Tranexamic Acid 100 mg/ml solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tranexamic acid

Available from:

Ibigen Srl

ATC code:

B02AA; B02AA02

INN (International Name):

Tranexamic acid

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Amino acids; tranexamic acid

Authorization status:

Marketed

Authorization date:

2014-12-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRANEXAMIC ACID 100 MG/ML, SOLUTION FOR INJECTION/INFUSION
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. See section 4.
WHAT IS IN THIS LEAFLET
1. What Tranexamic Acid is and what it is used for
2. What you need to know before you are given Tranexamic Acid
3. How to take Tranexamic Acid
4. Possible side effects
5. How to store Tranexamic Acid
6. Contents of the pack and other information
1.
WHAT TRANEXAMIC ACID IS AND WHAT IT IS USED FOR
Tranexamic Acid Solution for Injection/Infusion contains tranexamic
acid which belongs to a group of
medicines called ‘anti-haemorrhagics’ or ‘anti-fibrinolytics’.
Tranexamic Acid is used in adults and children above one year of age
for the prevention and treatment of
bleeding which is caused by a process that inhibits blood clotting
called fibrinolysis.
Specific indications include:
•
heavy periods in women
•
gastrointestinal bleeding
•
haemorrhagic urinary disorders, after having an operation on your
prostate gland or urinary tract
•
after having an operation on your ear, nose or throat
•
after having heart, abdominal or gynaecological surgery
•
bleeding after you have been treated with another medicine to treat
blood clots
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN TRANEXAMIC ACID
DO NOT TAKE TRANEXAMIC ACID IF YOU:
•
are allergic to tranexamic acid or any of the other ingredients of
this medicine (listed in section 6)
•
currently have a blood clot(s) or have every had a disease leading to
blood clots. (If you are at risk of
having blood clots, see ‘Warnings and precautions’ below)
•
have a condition called ‘consumption coagulopathy’ where blood in
the whole body

Summary of Product characteristics

Health Products Regulatory Authority
30 January 2020
CRN009JGD
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tranexamic Acid 100 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 100 mg of tranexamic acid.
Each 5 ml of solution contains 500 mg of tranexamic acid.
Each 10 ml of solution contains 1 g of tranexamic acid.
Excipient with known effect: Contains less than 1mmol sodium per dose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear solution free of particles in a colourless glass ampoule.
pH 6.5 - 8.0
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
_ _
_Patients with renal impairment_
In renal insufficiency leading to a risk of acc