Kanada - Inggris - Health Canada

amgen canada inc - blinatumomab - powder for solution - 38.5mcg - blinatumomab 38.5mcg - antineoplastic agents

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

interpharma pty ltd - dexmedetomidine hydrochloride, quantity: 236.4 microgram (equivalent: dexmedetomidine, qty 200 microgram) - injection, concentrated - excipient ingredients: sodium chloride; water for injections - icu sedation.,for sedation of initially intubated patients during treatment in an intensive care setting. the use of dexmedetomidine ever pharma by continuous infusion in these patients should not exceed 24 hours.,procedural sedation,for sedation of non-intubated patients prior to and/or during surgical and other procedures.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - buprenorphine (unii: 40d3scr4gz) (buprenorphine - unii:40d3scr4gz) - buprenorphine 5 ug in 1 h - buprenorphine transdermal system 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 risk of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve buprenorphine transdermal system 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. - buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic buprenorphine transdermal system is contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] - acute or severe bronchial asthma in an unmonitored setting or in the

Amerika Serikat - Inggris - NLM (National Library of Medicine)

ajanta pharma usa inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole oral tablets are indicated for the treatment of: - schizophrenia - irritability associated with autistic disorder - treatment of tourette’s disorder aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs, including aripiprazole, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see clinical considerations) . overall av

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. because the benefits of montelukast sodium may not outweigh the risk of neuropsychiatric symptoms in patients with allergic rhinitis [see warnings and precautions (5.1)] , reserve use for patients who have an inadequate response or intolerance to alternative therapies. - hypersensitivity to any component of this product. risk summary available data from published prospective and retrospective cohort studies over decades with montelukast use in pregnant women have not established a drug-associated risk of major birth defects [see data] . in animal r

Amerika Serikat - Inggris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - vortioxetine hydrobromide (unii: tks641koay) (vortioxetine - unii:3o2k1s3wqv) - vortioxetine 5 mg - brintellix is indicated for the treatment of major depressive disorder (mdd). the efficacy of brintellix was established in six 6 to 8 week studies (including one study in the elderly) and one maintenance study in adults [see clinical studies (14)] . pregnancy category c risk summary there are no adequate and well-controlled studies of brintellix in pregnant women. vortioxetine caused developmental delays when administered during pregnancy to rats and rabbits at doses 15 and 10 times the maximum recommended human dose (mrhd) of 20 mg, respectively. developmental delays were also seen after birth in rats at doses 20 times the mrhd of vortioxetine given during pregnancy and through lactation. there were no teratogenic effects in rats or rabbits at doses up to 77 and 58 times, the mrhd of vortioxetine, respectively, given during organogenesis. the incidence of malformations in human pregnancies has not been established for brintellix. all human pregnancies, regardless of drug exposure, have a background rate of

Amerika Serikat - Inggris - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm), bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - naltrexone hydrochloride 8 mg - contrave is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (bmi) of: limitations of use: pregnancy category x risk summary contrave is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. 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 of maternal weight loss to the fetus. clinical considerations a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. human data there are no adequate and well-controlled studies of contrave in pregnant women. in clinical studies, 21 (0.7%) of 3,024 women became pregnant while taking contrave: 11 carried to term and gave b

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are 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 delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules 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 delayed-release capsules 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

Amerika Serikat - Inggris - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - aripiprazole tablets are indicated for the treatment of: - schizophrenia [see clinical studies (14.1) ] additional pediatric use information is approved for otsuka america pharmaceutical, inc.’s abilify® (aripiprazole) product. however, due to otsuka america pharmaceutical, inc.’s marketing exclusivity rights, this drug product is not labeled with that information. aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2) ]. pregnancy category c pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aripiprazole during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. risk summary neonates exposed to antipsychotic drugs (including aripiprazole) during t

Filipina - Inggris - FDA (Food And Drug Administration)

alman pharmaceuticals, inc. - zinc (as sulfate monohydrate) - syrup - 55mg/ 5ml