Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
DIATRIZOATE MEGLUMINE (UNII: 3X9MR4N98U) (DIATRIZOIC ACID - UNII:5UVC90J1LK), DIATRIZOATE SODIUM (UNII: V5403H8VG7) (DIATRIZOIC ACID - UNII:5UVC90J1LK)
Liebel-Flarsheim Company LLC
DIATRIZOATE MEGLUMINE
DIATRIZOATE MEGLUMINE 600 mg in 1 mL
ORAL
PRESCRIPTION DRUG
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is indicated for radiographic examination of segments of the gastrointestinal tract (esophagus, stomach, proximal small intestine, and colon). The preparation is particularly indicated when a more viscous agent such as barium sulfate, which is not water-soluble, is not feasible or is potentially dangerous. MD-Gastroview may also be used as an adjunct to contrast enhancement in computed tomography of the torso (body imaging); the preparation is indicated, in conjunction with intravenous administration of a radiopaque contrast agent, when unenhanced imaging may not provide sufficient definition in distinguishing normal loops of bowel from adjacent organs or areas of suspected pathology. Do not administer to patients with a known hypersensitivity to MD-Gastroview or any of its components.
Available as an aqueous lemon-vanilla flavored solution in bottles of 30 mL in packages of 25 (NDC 0019-4816-04). Protect from light. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; Avoid excessive heat. If precipitation or solidification has occurred due to storage in the cold, the bottle should be brought to room temperature. Shake intermittently to redissolve any solids. As with all contrast media, containers should be inspected prior to use to ensure that breakage or other damage has not occurred during shipping and handling. All containers should be inspected for closure integrity. Damaged containers should not be used. Manufactured by: Liebel-Flarsheim Company LLC Raleigh, NC 27616 Made in USA GBT 48160817 Rev 08/17
Abbreviated New Drug Application
MD GASTROVIEW- DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION LIEBEL-FLARSHEIM COMPANY LLC ---------- AUGUST 2017 MD-GASTROVIEW (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM SOLUTION USP) DESCRIPTION MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution) is a palatable lemon-vanilla 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. MD-Gastroview does not contain the wetting agent polysorbate 80. The inactive ingredients are: Edetate Disodium Dihydrate, Lemon-Vanilla Flavor, Sodium Citrate, Sodium Hydroxide, Sodium Saccharin, Water for Injection. Air in the container is displaced with nitrogen. Diatrizoate meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol 3,5- diacetamido-2,4,6-triiodobenzoate (salt); diatrizoate sodium is monosodium 3,5-diacetamido-2,4,6- triiodobenzoate. The two salts have the following structural formulae: CLINICAL PHARMACOLOGY The most important characteristic of contrast media is the iodine content. The relatively high atomic weight of iodine contributes sufficient radiodensity for radiographic contrast with surrounding tissues. Diagnostic enteral radiopaque agents have few known pharmacological effects. Diatrizoate meglumine and diatrizoate sodium exert a mild laxative effect attributable to their high osmolarity. Diatrizoate meglumine and diatrizoate sodium are sparingly absorbed from the intact gastrointestinal tract, and therefore permit gastrointestinal opacification and delineation after oral or rectal administration. Oral administration is used for radiographic evaluation of the esophagus, stomach and ® proximal small intestine. Rectal administration is used for examination of the colon; however, visualization of the distal small bowel is generally unsatisfactory, sin Belgenin tamamını okuyun