Isentress

Kraj: Unia Europejska

Język: angielski

Źródło: EMA (European Medicines Agency)

Składnik aktywny:

Raltegravir

Dostępny od:

Merck Sharp & Dohme B.V.

Kod ATC:

J05AJ01

INN (International Nazwa):

raltegravir

Grupa terapeutyczna:

Antivirals for systemic use

Dziedzina terapeutyczna:

HIV Infections

Wskazania:

Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.

Podsumowanie produktu:

Revision: 42

Status autoryzacji:

Authorised

Data autoryzacji:

2007-12-19

Ulotka dla pacjenta

114
PARTICULARS TO APPEAR ON T
HE IMMEDIAT
E PACKAGIN
G
ISENTRESS 100 MG
–
BOTTLE LABELING
1.
NAME OF THE MEDICINAL PRODUCT
ISENTRESS 100
mg chewable tablets
raltegravir
2.
STATEMENT OF ACTIVE SUBSTANCE(S
)
Each tablet contains 100 mg of raltegravir (as potassium).
3.
LIST OF EXCI
PIENTS
Contains fructose, E 420, sucrose, and E 951.
See leaflet for further information.
4.
PHARMACEUTICAL FORM AND CONTENTS
60
chewable tablets
5.
METHOD AN
D ROUTES OF ADMINIS
TRATION
Read th
e package leafle
t before use.
Oral use
6.
SP
ECIAL WARNING TH
AT THE MEDICINA
L PRODUCT MUST
BE STORED OUT
OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Do not switch with othe
r strengths or f
ormulations of Isentress withou
t first talking
with your doctor,
pharmacist o
r nurse.
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
115
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUC
TS
OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL P
RODUCTS, IF
AP
PROPRIATE
11.
N
AME AND ADDRESS
OF THE MARKETIN
G AUTHORISATION HOLDER
MSD
12.
MARKETING AUTHORISATION NUMBER(S)
EU/1/07/436/004
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR
SUPPLY
15.
INSTRUCTIONS ON USE
16.
INFORMATION
IN BRAILLE
17.
UNIQUE IDENTIFIER
–
2D BARCODE
18.
UNIQUE I
DENTIFIER
- HUM
AN READABLE DATA
116
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON FOR THE 25
MG CHEWABLE TABLETS
1.
NAME OF THE MEDICIN
AL PRODUCT
ISENTRESS 25 mg chewable tablets
raltegravir
2.
STA
TEMENT OF ACTIVE
SUBSTANCE(S)
Each tablet contains 25 mg of ra
ltegravir (as potassium).
3.
LIST OF EXCIPIENTS
Contains fructose, sorbitol
, sucrose and aspartame. See leafle
t for further informati
on.
4.
PH
ARMACEU
TICAL FOR
M AND CONTENTS
60 chewable tablets
5.
METHOD
AND ROUTES OF ADMINISTRA
TION
Re
ad the package leaflet
before use.
Oral use
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE SIGHT A
N
D REACH OF CHILDREN
Keep out of the sight and rea
ch of children.
7.
OTHER SPE
CIAL WARN
ING(S),
IF

Charakterystyka produktu

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF T
HE MEDICINAL PR
ODUCT
ISENTRESS 400
mg film-
coated tablets
2.
QUALITATIVE AND QUA
NTITATIVE
COMPOSITION
Each film-coated tablet contains 400 mg of ralteg
ravir (as potassium
).
Excipient(s)
with known effect
Each tablet contains 26.06
mg lactose (as monohydrate).
For the full lis
t of excipients, see section
6.1.
3.
PHARMACE
UTI
CAL FORM
Film-coated tablet.
Pink, oval tabl
et, marked
with "227" on one side.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ISENTRESS is indicated in combination with
other anti-ret
roviral med
icinal products for the
treatment of h
uman immu
nodeficiency virus (HIV-1) infection (see sections 4.2, 4.4,
5.1 and 5.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the ma
nagement of HIV infection.
Posology
ISENTRESS should be used i
n 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.
Paediatric population
The recommended dosage for paediat
ric patients of at least 25
kg body we
ight is 400 mg (one tablet)
twice da
ily. If unable to
swallow a table
t, consider the chewable tablet.
Additional formul
ations and strengths available
:
ISENTRESS is also available in a chewabl
e tablet formulation and
in granules for oral suspension
formulation Refer to the chewable tablet an
d granules for or
al suspension Sm
PCs for additional dosing
information.
The safety a
nd efficacy of raltegravir in preterm (<37
weeks of gestation) and low b
irth weight
(<2,000 g) n
ewborns have not been established. No da
ta are available in this population
and no dosing
recommendations can be made.
The maximum dose of the
chewable tablet is 300
mg twice daily. Because the formulations
have
different pharmacok
inetic profiles neither
the chewable tablets
nor the granules for oral suspension
should be substitu
ted for the 40
0 mg tablet or 600 mg tablet
(see section
5.2). The ch
ewable tablets
3