CIPLA TENOFOVIR + EMTRICITABINE 300/200 Tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg tablet bottle pack

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

emtricitabine, Quantity: 200 mg; tenofovir disoproxil fumarate, Quantity: 300 mg

Доступна з:

Cipla Australia Pty Ltd

Фармацевтична форма:

Tablet, film coated

Склад:

Excipient Ingredients: microcrystalline cellulose; pregelatinised starch; croscarmellose sodium; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake

Адміністрація маршрут:

Oral

Одиниць в упаковці:

30 tablets

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Treatment of HIV-1 infection: CIPLA TENOFOVIR + EMTRICITABINE 300/200 is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents. Pre-exposure prophylaxis: CIPLA TENOFOVIR + EMTRICITABINE 300/200 is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.

Огляд продуктів:

Visual Identification: Blue coloured capsule shaped, biconvex film-coated tablet, plain on both sides; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизація:

Registered

Дата Авторизація:

2020-12-09

інформаційний буклет

CIPLA TENOFOVIR + EMTRICITABINE 300/200
_T_
_ABLETS _
_300 mg tenofovir disoproxil fumarate / 200 mg emtricitabine_
CONSUMER MEDICINE INFORMATION
WHA
T IS IN THIS LEAFLET
Read all of this leaflet
c
arefully before you start
taking this medicine.
This leaflet answers some of
the common questions about
CIPLA TENOFOVIR +
EMTRICITABINE 300/200.
It does not contain all of the
available information.
It does not take the place of
talking to your doctor or
pharmacist about your
medical condition or
treatment. If you have
further questions, please ask
your doctor or your
pharmacist.
Keep this leaflet with your
CIPLA TENOFOVIR +
EMTRICITABINE 300/200
medicine. You may need to
read it again.
WHAT CIPLA
TENOFOVIR +
EMTRICITABINE
300/200 IS USED FOR
_WHAT IS IT USED FOR_

to treat Hum
an
Im
munodeficiency
Virus-1 (HIV-1
)
infection in adults when
tak
en in combinatio
n
with
o
ther anti-HIV
medicines
;

to help reduce the risk
of getting HI
V infection
w
hen used with safer
sex practices in:

HIV-negativ
e men
wh
o have sex with
men, who are at
high
risk of get
ting
infected with HIV-1
through sex.

Male-female sex
partners when on
e
pa
rtner has HIV-
1
infection and the
othe
r does not.
_HOW CIPLA TENOFOVIR _
_+ EMTRICITABINE _
_300/200 WORKS_
CIPLA TENOFOVIR +
EMTRICITABINE 300/200
consists of two medicines
combined in one tablet:

tenofovir disoproxil
fum
arate, al
so called
tenofovir DF

emtricitabine or FTC
Thes
e are combined in one
tablet to help control Human
Immunodeficiency Virus
(HIV) infection.
CIPLA TENOFOVIR +
EMTRICITABINE 300/200
contains two active
ingredients that belong to a
group of antiviral medicines
known as nucleoside and
nucleotide reverse
transcriptase inhibitors
(NRTI).
_WHEN CIPLA _
_TENOFOVIR + _
_EMTRICITABINE 300/200 _
_IS USED TO TREAT HIV _
_INFECTION_
When used with other HIV-
1 medicines to treat HIV-1
infection, CIPLA
TENOFOVIR +
EMTRICITABINE 300/200
may help:

Reduce the amount of
HIV-1 in your blood.
This is called “viral
load”.

In
crease the number o
f
CD
4+

Характеристики продукта

AUSTR
ALIA PRODUCT INFORMATION – CIPLA TENOFOVIR + EMTRICITABINE
300/200
(TENOFOVIR DISOPROXIL FUMARATE AND EMTRICITABINE) TABLETS
1.
NAME OF THE MEDICINE
Tenofovir disoproxil fumarate/Emtricitab
ine
2.
QUA
LITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate
which is equivalent to 245
mg
of
tenofovir disoproxil and 200 mg emtricitabine.
Excipients with known effect: lactose.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARM
ACEUTICAL FORM
Film-coated tablets.
The tablets are blue, coloured capsule shaped, biconvex film-coated
tablet, plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of HIV-1 infection
CIPL
A TENOFOVIR + EMTRICITABINE 300/200 is indicated for the treatment of
HIV infected
adults over the age of 18 years, in combination with other
antiretroviral agents.
Pre-exposure prophylaxis
CIPL
A TENOFOVIR + EMTRICITABINE 300/200 is indicated in combination with
safer sex
practices for pre-exposure prophylaxis (PrEP) to reduce the risk of
sexually acquired HIV-1 in adults
at high risk. This indication is based on clinical trials in men who
have sex with men (MSM) at high
risk for HIV-1 infection and in heterosexual serodiscordant couples
(see section 5.1).
4.2
DOSE AND METHOD OF ADMINISTRATION
Recommended dose for treatment of HIV-1 infection
_Adults_
The recommended dose of CIPLA TENOFOVIR + EMTRICITABINE 300/200 is one
tablet
(containing 300 mg tenofovir disoproxil fumarate and 200 mg
emtricitabine), taken orally, once daily.
In order to optimise the absorption of tenofovir, it is recommended
that CIPLA TENOFOVIR +
EMTRICITABINE 300/200 should be taken with food.
Recommended dose for pre-exposure prophylaxis
_Adults_
The dose of CIPLA TENOFOVIR + EMTRICITABINE 300/200 in HIV-1
uninfected adults is one
tablet (containing 300 mg tenofovir disoproxil fumarate and 200 mg of
emtricitabine), taken orally,
once daily. In order to optimise the absorption of tenofovir, it is
recommended that CIPLA
TE