| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4884 | 183325-78-2 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
Infasurf is tradename; a lung surfactant extract from new born calves containing 35 mg/mL phospholipid & 2% surfactant-associated proteins B & C (wt/wt)
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 1, 1998 | FDA | ONY |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Endotracheal intubation complication | 109.09 | 84.85 | 10 | 5 | 437 | 63488570 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Endotracheal intubation complication | 93.53 | 77.42 | 9 | 5 | 380 | 34956537 |
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| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000000079 | Surfactant Activity |
| FDA PE | N0000008294 | Alveolar Surface Tension Reduction |
| MeSH PA | D011663 | Pulmonary Surfactants |
| MeSH PA | D019141 | Respiratory System Agents |
| FDA EPC | N0000175778 | Surfactant |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Respiratory distress syndrome in the newborn | indication | 46775006 |
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| ID | Source |
|---|---|
| Q4K217VGA9 | UNII |
| D03317 | KEGG_DRUG |
| 4021124 | VUID |
| N0000148578 | NUI |
| 4021124 | VANDF |
| C0763530 | UMLSCUI |
| CHEMBL1201447 | ChEMBL_ID |
| DB06415 | DRUGBANK_ID |
| C117342 | MESH_SUPPLEMENTAL_RECORD_UI |
| 232538 | RXNORM |
| 31288 | MMSL |
| 8294 | MMSL |
| d04330 | MMSL |
| 007864 | NDDF |
| 108641008 | SNOMEDCT_US |
| 409376009 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| INFASURF | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61938-456 | SUSPENSION | 35.70 mg | ENDOTRACHEAL | BLA | 13 sections |