Tranexamic acid 100 mg/mL solution for injection/infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

TRANEXAMIC ACID PH. EUR.

Inapatikana kutoka:

Baxter Holding B.V.

ATC kanuni:

B02AA02

INN (Jina la Kimataifa):

TRANEXAMIC ACID PH. EUR.

Kipimo:

100 milligram(s)/millilitre

Dawa fomu:

Solution for injection/infusion

Eneo la matibabu:

tranexamic acid

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2020-06-05

Taarifa za kipeperushi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANEXAMIC ACID 100MG/ML SOLUTION FOR INJECTION/INFUSION
tranexamic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist 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 use Tranexamic acid
3. How to use 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 injection/infusion contains tranexamic acid which
belongs to a
group of medicines called antihaemorragics; antifibrinolitics,
aminoacids.
Tranexamic acid 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 USE TRANEXAMIC ACID
DO NOT USE TRANEXAMIC ACID:
•
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
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Due to the risk of cerebral oedema and convulsions, intrath

Tabia za bidhaa

Health Products Regulatory Authority
05 June 2020
CRN008TJ2
Page 1 of 6
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 mL vial contains 100 mg of tranexamic Acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colorless and essentially free from visible particles.
pH of the solution is between 6.5 to 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 vial of 5 mL) to 1 g (1 vial of 10 mL or 2 vials 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 vial of 10 mL or 2 vials 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 patients with severe
renal impairment (see section 4.3). For patients with mild