United States - English - NLM (National Library of Medicine)

remedyrepack inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and

United States - English - NLM (National Library of Medicine)

alvogen inc. - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness. bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (stevens-johnson syndrome). primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in ad

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and

United States - English - NLM (National Library of Medicine)

alvogen, inc. - nitroglycerin (unii: g59m7s0ws3) (nitroglycerin - unii:g59m7s0ws3) - nitroglycerin 0.1 mg in 1 h - transdermal nitroglycerin is indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute attack. nitroglycerin is contraindicated in patients who are allergic to it. allergy to the adhesives used in nitroglycerin patches has also been reported, and it similarly constitutes a contraindication to the use of this product. do not use nitroglycerin transdermal infusion system in patients who are taking phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil) for erectile dysfunction or pulmonary arterial hypertension. concomitant use can cause severe drops in blood pressure. do not use nitroglycerin transdermal infusion system in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

Malta - English - Medicines Authority

alvogen malta operations (row) ltd malta life sciences park, building 1, level 4 sir temi, zammit buildings, san gwann, malta - febuxostat - film-coated tablet - febuxostat 80 mg - antigout preparations

Malta - English - Medicines Authority

alvogen malta operations (row) ltd malta life sciences park, building 1, level 4 sir temi, zammit buildings, san gwann, malta - febuxostat - film-coated tablet - febuxostat 120 mg - antigout preparations

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

lotus healthcare malaysia sdn. bhd. - lenalidomide -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

lotus healthcare malaysia sdn. bhd. - lenalidomide -

United States - English - NLM (National Library of Medicine)

alvogen, inc. - rasagiline mesylate (unii: lh8c2ji290) (rasagiline - unii:003n66ts6t) - rasagiline 0.5 mg - rasagiline mesylate tablets are indicated for the treatment of parkinson’s disease (pd). rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2)]. at least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. rasagiline is contraindicated for use with st. john’s wort and with cyclobenzaprine. rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. pregnancy category c there are no adequate and well-controlled studies of rasagiline in pregnant women. rasagiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in a combined mating/fertility and embryo-fetal development study in pregnant rats, no effect on embryo-fetal development was observed at oral doses

United States - English - NLM (National Library of Medicine)

alvogen, inc. - budesonide (unii: q3oks62q6x) (budesonide - unii:q3oks62q6x) - budesonide 3 mg - budesonide capsules (enteric coated)  are indicated for the treatment of mild to moderate active crohn's disease involving the ileum and/or the ascending colon. pediatric use information is approved for perrigo pharma international dac’s entocort ec (budesonide) capsules. however, due to perrigo pharma international dac’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. budesonide capsules (enteric coated) are indicated for the maintenance of clinical remission of mild to moderate crohn's disease involving the ileum and/or the ascending colon for up to 3 months in adults. budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). serious hypersensitivity reactions, including anaphylaxis have occurred  [see adverse reactions (6.2)]. risk summary limited published studies report on the use of budesonide in pregnant women; however, the data are insuffici