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

boehringer ingelheim pty ltd - nevirapine hemihydrate, quantity: 10.35 mg/ml (equivalent: nevirapine, qty 10 mg/ml) - oral liquid, suspension - excipient ingredients: purified water; sorbitol solution (70 per cent) (non-crystallising); propyl hydroxybenzoate; sodium hydroxide; carbomer 934p; polysorbate 80; sucrose; methyl hydroxybenzoate - viramune (nevirapine) oral suspension in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of 2 months. viramune xr (nevirapine) extended-release tablets in combination with antiretroviral agents is indicated for the treatment of hiv-1 infection in adults and children over the age of three years. extended-release tablets are not suitable for the 14 day lead-in period for patients starting nevirapine. other nevirapine formulations, such as immediate-release tablets or oral suspension should be used. resistant virus emerges rapidly when viramune is administered as monotherapy or in dual combination therapy with an antiretroviral agent. therefore, viramune should always be administered in combination with at least two additional antiretroviral agents.

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

ascend laboratories, llc - diclofenac potassium (unii: l4d5ua6cb4) (diclofenac - unii:144o8ql0l1) - diclofenac potassium for oral solution is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). limitations of use - diclofenac potassium for oral solution is not indicated for the prophylactic therapy of migraine. - the safety and effectiveness of diclofenac potassium for oral solution have not been established for cluster headache, which is present in an older, predominantly male population. diclofenac potassium for oral solution is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac 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 [

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

advanced rx pharmacy of tennessee, llc - ondansetron (unii: 4af302esos) (ondansetron - unii:4af302esos) - ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - initial and repeat courses of moderately emetogenic cancer chemotherapy - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron orally disintegrating tablets are contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see adverse reactions (6.2)] - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness 8.1 pregnancy risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pregnancy (see data). available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area (bsa), respectively (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age. two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however, this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the u.s. medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis. with the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on bsa. in a pre- and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. at a dose of 15 mg/kg/day in rats, the maternal exposure margin was approximately 6 times the maximum recommended human oral dose of 24 mg/day, based on bsa. 8.2 lactation risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breastfed infant from ondansetron or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. use of ondansetron in these age-groups is supported by evidence from adequate and well- controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-u.s. trials in 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see dosage and administration (2.2), clinical studies (14.1)]. additional information on the use of ondansetron in pediatric patients may be found in ondansetron injection prescribing information. the safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for: prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy prevention of nausea and vomiting associated with radiotherapy prevention of postoperative nausea and/or vomiting 8.5 geriatric use of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in u.s.- and foreign-controlled clinical trials, for which there were subgroup analyses, 938 (19%) were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)]. there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is needed in elderly patients. 8.6 hepatic impairment no dosage adjustment is needed in patients with mild or moderate hepatic impairment. in patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron. therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (child-pugh score of 10 or greater) [see dosage and administration (2.2), clinical pharmacology (12.3)]. 8.7 renal impairment no dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe). there is no experience beyond first-day administration of ondansetron [see clinical pharmacology (12.3)]. animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

Spojené arabské emiráty - angličtina - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

city medical store - sole proprietorship l.l.c netherlands - 220ml plastic bottle - liquid - combination - nutrition , blood-oral nutrition

Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

wsd agribusiness pty ltd - levamisole hydrochloride; fenbendazole - oral solution/suspension - levamisole hydrochloride anthelmintic active 40.0 g/l; fenbendazole carbamate-benzimidazole active 25.0 g/l - parasiticides - lamb | sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - barber's pole worm-haemonchus contortus | black scour worm - trichostrongylus spp. | hookworm - bunostomum spp. | intestinal threadworm - s. papillosus | large lungworm - dictyocaulus filaria | large mouthed bowel worm | nodule worm - o. columbianum | small brown stomach worm-ostertagia spp. | small intestinal worm - cooperia spp. | tapeworm - monieza expansa | thin necked intestinal worm | whipworm - trichuris ovis | hair worm | intestinal hair worm | small hair worm | teladorsagia

Írsko - angličtina - HPRA (Health Products Regulatory Authority)

essential pharmaceuticals limited - lisinopril dihydrate - oral solution - 1 mg/ml - lisinopril - angiotensin-converting enzyme inhibitors - treatment of hypertension; treatment of symptomatic heart failure; treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction; treatment of renal disease in hypertensive patients with type 2 diabetes mellitus and incipient nephropathy

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

boehringer ingelheim ltd - nevirapine hemihydrate - oral suspension - 10mg/1ml

Spojené kráľovstvo - angličtina - MHRA (Medicines & Healthcare Products Regulatory Agency)

viiv healthcare uk ltd - fosamprenavir calcium - oral suspension - 50mg/1ml

Nový Zéland - angličtina - Medsafe (Medicines Safety Authority)

glaxosmithkline nz limited - zidovudine 10 mg/ml - oral solution - 10 mg/ml - active: zidovudine 10 mg/ml excipient: citric acid monohydrate glycerol hydrogenated glucose syrup purified water saccharin sodium sodium benzoate strawberry flavour phl-134189 white sugar flavour da13780 - retrovir oral formulations are indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (hiv) infection in adults and children.

Austrália - angličtina - APVMA (Australian Pesticides and Veterinary Medicines Authority)

wsd agribusiness pty ltd - abamectin; selenium as sodium selenate - oral solution/suspension - abamectin anthelmintic active 0.8 g/l; selenium as sodium selenate mineral-selenium active 0.4 g/l - parasiticides - lamb | sheep | ewe | hogget | lamb | ovine | ram | weaner | wether - barber's pole worm-haemonchus contortus | cooperia curticei | intestinal threadworm - s. papillosus | large bowel worm - o. venulosum | large lungworm - dictyocaulus filaria | large mouthed bowel worm | large stomach worm | nasal bot | nematodirus filicollis | nodule worm - o. columbianum | ostertagia circumcincta | sheep itch mite | stomach hair worm | trichostrongylus vitrinus | whipworm - trichuris ovis | barber's pole worm | black scour worm | psorobia ovis | sheep nasal bot fly | small brown stomach worm | small intestinal worm | thin necked intestinal worm