Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied.

Eiropas Savienība - angļu - EMA (European Medicines Agency)

ipsen pharma - mecasermin - laron syndrome - pituitary and hypothalamic hormones and analogues - for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary igfd).severe primary igfd is defined by:height standard deviation score ≤ -3.0 and;basal insulin-like growth factor-1 (igf-1) levels below the 2.5th percentile for age and gender and;growth hormone (gh) sufficiency;exclusion of secondary forms of igf-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.severe primary igfd includes patients with mutations in the gh receptor (ghr), post-ghr signalling pathway, and igf-1 gene defects; they are not gh deficient, and therefore, they cannot be expected to respond adequately to exogenous gh treatment. it is recommended to confirm the diagnosis by conducting an igf-1 generation test.

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lansoprazole 15mg (lansoprazole (r,s racemic mixture));   - capsule - 15 mg - active: lansoprazole 15mg (lansoprazole (r,s racemic mixture))   excipient: gelatin   hypromellose macrogol 6000 mannitol meglumine methacrylic acid - ethyl acrylate copolymer polysorbate 80 purified talc purified water   quinoline yellow   sodium laurilsulfate sugar spheres titanium dioxide     - healing and long-term management of reflux oesophagitis healing and maintenance therapy for patients with duodenal ulcer healing of benign gastric ulcer lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists

Jaunzēlande - angļu - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - lansoprazole 30mg (lansoprazole (r,s racemic mixture) );   - capsule - 30 mg - active: lansoprazole 30mg (lansoprazole (r,s racemic mixture) )   excipient: gelatin   hypromellose macrogol 6000 mannitol meglumine methacrylic acid - ethyl acrylate copolymer polysorbate 80 purified talc sodium laurilsulfate sugar spheres titanium dioxide     water   - healing and long-term management of reflux oesophagitis healing and maintenance therapy for patients with duodenal ulcer healing of benign gastric ulcer lansoprazole is also effective in patients with benign peptic lesions that do not respond to h2-receptor antagonists

Īrija - angļu - HPRA (Health Products Regulatory Authority)

pharma regulatory solutions ltd - voriconazole - pdr for soln for infusion - 200 milligram - triazole derivatives - antimycotics for systemic use, triazole derivatives - voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis. treatment of candidaemia in non-neutropenic patients. treatment of fluconazole-resistant serious invasive candida infections (including c. krusei). treatment of serious fungal infections caused by scedosporium spp. and fusarium spp. voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (hsct) recipients.

Filipīnas - angļu - FDA (Food And Drug Administration)

qualimed pharma, inc. (c/o united douglas pharm. phils. inc.); distributor: qualimed pharma, inc. (c/o united douglas pharm. phils. inc.) - carboplatin - solution for injection (i.v.) - 10 mg/ml (450 mg/45 ml)

Eiropas Savienība - angļu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptics - aripiprazole mylan pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.aripiprazole mylan pharma is indicated for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.aripiprazole mylan pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in bipolar i disorder in adolescents aged 13 years and older.

Īrija - angļu - HPRA (Health Products Regulatory Authority)

provimi ltd - zinc oxide - premix for medicated feeding stuff - 100 percent - zinc oxide - pigs - miscellaneous

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

magna pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpimist (zolpidem tartrate) oral spray (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpimist (zolpidem tartrate) oral spray is contraindicated in patients with known hypersensitivity to zolpidem. observed reactions with zolpidem include anaphylaxis and angioedema [see warnings and precautions (5.3)]. pregnancy category c there are no adequate and well-controlled studies of zolpimist (zolpidem tartrate) oral spray in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)]. limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine is contraindicated: there is a pregnancy registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at < 20 weeks gestation. in literature reports, immediate-release nevirapine exposure (cmin ) can be up to 29% lower during pregnancy. however, as this reduction was not found to be clinically meaningful, dose adjustment is not necessary [see data] . there is a risk for severe hepatic events in pregnant women exposed to nevirapine [see clinical considerations]. in animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (auc) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see data]. severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see warnings and precautions (5.1)] . based on prospective reports to the apr of exposures to nevirapine during pregnancy resulting in live births (including over 1100 exposed in the first trimester and over 1500 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% ci: 2.1%, 4.1%) and 3.3% (95% ci: 2.4%, 4.3%) following first and second/third trimester exposure, respectively, to nevirapine-containing regimens, compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. there are several literature reports of chronic administration of immediate-release nevirapine during pregnancy, in which nevirapine pharmacokinetics were compared between pregnancy and postpartum. in these studies, the mean difference in nevirapine cmin during pregnancy as compared to postpartum ranged from no difference to approximately 29% lower. nevirapine was administered orally to pregnant rats (at 0, 12.5, 25, and 50 mg per kg per day) and rabbits (at 0, 30, 100, and 300 mg per kg per day) through organogenesis (on gestation days 7 through 16, and 6 through 18, respectively). no adverse developmental effects were observed at doses producing systemic exposures (auc) approximately equivalent to (rats) or approximately 50% higher (rabbits) than human exposure at the recommended daily dose. in rats, decreased fetal body weights were observed at a maternally toxic dose at an exposure approximately 50% higher than the recommended daily dose. the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. published data report that nevirapine is present in human milk [see data] . there are limited data on the effects of nevirapine on the breastfed infant. there is no information on the effects of nevirapine on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine. based on five publications, immediate-release nevirapine was excreted in breast milk at median concentrations ranging from 4080 to 6795 ng/ml, and the median maternal breast milk to maternal plasma concentration ratio range was 59 to 88%. reported infant nevirapine median plasma concentrations were low, ranging from 734 to 1140 ng/ml. the estimated nevirapine dose of 704 to 682 mcg/kg/day for infants fed exclusively with breast milk was lower than the daily recommended nevirapine dose for infants. published literature indicates that rash and hyperbilirubinemia have been seen in infants exposed to nevirapine through breastmilk. limited human data are insufficient to determine the risk of infertility in humans. based on results from animal fertility studies conducted in rats, nevirapine may reduce fertility in females of reproductive potential. it is not known if these effects on fertility are reversible [see nonclinical toxicology (13.1)]. the safety, pharmacokinetic profile, and virologic and immunologic responses of nevirapine have been evaluated in hiv-1 infected pediatric subjects aged 3 months to 18 years [see adverse reactions (6.1) and clinical studies (14.2)] . the safety and pharmacokinetic profile of nevirapine has been evaluated in hiv-1 infected pediatric subjects aged 15 days to less than 3 months [see adverse reactions (6.1) and clinical studies (14.2)] . the most frequently reported adverse events related to nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and nevirapine [see adverse reactions (6.1) and clinical studies (14.2)] . clinical trials of nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml per min. the pharmacokinetics of nevirapine have not been evaluated in patients with crcl less than 20 ml per min. in patients undergoing chronic hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated [see dosage and administration (2.4) and clinical pharmacology (12.3)] . because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)] .