Tranexamic Acid Link

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Tranexamic acid 100 mg/mL

Disponible depuis:

Luminarie Group Limited

DCI (Dénomination commune internationale):

Tranexamic acid 100 mg/mL

Dosage:

100 mg/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Tranexamic acid 100 mg/mL Excipient: Water for injection

Type d'ordonnance:

Prescription

Fabriqué par:

Hunan Dongting Pharmaceutical Co Ltd

indications thérapeutiques:

Adults: For the reduction of peri - and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. Paediatrics: For the reduction of peri - and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, glass, Type I clear, 5 x 5ml in printed carton - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Date de l'autorisation:

2014-10-24

Résumé des caractéristiques du produit

TRANEXAMIC ACID INJECTION
500MG/5ML AMPOULE
NEW ZEALAND DATA SHEET LUMINARIE PTY LTD
__________________________________________________________________________________
TRANEXAMIC ACID
-LINK
(Tranexamic acid)
1 NAME OF THE MEDICINE
Tranexamic acid
Tranexamic acid 500 mg/5mL solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANEXAMIC ACID LINK Solution for Injection contains 100 mg/mL
tranexamic acid.
Tranexamic acid is a white crystalline powder that is odourless or
almost odourless. It is freely
soluble in water and in glacial acetic acid, practically insoluble in
methanol, ethanol, acetone,
diethyl ether and benzene.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for Injection. Sterile, clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRANEXAMIC ACID LINK is indicated in the treatment of;
INTRAVENOUS ADMINISTRATION
_ADULTS_
For the reduction of peri
–
and post-operative blood loss and the need for blood transfusion in
patients undergoing cardiac surgery or total knee arthroplasty or
total hip arthroplasty.
_PAEDIATRICS_
For the reduction of peri
–
and post-operative blood loss and the need for blood transfusion in
patients undergoing cardiac surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
INTRAVENOUS ADMINISTRATION
_ADULT CARDIAC SURGERY_
After induction of anaesthesia and prior to skin incision, administer
a pre-surgical loading dose
of 15 mg/kg TRANEXAMIC ACID LINK, followed by infusion of 4.5 mg/kg/h
for the
TRANEXAMIC ACID INJECTION
500MG/5ML AMPOULE
NEW ZEALAND DATA SHEET LUMINARIE PTY LTD
__________________________________________________________________________________
duration of surgery. 0.6 mg/kg of this elder dose may be added in the
priming volume of the
heart- lung machine.
_ADULT TOTAL KNEE ARTHROPLASTY_
Administration of 15 mg/kg TRANEXAMIC ACID LINK prior to release of
the tourniquet
followed by repeat bolus injection of 15 mg/kg at 8 hourly intervals
after the initial dose.
The last bolus dose i