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 PIPERACILLINE/TAZOBACTAM PANPHARMA 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.
PIPERACILLINE/TAZOBACTAM PANPHARMA should not be mixed with other substances in a syringe or infusion bottle since compatibility has not been established.
Simultaneous administration of PIPERACILLINE/TAZOBACTAM PANPHARMA and aminoside by Y- line infusion can cause an inactivation of the aminoside by PIPERACILLINE/TAZOBACTAM PANPHARMA.
Due to chemical instability, PIPERACILLINE/TAZOBACTAM PANPHARMA should not be used in solutions containing only sodium bicarbonate.
In the absence of compatibility study, the Ringer-lactate solution must not be mixed with PIPERACILLINE/TAZOBACTAM PANPHARMA.
PIPERACILLINE/TAZOBACTAM PANPHARMA should not be added to blood products or albumin hydrolysates.


6.3.  Shelf life
Unopened vial: 3 years.
Reconstituted solution in vial :
Chemical and physical stability of the diluted product has not been demonstrated. The solution after reconstitution should be diluted immediately (see section 6.6).
Diluted infusion solution :
Chemical and physical in-use stability of diluted infusion solutions has been demonstrated for 48 hours when stored in a refrigerator at 2-8°C, when reconstituted using one of the compatible solvents for further dilution of the reconstituted solution at the suggested dilution volumes (see section 6.6).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions after reconstitution and prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.

6.4.     Special precautions for storage
Unopened vials: Store below 30°C.
For storage conditions of the medicinal product after reconstitution and dilution, see section 6.3.

6.5.     Nature and contents of container
Powder for infusion in vial.
Box of 1, 10, 12, 25, 50 or 100 vials.
Not all pack sizes may be marketed.
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 discolouration prior to administration. The solution should only be used if the solution is clear and free from particles.
Intravenous use.
Reconstitute each vial with the volume of solvent shown in the table below, using one of the compatible solvents for reconstitution. Swirl until dissolved. When swirled constantly, reconstitution generally occurs within 5 to 10 minutes (for details on handling, please see below).
Content of vial                                     Volume of solvent* to be added to vial 4 g / 500 mg
20 mL
(4 g piperacillin and 500 mg tazobactam)

* Compatible solvents for reconsitution :
- 0.9% (9 mg/mL) sodium chloride solution for injection
- Water for injections
- Glucose 5 %

The reconstituted solutions should be withdrawn from the vial by syringe. When reconstituted as directed, the vial contents withdrawn by syringe will provide the labelled amount of piperacillin and tazobactam.
The reconstituted solutions may be further diluted in bag of 50 or 100 mL with one of the following compatible solvents:
- 0.9% (9 mg/mL) sodium chloride solution for injection
- Glucose 5 %

Then, the solution will be administered by infusion over 30 minutes.
Co-administration with aminoglycosides
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, PIPERACILLINE/TAZOBACTAM PANPHARMA and the aminoglycoside are recommended for separate administration.
PIPERACILLINE/TAZOBACTAM PANPHARMA and the aminoglycoside should be reconstituted and diluted separately when concomitant therapy with aminoglycosides is indicated.
See section 6.2 for incompatibilities.
Any unused product or waste material should be disposed of in accordance with local requirements.
For single use only. Discard any unused solution.