CLARISCAN 376.9 mg/mL
gadoterate meglumine · INJECTION, SOLUTION · GE Healthcare
CLARISCAN is a injection, solution containing gadoterate meglumine at 376.9 mg/mL, taken intravenous. Manufactured by GE Healthcare.
Key Facts
- Brand Name
- CLARISCAN
- Generic Name
- gadoterate meglumine
- NDC Code (Product)
0407-2943- Manufacturer
- GE Healthcare
- Strength
- 376.9 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA210016
- Marketing Start
- 11/01/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adult and pediatric patients: The recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients (including term neonates). The dose is delivered by manual or power injection. ( 2 ) 2.1 Dosing Guidelines For adult and pediatric patients (including term neonates), the recommended dose of Clariscan is 0.2 mL/kg (0.1 mmol/kg) body weight administered as an intravenous bolus injection, manually or by power injector, at a flow rate of approximately 2 mL/second for adults and 1 to 2 mL/second for pediatric patients. Table 1 provides weight-adjusted dose volumes. Table 1: Volumes of Clariscan Injection by Body Weight Body Weight Volume Pounds (lb) Kilograms (kg) Milliliters (mL) 5.5 2.5 0.5 11 5 1 22 10 2 44 20 4 66 30 6 88 40 8 110 50 10 132 60 12 154 70 14 176 80 16 198 90 18 220 100 20 242 110 22 264 120 24 286 130 26 308 140 28 330 150 30 To ensure complete injection of Clariscan, the injection may be followed by normal saline flush. Contrast MRI can begin immediately following Clariscan injection. 2.2 Drug …
Contraindications
4 CONTRAINDICATIONS History of clinically important hypersensitivity reactions to Clariscan [see Warnings and Precautions (5.3) ]. Clinically important hypersensitivity reactions to Clariscan. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Gadoterate does not interfere with serum and plasma calcium measurements determined by colorimetric assays. Specific drug interaction studies with gadoterate meglumine have not been conducted.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Nephrogenic systemic fibrosis [see Warnings and Precautions (5.2) ] Hypersensitivity reactions [see Warnings and Precautions (5.3) ] Gadolinium Retention [see Warnings and Precautions (5.4) ] The most frequent (≥ 0.2%) adverse reactions in clinical studies were nausea, headache, injection site pain, injection site coldness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect gadoterate meglumine exposure in 2867 patients, representing 2682 adults and 185 pediatric patients. Overall, 55% of the patients were men. In clinical trials where ethnicity was recorded, the ethnic distribution was 81% Caucasian, 11% Asian, 4% Black, and 4% others. The av…
Frequently Asked Questions
What is CLARISCAN used for?
CLARISCAN contains gadoterate meglumine. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is CLARISCAN a controlled substance?
CLARISCAN is not classified as a controlled substance by the DEA.
What is the generic name for CLARISCAN?
The generic name for CLARISCAN is gadoterate meglumine. There are 9 other brand versions of gadoterate meglumine.
What is the NDC code for CLARISCAN 376.9 mg/mL?
The NDC (National Drug Code) for CLARISCAN 376.9 mg/mL is 0407-2943, listed by GE Healthcare.
Other Gadoterate Brands
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- Gadoterate Meglumine376.9 mg/mL65219-082
- Gadoterate Meglumine376.9 mg/mL65219-084
- DOTAREM376.9 mg/mL67684-2000
- Gadoterate Meglumine376.9 mg/mL65219-080
- DOTAREM376.9 mg/mL67684-3001
- gadoterate meglumine376.9 mg/mL70436-123
- DOTAREM376.9 mg/mL67684-2001
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)