Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

apotex nz ltd - celecoxib 100mg - capsule - 100 mg - active: celecoxib 100mg excipient: crospovidone gelatin magnesium stearate povidone purified water sodium laurilsulfate tekprint blue sb-6018 titanium dioxide - symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. for the management of acute pain and treatment of primary dysmenorrhoea in adults. the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmaceutical interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. as the cardiovascular risks of the selective cox-2 inhibitors may increase with dose and duration of exposures, the shortest duration possible and the lowest effective daily dose should be used. patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

apotex nz ltd - celecoxib 200mg - capsule - 200 mg - active: celecoxib 200mg excipient: crospovidone gelatin magnesium stearate povidone purified water sodium laurilsulfate tekprint gold sb-3002 titanium dioxide - symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. for the management of acute pain and treatment of primary dysmenorrhoea in adults. the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmaceutical interventions and simple analgesic therapies have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient, and · after assessment of the individual patient's overall risks. as the cardiovascular risks of the selective cox-2 inhibitors may increase with dose and duration of exposures, the shortest duration possible and the lowest effective daily dose should be used. patients on long-term treatment should be reviewed regularly, such as every three months, with regards to efficacy, risk factors and ongoing need for treatment

Kanada - angleščina - Health Canada

pendopharm division of pharmascience inc - lidocaine hydrochloride (lidocaine hydrochloride monohydrate); chlorhexidine gluconate - gel - 2%; 0.05% - lidocaine hydrochloride (lidocaine hydrochloride monohydrate) 2%; chlorhexidine gluconate 0.05% - miscellaneous local anti-infectives

Združene države Amerike - angleščina - NLM (National Library of Medicine)

actavis pharma, inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 100 mg in 1 g - gelnique is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency [see clinical studies (14 )]. the use of gelnique is contraindicated in the following conditions: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma - known serious hypersensitivity reaction to gelnique, oxybutynin, or to any of the components of gelnique [see warnings and precautions (5.3 , 5.4) ]. pregnancy category b there are no adequate and well-controlled studies of topical or oral oxybutynin use in pregnant women. subcutaneous administration to rats at doses up to 25 mg/kg (approximately 50 times the human exposure based on surface area) and to rabbits at doses up to 0.4 mg/kg (approximately 1 times the human exposure) revealed no evidence of harm to the fetus due to oxybutynin chloride. the safety of gelnique administration to women who are or who may become pregnant has not been established. therefore, gelnique should not

Singapur - angleščina - HSA (Health Sciences Authority)

orion pharma (sg) pte. ltd. - estradiol hemihydrate eqv estradiol - gel - 0.5 mg - estradiol hemihydrate eqv estradiol 0.5 mg/dose

Singapur - angleščina - HSA (Health Sciences Authority)

orion pharma (sg) pte. ltd. - estradiol hemihydrate eqv estradiol - gel - 1 mg - estradiol hemihydrate eqv estradiol 1 mg/dose

Malezija - angleščina - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

b.braun medical industries sdn bhd - calcium chloride dihydrate; potassium chloride; sodium acetate trihydrate; sodium chloride; magnesium chloride hexahydrate; succinylated gelatine -

Irska - angleščina - HPRA (Health Products Regulatory Authority)

laboratoires besins international - testosterone - transdermal gel in sachet - 25 milligram(s) - 3-oxoandrosten (4) derivatives; testosterone

Združene države Amerike - angleščina - NLM (National Library of Medicine)

galderma laboratories, l.p. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 10 mg in 1 g - metrogel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.  metrogel 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 between 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 metrogel. 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 2-4% and 15-20%, 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 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 metrogel. safety and effectiveness of metrogel have not been established in pediatric patients. sixty-six subjects aged 65 years and older were treated with metrogel 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.

Irska - angleščina - HPRA (Health Products Regulatory Authority)

laboratoires besins international - testosterone - transdermal gel in sachet - androgens; testosterone