Gadoteric Acid/Iodamide 1481 Preparations cholangiopancreatography, and hysterosalpingography. It is also used for contrast enhancement in computed tomography. USP 31: Gadoversetamide Injection. HO It is usually available as solutions containing 54.84 to 76.78% of Proprietary Preparations (details are given in Part 3) iobitridol (equivalent to 250 to 350 mg/mL of iodine). The dose Arg.: Optimark; Austral.: Optimark; Canad.: Optimark; Cz.: Optimark; O and strength used varies depending on the procedure and route. Port.: Optimark; USA: Optimark. OH ◊ References. HO OH 1. Petersein J, et al. Results of the safety and efficacy of iobitridol in more than 61,000 patients. Eur Radiol 2003; 13: 2006–11. HO Gadoxetic Acid (rINN) Preparations Acide Gadoxétique; Ácido gadoxético; Acidum Gadoxeticum; Pharmacopoeias. In Eur. (see p.vii). Also in USNF. Proprietary Preparations (details are given in Part 3) Gd-EOB-DTPA. Dihydrogen [N-{(2S)-2-[bis(carboxymethyl)- Arg.: Xenetic; Xenetix; Austria: Xenetix; Belg.: Xenetix; Braz.: Henetix†; Ph. Eur. 6.2 (Galactose). A white or almost white, crystalline or Chile: Xenetix; Cz.: Xenetix; Denm.: Xenetix; Fin.: Xenetix; Fr.: Xenetix; amino]-3-(p-ethoxyphenyl)propyl}-N-{2-[bis(carboxymethyl)- finely granulated powder. Freely soluble or soluble in water; very Ger.: Xenetix; Gr.: Xenetix; Hung.: Xenetix; Israel: Xenetix; Ital.: amino]ethyl}glycinato(5−)]gadolinate(2−). slightly soluble in alcohol. Xenetix; Neth.: Xenetix; Norw.: Xenetix; Port.: Xenetix; Spain: Xenetix; Swed.: Xenetix; Switz.: Xenetix; Venez.: Xenetix. Гадоксетовая Кислота USNF 26 (Galactose). A white, crystalline or finely granulated powder. Soluble in water; very slightly soluble in alcohol. Store C23H30GdN3O11 = 681.7. in airtight containers. CAS — 135326-11-3 (gadoxetic acid). Profile Iocetamic Acid (BAN, USAN, pINN) ATC — V08CA10. Galactose is a naturally occurring monosaccharide used as an Acide Iocétamique; Ácido iocetámico; Acidum Iocetamicum; ATC Vet — QV08CA10. ultrasound contrast medium (p.1474); dissolution of galactose DRC-1201; Jocetamsyra; Josetaamihappo; MP-620. N-Acetyl-N- microparticles releases microbubbles of air that provide echo- (3-amino-2,4,6-tri-iodophenyl)-2-methyl-β-alanine; 2-[N-(3- enhancement. Galactose is used to enhance ultrasound imaging Amino-2,4,6-tri-iodophenyl)acetamidomethyl]-propionic acid. + of the female genital tract. It is given transcervically as a micro- 2H Йоцетамовая Кислота O- O- bubble-microparticle suspension prepared immediately before C H I N O = 614.0. Gd+++ use by suspending 3 g of galactose microparticles in 13.5 mL of 12 13 3 2 3 a solution containing 200 mg/mL galactose. The usual dose is 2 CAS — 16034-77-8. O O ATC — V08AC07. O O to 5 mL, with additional doses of 1 to 2 mL as required, to a max- NN imum of 30 mL. Similar suspensions of galactose, with palmitic ATC Vet — QV08AC07. acid to stabilise the microbubbles, have been used in echocardi- O- O- N ography. H I - The clearance of galactose given intravenously has been used as O a measure of liver function. Galactose labelled with carbon-13 (p.2277) has also been used. I NH2 O Precautions. Preparations that contain, or are metabolised to, galactose may interfere with the results from glucose tests O (p.2314). Overestimation of glucose results may mask hypogly- O N I caemia, resulting in the inappropriate use of insulin.1,2 CH3 CH3 1. Medicines and Healthcare products Regulatory Agency. Medical device alert: ref MDA/2007/058 issued 19 July 2007. Available HO H3CO at: http://www.mhra.gov.uk/PrintPreview/PublicationSP/ Sodium Gadoxetate (rINNM) CON2031807 (accessed 01/07/08) Description. Iocetamic acid contains about 62% of I. 2. FDA. Important safety information on interference with blood Gadoxétate de Sodium; Gadoxetate Disodium (USAN); Gadoxe- glucose measurement following use of parenteral mal- Profile tate Sodium; Gadoxetato de sodio; Natrii Gadoxetas; ZK- tose/parenteral galactose/oral xylose-containing products (is- Iocetamic acid is an ionic monomeric iodinated radiographic 139834. sued November 2005). Available at: http://www.fda.gov/cber/ contrast medium with similar properties to iopanoic acid safety/maltose110405.htm (accessed 01/07/08) (p.1484). It is absorbed from the gastrointestinal tract and excret- Натрий Гадоксетат Preparations ed in bile and has been given orally for cholecystography. C H GdN Na O = 725.7. 23 28 3 2 11 Proprietary Preparations (details are given in Part 3) Preparations CAS — 135326-22-6. Arg.: Levovist†; Austral.: Levovist; Austria: Echovist; Levovist†; Om- Proprietary Preparations (details are given in Part 3) ATC — V08CA10. bravist†; Canad.: Echovist†; Levovist†; Cz.: Levovist†; Denm.: Levovist†; Neth.: Cholebrine†. Fin.: Echovist†; Levovist†; Fr.: Echovist; Levovist; Ger.: Echovist; Levovist; ATC Vet — QV08CA10. Hung.: Echovist; Israel: Echovist; Ital.: Levovist; Neth.: Echovist†; Levovist; Norw.: Levovist†; NZ: Levovist; Port.: Levovist; S.Afr.: Echovist†; Spain: Adverse Effects and Precautions Levograf; Levovist; Swed.: Echovist; Levovist†; Switz.: Levovist; UK: Echo- As for Gadopentetic Acid, p.1479. vist; Levovist†. Iodamide (BAN, USAN, rINN) Ametriodinic Acid; B-4130; Iodamida; Iodamidum; Jodamid; Jodi- Pharmacokinetics Multi-ingredient: Gr.: L-Vist. amidi; SH-926. α,5-Diacetamido-2,4,6-tri-iodo-m-toluic acid; 3- Gadoxetate is distributed into the extracellular space after intra- venous injection and is also taken up by the liver. It is less than Acetamido-5-acetamidomethyl-2,4,6-tri-iodobenzoic acid. 10% bound to plasma proteins. It is excreted in about equal Йодамид Iobitridol (BAN, rINN) amounts in the bile and in the urine. An elimination half-life of C12H11I3N2O4 = 627.9. about 1 hour has been reported. Gadoxetate is removed by Iobitridolum; Jobitridol; Jobitridoli. N,N′-Bis(2,3-dihydroxypro- CAS — 440-58-4. haemodialysis. pyl)-5-[2-(hydroxymethyl)hydracrylamido]-2,4,6-triiodo-N,N′- ATC — V08AA03. dimethylisophthalamide; . ATC Vet — QV08AA03. Uses and Administration Gadoxetic acid is an ionic gadolinium chelate with actions simi- Йобитридол lar to those of gadopentetic acid (p.1480). It has paramagnetic C20H28I3N3O9 = 835.2. O CH3 properties and is used as a magnetic resonance contrast medium CAS — 136949-58-1. O I (p.1474). It is taken up by the liver and excreted in bile and is ATC — V08AB11. used in imaging of the liver. NH ATC Vet — QV08AB11. HO Gadoxetic acid is given intravenously as the sodium salt. It is available as a solution containing sodium gadoxetate 181.4 mg/mL (0.25 mmol/mL). The usual dose is 0.1 mL/kg OH I I (0.025 mmol/kg). CH Preparations 3 HN HO N Proprietary Preparations (details are given in Part 3) I O Austria: Primovist; Cz.: Primovist; Fin.: Primovist; Gr.: Primovist; Hung.: H3CO Primovist; Neth.: Primovist; Norw.: Primovist; Swed.: Primovist; Switz.: O Primovist; UK: Primovist. I Description. Iodamide contains about 60.6% of I. Pharmacopoeias. In Jpn. H3C N O Galactose (USAN) I HN OH Meglumine Iodamide (BANM, rINNM) D-Galactopyranose; α-D-Galactopyranose; Galactosa; D-Galac- HO Iodamida de meglumina; Iodamide Meglumine (USAN); Iodamide tose; Galactosum; Galaktoosi; Galaktos; Galaktosa; Galaktóz; OH Méglumine; Meglumini Iodamidum. The N-methylglucamine salt Galaktoza; Galaktoze˙. of iodamide. OH C6H12O6 = 180.2. Меглумина Йодамид CAS — 59-23-4 (D-galactose); 3646-73-9 (α-D-galac- Profile C12H11I3N2O4,C7H17NO5 = 823.2. CAS — 18656-21-8. tose). Iobitridol is a nonionic monomeric iodinated radiographic con- ATC — V04CE01; V08DA02 (microparticles of galactose). trast medium (see p.1474). It may be given intravenously, intra- ATC — V08AA03. ATC Vet — QV08AA03. ATC Vet — QV04CE01; QV08DA02 (microparticles of ga- arterially, or by instillation into body cavities and is used in a lactose). wide range of procedures including angiography, arthrography, Description. Meglumine iodamide contains about 46.3% of I. The symbol † denotes a preparation no longer actively marketed The symbol ⊗ denotes a substance whose use may be restricted in certain sports (see p.vii) 1482 Contrast Media Sodium Iodamide (BANM, rINNM) Because it is slowly metabolised to release iodine, iodised oil is Iodixanol is usually available as a solution containing between Iodamida sódica; Iodamide Sodique; Iodamide Sodium; Natrii Io- used in the management of iodine deficiency (p.2170). 30.5 and 65.2% of iodixanol (equivalent to between 150 and 320 mg/mL of iodine). The dose and strength used vary accord- Infertility. For reference to the use of iodised oil in the manage- damidum. ing to the procedure and route. Натрий Йодамид ment of infertility, see Hysterosalpingography under Adverse Ef- fects and Precautions, above. ◊ References. C12H10I3N2NaO4 = 649.9. CAS — 10098-82-5. Malignant neoplasms. Intra-arterial injection of iodised oil 1. Spencer CM, Goa KL. Iodixanol: a review of its pharmacody- namic and pharmacokinetic properties and diagnostic use as an ATC — V08AA03. has been used in both the diagnosis and management of malig- x-ray contrast medium. Drugs 1996; 52: 899–927. ATC Vet — QV08AA03. nant neoplasms of the liver (p.667). After injection into the he- patic artery, iodised oil is selectively retained by hepatic carcino- Preparations Description. Sodium iodamide contains about 58.6% of I. mas and may have a role as an adjunct to computed tomography USP 31: Iodixanol Injection. Profile for both diagnosis and monitoring.1-3 It has also been used in the Proprietary Preparations (details are given in Part 3) Iodamide is an ionic monomeric iodinated radiographic contrast management of hepatic
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