United States - English - NLM (National Library of Medicine)

xiamen lp pharmaceutical co., ltd. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation . risk  summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women.  adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules  [see  data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and

United States - English - NLM (National Library of Medicine)

hra pharma america, inc. - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - uses • helps prevent sunburn do not use on • damaged or broken skin stop use and ask a doctor • if rash occurs

United States - English - NLM (National Library of Medicine)

merz north america, inc - polidocanol (unii: 0awh8bfg9a) (polidocanol - unii:0awh8bfg9a) - polidocanol 0.01000 g in 1 ml - asclera® (polidocanol) is indicated to sclerose uncomplicated spider veins (varicose veins ≤1 mm in diameter) and uncomplicated reticular veins (varicose veins 1 to 3 mm in diameter) in the lower extremity. asclera has not been studied in varicose veins more than 3 mm in diameter. asclera is contraindicated for patients with known allergy to polidocanol and patients with acute thromboembolic diseases. risk summary the available data from case reports on use of polidocanol-containing products, including asclera, in pregnant women have not identified any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. although none of these risks have been identified, there is minimal benefit in treating uncomplicated spider veins and reticular veins in the lower extremity during pregnancy and lower extremity varicosities that develop during pregnancy as they may spontaneously regress postpartum. the animal reproduction studies were conducted in a manner to achieve systemic e

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

merz pharmaceutical, germany - heparin sodium,liquid extract from onion,allantoin - gel - 5000,10,1 iu, g,

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

merz pharmaceutical, germany - heparin sodium,liquid extract from onion,allantoin - gel - 5000,10,1 iu, g,

Panama - English - Ministerio de Salud (Dirección Nacional de Farmacia Y Drogas)

merz north america, inc. - hidroxiapatita de calcio - hidroxiapatita de calcio....935,2 mg / lidocaÍna clorhidrato....3,3 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

merz pharmaceutical, germany - heparin sodium,liquid extract from onion,allantoin - gel - 5000,10,1 iu, g,

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

merz pharmaceutical, germany - heparin sodium,liquid extract from onion,allantoin - gel - 5000,10,1 iu, g,

United States - English - NLM (National Library of Medicine)

vitruvias therapeutics, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk  summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women.  adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules [see  data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal  data oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg) is 2 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride extended-release capsules (28 mg) on a body surface area (mg/m2 ) basis. oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. the highest dose tested is approximately 20 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. in rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. the higher no-effect dose (6 mg/kg/day) is approximately 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. risk  summary there are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from memantine hydrochloride extended-release capsules or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders (asd), including autism, asperger's disorder and pervasive development disorder - not otherwise specified (pdd-nos).memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age. memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20-39 kg, 40-59 kg and ≥ 60 kg, respectively. in a randomized, 12-week double-blind, placebo-controlled parallel study (study a) in patients with autism, there was no statistically significant difference in the social responsiveness scale (srs) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53). in a 12-week responder-enriched randomized withdrawal study (study b) in 471 patients with asd, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). the overall safety profile of memantine in pediatric patients was generally consistent with the known safety profile in adults [see adverse reactions ( 6.1 )] . in study a, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (n=58) are listed in table 2. the adverse reactions that were reported in at least 5% of patients in the 12-48 week open-label study to identify responders to enroll in study b are listed in table 3. in the randomized withdrawal study (study b), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and twice that of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a juvenile animal study, male and female juvenile rats were administered memantine (15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 14 through pnd 70. body weights were reduced at 45 mg/kg/day. delays in sexual maturation were noted in male and female rats at doses ≥ 30 mg/kg/day. memantine induced neuronal lesions in several areas of the brain on pnd 15 and 17 at doses ≥ 30 mg/kg/day. behavioral toxicity (decrease percent of auditory startle habituation) was noted for animals in the 45 mg/kg/day dose group. the 15 mg/kg/day dose was considered the no-observed-adverse-effect-level (noael) for this study. in a second juvenile rat toxicity study, male and female juvenile rats were administered memantine (1, 3, 8, 15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 7 through pnd 70.  due to early memantine-related mortality, the 30 and 45 mg/kg/day dose groups were terminated without further evaluation. memantine induced apoptosis or neuronal degeneration in several areas of the brain on pnd 8, 10, and 17 at a dose of 15 mg/kg/day. the noael for apoptosis and neuronal degeneration was 8 mg/kg/day. behavioral toxicity (effects on motor activity, auditory startle habituation, and learning and memory) was noted at doses ≥ 3 mg/kg/day during treatment, but was not seen after drug discontinuation. therefore, the 1 mg/kg/day dose was considered the noael for the neurobehavioral effect in this study. the majority of people with alzheimer's disease are 65 years of age and older. in the clinical study of memantine hydrochloride extended-release, the mean age of patients was approximately 77 years; over 91% of patients were 65 years and older, 67% were 75 years and older, and 14% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration ( 2.3 ) and clinical pharmacology ( 12.3 )] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride extended-release capsules was not studied in patients with severe hepatic impairment [see clinical pharmacology ( 12.3 )] .