TRANMENXIO IV INJECTION

Pajjiż: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Biotech Laboratories (Pty) Ltd

Dożaġġ:

See ingredients

Għamla farmaċewtika:

INJECTION

Kompożizzjoni:

EACH AMPOULE CONTAINS TRANEXAMIC ACID 500,0 mg

L-istatus ta 'awtorizzazzjoni:

Registered

Fuljett ta 'informazzjoni

Biotech Laboratories (Pty) Ltd TRANMENXIO IV
Page 1 of 8
PATIENT INFORMATION LEAFLET FOR
TRANMENXIO IV
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4I
TRANMENXIO IV, 500 MG/ 5 ML SOLUTION FOR INJECTION
TRANEXAMIC ACID
SUGAR FREE
Read all of this leaflet carefully before you are given TRANMENXIO IV.
Keep this leaflet. You may
need to read it again.
•
If you have further questions, please ask your doctor, pharmacist or
other health care
provider.
WHAT IS IN THIS LEAFLET
1.What TRANMENXIO IV is and what it is used for
2. What you need to know before you use TRANMENXIO IV
3. How to use TRANMENXIO IV
4. Possible side effects
5. How to store TRANMENXIO IV
6. Contents of the pack and other information
1. WHAT TRANMENXIO IV IS AND WHAT IT IS USED FOR
The name of your medicine is TRANMENXIO IV. TRANMENXIO IV contains a
medicine called
tranexamic acid. This belongs to a group of medicines called
coagulants, antihaemorrhagics,
antifibrinolytics.
Specific indications include:
• Blood inside the front chamber of eye,
• Hereditary angioedema, a genetic form of relapsing subcutaneous or
submucosal edema.
Biotech Laboratories (Pty) Ltd TRANMENXIO IV
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PATIENT INFORMATION LEAFLET FOR
TRANMENXIO IV
2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRANMENXIO IV
Do not take TRANMENXIO IV if:
•
If you are allergic to tranexamic acid or any of the other ingredients
of TRANMENXIO IV.
•
If you have currently a disease leading to blood clots in your blood
vessels (arteries or veins).
•
If you have a condition called ‘consumption coagulopathy’ where
blood in the whole body starts
to clot,
•
If you have a history of convulsions (fits),
•
If you have a massive upper urinary tract bleeding episode,
•
If you have known or pronounced tendency of clotting of the blood in a
part of circulatory system,
•
If you have known or pronounced disturbances in your colour vision,
•
If you suffer from thrombophlebitis (swelling/inflammation of a vien
caused by a blood clot),
•
If you have impaired liver function,
•
If you h

Karatteristiċi tal-prodott

Biotech Laboratories (Pty) Ltd TRANMENXIO IV
Page 1 of 13
PROFESSIONAL INFORMATION FOR
TRANMENXIO IV
SCHEDULING STATUS
S4
_ _
1. NAME OF THE MEDICINE
TRANMENXIO IV
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains 500 mg Tranexamic acid.
Sugar free.
For a 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
•
Short term use in the treatment of hyphaema
•
Hereditary angioedema
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Tranexamic acid is given by slow intravenous infusion/injection.
Administration by injection is
usually changed to oral administration after a few days.
TRAUMATIC HYPHAEMA:
1,0 to 1,5 g every 8 hours for six to seven days.
Biotech Laboratories (Pty) Ltd TRANMENXIO IV
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PROFESSIONAL INFORMATION FOR
TRANMENXIO IV
HEREDITARY ANGIOEDEMA:
Some patients are aware of the onset of illness; a suitable treatment
for these patients is 1,0 -
1,5 g two to three times daily for some days. Other patients are
treated continually at this
dosage.
SPECIAL POPULATIONS:
RENAL IMPAIRMENT
For patients in renal failure, tranexamic acid should be given with
caution because of the risk of
accumulation.
Dosages should be reduced in patients with renal impairment. For
patients with moderate to
severe impaired renal function, the following dosages are recommended.
SERUM CREATININE (ΜMOL/L)
INTRAVENOUS DOSE
120 – 250
10 mg/kg body weight twice daily
250 – 500
10 mg/kg body weight daily
> 500
5 mg/kg body weight daily
METHOD OF ADMINISTRATION
Tranexamic acid solution for injection is administered intravenously
by slow injection over a
period of at least five minutes.
Biotech Laboratories (Pty) Ltd TRANMENXIO IV
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PROFESSIONAL INFORMATION FOR
TRANMENXIO IV
4.3 CONTRAINDICATIONS
•
Hypersensitivity to tranexamic acid or to any of the excipients.
•
Acute venous or arterial thrombosis (see section 4.4).
•
Fibrinolytic conditio