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.

Whenever piperacillin/tazobactam is used concurrently with another antibiotic (e.g.
aminoglycosides), the substances must be administered separately. The mixing of beta-lactam antibiotics with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.

Piperacillin/tazobactam should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.

Piperacillin/tazobactam should be administered through an infusion set separately from any other drugs unless compatibility is proven.

Due to chemical instability, piperacillin/tazobactam should not be used in solutions containing only sodium bicarbonate or having a pH in the basic range.

Lactated Ringer's solution is not compatible with piperacillin/tazobactam.

Piperacillin/tazobactam should not be added to blood products or albumin hydrolysates.
6.3    Shelf life

Unopened vial: 2 years

Diluted infusion solution
After reconstitution, chemical and in-use stability has been demonstrated for 24 hours when stored in a refrigerator at 2-8°C.

From a microbiological point of view, once opened, the 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 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4    Special precautions for storage

Storage below 25°C
For storage conditions of the reconstituted/diluted product see section 6.3.
6.5    Nature and contents of container

Type I glass vials with a bromo butyl rubber stopper and flip off seal.
Pack sizes: 1 or 12 vials per carton.

6.6    Special precautions for disposal and other handling

The reconstitution and dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.

Intravenous use

Each vial of Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion should be reconstituted with 20 ml of one of the following diluents: 
• Sterile Water for Injection
• 9 mg/ml (0.9%) Sodium Chloride for Injection Swirl until dissolved.

The reconstituted solution should be further diluted to at least 50 ml with one of the reconstitution diluents, or with Dextrose 5% in Water.


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

For single use only. Discard any unused solution.