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octanorm 16.5%
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.
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.
At a glance
| Generic name | octanorm 16.5% |
|---|---|
| Sponsor | Octapharma |
| Drug class | Human albumin (colloid plasma expander) |
| Modality | Biologic |
| Therapeutic area | Critical Care / Hematology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Hypoproteinemia and hypovolemia in acute blood loss or severe burns
- Plasma volume expansion in critical care settings
Common side effects
- Hypervolemia / fluid overload
- Allergic reactions
- Fever
- Chills
Key clinical trials
- Study of Octanorm Subcutaneous IG in Patients With PID (PHASE3)
- Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis (PHASE3)
- 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 (PHASE3)
- Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- octanorm 16.5% CI brief — competitive landscape report
- octanorm 16.5% updates RSS · CI watch RSS
- Octapharma portfolio CI