TELDY (Dolutegravir 50mgLamivudine 300mgTenofovir Disoproxil Fumarate 300mg) Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; Dolutegravir Sodium

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; Dolutegravir Sodium

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
TELDY
_ _
Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Film-Coated
Tablets 50 mg/300 mg/300 mg
Page. 1
WHAT IS IN THIS LEAFLET
1.
What TELDY is used for
2.
How TELDY works
3.
Before you use TELDY
4.
How to use TELDY
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TELDY
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
Read this Patient Information before you
start taking TELDY and each time you
get
a
refill.
There
may
be
new
information. This information does not
take
the
place
of
talking
with
your
healthcare provider about your medical
condition or your treatment.
1. WHAT TELDY IS USED FOR
TELDY is a prescription medicine that is
used alone as a complete regimen to treat
Human Immunodeficiency Virus type 1
(HIV-1)
infection
in
adults
and
adolescent
above
12
years
of
age
weighing 40 kg or or more.
HIV-1 is the virus that causes Acquired
Immune Deficiency Syndrome (AIDS).
TELDY
contain
3
prescription
medicines, dolutegravir, lamivudine and
tenofovir disoproxil fumarate.
•
TELDY is not for use by itself in
people
who
have
or
have
had
resistance
to
dolutegravir,
lamivudine, or tenofovir disoproxil
fumarate.
2. HOW TELDY WORKS
TELDY may reduce the amount of HIV
in
your
blood
(called
“viral
load”).
TELDY may also help to increase the
number of CD4 (T) cells in your blood
which
help
fight
off
other
infections.
Reducing
the
amount
of
HIV
and
increasing the CD4 (T) cell count may
improve your immune system. This may
reduce your risk of death or infections
that
can
happen
when
your
immune
system
is
weak
(opportunistic
infections).
TELDY DO NOT CURE HIV INFECTION OR
AIDS.
You
must
keep
taking
HIV-1
medicines to control HIV-1 infection and
decrease HIV-related illnesses.
Avoid doing things that can spread HIV-
1 infection to others.
•
Do not share or re-use needles or
other injection equipment.
•
Do not share personal items that can
have blood or body fluids on them,

Ciri produk

TELDY (Dolutegravir 50mg/Lamivudine 300mg/Tenofovir Disoproxil
Fumarate 300mg) Film-Coated Tablets
Font: Times New Roman, size 8
WARNING:
LACTIC
ACIDOSIS
AND
SEVERE
HEPATOMEGALY
WITH
STEATOSIS
AND
POST
TREATMENT
EXACERBATIONS OF HEPATITIS B
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: LACTIC
ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL
CASES,
HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES. DISCONTINUE
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
TABLETS IF CLINICAL OR LABORATORY FINDINGS SUGGESTIVE OF LACTIC
ACIDOSIS OR PRONOUNCED HEPATOTOXICITY OCCUR _[SEE WARNINGS AND
PRECAUTIONS _
_(5.1)]_.
EXACERBATIONS OF HEPATITIS B: SEVERE ACUTE EXACERBATIONS OF HEPATITIS
B HAVE BEEN REPORTED IN PATIENTS WHO ARE COINFECTED WITH HBV
AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) AND HAVE DISCONTINUED
ANTI-HEPATITIS B THERAPY, INCLUDING LAMIVUDINE OR TENOFOVIR
DISOPROXIL FUMARATE. HEPATIC FUNCTION SHOULD BE MONITORED CLOSELY WITH
BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT LEAST SEVERAL
MONTHS IN PATIENTS WHO DISCONTINUE DOLUTEGRAVIR, LAMIVUDINE AND
TENOFOVIR DISOPROXIL FUMARATE TABLETS AND ARE CO-INFECTED WITH HIV-
1 AND HBV. IF APPROPRIATE, INITIATION OF ANTI-HEPATITIS B THERAPY MAY
BE WARRANTED _[SEE WARNINGS AND PRECAUTIONS (5.2)]_.
1 INDICATIONS AND USAGE
Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets are
indicated for use alone as a complete regimen for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in adults and
adolescents above 12 years of age weighing 40 kg or greater.
Limitation of Use:
•
Dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets
alone are not recommended in patients with resistance associated
integrase substitutions or clinically suspected integrase strand
transfer inhibitor resistance because the dose of dolutegravir in
dolutegravir,
lamivudine and tenofovir disoproxil fumarate tablets is insufficient
in these subpopulations. See the dolutegravir prescribing information.
2 DOSAGE AND ADMINISTR