| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4105 | 337376-15-5 |
| Molecule | Description |
|---|---|
|
Synonyms:
|
A glucan that is structurally related to maltodextrin, with more than 85% of its molecules having molecular weights between 1640 and 45 000 Daltons (Da), and a weight-average molecular weight of about 20 000 Da; it is used in dialysis fluids as an alternative to glucose-based solutions, and to reduce adhesions after gynecological or abdominal surgery. It has also been used as a vehicle for drugs given via the peritoneal cavity.
|
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 20, 2002 | FDA | BAXTER HLTHCARE |
| 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 |
|---|---|---|---|---|---|---|
| Death | 924.75 | 38.00 | 427 | 2972 | 373954 | 63111669 |
| Peritonitis bacterial | 661.36 | 38.00 | 127 | 3272 | 4752 | 63480871 |
| Peritonitis | 448.18 | 38.00 | 116 | 3283 | 17038 | 63468585 |
| Peritoneal dialysis complication | 398.26 | 38.00 | 67 | 3332 | 1153 | 63484470 |
| Fungal peritonitis | 272.29 | 38.00 | 43 | 3356 | 486 | 63485137 |
| Device interaction | 189.29 | 38.00 | 28 | 3371 | 196 | 63485427 |
| Sepsis | 188.00 | 38.00 | 111 | 3288 | 153012 | 63332611 |
| Encapsulating peritoneal sclerosis | 126.54 | 38.00 | 21 | 3378 | 329 | 63485294 |
| Ultrafiltration failure | 107.27 | 38.00 | 17 | 3382 | 196 | 63485427 |
| Cerebrovascular accident | 77.30 | 38.00 | 56 | 3343 | 107968 | 63377655 |
| Peritoneal cloudy effluent | 76.23 | 38.00 | 12 | 3387 | 132 | 63485491 |
| Myocardial infarction | 74.24 | 38.00 | 53 | 3346 | 99840 | 63385783 |
| Cardiac disorder | 67.76 | 38.00 | 39 | 3360 | 50777 | 63434846 |
| Cardiovascular disorder | 67.65 | 38.00 | 25 | 3374 | 11787 | 63473836 |
| Hypervolaemia | 67.14 | 38.00 | 32 | 3367 | 28381 | 63457242 |
| Cardiac arrest | 66.23 | 38.00 | 48 | 3351 | 92497 | 63393126 |
| Cardiac failure | 60.98 | 38.00 | 45 | 3354 | 89097 | 63396526 |
| Gangrene | 50.49 | 38.00 | 17 | 3382 | 6106 | 63479517 |
| Hypoglycaemia | 49.54 | 38.00 | 34 | 3365 | 60031 | 63425592 |
| Bloody peritoneal effluent | 46.26 | 38.00 | 7 | 3392 | 58 | 63485565 |
| Marasmus | 42.96 | 38.00 | 9 | 3390 | 516 | 63485107 |
| 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 |
|---|---|---|---|---|---|---|
| Death | 919.37 | 41.57 | 587 | 3991 | 397462 | 34554891 |
| Peritonitis bacterial | 915.02 | 41.57 | 201 | 4377 | 5909 | 34946444 |
| Peritonitis | 556.78 | 41.57 | 165 | 4413 | 16200 | 34936153 |
| Peritoneal dialysis complication | 505.41 | 41.57 | 99 | 4479 | 1610 | 34950743 |
| Fungal peritonitis | 361.41 | 41.57 | 66 | 4512 | 717 | 34951636 |
| Device interaction | 149.43 | 41.57 | 30 | 4548 | 552 | 34951801 |
| Encapsulating peritoneal sclerosis | 143.12 | 41.57 | 29 | 4549 | 560 | 34951793 |
| Myocardial infarction | 139.92 | 41.57 | 120 | 4458 | 120965 | 34831388 |
| Ultrafiltration failure | 130.71 | 41.57 | 22 | 4556 | 141 | 34952212 |
| Cardiac disorder | 130.37 | 41.57 | 77 | 4501 | 43049 | 34909304 |
| Cardiac failure | 116.76 | 41.57 | 96 | 4482 | 91152 | 34861201 |
| Gangrene | 103.95 | 41.57 | 34 | 4544 | 4552 | 34947801 |
| Peritoneal cloudy effluent | 102.26 | 41.57 | 18 | 4560 | 155 | 34952198 |
| Sepsis | 95.60 | 41.57 | 113 | 4465 | 166448 | 34785905 |
| Hypervolaemia | 92.19 | 41.57 | 47 | 4531 | 19662 | 34932691 |
| Noninfectious peritonitis | 86.42 | 41.57 | 15 | 4563 | 118 | 34952235 |
| Cardiac arrest | 82.87 | 41.57 | 81 | 4497 | 96078 | 34856275 |
| Cardiovascular disorder | 68.33 | 41.57 | 31 | 4547 | 10025 | 34942328 |
| Catheter site infection | 65.97 | 41.57 | 21 | 4557 | 2576 | 34949777 |
| Bloody peritoneal effluent | 55.18 | 41.57 | 10 | 4568 | 103 | 34952250 |
| Drug ineffective | 48.19 | 41.57 | 3 | 4575 | 456748 | 34495605 |
| Off label use | 43.52 | 41.57 | 3 | 4575 | 419521 | 34532832 |
| 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 |
|---|---|---|---|---|---|---|
| Peritonitis bacterial | 1290.37 | 35.65 | 253 | 4613 | 9314 | 79730208 |
| Peritonitis | 653.73 | 35.65 | 178 | 4688 | 27858 | 79711664 |
| Death | 615.56 | 35.65 | 395 | 4471 | 566119 | 79173403 |
| Peritoneal dialysis complication | 555.74 | 35.65 | 100 | 4766 | 2254 | 79737268 |
| Fungal peritonitis | 403.16 | 35.65 | 68 | 4798 | 1032 | 79738490 |
| Device interaction | 272.26 | 35.65 | 46 | 4820 | 704 | 79738818 |
| Encapsulating peritoneal sclerosis | 219.45 | 35.65 | 39 | 4827 | 812 | 79738710 |
| Sepsis | 140.12 | 35.65 | 122 | 4744 | 269306 | 79470216 |
| Ultrafiltration failure | 129.85 | 35.65 | 21 | 4845 | 241 | 79739281 |
| Peritoneal cloudy effluent | 124.45 | 35.65 | 21 | 4845 | 318 | 79739204 |
| Cardiac arrest | 114.50 | 35.65 | 90 | 4776 | 172006 | 79567516 |
| Gangrene | 107.07 | 35.65 | 34 | 4832 | 8930 | 79730592 |
| Myocardial infarction | 102.90 | 35.65 | 87 | 4779 | 184042 | 79555480 |
| Cardiac disorder | 82.90 | 35.65 | 51 | 4815 | 65706 | 79673816 |
| Noninfectious peritonitis | 81.16 | 35.65 | 14 | 4852 | 243 | 79739279 |
| Hypervolaemia | 77.54 | 35.65 | 42 | 4824 | 42648 | 79696874 |
| Cardiac failure | 70.12 | 35.65 | 65 | 4801 | 154777 | 79584745 |
| Bloody peritoneal effluent | 65.03 | 35.65 | 11 | 4855 | 169 | 79739353 |
| Hypoglycaemia | 62.88 | 35.65 | 51 | 4815 | 101543 | 79637979 |
| Blood glucose false positive | 62.56 | 35.65 | 9 | 4857 | 43 | 79739479 |
| Catheter site infection | 57.98 | 35.65 | 20 | 4846 | 6775 | 79732747 |
| Complication associated with device | 54.96 | 35.65 | 25 | 4841 | 17471 | 79722051 |
| Cerebrovascular accident | 51.41 | 35.65 | 55 | 4811 | 155237 | 79584285 |
| Drug ineffective | 48.45 | 35.65 | 5 | 4861 | 1080908 | 78658614 |
| Peritoneal effluent abnormal | 40.42 | 35.65 | 6 | 4860 | 37 | 79739485 |
| Peritoneal disorder | 38.77 | 35.65 | 9 | 4857 | 726 | 79738796 |
None
| Source | Code | Description |
|---|---|---|
| MeSH PA | D015314 | Dialysis Solutions |
| MeSH PA | D019999 | Pharmaceutical Solutions |
None
None
None
None
None
None
None
| ID | Source |
|---|---|
| 4021369 | VUID |
| N0000148788 | NUI |
| D03266 | KEGG_DRUG |
| 4021369 | VANDF |
| C0538727 | UMLSCUI |
| CHEMBL1201472 | ChEMBL_ID |
| D000077607 | MESH_DESCRIPTOR_UI |
| DB00702 | DRUGBANK_ID |
| 7048 | INN_ID |
| 2NX48Z0A9G | UNII |
| 3517 | PUBCHEM_CID |
| 1100743 | RXNORM |
| 19728 | MMSL |
| 59958 | MMSL |
| 006146 | NDDF |
| 412135003 | SNOMEDCT_US |
| 417226008 | SNOMEDCT_US |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EXTRANEAL | HUMAN PRESCRIPTION DRUG LABEL | 5 | 0941-0679 | INJECTION, SOLUTION | 7.50 g | INTRAPERITONEAL | NDA | 25 sections |
| EXTRANEAL | HUMAN PRESCRIPTION DRUG LABEL | 5 | 0941-0679 | INJECTION, SOLUTION | 7.50 g | INTRAPERITONEAL | NDA | 25 sections |