Optimark - instructions for use, dose, side effects, contraindications

Active substanceGadoversetamideGadoversetamide

Similar drugsTo uncover

solution in / in

Dosage form: & nbspsolution for intravenous administration

Composition:In 1 ml of the preparation contains:

Active substance: gadoversetamide - 330.9 mg;

Excipients: vercetamide 25.4 mg, calcium hydroxide 3.7 mg, calcium chloride dihydrate 0.74 mg, sodium hydroxide or hydrochloric acid to pH 6.0-7.5, water for injection up to 1 ml.

Description:Transparent, colorless or slightly yellowish liquid, odorless or with a faint odor.

Pharmacotherapeutic group:Contrast agent for magnetic resonance imaging

ATX: & nbsp

V.08.C.A Paramagnetic contrast media

Pharmacodynamics:Paramagnetic properties cause contrast enhancement when performing magnetic resonance imaging (MRI). The introduction of gadoveretamid causes signal amplification in the areas of impaired function of the blood-brain barrier caused by the pathological process or intracranial or spinal forms, as well as in areas of focal liver lesions with abnormal vascularization, which provides greater visualization information compared to MRI data without contrast enhancement. Optimum contrast enhancement is usually observed during the first minutes after administration (depending on the type of pathological process / tissue).Contrast enhancement is usually maintained up to 45 min after the administration of gadoversetamide.

Pharmacokinetics:

Rapidly distributed in the extracellular fluid, the volume of distribution is equivalent to the volume of extracellular fluid. The half-distribution period is about 13 minutes, does not bind to plasma proteins, is not metabolized. It is excreted mainly by the kidneys in an unchanged form by glomerular filtration within 24 hours. The half-life is 104 min. Does not penetrate the intact blood-brain barrier.

Characteristic

Optimark - non-ionic paramagnetic contrast medium with the following physico-chemical properties:

Osmolality (mOsm / kg water) at 37 ° C - 1100

The density (g /m3) at 25 ° C - 1,160

Viscosity (mPa×c) at 20 ° C -3.1 Viscosity (mPa×c) at 37 ° C - 2.0

pH 6.0-7.7.

The osmolality of Optimark is approximately 3.9 times higher than that of blood plasma (285 mOsm / kg of water). Accordingly, in clinical use, the drug solution is hyperosmolar with respect to blood plasma.

Indications:

MRI of the brain and spinal cord, liver.

Optimark is indicated for performing contrast enhancement with MRI of the brain and spinal cord in patients with blood-brain barrier abnormalities or foci of abnormal vascularization of the brain, spinal cord and associated tissues / structures.

Optimark is indicated for performing contrast enhancement in liver MRI in patients with the aim of improving the detection of focal liver lesions with abnormal vascularization, in patients with suspected CT scans of the liver parenchyma.

Contraindications:Hypersensitivity to gadoveretamidu, vetsetamidu or any inactive ingredients of the drug; renal failure (glomerular filtration rate less than 30 ml / min), children's age (up to 2 years), as well as patients who have had or are waiting for liver transplantation.

Carefully:

Anemia, especially sickle cell and hemolytic, hemoglobinopathy, hepatic insufficiency, allergic reactions in history, bronchial asthma, severe circulatory failure, epilepsy, renal dysfunction (glomerular filtration rate 30-60 ml / min).

Pregnancy and lactation:

During pregnancy, apply only in cases where carrying out contrast intensified research is extremely necessary, and there is no way to replace it with other methods, and if the potential benefit to the mother exceeds the possible risk to the fetus.

During lactation, breastfeeding should be discontinued and resumed no earlier than 72 hours after drug administration.

Dosing and Administration:Intravenous (bolus) once. In a dosage of 0.2 ml / kg (0.1 mmol / kg) at a rate of 1-2 ml / s by hand or with an automatic injector. The drug is injected into the syringe immediately before use; To ensure complete administration of the dose, the cannula is washed with 5 ml of 0.9% sodium chloride solution. The beginning of the study - a few minutes after the introduction, the end - for 1 hour.

Optimark dosage table
Body weight	For a dose of 0.1 mmol / kg
Kilograms (kg)	Volume (ml)
20	4,0
30	6,0
40	8,0
50	10,0
60	12,0
70	14,0
80	16,0
90	18,0
100	20,0
110	22,0
120	24,0
130	26,0
140	28,0
150	30,0

Side effects:Organism as a whole: fever, chills

A list of adverse reactions that occurred in ≥1% of patients
From the nervous system
Headache	9,4%
Dizziness	3,7%
Changes in taste and smell	13,5%
Asthenia	1,5%
Backache	1,2%
Paresthesia	2,2%
From the side of the cardiovascular system
Vasodilation	6,4%
From the digestive system	7,6%
Abdominal pain	1,8%
Nausea	3,2%
Diarrhea	1,9%
Dyspepsia	1,2%
Local reactions (local soreness or a feeling of raspiraniya at the injection site)	26,4

The following adverse reactions were noted in less than 1% of patients:

Are common: fever, flu-like syndrome, malaise, neck stiffness, neck pain, pelvic pain, increased sweating.

Allergic reactions: allergic conjunctivitis, Quincke's edema, erythema multiforme, pruritus, rash, hives, rarely anaphylactic shock.

From the cardiovascular system: arrhythmia, chest pain, hypertension, hypotension, pallor, palpitation, fainting, tachycardia, vasospasm.

From the digestive system: anorexia, increased ap-petit, constipation, dry mouth, difficulty swallowing, belching, flatulence, increased salivation, thirst, vomiting.

From the musculoskeletal system: arthralgia, leg cramps, muscle pain, myasthenia gravis, spasm.

From the nervous system: anxiety, increased excitability, a sense of fear, drowsiness, confusion, depersonalization, dystonia, hallucinations, hypertonia, paresthesia, tremor, blurred vision, diplopia, hyperacusis, change in smell, ringing in the ears.

On the part of the respiratory system: cough, shortness of breath, voice change, epistaxis, hemoptysis, laryngospasm, bronchospasm, pharyngitis, sinusitis. From the genitourinary system: upset urination, oliguria, frequent urination.

Laboratory indicators: thrombocytopenia, increased serum creatinine, hypercalcemia, hyperglycemia, hyponatremia.

Local reactions: hyperemia, edema or inflammation at the injection site, thrombophlebitis at the injection site. There were isolated cases of nephrogenic systemic fibrosis with gadolinium preparations in patients with marked renal dysfunction (glomerular filtration rate less than 30 ml / min).

Overdose:

Symptoms: it is possible to intensify the manifestations of the described side effects (except for allergic reactions).

Treatment is symptomatic. Removed from the body by hemodialysis.

Interaction:Pharmaceutically incompatible with other medicines.

Special instructions:

In connection with the possibility of developing an anaphylactic shock during the introduction of the drug, it is necessary to create all conditions for the provision of resuscitation.

Before the introduction of a contrast agent in patients should be aware of the presence of allergic history, bronchial asthma,since the incidence of adverse reactions to contrast agents is higher and for them, for presedication, the appointment of antihistamines and / or glucocorticosteroids is indicated. Patients with bronchial asthma have an increased risk of developing bronchospasm or hypersensitivity reactions.

Before each use of a contrast agent, it is necessary to obtain accurate information about the patient, including important laboratory data (eg, serum creatinine, electrocardiogram, pregnancy). Before the study, the patient should eliminate the disturbances of the water-electrolyte balance and ensure sufficient supply of fluid and electrolytes.

When using Optimark and some other gadolinium-containing radiopaque agents, the development of nephrogenic systemic fibrosis (NSF) was reported in patients with acute or severe chronic renal impairment (GFR less than 30-60 ml / min) or acute renal failure of any severity that developed as a result of hepatorenal syndrome or in the period after the liver transplantation.In such patients, Optimark should be used only after a thorough assessment of the risk / benefit ratio, considering the possibility of using alternative imaging techniques.

The lack of contrast enhancement is not unambiguous evidence of the absence of pathology since some types of tumors or soft plaques in atherosclerosis not vizualiziruyutsya. The presence or absence of contrast enhancement can be used for differential diagnosis.

Each vial or disposable syringe is designed to administer the drug to one patient. Unused remnants of the drug should be destroyed. With the introduction of other drugs, you need to use a separate syringe and needle.

It is not recommended to perform preliminary testing of individual sensitivity with the use of small doses of the drug, due to the risk of severe hypersensitivity reactions.

Patients who are afraid of waiting before the procedure need premedication with sedatives.

Optimark distorts the results of measuring the concentration of calcium and serum iron in the blood using some colorimetric techniques,usually used in medical institutions. It is not recommended to use these methods within 12-24 hours after the introduction of Optimark. If such studies are necessary, other methods of analysis should be used.

When changing the color of the solution or the presence of large particles, the drug should not be used.

Effect on the ability to drive transp. cf. and fur:

The influence of Optimark on the speed of psychomotor reactions and the ability to concentrate attention, necessary for driving transport and engaging in other potentially hazardous activities, has not been studied.

Form release / dosage:

Solution for intravenous administration is 550 μmol / ml.

Packaging:

10 ml, 15 ml, 20 ml in bottles of hydrolytic glass type I, hermetically sealed with bromobutyl stoppers and crimped with an aluminum cap of red color with a blue plastic protective cover.

For 15 ml and 30 ml in polypropylene syringes, hermetically sealed with a gray tip and a piston made of non-latex artificial rubber.

The bottles are packed in 10 pieces each in a cardboard box with a cardboard separator and instructions for use.

Syringes are packed one by one into a cardboard box with a cardboard separator; 10 packs of cardboard, containing 1 syringe each, with instructions for use, are packed in a cardboard box.

Storage conditions:In the dark place at a temperature of 15 - 30 ° C. Do not freeze. Keep out of the reach of children!

Shelf life:3 years - for syringes from polypropylene, 2 years - for glass bottles.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001897/10

Date of registration:12.03.2010 / 20.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:Mallinkrodt Inc.Mallinkrodt Inc. USA

Manufacturer: & nbsp

MALLINCKRODT, Inc. USA

Representation: & nbsppharmre.ru.rupharmre.ru.ruRussia

Information update date: & nbsp10.06.2017

Illustrated instructions

Instructions

Optimark (Optimark)