6.1 List of excipients
Sucrose
Sodium chloride
L-Arginine hydrochloride
Sodium phosphate monobasic dihydrate
Sodium phosphate dibasic dihydrate
Water for injections
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf life
Enbrel 25 mg or 30 mg solution for injection in pre-filled syringe and Enbrel 25 mg or 50 mg solution for injection in pre-filled pen:
30 months.
Enbrel 25 mg powder and solvent for solution for injection:
4 years.
Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution. From a microbiological point of view, the reconstituted medicinal product should be used immediately. If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Enbrel 10 mg for injection for paediatric use
3 years.
From a microbiological point of view, the reconstituted medicinal product should be used immediately. Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures not above 25°C after reconstitution.
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Enbrel 25 mg powder and solvent, Enbrel 25 mg or 50 mg solution for injection in pre-filled syringe, Enbrel 25 mg or 50 mg solution for injection in pre-filled pen
Enbrel may be stored at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks of removal from refrigeration.
Enbrel 25 mg or 50 mg solution for injection in pre-filled syringe, Enbrel 25 mg or 50 mg solution for injection in pre-filled pen
Keep the pre-filled syringes in the outer carton in order to protect from light.
Enbrel 10 mg for injection for paediatric use
Enbrel may be stored at temperatures up to a maximum of 25° C for a single period of up to four weeks; after which, it should not be refrigerated again. Enbrel should be discarded if not used within four weeks of removal from refrigeration.
Enbrel 25 mg powder and solvent and Enbrel 10 mg for injection for paediatric use
For storage conditions of the reconstituted medicinal product, see section 6.3.
6.5 Nature and contents of container
Enbrel 25 mg or 50 mg solution for injection in pre-filled syringe
Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger. Cartons contain 4 pre-filled syringes of Enbrel and 4 alcohol swabs. The needle cover contains dry natural rubber (latex) (see section 4.4).
Enbrel 25 mg powder and solvent
Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps. Enbrel is supplied with pre-filled syringes containing water for injection. The syringes are type I glass. Cartons contain 4 vials of Enbrel with 4 pre-filled solvent syringes, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Enbrel 25 mg or 50 mg solution for injection in pre-filled pen
Pre-filled pen (MYCLIC) containing a 25 mg or 50 mg pre-filled syringe of Enbrel. The syringe inside the pen is made from clear type 1 glass with a stainless steel 27gauge needle, rubber needle cover, and plastic plunger. The needle cap of the pre-filled pen contains dry natural rubber (a derivative of latex). See section 4.4.
Cartons contain 4 pre-filled pens of Enbrel with 4 alcohol swabs.
Enbrel 10 mg for injection for paediatric use
Clear glass vial (4 ml, type I glass) with rubber stopper, aluminium seal, and flip-off plastic cap. Enbrel is supplied with pre-filled syringes containing water for injection. The syringes are type I glass.
Cartons contain 4 vials of Enbrel, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
6.6 Special precautions for disposal and other handling
Before injection, Enbrel single-use pre-filled syringe should be allowed to reach room temperature (approximately 15 to 30 minutes). The needle cover should not be removed while allowing the pre- filled syringe to reach room temperature. The solution should be clear to slightly opalescent, colourless to pale yellow or pale brown and may contain small translucent or white particles of protein.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Any unused product or waste material should be disposed of in accordance with local requirements.