Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Powder and solvent for solution for injection or infusion

Powder
Mannitol
Glycine
Sucrose
Potassium dihydrogen phosphate
Sodium chloride
Disodium phosphate, anhydrous

Solvent

Water for injections
Powder for solution for injection or infusion

Powder

Mannitol
Glycine
Sucrose
Potassium dihydrogen phosphate
Sodium chloride
Disodium phosphate, anhydrous
6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature (see section 6.6).

6.4 Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
6.5 Nature and contents of container

Powder and solvent for solution for injection or infusion
Powder
Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.

Solvent

Colourless glass one point cut ampoule, type I glass, containing 5 ml water for injections.

Powder for solution for injection or infusion

Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 20 mg basiliximab as powder for solution for injection or infusion.

6.6 Special precautions for disposal and other handling

Powder and solvent for solution for injection or infusion


Reconstitution
To prepare the solution for infusion or injection, add 5 mL of water for injection 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 50mg/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 the following infusion sets has been verified.

Infusion bag
Baxter minibag NaCl 0.9%
Infusion sets
Luer LockTM, H. Noolens
Sterile vented i.v. set, Abbott
Infusion set, Codan
InfusomatTM, Braun
Infusionsgerät R 87 plus, Ohmeda
Lifecare 5000TM Plumset Microdrip, Abbott
Vented basic set, Baxter
Flashball device, Baxter
Vented primary administration set, Imed
Any unused medical product or waste material should be disposed of in accordance with local requirements.

Powder for solution for injection or infusion

Reconstitution
To prepare the solution for infusion or injection, add 5 ml of water for injections compliant with the European Pharmacopoeia and without any additives 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.

Infusion bag
Baxter minibag NaCl 0.9%

Infusion sets
Luer LockTM, H. Noolens
Sterile vented i.v. set, Abbott
Infusion set, Codan
InfusomatTM, Braun
Infusionsgerät R 87 plus, Ohmeda
Lifecare 5000TM Plumset Microdrip, Abbott
Vented basic set, Baxter
Flashball device, Baxter
Vented primary administration set, Imed
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.