Gadovist solution for iv. enter 1 mmol / ml 15 ml vials 5 pcs. (Hadobutrol)

Release form

Solution for intravenous administration

Packing

5 bottles of 15 ml.

Pharmacological Action

Gadovist® is a paramagnetic contrast medium for magnetic resonance imaging (MRI). The increase in contrast is due to its active component gadobutrol, which is a neutral (nonionic) complex of gadolinium (III) with a macrocyclic ligand - dihydroxy-hydroxy-methyl-propyl-tetraazacyclododecane-triacetic acid (butrol).

During T1-weighted scanning during MRI, the gadolinium ion shortens the spin-lattice relaxation time, leading to an increase in signal intensity and, thereby, to a contrast enhancement of the image of the zone of interest.

When using T2 * -weighted pulse sequences, the induction of local inhomogeneity of the magnetic field under the influence of the strong magnetic moment of gadolinium at its high concentration (bolus injection) leads to a change in the signal from the tissues (contrasting effect).

Gadobutrol even in low concentrations causes a significant shortening of the relaxation time. Quantitatively, the ability to change the relaxation times T1 and T2, determined by the effect on the time of spin-lattice and spin-spin relaxation of protons in plasma at pH 7 and 40 ° C, is about 5.6 and 6.5 l / mmol · s, respectively. The ability to influence relaxation times only to a small extent depends on the magnetic field strength.

Introduction Gadovista® provides more accurate diagnostic information compared to conventional MRI in areas with impaired BBB permeability, for example, in cases of primary or secondary tumors, inflammatory and demyelinating diseases.

Gadovist® does not activate the complement system, and therefore the probability of inducing anaphylactoid reactions by this substance is extremely low.

No binding of gadobutrol with any proteins or their inhibition of enzyme activity was detected.

The results of clinical trials indicate the absence of a negative effect of Gadovist® on overall well-being, as well as on the function of the liver, kidneys and cardiovascular system.

Pharmacokinetics

The behavior of gadobutrol in the body is similar to the behavior of other highly hydrophilic biologically inert substances, excreted by the kidneys (e.g. mannitol or inulin).

Intravenous gadobutrol is rapidly distributed in the extracellular space and excreted unchanged by the kidneys through glomerular filtration. Extrarenal elimination is so insignificant that it may not be taken into account.

Pharmacokinetics in humans are proportional to the dose of gadobutrol administered. If the dose of gadobutrol does not exceed 0.4 mmol / kg, the elimination phase begins after the initial distribution phase, and its concentration in the plasma decreases from T1 / 2 1.81 h (1.33–2.13) h, which corresponds to the rate of excretion by the kidneys . At a dose of gadobutrol of 0.1 mmol / kg 2 minutes after injection, its plasma level was 0.59 mmol / L, and 60 minutes after injection it was 0.3 mmol / L. Within 2 hours, more than 50% of the administered dose is excreted in the urine, and over 90% within 12 hours. If the administered dose of gadobutrol is 0.1 mmol / kg, then (100.3 ± 2.6)% of this dose is excreted in 72 hours. The renal clearance of gadobutrol in healthy individuals is from 1.1 to 1.7 ml / min. / kg thus, it is comparable with the clearance of inulin, which indicates the predominant excretion of gadobutrol by glomerular filtration. Less than 0.1% of the substance administered is excreted in the feces. No metabolites in plasma and urine could be detected.

T1 / 2 gadobutrol in patients with impaired renal function increases in proportion to the degree of decrease in glomerular filtration. In patients with mild or moderate renal impairment, gadobutrol is completely excreted in the urine within 72 hours. In patients with severe renal impairment, at least 80% of the administered dose is excreted in the urine within 120 hours.

Indications

This drug is intended for diagnostic purposes only. Gadovist® is indicated for adults, adolescents, and children over the age of 7 years to increase contrast during whole body MRI, including: increased contrast during cranial and spinal MRI

increased contrast during MRI of the head and neck

increased contrast during MRI of the chest

increased contrast during MRI of the mammary

increased contrast during MRI of the abdominal cavity (including the pancreas glands, liver, spleen)

increased contrast during MRI of the pelvis (including the prostate, bladder and uterus)

increased contrast during MRI Jushin space (including the kidneys)

contrast enhancement when conducting MRI musculoskeletal system and limbs

contrast enhancement during magnetic resonance angiography (MRA)

contrast enhancement when conducting MRI heart (in t. h. to assess myocardial perfusion under conditions of pharmacological stress and diagnosis of tissue viability "delayed contrasting").

Contraindications

There are no absolute contraindications.

Caution:

hypersensitivity to one of the ingredients of the drug

severe renal dysfunction

severe cardiovascular disease

low threshold for convulsive readiness.

Special instructions

Hypersensitivity. In patients with known hypersensitivity to the drug, a particularly careful assessment of the risk / benefit ratio of the use of the Gadovist® drug is required. As with the use of other contrast agents for iv administration, the use of the Gadovist® preparation may be accompanied by manifestations of hypersensitivity - anaphylactoid reactions and other manifestations of idiosyncrasy, characterized by reactions from the CCC, respiratory system or skin reactions that turn into serious conditions, including shock.

The risk of hypersensitivity reactions is higher in the following cases:

- previous reaction to contrast medium

- bronchial asthma

- a history of allergic diseases.

Most of these reactions develop within 0.5–1 hours after administration. In patients with a predisposition to the development of allergic reactions, the decision to use the drug Gadovist® should be made only after a thorough assessment of the risk / benefit ratio.

Delayed allergic reactions are rarely observed (a few hours to a day after administration) (see “Side effects”). After a diagnostic procedure with Gadovist® (as well as after the use of other contrast agents), monitoring of the patient's condition is recommended.

During the examination, it is necessary to have drugs and equipment for resuscitation. Patients taking -Adrenergic blockers, with the development of a hypersensitivity reaction, may be resistant to drugs with beta-adrenomimetic action used to treat such reactions.

Severe renal impairment. So far, no renal impairment has been observed. Before administering Gadovist®, all patients should be checked for impaired renal function by collecting medical history and / or laboratory tests. It is necessary to carefully evaluate the risk / benefit ratio of the drug in patients with severe impaired renal function, since in such cases the excretion of the contrast medium is slowed down.

After three courses of dialysis, approximately 98% of gadobutrol is excreted from the body. For patients on hemodialysis, the feasibility of immediately starting hemodialysis after administration of the Gadovist® preparation should be considered in order to accelerate the elimination of the contrast agent. Cases of the development of nephrogenic systemic fibrosis (NSF) due to the administration of gadolinium-containing contrast agents, including the Gadovist® preparation, to patients with the following diseases / conditions were reported:

- acute or chronic renal failure (glomerular filtration rate2) or

- acute renal failure of any severity caused by hepatorenal syndrome, or in the period before and after liver transplantation.

Despite the fact that the drug Gadovist® has a very high stability of the complex due to its macrocyclic structure, there is a possibility of developing NSF when using the drug Gadovist®. Therefore, in such patients, the use of the Gadovist® drug should only be after a careful assessment of the benefit / risk ratio (see "Side effects").

Convulsive conditions. Particular caution is required when prescribing Gadovist®, as well as other contrast agents containing gadolinium chelate, to patients with a low threshold for convulsive readiness.

Influence on the ability to drive a car and use complex mechanisms. Not found.

Composition of

Active ingredient: gadobutrol 604.72 mg (1 mmol)

Excipients: calcobutrol sodium - 0.513 mg trometamol - 1.211 mg hydrochloric acid, hydrochloric acid, pH 7, 0.111, hydrochloride 2 В± 1.2 water for injection - up to 1 ml

Dosage and Administration

Intravenously, as a bolus. MRI with increased contrast can be started immediately (shortly after injection, depending on the pulse sequence used and the study protocol).

Optimal contrast enhancement is observed during the arterial phase when performing MPA with contrasting and for a period of time, measured in minutes, after administration of the drug Gadovist® during other studies (the time depends on the type of damage / tissue).

When performing an MRI, the general safety rules must be observed (see "Special Instructions").

For studies with increased contrast, T1-weighted pulse sequences are most suitable for scanning.

Terms of use of the drug

Before administration, carefully examine the vial, syringe or cartridge. With a significant change in color, detection of visible particles or violation of the integrity of the package, the drug should not be used.

Gadovist® should only be taken into the syringe immediately before administration. The rubber stopper of the vial should not be punctured more than 1 time.

Gadovist® in a syringe should be removed from the packaging and prepared for injection immediately before administration. The syringe tip cover should be removed immediately before insertion.

Gadovist® in cartridges must be administered by a specialist in accordance with the instructions supplied with the equipment for use with the cartridges. The introduction of the drug should be carried out under sterile conditions. Unused in one study, part of the drug should be destroyed. Gadovist® should not be mixed with other drugs, since compatibility data are not available.

Dosing regimen

When choosing a dosage regimen for adults, the following rules should be followed.

Dose depends on the indication. A single intravenous administration of the drug Gadovist® (1 mmol / ml) at a dose of 0.1 ml / kg is usually sufficient. The maximum dose of Gadovist® is 0.3 mmol / kg (equivalent to 0.3 ml / kg).

whole body MRI (except MPA)

As a rule, iv administration of Gadovist® (1 mmol / ml) is sufficient at a dose of 0.1 ml / kg (which is equivalent to 0.1 mmol / kg).

Additionally, for cranial and spinal MRI

, iv administration of Gadovist® (1 mmol / ml) at a dose of 0.1 ml / kg (equivalent to 0.1 mmol / kg) is usually sufficient.

If at the same time there are suspicions of the presence of lesions or more accurate information is needed on the number, size and prevalence of lesions, then the diagnostic effectiveness of the study can be increased by additionally introducing a solution of Gadovist® (0.1 mmol / ml) in a dose of 0.1 or even 0.2 ml / kg for 30 min after the previous injection.

To exclude metastases or tumor recurrence, a solution of Gadovist® (0.1 mmol / ml) is administered at a dose of 0.3 ml / kg, which often contributes to increasing the diagnostic effectiveness of the study. This applies to lesions with a weak severity of the blood vessel network, a small extracellular space or a combination of these factors, as well as the use of relatively less intense T1-weighted pulse sequences during scanning.

For perfusion studies of the brain, it is recommended to use an injector and a solution of Gadovist® (1 mmol / ml), which is administered at a dose of 0.3 ml / kg at a rate of 3-5 ml / s.

MPA

One scan area: 7.5 ml for body weight

Two or more scan areas: 15 ml for body weight

Use in children

For children over 7 years of age and adolescents, the recommended dose of Gadovist® is 0.1 mmol / kg (equivalent to 0.1 ml / kg) for all indications (see. "Indications").

Gadovist® is not recommended for use in children under 2 years of age due to insufficient data on efficacy and safety.

Side effects

Immune system: hypersensitivity, anaphylactic and anaphylactoid reactions (anaphylactic shock, cardiovascular failure, respiratory arrest, bronchospasm, cyanosis, laryngeal edema, lowering body temperature, increased blood pressure, chest pain, swelling of the face, swelling of the face conjunctivitis, swelling of the eyelids, hot flashes, increased sweating, coughing, sneezing, sensation of heat, pallor.

Nervous system: headache, dizziness, dysgeusia, paresthesia, loss of consciousness (fainting), convulsions, parosmia.

From the CCC side: tachycardia, palpitations, cardiac arrest.

Respiratory system: dyspnea.

From the gastrointestinal tract: nausea. vomiting, dry mouth.

Skin and subcutaneous structures: erythema, pruritus (including generalized form), rash (including maculopapular rash with pruritus). nephrogenic systemic fibrosis.

General pathology and changes at the injection site: reaction at the injection site, sensation of fever, malaise, chills.

Storage conditions

At a temperature not exceeding 30 ° C.

Expiration

3 years

Deystvuyuschee substances

Hadobutrol

Terms and conditions

prescription

dosage form

infusion solution



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