Singapore - English - HSA (Health Sciences Authority)

lotus international pte. ltd. - ceftriaxone sodium 2.158g eqv to ceftriaxone - injection, powder, for solution - 2.0 g - ceftriaxone sodium 2.158g eqv to ceftriaxone 2.0 g

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

alvogen, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g

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

alvogen, inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline mesylate tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)]. at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. pregnancy category c there are no adequate and well-controlled studies of rasagiline in pregnant women. rasagiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a combined mating/fertility and embryo-fetal development study in pregnant rats, no effect on embryo-fetal development was observed at oral doses

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

alvogen inc. - rivastigmine (unii: pki06m3iw0) (rivastigmine - unii:pki06m3iw0) - rivastigmine 4.6 mg - rivastigmine transdermal system is indicated for the treatment of dementia of the alzheimer’s type (ad). efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. rivastigmine transdermal system is indicated for the treatment of mild-to-moderate dementia associated with parkinson’s disease (pdd). rivastigmine transdermal system is contraindicated in patients with: - known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation [see description (11)] . - previous history of application site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis [see warnings and precautions (5.3)] . isolated cases of generalized skin reactions have been described in postmarketing experience [see adverse reactions (6.2)] . risk summary   there are no adequate data on the developmental risks associated with the use of rivastigmine transdermal system in pregnant women. in animals, no adverse effects on embryo-

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

alvogen, inc. - estradiol (unii: 4ti98z838e) (estradiol - unii:4ti98z838e) - estradiol 0.025 mg in 1 d -     when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.     when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered. the estradiol transdermal system is contraindicated in women with any of the following conditions: the estradiol transdermal system should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as oral contraceptives inadvertently during early pregnancy. the estradiol transdermal system should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the b

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

alvogen inc. - exemestane (unii: ny22hmq4bx) (exemestane - unii:ny22hmq4bx) - exemestane 25 mg - exemestane is indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy [see clinical studies ( 14.1 )] . exemestane is indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see clinical studies ( 14.2 )] . exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. risk summary based on findings in animal studies and its mechanism of action, exemestane can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . limited human data from case reports are insufficient to inform a drug-associated risk. in animal reproduction studies, administration of exemestane to pregnant rats and rabbits caused increased incidence of abo

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

alvogen inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin injection, usp used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: - adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. - treatment of advanced colorectal cancer. oxaliplatin injection, usp should not be administered to patients with a history of known allergy to oxaliplatin injection, usp or other platinum compounds [see warnings and precautions (5.1)] . pregnancy category d based on direct interaction with dna, oxaliplatin injection, usp may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of oxaliplatin injection, usp in pregnant women. reproductive toxicity studies in rats demonstrated adverse effects on fertility and embryo-fetal development at maternal doses that were below the recommended human dose based on body surface area. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should

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

alvogen inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg

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

alvogen inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 10 mg in 1 ml - voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus. there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1, 14.5) and microbiology (12.4)] . voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2, 14.5) and microbiology (12.4)] . voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (ec) [see clinical studies (14.3, 14.5) and microbiology (12.4)] . voriconazole for injection is indicated for the trea

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

alvogen inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 150 mg in 1 ml - clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin injection, usp is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin injection, usp is indicated in the treatment of serious infections caused by susceptible strains of the d