Simulect
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
12-10-2023
Fachinformation
(SPC)
12-10-2023
Öffentlichen Beurteilungsberichts
(PAR)
31-10-2008
Wirkstoff:
basiliximab
Verfügbar ab:
Novartis Europharm Limited
ATC-Code:
L04AC02
INN (Internationale Bezeichnung):
basiliximab
Therapiegruppe:
Immunosuppressants
Therapiebereich:
Graft Rejection; Kidney Transplantation
Anwendungsgebiete:
Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years).It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Produktbesonderheiten:
Revision: 28
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1998-10-09
Gebrauchsinformation
33
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
AMPOULE LABEL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Solvent for Simulect
Water for injections
2.
METHOD OF ADMINISTRATION
See package leaflet
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
5 ml
6.
OTHER
34
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
FOLDING BOX FOR PACK CONTAINING 1 POWDER VIAL AND 1 SOLVENT AMPOULE
1.
NAME OF THE MEDICINAL PRODUCT
Simulect 10 mg powder and solvent for solution for injection or
infusion
basiliximab
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
One vial contains 10 mg of basiliximab.
3.
LIST OF EXCIPIENTS
It also contains potassium dihydrogen phosphate; disodium phosphate,
anhydrous; sodium chloride;
sucrose; mannitol (E421); glycine.
The solvent ampoule contains 5 ml water for injections.
4.
PHARMACEUTICAL FORM AND CONTENTS
Powder and solvent for solution for injection or infusion
1 vial with 10 mg powder
1 ampoule with 5 ml solvent
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
Intravenous use
6.
SPECIAL WARNING THAT THE MEDICINAL 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
8.
EXPIRY DATE
EXP
Use immediately after reconstitution (chemically and physically stable
at 2°C - 8°C for 24 hours or at
room temperature for 4 hours).
35
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator.
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
12.
MARKETING AUTHORISATION NUMBER(S)
EU/1/98/084/002
13.
BATCH NUMBER
Lot
14.
GENERAL CLASSIFICATION FOR SUPPLY
15.
INSTRUCTIONS ON USE
Please open here.
16.
INFORMATION IN BRAILLE
Justification for not including Braille accepted.
17.
UNIQUE IDENTIFIER – 2D BARCODE_ _
2D
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Simulect 20 mg powder and solvent for solution for injection or
infusion
Simulect 20 mg powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg basiliximab*.
One ml of the reconstituted solution contains 4 mg basiliximab.
* recombinant murine/human chimeric monoclonal antibody directed
against the interleukin-2
receptor
-chain (CD25 antigen) produced in a mouse myeloma cell line by
recombinant DNA
technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Simulect 20 mg powder and solvent for solution for injection or
infusion
Powder and solvent for solution for injection or infusion
White powder
Simulect 20 mg powder for solution for injection or infusion
Powder for solution for injection or infusion
White powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Simulect is indicated for the prophylaxis of acute organ rejection in
_de novo_
allogeneic renal
transplantation in adult and paediatric patients (1-17 years) (see
section 4.2). It is to be used
concomitantly with ciclosporin for microemulsion- and
corticosteroid-based immunosuppression, in
patients with panel reactive antibodies less than 80%, or in a triple
maintenance immunosuppressive
regimen containing ciclosporin for microemulsion, corticosteroids and
either azathioprine or
mycophenolate mofetil.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Simulect should be prescribed only by physicians who are experienced
in the use of
immunosuppressive therapy following organ transplantation. Simulect
should be administered under
qualified medical supervision.
Simulect
MUST NOT
be administered unless it is absolutely certain that the patient will
receive the graft
and concomitant immunosuppression.
Simulect is to be used concomitantly with ciclosporin for
microemulsion- and corticosteroid-based
immunosuppression. It can be used in a ciclosporin for microemulsion-
and corticosteroid-based triple
i
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