Xylocaine (lidocaine HCl)

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Contact: BCANS Enquiries

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from AstraZeneca Canada Inc.
Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on
Xylocaine (lidocaine HCl) Jelly 2% Single Use Plastic Syringe (10 mL)
Product No. 063, DIN 00385484

November 29, 2006

Dear Pharmacy Director,

Please distribute to the Chief of Staff, Department of Nursing, Department of Urology, Department of Surgery, Department of Emergency Medicine, Department of Intensive Care, Department of Respirology, Department of Internal Medicine, Department of Ophthalmology and other professional staff that might administer this product and post this NOTICE and updated Handling Instructions in appropriate locations in your hospital.

Subject: Xylocaine^® (lidocaine HCl) Jelly 2% Single Use Plastic Syringe (10 mL)

On September 22, 2006 AstraZeneca recalled Xylocaine^® (lidocaine HCl) Jelly 2% Single Use Plastic Syringe (10 mL) because of an issue related to the break seal construction of this syringe product and how it was being opened. On September 27, 2006 Health Canada issued a Public Advisory that also described the potential risk. Due to the lack of appropriate alternative options in some situations as identified to Health Canada by hospitals, it has become apparent that there is a continuing need for this product for in-hospital use only.

Following consultations between AstraZeneca and Health Canada it has been concluded by both that the risk can be managed by users following the attached updated Handling Instructions.

Effective December 5, 2006 the above product will be made available for use in hospitals for indicated procedures where there are no appropriate alternatives. Please ensure that this product is restricted to in-hospital use only and is not given to patients for use in the home. These restrictions will be in place until the new Xylocaine Jelly 2% syringe becomes available, approximately May 2007.

Please ensure that: all hospital healthcare professionals administering this product are informed of the potential risks identified in the Health Canada Advisory dated September 27, 2006. all hospital healthcare professionals administering this product follow the updated Handling Instructions attached to this Product Update and enclosed with the product to avoid the potential risk. the updated Handling Instructions are circulated and posted in appropriate locations in the hospital where it will be seen by all hospital healthcare professionals administering this product.

Please note that all orders for the product must be placed directly with AstraZeneca Customer Relations at 1-800-668-6000.

AstraZeneca Canada is working with Health Canada to revise the Prescribing Information to include the following updated Handling Instructions summarized below (please refer to the attached updated Handling Instructions for full details):

• Twist the protective tab and then, without bending, pull slightly to break the seal.
• Extrude a small amount (i.e. 1 cm) of Jelly. Inspect the syringe to ensure that there is no plastic fragment present in the Jelly.
  NOTE: UPON VISUAL INSPECTION, A CLEAR PLASTIC FRAGMENT IN CLEAR JELLY MAY BE DIFFICULT TO DETECT AND MAY LOOK LIKE AN AIR POCKET. If the protective tab is broken, do not use the syringe.
• The syringe must not be used and must be discarded if there is any suspicion of a broken plastic fragment.

Xylocaine^® (lidocaine HCl) Jelly 2% Single Use Plastic Syringe (10 mL) is indicated for surface anesthesia and lubrication for:

• The male and female urethra during cystoscopy, catheterization exploration by sound and other endourethral operations
• Nasal and pharyngeal cavities in endoscopic procedures such as gastroscopy and bronchoscopy
• Proctoscopy and rectoscopy
• Tracheal intubation

This product is also indicated for symptomatic treatment of pain in connection with cystitis and urethritis.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any suspected adverse reactions in patients receiving Xylocaine Jelly 2% should be reported to AstraZeneca or Health Canada at the following addresses:

AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 Tel: 1-800-668-6000 Fax: 1-800-267-5743 Any suspected adverse reaction can also be reported to: Canadian Adverse Drug Reaction Monitoring Program (CADRMP) Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C OTTAWA, Ontario, K1A 0K9 Tel: (613) 957-0337 or Fax: (613) 957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Tel: 866 234-2345 Fax: 866 678-6789 cadrmp@hc-sc.gc.ca The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. For other inquiries related to this communication, please contact Health Canada at: Bureau of Cardiology, Allergy and Neurological Sciences (BCANS) E-mail: BCANS_Enquiries@hc-sc.gc.ca Telephone: (613) 941-1499 Fax: (613) 941-1668

original signed by

Karen Feltmate
Vice-President Regulatory Affairs

PLEASE POST

Handling Instructions for
Xylocaine^® Jelly 2% (lidocaine hydrochloride)
Single Use Plastic Syringe (10mL)

1. Tear off the paper cover.

2. Screw plunger rod clockwise into grey rubber until rubber rotates.

3. Twist the protective tab and then, without bending, pull slightly to break the seal.

4. Extrude a small amount (i.e. 1 cm) of Jelly. Inspect the syringe to ensure that there is no plastic fragment present in the Jelly. NOTE: UPON VISUAL INSPECTION, A CLEAR PLASTIC FRAGMENT IN CLEAR JELLY MAY BE DIFFICULT TO DETECT AND MAY LOOK LIKE AN AIR POCKET.

5. The syringe must not be used and must be discarded if there is any suspicion of a broken plastic fragment.

6. If the protective tab is intact and no plastic fragment is found in the Jelly, the syringe is ready for use.

For further assistance please contact AstraZeneca Canada at 1-800-668-6000.