Country: Denmark
Language: Danish
Source: Lægemiddelstyrelsen (Danish Medicines Agency)
Bacitracin, BENZYLPENICILLINKALIUM, NEOMYCIN
Pharmaxim Sweden AB
QJ51RC
Bacitracin, BENZYLPENICILLINKALIUM, NEOMYCIN
intramammær salve
Kvæg
17 JUNE 2016 SUMMARY OF PRODUCT CHARACTERISTICS FOR NANOSCAN, KIT FOR RADIOPHARMACEUTICAL PREPARATION 1. NAME OF THE MEDICINAL PRODUCT NanoScan 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance Human Serum Albumin nano sized colloid 500 micrograms. At least 95 % of human albumin colloidal particles have a diameter ≤ 80 nm. NanoScan is prepared from human serum albumin derived from human blood donations tested according to the EEC Regulations and found non-reactive for: - hepatitis B surface antigen (HBsAg) - antibodies to human immunodeficiency virus (anti-HIV 1/2) - antibodies to hepatitis C virus (anti-HCV) The radionuclide is not part of the kit. Excipient(s) with known effects: Sodium: 0.045 mmol For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. White powder. Powder for solution for injection. To be reconstituted with sodium pertechnetate ( 99m Tc) solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with sodium ( 99m Tc) pertechnetate solution, the solution obtained is indicated in adults, children aged 1 to 18 years and neonates for: _00110_spc.docx_ _Page 1 of 15_ _Intravenous administration:_ Bone marrow scanning (The product is not suitable to study the haematopoietic activity of the bone marrow) Inflammation scanning in areas other than the abdomen _Subcutaneous administration:_ Conventional lymphoscintigraphy to demonstrate integrity of the lymphatic system and differentiation of venous from lymphatic obstruction Sentinel node detection in: o Melanoma malignum o Breast cancer 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended activities in adults are as follows: - Bone marrow scanning: 185-500 MBq as a single intravenous injection. - Inflammation scanning: 370-500 MBq as a single intravenous injection. _Subcutaneous administration:_ - Conventional lymphoscintigraphy: The recommended activity by single or mu Read the complete document