Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - ascorbic acid,magnesium amino acid chelate,pyridoxine hydrochloride,retinol acetate,zinc amino acid chelate -

United States - English - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - lifitegrast (unii: 038e5l962w) (lifitegrast - unii:038e5l962w) - lifitegrast 50 mg in 1 ml - xiidra® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (ded). xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see adverse reactions (6.2)] . risk summary there are no available data on xiidra use in pregnant women to inform any drug-associated risks. intravenous (iv) administration of lifitegrast to pregnant rats, from pre-mating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [rhod], based on the area under the curve [auc] level). since human systemic exposure to lifitegrast following ocular administration of xiidra at the rhod is low, the applicability of animal

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - lifitegrast (unii: 038e5l962w) (lifitegrast - unii:038e5l962w) - lifitegrast ophthalmic solution 5% is indicated for the treatment of the signs and symptoms of dry eye disease (ded). lifitegrast is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation [see adverse reactions (6.2)]. risk summary there are no available data on lifitegrast use in pregnant women to inform any drug-associated risks. intravenous (iv) administration of lifitegrast to pregnant rats, from premating through gestation day 17, did not produce teratogenicity at clinically relevant systemic exposures. intravenous administration of lifitegrast to pregnant rabbits during organogenesis produced an increased incidence of omphalocele at the lowest dose tested, 3 mg/kg/day (400-fold the human plasma exposure at the recommended human ophthalmic dose [rhod], based on the area under the curve [auc] level). since human systemic exposure to lifitegrast following ocular administration of lifitegrast at the rhod is low, the applicabili

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - conifer phytosterol complex,crateva magna,cucurbita pepo,lycopene,prunus africana,selenomethionine,secale cereale,zinc amino acid chelate -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - ubiquinol-10 -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - bifidobacterium animalis ssp lactis,bifidobacterium bifidum,bifidobacterium breve,lactobacillus acidophilus,lactobacillus casei,lactobacillus fermentum,lactobacillus plantarum,lactobacillus rhamnosus,streptococcus thermophilus -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - bifidobacterium animalis ssp lactis,bifidobacterium bifidum,bifidobacterium breve,lactobacillus acidophilus,lactobacillus casei,lactobacillus fermentum,lactobacillus plantarum,lactobacillus rhamnosus,streptococcus thermophilus -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - ascorbic acid,borax,biotin,calcium folinate,calcium pantothenate,calcium phosphate,choline bitartrate,chromium nicotinate,colecalciferol,cyanocobalamin,d-alpha-tocopheryl acid succinate,inositol,levomefolate calcium,magnesium phosphate pentahydrate,manganese amino acid chelate,mecobalamin (co-methylcobalamin),menaquinone 7,molybdenum trioxide,nicotinamide,nicotinic acid,potassium iodide,pyridoxal 5-phosphate monohydrate,pyridoxine hydrochloride,punica granatum,retinol -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - curcumin -

Australia - English - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals limited - concentrated fish omega-3 triglycerides,d-alpha-tocopherol -