Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - etodolac (unii: 2m36281008) (etodolac - unii:2m36281008) - carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). etodolac tablets are indicated: - for acute and long-term use in the management of signs and symptoms of the following: osteoarthritis rheumatoid arthritis - osteoarthritis - rheumatoid arthritis - for the management of acute pain etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. etodolac tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions and precautions, pre-existing asthma ). - in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

Միացյալ Թագավորություն - անգլերեն - MHRA (Medicines & Healthcare Products Regulatory Agency)

noumed life sciences ltd - gabapentin - oral capsule - 400mg

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal pharmaceuticals llc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations) . in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population are 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% to 4% and 15% to 20%, respectively.   clinical considerations disease-associated maternal and/or embryofetal risk untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. a decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis. fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports describe umbilical artery ph of ≤7.2 at the time of delivery [see clinical pharmacology 12.3] . monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible.   data animal data decreased fetal body weights were observed when pregnant rats were administered intravenous bolus doses of 60 mg/kg ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6 to 17. this dose was associated with evidence of maternal toxicity (decreased body weight of dams and abnormal head movements). no malformations or fetal deaths were noted at this dose. no effects on fetal body weight were noted at 10 mg/kg (1.9 times the mrhd of 50 mg). no evidence of malformations or embryo-fetal toxicity were noted in pregnant rabbits administered intravenous bolus doses up to 20 mg/kg ephedrine sulfate (7.7 times the maximum recommended human dose (mrhd) of 50 mg based on body surface area) from gestation day 6 to 20. this dose was associated with expected pharmacological maternal effects (increased respiration rate, dilated pupils, piloerection). decreased fetal survival and body weights in the presence of maternal toxicity (increased mortality) were noted when pregnant dams were administered intravenous bolus doses of 60 mg/kg epinephrine sulfate (approximately 12 times the mrhd based on body surface area) from gd 6 through lactation day 20. no adverse effects were noted at 10 mg/kg (1.9 times the mrhd). risk summary a single published case report indicates that ephedrine is present in human milk. however, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. the safety and effectiveness of ephedrine sulfate in pediatric patients have not been established. animal toxicity data in a study in which juvenile rats were administered intravenous bolus doses of 2, 10, or 60 mg/kg ephedrine sulfate daily from postnatal day 35 to 56, an increased incidence of mortality was noted at the high dose of 60 mg/kg. the no-adverse-effect level was 10 mg/kg (approximately 1.9 times a maximum daily dose of 50 mg in a 60 kg person based on body surface area). clinical studies of ephedrine 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 or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. ephedrine and its metabolite are excreted in urine. in patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. monitor patients with renal impairment carefully after the initial bolus dose for adverse events.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal pharmaceuticals llc - atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest. none. animal reproduction studies have not been conducted with atropine. it also is not known whether atropine can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. trace amounts of atropine was found in breast milk. the clinical impact of this is not known. recommendations for use in pediatric patients are not based on clinical trials. an evaluation of current literature revealed no clinical experience identifying differences in response between 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 or other drug therapy.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal pharmaceuticals llc - carboprost tromethamine (unii: u4526f86fj) (carboprost - unii:7b5032xt6o) - carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1.   failure of expulsion of the fetus during the course of treatment by another method; 2.   premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3.   requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4.   inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. in a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention. 1.   hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection [see adverse reactions, post-marketing experience ]. 2.   acute pelvic inflammatory disease. 3.   patients with active cardiac, pulmonary, renal or hepatic disease. warnings carboprost tromethamine, like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. carboprost tromethamine should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. carboprost tromethamine does not appear to directly affect the fetoplacental unit. therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. carboprost tromethamine should not be considered a feticidal agent. evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. although these studies do not indicate that carboprost tromethamine is teratogenic, any pregnancy termination with carboprost tromethamine that fails should be completed by some other means. this product contains benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants.

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

gilead sciences pty ltd - brexucabtagene autoleucel, quantity: 1000000 cells/kg - injection, intravenous infusion - excipient ingredients: dimethyl sulfoxide; sodium chloride; albumin - cellular therapies - tecartus is a genetically modified autologous immunocellular therapy for the treatment of patients greater than or equal to 18 years of age with relapsed or refractory (r/r) b-cell acute lymphoblastic leukaemia (b-all).

Մալթա - անգլերեն - Malta Medicines Authority

adalvo limited malta life sciences park, building 1, level 4 sir temi zammit san gwann industrial est, sgn 3000 san gwann, malta - prolonged-release tablet - pregabalin 82.5 mg - analgesics

Մալթա - անգլերեն - Malta Medicines Authority

adalvo limited malta life sciences park, building 1, level 4 sir temi zammit san gwann industrial est, sgn 3000 san gwann, malta - prolonged-release tablet - pregabalin 165 mg - analgesics

Մալթա - անգլերեն - Malta Medicines Authority

adalvo limited malta life sciences park, building 1, level 4 sir temi zammit san gwann industrial est, sgn 3000 san gwann, malta - prolonged-release tablet - pregabalin 330 mg - analgesics

Ֆիլիպիններ - անգլերեն - FDA (Food And Drug Administration)

biocare lifesciences inc.; distributor: corbridge group phils. inc. - calcitriol - softgel capsule - 0.25 mcg