n a 3ml Type I glass vial sealed with a chlorobutyl rubber stopper and an aluminum seal with a plastic flip-off cap.
The solvent is packaged in a 1.5ml Type 1 glass pre-filled syringe sealed with a bromobutyl rubber cap and a rubber plunger.
Each single-dose kit contains one vial of 2mg exenatide, one pre-filled syringe of 0.65ml solvent, one vial connector, and two injection needles (one spare).
Pack size of 4 single-dose kits and a multipack consisting of 3 x 4 single-dose kits. Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The patient should be instructed to discard the syringe safely, with the needle still attached after each injection. The patient should recap the needle. The patient does not need to save any part of the single-use kit.
The solvent should be visually inspected prior to use. The solvent should only be used if it is clear and free of particulate matter. After suspension, BYDUREON should only be used if the mixture is white to off white and cloudy.
BYDUREON must be injected immediately after suspension of the powder in the solvent.
BYDUREON that has been frozen must not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
8. MARKETING AUTHORISATION NUMBER(S)
EU/1/11/696/001
4 single-dose kits
EU/1/11/696/002
3 x 4 single-dose kits
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17 June 2011
10. DATE OF REVISION OF THE TEXT
17 June 2011
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
LEGAL CATEGORY
POM
BYDUREON® (exenatide) is a registered trade mark of Amylin Pharmaceuticals, Inc.
BYD1M (RoI)
Pharmaceuticals, Inc.
