AMPHOLIP Injection 50mg10ml

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

AMPHOTERICIN B

Tilgængelig fra:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

AMPHOTERICIN B

Enheder i pakken:

10ml1Units mL

Fremstillet af:

BHARAT SERUMS AND VACCINES LTD.

Produktets egenskaber

SIZE : L X H = 266 X 179 MM
SIZE : L X H = 133 X 179 MM
IN90006E4MY
_FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL
OR A LABORATORY_
PANTONE PROCESS BLACK C
Paper : 40 gsm, ITC Print Paper
Outlines & Cutting marks not to print
Back to Back Printing
2 Vertical & 2 Horizontal Folds
Artwork Code No. : IN90006E4MY
AMPHOLIP, Amphotericin B levels were higher in the liver and spleen.
Amphotericin B in AMPHOLIP was rapidly
distributed to tissues. The ratio of drug concentrations in tissues to
those in blood increased disproportionately
with increasing dose, suggesting that elimination of the drug from the
tissues was delayed. Peak blood levels of
Amphotericin B were lower after administration of AMPHOLIP than after
administration of equivalent amounts of
conventional drug. Administration of conventional Amphotericin B
resulted in much lower tissue levels than did
dosing with AMPHOLIP.
The rapid clearance and large volume of distribution of AMPHOLIP
result in a relatively low AUC and are
consistent with preclinical data showing high tissue concentrations.
The kinetics of AMPHOLIP is nonlinear.
PHARMACEUTICAL INFORMATIONS :
STORAGE CONDITIONS :
AMPHOLIP should be stored under refrigeration at 2°C to 8°C. Do not
freeze. Protect from direct exposure to
light.
PRESENTATION :
Single
dose
vials
containing
10ml
(50
mg
Amphotericin
B).
Each
vial
is
packed
individually
in
a
carton along with one 5µ filter needle and a pack insert.
Keep out of reach of children.
INCOMPATIBILITIES :
The use of any solution other than those recommended or the presence
of a bacteriostatic agent (eg. benzyl
alcohol) in the solution may cause precipitation of AMPHOLIP.
DATE OF REVISION :
th
25 Jan 2022.
MODE OF ADMINISTRATION :
Intravenous.
DESCRIPTION :
Yellow coloured suspension, which settles on keeping and gets
dispersed uniformly on mild shaking.
COMPOSITION :
Each
ml
of
the
suspension
contains
5.0mg
of
Amphotericin
B.
Additionally
it
contains
Dimyristoylphosphatidylcholine (DMPC), Dimyristoylphosphatidylglycerol
(DMPG), So