DBL™ Tranexamic Acid Injection

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Tranexamic acid 100 mg/mL

Доступно од:

Pfizer New Zealand Limited

INN (Међународно име):

Tranexamic acid 100 mg/mL

Дозирање:

100 mg/mL

Фармацеутски облик:

Solution for injection

Састав:

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

Тип рецептора:

Prescription

Произведен од:

Hunan Dongting Pharmaceutical Co Ltd

Терапеутске индикације:

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Localfibrinolysis may occur in the following conditions: · Prostatectomy and bladder surgery · Menorrhagia · Epistaxis · Conisation of the cervix · Management of dental extraction in patients with coagulopathies · Ulcerative colitis · Haematuria (Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma (also see PRECAUTIONS). · Gastrointestinal haemorrhage

Резиме производа:

Package - Contents - Shelf Life: Ampoule, glass, Type 1, 1000 mg/10 mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 500 mg/5 mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 500 mg/5 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze. - Ampoule, glass, Type 1, 1000 mg/10 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C protect from light. Do not freeze.

Датум одобрења:

2015-04-09

Карактеристике производа

DATA SHEET
HOSPIRA™ TRANEXAMIC ACID INJECTION
TRANEXAMIC ACID
500 MG/5 ML & 1000 MG/10 ML SOLUTION FOR INJECTION
PRESENTATION
Hospira™ Tranexamic Acid Injection is a sterile, clear and
colourless solution, containing 100
mg/mL tranexamic acid.
Each 5 mL ampoule of Hospira™ Tranexamic Acid Injection contains 500
mg tranexamic acid,
made up to 5 mL with Water for Injections (as the inactive
ingredient).
Each 10 mL ampoule of Hospira™ Tranexamic Acid Injection contains
1000 mg tranexamic
acid, made up to 10 mL with Water for Injections (as the inactive
ingredient).
USES
MECHANISM OF ACTION
Tranexamic acid is a competitive inhibitor of plasminogen activation
and at much higher
concentrations
a
noncompetitive
inhibitor
of
plasmin,
thus
implying
that
tranexamic
acid
interferes with the fibrinolytic process in the same way as
aminocaproic acid. Tranexamic
acid is about 10 times more potent in vitro than aminocaproic acid.
Tranexamic acid binds considerably more strongly than aminocaproic
acid to both the strong
and weak sites of the plasminogen molecule in a ratio corresponding to
the difference in
potency between the compounds.
Tranexamic
acid
in
a
concentration
of
1 mg/mL
does
not
aggregate
platelets
_in _
_vitro_.
Tranexamic acid in concentrations up to 10 mg/mL blood has no
influence on the platelet
count, the coagulation time or various coagulation factors in whole
blood or citrated blood in
normal subjects. On the other hand tranexamic acid in concentrations
of 10 mg/mL and 1
mg/mL blood prolongs the thrombin time.
Clinical
pharmacodynamics
data that examined
the
_in vivo _ effect of tranexamic acid on
prothrombotic
and
fibrinolytic
factors
showed
similar changes
in
anti-thrombin
(ATIII and
TAT)
and
anti-plasmin
(α2-PI & α2-PIP) complexes
in
both the tranexamic acid treated
patients and placebo in cardiac surgery. One study involving total
knee arthroplasty, PF1&2
coagulation factor levels increased to a similar extent in both the
tranexamic acid and the
patients receiving placebo.
D-Dimer
levels
were
si