Armenia - englanti - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

zim laboratories ltd. - etoricoxib - tablets film-coated - 120mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

apnar pharma lp - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)]. - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)]. - bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see warnings and precautions (5.3), drug interactions (7.3)]. - the use of maois (intended to treat psychiatric disorders) concomitantly with bupropion hydrochloride tablets or within 14 days of discontinuing treatment with bupropion hydrochloride tablets are contraindicated. there is an increased risk of hypertensive reactions when bupropion hydrochloride tablets are used concomitantly with maois. the use of bupropion hydrochloride tablets within 14 days of discontinuing treatment with an maoi is also contraindicated. starting bupropion hydrochloride tablets in a patient treated with reversible maois such as linezolid or intravenous methylene blue is contraindicated [see dosage and administration (2.4, 2.5), warnings and precautions (5.4), drug interactions (7.6)]. - bupropion hydrochloride tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrochloride tablets. anaphylactoid/anaphylactic reactions and stevens- johnson syndrome have been reported [see warnings and precautions (5.8)]. pregnancy exposure registry there is an independent pregnancy exposure registry that monitors pregnancy outcomes in women exposed to any antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see data) . there are risks to the mother associated with untreated depression in pregnancy (see clinical considerations) . when bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (mrhd) of 450 mg/day. when given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the mrhd and greater. decreased fetal weights were seen at doses twice the mrhd and greater (see animal data) . the estimated background risk for major birth defects and miscarriage is unknown for the indicated population. 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 of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. data human data: data from the international bupropion pregnancy registry (675 first- trimester exposures) and a retrospective cohort study using the united healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. the registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. no increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. the prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international pregnancy registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%). data from the united healthcare database, which had a limited number of exposed cases with cardiovascular malformations, and a case-control study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) of self-reported bupropion use from the national birth defects prevention study (nbdps) did not show an increased risk for cardiovascular malformations overall after bupropion exposure during the first trimester. study findings on bupropion exposure during the first trimester and risk for left ventricular outflow tract obstruction (lvoto) are inconsistent and do not allow conclusions regarding a possible association. the united healthcare database lacked sufficient power to evaluate this association; the nbdps found increased risk for lvoto (n = 10; adjusted or = 2.6; 95% ci: 1.2, 5.7), and the slone epidemiology case control study did not find increased risk for lvoto. study findings on bupropion exposure during the first trimester and risk for ventricular septal defect (vsd) are inconsistent and do not allow conclusions regarding a possible association. the slone epidemiology study found an increased risk for vsd following first trimester maternal bupropion exposure (n = 17; adjusted or = 2.5; 95% ci: 1.3, 5.0) but did not find increased risk for any other cardiovascular malformations studied (including lvoto as above). the nbdps and united healthcare database study did not find an association between first trimester maternal bupropion exposure and vsd. for the findings of lvoto and vsd, the studies were limited by the small number of exposed cases, inconsistent findings among studies, and the potential for chance findings from multiple comparisons in case control studies. animal data: in studies conducted in pregnant rats and rabbits, bupropion was administered orally during the period of organogenesis at doses of up to 450 and 150 mg/kg/day, respectively (approximately 10 and 6 times the mrhd, respectively, on a mg/m 2 basis). there was no evidence of fetal malformations in rats. when given to pregnant rabbits during organogenesis, non-dose–related increases in incidence of fetal malformations and skeletal variations were observed at the lowest dose tested (25 mg/kg/day, approximately equal to the mrhd on a mg/m 2 basis) and greater. decreased fetal weights were observed at doses of 50 mg/kg/day (approximately 2 times the mrhd on a mg/m 2 basis) and greater. no maternal toxicity was evident at doses of 50 mg/kg/day or less. in a pre-and postnatal development study, bupropion administered orally to pregnant rats at doses of up to 150 mg/kg/day (approximately 3 times the mrhd on a mg/m 2 basis) from embryonic implantation through lactation had no effect on pup growth or development. risk summary data from published literature report the presence of bupropion and its metabolites in human milk (see data) . there are no data on the effects of bupropion or its metabolites on milk production. limited data from postmarketing reports have not identified a clear association of adverse reactions in the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bupropion hydrochloride tablets and any potential adverse effects on the breastfed child from bupropion hydrochloride tablets or from the underlying maternal condition. data in a lactation study of 10 women, levels of orally dosed bupropion and its active metabolites were measured in expressed milk. the average daily infant exposure (assuming 150 ml/kg daily consumption) to bupropion and its active metabolites was 2% of the maternal weight-adjusted dose. postmarketing reports have described seizures in breastfed infants. the relationship of bupropion exposure and these seizures is unclear. safety and effectiveness in the pediatric population have not been established [see boxed warning, warnings and precautions (5.1)]. of the approximately 6,000 subjects who participated in clinical trials with bupropion sustained-release tablets (depression and smoking cessation trials), 275 were aged ≥65 years and 47 were aged ≥75 years. in addition, several hundred subjects aged ≥65 years participated in clinical trials using the immediate-release formulation of bupropion (depression trials). no overall differences in safety or effectiveness were observed between these subjects and younger subjects. 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. bupropion is extensively metabolized in the liver to active metabolites, which are further metabolized and excreted by the kidneys. the risk of adverse reactions may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, it may be necessary to consider this factor in dose selection; it may be useful to monitor renal function [see dosage and administration (2.3), use in specific populations (8.6), clinical pharmacology (12.3)]. consider a reduced dose and/or dosing frequency of bupropion hydrochloride tablets in patients with renal impairment (gfr less than 90 ml per min). bupropion and its metabolites are cleared renally and may accumulate in such patients to a greater extent than usual. monitor closely for adverse reactions that could indicate high bupropion or metabolite exposures [see dosage and administration (2.3), clinical pharmacology (12.3)]. in patients with moderate to severe hepatic impairment (child-pugh score: 7 to 15), the maximum dose of bupropion hydrochloride tablets is 75 mg daily. in patients with mild hepatic impairment (child-pugh score: 5 to 6), consider reducing the dose and/or frequency of dosing [see dosage and administration (2.2), clinical pharmacology (12.3)]. bupropion is not a controlled substance. humans controlled clinical trials conducted in normal volunteers, in subjects with a history of multiple drug abuse, and in depressed subjects showed some increase in motor activity and agitation/excitement, often typical of central stimulant activity. in a population of individuals experienced with drugs of abuse, a single oral dose of 400 mg of bupropion produced mild amphetamine-like activity as compared with placebo on the morphine-benzedrine subscale of the addiction research center inventories (arci) and a score greater than placebo but less than 15 mg of the schedule ii stimulant dextroamphetamine on the liking scale of the arci. these scales measure general feelings of euphoria and drug liking which are often associated with abuse potential. findings in clinical trials, however, are not known to reliably predict the abuse potential of drugs. nonetheless, evidence from single-dose trials does suggest that the recommended daily dosage of bupropion when administered orally in divided doses is not likely to be significantly reinforcing to amphetamine or cns stimulant abusers. however, higher doses (which could not be tested because of the risk of seizure) might be modestly attractive to those who abuse cns stimulant drugs. bupropion hydrochloride tablets are intended for oral use only. the inhalation of crushed tablets or injection of dissolved bupropion has been reported. seizures and/or cases of death have been reported when bupropion has been administered intranasally or by parenteral injection. animals studies in rodents and primates demonstrated that bupropion exhibits some pharmacologic actions common to psychostimulants. in rodents, it has been shown to increase locomotor activity, elicit a mild stereotyped behavior response, and increase rates of responding in several schedule-controlled behavior paradigms. in primate models assessing the positive reinforcing effects of psychoactive drugs, bupropion was self-administered intravenously. in rats, bupropion produced amphetamine-like and cocaine-like discriminative stimulus effects in drug discrimination paradigms used to characterize the subjective effects of psychoactive drugs.

Yhdistynyt kuningaskunta - englanti - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi consumer healthcare - fexofenadine hydrochloride - oral tablet - 120mg

Australia - englanti - Department of Health (Therapeutic Goods Administration)

jshealth vitamins pty ltd - zinc amino acid chelate, quantity: 50 mg (equivalent: zinc, qty 10 mg); tribulus terrestris, quantity: 200 mg (equivalent: tribulus terrestris, qty 10 g); fucus vesiculosus, quantity: 50 mg (equivalent: fucus vesiculosus, qty 1 g; equivalent: iodine, qty 10 microgram); ascophyllum nodosum, quantity: 211.11 mg (equivalent: iodine, qty 190 microgram); ginkgo biloba, quantity: 120 mg (equivalent: ginkgo biloba, qty 6 g) - tablet, film coated - excipient ingredients: crospovidone; hypromellose; calcium hydrogen phosphate dihydrate; povidone; macrogol 400; carnauba wax; peppermint oil; maltodextrin; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; lavender oil; microcrystalline cellulose - antioxidant/reduce free radicals formed in the body ; helps reduce/decrease free radical damage to body cells ; maintain/support energy levels ; maintain/support body metabolism/metabolic rate ; maintain/support energy production ; maintain/support general health and wellbeing ; maintain/support hair growth ; maintain/support hair health ; maintain/support hair strength/thickness ; maintain/support nail health/strength/thickness ; maintain/support connective tissue health ; aid/assist/helps connective tissue production/formation ; maintain/support healthy blood circulation ; maintain/support healthy thyroid gland function ; maintain/support healthy thyroid hormones ; maintain/support thyroid gland health ; aid/assist thyroid hormone production ; maintain/support immune system health ; maintain/support healthy immune system function ; maintain/support immune system to fight illness ; aid/assist/helps glucose/sugar/carbohydrate metabolism ; aid/assist/helps protein synthesis in the body ; maintain/support mental concentration/focus/clarity ; maintain/support cognitive function/mental function ; maintain/support memory/mental recall ; maintain/support general mental wellbeing ; maintain/support brain function ; maintain/support nervous system health ; maintain/support female reproductive system health ; maintain/support preconception health ; maintain/support reproductive system health ; maintain/support healthy reproductive hormones ; traditionally used in ayurvedic medicine to aphrodisiac/enhance/improve/promote healthy libido ; traditionally used in ayurvedic medicine to maintain/support healthy libido ; traditionally used in ayurvedic medicine to maintain/support healthy sexual function ; maintain/support sperm health ; maintain/support sperm motility ; maintain/support sperm production ; maintain/support testosterone level ; maintain/support skin health ; maintain/support wound healing

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

a. menarini new zealand pty ltd - febuxostat 120mg;   - film coated tablet - 120 mg - active: febuxostat 120mg   excipient: colloidal silicon dioxide croscarmellose sodium hyprolose lactose monohydrate magnesium stearate microcrystalline cellulose opadry yellow 85f42129 - treatment of chronic hyperuricaemia in patients with gout (including a history, or presence of, tophus and/or gouty arthritis). adenuric is indicated in adults.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

organon (new zealand) limited - etoricoxib 120mg; etoricoxib 120mg - film coated tablet - 120 mg - active: etoricoxib 120mg excipient: calcium hydrogen phosphate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11529 purified water active: etoricoxib 120mg excipient: calcium hydrogen phosphate dihydrate carnauba wax croscarmellose sodium magnesium stearate microcrystalline cellulose opadry green 39k11529 purified water - arcoxia is indicated for: · acute and chronic treatment of the signs and symptoms of osteoarthritis (oa) and rheumatoid arthritis (ra) · the management of ankylosing spondylitis (as) · treatment of acute gouty arthritis · relief of acute pain, including pain related to minor dental procedures · relief of chronic musculoskeletal pain the decision to prescribe a selective cox-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

viatris limited - verapamil hydrochloride 120mg - modified release tablet - 120 mg - active: verapamil hydrochloride 120mg excipient: glycol montanate hypromellose macrogol 400 macrogol 6000 magnesium stearate microcrystalline cellulose povidone purified talc purified water sodium alginate titanium dioxide - · angina pectoris - for the prophylaxis and treatment of coronary insufficiency: chronic stable angina pectoris; angina at rest including vasospastic (prinzmetal's, variant angina) and unstable angina (crescendo, pre-infarction angina); angina pectoris post myocardial infarction.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

mundipharma new zealand ltd - oxycodone hydrochloride 120mg - modified release tablet - 120 mg - active: oxycodone hydrochloride 120mg excipient: ammonio methacrylate copolymer lactose monohydrate magnesium stearate opadry purple 15b20201 povidone purified talc purified water stearyl alcohol triacetin - the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - fexofenadine hydrochloride 120mg;  ;   - film coated tablet - 120 mg - active: fexofenadine hydrochloride 120mg     excipient: colloidal silicon dioxide croscarmellose sodium ferric oxide, pink hypromellose e-15 hypromellose e-5 iron oxide yellow macrogol 400 magnesium stearate microcrystalline cellulose povidone pregelatinised maize starch titanium dioxide - relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.

Uusi-Seelanti - englanti - Medsafe (Medicines Safety Authority)

viatris limited - verapamil hydrochloride 120mg;  ; verapamil hydrochloride 120mg - modified release tablet - 120 mg - active: verapamil hydrochloride 120mg   excipient: carnauba wax chloroform diethyl phthalate ethanol hydrogenated castor oil hypromellose lactose monohydrate magnesium stearate methacrylic acid copolymer purified talc active: verapamil hydrochloride 120mg excipient: carnauba wax diethyl phthalate ethanol hydrogenated castor oil hypromellose lactose monohydrate magnesium stearate methacrylic acid copolymer purified talc purified water - · essential hypertension.