国: 南アフリカ
言語: 英語
ソース: South African Health Products Regulatory Authority (SAHPRA)
Hexal
KETOHEXAL syrup SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): KETOHEXAL syrup COMPOSITION Each 5 mL syrup contains 1,38 mg ketotifen hydrogen fumarate equivalent to 1 mg ketotifen base. Each 5 mL syrup contains 0,016% Propylparahydroxybenzoate as preservative Each 5 mL syrup contains 0,034% Methylparahydroxybenzoate as preservative CONTAINS ALCOHOL 2,49% v/v PHARMACOLOGICAL CLASSIFICATION A.10.2.2 Medicines Acting on the respiratory tract –other PHARMACOLOGICAL ACTION KetoHexal syrup has anti-histaminic properties. KetoHexal syrup exhibits H 1 receptor blocking ability The absorption of KetoHexal syrup is almost complete following oral dosing and within 48 hours approximately 60 to 70% of the medicine is excreted via the urine in the form of metabolites. INDICATIONS Long term prevention of asthma. KetoHexal syrup is not effective in aborting an asthma attack. Prevention and treatment of rhinitis and skin reactions of allergic nature. CONTRA-INDICATIONS Hypersensitivity to any of the ingredients of this formulation. The administration of KetoHexal syrup is contra-indicated in patients suffering from hepatic disease. Safety in pregnancy and lactation has not been established . WARNINGS KetoHexal syrup may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against taking charge of vehicles or machinery or performing potentially hazardous tasks where the loss of concentration may lead to accidents. DOSAGE AND DIRECTIONS FOR USE Each 5 mL contains 1 mg ketotifen base. Below 14kg body mass - 0,3 mg (1,5 mL) twice daily. 14 - 25kg body mass - 0,5 mg (2,5 mL) twice daily. 25kg body mass and over - 1 mg (5 mL) twice daily. Therapeutic effect 完全なドキュメントを読む