Tranexamic Acid Juno

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Tranexamic acid 100 mg/mL

Tersedia dari:

Juno Pharmaceuticals NZ Limited

INN (Nama Internasional):

Tranexamic acid 100 mg/mL

Dosis:

500 mg/5mL

Bentuk farmasi:

Solution for injection

Komposisi:

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

Jenis Resep:

Prescription

Diproduksi oleh:

Changzhou Yinsheng Pharmaceutical Co Ltd

Indikasi Terapi:

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

Ringkasan produk:

Package - Contents - Shelf Life: Ampoule, clear type 1 glass - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, clear type 1 glass - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Tanggal Otorisasi:

2015-09-24

Karakteristik produk

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_Tranexamic Acid Juno Datasheet _
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_Juno Pharmaceuticals NZ Pty Ltd _
NEW ZEALAND DATASHEET
1
PRODUCT NAME
TRANEXAMIC ACID JUNO, 500 mg / 5 mL solution for injection.
TRANEXAMIC ACID JUNO, 1000 mg / 10 mL solution for injection.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tranexamic Acid Juno 5 mL ampoule contains 500 mg of tranexamic
acid and 5 mL water
for injections.
Each Tranexamic Acid Juno 10 mL ampoule contains 1000 mg tranexamic
acid and 10 mL water
for injections.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tranexamic Acid Juno Solution for injection is a sterile, clear and
colourless solution, containing
100 mg/mL tranexamic acid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
For the reduction of peri– and post-operative blood loss and the
need for blood transfusion
in
adult
patients
undergoing
cardiac
surgery or
total
knee
arthroplasty or
total
hip
arthroplasty.
•
For the reduction of peri- and post-operative blood loss and the need
for blood transfusion
in paediatric 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.
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_Tranexamic Acid Juno Datasheet _
_ _
_Juno Pharmaceuticals NZ Pty Ltd _
_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 do