Ultravist 370 solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

iopromide

Available from:

Bayer AG

ATC code:

V08AB05

INN (International Name):

iopromide

Dosage:

769mg/ml (370mg iodine/ml)

Pharmaceutical form:

solution for injection

Units in package:

(10) glass vial 50ml, (10) glass vial 100ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-01-31

Summary of Product characteristics

1
PROFESSIONAL DATASHEET
1.
NAME OF THE MEDICINAL PRODUCT
Ultravist
®
-150, 150 mg iodine/mL, solution for injection
Ultravist
®
-240, 240 mg iodine/mL, solution for injection or infusion
Ultravist
®
-300, 300 mg iodine/mL, solution for injection or infusion, or oral
solution
Ultravist
®
-370, 370 mg iodine/mL, solution for injection or infusion, or oral
solution
Iopromide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist-150:
1 mL solution for injection contains:
312 mg iopromide (equivalent to 150 mg bound iodine).
Ultravist-240:
1 mL solution for injection or infusion contains:
499 mg iopromide (equivalent to 240 mg bound iodine).
Ultravist-300:
1 mL solution for injection or infusion, or oral solution contains:
623 mg iopromide (equivalent to 300 mg bound iodine).
Ultravist-370:
1 mL solution for injection or infusion, or oral solution contains:
769 mg iopromide (equivalent to 370 mg bound iodine).
For the full list of excipients, see section 6.1.
ULTRAVIST-
150
240
300
370
IOPROMIDE concentration (mg/mL)
312
499
623
769
IOPROMIDE content (g) in
Vial containing:
10 mL
–
–
6.2
–
Bottle containing
50 mL
15.6
24.9
31.2
38.4
75 mL
–
–
46.8
–
100 mL
–
–
62.3
76.9
150 mL
–
–
93.5
–
200 mL
–
–
124.6
153.8
500 mL
–
–
311.5
384.5
Prefilled plastic cartridge containing
75 mL
–
–
46.8
57.7
100 mL
–
–
62.3
76.9
125 mL
–
–
77.9
96.1
150 mL
–
–
93.5
115.4
2
ULTRAVIST
-
150
240
300
370
IODINE concentration (mg/mL)
150
240
300
370
IODINE content (g) in
Vial containing:
10 mL
–
–
3.0
–
Bottle containing
50 mL
7.5
12.0
15.0
18.5
75 mL
–
–
22.5
–
100 mL
–
–
30.0
37.0
150 mL
–
–
45.0
–
200 mL
–
–
60.0
74.0
500 mL
–
–
150.0
185.0
Prefilled plastic cartridge containing
75 mL
–
–
22.5
27.8
100 mL
–
–
30.0
37.0
125 mL
–
–
37.5
46.3
150 mL
–
–
45.0
55.5
3.
PHARMACEUTICAL FORM
Ultravist
-150: solution for injection
Ultravist
-240: solution for injection or infusion
Ultravist
-300, -370: solution for injection or infusion, or oral soluti