Abelcet

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Amphotericin B 5 mg/mL (As a lipid complex; For manufacture see DMF TT60-104-24-4);  

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Amphotericin B 5 mg/mL (As a lipid complex; For manufacture see DMF TT60-104-24-4)

Dosering :

5 mg/mL

Legemiddelform:

Emulsion for infusion

Sammensetning:

Active: Amphotericin B 5 mg/mL (As a lipid complex; For manufacture see DMF TT60-104-24-4)   Excipient: Dimyristoylphosphatidylcholine Dimyristoylphosphatidylglycerol as sodium and ammonium salts Sodium chloride Water for injection

Enheter i pakken:

Vial, glass, single dose, 20 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Xellia Pharmaceuticals ApS

Indikasjoner:

ABELCET is indicated for the treatment of invasive fungal disease caused by organisms susceptible to amphotericin B.

Produkt oppsummering:

Package - Contents - Shelf Life: Vial, glass, single dose, - 20 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisasjon dato:

1999-04-30

Preparatomtale

ABELCET – Data Sheet 
Page 1 of 13 
NEW ZEALAND DATA SHEET 

ABELCET
®

_(AMPHOTERICIN LIPID COMPLEX) SOLUTION FOR INFUSION _
_ _
_ _
DESCRIPTION 

ABELCET
®
 is a sterile, pyrogen-free suspension in
isotonic saline. It consists of 
amphotericin, of which amphotericin
B is the major component, in a complex with 
phospholipids. Amphotericin
is a macrocyclic, polyene, broad-spectrum antifungal 
antibiotic produced by_ Streptomyces nodosus._ The lipophilic moiety of amphotericin 
B allows molecules of the drug to be complexed in a ribbon-like
structure with the 
phospholipids. 

The chemical structure of amphotericin B is as follows: 

CAS Number: 1397-89-3 

ABELCET is supplied as a 20 mL suspension in a vial. Each
vial contains the 
equivalent of 100 mg of amphotericin B. Before
infusion, the suspension must be 
filtered using the filter needle provided (to remove any large
particles present) and 
then diluted with 5.0% glucose injection, according to the
Section below titled, 
_Preparation of the Suspension
for Infusion_. Each mL of ABELCET suspension 
contains: 

AMPHOTERICIN EQUIVALENT TO AMPHOTERICIN B 
5.0 mg 
DIMYRISTOYLPHOSPHATIDYLCHOLINE 
3.4 mg 
DIMYRISTOYLPHOSPHATIDYLGLYCEROL (AS THE SODIUM AND AMMONIUM 
SALTS) 
1.5 mg 
SODIUM CHLORIDE 
9.0 mg 
WATER FOR INJECTIONS, SUFFICIENT TO MAKE 
1.0 mL 

ABELCET – Data Sheet 
Page 2 of 13 
PHARMACOLOGY 
_ _
_PHARMACOKINETICS _

Amphotericin B is complexed to phospholipids in ABELCET. The
pharmacokinetic 
properties of ABELCET and conventional amphotericin B are
different. Amphotericin 
B when administered as ABELCET is rapidly distributed
to tissues. Limited human 
autopsy data showed that, after administration
of ABELCET, amphotericin B levels in 
tissue were highest in the liver, spleen and lung. Peak blood
levels of amphotericin B 
were low