Heparin Sodium Injection - Consumer Medicine Information
|Condition:||Angina, Anticoagulation During Pregnancy, Antiphospholipid Syndrome, Deep Vein Thrombosis, Deep Vein Thrombosis, Prophylaxis, Heart Attack (Myocardial Infarction), Pulmonary Embolism, Thrombotic/Thromboembolic Disorder|
|Form:||Liquid solution, Subcutaneous (SC), Intravenous (IV)|
|Ingredients:||heparin sodium, sodium chloride, benzyl alcohol as preservative|
About this Medication
What the Medication is Used For
Heparin Sodium Injection is indicated for:
- treatment to stop your blood from clotting in many surgical and non-surgical situations
- preventing and stopping the spread of blood clots in your veins
- preventing and stopping the spread of blood clots to your lungs
- treatment of some disorders of blood clotting
- prevention of blood clotting during surgery
- prevention and treatment of blood clots in your arteries
What it Does
Heparin stops reactions that lead to the clotting of blood and the formation of clots. Once an active blood clot has developed, larger amounts of heparin can inhibit further clotting.
Peak levels of heparin are achieved 2-4 hours following intravenous administration, although there are considerable individual variations.
When it Should not be Used
BEFORE you use Heparin Sodium Injection, talk to your doctor if you have:
- severe reduction of blood platelets
- an uncontrollable active bleeding state (see WARNINGS AND PRECAUTIONS), except when this is due to disseminated intravascular coagulation
- a hypersensitivity or allergy to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see What the important nonmedicinal ingredients are.
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
Benzyl alcohol as preservative
(one preservative-free vial of 1000 units per mL is also available)
What Dosage Form it Comes In
Heparin Sodium Injection is available as:
- 1000 units per mL: preservative-free vials of 2000 units in a 2 mL vial (2 mL fill)
- 1000 units per mL: vials of 10 000 units in 10 mL (10 mL fill) with preservative
- 5 000 units per mL: vials of 5 000 units in 2 mL (1 mL fill) with preservative
- 10 000 units per mL: vials of 10 000 units in 2 mL (1 mL fill) with preservative
Warnings and Precautions
Serious Warnings and Precautions
Fatal bleeding has occurred in infants and children due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush’ vials.
Bleeding can occur at virtually any site in patients receiving heparin.
Increased resistance to heparin is frequently encountered in fever, blood clot, vein inflammation associated with a blood clot, infection with blood clotting tendencies, heart attack, cancer and in patients after surgery.
Heparin sodium should be used with extreme caution in disease states in which there is increased danger of bleeding. Some of the conditions in which increased danger bleeding exists are:
- Infections of the heart and heart valves. Severe high blood pressure.
- During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
- Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia (low platelets) and some vascular purpuras.
- Ulcers of the stomach and continuous tube drainage of the stomach or small intestine.
- Menstruation, liver disease with impaired blood clotting.
Excessive administration of potassium-free solutions may result in significant low concentrations of potassium in the blood.
Heparin is not intended for Intramuscular Use.
Allergic reaction to this drug might happen, stop the medication and consult your doctor.
Platelet count should be tested and monitored.
Proper Use of This Medication
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
The product should be administered under the supervision of a qualified health professional who is experienced in the use of anticoagulant agents and in the management of patients with venous thrombosis, pulmonary embolism, acute and chronic consumptive coagulopathies and peripheral arterial embolism. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001.