Tranexamic Acid 100mg/ml Solution for Injection (10ml amp)

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

TRANEXAMIC ACID

Disponibbli minn:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Kodiċi ATC:

B02AA02

INN (Isem Internazzjonali):

TRANEXAMIC ACID 100 mg/ml

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

TRANEXAMIC ACID 100 mg/ml

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

ANTIHEMORRHAGICS

L-istatus ta 'awtorizzazzjoni:

Withdrawn

Data ta 'l-awtorizzazzjoni:

2017-01-26

Fuljett ta 'informazzjoni

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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 convul

Karatteristiċi tal-prodott

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1. NAME OF THE MEDICINAL PRODUCT
Tranexamic acid 100mg/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:
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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 tran