🇨🇦 Importation of US-Authorized Vasopressin Injection, USP, 20 units/mL (For IV Infusion) Due to the Current Shortage of Canadian-Authorized Vasopressin Injection, USP, 20 units/mL (For IM or SC Administration)

Hazard/Reason: There is a shortage of Vasopressin Injection, USP, 20 units/mL (for intramuscular [IM] or subcutaneous [SC] administration) in Canada.  This shortage presents serious risks to patients who may require vasopressin therapy in critical care settings, based on the clinical judgment of qualified healthcare professionals. Given the medical need, Health Canada has permitted the exceptional, temporary importation and sale of a similar but not identical product, US-authorized Vasopressin, USP, 20 units/mL (for intravenous [IV] infusion), with English-only labels by Fresenius Kabi USA, LLC.   Audience Healthcare professionals including emergency medicine physicians, critical care physicians, anesthesiologists, nurse practitioners, critical care nurses, and pharmacists.   Key messages There is a shortage of Vasopressin Injection, USP, 20 units/mL (for intramuscular [IM] or subcutaneous [SC] administration) (DIN 02139502) in Canada. Given the serious risks this shortage presents to patients in critical care settings, Health Canada has permitted the exceptional, temporary importation and sale of a similar but not identical product, US-authorized Vasopressin Injection, USP, 20 units/mL (for intravenous [IV] infusion) with English-only labels by Fresenius Kabi USA, LLC. Healthcare professionals are advised to: Be aware that US-authorized Vasopressin Injection, USP (for IV infusion) differs significantly from the Canadian-authorized Vasopressin Injection, USP (for IM or SC administration) in indication, route of administration, packaging and formulation, dilution requirements, storage conditions and in-use periods, and safety information (see the Information for healthcare professionals section). Be aware that the US-authorized product is intended exclusively for IV infusion after dilution. It is not labelled for IM or SC use, and the safety of IM or SC administration has not been established. Consult the US Prescribing Information (USPI), available in English and French on the Fresenius Kabi Canada Ltd. website, as well as the US-authorized inner and outer labels (see Appendix 1), for complete instructions on the proper use of US-authorized Vasopressin Injection, USP (for IV infusion), including the indication, route of administration, dilution, dosing, storage, contraindications, warnings and precautions, and other important information.   Background In Canada, Vasopressin Injection, USP, 20 units/mL, is authorized for IM or SC administration for the prevention and treatment of postoperative abdominal distention, in abdominal roentgenography to dispel interfering gas shadows, and in diabetes insipidus. Health Canada is aware that the Canadian-authorized product has also been used off-label to treat vasodilatory shock. In the US, Vasopressin Injection, USP, 20 units/mL (for IV infusion) is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.   Information for healthcare professionals The US-authorized product has the same active ingredient (vasopressin) and strength (20 units/mL) as Fresenius Kabi Canada Ltd.’s Canadian-authorized Vasopressin Injection, USP (DIN 02139502). However, there are key differences in indication, route of administration, packaging and formulation, dilution requirements, and storage conditions and in-use periods, which are important to note (see Table 1). The Canadian- and US-authorized products also have differences in safety information, including contraindications, serious warnings and precautions, adverse reactions, and drug interactions, which are detailed in their respective prescribing information.   Table 1: Key differences between US-authorized Vasopressin Injection, USP, 20 units/mL (for IV infusion) and Canadian-authorized Vasopressin Injection, USP, 20 units/mL (for IM or SC administration).     US-Authorized Vasopressin Injection, USP, 20 units/mL Canadian-Authorized Vasopressin Inje

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