Descovy® (emtricitabine 200 mg tenofovir alafenamide 25 mg) film-coated tablets

Страна: Малайзия

Език: английски

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

Активна съставка:

EMTRICITABINE; Tenofovir alafenamide fumarate

Предлага се от:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Международно Name):

EMTRICITABINE; Tenofovir alafenamide fumarate

Броя в опаковка:

30 Tablets

Произведено от:

PATHEON INC

Листовка

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DESCOVY
® 200MG/10MG AND 200MG/25MG
FILM-COATED TABLETS
_EMTRICITABINE (200MG) AND TENOFOVIR ALAFENAMIDE (10MG), _
_EMTRICITABINE (200MG) AND TENOFOVIR ALAFENAMIDE (25MG) _
1
WHAT IS IN THIS LEAFLET?
1.
What Descovy is used for
2.
How Descovy works
3.
Before you take descovy
4.
How to use Descovy
5.
While you are using
Descovy
6.
Side effects
7.
Storage and disposal of
Descovy
8.
Product description
9.
Manufacturer
10.
Product RegistrationHolder
WHAT DESCOVY IS USED FOR
Descovy in combination with
other medicines is for the
TREATMENT OF HUMAN
IMMUNODEFICIENCY VIRUS 1
(HIV-1) INFECTION
in adults
and adolescents 12 years of age
and older, who weigh at least
35 kg.
HOW DESCOVY WORKS
Descovy contains two active
substances:
•
EMTRICITABINE,
an
antiretroviral medicine of a
type known as a
nucleoside reverse
transcriptase inhibitor
(NRTI)
•
TENOFOVIR ALAFENAMIDE,
an
antiretroviral medicine of a
type known as a nucleotide
reverse transcriptase
inhibitor (NtRTI)
Descovy blocks the action of
the reverse transcriptase
enzyme, which is essential for
the virus to multiply. Descovy
therefore reduces the amount
of HIV in your body.
BEFORE YOU TAKE DESCOVY
_-When you must not use it _
DO NOT TAKE DESCOVY:
•
IF YOU ARE ALLERGIC TO
EMTRICITABINE, TENOFOVIR
ALAFENAMIDE
or any of the
other ingredients of this
medicine (listed in
section 6 of this leaflet).
CHILDREN AND ADOLESCENTS
Do not give this medicine to
children
aged 11 years or
under, or weighing less than
35 kg. The use of Descovy in
children aged 11 years or under
has not yet been studied.
_-Before you start to use it _
WARNINGS AND PRECAUTIONS
You must remain under the
care of your doctor while
taking Descovy.
TALK TO YOUR DOCTOR BEFORE
TAKING DESCOVY:
•
IF YOU HAVE LIVER
PROBLEMS OR HAVE
SUFFERED LIVER DISEASE,
INCLUDING HEPATITIS.
Patients with liver disease
including chronic
hepatitis B or C, who are
treated with antiretrovirals,
have a higher risk of
severe and potentially fatal
liver complications. If you
have

Данни за продукта

1
DESCOVY ®
(200 mg/10 mg film -coated tablets emtricitabine/tenofovir alafenamide ) for oral use
(200 mg/25 mg film -coated tablets emtricitabine/tenofovir alafenamide) for oral use
FULL PRESCRIBING INFORMATION
1. NAME OF THE MEDICINAL PRODUCT
Descovy ® 200 mg /10 mg film -coated tablets
Descovy ® 200 mg/25 mg film -coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Descovy 200 mg/10 mg film -coated tablets
Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 10 mg
of tenofovir alafenamide .
Descovy 200 mg/25 mg film -coated tablets.
Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg
of tenof ovir alafenamide.
3. PHARMACEUTICAL FORM
Film -coated tablet.
Descovy 200 mg/10 mg film -coated tablets
Grey, rectangular -shaped, film -coated tablet debossed with “GSI” on one side and “210” on the other
side of the tablet .
Descovy 200 mg/25 mg film -coated tablets.
Blue, rectangular -shaped, film -coated tablet debossed with “ GSI” on one side and “225” on the other
side of the tablet.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and
adolescents ( aged 12 years and older wi th body weight at least 35 kg) infected with human
immunodeficiency virus type 1 ( HIV -1) (see section s 4.2 and 5.1).
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection.
Pos ology
Adults and adolescents aged 12 years and older, weighing at least 35 kg
Descovy should be administered as shown in Table 1.