Imiro 350

SECTION I- INTRATHECAL

Iohexol 180, Iohexol 240, and Iohexol 300 are indicated for intrathecal administration in adults including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography (myelography, cisternography, ventriculography). Iohexol 180 is indicated for intrathecal administration in children including myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for computerized tomography(myelography, cisternography).

SECTION II- INTRAVASCULAR

Iohexol 350 is indicated in adults for angiocardiography (ventriculography, selective coronary arteriography), aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels, peripheral arteriography, and excretory urography.

Iohexol 350 is indicated in children for angiocardiography (ventriculography, pulmonary arteriography, and venography; studies of the collateral arteries and aortography, including the aortic root, aortic arch, ascending and descending aorta).

Iohexol 300 is indicated in adults for aortography including studies of the aortic arch, abdominal aorta and its branches, contrast enhancement for computed tomographic head and body imaging, cerebral arteriography, peripheral venography (phlebography), and excretory urography.

Iohexol 300 is indicated in children for angiocardiography (ventriculography), excretory urography, and contrast enhancement for computed tomographic head imaging. Iohexol 240 is indicated in adults for contrast enhancement for computed tomographic head imaging and peripheral venography (phlebography).

Iohexol 140 is indicated in adults for intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels.

Iohexol 240 is indicated in children for contrast enhancement for computed tomographic head imaging.

SECTION III – ORAL/BODY CAVITY USE

Iohexol 240, Iohexol 300, and Iohexol 350 have osmolalities from approximately 1.8 to 3.0 times that of plasma (285 mOsm/kg water) and are hypertonic under conditions of use.

Adults: Iohexol 350 is indicated in adults for arthrography and oral pass-thru examination of the gastrointestinal tract.

Iohexol 300 is indicated in adults for arthrography and hysterosalpingography. Iohexol 240 is indicated in adults for arthrography, endoscopic retrograde pancreatography and cholangiopancreatography, herniography, and hysterosalpingography. Iohexol diluted to concentrations from 6 mgI/mL to 9 mgI/mL administered orally in conjunction with Iohexol 300 at a concentration of 300 mgI/mL administered intravenously is indicated in adults for contrast enhanced computed tomography of the abdomen.

Children: Iohexol 300 is indicated in children for examination of the gastrointestinal tract.

Iohexol 240 is indicated in children for examination of the gastrointestinal tract.

Iohexol 180 is indicated in children for examination of the gastrointestinal tract.

Iohexol diluted to concentrations from 50 mgI/mL to 100 mgI/mL is indicated in children for voiding cystourethrography.

Iohexol diluted to concentrations from 9 mgI/mL to 21 mgI/mL administered orally in conjunction with Iohexol 240 at a concentration of 240 mgI/mL or Iohexol 300 at a concentration of 300 mgI/mL administered intravenously is indicated in children for use in contrast enhanced computed tomography of the abdomen.

Contrast medium for diagnostic procedure

Iohexol is a nonionic, water-soluble radiographic contrast medium with a molecular weight of 821.14 (Iodine content 46.36%). In aqueous solution each triiodinated molecule remains undissociated. Iohexol is provided as a sterile, pyrogen-free, colorless to pale-yellow solution, in the following iodine concentrations: 350 mg I/mL. All solutions are sterilized by autoclaving and contain no preservatives. Unused portions must be discarded. Iohexol solution is sensitive to light and therefore should be protected from exposure.

Injection As iohexol soln containing 6-350 mg iodine/mL: Dose and strength used depends on the procedure and route of administration.

Injection-

Angiocardiography:

• Adult: Ventriculography: 350 mg iodine/ml: 30-60 ml, usual: 40 ml, may be repeated as necessary. If with selective coronary arteriography: max 250 ml. Selective coronary arteriography: 350 mg iodine/ml: 3-14 ml per inj, usual: 5 ml. Aortic root and arch study when used alone: 350 mg iodine/ml: 20-75 ml, usual 50 ml. Multiple procedures: 350 mg iodine/ml: max 250 ml.
• Child: Ventriculography: 350 mg iodine/ml: 1-1.5 ml/kg, usual: 1.25 ml/kg; 300 mg iodine/ml: 1.5-2 ml/kg, usual 1.75 ml/kg. Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml. Pulmonary angiography: 350 mg iodine/ml: 1 ml/kg. Multiple procedures: Max: 5 ml/kg; 350 mg iodine/ml: 250 ml; 300 mg iodine/ml: 291 ml.

Aortography and selective visceral arteriography

• Adult: Use 300 or 350 mg iodine/ml solution, single inj. Aorta: 50-80 ml; major branches: 30-60 ml; renal arteries: 5-15 ml. Repeat as necessary. Max: 300 mg iodine/ml: 291 ml; 350 mg iodine/ml: 250 ml.
• Child: Use 350 mg iodine/ml solution: 1 ml/kg, single dose. Max: 5 ml/kg up to 250 ml.

Voiding cystourethrography:

• Adult: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml. Usual volume: 50 mg iodine/ml solution: 50-600 ml; 100 mg iodine/ml: 50-300 ml.
• Child: Children: Use diluted solutions using sterile water for inj to concentrations of 50-100 mg iodine/ml: 50-300 ml.

Hysterosalpingography:

• Adult: 240 mg iodine/ml: 15-20 ml; 300 mg iodine/ml: 15-20 ml.

Arthrography:

• Adult: Knee: 240 mg iodine/ml: 5-15 ml; 300 mg iodine/ml: 5-15 ml; 350 mg iodine/ml: 5-10 ml. Shoulder: 240 mg iodine/ml: 3 ml; 300 mg iodine/ml: 10 ml. Temporomandibular: 300 mg iodine/ml: 0.5-1 ml. Lower volumes are recommended for double-contrast examinations; higher volumes are recommended fro single-contrast examinations.

Herniography:

• Adult: 240 mg iodine/ml: 50 ml.

Excretory urography:

• Adult: Use 300 or 350 mg iodine/ml solution: 200-350 mg iodine/kg.
• Child: Use 300 mg iodine/ml solution: 0.5-3 ml/kg, usual: 1-1.5 ml/kg; max: 3 ml/kg.

Endoscopic retrograde cholangiopancreatography (ERCP), Endoscopic retrograde pancreatography (ERP):

• Adult: Use 240 mg iodine/ml: 10-50 ml.

Intra-arterial-

Peripheral arteriography:

• Adult: Aortofemoral runoffs: 350 mg iodine/ml: 20-70 ml; 300 mg iodine/ml: 30-90 ml. Selective arteriograms (femoral/iliac): 350 mg iodine/ml: 10-30 ml; 300 mg iodine/ml: 10-60 ml. Venography (per leg): 240 mg iodine/ml: 20-150 ml; 300 mg iodine/ml: 40-100 ml.

Cerebral arteriography:

• Adult: Use 300 mg iodine/ml solution: Common carotid artery: 6-12 ml; internal carotid artery: 8-10 ml; external carotid artery: 6-9 ml; vertebral artery: 6-10 ml.

Digital subtraction angiography:

• Adult: Use 140 mg iodine/ml solution: Aorta: 20-45 ml at 8-20 ml/sec; carotid: 5-10 ml at 3-6 ml/sec; femoral: 9-20 ml at 3-6 ml/sec; vertebral: 4-10 ml at 2-8 ml/sec; renal: 6-12 ml at 3-6 ml/sec; other branches of the aorta (includes subclavian, axillary, innominate and iliac): 8-25 ml at 3-10 ml/sec.

Intrathecal-

Contrast-enhanced computerized tomography:

• Adult: Lumbar (via lumbar inj): 180 mg iodine/ml: 10-17 ml; 240 mg iodine/ml: 7-12.5 ml. Thoracic (via lumbar or cervical inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml. Cervical (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml solution: 6-10 ml. Cervical (via C1-2 inj): 180 mg iodine/ml: 7-10 ml; 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 4-10 ml. Total columnar (via lumbar inj): 240 mg iodine/ml: 6-12.5 ml; 300 mg iodine/ml: 6-10 ml.
• Child: Use 180 mg iodine/ml solution. 0-<3 mth: 240 ml; 3-<36 mth: 4-8 ml; 3-<7 yr: 5-10 ml; 7-<13 yr: 5-12 ml; 13-18 yr: 6-15 ml.

Intravenous-

Contrast-enhanced computerized tomography of the abdomen:

• Adult: In conjunction with dilute oral admin, use 300 mg iodine/ml solution: 100-150 ml. The oral dose is administered 20-40 min prior to IV dose and image acquisition.
• Child: In conjunction with dilute oral admin, use 240 or 300 mg iodine/ml solution: 1-2 ml/kg; max 3 ml/kg. The oral dose is administered 30-60 min prior to IV dose and image acquisition.

Digital subtraction angiography:

• Adult: 350 mg iodine/ml: 30-50 ml, as a bolus at 7.5-30 ml/second using a pressure injector, usually for 3 or more inj; max: 250 ml.

Contrast-enhanced computerized tomography:

• Adult: Head imaging by inj: 300 mg iodine/ml: 70-150 ml; 350 mg iodine/ml: 80 ml. Head imaging by infusion: 240 mg iodine/ml: 120-250 ml. Body imaging by inj: 300 mg iodine/ml: 50-200 ml; 350 mg iodine/ml: 60-100 ml.
• Child: Head imaging: 240 or 300 mg iodine/ml: 1-2 ml/kg. Max: 28 g iodine with 240 mg iodine/ml solution or 35 g iodine with 300 mg iodine/ml solution.

Dose and strength used depends on the procedure and route of administration.

Procedure-specific. Intrathecal: Myelography in significant local or systemic infection where bacteremia is likely; concurrent use with corticosteroids; repeat myelography in the event of technical failure (risk of overdosage). Hysterosalpingography: During menstrual period or when menstrual flow in imminent; presence of infection; pregnancy, 6 mth after termination of pregnancy or 30 days after conization or curettage.

Flushing or a sensation of heat; pain, extravasation, thrombophlebitis at the inj site; nausea, vomiting, headache, and dizziness; urticaria, pruritus, pallor, sweating, metallic taste, weakness, coughing, rhinitis, sneezing, lachrymation, visual disturbances; hypotension, tachycardia, bradycardia, transient ECG abnormalities, haemodynamic disturbances; dyspnoea, bronchospasm, angioedema, severe urticaria; convulsions, paraesthesia, paralysis; acute renal failure; thromboembolism, disseminated intravascular coagulation, thrombocytopenia; hyperthyroidism, thyroid storm thyrotoxicosis.

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters)