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

seton pharmaceuticals - sulfacetamide (unii: 4965g3j0f5) (sulfacetamide - unii:4965g3j0f5), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - sulfacetamide 100 mg in 1 ml - 10% sodium sulfacetamide 5% sulfur cleanser (in a urea vehicle) is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. 10% sodium sulfacetamide 5% sulfur cleanser (in a urea vehicle) is contraindicated for patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. 10% sodium sulfacetamide 5% sulfur cleanser (in a urea vehicle) is not to be used by patients with kidney disease.

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

seton pharmaceuticals - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.01% topical oil (scalp oil) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section). pediatric use: fluocinolone acetonide 0.01% topical oil may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis. fluocinolone acetonide 0.01% topical oil should not be applied to the diaper area. application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible. the smallest amount of drug needed to cover the affected areas should be applied. long term safety in the pediatric population has not been established. fluocinolone acetonide 0.01% topical oil is not recommended for use on the face (see adverse reactions section). because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of hpa-axis-suppression when they are treated with topical corticosteroids. they are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of cushing's syndrome while on treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (see precautions). hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. fluocinolone acetonide 0.01% topical oil is formulated with 48% refined peanut oil nf. peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million. physicians should use caution in prescribing fluocinolone acetonide 0.01% topical oil for peanut sensitive individuals.

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

seton pharmaceuticals - methenamine mandelate (unii: 695n30cinr) (methenamine - unii:j50oix95qv) - methenamine mandelate is indicated for the suppression or elimination of bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections; also those neurologic diseases leading to an infected residual urine. when used as recommended, methenamine mandelate is particularly suitable for long-term therapy because of its safety and because resistance to the nonspecific bactericidal action of formaldehyde does not develop.  pathogens resistant to other antibacterial agents may respond to methenamine mandelate because of the nonspecific effect of formaldehyde formed in an acid urine. prophylactic use rationale: urine is a good culture medium for many urinary pathogens. inoculation by a few organisms (relapse or reinfection) may lead to bacteriuria in susceptible individuals. thus, the rationale of management in recurring urinary tract infection (bacteriuria) is to change the urine from a growth-supporting to a growth-inhibiting medium. there is a growing body of evidence that lon

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

seton pharmaceuticals - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating and continuing through the postpartum period. slight maternal toxicity and decreased pup weights were also seen at this dose in a study in which rats were treated from day 15 of gestation through the postpartum period. the no-effect dose for these effects was 6 mg/kg, which is 3 times the mrhd on a mg/m2 basis. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when memantine hydrochloride is administered to a nursing mother. safety and effectiveness in pediatric patients have not been established. the majority of people with alzheimer’s disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 year old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration (2) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)] . instructions for use memantine hydrochloride (me-man-teen hye-droe-klor-ide) oral solution directions for using your memantine hydrochloride oral solution read these instructions before taking memantine hydrochloride oral solution and each time you get a refill. there may be new information. this information does not take the place of talking to your doctor about your medical condition or your treatment. preparing your dose of memantine hydrochloride oral solution. you will need the following supplies: - memantine hydrochloride oral solution bottle with child-resistant cap - press-in bottle adaptor - oral dosing syringe - prescribing information ​instructions this patient information and instructions for use have been approved by the u.s. food and drug administration. manufactured for: seton pharmaceuticals, wall, nj 07719 1 (800) 510-3401 manufactured by: medley pharmaceuticals ltd. plot no. 18 & 19, zari causeway road kachigram, daman 396210, india revised 02/2021

Bangladesh - English - DGDA (Directorate General of Drug Administration)

alco pharma limited - frusemide + spironolactone - tablet - 20 mg + 50 mg

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ms pharma jordan, jordan - granisetron - solution for injection - 3 mg/3ml

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

ms pharma jordan, jordan - granisetron - solution for injection - 1 mg/ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة ام اس فارما - ms pharma - granisetrone hcl 1 mg/1ml - 1 mg/1ml

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة ام اس فارما - ms pharma - granisetrone hcl 3 mg/3ml - 3 mg/3ml

Kenya - English - Pharmacy and Poisons Board

ms pharma jordan king abdulla (ii) bin al-hussein industrial - granisetron hydrochloride ep - solution for injection - each ml contains: granisetron hydrochloride bp… - granisetron