🇨🇦 Importation of South Korean-Authorized BONKY Injection, 1 mcg/mL Calcitriol, due to the Current Shortage of Canadian-Authorized Calcitriol Injection USP, 1 mcg/mL

Hazard/Reason: There is a shortage of Calcitriol Injection USP in Canada. Given the medical necessity of Calcitriol Injection USP, 1 mcg/mL and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of South Korean-authorized BONKY Injection, 1 mcg/mL  Calcitriol, with Korean-only labels to mitigate the shortage. Healthcare professionals should be aware that there are differences between the South Korean-authorized and Canadian-authorized products (see Information for healthcare professionals section).   Audience  Healthcare professionals at hospitals and units such as dialysis clinics and renal units.   Key messages Due to a shortage of Calcitriol Injection USP, 1 mcg/mL in Canada, and given the medical necessity of this drug, Health Canada has permitted the exceptional, temporary importation and sale of South Korean-authorized BONKY Injection, 1 mcg/mL Calcitriol with Korean-only labels. This South Korean-authorized product has the same active ingredient (calcitriol), strength (1 mcg / mL), dosage form (injection), and route of administration (intravenous) as the Canadian-authorized product. However, there are differences between these products. Healthcare professionals are advised that: The South Korean-authorized product has a different brand name, carton and ampoule label, and pack size               (10 x 1 mL ampoules instead of 25 x 1 mL ampoules) than the Canadian-authorized product (see Appendix 1). The expression of strength displayed on the South Korean-authorized product carton appears as “1 µg”, whereas the South Korean-authorized ampoule displays the strength as “1 mcg/mL”. Please note that “µg” denotes microgram (mcg). Refer to the expression of strength displayed on the ampoule label when verifying the product strength. The Canadian-authorized product displays the strength as “1 mcg/mL” on both the carton and ampoule. Although the South Korean-authorized product has differences in carton and ampoule labelling, healthcare professionals should continue to consult the Indications, Contraindications, Warnings and Precautions, Adverse Reactions, Dosage and Administration, and Storage Conditions sections of the Canadian Product Monograph for Calcitriol Injection USP, 1 mcg/mL by SteriMax Inc. (DIN 02399334), available in English and French on Health Canada’s Drug Product Database. Pharmacies/hospitals are advised to generate a sticker or auxiliary label for the outer carton label (and ampoules, if feasible) to ensure proper identification of the product and access to safe use information (including the active ingredient and strength using mcg/mL).   Background Information In Canada, Calcitriol Injection USP is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis. It has also been shown to help with the improvement of renal osteodystrophy by reducing elevated parathyroid hormone levels. Calcitriol Injection USP is NOT recommended for use in pediatric patients. Currently, there is a critical shortage of Canadian-authorized Calcitriol Injection USP, 1 mcg/mL in Canada. To help mitigate the shortage, Health Canada has permitted the exceptional, temporary importation and sale of South Korean-authorized BONKY Injection, 1 mcg/mL Calcitriol, with Korean-only labels.   Information for healthcare professionals  The South Korean-authorized product has the same active ingredient (calcitriol), strength (1 mcg/mL), dosage form (injection), and route of administration (intravenous) as the Canadian-authorized product. However, there are differences between these products. Healthcare professionals are advised that: The South Korean-authorized product has a different brand name, carton and ampoule label, and pack size (10 x 1 mL ampoules instead of 25 x 1 mL ampoules) than the Canadian-authorized product (see Appendix 1). Proper selection of the intended pr

This page links to official sources. Verify model/lot/batch details in the official notice.