Tranexamic Acid Injection

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Tranexamic acid 100 mg/mL;  

Pieejams no:

Medsurge Pharma Limited

SNN (starptautisko nepatentēto nosaukumu):

Tranexamic acid 100 mg/mL

Deva:

500 mg/5mL

Zāļu forma:

Solution for injection

Kompozīcija:

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

Receptes veids:

Prescription

Ražojis:

Asahi Kasei Finechem Co Ltd

Ārstēšanas norādes:

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis 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.

Produktu pārskats:

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

Autorizācija datums:

2015-02-10

Lietošanas instrukcija

_MEDSURGE TRANEXAMIC ACID INJECTION_ CMI NZ V1.0 (JANUARY 2019)
1
_TRANEXAMIC ACID INJECTION _
_ _
_TRANEXAMIC ACID _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before
you
start
taking
Tranexamic
Acid
Injection.
This
leaflet
answers
some
common questions about Tranexamic
Acid Injection. It does not contain all
the available information. It does not
take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Tranexamic Acid Injection
against
the
expected
benefits
it
will
have for you.
Use
Tranexamic
Acid
Injection
as
instructed and follow the advice given
in this leaflet.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TRANEXAMIC ACID
INJECTION IS USED FOR
Tranexamic Acid Injection is used to
reduce
bleeding
and
the
need
for
transfusion
of
blood
in
patients
undergoing
heart
surgery,
total
knee
replacement and total hip replacement
surgery.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
HOW TRANEXAMIC ACID
INJECTION WORKS
Tranexamic
Acid
Injection
contains
tranexamic acid. Tranexamic acid is an
antifibrinolytic that works by slowing
the processes that cause bleeding.
BEFORE TAKING
TRANEXAMIC ACID
INJECTION
_WHEN YOU MUST NOT TAKE IT _
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU HAVE AN ALLERGY TO
TRANEXAMIC ACID INJECTION OR ANY OF
THE INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU ARE BEING TREATED FOR
A STROKE.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU ARE BEING TREATED FOR
BLOOD
CLOTS
IN
YOUR
LEGS,
LUNGS
OR
ANYWHERE ELSE IN YOUR BODY.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU HAVE A PROBLEM WITH
COLOUR VISION THAT DEVELOPED AFTER YOU
WERE BORN.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION AFTER THE EXPIRY DATE (EXP)
PRINTED ON THE PACK.
If you take this medi

Produkta apraksts

TRANEXAMIC ACID INJECTION
500 MG/ 5 ML AMPOULE
NEW ZEALAND DATA SHEET
Edition 2.0 (October 2021)
Page 1 of 19
1
PRODUCT NAME
Tranexamic Acid Injection
Tranexamic acid 500 mg/5mL solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tranexamic acid 500mg/5mL
For the full list of excipients, see section _6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Solution for injection.
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
•
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 section _4.4 Special warnings and
precautions for use_)
•
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.
Hereditary angioneurotic oedema.
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.
TRANEXAMIC ACID INJECTION
500 MG/ 5 ML AMPOULE
NEW ZEALAND DATA SHEET
Edition 2.0 (October 2021)
Page 2 of 19
4.2
DOSE AND METHOD OF ADMINISTRATION
TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL
ADMINISTRATION.
Dose
Intravenous Administration
ADULT CARDIAC SURGERY
After induction of anaesthesia and prior to skin incision, administer
a pre-surgical loading dose of 15