Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy’s laboratories, inc. - naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids, including propoxyphene, methadone and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol and cyclazocine. naloxone hydrochloride is also indicated for diagnosis of suspected or known acute opioid overdosage. naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see clinical pharmacology; adjunctive use in septic shock ). naloxone hydrochloride injection is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in naloxone hydrochloride. naloxone hydrochloride is an opioid antagonist. physical dependence associated with the use of naloxone hydrochloride has not been reported. tolerance to the opioid antagonist effect of naloxone hydrochloride is not known to occur

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddy’s laboratories, inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride oral solution, usp is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. potassium chloride is contraindicated in patients on potassium sparing diuretics. there are no human data related to use of potassium chloride during pregnancy and animal studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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 2-4% and 15-20% respectively. risk summary the normal potassium ion content of human milk is about 13 meq per liter. since potassium from oral s

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

dr reddy's new zealand limited - omeprazole 20mg;   - modified release capsule - 20 mg - active: omeprazole 20mg   excipient: crospovidone gelatin hypromellose isopropyl alcohol magnesium stearate mannitol meglumine methacrylic acid - ethyl acrylate copolymer opacode black s-1-27794 poloxamer povidone purified water triethyl citrate

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - bosentan monohydrate, quantity: 129.082 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type a; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type a; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents.,daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age) complicated skin and skin structure infections,daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

Kanada - angličtina - Health Canada

dr. reddy's laboratories inc - progesterone - capsule - 100mg - progesterone 100mg - progestins

Spojené státy - angličtina - NLM (National Library of Medicine)

dr. reddys laboratories inc - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine 12.5 mg - tetrabenazine tablets are indicated for the treatment of chorea associated with huntington’s disease. tetrabenazine tablets are contraindicated in patients: • who are actively suicidal, or in patients with untreated or inadequately treated depression [see warnings and precautions ( 5.1) ]. • with hepatic impairment [see use in specific populations (8.6 ), clinical pharmacology ( 12.3) ]. • taking monoamine oxidase inhibitors (maois). tetrabenazine should not be used in combination with an maoi, or within a minimum of 14 days of discontinuing therapy with an maoi [see drug interactions (7.3)]. • taking reserpine. at least 20 days should elapse after stopping reserpine before starting tetrabenazine[see drug interactions ( 7.2 )]. • taking deutetrabenazine or valbenazine [see drug interactions (7.7)]. risk summary there are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women. administration of tetrabenazine to rats throughout pregnancy and lactation resulted in

Spojené státy - angličtina - NLM (National Library of Medicine)

dr.reddys laboratories inc - sunitinib malate (unii: lvx8n1ut73) (sunitinib - unii:v99t50803m) - sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (gist) after disease progression on or intolerance to imatinib mesylate. sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (rcc). sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent rcc following nephrectomy. sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pnet) in adult patients with unresectable locally advanced or metastatic disease. none. risk summarybased on animal reproduction studies and its mechanism of action, sunitinib malate can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women to inform a drug-associated risk. in animal developmental and reproductive toxicology studies, oral administration of sunitinib to