Indications : התוויות

Therapeutic indications                                                                                                                                                                                                                           RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
reactions including renal adverse reactions may still occur.                        performed. Some of the undesirable effects of AmBisome presented below
AmBisome is indicated:                                                                                                                                               may impact the ability to drive and use machines.                                Common: dyspnoea
In studies comparing AmBisome 3 mg/kg daily with higher doses (5,6 or                                                                                                Uncommon: bronchospasm
In the treatment of severe systemic and/or deep mycoses where toxicity           10 mg/kg daily), it was found that the incidence rates of increased serum           4.8 Undesirable effects
(particularly nephrotoxicity) precludes the use of conventional systemic         creatinine, hypokalemia and hypomagnesaemia were notably higher in the              Fever and chills/rigors are the most frequent infusion-related reactions         GASTROINTESTINAL DISORDERS
amphotericin B in effective dosages.                                             high dose groups.                                                                   expected to occur during AmBisome administration. Less frequent infusion-        Very common: nausea, vomiting
This drug should not be used to treat the common clinically inapparent forms                                                                                         related reactions may consist of one or more of the following symptoms: chest
Regular laboratory evaluation of serum electrolytes, particularly potassium                                                                                          Common: diarrhoea, abdominal pain
of fungal disease which show only positive skin or serologic tests.                                                                                                  tightness or pain, dyspnoea, bronchospasm, flushing, tachycardia
and magnesium, as well as renal, hepatic and haematopoietic function should
hypotension and musculoskeletal pain (described as arthralgia, back pain, or     HEPATOBILIARY DISORDERS
In the treatment of systemic fungal infections in immuno-compromised             be performed. This is particularly important in patients receiving concomitant
bone pain). These resolved rapidly on stopping the infusion and may not
patients (e.g. patients with AIDS or Cancer).                                    nephrotoxic medications (see section 4.5). Due to the risk of hypokalaemia,                                                                                          Common: liver function tests abnormal, hyperbilirubinaemia, alkaline
occur with every subsequent dose or when slower infusion rates (over 2 hours)
appropriate potassium supplementation may be required during the course                                                                                              phosphatase increased
As the primary therapy of visceral leishmaniasis in immunocompetent                                                                                                  are used.
of AmBisome administration. If clinically significant reduction in renal function
patients and immunocompromised patients (e.g. HIV Positive).                     or worsening of other parameters occurs, consideration should be given to           In addition, infusion-related reactions may also be prevented by the use of      SKIN AND SUBCUTANEOUS DISORDERS
In the empirical treatment of presumed fungal infection in febrile neutropenic   dose reduction, treatment interruption or discontinuation.                          premedication. However, severe infusion-related reactions may necessitate        Common: rash
patients.                                                                                                                                                            the permanent discontinuation of AmBisome (see section 4.4).                     Not known: angioneurotic oedema
Acute pulmonary toxicity has been reported in patients given amphotericin B