Solution for intravenous and intra-arterial administration at a concentration of 150 mg iodine / ml, 270 mg iodine / ml, 320 mg iodine / ml
|active ingredient||Concentration||The content in 1 ml yodnksanola|
|anavar results (INN)||150 mg of iodine / ml||305 mg eq.|
|anavar results (INN)||270 mg of iodine / ml||550 mg eq.|
|anavar results (INN)||320 mg of iodine / ml||652 mg eq.|
Excipients: trometamol, sodium chloride, calcium chloride, sodium calcium edetate, hydrochloric acid (for adjusting pH), water for injection.
DESCRIPTION: Clear, colorless or pale yellow solution.
anavar results – soluble nonionic dimer geksayodirovannoe radiopaque agent. . The pH of the preparation 6.8 – 7.6
anavar results all clinically used concentration has a lower osmolality than whole blood.
The osmolarity and viscosity Visipaque are listed below:
|Concentration||osmolarity *||Viscosity (Tra)|
|mOsm / kg H 2 0 at 37 ° C||20 ° C||37 ° C|
|150 mg of iodine / ml||290||2.7||1.7|
|270 mg of iodine / ml||290||11.3||5.3|
|320 mg of iodine / ml||290||25.4||11.4|
Visipaque non-ionic iodine-containing radio-opaque drug. Following intravenous administration Visipaque organically bound iodine is concentrated in the blood vessels and some tissues (kidney, thyroid gland, and others.), Cerebrospinal fluid making them radiopaque.
When administered drug in the bloodstream anavar results rapidly distributed in the extracellular fluid of the body. Distribution Period is on average about 21 minutes.
With the proteins bind to less than 2% of the drug. The half-life of about 2 hours. Not identified metabolites Visipaque. anavar results mainly excreted by the kidneys by glomerular filtration.
After intravenous administration to healthy volunteers anavar results after 4 hours about 80% of the administered dose passes into the urine, but after 24 hours 97% of the formulation. Only 1.2% of the dose excreted in feces within 72 hours. The maximum drug concentration in the urine is detected after about 1 hour after the injection.
kardioangiografii, cerebral angiography, digital subtraction angiography (DSA), peripheral arteriography, abdominal angiography, urography, venography and contrast enhancement at the X-ray computed tomography (CT).
Hypersensitivity to iodine-containing contrast media.
A history of serious adverse reactions to Visipaque. Chronic renal failure, hepatic, cardiac insufficiency II – III stage, severe thyrotoxicosis, dehydration, acute disorders of the liver and kidneys. Epilepsy.
In acute inflammatory diseases of the pelvic organs is contraindicated hysterosalpingography.
In acute pancreatitis, endoscopic retrograde cholangiopancreatography is contraindicated.
Intrathecal is not recommended to enter Visipaque.
When using non-ionic contrast media should be careful when:
1. A history of allergies, bronchial spasms, or other adverse reactions to iodinated contrast media. In patients with bronchial asthma or allergic reactions in history you must first enter the steroids and antihistamine drugs.
2. In the study of patients with severe cardiovascular disease and pulmonary hypertension due to the risk of cardiac arrhythmias or hemodynamic disorders.
3. Availability in patients with acute cerebral disorders, brain tumors, the presence of seizures. Increased risk of seizures and neurological reactions as in patients with alcoholism and drug addiction.
4. Particular caution should be exercised in patients with severe concomitant disorders of the liver and kidneys, as they have significantly reduced the clearance of contrast media.
5. To prevent the development of acute renal failure associated with the administration of contrast medium, requires special care with the introduction of the drug to patients with pre-existing renal impairment and diabetes mellitus as well as paraproteinemia (mielomatoz and Waldenstrom’s macroglobulinemia).
6. It should be particularly careful when examining patients with hyperthyroidism.
Patients with multinodular goiter after administration of iodinated contrast media are at risk of hyperthyroidism. You should be aware of the opportunities for development in connection with the introduction of contrast agents transient hypothyroidism in premature infants.
Pregnancy and lactation
1. Visipaque should not be used in pregnant women except in cases where the benefits of its use outweigh the risks, and such a study is assigned a doctor because of the need.
2. Contrast agents to a small extent excreted into breast milk and minimally absorbed in the intestine. Therefore, the probability of harm to the baby through breast-feeding is unlikely. However, it is desirable to stop breast-feeding for 24 hours as needed administration.
DOSAGE AND ADMINISTRATION General information on the treatment of drug product is intended for intra-arterial and intravenous administration. Like all parenteral formulations, Visipaque before use should be inspected visually for the absence of nerastvorimgh particles, color changes and package integrity violations. The drug should be typed into the syringe immediately before use. Vials are intended for single use only; Unused drug residues shall be destroyed. Do not mix with other drugs Visipaque. You must use a separate syringe and needle. Preparation of the patient and the procedure of administration Before each use of a contrast agent is necessary to obtain accurate information about the patient, including important laboratory findings (eg, creatinine level in blood serum, ECG, allergy anemneze, pregnancy). Before examining the patient should eliminate violations of water-eletrolitnogo balance and to ensure adequate intake of fluids and electrolytes. This applies especially to patients with multiple myeloma, diabetes mellitus, polyuria, or gout, as well as neonates, infants and young children, elderly patients. 2 hours before the procedure, the patient should stop eating. With the introduction of the drug the patient should be in a horizontal position. Within 30 minutes after the procedure is carried out medical supervision of the patient, because Most adverse reactions occur during this period. It is not recommended to carry out preliminary testing of individual sensitivity using small doses of the drug, because of the risk vozniknovekniya severe hypersensitivity reactions. Patients experiencing fear of waiting before the procedure, required premedication with sedatives. Contrast agent prior to administration is always heated to body temperature. Should be carefully observed when performing angiographic studies their methodology and often washed catheters (e.g., heparinized saline solution) to minimize the risk of thrombosis and embolism. Doses may vary depending on the type of study, the age, body weight, condition and hemodynamic state of the patient, as well as research technique used. The same iodine concentration and volume are commonly used administration, as well as the application of other modern iodine-containing contrast media. You can navigate to the following dosing. The doses specified for intraarterial administration refer to a single injection that can be administered repeatedly.
|Indication / study||The concentration of the drug||The amount and method of administration|
|Intra-arterial (B / A) introduction|
|selective cerebral||270/320 mg iodine / ml (1)||5.10 ml / injection|
|selective cerebral in / ACD and||150 mg of iodine / ml||5.10 ml / injection|
|aortography||270/320 mg iodine / ml||40-60 ml / injection|
|peripheral||270/320 mg iodine / ml||30-60 ml / injection|
|peripheral I / DSU and||150 mg of iodine / ml||30-60 ml / injection|
|Selective visceral in / ACD and||270 mg of iodine / ml||10-40 ml / injection|
|The left ventricle and aortic root||320 mg of iodine / ml||30-60 ml / injection|
|Selective coronary angiography||270 mg of iodine / ml||4.8 ml / injection|
|Intravenous (i / v) introducing|
|urography||270/320 mg iodine / ml||40-80 ml (2) injection|
|venography||270 mg of iodine / ml||50-80 ml / limb|
|Gain at RT|
|CT brain||270/320 mg iodine / ml||50-150 ml|
|body CT||270/320 mg iodine / ml||75-150 ml|
(2) In some cases, the introduction of more than 80 ml.
Elderly patients: The same recommendations as for adults in general.
Adverse and side effects on non-ionic X-ray contrast agents are usually moderately severe, reversible and less common than with ionic drugs.
If you use Visipaque most often found slightly expressed feeling of warmth or cooling throughout the body. When peripheral angiography sensation of heat observed frequently (incidence> 1:10), while complaints of pain in the distal extremities is rare (incidence <1:10 but> 1: 100).
The feeling of discomfort or pain in the abdomen are rare (<1: 1000) and gastrointestinal reactions such as nausea and vomiting (from> 1: 1000 to <1: 10 °). May include the hypersensitivity reaction, which usually manifest themselves in the form of moderately severe respiratory disorders (dyspnea, bronchospasm) or skin reactions such as rash, erythema, urticaria, pruritus, in some cases, edema develops.Allergic symptoms may occur directly after administration of the drug, and a few days later. There are reports of toxic skin reactions. Severe hypersensitivity reactions such as laryngeal edema, pulmonary edema and anaphylactic shock are extremely rare. Anaphylactoid reactions may occur regardless of the dose and route of administration; serious adverse reaction may begin with minor manifestations of hypersensitivity reactions. In this case, you should immediately stop the introduction Visipaque and start, if necessary, therapy using intravascular administration of drugs.
Sometimes there vasovagal reactions such as hypotension and bradycardia.
Chance iodism or “iodine pig” – to introduce Visipaque, which is expressed in the increase and tenderness of salivary glands for up to 10 days after the study.
Acute renal failure is rare.
When administered in coronary, cerebral or renal artery may develop arterial spasm, leading to transient ischemia respective organ tissues.
Severe reaction with the cardiovascular system as arrhythmias, reduction contractile function of the myocardium, or myocardial ischemia are rare. Perhaps the development of hypertension.
Can vstrechatsya neurological reactions that manifest as convulsions, transient disturbances of motor or sensitive functions. In rare cases
Visipaque can penetrate the blood-brain barrier, resulting in accumulation of the drug in the cerebral cortex can be visualized by CT. This effect may persist for 1-2 days and sometimes accompanied by transient disturbances of orientation in space or korktikalnoy blindness.
Can occur postflebograficheskie thrombophlebitis or thrombosis. Described isolated cases arthralgia.
After the introduction of iodine-containing contrast media quite often observed a transient increase in serum creatinine level, but it usually has no clinical significance.
Perhaps taste disturbance, blurred vision, headache, allergic reactions and dikomfort at the injection site. Measures prevention of adverse reactions: – identification of patients at high risk – to ensure adequate hydration. If necessary, it can be achieved with constant on / in infusion started before the introduction of the contrast agent and continuing until its excretion by the kidneys. – Preventing an additional load on the kidneys, arising from the use of nephrotoxic drugs, drugs for oral holetsistografii, cross-clamping of the renal arteries, renal artery angioplasty, surgical procedures – to deducing contrast agent from the body. – repeated X-ray studies should be performed no earlier than the point where kidney function is restored to the original level.
Overdose Visipaque unlikely in patients with normal renal function. In the case of using high doses of great importance in regard to the effect on the kidney is the duration of the procedure (half-life of the drug is approximately 2 hours).
When the random overdose, loss of water and electrolytes to be replenished via infusion therapy.
It is to monitor renal function during at at least 3 days. If necessary, possible to use dialysis to remove the patient from anavar results. There is no specific antidote.
Interactions with other drugs
used concomitantly with antipsychotics, antidepressants and analgesics Visipaque may reduce the seizure threshold, increasing the risk of adverse reactions.
The use of Visipaque in patients with diabetic nephropathy, taking biguanides (metformin) may lead to a transient disturbance of kidney function and the development of lactic acidosis. As a precaution, you should stop taking biguanide for 48 hours prior to the study and resume after complete stabilization of renal function.
Patients who took less than 2 weeks before the study interleukin-2, are prone to a higher frequency of delayed adverse reactions (flu-like condition or skin reactions) .
patients taking beta-blockers, the manifestations of anaphylaxis may be atypical and mistaken for vagal reaction.
distort the results of radioisotope thyroid studies (yodosvyazyvayuschaya ability of thyroid tissue is reduced for 2 weeks).
The introduction of iodinated contrast media may aggravate myasthenia gravis symptoms.
When you perform invasive investigations and interventions in patients with pheochromocytoma is necessary prophylactic use of alpha-blockers for preventing hypertensive crises.
Perhaps the performance of X-ray contrast studies in patients on hemodialysis – provided that the dialysis will be held immediately after the study case of violation of liver and kidney function is significantly reduced clearance of the drug. High concentrations of the drug in the patient’s plasma could affect the results of laboratory tests to determine the concentration of bilirubin, protein, iron, calcium, copper and phosphate. Therefore, these tests should not be performed in the study day.
Breast-feeding should be discontinued prior to the study and resume no earlier than 24 hours after administration.
In order to reduce the risk of thrombosis and embolism should be flushed catheter 0.9% sodium chloride solution with the addition of heparin .
Effects on ability to drive a car and involve mechanisms
is not recommended to drive or use any other mechanisms within the first 24 hours after the administration of contrast agents.