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

mylan pharmaceuticals inc. - miconazole nitrate (unii: vw4h1cyw1k) (miconazole - unii:7nno0d7s5m), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - miconazole nitrate, zinc oxide and white petrolatum ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. a positive fungal culture for candida albicans is not adequate evidence of candidal infection since colonization with c. albicans can result in a positive culture. the presence of candidal infection should be established by microscopic evaluation prior to initiating treatment. miconazole nitrate, zinc oxide and white petrolatum ointment should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. miconazole nitrate, zinc oxide and white petrolatum ointment should not be used as a substitute for frequent diaper changes. the safety and efficacy of miconazole nitrate, zinc oxide and white petrolatum

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

taro pharmaceuticals u.s.a., inc. - deferiprone (unii: 2bty8kh53l) (deferiprone - unii:2bty8kh53l) - deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. limitations of use - safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with diamond blackfan anemia. pediatric use information is approved for chiesi usa, inc.'s ferriprox ® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. the following reactions have been reported in association with the administration of deferiprone: henoch-schönlein purpura; urticaria; and periorbital edema with skin rash [see adverse reactions (6.2)]. risk summary in animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (mrhd) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see data) . the limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. based on evidence and developmental toxicity in animal studies, deferiprone can cause fetal harm when administered to a pregnant woman. advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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 . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage is 2 to 4% and 15 to 20%, respectively. data human data post-marketing data available from 39 pregnancies of deferiprone-treated patients and 10 pregnancies of partners of deferiprone-treated patients are as follows: of the 39 pregnancies in deferiprone-treated patients, 23 resulted in healthy newborns, 6 ended in spontaneous abortion, 9 had unknown outcomes, and 1 infant was born with anal atresia, nephroptosis, ventricular septal defect, hemivertebra and urethral fistula. of the 10 pregnancies in partners of deferiprone-treated patients, 5 resulted in healthy newborns, 1 resulted in a healthy newborn with slight hypospadias, 1 was electively terminated, 1 resulted in the intrauterine death of twins, and 2 had unknown outcomes. animal data during organogenesis, pregnant rats and rabbits received deferiprone at oral doses of 0, 30, 80 or 200 mg/kg/day, and 0, 10, 50, or 150 mg/kg/day, respectively. the daily dose was administered as two equal divided doses approximately 7 hours apart. doses of 200 mg/kg/day in rats and 150 mg/kg/day in rabbits, approximately 33% and 49% of the mrhd, respectively, resulted in increased post-implantation loss and reduced fetal weights in the presence of maternal toxicity (reduced maternal body weight and body weight gain in both rats and rabbits; abnormal large placenta at low incidence in rats). the 200 mg/kg/day dose in rats resulted in external, visceral and skeletal fetal malformations such as cranial malformations, cleft palate, limb malrotation, anal atresia, internal hydrocephaly, anophthalmia and fused bones. the dose of 150 mg/kg/day in rabbits resulted in external fetal malformations (partially opened eyes) and minor blood vessel and skeletal variations. in rats, malformations including micrognathia and persistent ductus arteriosus could be observed in the absence of maternal toxicity at doses equal to or greater than 30 and 80 mg/kg/day, approximately 5% and 13% of the mhrd, respectively. risk summary there is no information regarding the presence of deferiprone in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, including the potential for tumorigenicity shown for deferiprone in animal studies, advise patients that breastfeeding is not recommended during treatment with deferiprone, and for at least 2 weeks after the last dose. pregnancy testing pregnancy testing is recommended for females of reproductive potential prior to initiating deferiprone. contraception females deferiprone can cause embryo-fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment with deferiprone and for at least 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with deferiprone and for at least 3 months after the last dose [see nonclinical toxicology (13.1)] . safety and effectiveness of deferiprone tablets have not been established in pediatric patients with chronic iron overload due to blood transfusions who are less than 8 years of age. pediatric use information is approved for chiesi usa, inc.'s ferriprox® (deferiprone) tablets. however, due to chiesi usa, inc.'s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of deferiprone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

lab equip limited, tanzania - pharmaceutical refrigerator -

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

taro pharmaceuticals u.s.a., inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - diclofenac sodium topical solution is indicated for the treatment of the pain of osteoarthritis of the knee(s). diclofenac sodium is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1) ] risk summary use of nsaids, including diclofenac sodium, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. because of these risks, limit dose and duration of diclofenac sodium topical solution use between about 20 and

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

taro pharmaceuticals u.s.a., inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen oral suspension and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). in pediatric patients, ibuprofen oral suspension is indicated: - for reduction of fever in patients aged 6 months up to 2 years of age. - for relief of mild to moderate pain in patients aged 6 months up to 2 years of age. - for relief of signs and symptoms of juvenile arthritis. in adults, ibuprofen oral suspension is indicated: - for treatment of primary dysmenorrhea. - for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjunction with aspirin, the combination cannot be recommended (see precautions-drug interactions ). ibuprofen oral suspension is contraindicated in pat

Canada - English - Health Canada

sandoz canada incorporated - zinc (zinc sulfate); copper (cupric sulfate); manganese (manganese sulfate); chromium (chromic chloride); selenium (selenious acid); iodine (sodium iodide) - liquid - 5mg; 1mg; 0.5mg; 10mcg; 60mcg; 75mcg - zinc (zinc sulfate) 5mg; copper (cupric sulfate) 1mg; manganese (manganese sulfate) 0.5mg; chromium (chromic chloride) 10mcg; selenium (selenious acid) 60mcg; iodine (sodium iodide) 75mcg - replacement preparations

Canada - English - Health Canada

sandoz canada incorporated - zinc (zinc sulfate); copper (cupric sulfate); manganese (manganese sulfate); chromium (chromic chloride); selenium (selenium dioxide); iodine (sodium iodide) - solution - 5mg; 300mcg; 55mcg; 10mcg; 60mcg; 75mcg - zinc (zinc sulfate) 5mg; copper (cupric sulfate) 300mcg; manganese (manganese sulfate) 55mcg; chromium (chromic chloride) 10mcg; selenium (selenium dioxide) 60mcg; iodine (sodium iodide) 75mcg - replacement preparations

Canada - English - Health Canada

strides pharma canada inc - vancomycin (vancomycin hydrochloride) - powder for solution - 500mg - vancomycin (vancomycin hydrochloride) 500mg - glycopeptides

Canada - English - Health Canada

strides pharma canada inc - vancomycin (vancomycin hydrochloride) - powder for solution - 1g - vancomycin (vancomycin hydrochloride) 1g - glycopeptides

Canada - English - Health Canada

strides pharma canada inc - vancomycin (vancomycin hydrochloride) - powder for solution - 5g - vancomycin (vancomycin hydrochloride) 5g - glycopeptides