Country: Canada
Language: English
Source: Health Canada
BEDINVETMAB
ZOETIS CANADA INC
5MG
SOLUTION
BEDINVETMAB 5MG
SUBCUTANEOUS
15G/50G
Prescription
DOGS
Active ingredient group (AIG) number: 0162744001
APPROVED
2021-02-01
LIBRELA Zoetis Version – October 17, 2022 PACKAGE INSERT DIN 02511797, DIN 02511800 DIN 02511819, DIN 02511827 DIN 02511835 LIBRELA ® BEDINVETMAB INJECTION _VETERINARY USE ONLY _ CANINE ANTI-NERVE GROWTH FACTOR MONOCLONAL ANTIBODY FOR DOGS STERILE DESCRIPTION: LIBRELA ® is an injectable solution containing bedinvetmab (5 mg, 10 mg, 15 mg, 20 mg or 30 mg per mL) as the active ingredient. The product does not contain a preservative. Bedinvetmab is a canine therapeutic monoclonal antibody that neutralizes Nerve Growth Factor (NGF). INDICATIONS: LIBRELA is indicated for the alleviation of pain associated with osteoarthritis in dogs. DOSAGE AND ADMINISTRATION: The recommended dosage of LIBRELA is 0.5-1.0 mg/kg body weight, administered subcutaneously once monthly as needed. DOSING INFORMATION DOGS WEIGHING <5.0 KG: Aseptically withdraw 0.1 mL/kg from a single 5 mg vial and administer subcutaneously. DOGS WEIGHING ≥5.0 KG: For dogs weighing 5.0-60.0 kg, aseptically withdraw 1 mL from the appropriate strength vial according to the dosing table below and administer subcutaneously. For dogs weighing >60.0 kg, the contents of more than one strength or vial are required to be administered as a single dose. In those cases, withdraw the content from each required vial into the same syringe and administer as a single subcutaneous injection. LIBRELA Zoetis Version – October 17, 2022 DOSING TABLE NUMBER AND STRENGTH (MG) OF LIBRELA VIALS TO BE ADMINISTERED DOG’S WEIGHT IN KG 5 MG/ML 10 MG/ML 15 MG/ML 20 MG/ML 30 MG/ML 5.0 to 10.0 1 vial 10.1 to 20.0 1 vial 20.1 to 30.0 1 vial 30.1 to 40.0 1 vial 40.1 to 60.0 1 vial 60.1 to 80.0 2 vials 80.1 to 100.0 1 vial + 1 vial 100.1 to 120 2 vials CONTRAINDICATIONS: Do not administer to dogs with known hypersensitivity to bedinvetmab. Do not use in breeding, pregnant, or lactating dogs. Do not use in dogs less than 12 months of age. CAUTIONS: Discontinue use if signs of intolerance or anaphylaxis are observed (see IMMUNOGENICITY section). Since it may take two (2) monthly Read the complete document