Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
ETAMSYLATE
PHARMA TO MARKET PTE. LTD.
B02BX01
250 mg/2 ml
INJECTION
ETAMSYLATE 250 mg/2 ml
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
SANOFI WINTHROP INDUSTRIE
ACTIVE
1988-04-21
DICYNONE ® 250 MG/ 2 ML SOLUTION FOR INJECTION COMPOSITION _Active substance:_ Etamsylate _Excipients_: sodium metabisulfite, sodium hydrogen carbonate, water for injections PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT Solution for injection in an ampoule (2 ml). Each ampoule contains 250 mg of etamsylate. 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. 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). CONTRAINDICATIONS – Acute porphyria – Bronchial asthma, confirmed hypersensitivity to sulphites – Hypersensitivity to any of the ingredients of the medicinal product SPECIAL WARNINGS AND PRECAUTIONS Due to the risk of a fall in blood pressure during parenteral administration, caution is required in patients presenting unstable blood pressure or hypotension (see “Undesirable effects”). DICYNONE 250 solution for injection contains sodium metabisulfite as antioxidant, which may cause allergic reactions, nausea and diarrhea in susceptible patients. The allergic reactions may go as far as anaphylactic shock and cause life-threatening asthma attacks. The prevalence in the population is not known but is p Прочетете целия документ
DICYNONE ® 250 MG/ 2 ML SOLUTION FOR INJECTION COMPOSITION _Active substance:_ Etamsylate _Excipients_: sodium metabisulfite, sodium hydrogen carbonate, water for injections PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT Solution for injection in an ampoule (2 ml). Each ampoule contains 250 mg of etamsylate. 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. 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). CONTRAINDICATIONS – Acute porphyria – Bronchial asthma, confirmed hypersensitivity to sulphites – Hypersensitivity to any of the ingredients of the medicinal product SPECIAL WARNINGS AND PRECAUTIONS Due to the risk of a fall in blood pressure during parenteral administration, caution is required in patients presenting unstable blood pressure or hypotension (see “Undesirable effects”). DICYNONE 250 solution for injection contains sodium metabisulfite as antioxidant, which may cause allergic reactions, nausea and diarrhea in susceptible patients. The allergic reactions may go as far as anaphylactic shock and cause life-threatening asthma attacks. The prevalence in the population is not known but is probably low. However, hypersensitivity to sulphites is observed more frequently in patient with asthma than in those without asthma (see «Contraindications»). If a hypersensitivity reaction occurs, the administration of Dicynone 250 solution f Прочетете целия документ