Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Azeptil 250mg/5ml solution for injection.
Azeptil 500mg/5ml solution for injection.
| Pharmaceutical Form |
|---|
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Solution for injection. A clear colourless solution, pH 6.5 to 8.0. |
Azeptil 250mg/5ml solution for injection: Each ampoule contains 5ml of an aqueous solution containing 250mg tranexamic acid.
Azeptil 500mg/5ml solution for injection: Each ampoule contains 5ml of an aqueous solution containing 500mg tranexamic acid.
Excipients with known effect: sodium methabisulphite.
Each 250mg/5ml ampoule contains 9.15mg sodium methabisulphite.
Each 500mg/5ml ampoule contains 9.15mg sodium methabisulphite
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tranexamic acid |
Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin. Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. |
| List of Excipients |
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Azeptil 250mg/5ml and 500mg/5ml solution for injection also contain propylene glycol, sodium metabisulfite (E223), sodium hydroxide and water for injection. |
Azeptil 250mg/5ml and 500mg/5ml solution for injection are filled into brown glass type I ampoules. 5 ampoules are placed into a PVC case. Cases and leaflet in an outer carton. Boxes of ten ampoules are available.
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Azeptil 250mg/5ml solution for injection: 19835
Azeptil 500mg/5ml solution for injection: 19834
Azeptil 250mg/5ml solution for injection: 19.12.2005/30.05.2012
Azeptil 500mg/5ml solution for injection: 19.12.2005/31.05.2012
| Drug | Countries | |
|---|---|---|
| AZEPTIL | Cyprus, Hong Kong |
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