Omniskan

Omniscan is a contrast agent used for MRI procedures.

[1], [2], [3]

Indications Omniskan

It is used exclusively for diagnosis. It is used for MRI in the area of the spine with the skull, and in addition, with MRI of various parts of the body, including the head, cervical areas, the sternum (this includes the heart) and limbs. Injection of the drug allows you to examine the peritoneum and retroperitoneal region together with the pelvis (liver, urea, pancreas, prostate and kidneys), breast glands, muscle and skeleton structure, and vessels (angiography procedure).

Thanks to Omniskan, various lesions and abnormal formations are visualized, which helps differentiate pathological and healthy tissues.

[4], [5]

Release form

The release of the substance is realized in the form of an injection liquid, in flakonchikah capacity of 10, 15 or 20 ml. Inside the package there are 10 such bottles.

[6], [7]

Pharmacodynamics

Omniscan is a non-ionic substance used to perform MRI. Due to its paramagnetic characteristics during the MRI procedure, it is possible to produce a contrast enhancement. The drug contains a gadodiamide, which mainly affects the relaxation time of T1.

The introduction of a drug element leads to an amplification of the signal from those areas where BBB dysfunction is observed, associated with its damage due to pathological lesion. The drug provides more voluminous informative images in comparison with the information obtained with MRI before performing contrast enhancement. The optimum level of increased contrast is often reached within the first minutes after the injection (with tissue type and lesion taken into account). This effect is often maintained for 45 minutes after the injection.

The medication helps to intensify the contrast and simplify the visualization of lesions and abnormal areas within different parts of the body, including the central nervous system. The medicine can not pass through the BBB. The use of Omniscan in the case of dysfunction of the BBB potentiates the visualization of lesions that have abnormal vascularization and pathological changes (or those that lead to a breach of the integrity of the BBB) within the brain (intracranial disorders), connective tissues with the spine, and in addition to lesions within the sternum, cavity and retroperitoneal site.

Along with this, the drug improves the quality of visualization of tumors, as well as determining the severity of their invasiveness. The substance does not accumulate inside the brain, which has no pathological changes, as well as in lesions that do not have abnormal vascularization (for example, inside bones or old post-operative scars).

The medication does not lead to the potentiation of the signal of various types of pathogenic processes - for example, certain types of highly differentiated neoplasms or those that do not have plaque activity that appear in multiple sclerosis.

Omniscan can be used to differentiate pathological and healthy tissues, various pathogenic structures, as well as to differentiate tumors or tumor relapses with scar tissues that appear after therapy.

[8], [9], [10]

Pharmacokinetics

The drug undergoes rapid distribution within the extracellular fluid. The distribution volume is similar to the indices of the volume of liquids that are outside the cells.

The half-distribution time is about 4 minutes, and the half-life is about 70 minutes.

In people with disorders of renal activity, the half-life increases in inverse proportion to the severity of renal function impairment. You can withdraw the medicine from the body with hemodialysis.

Excretion occurs through the kidneys by filtering the glomeruli. In people with healthy renal function, approximately 85% of the substance is excreted in the urine unchanged 4 hours after the administration of the gadodiamide, and 95-98% after 24 hours.

When dosages of 0.1, as well as 0.3 mmol / kg were used, there were no dose-dependent changes in pharmacokinetic parameters of drugs. The substance is not subjected to exchange processes and is not synthesized with proteins.

[11], [12]

Dosing and administration

The medicine is injected intravenously. Collect the substance in the syringe immediately before the procedure.

An adult and a child are injected with a bolus injection. To ensure the necessary completeness of drug administration, it is necessary to wash the catheter for intravenous administration with a 0.9% NaCl solution.

Potentiation of contrast inside the central nervous system.

The sizes of portions for the child and the adult.

The recommended dosage amount is 0.1 mmol / kg (or 0.2 ml / kg) if the weight is less than 100 kg. People with a weight of more than 100 kg often enough 20 ml of substance to provide an adequate contrast for diagnosis.

If there is a suspicion of developing metastatic lesions within the brain, you need to inject the medication in 2 or 3 portions, up to 0.3 mmol / kg (or 0.6 ml / kg), with a weight of up to 100 kg. People, whose weight exceeds 100 kg, more than enough 60 ml to get adequate for diagnosing the contrast. A portion of 0.6 ml / kg is allowed to be administered by a 1-time injection. If the test is ambiguous after the potentiation of contrast using 0.1 mmol / kg of the substance, a bolus may be repeated for a further 20 minutes - in a dose of 0.2 mmol / kg (or 0.4 ml / kg). This can help in obtaining additional diagnostic data.

Potentiation of contrast of internal organs, as well as tissues.

Adults.

The recommended portion dose is 0.1 mmol / kg (0.2 ml / kg), and 0.3 mmol / kg (or 0.6 ml / kg), if necessary, which is used in weights below 100 kg . People who weigh more than 100 kg, in order to obtain the optimal diagnostic contrast, often require 20-60 ml of the substance.

Children over 6 months of age.

It is required to administer 0.1 mmol / kg of the substance (or 0.2 ml / kg).

Magnetic resonance examination.

When potentiating the contrast, the MRI should be started a few minutes after Omniscan's injection, taking into account the pulse sequences that are occurring, as well as the examination protocol. Typically, tissue contrast is maintained for approximately 45 minutes from the time of the injection. With MRI with contrast potentiation, the most optimal are the T1-weighted pulse sequences. 

When you enter a LAN using a system with an automatic type of input, you need a certificate from the manufacturer that it is suitable for Omniskan. It is also necessary to follow exactly the instructions for use of the medical device.

People with deficiency of renal function.

The drug is used only after a preliminary assessment of the risk and benefit for people with a moderate form of kidney failure (glomerular filtration rate is 30-59 ml / minute / 1.73 m²). Such patients can be administered a dose not exceeding 0.1 mmol / kg.

During the scan, only one portion is used. Since there is no data on the repeated use of the drug, it is only possible to inject a new injection at least 7 days later.

Use in newborns, infants, and also children.

Use in infants younger than 12 months of age is allowed only after a very careful examination. Such children are prescribed only a dosage of 0.1 mmol / kg. For scanning, only 1-fold portion is used. Repeated injection may be prescribed at least 7 days after the first procedure, because there is no evidence of repeated use of the drug.

Potentiating the contrast of internal tissues and organs for children under the age of six is prohibited.

[19]

Use Omniskan during pregnancy

There is no information on the use of the drug during pregnancy. Animal tests have shown that reproductive toxicity develops in the case of repeated use of drugs in large portions. It is not recommended to use Omniskan during pregnancy, if there is no vital necessity for it.

Clinical information about the excretion of a substance with human milk is absent in humans. In animal tests, it was found that the drug is excreted in milk, so the likelihood of a risk to the infant is present. In this regard, before using the drug, you must stop breastfeeding - for a period of the next 24 hours a minimum.

Contraindications

The main contraindications:

• presence of strong sensitivity to the elements of the drug;
• renal diseases of severe severity and chronic form (glomerular filtration rate is <30 ml / minute / 1.73 m²);
• disorders of renal activity in acute form;
• people who have recently undergone a liver transplant.

[13], [14], [15]

Side effects Omniskan

The use of medication can cause the appearance of various side effects:

• immune defeats: sometimes there are allergy symptoms on the epidermis and mucous membranes, as well as intolerance. Perhaps the development of anaphylactoid or anaphylactic manifestations (this includes skin and respiratory reactions, as well as symptoms from the CCC) *;
• mental disorders: occasionally there is an anxious feeling;
• problems with the work of the National Assembly: headaches are often noted. Sometimes there is paresthesia, dizziness and transient taste disorder. Occasionally, there is tremor, convulsions and a feeling of drowsiness, as well as a transient impairment of smell. Perhaps the emergence of paresthesias, ataxia, paresis, the development of coma and the disorder of coordination;
• visual disorders: visual impairment is possible;
• lesions affecting the function of CCC: sometimes there is hyperemia. Possible development of tachycardia;
• Respiratory disorders: occasionally there is a cough or dyspnea. There may be spasms of bronchi, irritation in the throat or sneezing, as well as the development of RDS;
• problems with digestive activity: often there is a nausea. Sometimes - diarrhea or vomiting. There may be eructation;
• disorders of hepatic function: there may be problems in the liver;
• damage to the subcutaneous layer and epidermis: sometimes there is itching. Occasionally - hives, rashes, hyperhidrosis and swelling (facial and edema of Quincke). Perhaps the development of the NSF;
• disorders in the work of connective tissue or ODA: occasionally there is myalgia or pain in the joints;
• problems affecting renal function and urinary processes: occasionally there is an acute kidney failure, as well as an increase in the blood levels of creatinine;
• systemic disorders and symptoms at the site of injection: often there is a transient feeling of pressure, cold or heat in the area of drug administration. There may also be temporary pain in the areas of injection. Occasionally, there is fever, hot flashes, pain in the sternum, manifestations on the site of injection and trembling. Perhaps the development of a feeling of malaise or fatigue, as well as fainting.

* Anaphylactoid or anaphylactic symptoms that develop without binding to the size of the portion and the method of injection may be the initial sign of the development of the shock state.

Delayed negative manifestations can develop after a few hours or days from the moment of application of drugs.

Individual people had temporary asymptomatic changes in the values of iron within the serum.

[16], [17], [18]

Overdose

Excess amount of the substance is excreted by hemodialysis. But there are no confirmations that hemodialysis is used to prevent the development of NSF.

[20], [21]

Storage conditions

Omniscan is required to be kept in a place that is closed from small children and X-ray radiation of a secondary type. The substance must not be frozen. Temperature indicators - within the limits of marks 2-30 ° С.

[22]

Shelf life

Omniscan can be used within 36 months from the date of manufacture of the drug substance.

The finished solution retains its physical and chemical stability for an additional 8 hours at temperatures up to 25 ° C. But from a microbiological point of view, it must be used immediately.

[23], [24]

Application for children

Omniscan can be used in pediatrics - for children and infants from 0.5 years.

[25]

Analogues

The analogues of the medicine are the medicines Vazovist, Tomovist, Gadovist with Magnevist and Lantavista, and besides Magneghita, Multihans, Magnilek and Optimark with Megarei.

[26], [27], [28]