NEGABAN Powder for solution for injection/infusion Ref.[9595] Active ingredients:

Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving therapy with penicillins. If an allergic reaction occurs during therapy with Negaban, the drug must be discontinued.

Cross-allergy with cephalosporins is frequent (10 to 15%).

In patients with kidney failure, the posology must be adapted to the degree of insufficiency, as recommended in Section 4.2. Posology and Method of Administration.

Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions have sometimes been assessed with abnormalities of coagulation tests and are more likely to occur in patients with renal failure.

If bleeding manifestations occur, the antibiotic should be discontinued and appropriate therapy instituted.

As with any antibiotic, temocillin may be associated with induced pseudomembranous colitis, although animal studies have never shown any induction of Clostridium difficile infection. In case of severe, persistent diarrhoea, caution is recommended, Negaban must be discontinued and suitable therapy be initiated (eg oral metronidazole or oral vancomycin). Preparations which inhibit peristalsis are contra-indicated.

As with other antibiotics, the possibility of emergence of resistant organisms which might cause superinfections should be kept in mind, particularly during prolonged treatment. Microbiological follow-up may be required to detect any important superinfection. If this occurs, appropriate measures should be taken.

As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously.

Periodic electrolyte determinations should be made in patients with low potassium reserves and the possibility of hypokalaemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics. Modest elevations of indices of liver function may be observed.

Sodium content: approximately 5 mmol per vial.

None known.

Pregnancy

Animal studies with temocillin have shown no teratogenic effects. There is no experience of temocillin in human pregnancy. Therefore, its use in pregnancy cannot be recommended.

Breastfeeding

Trace quantities of penicillins can be detected in the milk of lactating mothers. Therefore, mothers should not breastfeed their infants while receiving temocillin.

Fertility

In animal studies, no effects on fertility have been observed with temocillin (see Section 5.3).

None known.

Undesirable effects are typical of the injectable penicillins: they may include diarrhoea, pain at the site of I.M. injection, occasionally rash, either urticarial or erythematous.

Certain reactions such as fever, arthralgia or myalgia, sometimes develop more than 48 hours after the start of the treatment. In any case, discontinuance of treatment and recourse to another appropriate antibiotic therapy are essential.

In common with other β-lactam antibiotics angioedema and anaphylaxis have been reported.

There is also a risk of phlebitis and thrombophlebitis with intravenous administration of β-lactam antibiotics, although to a lesser extent in the case of Negaban.

In patients suffering from renal failure, neurological disorders with convulsions have been reported following the I.V. injection of high doses of penicillin.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme on the website www.mhra.gov.uk/yellowcard.

Negaban should not be mixed with the following in the syringe, intravenous fluid container or giving set:

• Proteinaceous fluids (e.g. protein hydrolysates)
• Blood products
• Intravenous lipid emulsions
• Aminoglycosides

This medicinal product must not be mixed with other products except those mentioned in section 6.6.