Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Gemcitabine Teva Concentrate for Solution for Infusion, KL05/2024
Hydrochloric acid
Water for injections
6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3      Shelf life after first opening

The expiry date of the product is indicated on the packaging materials.
After first opening
Chemical and physical in use stability has been demonstrated for 28 days at 25°C.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Stability after dilution
Chemical and physical in-use stability has been demonstrated for 28 days at 2ºC to 8ºC and about 25ºC upon dilution in 0.9% sodium chloride solution to a final concentration in the range between 2 – 25 mg/ml (2.0 mg/ml, 12 mg/ml and 25 mg/ml). The pH of the diluted solution is in the range of 2-3 and the osmolality is approximately 285 mOsm/kg. Diluted solutions are stable when packaged into either PVC or PE infusion bags.
From a microbiological point of view, the solution for infusion 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°C to 8°C unless dilution has taken place in controlled and validated aseptic conditions.

6.4      Special precautions for storage

Store at 2°C - 8°C in the original package .
For storage conditions of the diluted medicinal product see section 6.3.
6.5      Nature and contents of container

Colourless glass vial (type I) with rubber stopper with aluminium metallic caps with flip off disk.
Pack sizes:
1 x 5 ml vial
1 x 25 ml vial
1 x 50 ml vial
Not all pack sizes may be marketed

6.6      Special precautions for disposal and other handling

Handling
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Pregnant personnel should not handle the product.
Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses.
Gemcitabine Teva Concentrate for Solution for Infusion, KL05/2024
If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water.

Instructions for dilution
The only approved diluent for dilution of Gemcitabine Teva concentrate for solution for infusion is sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative).

-      Use aseptic technique during dilution of gemcitabine for intravenous infusion administration.

-      Diluted solution is a clear colourless or light straw-coloured solution.

-      Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.


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


7. NAME AND ADDRESS OF THE REGISTRATION HOLDER
Teva Israel Ltd.,124 Dvora HaNevi'a St., Tel Aviv 6944020 Israel.
8. NAME AND ADDRESS OF THE MANUFACTURER
Actavis Group PTC ehf.,
Reykjavikurvegi 76-78,
220 Hafnarfjordur
Iceland