panitumumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
human origin	4955	339177-26-3

Description:

Molecule	Description
Synonyms: panitumumab vectibix ABX-EGF	Recombinant human monoclonal antibody that binds to and inhibits the function of the EPIDERMAL GROWTH FACTOR RECEPTOR. It is used in the treatment of EGFR-expressing metastatic colorectal cancer that expresses wild-type ras gene (see GENES, RAS). Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

panitumumab
vectibix
ABX-EGF

Recombinant human monoclonal antibody that binds to and inhibits the function of the EPIDERMAL GROWTH FACTOR RECEPTOR. It is used in the treatment of EGFR-expressing metastatic colorectal cancer that expresses wild-type ras gene (see GENES, RAS).

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 3, 2007	EMA	Amgen Europe B.V.
Sept. 27, 2006	FDA	AMGEN

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
Dermatitis acneiform	1116.22	27.82	238	10137	4758	63473889
Skin toxicity	642.58	27.82	150	10225	4564	63474083
Paronychia	617.83	27.82	150	10225	5415	63473232
Hypomagnesaemia	396.30	27.82	156	10219	28581	63450066
Dry skin	277.41	27.82	150	10225	56737	63421910
Neutropenia	251.04	27.82	216	10159	174789	63303858
Neuropathy peripheral	241.81	27.82	177	10198	113490	63365157
Rash	224.91	27.82	358	10017	560513	62918134
Skin fissures	208.06	27.82	76	10299	11312	63467335
Stomatitis	204.40	27.82	174	10201	138551	63340096
Rash pustular	200.43	27.82	66	10309	7216	63471431
Disease progression	195.33	27.82	161	10214	122597	63356050
Diarrhoea	185.86	27.82	378	9997	714988	62763659
Therapy partial responder	168.59	27.82	64	10311	10594	63468053
Skin disorder	122.30	27.82	70	10305	29437	63449210
Metastases to liver	119.72	27.82	64	10311	23575	63455072
Xerosis	106.47	27.82	26	10349	956	63477691
Neurotoxicity	103.26	27.82	52	10323	16938	63461709
Palmar-plantar erythrodysaesthesia syndrome	101.85	27.82	57	10318	22958	63455689
Peripheral sensory neuropathy	100.97	27.82	40	10335	7411	63471236
Mucosal inflammation	97.11	27.82	72	10303	46856	63431791
Polyneuropathy	92.63	27.82	46	10329	14543	63464104
Thrombocytopenia	90.09	27.82	117	10258	151040	63327607
Trichomegaly	88.94	27.82	15	10360	75	63478572
Skin reaction	88.92	27.82	45	10330	14804	63463843
Neutrophil count decreased	83.35	27.82	71	10304	56335	63422312
Drug ineffective	82.78	27.82	34	10341	1044731	62433916
Hypocalcaemia	75.52	27.82	53	10322	31660	63446987
Hypertrichosis	64.26	27.82	18	10357	1136	63477511
Acne	62.72	27.82	42	10333	23251	63455396
Malignant neoplasm progression	62.54	27.82	72	10303	82049	63396598
Colorectal cancer metastatic	60.25	27.82	15	10360	598	63478049
Blood magnesium decreased	59.22	27.82	33	10342	13165	63465482
Anaemia	58.37	27.82	140	10235	293290	63185357
Growth of eyelashes	57.66	27.82	12	10363	210	63478437
Hypokalaemia	55.11	27.82	76	10299	103728	63374919
Erythema	54.98	27.82	101	10274	175650	63302997
Arthralgia	52.88	27.82	14	10361	569696	62908951
Dehydration	52.19	27.82	98	10277	173256	63305391
Metastases to ovary	49.01	27.82	12	10363	446	63478201
Carcinoembryonic antigen increased	48.56	27.82	16	10359	1749	63476898
Decreased appetite	47.98	27.82	118	10257	250934	63227713
Conjunctivitis	47.75	27.82	34	10341	20762	63457885
Febrile neutropenia	47.46	27.82	76	10299	118373	63360274
Death	47.00	27.82	151	10224	374230	63104417
Leukopenia	46.23	27.82	60	10315	77230	63401417
Ileal perforation	44.07	27.82	11	10364	443	63478204
Dermatitis	41.90	27.82	29	10346	16929	63461718
Interstitial lung disease	41.70	27.82	51	10324	61857	63416790
Fall	39.62	27.82	8	10367	392326	63086321
Metastases to lung	39.23	27.82	25	10350	12725	63465922
Ileus	38.31	27.82	26	10349	14699	63463948
Abdominal discomfort	38.26	27.82	4	10371	320881	63157766
Headache	36.60	27.82	30	10345	633211	62845436
Gastrointestinal toxicity	33.76	27.82	19	10356	7722	63470925
Scab	33.71	27.82	19	10356	7744	63470903
Xeroderma	33.61	27.82	7	10368	123	63478524
Haematotoxicity	32.93	27.82	20	10355	9356	63469291
Pain of skin	31.36	27.82	21	10354	11613	63467034
Eye irritation	31.09	27.82	27	10348	21944	63456703
Nasopharyngitis	30.74	27.82	3	10372	254254	63224393
Pulmonary embolism	30.26	27.82	62	10313	116622	63362025
Peripheral swelling	29.99	27.82	4	10371	265938	63212709
Pain	28.90	27.82	48	10327	740580	62738067
Ascites	28.14	27.82	34	10341	40694	63437953

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
Dermatitis acneiform	2086.20	24.86	506	16878	5683	34933864
Skin toxicity	1190.13	24.86	307	17077	4477	34935070
Paronychia	1103.15	24.86	270	17114	3135	34936412
Hypomagnesaemia	742.23	24.86	310	17074	21541	34918006
Rash	560.89	24.86	617	16767	222135	34717412
Rash pustular	436.45	24.86	145	17239	5263	34934284
Skin reaction	377.67	24.86	129	17255	5101	34934446
Stomatitis	346.18	24.86	232	17152	42282	34897265
Interstitial lung disease	292.11	24.86	249	17135	65033	34874514
Metastases to liver	275.80	24.86	135	17249	13528	34926019
Dry skin	252.75	24.86	170	17214	31117	34908430
Neuropathy peripheral	249.45	24.86	254	17130	83009	34856538
Disease progression	249.11	24.86	287	17097	107790	34831757
Neutropenia	246.65	24.86	344	17040	156434	34783113
Diarrhoea	242.67	24.86	570	16814	389342	34550205
Skin disorder	212.64	24.86	113	17271	13442	34926105
Therapy partial responder	196.97	24.86	96	17288	9520	34930027
Acne	195.75	24.86	100	17284	10966	34928581
Folliculitis	182.75	24.86	73	17311	4493	34935054
Skin fissures	166.14	24.86	71	17313	5188	34934359
Polyneuropathy	149.92	24.86	93	17291	14803	34924744
Conjunctivitis	144.03	24.86	78	17306	9627	34929920
Mucosal inflammation	130.55	24.86	126	17258	38496	34901051
Metastases to lung	116.71	24.86	67	17317	9253	34930294
Drug ineffective	103.91	24.86	49	17335	456702	34482845
Decreased appetite	102.27	24.86	243	17141	166149	34773398
Peripheral sensory neuropathy	102.16	24.86	55	17329	6705	34932842
Xerosis	94.78	24.86	27	17357	577	34938970
Palmar-plantar erythrodysaesthesia syndrome	93.73	24.86	73	17311	16722	34922825
Neurotoxicity	91.34	24.86	74	17310	17936	34921611
Carcinoembryonic antigen increased	90.66	24.86	27	17357	678	34938869
Thrombocytopenia	86.21	24.86	219	17165	156028	34783519
Hypocalcaemia	85.36	24.86	81	17303	24208	34915339
Neutrophil count decreased	78.27	24.86	111	17273	50993	34888554
Growth of eyelashes	75.97	24.86	16	17368	87	34939460
Erythema	69.49	24.86	143	17241	88637	34850910
Drug interaction	69.49	24.86	14	17370	225932	34713615
Blood magnesium decreased	69.44	24.86	42	17342	6381	34933166
Colorectal cancer metastatic	68.38	24.86	22	17362	718	34938829
Dermatitis	63.61	24.86	46	17338	9422	34930125
Headache	58.49	24.86	14	17370	200621	34738926
Arthralgia	57.87	24.86	8	17376	170033	34769514
Metastases to lymph nodes	56.55	24.86	33	17351	4695	34934852
Trichomegaly	54.77	24.86	10	17374	21	34939526
Pulmonary embolism	50.64	24.86	127	17257	89619	34849928
Ileus	46.82	24.86	49	17335	16450	34923097
Metastases to peritoneum	45.68	24.86	21	17363	1823	34937724
Hypertrichosis	45.32	24.86	14	17370	399	34939148
Gastrointestinal toxicity	43.54	24.86	23	17361	2696	34936851
Fall	42.60	24.86	24	17360	202861	34736686
Gene mutation	41.15	24.86	18	17366	1390	34938157
Blepharitis	40.70	24.86	18	17366	1427	34938120
Hepatectomy	40.18	24.86	9	17375	68	34939479
Metastases to pelvis	40.15	24.86	12	17372	305	34939242
Skin exfoliation	39.64	24.86	58	17326	27374	34912173
Perioral dermatitis	39.19	24.86	10	17374	138	34939409
Dehydration	38.62	24.86	147	17237	129822	34809725
Pustule	37.32	24.86	13	17371	544	34939003
Transient aphasia	37.25	24.86	12	17372	393	34939154
Intestinal obstruction	37.03	24.86	51	17333	22771	34916776
Skin lesion	37.03	24.86	50	17334	21911	34917636
Enterocolitis	36.56	24.86	31	17353	7995	34931552
Hypersensitivity	36.12	24.86	88	17296	60947	34878600
Somnolence	36.01	24.86	6	17378	111110	34828437
Febrile neutropenia	36.01	24.86	149	17235	136700	34802847
Mucocutaneous rash	35.85	24.86	7	17377	24	34939523
Carbohydrate antigen 19-9 increased	35.27	24.86	10	17374	210	34939337
Mucosal toxicity	33.58	24.86	10	17374	251	34939296
Dizziness	33.05	24.86	36	17348	218485	34721062
Device related infection	31.77	24.86	41	17343	17196	34922351
Product dose omission issue	31.76	24.86	10	17374	119701	34819846
Nail disorder	31.64	24.86	17	17367	2062	34937485
Overdose	31.63	24.86	4	17380	91055	34848492
Catheter site thrombosis	31.25	24.86	8	17376	112	34939435
Cough	31.15	24.86	18	17366	150122	34789425
Livedo reticularis	30.39	24.86	17	17367	2232	34937315
Hypokalaemia	30.34	24.86	80	17304	58134	34881413
Product use in unapproved indication	29.13	24.86	11	17373	117488	34822059
Diaphragmatic operation	28.91	24.86	6	17378	30	34939517
Confusional state	28.90	24.86	18	17366	144142	34795405
Toxicity to various agents	28.14	24.86	35	17349	200327	34739220
Cardiac failure congestive	28.10	24.86	4	17380	83266	34856281
Pain in extremity	27.95	24.86	14	17370	126499	34813048
Epidermal naevus syndrome	27.89	24.86	5	17379	9	34939538
Depression	27.82	24.86	7	17377	97091	34842456
Acne pustular	27.41	24.86	7	17377	97	34939450
Myocardial infarction	27.35	24.86	13	17371	121072	34818475
Hepatic lesion	27.15	24.86	19	17365	3693	34935854
Dermatitis infected	26.83	24.86	7	17377	106	34939441
Eyelash changes	26.64	24.86	5	17379	13	34939534
Ectropion	26.13	24.86	7	17377	118	34939429
Astringent therapy	25.41	24.86	5	17379	18	34939529
Insomnia	25.30	24.86	10	17374	103897	34835650

FDA Adverse Event Reporting System (Geriatric)

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
Dermatitis acneiform	2964.75	23.55	670	23321	9323	79711074
Skin toxicity	1605.18	23.55	394	23597	7920	79712477
Paronychia	1446.50	23.55	358	23633	7450	79712947
Hypomagnesaemia	914.84	23.55	388	23603	46523	79673874
Rash pustular	570.34	23.55	188	23803	11123	79709274
Neuropathy peripheral	535.11	23.55	397	23594	140908	79579489
Rash	509.07	23.55	738	23253	577620	79142777
Stomatitis	460.81	23.55	369	23622	146388	79574009
Dry skin	456.19	23.55	273	23718	67722	79652675
Disease progression	454.22	23.55	403	23588	183959	79536438
Neutropenia	442.46	23.55	486	23505	287224	79433173
Therapy partial responder	389.52	23.55	159	23832	17238	79703159
Metastases to liver	387.47	23.55	183	23808	28131	79692266
Interstitial lung disease	363.63	23.55	288	23703	112312	79608085
Diarrhoea	342.87	23.55	789	23202	879700	78840697
Skin fissures	301.25	23.55	122	23869	12951	79707446
Skin reaction	289.98	23.55	126	23865	15942	79704455
Skin disorder	279.96	23.55	156	23835	33787	79686610
Polyneuropathy	261.25	23.55	133	23858	24018	79696379
Acne	227.03	23.55	126	23865	27064	79693333
Thrombocytopenia	199.85	23.55	316	23675	264943	79455454
Palmar-plantar erythrodysaesthesia syndrome	196.31	23.55	123	23868	33011	79687386
Mucosal inflammation	195.19	23.55	170	23821	75410	79644987
Neurotoxicity	175.94	23.55	114	23877	32404	79687993
Metastases to lung	170.57	23.55	91	23900	18072	79702325
Peripheral sensory neuropathy	165.30	23.55	80	23911	12953	79707444
Neutrophil count decreased	152.99	23.55	164	23827	93795	79626602
Conjunctivitis	151.15	23.55	95	23896	25620	79694777
Decreased appetite	136.55	23.55	311	23680	342107	79378290
Hypocalcaemia	128.24	23.55	112	23879	49812	79670585
Trichomegaly	123.37	23.55	23	23968	109	79720288
Drug ineffective	123.35	23.55	88	23903	1080825	78639572
Xerosis	120.75	23.55	34	23957	1172	79719225
Carcinoembryonic antigen increased	116.45	23.55	38	23953	2171	79718226
Arthralgia	109.47	23.55	20	23971	571783	79148614
Hypertrichosis	105.39	23.55	31	23960	1251	79719146
Colorectal cancer metastatic	102.06	23.55	30	23961	1208	79719189
Headache	98.41	23.55	37	23954	653735	79066662
Dermatitis	96.68	23.55	67	23924	21254	79699143
Growth of eyelashes	90.60	23.55	19	23972	179	79720218
Erythema	81.40	23.55	196	23795	223094	79497303
Drug interaction	76.28	23.55	16	23975	415167	79305230
Fall	76.02	23.55	26	23965	487603	79232794
Gene mutation	72.09	23.55	28	23963	2658	79717739
Ileus	71.74	23.55	61	23930	26150	79694247
Metastases to lymph nodes	70.25	23.55	42	23949	10355	79710042
Leukopenia	66.62	23.55	123	23868	116390	79604007
Pain	63.57	23.55	71	23920	703731	79016666
Metastases to peritoneum	62.04	23.55	29	23962	4343	79716054
Febrile neutropenia	59.15	23.55	178	23813	230821	79489576
Hypokalaemia	57.41	23.55	131	23860	143909	79576488
Peripheral swelling	57.08	23.55	7	23984	269610	79450787
Xeroderma	56.17	23.55	14	23977	298	79720099
Death	55.72	23.55	325	23666	566189	79154208
Gastrointestinal toxicity	55.41	23.55	33	23958	8076	79712321
Blood magnesium decreased	54.80	23.55	43	23948	16469	79703928
Pulmonary embolism	52.43	23.55	141	23850	171513	79548884
Blepharitis	51.49	23.55	23	23968	3101	79717296
Nasopharyngitis	50.43	23.55	8	23983	253873	79466524
Skin lesion	49.49	23.55	62	23929	41782	79678615
Pain in extremity	49.36	23.55	24	23967	364514	79355883
Folliculitis	48.65	23.55	71	23920	55309	79665088
Mucocutaneous rash	48.04	23.55	9	23982	44	79720353
Malignant neoplasm progression	48.03	23.55	118	23873	135872	79584525
Depression	47.46	23.55	5	23986	216785	79503612
Scab	47.40	23.55	33	23958	10539	79709858
Ectropion	47.12	23.55	13	23978	415	79719982
Pustule	46.98	23.55	19	23972	2006	79718391
Intestinal obstruction	46.56	23.55	61	23930	42959	79677438
Product dose omission issue	46.54	23.55	9	23982	247528	79472869
Hepatectomy	46.30	23.55	11	23980	190	79720207
Confusional state	46.08	23.55	19	23972	317978	79402419
Carbohydrate antigen 19-9 increased	46.06	23.55	13	23978	452	79719945
Skin exfoliation	46.04	23.55	69	23922	55031	79665366
Neoplasm progression	45.02	23.55	66	23925	51616	79668781
Dizziness	44.38	23.55	56	23935	526385	79194012
Cough	42.73	23.55	29	23962	366760	79353637
Abdominal discomfort	41.46	23.55	12	23979	250715	79469682
Transient aphasia	41.19	23.55	12	23979	468	79719929
Musculoskeletal stiffness	41.11	23.55	3	23988	175005	79545392
Haematotoxicity	40.19	23.55	35	23956	15484	79704913
Hepatic lesion	39.10	23.55	25	23966	6934	79713463
Mucosal toxicity	38.55	23.55	12	23979	588	79719809
Somnolence	38.49	23.55	12	23979	238969	79481428
Swelling	38.44	23.55	9	23982	216702	79503695
Device related infection	37.69	23.55	49	23942	34245	79686152
Asthenia	37.07	23.55	272	23719	511417	79208980
Dermatitis infected	37.04	23.55	10	23981	294	79720103
Product use issue	36.66	23.55	9	23982	209813	79510584
Toxicity to various agents	36.39	23.55	44	23947	421496	79298901
Drug intolerance	36.33	23.55	17	23974	264102	79456295
Ileal perforation	35.95	23.55	13	23978	1012	79719385
Drug hypersensitivity	35.66	23.55	23	23968	298893	79421504
Overdose	33.98	23.55	7	23984	184199	79536198
Papule	32.92	23.55	23	23968	7384	79713013
Therapeutic product effect decreased	32.90	23.55	5	23986	163858	79556539
Hyperammonaemia	32.80	23.55	27	23964	11066	79709331
Eczema impetiginous	32.26	23.55	6	23985	28	79720369
Weight increased	32.20	23.55	22	23969	277364	79443033
Diaphragmatic operation	31.91	23.55	6	23985	30	79720367
Cardiac failure congestive	31.90	23.55	3	23988	142399	79577998
Livedo reticularis	31.48	23.55	18	23973	4085	79716312
Thrombocytopenic purpura	30.83	23.55	15	23976	2454	79717943
Insomnia	30.44	23.55	18	23973	245152	79475245
Epidermal naevus syndrome	30.40	23.55	5	23986	9	79720388
Ascites	30.39	23.55	69	23922	75493	79644904
Perioral dermatitis	30.36	23.55	9	23982	373	79720024
Anaemia	30.19	23.55	233	23758	444782	79275615
Colon cancer metastatic	29.51	23.55	14	23977	2167	79718230
Metastases to pelvis	29.36	23.55	10	23981	652	79719745
IgA nephropathy	29.09	23.55	13	23978	1755	79718642
Product use in unapproved indication	28.86	23.55	20	23971	250339	79470058
Subileus	28.56	23.55	19	23972	5635	79714762
Metastasis	27.44	23.55	20	23971	6860	79713537
Dysgeusia	27.33	23.55	56	23935	57121	79663276
Nail disorder	27.26	23.55	25	23966	11827	79708570
Anxiety	27.16	23.55	21	23970	248491	79471906
Contusion	26.73	23.55	6	23985	148770	79571627
Metastases to ovary	26.59	23.55	8	23983	349	79720048
Enterocolitis	26.57	23.55	27	23964	14485	79705912
Bronchitis	26.19	23.55	4	23987	130640	79589757
Astringent therapy	25.97	23.55	5	23986	29	79720368
Lower respiratory tract infection	25.81	23.55	4	23987	129216	79591181
Blood pressure increased	25.56	23.55	16	23975	211344	79509053
Urinoma	25.42	23.55	7	23984	222	79720175
Drug effective for unapproved indication	25.20	23.55	18	23973	5983	79714414
Eye irritation	25.02	23.55	31	23960	20650	79699747
Dehydration	24.04	23.55	142	23849	248045	79472352
Feeling abnormal	23.88	23.55	9	23982	159190	79561207

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FE02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES EGFR (Epidermal Growth Factor Receptor) inhibitors
FDA CS	M0001357	Antibodies, Monoclonal
FDA MoA	N0000020010	HER1 Antagonists
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
FDA EPC	N0000175664	Epidermal Growth Factor Receptor Antagonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Secondary malignant neoplasm of colon	indication	94260004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

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])	Mechanism action	Bioact source	MoA source
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN	AGONIST	Kd	10.30		IUPHAR	DRUG LABEL

External reference:

ID	Source
D05350	KEGG_DRUG
4025701	VUID
N0000179714	NUI
4025701	VANDF
CHEMBL1201827	ChEMBL_ID
6883	IUPHAR_LIGAND_ID
DB01269	DRUGBANK_ID
263034	RXNORM
22205	MMSL
88497	MMSL
d05879	MMSL
011743	NDDF
423259008	SNOMEDCT_US
424401006	SNOMEDCT_US
C0879427	UMLSCUI
D000077544	MESH_DESCRIPTOR_UI
8499	INN_ID
6A901E312A	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-954	SOLUTION	100 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-954	SOLUTION	100 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-954	SOLUTION	100 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-956	SOLUTION	400 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-956	SOLUTION	400 mg	INTRAVENOUS	BLA	28 sections
Vectibix	HUMAN PRESCRIPTION DRUG LABEL	1	55513-956	SOLUTION	400 mg	INTRAVENOUS	BLA	28 sections