Consumer medicine information

Heparin Sodium in 0.9% Sodium Chloride Intravenous Infusion (Baxter)

Heparin sodium + Sodium chloride

BRAND INFORMATION

Brand name

Baxter Heparin Sodium in 0.9% Sodium Chloride

Active ingredient

Heparin sodium + Sodium chloride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Heparin Sodium in 0.9% Sodium Chloride Intravenous Infusion (Baxter).

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;
  • have kidney disease;
  • have stomach ulcer;
  • have bleeding or clotting problems;
  • have heavy or unusual period;
  • have recently had a medical or dental procedure;
  • have had heparin before and experienced the allergic-type reactions called HIT or HITTS
  • have recently had any surgery
  • have any other illness
  • are taking any other medicine including those you can buy without a prescription, in particular pain relieving medicines (aspirin and ibuprofen); medicines for heart and circulation problems (digitalis, nitroglycerine, dipyridamole and epoprostenol); medicines for hayfever, insomnia or travel sickness (antihistamines); medicines for rheumatoid arthritis (hydroxychloroquine); anti-inflammatory medicines (indomethacin and phenylbutazone); nicotine (eg. smoking cessation gum or patches); anticlotting medicines (dicumarol and warfarin).
  • are pregnant
    Ask your doctor or pharmacist if you are not sure.
  • have recently had a spinal tap or local anaesthetic around the spinal chord.

If you have had or are having an epidural anaesthetic or spinal puncture:

  • Tell your doctor immediately if you notice any of the following symptoms:
    - numbness, tingling or muscle weakness
    - abnormal function or loss of control of bowel or urine
    - any other symptom that worries you

How Heparin Sodium in 0.9% Sodium Chloride IV Infusion is given

How much it is given:

Your doctor will decide how much Heparin Sodium in 0.9% Sodium Chloride IV Infusion you need and when it is will be given to you, depending on your need and condition. If the solution is being used to clear your catheter, the dosage will depend upon the type of catheter you have.

How it is given:

The Heparin Sodium in 0.9% Sodium Chloride IV Infusion will be given at a slow rate of injection (drip) by your health professional. Usually you will need to stay in a health institution (hospital, nursing home, etc.), as it requires a special medical equipment to deliver the medicine into your circulation. A cannula (administration needle) is placed in a vein by your doctor or nurse.

If Heparin Sodium in 0.9% Sodium Chloride IV Infusion is being used to prevent your blood from clotting during dialysis, it will be added to the dialysis machine, before and possibly at intervals during the cycle.

If it is being used to ensure that your catheter does not become blocked, a small amount may be injected into your catheter from time to time.

Your doctor will decide what is the best way to give you Heparin Sodium in 0.9% Sodium Chloride IV Infusion.

The infusion is for single use, and for one person only. Any unused portion must be discarded and not used later, either for you or anyone else.

Overdose

The doctor or nurse giving you the Heparin Sodium in 0.9% Sodium Chloride IV Infusion has had experience in the use of this sort of medicine, so it is unlikely that you will be given an overdose. However, in case of an overdose, the infusion will be discontinued and another treatment may be needed. You may experience some of the effects listed under “Side Effects” below.

While you are receiving Heparin Sodium in 0.9% Sodium Chloride IV Infusion

Discuss with your doctor your progress after the treatment, and whether any complication has occurred, especially during the first few days of therapy. Frequent clinical evaluation and laboratory tests may be required. As Heparin Sodium in 0.9% Sodium Chloride IV Infusion is normally given in a hospital, your nurse provider will take records of the progress and unexpected reactions.

Side effects

As with any medicine, some side effects may occur. Undesirable side effect such as bruising or bleeding more than normal (eg. blood in your urine or faeces, or nose bleeds). allergic reaction. The symptoms of an allergic reaction may include chills, fever and redness or itching of the skin and less often runny nose, excess production of saliva, headache, nausea and vomiting, and itching on the soles of the feet. A severe allergic reaction may cause swelling of the face, lips, mouth and difficulty breathing. an increased tendency for your bones to break, especially if you have been using heparin for a long time irritation around the injection site.

Additionally, as with other preparations similar to Heparin Sodium in 0.9% Sodium Chloride IV Infusion, pain, irritation, inflammation, swelling or abnormal clotting at the site of injection is also possible.

Always tell your doctor or nurse if you have any unexpected side effects during or after receiving Heparin Sodium in 0.9% Sodium Chloride IV Infusion and they worry you.

In rare circumstances, more serious side effects may occur such as chest pain, fast or slow heartbeat, painful lumps in your hands, feet or legs, runny nose, nausea, vomiting, or fluid on the lungs or swelling of the face, lips or mouth causing breathing difficulties. If these occur, tell your health professional on duty immediately. These may be symptoms of serious allergic reaction. Your health professional will take appropriate action promptly, such as stopping the infusion.

Product description

What Heparin Sodium with 0.9% Sodium Chloride IV Infusion looks like

It is a clear, colourless solution filled in plastic bags.

What is in Heparin Sodium in 0.9% Sodium Chloride IV Infusion?

The active component is Heparin Sodium, standardised in sodium chloride, dissolved in water for injection and buffered with citric acid monohydrate and sodium phosphate – dibasic dodecahydrate.

Heparin Sodium 1000 IU (AHB0953), AUST R 19434, 500 mL

Heparin Sodium 2000 IU (AHB0944) AUST R 19435, 1000mL

Storage

Heparin Sodium in 0.9% Sodium Chloride IV Infusion will be stored in the pharmacy or hospital ward. It is recommended that the product be stored below 30 °C.

Where can you get more information?

You can get more information from your doctor or pharmacist.

Name and address of the Sponsor

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie NSW 2146,
Australia

Date of preparation
February 2014

88-05-01-065

Published by MIMS April 2021

BRAND INFORMATION

Brand name

Baxter Heparin Sodium in 0.9% Sodium Chloride

Active ingredient

Heparin sodium + Sodium chloride

Schedule

S4

 

1 Name of 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 (Na2HPO4.12H2O) 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

4.9 Overdose

Symptoms. An overdose requires immediate medical attention and treatment. Bleeding is the primary sign of heparin overdose. Easy bruising, petechial formations, nosebleeds, blood in urine or tarry stools may be the first signs or symptoms of a heparin overdose.
Treatment. Neutralization of heparin effect.
When clinical circumstances (bleeding) require reversal of heparinisation, protamine sulfate (1% solution) by slow infusion will neutralise heparin sodium. No more than 50 mg should be administered, very slowly in any 10-minute period. Each mg of protamine sulfate neutralises approximately 100 USP heparin units. Ideally, the dose required to neutralise the action of heparin should be guided by blood coagulation tests or calculated from a protamine neutralisation test. The amount of protamine required decreases over time as heparin is metabolised. Although the metabolism of heparin is complex, it may, for the purpose of choosing a protamine dose, be assumed to have a half-life of about 30 minutes after intravenous injection.
Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions often resembling anaphylaxis have been reported, the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available. For additional information the labeling of protamine sulfate products should be consulted.
Blood or plasma transfusions may be necessary; these dilute but do not neutralise heparin.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No reproduction studies in animals have been performed concerning mutagenesis or impairment of fertility.
Carcinogenicity. No long-term studies in animals have been performed to evaluate carcinogenic potential of heparin.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSHEPSOD.gif Molecular formula: C26H41NO34S4.
Molecular Weight: 1039.83.
Appearance: white or almost off-white powder, odorless, hygroscopic.
Solubility: soluble in water; insoluble in ethanol, acetone and other organic solvents.
CAS number. CAS No.: 9041-08-1.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/BAXHEPST.gif