🇨🇦 Importation of Portuguese-authorized Lentocilin S 1200 1 200 000 IU / 4 mL, due to the current shortage of Canadian-authorized Bicillin L-A 1 200 000 IU / 2 mL

Hazard/Reason: UPDATED INFORMATION – March 3, 2026    Further to the Health Canada communication below, issued on February 18, 2026, additional supply of the Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL has been made available to mitigate the ongoing shortage. This new supply is available with bilingual (English and French) labels (see images in Appendix 2 below).   Given the medical necessity of Bicillin L-A 1 200 000 IU / 2 mL and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL, manufactured by Laboratórios Atral, S.A. with English-only labels, by Septa Pharmaceuticals Inc., to mitigate the shortage. Lentocilin S has the same active ingredient, strength (1 200 000 IU), and route of administration (intramuscular) as Bicillin L-A. However, there are differences in the formulation, dosage form, reconstitution requirement, and presentation between Lentocilin S and Bicillin L-A. Healthcare professionals are advised to enhance the safety monitoring of the imported drug, including monitoring for potential adverse effects.   Audience Healthcare professionals including physicians, nurses, hospital pharmacists, public health and sexual health clinics, group purchasing organizations, and wholesalers.   Key messages Due to a critical shortage of the antibiotic Bicillin L-A 1 200 000 IU / 2 mL in Canada, and given the medical necessity of this drug, Health Canada has permitted the exceptional, temporary importation and sale of Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL with English-only labels. Lentocilin S has the same active ingredient, strength (1 200 000 IU) and route of administration (intramuscular) as Bicillin L-A. However, Lentocilin S has a different formulation, dosage form, reconstitution requirement, and presentation than Bicillin L-A (see Appendix 1). Healthcare professionals are advised to: Be aware that the active ingredient (benzathine benzylpenicillin) in Lentocilin S is identical to the active ingredient (penicillin G benzathine) in Bicillin L-A. The products use different nomenclature on their labels. Be aware that Lentocilin S is supplied as a powder in a vial, to be reconstituted with the co-packaged diluent containing lidocaine hydrochloride 1.5% (final volume 4 mL), whereas Bicillin L-A is supplied as a suspension in a ready-to-use pre-filled syringe and does not contain lidocaine (final volume 2 mL) (see the Information for healthcare professionals section). Be aware that Lentocilin S contains soy phospholipids and may cause hypersensitivity reactions (urticaria, anaphylactic shock) in patients with a history of allergy to soybeans. Refer to the indications and the Serious Warnings and Precautions Box, including information related to severe cutaneous adverse reactions (SCAR) associated with penicillin G benzathine, in the Canadian Product Monograph for Bicillin L-A from Pfizer Canada ULC, available in English and French on Health Canada’s Drug Product Database. Refer to the Lentocilin S Summary of Product Characteristics (SmPC) in English and French for product specific information on dosing, preparation and administration, warnings and precautions, and storage and handling.   Background Bicillin L-A (intramuscular penicillin G benzathine) is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. Currently, there is a critical shortage of Canadian-authorized Bicillin L-A 1 200 000 IU / 2 mL in Canada. To help mitigate the shortage, Health Canada has permitted the exceptional, temporary importation and sale of Portuguese-authorized Lentocilin S 1200; 1 200 000 IU / 4 mL, wi

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