BAXTER HEPARIN SODIUM 2000IU 1000mL injection AHB0944A

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

heparin sodium, Quantity: 2000 IU/L

Disponibil de la:

Baxter Healthcare Pty Ltd

Forma farmaceutică:

Injection, solution

Compoziție:

Excipient Ingredients: water for injections; sodium chloride; citric acid monohydrate; dibasic sodium phosphate dodecahydrate

Calea de administrare:

Intravenous

Unități în pachet:

1000mL x 12

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

INDICATIONS AS AT 11 JULY 2003: Heparin Sodium in 0.9% Sodium Chloride Intravenous Infusion is indicated as an anticoagulant in extracorporeal circulation, dialysis procedures, and as an aid in the maintenance of catheter patency.

Rezumat produs:

Visual Identification: Clear solution; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Statutul autorizaţiei:

Registered

Data de autorizare:

1991-09-30

Prospect

________________________________________________________________________________
Heparin CMI
Page 1 of 3
HEPARIN SODIUM IN 0.9% SODIUM CHLORIDE
INTRAVENOUS INFUSION
Consumer Medicine Information
WHAT IS IN THIS LEAFLET?
This leaflet answers some
common questions about the
HEPARIN SODIUM IN 0.9%
SODIUM CHLORIDE INTRAVENOUS
(IV) INFUSION.
It does not contain all of the
available information. All
medicines have risks and
benefits. Your doctor has
weighed the risks of you using
Heparin Sodium in 0.9%
Sodium Chloride IV Infusion
against the benefit they expect
it will have for you.
It does not take the place of
talking to your doctor or
pharmacist.
If you have any concerns about
having this medicine, ask your
doctor or pharmacist.
WHAT HEPARIN SODIUM IN
0.9% SODIUM CHLORIDE IV
INFUSION IS USED FOR
This medicine is used to
prevent the blood clotting when
blood is removed from the
body, for example during
dialysis. It is also useful to
ensure that catheters do not
become blocked.
Your doctor may have
prescribed Heparin Sodium in
0.9% Sodium Chloride IV
Infusion for another reason.
Ask your doctor if you have any
questions about why it has
been prescribed for you.
BEFORE YOU ARE GIVEN
HEPARIN SODIUM IN 0.9%
SODIUM CHLORIDE INFUSION
_ _
_THE HEPARIN SODIUM IN 0.9% _
_SODIUM CHLORIDE INFUSION _
_MUST NOT BE GIVEN TO YOU IF: _
•
you have an allergy to any
ingredient listed at the end
of this leaflet;
•
you have had an allergic
reaction to heparin or pork
products. Some of the
symptoms of an allergic
reaction may include skin
rash, peeling of the skin
and swelling of the face,
lips or tongue, causing
difficulty swallowing or
shortness of breath;
•
you have a bleeding
disease or a problem with
your blood vessels;
•
you have low blood platelet
count, or are bleeding or
bruising more easily than
normal;
•
the expiry date printed on
the pack has passed.
_YOU SHOULD TELL YOUR DOCTOR IF _
_YOU: _
•
have had a reaction to
heparin in the past
•
have heart problems or
high blood pressure;
•
have liver disease;
•
hav

Caracteristicilor produsului

BAXTER HEPARIN SODIUM in 0.9% SODIUM CHLORIDE Intravenous Infusion
Version 2.0
1 of 13
AUSTRALIAN PRODUCT INFORMATION –
BAXTER HEPARIN SODIUM (HEPARIN SODIUM) IN
0.9% SODIUM CHLORIDE INTRAVENOUS INFUSION
1
NAME OF THE MEDICINE
Heparin sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Baxter Heparin Sodium in 0.9% Sodium Chloride Intravenous (IV)
Infusion is a sterile,
nonpyrogenic solution of heparin sodium standardised for use as an
anticoagulant in 0.9%
Sodium Chloride IV Infusion buffered with 0.4 mg citric acid
monohydrate and 5.8 mg dibasic
sodium phosphate dodecahydrate (Na
2
HPO
4
.12H
2
O) per mL to pH range of 5.5 – 8.0. It is
supplied in single dose VIAFLEX plastic bag containers for intravenous
administration.
Heparin is a heterogenous mixture of variably sulfated 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. Heparin is strongly acidic because of its content of
covalently linked sulfate
and carboxylic acid groups. In heparin sodium, the acidic protons of
the sulfate units are
partially replaced by sodium ions.
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.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Clear solution for intravenous infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Baxter Heparin Sodium in 0.9% Sodium Chloride Intravenous IV Infusion
is indicated as an