USA - engelsk - NLM (National Library of Medicine)

seton pharmaceuticals llc - butalbital (unii: khs0az4jvk) (butalbital - unii:khs0az4jvk), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - butalbital, acetaminophen and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. caution in this regard is required because butalbital is habit-forming and potentially abusable. this product is contraindicated under the following conditions: - hypersensitivity or intolerance to any component of this product. - patients with porphyria. abuse and dependence butalbital barbiturates may be habit-forming : tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. the average daily dose for the barbiturate addict is usually about 1500 mg. as tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. as this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. the lethal dose of a barbiturate is far less if alcohol is also ingested. major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. one method involves initiating treatment at the patient's regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.

USA - engelsk - 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.

USA - engelsk - 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.

USA - engelsk - NLM (National Library of Medicine)

seton pharmaceuticals - hydrocortisone (unii: wi4x0x7bpj) (hydrocortisone - unii:wi4x0x7bpj), iodoquinol (unii: 63w7ie88k8) (iodoquinol - unii:63w7ie88k8) - based on a review of a related drug by the national research council and subsequent fda classification for that drug, the indications are as follows: "possibly" effective: contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); moniliasis; intertrigo. final classification of the less-than-effective indications requires further investigation. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

USA - engelsk - 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

USA - engelsk - NLM (National Library of Medicine)

seton pharmaceuticals, llc - prednisolone sodium phosphate (unii: iv021nxa9j) (prednisolone - unii:9phq9y1olm) - prednisolone 5 mg in 5 ml - prednisolone sodium phosphate oral solution is indicated in the following conditions: 1. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. dermatologic diseases pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (stevens-johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. edematous states to induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephrotic syndrome, without uremia. 4. endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid su

USA - engelsk - 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

Polen - polsk - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

mylan s.a.s. - ethinylestradiolum + etonogestrelum - system terapeutyczny dopochwowy - (0,120 mg + 0,015 mg)/24 h

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

seton healthcare england - phenothrin - ΣΑΠΩΝ ΓΙΑ ΤΟ ΤΡΙΧΩΤΟ ΤΗΣ ΚΕΦΑΛΗΣ (ΣΑΜΠΟΥΑΝ) - 0.2% - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

seton healthcare england - phenothrin - ΛΟΣΙΟΝ - 0.2% - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ