Posology : מינונים

4.2    Posology and method of administration
Posology
Administer one vial (100 mL) Combodex IV as a 15-minute infusion every 6 hours, as necessary. Do not exceed a total daily dose of 4000 mg (4 g) paracetamol.

Special populations
Paediatric population
The safety and efficacy of Combodex IV in children aged under 18 years have not been established.

Elderly
Clinical studies of Combodex IV did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently to younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients are at increased risk for serious GI adverse events (see section 4.4, Gastrointestinal events).

Renal impairment
Caution is also recommended in patients with pre-existing renal disease. No information is available from controlled clinical studies regarding the use of Combodex IV in patients with advanced renal disease. If Combodex IV therapy must be initiated in patients with advanced renal disease, closely monitor the patient’s renal function.

Hepatic impairment
The use of paracetamol at higher than recommended doses can lead to hepatotoxicity and even hepatic failure and death.

A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), Combodex IV should be discontinued.

Adverse gastrointestinal events
To minimise the potential risk for an adverse GI event in patients treated with a NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected.

This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

Method of administration
Combodex IV should be administered as a 15-minute intravenous infusion.

Visually inspect Combodex IV for particulate matter and discolouration prior to administration, whenever solution and container permit. If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used.

Combodex IV should be used in one patient on one occasion only. It contains no antimicrobial preservative. Unused solution should be discarded.

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.
It is recommended that for the administration of Combodex IV a syringe or giving set with a diameter equal to or below 0.8 mm should be used for solution sampling. In addition, it is recommended that the bung is pierced at the location specifically designed for needle introduction (where the thickness of the bung is the lowest). If these recommendations are not adhered to the likelihood of bung fragmentation or the bung being forced into the vial is increased.

To facilitate administration, the label attached to the vials of Combodex IV allows hanging.