Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients
None

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6.2 Incompatibilities
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.

Tazo-Pip Avenir 4.5g should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

Tazo-Pip Avenir 4.5g should be administered through an infusion set separately from any other drugs unless compatibility is proven.
Because of chemical instability, Tazo-Pip Avenir 4.5g should not be used with solutions containing only sodium bicarbonate.

Lactated Ringer's solution is not compatible with Tazo-Pip Avenir 4.5g.

Tazo-Pip Avenir 4.5g should not be added to blood products or albumin hydrolysates 

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6.3 Shelf life
Unopened - 3 years
When Tazo-Pip Avenir 4.5g is reconstituted with water for injections or saline, reconstituted solutions will remain stable for 24 hours at 25°C and for 48 hours under refrigeration 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.


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6.4 Special precautions for storage
Unopened: Store at room temperature up to 25°C.
o
After reconstitution: Store at 2-8 C (see 6.3 Shelf Life).


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6.5 Nature and contents of container
Packs of one Type II glass vial with butyl rubber stopper and aluminium/plastic seal 

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6.6 Special precautions for disposal and other handling
Intravenous Injection
Each vial of Tazo-Pip Avenir 4.5g Powder for Solution for Injection or Infusion should be reconstituted with 20ml of one of the following diluents:

• Sterile water for injections

• 0.9% sodium chloride for injection
Swirl until dissolved. Intravenous injection should be given over at least three to five minutes.

Intravenous Infusion

Each vial of Tazo-Pip Avenir 4.5g Powder for Solution for Injection or Infusion should be reconstituted with 20ml of Sterile water for injection or 0.9% sodium chloride for injection.

The reconstituted solution should be further diluted to at least 50ml with one of the reconstitution diluents, or with Dextrose 5% in Water or Dextrose 5% in saline or Dextrose 6% in saline.
Displacement Volume

Each gram of Tazo-Pip Avenir 4.5g Powder for Solution for Injection or Infusion has a displacement volume of 0.7ml.

Tazo-Pip Avenir 4.5g Powder for Solution for Injection or Infusion will displace 3.15ml.

The reconstitution/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.

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


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