Celsentri

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

maraviroc

Saadav alates:

ViiV Healthcare B.V.

ATC kood:

J05AX09

INN (Rahvusvaheline Nimetus):

maraviroc

Terapeutiline rühm:

Antivirals for systemic use

Terapeutiline ala:

HIV Infections

Näidustused:

Celsentri, in combination with other antiretroviral medicinal products, is indicated for treatment experienced adults, adolescents and children of 2 years of age and older and weighing at least 10 kg infected with only CCR5-tropic HIV-1 detectable,

Toote kokkuvõte:

Revision: 28

Volitamisolek:

Authorised

Loa andmise kuupäev:

2007-09-18

Infovoldik

92
B. PACKAGE LEAFLET
93
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELSENTRI 25 MG FILM-COATED TABLETS
CELSENTRI 75 MG FILM-COATED TABLETS
CELSENTRI 150 MG FILM-COATED TABLETS
CELSENTRI 300 MG FILM-COATED TABLETS
maraviroc
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What CELSENTRI is and what it is used for
2.
What you need to know before you take CELSENTRI
3.
How to take CELSENTRI
4.
Possible side effects
5.
How to store CELSENTRI
6.
Contents of the pack and other information
1.
WHAT CELSENTRI IS AND WHAT IT IS USED FOR
CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a
group of medicines
called
_CCR5 antagonists_
. CELSENTRI works by blocking a receptor called CCR5 which HIV uses
to enter and infect your blood cells.
CELSENTRI IS USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS TYPE-1 (HIV-1)
IN ADULTS,
ADOLESCENTS AND CHILDREN OF 2 YEARS AND OLDER, AND WEIGHING AT LEAST
10 KG.
CELSENTRI must be taken in combination with other medicines which are
also used to treat the
HIV infection. These medicines are all called
_anti-HIV medicines _
or
_ antiretrovirals_
.
CELSENTRI, as part of combination therapy, reduces the amount of virus
in your body, and keeps
it at a low level. This helps your body to increase the CD4 cell count
in your blood. CD4 cells are a
type of white blood cell that are important in helping your body to
fight infection.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELSENTRI
DO NOT TAKE CELSENTRI
•
if you (or your child, if they are the patient) are
ALLERGIC
to maravir

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CELSENTRI 25 mg film-coated tablets
CELSENTRI 75 mg film-coated tablets
CELSENTRI 150 mg film-coated tablets
CELSENTRI 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CELSENTRI 25 mg film-coated tablets
Each film-coated tablet contains 25 mg of maraviroc.
Excipient with known effect: each 25 mg film-coated tablet contains
0.14 mg of soya lecithin.
CELSENTRI 75 mg film-coated tablets
Each film-coated tablet contains 75 mg of maraviroc.
Excipient with known effect: each 75 mg film-coated tablet contains
0.42 mg of soya lecithin.
CELSENTRI 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of maraviroc.
Excipient with known effect: each 150 mg film-coated tablet contains
0.84 mg of soya lecithin.
CELSENTRI 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of maraviroc.
Excipient with known effect: each 300 mg film-coated tablet contains
1.68 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
CELSENTRI 25 mg film-coated tablets
Blue, biconvex, oval film-coated tablets, approximate dimensions 4.6
mm x 8.0 mm and debossed
with “MVC 25”.
CELSENTRI 75 mg film-coated tablets
Blue, biconvex, oval film-coated tablets, approximate dimensions 6.74
mm x 12.2 mm and
debossed with “MVC 75”.
CELSENTRI 150 mg film-coated tablets
Blue, biconvex, oval film-coated tablets, approximate dimensions 8.56
mm x 15.5 mm and
debossed with “MVC 150”.
CELSENTRI 300 mg film-coated tablets
Blue, biconvex, oval film-coated tablets, approximate dimensions 10.5
mm x 19.0 mm and
debossed with “MVC 300”.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CELSENTRI, in combination with other antiretroviral medicinal
products, is indicated for
treatment-experienced adults, adolescents and children of 2 years of
age, and older
and weighing at
least 10 kg infected with only CCR5-tropic HIV-1 detectable (see
sections 4.2 and 5.1).
4.2
POSOLO