Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

Powder
Mannitol (E 421)
Sucrose (E 473)
Sodium chloride
Histidine
Polysorbate 80 (E 433) water for injection
Sodium hydroxide (for pH adjustment) (E 524)
Hydrochloric acid (for pH adjustment) (E 507)

Solvent
Histidine
Water for injections

6.2     Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or reconstituted with infusion solutions other than the provided histidine solvent.

6.3    Shelf life

Unopened
The expiry date of the product is indicated on the packaging material .
During the shelf life Refixia may be stored up to 30 °C for a single period not exceeding 6 months.
Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator. Please record the beginning of storage at room temperature on the product carton.

After reconstitution

Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator (2 °C – 8 °C) and 4 hours stored at room temperature (≤ 30 °C) protected from light.

From a microbiological point of view, the reconstituted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30 °C) or 24 hours in a refrigerator (2 °C – 8 °C), unless reconstitution has taken place under controlled and validated aseptic conditions. Store the reconstituted medicinal product in the vial.

6.4   Special precautions for storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Each pack contains:
–     1 glass vial (type I) with powder and chlorobutyl rubber stopper –     1 sterile vial adapter for reconstitution
–     1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger (bromobutyl) and a tip cap with a stopper (bromobutyl)
–     1 plunger rod (polypropylene).

Pack size of 1.

6.6   Special precautions for disposal and other handling
Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe. After reconstitution the solution appears as a clear and colourless to slightly yellow liquid, free of visible particles. Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy or have deposits. Store the reconstituted medicinal product in the vial.


For instructions on reconstitution of the medicinal product before administration, see the package leaflet.

The rate of administration should be determined by the patient’s comfort level up to a maximum injection rate of 4 ml/min.

An infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters will also be needed. These devices are not included in the Refixia package.

Always use an aseptic technique.

Disposal
After injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


7.    MANUFACTURER:
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark


8.    REGISTRATION HOLDER
Novo Nordisk Ltd.
1 Atir Yeda St.
Kfar-Saba, 4464301