Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Amphotericin B USP
CIPLA MALAYSIA SDN BHD
Amphotericin B USP
1Units Units
CIPLA LTD
• INSTRUCTIONS / REMARK: ---------- FILE LOADED IN SERVER SECTION HEAD CORDINATOR ARTIST CHECKED BY PHARMA CODE 2D CODE QR CODE BAR CODE ARTWORK SPELL CHECK PACKAGING DEVELOPMENT PRODUCT NAME: Photericin B Injection MATERIAL NO.: xxxxxxxx ITEM: Leaflet VERSION: 01 DATE: 20-04-2018 CO-ORDINATOR: Shruti ARTIST: Vasundhara SOFTWARE: Illustrator CC ACTUAL SCALED Black FONTS: ------ COLOURS: BLUE WOOL TEST VALUE 5-8 (LIGHT FASTENING DATA) VARNISH: MATERIAL: 54 GSM Maplitho Paper ACTUAL SIZE: 140 x 180 mm GRAIN DIRECTION : Parallel to length PATH: PC:/D:/Vasundhara/Malaysia/Photericin B/xxxxxxxx Photericin B Injection Leaflet Malaysia.ai INK: Oil based Ink from DIC OR MICRO SCREEN : # __ SUPERSEDES: 21066501 LINKS: -------- PHARMACODE: ---_MINI ARTWORK PRINT SIZE: DESIGN: Unfolded SIZE AFTER FOLDING: ----- • Any deviation must be brought to the notice of packaging development co-ordinator immediately. • For any clarification, please contact packaging development co-ordinator immediately. NO CHANGES IN ARTWORK SHOULD BE DONE BY THE PRINTER • The printer should verify the e-proof against the approved artwork before submitting for approval and the e-proof should have printer details . xxxxxxxx For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory PHOTERICIN B INJECTION 50 MG/VIAL (Amphotericin B for Injection USP) COMPOSITION Each vial contains Amphotericin B USP………….50 mg As sterile freeze dried powder for reconstitution DESCRIPTION Yellow to orange powder/cake filled in glass vial DESCRIPTION OF RECONSTITUTED SOLUTION Yellow to orange coloured, clear solution Route of Administration: Single dose Intravenous administration only. PHARMACOLOGY PHARMACODYNAMICS MICROBIOLOGY Amphotericin B shows a high order of _in vitro _activity against many species of fungi. _ Histoplasma capsulatum, Coccidioides immitis, Candida _ species, _Blastomyces dermatitidis, Rhodotorula, Cryptococcus neoformans,_ _ Sporothrix _ _schenckii, Mucor mucedo, _ and _ Aspergillus fumigatus _ are all inhibite Læs hele dokumentet