Omniscan - Instructions For Using A Contrast Agent, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Omniscan

Omniscan: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Omniscan

ATX code: V08CA03

Active ingredient: gadodiamide (Gadodiamide)

Manufacturer: GE Healthcare AS (Norway); GE Healthcare Ireland (Ireland)

Description and photo update: 2019-14-10

Prices in pharmacies: from 14524 rubles.

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Omniscan is a contrast diagnostic drug used in magnetic resonance imaging (MRI) to enhance image contrast.

Release form and composition

The drug is available in the form of a solution for intravenous (iv) administration: colorless or slightly yellowish transparent liquid (10, 15, 20 ml in glass vials without color, in a cardboard box 10 vials; 10, 15, 20 ml in syringes from transparent polymer, in a cardboard box 1 syringe, in a cardboard box 10 packs of syringes. Each pack also contains instructions for the use of Omniscan).

1 ml of solution contains:

• active substance: gadodiamide - 287 mg (0.5 mmol);
• auxiliary components: sodium caldiamide, 1 M hydrochloric acid solution or 1 M sodium hydroxide solution, water for injection.

Pharmacological properties

Pharmacodynamics

Omniscan is a paramagnetic contrast agent. Its active ingredient, gadodiamide, has the ability to enhance contrast in MRI scans. This is due to the effect on the T1-relaxation time of protons, as a result of which the signal intensity increases and thereby improves the contrast during MRI studies.

Intravenous administration of Omniscan provides improved visualization of lesions and pathological structures both in the central nervous system (CNS) and in other parts of the body. In case of disturbances in the functioning of the blood-brain barrier, the contrast of the image of changes and foci with pathological vascularization in the intracranial lesions (brain), in the spine and adjacent tissues, the chest area, the pelvic cavity and the retroperitoneal space improves. The use of the drug helps to establish the degree of invasiveness, improving the definition of the tumor boundaries.

Signal amplification does not occur in all pathological processes, therefore Omniscan is recommended to be used for differential diagnosis of healthy and diseased tissues in order to detect pathological foci, and after an appropriate course of treatment - to differentiate the tumor from tumor recurrence and scar tissue.

The degree of contrast enhancement depends on the type of tissue / pathological process, the optimal effect is usually observed within the first minutes after administration.

Pharmacokinetics

After administration of the solution, the drug is rapidly distributed in the extracellular fluid. The volume of distribution corresponds to the volume of extracellular fluid.

It does not bind to blood plasma proteins.

Does not cross the intact blood-brain barrier.

Gadodiamide is not metabolized.

The half-life is about 4 minutes, the half-life (T _1/2) is about 70 minutes. It is excreted through the kidneys through the glomerular filtration process. After IV administration, about 85% of the administered gadodiamide is found in the urine after 4 hours, and up to 95–98% after 24 hours.

In severe renal dysfunction with creatinine clearance (CC) less than 30 ml / min, T _1/2 is lengthened in proportion to the degree of filtration rate decrease. Hemodialysis can be used to remove gadodiamide.

Renal and total clearance rates are almost identical and are typical of substances that are completely excreted by glomerular filtration.

After the administration of gadodiamide at a dose of 0.1 or 0.3 mmol per 1 kg of patient weight (mmol / kg), no changes in the kinetics dependent on the dose of Omniscan were detected.

Indications for use

Omniscan can be used only for diagnostic tests of the following nature:

• MRI of the brain and spinal cord in patients over 1 month of age;
• contrasting of the whole body in patients over 6 months of age, including MRI of the head and neck, chest (including the heart), mammary glands in women, abdominal cavity (including liver, pancreas), pelvic organs (including bladder, prostate gland), retroperitoneal space (including kidneys), musculoskeletal system, limbs;
• MR angiography in adults;
• MRI of the heart to assess coronary artery disease (coronary artery disease) by imaging under myocardial perfusion (exercise or at rest and delayed study with contrast enhancement), as well as to detect and localize coronary artery disease or distinguish between ischemia and infarction sites in patients with established or suspected coronary artery disease …

Contraindications

Absolute:

• severe renal dysfunction (CC less than 30 ml / min);
• acute renal failure;
• children's age up to 1 month of life, with contrasting the whole body - up to 6 months of life;
• hypersensitivity to the components of the drug.

In addition, the drug is contraindicated in patients undergoing or awaiting liver transplantation.

It is recommended to use Omniscan with caution in case of impaired renal function (CC 30-59 ml / min), liver failure, anemia (especially sickle cell and hemolytic anemia), hemoglobinopathy, bronchial asthma, allergies, epilepsy, brain diseases, a history of indications of the development of adverse events with the introduction of a radiopaque substance (except for allergic reactions), during pregnancy and lactation, in childhood from 1 to 12 months, with contrasting the whole body - from 6 to 12 months, in old age.

Omniscan, instructions for use: method and dosage

Omniscan contrast agent is intended for intravenous bolus administration.

You should not eat 2 hours before the procedure, no other special preparation is required.

It is necessary to visually examine the condition of the vial or syringe for the absence of violations of their integrity, mechanical impurities and color changes of the solution. The intake of the solution into the syringe is carried out immediately before the procedure. After injection, 5 ml of 0.9% sodium chloride solution can be passed through the IV catheter, this will ensure the introduction of the full dose.

The required dose is administered by a single injection, except for cardiac MRI, when two injections are required to study perfusion at rest and during exercise. It is recommended that the injection for cardiac MRI be performed using an injector with a contrast medium delivery rate of up to 8 ml per second (ml / sec).

When Omniscan is introduced, the patient should be in a horizontal position. Within half an hour after the end of the procedure, his condition must be carefully monitored. This will allow timely identification of possible symptoms of adverse reactions, most of which appear during this period.

When prescribing Omniscan to children aged 1 to 12 months, with contrasting the whole body - from 6 to 12 months, or patients with moderate renal impairment (CC 30–59 ml / min), it is necessary to carefully compare the potential risks and benefits. The applied dose should not exceed 0.1 mmol / kg of body weight, and the drug can be re-administered no earlier than after 7 days.

Magnetic resonance imaging under conditions of contrast enhancement begins in accordance with the study protocol and, depending on the pulse mode used, shortly after administration of the contrast medium. It should be borne in mind that after injection, the optimal image enhancement is observed after a few minutes and usually lasts for the next 45 minutes. When enhancing contrast with Omniscan, the use of T1-weighted pulse trains is considered optimal. In the range of used magnetic field strengths of tomographs, which is from 0.15 to 1.5 Tesla, the dependence of the image contrast on the magnitude of the device field has not been revealed.

Recommended dosage:

• CNS study in adults and children older than 1 month of life: with a body weight of less than 100 kg - at the rate of 0.2 ml (equivalent to 0.1 mmol) per 1 kg of body weight (ml / kg), with a weight of more than 100 kg - 20 ml of solution. If brain metastases are suspected in adult patients weighing less than 100 kg, a dose of 0.6 ml / kg (0.3 mmol / kg) is indicated, with a body weight of more than 100 kg, the dose is usually 60 ml. With a fuzzy image against the background of the introduction of Omniscan at a dose of 0.2 ml / kg, after 1/3 hour, a second injection of the drug is carried out at a dose of 0.4 ml / kg (equivalent to 0.2 mmol / kg);
• whole body study in adults: with a body weight of less than 100 kg - 0.2 or 0.6 ml / kg (0.1 or 0.3 mmol / kg); with a body weight of more than 100 kg - 20 ml, in some cases - 60 ml;
• whole body examination in children over 6 months of age: 0.2 ml / kg (0.1 mmol / kg);
• MR angiography in adults: 0.2 ml / kg (0.1 mmol / kg). For additional diagnostic information, patients with stenosis of the abdominal and iliac arteries are shown to use higher doses, but not higher than 0.6 ml / kg (0.3 mmol / kg);
• study of ischemic heart disease in adults: to assess the perfusion of the heart, 2 separate injections are performed at a dose of 0.15 ml / kg (0.075 mmol / kg) with an interval of 10 minutes or more. The first dose is administered under conditions of pharmacological stress, the second at rest. A separate catheter should be used to inject drugs that cause pharmacological stress. To assess late enhancement, a total dose of 0.3 ml / kg (0.15 mmol / kg) is indicated.

The maximum dose with an average degree of impaired renal function (CC 30-59 ml / min) is 0.2 ml / kg (0.1 mmol / kg).

Side effects

Classification of adverse reactions by frequency of development: very common (≥ 10%); often (≥ 1% to <10%); infrequently (from ≥ 0.1% to <1%); rarely (from ≥ 0.01% to <0.1%); very rare (<0.01%, including individual messages); the frequency has not been established (it is impossible to assess the incidence of side effects based on the available data).

When using Omniscan on the part of systems and organs, the following side effects may occur:

• mental disorders: rarely - anxiety; frequency not established - mental disorders;
• nervous system: often - headache; infrequently - transient perversion of taste, dizziness, paresthesia; rarely - short-term perversion of smell, drowsiness, tremors, convulsions, development of status epilepticus; frequency not established - tinnitus, ataxia, loss of consciousness, impaired coordination of movements, deep coma;
• immune system: infrequently - allergic reactions of mucous membranes and skin, hypersensitivity reactions; rarely - anaphylactoid reactions, anaphylactic shock; frequency not established - idiosyncrasy (can occur over a period of time from several hours to several days after the administration of the solution);
• blood and lymphatic system: frequency not established - asymptomatic decrease in serum iron levels (within 8–48 hours after Omniscan administration);
• respiratory system, organs of the chest and mediastinum: rarely - cough, dyspnea; frequency not established - sore throat, sneezing, bronchospasm, shortness of breath;
• urinary system: rarely - the development of acute renal failure in patients with severe previous renal impairment; frequency not established - increase in serum creatinine;
• organ of vision: rarely - visual impairment;
• blood vessels: infrequently - skin redness;
• heart: frequency not established - tachycardia;
• gastrointestinal tract: often - nausea; infrequently - diarrhea, vomiting; frequency not established - belching, decreased appetite, abdominal pain;
• musculoskeletal and connective tissue: rarely - arthralgia; frequency not established - myalgia;
• dermatological reactions: infrequently - itchy skin; rarely - rash, urticaria, edema (including facial edema, angioedema); frequency not established - development of nephrogenic systemic fibrosis in patients with severe renal impairment;
• general disorders and disorders at the injection site: often - local soreness, a feeling of coolness, warmth or distention at the injection site; rarely - chest pain, fever, chills; the frequency has not been established - flushing of the skin of the face, sensations of heat, increased sweating.

Overdose

Symptoms of an overdose of Omniscan may be increased manifestations of adverse reactions.

When signs of overdose appear, symptomatic therapy is prescribed. For the rapid removal of the contrast agent from the body, the use of hemodialysis is indicated.

special instructions

Omniscan injections must be performed in an office with the necessary conditions for immediate intensive anti-shock therapy.

Before the procedure for administering a contrast agent, the patient must undergo electrocardiography, an examination to determine the concentration of creatinine in the blood serum and exclude pregnancy. Before conducting an MRI, the existing violations of the water-electrolyte balance should be eliminated, and a sufficient intake of fluid and electrolytes into the patient's body should be ensured. The state of water and electrolyte balance is especially important in the study of newborns, infants and young children, patients with diabetes mellitus, multiple myeloma, polyuria, gout, in old age.

It should be borne in mind that when using Omniscan, there may be no contrast enhancement of some types of neoplasms or non-contrasting plaques in atherosclerosis, therefore, this cannot be taken as unequivocal evidence of the absence of pathology. The presence or absence of contrast enhancement can be used for differential diagnosis.

The contents of the vial or disposable syringe are intended to be administered to one patient only. Unused residues of the drug must be disposed of.

For patients awaiting the procedure, sedation with sedatives is indicated to relieve fear.

During the first days after the administration of Omniscan, it is not recommended to use complex colorimetric methods to measure the concentration of calcium in the plasma, this is due to the effect of gadodiamide on the research results.

If the patient has epilepsy or brain damage, the increased risk of seizures during the study should be considered. Therefore, it is necessary to provide for the availability of drugs and appropriate equipment for the relief of seizures.

Influence on the ability to drive vehicles and complex mechanisms

The influence of Omniscan on the ability of patients to drive transport or work with machines and mechanisms has not been established.

Application during pregnancy and lactation

It is recommended to use Omniscan with caution during pregnancy and lactation.

During pregnancy, the use of the drug is allowed only in cases of extreme necessity, when the expected benefit to the mother from contrast enhancement during MRI exceeds the potential threat to the fetus.

Breastfeeding should be discontinued for a period of at least 24 hours after the administration of Omniscan.

Pediatric use

Omniscan contrast agent is contraindicated in children under 1 month of age.

It is required to be careful and strictly adhere to the recommendations for the use of the drug in children aged 1 to 12 months, when contrasting the whole body - from 6 to 12 months.

With impaired renal function

The use of Omniscan is contraindicated in severe renal dysfunction (CC less than 30 ml / min), acute renal failure.

The drug should be used with caution in patients with impaired renal function (CC 30–59 ml / min).

For violations of liver function

The use of Omniscan is contraindicated in patients undergoing or awaiting liver transplantation.

A contrast agent should be used with caution in patients with hepatic impairment.

Use in the elderly

Omniscan should be used with caution in elderly patients.

No dose adjustment is required for patients of this age category.

Drug interactions

The interaction of Omniscan with other drugs is not known.

A separate syringe must be used to inject the drug.

Analogs

Omniscan analogs are Gadodiamide, Gadodiamid-TL.

Terms and conditions of storage

Keep out of the reach of children.

Store at 2-30 ° C in a place protected from secondary X-rays and light.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Omniscan

There are currently no reviews about Omniscan.

Omniscan price in pharmacies

The price for Omniscan for a package containing 10 vials of 20 ml of solution can be from 27,143 rubles, 10 vials of 10 ml of solution - from 17,477 rubles.

Omniscan: prices in online pharmacies

Drug name Price Pharmacy

Omniscan 0.5 mmol / ml solution for intravenous administration 10 ml 10 pcs. RUB 14524 Buy

Omniscan 0.5 mmol / ml solution for intravenous administration 15 ml 10 pcs. RUB 17346 Buy

Omniscan 0.5 mmol / ml solution for intravenous administration 20 ml 10 pcs. RUB 22,100 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!