Photericin B Injection 50 mgvial

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Hent Produktets egenskaber (SPC)
23-04-2018

Aktiv bestanddel:

Amphotericin B USP

Tilgængelig fra:

CIPLA MALAYSIA SDN BHD

INN (International Name):

Amphotericin B USP

Enheder i pakken:

1Units Units

Fremstillet af:

CIPLA LTD

Produktets egenskaber

                                • 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
                                
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