Valsts: Singapūra
Valoda: angļu
Klimata pārmaiņas: HSA (Health Sciences Authority)
posaconazole
MSD PHARMA (SINGAPORE) PTE. LTD.
J02AC04
TABLET, DELAYED RELEASE
posaconazole 100mg
ORAL
Prescription Only
N. V. Organon
ACTIVE
2016-07-05
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 Izlasiet visu dokumentu