Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Powder
Mannitol
Disodium phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Solvent m-cresol
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
The expiry date of the product is indicated on the packaging materials.
After reconstitution, store vials in an upright position.
After reconstitution, the solution must be stored for a maximum of 28 days in a refrigerator at 2° C - 8° C.
6.4 Special precautions for storage
Store in a refrigerator (2° C to - 8° C); keep in the outer carton in order to protect from light.
For storage condition of the reconstituted medicinal product, see section 6.3.

6.5 Nature and contents of container
Zomacton 10 mg is supplied in set containing: 1 type I glass vial with powder, 1 type I glass prefilled syringe with solvent and 1 vial adaptor

6.6 Special precautions for disposal
Reconstitution
The powder should be reconstituted only with the solvent provided.
See the package leaflet for detailed instructions for reconstitution.

The following is a general description of the reconstitution and administration process. Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.

1. Hands should be washed.
2. Flip off the yellow plastic protective cap from the vial.
3. The top of the vial should be wiped with an antiseptic solution to prevent contamination of the content.
4. Place the vial adaptor over the centre of the vial with the spike facing downwards then push down firmly until it clicks into place. Remove the adaptor cap.
5. Take the syringe.

Remove the grey cap. Place the syringe into the adaptor of the vial and inject the solvent slowly into the vial aiming the stream of liquid against the glass wall in order to avoid foam.
6. Place the adaptor cap/connector cap back on the adaptor/connector.
7. Gently swirl the vial a few times until the content is completely dissolved. Do not shake; this may cause denaturation of the active substance.
8. If the solution is cloudy or contains particulate matter, it should not be used. In the case of cloudiness after refrigeration, the product should be allowed to warm to room temperature. If cloudiness persists, discard the vial and its contents.
The content must be clear and colourless after reconstitution.
Any unused product or waste material should be disposed of in accordance with local requirements.
Reconst it ut ion wit h vial adapt or for use wit h ZomaJ et 10 device 


Step 1
Remove the yellow cap from the ZOMACTON vial.


•                                                            Step 2                          Step 3 and 4 Place the vial adaptor over     Remove the grey syringe the centre of the vial with     cap and also remove the the spike facing downwards.     white vial adaptor cap.
Push down firmly until it clicks into place.



Step 6                                                         Step 8 Press the syringe plunger                                      Place the white vial adaptor slowly. Ensure that all the                                    cap back on the adaptor by solution goes into the vial.                                   pushing firmly until it clicks into place.
Step 5
Place the vial on a flat surface and hold the vial adaptor. Place the syringe into the vial adaptor and push down. firmly.
Step 7
Hold the vial and firmly pull the syringe away. The syringe adaptor will remain in place.
Step 9
The vial must then be swirled gently until the powder has dissolved completely to form a clear, colourless solution.
Place the reconstituted vial of ZOMACTON in an upright position in the refrigerator at 2°C to 8°C.
Avoid shaking or vigorous mixing. If the solution remains cloudy or contains particles, the vial and its contents should be discarded. In case of cloudiness after refrigeration, the solution should be allowed to warm up to room temperature. If cloudiness still persists, discard the vial and its contents.