E. R. Squibb & Sons Limited

The updates are as follows:

6.1 List of Excipients

Other ingredients: desoxycholic acid, concentrated phosphoric acid, sodium

hydroxide, disodium phosphate dodecahydrate, monosodium phosphate dehydrate,

water.

6.5 Nature and contents of container

Type I flint glass vials closed with a grey chlorobutyl rubber stopper.

Vials of 50mg

Sections updated are as follows:

1.         Name of the medicinal product

Fungizone 50mg Powder for Sterile Concentrate

3.         Pharmaceutical form

Powder for Concentrate for Solution for Infusion. (Powder for Sterile Concentrate)

4.2       Posology and method of administration

CAUTION:

Under no circumstances should a total daily dose of 1.5mg/kg be exceeded. Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest (see section 4.4 & 4.9).  The recommended concentration for intravenous infusion is 10mg/100ml.

4.4       Special warnings and precautions for use

Care must be taken when administering Fungizone Intravenous to prevent overdose, which can result in potentially fatal cardiac or cardiorespiratory arrest. Verify the product name and dosage pre-administration, especially if the dose prescribed exceeds 1.5mg/kg (see section 4.2 Posology and Method of Administration and section 4.9 Overdose Symptoms, Emergency Procedures, Antidotes).

4.9       Overdose symptoms, emergency procedures, antidotes

Amphotericin overdoses can result in potentially fatal cardiac or cardio-respiratory arrest.  If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardio-respiratory, renal, and liver function, haematologic status serum electrolytes) and administer supportive therapy as required.  Amphotericin is not haemodialysable.  Prior to reinstituting therapy, the patient's condition should be stabilised (including correction of electrolyte deficiencies, etc.)

10.       Date of revision of the text

22 December 2009

 Section 4.8  Abnormal renal function (including renal impairment, renal insufficiency, acute renal failure and nephrogenic diabetes insipidus) added.