GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Tranexamic Acid Injection BP 1,000mg/10ml
B. Tranexamic Acid Injection BP 500mg/5ml
C. Tranexamic Acid Injection BP 250mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Tranexamic Acid Injection BP 1,000mg/10ml
Each ml contains:
Tranexamic Acid BP………..100mg
Water for Injection BP…….q.s


B. Tranexamic Acid Injection BP 500mg/5ml
Each ml contains:
Tranexamic Acid BP………..100mg
Water for Injections BP…….q.s

C. Tranexamic Acid Injection BP 250mg/ml
Each ml contains:
Tranexamic Acid BP………..250mg
Water for Injection BP…….q.s

THERAPEUTIC INDICATIONS:

Tranexamic acid injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia. Tranexamic acid injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.

DIRECTION OF USE:

For Intravenous use only.
Refer accompanying package leaflet.

CAUTION & WARNING:

CAUTION: Do not use the injection, if the contents are not clear or show particulate matter.
Discard unused portion after single use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C(59°F to 86°F).
Store in a cool, dry and dark place.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Tranexamic Acid Injection BP 1000mg/10ml Technical Specification:

Product Name:Tranexamic Acid Injection BP
Brand Name:Generic
Strength:1,000mg/10ml, 500mg/5ml, 250mg/ml
Dosage Form:Liquid Injection (Sterile)
Packing:100mg/ml – 10ml Single Dose Ampoule
100mg/ml – 5ml Single Dose Ampoule
250mg/ml -5ml Single Dose Ampoule
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Fibrinolytic/Haemostat
Indication: Tranexamic acid injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia. Tranexamic acid injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.
Storage:Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C (59°F to 86°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tranexamic Acid Injection BP 1,000mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tranexamic Acid Injection BP 1,000mg/10ml
    Each ml contains:
    Tranexamic Acid BP………..100mg
    Water for Injection BP…….q.s

THERAPEUTIC INDICATIONS:

Tranexamic acid injection is used to control or prevent excessive or heavy bleeding during dental procedures in patients with hemophilia. Tranexamic acid injection is an antifibrinolytic agent. It works by blocking the breakdown of blood clots. It may also be used for other conditions as determined by your doctor.

DIRECTION OF USE:

For Intravenous use only.
Refer accompanying package leaflet.

CAUTION & Warning:

CAUTION: Do not use the injection, if the contents are not clear or show particulate matter.
Discard unused portion after single use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F);excursions permitted to 15°C to 30°C(59°F to 86°F).
Store in a cool, dry and dark place.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.