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

triax pharmaceuticals, llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 0.25 mg in 1 g - tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. the safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. use of the product should be discontinued if hypersensitivity to any of the ingredients is noted. safety and effectiveness in pediatric patients below the age of 12 have not been established. safety and effectiveness in a geriatric population have not been established. clinical studies of tretinoin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.

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

bionpharma inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. specif

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

baxter healthcare corporation - norepinephrine bitartrate (unii: ify5pe3zrw) (norepinephrine - unii:x4w3enh1cv) - norepinephrine bitartrate in dextrose injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. none. risk summary limited published data consisting of a small number of case reports and multiple small trials involving the use of norepinephrine in pregnant women at the time of delivery have not identified an increased risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. there are risks to the mother and fetus from hypotension associated with septic shock, myocardial infarction and stroke which are medical emergencies in pregnancy and can be fatal if left untreated. (see clinical considerations). in animal reproduction studies, using high doses of intravenous norepinephrine resulted in lowered maternal placental blood flow. clinical relevance to changes in the human fetus is unknown since the average maintenance dose is ten times lower (see data). increased fetal reabsorptions were observed in pregnant hamsters after receiving daily injections at approximately 2 times the maximum recommended dose on a mg/m3 basis for four days during organogenesis (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 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 miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypotension associated with septic shock, myocardial infarction, and stroke are medical emergencies in pregnancy which can be fatal if left untreated. delaying treatment in pregnant women with hypotension associated with septic shock, myocardial infarction and stroke may increase the risk of maternal and fetal morbidity and mortality. life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of norepinephrine on the fetus. data animal data a study in pregnant sheep receiving high doses of intravenous norepinephrine (40 mcg/min, at approximately 10 times the average maintenance dose of 2-4 mcg/min in human, on a mg/kg basis) exhibited a significant decrease in maternal placental blood flow. decreases in fetal oxygenation, urine and lung liquid flow were also observed. norepinephrine administration to pregnant rats on gestation day 16 or 17 resulted in cataract production in rat fetuses. in hamsters, an increased number of resorptions (29.1% in study group vs. 3.4% in control group), fetal microscopic liver abnormalities and delayed skeletal ossification were observed at approximately 2 times the maximum recommended intramuscular or subcutaneous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day from gestation day 7-10). risk summary there are no data on the presence of norepinephrine in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. clinically relevant exposure to the infant is not expected based on the short half-life and poor oral bioavailability of norepinephrine. safety and effectiveness in pediatric patients have not been established. clinical studies of norepinephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. avoid administration of norepinephrine bitartrate in dextrose injection into the veins in the leg in elderly patients [see warnings and precautions (5.1) ].

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: polysorbate 80; aluminium; histidine; sodium chloride; borax; water for injections - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

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

merck sharp & dohme (australia) pty ltd - hpv type 6 l1 protein, quantity: 30 microgram; hpv type 11 l1 protein, quantity: 40 microgram; hpv type 16 l1 protein, quantity: 60 microgram; hpv type 18 l1 protein, quantity: 40 microgram; hpv type 31 l1 protein, quantity: 20 microgram; hpv type 33 l1 protein, quantity: 20 microgram; hpv type 45 l1 protein, quantity: 20 microgram; hpv type 52 l1 protein, quantity: 20 microgram; hpv type 58 l1 protein, quantity: 20 microgram - injection, suspension - excipient ingredients: sodium chloride; histidine; borax; aluminium; water for injections; polysorbate 80 - gardasil 9 is indicated in females aged 9 to 45 years* for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,gardasil 9 is indicated in males aged 9 to 45 years* for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions, and infection caused by human papillomavirus (hpv) types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (which are included in the vaccine).,* evidence of vaccine efficacy is based on the core efficacy population of females aged 16 to 26 years. immunogenicity studies have been conducted to link efficacy to younger populations (females and males aged 9 to 15 years). immunogenicity studies of gardasil 9 have been conducted relating to females over 26 years of age (see section 5.1 clinical trials for gardasil 9).

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

glaxosmithkline llc - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole 0.25 mg - requip is indicated for the treatment of parkinson’s disease. requip is indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). requip is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of requip in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see data] . in the u.s. general population, the estimated ba

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

pfizer laboratories div pfizer inc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c), naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm) - morphine sulfate 20 mg - embeda is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve embeda for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - embeda is not indicated as an as-needed (prn) analgesic. embeda is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - con

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

app pharmaceuticals, llc - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 10 mg in 1 ml - naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

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

sagent pharmaceuticals - ropivacaine hydrochloride (unii: v910p86109) (ropivacaine - unii:7io5lya57n) - ropivacaine hydrochloride 2 mg in 1 ml - ropivacaine hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. surgical anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration acute pain management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration ropivacaine hydrochloride is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type.

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

bionpharma inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole tablets are indicated for the treatment of parkinson’s disease. ropinirole tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). ropinirole is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. risk summary there are no adequate data on the developmental risk associated with the use of ropinirole in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see data ]. 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. the background risk of major birth defects and miscarriage in the indicated populations is unknown. data animal data: oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the 2 highest doses. these doses were also associated with maternal toxicity. the highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the mrhd for parkinson’s disease (24 mg/day) on a body surface area (mg/m2 ) basis. no effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the mrhd on a mg/m2 basis). in pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with l-dopa (250 mg/kg/day) than when l-dopa was administered alone. this drug combination was also associated with maternal toxicity. oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. the no-effect dose of 1 mg/kg/day is less than the mrhd on a mg/m2 basis. risk summary there are no data on the presence of ropinirole in human milk, the effects of ropinirole on the breastfed infant, or the effects of ropinirole on milk production. however, inhibition of lactation is expected because ropinirole inhibits secretion of prolactin in humans. ropinirole or metabolites, or both, are present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropinirole and any potential adverse effects on the breastfed infant from ropinirole or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole is individually titrated to clinical therapeutic response and tolerability. pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see clinical pharmacology (12.3) ]. in flexible-dose clinical trials of extended-release ropinirole for parkinson’s disease, 387 patients were 65 years and older and 107 patients were 75 years and older. among patients receiving extended-release ropinirole, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). in these trials, the incidence of overall adverse reactions increased with increasing age for both patients receiving extended-release ropinirole and placebo. in the fixed-dose clinical trials of extended-release ropinirole, 176 patients were 65 years and older and 73 were 75 and older. among patients with advanced parkinson’s disease receiving extended-release ropinirole, vomiting and nausea were more common in patients greater than 65 years (5% and 9%, respectively) compared with patients less than 65 (1% and 7%, respectively). no dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 ml/min). for patients with end-stage renal disease on hemodialysis, a reduced maximum dose is recommended [see dosage and administration (2.2, 2.3), clinical pharmacology (12.3)] . the use of ropinirole in patients with severe renal impairment (creatinine clearance  30 ml/min) without regular dialysis has not been studied. the pharmacokinetics of ropinirole have not been studied in patients with hepatic impairment.