edicinal products.
6.3 Shelf life
2 years.
Shelf life and storage conditions after first opening
The cartridge in-use in the pen may be stored for a maximum of 28 days. Do not store above 25 °C. The patient should write down in the patient diary provided with the Ovaleap Pen the date of first use.
The pen cap must be put back on the pen after each injection in order to protect from light.
6.4 Special precautions for storage
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, without being refrigerated again, for up to 3 months. Do not store above 25 °C. The medicinal product must be discarded if it has not been used after 3 months.
For storage conditions after first opening of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Ovaleap 300 IU/0.5 mL solution for injection
Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution.
Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½")
Pack size of 1 cartridge and 10 injection needles.
Not all pack sizes may be marketed.
Ovaleap 450 IU/0.75 mL solution for injection
Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.75 mL of solution..
Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½")
Pack size of 1 cartridge and 10 injection needles.
Not all pack sizes may be marketed.
Ovaleap 900 IU/1.5 mL solution for injection
Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 1.5 mL of solution..
Injection needles (stainless steel; 0.33 mm x 12 mm, 29 G x ½")
Pack size of 1 cartridge and 20 injection needles.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
No special requirements for disposal.
The solution must not be used if it contains particles or if the solution is not clear.
Ovaleap is designed for use in conjunction with the Ovaleap Pen only. The instructions for use of the pen must be followed carefully.
Each cartridge must be used by a single patient only.
Empty cartridges must not be refilled. Ovaleap cartridges are not designed to allow any other medicinal product to be mixed in the cartridges. Discard used needles immediately after injection.
7. Marketing authorisation holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands
8. Marketing authorisation number(s)
Ovaleap 300 IU/0.5 mL solution for injection
EU/1/13/871/001
Ovaleap 450 IU/0.75 mL solution for injection
EU/1/13/871/002
Ovaleap 900 IU/1.5 mL solution for injection
EU/1/13/871/003
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 27 September 2013.
Date of latest renewal: 16 May 2018
10. Date of revision of the text
25/05/2018
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu. |
