TENOHOPE E (EMTRICITABINE 200 MG & TENOFOVIR DISOPROXIL FUMARATE 300 MG TABLETS)

Riik: Malaisia

keel: inglise

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

Toimeaine:

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Saadav alates:

SYNERRV SDN BHD

INN (Rahvusvaheline Nimetus):

TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE

Ühikuid pakis:

30 Tablets

Valmistatud:

Macleods Pharmaceuticals Ltd

Infovoldik

1
TENOHOPE E (EMTRICITABINE 200MG &
TENOFOVIR DISOPROXIL FUMARATE 300MG
TABLETS)
Tenofovir Disoproxil Fumarate/Emtricitabine (300mg/200mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
WHAT IS IN THIS LEAFLET
1.
What
_Tenohope-E _
is used for
2.
How
_Tenohope-E _
works
_3._
_ _
Before you use
_Tenohope-E _
_4._
_ _
How to use
_Tenohope-E _
5.
While you are using it
6.
Side Effects
_7._
_ _
Storage and Disposal of
_Tenohope-E _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT _TENOHOPE-E _IS USED FOR
_Tenohope-E _
is indicated in
combination with other antiretroviral
agents for the treatment of HIV-1 in
adults.
HOW _TENOHOPE-E _WORKS _Tenohope-_
_E _
tablet contains two active
substances, emtricitabine and
tenofovir disoproxil. Both of these
active substances are
antiretroviral medicines which are
used to treat HIV infection.
Emtricitabine is a nucleoside reverse
transcriptase inhibitor and tenofovir
is a nucleotide reverse transcriptase
inhibitor. However, both are
generally known as NRTIs and they
work by interfering with the normal
working of an enzyme (reverse
transcriptase) that is essential for the
virus to reproduce itself.
BEFORE YOU USE _TENOHOPE-E _
_ _
-
_When you must not use it _
Do not take
_Tenohope-E _
If you are allergic (hypersensitive) to
emtricitabine, tenofovir, tenofovir
disoproxil fumarate, or any of the
other ingredients of
_Tenohope-E _
listed at the end of this leaflet. If this
applies to you, tell your doctor
immediately.
-
_Before you start use it _
Tell your doctor if you have had kidney
disease, or if tests have shown
problems with your kidneys.
_Tenohope-_
_E _
may affect your kidneys. Before
starting treatment, your doctor may
order blood tests to assess kidney
function. Your doctor may also
order blood tests during treatment to
monitor your kidneys and may
advise you to take the tablets less
often.
_Tenohope-E _
is not
recommended if you have severe
kidney disease or are receiving
haemodialysis.
_Tenohope-E _
is n

Toote omadused

TENOHOPE E
MACLEODS PHARMACEUTICALS LTD.
(Emtricitabine 200 mg and Tenofovir Disoproxil Fumarate 300 mg
Tablets)
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
TENOHOPE E
(Emtricitabine 200mg and Tenofovir Disoproxil Fumarate 300mg Tablets)
COMPOSITION
Each film coated tablet contains:
Emtricitabine…………………….200mg
Tenofovir disoproxil fumarate......300mg
equivalent to Tenofovir Disoproxil…..245mg
PRODUCT DESCRIPTION
Blue colored, Capsule shaped, biconvex, film coated tablets, debossed
with ‘L 24’ on one side of the tablet and plain
on other side.
PHARMACOLOGICAL ACTION
PHARMACOKINETICS
Absorption
Following oral administration of Tenohope E Tablet, emtricitabine and
tenofovir disoproxil are rapidly absorbed and
tenofovir disoproxil is converted to tenofovir. Maximum emtricitabine
and tenofovir concentrations are observed in
serum within 0.5 to 3.0 h of dosing in the fasted state.
Administration of Tenohope E with food resulted in a delay of
approximately three quarters of an hour in reaching maximum tenofovir
concentrations and increases in tenofovir
AUC and C
max
of approximately 35% and 15%, respectively, when administered with a
high fat or light meal,
compared to administration in the fasted state. In order to optimise
the absorption of tenofovir, it is recommended that
Tenohope E should preferably be taken with food.
Distribution
Following intravenous administration, the volume of distribution of
emtricitabine and tenofovir was approximately 1.4
L/kg and 800 mL/kg, respectively. After oral administration of
emtricitabine or tenofovir disoproxil, emtricitabine and
tenofovir are widely distributed throughout the body.
_In vitro_
binding of emtricitabine to human plasma proteins was <
4% and independent of concentration over the range of 0.02 to 200
µg/mL.
_In vitro_
protein binding of tenofovir to
plasma or serum protein was less than 0.7 and 7.2%, respectively, over
the tenofovir concentration range 0.01 to 25
µg/mL.
Biotransformation
There is limited