e mixed with other medicinal products.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
6.5 Nature and contents of container
0.5 ml of solution in pre-filled syringe (type I glass) with a plunger stopper (butyl rubber), a tip cap (butyl rubber), plunger rod (plastic), needle (stainless steel); pack sizes of 1, 5, 6, 12 and 30.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
For single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW, United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
UK
PL 00031/0485
PL 00031/0486
PL 00031/0487
PL 00031/0488
IRISH
PA 50/68/20
PA 50/68/21
PA 50/68/22
PA 50/68/23
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25 July 1996
Date of last renewal: 22 July 2009
10. DATE OF REVISION OF THE TEXT
28th August 2011
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