Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Sodium dihydrogen phosphate dihydrate
Sodium hydroxide (2 M) (for pH adjustment)
Ovaleap solution for injection                                                         8.2.2018     ME Mannitol
Methionine
Polysorbate 20
Benzyl alcohol
Benzalkonium chloride
Water for injections

6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 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 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.

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.

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")


Ovaleap solution for injection                                                          8.2.2018   ME 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        REGISTRATION NUMBER

157-82-34716-00