Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

bayer healthcare llc - damoctocog alfa pegol (unii: by4tsk952y) (damoctocog alfa pegol - unii:by4tsk952y) - jivi, antihemophilic factor (recombinant), pegylated-aucl, is a recombinant dna-derived, factor viii concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia a (congenital factor viii deficiency) for: limitations of use jivi is not indicated for use in children < 12 years of age due to greater risk for hypersensitivity reactions [see use in specific populations (8.4)] . jivi is not indicated for use in previously untreated patients (pups). jivi is not indicated for the treatment of von willebrand disease. jivi is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (peg), mouse or hamster proteins, or other constituents of the product [see description (11)]. there are no data with jivi use in pregnant women to inform on drug-associated risk. animal developmental and reproductive toxicity studies have not been conducted with jivi. it is not known whether jivi can cause fetal harm when administered to a pregnant woman or can affect reproduction 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 jivi 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 jivi and any potential adverse effects on the breastfed infant from jivi or from the underlying maternal condition. the safety and effectiveness in patients below the age of 12 have not been established. jivi is not indicated for use in previously untreated patients. jivi is not indicated for use in children below 12 years of age [see clinical studies (14)] .  in completed clinical studies with 73 pediatric previously treated patients (ptps) < 12 years of age (44 ptps < 6 years, 29 ptps 6 to < 12 years), adverse reactions due to immune response to peg were observed in children less than 6 years of age. in 23% of subjects in the age group < 6 years of age, loss of drug effect due to neutralizing anti-peg igm antibodies during the first 4 exposure days (eds) was observed. in 7% of the subjects < 6 years of age, loss of drug effect was combined with hypersensitivity reactions [see warnings and precautions (5.3)] . clinical studies of jivi 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 and other drug therapy.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are 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 (7.1)]. 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 (7.1)]. 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 register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://wome

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

quality care products, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the ef

Израел - Енглески - Ministry of Health

j-c health care ltd - apalutamide - film coated tablets - apalutamide 60 mg - apalutamide - "erleada is indicated in adult men for the treatment of• metastatic hormone‐sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt)• non-metastatic castration-resistant prostate cancer (nm-crpc)."

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

solco healthcare llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene. risk summary there are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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. risk su

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

solco healthcare llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - because of reports of intestinal and gastric ulceration and bleeding with controlled-release potassium chloride preparations, these drugs should be reserved for those patients who cannot tolerate or refuse to take liquid or effervescent potassium preparations or for patients in whom there is a problem of compliance with these preparations. the use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. in more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated. potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such p

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

solco healthcare us, llc - amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - amphetamine sulfate tablets, usp, are indicated for: controlled substance amphetamine sulfate tablets contain amphetamine, a schedule ii controlled substance. abuse amphetamine sulfate tablets have a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction (see warnings ). amphetamine sulfate tablets can be diverted for non-medical use into illicit channels or distribution. abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activit

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

skya health, llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride tablets, usp are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) inhibitors or w

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

skya health, llc - phenazopyridine hydrochloride (unii: 0ewg668w17) (phenazopyridine - unii:k2j09emj52) - phenazopyridine hcl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. the use of phenazopyridine hcl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and phenazopyridine hcl should be discontinued when symptoms are controlled. the analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. it is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. treatment of a urinary tract infection with phenazopyridine hcl should not exceed two days because there is a lack of evidence that the combined administration o

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

skya health, llc - cyclobenzaprine hydrochloride (unii: 0ve05jys2p) (cyclobenzaprine - unii:69o5wqq5ti) - cyclobenzaprine hydrochloride tablets, usp are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride tablets have not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy. hypersensitivity to any component of this product. concomitant use of monoamine oxidase (mao) inhibitors or w