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Uses
MultiHance is indicated for intravenous use in magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and children over 2 years of age to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
MultiHance is indicated for use in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
History
There is currently no drug history available for this drug.
Other Information
MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only. Each mL of MultiHance contains 529 mg gadobenate dimeglumine and water for injection. MultiHance contains no preservatives.
Gadobenate dimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)- 1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogen compound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecular weight of 1058.2 and an empirical formula of C22H28GdN3O11 • 2C7H17NO5. The structural formula is as follows:
MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parameters are provided below:
Osmolality | 1.970 osmol/kg @ 37°C |
Viscosity | 5.3 mPas @ 37°C |
Density | 1.220 g/mL @ 20°C |
MultiHance has an osmolality 6.9 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use.
Sources
Multihance Manufacturers
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Bracco Diagnostics Inc
Multihance | Bracco Diagnostics Inc
2.1 Dosing and Imaging Instructions 2.1.1 MRI of the CNSThe recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.
2.1.2 MRA of Renal and Aorto-ilio-femoral VesselsFor MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.
2.2 Dosing Table TABLE 1: WEIGHT-BASED DOSING VOLUMES FOR: CNS IMAGING (ADULTS AND PEDIATRICS ≥2 YEARS OF AGE) AND MRA IMAGING (ADULTS ONLY) Volume Kilograms (Kg) Pounds (lb) Milliliters (mL) 5 11 1.0 10 22 2.0 15 33 3.0 20 44 4.0 25 55 5.0 30 66 6.0 35 77 7.0 40 88 8.0 45 99 9.0 50 110 10.0 55 121 11.0 60 132 12.0 65 143 13.0 70 154 14.0 75 165 15.0 80 176 16.0 85 187 17.0 90 198 18.0 95 209 19.0 100 220 20.0 105 231 21.0 110 242 22.0 115 253 23.0 120 264 24.0 125 275 25.0 130 286 26.0 135 297 27.0 140 308 28.0 145 319 29.0 150 330 30.0 2.3 AdministrationInspect the MultiHance bottle visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.
Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.
2.4 Directions for Proper Use of MultiHance MultipackThe pharmacy bulk package is used as a multiple dose container with an appropriate transfer device to fill empty syringes.
MultiHance Multipack injection should be drawn into the syringe and administered using sterile technique. Unused portions of the drug must be discarded.
When MultiHance Multipack injection is to be injected using plastic disposable syringes, the agent should be drawn into the syringe and used immediately.
The transferring of MultiHance (gadobenate dimeglumine) injection from the Pharmacy Bulk Package should be performed in a suitable work area, such as a laminar flow hood, utilizing aseptic technique. The container closure may be penetrated only one time, utilizing a suitable transfer device. Once the pharmacy bulk package is punctured, it should not be removed from the aseptic work area during the entire period of use. The withdrawal of container contents should be accomplished without delay. However, should this not be possible, a maximum time of 8 hours from initial closure entry is permitted to complete fluid transfer operation. Any unused MultiHance Multipack injection must be discarded 8 hours after initial puncture of the bulk package. Temperature of container after the closure has been entered should not exceed 25°C (77°F). -
Bracco Diagnostics Inc
Multihance | Bracco Diagnostics Inc
2.1 Dosing and Imaging Instructions 2.1.1 MRI of the CNSThe recommended dose of MultiHance for MRI of the CNS is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection. To ensure complete injection of the contrast medium, follow the injection with a saline flush of at least 5 mL. Imaging of the CNS can be performed starting immediately after the bolus injection of MultiHance.
2.1.2 MRA of Renal and Aorto-ilio-femoral VesselsFor MRA examination, the recommended dose is 0.1 mmol/kg (0.2 mL/kg) administered as a rapid bolus intravenous injection followed by at least 20 mL saline flush either manually or using an automatic injector system. Start imaging immediately after the administration of MultiHance, with scan delay calculated by test bolus or automatic bolus detection technique. If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection of 1-2 mL of MultiHance should be used to calculate the appropriate scan delay.
2.2 Dosing Table TABLE 1: WEIGHT-BASED DOSING VOLUMES FOR: CNS IMAGING (ADULTS AND PEDIATRICS ≥2 YEARS OF AGE) AND MRA IMAGING (ADULTS ONLY) Volume Kilograms (Kg) Pounds (lb) Milliliters (mL) 5 11 1.0 10 22 2.0 15 33 3.0 20 44 4.0 25 55 5.0 30 66 6.0 35 77 7.0 40 88 8.0 45 99 9.0 50 110 10.0 55 121 11.0 60 132 12.0 65 143 13.0 70 154 14.0 75 165 15.0 80 176 16.0 85 187 17.0 90 198 18.0 95 209 19.0 100 220 20.0 105 231 21.0 110 242 22.0 115 253 23.0 120 264 24.0 125 275 25.0 130 286 26.0 135 297 27.0 140 308 28.0 145 319 29.0 150 330 30.0 2.3 AdministrationInspect the MultiHance vial visually for particulate matter and discoloration prior to administration. Do not use the solution if it is discolored or particulate matter is present. Draw MultiHance into a syringe and inject using sterile technique.
Do not mix intravenous medications or parenteral nutrition solutions with MultiHance. Do not administer other medications in the same intravenous line with MultiHance.
MultiHance vials are intended for single use only. Administer immediately after opening and discard any unused product.
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