Australija - engleski - Department of Health (Therapeutic Goods Administration)

cochlear ltd - 58734 - cochlear implant system evaluation application software - nucleus fitting software provides a pc-based means for clinicians to easily configure cochlear implant systems. the software uses the neural response telemetry capabilities of the cochlear implant systems to automatically capture auditory nerve responses at individual electrodes. these responses, along with simple audio controls provided by the user interface, are used by clinicians to configure the implant system for each patient. software or interface between the computer and the sound processor to enable programming of the cochlear implant system.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: indomethacin capsules are contraindicated in the following patients: use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including indomethacin capsules, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of indomethacin capsules in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2 to 4% for major malformations, and 15 to 20% for pregnancy loss. in animal reproduction studies, retarded fetal ossification was observed with administration of indomethacin to mice and rats during organogenesis at doses 0.1 and 0.2 times, respective

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

actavis pharma, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - oxycodone hydrochloride 4.8355 mg - oxycodone and aspirin tablets are indicated for the management of 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), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g., non- opioid analgesics) - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia oxycodone and aspirin tablets are contraindicated in patients with: - significant respiratory depression (see warnings) - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (see warnings) - known or suspected gastrointestinal obstruction, including paralytic ileus (see warnings) - hypersensitivity to oxycodone or aspirin, (e.g. angioedema) (see warnings) - patients with hemophilia. - aspi

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

mylan institutional inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [ see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ] use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal d

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin or any components of the drug product [ see warnings and precautions (5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions (5.1) ] use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal d

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6 week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation. the effectiveness of mirtazapine tablets in hospitali

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 200 mg - celecoxib capsules are  indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ] for the management of the signs and symptoms of ra [see clinical studies (14.2) ] for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] for the management of the signs and symptoms of as [see clinical studies (14.4) ] for the management of acute pain in adults [see clinical studies (14.5) ] for  the   management   of   primary   dysmenorrhea  [see  clinical  studies  (14.5) ] celecoxib capsules are contraindicated in the following patients: pregnancy category c. pregnancy category d from 30 weeks of gestation onward. risk summary use of nsaids, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including celecoxib, in pregnant women starting at 30 weeks of gestation. there are no adequate and well-controlled studies of celec

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 200 mg - celecoxib is contraindicated in the following patients : pregnancy category c. pregnancy category d from 30 weeks of gestation onward. risk summary use of nsaids, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including celecoxib, in pregnant women starting at 30 weeks of gestation. there are no adequate and well-controlled studies of celecoxib in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2–4% for major malformations, and 15–20% for pregnancy loss. in animal reproduction studies, embryo-fetal deaths and an increase in diaphragmatic hernias were observed in rats administered celecoxib daily during the period of organogenesis at oral doses approximately

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - brintellix is indicated for the treatment of major depressive disorder (mdd). the efficacy of brintellix was established in six 6 to 8 week studies (including one study in the elderly) and one maintenance study in adults [see clinical studies (14)] . pregnancy category c risk summary there are no adequate and well-controlled studies of brintellix in pregnant women. vortioxetine caused developmental delays when administered during pregnancy to rats and rabbits at doses 15 and 10 times the maximum recommended human dose (mrhd) of 20 mg, respectively. developmental delays were also seen after birth in rats at doses 20 times the mrhd of vortioxetine given during pregnancy and through lactation. there were no teratogenic effects in rats or rabbits at doses up to 77 and 58 times, the mrhd of vortioxetine, respectively, given during organogenesis. the incidence of malformations in human pregnancies has not been established for brintellix. all human pregnancies, regardless of drug exposure, have a background rate of

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - olanzapine 10 mg - olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6 week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6 week trial [ see clinical studies (14.1) ]. when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [ see warnings and precautions ( 5.5 ) ]. olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed epi