Iothalamate Meglumine (Conray 43)

Trade Name : Conray 43

Liebel-Flarsheim Company LLC

INJECTION

Strength 430 mg/mL

IOTHALAMATE MEGLUMINE Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Iothalamate Meglumine (Conray 43) which is also known as Conray 43 and Manufactured by Liebel-Flarsheim Company LLC. It is available in strength of 430 mg/mL per ml. Read more

Iothalamate Meglumine (Conray 43) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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NOT FOR INTRATHECAL USE

Conray 43 is a sterile aqueous solution intended for use as a diagnostic radiopaque medium. Conray 43 contains 43% w/v iothalamate meglumine which is 1-deoxy-1-(methylamino)-D-glucitol 5-acetamido-2,4,6-triiodo-N-methylisophthalamate (salt), and has the following structural formula:n
Each milliliter contains 430 mg of iothalamate meglumine, 0.110 mg edetate calcium disodium as a stabilizer and 0.115 mg of monobasic sodium phosphate as a buffer. The solution provides 20.2% (202 mg/mL) organically bound iodine. Conray 43 has an osmolarity of approximately 800 mOsmol per liter, an osmolality of approximately 1000 mOsmol per kilogram and is, therefore, hypertonic under conditions of use. The viscosity (cps) is approximately 3 at 25u00b0C and 2 at 37u00b0C. The pH is 6.6 to 7.6.n
Conray 43 is a clear solution containing no undissolved solids. Crystallization does not occur at normal room temperatures. It is supplied in containers from which the air has been displaced by nitrogen.n

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Conray 43 should not be used for myelography.n
Refer to , concerning hypersensitivity.n
Contraindications to the procedure of retrograde pyelography include obstruction to endoscopy or catheterization of the ureters, severe systemic disease which contraindicates instrumentation and acute infection of the upper urinary tract.n

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to ensure that this drug product is not administered intrathecally.
Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.
Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.
Serious or fatal reactions have been associated with the administration of iodine containing radiopaque media. It is of utmost importance to be completely prepared to treat any contrast medium reaction.
Serious neurologic sequelae, including permanent paralysis, have been reported following cerebral arteriography, selective spinal arteriography and arteriography of vessels supplying the spinal cord. The intravascular injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate neurologic effects.
In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported. Therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution.
A definite risk exists in the use of intravascular contrast agents in patients who are known to have multiple myeloma.
Administration of radiopaque materials to patients known or suspected to have pheochromocytoma should be performed with extreme caution.
Contrast media have been shown to promote the phenomenon of sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.
Convulsions have occurred in patients with primary or metastatic cerebral lesions following the administration of iodine-containing radiopaque media for the contrast enhancement of CT brain images.
In patients with advanced renal disease, iodinated contrast media should be used with caution, and only when the need for the examination dictates, since excretion of the medium may be impaired. Patients with combined renal and hepatic disease, those with severe hypertension or congestive heart failure, and recent renal transplant recipients may present an additional risk.
Renal failure has been reported in patients with liver dysfunction who were given an oral cholecystographic agent followed by an intravascular iodinated radiopaque agent and also in patients with occult renal disease, notably diabetics and hypertensives. In these classes of patients there should be no fluid restriction and every attempt made to maintain normal hydration, prior to contrast medium administration, since dehydration is the single most important factor influencing further renal impairment.
Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible non-diabetic patients (often elderly with pre-existing renal disease) following the administration of iodinated contrast agents. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients.
Caution should be exercised in performing contrast medium studies in patients with endotoxemia and/or those with elevated body temperatures.
Reports of thyroid storm occurring following the intravascular use of iodinated radiopaque agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule, suggest that this additional risk be evaluated in such patients before use of this drug. Iodine containing contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g. PBI and radioactive iodine uptake studies. Such tests, if indicated, should be performed prior to the administration of this preparation.
Severe Cutaneous Adverse Reactions:

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Overdosage may occur. The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular system. The symptoms may include cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma and cardiac arrest. Treatment of an overdose is directed toward the support of all vital functions and prompt institution of symptomatic therapy.n
Iothalamate salts are dialyzable.n
The intravenous LD value of various concentrations of Iothalamate Meglumine (in grams of iodine/kilogram body weight) varied from 5.7 to 8.9 g/kg in mice and 9.8 to 11.2 g/kg in rats. The LD values decrease as the rate of injection increases.n

It is advisable that Conray 43 be at or close to body temperature when injected.n
The patient should be instructed to omit the meal that precedes the examination. Appropriate premedication, which may include a barbiturate, tranquilizer or analgesic drug, may be administered prior to the examination.n
A preliminary film is recommended to check the position of the patient and the x-ray exposure factors.n
If during administration a minor reaction occurs the injection should be slowed or stopped until the reaction has subsided. If a major reaction occurs the injection should be discontinued immediately.n
Under no circumstances should either corticosteroids or antihistamines be mixed in the same syringe with the contrast medium because of a potential for chemical incompatibility.n
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.n

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Intravenous infusion urography enhances the potential for more diagnostic information in those patients in whom the usual excretory urographic technique either has not provided or is not expected to provide satisfactory visualization. The entire urinary tract, including nephrogram and cystogram, may be visualized in the unobstructed patient with normal renal function.n

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Arterial digital subtraction angiography provides images similar in quality to conventional film-screen systems. The advantages of arterial DSA when compared to standard film angiography include the use of less contrast medium; the use of a lower concentration of contrast medium as provided by Conray 43; a decreased need for selective arterial catheterization and a shortened examination time. The limitations of arterial DSA include: reduced spatial resolution and limited field size.n

Store below 30u00b0C (86u00b0F). Exposing this product to very cold temperatures may result in crystallization of the salt. If this occurs the container should be brought to room temperature. Shake vigorously to assure complete dissolution of any crystals. The speed of dissolution may be increased by heating with circulating warm air. Before use, examine the product to assure that all solids are redissolved and that the container and closure have not been damaged. This preparation is sensitive to light and must be protected from strong daylight or direct exposure to the sun.n
As with all contrast media, the 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.n

Manufactured by:Liebel-Flarsheim Company LLCRaleigh, NC 27616
Made in USA
GBT 3183A0817Revised 08/17

For Intravascular Use
Conray 43
250 mLn- Iothalamate Meglumine Injection USP 43%
202 mg/mL Organically Bound Iodine
NOT FOR INTRATHECAL USEn Rx Only
Protect from light u2022n- Single dose container u2022 Discard unused portionnUsual Dosage:
10790817
Manufactured by:Liebel-Flarsheim Company LLCRaleigh, NC 27616Made in USA
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Iothalamate Meglumine (Conray 43)

Trade Name : Conray 43

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Iothalamate Meglumine (Conray 43)

Trade Name : Conray 43

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

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