Gallium citrate, 67Ga - instructions for use, dose, side effects, contraindications

Active substanceGallium [67Ga] citrateGallium [67Ga] citrate

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Gallium citrate, 67Ga

solution in / in

Federal Center for Design and Development of Nuclear Medicine Facilities of FMBA of Russia, FSUE Russia

Dosage form: & nbspsolution for intravenous administration

Composition:In 1 ml of the drug contains:

Active substances: gallium-67 not less than 185 MBq

Excipients: sodium citrate 5.5-aqueous 28.5 mg, sodium chloride 4.6 mg, water for injection up to 1.0 ml

Description:Colorless transparent liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool

ATX: & nbsp

V.09.H.X Other radiopharmaceuticals for the diagnosis of inflammation and infections

Pharmacodynamics:Physicochemical characteristics

Gallium citrate,⁶⁷Ga is a chemical compound of sodium citrate with radionuclide Ga-67 in the form of a sterile solution, ready for use, with pH = 5-6. Radionuclide⁶⁷Ga with a half-life of 78.26 hours emits gamma quanta with energies of 0.091 (3.0%) during decay; 0.093 (37.0%); 0.185 (20.7%); 0.209 (2.3%); 0.300 (16.6%); 0.393 (4.6%) MeV.

Pharmacokinetics:Gallium citrate,⁶⁷Ga actively accumulates in the primary and metastatic malignancies, as well as in the foci of the nonspecific inflammatory process, which allows the use of the drug for the diagnosis of malignant neoplasms.

After intravenous administration of Gallium Citrate,⁶⁷Ga is slowly removed from the bloodstream. After 24 hours after administration, about 10% of the drug remains in the blood.Accumulation in the liver 3-5 hours from the time of administration reaches 10-12% and remains at this level until 48 hours, after which it slowly decreases. Within 72 hours, about 50% of the administered amount of Gallium Citrate is excreted from the body,⁶⁷Ga. Excretion occurs through the hepatobiliary and urinary systems, approximately in equal amounts.

Indications:For the diagnosis of systemic malignant lymphoproliferative diseases (lymphogranulomatosis, Beck's sarcoidosis, etc.), primary and metastatic lung tumors, soft tissue sarcoma.

Contraindications:Pregnancy, breast-feeding. Presence of hypersensitivity to the drug or its components.

Pregnancy and lactation:Contraindicated use of the drug.

Dosing and Administration:The drug is administered intravenously at a rate of 1.5-2.0 MBq per 1 kg of body weight. Scintigraphic examination is carried out 24-48 hours after the administration of the drug. The criterion testifying to the pathological increased fixation of the drug in some parts of the organs and tissues under investigation is the coefficient of differential accumulation of more than 1.3 relative to the areas with normal accumulation within one or a pair organ.

Radiation load on the organs and entire body of the patient when using the drug Gallium Citrate,⁶⁷Ga.

Organs and Systems	Absorbed dose, mGy / MBq
Red marrow	0,12
Ovaries	0,09
Testes	0,05
Liver	0,11
Kidneys	0,11
Bladder	0,06
Skeleton	0,32
Total body (effective equivalent dose) m3v / MBq	0,1

Side effects:Any side effects when using Gallia Citrate,⁶⁷Ga is not detected, however, allergic reactions may occur.

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 requirements of the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), "Radiation Safety Standards" (NRB-99) and the Guidelines "Hygienic Requirements for Radiation Safety during Radionuclide Diagnosis with Radiopharmaceuticals "(MU 2.6.1, 1892-04).

Form release / dosage:Solution for intravenous administration 400 and 800 MBq.

Packaging:Solution for intravenous administration 400 and 800 MBq for the set delivery date in hermetically sealed vials.

A vial with a passport and instruction for medical use in a package transport packaging for radioactive substances.

Storage conditions:The drug is stored in accordance with the requirements of OSPORB-99.

Shelf life:10 days from the date of manufacture.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:P N001744 / 01

Date of registration:15.08.2008 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:Federal Center for Design and Development of Nuclear Medicine Facilities of FMBA of Russia, FSUE Federal Center for Design and Development of Nuclear Medicine Facilities of FMBA of Russia, FSUE Russia

Manufacturer: & nbsp

Plant Medradiopreparat branch Federal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA Russia

Information update date: & nbsp13.03.2017

Illustrated instructions

Instructions

Gallium citrate, 67Ga (Gallium citrate, 67Ga)