Products

Savibleed Ampoules

Tranexamic acid 500 mg
 

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Active ingredient

Tranexamic acid 500 mg
 

Indications

• Local fibrinolysis
For short term use in prophylaxis and treatment in patients at high risk of per - and post-operative haemorrhage is following:
a) Prostatectomy.
b) Conisation of the cervix.
c) Surgical procedures and dental extractions in haemophiliacs.
• General fibrinolysis
a) Haemorrhagic complications in association with thrombolytic therapy.
b) Haemorrhage associated with disseminated intravascular coagulation with predominant activation of the fibrinolytic system.

Dosage and Administration

  • Route of administration: by slow intravenous injection.
  • Local fibrinolysis: the recommended standard dose is 5-10 ml (500-1000 mg) by slow intravenous injection (1 ml/min), three times daily. If treatment continues for more than three days, consideration should be given to the use of Savibleed tablets. Alternatively, following an initial intravenous injection, subsequent treatment may proceed by intravenous infusion. Following addition to a suitable diluent. Savibleed may be administered at a rate of 25-50 mg/kg body wt/day.
  • In children: the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited.
    Injectable solution: The efficacy, posology and safety of Tranexamic acid in children undergoing cardiac surgery have not been fully established.
  • Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.
  • General fibrinolysis
    - In disseminated intravascular coagulation with predominant activation of the fibrinolytic system, usually a single dose of
    10 ml (1g) is sufficient to control bleeding.
    - Neutralisation of thrombolytic therapy; 10 mg/kg body wt by slow intravenous injection.

Contraindication

  • History of venous or arterial thrombosis.
  • History of convulsions.
  • Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions).

Side effects

Very rare adverse events have been reported.

Drug Interaction

Pregnancy and Lactation

  • Pregnancy
    Although there is no evidence from animal studies of a teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed. Tranexamic acid crosses the placenta.
  • Lactation
    Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in
    the maternal blood. An antifibrinolytic effect in the infant is unlikely.

Warning and Precaution

  • The indications and method of administration indicated above should be followed strictly:
    - Intravenous injections should be given very slowly.
    - Tranexamic acid should not be administered by the intramuscular route.
  • Due to the risk of cerebral oedema and convulsions, intrathecal or intraventricular injection and intracerebral application are contra-indicated. In patients with a history of convulsion, tranexamic acid should not be administered.
  • In case of haematuria of renal origin, there is a risk of mechanical anuria due to formation of a ureteral clot.
  • In patients with renal insufficiency, because of the risk of accumulation: See the insert leaflet for dose adjustment.
  • In massive haematuria from the upper urinary tract (especially in haemophilia) since, in a few cases, ureteric obstruction has been reported.
  • In patients with disseminated intravascular coagulation (DIC) treatment must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding.

Package and Storage

  • Carton box containing 5 ampoules each of 5 ml & insert leaflet.
  • Store at temperature not exceeding 30ºC in a dry place.

Mother Company

Manufactured by Sunny Pharmaceuticals , Under licence from Marcyrl