Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**DOSAGE AND ADMINISTRATION** Usual dosages: - Adults: - emergency: 2 to 3 ampoules 3 times daily - pre-operative period, 1 hour before surgery: 2 ampoules - peri-operative period: according to requirement - post-operative period: 1 ampoule, twice daily - In newborn and children: half the adult dose IV or IM ROUTE. The Injectable solution may also be used by the oral route (diluted in a half-glass water) or locally (dabbing).
INTRAVENOUS, INTRAMUSCULAR
Medical Information
**INDICATIONS** In general medicine: - blood loss through fragile capillaries - menorrhagia (heavy periods) with no detectable organic cause - in general or specialized surgery (ENT, ophthalmology, gynaecology): reduction of blood loss during operations, particularly diffuse haemorrhage, patients treated with anticoagulants.
**CONTRAINDICATIONS** - Acute porphyria - Bronchial asthma, confirmed hypersensitivity to sulphites - Hypersensitivity to any of the ingredients of the medicinal product
B02BX01
etamsylate
Manufacturer Information
PHARMA TO MARKET PTE. LTD.
SANOFI WINTHROP INDUSTRIE
Active Ingredients
Documents
Package Inserts
Dicynone_PI.pdf
Approved: October 29, 2014