Tranexamic-AFT tranexamic acid 1000 mg/10 mL solution for injection ampoule

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

tranexamic acid, Quantity: 100 mg/mL

MAH:

AFT Pharmaceuticals Pty Ltd

INN:

Tranexamic acid

pharmaceutical_form:

Injection

composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

administration_route:

Intravenous

units_in_package:

10 ampoules, 1 ampoule, 5 ampoules

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

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.

leaflet_short:

Visual Identification: Clear liquid free of particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Licence status A

authorization_date:

2015-11-09

PIL

1
AUSTRALIAN PRODUCT INFORMATION TRANEXAMIC-AFT (TRANEXAMIC ACID)
1
NAME OF THE MEDICINE
Tranexamic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tranexamic-AFT contains tranexamic acid 500 mg per 5 mL or 1,000 mg
per 10 mL ampoule.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection.
Tranexamic-AFT is a sterile, clear, colourless solution containing
tranexamic acid 500 mg per 5 mL
or 1,000 mg per 10 mL ampoule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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, followed by infusion of 4.5 mg/kg/h for the
duration of surgery. 0.6 mg/kg of
this infusion dose may be added in the priming volume of the
heart-lung machine.
_ADULT TOTAL KNEE ARTHROPLASTY _
Administration of 15 mg/kg tranexamic acid 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 is to be
administered 16 hours after the initial dose.
2
_ADULT TOTAL HIP ARTHROPLASTY _
Administration of 15mg/kg tranexamic acid immediately prior to skin
incision, followed by a repeat
bolus of 15 mg/kg at 8 hourly intervals after the initial dose. The
last bolus dose is to be administered
16 hours after the initial dose (also see 5.1 PHARMACODYNAMIC PROPERTIES -
CLINICAL TRIALS
).
_DOSAGE ADJUSTMENT IN THE ELDERLY _
No reduction in dosage is necessary, unless there is evidence of renal
failure.
_DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT _
Table 1:
_ _
Adult Cardiac Surgery
_ _
EGFR (ML/MIN

SPC

Sequence n0001
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
TRANEXAMIC-AFT (TRANEXAMIC ACID)
1.
NAME OF THE MEDICINE
Tranexamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tranexamic-AFT contains tranexamic acid 500 mg per 5 mL or 1,000 mg
per 10 mL ampoule. For the full
list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection.
Tranexamic-AFT is a sterile, clear, colourless solution containing
tranexamic acid 500 mg per 5 mL
or
1,000 mg per 10 mL ampoule.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
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, followed by infusion of 4.5 mg/kg/h for the
duration of surgery. 0.6 mg/kg of
this infusion dose may be added in the priming volume of the
heart-lung machine.
_ADULT TOTAL KNEE ARTHROPLASTY _
Administration of 15 mg/kg tranexamic acid 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 is to be administered
16 hours after the initial dose.
_ADULT TOTAL HIP ARTHROPLASTY _
Administration of 15mg/kg tranexamic acid immediately prior to skin
incision, followed by a repeat bolus
of 15 mg/kg at 8 hourly intervals after the initial dose. The last
bolus dose is to be administered 16 hours
after the initial dose (also see CLINICAL TRIALS).
Sequence n0001
Page 2 of 23
_DOSAGE ADJUSTMENT IN THE ELDERLY _
No reduction in dosage is necessary, unless there is evidence of renal
failure.
_DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT _
_Table 1: Adult Cardiac Sur