MACTRIVIR (EFAVIRENZ 600MG EMTRICITABINE 200MG & TENOFOVIR DISOPROXIL FUMARATE 300MG TABLETS)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Δραστική ουσία:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; EFAVIRENZ

Διαθέσιμο από:

SYNERRV SDN BHD

INN (Διεθνής Όνομα):

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; EFAVIRENZ

Μονάδες σε πακέτο:

30 Tablets

Κατασκευάζεται από:

Macleods Pharmaceuticals Ltd

Φύλλο οδηγιών χρήσης

MACTRIVIR
_Consumer Medication Information Leaflet (RiMUP) _
Efavirenz 600 mg, Emtricitabine 200 mg & Tenofovir Disoproxil Fumarate
300 mg Tablets
Page 1 of 5
WHAT IS IN THIS LEAFLET?
1.
What Mactrivir is used for
2.
How Mactrivir works
3.
Before you use Mactrivir
4.
How to use Mactrivir
5.
While you are using Mactrivir
6.
Side effects
7.
Storage and Disposal of Mactrivir
8.
Product Description
9.
Manufacturer and
Product
Registration Holder
10.
Date of Revision
1.
WHAT MACTRIVIR IS USED FOR:
Mactrivir is a treatment for Human
Immunodeficiency
Virus
(HIV)
infection in adults and adolescents.
2.
HOW MACTRIVIR WORKS
Mactrivir
contains
three
active
substances, efavirenz, emtricitabine and
tenofovir
disoproxil
fumarate.
These
active
substances
are
antiretroviral
medicines which are used to treat HIV
infection. Emtricitabine is a nucleoside
reverse transcriptase inhibitor (NRTI).
Efavirenz is a non-nucleoside reverse
transcriptase
inhibitor
(NNRTI).
Tenofovir
is
a
nucleotide
reverse
transcriptase inhibitor (NtRTI). Each of
these active substances, also known as
antiretroviral
medicines,
work
by
interfering
with
an
enzyme
(reverse
transcriptase) that is essential for the
virus to multiply.
3.
BEFORE YOU USE MACTRIVIR
_- When you must not use it _
•
If you are allergic (hypersensitive) to
efavirenz,
emtricitabine,
tenofovir
disoproxil fumarate or any of the other
ingredients of Mactrivir.
•
if you have severe liver disease.
•
if you have a heart condition, such as
an
abnormal
electrical
signal
called
prolongation
of
the
QT
interval
that
puts you at high risk for severe heart
rhythm problems (Torsade de Pointes).
•
if
any
member
of
your
family
(parents,
grandparents,
brothers
or
sisters) has died suddenly due to a
heart problem or was born with heart
problems.
•
if your doctor has told you that you
have high or low levels of electrolytes
such
as
potassium
or
magnesium
in
your blood.
•
if you are currently taking any of the
following medicines
- astemizole or terfenadine (used to
treat hay fever or other aller

Αρχείο Π.Χ.Π.

MACTRIVIR
EFAVIRENZ 600 MG , EMTRICITABINE 200 MG & TENOFOVIR DISOPROXIL
FUMARATE 300 MG TABLETS
MACLEODS PHARMACEUTICALS LTD.
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
MACTRIVIR
EFAVIRENZ 600 MG , EMTRICITABINE 200 MG & TENOFOVIR
DISOPROXIL FUMARATE 300 MG TABLETS
COMPOSITION
Each film coated tablet contains:
Efavirenz USP….600 mg
Emtricitabine….200 mg
Tenofovir Disoproxil Fumarate…….. 300 mg equivalent to Tenofovir
Disoproxil…..245 mg
PRODUCT DESCRIPTION
Pink Capsule shaped biconvex film coated tablets debossed “CL
81“on one side and plain on other side.
PHARMACOLOGICAL ACTION:
PHARMACOKINETICS:
_Absorption _
In HIV infected patients, peak efavirenz plasma concentrations were
attained by 5 hours and steady- state
concentrations reached in 6 to 7 days. Emtricitabine is rapidly
absorbed with peak plasma concentrations
occurring at 1 to 2 hours post-dose. Following oral administration of
a single 245 mg dose of tenofovir
disoproxil to HIV-1 infected patients in the fasted state, maximum
tenofovir concentrations were achieved within
one hour. The oral bioavailability of tenofovir from tenofovir
disoproxil in fasted patients was approximately
25%.
_Effect of food _
The fixed-dose combination of efavirenz/emtricitabine/tenofovir
disoproxil has not been evaluated in the
presence of food.
Efavirenz/Emtricitabine/Tenofovir Disoproxil is recommended for
administration on an empty stomach since
food may increase efavirenz exposure and may lead to an increase in
the frequency of adverse reactions .It is
anticipated that tenofovir exposure (AUC) will be approximately 30%
lower following administration of
Efavirenz/Emtricitabine/Tenofovir Disoproxil on an empty stomach as
compared to the individual component
MACTRIVIR
EFAVIRENZ 600 MG , EMTRICITABINE 200 MG & TENOFOVIR DISOPROXIL
FUMARATE 300 MG TABLETS
MACLEODS PHARMACEUTICALS LTD.
tenofovir disoproxil when taken with food .
_Distribution _
Efavirenz is highly bound (> 99%) to human plasma proteins,
predominantly album