Fragmin

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

Dalteparin sodium

Dostupné z:

Pfizer Australia Pty Ltd

Trieda:

Medicine Registered

Príbalový leták

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
•
before and after an operation to
prevent DVT
•
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 the face.
DO NOT USE FRAGMIN IF YOU HAVE
OR EVE

Súhrn charakteristických

Version: pfpfragi10313 
Supersedes: pfpfragi10610 

Page 1 of 19 
PRODUCT INFORMATION 
FRAGMIN® INJECTION 
DALTEPARIN SODIUM 
NAME OF THE MEDICINE 
Active ingredient:  Dalteparin sodium. 
CAS number:  9041-08-1. 
DESCRIPTION 
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. 
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 5000 Da with 90% between 2000 - 9000 Da. 
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 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 5 000 IU (anti-Xa)/0.2 mL single dose syringe, corresponding to 4900, 
5880 and 7060 IU anti-IIa respectively per syringe. 
PHARMACOLOGY 
PHARMACODYNAMICS 
FRAGMIN  is  composed  of  molecules  with  and  without  the  specially  characterised 
pentasaccharide (the antithrombin binding site).  FRAGMIN therefore acts a