Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Not applicable

6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products excepting 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 solution has to be used immediately and any residue should be discarded.

6.4 Special precautions for storage
Below 30o C
6.5 Nature and contents of container
AmpiSulVenir 1.5G is presented in the following package:
- Cardboard box containing: Ampicillin/Sulbactam 1g + 500 mg powder in a 20 ml glass vial (10 powder vials)
AmpiSulVenir 3G is presented in the following package:
- Cardboard box containing: Ampicillin/Sulbactam 2g + 1g powder in a 20 ml glass vial (10 powder vials)

6.6 Special precaution for disposal and other handlings
For AmpiSulVenir 1.5G:
Intravenous use
Intravenous injection: the sterile dry powder in the vial should be reconstituted with about 3 ml of water for injection and should be administered by bolus intravenous injection over at least 3 minutes, after completed dissolution (see section 4.2).
Intravenous infusion: the sterile dry powder in the vial may be reconstituted with 50/100 ml of one of the compatible solutions (not water for injection) and should be administered by intravenous infusion in 15 to 30 minutes (see section 4.2).
AmpiSulVenir is compatible with the following solvent solutions:
• sodium chloride 9 mg/ml (0.9%) solution for infusion
• sodium lactate solution
• lactated Ringer’s solution
• glucose 50 mg/ml (5%) solution for infusion
• saccarose 100 mg/ml (10%) solution for infusion
After reconstitution the solution should be used immediately and any residue should be discarded.
Intramuscular use
The sterile dry powder in the vial should be reconstituted with about 3 ml of water for injection or lidocaine hydrochloride 5 mg/ml (0,5%) solution (for contraindications see section 4.3). The solution should be administered by deep intramuscular injection (for contraindications see section 4.2) After reconstitution the solution should be used immediately and any residue should be discarded.

The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution is clear and colorless.

For single use only. Any unused solution and the vial should be adequately disposed of, in accordance with local requirements.
For AmpiSulVenir 3G:

Intravenous use
Intravenous injection: the sterile dry powder in the vial should be reconstituted with about 6-7 ml of water for injection and should be administered by bolus intravenous injection over at least 3 minutes, after completed dissolution (see section 4.2).
Intravenous infusion: the sterile dry powder in the vial may be reconstituted with 100 ml of one of the compatible solutions (not water for injection) and should be administered by intravenous infusion in 15 to 30 minutes (see section 4.2).
AmpiSulVenir is compatible with the following solvent solutions:
• sodium chloride 9 mg/ml (0.9%) solution for infusion
• sodium lactate solution
• lactated Ringer’s solution
• glucose 50 mg/ml (5%) solution for infusion
• saccarose 100 mg/ml (10%) solution for infusion
After reconstitution the solution should be used immediately and any residue should be discarded.
Intramuscular use
The sterile dry powder in the vial should be reconstituted with about 6-7 ml of water for injection or lidocaine hydrochloride 5 mg/ml (0,5%) solution (for contraindications see section 4.3). The solution should be administered by deep intramuscular injection (for contraindications see section 4.2) After reconstitution the solution should be used immediately and any residue should be discarded.

The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration. The reconstituted solution is clear and colorless.

For single use only. Any unused solution and the vial should be adequately disposed of, in accordance with local requirements.