Mioviu (Myoview)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
Composition:

1 bottle with lyophilizate contains:

Active substance:

Tetrophosmin 0.23 mg Excipients:

Disodium salt of sulphosalicylic acid 0.32 mg Tin chloride dihydrate 0.03 mg Sodium gluconate 1.0 mg Sodium bicarbonate 1.8 mg

Composition of the active drug *:

Active substance:

Tetrofosmin 0.029-0.058 mg 99tT-138-275 MBq

Excipients:

Tin (II) 0.9-4.0 μg

Disodium salt of sulfosalicylic acid - 0.036-0.088 mg D-gluconate sodium - 0,125-0,250 mg Sodium bicarbonate - 0,225-0,450 mg Water for injection - up to 1 ml

* for preparation of the preparation of the proper quality, it is necessary to use an eluate conforming to the specifications given in Heb. Farm.

Description:

Powder of white color.

The prepared preparation 99mTc-tetrofosmin is a clear, colorless solution.

Pharmacotherapeutic group:Diagnostic tool.
Pharmacodynamics:

Pharmacological effects after intravenous administration of the prepared drug Miovyu in the recommended dose is not noted. Studies of the effect of the drug on animals have shown that accumulation 99mTc-tetrofosmin myocardium is linearly associated with coronary blood flow, which confirms the effectiveness of the complex as a diagnostic drug for evaluating myocardial perfusion.

Pharmacokinetics:

With intravenous administration 99mTc-tetrofosmin is rapidly excreted from the blood: less than 5% of the injected activity remains in the blood by 10 minutes after administration.

The drug is characterized by a high rate of excretion from the lung and liver tissues. His activity in these organs decreases after exercise, and in skeletal muscles increases. About 66% of the injected activity is excreted within 48 hours after the injection, approximately 40% is excreted in the urine, 26% with feces.

Accumulation in the myocardium:

Accumulation in the myocardium very quickly reaches a maximum of 1.2% of the injected activity, which allows one to obtain a planar or SPECT (single photon emission computed tomography) image in the interval from 15 minutes to 4 hours after drug administration.

Indications:

Miovju is used as a reagent for the preparation of a solution that allows to obtain an image of myocardial perfusion in the radioisotope diagnosis of ischemia and myocardial infarction.

Contraindications:

Hypersensitivity to the active component of the drug or any auxiliary substance.

Pregnancy (see the section "Pregnancy and the period of breastfeeding").

Mildew is not recommended for use in children and adolescents (there is no evidence of clinical use).

Carefully:
Pregnancy and lactation:

The drug should not be used in pregnant women, except when the intended benefit to the mother from its use exceeds the potential risk to the fetus.

If it is necessary to administer radiopharmaceuticals to women of childbearing age, it is necessary to obtain reliable information about the absence of pregnancy. Any woman who has a delay in menstruation should be considered pregnant until the opposite is proven. Consider using alternative methods that do not use ionizing radiation.

Before the introduction of the drug, a nursing woman should consider the possibility of transferring the study to the time when the woman stops breastfeeding, or the use of alternative methods. Data on excretion 99mTc-tetrofosmin in breast milk is not available, so if it is necessary to administer a radiopharmaceutical to a patient breastfeeding, it should be recommended that she stop breast-feeding at least 12 hours after the drug is administered.

Dosing and Administration:

The examination is performed on an empty stomach or after a light breakfast.

The usual diagnostic procedure for the localization of myocardial ischemia (using planar or SPECT methods) includes two intravenous injections 99mTc-tetrofosmin: one injection is injected at the peak of physical activity, the other - at rest. The order of introduction "at peak load - at rest" or "at rest - at peak load" does not matter.

If both doses are administered on the same day, the second dose dose activity should be at least 3 times higher than the residual activity from the first dose. Recommended activity for the first dose is 250-400 MBq; the recommended activity for the second injection, introduced at least after 1 hour, is 600-800 MBq. For cardiac studies with ECG synchronization, the maximum values ​​of the recommended activities should be used. In the event that injections during rest periods and peak loads are administered on different days, the recommended activity for each dose 99mTc-tetrofosmin 400-600 MBq.

In the study of large patients (for example, patients with central type of fat deposits or women with large breasts) or for SPECT with ECG synchronization, it is necessary to use the maximum values ​​of the recommended activities.The total activity, entered at the peak of the load and at rest, should not exceed 1200 MBq, regardless of whether the procedure was carried out for one or two days.

According to clinical studies, minimal activity for cardiac studies with ECG synchronization is 550 MBq. The entered activity in this case should correspond to the recommendations given above.

To diagnose the localization of myocardial infarction, one injection 99mTc-tetrofosmin (250-400MBq) at rest.

Planar or SPECT (more preferably) the study should begin no earlier than 15 minutes after the injection.

Significant changes in concentration in the myocardium or redistribution 99mTc-tetrofosmin is not observed, therefore images can be obtained for at least 4 hours after the injection.

For a planar image, standard projections are used (front, LAO 40°- 45°, LAO 65-70 ° and / or left side).

Radiation dosimetry

The absorbed dose of ionizing radiation for an adult patient (70 kg) after intravenous injection 99mTc-tetrofosmin is indicated in the table below.Evaluation was carried out under the condition of emptying the bladder every 3.5 hours.

After the introduction, frequent emptying of the bladder should be performed to minimize radiation exposure.

The dose of radiation (mGy / MBq)

Organ

Load

Peace

Wall of the gallbladder

3, ЗЕ-02

4,9Е-02

The upper part of the large intestine

2,0Е-02

3,0Е-02

Lower part of large intestine

1.5Е-02

2.2E-02

The wall of the bladder

1,6E-02

1.9Е-02

Small intestine

1.2Е-02

1.7Е-02



Kidneys

1,0Е-02

1, ЗЕ-02

Salivary glands

8,0Е-03

1,2Е-02

Ovaries

7,9Е-03

9,6Е-03

Uterus

7, ZE-03

8,4Е-03

Bone surface

6,2Е-03

5,6Е-03

Thyroid

4, ЗЕ-03

5,8Е-03

Pancreas

5,0Е-03

5,0Е-03

Stomach

4,6Е-03

4,6Е-03

Adrenal glands

4, ЗЕ-03

4.1 E-03

Red marrow

4DE-03

4,0Е-03

Heart wall

4.1 E-03

4,0Е-03

Spleen

4,1Е-03

3,8Е-03

Muscles

3,5Е-03

3, ЗЕ-03

Eggs

3,4Е-03

HERE-03

Liver

3,2Е-03

4,2Е-03

Thymus

3.1E-03

2,5Е-03

Brain

2,7Е-03

2,2Е-03

Lungs

2, ЗЕ-03

2DE-03

Leather

2,2Е-03

1,9Е-03

Mammary gland

2,2Е-03

1,8Е-03

The effective dose (mSv / MBq)

6,0Е-03

7,2Е-03


The effective dose obtained after the introduction of 800 MBq at rest is 5.7 mSv (for an adult patient weighing 70 kg)

Absorbed by the heart at rest, the dose of ionizing radiation is 4.0E-03 mGy / MBq and after the load - 4.1E-03 mGy / MBq. The dose of radiation absorbed by mammary glands is 1,8E-03 mEur / MBq.The absorbed dose of ionizing radiation of the bladder (during emptying every 3.5 hours) after a load is 1.6e-02 mGy / MBq and 1,9E-02 mGy / MBq at rest.

Sodium 99mTc-pertechnetate for injection is obtained from 99Mo /99mTc generators. Energy of gamma radiation 99mTc is 141 keV, and the half-life is 6.02 hours.

Procedure of solution preparation 99mTc-tetrofosmin:

The procedure should be performed under aseptic conditions:

1. The bottle is placed in a protective container, disinfected the stopper from chlorobutyl rubber with a tissue from the kit.

2. Enter a sterile needle (see Note, point a) through the treated stopper into the vial. Using a 10 ml sterile syringe with protection from ionizing radiation, the required sodium activity is introduced into the vial with protection from ionizing radiation 99mTc-pertechnetate * (previously diluted with 0.9% sodium chloride solution **) (see Note, paragraph b-d). Before removing the syringe from the vial, 5 ml of gas above the solution is drawn into it (see Note, p. E). Remove the needle from the vial. Shake the bottle to completely dissolve the lyophilizate.

3. Incubate at room temperature for 15 minutes.

4. Fill the attached sticker and fix it on the vial.

5. Store the prepared injection for 2-8 ° C and use for 12 hours after preparation.

Dispose of any unused material in designated areas.

* for preparation of the preparation of the proper quality, it is necessary to use an eluate conforming to the specifications given in Heb. Farm.

** Use a solution that meets the specifications given in Brit. Farm.

Notes:

a) Needles 1 can be used9G or 26G

b) Sodium 99mTc-pertechnetate, used for dissolution, should contain less than 5 μg of aluminum.

at) Volume of diluted sodium 99mTc-pertechnetate, added to the vial, should be within 4-8 ml.

d) Volumetric activity of diluted sodium 99mTc-pertechnetate after dissolution of the drug in the vial should not exceed 1.5 GBq / ml.

e) To prepare a solution with a volume of more than 6 ml, the remaining space in the bottle above the solution is less than 5 ml of added air. In these cases, the extraction of 5 ml of gas ensures that the entire space above the solution is replaced by air.

(e) The pH of the prepared preparation is 7.5-9.0
Side effects:

Undesirable reactions associated with the use of 99mTc-tetrofosmin, are very rare (less than 1 case per 10000).

After administration, the following adverse reactions are possible:

From the immune system: edema of the face, hypersensitivity reactions, allergic reactions, anaphylactic reactions.

From the nervous system: headache, dizziness, metallic taste, impaired sense of smell and taste.

From the side of the vascular system: hyperemia, hypotension.

On the part of the respiratory system and the organs of the mediastinum: dyspnoea.

From the gastrointestinal tract: nausea, vomiting, burning sensation in the mouth. Skin: urticaria, pruritus, erythematous rash.

Organism as a whole: sensation of heat.

Laboratory test data: increase in the number of leukocytes.

Some reactions may be delayed, up to several hours after administration 99mTc-tetrofosmin. There are reports of single cases of serious reactions, including anaphylactic reactions (less than 1 per 100,000) and severe allergic reactions (also a single message).

Becausethe amount of injected substance is very small, the main danger is ionizing radiation. Ionizing radiation can cause cancer and genetic disorders.

Most studies in nuclear medicine are conducted using low radiation doses, less than 20 mSv, so the expected incidence of adverse reactions is very low. The effective dose is 8.5 mSv, while the maximum recommended activity is 1200 MBq.

Overdose:

In case of an overdose, urinary frequency and defecation should be stimulated to reduce the radiation burden on the patient.

Interaction:

Studies of interaction with other drugs have not been conducted. However, there were no reports of the interaction of Miovyu with other drugs that patients were taking. Medications that affect the function or blood supply of the myocardium, such as beta-blockers, calcium antagonists or nitrates, can lead to false-negative results. In this case, the results of the study should be considered taking into account current therapy.

It is not recommended to mix Miovyu with other medicines,which are listed in the section "Procedure for the preparation of solution 99mT c-tetrofosmin. "

Special instructions:

The use of the drug may cause hypersensitivity reactions, including anaphylactic and anaphylactoid reactions. In case of their occurrence, it is necessary to have the necessary drugs and equipment for immediate medical care.

At a scintigraphy of a myocardium at peak of loading contraindications connected with an induction of stress should be considered.

For each patient, the effects of ionizing radiation should be justified in view of the expected positive effect. The radioactivity of the drug administered should be such that the final radiation is as low as possible to obtain the required diagnostic result.

The drug should be used by qualified personnel in appropriate clinical conditions aseptic in accordance with the requirements of Good Manufacturing Practice (GMP). The receipt, storage, use, movement and destruction must be in accordance with national rules for ensuring radiation safety.

The introduction of radiopharmaceuticals creates risks of external radiation contamination with urine, vomit, etc. Normal precautions should be followed when working with radioactive materials.

After use, all materials associated with the preparation and administration of radiopharmaceuticals, including unused product residues and containers, must be decontaminated or disposed of in accordance with applicable law.

Before using the drug, to confirm the quality, it is necessary to determine the radiochemical purity of the preparation according to the procedure described below:

Determination of radiochemical purity

To confirm the quality of the drug before use, it is necessary to determine its radiochemical purity by the following procedure:

Equipment and reagents:

1. Strips GMCP-SA* for thin-layer chromatography (2cm x 20cm). - Do not heat.

2. Columns for ascending chromatography with a cover.

3. A mixture of acetone and dichloromethane in a volume ratio of 65: 35% (freshly prepared).

4. 1 ml syringe with needles 22-25G.

5. Suitable counting equipment.

* microfine-glass chromatographic paper treated with silicic acid

To determine the radiochemical purity of the drug solution, it is necessary to use a chromatographic system of a mixture of acetone and dichloromethane in a volume ratio of 65: 35%. The mixture is placed in a chromatographic chamber (1 cm layer thickness) and closed to establish equilibrium. On the chromatography strip GMCP-SA (2 cm x 20 cm) make pencil marks at a distance of 3 cm from the bottom edge (the start line) and an ink marker at a distance of 15 cm from the line of the pencil (finish line). The pencil mark indicates the place of application of the sample, and the erosion of the boundaries of the ink line will show the position of the solvent front when the upward elution should be completed. At a level of 3.75 cm and 12 cm above the start line (Rfs 0.25 and 0.8, respectively) to make cutoffs. Using a 1 ml syringe with a needle, take 10 μl of the prepared sample and transfer to a strip. The sample should not be in contact with the mark with a pencil. Without letting the stain dry, immediately place the strip in a chromatographic chamber and cover with a lid. Make sure that the strip does not stick to the wall of the chamber.

Note: 10 μl of the sample form a spot with a diameter of approximately 10 mm.Other volumes of the sample show unreliable values ​​of radiochemical purity.

When the solvent reaches the ink mark, the strip is removed from the chamber and dried. The strip is cut into 3 parts according to previously noted incisions and the activity of each of them is measured on the counting equipment. It is necessary to try to use the same geometric parameters for each segment and minimize the loss of time.

The radiochemical purity is calculated by the formula:

Activity of the central part of the segment

% 99mTc-tetrofosmin =---------------------------------------- x 100

Total activity of all 3 segments

Note: Free 99mTc-pertechnetate tends to the upper part of the strip, 99mTc-tetrofosmin - to the center of the segment. The reconstituted hydrolyzed 99mTc and other hydrophilic impurities remain at the beginning of the column.

Do not use the drug if the radiochemical purity is less than 90%.

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

The effect of using the drug in applying it in accordance with the instruction for medical use on the ability to drive vehicles, as well as machines and mechanisms, has not been established.

Form release / dosage:

3.38 mg of lyophilizate for the preparation of a solution for intravenous administration.

Packaging:BColorless transparent bottle with a capacity of 10 ml, closed with a plug of chlorobutyl rubber and crimped aluminum cap.

For 2 or 5 bottles complete with disinfecting napkins (2 or 5), stickers (2 or 5) and instructions for medical use are placed in a cardboard box.

Storage conditions:

List B.

Store at 2-8 ° C (both before and after dissolving).

Keep out of the reach of children.

Shelf life:

35 weeks.

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

The finished product should be used within 12 hours.

Terms of leave from pharmacies:For hospitals
Registration number:П N015452 / 01
Date of registration:24.03.2009
The owner of the registration certificate:JI Halskea LimitedJI Halskea Limited United Kingdom
Manufacturer: & nbsp
JI Halskea Limited United Kingdom
Representation: & nbspJI Halskea LimitedJI Halskea Limited
Information update date: & nbsp27.09.2015
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