re the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
Do not refrigerate or freeze.
Do not store above 25°C. Keep container in the outer carton, in order to protect from light.
6.5 Nature and contents of container
Clear Type I glass vial with rubber stopper
Clear Type I glass Onco-Tain® vial with rubber stopper
Clear Type I glass Onco-Vial® with rubber stopper
Pack sizes 1's, 5's, 10's and 20's.
Not all presentations and pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Prior to use, vials of Cytarabine 100mg/ml Injection must be warmed to 55°C, for 30 minutes, with adequate shaking, and allowed to cool to room temperature.
Use in the paediatric population
No special requirements
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Hospira UK Limited
Horizon
Honey Lane
Hurley
Maidenhead
SL6 6RJ
United Kingdom
8. Marketing authorisation number(s)
PL 04515/0057
9. Date of first authorisation/renewal of the authorisation
Date of last renewal: 10th October 2006
10. Date of revision of the text
02/2018
Ref: gxCY 2_4
https://www.medicines.org.uk/emc/product/1570/smpc |
