Importation of Danish-authorized Marcain–Adrenalin , 5 mg/mL and 5 mcg/mL due to the Current Shortage of Canadian-authorized SENSORCAINE with Epinephrine, 5 mg/mL and 5 mcg/mL
Summary
See Key Messages below
Affected products
Importation of Danish-authorized Marcain–Adrenalin , 5 mg/mL and 5 mcg/mL
Product Brand Name |
Dosage Form, Strength, and Packaging Format |
Country of Authorization and Identifying Code |
Manufacturer |
Importer in Canada |
---|---|---|---|---|
Marcain – Adrenalin |
Solution for injection 5 mg/mL and 5 mcg/mL 20 mL single use vials preservative-free |
Denmark 10213 |
Aspen Pharma Trading Limited, Ireland |
Aspen Pharmacare Canada Inc. |
Issue
Given the critical shortage of SENSORCAINE with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL), and to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of Danish-authorized Marcain-Adrenalin (bupivacaine hydrochloride, 5 mg/mL and adrenaline (adrenaline tartrate), 5 mcg/mL) with Danish-only labels by Aspen Pharmacare Canada Inc.
Audience
Healthcare professionals including pharmacists, anesthesiologists, critical care physicians, emergency physicians and those involved with administering anesthesia.
Key messages
- Due to a critical shortage of SENSORCAINE with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL) in Canada and given the medical importance of this local anesthetic, Health Canada has permitted the exceptional, temporary importation and sale of Danish-authorized Marcain-Adrenalin (bupivacaine hydrochloride, 5 mg/mL and adrenaline (adrenaline tartrate), 5 mcg/mL) with Danish-only labels by Aspen Pharmacare Canada Inc.
- Healthcare professionals are advised to:
- Be aware that there are important differences in product labelling between the Danish-authorized product and the Canadian-authorized product (see Information for healthcare professionals section and Table 1).
- Refer to the Canadian Product Monograph for SENSORCAINE with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL) by Aspen Pharmacare Canada Inc., available in English and French on Health Canada’s Drug Product Database, for information on proper use.
Background
In Canada, SENSORCAINE with Epinephrine (bupivacaine hydrochloride and epinephrine) is indicated for the production of local or regional anesthesia or analgesia with the following procedures:
- Local infiltration
- Peripheral minor or major nerve blocks
- Epidural block for surgery
- Epidural block by continuous infusion or intermittent bolus for postoperative or labour pain relief.
Standard procedures for local infiltration, minor and major nerve blocks, retrobulbar block or epidural block should be observed.
Information for healthcare professionals
This product should be administered by appropriately trained healthcare professionals, familiar with its actions, characteristics, and hazards.
The Danish-authorized product has the same active ingredients, concentration and dosage form as the Canadian-authorized SENSORCAINE with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL). Both the Danish-authorized product and the Canadian-authorized product are packaged in the same single-use vials of 20 mL (see Appendix 1). However, there are differences in labelling between the Danish-authorized product and Canadian-authorized product, including product naming and differences in expression of strength, which may pose a risk for significant patient harm if dosing or product selection errors occur.
- The product labels and information for the Danish-authorized product use the term “adrenaline tartrate” for one of the active ingredients, whereas “epinephrine bitartrate” is used in the Canadian product labelling. Epinephrine bitartrate and adrenaline tartrate are identical substances; the only difference is in the naming convention used.
- Despite having the same concentration, the expression of strength for bupivacaine is listed differently on the labels of the Danish-authorized product. There is no percentage expression of strength (i.e., 0.5%) or total quantity per total volume (i.e., 100 mg/20 mL) on the Danish-authorized labels.
- On the labels of the Danish-authorized product, adrenaline (epinephrine) is listed in mikrog/ml, rather than in mcg/mL and the ratio (i.e., 1: 200, 000) is absent.
- The Danish-authorized product labels do not identify that the product is a sterile single use vial.
- The precautionary statement, “Do not use if solution is coloured or contains a precipitate”, which appears on the label of the Canadian-authorized product, is not found on the label of the Danish-authorized product.
The Danish-authorized product does not have a Drug Identification Number (DIN) or a barcode that scans in medication management systems in Canada. A facility-generated sticker is recommended to enable barcode scanning and allow proper identification of the product being dispensed and administered.
Table 1: Labelling differences between Danish-authorized Marcain – Adrenalin and Canadian-authorized SENSORCAINE with Epinephrine
|
Drug Product for importation |
Canadian drug product |
||
Product Brand Name |
Marcain – Adrenalin |
SENSORCAINE with Epinephrine |
||
Dosage Form | Solution for injection | Solution for Block/Infiltration, Epidural | ||
Expression of Strength | bupivacaine hydrochloride, 5 mg/mL adrenaline (adrenaline tartrate), 5 mikrog/mL |
0.5% bupivacaine hydrochloride 100 mg/20mL (5 mg/mL) epinephrine (epinephrine bitartrate) 1:200,000, 100 mcg/20 mL (5 mcg/mL) |
||
Identifying Code |
10213 |
DIN 01976206 |
||
|
5 x 20 mL vials |
|
||
|
Danish |
|
Healthcare professionals are advised that:
- The Danish-authorized product should be used in the same manner as the Canadian-authorized product.
- The Canadian Product Monograph for SENSORCAINE with Epinephrine (bupivacaine hydrochloride, 5 mg/mL and epinephrine (epinephrine bitartrate), 5 mcg/mL), by Aspen Pharmacare Canada Inc., available in English and French on Health Canada’s Drug Product Database, should be consulted for information on proper use.
- Additional information on the Danish-authorized product can be found in Aspen’s English and French translation of the Summary of Product Characteristics for Marcain – Adrenalin, available at www.aspenpharma.ca.
Action taken by Health Canada
To help mitigate the critical shortage of SENSORCAINE with Epinephrine (bupivacaine hydrochloride and epinephrine) in Canada, Health Canada has permitted the exceptional, temporary importation and sale of Danish-authorized Marcain – Adrenalin (bupivacaine hydrochloride and adrenaline) by Aspen Pharmacare Canada Inc. and added this product to the List of Drug for Exceptional Importation and Sale.
Health Canada has worked with Aspen Pharmacare Canada Inc. to prepare this alert for SENSORCAINE with Epinephrine. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect™ e-Notice email notification system.
Report health or safety concerns
Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Marcain – Adrenalin should be reported to Aspen Pharmacare Canada Inc. or Health Canada.
Aspen Pharmacare Canada Inc.
Unit 8, 1155 North Service Road W.
Oakville, ON, L6M 3E3
Telephone: 1-844-330-1213
Fax: 1-437-800-4554
To correct your mailing address or fax number, contact Aspen Pharmacare Canada Inc.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Regulatory Operations and Enforcement Branch
E-mail: hpce-cpsal@hc-sc.gc.ca
Telephone: 1-800-267-9675
Original signed by
Mike Egli
General Manager
Aspen Pharmacare Canada Inc.
Appendix 1.
A. Image(s) of Marcain-Adrenalin with Danish-only labelling
B. Marcain – Adrenalin vial label
C. Marcain – Adrenalin carton label
D. Marcain – Adrenalin leaflet mock up (EN-translated):
Additional information
Details
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