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.
e.g., aminoglycosides), these should be administered separately. The Antibiotic Mix beta-lactams with aminoglycosides 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, as compatibility has not been established.

Due to chemical instability, Piperacillin/Tazobactam should not be used with solutions containing only sodium bicarbonate.

Piperacillin/Tazobactam is not compatible with lactate Ringer's solution (compound sodium chloride solution).

Piperacillin/Tazobactam should not be added to blood products or albumin hydrolysates 6.3.     Shelf life
Prior to reconstitution:
The expiry date of the product is indicated on the packaging materials.
Reconstituted solution in vial:
Chemical and physical stability has been demonstrated in use for up to 24 hours at 25°C and for 48 hours when stored in a refrigerator between 2°C and 8°C, when reconstituted with one of the compatible solvents for reconstitution (see section 6.6).


Diluted solution for infusion:
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 subsequent 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.
Any unused solution should be discarded.


6.4.      Special precautions for storage
Unopened vials: Store at room temperature up to 25°C.


For storage conditions of the medicinal product after reconstitution and dilution, see section 6.3.
6.5.      Nature and contents of container
50 ml Type II glass vial with grey bromobutyl rubber stopper and flip-off capsule.
The package contains 1 vial.
6.6 Instructions for use and handling
Reconstitution and dilution should be carried out under aseptic conditions. Prior to administration, the solution should be visually inspected for particles and color change. The solution should only be used if it is clear and free of particles

Directions for use
Piperacillin/Tazobactam will be given by intravenous infusion (dropper during 30 minutes).

Intravenous use
Each vial should be reconstituted with the volume of solvent shown in the following table, by using one of the compatible solvents for reconstitution. To promote the Reconstitution of the vial, invert it and shake it to loosen the dust adhering to the walls. Shake in rotating motions until dissolved. If shaken constantly, it is usually reconstituted within 5 to 10 minutes (see handling details below).

Vial contents                             Volume of solvent* to be added to the vial 4 g /0.5 g (4 g piperacillin and 0.5                          20 ml g tazobactam)

* Compatible solvents for reconstitution:
-    0.9% sodium chloride solution for injection (9 mg/ml)
-    Sterile water for injections (1)
-    Glucosa al 5%

(1)
The maximum recommended volume of sterile water for injections per dose is 50 ml.
The reconstituted solutions should be removed from the vial with a syringe. After reconstitution as indicated, the contents of the vial removed with a syringe will provide the nominal amount of piperacillin and tazobactam.

The reconstituted solutions can then be diluted to the desired volume (e.g. 50 ml to 150 ml) with one of the following compatible solvents:

-       0.9% sodium chloride solution for injection (9 mg/ml)
-       Glucosa al 5%
-       6% dextran in 0.9% sodium chloride
For incompatibilities, see section 6.2.
For single use only. Discard any unused solution.

Co-administration with aminoglycosides
Due to the in vitro inactivation of the aminoglycoside by beta-lactam antibiotics, TAZO-PIP AVENIR 4.5G and the aminoglycoside are recommended for separate administration.
TAZO-PIP AVENIR 4.5G 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.