Egipt - angielski - EDA (Egyptian Drug Authority)

otsuka egypt - infusion - 10 %

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

international laboratories, llc - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril 2.5 mg - lisinopril tablet usp is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variet

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

international laboratories, llc - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 40 mg

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

fresenius kabi usa, llc - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a) - heparin 5000 [usp'u] in 1 ml - heparin sodium injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism; - prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; - atrial fibrillation with embolization; - treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); - prevention of clotting in arterial and cardiac surgery; - prophylaxis and treatment of peripheral arterial embolism. - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see warnings and precautions (5.3)] ; - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see adverse reactions

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

wg critical care, llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 3 g in 15 ml - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) [see data]. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin/tazobactam up to 3000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/ day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breast-fed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam for injection and any potential adverse effects on the breastfed child from piperacillin and tazobactam for injection or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for injection for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam for injection in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see adverse reactions ( 6.1) and clinical pharmacology (12.3)] . use of piperacillin and tazobactam for injection in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam for injection and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions ( 6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam for injection have not been established in pediatric patients less than 2 months of age [see clinical pharmacology ( 12) and dosage and administration (2)] . dosage of piperacillin and tazobactam for injection in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age.  however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ]. 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. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product.  at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium.  the geriatric population may respond with a blunted natriuresis to salt loading.  this may be clinically important with regard to such diseases as congestive heart failure. this drug is known to be substantially excreted by the kidney, and the risk of toxic 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. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ]. dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3 )]. as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

agila specialties private limited - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx) - piperacillin anhydrous 2 g in 10 ml

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

b. braun medical inc. - heparin sodium (unii: zz45ab24ca) (heparin - unii:t2410km04a), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - heparin 4000 [usp'u] in 100 ml - heparin sodium in 5% dextrose injection is indicated for: - prophylaxis and treatment of venous thrombosis and pulmonary embolism - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation - treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation) - prevention of clotting in arterial and cardiac surgery - prophylaxis and treatment of peripheral arterial embolism - anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. the use of heparin sodium in 5% dextrose injection is contraindicated in patients with the following conditions: - history of heparin-induced thrombocytopenia (hit) and heparin-induced thrombocytopenia and thrombosis (hitt) [see warnings and precautions (5.3)] - known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see warnings and precautions (5.7) and adverse reactions (6.1)] - in whom suitable blood coagulation tests – e.g., the whole blood clotti

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

major pharmaceuticals - benazepril hydrochloride (unii: n1sn99t69t) (benazeprilat - unii:jrm708l703) - benazepril hydrochloride 5 mg

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

international laboratories, llc - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd) - lisinopril 5 mg - lisinopril tablet usp is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variet

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

gamida cell inc. - omidubicel (unii: et4jc4s66e) (omidubicel - unii:et4jc4s66e) - omisirge is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection. omisirge is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (dmso), dextran 40, gentamicin, human serum albumin, or bovine products. risk summary there are no available data with omisirge use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with omisirge to assess whether it can cause fetal harm when administered to a pregnant woman. omisirge should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in the united states (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 summary there is no information regarding the presence of omisirge in human milk, the effect on the breastfed infant, and the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for omisirge and any potential adverse effects on the breastfed infant from omisirge or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting the conditioning regimen for omisirge. contraception see the prescribing information for the medications used for conditioning for information on the need for effective contraception in patients who receive a conditioning regimen. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with omisirge. infertility there are no data on the effect of omisirge on fertility. the safety and efficacy of omisirge have been established in adolescents (12 years to less than 17 years). the efficacy and safety outcomes in study p0501 suggest consistent efficacy and safety across age groups. safety and efficacy of omisirge in pediatric patients below the age of 12 have not been established. clinical studies of omisirge did not include patients aged 65 and over; therefore, it cannot be determined whether patients 65 years and over respond differently from younger patients.