ns in children with febrile neutropenia have been successfully treated with AmBisome, without reports of unusual adverse events. AmBisome has been studied in paediatric patients aged one month to 18 years old. Doses used in these clinical studies were the same as those used in adults on a mg/kg body weight basis.
AmBisome is not recommended for use in children below 1 month old due to lack of data on safety and efficacy.
Elderly Patients: No alteration in dose or frequency of dosing is required.
Renal Impairment: AmBisome has been administered to a large number of patients with pre-existing renal impairment at starting doses ranging from 1-3 mg/kg/day in clinical trials and no adjustment in dose or frequency of administration was required (See section 4.4).
Hepatic Impairment: No data are available on which to make a dose recommendation for patients with hepatic impairment (See section 4.4).
For instructions on reconstitution and dilution of the product before administration, see section 6.6.
Go to top of the page4.3 Contraindications
AmBisome is contraindicated in those patients who have shown hypersensitivity to the active substance or to any of the excipients unless, in the opinion of the physician, the condition requiring treatment is life-threatening and amenable only to AmBisome therapy.
Go to top of the page4.4 Special warnings and precautions for use
Anaphylaxis and anaphylactoid reactions have been reported in association with AmBisome infusion. Allergic type reactions, including severe infusion-related reactions can occur during administration of amphotericin-containing products, including AmBisome (see section 4.8). Therefore, administration of a test dose is still advisable before a new course of treatment. For this purpose a small amount of an AmBisome infusion (e.g. 1 mg) can be administered for about 10 minutes, the infusion stopped and the patient observed carefully for the next 30 minutes. If there have been no severe allergic or anaphylactic/anaphylactoid reactions the infusion of AmBisome dose can be continued. If a severe allergic or anaphylactic/anaphylactoid reaction occurs, the infusion should be immediately discontinued and the patient should not receive further infusion of AmBisome.
Other severe infusion-related reactions can occur during administration of amphotericin B-containing products, including AmBisome (see section 4.8). Although infusion-related reactions are not usually serious, consideration of precautionary measures for the prevention or treatment of these reactions should be given to patients who receive AmBisome therapy. Slower infusion rates (over 2 hours) or routine doses of diphenhydramine, paracetamol, pethidine and/or hydrocortisone have been reported as successful in their prevention or treatment.
AmBisome has been shown to be substantially less toxic than conventional amphotericin B, particularly with respect to nephrotoxicity; however, adverse reactions including renal adverse reactions, may still occur.
In studies comparing AmBisome 3 mg/kg daily with higher doses (5, 6 or 10 mg/kg daily, it was found that the incidence rates of increased serum creatinine, hypokalaemia and hypomagnesaemia were notably higher in the high dose groups.
In particular, caution should be exercised when prolonged therapy is required. Regular laboratory eva luation of serum electrolytes, particularly potassium and magnesium as well as renal, hepat
