Pharmaceutical particulars : מידע רוקחי

6.        PHARMACEUTICAL PARTICULARS
6.1       List of excipients

Powder

Sodium chloride
Sucrose
L-Histidine
Calcium chloride dihydrate
Polysorbate 80
L-Methionine
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Solvent

Sodium chloride
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 injection solutions other than the provided sodium chloride solvent.

The reconstituted product should not be administered in the same tubing or container with other medicinal products.

6.3       Shelf life

The expiry date of the product is indicated on the package.
Unopened vial (before reconstitution):
36 months when stored in a refrigerator (2°C – 8°C).

During the shelf life the product may be kept:
• at room temperature (≤30oC) for a single period no longer than 12 months or
• above room temperature (>30°C up to 40°C) for a single period no longer than 3 months

Once the product has been stored outside of the refrigerator, the product must not be returned for storage in the refrigerator.

Record the beginning of storage outside refrigerator and the storage temperature in the space provided on the carton.

After reconstitution

Chemical and physical in-use stability have been demonstrated for:
• 24 hours when stored in a refrigerator (2°C - 8°C) or
• 4 hours at ≤30oC or
• 1 hour between >30oC and 40oC. only if the product was stored above room temperature (>30oC up to 40oC) before reconstitution for no longer than 3 months.

From a microbiological point of view, the product should be used immediately after reconstitution. 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 as stated above, unless reconstitution has taken place in controlled and validated aseptic conditions.

The reconstituted solution should be stored in the vial.

6.4      Special precautions for storage
Store in a refrigerator (2°C - 8°C). Do not freeze.
Store in the original package in order to protect from light.

For storage at room temperature (≤30oC) or up to 40oC and storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5      Nature and contents of container

Each pack of Esperoct contains:
- 1 glass vial (type I) with powder closed with a chlorobutyl rubber stopper, an aluminium seal with a plastic snap-off cap
- 1 sterile vial adapter for reconstitution
- 1 pre-filled syringe of 4 mL solvent with backstop (polypropylene), a rubber plunger (bromobutyl) and a rubber tip cap (bromobutyl)
- 1 plunger rod (polypropylene).

6.6      Special precautions for disposal and other handling

Esperoct 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 liquid free of visible particles. The reconstituted medicinal product should be inspected visually for particulate matter and discolouration prior to administration. The solution should be clear and colourless. Do not use solutions that are cloudy or have deposits.


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 over approximately 2 minutes.

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

Always use an aseptic technique.

Disposal
After the 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.      MARKETING AUTHORISATION HOLDER

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