Medsamic 100 mg/ml solution for injection (5ml)

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

TRANEXAMIC ACID

Disponibbli minn:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

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

Sommarju tal-prodott:

Licence number in the source country: NOT APPLICAPABLE

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2021-11-01

Fuljett ta 'informazzjoni

PIL-tranexamic-v1.1MT
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDSAMIC 100MG/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 further questions, ask your doctor or nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

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 Medsamic is and what it is used for
2.
What you need to know before you are given Medsamic
3.
How to use Medsamic
4.
Possible side effects
5.
How to store Medsamic
6.
Contents of the pack and other information
1.
WHAT MEDSAMIC IS AND WHAT IT IS USED FOR
Medsamic contains tranexamic acid which belongs to a group of
medicines called antihaemorragics;
antifibrinolitics, aminoacids.
Medsamic 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.
PIL-tranexamic-v1.1MT
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2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MEDSAMIC DO
NOT USE MEDSAMIC:
•
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

Karatteristiċi tal-prodott

SPC-tranexamic-MT-v1.1
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medsamic 100 mg/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL contains: 100 mg of tranexamic acid.
Each 5 mL ampoule contains 500 mg of tranexamic acid.
Each 10 mL ampoule contains 1000 mg of tranexamic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution, pH 6.5 to 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:
SPC-tranexamic-MT-v1.1
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1.
Standard treatment of local fibrinolysis:
0.5 g (1 ampoule of 5 ml) to 1g (1 ampoule of 10 ml or 2 ampoules of
5ml) 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 5ml) 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 patient with severe renal impairment (see section
4.3). For patient with mild
to moderate renal impairment, the dosage of t