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 drugs must be administered separately. The mixing of piperacillin/tazobactam with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside.

Piperacillin/tazobactam should not be mixed with other drugs 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 that contain sodium bicarbonate.

Lactated Ringer's (Hartmann’s) solution is not compatible with piperacillin/tazobactam.

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

The expiry date of the product is indicated on the packaging materials.

Reconstituted/diluted Pipercillin/Tazobatam: Chemical and physical in use stability has been demonstrated for 24 hours at 2-8 °C.
From the microbiological point of view, 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 to 8° C, unless reconstitution/dilution has taken place in controlled and validated conditions.
Unused solution should be discarded.
6.4     Special precautions for storage

Do not store above 25°C.
For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.

6.5     Nature and contents of container
Piperacillin/Tazobactam - Fresenius 2 g/0.25 g:
Colourless glass vial (type II) of 15 ml closed with a halobutyl rubber stopper Pack sizes: 1, 5 and 10 vials.
Colourless glass vial (type II) of 50 ml closed with a halobutyl rubber stopper Pack sizes: 1, 5 and 10 vials.
Piperacillin/Tazobactam - Fresenius 4 g/0.5 g:
Colourless glass vial (type II) of 50 ml closed with a halobutyl rubber stopper Pack sizes: 1, 5 and 10 vials.
Not all pack sizes may be marketed.

6.6    Special precautions for disposal

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. Shake until dissolved. When shaken 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
2 g / 0.25 g (2 g piperacillin and 0.25 g tazobactam)   10 ml

4 g / 0.5 g (4 g piperacillin and 0.5 g tazobactam)     20 ml

* Compatible solvents for reconstitution:
- 0.9% (9 mg/ml) sodium chloride solution for injection
- Sterile water for injections (1)
(1)
Maximum recommended volume of sterile water for injection per dose is 50 ml.
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 to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:
-       0.9% (9 mg/ml) sodium chloride solution for injection
-       Glucose 5%
-       Dextran 6% in 0.9% sodium chloride

See section 6.2 for incompatibilities.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

For single use only. Discard any unused solution.