[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$ffyof8j352z1b":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":27,"available_strengths":38,"label_statements":43,"drug_classes":63,"specialties":69,"medical_conditions":70,"animal_species":71},1852,"xj42b4a5d95g8fejlrofeh5h","bedinvetmab",null,[],[13,19,23],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[28,34],{"id":29,"dose_text":30,"species":31,"administration_route":32,"limitation":10,"source_label":33},13668,"Administer 0.23 mg\u002Fpound (0.5 mg\u002Fkilogram) body weight monthly by subcutaneous injection.","Dogs","Subcutaneous","Librela™",{"id":35,"dose_text":36,"species":10,"administration_route":37,"limitation":10,"source_label":33},13669,"Always provide the Client Information Sheet and discuss potential adverse drug events with the dog owner prior to administering each injection of LIBRELA (see Post-Approval Experience and Information for Dog Owners).\nThe minimum target dose of LIBRELA is 0.23 mg\u002Flb (0.5 mg\u002Fkg) body weight, administered subcutaneously once a month. Dogs should be dosed by weight range according to the specific dosing information below.\nThe product does not contain a preservative. The full content of each vial is for single-use only. Once punctured, contents of the vial should be used immediately and any remaining solution should be discarded.\nDogs weighing ≥ 11 lb (≥ 5 kg):\nDogs should be dosed by weight range according to the Dosing Table below (Table 1). Dogs are given the full content of 1 or 2 vials of the appropriate concentration based on body weight. Aseptically withdraw the total dose into a single syringe and administer immediately.\nTable1. Dosing Table\nNumber and Strength (mg\u002FmL) of LIBRELA Vials to be Administered\nDog Body Weight in Pounds (lb)\nDog Body Weight in Kilograms (kg)\n5 mg\u002FmL\norange\n10 mg\u002FmL\nblue\n15 mg\u002FmL\ngreen\n20 mg\u002FmL\ngold\n30 mg\u002FmL\npurple\n11-22.1\n5-10\n1 vial\n22.2-44.1\n10.1-20\n1 vial\n44.2-66.1\n20.1-30\n1 vial\n66.2-88.2\n30.1-40\n1 vial\n88.3-132.3\n40.1-60\n1 vial\n132.4-176.4\n60.1-80\n2 vials\n176.5-220.5\n80.1-100\n1 vial\n1 vial\n220.6-264.6\n100.1-120\n2 vials\nDogs \u003C 11 lb:\nAseptically withdraw 0.045 mL\u002Flb (0.1 mL\u002Fkg) from a 5 mg\u002FmL vial (orange vial) into a single syringe and administer immediately. Discard the vial after the dose has been withdrawn.\nEffectiveness may not be achieved until after the second dose (see EFFECTIVENESS).","SUBCUTANEOUS",[39],{"id":40,"strength_text":41,"dosage_form":42,"proprietary_name":33,"species":31,"source_label":33},11885,"5, 10, 15, 20, and 30 mg bedinvetmab\u002FmL in sterile solution","Injectable Solution",[44,48,51,55,59],{"id":45,"kind":46,"statement":47,"species":31,"limitation":10,"source_label":33},20044,"indication","For the control of pain associated with osteoarthritis in dogs.",{"id":49,"kind":46,"statement":50,"species":10,"limitation":10,"source_label":33},20045,"LIBRELA is indicated for the control of pain associated with osteoarthritis in dogs.",{"id":52,"kind":53,"statement":54,"species":10,"limitation":10,"source_label":33},20046,"contraindication","LIBRELA should not be administered to dogs with known hypersensitivity to bedinvetmab.\nLIBRELA should not be used in breeding dogs or in pregnant or lactating dogs. Immunoglobulin G class antibodies such as LIBRELA can pass through the placental blood barrier and be excreted in milk. Fetal abnormalities, increased rates of stillbirths and increased postpartum fetal mortality were noted in rodents and primates receiving anti-NGF monoclonal antibodies.",{"id":56,"kind":57,"statement":58,"species":10,"limitation":10,"source_label":33},20047,"warning","User Safety Warnings\nNot for use in humans. Keep this and all drugs out of reach of children.\nFor use in dogs only.\nHypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection.\nIn case of accidental self-injection, seek medical advice immediately and show the package leaflet, vial or carton to the physician.\nPregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid accidental self-injection.\nThe importance of Nerve Growth Factor in ensuring normal fetal nervous system development is well-established and laboratory studies conducted on nonhuman primates with human anti-NGF antibodies have shown evidence of reproductive and developmental toxicity.",{"id":60,"kind":61,"statement":62,"species":10,"limitation":10,"source_label":33},20048,"adverse_reaction","The safety of LIBRELA was assessed in a masked, controlled 84-day US field study evaluating the effectiveness of LIBRELA for the control of pain associated with osteoarthritis. Enrollment included 272 dogs, 135 dogs treated with LIBRELA and 137 dogs treated with a negative control (sterile saline). The enrolled dogs were at least 1 year of age (1 to 17 years old), weighed between 1.8 to 62.7 kg and were of various breeds or non-purebred. Dogs were dosed at 28-day intervals and received up to three injections. The most common adverse reactions reported during the study are summarized in Table 2 below.\nTable 2. Number (%) of Dogs with Adverse Reactions Reported in the US Field Study\nAdverse Reaction*\nLIBRELA\nn (%)\n(Total N = 135)\nNegative Control\nn (%)\n(Total N = 137)\nUrinary tract infection\n15 (11.1)\n11 (8.0)\nBacterial skin infection\n11 (8.1)\n9 (6.6)\nDermatitis\n10 (7.4)\n8 (5.8)\nDermal mass\n8 (5.9)\n5 (3.6)\nErythema\n6 (4.4)\n5 (3.6)\nDermal cyst(s)\n4 (3.0)\n2 (1.5)\nPain on injection\n4 (3.0)\n2 (1.5)\nInappropriate urination**\n4 (3.0)\n1 (0.7)\nHistiocytoma\n3 (2.2)\n0 (0.0)\n*An adverse reaction may have occurred more than once in a dog; only the first occurrence was counted.\n** Of these, two dogs treated with LIBRELA were among those reported with a urinary tract infection.\nThe safety of LIBRELA was also evaluated in a masked, controlled 84-day European field study evaluating the effectiveness of LIBRELA for the control of pain associated with osteoarthritis. Enrollment included 281 dogs, 138 dogs were treated with LIBRELA and 143 treated with a negative control (sterile saline). The enrolled dogs were at least 1 year of age (1 to 17.5 years old), weighed between 1.7 to 66 kg and were of various breeds or non-purebred. Dogs were dosed at 28-day intervals and received up to three injections. The most common adverse reactions reported during the study are summarized in Table 3 below.\nTable 3. Number (%) of dogs with Adverse Reactions Reported in the European Field Study\nAdverse Event Reported*\nLIBRELA\nn (%)\n(Total N = 138)\nNegative Control\nn (%)\n(Total N = 143)\nIncreased Blood Urea Nitrogen 19 (13.8) 7 (4.9)\n(BUN)**\n19 (13.8)\n7 (4.9)\nLethargy\n5 (3.6)\n0 (0.0)\nEmesis\n4 (2.9)\n1 (0.7)\nAnorexia\n3 (2.2)\n0 (0.0)\nLameness\n3 (2.2)\n1 (0.7)\nCough\n3 (2.2)\n1 (0.7)\n*An adverse reaction may have occurred more than once in a dog; only the first occurrence was counted.\n** Two dogs treated with LIBRELA suffered serious adverse events and were euthanized during or after study completion: A 13-year old Bichon Frise had pre-existing increased urine protein-creatinine ratio and heart failure that worsened during study; the dog also had an increase in creatinine during the study and was diagnosed with renal failure and was euthanized 3 days after completing the study. An 8-year-old mixed breed dog had pancreatitis and was euthanized on Day 74. The remainder of the dogs that had elevations in the BUN did not have any obvious adverse events associated with this finding.\nOne dog in the LIBRELA group was diagnosed with pyelonephritis on Day 15; this dog had pre-existing increased serum BUN and creatinine and a recent history of urinary tract infection that was not confirmed resolved prior to enrollment. Non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen were initiated on Day 7 for osteoarthritis-associated joint pain but NSAIDs were discontinued on Day 10 due to anorexia and gastroenteritis; azotemia worsened at Day 13 and the dog received no further LIBRELA treatment.\nOne dog in the LIBRELA group with a history of atopy, developed mild alopecia and mild erythema on the injection site on Days 5 and 23. Both episodes of alopecia and erythema resolved with treatment.\nA total of 89 dogs were enrolled in a 6-month, single arm, open labeled, uncontrolled continuation of the EU field study and received monthly subcutaneous injections of LIBRELA. The study provided additional field safety information.\nOne dog experienced acute gastroenteritis and recovered following treatment for abdominal pain, fever, vomiting, and anorexia. One large breed dog enrolled for stifle osteoarthritis developed acute forelimb lameness that was diagnosed as elbow dysplasia. Two dogs presented with rear limb paresis of unknown etiology, one of whom responded to ongoing NSAID treatment and one who did not.",[64],{"id":65,"documentId":66,"slug":67,"name":68},990,"5ey0kai3dgevvyexdda6shvm","other-analgesics-and-antipyretics","Other analgesics and antipyretics",[],[],[]]