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Omniscan (Gadodiamide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

CNS (Central Nervous System)

OMNISCAN is a gadolinium-based contrast agent 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 [ see Clinical Studies ].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

OMNISCAN is a gadolinium-based contrast agent indicated for intravenous use to facilitate the visualization of lesions with abnormal vascularity within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space [ see Clinical Studies ].

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 Dosage and Administration ].

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 Dosage and Administration ].

Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)

Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [ see Dosage and Administration ].

Dosage Chart

BODY
WEIGHT
PEDIATRICADULTS
0.050.10.050.10.2
kglb(mmol/kg)(mmol/kg)
VOLUME (mL)VOLUME (mL)
12261.22.4---
14311.42.8---
16351.63.2---
18401.83.6---
20442.04.0---
22482.24.4---
24532.44.8---
26572.65.2---
28622.85.6---
30663.06.0---
40884.08.04.08.016.0
501105.010.05.010.020.0
601326.012.06.012.024.0
701547.014.07.014.028.0
801768.016.08.016.032.0
90198--9.018.036.0
100220--10.020.040.0
110242--11.022.044.0
120264--12.024.048.0
130The heaviest patient in clinical studies weighed 136 kg.286--13.026.052.0

Dosing Guidelines

Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

Do not use the solution if it is discolored or particulate matter is present.

Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride. Complete the imaging procedure within 1 hour of administration of OMNISCAN.

A physician with the prerequisite training and knowledge of the procedure to be performed should supervise diagnostic procedures involving the use of gadolinium-based contrast agents.

Directions for Proper Use of OMNISCAN Pharmacy Bulk Package

  • Use only a suitable work area, such as a laminar flow hood, to withdraw OMNISCAN Injection doses from the Pharmacy Bulk Package.
  • Penetrate the Pharmacy Bulk Package container closure only once using a suitable transfer device and aseptic technique.
  • Once the closure is penetrated, withdraw the container contents without delay. If delay is unavoidable, complete the fluid transfer as soon as possible within a maximum time of 8 hours.
  • Once the closure is penetrated, keep the Pharmacy Bulk Package container in the aseptic area and at room temperature (do not exceed 30°C).
  • Following withdrawal of any dose from the Pharmacy Bulk Package, immediately label the dose with the supplied peel-off label that identifies the dose contents as OMNISCAN and that OMNISCAN is not for intrathecal use.
  • Use each individual dose of OMNISCAN Injection immediately following withdrawal from the Pharmacy Bulk Package container; discard any unused portion of the OMNISCAN Injection dose not used immediately.
  • Discard any unused OMNISCAN doses remaining in the Pharmacy Bulk Package 8 hours after the penetration of the container closure.

Repeat Dosing

Sequential use during the same diagnostic session has been studied in adult CNS use only. If the physician determines repeat dosing is required in non-CNS imaging in adults or pediatric patients, renal function should be normal and the time interval between repeat doses should be at least 7 hours to allow for clearance of the drug from the body [ see Clinical Pharmacology ].

DOSAGE FORMS AND STRENGTHS

Sterile aqueous solution for intravenous injection; 287 mg/mL.

HOW SUPPLIED/STORAGE AND HANDLING

OMNISCAN (gadodiamide) Injection is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of gadodiamide supplied in the following sizes:

50 mL in + PLUS PAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-71)

100 mL in + PLUS PAK™ (polymer bottle), boxes of 10 Pharmacy Bulk Packages (NDC 0407-0690-70)

SPECIAL HANDLING AND STORAGE FOR POLYMER BOTTLES.
DO NOT USE IF TAMPER-EVIDENT RING IS BROKEN OR MISSING.

Protect polymer bottles of OMNISCAN from strong daylight and direct exposure to sunlight. Do not freeze. Do not use if the product is inadvertently frozen.

Store OMNISCAN at controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].

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