Yopromide-Biarvist - instructions for use, dose, side effects, contraindications

Excipients: trometamol - 2.42 mg, sodium calcium edetate - 0.10 mg, hydrochloric acid - the required amount to pH from 6.5 to 8.0, water for injection to 1 ml.

Theoretical osmolality (Osm / kg): solution for injection 300 mg iodine / ml - 0.59, solution for injection 370 mg iodine / ml - 0.77.

Description:

Transparent, colorless or light yellow liquid.

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:Yopromide (molecular weight - 791.1) is a non-ionic, water-soluble, triiodinated, radiocontrast (triiodizophthalic acid derivative),which increases the contrast of the image due to the absorption of X-rays by iodine, which is part of its composition.

Pharmacokinetics:

Distribution

After intravenous administration, the concentration of iopromide in plasma highly fast decreases due to its distribution in the intercellular space and subsequent elimination. The total volume of distribution in the equilibrium state is about 16 liters, which roughly corresponds to the volume of the extracellular space.

The connection with plasma proteins is insignificant (about 1%). Yopromide can not penetrate through the intact blood-brain barrier, but in a small amount passes through the placental barrier (less than 0.3% of the administered dose in rabbits).

After 1-5 min after bolus intravenous administration of iopromide containing 300 mg of iodine in 1 ml of plasma, 28 ± 6% of its administered amount is detected, regardless of the dose. After insertion under the membranes of the brain, the maximum concentration of iodine in the plasma is 4.5% from the administered dose, were observed after 3.8 hours. After administration to the bile and / or pancreatic duct during endoscopic retrograde cholangiopancreatography (ERCP), iodine-containing radiopaque agents are absorbed,reaching a peak concentration in the blood plasma at 1 and 4 hours after administration. After the administration of 7.3 g iodine, its maximum serum concentration is about 40 times lower than the maximum levels that occur after intravenous administration of a similar dose.

Metabolism

Yopromide is not metabolized.

Excretion

Yopromide excretion in patients in the final phase is characterized by a half-life of about 2 hours, regardless of the dose.

In the doses studied, the total clearance of iopromide was 106 ± 12 ml / min, which is similar to the magnitude of renal clearance of 102 ± 15 ml / min. Consequently, iopromide almost completely excreted by the kidneys. Only about 2% of the administered dose is released through the intestine within 3 days. After 3 hours after intravenous injection, about 60% of the administered dose is excreted by the kidneys. After 12 hours, ≥ 93% of the total dose is released. Almost completely iopromide excreted in 24 hours.

After 72 hours approximately 80% of the total amount of iopromide is excreted by the kidneys. After introduction into the bile and / or pancreatic duct during ERCPH concentration of iodine in the serum return to the baseline level after 7 days.

Additional information for specific patient groups

Elderly age (over 65 years)

Total plasma clearance in middle-aged patients (from 49 to 64 years old) without clinically significant decrease in kidney function is 74 - 114 ml / min (average 102 ml / min), in elderly patients (65 to 70 years) without clinically significant decrease in kidney function, this figure is 72-100 ml / min (average 89 ml / min). These values are only slightly lower than in young healthy individuals 88 - 138 ml / min (average 106 ml / min). Individual values of the half-life in the interval 1.9-2.9 hours and 1.5-2.7 hours, respectively. When compared with an interval of 1.4-2.1 hours in young healthy volunteers, the terminal half-lives were similar. Small differences correspond to a physiological decrease in the rate of glomerular filtration with age.

Dysfunction of the liver and kidneys

In patients with impaired renal function, the half-life of yopromide from plasma is increased due to a decrease in the rate of glomerular filtration. In patients with terminal renal failure, non-ionic X-ray contrast media can be eliminated by hemodialysis. Approximately 60% of the dose of yopromide is removed during 3-hour dialysis.

Disturbance of liver function does not affect the excretion of iopromide, since for 3 days with feces only 1.5% of the administered dose.

Indications:

The drug is intended for diagnostic purposes only!

It is indicated for the enhancement of the contrast of the image during computed tomography (CT), arteriography and venography, including intravenous / intra-arterial digital subtraction angiography (CSA); for intravenous urography, endoscopic retrograde cholangiopancreatography (ERHPG), arthrography and studies of other body cavities.

Contraindications:

Hypersensitivity to iopromide, iodine preparations, or other auxiliary component of the drug.

Injection solutions 300 mg iodine / ml and 370 mg iodine / ml contraindicated for research subarachnoid spacetva.

The drug is not used for intrathecal administration.

Carefully:

The above warnings and precautions refer to all the routes of administration of the X-ray contrast medium, but the noted risk is higher with its intravascular administration.

- Thyroid dysfunction

- Elderly age

- Severe patient condition

Intravascular administration

Renal damage

Nephrotoxicity caused by X-ray contrast agents, which is a transient renal dysfunction, may occur after administration of the drug. In rare cases, acute renal failure may develop.

Risk factors:

- kidney failure;

- dehydration;

- diabetes;

- multiple myeloma / paraproteinaemia;

- administration of iopromide in repeated and / or high doses.

Cardiovascular diseases

In patients with severe heart disease or severe coronary artery disease, the risk of developing clinically significant changes in hemodynamics and arrhythmia is increased. In patients with valvular heart disease and pulmonary hypertension, administration of an X-ray contrast agent can lead to severe hemodynamic disturbances. Reactions involving ischemic changes in the electrocardiogram (ECG) and severe arrhythmias are most common in elderly patients and in patients with a history of cardiac pathology.

Intravascular injection of radiocontrast can cause pulmonary edema in patients with heart failure.

Diseases of the central nervous system (CHC)

In patients with seizures in the history or with other diseases of the central nervous system, the risk of seizures or neurological complications may increase, due to the administration of the drug.

Pheochromocytoma

In patients with pheochromocytoma, there is a risk of developing a hypertensive crisis. Premedication with alpha-blockers is recommended.

Patients with autoimmune diseases

There are cases of severe vasculitis or Stevens-Johnson syndrome, in patients with a history of autoimmune diseases.

Myasthenia gravis gravis

The introduction of iodine-containing X-ray contrast substance may increase the severity of myasthenia gravis symptoms.

Alcoholism

An acute or chronic form of alcoholism can increase the permeability of the blood-brain barrier. The facilitated penetration of X-ray contrast material into brain tissue can lead to reactions from the CNS.

Introduction to other body cavities

Inflammation of the bile ducts may increase the risk of reactions after ERCP. Inflammation of the bile duct or tubal can increase the risk of reactions after ERCP or hysterosalpingography.Pregnancy should be excluded before hysterosalpingography.

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 appointed by the doctor, as necessary.

Excretion of iopromide with breast milk is insignificant, and it is unlikely that it would pose a risk to infants. However, if the drug is necessary, stop breastfeeding for at least 24 hours after the test.

Dosing and Administration:

General information

Before use, Yopromide-Biarwist should be heated to body temperature.

Before administration, you should carefully inspect the bottle. If the integrity of the vial is violated, a significant change in color, the detection of visible particles (including crystals), the drug should not be used. Since Yopromide-Biarvist is a highly concentrated solution, it is extremely rare to crystallize (the appearance of milk-like opacities and / or precipitation or crystals in the form of suspended matter).

For the introduction of a radiopaque solution, it is necessary to use an automatic injector or other special instruments with preservation of sterility. To recruit Yopromide-Biarvist in a syringe or infusion is immediately before the introduction.

Do not make more than one puncture of the rubber stopper in order to prevent a large number of microparticles from entering the prepared solution from the plug. Therefore, to puncture the rubber plug and set radiopaque, it is recommended to use cannulae with long tips with a diameter of no more than 18 G (best suited are marked cannulae with a lateral opening of the type Nocore-Admix).

The solution of the drug unused after opening the vial should be destroyed.

Vials containing 200 and 500 ml of the drug should be used only for intravascular injection. For the introduction it is necessary to use an automatic injector or other equipment that provides sterility of the drug. Follow the instructions for using an automatic injector or other equipment. Unused after opening the bottle the drug can be applied within 10 hours after the first opening. Then it should be destroyed.

Doses for intravascular injection

The intravascular injection of the radiopaque means, if possible, is best carried out while the patient is lying down.

The dose of radiopaque means should correspond to the age, body weight to be solved by the clinical problem and the research method. The doses given below should only be considered as recommended; they are the usual dose for an average adult person with a body weight of 70 kg. The dose is expressed in ml for a single injection or per kg of body weight.

As a rule, doses up to 1.5 g of iodine per kg of body weight are usually well tolerated. Recommended doses for single injections

Ordinary angiography

Type of research	Dosage of the drug Yopromide-Biarvist (concentration of iodine mg / ml)	Dose, ml
Angiography of the arch of the aorta	300	50-80
Selective angiography	300	6-15
Breast aortography	300/370	50-80
Abdominal aortography	300	40-60
Arteriography
Upper limbs	300	8-12
Lower limbs	300	20-30
Angiocardiography
Ventricles of the heart	370	40-60
Coronary angiography	370	5-8
Venography
Upper limbs	300	15-30
Lower limbs	300	30-60

Intravenous CSA

To carry out large-vessel CAA, use the drug Yopromide-Biarvist solutions for injection 300 mg iodine / ml and 370 mg iodine / ml in a volume of 30-60 ml.The drug is administered bolus at a rate of 8-12 ml / s to the ulnar vein or at a rate of 10-20 ml / s through the catheter into the vena cava. The contact time of the radiopaque substance with the vein wall can be shortened by a rapid bolus injection immediately after the preparation of Yopromide-Biarvist 0.9% sodium chloride solution.

Adults

30-60 ml of injection for 300 mg of iodine / ml and solution for injection 370 mg of iodine / ml of Yopromide-Biarvist.

Intraarterial CSA

When performing intra-arterial CSA, in contrast to conventional angiography, smaller amounts of Yopromide-Biarvist and its lower concentrations can be administered.

If possible, Yopromide-Biarvist should be injected into a vein in the form of a bolus using an automatic injector. Only with slow scanning, about half the dose should be administered bolus, and the rest for 2-6 minutes to ensure a relatively constant concentration of the drug in the blood.

Spiral CT and especially multi-layer CT allows a large amount of data to be obtained with a single breath delay. To obtain the optimal diagnostic effect from the intravenously administered bolus (80-150 ml of injection for 300 mg of iodine / ml of the drug Yopromide-Biarvist) in the study area (peak,time and duration of contrast) it is recommended to use an automatic injector and to control the time interval from the beginning of the introduction of radiopaque means before the scan begins.

Whole body CT

The necessary doses of radiopaque means and the speed of their administration depend on the organ under examination, the diagnostic problem being solved and, in particular, on the differences in scanning and the duration of image reconstruction.

CT of the skull

Adults:

Yopromide-Biarvist injection 300 mg iodine / ml: 1.0-2.0 ml / kg

Yopromide-Biarvist injection for 370 mg iodine / ml: 1.0-1.5 ml / kg

Intravenous urography

In connection with the physiologically weak concentration capacity of immature kidney nephrons in children, relatively high doses of radiopaque agents are required.

The following doses of Yopromide-Biarvist are recommended:

Age	Amount of iodine, g / kg body weight	Yopromide-Biarwist ml / kg body weight
Age	Amount of iodine, g / kg body weight	300 mg iodine / ml	370 mg iodine / ml
Newborns (<1 month)	1,2	4,0	3,2
Young children (1 month - 2 years)	1,0	3,0	2,7
Children (2-12 years old)	0,5	1,5	1,4
Children over 12 years and adults	0,3	1,0	0,8

If necessary, in some cases, adults may increase these doses.

Snapshot Time

The timing of the images after the administration of the drug Yopromide-Biarvist 300 mg iodine / ml / 370 mg iodine / ml with a duration of 1-2 minutes is for the kidney parenchyma 3-5 min, and for visualization of the renal pelvis and ureter system - 8-15 min after beginning of the introduction of radiopaque substance. The younger the patient, the earlier the picture is taken. Usually, you should take the first picture 2-3 minutes after the introduction of radiopaque. In newborns, children under 2 years and patients with impaired renal function, imaging at a later date can improve visualization of the urinary tract.

Doses when administered to the body cavity

When carrying out arthrography, ERCP, the introduction of an X-ray contrast agent should be carried out under the control of fluoroscopy.

Recommended doses for individual studies:

The dose can be highly dependent on age, body weight, general condition of the patient, as well as on the clinical problem being solved, the technical equipment used and the field of examination. Below are the average doses recommended to adults in the norm.

Arthrography:

5-15 ml Yopromide-Biarvist 300 mg iodine / ml / 370 mg iodine / ml

ERCPR:

The dose depends on the clinical problem being solved and the size of the visualized structure.

Other cavities:

The dose depends on the clinical problem being solved and the size of the visualized structure.

Additional information for specific patient groups

Newborns (<1 month) and small children (1 month - 2 years)

Children under the age of 1 year and especially newborns are characterized by sensitivity to disturbance of the water-electrolyte balance and hemodynamic disorders. Attention should be paid to the dose of radiocontrast, technical support of radiological examination and the condition of the patient.

Elderly age (over 65 years)

There was no difference in the pharmacokinetics of yopromide between the elderly (age 65 years and older) and younger patients. Therefore, there are no specific recommendations for dosage adjustment for elderly patients, other than those indicated in the section "Method of administration and dose".

Dysfunction of the liver

The excretion of iopromide does not have an effect of impaired liver function, since only about 2% of the dose is excreted through the intestine, and iopromide not metabolized.No dosage adjustment is required for patients with hepatic insufficiency.

Renal impairment

Because the iopromide is excreted by the kidneys in practically unchanged form, in patients with renal insufficiency, its excretion takes longer than usual.

To reduce the risk of additional renal dysfunction caused by radiopaque, patients with a history of renal insufficiency should use the lowest possible dose.

Side effects:

The most frequent adverse adverse reactions (NAD) (≥ 4%) in patients receiving the drug were headache, nausea and vasodilation.

The most serious NDP were: anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal edema, pharyngeal edema, bronchial asthma, coma, cerebral infarction, stroke, cerebral edema, convulsions, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction, heart failure, bradycardia, cyanosis, lowering of arterial pressure, shock, dyspnea, pulmonary edema, respiratory failure and aspiration.

The adverse reactions reported in connection with the use of the drug are shown in the table. The frequency is defined as Often (≥1/10), often (from ≥1/100 up to <1/10), infrequently (from ≥1/1 000 up to <1/100), rarely (from ≥1/10000 up to <1/1000), rarely (<1/10 000).

For additional NDPs detected only during post-marketing observations and for which an estimate of incidence was not possible, "frequency is unknown" is indicated.

System of organs	Often	Infrequently	Rarely	Frequency unknown
Immune system disorders		Hypersensitivity reactions / anaphylactoid reactions (anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal / pharyngeal edema, facial swelling of the tongue, laryngeal / pharyngeal spasm, bronchial asthma, conjunctivitis, lacrimation, sneezing, cough, mucosal edema, rhinitis, hoarseness, sore throat, urticaria, itching, angioedema)
Disorders from the endocrine system				Thyrotoxic crisis, thyroid dysfunction
Disorders of the psyche			Anxiety
Disturbances from the nervous system	Dizziness, headache, dysgeusia	Vasovagal reactions, confusion, anxiety, paresthesia / hypersensitivity, drowsiness		Coma , cerebral ischemia / infarct , stroke , cerebral edema^a, convulsions *, short-term cortical blindness^a, loss of consciousness, agitation, amnesia, tremor, speech disorders, paresis / paralysis
Disturbances on the part of the organ of sight	Blurred vision / vision impairment
Hearing disorders and labyrinthine disorders				Hearing Impairment
Heart Disease	Pain / discomfort in the chest	Arrhythmia*	Stop hearts , ischemia myocardium , sensation palpitation	Myocardial infarction , heart failure , bradycardia , tachycardia, cyanosis
Vascular disorders	Increased blood pressure, vasodilation	Lowering arterial pressure *		Shock*, thromboembolism, vasospasm
Disturbances from the respiratory system, chest and mediastinal organs		Dyspnea*		Pulmonary edema , respiratory failure aspiration *
Disturbances from the liver and bile ducts	Vomiting, nausea	Abdominal pain		Dysphagia, an increase in the salivary glands, diarrhea
Disturbances from the skin and subcutaneous tissues				Bullous skin diseases (including Stevens-Johnson syndrome or Lyell's syndrome), rash, erythema, hyperhidrosis
Disturbances from musculoskeletal and connective tissue				Compartment syndrome in the case of extravasation^a
Disorders from the kidneys and urinary tract				Renal impairment^a , acute renal failure^a
General disorders and disorders at the site of administration	Pain, reactions at the injection site (various types, for example, pain, sensation of heat, swelling, inflammation and soft tissue damage in the case of extravasation, a feeling of heat)	Edema		Malaise, chills, pallor
Laboratory and instrumental data indicators				Changes in body temperature

* Cases of a life threat and / or with a lethal outcome are marked,

^a only with intravascular application.

In addition to the NDPs listed above, the following NDPs were observed in ERCPH: increased activity of pancreatic enzymes and pancreatitis with an unknown frequency.

Most of the reactions when introduced into the body cavity arose several hours after the administration.

Overdose:

In the study of acute toxicity in animals, there was no risk of acute intoxication after application of iopromide.

Intravascular administration

Symptoms: may include disturbance of the water-electrolyte balance, the development of renal failure, complications of the cardiovascular system and lungs.In case of an unintentional overdose with intravascular injection, it is necessary to monitor the volume of fluid, the content of electrolytes, the function of the kidneys.

Treatment: should be aimed at maintaining life important functions organism. Yopromide can be removed from the body by hemodialysis.

Interaction:

Biguanides (metformin): in patients with renal insufficiency or severe chronic kidney disease, elimination of biguanides can be reduced, which leads to their accumulation and development of lactic acidosis. To prevent this complication, you should stop taking biguanides 48 hours before the radiopaque test and do not resume it for at least 48 hours after the radiocontrast injection. Resume their reception should only after the restoration of kidney function. Since the use of yopromide can lead to acute renal failure or its amplification, patients receiving metformin, may have an increased risk of developing lactic acidosis, especially with acute renal insufficiency in the anamnesis.

Interleukin-2: nIn the previous treatment with interleukin-2 (within a few weeks), the risk of developing delayed reactions with iopromide is increased.

Radioisotopes: within a few weeks after the administration of yopromide, there is a decrease in the absorption of thyroid-stimulating isotopes by the thyroid gland, which reduces their effectiveness for the diagnosis and treatment of thyroid diseases.

It should be borne in mind that patients receiving beta-blockers, may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-adrenergic effect.

Simultaneous application antipsychotics and antidepressants can reduce the convulsive threshold, increasing the risk of reactions associated with the use of radiopaque.

Special instructions:

Hypersensitivity

Sometimes, after using non-ionic radiopaque agents such as yopromide, anaphylactoid reactions or hypersensitivity reactions or other manifestations of idiosyncrasy from the side of the cardiovascular, respiratory systems and skin are observed. Usually, these reactions, the severity of which can be mild to severe, including the development of shock, occur within 30 minutes after the administration of radiopaque.However, in rare cases, deferred reactions (from hours to days) may develop.

The risk of developing hypersensitivity reactions is higherin the following cases:

- in the presence of previously existing reactions to iodine-containing radiopaque agents,

- if there is an anamnesis of bronchial asthma or other allergic diseases.

In patients with known hypersensitivity to iopromide or any of its components, or with a previous hypersensitivity reaction to some other iodine-containing radiopaque agent, there is an increased risk of developing hypersensitivity reactions (including severe).

Nevertheless, such reactions are rare and unpredictable.

It should be borne in mind that patients taking beta-blockers may be resistant to the treatment of hypersensitivity reactions with drugs that have a beta-adrenergic effect.

In cases of development of severe hypersensitivity reactions, the consequences can be more serious and even lead to a fatal outcome.

In connection with the possibility of developing severe hypersensitivity reactions after the administration of the radiopaque means after the end of the procedure, it is necessary to observe the patient's condition.

In all cases, it is necessary to be prepared, if necessary, to provide emergency care to the patient.

It is recommended to consider the provision of glucocorticosteroid premedication to patients with bronchial asthma or other allergic diseases.

Thyroid dysfunction

Particularly careful weighing of the risk / benefit ratio follows in patients with established or suspected hyperthyroidism, since iodine-containing radiopaque agents can cause them to have hyperthyroidism or a thyrotoxic crisis. Consideration should be given to the need to evaluate thyroid function before administration of yopromide and / or prescribe thyreostatic therapy for preventive purposes in patients with established or suspected hyperthyroidism.

In newborns, especially preterm infants who received iopromide either through the mother during pregnancy or after childbirth, it is recommended to monitor the function of the thyroid gland, since exposure to excessive amounts of iodine can cause hypothyroidism, which may require treatment.

Diseases of the central nervous system

Patients with CNS diseases have an increased risk of neurologic complications due to the administration of yopromide.Neurological complications develop more often when carrying out cerebral angiography and related procedures.

Caution should be exercised in situations where there may be a lowered convulsive threshold, such as having a history of seizures and the concomitant use of certain medications.

Factors that increase the permeability of the blood-brain barrier, facilitate the penetration of radiopaque into the brain tissue, which can cause reactions from the CNS.

Hydration

Before and after intravascular injection of yopromide, adequate hydration should be provided to minimize the risk of contrast-induced nephrotoxicity. This is of particular importance for patients with multiple myeloma, diabetes, polyuria, oliguria, hyperuricemia, as well as for newborns, infants, young children, and elderly patients.

Fear

If there is a feeling of excitement, anxiety and pain, the risk of developing CPD or the intensity of these reactions caused by the radiopaque means may increase. Such patients require more careful observation. In some cases, they may need medication to reduce anxiety.

Conducting a preliminary test

The use of a small amount of radiopaque for carrying out the sensitivity test is not recommended, since it has no prognostic significance. Moreover, carrying out such testing alone can lead to serious and even fatal hypersensitivity reactions.

Renal damage

Nephrotoxicity caused by radiopaque means, which is a transient impairment of kidney function, may occur after intravascular injection of iopromide. In rare cases, acute renal failure may develop.

Risk factors include, for example:

- renal insufficiency;

- dehydration;

- diabetes;

- multiple myeloma / paraproteinaemia;

- repeated and / or large doses of iopromide.

Adequate hydration should be provided in all patients when administered with iopromide. Patients on dialysis can be administered iopromide with a diagnostic purpose, since the iodine-containing radiopaque can be removed from the body by dialysis.

Cardiovascular diseases

In patients with severe heart disease or severe coronary artery disease, the risk of clinically significant changes in hemodynamics and arrhythmia is increased.

Intravascular injection of radiocontrast can cause pulmonary edema in patients with heart failure.

Pheochromocytoma

In patients with pheochromocytoma, there is a risk of developing a hypertensive crisis.

Myasthenia gravis

The introduction of iodine-containing radiopaque means may increase the severity of symptoms of myasthenia gravis gravis.

Thrombogenicity

One of the properties of nonionic radiopaque means is their low ability to influence the normal physiological functions of the body. That is why non-ion radiopaque agents have less anticoagulant activity in vitro, than ionic ones. A number of factors, in addition to the properties of the radiopaque agent itself, such as the duration of the study, the number of injections, the properties of the catheter and the syringe, the state of the disease and the treatment being administered, can influence the development of thromboembolism. Therefore, during the catheterization of the vessel it is necessary to take into account these factors and pay special attention to the performance of the technique of angiography,and also to wash the catheter with 0.9% solution of sodium chloride (if necessary with the addition of heparin) and to minimize the timing of this procedure, in order to minimize the risk of thrombosis and embolism.

Diet suggestions

You can adhere to the usual diet, but in the last 2 hours before the study should refrain from eating.

Solution for injection 370 mg iodine / ml: has special advantages in the conduct of angiocardiography.

Effect on the ability to drive transp. cf. and fur:

It is not recommended to drive vehicles or work with any other mechanisms during the first 24 hours after the administration of the drug.

Form release / dosage:

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

Packaging:

For the concentration of 300 mg iodine / ml: 20, 50 or 100 ml in neutral colorless glass bottles (class I), sealed with rubber stoppers, rolled aluminum caps with plastic covers of the first opening. Each label is labeled. Each bottle is equipped with an applicator (over the label) made of transparent plastic with a die-cutting, which allows to fix the bottle on a tripod.For 10 vials along with the instructions for use are placed in a cardboard box.

For the concentration of 370 mg iodine / ml: 30, 50 or 100 ml in neutral colorless glass bottles (class I), sealed with rubber stoppers, rolled aluminum caps with plastic covers of the first opening. Each label is labeled. Each bottle is equipped with an applicator (over the label) made of transparent plastic with a die-cutting, which allows to fix the bottle on a tripod. For 10 vials along with the instructions for use are placed in a cardboard box.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 FROM.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003696

Date of registration:21.06.2016

Expiration Date:21.06.2021

The owner of the registration certificate:ALVILS, LTD. ALVILS, LTD. Russia

Manufacturer: & nbsp

Daewon Pharmaceutical Co. Ltd The Republic of Korea

Representation: & nbspAlvils, OOOAlvils, OOO

Information update date: & nbsp29.11.2017

Illustrated instructions

Instructions

Yopromide-Biarvist (Iopromide)