IOMERON 400 INJECTION 400 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

IOMEPROL EQV IODINE

Available from:

DCH AURIGA SINGAPORE

ATC code:

V08AB10

Dosage:

400 mg/ml

Pharmaceutical form:

INJECTION

Composition:

IOMEPROL EQV IODINE 400 mg/ml

Administration route:

INTRAVASCULAR

Prescription type:

Prescription Only

Manufactured by:

PATHEON ITALIA S.P.A

Authorization status:

ACTIVE

Authorization date:

1995-11-24

Patient Information leaflet

0123456789
1
0
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
0
_IMPIANTO DI PROPRIETÀ DELLA:_
_BRACCO S.P.A. VIA E. FOLLI, 50 - 20134 MILANO - ITALY_
_Cliente:_
BRACCO S.P.A.
_Prodotto:_
IOMERON (SINGAPORE)
SPECIFICA
RIFERIMENTO:
_Materiale:_
ISTRUZIONE
_Codice Patheon:_
_Codice Patheon superato:_
_Codice Bracco:_
_Stesa_
_Codice Bracco superato:_
_Piegata_
_Bobina_
_Pre taglio_
_CODICE LAETUS_
TIPO VERNICE
_APRI NOTA_
_DIGITALE_
_SE PRESENTE_
_Dimensioni:_
_Color i n°:_
PANTONE REFLEX BLU
_Modifica rispetto la versione precedente:_
_QUALITY ASSURANCE_
_P. PACKAGING M. DEVELOPMENT_
_DATA OBSOLESCENZA_
_ARCHIVIARE ALMENO FINO A:_
_DATA EMISSIONE_
_STATUS_
I COLORI SU QUESTA PROVA SONO APPROSSIMATIVI, questa è una stampa a
600 dpi ottenuta con colori a base acqua CMYK.
Definizione e colori non riflettono il risultato finale della
produzione stampata.
000000
255565
CI00S602
CI00S6
01
PANTONE GREEN 372
PANTONE RED 185
PANTONE GREEN 347
PANTONE BLU 297
CROM
_i_
_n_
FOTO

S.N.C.
GRAFICA - FOTOCOMPOSIZIONE
VIA G. TARTINI, 2
-
2 0 15 8   -   M I L A N O
AZIENDA CERTIFICATA UNI EN ISO 9001:2008
03 APR 2013
FCI00S602-PIL-IOME
Versione Bracco: 01
Versione interna: 01
150 X 560 MM
_Passo di taglio a mm_
00
FRONTE
SF 0003 IS+P
_PATHEON ITALIA S.P.A. VIALE G.B. STUCCHI, 110 - 20900 MONZA (MB) -
 ITALY_
CHANGE IN PATHEON ADDRESS.
Iomeprol,
N,N’-bis(2,3-dihydroxypropyl)-5[(hydroxyacetyl)methylamino]-2,4,6-triiodo-1,3-
benzenedicarboxamide, the active component of Iomeron
®
, is a triiodinated, non-ionic, water
soluble X-ray contrast agent with a molecular weight of 777.09,
formulations of which yield contrast
media of particularly low osmolality and viscosity in comparison with
other non-ionic media.
Iomeprol has been formulated in a wide range of concentrations (up to
400 mg iodine/ml). All
have proved to be extremely stable both to heat sterilization and
prolonged room te

Summary of Product characteristics

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
0
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
42
43
44
45
46
47
48
49
50
51
52
53
54
55
Iomeprol,
N,N’-bis(2,3-dihydroxypropyl)-5[(hydroxyacetyl)methylamino]-2,4,6-triiodo-1,3-benzenedicarboxamide,
the active component of Iomeron, is a triiodinated, non-ionic, water
soluble X-ray contrast agent with a
molecular weight of 777.09, formulations of which yield contrast media
of particularly low osmolality and
viscosity in comparison with other non-ionic media.
Iomeprol has been formulated in a wide range of concentrations (up to
400 mg iodine/ml). All have proved
to be extremely stable both to heat sterilization and prolonged room
temperature storage, without the
chelator (EDTA salt) required by other contrast agents. The
physico-chemical characteristics of injectable
solutions of Iomeron at the concentrations listed below are:
Iodine
Osmolality*
Viscosity
Concentration
mosmol/kg water
mPa.s
mg/ml
_(x ± s•t_
_95_
_) _
_(x ± s•t_
_95_
_)_
37° C
20° C
37° C
300
521 ±24
8.1 ±0.7
4.5 ±0.4
350
618 ±29
14.5 ±1.1
7.5 ±0.6
400
726 ±34
27.5 ±2.3
12.6 ±1.1
* By vapour-pressure osmometry
Clinical Pharmacology
The pharmacokinetics, tolerability and diagnostic efficacy of iomeprol
in solutions containing up to 400 mg
iodine/ml have been determined in healthy volunteers and patients
requiring urographic, angiographic, computed
tomography (CT) and body cavity examinations. There were no clinically
significant changes in laboratory test
values and vital signs.
The pharmacokinetics of iomeprol, following intravascular
administration, when described by a two compartment
model, show a rapid phase for drug distribution and a slower phase for
drug elimination. In 18 healthy volunteers the
mean half-lives of the distribution and elimination phases were 23 ±
14 (s) min and 109 ± 20 (s) min, respectively,
with an excretion of 50% by the urinary tract within 2 hours aft