FRAXIPARINE nadroparin calcium 9500IU anti-Xa/1.0mL

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nadroparin calcium, Quantity: 9500 anti-Xa IU

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: calcium hydroxide; water for injections

Administration route:

Subcutaneous

Units in package:

2 x 1.0mL, 10 x 1.0mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylaxis against deep vein thrombosis (DVT) associated with general or orthopaedic surgery. Treatment of DVT. Prevention of clotting during haemodialysis. Prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

Product summary:

Visual Identification: Syringe containing a clear to slightly opalescent, colourless or slightly yellow solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1995-09-11

Patient Information leaflet

Fraxiparine
®
Injection
FRAXIPARINE
®
INJECTION
_nadroparin calcium_
_9,500 IU anti-Xa / mL solution for injection_
_ _
AUSTRALIAN CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fraxiparine
injections. It does not contain all the
available information. It does not
take the place of talking to your
doctor, pharmacist or nurse.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Fraxiparine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE INJECTION.
You may need to read it again.
WHAT FRAXIPARINE IS
USED FOR
Fraxiparine belongs to a group of
medicines called Low Molecular
Weight Heparins.
Fraxiparine is used to prevent the
blood from clotting after having
surgery, during haemodialysis,
during hospitalisation for acute
illness or in intensive care unit with
extended bed rest and is also used to
treat existing blood clots that are
blocking blood vessels.
It is a medicine that works by
delaying the action by which blood
clots form. This results in the blood
remaining thin and prevents
formation of clots which may
become lodged in blood vessels and
treats blood clots if they have
already formed.
This medicine is available only with
a doctor's prescription.
There is not enough information to
recommend how the use of this
medicine can affect your ability to
drive a car or operate machinery.
There is not enough information to
recommend the use of this medicine
for patients aged less than 18 years.
Therefore, Fraxiparine is not
recommended for use in children or
adolescents.
BEFORE YOU USE
FRAXIPARINE
_WHEN YOU MUST NOT USE IT_
DO NOT USE FRAXIPARINE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
nadroparin calcium
•
heparin or low-molecular weight
heparins
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
whee

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - FRAXIPARINE
®
(NADROPARIN
CALCIUM)
1
. NAME OF THE MEDICINE
Nadroparin calcium
2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Sterile, clear preservative-free solution containing nadroparin
calcium 9,500 IU anti-Xa/mL per 1.0mL
dissolved in water for injections with sufficient calcium hydroxide or
dilute hydrochloric acid to adjust
the pH to between 5 and 7.5.
The excipients contained in the Fraxiparine solution are:
Calcium hydroxide solution or dilute hydrochloric acid (to adjust pH)
and water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
Disposable glass pre-filled single use syringes containing a clear
solution usually for subcutaneous
injection.
4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
Prophylaxis against deep vein thrombosis (DVT) associated with general
or orthopaedic surgery.
Treatment of DVT.
Prevention of clotting during haemodialysis.
Prophylaxis of venous thromboembolism in high-risk medical patients
who are immobilised due to
acute illness or hospitalised in an intensive care unit.
4.2 DOSE AND METHOD OF ADMINISTRATION
Particular attention should be paid to the specific dosing
instructions for each proprietary LMWH as
different units of measurement (units or mg) are used to express
doses. Fraxiparine should therefore
not be used interchangeably with other low weight molecular weight
heparins during ongoing treatment.
In addition, care should be taken to use the correct formulation of
nadroparin, either Fraxiparine or
Fraxiparine Forte, as this will affect the dosing regimen.
Platelet count must be monitored throughout treatment with Fraxiparine
(see See Section 4.4 Special
warnings and precautions for use).
Specific recommendations regarding the timing of Fraxiparine dosing
surrounding spinal/epidural
anaesthesia or spinal lumbar puncture should be followed (see See
Section 4.4 Special warnings and
precautions for use).
ADMINISTRATION
Usually by subcutaneous injection into the lateral abdom