Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

L-Arginine
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

The expiry date of the product is indicated on the packaging materials After reconstitution:
The reconstituted vial should be diluted immediately.

After dilution:
Once the intravenous solution is prepared with diluents listed in section 6.6 it should be administered within 6 hours of preparation. The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8°C. Once removed from refrigeration to room temperature, the diluted product must be used within 6 hours.

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/dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store below 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

20 mL glass vial (Type 1) closed with a rubber (bromobutyl) stopper and aluminium seal with flip-off cap.

The medicinal product is supplied in packs of 10 vials.
6.6   Special precautions for disposal and other handling

The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use. The reconstituted solution is a pale yellow solution that is free of any particles.

Standard aseptic techniques should be used for solution preparation and administration.

Zinforo powder should be reconstituted with 20 mL of sterile water for injections. The resulting solution should be shaken prior to being transferred to an infusion bag or bottle containing either sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium 
chloride and 2.5% dextrose) or Lactated Ringer’s solution. A 250 mL, 100 mL or 50 mL infusion bag can be used to prepare the infusion, based on the patient’s volume requirements. The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.

Infusion volumes for paediatric patients will vary according to the weight of the child. The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.

Each vial is for single use only.

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