FRAGMIN dalteparin sodium 12,500 anti-Xa IU/0.5mL injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dalteparin sodium, Quantity: 12500 anti-Xa IU

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; water for injections

Administration route:

Subcutaneous, Intravenous

Units in package:

5 x 0.5mL, 2 x 0.5mL, 10 x 0.5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Prophylaxis against thrombotic complications during haemodialysis and treatment of acute deep vein thrombosis (DVT). Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or pulmonary embolism) to reduce the recurrence of VTE in patients with solid tumour cancers. Treatment of unstable coronary artery disease, i.e. unstable angina and non-ST-elevation myocardial infarction (also known as non-Q-wave myocardial infarction). Prophylaxis against thrombo-embolic complications in the peri- or postoperative period of surgery.

Product summary:

Visual Identification: A clear, colourless or straw-coloured solution for injection; Container Type: Syringe; Container Material: Glass; 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:

1997-11-11

Patient Information leaflet

FRAGMIN
®
_Dalteparin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FRAGMIN.
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 using FRAGMIN
against the expected benefits it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again later.
WHAT FRAGMIN IS
USED FOR
FRAGMIN is used to prevent blood
clots forming in blood vessels. It is
used in the following conditions:
•
treatment of deep vein thrombosis
(also known as DVT, a blood clot
in the veins of the leg)
•
treatment of DVT and pulmonary
embolism (blood clot in the veins
of the lungs) for up to 6 months
in patients with certain types of
cancers
•
prevention of DVT before and
after an operation
•
treatment of unstable heart
disease (e.g. angina and heart
attack), which is caused by poor
blood flow in the blood vessels of
the heart.
•
FRAGMIN is also used to
prevent blood clotting during
haemodialysis, a procedure that
uses a machine to remove waste
products from the blood in people
with kidney failure.
•
FRAGMIN belongs to a group of
medicines called low molecular
weight heparins (LMWHs).
These medicines work by
reducing blood clotting activity.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FRAGMIN
HAS BEEN PRESCRIBED FOR YOU.
•
Your doctor may have prescribed
FRAGMIN for another reason.
•
This medicine is available only
with a doctor's prescription.
BEFORE YOU USE
FRAGMIN
_WHEN YOU MUST NOT USE IT_
•
DO NOT USE FRAGMIN IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
dalteparin sodium
•
any other low molecular weight
heparin or similar medicines such
as heparin
•
pork products
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of b

Summary of Product characteristics

Version: pfpfragi10420
Supersedes: pfpfragi11219
Page 1 of 21
AUSTRALIAN
PRODUCT
INFORMATION
-
FRAGMIN
®
INJECTION
(DALTEPARIN
SODIUM)
1.
NAME OF THE MEDICINE
Dalteparin sodium.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2,500 IU (anti-Xa) dalteparin sodium/0.2 mL injection syringe
5,000 IU (anti Xa) dalteparin sodium/0.2 mL injection syringe
7,500 IU (anti-Xa) dalteparin sodium/0.75 mL injection syringe
10,000 IU (anti-Xa) dalteparin sodium/1 mL injection syringe
12,500 IU (anti-Xa) dalteparin sodium/0.5mL injection syringe
15,000 IU (anti-Xa) dalteparin sodium/0.6mL injection syringe
18,000 IU (anti-Xa) dalteparin sodium/0.72mL injection syringe
The 10000 IU (anti-Xa)/1 mL syringe, 7500 IU (anti-Xa)/0.75 mL
syringe, 5000 IU (anti
Xa)/0.2 mL syringe and 2500 IU (anti-Xa)/0.2 mL syringe have the
following anti-IIa factor
potencies 3900, 2940, 1960 and 980 respectively.
The 0.5, 0.6 and 0.72 mL single dose syringe presentations have the
same anti-IIa factor
potency per mL as the 5000 IU (anti-Xa)/0.2 mL single dose syringe,
corresponding to 4900,
5880 and 7060 IU anti-IIa respectively per syringe.
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear colourless or straw-coloured solution.
Version: pfpfragi10420
Supersedes: pfpfragi11219
Page 2 of 21
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis against thrombotic complications during haemodialysis and
treatment of acute
deep vein thrombosis (DVT).
Extended treatment of symptomatic venous thromboembolism (VTE)
(proximal deep vein
thrombosis and/or pulmonary embolism) to reduce the recurrence of VTE
in patients with
solid tumour cancers.
Treatment of unstable coronary artery disease, i.e. unstable angina
and non-ST-elevation
myocardial infarction (also known as non-Q wave myocardial
infarction).
Prophylaxis against thromboembolic complications in the peri- or
postoperative period of
surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
THROMBOPROPHYLAXIS IN CONJUNCTION WITH SURGERY
2 5