Irland - engelsk - HPRA (Health Products Regulatory Authority)

mediam - medronic acid; stannous fluoride - powder for solution for infusion - 4.0 mg/6.8 milligram(s) - technetium (99mtc) compounds; technetium (99mtc) stannous agent labelled cells

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

landauer radiopharmaceuticals pty ltd - stannous chloride dihydrate, quantity: 19.2 microgram/ml - injection, powder for - excipient ingredients: sodium citrate dihydrate; glucose - technetium tc99m- labelled red blood cells are used for cardiac first pass & gated equilibrium imaging

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited - sodium pertechnetate(99mtc), quantity: 18.5 gbq - injection, solution - excipient ingredients: water for injections; sodium chloride - technetium [99mtc] generator is used for the preparation of sodium pertechnetate 99m tc injection. sodium pertechnetate 99mtc is used as an agent for: brain imaging, thyroid imaging, salivary gland imaging, blood pool imaging.

USA - engelsk - NLM (National Library of Medicine)

medi-physics inc. - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - technetium tc-99m exametazime 0.5 mg in 5 ml - technetium tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. none known. the technetium tc99m labeling reaction involved in preparing technetium tc99m exametazime injection depends on maintaining tin in the divalent (reduced) state. any oxidant present in the sodium pertechnetate tc99m employed may adversely affect the quality of the preparation. sodium pertechnetate tc99m containing oxidants should not be used for the preparation of the labeled product. to meet the last requirement, a generator must be eluted within 24 hours prior to obtaining any elute for reconstitution with the ceretec kit. sodium chloride injection, usp must be used as the diluent. do not use bacteriostatic sodium chloride as a diluent for sodium pertechnetate tc99m injection because it will increase the oxidation products and adversely affect the biological distribution of ceretec. the contents of the ceretec vial are sterile and pyrogen free. the vial contains no bacteriostatic preservative. it is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical. technetium tc99m exametazime injection, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. care should be taken when handling blood specimens to be labeled using this radiopharmaceutical. even if the subject has been tested, no method can offer complete assurance that hepatitis b virus, human immuno-deficiency virus (hiv) or other infectious agents are absent. all human blood samples should be considered potentially infectious. precautions for handling are as those for handling radioactive materials. note: do not use this procedure for leukocyte labeling. see procedure for the radiolabeling of autologous leukocytes with technetium tc99m exametazime injection. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. radiochemical purity determination must be performed before administration to the patient. three potential radiochemical impurities may be present in the prepared injection of the lipophilic technetium tc99m exametazime complex. these are a secondary technetium tc99m exametazime complex, free pertechnetate, and reduced-hydrolyzed-technetium tc99m. a combination of 3 chromatographic systems is necessary for the complete definition of the radiochemical composition of the injection. the following protocol has been designed to enable analysis of the radiochemical purity of ceretec (99mtc-exametazime). it should be started within 2 minutes of reconstitution. the entire procedure takes approximately 15 minutes. secondary tc exametazime complex and reduced-hydrolyzed-tc remain at the origin. lipophilic tc exametazime complex and pertechnetate migrate at rf 0.8-1.0. lipophilic-tc exametazime complex, secondary tc exametazime complex and reduced-hydrolyzed-tc remain at the origin. pertechnetate migrates at rf 0.8-1.0. reduced-hydrolyzed-tc remains at the origin. lipophilic tc exametazime complex, secondary tc exametazime complex and pertechnetate migrate at rf 0.8-1.0.

Nederland - nederlandsk - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

mediam - dinatriummedronaat samenstelling overeenkomend met; medroninezuur; tin(ii)fluoride; - poeder voor oplossing voor injectie - technetium (99m tc) stannous agent labelled cells

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

australian nuclear science and technology organisation t/a ansto - sodium pertechnetate(99mtc), quantity: 370 gbq - injection - excipient ingredients: water for injections; sodium chloride - sodium pertechnetate [99mtc] is used for scintigraphy, principally of the brain and thyroid. it can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

australian nuclear science and technology organisation t/a ansto - sodium pertechnetate(99mtc), quantity: 20 gbq - injection, solution - excipient ingredients: water for injections; sodium chloride - indications: sodium pertechnetate [99mtc] is used for scintigraphy, principally of the brain and thyroid. it can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - sodium pyrophosphate, quantity: 30 mg - injection, powder for - excipient ingredients: stannous chloride - indications as at 25 september: technetium (99mtc) labelled erthrocytes are used in the non invasive evaluation of cardiac ventricular function and heart wall motion.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - pentetic acid, quantity: 5 mg - injection, powder for - excipient ingredients: stannous chloride - indications as at 25 september 1996: technetium (99mtc) pentetate may be used as a renal perfusion imaging pharmaceutical.

Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

national centre for nuclear research (0000009483) andrzeja soltana str. 7, otwock, 05-400 - sodium pyrophosphate decahydrate - powder for injection - 13.40mg/vial - sodium pyrophosphate decahydrate (0013472361) 13,4mg - technetium (99mtc) stannous agent labelled cells