Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Tranexamic acid 100 mg/mL
Pfizer New Zealand Limited
Tranexamic acid 100 mg/mL
100 mg/mL
Solution for injection
Active: Tranexamic acid 100 mg/mL Excipient: Nitrogen Water for injection
Prescription
Hunan Dongting Pharmaceutical Co Ltd
Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Localfibrinolysis may occur in the following conditions: · Prostatectomy and bladder surgery · Menorrhagia · Epistaxis · Conisation of the cervix · Management of dental extraction in patients with coagulopathies · Ulcerative colitis · Haematuria (Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma (also see PRECAUTIONS). · Gastrointestinal haemorrhage
Package - Contents - Shelf Life: Ampoule, glass, Type 1, 1000 mg/10 mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 500 mg/5 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 500 mg/5 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 1000 mg/10 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.
2015-04-09
DATA SHEET HOSPIRA™ TRANEXAMIC ACID INJECTION TRANEXAMIC ACID 500 MG/5 ML & 1000 MG/10 ML SOLUTION FOR INJECTION PRESENTATION Hospira™ Tranexamic Acid Injection is a sterile, clear and colourless solution, containing 100 mg/mL tranexamic acid. Each 5 mL ampoule of Hospira™ Tranexamic Acid Injection contains 500 mg tranexamic acid, made up to 5 mL with Water for Injections (as the inactive ingredient). Each 10 mL ampoule of Hospira™ Tranexamic Acid Injection contains 1000 mg tranexamic acid, made up to 10 mL with Water for Injections (as the inactive ingredient). USES MECHANISM OF ACTION Tranexamic acid is a competitive inhibitor of plasminogen activation and at much higher concentrations a noncompetitive inhibitor of plasmin, thus implying that tranexamic acid interferes with the fibrinolytic process in the same way as aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds considerably more strongly than aminocaproic acid to both the strong and weak sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. Tranexamic acid in a concentration of 1 mg/mL does not aggregate platelets _in _ _vitro_. Tranexamic acid in concentrations up to 10 mg/mL blood has no influence on the platelet count, the coagulation time or various coagulation factors in whole blood or citrated blood in normal subjects. On the other hand tranexamic acid in concentrations of 10 mg/mL and 1 mg/mL blood prolongs the thrombin time. Clinical pharmacodynamics data that examined the _in vivo _ effect of tranexamic acid on prothrombotic and fibrinolytic factors showed similar changes in anti-thrombin (ATIII and TAT) and anti-plasmin (α2-PI & α2-PIP) complexes in both the tranexamic acid treated patients and placebo in cardiac surgery. One study involving total knee arthroplasty, PF1&2 coagulation factor levels increased to a similar extent in both the tranexamic acid and the patients receiving placebo. D-Dimer levels were si Przeczytaj cały dokument