Zenapax
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-04-2008
Fachinformation
(SPC)
08-04-2008
Öffentlichen Beurteilungsberichts
(PAR)
08-04-2008
Wirkstoff:
daclizumab
Verfügbar ab:
Roche Registration Ltd.
ATC-Code:
L04AA08
INN (Internationale Bezeichnung):
daclizumab
Therapiegruppe:
Immunosuppressants
Therapiebereich:
Graft Rejection; Kidney Transplantation
Anwendungsgebiete:
Zenapax is indicated for the prophylaxis of acute organ rejection in de novo allogenic renal transplantation and is to be used concomitantly with an immunosuppressive regimen, including cyclosporine and corticosteroids in patients who are not highly immunised.
Produktbesonderheiten:
Revision: 8
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
1999-02-26
Gebrauchsinformation
Medicinal product no longer authorised
19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zenapax 5 mg/ml concentrate for solution for infusion
Daclizumab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Zenapax is and what it is used for
2.
Before you use Zenapax
3.
How to use Zenapax
4.
Possible side effects
5.
How to store Zenapax
6.
Further information
1.
WHAT ZENAPAX IS AND WHAT IT IS USED FOR
Daclizumab belongs to a group of medicines called immunosuppressants.
These medicines help to
suppress your body’s natural response to reject your transplanted
organ.
Daclizumab is a humanised monoclonal antibody produced in a murine NSO
myeloma cell line using
a glutamine synthetase (GS) expression system (NS_GSO) by recombinant
DNA technology.
Monoclonal antibodies are proteins which recognise and bind to other
unique proteins in the body
called antigens. Daclizumab binds to an antigen found on the surface
of specific white blood cells
called T lymphocytes. This activity suppresses the body’s natural
immune response which otherwise
might cause transplant rejection.
Zenapax is used to prevent your body from rejecting transplanted
kidneys. Zenapax is used together
with other immunosuppressive drugs, including cyclosporine and
corticosteroids.
2.
BEFORE YOU USE ZENAPAX
DO NOT USE ZENAPAX
-
if you are allergic (hypersensitive) to daclizumab or to any of the
other ingredients of Zenapax.
-
if you are breast-feeding.
Please read the section below on breast-feeding.
TAKE SPECIAL CARE WITH ZENAPAX
-
if you have ever had an a
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Fachinformation
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Zenapax 5 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Daclizumab*…………5 mg per 1 ml infusion
One vial of 5 ml contains 25 mg of daclizumab* (5 mg/ml).
* Recombinant humanized IgG1 anti-Tac antibody produced in a murine
NSO myeloma cell line using
a glutamine synthetase (GS) expression system (NS_GSO) by recombinant
DNA technology
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear to slightly opalescent, colourless to slightly yellowish liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zenapax is indicated for the prophylaxis of acute organ rejection in
_de novo_ allogenic renal
transplantation and is to be used concomitantly with an
immunosuppressive regimen, including
cyclosporine and corticosteroids in patients who are not highly
immunised.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zenapax should be prescribed only by physicians who are experienced in
the use of
immunosuppressive therapy following organ transplantation.
The recommended dose for Zenapax in adult and paediatric patients is 1
mg/kg. The volume of
Zenapax containing the appropriate dose is added to 50 ml of sterile
0.9% saline solution and is
administered intravenously over a 15 minute period. It may be given
via a peripheral or central vein.
Zenapax should initially be given within 24 hours before
transplantation. The next and each
subsequent dose should be given at intervals of fourteen days, for a
total of five doses.
Elderly
Experience with Zenapax in elderly patients (older than 65 years) is
limited because of the small
number of older patients who undergo renal transplantation, but there
is no evidence that elderly
patients require a different dosage from younger patients.
Patients with severe renal impairment
No dosage adjustment is necessary for
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