Tranexamic-AFT

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Tranexamic acid 100 mg/mL;  

Tersedia dari:

AFT Pharmaceuticals Ltd

INN (Nama Internasional):

Tranexamic acid 100 mg/mL

Dosis:

100 mg/mL

Bentuk farmasi:

Solution for injection

Komposisi:

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

Jenis Resep:

Prescription

Diproduksi oleh:

Hunan Dongting Pharmaceutical Co Ltd

Indikasi Terapi:

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: - prostatectomy and bladder surgery - epistaxis - management of dental extraction in patients with coagulopathies - ulcerative colitis - gastrointestinal haemorrhage. General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: - in obstetrical complications such as abruption placentae and post-partum haemorrhage - in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase. 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, glass, Clear type I - 1x10mLpack - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Clear type I - 1x5mLpack - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Clear type I - 5x10mLpack - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Clear type I - 5x5mLpack - 5 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Clear type I - 10x10mLpack - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light - Ampoule, glass, Clear type I - 10x5mLpack - 10 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Tanggal Otorisasi:

2015-05-28

Karakteristik produk

NEW ZEALAND DATA SHEET
Page 1 of 18
1
TRANEXAMIC-AFT
Tranexamic acid 500 mg/5 mL & 1000 mg/10 mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule contains 500 mg of tranexamic acid and 5 mL water
for injection.
Each 10 mL ampoule contains 1000 mg of tranexamic acid and 10 mL water
for injection.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection.
Tranexamic-AFT s
olution for injection is a sterile, clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Haemorrhage or risk of haemorrhage in increased fibrinolysis or
fibrinogenolysis. Local
fibrinolysis may occur in the following conditions:
•
Prostatectomy and bladder surgery
•
Epistaxis
•
Management of dental extraction in patients with coagulopathies
•
Ulcerative colitis
•
Gastrointestinal haemorrhage.
General fibrinolysis as in prostatic and pancreatic cancer; after
thoracic and other major
surgery:
•
in obstetrical complications such as abruptio placentae and
post-partum haemorrhage
•
in leukaemia and liver diseases and in connection with thrombolytic
therapy with
streptokinase.
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 is necessary only if it is difficult to
give adequate doses by mouth.
The recommended standard dose is 5-10 mL by slow intravenous injection
at a rate of 1
mL/minute, two to three times daily. For the indications listed below
the following doses are
recommended.
NEW ZEALAND DATA SHEET
Page 2 of 18
Prostatectomy
5-10mL by slow intravenous injection every eight hours (the first
injection being given during
the operation) for the first three days after surgery then 1-1.5g
orally three