Yopamiro - instructions for use, dose, side effects, contraindications

Active substanceYopamidolYopamidol

Similar drugsTo uncover

Yopamidol

solution for injections

JODAS EKSPOIM, LLC Russia

Yopamiro

solution for injections

Brakko SpA Italy

Scanlux® 300

solution in / vessel.

Sanochemistry Pharmaceuticals AG Austria

Scanlux® 370

solution in / vessel.

Sanochemistry Pharmaceuticals AG Austria

Dosage form: & nbspinjection

Composition:

Per 1 ml of the preparation:

Active ingredient: yopamidol 612.4 mg (equivalent to 300 mg iodine) or 755.3 mg (equivalent to 370 mg iodine);

atAuxiliary components: sodium calcium edetate 0.33 mg or 0.41 mg, trometamol 1.0 mg, hydrochloric acid to pH 6.9-7.1, water for injection up to 1 ml.

Description:

Transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:X-ray contrast medium

ATX: & nbsp

V.08.A.B Water-soluble low-osmolarity radiopaque substances for the study of the kidneys

Pharmacodynamics:

Yopamiro is a nonionic, triiodinated, low osmolar, water-soluble radiocontrast agent.

Pharmacokinetics:

Yopamidol is not metabolized, does not accumulate in the liver and is excreted chemically unchanged by glomerular filtration. Half-life in patients with normal renal function is about 2 hours, the creatinine clearance in these cases is from 60 to 146 ml / min, depending on age, gender and anthropometric parameters. After 24 hours Yopamidol almost completely eliminated from the body with urine. Yopamidol does not penetrate the blood-brain barrier, through the placental barrier - in an extremely small degree.

In patients with impaired renal function, the half-life period is prolonged depending on the degree of kidney damage, the creatinine clearance in these cases is from 20 to 59 ml / min.

Yopamidol does not bind to serum or plasma proteins.

Indications:

Neuroradiography: mieloradiculography, cisternography, ventriculography.

Angiography: cerebral and coronary arteriography, thoracic aortography, abdominal aortography, angiocardiography, selective visceral and peripheral arteriography, venography, digital angiography of cerebral, peripheral and abdominal arteries.

Contrast enhancement in scanning computed tomography.

Intravenous urography.

Arthrography.

Fistulography.

Contraindications:

Hypersensitivity to iodine-containing radiopaque agents.

Expressed thyrotoxicosis.

Epilepsy.

Multiple myeloma.

Waldenstrom's macroglobulinemia.

Severe hepatic, renal and cardiovascular failure.

In acute inflammatory diseases of the pelvic organs, hysterosalpingography is contraindicated.

In acute pancreatitis, endoscopic retrograde cholangiopancreatography is contraindicated.

Carefully:

Particular care should be taken when administering the drug to patients with impaired renal function, liver and cardiovascular system, pulmonary emphysema, severe general condition, severe atherosclerosis, requiring correction of diabetes mellitus, latent hyperthyroidism, nodular goiter of mild and moderate severity.

Pregnancy and lactation:

The drug should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus, and such a study is prescribed by the doctor because of extreme necessity.

If it is necessary to conduct a study during lactation, breast-feeding should be stopped before the introduction of the drug and not resumed at least 24 hours after the test.

Dosing and Administration:

General information

The solution of contrast agent is typed in a syringe or a bottle for drip introduction just before the beginning of the procedure.The solution of the contrast agent is intended exclusively for single use, the rubber stopper of the bottle is pierced only once, the rest of the contrast agent is destroyed. For the introduction of contrast agent it is necessary to use a separate syringe and needle; Do not mix it with other medicines.

Preparation of the patient and the procedure for administering the drug

Before each use of a contrast agent, it is necessary to obtain accurate information about the patient, including important laboratory data (eg, serum creatinine, ECG, allergy in history, taking medications); exclude the existence pregnancy.

Before the study, the patient should eliminate violations of water electrolyte balance and ensure sufficient supply of fluid and electrolytes. This is especially true for patients with multiple myeloma, diabetes, polyuria, oliguria or gout, as well as newborns, infants and young children, elderly patients.

Two hours before the procedure, the patient should not eat.

The contrast agent is always heated to the body temperature before administration.

When the drug is administered, the patient should be in a horizontal position.

Within 30 minutes after the end of the procedure, it is necessary to monitor the stability of the patient's condition, his hemodynamic parameters, due to the risk of most side effects occurring during this period. The patient should be warned about the possibility of delayed-type reactions (up to 7 days).

It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.

To provide immediate assistance in the event of acute side effects, you should ensure safe access to the vessel (permanent cannula). The funds required in these cases must be available.

Patients who are afraid of waiting need premedication with sedatives.

Application

Angiography:

The drug is administered intravenously and intraarterially, the recommended doses are given in the table:

	Dosage (mg / ml)	Recommended dose (ml)
Cerebral arteriography	300	5-10 (bolus)
Coronary arteriography	370	8-15 (bolus)
Breast aortography	370	1.0-1.2 / kg body weight
Abdominal aortography	370	1.0-1.2 / kg body weight
Angiocardiography	370	1.0-1.2 / kg body weight
Selective visceral	300	1.0-1.2 / kg body weight
Arteriography	370	0,8-1,2 / kg of body weight
Peripheral arteriography	300-370	40-50
Digital subtraction angiography	300-370	40 (bolus)
Venography	300	30-50

Urography:

The drug is administered intravenously.

Recommended doses are given in the table:

	Dosage (mg / ml)	Recommended dose (ml)
Children weighing up to 7 kg	300	3.0 / kg body weight
Children weighing over 7 kg	370	2.0 / kg body weight (not more than 40 ml)
Adults	300 370	30-50 30-50

For examination of patients with impaired renal function, the most acceptable is Yopamiro 370 mg / ml, which is characterized by the least pronounced osmotic diuresis.

Other types of diagnostics:

The drug is administered intravenously with computed tomography, as well as into the joint cavity.

The recommended doses are given in the table:

	Dosage (mg / ml)	Recommended dose (ml)
Increased contrast in computed tomography	300-370	0,5-2,0 / kg
Arthrography	300	Depending on the type of examination
Fistulography	300	Depending on the type of examination

To increase the contrast in scanners during CT, the drug can be administered as a bolus, or by drip infusion; and also in a combination of these two methods.

Side effects:

Possible headache, pain at the injection site, nausea, vomiting, generalized sensation of fever, increased sweating, acute rhinitis, edema of the larynx; asthenia, pallor of the skin, shortness of breath and moderate arterial hypotension. These effects are usually short-lived. Skin reactions may occur in the form of various types of rash.

Very rarely there is dizziness, stiff neck, low back pain, temporary confusion. In a few cases, fever occurs.

In some cases, patients with increased convulsive readiness or using psychotropic drugs, with the introduction of the drug may cause spasms of skeletal muscles or generalized convulsions.

From the cardiovascular system: peripheral vasodilation, severe arterial hypotension, tachycardia, shortness of breath, agitation, cyanosis and loss of consciousness (may require urgent treatment), transient bradycardia.

From the nervous system: tonic / clonic convulsions, aphasia, syncope, temporary narrowing of the visual fields, hemiparesis, coma (developed in patients suffering from CNS diseases).

Individual hypersensitivity is possible, especially in people with a predisposition to allergies, and also taking beta-blockers.

Adverse reactions and warnings in neuroradiogenological studies

In the case of cerebrospinal blockade when the drug is administered, as much as possible of the injected contrast solution should be removed.

In cases of the presence of blood in the cerebrospinal fluid, the physician should carefully evaluate the necessary need for a diagnostic procedure taking into account the risk to the patient.

Adverse reactions and warnings in angiographic studies

In patients undergoing angiocardiographic procedures, special attention should be given to the state of the right heart and pulmonary circulation.

The introduction of an organic iodine-containing solution with insufficient right heart and pulmonary hypertension can cause bradycardia and arterial hypotension.

Increased caution should be observed when a contrast agent is inserted into the right heart cavity Newborns with pulmonary hypertension and impaired cardiac function.

When contrasting the aortic arch in a number of cases, it is possible to develop arterial hypotension, bradycardia.

With abdominal aortography there may be a kidney infarction, spinal cord injury, retroperitoneal bleeding, and bowel necrosis.

With peripheral arteriography with the drug at a dosage of 370 mg / ml, pain in the examined limb can sometimes occur. Usually this is not observed when using a less concentrated solution - 300 mg / ml.

When the vessels are catheterized it is necessary to pay special attention to angiographic technique, since nonionic contrast preparations, in comparison with ionic ones, have a lower anticoagulant activity in vitro. In this regard, to minimize the risk of thromboembolism associated with the procedure, it is necessary to properly install the catheter, wash it with saline, if possible with the addition of heparin, and also minimize the duration of the procedure.

Overdose:

Overdose is unlikely in patients with normal renal function. In the case of high doses, the long-term effect of the drug on the kidneys is of great importance (the half-life of the drug is approximately 2 hours).

There is no specific antidote, the treatment is symptomatic; it is possible to conduct hemodialysis.

Interaction:

When used concomitantly with psychotropic drugs, analgesics and antidepressants yopamidol can reduce the convulsive threshold, increasing the risk of adverse reactions.

Use of yopamidol in patients with diabetic nephropathy who take biguanides (metformin), can lead to a transient disruption of kidney function and the development of lactic acidosis. As a precaution, you should stop taking biguanides 48 hours before the test and resume after complete stabilization of kidney function.

In patients taking beta-adrenoblockers, the manifestations of anaphylaxis with yopamidol can be atypical and mistaken for vagal reactions.

Patients who took less than 2 weeks before the study of interleukin-2 are prone to an increased incidence of delayed adverse reactions (flu-like conditions, rash).

Special instructions:

Precautions

It is forbidden to mix radiopaque drug with other drugs in one syringe.

When appointing the drug to patients who are to study the function of the thyroid gland, it should be borne in mind that the absorption of iodine by the tissues of the thyroid gland is reduced for a period of up to 2 weeks, which may affect the results of the study.

Premises in which procedures are performed using radiocontrast preparations should be provided with equipment and medicines that are needed in emergency situations (oxygen cylinders, antihistamines and vasoconstrictors, glucocorticosteroid agents).

Form release / dosage:

Solution for injection, 300 mg iodine / ml, 370 mg iodine / ml.

Packaging:

For the dosage of 300 mg iodine / ml:

To 30, 50, 100, 200, 500 ml in bottles of colorless glass type I (Eur. Ph.), sealed with a rubber stopper and rolled up with an aluminum cap. 1 bottle per cardboard pack together with instructions for medical use.

For the dosage of 370 mg iodine / ml:

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N014150 / 01

Date of registration:05.10.2009 / 07.08.2015

Expiration Date:Unlimited

The owner of the registration certificate:Brakko SpABrakko SpA Italy

Manufacturer: & nbsp

PATHEON ITALIA, S.p.A. Italy

Representation: & nbspIMEX, CJSCIMEX, CJSCRussia

Information update date: & nbsp29.11.2017

Illustrated instructions

Instructions

Yopamiro (Iopamiro)