Rezoscan, 99mTc - instructions for use, dose, side effects, contraindications

Active substances: Technetium-99m 185-740MBq, Zoledronic acid 0.3mg, Tin dichloride anhydrate 0.066mg, Sodium chloride 9.0mg, Water for injection up to 1.0ml.

Description:

Lyophilizate:

White or almost white lyophilizate in the form of a cake or individual aggregates, or in the form of a powder.

Ready-mixed solution:

Colorless transparent liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool.

ATX: & nbsp

M.05.B.A.08 Zoledronic acid

Pharmacodynamics:

Zoledronic acid labeled 99mTc, has a high tropism to the bone tissue. The basic substance of the lyophilisate is bisphosphonate - zoledronic acid, which has the maximum affinity for areas of increased metabolism and accelerated resorption in bone tissue.

Pharmacokinetics:

Studies of the pharmacokinetics of zoledronic acid labeled with 99mTc showed that its distribution is characterized by pronounced osteotropism against the background of a high rate of excretion from organs, tissues and the whole body. The peak concentration of the drug in the main organs and tissues, including the kidneys, is observed after 10 min. after administration. In the bladder, the peak concentration is noted 1 hour after the administration. The maximum accumulation of the drug in the skeleton (up to 40% of the injected activity) is observed 1 to 2 hours after administration. High accumulation of the drug in the skeleton persists up to 8 -12 hours of observation.

Zoledronic acid labeled 99mTc, is characterized by a high rate of excretion. The level of activity in the blood after administration does not exceed 1% and is already 4 to 5 minutes. decreases to trace values. 1 hour after the injection, up to 20% of the drug is excreted from the body with urine, there is a significant decrease in the level of the isotope in the kidneys, liver, skeletal muscles and throughout the body.

Features of the pharmacokinetics of zoledronic acid labeled 99mTc, which is characterized by a fast rate of excretion, against the background of high affinity for sites of increased metabolism and accelerated resorption in bone tissue, explain the possibility of conducting osteoscintigraphy, already 1 hour after the introduction, providing a qualitative visualization of the skeleton.

Indications:

The drug Resozcan,^99mTc is used to identify foci of pathological resorption and areas of increased metabolism in bone tissue with various pathological processes in the skeleton:

to identify and identify lytic, mixed and blast metastases in the skeleton, with malignant tumors of various origin and prevalence,
with osteomyelitis, osteoarticular tuberculosis, osteoporosis, various osteoarticular degenerative processes, including arthritis and arthrosis of various origin,
for the selection of specific therapy for bone lesions with zoledronic acid preparations and for monitoring the effectiveness of treatment.

Contraindications:

Hypersensitivity to the drug or its components. The drug is not recommended for patients under the age of 18 years.

Pregnancy and lactation:

The drug is contraindicated in pregnancy. Breastfeeding mothers should refrain from breastfeeding the baby within 24 hours after the administration of the drug.

Dosing and Administration:

The drug is administered intravenously. Dosage is carried out in accordance with the objectives of the study and the nature of the methods performed, as well as the technical characteristics of the equipment used. As a rule, the administered dose is 5 MBq per 1 kg of body weight.

Preparation of Resozcan, ^99mTc

5 ml eluate from technetium-99 generatorm with a volume activity 185 -740 MBq / ml aseptically injected with a syringe into the vial with the lyophilisate, the needle piercing the rubber stopper;

if necessary in advance dilute the eluate with an isotonic solution of sodium chloride to the required volume activity;

the contents of the vial are stirred by shaking until the lyophilizate is completely dissolved;

the drug is ready for use in 20 minutes. after cooking;

A ready-made preparation prepared on the basis of a lyophilizate contained in a single vial can be used to study 5 patients.

Methods of conducting the survey.

The study is carried out using a gamma camera using whole-body scintigraphy in the anterior and posterior projections 1-2 hours after the administration of the preparation with mandatory pre-emptying of the bladder.

Interpretation of the results of the study is carried out by estimating the distribution of the drug in the skeleton. Zones of pathological changes in bone tissue are characterized by foci of hyperfixation of the drug Resozcan,^99mTc.

Radiation loads on the organs and entire body of the patient when using the drug Resoscan,^99mTc

№	Organs	Dose (rad / MBq)
1	Stomach	1.5x10^-4
2	Lungs	Z.8 x10^-4
3	Kr.ost. brain	1.0x10^-3
4	Ovaries	3.6 x10^-4
5	Testes	2.4 x10^-4
6	The superior part of the large intestine	2.1 x10^-4
7	Lower part of large intestine	3.8x10^-4
8	Bladder	2.3x10^-2
9	Liver	2.3x10^-4
10	Thyroid	1.5x10^-4
11	Breast	8.5x10^-5
12	Bones	7.0x10^-3
13	Leather	1.0x10^-4
14	Small intestine	2.4x10^-4
15	Kidneys	1.4x10^-3
16	Skeletal muscles	2.1x10^-4
17	Pancreas	2.1x10^-4
18	Spleen	1.9x10^-4
19	The whole body (remains)	2.5x10^-4
20	A heart	2.4x10^-4
21	Adrenal glands	2.8x10^-4
22	Brain	1.7 x10^-4
23	Gallbladder	1.9 x10^-4
24	Thymus	1.3x10^-4
25	Uterus	6.1x10^-4
The effective dose (mSv / MBq) is 0.0016

Side effects:

Allergic reactions are possible.

Overdose:

Overdose of the drug is unlikely in connection with the careful control of the injected activity in the conditions of a specialized hospital.

Interaction:

In the dosages used, no interaction with other drugs was noted.

Special instructions:

Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010), "Radiation Safety Standards" (NRB - 99/2009) and guidelines "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics with the help of radiopharmaceuticals "(MU 2.6.1.1892-04).

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

The study of the effect of the drug on the ability to drive vehicles and work with complex mechanisms was not carried out.

Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration.

Packaging:

According to 1.83 mg of lyophilizate in bottles of dark neutral glass a capacity of 10 ml, hermetically sealed with stoppers made of rubber and caps of aluminum-plastic.

1 or 5 vials with lyophilizate are placed in a contour mesh package made of a polyvinyl chloride film.

1 circuit cell pack together with instructions for medical use is placed in a cardboard box.

Storage conditions:

The lyophilizate is stored in a dry, dark place at a temperature of 2 ° C to 8 ° C.

The finished product is stored at a temperature of no higher than 25 ° C in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010).

Keep out of the reach of children.

Special precautions when destroying an unused product:

Destruction of the unused preparation should be carried out in accordance with the sanitary regulations of SP 2.6.1.2612-10 "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB 99/2010).

Shelf life:

Lyophilizate - 18 months.

Ready-made preparation - 5 hours from the time of preparation.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-003095/09

Date of registration:22.04.2009

The owner of the registration certificate:FARM-SYNTHESIS, CJSC FARM-SYNTHESIS, CJSC Russia

Manufacturer: & nbsp

FARM-SYNTHESIS, CJSC Russia

Information update date: & nbsp18.10.2015

Illustrated instructions

Instructions

Resozcan, 99mTc (Rezoscan, 99mTc)