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Details for: TNKASE

Company: HOFFMANN-LA ROCHE LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02244826TNKASETENECTEPLASE50 MG / VIALPOWDER FOR SOLUTIONINTRAVENOUS
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

TNKase (tenecteplase) is used in adults to treat acute myocardial infarctions (heart attacks). Treatment should begin as soon as possible after symptoms start.

What it does

TNKase belongs to a group of medicines called thrombolytics. This medicine dissolves blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.

When it should not be used
  • if you are allergic to TNKase or any of the ingredients it contains

In addition, TNKase will not be given by your doctor if you have, or have recently had, an illness that increases your risk of bleeding, including:

  • a bleeding disorder or recent history of bleeding
  • stroke
  • recent major surgery or trauma to your brain or spine
  • brain tumour
  • abnormality of the blood vessels or aneurysm
  • severe high blood pressure
What the medicinal ingredient is

Tenecteplase

What the non-medicinal ingredients are

L-arginine, phosphoric acid, polysorbate 20

What dosage form it comes in

A vial containing 50 mg (10,000 units) TNKase to be prepared for intravenous injection

Warnings and precautions

BEFORE TNKase is given, your doctor will review the possible risks based on your medical condition and history, including if you have/had:

  • recent major surgery
  • stroke
  • recent bleeding in the gut or urinary system
  • recent trauma
  • high blood pressure
  • problems with your heart or heartbeat
  • bleeding disorder
  • severe liver failure
  • pregnancy
  • serious infection or inflammation
  • advanced age
  • taken medications that affect blood clotting
Interactions with this medication

Medications that affect blood clotting may increase the risk of bleeding prior to, during or after therapy with TNKase.

Proper use of this medication

TNKase is given as a single injection into a vein. Your doctor will give TNKase as soon as possible after your chest pain starts.

Usual dose

The doctor calculates your dose of TNKase according to your body weight, with a maximum dose of 50 mg (10,000 units). Acetylsalicylic acid (ASA) and heparin are usually given as part of your treatment.

Overdose

In the event of overdose, there may be an increased risk of bleeding. Any patients receiving greater than the recommended dose should be carefully monitored.

Side effects and what to do about them

Like all medicines, TNKase can have side effects.

The most frequent side effect associated with TNKase is bleeding. Most of the time the bleeding is minor, however sometimes major bleeding can occur requiring blood transfusion or leading to circulation problems. If major bleeding occurs, your doctor will stop any medications that can make bleeding worse. Death or permanent disability can occur in patients who experience stroke or other serious bleeding episodes.

Allergic-type reactions such as swelling of the skin and throat, rash or hives can occur.

Other serious side effects affecting the heart and lungs have been reported among patients receiving TNKase and are often caused by the underlying disease. These effects can be life-threatening and may lead to death.

This is not a complete list of side effects. For any unexpected effects while taking TNKase, contact your doctor or pharmacist.

How to store

Store the vials below 30°C or in a refrigerator at 2°C - 8°C.

The reconstituted solution may be stored for 8 hours in a refrigerator at 2°C - 8°C.

Reporting 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
      Health Canada
      Postal Locator 1908C
      Ottawa, Ontario
      K1A 0K9

    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 the side effect, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: www.rochecanada.com or by contacting the sponsor Hoffmann-La Roche Limited, at: 1- 888-762-4388.

This leaflet was prepared by Hoffmann-La Roche Limited

Last revised: TBD

©Copyright 2000 - 2018, Hoffmann-La Roche Limited

ACTIVASE® is a registered trade-mark of Genentech, Inc. used under licence.

All other trade-marks are the property of its respective owner.

Hoffmann-La Roche Limited
Mississauga, ON L5N 5M8
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