propofol Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2302	2078-54-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: propofol ampofol diprivan disoprofol pofol	An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS. Molecular weight: 178.28 Formula: C12H18O CLOGP: 3.93 LIPINSKI: 0 HAC: 1 HDO: 1 TPSA: 20.23 ALOGS: -3.05 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

propofol
ampofol
diprivan
disoprofol
pofol

An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.

Molecular weight: 178.28
Formula: C12H18O
CLOGP: 3.93
LIPINSKI: 0
HAC: 1
HDO: 1
TPSA: 20.23
ALOGS: -3.05
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.16 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	14.02 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	4.70 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	36 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.02 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	3.20 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 2, 1989	FDA	FRESENIUS KABI USA

FDA Adverse Event Reporting System (Female)

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
Anaphylactic shock	1340.53	58.76	281	3367	4005	2350432
Hypotension	1177.21	58.76	382	3266	32054	2322383
Propofol infusion syndrome	767.06	58.76	104	3544	10	2354427
Bronchospasm	698.65	58.76	155	3493	2869	2351568
Cardiac arrest	619.85	58.76	196	3452	14734	2339703
Anaphylactic reaction	501.89	58.76	151	3497	9554	2344883
Bradycardia	429.78	58.76	135	3513	9846	2344591
Circulatory collapse	380.94	58.76	99	3549	3621	2350816
Tachycardia	375.09	58.76	138	3510	16271	2338166
Delayed recovery from anaesthesia	327.20	58.76	53	3595	139	2354298
Oxygen saturation decreased	323.67	58.76	102	3546	7484	2346953
Metabolic acidosis	269.72	58.76	84	3564	5914	2348523
Respiratory depression	267.40	58.76	67	3581	2103	2352334
Hyperthermia malignant	254.57	58.76	42	3606	128	2354309
Rhabdomyolysis	228.15	58.76	76	3572	6628	2347809
Shock	226.74	58.76	67	3581	3937	2350500
Blood pressure decreased	226.60	58.76	82	3566	9154	2345283
Erythema	220.01	58.76	107	3541	25052	2329385
Stress cardiomyopathy	199.47	58.76	49	3599	1412	2353025
Ventricular fibrillation	198.35	58.76	53	3595	2148	2352289
Acute kidney injury	197.15	58.76	103	3545	28019	2326418
Pulseless electrical activity	195.65	58.76	45	3603	970	2353467
Multiple organ dysfunction syndrome	191.70	58.76	69	3579	7572	2346865
Exposure during pregnancy	181.38	58.76	94	3554	25125	2329312
Drug ineffective	180.12	58.76	158	3490	101466	2252971
Status epilepticus	178.35	58.76	50	3598	2428	2352009
Hypoxia	174.27	58.76	61	3587	6166	2348271
Drug interaction	174.04	58.76	96	3552	29067	2325370
Post procedural complication	169.66	58.76	50	3598	2904	2351533
Maternal exposure during pregnancy	162.98	58.76	74	3574	14789	2339648
Seizure	155.48	58.76	84	3564	24382	2330055
Procedural complication	154.57	58.76	38	3610	1097	2353340
Haemodynamic instability	148.11	58.76	37	3611	1142	2353295
Pyrexia	144.79	58.76	107	3541	53601	2300836
Rash	141.46	58.76	110	3538	59448	2294989
Toxicity to various agents	140.28	58.76	87	3561	32667	2321770
Ventricular tachycardia	138.66	58.76	43	3605	2968	2351469
Oliguria	138.10	58.76	36	3612	1321	2353116
Dystonia	134.16	58.76	39	3609	2155	2352282
Respiratory arrest	129.81	58.76	49	3599	6129	2348308
Apnoea	122.46	58.76	33	3615	1378	2353059
Cardio-respiratory arrest	121.01	58.76	52	3596	9094	2345343
Myoclonus	120.83	58.76	37	3611	2446	2351991
Medication error	119.36	58.76	46	3602	6085	2348352
Respiratory failure	116.34	58.76	57	3591	13471	2340966
Intestinal ischaemia	116.13	58.76	30	3618	1061	2353376
Urticaria	115.47	58.76	69	3579	24192	2330245
Chills	114.57	58.76	59	3589	15493	2338944
Procedural hypotension	111.69	58.76	22	3626	216	2354221
Hepatitis	110.85	58.76	44	3604	6293	2348144
Sinus tachycardia	110.21	58.76	37	3611	3288	2351149
Anaesthetic complication	108.43	58.76	24	3624	431	2354006
Generalised tonic-clonic seizure	107.04	58.76	41	3607	5331	2349106
Unwanted awareness during anaesthesia	105.89	58.76	17	3631	41	2354396
Agitation	105.40	58.76	50	3598	11001	2343436
Blood creatine phosphokinase increased	105.21	58.76	40	3608	5096	2349341
Arteriospasm coronary	103.79	58.76	25	3623	660	2353777
Product contamination	99.80	58.76	20	3628	216	2354221
Transmission of an infectious agent via product	99.60	58.76	17	3631	67	2354370
Carcinoid crisis	97.12	58.76	15	3633	25	2354412
Anaphylactoid reaction	95.59	58.76	25	3623	928	2353509
Atrioventricular block complete	90.27	58.76	26	3622	1388	2353049
Septic shock	86.39	58.76	38	3610	7016	2347421
Hyperkalaemia	86.20	58.76	36	3612	5857	2348580
Unresponsive to stimuli	85.75	58.76	34	3614	4842	2349595
Depressed level of consciousness	83.65	58.76	38	3610	7566	2346871
Cardiogenic shock	83.64	58.76	28	3620	2463	2351974
Labile blood pressure	83.03	58.76	17	3631	206	2354231
Tryptase increased	82.89	58.76	14	3634	51	2354386
Hypertriglyceridaemia	82.67	58.76	22	3626	874	2353563
Anaphylactoid shock	81.69	58.76	15	3633	97	2354340
Hepatocellular injury	80.94	58.76	31	3617	4024	2350413
Diabetes insipidus	79.47	58.76	18	3630	360	2354077
Coma	77.32	58.76	38	3610	9018	2345419
Premature delivery	76.78	58.76	28	3620	3172	2351265
Arrhythmia	75.51	58.76	33	3615	5995	2348442
Airway complication of anaesthesia	75.01	58.76	12	3636	28	2354409
Anaesthetic complication pulmonary	72.97	58.76	11	3637	14	2354423
Drug use disorder	69.23	58.76	16	3632	351	2354086
Renal failure	68.85	58.76	44	3604	17305	2337132
Completed suicide	68.14	58.76	47	3601	20987	2333450
Laryngospasm	68.07	58.76	18	3630	697	2353740
Encephalopathy	67.14	58.76	28	3620	4533	2349904
Toxic epidermal necrolysis	66.21	58.76	25	3623	3119	2351318
Lactic acidosis	66.17	58.76	29	3619	5301	2349136
Aspartate aminotransferase increased	65.48	58.76	38	3610	12574	2341863
Hepatitis C	63.60	58.76	20	3628	1441	2352996
Vomiting	63.36	58.76	77	3571	71525	2282912
Intra-abdominal pressure increased	63.23	58.76	10	3638	21	2354416
Dyskinesia	62.53	58.76	27	3621	4762	2349675
Cyanosis	62.31	58.76	24	3624	3161	2351276
Alanine aminotransferase increased	61.73	58.76	38	3610	13994	2340443
Acute respiratory distress syndrome	61.54	58.76	24	3624	3268	2351169
Mitochondrial DNULL mutation	61.37	58.76	9	3639	8	2354429
Electrocardiogram ST segment elevation	61.34	58.76	16	3632	587	2353850
Disseminated intravascular coagulation	61.13	58.76	24	3624	3326	2351111
Hepatorenal failure	60.44	58.76	12	3636	123	2354314
Delirium	60.28	58.76	27	3621	5196	2349241
Foetal growth restriction	59.77	58.76	18	3630	1122	2353315
Stridor	59.64	58.76	16	3632	655	2353782
Pneumatosis	59.27	58.76	11	3637	76	2354361
Stevens-Johnson syndrome	58.86	58.76	25	3623	4234	2350203

FDA Adverse Event Reporting System (Male)

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
Propofol infusion syndrome	1232.93	60.28	176	3094	15	1743496
Hypotension	944.79	60.28	350	2920	29304	1714207
Anaphylactic shock	895.12	60.28	202	3068	2697	1740814
Rhabdomyolysis	667.96	60.28	212	3058	10878	1732633
Cardiac arrest	661.90	60.28	230	3040	15700	1727811
Anaphylactic reaction	552.43	60.28	160	3110	5953	1737558
Bradycardia	474.55	60.28	162	3108	10372	1733139
Hyperthermia malignant	426.14	60.28	76	3194	253	1743258
Bronchospasm	389.41	60.28	97	3173	1985	1741526
Delayed recovery from anaesthesia	329.49	60.28	54	3216	88	1743423
Oxygen saturation decreased	317.55	60.28	103	3167	5572	1737939
Tachycardia	315.24	60.28	126	3144	12502	1731009
Metabolic acidosis	302.02	60.28	98	3172	5304	1738207
Circulatory collapse	282.64	60.28	84	3186	3383	1740128
Ventricular fibrillation	260.86	60.28	75	3195	2681	1740830
Chills	255.11	60.28	106	3164	11581	1731930
Erythema	228.95	60.28	104	3166	14084	1729427
Blood creatine phosphokinase increased	226.30	60.28	90	3180	8766	1734745
Blood pressure decreased	203.30	60.28	80	3190	7566	1735945
Shock	198.32	60.28	67	3203	4094	1739417
Post procedural complication	190.91	60.28	57	3213	2323	1741188
Ventricular tachycardia	176.42	60.28	60	3210	3738	1739773
Drug interaction	175.22	60.28	109	3161	27849	1715662
Anaesthetic complication	164.09	60.28	33	3237	235	1743276
Pyrexia	157.21	60.28	124	3146	46276	1697235
Electrocardiogram ST segment elevation	151.90	60.28	39	3231	897	1742614
Respiratory arrest	151.25	60.28	60	3210	5779	1737732
Pulseless electrical activity	139.01	60.28	37	3233	983	1742528
Hyperkalaemia	135.50	60.28	62	3208	8485	1735026
Cardio-respiratory arrest	133.62	60.28	63	3207	9230	1734281
Agitation	129.24	60.28	65	3205	10961	1732550
Respiratory depression	122.18	60.28	40	3230	2207	1741304
Acute kidney injury	121.55	60.28	95	3175	34849	1708662
Hypoxia	119.45	60.28	51	3219	5912	1737599
Procedural complication	117.28	60.28	33	3237	1083	1742428
Drug ineffective	115.72	60.28	120	3150	63681	1679830
Hypoxic-ischaemic encephalopathy	110.43	60.28	30	3240	862	1742649
Lactic acidosis	109.81	60.28	46	3224	5083	1738428
Laryngospasm	109.00	60.28	25	3245	350	1743161
Cyanosis	103.87	60.28	37	3233	2637	1740874
Status epilepticus	101.53	60.28	34	3236	2012	1741499
Seizure	96.72	60.28	67	3203	20374	1723137
Toxicity to various agents	96.41	60.28	77	3193	29064	1714447
Pulmonary oedema	95.66	60.28	45	3225	6541	1736970
Transmission of an infectious agent via product	93.75	60.28	17	3253	63	1743448
Drug use disorder	93.49	60.28	23	3247	441	1743070
Ventricular arrhythmia	93.14	60.28	25	3245	685	1742826
Foetal exposure during pregnancy	87.91	60.28	42	3228	6317	1737194
Urticaria	87.32	60.28	52	3218	12189	1731322
Haemodynamic instability	85.77	60.28	27	3243	1310	1742201
Diabetes insipidus	85.44	60.28	21	3249	401	1743110
Vasoplegia syndrome	83.66	60.28	18	3252	184	1743327
Blood lactic acid increased	82.84	60.28	24	3246	875	1742636
Completed suicide	80.72	60.28	55	3215	16257	1727254
Anaphylactoid shock	80.26	60.28	16	3254	108	1743403
Medication error	80.11	60.28	36	3234	4707	1738804
Respiratory acidosis	79.86	60.28	22	3248	666	1742845
Respiratory failure	76.77	60.28	51	3219	14454	1729057
Hypertriglyceridaemia	75.82	60.28	24	3246	1185	1742326
Premature baby	75.27	60.28	30	3240	2912	1740599
Hypoventilation	75.25	60.28	20	3250	527	1742984
Post procedural fever	73.31	60.28	14	3256	73	1743438
Delirium	72.95	60.28	37	3233	6325	1737186
Renal failure	72.81	60.28	56	3214	19961	1723550
Brain oedema	72.64	60.28	27	3243	2169	1741342
Pulse absent	71.64	60.28	22	3248	982	1742529
Apnoea	71.55	60.28	24	3246	1425	1742086
Myoclonus	71.48	60.28	27	3243	2268	1741243
Multiple organ dysfunction syndrome	70.44	60.28	41	3229	9201	1734310
Respiratory distress	68.04	60.28	33	3237	5124	1738387
Dyskinesia	67.72	60.28	30	3240	3789	1739722
Product contamination	67.06	60.28	15	3255	186	1743325
Haemodialysis	64.57	60.28	26	3244	2590	1740921
Confusional state	63.46	60.28	53	3217	21225	1722286
Coma	62.81	60.28	35	3235	7227	1736284
Neonatal respiratory depression	62.77	60.28	12	3258	63	1743448
Torsade de pointes	61.71	60.28	21	3249	1303	1742208
Chromaturia	60.82	60.28	25	3245	2625	1740886
Arrhythmia	60.37	60.28	32	3238	5984	1737527

Pharmacologic Action:

Source	Code	Description
ATC	N01AX10	NERVOUS SYSTEM ANESTHETICS ANESTHETICS, GENERAL Other general anesthetics
FDA PE	N0000175975	General Anesthesia
FDA EPC	N0000175681	General Anesthetic
MeSH PA	D000777	Anesthetics
CHEBI has role	CHEBI:38877	intravenous anaesthetic
CHEBI has role	CHEBI:35717	sedative
CHEBI has role	CHEBI:50919	antiemetic
CHEBI has role	CHEBI:35623	anticonvulsant
MeSH PA	D018686	Anesthetics, Intravenous
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D006993	Hypnotics and Sedatives

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
General anesthesia	indication	50697003
Sedation in Intubated Patients	indication
Sedation as Adjunct to Anesthesia	indication
Apnea	contraindication	1023001
Asthenia	contraindication	13791008
Hypovolemia	contraindication	28560003
Low blood pressure	contraindication	45007003
Cerebral arteriosclerosis	contraindication	65312002
Decreased respiratory function	contraindication	80954004
Epilepsy	contraindication	84757009	DOID:1826
Myocardial dysfunction	contraindication	233928007
Disorder of lipid metabolism	contraindication	267431006
Hypoxia	contraindication	389086002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.8	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
GABA A receptor alpha-2/beta-2/gamma-2	Ion channel	P18507 P47869 P47870	GBRA2_HUMAN GBRB2_HUMAN GBRG2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	EC50	4.95	CHEMBL	CHEMBL
GABA-A receptor alpha-1/beta-3/gamma-2	Ion channel	P14867 P18507 P28472	GBRA1_HUMAN GBRB3_HUMAN GBRG2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	EC50	5.39	CHEMBL	CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2	Ion channel	P14867 P18507 P47870	GBRA1_HUMAN GBRB2_HUMAN GBRG2_HUMAN	POSITIVE ALLOSTERIC MODULATOR	EC50	5.70	CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	5.22	DRUG MATRIX
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	4.91	WOMBAT-PK
Carbonic anhydrase 1	Enzyme	P00915	CAH1_HUMAN		IC50	4.71	WOMBAT-PK
Carbonic anhydrase 2	Enzyme	P00918	CAH2_HUMAN		IC50	4.01	WOMBAT-PK
Fatty-acid amide hydrolase 1	Enzyme	O00519	FAAH1_HUMAN		IC50	4.28	WOMBAT-PK
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN		IC50	5.42	DRUG MATRIX
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	5.03	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	5.46	DRUG MATRIX
Arachidonate 15-lipoxygenase	Enzyme		LOX15_RABIT		IC50	5.12	DRUG MATRIX
Fatty-acid amide hydrolase 1	Enzyme		FAAH1_RAT		IC50	4.85	CHEMBL
GABA-A receptor; anion channel	Ion channel		GBRA1_RAT GBRA2_RAT GBRA3_RAT GBRA4_RAT GBRA5_RAT GBRA6_RAT GBRB1_RAT GBRB2_RAT GBRB3_RAT GBRD_RAT GBRE_RAT GBRG1_RAT GBRG2_RAT GBRG3_RAT GBRP_RAT Q91ZM7_RAT		IC50	5.40	CHEMBL
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 1	Ion channel		HCN1_MOUSE	BLOCKER	IC50	5.20	IUPHAR

External reference:

ID	Source
4019500	VUID
N0000147620	NUI
C0033487	UMLSCUI
D00549	KEGG_DRUG
74674007	SNOMEDCT_US
4019500	VANDF
14179	MMSL
8782	RXNORM
387423006	SNOMEDCT_US
5372	MMSL
d00933	MMSL
003528	NDDF
4943	PUBCHEM_CID
CHEBI:44915	CHEBI
CHEMBL526	ChEMBL_ID
DB00818	DRUGBANK_ID
PFL	PDB_CHEM_ID
YI7VU623SF	UNII
5073	INN_ID
D015742	MESH_DESCRIPTOR_UI
5464	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PROPOFOL	HUMAN PRESCRIPTION DRUG LABEL	1	0409-4699	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2136	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6194	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6195	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	0641-6196	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
propofol	HUMAN PRESCRIPTION DRUG LABEL	1	25021-608	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	15 sections
Propofol Injectable Emulsion	HUMAN PRESCRIPTION DRUG LABEL	1	43598-265	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	15 sections
Propofol Injectable Emulsion	HUMAN PRESCRIPTION DRUG LABEL	1	43598-548	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	15 sections
Propofol Injectable Emulsion	HUMAN PRESCRIPTION DRUG LABEL	1	43598-549	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	15 sections
Anesthesia S/I-60	HUMAN PRESCRIPTION DRUG LABEL	2	49836-024	KIT	10 mg	None	NDA	17 sections
Anesthesia S/I-40	HUMAN PRESCRIPTION DRUG LABEL	2	49836-025	KIT	10 mg	None	NDA	16 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4569	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	15 sections
PROPOFOL	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1293	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
PROPOFOL	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1470	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
PROPOFOL	HUMAN PRESCRIPTION DRUG LABEL	1	51662-1471	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
PROPOFOL	HUMAN PRESCRIPTION DRUG LABEL	1	52584-098	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Diprivan	HUMAN PRESCRIPTION DRUG LABEL	1	52584-269	INJECTION, EMULSION	10 mg	INTRAVENOUS	NDA	11 sections
Propofol	HUMAN PRESCRIPTION DRUG LABEL	1	52584-699	INJECTION, EMULSION	10 mg	INTRAVENOUS	ANDA	14 sections
Diprivan	HUMAN PRESCRIPTION DRUG LABEL	1	63323-269	INJECTION, EMULSION	10 mg	INTRAVENOUS	NDA	14 sections
Diprivan	HUMAN PRESCRIPTION DRUG LABEL	1	65219-800	INJECTION, EMULSION	10 mg	INTRAVENOUS	NDA	14 sections