Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
Warnings
The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.

Before initiating therapy with Tazo-Pip Avenir 4.5g, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta lactam agents (e.g.cephalosporins,monobactam or carbapenem) and other allergens.

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins including piperacillin/tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens.
Serious hypersensitivity reactions require the discontinuation of the antibiotic, and may require administration of epinephrine and other emergency measures.

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients receiving piperacillin/tazobactam (see section 4.8). If patients develop a skin rash they should be monitored closely and piperacillin/tazobactam discontinued if lesions progress.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases piperacillin/tazobactam, should be discontinued.

Precautions

Periodic assessment of organ system functions including renal and hepatic during prolonged therapy is advisable.
Therapy with piperacillin/tazobactam may result in the emergence of resistant organisms, which might cause super-infections.

Bleeding manifestations have occurred in some patients receiving β-lactam antibiotics.
These reactions have sometimes been associated with abnormalities of coagulation tests such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure. If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted

Leukopenia and neutropenia may occur, especially during prolonged therapy. Therefore, periodic assessment of haematopoietic (a full blood count) should be performed.

Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.
As with treatment with other penicillins, neurological complications in the form of convulsions may occur when high doses are administered, especially in patients with impaired renal function.

This medicinal product contains 9.44 mmol (217 mg) of sodium per vial of powder for solution for injection or infusion. This should be taken into consideration for patients who are on a controlled sodium diet.

Hypokalaemia may occur in patients with low potassium reserves or who are receiving concomitant medications that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Modest elevation of indices of liver function may be observed.

Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients (see also 4.8).

Until further experience is available, Tazo-Pip Avenir 4.5g should not be used in children who do not have neutropenia.


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Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, side effects may occur (see also 4.8), which may influence the ability to drive and use machines.


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