Pamiray 300/Pamiray 370

Pamiray 300/Pamiray 370

iopamidol

Manufacturer:

Dongkook Pharma

Distributor:

Masu
Full Prescribing Info
Contents
Iopamidol.
Description
Pamiray 300 Injection contains iopamidol 0.612 g per mL (300 mg as iodine) and Pamiray 370 Injection contains iopamidol 0.7552 g per mL (370 mg as iodine).
Excipients/Inactive Ingredients: Pamiray 300 and 370 Injection also contain 1.0 mg/mL of tromethamine, 0.39 mg/mL of edentate calcium disodium, hydrochloric acid, and water for injection.
Indications/Uses
Pamiray 300 Injection: X-ray contrast media for neuroradiology (ventriculography, basilarography, myelography); Angiography (arteriography, venography); Urography; Computer tomography (CAT Scanning).
Pamiray 370 Injection: X-ray contrast media for angiography: coronary arteriography, thoracic aortography, abdominal aortography, angiocardiography, selective visceral arteriography, peripheral arteriography; Computer tomography (CAT Scanning).
Dosage/Direction for Use
Pamiray is injected intravenously or infused with catheter insertion or direct centesis in accordance with doctor's directions.
Pamiray 300 Injection: Neuroradiology: Ventriculography and basilarography: 3-15 mL.
Myelography: 5-15 mL.
Angiography: Cerebral arteriography: 5-10 mL.
Venography: 30-50 mL.
Peripheral arteriography: 40-50 mL.
Urography: 40-100 mL.
Computer tomography (CAT Scanning): 0.5-2.0 mL/kg.
Pamiray 370 Injection: Angiography: Coronary arteriography: 8-15 mL.
Thoracic aortography: 1.0-1.2 mL/kg.
Abdominal aortography: 1.0-1.2 mL/kg.
Angiocardiography: 1.0-1.2 mL/kg.
Selective visceral arteriography: Administer in accordance with doctor's directions.
Peripheral arteriography: 40-50 mL.
Computer tomography (CAT Scannig): 0.5-2.0 mL/kg.
Contraindications
Proven or suspected hypersensitivity to iodine containing preparations of this type.
Warnings
As with all other contrast media this product may provoke anaphylaxis or other manifestations of allergy with nausea, vomiting, dyspnea, erythema, urticaria and hypotension. A positive history of allergy, asthma or untoward reaction during previous similar investigations indicates a need for extra caution; the benefit should clearly outweigh the risk in such patients. Appropriate resuscitative measures should be immediately available.
Care should be exercised in carrying out radiographic procedures with contrast media in patients with severe functional impairment of the liver or myocardium, severe systemic disease and in myelomatosis. In the latter condition patients should not be exposed to dehydration; similarly abnormalities of fluid or electrolyte balance should be corrected prior to use. Care should also be exercised in patients with moderate to severe impairment of renal function (as reflected by a raised blood urea) or in diabetes. Substantial deterioration in renal function is minimized if the patient is well hydrated. Renal function parameters should be monitored after the procedure in these patients.
Patients with severe hepato-renal insufficiency should not be examined unless absolutely indicated.
Re-examination should be delayed for 5-7 days.
Special care should be exercised when this product is injected into the right heart or pulmonary artery in patients with pulmonary hypertension. Right heart angiography should be carried out only when absolutely indicated. During intracardiac and/or coronary arteriography, ventricular arrhythmias may infrequently occur.
In patients who are known epileptics or have a history of epilepsy, anticonvulsant therapy should be maintained before and following myelographic procedures, in some instances, anticonvulsant therapy may be increased for 48 hours before the examination.
Use of this product may interfere with tests for thyroid function.
Pamiray should be used with caution in patients with hyperthyroidism. It is possible that hyperthyroidism may recur in patients previously treated for Graves' disease.
Non-ionic contrast media have less anti-coagulant activity in-vitro than ionic media. Meticulous attention should therefore be paid to angiographic technique. Non-ionic media should not be allowed to remain in contact with blood in the syringe and intravascular catheters should be flushed frequently, to minimize the risk of clotting, which rarely has led to serious thromboembolic complications after procedures.
X-ray examination of women should if possible be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy; also since it has not been demonstrated that Pamiray is safe for use in pregnant women, it should be administered only if the procedure is considered essential by the physician.
No other drugs should be mixed with the contrast media.
Side Effects
The use of lopamidol as a contrast medium for cerebral angiography, may cause side effects, which are usually mild and of short duration. Many patients report a sensation of heat in the face and neck; a few complain of headache. A fairly frequent cardiovascular reaction to dosing with lopamidol is bradycardia associated with systemic hypotension. The reaction is transient and requires no treatment. Severe neurological sequelae may arise as direct complications of pre-existing pathology in the individual patient. Such reactions are diverse and may include tonic/clonic convulsions, aphasia, fainting, transient narrowing of visual field, hemiparesis and coma. The risk associated with a particular investigation involved maybe increased by conditions such as advanced arteriosclerosis, hypertension, heart failure, major systemic diseases and recent cerebral embolism or thrombosis. In patients undergoing angiocardiographic procedures special attention should be paid to the status of the right heart and pulmonary circulation. Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension, when the organic iodine solution is injected. In examinations of the aortic arch, the tip of the catheter should be positioned carefully to avoid hypotension, bradycardia and CNS injury due to excess pressure transmitted from the injector pump to the brachiocephalic branches of the aorta. Likewise, in abdominal aortography, excess pressure from the pump may cause renal infarction, spinal cord injury, retroperitoneal bleeding, intestinal infarction and necrosis. In peripheral arteriography, lopamidol 370 may sometimes cause a painful reaction in the involved limb. This usually is not the case with the less concentrated solution lopamidol 300. A property of non-ionic contrast media is the extremely low interference with normal physiological functions. As a consequence of this, nonionic contrast media are less anticoagulant activity in-vitro than ionic media. Medical personnel performing vascular catheterization procedures should be aware of this and pay meticulous attention to the angiographic technique and catheter flushing so as to minimize the risk of procedure related thrombosis and embolism.
Storage
Protect the solution from light. Store below 30°C.
Discard if solution is not clear of particulate matter.
Shelf-Life: 3 years.
ATC Classification
V08AB04 - iopamidol ; Belongs to the class of watersoluble, nephrotropic, low osmolar preparations used as X-ray contrast media.
Presentation/Packing
Inj (vial) 300 mg/mL x 50 mL x 1's, 100 mL x 1's. 370 mg/mL x 50 mL x 1's, 100 mL x 1's.
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