USA - engelsk - NLM (National Library of Medicine)

medsource pharmaceuticals - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium delayed release tablets are a valproate and are indicated for the treatment of the manic episodes associated with bipolar disorder. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. the efficacy of divalproex sodium delayed release tablets were established in 3-week trials with patients meeting dsm-iii-r criteria for bipolar disorder who were hospitalized for acute mania [see clinical studies ( 14.1)] . the safety and effectiveness of divalproex sodium delayed release tablets for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. therefore, healthcare providers who elect to use divalproex sodium delayed release tablets for extended periods should continually reevaluate the long-term usefulness of t

USA - engelsk - NLM (National Library of Medicine)

cardinal health - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium extended-release tablets, usp are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical stud

USA - engelsk - NLM (National Library of Medicine)

merck sharp & dohme llc - ertapenem sodium (unii: 2t90ke67l0) (ertapenem - unii:g32f6eid2h) - ertapenem 1 g - invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated intra-abdominal infections due to escherichia coli , clostridium clostridioforme , eubacterium lentum , peptostreptococcus species, bacteroides fragilis , bacteroides distasonis , bacteroides ovatus , bacteroides thetaiotaomicron , or bacteroides uniformis . invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to staphylococcus aureus (methicillin susceptible isolates only), streptococcus agalactiae , streptococcus pyogenes , escherichia coli , klebsiella pneumoniae , proteus mirabilis , bacteroides fragilis , peptostreptococcus species, porphyromonas asaccharolytica , or prevotella bivia . invanz has not been studied in diabetic foot infections with concomitant osteomyelitis [see clinical studies (14)]. invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with community acquired pneumonia due to streptococcus pneumoniae (penicillin susceptible isolates only) including cases with concurrent bacteremia, haemophilus influenzae (beta-lactamase negative isolates only), or moraxella catarrhalis . invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated urinary tract infections including pyelonephritis due to escherichia coli , including cases with concurrent bacteremia, or klebsiella pneumoniae . invanz is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecological infections due to streptococcus agalactiae, escherichia coli , bacteroides fragilis, porphyromonas asaccharolytica, peptostreptococcus species, or prevotella bivia . invanz is indicated in adults for the prevention of surgical site infection following elective colorectal surgery. to reduce the development of drug-resistant bacteria and maintain the effectiveness of invanz and other antibacterial drugs, invanz 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. - invanz is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. - due to the use of lidocaine hcl as a diluent, invanz administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type. risk summary available data from a small number of post-marketing cases with invanz use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies after intravenous administration of ertapenem during the period of organogenesis, there was no evidence of developmental malformations in rats at systemic exposures (auc) up to approximately 1.2 times the human exposure at the maximum recommended human dose (mrhd) and in mice at doses up to approximately 3 times the mrhd based on body surface area comparison. in pregnant rats administered ertapenem during organogenesis through lactation, fetal toxicity, developmental delays, and impaired reproduction did not occur in first generation offspring at systemic exposures (auc) approximately 1.2 times the human exposure at the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for 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 to 4% and 15 to 20%, respectively. data animal data in pregnant rats, intravenous administration of ertapenem dosages of up to 700 mg/kg/day (approximately 1.2 times the mrhd based on auc) during the period of organogenesis (gestation days [gd] 6-20) revealed no maternal or embryofetal effects. pregnant mice intravenously administered ertapenem dosages of up to 700 mg/kg/day (approximately 3 times the mrhd based on body surface area comparison) during the period of organogenesis (gd 6-15) showed slight decreases in average fetal weight and an associated decrease in the average number of ossified sacrocaudal vertebrae. there were no maternal effects at any dosage. in a pre-postnatal study in rats, ertapenem administered to pregnant rats at dosages up to 700 mg/kg/day (approximately 1.2 times the mrhd based on auc) during organogenesis through lactation, (gd 6 until lactation day (ld) 20) did not result in fetal toxicity, developmental delays, or impaired reproduction in first generation offspring, and fetal deaths and malformations were not increased in second generation offspring. risk summary ertapenem is present in human milk (see data) . there are no data on 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 invanz and any potential adverse effects on the breastfed infant from invanz or from the underlying maternal condition. data the concentration of ertapenem in breast milk from 5 lactating women with pelvic infections (5 to 14 days postpartum) measured at random time points daily for 5 consecutive days following the last 1 g dose of intravenous therapy (3 to 10 days of therapy) showed low levels. the concentration of ertapenem in breast milk within 24 hours of the last dose of therapy in all 5 women ranged from (<0.13 (lower limit of quantitation) to 0.38 mcg/ml), although peak concentrations were not assessed. by day 5 after discontinuation of therapy, the level of ertapenem was undetectable in the breast milk of 4 women and below the lower limit of quantitation (<0.13 mcg/ml) in 1 woman. the concentration of ertapenem in transitional milk observed in this study may not reflect the concentration of ertapenem in mature milk. safety and effectiveness of invanz in pediatric patients 3 months to 17 years of age are supported by evidence from adequate and well-controlled trials in adults, pharmacokinetic data in pediatric patients, and additional data from comparator-controlled trials in pediatric patients 3 months to 17 years of age [see indications and usage (1.1), (1.2), (1.3), (1.4) and (1.5) and clinical studies (14.2)] . invanz is not recommended in infants under 3 months of age as no data are available. invanz is not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient csf penetration. of the 1,835 patients in phase 2b/3 trials treated with invanz, approximately 26 percent were 65 and over, while approximately 12 percent were 75 and over. no overall differences in safety or effectiveness were observed between these patients and younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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 [see dosage and administration (2.2)]. dosage adjustment is necessary in patients with creatinine clearance 30 ml/min or less [see dosage and administration (2.4) and clinical pharmacology (12.3)] . the pharmacokinetics of ertapenem in patients with hepatic impairment have not been established. of the total number of patients in clinical trials, 37 patients receiving ertapenem 1 g daily and 36 patients receiving comparator drugs were considered to have child-pugh class a, b, or c liver impairment. the incidence of adverse experiences in patients with hepatic impairment was similar between the ertapenem group and the comparator groups.

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets are based in part on studies of divalproex sodium delayed release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies

USA - engelsk - NLM (National Library of Medicine)

impax generics - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets are based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies

Jordan - engelsk - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

شركة أدوية الحكمة - hikma pharmaceuticals - ertapenem (as sodium) 1000 mg - (as sodium) 1000 mg

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sodium valproate -

Australien - engelsk - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - sodium valproate, quantity: 400 mg - injection, powder for - excipient ingredients: - epilim iv is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Canada - engelsk - Health Canada

merck canada inc - ertapenem (ertapenem sodium) - powder for solution - 1g - ertapenem (ertapenem sodium) 1g - carbapenems

Singapore - engelsk - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - ertapenem sodium eqv ertapenem - injection, powder, lyophilized, for solution - ertapenem sodium eqv ertapenem 1g/vial