Heparin Sodium (Baxter)

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Heparin sodium 2 IU/mL

Disponible depuis:

Baxter Healthcare Ltd

DCI (Dénomination commune internationale):

Heparin sodium 2 IU/mL (as 1mL of 100IU/mL heparin sodium)

Dosage:

2 U/mL

forme pharmaceutique:

Solution for infusion

Composition:

Active: Heparin sodium 2 IU/mL Excipient: Citric acid monohydrate Dibasic sodium phosphate dodecahydrate Sodium chloride Water for injection

Unités en paquet:

Bag, plastic, viaflex, 500 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Laboratori Derivati Organici SpA

indications thérapeutiques:

HEPARIN SODIUM Intravenous Infusion is indicated as an anticoagulant in extracorporeal circulation, dialysis procedures, and as an aid in the maintenance of catheter patency.

Descriptif du produit:

Package - Contents - Shelf Life: Bag, plastic, viaflex - 500 mL - 24 months from date of manufacture stored at or below 30°C - Bag, plastic, viaflex - 1000 mL - 24 months from date of manufacture stored at or below 30°C

Date de l'autorisation:

1986-03-13

Résumé des caractéristiques du produit

NEW ZEALAND DATA SHEET
HEPARIN SODIUM Data Sheet 19 January 2022
Page 1 of 12
Baxter Healthcare Ltd
1 HEPARIN SODIUM (2U/mL solution for infusion)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active substance _
Heparin sodium (2U/mL).
_The biological origin of the active substance _
Heparin is a heterogenous mixture of variably sulphated polysaccharide
chains composed of
repeating units of disaccharides, _D_‐glucosamine and _L_‐iduronic
acid or _D_‐ glucosamine and _D_‐
glucuronic acids. It is extracted from porcine intestinal mucosa.
Upon complete hydrolysis,
it yields a mixture of _D_‐glucosamine, _D_‐glucuronic acid,
_L_‐ iduronic acid,
acetic acid and sulphuric acid.
Although others may be present, the main sugars occurring in heparin
are: (1) α‐L‐iduronic acid 2‐
sulfate, (2) 2‐deoxy‐2‐sulfamino‐α‐_D_‐glucose
6‐sulfate, (3) β‐_D_‐glucuronic acid, (4) 2‐acetamido‐2‐
deoxy‐α‐_D_‐glucose, and (5) α‐_L_‐iduronic acid. These
sugars are present in decreasing amounts,
usually in the order (2) > (1) > (4) > (3) > (5), and are joined by
glycosidic linkages, forming polymers
of varying sizes.
_Excipient with known effect _
Sodium chloride (0.9%).
For the
full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
HEPARIN SODIUM intravenous infusion is a clear, sterile,
non‐pyrogenic solution of heparin sodium
standardised for use as an anticoagulant in 0.9% Sodium Chloride
intravenous infusion buffered with
0.4mg citric acid monohydrate and 5.8mg dibasic sodium phosphate
dodecahydrate (Na
2
HPO
4
12H
2
O) per mL to pH range of 5.5 ‐ 8.0.
Heparin is strongly acidic because of its content of covalently linked
sulphate and carboxylic acid
groups. In heparin sodium, the acidic protons of the sulphate units
are partially replaced by sodium
ions.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
HEPARIN SODIUM solution for intravenous infusion is indicated as an
anticoagulant in
extracorporeal circulation, dialysis procedures, and as a