ארצות הברית - אנגלית - NLM (National Library of Medicine)

b. braun medical inc. - lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5 - lysine 1.18 g in 100 ml - plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. this use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: —   gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; —   bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; —   tube feeding methods alone cannot provide adequate nutrition. this solution should not be used in patients in hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization or hypersensitivity to one or more amino acids.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

bayer healthcare llc - antihemophilic factor, human recombinant (unii: p89dr4ny54) (antihemophilic factor, human recombinant - unii:p89dr4ny54) - antihemophilic factor, human recombinant 1000 [iu] in 2.5 ml - kogenate® fs is a recombinant antihemophilic factor indicated for: kogenate fs is not indicated for the treatment of von willebrand disease. kogenate fs is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product (sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper). there are no data with kogenate fs use in pregnant women to inform on drug-associated risk. animal reproduction studies have not been conducted with kogenate fs. it is also not known whether kogenate fs can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. 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. there is no information regarding the presence of kogenate fs in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kogenate fs and any potential adverse effects on the breastfed child from kogenate fs or from the underlying maternal condition. safety and efficacy studies have been performed in previously untreated and minimally treated pediatric patients. children, in comparison to adults, present higher factor viii clearance values and, thus, lower half-life and recovery of factor viii. this may be due to differences in body composition.13 account for this difference in clearance when dosing or following factor viii levels in the pediatric population [see clinical pharmacology (12.3)] . routine prophylactic treatment in children ages 0–2.5 years with no pre-existing joint damage has been shown to reduce spontaneous joint bleeding and the risk of joint damage. this data can be extrapolated to ages >2.5–16 years for children who have no existing joint damage [see clinical studies (14)] . clinical studies with kogenate fs did not include patients aged 65 and over. dose selection for an elderly patient should be individualized.

ארצות הברית - אנגלית - NLM (National Library of Medicine)

teva select brands - loxapine (unii: ler583670j) (loxapine - unii:ler583670j) - loxapine 10 mg - adasuve  is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar i disorder in adults. “psychomotor agitation” is defined in dsm-iv as “excessive motor activity associated with a feeling of inner tension.” patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior), leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation [ see  clinical studies ( 14 ) ] . the efficacy of adasuve was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar i disorder [ see clinical studies ( 14 ) ] . limitations of use: as part of the adasuve rems program to mitigate the risk of bronchospasm, adasuve must be administered only in an enrolled healthcare facility [ see warnings and precautions ( 5.2 ) ] .

ארצות הברית - אנגלית - NLM (National Library of Medicine)

allergan, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - namenda xr®  is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. namenda xr 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 xr 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 xr [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 

ארצות הברית - אנגלית - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 8 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine hydrobromide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal

ארצות הברית - אנגלית - NLM (National Library of Medicine)

harris pharmaceutical, inc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae. - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

harris pharmaceutical, inc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 100 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline is indicated for the treatment of the following infections - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae. - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judg

ארצות הברית - אנגלית - NLM (National Library of Medicine)

apotheca inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets usp are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14) ] . none. pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may

ארצות הברית - אנגלית - NLM (National Library of Medicine)

actavis pharma, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. limitations of use the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see ad

ארצות הברית - אנגלית - NLM (National Library of Medicine)

dr reddys laboratories inc - silver sulfadiazine (unii: w46jy43ejr) (sulfadiazine - unii:0n7609k889) - silver sulfadiazine 10 g in 1000 g - silver sulfadiazine cream is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second and third degree burns. silver sulfadiazine cream is contraindicated in patients who are hypersensitive to silver sulfadiazine or any of the other ingredients in the preparation. because sulfonamide therapy is known to increase the possibility of kernicterus, silver sulfadiazine cream should not be used on pregnant women approaching or at term, on premature infants, or on newborn infants during the first 2 months of life. prompt institution of appropriate regimens for care of the burned patient is of prime importance and includes the control of shock and pain.  the burn wounds are then cleansed and debrided; silver sulfadiazine cream is then applied u