Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
None

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
Unopened vial: 24 months
After reconstitution, or reconstitution and dilution, chemical and physical in use stability has been demonstrated for 12 hours at 25 °C.

From a microbiological point of view, the product should be used immediately.
If not used immediately, in‐use storage times and conditions are the responsibility of the user.

6.4 Special precautions for storage
Do not store above 250 C.
Keep the vial in the original outer carton in order to protect from light.
For storage conditions of the reconstituted and diluted medicinal product see section 6.3.


6.5 Nature and contents of container
Carton box which contains type I glass vial with an aluminium cap and rubber stopper.
Pack sizes of 1 vial and 5 vials with powder for solution for injection.


6.6 Special precautions for disposal


A ready‐to‐use solution is prepared by injecting 10 ml of sodium chloride 9mg/ml (0.9%) solution for injection into the vial containing the powder. The appearance of the product after reconstitution is a clear yellowish solution. This solution may be administered directly or may be administered after mixing with 100 ml sodium chloride 9mg/ml (0.9%) solution for injection or glucose 55 mg/ml (5%) solution for injection. Glass or plastic containers should be used for dilution.

After reconstitution, or reconstitution and dilution, chemical and physical in use stability has been demonstrated for 12 hours at 25 °C.

From a microbiological point of view, the product should be used immediately.
Ulceron must not be prepared or mixed with solvents other than those stated.
The medicine should be administered intravenously over 2 ‐15 minutes.
The contents of the vial are for single use only. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) should be disposed of in accordance with local requirements.

7. Manufacturer:
ANFARM HELLAS S.A.
4 ACHAIAS STR. & TRIZINIAS, 14564
KIFISSIA, ATTIKI, GREECE