Cyklokapron 100 mg/mL solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tranexamic acid

Available from:

Pfizer Healthcare Ireland

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:

1983-04-01

Patient Information leaflet

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 Cyklokapron is and what it is used for
2. What you need to know before you are given Cyklokapron
3. How to take Cyklokapron
4. Possible side effects
5. How to store Cyklokapron
6. Contents of the pack and other information
1. WHAT CYKLOKAPRON IS AND WHAT IT IS USED FOR
Cyklokapron contains tranexamic acid which belongs to a group of
medicines called antihaemorragics;
antifibrinolitics, aminoacids.
Cyklokapron 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 gynecological 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 CYKLOKAPRON
DO NOT TAKE CYKLOKAPRON:
• If you are allergic to tranexamic acid or any of the other
ingredients of this medicine (listed in section 6).
• If you currently have a disease leading to blood clots.
• If you have a condition called ‘consumption coagulopathy’
where blood in the whole body starts to clot.
• If you have kidney problems.
• If you have a history of convulsions.
Due to the risk of cerebral oedema and convulsions, intrathecal and
intraventricular injection and intracerebral
application are not recommended.
If you think any of these apply to you, or if you are in any doubt at
all, tell your doctor before taking C

Summary of Product characteristics

Health Products Regulatory Authority
02 August 2023
CRN00DF46
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyklokapron 100 mg/mL solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains 500 mg tranexamic acid.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution with pH of 6.5-8.0.
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 tranex