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

Posology

Patients with normal renal function

Adults (including the elderly)

Usual dose: 4 g per day to be divided into 2 administrations or as continuous infusion.

High dose notably in critically ill patients: 6 g per day to be divided into 3 administrations or as continuous infusion.

A loading dose of 2 g should be administered before starting the continuous infusion (see Method of administration).

Children

Insufficient data are available to recommend an appropriate dosage regimen.

Patients with renal insufficiency

Adults (including the elderly)

Temocillin is mainly excreted renally and unchanged. Excretion is reduced in renal impairment and half-life is increased according to the severity of renal failure. In moderate and severe renal failure, dose adjustments are necessary in accordance with the following regimen:

In case of intermittent high-flux hemodialysis: As a rule, the I.M. route should be avoided, considering the patient’s treatment with heparin. I.V. injection of Negaban is recommended, using water for injection or physiological saline as solvent: 1 g (I.V. injection) per 24 h of inter-dialytic session, preferably at the end of the hemodialysis (1 g q24 h, 2 g q48 h, 3 g q72 h).

In case of continuous peritoneal dialysis in ambulatory patients: 1 g Negaban I.M. every 24 hours.

These data are based on studies where creatinine clearance was used to estimate the degree of renal impairment.

Patients with impaired liver function

Limited experience in patients with impaired hepatic function has not indicated a need for a reduction in dosage.

Method of administration

Negaban may be administered by intravenous injection, intermittent or continuous intravenous infusion, or intramuscular injection.

Intravenous solutions: Negaban solutions should be administered by slow injection into the vein (3-4 minutes) or as an intravenous infusion over a period of 30-40 minutes. Continuous intravenous infusion of temocillin might be considered when therapeutic objectives are difficult to reach with intermittent administrations. A loading dose of 2 g should be administered before starting the continuous infusion.

Intramuscular injection: Negaban may be given intramuscularly after reconstitution. If pain is experienced at the site of I.M. injection, a sterile solution of lidocaine hydrochloride 0.5-1% may be used in place of water for injection.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

There have been no reported cases of overdosage. Dosages of up to 8 g daily have been administered to volunteers without untoward effects.

Negaban may be removed from the circulation by haemodialysis.

Shelf life

Unopened vials: 3 years.

Reconstituted and diluted solutions: refer to details on appropriate solvents and administration times to section 6.6.

The solutions should preferably be used immediately after their preparation.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C for the following solvents: water for injection, physiological saline (0.9% sodium chloride), dextrose 5%, sodium chloride compound (Ringer’s solution), Hartmann solution (sodium lactate compound + Ringer’s lactate solution).

Unopened vials: Store in a refrigerator (2°C-8°C). Store in the original package.

Reconstituted and diluted solutions: for storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

From a 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 should normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Clear glass vial with butyl rubber stoppers and either aluminium seal or aluminium plastic seal in packs of 1 vial or 5 vials.

Not all pack sizes may be marketed.

For single-use only.

Negaban is not intended for multi-dose use, any part-used antibiotic solution should be discarded. Solutions are normally a pale yellow colour.

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

Intravenous administration

Intravenous injection

Inject I.V. solutions in 3-4 minutes, within one hour following their preparation.

Intermittent intravenous infusion

Solutions should be prepared as described for intravenous injection and then added to an intravenous infusion solution in a mini-bag or in-line burette and administered over a period of 30-40 minutes. Alternatively, using a suitable reconstitution device, the appropriate volume of intravenous fluid may be transferred from the infusion bag into the vial and then drawn back into the bag after dissolution.

Continuous intravenous infusion

Solutions should be prepared as described and administered over 24 h at a rate of 2 mL/hour. A loading dose of 2 g temocillin is required before starting the continuous infusion.

Intramuscular administration

Intramuscular injection

After addition of water to the vial, shake vigorously. Inject I.M. solutions immediately after preparation.