{"id":"octanorm-16-5","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypervolemia / fluid overload"},{"rate":null,"effect":"Allergic reactions"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Chills"}]},"_chembl":{"chemblId":"CHEMBL3686051","moleculeType":"Small molecule","molecularWeight":"451.38"},"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"This is a colloid replacement therapy containing human serum albumin at 16.5% concentration. Albumin functions as the primary plasma protein responsible for maintaining oncotic pressure, which draws and retains fluid within the intravascular space. It is used to restore circulating blood volume and protein levels in conditions of severe protein depletion or acute hemorrhage.","oneSentence":"Octanorm 16.5% is a human albumin solution that restores intravascular oncotic pressure and maintains plasma volume in patients with hypoproteinemia or acute blood loss.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:23:53.237Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypoproteinemia and hypovolemia in acute blood loss or severe burns"},{"name":"Plasma volume expansion in critical care settings"}]},"trialDetails":[{"nctId":"NCT01888484","phase":"PHASE3","title":"Study of Octanorm Subcutaneous IG in Patients With PID","status":"COMPLETED","sponsor":"Octapharma","startDate":"2014-03","conditions":"Primary Immune Deficiency Disorder","enrollment":75},{"nctId":"NCT03686969","phase":"PHASE3","title":"Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis","status":"TERMINATED","sponsor":"Octapharma","startDate":"2018-08-02","conditions":"Dermatomyositis","enrollment":1},{"nctId":"NCT03907241","phase":"PHASE3","title":"CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL","status":"COMPLETED","sponsor":"Octapharma","startDate":"2016-03-01","conditions":"Primary Immunodeficiency","enrollment":27},{"nctId":"NCT03988426","phase":"PHASE3","title":"Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases","status":"COMPLETED","sponsor":"Octapharma","startDate":"2017-03-07","conditions":"Primary Immune Deficiency Disorder","enrollment":25}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"octanorm 16.5%","genericName":"octanorm 16.5%","companyName":"Octapharma","companyId":"octapharma","modality":"Biologic","firstApprovalDate":"","aiSummary":"Octanorm 16.5% is a human albumin solution that restores intravascular oncotic pressure and maintains plasma volume in patients with hypoproteinemia or acute blood loss. Used for Hypoproteinemia and hypovolemia in acute blood loss or severe burns, Plasma volume expansion in critical care settings.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}