Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Sucrose
Sodium citrate dihydrate
Citric acid monohydrate

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

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials Reconstituted solution
Reconstituted drug product is stable for 48 hours when stored between 5˚C and 25˚C. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Do not store above 25°C.
Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

2100 units of conestat alfa powder in a 25 ml vial (type 1 glass) with a stopper (siliconized chlorobutyl rubber) and a flip-off seal (aluminium and coloured plastic).
Pack size of 1.
6.6   Special precautions for disposal and other handling

Each vial of Ruconest is for single use only.
An aseptic technique should be used for reconstitution, combining and mixing the solutions.

Reconstitution
Each vial of Ruconest (2100 U) should be reconstituted with 14 ml water for injections.
Water for injections should be added slowly to avoid forceful impact on the powder and mixed gently to minimise foaming of the solution. The reconstituted solution contains 150 U/ml conestat alfa and appears as a clear colourless solution.

The reconstituted solution in each vial should be visually inspected for particulate matter and discoloration. A solution exhibiting particulates or discoloration should not be used. The medicinal product should be used immediately (see section 6.3).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.    MARKETING AUTHORISATION HOLDER

Kamada Ltd
BEIT KAMA, Israel