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Puregon 300 IU/0.36 ml, 600 IU/0.72 ml , 900 IU/1.08 ml solution for injection (九)
2014-06-22 20:35:57 来源: 作者: 【 】 浏览:5289次 评论:0
sed with the Puregon Pen.

Cartridges contain a minimum of 400 IU FSH activity in 0.480 ml aqueous solution, which is sufficient for a net total dose of 300 IU.

Puregon 600 IU/0.72 ml solution for injection

0.72 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.

Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 700 IU FSH activity in 0.840 ml aqueous solution, which is sufficient for a net total dose of 600 IU.

Puregon 900 IU/1.08 ml solution for injection

1.08 ml of solution in 1.5 ml cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.

Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.

Cartridges contain a minimum of 1025 IU FSH activity in 1.230 ml aqueous solution, which is sufficient for a net total dose of 900 IU.
6.6 Special precautions for disposal and other handling
 Do not use if the solution contains particles or if the solution is not clear.

Puregon 300 IU/0.36 ml, 600 IU/0.72 ml and 900 IU/1.08ml solution for injection is designed for use in conjunction with the Puregon Pen. The instructions for using the pen must be followed carefully.

Air bubbles must be removed from the cartridge before injection (see instructions for using the pen).

Empty cartridges must not be refilled.

Puregon cartridges are not designed to allow any other drug to be mixed in the cartridges.

Discard used needles immediately after injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
 Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

8. Marketing authorisation number(s)
 
EU/1/96/008/038
 (Puregon 300 IU/0.36 ml solution for injection)
 
EU/1/96/008/039
 (Puregon 600 IU/0.72 ml solution for injection)
 
EU/1/96/008/041
 (Puregon 900 IU/1.08ml solution for injection)

9. Date of first authorisation/renewal of the authorisation
 Date of first authorisation: 03 May 1996

Date of latest renewal: 03 May 2006

10. Date of revision of the text
 20 February 2014

11. Legal category
 Prescription Only Medicine

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu 

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