TRUVADA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

EMTRICITABINE; TENOFOVIR DISOPROXIL AS FUMARATE

متاح من:

GILEAD SCIENCES ISRAEL LTD

ATC رمز:

J05AF07

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

EMTRICITABINE 200 MG; TENOFOVIR DISOPROXIL AS FUMARATE 245 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GILEAD SCIENCES IRELAND UC, IRELAND

المجموعة العلاجية:

TENOFOVIR DISOPROXIL

المجال العلاجي:

TENOFOVIR DISOPROXIL

الخصائص العلاجية:

Truvada is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age.Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk .

تاريخ الترخيص:

2021-05-31

نشرة المعلومات

1
Patient leaflet in accordance with the Pharmacists’ (Products)
Regulations - 1986
This medicine is dispensed according to a physician’s prescription
only
TRUVADA
®
Film-coated tablets
Active ingredients: Each film-coated tablet contains –
emtricitabine
200 mg
tenofovir disoproxil
245 mg
(equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of
tenofovir)
Inactive agents and allergens: See section 6 “_Additional
information”_.
Read the entire leaflet carefully before using the medicine. This
leaflet contains summary
information about the medicine. If you have any other questions, refer
to the physician or the
pharmacist. This medicine has been prescribed for you only. Do not
pass it on to others. It may harm
them, even if their medical condition is similar to yours.
The medicine is intended for adults above the age of 18.
1.
What is Truvada intended for?
Truvada is a treatment for Human Immunodeficiency Virus (HIV)
infection in adults aged 18 years
and over, in combination with other anti-retroviral medicinal
products.
Therapeutic Group: Antiviral reverse transcriptase inhibitors.
Truvada 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.
•
Truvada is used to treat Human Immunodeficiency Virus 1 (HIV-1)
infection in adults aged
18 years and over.

Truvada should always be used combined with other medicines to treat
HIV infection.

Truvada can be administered in place of emtricitabine and tenofovir
disoproxil used
separately at the same doses.
This medicine is not a cure for HIV infection. While taking Truvada
you may still develop
infections or ot

خصائص المنتج

1
Truvada
®
(emtricitabine / tenofovir disoproxil)
Film-coated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Truvada
®
Patient safety information card
The marketing of Truvada is subject to a risk management plan (RMP)
including a 'Patient safety
information card'. The 'Patient safety information card', emphasizes
important safety information that
the patient should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of
tenofovir disoproxil
(equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of
tenofovir).
Excipient with known effect
Each tablet contains 96 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, capsule-shaped, film-coated tablet, of dimensions 19 mm x 8.5
mm, debossed on one side with
“GILEAD” and on the other side with “701”.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_Treatment of HIV-1 infection:_
Truvada is a fixed dose combination of emtricitabine and tenofovir
disoproxil fumarate. It is indicated
in combination with other anti-retroviral medicinal products for the
treatment of HIV-1 infected adults
over 18 years of age.
_Pre-exposure prophylaxis (PrEP):_
Truvada is indicated in combination with safer sex practices for
pre-exposure prophylaxis to reduce
the risk of sexually acquired HIV-1 infection in adults at high risk
(see sections 4.4 and 5.1).
4.2
Posology and method of administration
Truvada should be initiated by a physician experienced in the
management of HIV infection.
2
Posology
_Treatment or prevention of HIV in adults:_ One tablet, once daily.
Separate preparations of emtricitabine and tenofovir disoproxil are
available for treatment of HIV-1
infection if it becomes necessary to discontinue or modify the dose of
one of the components of
Truvada. Please refer to the Summary of Product Characteristics for