacokinetic data are currently available in patients over 65
years of age. Special care is
advised in this age group due to age