Australien - engelska - Department of Health (Therapeutic Goods Administration)

metagenics (aust) pty ltd - calcium ascorbate dihydrate, quantity: 96 mg (equivalent: ascorbic acid, qty 80 mg); brassica oleracea var. italica, quantity: 200 mg (equivalent: brassica oleracea var. italica, qty 2 g; equivalent: allyl isothiocyanate, qty 2 microgram); brassica oleracea var. italica, quantity: 200 mg - capsule, hard - excipient ingredients: hyprolose; tartaric acid; microcrystalline cellulose; magnesium stearate; silicon dioxide; hypromellose; disodium edetate; potable water; potassium acetate; gellan gum - antioxidant/reduce free radicals formed in the body ; aids/assists natural body cleansing/detoxification processes

Australien - engelska - Department of Health (Therapeutic Goods Administration)

fit-bioceuticals pty ltd - vitis vinifera, quantity: 4.4444 mg (equivalent: vitis vinifera, qty 533.3 mg; equivalent: procyanidins (of vitis vinifera), qty 4.22 mg); rosmarinus officinalis, quantity: 200 mg (equivalent: rosmarinus officinalis, qty 1 g; equivalent: cineole, qty 725 microgram; equivalent: camphor, qty 680 microgram); brassica oleracea var. italica, quantity: 200 mg (equivalent: brassica oleracea var. italica, qty 300 mg; equivalent: allyl isothiocyanate, qty 0.6 microgram); methionine, quantity: 25 mg; molybdenum trioxide, quantity: 62.496 microgram (equivalent: molybdenum, qty 41.66 microgram); bupleurum falcatum, quantity: 100 mg (equivalent: bupleurum falcatum, qty 1 g) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate dihydrate; magnesium stearate; ethylcellulose; microcrystalline cellulose; hypromellose; crospovidone; macrogol 400; colloidal anhydrous silica; chlorophyllin-copper complex; carnauba wax; croscarmellose sodium; maltodextrin; macrogol 8000 - maintain/support natural body cleansing/detoxification processes ; traditionally used in western herbal medicine to decrease/reduce/relieve symptoms of indigestion/dyspepsia ; traditionally used in chinese medicine to maintain/support healthy liver function ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; traditionally used in chinese medicine to decrease/reduce/relieve menstrual cycle irregularity/irregular periods ; traditionally used in chinese medicine to decrease/reduce/relieve symptoms of premenstrual tension

Australien - engelska - Department of Health (Therapeutic Goods Administration)

bio concepts pty ltd - brassica oleracea var. italica, quantity: 50 mg (equivalent: brassica oleracea var. italica, qty 500 mg; equivalent: allyl isothiocyanate, qty 0.5 microgram); allium sativum, quantity: 5 mg (equivalent: allium sativum, qty 60 mg); hesperidin, quantity: 50 mg; glutamine, quantity: 50 mg; vitis vinifera, quantity: 8.33 mg (equivalent: vitis vinifera, qty 1000 mg; equivalent: procyanidins (of vitis vinifera), qty 7.91 mg); d-alpha-tocopheryl acid succinate, quantity: 20 mg; biotin, quantity: 100 microgram; petroselinum crispum, quantity: 15 mg (equivalent: petroselinum crispum, qty 60 mg); zinc amino acid chelate, quantity: 10 mg (equivalent: zinc, qty 2 mg); selenomethionine, quantity: 62.5 microgram (equivalent: selenium, qty 25 microgram); ascorbic acid, quantity: 60 mg; magnesium orotate dihydrate, quantity: 152.44 mg (equivalent: magnesium, qty 10 mg); vaccinium myrtillus, quantity: 0.6 mg (equivalent: vaccinium myrtillus, qty 60 mg; equivalent: anthocyanosides (of vaccinium myrtillus), qty 0.15 mg); cysteine, quantity: 50 mg; pinus pinaster, quantity: 0.6 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; calcium hydrogen phosphate dihydrate; carnauba wax; crospovidone; colloidal anhydrous silica; hypromellose; garlic bulb powder; povidone; chlorella pyrenoidosa; maltodextrin; magnesium stearate; macrogol 400 - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support collagen formation ; aids/assists natural body cleansing/detoxification processes ; maintain/support natural body cleansing/detoxification processes ; maintain/support natural liver cleansing/detoxification processes ; maintain/support energy production ; maintain/support healthy eye function ; maintain/support eye health ; maintain/support healthy eyesight/vision ; maintain/support healthy growth and development ; maintain/support general health and wellbeing ; maintain/support healthy teeth ; maintain/support connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support bone health ; helps maintain/support joint cartilage health ; maintain/support cardiovascular system health ; maintain/support healthy cardiovascular system function ; maintain/support blood capillary health ; maintain/support healthy thyroid gland function ; maintain/support thyroid gland health ; aid/assist thyroid hormone production ; maintain/support smell sensation ; maintain/support taste sensation ; maintain/support bile production ; maintain/support immune system health ; maintain/support immune system to fight illness ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; aid/assist/helps protein synthesis in the body ; maintain/support absorption of dietary (state vitamin/mineral/nutrient) ; maintain/support (state vitamin/mineral/nutrient) levels in the body ; helps prevent dietary (state vitamin/mineral/nutrient) deficiency ; aid/assist/helps metabolism of (state vitamin/mineral/nutrient) ; support healthy stress response in the body ; aid/assist/helps synthesis of neurotransmitters ; maintain/support nervous system health ; maintain/support nervous system function ; maintain/support female reproductive system health ; maintain/support/regulate healthy menstrual cycle ; maintain/support reproductive system health ; maintain/support healthy reproductive hormones ; maintain/support sperm production ; maintain/support skin health ; maintain/support skin integrity/structure ; maintain/support wound healing ; maintain/support skin repair/healing/regeneration

USA - engelska - NLM (National Library of Medicine)

sebela pharmaceuticals inc. - naftifine hydrochloride (unii: 25ur9n9041) (naftifine - unii:4fb1ton47a) - naftin ® gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms trichophyton rubrum , trichophyton mentagrophytes , and epidermophyton floccosum . none. risk summary there are no available data on naftin® gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (mrhd) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the mrhd in pregnant rats or 7 times the mrhd in pregnant rabbits ( see data ). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data systemic embryofetal development studies were conducted in rats and rabbits. for the comparison of animal to human doses, the mrhd is set at 4 g 2% gel per day (1.33 mg/kg/day for a 60 kg individual). oral doses of 30, 100, and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. no treatment-related effects on embryofetal toxicity were noted at doses up to 300 mg/kg/day (37 times the mrhd based on mg/m 2 comparison). subcutaneous doses of 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. no treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (4 times the mrhd based on mg/m 2 comparison). subcutaneous doses of 3, 10, and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rabbits. no treatment-related effects on embryofetal toxicity were noted at 30 mg/kg/day (7 times the mrhd based on mg/m 2 comparison). a peri-and post-natal development study was conducted in rats. oral doses of 30, 100, and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (37 times the mrhd based on mg/m 2 comparison). no developmental toxicity was noted at 100 mg/kg/day (12 times the mrhd based on mg/m 2 comparison). risk summary there is no information available on the presence of naftifine hydrochloride in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of naftin gel to women who are breastfeeding. it is not known whether naftifine hydrochloride is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when naftifine hydrochloride is administered to a nursing woman. the lack of clinical data during lactation precludes a clear determination of the risk naftin gel to an infant during lactation. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for naftin gel and any potential adverse effects on the breastfed infant from naftin gel or from the underlying maternal condition. the safety and effectiveness of naftin® gel have been established in the age group 12 to 18 years of age with interdigital tinea pedis. use of naftin® gel in this age group is supported by evidence from adequate and well controlled trials in adults with additional safety and pk data from an open label trial, conducted in 22 adolescents ≥12 years of age who were exposed to naftin® gel at a dose of approximately 4 g/day  [see clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients <12 years of age have not been established. during clinical trials, 99 subjects (9%) aged 65 years and over were exposed to naftin ® gel. safety and effectiveness were similar to those reported by younger subjects.

USA - engelska - NLM (National Library of Medicine)

sebela pharmaceuticals inc. - naftifine hydrochloride (unii: 25ur9n9041) (naftifine - unii:4fb1ton47a) - naftin® cream is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism trichophyton rubrum. none risk summary there are no available data with naftin ® cream in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (mrhd) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the mrhd in pregnant rats or 4 times the mrhd in pregnant rabbits [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes

Malaysia - engelska - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cipla malaysia sdn bhd - terbinafine hydrochloride -

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - terbinafine hydrochloride - cutaneous cream - 10mg/1gram

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

de pharmaceuticals - terbinafine hydrochloride - oral tablet - 250mg

Australien - engelska - Department of Health (Therapeutic Goods Administration)

atp science pty ltd - raphanus sativus, quantity: 100 mg; brassica oleracea var. italica, quantity: 38.46 mg (equivalent: brassica oleracea var. italica, qty 384.6 mg; equivalent: allyl isothiocyanate, qty 7.18 microgram); brassica oleracea var. italica, quantity: 100 mg; rosmarinus officinalis, quantity: 100 mg (equivalent: rosmarinus officinalis, qty 1 g; equivalent: camphor, qty 12.5 microgram; equivalent: cineole, qty 15 microgram); fucus vesiculosus, quantity: 6.25 mg (equivalent: fucus vesiculosus, qty 31.25 mg; equivalent - capsule, hard - excipient ingredients: silicon dioxide; hypromellose; acacia; purified water; maltodextrin; cocoa powder; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose - maintain/support natural liver cleansing/detoxification processes ; maintain/support female healthy hormonal balance ; maintain/support female reproductive system health ; decrease/reduce/relieve menstrual cycle irregularity/irregular periods ; decrease/reduce/relieve symptoms of premenstrual tension (linked indication:temporarily relieve mild fluid retention; decrease/reduce/relieve abdominal bloating/distention; helps reduce occurrence of symptoms of headaches; decrease/reduce feelings of aggression/irritability associated with premenstrual tension; decrease/reduce/relieve mood changes/mood swings associated with premenstrual tension; decrease/reduce/relieve breast pain/tenderness associated with premenstrual tension)

Australien - engelska - Department of Health (Therapeutic Goods Administration)

nu skin enterprises australia inc - citrus sinensis, quantity: 62.5 mg (equivalent: citrus sinensis, qty 13.125 g; equivalent: oxedrine, qty 0 microgram); brassica oleracea var. italica, quantity: 57.7 mg (equivalent: brassica oleracea var. italica, qty 577 mg; equivalent: allyl isothiocyanate, qty 144 microgram); vitis vinifera, quantity: 105.7 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; gelatin; silicon dioxide; purified water; stearic acid - helps reduce/decrease free radical damage to body cells ; aids/assists natural body cleansing/detoxification processes ; maintain/support natural liver cleansing/detoxification processes ; maintain/support general health and wellbeing