Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

kramer novis - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - pain reliever/fever reducer temporarily relieves of minor aches and pains due to • headache • backache •  muscular aches •  minor pain of arthritis • the  common cold •  toothache • premenestrual and  menstrual cramps temporarily reduces fever.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

kramer novis - diphenhydramine hydrochloride (unii: tc2d6jad40) (diphenhydramine - unii:8gts82s83m) - antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat temporarily relieves these symptoms due to the common cold: • runny nose • sneezing

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

kramer laboratories - tolnaftate (unii: 06kb629tkv) (tolnaftate - unii:06kb629tkv) - uses ■ proven clinically effective in the treatment of most jock itch (tinea cruris). ■ for effective relief of itching, burning, or chafing associated with jock itch. do not use on children under 2 years of age unless directed by a doctor. stop use and ask a doctor if ■ irritation occurs. ■ there is no improvement within 2 weeks.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

kramer laboratories - dextromethorphan (unii: 7355x3rots) (dextromethorphan - unii:7355x3rots), doxylamine succinate (unii: v9bi9b5yi2) (doxylamine - unii:95qb77jkpl) - stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. these could be signs of a serious condition.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

fabre kramer pharmaceuticals, inc. - gepirone hydrochloride (unii: 80c9l8ep6v) (gepirone - unii:jw5y7b8z18) - exxua is indicated for the treatment of major depressive disorder (mdd) in adults. exxua is contraindicated in patients: - with known hypersensitivity to gepirone or components of exxua [see adverse reactions (6.1)].  - with prolonged qtc interval > 450 msec at baseline [see warnings and precautions (5.2)]. - with congenital long qt syndrome [see warnings and precautions (5.2)]. - receiving concomitant strong cyp34a inhibitors [see warnings and precautions (5.2)and drug interactions (7)].   - with severe hepatic impairment [see warnings and precautions (5.2)and use in specific populations (8.7)] . - taking, or within 14 days of stopping, maois due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome [see warnings and precautions (5.3)and drug interactions (7)] . starting exxua in a patient treated with reversible maois such as linezolid or intravenous methylene blue is also contraindicated. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including exxua, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/. risk summary based on animal reproduction studies, gepirone has been shown to have adverse effects on embryo/fetal and postnatal development. in rats, increased mortality during the first 4 days after birth and persistent reduction in body weight through lactation and weaning were observed at all doses and increased still births were seen with a no observed adverse effect level (noael) at 3 times the maximum recommended human dose (mrhd) on a mg/m 2 basis. in embryofetal development studies in rats and rabbits, decreased embryofetal growth, body weights and lengths, with accompanying skeletal variations were seen with a noael at 9 and 12 times the mrhd on a mg/m 2 basis, respectively (see data) . there are insufficient clinical data on gepirone use during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. there are clinical considerations regarding neonates exposed to serotonergic antidepressants during the third trimester of pregnancy (see clinical considerations and data) . there are risks associated with untreated depression during pregnancy (see clinical considerations) . consider if the risks outweigh the benefits of treatment with gepirone during pregnancy. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study of 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. fetal/neonatal adverse reactions neonates exposed to other serotonergic antidepressants in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of ssris or possibly a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.3)]. data human data exposure during late pregnancy to serotonergic antidepressants may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1- 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. animal data in embryofetal development studies, oral administration of gepirone to pregnant rats (75, 150, and 300 mg/kg) or pregnant rabbits (50, 100, and 200 mg/kg) during the period of organogenesis resulted in decreased embryofetal growth, body weights and lengths, with accompanying skeletal variations at mid and high doses; the mid doses are 18 and 24 times the mrhd on a mg/m 2 basis in rats and rabbits, respectively. no malformations were seen in these studies. the developmental noael was 9 and 12 times the mrhd on a mg/m 2 basis in rats and rabbits, respectively. when pregnant rats were treated with gepirone (10, 20, and 40 mg/kg) from late gestation through weaning, decreased birth weights were seen at mid and high doses; the mid dose is twice the mrhd. increased offspring mortality during the first 4 days after birth and persistent reduction in body weight were observed at all doses; the lowest dose is approximately equal to the mrhd on a mg/m 2 basis. the no-effect dose for fetal effects was not determined in this study. when gepirone was administered orally to male and female rats prior to and throughout mating, gestation, and lactation at doses of 5, 27, 64, and 150 mg/kg/day. increased still births were seen at ≥64 mg/kg. early postnatal mortality was increased at 150 mg/kg (18 times the mrhd on a mg/m 2 basis). the noael (27 mg/kg) for still births was associated with a maternal dose 3 times the mrhd on a mg/m 2 basis. fetal weights were decreased at 27 mg/kg (3 times the mrhd on a mg/m 2 basis) and fetal lengths were decreased at 64 mg/kg (8 times the mrhd on a mg/m 2 basis) and above. pup weights were decreased at birth, throughout lactation and weaning, and until at least 14 weeks of age, with delays of some developmental landmarks, at 64 mg/kg and above. the noael for growth and development (5 mg/kg) was associated with a maternal dose below the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. gepirone is present in rat milk. when a drug is present in animal milk, it is likely that the drug will be present in human milk. there are reports of breastfed infants exposed to other serotonergic antidepressants experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss (see clinical considerations) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for exxua and any adverse effects on the breastfed infant from exxua or from the underlying maternal condition. clinical considerations monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. the safety and effectiveness of exxua in pediatric patients have not been established for the treatment of mdd. efficacy was not demonstrated in two 8-week, randomized, placebo-controlled trials in 426 pediatric patients 7 to 17 years of age with mdd. the primary efficacy endpoint was change from double-blind baseline to week 8 on the children’s depression rating scale-revised (cdrs-r) measure. the effect of treatment with exxua was not significantly different from placebo. in the pediatric trial patients, there was a higher occurrence of vomiting in pediatric patients (13%) compared adults (6.6%). antidepressants, such as exxua, increase the risk of suicidal thoughts and behaviors in pediatric patients [see warnings and precautions (5.1)]. juvenile animal toxicity data in a juvenile animal study, male and female rats were treated with gepirone once daily with oral doses of 0, 10, 40, and 70 mg/kg, from postnatal day 14 to 42. increased motor activity and impaired performance in the morris water maze were observed at 40 and 70 mg/kg after a two-week recovery period. the no observed adverse effect level (noael) for the neurobehavioral development effect was 10 mg/kg. when the animals were mated after a 3-week recovery period, increased pre-implantation loss was observed for mated pairs treated with 70 mg/kg. the noael for this finding was 40 mg/kg/day. of the 1,639 patients exposed to exxua in placebo-controlled clinical studies of mdd, 0.7% (12 patients) were 65 years of age or older and 0.2% (3 patients) were 75 years or older. geriatric patients (65 to 81 years of age) had higher exxua auc and c max values than younger adult (18 to 40 years of age) patients  [see clinical pharmacology (12.3)] . the maximum recommended daily dosage of exxua in geriatric patients is lower than in younger adult patients [see dosage and administration (2.4)]. in patients with creatinine clearance <50 ml/min, the metabolism and excretion of exxua and some of its major metabolites were decreased  [see clinical pharmacology (12.3)] . the maximum recommended daily dosage of exxua in patients with a creatinine clearance <50 ml/min is lower than in patients with normal renal function [see dosage and administration (2.5)] . the recommended dosage in patients with a creatinine clearance ≥50 ml/min is the same as in patients with normal renal function [see dosage and administration (2.5)] .  in patients with mild (child-pugh a) hepatic impairment to moderate (child-pugh b) hepatic impairment, the metabolism of exxua and its major metabolites was decreased  [see clinical pharmacology (12.3)]. the maximum recommended dosage of exxua in patients with moderate hepatic impairment is lower than in patients with normal hepatic function [see dosage and administration (2.6)] . the recommended dosage in patients with mild hepatic impairment is the same as in patients with normal hepatic function. exxua is contraindicated in patients with severe (child- pugh c) hepatic impairment [see warnings and precautions (5.2)and clinical pharmacology (12.3)] .

Канада - Енглески - Health Canada

kramer laboratories, inc - ketoconazole - shampoo - 2% - ketoconazole 2% - azoles

Канада - Енглески - Health Canada

weleda ag heilmittelbetriebe - esculin; calcium fluoride; magnesium sulfate; myrrh; krameria triandra; olea europea homeo chemical; silver nitrate - drops - 19d; 9d; 19d; 1d; 1d; 2d; 14d - esculin 19d; calcium fluoride 9d; magnesium sulfate 19d; myrrh 1d; krameria triandra 1d; olea europea homeo chemical 2d; silver nitrate 14d - homeopathic products

Канада - Енглески - Health Canada

seroyal international inc. - aesculus hippocastanum; collinsonia canadensis; paeonia officinalis; krameria triandra; box elder - gel - 1x; 1x; 1x; 1x; 1x - aesculus hippocastanum 1x; collinsonia canadensis 1x; paeonia officinalis 1x; krameria triandra 1x; box elder 1x - homeopathic products

Канада - Енглески - Health Canada

sandoz canada incorporated - nitrazepam - tablet - 5mg - nitrazepam 5mg - benzodiazepines

Канада - Енглески - Health Canada

sandoz canada incorporated - nitrazepam - tablet - 10mg - nitrazepam 10mg - benzodiazepines