Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - betamethasone acetate 3 mg/ml; betamethasone sodium phosphate 3.9 mg/ml;   - solution for injection - active: betamethasone acetate 3 mg/ml betamethasone sodium phosphate 3.9 mg/ml   excipient: benzalkonium chloride dibasic sodium phosphate disodium edetate dihydrate monobasic sodium phosphate monohydrate water for injection

Австралия - английски - Department of Health (Therapeutic Goods Administration)

organon pharma pty ltd - betamethasone acetate, quantity: 3 mg/ml (equivalent: betamethasone, qty 5.7 mg/ml); betamethasone sodium phosphate, quantity: 3.9 mg/ml - injection, suspension - excipient ingredients: disodium edetate; monobasic sodium phosphate; water for injections; dibasic sodium phosphate; benzalkonium chloride - celestone chronodose is indicated in the treatment of both severe and moderate conditions in acute and chronic self-limiting diseases responsive to systemic corticosteroid therapy and is especially useful in patients for whom treatment with oral corticosteroid medication is not feasible. representative conditions: rheumatic disorders: rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, myositis, fibrositis, tendonitis, psoriatic arthritis. collagen diseases: systemic lupus erythematosus, scleroderma, dermatomyositis. allergic states: status asthmaticus, chronic bronchial asthma, seasonal or perennial allergic rhinitis, severe allergic bronchitis, contact dermatitis, atopic dermatitis, hypersensitivity reactions to drug and insect bites. dermatologic conditions: localised, hypertrophic infiltrated lesions of lichen planus, psoriatic plaques, granuloma annulare and lichen simplex chronicus(neurodermatitis). keloids, discoid lupus erythematosus, necrobiosis lipoidi

САЩ - английски - NLM (National Library of Medicine)

asclemed usa, inc. - betamethasone sodium phosphate (unii: 7bk02scl3w) (betamethasone - unii:9842x06q6m), betamethasone acetate (unii: ti05ao53l7) (betamethasone - unii:9842x06q6m) - adults omnipaque 180, 240, and 300 - myelography (lumbar, thoracic, cervical, total columnar) - computerized tomography (ct) (myelography, cisternography, ventriculography) pediatrics omnipaque 180 - myelography (lumbar, thoracic, cervical, total columnar) - ct (myelography, cisternography) adults omnipaque 140 - intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels omnipaque 240 - ct head imaging - peripheral venography (phlebography) omnipaque 300 - aortography including studies of the aortic arch, abdominal aorta and its branches - ct head and body imaging - cerebral arteriography - peripheral venography (phlebography) - peripheral arteriography - excretory urography omnipaque 350 - angiocardiography (ventriculography, selective coronary arteriography) - aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches - ct head and body imaging - intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels - peripheral arteriography - excretory urography pediatrics omnipaque 240 - ct head and body imaging omnipaque 300 - angiocardiography (ventriculography) - excretory urography - ct head and body imaging omnipaque 350 - angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) - aortography including the aortic root, aortic arch, ascending and descending aorta adults omnipaque 350 - oral radiographic examination of the gastrointestinal tract pediatrics omnipaque 180, 240 and 300 - oral and rectal radiographic examination of the gastrointestinal tract diluted omnipaque injection adults omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque 240, 300 and 350 diluted and administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen omnipaque oral solution adults omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 300 administered intravenously - ct of the abdomen pediatrics omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque 240 or omnipaque 300 administered intravenously - ct of the abdomen adults omnipaque 240, 300, and 350 - arthrography adults omnipaque 240 - endoscopic retrograde pancreatography (erp) and cholangiopancreatography (ercp) - herniography - hysterosalpingography omnipaque 300 - hysterosalpingography pediatrics omnipaque 240, 300 and 350 diluted - voiding cystourethrography (vcu) - omnipaque 140 and omnipaque 350 are contraindicated for intrathecal use [ see warnings and precautions (5.1)] - omnipaque oral solution 9 and 12 are contraindicated for parenteral administration [ see warnings and precautions (5.2)] - omnipaque body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. risk summary hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see contraindications (4)]. there are no data with iohexol use in pregnant women to inform any drug-associated risks. iohexol crosses the placenta and reaches fetal tissues in small amounts (see data) . in animal reproduction studies, no developmental toxicity occurred with intravenous iohexol administration to rats and rabbits at doses up to 0.4 (rat) and 0.5 (rabbit) times the maximum recommended human intravenous dose ( see data ). 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 miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data human data literature reports show that intravenously administered iohexol crosses the placenta and is visualized in the digestive tract of exposed infants after birth. animal data iohexol was neither embryotoxic nor teratogenic in either rats or rabbits at the following dose levels tested: 1.0, 2.0, 4.0 g iodine/kg in rats, administered intravenously to 3 groups of 25 dams once daily during days 6 through 15 of pregnancy; 0.3, 1.0, 2.5 g iodine/kg in rabbits, administered intravenously to 3 groups of 18 rabbits dosed once a day during days 6 through 18 of pregnancy. risk summary published literature reports that breast feeding after intravenous iohexol administration to the mother would result in the infant receiving an oral dose of approximately 0.7% of the maternal intravenous dose; however, lactation studies have not been conducted with oral, intrathecal, or intracavity administration of iohexol. there is no information on the effects of the drug on the breastfed infant or on milk production. iodinated contrast agents are excreted unchanged in human milk in very low amounts with poor absorption from the gastrointestinal tract of a breastfed infant. exposure to iohexol to a breastfed infant can be minimized by temporary discontinuation of breastfeeding (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omnipaque and any potential adverse effects on the breastfed infant from omnipaque or from the underlying maternal condition. clinical considerations interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. however, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after omnipaque administration to minimize drug exposure to a breastfed infant. intrathecal use the safety and effectiveness of omnipaque 180 have been established in pediatric patients 2 weeks to 17 years of age for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography). use of omnipaque 180 is supported by controlled clinical studies in adults for myelography, in addition to clinical studies in pediatric patients undergoing myelography. the safety and effectiveness of omnipaque 180 have not been established for intrathecal use in patient pediatric patients less than 2 weeks of age. the safety and effectiveness of omnipaque 240 and 300 have not been established in pediatric patients for myelography (lumbar, thoracic, cervical, total columnar) and for ct (myelography, cisternography, or ventriculography). intravascular use angiocardiography ( ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography the safety and effectiveness of omnipaque 300 have been established in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography) and of omnipaque 350 in pediatric patients from birth to 17 years of age for angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) and aortography. use of omnipaque 300 and 350 is supported by controlled clinical studies in adults for angiocardiography and aortography, in addition to controlled clinical studies in pediatric patients undergoing angiocardiography, including aortography. the safety and effectiveness of omnipaque 300 have not been established in pediatric patients for aortography. intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography the safety and effectiveness of omnipaque have not been established in pediatric patients for intra-arterial digital subtraction angiography, intravenous digital subtraction angiography, cerebral arteriography, or peripheral arteriography and venography. ct of the head and body the safety and effectiveness of omnipaque 240 and 300 have been established in pediatric patients from birth to 17 years of age for ct imaging of the head and body. use of omnipaque 240 and 300 is supported by controlled clinical studies in adults for head and body ct, in addition to clinical studies in pediatric patients undergoing head ct and in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. the safety and effectiveness of omnipaque 350 have not been established in pediatric patients for ct imaging of the head and body. urography the safety and effectiveness of omnipque 300 have been established in pediatric patients from birth to 17 years of age for urography. use of omnipaque 300 is supported by controlled clinical studies in adults for urography, in addition to controlled clinical studies in pediatric patients undergoing urography and clinical safety data in pediatric patients down to birth. oral or rectal use undiluted omnipaque injection the safety and effectiveness of omnipaque 180, 240, and 300 administered orally and rectally have been established in pediatric patients, from birth to 17 years of age for examination of the gi tract. use of omnipaque 180, 240, and 300 administered orally and rectally is supported by controlled studies in adults for examination of the gi tract, in addition to clinical studies in pediatric patients undergoing examination of the gi tract. oral use in conjunction with intravenous use diluted omnipaque injection the safety and effectiveness of omnipaque injection diluted to concentrations from 9 to 21 mg iodine/ml administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen have been established in pediatric patients from birth to 17 years of age. use is supported by clinical trials in adults, in addition to clinical studies in 69 pediatric patients undergoing ct of the abdomen after oral administration of diluted omnipaque plus intravenous administration of omnipaque. omnipaque oral solution the safety and effectiveness of omnipaque oral solution 9 and 12 administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients have been established in pediatric patients from birth to 17 years of age. use is supported by the data establishing safety and effectiveness for omnipaque injection diluted and administered orally in conjunction with omnipaque injection administered intravenously for ct of the abdomen in pediatric patients. intraarticular use the safety and effectiveness of omnipaque have not been established in pediatric patients for arthrography. body cavity use omnipaque 240, 300, 350 diluted to concentrations from 50 mg iodine/ml to 100 mg iodine/ml is indicated for use in pediatric patients from birth to 17 years of age for voiding cystourethrography (vcu). the use for voiding cystourethrography is supported by clinical studies in 51 pediatric patients undergoing vcu. the safety and effectiveness of omnipaque have not been established in pediatric patients for ercp, herniography, or hysterosalpingography. in general, the frequency of adverse reactions in pediatric patients was similar to that seen in adults [see adverse reactions (6.1)] . pediatric patients at higher risk of experiencing adverse events during contrast-medium administration may include those having asthma, a sensitivity to medication and/or allergens, congestive heart failure, a serum creatinine greater than 1.5 mg/dl or those less than 12 months of age. thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates. some patients were treated for hypothyroidism. after exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see warnings and precautions (5.9)and adverse reactions (6.2)] . in clinical studies of omnipaque for ct, 52/299 (17%) of patients were 70 and over. no overall differences in safety were observed between these patients and younger patients. other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. in general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. when oral therapy is not feasible, the intramuscular use of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated as follows: allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. dermatologic diseases bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). endocrine disorders congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. gastrointestinal diseases to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. hematologic disorders acquired (autoimmune) hemolytic anemia, diamond-blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. miscellaneous trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. neoplastic diseases for palliative management of leukemias and lymphomas. nervous system acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. ophthalmic diseases sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. renal diseases to induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. respiratory diseases berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). for the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. the intra-articular or soft tissue administration of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. the intralesional administration of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. betamethasone sodium phosphate and betamethasone acetate injectable suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). betamethasone sodium phosphate and betamethasone acetate injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see description ). intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. purpose: - first aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. - for preparation of the skin prior to surgery. - helps reduce bacteria that can potentially cause skin infections. - as a first aid antiseptic for more than 1 week. - in the eyes. - over large areas of the body. - deep puncture wounds - animal bites - serious burns - if irritation and redness develop - if condition persists for more than 72 hours, consult a physician. for use as an - first aid antiseptic - pre-operative skin preperation antiseptic for first aid to decrease germs in - minor cuts - scrapes - burns for preparation of the skin prior to injection

САЩ - английски - NLM (National Library of Medicine)

advanced rx pharmacy of tennessee, llc - betamethasone sodium phosphate (unii: 7bk02scl3w) (betamethasone - unii:9842x06q6m), betamethasone acetate (unii: ti05ao53l7) (betamethasone - unii:9842x06q6m) - when oral therapy is not feasible, the intramuscular use of betamethasone sodium phosphate and betamethasone acetate injectable suspension is indicated as follows: allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. dermatologic diseases bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (stevens-johnson syndrome). endocrine disorders congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency.  synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. gastrointesti

Австралия - английски - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - betamethasone acetate - unknown - betamethasone acetate steroid-glucocorticoid active 0.0 - active constituent

САЩ - английски - NLM (National Library of Medicine)

actavis pharma, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

САЩ - английски - NLM (National Library of Medicine)

preferred pharmaceuticals, inc - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

САЩ - английски - NLM (National Library of Medicine)

actavis pharma, inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone 0.5 mg in 1 g - betamethasone dipropionate ointment is a high-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. betamethasone dipropionate ointment is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in these preparations.

САЩ - английски - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone dipropionate 0.64 mg in 1 g - betamethasone dipropionate cream is a medium-potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 13 years and older. betamethasone dipropionate cream is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

САЩ - английски - NLM (National Library of Medicine)

e. fougera & co. a division of fougera pharmaceuticals inc. - betamethasone dipropionate (unii: 826y60901u) (betamethasone - unii:9842x06q6m) - betamethasone .50 mg in 1 g - betamethasone dipropionate gel (augmented) is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. treatment beyond two consecutive weeks is not recommended, and the total dose should not exceed 50 g per week because of potential for the drug to suppress the hypothalamic-pituitary-adrenal (hpa) axis. this product is not recommended for use in pediatric patients under 12 years of age. betamethasone dipropionate gel (augmented) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.