A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Omniscan Indications, Dosage, Storage, Stability - Gadodiamide
Omniscan Indications, Dosage, Storage, Stability - Gadodiamide
INDICATIONS AND USAGE
CNS (Central Nervous System)
OMNISCAN is indicated for intravenous use in MRI to visualize
lesions with abnormal vascularity (or those thought to cause abnormalities in
the blood-brain barrier) in the brain (intracranial lesions), spine, and associated
tissues.
Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and
Retroperitoneal Regions)
OMNISCAN is indicated for intravenous administration to facilitate
the visualization of lesions with abnormal vascularity within the thoracic (noncardiac),
abdominal, pelvic cavities, and the retroperitoneal space.
DOSAGE AND ADMINISTRATION
CNS (Central Nervous System)
Adults: The recommended dose of OMNISCAN is 0.2
mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection. An additional
0.4 mL/kg (0.2 mmol/kg) can be given within 20 minutes of the first dose.(See
the Dosage Chart.)
Pediatric Patients (2-16 years): The recommended
dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous
injection.(See the Dosage Chart.)
Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and
Retroperitoneal Regions)
Adult and Pediatric Patients (2-16 years of age): For
the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For
the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended
dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg). (See the Dosage Chart.)
|
DOSAGE CHART
|
|
BODY WEIGHT
|
PEDIATRIC
|
ADULTS
|
|
0.05
|
0.1
|
0.05
|
0.1
|
0.2
|
|
(mmol/kg)
|
(mmol/kg)
|
|
kg
|
lb
|
VOLUME (mL)
|
VOLUME (mL)
|
|
12
|
26
|
1.2
|
2.4
|
-
|
-
|
-
|
|
14
|
31
|
1.4
|
2.8
|
-
|
-
|
-
|
|
16
|
35
|
1.6
|
3.2
|
-
|
-
|
-
|
|
18
|
40
|
1.8
|
3.6
|
-
|
-
|
-
|
|
20
|
44
|
2.0
|
4.0
|
-
|
-
|
-
|
|
22
|
48
|
2.2
|
4.4
|
-
|
-
|
-
|
|
24
|
53
|
2.4
|
4.8
|
-
|
-
|
-
|
|
26
|
57
|
2.6
|
5.2
|
-
|
-
|
-
|
|
28
|
62
|
2.8
|
5.6
|
-
|
-
|
-
|
|
30
|
66
|
3.0
|
6.0
|
-
|
-
|
-
|
|
40
|
88
|
4.0
|
8.0
|
4.0
|
8.0
|
16.0
|
|
50
|
110
|
5.0
|
10.0
|
5.0
|
10.0
|
20.0
|
|
60
|
132
|
6.0
|
12.0
|
6.0
|
12.0
|
24.0
|
|
70
|
154
|
7.0
|
14.0
|
7.0
|
14.0
|
28.0
|
|
80
|
176
|
8.0
|
16.0
|
8.0
|
16.0
|
32.0
|
|
90
|
198
|
-
|
-
|
9.0
|
18.0
|
36.0
|
|
100
|
220
|
-
|
-
|
10.0
|
20.0
|
40.0
|
|
110
|
242
|
-
|
-
|
11.0
|
22.0
|
44.0
|
|
120
|
264
|
-
|
-
|
12.0
|
24.0
|
48.0
|
|
130*
|
286
|
-
|
-
|
13.0
|
26.0
|
52.0
|
|
*The heaviest patient in clinical studies weighed 136
kg.
|
To ensure complete injection of the contrast medium, the injection
should be followed by a 5 mL flush of 0.9% sodium chloride, as provided in the
Prefill Plus needle-free system. The imaging procedure should be completed within
1 hour of administration of OMNISCAN. Parenteral products should be inspected
visually for particulate matter and discoloration prior to administration, whenever
solution and container permit.
Do not use the solution if it is discolored or particulate
matter is present. Any unused portion must be discarded.
HOW SUPPLIED
OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless
to slightly yellow, aqueous solution containing 287 mg/mLof gadodiamide in rubber
stoppered vials and polypropylene syringes. OMNISCAN is supplied in the following
sizes:
5 mLfill in 10 mLvial, box of 10, (NDC 0407-0690-05)
10 mLvial, box of 10, (NDC 0407-0690-10)
15 mLfill in 20 mLvial, box of 10, (NDC 0407-0690-15)
20 mLvial, box of 10, (NDC 0407-0690-20)
50 mLvial, box of 10, (NDC 0407-0690-55)
10 mLfill in 20 mLprefilled syringe, box of 10, (NDC 0407-0690-12)
15 mLfill in 20 mLprefilled syringe, box of 10, (NDC 0407-0690-17)
20 mLprefilled syringe, box of 10, (NDC 0407-0690-22)
Prefill Plus™ needle-free system
Omniscan 15 mL, box of 10, (NDC 0407-0690-62)
Contains: Omniscan 15 mL fill in 20 mL Single Dose Prefilled
Syringe and 5 mL0.9% Sodium Chloride Injection, USP I.V. Flush Syringe
Prefill Plus™ needle-free system
Omniscan 20 mL, box of 10, (NDC 0407-0690-63)
Contains: Omniscan 20 mL fill in 20 mL Single Dose Prefilled
Syringe and 5 mL0.9% Sodium Chloride Injection, USP I.V. Flush Syringe
Storage: OMNISCAN should be stored at controlled room
temperature 15°C - 30°C (59°F - 86°F).
Protect from light.
Do not freeze. Freezing could cause small cracks in the vials
which would compromise the sterility of the product. Do not use if the product
is inadvertently frozen.
MAGNEVIST® is a registered trademark of Berlex
Laboratories, Inc.
Distributed by Amersham Health Inc., Princeton,
NJ 08540, Manufactured by Amersham Health AS, Olso, Norway, Printed in USA,
Revised November 2002
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