bracco diagnostics inc - Medication Listings

11.1 Generator Characteristics CardioGen-82 (rubidium Rb 82 generator) contains accelerator-produced Sr 82 adsorbed on stannic oxide in a lead-shielded column and provides a means to produce sterile nonpyrogenic Rubidium Chloride Rb 82 Injection, a radioactive diagnostic agent, for intravenous use. The chemical form of Rb 82 is 82 RbCl. The amount (mCi) of Rb 82 obtained in each elution will depend on the potency of the generator. When eluted at a rate of 50 mL/minute, each generator eluate at the end of elution should not contain more than 0.02 microCi of Sr 82 and not more than 0.2 microCi of Sr 85 per mCi of Rubidium Chloride Rb 82 Injection, and not more than 1 mcg of tin per mL of eluate. 11.2 Nuclear Physical Characteristics Rb 82 decays by positron emission and associated gamma emission with a physical half-life of 75 seconds. Table 5 shows the annihilation photons released following positron emission which are useful for detection and imaging studies. The decay modes of Rb 82 are: 95.5% by positron emission, resulting in the production of annihilation radiation, i.e., two 511 keV gamma rays; and 4.5% by electron capture, resulting in the emission of “prompt” gamma rays of predominantly 776.5 keV. Both decay modes lead directly to the formation of stable krypton 82 (Kr 82). Table 5. Principal Radiation Emission Data for Rb 82 Radiation Mean Percent Per Disintegration Mean Energy (keV) Annihilation photons (2) 191.01 511 (each) Gamma rays 13-15 776.5 The specific gamma ray constant for Rb 82 is 6.1 R/hour-mCi at 1 cm. The first half-value layer is 0.7 cm of lead (Pb). Table 6 shows a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of lead. For example, the use of a 7.0 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 6. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Attenuation Factor 0.7 0.5 2.3 10 -1 4.7 10 -2 7.0 10 -3 9.3 10 -4 Sr 82 (half-life of 25 days (600 hrs.) decays to Rb 82. To correct for physical decay of Sr 82, Table 7 shows the fractions that remain at selected intervals after the time of calibration. Table 7. Physical Decay Chart: Sr 82 half-life 25 days Days FractionRemaining Days FractionRemaining Days FractionRemaining 0* 1 15 0.660 30 0.435 1 0.973 16 0.642 31 0.423 2 0.946 17 0.624 32 0.412 3 0.920 18 0.607 33 0.401 4 0.895 19 0.591 34 0.390 5 0.871 20 0.574 35 0.379 6 0.847 21 0.559 36 0.369 7 0.824 22 0.543 37 0.359 8 0.801 23 0.529 38 0.349 9 0.779 24 0.514 39 0.339 10 0.758 25 0.500 40 0.330 11 0.737 26 0.486 41 0.321 12 0.717 27 0.473 42 0.312 13 0.697 28 0.460 14 0.678 29 0.448 *Calibration time To correct for physical decay of Rb 82, Table 1 shows the fraction of Rb 82 remaining in all 15 second intervals up to 300 seconds after time of calibration [see Dosage and Administration ( 2.6 , 2.7 )].

Each reaction vial contains a nonradioactive, sterile, nonpyrogenic mixture of 45 mg mebrofenin, 0.54 mg (minimum) stannous fluoride dihydrate, SnF 2 •2H 2 O and 1.03 mg total tin, maximum (as stannous fluoride dihydrate, SnF 2 •2H 2 O), not more than 5.2 mg methylparaben, and 0.58 mg propylparaben. The pH is adjusted with sodium hydroxide or hydrochloric acid prior to lyophilization. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 4.2 to 5.7. The structure of mebrofenin (2,2’-[[2-[(3-Bromo-2,4,6-trimethylphenyl)-amino]-2-oxoethyl]imino] bisacetic acid) is shown below: When sterile, pyrogen-free sodium pertechnetate Tc 99m injection is added to the vial, the diagnostic agent Technetium Tc 99m Mebrofenin is formed for administration by intravenous injection. Choletec-struct

Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 141 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen. The preparation should be protected from strong light.

Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of solution also contains approximately 85 mg organically bound iodine. At the time of manufacture, the air in the container is replaced by nitrogen.

Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is a palatable lemon-flavored water-soluble iodinated radiopaque contrast medium for oral or rectal administration only. Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and 367 mg organically bound iodine. Inactive ingredients: edetate disodium, flavor, polysorbate 80, purified water, saccharin sodium, simethicone, and sodium citrate. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas: Gastrografin Structure

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3 Oral Procedures † ISOVUE is indicated for: CT of the abdomen and pelvis to delineate the gastrointestinal tract in adults and pediatric patients † Specific concentrations of ISOVUE are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2 , 2.3 , 2.4 , 2.5 )]. 11 DESCRIPTION ISOVUE (iopamidol) injection is a radiographic contrast agent for intra-arterial or intravenous use. Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5- lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C17H22I3N3O8, and the following structural formula: ISOVUE is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine: ISOVUE 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine. ISOVUE 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine. ISOVUE 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine. ISOVUE 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine. The pH of ISOVUE has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. Physicochemical characteristics are shown in Table 5. ISOVUE is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Table 7: Physicochemical Characteristics of ISOVUE Concentration (mg Iodine/mL) 200 250 300 370 Osmolality @ 37°C (mOsm/kg water) 413 524 616 796 Viscosity (cP) @ 37°C 2.0 3.0 4.7 9.4 Viscosity (cP) @ 20°C 3.3 5.1 8.8 20.9 Specific Gravity @ 37°C 1.227 1.281 1.339 1.405 iopamidol-structure

ISOVUE (Iopamidol Injection) is a stable, aqueous, sterile, and nonpyrogenic solution for intravascular administration. Each bottle is to be used as an Imaging Bulk Package for dispensing multiple single doses of iopamidol injection for multiple patients, using an automated contrast injection system, contrast management system, or contrast media transfer set approved or cleared for use with this contrast agent in this Imaging Bulk Package. Each mL of ISOVUE-300 (Iopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. Each mL of ISOVUE-370 (Iopamidol Injection 76%) provides 755 mg iopamidol with 1 mg tromethamine and 0.48 mg edetate calcium disodium. The solution contains approximately 0.053 mg (0.002 mEq) sodium and 370 mg organically bound iodine per mL. The pH of ISOVUE contrast media has been adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE (Iopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Iopamidol Parameter 61% 76% Concentration (mg iodine/mL) 300 370 Osmolality @ 37° C (mOsm/kg water) 616 796 Viscosity (cP) @ 37° C 4.7 9.4 @ 20° C 8.8 20.9 Specific Gravity @ 37° C 1.339 1.405 Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula: MW 777.09 C 17 H 22 I 3 N 3 O 8 CAS-60166-93-0 Organically Bound Iodine: 49% Isovue structure

ISOVUE-M (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intrathecal administration. Each mL of ISOVUE-M 200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate calcium disodium. The solution contains approximately 0.029 mg (0.001 mEq) sodium and 200 mg organically bound iodine per mL. Each mL of ISOVUE-M 300 (lopamidol Injection 61%) provides 612 mg iopamidol with 1 mg tromethamine and 0.39 mg edetate calcium disodium. The solution contains approximately 0.043 mg (0.002 mEq) sodium and 300 mg organically bound iodine per mL. The pH of ISOVUE-M contrast media has bean adjusted to 6.5-7.5 with hydrochloric acid and/or sodium hydroxide. Pertinent physicochemical data are noted below. ISOVUE-M (lopamidol Injection) is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively). Iopamidol Parameter 41% 61% Concentration (mgl/mL) 200 300 Osmolality @ 37° C (mOsm/kg water) 413 616 Viscosity (cP) @ 37° C 2.0 4.7 @ 20° C 3.3 8.8 Specific Gravity @ 37° C 1.216 1.328 lopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]- 2,4,6-triiodo-5-lactamidoisophthalamide. Structural formula: Isovue-M structure

Kinevac (sincalide for injection) is a cholecystopancreatic-gastrointestinal hormone for parenteral administration. The agent is a synthetically-prepared C-terminal octapeptide of cholecystokinin. Each single-dose vial of sincalide provides a sterile nonpyrogenic lyophilized white powder consisting of 5 mcg sincalide with 30 mg arginine hydrochloride, 15 mg lysine hydrochloride, 170 mg mannitol, 4 mg methionine, 2 mg pentetic acid, 0.005 mcg polysorbate 20, 9 mg potassium phosphate dibasic, and 0.04 mg sodium metabisulfite. The pH is adjusted to 6.0 to 8.0 with hydrochloric acid and/or sodium hydroxide prior to lyophilization. Sincalide is designated chemically as L-α-aspartyl-O-sulfo-L-tyrosyl-L-methionylglycyl-L-tryptophyl-L-methionyl- L-α-aspartyl-L-phenylalaninamide. Graphic formula: kinevac-struct

Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): The single patient use kit contains the following three items: one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-cap one prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent) Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL. one Mini-Spike The 20-vial pack is comprised of: twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gas twenty Mini-Spikes twenty peel-off syringe labels Each vial is formulated as a 25 mg sterile, pyrogen-free lyophilized powder containing 24.56 mg of polyethylene glycol 4000, 0.19 mg of distearoylphosphatidyl-choline (DSPC), 0.19 mg of dipalmitoylphosphatidylglycerol sodium (DPPG-Na) and 0.04 mg of palmitic acid. The headspace of each vial contains 6.07 mg/mL (± 2 %) sulfur hexafluoride, SF 6 , or 60.7 mg per vial. Upon reconstitution with 5mL diluent, Lumason is a milky white, homogeneous suspension containing sulfur hexafluoride lipid-type A microspheres. The suspension is isotonic and has a pH of 4.5 to 7.5. The sulfur hexafluoride lipid microspheres are composed of SF 6 gas in the core surrounded by an outer shell monolayer of phospholipids consisting DSPC and DPPG-Na with palmitic acid as a stabilizer. Sulfur hexafluoride has a molecular weight of 145.9 and the following chemical structure: 1,2-Di s tearoyl- sn- glycero-3-phosphocholine (DSPC), with empirical formula C 44 H 88 NO 8 P, has a molecular weight of 790.6 and the following chemical structure: 1,2-Dipalmitoyl- sn -glycero-3-phospho- rac -glycerol sodium (DPPG-Na), with empirical formula C 38 H 74 NaO 10 P, has a molecular weight of 745 and the following chemical structure: Each milliliter of reconstituted Lumason suspension contains 1.5 to 5.6 x10 8 microspheres, 68 mcg SF 6 (12 mcL), 0.038 mg DSPC, 0.038 mg DPPG-Na, 4.91 mg polyethylene glycol 4000 and 0.008 mg palmitic acid. The sulphur hexafluoride associated with the microspheres suspension is 45 mcg/mL. Fifteen to twenty three percent of the total lipids in the suspension are associated with the microspheres. The sulfur hexafluoride lipid microsphere characteristics are listed in Table 2: Table 2. Microsphere Characteristics Mean diameter range 1.5 – 2.5 μm Percent of microspheres ≤ 10 µm ≥ 99% Upper size limit 100.0% ≤ 20 µm sulfur-hexafluoride-chemical-structure empirical-formula-790-6 empirical-formula-745

Lumason (sulfur hexafluoride lipid-type A microspheres) for injectable suspension, for intravenous or intravesical use is used to prepare the ultrasound contrast agent. Lumason is supplied in two presentations (single patient use kit or 20-vial pack): The single patient use kit contains the following three items: one clear glass 10 mL vial containing 25 mg of white lyophilized powder lipid-type A, 60.7 mg of sulfur hexafluoride gas and capped with a blue flip-cap one prefilled syringe containing 5 mL 0.9% Sodium Chloride Injection, USP (Diluent) Each prefilled syringe with 5 mL of diluent 0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, and additive-free containing 9 mg sodium chloride per mL. one Mini-Spike The 20-vial pack is comprised of: twenty Lumason clear vials, each containing 25 mg of lipid-type A sterile white lyophilized powder with headspace filled with 60.7 mg of sulfur hexafluoride gas twenty Mini-Spikes twenty peel-off syringe labels Each vial is formulated as a 25 mg sterile, pyrogen-free lyophilized powder containing 24.56 mg of polyethylene glycol 4000, 0.19 mg of distearoylphosphatidyl-choline (DSPC), 0.19 mg of dipalmitoylphosphatidylglycerol sodium (DPPG-Na) and 0.04 mg of palmitic acid. The headspace of each vial contains 6.07 mg/mL (± 2 %) sulfur hexafluoride, SF 6 , or 60.7 mg per vial. Upon reconstitution with 5mL diluent, Lumason is a milky white, homogeneous suspension containing sulfur hexafluoride lipid-type A microspheres. The suspension is isotonic and has a pH of 4.5 to 7.5. The sulfur hexafluoride lipid microspheres are composed of SF 6 gas in the core surrounded by an outer shell monolayer of phospholipids consisting DSPC and DPPG-Na with palmitic acid as a stabilizer. Sulfur hexafluoride has a molecular weight of 145.9 and the following chemical structure: 1,2-Di s tearoyl- sn- glycero-3-phosphocholine (DSPC), with empirical formula C 44 H 88 NO 8 P, has a molecular weight of 790.6 and the following chemical structure: 1,2-Dipalmitoyl- sn -glycero-3-phospho- rac -glycerol sodium (DPPG-Na), with empirical formula C 38 H 74 NaO 10 P, has a molecular weight of 745 and the following chemical structure: Each milliliter of reconstituted Lumason suspension contains 1.5 to 5.6 x10 8 microspheres, 68 mcg SF 6 (12 mcL), 0.038 mg DSPC, 0.038 mg DPPG-Na, 4.91 mg polyethylene glycol 4000 and 0.008 mg palmitic acid. The sulphur hexafluoride associated with the microspheres suspension is 45 mcg/mL. Fifteen to twenty three percent of the total lipids in the suspension are associated with the microspheres. The sulfur hexafluoride lipid microsphere characteristics are listed in Table 2: Table 2. Microsphere Characteristics Mean diameter range 1.5 – 2.5 μm Percent of microspheres ≤ 10 µm ≥ 99% Upper size limit 100.0% ≤ 20 µm sulfur-hexafluoride-chemical-structure empirical-formula-790-6 empirical-formula-745

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 C 22 H 28 GdN 3 O 11 • 2C 7 H 17 NO 5 . 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. MultiHance Structure

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 C 22 H 28 GdN 3 O 11 • 2C 7 H 17 NO 5 . 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. MultiHance Structure

ProHance, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, nonpyrogenic injectable solution. Each mL contains 279.3 mg (0.5 mmol/mL) gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection; pH adjusted with hydrochloric acid and/or sodium hydroxide. ProHance contains no antimicrobial preservative. Gadoteridol is the gadolinium complex of 10-(2-hydroxy-propyl)-1,4,7,10- tetraazacyclododecane-1,4,7-triacetic acid with a molecular weight of 558.7, an empirical formula of C 17 H 29 N 4 O 7 Gd and has the following structural formula: ProHance has a pH of 6.5 to 8.0. Pertinent physiochemical parameters are provided below: Osmolality 630 mOsmol/kg water at 37 °C Viscosity 1.3 cP at 37 °C Density 1.137 g/mL at 25 °C ProHance has an osmolality that is 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use. Prohance Structure

ProHance, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, nonpyrogenic injectable solution. Each mL contains 279.3 mg (0.5 mmol/mL) gadoteridol, 0.23 mg calteridol calcium, 1.21 mg tromethamine and water for injection; pH adjusted with hydrochloric acid and/or sodium hydroxide. ProHance contains no antimicrobial preservative. Gadoteridol is the gadolinium complex of 10-(2-hydroxy-propyl)-1,4,7,10-tetraazacyclododecane-1,4,7- triacetic acid with a molecular weight of 558.7, an empirical formula of C 17 H 29 N 4 O 7 Gd and has the following structural formula: ProHance has a pH of 6.5 to 8.0. Pertinent physiochemical parameters are provided below: Osmolality 630 mOsmol/kg water at 37 °C Viscosity 1.3 cP at 37 °C Density 1.137 g/mL at 25 °C ProHance has an osmolality that is 2.2 times that of plasma (285 mOsmol/kg water) and is hypertonic under conditions of use. ProHance Structure

Vueway is a gadolinium-based contrast agent, which contains gadopiclenol, a paramagnetic macrocyclic non-ionic complex of gadolinium. The chemical name for gadopiclenol is rac- [(2R,2'Ξ,2''Ξ)-2,2',2''-(3,6,9-triaza-κ 3 N 3 ,N 6 ,N 9 -1(2,6)-pyridina-κN 1 -cyclodecaphane-3,6,9-triyl)tris(5-{[(2Ξ)-2,3-dihydroxypropyl]amino}-5-oxopentanoato-κ 3 O 1 ,O 1 ',O 1 '')(3−)]gadolinium with a molecular weight of 970.11 g/mol and a molecular formula of C 35 H 54 GdN 7 O 15 . Vueway is a sterile, nonpyrogenic, clear, colorless to yellow aqueous solution for intravenous use. Each mL contains 485.1 mg of gadopiclenol (equivalent to 0.5 mmol of gadopiclenol and 78.6 mg of gadolinium) and the following inactive ingredients: 0.404 mg tetraxetan, 1.211 mg trometamol, hydrochloric acid and/or sodium hydroxide (for pH adjustment, if needed), and water for injection. The main physicochemical properties of Vueway are provided in Table 2. Table 2: Physicochemical properties of Vueway Parameter Value Density at 20°C 1.211 g/cm 3 Mean viscosity at 20°C 12.6 mPa.s Mean viscosity at 37°C 7.6 mPa.s Osmolality at 37°C 850 mOsm/kg water pH 7.0 – 7.8 Gadopiclenol Structure