powder, avoiding foaming. It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately. Reconstituted products should be inspected visually for particulate matter prior to administration. Do not use if foreign particles are present. After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Discard the reconstituted solution if not used within 24 hours.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
Compatibility with a number of infusion sets has been verified.
Any unused product or waste material should be disposed of in accordance with local requirements.
Simulect 20 mg powder and solvent for injection or infusion
Reconstitution
To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder, avoiding foaming. It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately. Reconstituted products should be inspected visually for particulate matter prior to administration. Do not use if foreign particles are present. After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Discard the reconstituted solution if not used within 24 hours.
The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.
Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.
Compatibility with a number of infusion sets has been verified.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
8. Marketing authorisation number(s)
Simulect 10 mg powder and solvent for solution for injection or infusion: EU/1/98/084/002
