États-Unis - anglais - NLM (National Library of Medicine)

allergan, inc. - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride 10 mg - viibryd®  is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )]. viibryd is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2 ) , drug interactions ( 7 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to advise patients to register 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 based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartu

États-Unis - anglais - NLM (National Library of Medicine)

allergan, inc. - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 12.5 mg - savella is indicated for the management of fibromyalgia.  savella is not approved for use in pediatric patients [see use in specific populations ( 8.4 )] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.5 ), warnings and precautions ( 5.2 )] . starting savella in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration ( 2.6 ), warnings and precautions ( 5.2 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to savella during pregnancy.  physicians are advised to recommend that pregnant patients taking savella enroll in the savella pregnancy registry. enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at pregnancyregistries@incresearch.com. data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. risk summary based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.2 )] . the available data on savella use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks associated with exposure to serotonin and norepinephrine reuptake inhibitors (snris) and selective-serotonin reuptake inhibitors (ssris), including savella, during pregnancy (see clinical considerations). animal reproduction studies have been performed in rats, rabbits and mice. milnacipran was shown to increase embryofetal and perinatal lethality in rats and the incidence of a minor skeletal variation in rabbits at doses below (rat) or approximately equal to (rabbit) the maximum recommended human dose (mrhd) of 200 mg/day on a mg/m2 basis. no effects were seen in mice when treated with milnacipran during the period of organogenesis at doses up to 3 times the mhrd on a mg/m2 basis (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 consideration maternal adverse reactions use of savella in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.9 )]. fetal/neonatal   adverse reactions neonates exposed to snris or ssris, including savella, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such 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, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either direct toxic effect of ssris and snris 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 ( 5.2 , 5.7 )]. data animal data studies were conducted in rats, rabbits and mice with dosing of milnacipran during the period of organogenesis. in rats, milnacipran was shown to increase embryofetal lethality at doses of 5 mg/kg/day (0.25 times the mrhd on a mg/m2 basis). in rabbits, dose-dependent increases in the incidence of the skeletal variation of an extra single rib were observed in several pups from multiple litters in the absence of maternal toxicity at 15 mg/kg/day (1.5 times the mrhd on a mg/m2 basis). the clinical significance of this finding is unknown. in mice, no embryotoxic or teratogenic effects were seen at doses up to 125 mg/kg/day (3 times the mhrd on a mg/m2 basis). with peri- and postnatal exposure to oral milnacipran in rats, decreases in viability and body weight were observed on postpartum day 4 at a dose of 5 mg/kg/day (approximately 0.25 times the mrhd on a mg/m2 basis). the no-effect dose for maternal and offspring toxicity was 2.5 mg/kg/day (approximately 0.1 times the mrhd on a mg/m2 basis). risk summary milnacipran is present in human milk [see data] . there are no reports on the effects of milnacipran on the breastfed child and on milk production/excretion. however, there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to ssris or snris through breast milk (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for savella and any potential adverse effects on the breastfed child from savella or from the underlying maternal conditions. clinical considerations monitor infants exposed to milnacipran for agitation, irritability, poor feeding and poor weight gain. data human data milnacipran is present in the milk of lactating women treated with milnacipran. in a lactation pharmacokinetic study with milnacipran, a single, oral dose of 50 mg milnacipran hcl tablet was administered to 8 lactating women who were at least 12 weeks postpartum and weaning their infants. the milk/plasma auc ratio of milnacipran was 1.85 ± 0.38. the maximum estimated weight adjusted daily infant dose for milnacipran from breast milk (assuming mean milk consumption of 150 ml/kg/day) was 5% of the maternal dose based on peak plasma concentrations.   safety and effectiveness of savella in a fibromyalgia pediatric population below the age of 18 have not been established [see boxed warning , indications and usage ( 1 ),   and warnings and precautions ( 5.1 )] . the use of savella is not recommended in pediatric patients. in controlled clinical studies of savella, 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. in view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age, renal function should be considered prior to use of savella in the elderly [see dosage and administration ( 2.2 )] . snris, ssris, and savella, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions ( 5.8 )] . milnacipran is not a controlled substance. milnacipran did not produce behavioral signs indicative of abuse potential in animal or human studies. milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other snris and ssris. these withdrawal symptoms can be severe. thus, taper savella and do not abruptly discontinue after extended use [see warnings and precautions ( 5.7 )] .

États-Unis - anglais - NLM (National Library of Medicine)

allergan, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - namenda (memantine hydrochloride) is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. namenda (memantine hydrochloride) 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 namenda 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 namenda [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 ora

Australie - anglais - Department of Health (Therapeutic Goods Administration)

b braun australia pty ltd - sodium chloride, quantity: 0.45 g - injection, solution - excipient ingredients: water for injections - the solutions are indicated for intravenous fluid therapy designed to correct deficiencies in hydration, electrolyte and energy levels. the solutions may also be used as solvents for intravenously administered drugs where compatibility has been established. 0.9% sodium chloride injection may also be used for irrigation of wounds and moistening of wound dressings. compound sodium lactate solution is particularly suitable for the replacement of extracellular fluid loss where isotonic dehydration is evident and in burn therapy.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - normal saline can be used as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - normal saline can be used as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - sodium chloride, quantity: 9 g/l - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - normal saline can be used as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - sodium bicarbonate, quantity: 84 mg/ml - injection, solution - excipient ingredients: disodium edetate; water for injections - sodium bicarbonate injection is indicated as an alkalinising agent in the treatment of metabolic acidosis which may occur in many conditions including diabetes, starvation, hepatitis, cardiac arrest, shock, severe dehydration, renal insufficiency, severe diarrhoea, addison's disease or administration of acidifying salts (e.g. excessive sodium chloride, calcium chloride, ammonium chloride). sodium bicarbonate injection is also used to increase urinary ph in order to increase the solubility of certain weak acids (e.g. cystine, sulphonamides, uric acid) and in the treatment of certain intoxications (e.g. methanol, phenobarbitone, salicylates, lithium) to decrease renal absorption of the drug or to correct acidosis.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - sodium chloride, quantity: 9 mg/ml - injection, solution - excipient ingredients: sodium hydroxide; water for injections; hydrochloric acid - as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - sodium chloride, quantity: 9 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; sodium hydroxide; water for injections - as a vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. it can also be used as a sterile irrigation medium.