When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
In Section 6.5, the colour description of the glass vials has changed to: Type I clear flint glass vials closed with a grey butyl rubber stopper. Vials of 50mg.
4.8 Undesirable Effects
Addition of heparin (1000 units per infusion), rotation of the injection site, the use of a paediatric scalp-vein needle and alternate-day therapy may lessen the incidence of thrombophlebitis. Extravasation may cause chemical irritation. The adverse reactions that are most commonly observed are: fever (sometimes with shaking chills), headache, anorexia, weight loss, nausea and vomiting, malaise, muscle and joint pains, dyspepsia, cramping epigastric pain, diarrhoea, local venous pain at the injection site with phlebitis and thrombophlebitis, normochromic normocytic anaemia and hypokalaemia. Abnormal renal function (including renal impairment, renal insufficiency, acute renal failure and nephrogenic diabetes insipidus) including hypokalaemia, azotaemia, hyposthenuria, renal tubular acidosis or nephrocalcinosis, is also commonly observed and usually improves upon interruption of therapy; however, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5g) of amphotericin.