Heparin Sodium (Baxter)

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Heparin sodium 2 IU/mL

Dostupno od:

Baxter Healthcare Ltd

INN (International ime):

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

Doziranje:

2 U/mL

Farmaceutski oblik:

Solution for infusion

Sastav:

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

Jedinice u paketu:

Bag, plastic, viaflex, 500 mL

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Laboratori Derivati Organici SpA

Terapijske indikacije:

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

Proizvod sažetak:

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

Datum autorizacije:

1986-03-13

Svojstava lijeka

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