欧盟 - 英文 - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - split influenza virus, inactivated, containing antigen: a/vietnam/1194/2004 (h5n1) like strain used (nibrg-14) - influenza, human, immunization, disease outbreaks - vaccines, - prophylaxis of influenza in an officially declared pandemic situation. pandemic influenza vaccine should be used in accordance with official guidance.,

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - jantoven® is indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. jantoven is contraindicated in: - pregnancy jantoven is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see warnings and precautions (5.7) and

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 100 mg - pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from post-marketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrhythmias, during

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigadrone  is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions ( 5.1 )] .  vigadrone  is not indicated as a first line agent for complex partial seizures. vigadrone is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions ( 5.1 )]. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigadrone, during pregnancy. encourage women who are taking vigadrone during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 or visiting the website,

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - isotretinoin (unii: eh28up18if) (isotretinoin - unii:eh28up18if) - isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. limitations of use : if a second course of isotretinoin therapy is needed, it is not recommended before a two-month waiting period because the patient's acne may continue to improve following a 15 to 20-week course of therapy [see dosage and administration (2.2)] . isotretinoin capsules are contraindicated in pregnancy [see warnings and precautions (5.1) and use in specific populations (8.1)] . isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or vitamin a, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam tablets are indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6) ]. pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. healthcare providers are encouraged to recommend that pregnant women taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8) and clinical considerations ]. available data from published ob

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate tablets are indicated for the management of: - adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. - adults with chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve morphine sulfate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia. pediatric use information is approved for hikma pharmaceuticals usa inc.'s morphine sulfate tablets. however, due to hikma pharmaceuticals usa inc.'s marketing exclusivity rights, this drug product is not labeled with that information. morphine sulfat

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - clomipramine hydrochloride (unii: 2lxw0l6gwj) (clomipramine - unii:nuv44l116d) - clomipramine hydrochloride 25 mg - clomipramine hydrochloride capsules, usp are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (ocd). the obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the dsm-iii-r (circa 1989) diagnosis of ocd. obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. the effectiveness of clomipramine hydrochloride for the treatment of ocd was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. patients in all studies had moderate-to-severe ocd (dsm-iii), with mean baseline ratings on the yale-brow

美国 - 英文 - NLM (National Library of Medicine)

upsher-smith laboratories, llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 600 mg - because of reports of intestinal and gastric ulceration and bleeding with controlled-release potassium chloride preparations, these drugs should be reserved for those patients who cannot tolerate or refuse to take liquid or effervescent potassium preparations or for patients in whom there is a problem of compliance with these preparations. - for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. if hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. - for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal