Pause Injection 500 mg/ 5 ml

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Tranexamic acid

Available from:

Emcure Pharmaceuticals Limited, INDIA

ATC code:

Antifibrinolytics

INN (International Name):

Tranexamic acid

Dosage:

500 mg/ 5 ml

Pharmaceutical form:

Injection

Manufactured by:

Emcure Pharmaceuticals Limited, INDIA

Product summary:

Physical description: A Clear colourless solution free from particulate matter; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited

Authorization status:

Registered/Compliant

Authorization date:

2020-12-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tranexamic Acid BP 500 mg in 5 ml for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains:
Tranexamic Acid BP 500 mg
Water for Injection BP q.s.
3.
PHARMACEUTICAL FORM
Clear colourless solution free from particulate matter
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tranexamic acid is indicated in adults and children from one year in
prevention and
treatment of haemorrhages due to general or local fibrinolysis.
Specific indications include:
- Haemorrhage caused by general or local fibrinolysis such as:
•
Menorrhagia and metrorrhagia,
•
Gastrointestinal bleeding,
-
Haemorrhagic
urinary
disorders,
further
to
prostate
surgery
or
surgical
procedures affecting the urinary tract,Ear Nose Throat surgery
(adenoidectomy,
tonsillectomy, dental extractions),
-
Gynaecological surgery or disorders of obstetric origin,
-
Thoracic and abdominal surgery and other major surgical intervention
such as
cardiovascular surgery,
-
Management of haemorrhage due to the administration of a fibrinolytic
agent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
Unless otherwise prescribed, the following doses are recommended:
1. Standard treatment of local fibrinolysis:
0.5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of
5 mL)
tranexamic acid by slow intravenous injection or infusion (= 1
mL/minute) two to
three times daily
2. Standard treatment of general fibrinolysis:
1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow
intravenous
injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent
to 15 mg/kg
body weight (BW)
_Renal impairment_
In renal insufficiency leading to a risk of accumulation, the use of
tranexamic acid is
contraindicated in patient with severe renal impairment (see section
4.3). For patients
with mild to moderate renal impairment, the dosage of tranexamic acid
should be
reduced according to the serum creatinine level:
Serum creatinine
micromol/L
mg/10 mL
Dose