NOXAFIL ORAL SUSPENSION 40 mgml

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Posaconazole

Tilgjengelig fra:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC-kode:

J02AC04

Dosering :

40mg/ml

Legemiddelform:

SUSPENSION

Sammensetning:

Posaconazole 40mg/ml

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

Patheon Inc.

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2009-05-25

Informasjon til brukeren

 
1 
NOXAFIL
®
 40MG/ML ORAL SUSPENSION 
Brand of Posaconazole 

FOR ORAL ADMINISTRATION 
DESCRIPTION:  NOXAFIL is a white, cherry flavored, immediate-release
oral 
suspension. Each ml of oral suspension contains 40mg
of posaconazole.    
Inactive
ingredients: Polysorbate 80, simeticone, sodium benzoate, sodium citrate 
dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium 
dioxide, artificial cherry flavor and purified water.  
PRECLINICAL INFORMATION: As observed with other azole
antifungal agents, effects 
related to inhibition of steroid hormone synthesis were seen in
repeated-dose toxicity 
studies with 
NOXAFIL. Adrenal suppressive effects were observed
in toxicity studies in 
rats and dogs at exposures equal to or greater than
those obtained at therapeutic doses 
in humans.  

Reproduction, peri- and postnatal development studies were
conducted in rats. At 
exposures lower than those obtained at therapeutic doses in
humans, 
NOXAFIL caused 
skeletal variations and malformations, dystocia, increased length of gestation, reduced 
mean litter size and postnatal viability. In rabbits, 
NOXAFIL was embryotoxic at 
exposures greater than those
obtained at therapeutic doses. As observed with other 
azole antifungal agents, these effects on reproduction
were considered related to a 
treatment-related effect on steroidogenesis. 

2 
NOXAFIL was not genotoxic in _in vitro_ and _in vivo_ studies.  Carcinogenicity studies did 
not reveal special hazards for humans. 

CLINICAL PHARMACOLOGY: 

PHARMACOKINETIC PROPERTIES 

ABSORPTION  
NOXAFIL is absorbed with a median Tmax of 3
hours (patients) and 5 hours (healthy 
volunteers).  The pharmacokinetics of 
NOXAFIL are linear following single and multiple 
dose administration of up
to 800 mg. No further increases in exposu

Preparatomtale

S-SG-MK5592-OS-T-042021
NOXAFIL®
100 mg DELAYED RELEASE TABLET
NOXAFIL® 40 mg/ml ORAL SUSPENSION
Brand of Posaconazole
FOR ORAL ADMINISTRATION
DESCRIPTION:
NOXAFIL Delayed Release Tablets are yellow-coated, capsule-shaped and
debossed
with “100” on one side. Each tablet contains 100 mg of
posaconazole.
Inactive
ingredients:
hypromellose
acetate
succinate,
microcrystalline
cellulose,
hydroxypropylcellulose, silica dental type, croscarmellose sodium,
magnesium stearate,
and Opadry® II Yellow [consists of the following ingredients:
polyvinyl alcohol partially
hydrolyzed, Macrogol/PEG 3350 (polyethylene glycol 3350), titanium
dioxide (E171), talc,
and iron oxide yellow].
NOXAFIL
Oral
Suspension
is
a
white,
cherry
flavored,
immediate-release
oral
suspension. Each ml of oral suspension contains 40 mg of posaconazole.
Inactive
ingredients:
Polysorbate
80,
simeticone,
sodium
benzoate,
sodium
citrate
dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid
glucose, titanium
dioxide, artificial cherry flavor, and purified water.
PRECLINICAL INFORMATION:
As observed with other azole antifungal agents, effects related to
inhibition of steroid
hormone synthesis were seen in repeated-dose toxicity studies with
NOXAFIL. Adrenal
suppressive effects were observed in toxicity studies in rats and dogs
at exposures
equal to or greater than those obtained at therapeutic doses in
humans.
Reproduction, peri- and postnatal development studies were conducted
in rats. At
exposures lower than those obtained at therapeutic doses in humans,
NOXAFIL caused
skeletal variations and malformations, dystocia, increased length of
gestation, reduced
mean
litter
size
and
postnatal
viability.
In
rabbits,
NOXAFIL
was
embryotoxic
at
exposures greater than those obtained at therapeutic doses. As
observed with other
azole antifungal agents, these effects on reproduction were considered
related to a
treatment-related effect on steroidogenesis.
NOXAFIL was not genotoxic in
in vitro
and
in vivo
studies. Carcinogenicity studies did
not reveal