FRAXIPARINE FORTE Nadroparin calcium 11,400 Anti- Xa IU/0.6mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Nadroparin calcium, Quantity: 11400 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:

6 Syringes, 10 Syringes, 2 Syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of deep vein thrombosis.

Product summary:

Visual Identification: Syringe containing a clear to slightly opalescent, colourless or slightly coloured 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:

1998-12-14

Patient Information leaflet

Fraxiparine
®
Forte Injection
FRAXIPARINE
®
FORTE
INJECTION
_nadroparin calcium_
_19,000 IU anti-Xa / mL solution for injection_
_ _
AUSTRALIAN CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Fraxiparine Forte
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 Forte
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
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 Forte is not
recommended for use in children or
adolescents.
BEFORE YOU USE
FRAXIPARINE FORTE
•
have an increased risk of bleeding
or a bleeding disorder
•
have a history of ulcers in the
stomach or intestine
•
have had a burst blood vessel in
your brain
•
have infective endocarditis (an
infection of the lining of the
heart)
•
have severe kidney failure and are
being treated for a blood clot
DO NOT USE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE CARTON
OR IF THE PACKAGING IS TORN OR SHOWS
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
SIGNS OF TAMPERING.
KEEP THIS LEAFLET WITH THE INJECTION.
You may need to read it again.
WHAT FRAXIPARINE
FORTE IS USED FOR
Fraxiparine Forte belongs to a group
of medicines called Low Molecular
Weight Heparins.
Fraxiparine Forte is 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.
_WHEN YOU MUST

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION - FRAXIPARINE
®
FORTE
(NADROPARIN CALCIUM)
1.
NAME OF THE MEDICINE
Nadroparin calcium
2 AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Sterile, clear preservative-free solution for subcutaneous injection
containing nadroparin calcium 19,000
IU anti-Xa per 1.0 mL dissolved in water for injections.
Nadroparin is a low molecular weight heparin made by depolymerisation
of standard heparin. It is a
glycosaminoglycan with a mean molecular weight around 4,500 daltons.
It possesses a high ratio of
anti-Xa activity to anti-IIa activity, between 2.5 to 4.0 compared to
unfractionated heparin for which this
ratio is one.
Anti-Xa denotes anti factor Xa activity. The ratio of anti-Xa to
anti-IIa activity is 2.5 to 4.0.
One ICU is equivalent to 0.38 IU anti-Xa.
The excipients contained in the Fraxiparine Forte 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 for subcutaneous injection.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of deep vein thrombosis (DVT).
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 Forte 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
Forte (see 4.4 SPECIAL
WARNINGS AND PRECAUTIONS FOR USE).
Specific recommendations regarding the timing of Fraxiparine Forte
dosing surrounding
spinal/epidural anaesthesia or spinal lumbar puncture should be
followed (see 4.4 S