Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about DBL™ Heparin Sodium Injection BP vial.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given heparin against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What DBL™ Heparin Sodium Injection BP is used for

This medicine is used for the prevention and treatment of disorders caused by blood clots, such as certain heart, blood vessel and lung conditions. It is also used to prevent blood clots from forming during some types of surgery, dialysis and blood transfusions.

This medicine belongs to a group of medicines called anticoagulants.

It works by decreasing the clotting ability of the blood.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

This medicine is not addictive.

Before you are given DBL™ Heparin Sodium Injection BP

When you must not be given it

You should not be given DBL™ Heparin Sodium Injection BP if you have an allergy to:

• any medicine containing heparin
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

You should not be given this medicine if you have any of the following medical conditions:

• conditions where bleeding is or may be a problem, such as haemophilia, hiatus hernia, bleeding haemorrhoids (piles)
• retinopathy (a disease of the retina)
• problems with fragile blood vessels
• endocarditis (inflammation of the lining of the heart)
• ascorbic acid (Vitamin C) deficiency
• very high blood pressure
• stomach or intestinal ulcers or other conditions which may bleed, such as ulcerative colitis
• severe kidney or liver disease
• major surgery involving the eyes, brain or spinal cord
• immediately after childbirth
• low blood platelet count (thrombocytopenia)
• a drop in blood platelet count due to heparin or pentosan polysulfate.

If you are not sure whether you should be given this medicine, talk to your doctor.

Premature or low birth weight babies should not be given DBL™ Heparin Sodium Injection BP 35,000 IU/35 mL vials as these contain benzyl alcohol. Note that the DBL™ Heparin Sodium Injection BP ampoules do not contain benzyl alcohol.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• asthma
• liver or kidney disease
• high blood pressure (hypertension)
• ulcer disease
• vascular disease
• recent dental procedures.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given heparin.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and heparin may interfere with each other. These include:

• other anticoagulants (such as warfarin) which also prevent blood clots
• aspirin or other non steroidal anti-inflammatory drugs (NSAID’s)
• dipyridamole (a medicine for heart problems)
• systemic corticosteroids eg prednisolone, hydrocortisone.

These medicines may be affected by heparin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given heparin.

How DBL™ Heparin Sodium Injection BP is given

How much is given

Your doctor will decide what dose of heparin you will receive and how long you will receive it for. This depends on your condition and other factors, such as your weight and results of blood tests.

How it is given

DBL™ Heparin Sodium Injection BP is given as an injection under the skin (subcutaneously) or as a slow injection into a vein (intravenously). It should not be given as an injection into a muscle (intramuscularly).

This medicine must only be given by a doctor, nurse, or other trained person.

If you have too much (overdose)

As DBL™ Heparin Sodium Injection BP is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given this medicine, tell your doctor or nurse immediately, or, if you are not in hospital, go to the Accident and Emergency department at your nearest hospital. You may need urgent medical attention.

Please contact the Poisons Information Centre in Australia on 131 126 or in New Zealand on 0800 764 766 for advice on overdose management.

If you are given too much heparin, you may experience bleeding.

While you are being given DBL™ Heparin Sodium Injection BP

Things you must do

If you are about to be started on any new medicine, remind your doctor, dentist or pharmacist that you are being given heparin.

Tell any other doctors, dentists, and pharmacists who treat you that you are being given this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine. It may affect other medicines used during surgery.

If you become pregnant while being treated with this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are being given this medicine. It may interfere with the results of some tests.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given heparin. This medicine helps to prevent or treat blood clots in most people, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 60 years of age you may have an increased chance of getting side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor, pharmacist or nurse to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

• irritation, redness or mild pain at the injection site.

The above list includes side effects which are usually mild and short-lived.

Tell your doctor or nurse immediately if you notice any of the following:

• easy bruising or bleeding (eg. nose bleeds) during or after treatment
• passing blood in the urine or faeces
• dark coloured faeces
• signs of an allergic reaction, such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin, chills or fever
• changes to skin around the injection site
• moderate or severe pain at the injection site
• numbness, tingling or muscle weakness
• abnormal bowel or urinary function, or loss of control of bowel motions or urine.

The above list includes serious side effects which may require medical attention.

Tell your doctor or nurse if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After being given DBL™ Heparin Sodium Injection BP

Storage

DBL™ Heparin Sodium Injection BP will be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Product description

What it looks like

DBL™ Heparin Sodium Injection BP is a colourless or straw coloured solution for injection. It comes in glass vials.

Ingredients

DBL™ Heparin Sodium Injection BP contains heparin sodium as the active ingredient. It also contains:

• water for injections
• benzyl alcohol (only in DBL™ Heparin Sodium Injection BP 35,000 IU/35 mL vials).

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Hospira Australia Pty Ltd
ABN 58 097 064 330
Level 3
500 Collins Street
Melbourne VIC 3000

DBL™ Heparin Sodium Injection BP is available in the following strengths and pack sizes:

This leaflet was updated in September 2018.

Published by MIMS December 2018

1 Name of Medicine

Heparin sodium.

6.7 Physicochemical Properties

No data available.

2 Qualitative and Quantitative Composition

DBL Heparin Sodium Injection BP 35,000 IU/35 mL: each mL contains 1,000 IU Heparin sodium.
Heparin sodium is prepared from porcine intestinal mucosa and is free from pyrogenic substances.

3 Pharmaceutical Form

DBL Heparin Sodium Injection BP is a colourless or straw coloured sterile solution of heparin sodium in water for injections. The pH of the injection ranges between 5.0 and 8.0.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

Heparin is indicated for the prophylaxis and treatment of thromboembolic disorders such as thrombophlebitis, pulmonary embolism and occlusive vascular disease. It is also used to prevent thromboembolic complications arising from cardiac and vascular surgery, frostbite, dialysis and other perfusion procedures. Heparin is also used as an anticoagulant in blood transfusions.

4.3 Contraindications

Heparin therapy is contraindicated in patients who are hypersensitive to the drug.
It should not be used in the following cases:
in the presence of actual or potential haemorrhagic states, e.g. haemophilia, ascorbic acid deficiency, increased capillary fragility, hiatus hernia, neoplasms, retinopathy, bleeding haemorrhoids or other organic lesions likely to bleed;
haemorrhagic vascular accident;
threatened abortion;
immediate postpartum period;
subacute bacterial endocarditis or acute infectious endocarditis;
severe hypertension;
gastric or duodenal ulcers or other ulcerative conditions which may have a tendency to haemorrhage, e.g. ulcerative colitis;
advanced renal or hepatic disease;
during and immediately after spinal or major surgery, especially those involving the brain, eye or spinal cord;
shock;
severe thrombocytopenia or a history of thrombocytopenia with any kind of heparin or with pentosan polysulfate;
patients in whom suitable blood coagulation tests, e.g. whole blood clotting time, partial thromboplastin time, etc. cannot be performed at appropriate intervals (this contraindication refers to full dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low dose heparin).
DBL Heparin Sodium Injection BP vials contain benzyl alcohol as a preservative, and should not be administered to premature or low birth weight neonates. Benzyl alcohol has been associated with deaths in these patients.

4.4 Special Warnings and Precautions for Use

Heparin should not be given by intramuscular injection, due to the risk of haematoma formation.
When neuraxial anaesthesia (epidural/ spinal anaesthesia) or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with unfractionated heparin or low molecular weight heparins/ heparinoids for prevention of thromboembolic complications are at risk of developing an epidural or spinal haematoma which can result in long term or permanent paralysis.
The risk of these events is increased by the use of indwelling epidural catheters for administration of analgesia or by concomitant use of drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.
Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis.
As heparin is derived from animal tissue, it should be used with caution in patients with a history of allergy or asthma. Before a therapeutic dose is given to such a patient, a trial dose of 1,000 units may be advisable.
Heparin should be used with extreme caution in patients with continuous tube drainage of the stomach or small intestine.
Any action which may cause vascular injury, with the exception of necessary intravenous or subcutaneous injections, should be avoided where possible.
Outpatients should be warned of the haemorrhagic risks in case of possible trauma.
Heparin should be administered with caution to patients hypertension, a history of ulcers, or with vascular diseases of the chorio-retina.
Increased resistance to heparin is frequently encountered with fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in post-surgical patients.
Heparin therapy increases the risk of localised haemorrhage during and following oral surgical (dental) procedures. Temporary heparin dosage reduction or withdrawal may therefore be advisable prior to oral surgery.
Heparin therapy should be monitored carefully. Adequate monitoring of therapy reduces the risk of overdosage and consequent risk of haemorrhage and is an important guide to the development of serious adverse reactions such as delayed onset thrombocytopenia.
Platelet counts should be monitored in patients receiving heparin for more than a few days, since heparin may cause thrombocytopenia with severe thromboembolic complications. Heparin should be discontinued if thrombocytopenia develops.
Patients on heparin may rarely develop Heparin-induced Thrombosis-Thrombocytopenia Syndrome (HITTS or "white clot syndrome"): new thrombus formation in association with thrombocytopenia, as a result of irreversible platelet aggregation. This may lead to severe thromboembolic complications such as skin necrosis, gangrene of the extremities, myocardial infarction, pulmonary embolism and stroke. Heparin administration should therefore be discontinued if a patient develops new thrombosis in association with thrombocytopenia. These effects are probably of immuno-allergic nature, and occur mostly between the fifth and 21st day of treatment in patients being treated with heparin for the first time.

Delayed onset of HIT and HITT.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Heparin may prolong the one-stage prothrombin time. Therefore, when heparin is given with oral anticoagulants such as warfarin, a period of at least 5 hours after the last intravenous dose, or 24 hours after the last subcutaneous dose of heparin, should elapse before blood is drawn for a valid prothrombin time to be obtained.
Medicines which affect platelet function, e.g. aspirin, other salicylates and other non-steroidal anti-inflammatory agents, dextran, dipyridamole and systemic corticosteroids, may increase the risk of haemorrhage and should be used with caution in patients receiving heparin. Where concomitant use cannot be avoided, careful clinical and biological monitoring should be undertaken.
Other medicines which may potentiate the effect of heparin include hydroxychloroquine, sulphinpyrazone, probenecid, ethacrynic acid, vitamin K antagonists, cytostatic agents, cephamandole, cefotetan, plicamycin, valproic acid and propylthiouracil. High doses of penicillins, some contrast media, asparaginase and epoprostenol may also affect the coagulation process and increase the risk of haemorrhage.
Concomitant use of thrombolytic agents such as alteplase, anistreplase, streptokinase or urokinase may also increase the risk of haemorrhage.
Antihistamines, digitalis glycosides, tetracyclines, nicotine, ascorbic acid and quinine may reduce the anticoagulant effect of heparin.
Glyceryl trinitrate has been reported to reduce the activity of heparin when both drugs are administered simultaneously intravenously. This effect may be due to the presence of propylene glycol as a solvent in many glyceryl trinitrate parenteral preparations. No interaction has been reported when the glyceryl trinitrate was administered immediately after the heparin. Adjustment of heparin dosage during and following administration of intravenous glyceryl trinitrate may be required.
Heavy alcohol drinkers are at greater risk of major heparin associated bleeding than moderate or non-drinkers.
Experimental evidence suggests that heparin may antagonise the actions of ACTH, corticosteroids and insulin.
Heparin is incompatible with certain substances in aqueous solution. Reference to specialised literature should be made to verify in which solution the incompatibility was noted. The following incompatibilities have been reported: hydrocortisone; hyaluronidase; hydroxyzine; some antihistamines, narcotic analgesics, phenothiazines and antibiotics. See Section 6.2 Incompatibilities.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

Haemorrhage is the major risk of heparin therapy and may range from minor local ecchymoses to major haemorrhagic complications. An overly prolonged clotting time or minor bleeding can usually be controlled by discontinuing the heparin (see Section 4.9 Overdose). The occurrence of significant gastrointestinal or urinary tract bleeding during heparin therapy may indicate the presence of an underlying occult lesion.
Bleeding can occur at any site, but some specific haemorrhagic complications can be difficult to detect.
a) Adrenal haemorrhage with resultant acute adrenal insufficiency has occurred during anticoagulant therapy. Anticoagulant treatment should be discontinued in patients who develop signs and symptoms of acute adrenal haemorrhage and insufficiency. Plasma cortisol levels should be measured immediately. Corticosteroid therapy should be initiated promptly, before laboratory confirmation of the diagnosis, as any delay in treatment may result in the patient's death.
b) Ovarian (corpus luteum) haemorrhage may be fatal if unrecognised.
c) Retroperitoneal haemorrhage.
Thrombocytopenia has been reported to occur in up to 30% of patients receiving heparin. Although the thrombocytopenia is often mild and of no obvious clinical significance, it may be accompanied by severe thromboembolic complications such as skin necrosis, gangrene of the extremities, myocardial infarction, pulmonary embolism and stroke (see Section 4.4 Special Warnings and Precautions for Use). Certain episodes of painful, ischaemic and cyanosed limbs have in the past been attributed to allergic vasospastic reactions; however these reactions may instead be complications of thrombocytopenia.
Delayed onset thrombocytopenia is also a possible complication of heparin therapy. If this occurs, the drug should be withdrawn immediately (see Section 4.4 Special Warnings and Precautions for Use).
Skin necrosis has infrequently been reported at injection sites. It is thought to be a localised manifestation of heparin-induced platelet aggregation and thrombosis, and should be taken as a warning sign in patients who develop it. Heparin should be discontinued immediately.
Local irritation, erythema, mild pain, haematoma or ulceration may follow deep subcutaneous injection. The emergence of firm nodules may be noted in some cases; however, these nodules usually disappear after a few days.
Allergic reactions to heparin occur rarely. Hypersensitivity may be manifested by pruritus, urticaria, chills, fever, asthma like symptoms, rhinitis, lacrimation, headache, nausea, vomiting and anaphylactoid reactions, including angioedema and shock. The most common manifestations are urticaria, chills and fever. Itching and burning, especially on the plantar side of the feet, may occur.
Osteoporosis complicated by spontaneous bone fracture has been reported with prolonged use of large doses of heparin.
Alopecia and priapism have occurred rarely in patients treated with heparin.
Suppression of aldosterone synthesis with hyperkalaemia and/or metabolic acidosis have been noted in patients at risk (e.g. diabetes, renal failure).
Suppression of renal functions has occurred following long-term, high dose administration of heparin.
Significant elevations of AST and ALT levels have occurred in a high percentage of subjects who have received heparin (see Section 4.4 Special Warnings and Precautions for Use, Effects on laboratory tests).
Hypereosinophilia, which is reversible on discontinuation of heparin treatment, has occurred.
Rebound hyperlipidaemia has been reported following discontinuation of heparin therapy has also been reported.

Reporting suspected adverse effects.

4.2 Dose and Method of Administration

Dosage.

Adults.

a) Continuous intravenous infusion.

b) Intermittent intravenous injection.

c) Deep subcutaneous injection.

Children.

Method of administration.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Symptoms.

Treatment.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzyl alcohol, water for injections.

6.2 Incompatibilities

Incompatibility has been reported between heparin (sodium) and alteplase, amikacin sulphate, amiodarone, ampicillin sodium, benzylpenicillin sodium, cephalothin sodium, ciprofloxacin lactate, cytarabine, dacarbazine, daunorubicin hydrochloride, diazepam, dobutamine hydrochloride, doxorubicin hydrochloride, droperidol, erythromycin lactobionate, gentamicin sulphate, haloperidol lactate, hyaluronidase, hydrocortisone sodium succinate, kanamycin sulphate, methicillin sodium, netilimicin sulphate, opioid analgesics, oxytetracycline hydrochloride, polymyxin B sulphate, promazine hydrochloride, promethazine hydrochloride, streptomycin sulphate, sulphafurazole diethanolamine, tetracycline hydrochloride, tobramycin sulphate, vancomycin hydrochloride and vinblastine sulphate. Heparin sodium has also been reported to be incompatible with cisatracurium besylate, labetalol hydrochloride and nicardipine hydrochloride. Admixture with glucose can have variable effects. Incompatibility has been reported between heparin and fat emulsion.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

DBL Heparin Sodium Injection BP is supplied in glass vials (with 1.0% benzyl alcohol as bacteriostat).

Pack size.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes