Omniscan injection for 0.5 mmol/ml 10 ml №10

Release form

Solution for IV administration

Composition

1 ml of solution contains 0.5 mmol gadodiamid

Mechanism of action

Contrast diagnostic paramagnetic non-ionic agent. Due to the paramagnetic properties, Omniskan enhances image contrast during MRI and facilitates visualization of anomalous structures or formations in the body, including in the central nervous system. It causes signal amplification in those areas where the BBB dysfunction occurs due to its damage during the pathological process.

Indications

For contrast enhancement during MRI of the head, spinal canal, the whole body.

Contraindications

Renal failure, hypersensitivity to gadodiamidom.

Use during pregnancy and lactation

The use of Omniskan during pregnancy is possible only in cases of extreme necessity. During lactation - breastfeeding should be stopped no less than 24 hours before the administration of gadodiamide and resumed not earlier than 24 hours after its introduction.

Experimental studies in rodents have shown that gadodiamide does not affect fertility and does not have a teratogenic effect.

Dosage and administration

With the on / in the introduction of adults and children over 2 years old with a body weight of up to 100 kg a single dose of Omniscan is 0.1 mmol / kg; with a body weight of more than 100 kg a single dose is 10 mmol.

Side effects

From the side of the central nervous system: rarely - dizziness, headache, change in taste and smell; in isolated cases - drowsiness.

On the part of the digestive system: rarely - nausea, in isolated cases - drowsiness.

Allergic reactions: rarely - urticaria, pruritus, sore throat.

Other: possible feeling of warmth or cold in the whole body.

Local reactions: local pain is possible, a feeling of pressure at the injection site.

Special notes

Omniscan should not be used in patients with impaired renal function at a glomerular filtration rate of less than 30 ml / min. Gadodiamide should be administered under conditions that allow, if necessary, immediate intensive therapy.

Overdosage

Symptoms: may increase the manifestations of the described side effects.

Treatment: conducting symptomatic therapy. Gadodiamide is removed from the body by hemodialysis (in patients with impaired renal function and receiving large doses).

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Shelf life

2 years.