Dotavist solution for injection 279.32 mg/ml bottle 20 ml No. 1

Dotavist injection solution is used exclusively for diagnostic purposes if the use of magnetic resonance imaging (MRI) without contrast enhancement is not possible.

adults:

Composition

Active ingredient: gadoteric acid;

1 ml of solution contains 279.32 mg (0.5 mmol) of gadoteric acid, which corresponds to 376.92 mg of gadoterate meglumine;

Excipients: meglumine, water for injections.

Contraindication

Hypersensitivity to gadoteric acid, meglumine or to any medicinal product containing gadolinium.

Method of application

The lowest dose that provides sufficient contrast for diagnostic purposes should be used.

The dose should be calculated based on the patient's body weight. This dose should not exceed the recommended dose per kilogram of body weight, as detailed in this section.

The drug is intended for intravenous administration only.

Intravenous administration of contrast media should, if possible, be performed with the patient in the supine position. After administration, the patient should be observed for at least half an hour, as experience shows that most adverse effects occur during this period.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless opened in controlled and validated aseptic conditions.

Pediatric population.

Depending on the amount of Dotavist to be administered to the child, it is best to use Dotavist vials that have a volume adapted to that amount in order to administer the most accurate volume of the drug.

In newborns and infants, the required dose should be administered manually.

Application features

Pregnant women

Gadoteric acid should not be used during pregnancy unless the clinical condition of the woman requires its use.

Children

Due to immature renal function in newborns up to 4 weeks of age and children up to 1 year of age, gadoteric acid should be used in these patients only after careful analysis of all risks.

Drivers

Patients who are administered the drug in an outpatient setting should be aware that they may suddenly experience nausea when driving or operating machinery.

Overdose

Gadoteric acid can be removed by hemodialysis. However, there is no evidence that hemodialysis is useful for preventing nephrogenic systemic fibrosis (NSF).

Side effects

Side effects associated with the use of gadoteric acid are usually mild to moderate in intensity and short-lived. The most common are injection site reactions, nausea, and headache.

During clinical studies, the most commonly observed adverse reactions were nausea, headache, injection site reactions, chills, hypotension, somnolence, dizziness, feeling hot, burning sensation, rash, asthenia, dysgeusia and hypertension.

Interaction

No interactions with other drugs have been observed. Adequate drug-drug interaction studies have not been conducted.

Concomitant medications to consider. Beta-blockers, vasoactive agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists - these medications reduce the effectiveness of the cardiovascular compensation mechanism for blood pressure disorders. Before administering gadolinium compounds, the radiologist must be informed that the patient is taking these medications, and equipment for resuscitation measures should be prepared in advance.

Storage conditions

Does not require special storage conditions.

Keep out of reach of children.

Shelf life - 5 years.