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

mundipharma pty ltd - bosentan monohydrate -

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

mundipharma pty ltd - bicalutamide, quantity: 50 mg - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; povidone; sodium starch glycollate type a; titanium dioxide; hypromellose; macrogol 400 - treatment of advanced prostate cancer in combination with lhrh agonist therapy.

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

mundipharma pty ltd -

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sandoz inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metronidazole gel usp, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. metronidazole gel usp, 1% is contraindicated in patients with a history of  hypersensitivity to metronidazole or to any other ingredient in the formulation. risk summary available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. no fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. the available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel usp, 1%. the 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. 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. risk summary it is not known whether metronidazole is present in human milk after topical administration. published literature reports the presence of metronidazole in human milk after oral administration. there are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. there are no data on the effects of metronidazole on milk production. because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with  metronidazole gel usp, 1%. safety and effectiveness in pediatric patients have not been established. sixty-six subjects aged 65 years and older were treated with metronidazole gel usp, 1% in the clinical study.   no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

asclemed usa, inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

asclemed usa, inc. - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation in which penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987), prilocaine (unii: 046o35d44r) (prilocaine - unii:046o35d44r) - lidocaine 25 mg in 1 g - lidocaine and prilocaine cream usp, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: • normal intact skin for local analgesia. • genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia. lidocaine and prilocaine cream is not recommended in any clinical situation when penetration or migration beyond the tympanic membrane into the middle ear is possible because of the ototoxic effects observed in animal studies (see warnings). lidocaine and prilocaine cream is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

den-mat holdings, llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - atridox® is indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing. atridox® should not be used in patients who are hypersensitive to doxycycline or any other drug in the tetracycline class.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sandoz inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin phosphate 12 mg in 1 g - clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5%. [see adverse reactions (6.2).] clindamycin phosphate and benzoyl peroxide gel, 1.2% / 5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

sandoz inc. - calcipotriene (unii: 143nq3779b) (calcipotriene - unii:143nq3779b), betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - calcipotriene 50 ug in 1 g - calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. none. risk summary calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. the limited data with calcipotriene and betamethasone dipropionate ointment and calcipotriene use in pregnant women are not sufficient to evaluate a calcipotriene and betamethasone dipropionate ointment -associated or calcipotriene-associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. observational studies suggest an increased risk of having low birthweight infants with the maternal use of potent or very potent topical corticosteroids (see data ) . advise pregnant women that calcipotriene and betamethasone dipropionate ointment may increase the potential risk of having a low birth weight infant and to use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible. in animal reproduction studies, oral administration of calcipotriene to pregnant rats during the period of organogenesis resulted in an increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs (see data ) . oral administration of calcipotriene to pregnant rabbits during the period of organogenesis had no apparent effects on embryo-fetal development. subcutaneous administration of betamethasone dipropionate to pregnant rats and rabbits during the period of organogenesis resulted in fetal toxicity, including fetal deaths, reduced fetal weight, and fetal malformations (cleft palate and crooked or short tail) (see data ) . the available data do not allow the calculation of relevant comparisons between the systemic exposures of calcipotriene and betamethasone diproprionate observed in animal studies to the systemic exposures that would be expected in humans after topical use of calcipotriene and betamethasone dipropionate ointment. the estimated background risk of major birth defects and miscarriage of 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 human data available observational studies in pregnant women did not identify a drug-associated risk of major birth defects, preterm delivery, or fetal mortality with the use of topical corticosteroids of any potency. however, when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy, maternal use was associated with an increased risk of low birth weight in infants. animal data embryo-fetal development studies with calcipotriene were performed by the oral route in rats and rabbits. pregnant rats received dosages of 0, 6, 18, or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) on days 6-15 of gestation (the period of organogenesis). there were no apparent effects on maternal survival, behavior, or body weight gain, no effects on litter parameters, and no effects on the incidence of major malformations in fetuses. fetuses from dams dosed at 54 mcg/kg/day exhibited a significantly increased incidence of minor skeletal abnormalities, including enlarged fontanelles and extra ribs. pregnant rabbits were dosed daily with calcipotriene at exposures of 0, 4, 12, or 36 mcg/kg/day (0, 48, 144, and 432 mcg/m2 /day, respectively) on days 6-18 of gestation (the period of organogenesis). mean maternal body weight gain was reduced in animals dosed at 12 or 36 mcg/kg/day. the incidence of fetal deaths was increased in the group dosed at 36 mcg/kg/day; reduced fetal weight was also observed in this group. the incidence of major malformations among fetuses was not affected. an increase in the incidence of minor skeletal abnormalities, including incomplete ossification of sternebrae, pubic bones, and forelimb phalanges, was observed in the group dosed at 36 mcg/kg/day. embryo-fetal development studies with betamethasone dipropionate were performed via subcutaneous injection in mice and rabbits. pregnant mice were administered doses of 0, 156, 625, or 2500 mcg/kg/day (0, 468, 1875, and 7500 mcg/m2 /day, respectively) on days 7 through 13 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, malformations (increased incidence of the cleft palate and crooked or short tail), and minor skeletal abnormalities (delayed ossification of vertebra and sternebrae). fetal toxicity was observed at the lowest exposure that was evaluated (156 mcg/kg/day). pregnant rabbits were injected subcutaneously at dosages of 0, 0.625, 2.5, and 10 mcg/kg/day (0, 7.5, 30, and 120 mcg/m2 /day, respectively) on days 6 through 18 of gestation (the period of organogenesis). betamethasone dipropionate induced fetal toxicity, including fetal deaths, reduced fetal weight, external malformations (including malformed ears, cleft palate, umbilical hernia, kinked tail, club foot, and club hand), and skeletal malformations (including absence of phalanges of the first digit and cranial dysplasia) at dosages of 2.5 mcg/kg/day and above. calcipotriene was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 6, 18 or 54 mcg/kg/day (0, 36, 108, and 324 mcg/m2 /day, respectively) from gestation day 15 through day 20 postpartum. no remarkable effects were observed on any parameter, including survival, behavior, body weight, litter parameters, or the ability to nurse or rear pups. betamethasone dipropionate was evaluated for effects on peri- and post-natal development when orally administered to pregnant rats at dosages of 0, 100, 300, and 1000 mcg/kg/day (0, 600, 1800, and 6000 mcg/m2 /day, respectively) from gestation day 6 through day 20 postpartum. mean maternal body weight was significantly reduced on gestation day 20 in animals dosed at 300 and 1000 mcg/kg/day. the mean duration of gestation was slightly, but statistically significantly, increased at 100, 300, and 1000 mcg/kg/day. the mean percentage of pups that survived to day 4 was reduced in relation to dosage. on lactation day 5, the percentage of pups with a reflex to right themselves when placed on their back was significantly reduced at 1000 mcg/ kg/day. no effects on the ability of pups to learn were observed, and the ability of the offspring of treated rats to reproduce was not affected. risk summary there is no information regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk, the effects on the breastfed infant, or the effects on milk production. it is not known whether topically administered calcipotriene or corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for calcipotriene and betamethasone dipropionate ointment and any potential adverse effects on the breastfed child from calcipotriene and betamethasone dipropionate ointment or from the underlying maternal condition. clinical considerations to minimize potential exposure to the breastfed infant via breast milk, use calcipotriene and betamethasone dipropionate ointment on the smallest area of skin and for the shortest duration possible while breastfeeding. advise breastfeeding women not to apply calcipotriene and betamethasone dipropionate ointment directly to the nipple and areola to avoid direct infant exposure [see use in specific populations ( 8.4 )] . safety and effectiveness of the use of calcipotriene and betamethasone dipropionate ointment in pediatric patients under the age of 12 years have not been established. the safety and effectiveness of calcipotriene and betamethasone dipropionate ointment for the treatment of plaque psoriasis have been established in the age group 12 to 17 years. in a prospective, uncontrolled trial, 33 pediatric subjects ages 12-17 years with plaque psoriasis on the body were treated with calcipotriene and betamethasone dipropionate ointment for 4 weeks up to a maximum of 55.8 g per week. subjects were assessed for hpa axis suppression and effects on calcium metabolism. no adverse effects on adrenal suppression were observed. no hypercalcemia was observed but one subject had a possible treatment-related increase in urinary calcium [see clinical pharmacology ( 12.2)]. because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. they are, therefore, also at greater risk of hpa axis suppression and adrenal insufficiency upon the use of topical corticosteroids [see warnings and precautions (5.2) ]. rare systemic toxicities such as cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients. of the total number of subjects in the clinical studies of calcipotriene and betamethasone dipropionate ointment, approximately 14% were 65 years and older and approximately 3% were 75 years and over. no overall differences in safety or effectiveness of calcipotriene and betamethasone dipropionate ointment were observed between these subjects and younger subjects. all other reported clinical experience has not identified any differences in response between elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out.