Omniscan solution for iv. enter 0.5 mmol / ml vials 10 ml 10 pcs. pack (Hadodyamyd)

Release form

Solution for injection

Packaging

10 vials of 10 ml

Indications

magnetic resonance imaging (MRI) of the brain and spinal cord in adults and children of all ages, including neonatal

full body contrasting in adults and children 6 months of age and older

angiography in adults.

Contraindications

severe renal impairment (glomerular filtration rate less than 30 ml / min / 1.73 m2)

surgery for liver transplantation

hypersensitivity to the drug.

Caution is advised to use the drug in case of anemia, especially with sickle cell, hemolytic hemoglobinopathy, liver failure in infants and children under the age of 1 year (due to insufficiently developed kidney function).

Use during pregnancy and lactation

Use of Omniscan during pregnancy is possible only in cases of emergency. During lactation - breastfeeding should be stopped at least 24 hours before the administration of gadodiamide and resumed no earlier than 24 hours after its administration.

In experimental studies on rodents, it was shown that gadodiamide does not affect fertility and does not have a teratogenic effect.

Composition

active substance: gadodiamide (non-ionic paramagnetic compound) at a concentration of 0, 5 mmol

excipients: sodium caldiamide, sodium hydroxide 1M or hydrochloric acid 1M, water for injection.

Dosage and administration

Intravenously, single dose.

Contrasting the central nervous system during MRI

For adults and children of all ages, including newborns, with a body weight of less than 100 kg, the recommended dose is 0.1 mmol / kg (equivalent to 0.2 ml / kg) with a body weight of more than 100 kg, 20 ml of Omniscan is usually sufficient.

In cases of suspected metastatic brain damage in adults with a body weight of up to 100 kg, it is possible to administer the drug in a double or triple dose - up to 0.3 mmol / kg (0.6 ml / kg) with a body weight of more than 100 kg, usually 60 ml of the drug is sufficient. In the case of mixed results of the study after contrast enhancement by Omniscan at a dose of 0.1 mmol / kg, a repeated bolus injection of the drug is possible over the next 20 minutes at a dose of 0.2 mmol / kg (0.4 ml / kg) in order to obtain additional diagnostic information.

Full body contrast

For adults with a body weight of up to 100 kg, the recommended dose is usually 0.1 mmol / kg (0.2 ml / kg), in some cases 0.3 mmol / kg (0.6 ml / kg) with a body weight of more than 100 kg - 20 ml, in some cases - 60 ml of the drug is usually enough to ensure diagnostically adequate contrast.

For children over 6 months of age, the recommended dose is 0.1 mmol / kg (0.2 ml / kg).

Angiography

For adults, the recommended dose is usually 0.1 mmol / kg (0.2 ml / kg)

For stenosis of the abdominal and iliac arteries, the drug is used in a higher dose - up to 0.3 mmol / kg (equivalent to 0.6 ml / kg), which allows you to get additional diagnostic information.

Side effects

On the part of the body as a whole: fever, chills.

Allergic reactions: urticaria, itching, sore throat, anaphylactoid reactions rarely - anaphylactic shock.

From the digestive system: loss of appetite, belching, abdominal pain, diarrhea, nausea, vomiting.

From the side of the central nervous system and peripheral nervous system: dizziness, headache, anxiety, mental disorders, ataxia, impaired coordination of movements, paresthesia, tremors, loss of consciousness (up to the development of deep coma), drowsiness rarely - convulsions (up to the development of epileptic status) .

On the part of the sensory organs: a change in taste and smell, visual impairment, tinnitus.

From the urinary system: there are indications of the possible development of nephrogenic systemic fibrosis (NSF) in patients with severe renal impairment (glomerular filtration rate less than 30 ml / min / 1.73 m2).

Local reactions: local soreness or a feeling of fullness at the injection site.

Other: asymptomatic decrease in serum iron (within 8 to 48 hours after drug administration), idiosyncrasy, arthralgia, myalgia, facial skin hyperemia, increased sweating.

Overdose

Symptoms: The manifestation of these side effects may be increased.

Treatment: carrying out symptomatic therapy. Gadodiamide is removed from the body by hemodialysis (in patients with impaired renal function and who have received high doses).

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

shelf life

3 years

Deystvuyushtee substance

gadodiamide

Dosage form

solution for infusion

Appointment

Appointment

Adults doctor's prescription

GE Helskea AS, Norway



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