NOXAFIL TABLET 100MG

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

posaconazole

Fáanlegur frá:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC númer:

J02AC04

Lyfjaform:

TABLET, DELAYED RELEASE

Samsetning:

posaconazole 100mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

N. V. Organon

Leyfisstaða:

ACTIVE

Leyfisdagur:

2016-07-05

Vara einkenni

SG-MK5592-OS-T-022022
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 sp