Fragmin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Dalteparin sodium 25000 IU/mL

Available from:

Pfizer New Zealand Limited

INN (International Name):

Dalteparin sodium 25000 IU/mL

Dosage:

25000 IU/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Dalteparin sodium 25000 IU/mL Excipient: Water for injection

Units in package:

Syringe, 7500IU/0.3mL (not marketed), 0.3 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pfizer Health AB

Therapeutic indications:

· for the prevention of clotting in the extracorporeal system during haemodialysis and haemofiltration in connection with acute renal failure or chronic renal insufficiency

Product summary:

Package - Contents - Shelf Life: Syringe, 7500IU/0.3mL - 0.3 mL - 36 months from date of manufacture stored at or below 30°C - Syringe, 18000IU/0.72mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 15000IU/0.6mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 12500IU/0.5mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 10000IU/0.4mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C - Syringe, 12500IU/0.5mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 15000IU/0.6mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 18000IU/0.72mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Syringe, 5000IU/0.2mL - 10 dose units - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1987-12-17

Patient Information leaflet

FRAGMIN
®
Page 1 of 5
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 legs)

treatment of pulmonary
embolism (PE), a blood clot in
the veins of the lungs

prevention of DVT and PE
before and after an operation

treatment of DVT and PE for
up to 6 months in patients with
certain types of cancers

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.
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 allergy
include skin rash, itching,
difficulty breathing, and swelling
of th

Summary of Product characteristics

Version: pfdfragi10320
Supersedes: pfdfragi10219
Page 1 of 21
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
FRAGMIN® 10,000 IU/mL, 12,500 IU/mL, 25,000 IU/mL Solution for
Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
FRAGMIN solution for injection contains 10,000 IU/mL, 12,500 IU/mL,
25,000 IU/mL
dalteparin sodium.
The active substance of FRAGMIN is the sodium salt of low molecular
weight heparin
extracted from the intestinal mucosa of pig and is manufactured by
controlled depolymerisation
of heparin to produce sulphated polysaccharide chains having an
average molecular weight of
5,000 Da with 90% between 2,000 – 9,000 Da.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Dalteparin
sodium
(low
molecular
weight
heparin),
sodium
chloride
q.s.
(in
the
2,500 IU/0.2 mL, 7,500 IU/0.75 mL and 10,000 IU/1 mL syringe
presentations only), Water
for Injections.
One unit anti-Xa of FRAGMIN is equivalent in effect to the activity of
one unit of the 1st
international standard for Low Molecular Weight Heparin with regard to
inhibition of
coagulation factor Xa in plasma.
The
10,000 IU
(anti-Xa)/1 mL
syringe,
7,500 IU
(anti-Xa)/0.75 mL
syringe,
5,000 IU
(anti-Xa)/0.2 mL syringe and 2,500 IU (anti-Xa)/0.2 mL syringe have
the following anti-IIa
factor potencies 3,900, 2,940, 1,960 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 5,000 IU (anti-Xa)/0.2 mL single dose syringe,
corresponding to 4,900,
5,880 and 7,060 IU anti-IIa respectively per syringe.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prevention of clotting in the extracorporeal system during
haemodialysis and haemofiltration
in connection with acute renal failure or chronic renal insufficiency.
Treatment of acute deep venous thrombosis (DVT) and pulmonary embolism
(PE).
Version: pfdfragi10320
Supersedes: pfdfragi10219
Page 2 of 21
Extended treatment of symptomatic venous thromboembolism (VTE)
(proximal deep vein
thrombosis and/or