Cyklokapron 500mg/5ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tranexamic acid

Available from:

Pfizer Ltd

ATC code:

B02AA02

INN (International Name):

Tranexamic acid

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02110000; GTIN: 5012882006006

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYKLOKAPRON® 500 MG 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. 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 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 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 have currently 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
Page 2 of 5
Due to the risk of cerebral oedema and convulsions, intrathecal and
intraventricular
injection and intracerebral application are

Summary of Product characteristics

OBJECT 1
CYKLOKAPRON INJECTION
Summary of Product Characteristics Updated 15-Mar-2016 | Pfizer
Limited
1. Name of the medicinal product
Cyklokapron 500mg Solution for Injection
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 intravenous injection.
Clear, colourless solution with 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
_Renal impairment_
In renal insufficiency leading to a risk of accumulation, the use of
tranexamic acid is contraindicated in
patients 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