ULTRAVYST

Active material: Yopromyd
When ATH: V08AB05
CCF: Nonionic radiopaque diagnostic drug for intravascular, intracavitary and subarachnoid administration
ICD-10 codes (testimony): Z03
When CSF: 30.02.01.04
Manufacturer: BAYER SCHERING PHARMA AG (Germany)

Pharmaceutical form, composition and packaging

Solution for injection clear, free of foreign particles.

1 ml
iopromide499 mg,
that corresponds to the content of iodine240 mg
osmolality at 37°C – 0.48 eight / kg N2ABOUT
viscosity at 20 ° C – 4.9 mPa × s, at 37 ° C – 2.8 mPa × s
density at 20 ° C – 1.263 g / ml, at 37 ° C – 1.255 g / ml
pH value 6.5-8.0

Excipients: sodium calcium edetate, trometamol, hydrochloric acid, water d / and.

10 ml – glass bottles (10) – packs cardboard.
50 ml – glass bottles (10) – packs cardboard.

Solution for injection clear, free of foreign particles.

1 ml
iopromide623 mg,
that corresponds to the content of iodine300 mg
osmolality at 37°C – 0.59 eight / kg N2ABOUT
viscosity at 20 ° C – 8.9 mPa × s, at 37 ° C – 4.7 mPa × s
density at 20 ° C – 1.328 g / ml, at 37 ° C – 1.322 g / ml
pH value 6.5-8.0

Excipients: sodium calcium edetate, trometamol, hydrochloric acid, water d / and.

10 ml – glass bottles (10) – packs cardboard.
20 ml – glass bottles (10) – packs cardboard.
50 ml – glass bottles (10) – packs cardboard.
100 ml – glass bottles (10) – packs cardboard.

Solution for injection clear, free of foreign particles.

1 ml
iopromide769 mg,
that corresponds to the content of iodine370 mg
osmolality at 37°C – 0.77 eight / kg N2ABOUT
viscosity at 20 ° C – 22 mPa × s, at 37 ° C – 10 mPa × s
density at 20 ° C – 1.409 g / ml, at 37 ° C – 1.399 g / ml
pH value 6.5-8.0

Excipients: sodium calcium edetate, trometamol, hydrochloric acid, water d / and.

30 ml – glass bottles (10) – packs cardboard.
50 ml – glass bottles (10) – packs cardboard.
100 ml – glass bottles (10) – packs cardboard.

 

Pharmacological action

Non-ionized, low-osmolarity triiodinated radiopaque agent, which increases the contrast of the image due to the absorption of X-rays by iodine, its members.

 

Pharmacokinetics

Distribution

Iopromide after intravascular administration is very quickly distributed in the intercellular space.

T1/2 in the distribution phase is 3 m.

Plasma protein binding at concentration 1.2 mg iodine / ml is 0.9 ± 0.2%. Ultravist® does not penetrate the intact BBB, but in a small amount passes through the placental barrier.

Through 1-5 min after bolus IV administration of Ultravist® 300 mg / ml in blood plasma is found 28 ± 6% of the administered amount, regardless of the dose. After insertion under the meninges Cmax iodine in plasma is 4.5% from the administered dose and is observed through 3.8 no.

Metabolism

No metabolites detected.

Deduction

T1/2 in patients with normal renal function is approximately 2 h regardless of dose. When used in doses, recommended for diagnostic purposes, the drug is excreted from the body by glomerular filtration. Through 30 minutes after the drug is administered by the kidneys, approximately 18% of the administered dose, through 3 no – 60%, and through 24 no – 92%. Overall clearance when using low (150 mg iodine / ml) and high (370 mg iodine / ml) dose is 110 ml / min 103 ml / min, respectively.

After lumbar myelography Ultravist® almost completely excreted by the kidneys for 72 no.

Pharmacokinetics in special clinical situations

In patients with end-stage renal disease, nonionic contrast media can be eliminated by dialysis.

Liver dysfunction does not affect the elimination of the drug Ultravist®, since for 3 day with feces only 1.5% of the administered dose.

 

Testimony

The drug is for diagnostic use only..

- enhancement of image contrast during computed tomography (CT), arteriography and venography (including intravenous / intra-arterial digital subtraction angiography / CSA /), iv urography, endoscopic retrograde cholangiopancreatography (ERKhP), arthrography and studies of other body cavities.

Solution for injection 240 mg iodine / ml is also intended for the study of the subarachnoid space.

Solution for injection 370 mg iodine / ml has special advantages for angiocardiography.

Solutions for injections 300 mg iodine / ml and 370 mg iodine / ml is not recommended for studies of the subarachnoid space.

 

Dosage regimen

Before use, the injection solution should be warmed up to body temperature.

Before administration, you should carefully inspect the bottle.. In case of violation of the integrity of the bottle, significant color change, if visible particles are detected, the drug should not be used.

To inject a contrast medium solution, an automatic injector or other special instruments must be used while maintaining sterility. Recruit Ultravist® in a syringe or infusomat should be immediately before administration.

Do not make more than one puncture of the rubber stopper to avoid getting a large amount of microparticles into the prepared solution from the cork. Therefore, it is recommended to use cannulas with long tips with a diameter of no more than 18 G (marked cannulas with a side opening, type Nocore-Admix are best suited).

The drug solution unused after opening the bottle should be destroyed.

Intravascular administration

Intravascular administration of contrast media, if possible, it is better to exercise when the patient is lying down.

In patients with severe renal and cardiovascular insufficiency, and in general poor condition, the dose of contrast agent should be as low as possible. In such patients, it is recommended to monitor renal function for, at least, 3-x days after examination.

The contrast agent dose should be age appropriate, body weight, solved clinical problem and research methodology.

Doses, given below, should only be considered as recommended; they represent the usual doses for an average adult with body weight 70 kg. Dose values ​​are expressed in ml for a single injection or per kg of body weight.

Usually, doses up to 1.5 g iodine / kg bw is generally well tolerated. Between individual injections, the body should be given sufficient time for fluid to leave the interstitial space to normalize increased serum osmolality. If necessary, in some cases, exceed the total dose 300-350 ml in adults, shows the introduction of water and, perhaps, electrolytes.

The following doses are recommended for single injections.

Conventional angiography

Study typeUltravist® (iodine concentration mg / ml)Dose (ml)
Aortic arch angiography30050-80
Selective angiography3006-15
Thoracic aortography300/37050-80
Abdominal aortography30040-60
Upper limb arteriography3008-12
Lower limb arteriography30020-30
Angiocardiography of the ventricles of the heart37040-60
Coronary angiography3705-8
Upper limb venography24050-60
Lower limb venography24050-80

I / V digital subtraction angiography (CSA)

For CSA of large vessels in Adult use Ultravist® solutions for injection 300 mg iodine / ml and 370 mg iodine / ml in volume 30-60 ml. The drug is administered as a bolus at a rate 8-12 ml / s into the ulnar vein or at a rate 10-20 ml / s through the catheter into the vena cava. Time of contact with the wall of the vein contrast material can be reduced subject to rapid bolusni izotoniceski solution of sodium chloride directly after the introduction of Ultravist®.

Intra-arterial CZA

When conducting intraarterial CZA Unlike conventional angiography can enter smaller amounts of drug Ultravist® and its smaller concentrations.

CT scan (CT)

If possible, Ultravist® should be inserted into the vein bolusno using auto-injector. Only when there is a slow scanning about half the dose should be bolusno, and the remainder within 2-6 min to guarantee relatively constant concentrations of the drug in the blood.

Spiral CT and multi-slice CT in particular allows you to receive a large amount of data in a single breath-hold. To obtain the optimum diagnostic effects of/in bolus-based (80-150 ml Ultravist® as a solution for injection 300 mg iodine / ml) in the survey area (peak, time and duration of contrast) We recommend that you use automatic Injector and control from the start time of the introduction of contrast prior to scanning tools.

Whole body CT

The required dose contrast means and speed their introduction depends on the subject body, solved problems and diagnostic, particularly from differences in scanning and duration of image reconstruction.

CT SCANS of the skull

Adults assign the following doses.

Ultravist® injection 240 mg iodine / ml: 1-2.5 ml / kg body weight.

Ultravist® injection 300 mg iodine / ml: 1-2 ml / kg body weight.

Ultravist® injection 370 mg iodine / ml: 1-1.5 ml / kg body weight.

In/in urografia

In connection with the weak ability to concentrate physiologically immature kidneys nefronov from children requires relatively high dose contrast means.

The recommended dose of Ultravist®.

AgeThe amount of iodine
(g / kg body weight)
Ultravist® (ml / kg body weight)
240 mg iodine / ml300 mg iodine / ml370 mg iodine / ml
Newborns (< 1 Months)1.2543.2
1 month-2 year14.232.7
Children (2-11 years)0.52.11.51.4
Teenagers and adults0.31.310.8

Optionally, in some cases, adults may increase doses.

The dates of performance of the images after injection of Ultravist® 300 mg iodine/ml and Ultravist® 370 mg iodine/ml when the length of the introduction 1-2 m (3-5 min in the case of Ultravist injection® 240 mg iodine / ml) make up for renal parenchyma 3-5 m (5-10 min in the case of Ultravist injection® 240 mg iodine / ml), and to visualize the renal pelvis dilatation system and ureters – 8-15 m (12-20 min in the case of Ultravist injection® 240 mg iodine / ml) After the beginning of the introduction of contrast agent.

The younger the patient, the earlier snapshot. Typically, you should do the first shot through 2-3 min after injection of contrast tools. In Newborn, infants and patients with compromised renal function taking pictures at a later date can improve visualization of urinary tract.

Introduction under the meninges

Dose for Adult depend on solving clinical problems, method and field survey.

If you have a hardware, allows to register the image in all projections without repositioning the patient's body and in imposing contrast means under rentgenoskopičeskim control, may be less sufficient diagnostic drug.

Myelography

Ultravist® 240 mg iodine/ml appointed dose to 12.5 ml. Maximum dosage of Ultravist® 240 mg iodine / ml (12.5 ml) corresponds to the total dose of iodine 3 and g It should not be exceed for a study.

After researching the contrast tool should send in the lumbar region, that is achieved by giving the patient prâmosidâčego status or raising the head at 15° from level beds for at least 6 no.

In children the safety and efficacy of Ultravist® When conducting mielografii not explored.

When introduced into the body cavities

At conducting arthrography., ERCP and hysterosalpingography Introduction contrast means must be carried out under the control of fluoroscopy.

Dose depends on the age of the, body weight, general condition of the patient, as well as solving clinical problems, used technical equipment and field survey.

At arthrography appointed 5-15 ml Ultravist® 240 mg iodine / ml, or Ultravist® 300 mg iodine / ml, or Ultravist® 370 mg iodine / ml.

At hysterosalpingography appointed 10-25 ml Ultravist® 240 mg iodine / ml.

At ERCP and study other cavities dose depends on solving clinical problems and the size of the womb structure.

 

Side effect

Side effects are usually mild, moderate and transient in nature and with the introduction of non-ionic means are less common, than imposing Ionic drugs. However, perhaps the most severe and life-threatening reactions, until the development of death.

The frequency of side effects was determined according to the following scale: often (≥1/100), infrequently (≥1/1000, but <1/100), rarely (<1/1000).

For all types of introduction

Allergic reactions: infrequently – hypersensitivity reactions, anaphylactoid reactions, hives, itch, rash, эritema; rarely – anaphylactic shock (including fatal cases), Vascular edema, muco-cutaneous syndrome (eg, Stevens-Johnson syndrome or Lyell's syndrome).

On the part of the endocrine system: rarely – changes in thyroid function, thyrotoxic crisis.

From the central and peripheral nervous system: often – headache; infrequently – dizziness, anxiety; rarely – paraesthesia, giposteziya, confusion, fear, excitation, amnesia, speech disorder, drowsiness, loss of consciousness, coma, tremor, convulsions, paresis, paralysis, cerebral ischemia, stroke, passing cortical blindness.

On the part of the organ of vision: infrequently – blurred vision, visual impairment; rarely – conjunctivitis, lacrimation.

On the part of the organ of hearing: rarely – hearing disorder.

Cardio-vascular system: infrequently – arrhythmia, vasodilation; rarely – palpitations, chest pain, feeling of tightness, bradycardia, tachycardia, cardiac arrest, heart failure, myocardial ischemia, infarct, cyanosis, increase or decrease in blood pressure, shock, vasospasm, thromboembolism.

The respiratory system: infrequently – chikhaniye, cough; rarely – rhinitis, breathlessness, swelling of the mucous membranes, bronchial asthma, disfonija, laryngeal edema, throat, language, person, bronchospasm, spasm of the larynx/throat, pulmonary edema, respiratory insufficiency, respiratory arrest.

From the digestive system: often – nausea; infrequently – vomiting, taste disturbance; rarely – throat irritation, dysphagia, swelling of the salivary glands, stomach ache, diarrhea.

From the urinary system: infrequently – impairment of renal function; rarely – acute renal failure.

From the body as a whole: often – feeling of warmth or pain; infrequently – malaise, chills, increased perspiration, fainting; rarely – paleness, changes of body temperature.

Local reactions: rarely – edema, local pain, a slight fever and swelling, inflammation and tissue damage in case of èkstravazal′nogo introduction.

When injected under the shell of the brain

In addition to the side effects, listed earlier, with the introduction of non-ionic contrast media under the brain shell, the following undesirable effects.

Often: neuralgia, meningism.

Infrequently: strangury.

Rarely: paraplegia, psychosis, aseptic meningitis, EEG changes, backache, pain in the extremities, pain at the injection site.

ERKhP

In addition to the undesirable effects when performing ERCP often can raise the level of pancreatic enzymes, rarely – the development of pancreatitis.

 

Contraindications

Absolute contraindications.

Carefully

The following warnings and precautions apply to all ways of introducing contrast tools, but the risk is higher when it is marked vnutrisosudistom introduction:

- Hypersensitivity, especially if you have severe cardiovascular disease;

- Thyroid dysfunction;

- Elderly patients;

-a serious condition of patient.

Intravascular administration

Renal

Nephrotoxicity, called contrasting means, a transitory kidney function, may occur after injection of Ultravist®. In rare cases may develop acute renal failure.

Risk factors:

— prior renal failure;

- Degidratatsiya;

- Diabetes;

is multiple myeloma/paraproteinemia;

-introduction of Ultravist® repeated and/or large doses.

Cardiovascular diseases

In patients with severe heart disease or coronary artery lesion marked increased risk of clinically significant changes of hemodynamics and arrhythmias. In patients with diseases of the heart valve apparatus and pulmonary hypertension introduction contrast means can lead to pronounced hemodynamic violations. Reaction, including ischemic ECG changes and severe arrhythmias, most often found in older patients and in patients with cardiac pathology in history.

Introduction intravascular contrast can cause pulmonary edema in patients with heart failure.

Central Nervous System Diseases

In patients with a history of seizures or with other diseases of the CENTRAL NERVOUS SYSTEM may be increased risk of seizures or neurological complications in connection with the introduction of the drug Ultravist®.

Pheochromocytoma

In patients with a risk of hypertensive feohromotsytoma kriza. Recommended premedication Alpha adrenergic.

Patients with autoimmune diseases

Described instances of heavy vasculites was demonstrated or syndrome, like Stevens-Johnson Syndrome, in patients with a history of autoimmune diseases.

Myasthenia

The introduction of iodine-containing contrast material can increase the severity of symptoms of myasthenia.

Alcoholism

Acute or chronic forms of alcohol can increase the permeability of GEB. Facilitated the penetration of contrast agent in the brain tissue can lead to reactions by the CNS.

Introduction under the shell of the brain

The drug should be used with caution in patients with a history of convulsions, tk. they have an increased risk of seizures in connection with the introduction of the drug Ultravist® under the shell of the brain. You must have a ready means to treat cramps.

Introduction in other body cavities

Before the hysterosalpingography should be deleted pregnancy.

Inflammation of the bile duct or fallopian tubes can increase the risk of reactions after ERCP or hysterosalpingography.

 

Pregnancy and lactation

Appropriate well-controlled studies in pregnant women have not been. If pregnancy should avoid x-ray studies. The use of any x-rays with or without contrast tools must be carefully weighed against possible risks. At the same time, the results of animal studies indicate that the risk of the use of diagnostic jopromida the aim of people on the course of pregnancy, development of the embryo / fetus, childbirth and postnatal development.

Safety of Ultravist® in infants, breastfed, It has not been studied. Excretion Of Ultravist® in breast milk insignificant, unlikely, to represent a danger to infants.

 

Cautions

The patient should refrain from eating for 2 h before the test.

Before and after of vnutrisosudistogo Ultravist® or its introduction under the shell of the brain should consume adequate amounts of fluids, that is especially important for patients with multiple myeloma, diabetes, polyuria, hyperuricemia, as well as for infants, young children and elderly patients.

Infants (up to a year) and especially infants are sensitive to disturbance of electrolyte balance and hemodynamic disorders. Special attention should be paid to the dose contrast means, technical support of radiological research and State of patient.

Ultravist®, as nizkoosmolârnoe water-soluble contrast tool, is used in routine studies DIGESTIVE TRACT in neonates, infants and older children due to the fact, that this category of patients have an increased risk of aspiration, intestinal obstruction and penetration of the gut lumen radiopaque in abdominal cavity.

When you have the State of excitement, the fear and the pain may increase the risk of side effects or intensity of reactions, caused by a cold remedy. You can assign such patients sedation.

Contrast tool, warmed to body temperature before the introduction, better tolerated and it's easier to enter due to lower viscosity solution. Preheat thermostat up to 37° c only the quantity of the drug, that presumably will be used.

Use a small amount of contrast tools to test for sensitivity is not recommended, tk. He has no prognostic value. Furthermore, such testing may lead to severe side reactions.

Sometimes after applying non-ionic radiopaque means there are allergopodobnye hypersensitivity reactions or other manifestations of idiosyncrasy from the circulatory, the respiratory system and skin. Typically, these reactions, the severity of which can vary from moderate to severe, including shock, occur within one hour after injection of contrast tools. However, in rare cases can develop delayed reactions (from hours to days).

In patients with a known hypersensitivity to Ul′travistu® or any of its components or to the previously occurring hypersensitivity reaction to any other jodsoderžaŝemu some means, There is an increased risk of hypersensitivity reactions (incl. severe reactions; However, such reactions are rare and unpredictable), that requires especially carefully weigh the risk/benefit ratio.

The risk of developing allergic reactions also increases with a history of asthma or other allergic diseases.

In patients with severe cardiovascular disease have an increased risk of developing severe or even fatal side effects.

With regard to the possibility of developing heavy gipercuvstvenosti reactions after injection of contrast means after the end of the procedure, you must monitor the patient.

In all cases, requires a willingness to provide, if required, the emergency patient.

When an gipercuvstvenosti reactions introduction contrast means should cease immediately and if necessary start adequate therapy, preferably in/in. So for the on/in the introduction of contrast means it is advisable to use a flexible catheter. In urgent cases to be able to take emergency measures, You must have ready the appropriate medicines, intubacionnuû endotracheal tube and apparatus for mechanical ventilation. It should be taken into account, patients, receiving beta-adrenoblokatora, can be resistant to treatment gipercuvstvenosti reactions drugs, having beta-agonist activity. There is a need for caution in the use of iodinated contrast media in patients, receiving beta-blockers.

When carrying out then it is recommended to use GKS.

Especially carefully weigh the risk/benefit ratio should be in patients with established or suspected hyperthyroidism or goiter, tk. iodized contrast media can cause hyperthyroidism or tireotoksicski Kriz. Consideration should be given to the need to assess thyroid function prior to injection of Ultravist® and/or assign preventative tireostatičeskuû therapy in patients with established or suspected hyperthyroidism.

Vascular pathology and neurological disorders, usually available in the elderly, increase the risk of adverse reactions to iodized contrast media.

Seek conducting the study should be carefully evaluated in patients with severe general condition.

All patients, which impose Ultravist®, should ensure adequate hydration prior to the introduction of contrast means preferably using intravascular infusions before and after the procedure, While the contrast tool will not receive kidneys.

Before deducing contrast means the kidneys to exclude additional load on the kidneys in the form of nefrotoksicskih medicines, oral holecistografičeskih funds, blood limits blood flow to the kidneys, Angioplasty of the renal arteries, extensive surgical interventions.

Should defer new research with the introduction of contrast means to restore the kidney to its original level.

Patients, dialysis, input contrast media removed from the body during dialysis.

The presence of intracranial tumors or metastases, as well as epilepsy, can increase the frequency of convulsive episodes after the introduction of the contrasting preparation. Neurological complications tend to occur when conducting such research or cerebral angiography.

You must be careful when conducting research in patients with alcohol and drug abuse in connection with the possibility of lowering the convulsant threshold.

One of the properties of non-ionic contrast is their extremely low impact on the normal physiological functions of the body. This is why non-ionic contrast media have less Anticoagulant activity in vitro, than Ionic. A number of factors, In addition to the properties of the contrast tool, such as duration of studies, the number of injections, properties of the catheter and syringe, stage of disease and treatment, may influence the development of thromboembolic complications. A catheterization of vessel must take these factors into account and to pay increased attention to the technology angiography, as well as washed catheter saline solution (If necessary, with the addition of heparin) and shorten the timing of this procedure, to minimize the risk of thrombosis and embolism.

Use plastic syringes instead of glass can reduce the, but does not eliminate the chance of blood coagulation in vitro.

There is a need for caution when examining patients with gomocistinuriej due to the risk of thrombosis and embolism.

The majority of adverse reactions after mielografii develops within a few hours after the injection of contrast tools. During this period, you should monitor the patient. Patients with epilepsy in history, or receiving protivosudorojnuu therapy, should continue treatment relevant drugs during the study with the introduction of contrast means under the shell of the brain.

There is a need for caution when examining patients with alcohol and drug abuse in connection with the possibility of lowering the convulsant threshold.

After the more mielografii patient moves or straining your muscles after injection of contrast tools, the sooner it is mixed with the body fluids of other areas, non-target area. As a consequence, the density contrast decreases faster than usual.

To exclude the discomfort, caused by loss of spinal fluid, the patient will need to rest for about 18 no. During this period, you must pay attention to the possibility of adverse reactions. Patients with low threshold sudorojna activity must be located under especially close supervision for a few hours.

 

Overdose

In the study of acute toxicity in animals have not been identified in the risk of acute intoxication after application of Ultravist®.

Intravascular administration

Symptoms: Perhaps the balance of fluids and electrolytes, renal failure, complications from the circulatory system and light.

Treatment: There is a need to control the level of liquids, electrolytes, renal function. Treatment of overdose should be aimed at the maintenance of the vital functions of the body. Ultravist® may be removed from the body via dialysis. In the case of erroneous dose exceeded vnutrisosudistom introduction of the drug in the human body, You must compensate for the loss of water and electrolytes through an infusion. It is necessary to carry out the monitoring of renal function during not less than 3 days.

If necessary, it can be used to derive the main part of the hemodialysis contrast material from the human body.

Introduction under the shell of the brain

May develop serious neurological complications. It is recommended that you carefully monitor the condition of the patient.

To prevent a large number of drug Ultravist® in the ventricles of the brain as possible should be made complete aspiration contrast agent. In the case of erroneous overdose with the introduction of the drug under the shell of the brain, You must carefully follow manifestations expressed violations of the CENTRAL NERVOUS SYSTEM is no less than during the first 12 no. Such signs may be mounting increased reflexes or tonico-clauniceskie cramping muscles, in severe cases – generalized seizures, hyperthermia, stupor and respiratory depression.

 

Drug Interactions

Patients, taking biguanides, When a drug vnutrisosudistom Ultravist® possible cumulation biguanide and development laktacidoza. To prevent this complication, discontinue use of biguanide for 48 h to conduct x-ray contrast study and not to renew it for at least 48 h after injection of contrast tools. Resume their admission should be only after the restoration of the kidney.

Simultaneous use of Ultravist® and Neuroleptics and antidepressants may reduce sudorozhny threshold, increasing the risk of reactions, associated with the use of contrast tools.

Patients, receiving beta-adrenoblokatora, may be resistant to drugs, having beta-agonističeskim action, applied for the treatment of hypersensitivity reactions.

Delayed reaction (eg, fever, rash, symptoms, resembling the flu, joint pain and itching) When using contrasting substances more commonly seen in patients, receiving interleukin in.

Within a few weeks after injection of Ultravist® There is a decrease(reduction) absorb the isotope thyroid tireotropnyh, that reduces their effectiveness for the diagnosis and treatment of thyroid diseases.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored in the dark and x-rays, inaccessible to children at temperature not exceeding 30 ° C. Shelf life – 3 year.

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