Omniscan injection for 0.5 mmol/ml 20 ml №10

Composition

In 1 ml solution for injection contains:

Active substance

Gadodiamide (non-ionic paramagnetic compound) in a concentration of 0.5 mmol.

In a bottle of 20 ml.

Indications for use

Magnetic resonance imaging of the brain and spinal cord.

Pharmacokinetics

It is rapidly distributed in the extracellular fluid, does not penetrate through the intact blood-brain barrier. The volume of distribution is equivalent to the volume of extracellular fluid. The half-life is approximately 4 minutes. No protein binding detected.

Almost completely excreted through the kidneys in unchanged form (glomerular filtration). Four hours after the intravenous injection, about 85% of the dose passes into the urine, after 24 hours - 95-98%. The half-life is about 70 minutes. With the introduction of the drug in the dose range from 0.1 to 0.3 mmol / kg, no dependence of the pharmacokinetic parameters on the dose was detected.

Clinical Pharmacology

An MRI study with contrast enhancement should be initiated shortly after drug administration, depending on the pulse sequences used and the study protocol. Optimal enhancement is usually observed within the first minutes after the injection (depending on the type of the pathological process and the tissue being examined).Contrast enhancement is usually maintained for 45 minutes after administration. T₁ -weighted pulse sequences are particularly suitable for MR studies with contrast enhancement by Omniscan.

Use during pregnancy and lactation

Pregnancy

In pregnancy, use is possible only for health reasons.

Lactation

During lactation, breastfeeding should be discontinued 24 hours before the administration of the drug and resumed no earlier than 24 hours after the administration.

Contraindications

Hypersensitivity

Impaired renal function (glomerular filtration rate less than 30 ml / min).

Side effect

An uncomfortable condition with a feeling of warmth or cold (in the whole body), local pain or pressure (at the injection site), Dizziness, headache, drowsiness, nausea, vomiting, changes in taste and smell, allergic reactions.

Interaction

Clinically significant interaction of gadodiamide with other drugs has not been established.

Overdosage

Symptoms: may increase side effects.

Treatment: symptomatic. There is no specific antidote. With delayed elimination due to renal failure and in patients who have received excessively high doses of the drug, it is theoretically possible to remove it by hemodialysis.

Dosage and administration

In / in the jet, once.

Adults with body mass up to 100 kg and children over 6 months: the recommended dose is 0.1 mmol / kg body weight (equivalent to 0.2 ml / kg).

When the patient's body weight is more than 100 kg: to provide a diagnostically adequate contrast, it is recommended to inject 20 ml of the drug.

Precautionary measures

The study should begin shortly after the introduction (optimal contrasting is usually observed within the first 45 minutes after application).

It is not recommended to use the drug for the examination of pregnant women, except in cases of extreme necessity or when it is impossible to use other methods.

Lactating women should stop breastfeeding and resume it no earlier than 24 hours after the procedure.

The drug is collected in a syringe immediately before use, avoid mixing with other solutions. To ensure complete dosing, it is recommended to wash the cannula with 5 ml of 0.9% sodium chloride solution.

Storage conditions

Store in a place protected from light and secondary x-rays, at room temperature no higher than 30 ° C.