美国 - 英文 - NLM (National Library of Medicine)

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. these products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. safety and efficacy in children have not been established.

美国 - 英文 - NLM (National Library of Medicine)

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. these products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. the more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time. safety and efficacy in children have not been established.

美国 - 英文 - NLM (National Library of Medicine)

seton pharmaceuticals - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate is indicated for the prevention of pneumocystis jiroveci pneumonia (pjp) in high-risk, hiv-infected patients defined by one or both of the following criteria: i. a history of one or more episodes of pjp ii. a peripheral cd4+ (t4 helper/inducer) lymphocyte count less than or equal to 200/mm3. these indications are based on the results of an 18-month randomized, dose-response trial in high risk hiv-infected patients and on existing epidemiological data from natural history studies. the patient population of the controlled trial consisted of 408 patients, 237 of whom had a history of one or more episodes of pjp. the remaining patients without a history of pjp included 55 patients with kaposi’s sarcoma and 116 patients with other aids diagnoses, arc or asymptomatic hiv infection. patients were randomly assigned to receive pentamidine isethionate via the respirgard® ii nebulizer at one of the following three doses: 30 mg every two weeks (n=135), 150 mg every two weeks (n=134) or 300 mg every four weeks (n=139). the results of the trial demonstrated a significant protective effect (p<0.01) against pjp with the 300 mg every four week dosage regimen compared to the 30 mg every two week dosage regimen. the 300 mg dose regimen reduced the risk of developing pjp by 50 to 70% compared to the 30 mg regimen. a total of 293 patients (72% of all patients) also received zidovudine at some time during the trial. the analysis of the data demonstrated the efficacy of the 300 mg dose even after adjusting for the effect of zidovudine. the results of the trial further demonstrate that the dose and frequency of dosing are important to the efficacy of pentamidine isethionate prophylaxis in that multiple analyses consistently demonstrated a trend toward greater efficacy with 300 mg every four weeks as compared to 150 mg every two weeks. no dose-response was observed for reduction in overall mortality; however, mortality from pjp was low in all three dosage groups. pentamidine isethionate is contraindicated in patients with a history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

w&s plastics pty ltd - 58376 - eye splash shield, single-use - a clear, transparent guard intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure when full face protection is not required. this is a non-sterile device.

澳大利亚 - 英文 - Department of Health (Therapeutic Goods Administration)

w&s plastics pty ltd - 11961 - shield, face - a clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. it is commonly known as a splash shield. this is a single-use device.

美国 - 英文 - NLM (National Library of Medicine)

seton pharmaceuticals - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - esterified estrogens and methyltestosterone full and half-strength tablets are indicated in the: - treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (there is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) - esterified estrogens and methyltestosterone full and half-strength tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus. esterified estrogens and methyltestosterone full and hall-strength tablets should not be used in women with any of the following conditions: - undiagnosed abnormal genital bleeding. - known, suspected, or history of cancer of the breast - known or suspected estrogen-dependent neoplasia - active deep vein thrombosis, pulmonary embolism or history of these conditions. - active or recent (e.g., within the past year) ar

美国 - 英文 - NLM (National Library of Medicine)

seton pharmaceuticals, llc - aminocaproic acid (unii: u6f3787206) (aminocaproic acid - unii:u6f3787206) - aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. in life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (see warnings. ) aminocaproic acid tablets should not be used when

欧盟 - 英文 - EMA (European Medicines Agency)

takeda pharma a/s - darvadstrocel - rectal fistula - immunosuppressants - alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy. alofisel should be used after conditioning of fistula.

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

ssl international plc - magnesium oxidum leve aluminium hydroxide dimethicone 350 - oral suspension

爱尔兰 - 英文 - HPRA (Health Products Regulatory Authority)

ssl international plc - aluminium hydroxide dimethicone 350 - tablets