Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

a-s medication solutions - varenicline tartrate (unii: 82269asb48) (varenicline - unii:w6hs99o8zo) - chantix is indicated for use as an aid to smoking cessation treatment. chantix is contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to chantix. risk summary available data have not suggested an increased risk for major birth defects following exposure to varenicline in pregnancy, compared with women who smoke [see data]. smoking during pregnancy is associated with maternal, fetal, and neonatal risks (see clinical considerations) . in animal studies, varenicline did not result in major malformations but caused decreased fetal weights in rabbits when dosed during organogenesis at exposures equivalent to 50 times the exposure at the maximum recommended human dose (mrhd). additionally, administration of varenicline to pregnant rats during organogenesis through lactation produced developmental toxicity in offspring at maternal exposures equivalent to 36 times human exposure at the mrhd [see data] . the estimated background risk of oral clefts is increased by

Đức - Tiếng Đức - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

sanofi-aventis deutschland gmbh (8030868) - enoxaparin-natrium ((mw: ca. 4500)) - injektionslösung in einer fertigspritze - 15.000 i.e. (150 mg)/1 ml - teil 1 - injektionslösung in einer fertigspritze; enoxaparin-natrium ((mw: ca. 4500)) (24797) 150 milligramm

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

amdipharm limited - cyclizine; morphine tartrate bpc 1959 - solution for injection - 15/50mg/ml milligram(s) - natural opium alkaloids; morphine, combinations

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - buprenorphine - transdermal patch - 15 microgram per hour - oripavine derivatives; buprenorphine

Ai-len - Tiếng Anh - HPRA (Health Products Regulatory Authority)

rowex ltd - buprenorphine - transdermal patch - 15 microgram per hour - oripavine derivatives; buprenorphine

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)] . the clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . there are no adequate and well-controlled studies of zolpidem in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other cns-depressants. children born to mothe

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

kaiser foundation hospitals - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

kaiser foundation hospitals - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

cipla usa inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine is indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) -the use of maois intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine 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 (2.9) and warnings and precautions (5.4)]. pregnancy category c risk summary

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

quality care products llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules, usp are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatalpostnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. in rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. at doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. temazepam is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. patients should be instructed to discontinue the drug prior to becoming pregnant. the possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. pediatric use safety and effectiveness in pediatric patients have not been established. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. the more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. as with any hypnotic, caution must be exercised in administering temazepam to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. it is desirable to limit repeated prescriptions without adequate medical supervision.