Opdivo 100mg/10ml Inj 100 mg/10ml

Krajina: Jordánsko

Jazyk: angličtina

Zdroj: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Aktívna zložka:

Nivolumab 100 mg/10ml

Dostupné z:

مستودع أدوية الشرق شخشير - ORIENT DRUG STORE CO

ATC kód:

L01XC17

INN (Medzinárodný Name):

Nivolumab 100 mg/10ml

Dávkovanie:

100 mg/10ml

Počet v balení:

1 Vial (10ml)

Výrobca:

Bristol Myers Squibb Holdings Pharma ,Ltd.Liability Company (امريكا)

Príbalový leták

Front
(Page 1)
I_10000225051
BRISTOL-MYERS SQUIBB:
LENGTH
HATCH LEGEND. ALL HATCHING DENOTES AREAS TO CONTAIN NOTED INFORMATION.
2870.2mm
Cut
SPECIFIC RULE LEGEND
IC Mark Area Page 1: 3/16" from left edge, 4 point width,
100% black
Susan Stewart
Brian Dangel
Galina Laufer
5/20/2019
COMMENTS:
GRAPHIC DESIGNER:
STRUCTURAL DESIGNER:
ENGINEER:
DATE OF APPROVAL:
STRUCTURE #:
Manufacturing Science & Technology
Outside Bleed
NA
128 Barcode
No Text
Edge Bar
I 2 of 5 Barcode
IC Mark
Glue (No Ink or Varnish)
3"
76.200mm
39"
990.600mm
3"
76.200mm
3
/
16
"
4.762mm
3
/
16
"
4.762mm
3
/
16
"
4.763mm
17
1
/
2
"
444.500mm
1
5
/
16
"
33.337mm
1
5
/
16
"
33.337mm
1
5
/
16
"
33.337mm
1
5
/
16
"
33.337mm
3
/
16
"
4.762mm
1
/
4
"
6.350mm
3
/
16
"
4.763mm
1
/
4
[ 6.350]
1
/
4
"
6.350mm
1
/
4
"
6.350mm
1
/
4
"
6.350mm
3
/
8
[ 9.525]
1
/
2
"
12.700mm
1
/
2
"
12.700mm
1
1
/
2
"
38.100mm
1
/
16
"
1.588mm
1
/
16
"
1.588mm
3
/
4
"
19.050mm
7
5
/
8
"
193.675mm
9
7
/
8
"
250.825mm
1
/
2
"
12.700mm
1
/
2
"
12.700mm
1
/
2
"
12.700mm
3
/
4
"
19.050mm
BLACK
PRODUCT:
ORIGINATOR:
DATE:
FILENAME:
PR CODE:
DEVELOPMENTAL COPY VERSION:
 Utilizes correct specification (drawing)
 Revisions correct per text provided
 Drug potency correct & consistent
 NDC on component verified ??
 Spellcheck
 Utilizes correct colors
 Tints, gradations and colors shown as swatches
 Proofread by
Reason for Change: Submission
.
INITIAL HERE
Susan Stewart
X
X
X
na
X
X
X
02Nov2021
00
B
DV_0059_Opdivo GEM insert
Opdivo GEM
OPDIVO
®
(NIVOLUMAB)
40 MG/4 ML (10 MG/ML) INJECTION
100 MG/10 ML (10 MG/ML) INJECTION
FULL PRESCRIBING INFORMATION
Note: Some numbered sections and subsections have been omitted from
the full prescribing information because
they are not applicable.
1
INDICATIONS AND USAGE
1.1
Unresectable or Metastatic Melanoma
OPDIVO, as a single agent or in combination with ipilimumab, is
indicated for the treatment of patients with
unresectable or metastatic melanoma.
1.2
Adjuvant Treatment of Melanoma
OPDIVO is indicated for the adjuvant treatmen