CYKLOKAPRON Solution for Injection 500mg/5ml MG/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
TRANEXAMIC ACID
Available from:
Pharmacia Ireland
Dosage:
500mg/5ml MG/5ml
Pharmaceutical form:
Solution for Injection
Authorization date:
1998-04-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyklokapron 500mg/5ml, Solution for injection or infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the solution contains 500 mg of Tranexamic Acid (100 mg per ml).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless, aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local fibrinolysis
In the short term management of haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.
General fibrinolysis
In the management of haemorrhage complications in association with thrombolytic therapy.
In the management of haemorrhage associated with disseminated intravascular coagulation with predominant activation
of fibrinolytic system.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Intravenous.
_Adults including elderly:_
Acute activation of fibrinolytic mechanisms
Local fibrinolysis
Upper gastrointestinal haemorrhage
1.0 g (2 ampoules) by slow intravenous injection every six hours for the first three days then 1.0 to 1.5 g orally every
six hours for a further three to four days.
Prostatectomy
1.0 g by slow intravenous infusion every eight hours for the first three days; thereafter 1 g three to four times daily until
macroscopic haematuria is no longer present. As a bladder washout, 1 g is added to 1000 ml of normal saline daily for
two to five days after surgery and the bladder is irrigated at a rate of 1 ml/min.
IRISH MEDICINES BOARD
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_Date Printed 27/10/2011_
_CRN 2107063_
_page number: 1_
Epistaxis
Topical application may be made to the nasal mucosa of patients suffering from epistaxis
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