Microsoft word - trad-pirofosfato.doc

PIROFOSFATO -Sn para marcaje con 99MTc

Pyrophosphoric acid, tetrasodium-tin chloride salt
product is fixed in only 60% of the cases. Fixation is not (PYROPHOSPATE)
stable in the case of threat or anguish syndrome. Pharmacological category
Pharmacokinetics
Pyrophosphate - 99mTc accumulates selectively in the damaged myocardium and in imperfect osteogenic Composition
zones of the skeleton. Uptake of this preparation is TEXT: The Pyrophosphate - 99mTc complex binds mainly to globulins and fibrinogen. Plasma concentration Decahydrate sodium pyrophosphate 84.0 mg reaches its maximum value 3-5 minutes after administration, with a half-life of 9.8 h. A total of 60% of the complex is excreted intact through the urine after 24 hours. The following table shows the dose absorbed in humans following an injection of 99mTc-Sn- Pharmacology
Radiation dose absorbed after an injection of 99mTc-Sn- Pyrophosphate -Sn is a complex consisting of Pyrophosphate and Sn2+. The 99mTc-Pirofosfato complex is formed by adding a solution of 99mTcO - vial containing the lyophilized, which exhibits marked attraction for normal bony tissue when administered intravenously. On the other hand, its distribution throughout the body reflects metabolic changes around lesions, a phenomenon which occurs before the accumulation and re-absorption of calcium by the bone and observable with a radiographic system. Therefore this procedure can be used for the early diagnosis of bone metastasis. The exact structure of the complex is Indications
Following the endovenous administration of a solution Used for In vivo labeling of circulating red blood cells of Pyrophosphate –Sn, Sn2+ diffuses into the red blood with 99mTc for visualizing the cavities of the heart using cells circulating in the system. When Na99mTcO4 is Gammagraphy and nuclear ventriculography; injectedi n the system, 99mTc is reduced with the visualization of the choroid plexus, diagnosis of occult subsequent formation of a chelate with the beta chain of the globulin molecule. The red blood is now labeled. After 15 minutes, approximately 98% of the activity is Contraindications
located in the red blood cells. After 18 hours, over 97% of the red blood cells have been labeled. Under these • Hypersensitivity to any of the components in the conditions, it is possible to obtain images of the choroid Tc-Sn-Pirofosfato accumulates in the mitochondria of muscle cells in areas where acute myocardial • This preparation should not be administered to infarction has occurred. During Gammagraphy of the nursing mothers as sodium pertechnetate99 is passed heart, pyrophosphate fixation intensity in septal infarcts dating less than 8 days is practically proportional to the Precautions
creatine-phosphokinase peak. After 8 days, fixation is either weak or null. In the case of primary infarcts, the CENTRO DE ISÓTOPOS: Ave. Monumental y Carretera La Rada, Km 3 ½ , Guanabacoa, Ciudad de la habana, Cuba.
Telef.: (53) (7) 682 1836 y 682 9524; Pizarra:(53) (7) 682 9563 al 70 ext. 176 y 112 Fax: (53) (7) 866 9821; (53) (7) 682 7850 E-mail: [email protected]
PIROFOSFATO -Sn para marcaje con 99MTc
• This preparation should be administered only by qualified personnel duly authorized to handle Dose
radioisotopes.
• Administer to pregnant women only when strictly Intravenous administration of the entire solution to necessary as it is not known if this patients weighing over 50kg. Administer half of the radiopharmaceutical can cause fetal damage or solution to patients whose body weight is less or equal to 50 kg. After 20 minutes, inject a solution of 99mTcO - Warnings
Overdose
• Make sure that both the patient and clinical staff working with radiopharmaceuticals receive as little There are no reports regarding the symptoms due to an overdose while using this product. Medial studies with • This preparation is sterile and non-pyrogenic and radionuclides are conducted using very small concentrations of the radiopharmaceutical which • Do not use after 2 hours following reconstitution. consequently have no pharmacological effects. The only possible effect resulting from an overdose would be the • Dot not administer through a plastic catheter or additional radiation of the patient. The dose absorbed from an injection of Pyrophosphate -99mTc is low and • Labeling reactions with 99mTc must keep tin ions in safe and consequently additional actions are not their reduced state and consequently Sodium required in the event of an overdose. Pertechnetate 99mTc injections containing oxidants Instructions for use
Interactions with other medications
Pour 4 - 5 ml of, sterile non-pyrogenic injection water into the vial with the lyophilized Pyrophosphate-Sn Low labeling efficiency has been reported due to the preparation. Eliminate the air in the needle as mush as co-administration of: digoxin; metyldopa, nifedipine, possible. Shake the vial for 1 or 2 minutes until the quinidine, prazosin and iodine contrast media. lyophilized has completely dissolved. The solution must Adverse reactions
Administration of radiopharmaceuticals to patients will inevitably generate a certain amount of radiation, The product is stored at 2- 80C. however somatic changes or genetic damage have After reconstitution, the preparation must be stored at been reported only during long term treatments room temperature in an armored lead casing. Although this risk may initially seem insignificant it must be borne in mind whenever treating a patient with Radiological safety measures
radiopharmaceuticals. The use of these preparations is justified as long as the benefits outweigh the possible The same measures normally used when handling open risks posed by the use of radioactive material. source diagnostic preparations, in keeping with the Allergic reactions due to the use of radiopharmaceuticals in most cases exhibit several clinical symptoms such as fever, flush, nauseas and a variety of rashes such as urticaria and erythema. Other types of allergic reactions associated with the
endovenous administration of the radiopharmaceuticals
Presentation:
such as pain or irritation at the administration site of the CENTRO DE ISÓTOPOS: Ave. Monumental y Carretera La Rada, Km 3 ½ , Guanabacoa, Ciudad de la habana, Cuba.
Telef.: (53) (7) 682 1836 y 682 9524; Pizarra:(53) (7) 682 9563 al 70 ext. 176 y 112 Fax: (53) (7) 866 9821; (53) (7) 682 7850 E-mail: [email protected]
PIROFOSFATO -Sn para marcaje con 99MTc


Registration No.:

CENTRO DE ISÓTOPOS: Ave. Monumental y Carretera La Rada, Km 3 ½ , Guanabacoa, Ciudad de la habana, Cuba.
Telef.: (53) (7) 682 1836 y 682 9524; Pizarra:(53) (7) 682 9563 al 70 ext. 176 y 112 Fax: (53) (7) 866 9821; (53) (7) 682 7850 E-mail: [email protected]

Source: http://www.centis.cu/documentos/especificacion/car_en243.pdf