Country: নরওয়ে
ভাষা: নরওয়েজীয়
সূত্র: Statens legemiddelverk
Albumin humant serum makroaggregater ad Tc-99m makroalbumin
Curium Netherlands B.V.
V09EB01
Albumin human serum macro aggregates by Tc-99m macroalbumin
Pulver til injeksjonsvæske, oppløsning
Hetteglass 5x2 mg
C
Markedsført
1999-11-01
18 APP 4378 Norway SPC 15052019_tc 1 NAME OF THE MEDICINAL PRODUCT TechneScan LyoMAA, Powder for suspension for injection/kit for radiopharmaceutical preparation. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per vial: Macroaggregates of human serum albumin: 2.0 mg In the labelled product the distribution of particle size (largest dimension) is as follows: 95 % of the particles is between 10 and 100 µm, of which the large majority is between 10 and 90 µm and less than 0.2 % of the particles is between 100-150 µm. No particles are larger than 150 µm. The number of particles per vial is 4.5 x 10 6 . The product is prepared from batches of human albumin but has been screened for hepatitis B surface antigen (HBsAg), antibodies for human immunodeficiency virus (anti-HIV) and antibodies for hepatitis C virus (anti-HCV). The radioisotope is not part of the kit. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation Powder for solution for injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. - Pulmonary perfusion scintigraphy - As secondary indication 99m Tc-albumin macroaggregates may be used for venoscintigraphy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended activities to be administered intravenously to an adult weighing 70 kg vary between 37-185 MBq (1-5 mCi). The number of particles per administered dose must be in a range of 60 x 10 3 -700 x 10 3 . The lung test may start immediately after injection. The activity to be administered in children should be a fraction of the adult activity and should be calculated according to the following equation: Paediatric dosage (MBq) = Adult dosage (MBq) x Child weight (kg) 70 Although body weight is the more used factor on which to base the adjustment of the activity administered, in a limited number of cases the body surface area may be considered to be more appropriate. Paediatric dosage (MBq) = Adult dosage (MBq) x Child body surface (m 2 ) 1.73 18 APP 4 সম্পূর্ণ নথি পড়ুন