ISENTRESS 400 MG TABLETS

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

RALTEGRAVIR AS POTASSIUM

Boleh didapati daripada:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Kod ATC:

J05AX08

Borang farmaseutikal:

FILM COATED TABLETS

Komposisi:

RALTEGRAVIR AS POTASSIUM 400 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

MERCK SHARP & DOHME B.V, HOLLAND

Kumpulan terapeutik:

RALTEGRAVIR

Kawasan terapeutik:

RALTEGRAVIR

Tanda-tanda terapeutik:

Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.This indication is based on safety and efficacy data from two double-blind, placebo-controlled trials in treatment-experienced patients and one double-blind, active-controlled trial in treatment-naive patients.

Tarikh kebenaran:

2014-03-31

Risalah maklumat

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
’
REGULATIONS (PREPARATIONS) 1986
This medicine
is marketed
upon physician’s
prescription only
ISENTRESS
® 400 MG TABLETS
Film-Coated Tablets
EACH FILM-COATED
TABLET CONTAINS:
Raltegravir 400 mg (as potassium)
For the list of the
inactive ingredients
see section 6.1 "What
I
SENTRESS
contains".
See also section 2.7
“
Important information about some of the ingredients of
the medicine
”
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.

This leaflet contains concise
information
about the medicine
.
If you have any further
questions,
refer to the doctor or pharmacist.

This medicine has been
prescribed
for you. Do not pass it on to others. It may harm them
even
if it seems to you that
their
medical condition
is similar.

This medicine is
not intended
for children and
adolescents
under 16
years of age.
1. WHAT ISENTRESS IS INTENDED FOR?
ISENTRESS
contains the active substance raltegravir.
ISENTRESS
is an antiviral medicine
that works against
the Human Immunodeficiency Virus (HIV)
,
that causes Acquired Immune
Deficiency Syndrome (AIDS).
The virus
produces
an enzyme called HIV
integrase. This
helps the virus to multiply in the cells
in your body.
ISENTRESS
stops this enzyme from working. When used with other
medicines,
ISENTRESS
may reduce the amount of HIV in your blood (this is called your "viral
load") and
increase your CD4-cell count (a type of white blood cells that plays
an
important
role in
maintaining a healthy immune system to help fight infection).
Reducing the amount of HIV in the
blood may improve the
functioning
of your immune system. This means your body may fight
infection better.
ISENTRESS
may not have these effects in all patients.
ISENTRESS
is not a cure for HIV infection.
ISENTRESS
is used to treat adults who are infected by HIV.
Your doctor has prescribed
ISENTRESS
to help control your HIV infection.
THERAPEUTIC GROUP
:
antivirals for systemic use.
2. BEFORE USING
ISENTRESS
2.1 DO NOT
USE
ISENTRESS IF:

you

Ciri produk

1
1.
NAME
OF THE MEDICINAL PRODUCT
ISENTRESS
®
400 mg TABLETS
2.
QUALITATIVE
AN
D QUANTITATIVE COMPOSIT
ION
Each film-coated
tablet contains 400
mg of raltegravir (as potassium).
Excipient(s)
with known
effect:
E
ach tablet contain
s 26.06 mg lactose (as monohydrate).
For the ful
l list of excipients, see section
6.1.
3.
PHARMACEU
TICAL FORM
Film-coated tablet.
Pink, oval
tablet, marked with "227" on one side
and plain
on the other
.
4.
CLINICAL PARTI
CULARS
4.1
THERAPEUTIC INDICA
TIONS
ISENTRESS is
indicated in combination with other anti-retrovira
l medicinal products for the
tr
eatment of human immunodefici
ency virus (HIV
-1) infection in adult patients.
This indication is based on safety and efficacy
data from two double-blind, placebo-controlled trials in
treatment-experienced patients
and one dou
ble-
blind, active
-controlled tr
ial in treatment
-naïve patients
(see sections 4.4 and 5.1).
4.2
P
OSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be ini
tiated by
a physician experien
ced in the manageme
nt of HIV infection.
Posology
ISE
NTRESS should be
used in combination with other
active anti-
retroviral thera
pies (ARTs) (see
sections 4.4 and 5.1).
Adults
The
recommended dosage is 400
mg (one tablet) twice daily.
Elderly
There is
limited informatio
n regar
ding the use of
raltegravir
in the elderly (see section
5.2). Therefor
e,
IS
ENTRESS should
be u
sed with caution
in this population.
Renal impairment
No dos
age adjustment is required for patients wi
th renal impair
ment (see section 5.2).
Hepatic impairment
N
o dosage adjustment is r
equired for patients with mild to mo
derate hepatic
impairment.
The safety
and efficacy of
raltegravir
have not been established in patients with severe underlying liver di
sorders.
Therefore, ISENTRESS should be
used with cauti
on in p
atients with severe hepa
tic impairment
(see
sections 4.4 and 5.2).
Method
of administration
Oral use.
2
ISENTRESS 400
mg tablets can be administered with
or without food.
The tablets should not be chewed, crushed or split due to anti