Fragmin

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Dalteparin sodium 2500 IU/mL

Disponible depuis:

Pharmacia Limited Company trading as Pharmacia

DCI (Dénomination commune internationale):

Dalteparin sodium 2500 IU/mL

Dosage:

2500 IU/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Dalteparin sodium 2500 IU/mL Excipient: Sodium chloride Water for injection

Unités en paquet:

Ampoule, 10 x 4mL, 40 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Recipharm Stockholm AB

Descriptif du produit:

Package - Contents - Shelf Life: Ampoule, 10 x 4mL - 40 mL - 36 months from date of manufacture stored at or below 30°C

Date de l'autorisation:

1988-03-24

Résumé des caractéristiques du produit

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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).
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Extended treatment of symptomatic venous thromboembolism (VTE)
(proximal deep vein
thrombosis and/or