Fibtin Injection 500 mg/5 mL Solution for injection.

Fibtin Injection 500 mg/5 mL Solution for injection.

S4
PDF Leaflet Revision Date: 28 April 2021

API: Tranexamic Acid | Company: Pharmacare

Clinical Summary

Quick overview from the medicine insert

Indication

Short term treatment of hyphaema, coagulopathies, dental extraction in haemophiliacs, hereditary angioedema, and menorrhagia.

Dosage (summary)

1.0 to 1.5 g every 8 hours for hyphaema; 25 mg/kg before dental surgery; 1.0 to 1.5 g 3-4 times daily for menorrhagia.

Special Populations

  • Renal impairment

Pregnancy & Breastfeeding

Safety in pregnancy not established; crosses placenta. Caution in breastfeeding as it passes into milk.

Key Drug Interactions

  • Anticoagulants
  • Oestrogens
  • Thrombolytics

Contraindications

  • Hypersensitivity to tranexamic acid
  • Massive upper urinary tract hemorrhage
  • Thrombotic tendency
  • Thrombophlebitis
  • Impaired liver function
  • Subarachnoid bleeding
  • Acute venous or arterial thrombosis
  • History of convulsions

Common side effects

  • Dizziness
  • Nausea
  • Vomiting
  • Diarrhoea
  • Visual disturbances

Counselling Points

  • Use effective contraception during treatment
  • Monitor for visual disturbances
  • Avoid driving until effects are known

Serious warnings

  • Risk of convulsions
  • Thromboembolic events
  • Care in patients with DIC
Important Disclaimer

The Fibtin Injection 500 mg/5 mL Solution for injection. professional information leaflet below is the property of Pharmacare and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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