Omnipaque solution for injection 350mg iodine/ml 100ml №10

Composition and release form

Injection - clear, colorless or slightly yellowish solution.
1 ml of solution contains: 140, 180, 240, 300 or 350 mg of Iodine (in the form of gogexol);
Excipients: Trometamol, sodium Calcium edeate (EDTA), hydrochloric acid (for pH correction) and water for injection;

Pharmacological properties

Omnipaque is a non-ionic, triiodinated, water-soluble radiopaque agent.
The time to reach maximum radiopacity with conventional myelography is up to 30 minutes (after 1 hour it is no longer visible). With computed tomography, visualization of contrast in the thoracic region is possible for 1 hour, the cervical region is about 2 hours, and the basal cisterns are 3-4 hours. Contrasting of the articular cavities, uterus, fallopian tubes, peritoneal protrusions, pancreatic and bile ducts, bladder is achieved immediately after the injection.

Omnipaque at a concentration of 140 mg iodine / ml is isotonic with blood and extracellular fluid. The pH of the drug is 6.8 - 7.6.
The viscosity of Omnipaque solutions in concentrations of 140, 180 and 240 mg of iodine in 1 ml is lower than the viscosity of blood, and in concentrations of 300 and 350 ml of iodine in 1 ml is slightly higher than the viscosity of blood.
Compared with other triyodo-containing radiopaque agents, Omnipaque has low toxicity.

Indications

Radiocontrast agent for use in children and adults, designed to perform cardioangiography, arteriography, urography, phlebography and contrast enhancement with computed tomography (CT); lumbar, thoracic and cervical myelography; CT cysternography after subarachnoid administration; arthrography, endoscopic retrograde pancreatography (ERPT), endoscopic retrograde cholangiopancreatography (ERCP), salpingography, sialography and gastrointestinal tract studies.

Contraindications

Hypersensitivity to the drug.
Severe thyrotoxicosis.
Local or systemic infections, pregnancy.
Epilepsy and cerebral infections for subarachnoid administration.
Immediate repeated intrathecal administration of the drug in case of poorly performed myelography.

Carefully: 
If you have a history of allergies, bronchospasm or other undesirable reactions when using iodine-containing contrast agents, caution should be exercised. In these cases, consideration should be given to the advisability of administering glucocorticosteroids or H1-histamine receptor blockers. Care should be taken when examining patients with decompensated cardiovascular diseases and pulmonary hypertension because of the risk of developing heart rhythm disturbances or aggravating hemodynamic disturbances. You should also be careful in the study of patients with bronchial asthma, pollinosis, multiple myeloma, food allergies,liver failure, dehydration, multiple sclerosis, sickle cell anemia, thromboangiitis obliterans (Buerger's disease), acute thrombophlebitis, severe atherosclerosis, old age, during lactation.
For lumbar punctures - local or systemic infections.
Patients with acute cerebral pathology, brain tumors or epilepsy are prone to seizures and require special attention. Increased risk of seizures and neurological reactions in patients with alcoholism and drug addiction.
In order to prevent the development of acute renal failure associated with the administration of a contrast agent, special care is required when examining patients with already existing kidney function disorders and diabetes mellitus who are at risk. The same applies to the examination of patients with paraproteinemia (multiple myeloma and Waldenstrom macroglobulinemia). The introduction of iodine-containing contrast agents can exacerbate the symptoms of myasthenia.
When performing invasive studies and interventions in patients with pheochromocytoma, prophylactic use of alpha-blockers to prevent hypertensive crisis is necessary. Special care is required when examining patients with moderate thyrotoxicosis, especially in patients with multinodular goiter. You should be aware of the possibility of development in connection with the introduction of contrast agents of transient thyrotoxicosis in premature babies.

Pregnancy and lactation

Omnipaque should not be used in pregnant women, unless the benefit of its use outweighs the risk and such a study is prescribed by a doctor because of necessity.
Contrast agents are slightly excreted into breast milk and minimally absorbed in the intestine. Therefore, the likelihood of harming the baby while breastfeeding seems unlikely. Nevertheless, it is advisable to refrain from breastfeeding for 24 hours after the introduction of Omnipaque.

Dosage and administration

Omnipaque is intended for intra-arterial, intravenous, intrathecal, intracavitary, oral and rectal administration. Vials are intended for single use only; unused remnants of the drug must be destroyed.
With the introduction of the drug the patient should be in a horizontal position. Within 30 minutes after the end of the procedure, medical supervision of the patient is carried out, since most adverse reactions occur during this period.

The dose of Omnipaque is set individually, depending on the indications, age and body weight of the patient.
Forexcretory urography usually administered to adults 40 - 80 ml of Omnipaque, containing 300 or 350 mg of iodine in 1 ml; children weighing up to 7 kg - per 1 kg of body weight 3 ml of Omnipaque containing 300 mg of iodine in 1 ml; with a body weight of more than 7 kg - 2 ml / kg of the same solution (not more than 40 ml).
For angiography of the aortic arch 30-40 ml of Omnipaque, containing 300 mg of iodine in 1 ml, are administered; for aortography - 40 - 60 ml of a solution containing 350 mg of iodine in 1 ml.
For cardioangiography 30 - 60 ml of Omnipaque solution containing 350 mg of iodine in 1 ml is administered to adults in the left ventricle and aortic root. For selective coronary arteriography - 4 - 6 ml of the same solution.
For peripheral arteriography (lower extremities) - 30 - 50 ml of Omnipaque solution containing 350 or 300 mg of iodine per 1 ml.
For phlebography (lower limbs) enter 20-100 ml of Omnipaque solution containing 240 or 300 mg of iodine in 1 ml.
In the cavity (forarthrography, retrograde endoscopic pancreatography, choleangiopancreatography, herniography, hysterosalpingography) Omnipaque is administered with iodine content of 240, 300 or 350 mg in 1 ml in doses from 5 to 50 ml.
Inside forX-ray examination of the gastrointestinal tract Omnipaque containing 180 mg of iodine in 1 ml, in doses from 10 to 200 ml or Omnipaque, containing 350 mg of iodine in 1 ml, in doses from 10 to 20 ml is used.
CT scan- enhancing the contrast in the study of the head in / in the jet 70-150 ml (300 mg / ml), 80 ml (350 mg / ml) or iv / 120-250 ml (240 mg / ml), to children Omnipak-240 or 300 at a dose of 1-2 ml / kg; in the study of the body in / in the jet 50-200 ml (300 mg / ml), 60-100 ml (350 mg / ml).
Subarachnoid Omnipaque is administered to adults and children forlumbar, thoracic and cervical myelography and for tomography of basal cisterns. Adults injected with Omnipaque solutions containing 180, 240 or Z00 mg of iodine in 1 ml; children - only solutions containing 180 mg of iodine in 1 ml. Depending on the indications, the doses of Omnipaque for adults range from 4 to 15 ml, for children - from 2 to 12 ml. The total amount of iodine with subarachnoid administration should not exceed 3 g.

Side effect

With intravascular and intracavitary injection of Omnipaque rarely allergic reactions (itching, urticaria), feeling of heat, nausea, vomiting, pain occur.
With intrathecal administration (subarachnoid application, myelography), nausea, vomiting, dizziness may appear; possible headache, pain in the back, neck, limbs and paresthesia, convulsions (in predisposed patients); marked case of short-term aseptic meningitis .

Interaction with other drugs:
The use of X-ray contrast agents in diabetic patients taking biguanides (metformin) can lead to transient renal dysfunction and the development of lactic acidosis. Patients who took less than 2 weeks before the interleukin-2 study. prone to increased frequency of delayed adverse reactions (flu-like states or skin reactions). In patients taking beta-blockers. manifestations of anaphylaxis can be atypical and mistaken for vagus reactions.
Pharmaceutically incompatible with drugs (drugs) of other groups. Incompatible (with intrathecal administration) with glucocorticosteroids. Phenothiazine derivatives and other antipsychotic drugs (neuroleptics), monoamine oxidase inhibitors. tetracyclic antidepressants, CNS stimulants, analeptics. antipsychotic drugs — the epileptic threshold is reduced and the risk of seizures increases.
Beta-blockers and other antihypertensive drugs increase the likelihood of arterial hypotension. Strengthens nephrotoxic properties of other medicines.

special instructions

Patient preparation and drug administration procedure
Before each use of a contrast agent, it is necessary to obtain accurate information about the patient, including important laboratory data (for example, serum creatinine level, electrocardiogram, history of allergies, pregnancy).
Before the examination of the patient, it is necessary to eliminate the violations of the water-electrolyte balance and to ensure an adequate intake of fluid and electrolytes. This is especially true for patients with multiple myeloma, diabetes mellitus, polyuria or gout, as well as newborns, infants and young children, elderly patients.
2 hours before the procedure, the patient should stop eating.
It is not recommended to conduct preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.
Patients experiencing fear of waiting for the procedure need sedation with sedatives.
The risk of developing severe adverse reactions to Omnipaque is small. However, iodine-containing contrast agents can cause anaphylactoid reactions or other manifestations of hypersensitivity.For this reason, it is necessary to foresee the sequence of therapeutic measures in case of their occurrence and to have the necessary preparations and equipment available.
Before and after the administration of a contrast drug, it is necessary to take care of the saturation of the organism being examined with fluid (hydration). This is of particular importance in patients with myeloma, diabetes mellitus, impaired renal function, as well as in children and elderly patients. In children under one year old, and especially in newborns, hemodynamic and electrolyte imbalances develop especially easily.
It should be used for the introduction of Omnipaque separate syringe and needle and not to mix it with other drugs.
Compared to ionic preparations, non-ionic radiopaque agents have less in vitro effect on the blood coagulation system. When performing angiographic studies, their methods should be carefully followed and catheters (eg, heparinized saline) should be frequently rinsed to minimize the risk of thrombosis and embolism associated with the intervention.
All iodine-containing contrast agents affect the results of tests for determining the function of the thyroid gland, since the iodine-binding ability of the gland may decrease in a few weeks.
High concentrations of contrast agents in the blood plasma or urine can influence the results of biochemical tests to determine the concentration of bilirubin, proteins or inorganic substances (for example, iron, copper, calcium and phosphates). Therefore, similar analyzes should not be performed on the day of the study.
It is necessary to stop taking the biguanides 48 hours before the study and resume after the complete stabilization of the kidney function. Measures for the prevention of adverse reactions:
- identification of high-risk patients
- ensuring adequate hydration. If necessary, it can be achieved by using a constant IV infusion. started before the injection of a contrast drug and continuing until its excretion by the kidneys.
- repeated X-ray contrast studies should be performed no earlier than the moment when the kidney function is restored to its original level.
Particular caution should be observed in patients with severe concomitant hepatic and renal dysfunction, as they significantly reduce the clearance of contrast media. It is possible to carry out X-ray contrast studies in patients on hemodialysis, provided that dialysis is carried out immediately after the study.

It is not recommended to drive a car or use any other mechanisms during the first 24 hours after intrathecal administration of contrast media.

Storage conditions

At a temperature not higher than 30 ° C. protected from light and secondary x-ray radiation.
Storage is allowed at 37 ° C for 3 months before use.
Keep out of the reach of children.

Shelf life

3 years.