India - Engels - Central Drugs Standard Control Organization

techyon bio. - tab - 10

India - Engels - Central Drugs Standard Control Organization

techyon bio. - cap - 10

India - Engels - Central Drugs Standard Control Organization

techyon bio. - tab - 10

India - Engels - Central Drugs Standard Control Organization

techyon bio. - tab - 10

Verenigde Staten - Engels - NLM (National Library of Medicine)

medi-physics inc. dba ge healthcare. - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - exametazime 0.5 mg in 5 ml - technetium tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. tc99m exametazime 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: 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. % bottom of saline strip – % bottom of mek strip (= % lipophilic exametazime complex) % top of saline strip (= % pertechnetate) % bottom of whatman no. 1 paper strip (= % reduced-hydrolyzed-tc) a radiochemical purity of >80% may be expected provided the measurement has been carried out within 4 hours of reconstitution for stabilized ceretec and 30 minutes for ceretec used for wbc labeling. 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.

Singapore - Engels - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - microbiology - it is a qualitative and semi-quantitative test which uses a simple agglutination technique to detect the capsular polysaccharide of cryptococcus neoformans, glycuronoxylomannan (gxm), in biological fluids (serum,csf, bal, urine).

Singapore - Engels - HSA (Health Sciences Authority)

bio-rad laboratories (singapore) pte ltd - microbiology - the fast test device uses the immunochromatography (ict or lateral migration) technique to detect anti-hiv-1 and anti-hiv-2 antibodies in human serum, plasma, venous blood and capillary blood. this kit is not intended for blood donor screening. any sample found to be reproducibly positive must be confirmed using an appropriate method (western-blot or equivalent) to prove the presence of anti-hiv antibodies.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

agilent technologies australia pty ltd - ct215 - biological stain ivds - dyes, chemicals, stains or solutions that are intended to be used specifically as an ivd, either alone or in combination with others, for the visualisation of structures and/or other intra/extracellular elements in biological tissues. the staining kits are class 2

Australië - Engels - Department of Health (Therapeutic Goods Administration)

agilent technologies australia pty ltd - ct215 - biological stain ivds - dyes, chemicals, stains or solutions that are intended to be used specifically as an ivd, either alone or in combination with others, for the visualisation of structures and/or other intra/extracellular elements in biological tissues.

Maleisië - Engels - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

quantarad technologies sdn bhd - sodium pertechnetate (radioactive) -