Tranexamic acid 100 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tranexamic acid

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

B02AA; B02AA02

INN (International Name):

Tranexamic acid

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

Amino acids; tranexamic acid

Authorization status:

Marketed

Authorization date:

2016-12-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANEXAMIC ACID 100 MG/ML SOLUTION FOR INJECTION
tranexamic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET
1. What Tranexamic acid Injection is and what it is used for
2. What you need to know before you are given Tranexamic acid
Injection
3. How to take Tranexamic acid Injection
4. Possible side effects
5. How to store Tranexamic acid Injection
6. Contents of the pack and other information
1. WHAT TRANEXAMIC ACID INJECTION AND WHAT IT IS USED FOR
Tranexamic acid Injection contains tranexamic acid which belongs to a
group of medicines called
antihaemorragics; antifibrinolitics.
Tranexamic acid Injection is used in adults and children above one
year of age for the prevention and
treatment of bleeding due to a process that inhibits blood clotting
called fibrinolysis.
Specific indications include:

Heavy periods in women

Gastrointestinal bleeding

Haemorrhagic urinary disorders, further to prostate surgery or
surgical procedures affecting
the urinary tract

Ear, nose or throat surgery

heart, abdominal or gynaecological surgery

bleeding after you have been treated with another medicine to break
down blood clots.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRANEXAMIC ACID
INJECTION
DO NOT TAKE TRANEXAMIC ACID INJECTION IF YOU:

are allergic to tranexamic acid or any of the other ingredients of
this medicine (listed in section 6)

have (or ever have had) a disease that leads to blood clots

have a condition called ‘consumption coagulopathy’ where blood in
the whole body starts to clot

have kidney problems

have a history of convulsions
Due to the risk of cerebral oedema and convulsions, intra

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2021
CRN00C6KS
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tranexamic acid 100 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is tranexamic acid.
Each 5 ml of the solution contains 500 mg of tranexamic acid.
Each 10 ml of the solution contains 1000 mg of tranexamic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
A clear colourless solution, free from visible particulate matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention and treatment of haemorrhages due to general or local
fibrinolysis in adults and children from one year.
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 (= 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 (= 1 ml/minute) every 6 to 8
hours, equivalent to 15 mg/kg BW
_Renal impairment_
Health Products Regulatory Authority
01 March 2021
CRN00C6KS
Page 2 of 7
In renal insufficiency leading to a risk of accumulation, the use of
tranexamic acid is contraindicated i