Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**4.2 Posology and method of administration** Usually 1–2 mg intravenously or intramuscularly. _Pulmonary oedema:_ Initially 2 mg by intravenous injection. This can be repeated, if necessary, after 20 minutes. In those conditions in which an infusion is appropriate, 2–5 mg may be given in 500 ml infusion fluid over 30–60 minutes. _Renal failure:_ 2–10 mg in 500 ml infusion fluid given over a period of 30–60 minutes. Repeated, if required, at intervals of 6–8 hours. _Drug poisoning with salicylates or barbiturates:_ Initially, 2 mg intravenously, followed by 1 mg every 4 hours. Totally, 7 mg in the course of 24 hours. The usual procedure for forced alkaline diuresis should be followed. Burinex® injection may be added to the commonly used infusion fluids based on glucose, sodium chloride, sodium bicarbonate, or potassium chloride.
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**4.1 Therapeutic indications** Burinex® is indicated whenever diuretic therapy is required in the treatment of oedema _e.g._ associated with congestive heart failure, cirrhosis of the liver, renal diseases including the nephrotic syndrome. Acute pulmonary oedema, drug induced fluid retention, and drug poisoning that can be treated by forced diuresis. Hypertension.
**4.3 Contraindications** - Hypersensitivity to formaldehyde (see Section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Hypersensitivity to active substance or to any of the excipients - Severe electrolyte depletion - Persisting anuria - Hepatic encephalopathy including coma
C03CA02
bumetanide
Manufacturer Information
ZUELLIG PHARMA PTE. LTD.
CENEXI
Active Ingredients
Documents
Package Inserts
Burinex Injection PI.pdf
Approved: March 15, 2022