Zomacton Caution For Usage

INCOMPATIBILITIES: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
INSTRUCTIONS FOR USE AND HANDLING AND SPECIAL PRECAUTIONS FOR DISPOSAL: Reconstitution: The powder should only be dissolved with the solvent provided.
Two concentrations can be prepared depending on the volume of solvent used: for administration using a syringe, use 1.3 ml of solvent for a concentration of 3.3 mg/ml (taking into account the whole content of the vial which is greater than 4 mg); use 3.2 ml of solvent for a concentration of 1.3 mg/ml (taking into account the whole content of the vial which is greater than 4 mg).
Reconstitution of the powder with the solvent, and administration of the solution for injection should be undertaken using syringe and needle.
Reconstitution should be performed in accordance with good practice rules, particularly in the respect of asepsis.
1. Hands should be washed.
2. Fit the needle into the graduated syringe. Remove the plastic top on the vial. The top of the vial should be wiped with an alcohol swab to prevent contamination of the content. Do not touch the rubber stopper after cleaning.
3. Snap off the top of the solvent ampoule. Remove the plastic cover on the needle. Make sure that the plunger is completely pushed in before introducing the needle into the ampoule.
4. Slowly draw up the required volume in the syringe.
5. Place the needle into the centre of the clean rubber stopper and into 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. Throw away the syringe and needle into a sharps disposal container.
7. The vial must then be swirled with a gentle rotary motion until the contents are completely dissolved in order to obtain a clear and colorless solution.
Since the powder mainly contains proteins, shaking or vigorous mixing is not recommended. If after mixing, the solution is cloudy or contains particles, the vial and its contents should be disposed of.
In case of cloudiness after refrigeration, the solution should be allowed to warm up to room temperature (25°C). If cloudiness still persist or coloration appears, dispose of the vial and its contents.
The solution should be used within 14 days after reconstitution if stored in a refrigerator. Any unused solution in the vial should be disposed of at the end of the 14‑day storage period.