USA - engelska - NLM (National Library of Medicine)

macleods pharmaceuticals limited - propylthiouracil (unii: 721m9407iy) (propylthiouracil - unii:721m9407iy) - propylthiouracil are indicated: • in patients with graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option • to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole propylthiouracil is contraindicated in patients who have demonstrated hypersensitivity to the drug or any of the other product components.

USA - engelska - NLM (National Library of Medicine)

newton laboratories, inc. - thyroid, unspecified (unii: 0b4fdl9i6p) (thyroid, unspecified - unii:0b4fdl9i6p) - goiter; obesity; excitability of heart; irritability; very dry skin; sleeplessness goiter; obesity; excitability of heart; irritability; very dry skin; sleeplessness

Australien - engelska - Department of Health (Therapeutic Goods Administration)

ecology medicine - tyrosine -

Europeiska unionen - engelska - EMA (European Medicines Agency)

allergan pharmaceuticals ireland - bimatoprost, timolol - glaucoma, open-angle, ocular hypertension - ophthalmologicals, - reduction of intraocular pressure (iop) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Europeiska unionen - engelska - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

Europeiska unionen - engelska - EMA (European Medicines Agency)

h. lundbeck a/s - nalmefene hydrochloride dihydrate - alcohol-related disorders - drugs used in alcohol dependence - selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (see section 5.1), without physical withdrawal symptoms and who do not require immediate detoxification.selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.selincro should be initiated only in patients who continue to have a high drinking-risk level two weeks after initial assessment.

Europeiska unionen - engelska - EMA (European Medicines Agency)

accord healthcare s.l.u. - docetaxel - head and neck neoplasms, carcinoma, non-small-cell lung, adenocarcinoma, prostatic neoplasms, breast neoplasms - antineoplastic agents, - breast cancerdocetaxel accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.for patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.docetaxel accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.docetaxel accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. previous chemotherapy should have included an anthracycline or an alkylating agent.docetaxel accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer w

Europeiska unionen - engelska - EMA (European Medicines Agency)

csl behring gmbh - alpha1-proteinase inhibitor (human) - genetic diseases, inborn, lung diseases - antihemorrhagics, - respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes pizz, piz(null), pi(null,null), pisz). patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (fev1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.,

USA - engelska - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone hydrochloride injection also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone hydrochloride injection, patients may be transferred to oral amiodarone therapy [see dosage and administration ( 2)]. use amiodarone hydrochloride injection for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone hydrochloride injection may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: known hypersensitivity to any of the components of amiodarone, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). cardiogenic shock. marked sinus bradycardia. second- or third-degree atrio-ventricular (av) block unless a functioning pacemaker is available. 8.1 pregnancy pregnancy category d [see warnings and precautions 5-(5.8)]. in addition to causing infrequent congenital goiter/hypothyroidism and hyperthyroidism, amiodarone has caused a variety of adverse effects in animals. in a reproductive study in which amiodarone was given intravenously to rabbits at dosages of 5, 10, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the maximum recommended human dose [mrhd] on a body surface area basis), maternal deaths occurred in all groups, including controls. embryotoxicity (as manifested by fewer full-term fetuses and increased resorptions with concomitantly lower litter weights) occurred at dosages of 10 mg/kg and above. no evidence of embryotoxicity was observed at 5 mg/kg and no teratogenicity was observed at any dosages. in a teratology study in which amiodarone was administered by continuous iv infusion to rats at dosages of 25, 50, or 100 mg/kg per day (about 0.4, 0.7, and 1.4 times the mrhd when compared on a body surface area basis), maternal toxicity (as evidenced by reduced weight gain and food consumption) and embryotoxicity (as evidenced by increased resorptions, decreased live litter size, reduced body weights, and retarded sternum and metacarpal ossification) were observed in the 100 mg/kg group. use amiodarone during pregnancy only if the potential benefit to the mother justifies the risk to the fetus. 8.2 labor and delivery it is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects. preclinical studies in rodents have not shown any effect on the duration of gestation or on parturition. 8.3 nursing mothers amiodarone and one of its major metabolites, desethylamiodarone (dea), are excreted in human milk, suggesting that breastfeeding could expose the nursing infant to a significant dose of the drug. nursing offspring of lactating rats administered amiodarone have demonstrated reduced viability and reduced body weight gains. the risk of exposing the infant to amiodarone must be weighed against the potential benefit of arrhythmia suppression in the mother. advise the mother to discontinue nursing. 8.4 pediatric use the safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended. in a pediatric trial of 61 patients, aged 30 days to 15 years, hypotension (36%), bradycardia (20%), and av block (15%) were common dose-related adverse reactions and were severe or life-threatening in some cases. injection site reactions were seen in 5 (25%) of the 20 patients receiving intravenous amiodarone through a peripheral vein irrespective of dose regimen. amiodarone injection contains the preservative benzyl alcohol [see description ( 11)]. there have been reports of fatal "gasping syndrome" in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. 8.5 geriatric use clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. carefully consider dose selection in an elderly patient. in general, start at the low end of the dosing range in the elderly to reflect the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

USA - engelska - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 50 mg in 1 ml - amiodarone hydrochloride injection, usp is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (vf) and hemodynamically unstable ventricular tachycardia (vt) in patients refractory to other therapy. amiodarone hydrochloride injection, usp also can be used to treat patients with vt/vf for whom oral amiodarone is indicated, but who are unable to take oral medication. during or after treatment with amiodarone hydrochloride injection, usp patients may be transferred to oral amiodarone therapy [see dosage and administration (2)] . use amiodarone hydrochloride injection, usp for acute treatment until the patient's ventricular arrhythmias are stabilized. most patients will require this therapy for 48 to 96 hours, but amiodarone hydrochloride injection may be safely administered for longer periods if necessary. amiodarone is contraindicated in patients with: - known hypersensitivity to any of the components of amiodarone, including iodine. hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periarteritis (inflammation around blood vessels). - cardiogenic shock. - marked sinus bradycardia. - second- or third-degree atrio-ventricular (av) block unless a functioning pacemaker is available. pregnancy category d [see warnings and precautions (5.8)] . in addition to causing infrequent congenital goiter/hypothyroidism and hyperthyroidism, amiodarone has caused a variety of adverse effects in animals. in a reproductive study in which amiodarone was given intravenously to rabbits at dosages of 5, 10, or 25 mg/kg per day (about 0.1, 0.3, and 0.7 times the maximum recommended human dose [mrhd] on a body surface area basis), maternal deaths occurred in all groups, including controls. embryotoxicity (as manifested by fewer full-term fetuses and increased resorptions with concomitantly lower litter weights) occurred at dosages of 10 mg/kg and above. no evidence of embryotoxicity was observed at 5 mg/kg and no teratogenicity was observed at any dosages. in a teratology study in which amiodarone was administered by continuous iv infusion to rats at dosages of 25, 50, or 100 mg/kg per day (about 0.4, 0.7, and 1.4 times the mrhd when compared on a body surface area basis), maternal toxicity (as evidenced by reduced weight gain and food consumption) and embryotoxicity (as evidenced by increased resorptions, decreased live litter size, reduced body weights, and retarded sternum and metacarpal ossification) were observed in the 100 mg/kg group. use amiodarone during pregnancy only if the potential benefit to the mother justifies the risk to the fetus. it is not known whether the use of amiodarone during labor or delivery has any immediate or delayed adverse effects. preclinical studies in rodents have not shown any effect on the duration of gestation or on parturition. amiodarone and one of its major metabolites, desethylamiodarone (dea), are excreted in human milk, suggesting that breastfeeding could expose the nursing infant to a significant dose of the drug. nursing offspring of lactating rats administered amiodarone have demonstrated reduced viability and reduced body weight gains. the risk of exposing the infant to amiodarone must be weighed against the potential benefit of arrhythmia suppression in the mother. advise the mother to discontinue nursing. the safety and effectiveness of amiodarone in pediatric patients have not been established; therefore, the use of amiodarone in pediatric patients is not recommended. in a pediatric trial of 61 patients, aged 30 days to 15 years, hypotension (36%), bradycardia (20%), and av block (15%) were common dose-related adverse reactions and were severe or life-threatening in some cases. injection site reactions were seen in 5 (25%) of the 20 patients receiving intravenous amiodarone through a peripheral vein irrespective of dose regimen. amiodarone injection contains the preservative benzyl alcohol [see description (11)] . there have been reports of fatal "gasping syndrome" in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse. clinical studies of amiodarone did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. carefully consider dose selection in an elderly patient. in general, start at the low end of the dosing range in the elderly to reflect the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.