United States - English - NLM (National Library of Medicine)

manildra milling coporation - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - purpose antiseptic uses - hand sanitizer to help reduce bacteria that potentially can cause disease - for use when soap and water are not available

Canada - English - Health Canada

apotex inc - tiaprofenic acid - tablet - 200mg - tiaprofenic acid 200mg - other nonsteroidal antiimflammatory agents

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 750 mg - levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin tablets are indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli, klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae . adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinicalstudies (14.1 ) ]. levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsie

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - sennosides 8.8 mg - laxative • relieves occasional constipation (irregularity) • generally causes bowel movement in 6 to 12 hours • have stomach pain, nausea or vomiting • notice a change in bowel habits that last over 2 weeks • are pregnant or breastfeeding. if you have rectal bleeding or failure to have a bowel movement after use.

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - clindamycin (unii: 3u02el437c) (clindamycin - unii:3u02el437c) - clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. clindamycin in 5% dextrose injection is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of antibiotic-associated pseudomembranous colitis, as described in the boxed warning , before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. indicated surgical procedures should be performed in conjunction with antibiotic therapy. clindamycin in 5% dextrose injection is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below: lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, streptococcus pneumoniae, other streptococci (except e. faecalis ), and staphylococcus aureus. skin and skin structure infections caused by streptococcus pyogenes, staphylococcus aureus , and anaerobes. gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes. intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms. septicemia caused by staphylococcus aureus , streptococci (except enterococcus faecalis ), and susceptible anaerobes. bone and joint infections including acute hematogenous osteomyelitis caused by staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms. to reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin in 5% dextrose injection and other antibacterial drugs, clindamycin in 5% dextrose injection 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.   this drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

United States - English - NLM (National Library of Medicine)

smiths medical asd, inc. - lidocaine hydrochloride anhydrous (unii: ec2cnf7xfp) (lidocaine - unii:98pi200987) - lidocaine hydrochloride anhydrous 10 mg in 1 ml - lidocaine hydrochloride injection, usp is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. indications and usage sodium chloride injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered. lidocaine hydrochloride and epinephrine injection, usp is indicated

United States - English - NLM (National Library of Medicine)

actelion pharmaceuticals us, inc. - bosentan (unii: q326023r30) (bosentan anhydrous - unii:xul93r30k2) - bosentan anhydrous 62.5 mg - tracleer is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - in adults to improve exercise ability and to decrease clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (60%), pah associated with connective tissue diseases (21%), and pah associated with congenital heart disease with left-to-right shunts (18%) [see clinical studies (14.1)] . - in pediatric patients aged 3 years and older with idiopathic or congenital pah to improve pulmonary vascular resistance (pvr), which is expected to result in an improvement in exercise ability. use of tracleer is contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping tracleer [see boxed warning, warnings and precautions (5.2), drug interactions (7.2), use in specific populations (8.1)] . co-administration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant use of tracleer and cyclosporine a is contraindicated [see cytochrome p450 drug interactions (7.1)] . an increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. therefore co-administration of glyburide and tracleer is contraindicated [see cytochrome p450 drug interactions (7.1)] . tracleer is contraindicated in patients who are hypersensitive to bosentan or any component of the product. observed reactions include drug reaction with eosinophilia and systemic symptoms (dress), anaphylaxis, rash, and angioedema [see adverse reactions (6.2), description (11)] . risk summary based on data from animal reproduction studies, tracleer may cause fetal harm, including birth defects and fetal death, when administered to a pregnant female and is contraindicated during pregnancy [see contraindications (4.1)] . there are limited data on tracleer use in pregnant women. in animal reproduction studies, oral administration of bosentan to pregnant rats at 2-times the maximum recommended human dose (mrhd) on a mg/m 2 basis caused teratogenic effects in rats, including malformations of the head, mouth, face, and large blood vessels [see animal data] . advise pregnant women of the potential risk to a fetus. 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 2–4% and 15–20%, respectively. data animal data bosentan was teratogenic in rats given oral doses two times the mrhd (on a mg/m 2 basis). in an embryo-fetal toxicity study in rats, bosentan showed dose-dependent teratogenic effects, including malformations of the head, mouth, face and large blood vessels. bosentan increased stillbirths and pup mortality at oral doses 2 and 10 times the mrhd (on a mg/m 2 basis). although birth defects were not observed in rabbits given oral doses of up to the equivalent of 10.5 g/day in a 70 kg person, plasma concentrations of bosentan in rabbits were lower than those reached in the rat. the similarity of malformations induced by bosentan and those observed in endothelin-1 knockout mice and in animals treated with other endothelin receptor antagonists indicates that embryo-fetal toxicity is a class effect of these drugs. risk summary data from a case report describe the presence of bosentan in human milk. there is insufficient information about the effects of bosentan on the breastfed infant and no information on the effects of bosentan on milk production. because of the potential for serious adverse reactions, such as fluid retention and hepatotoxicity, in breastfed infants from tracleer, advise women not to breastfeed during treatment with tracleer. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating tracleer, monthly during treatment and one month after stopping treatment with tracleer. the patient should contact her physician immediately for pregnancy testing if onset of menses is delayed or pregnancy is suspected. if the pregnancy test is positive, the physician and patient must discuss the risks to her, the pregnancy, and the fetus. contraception drug interaction studies show that bosentan reduces serum levels of the estrogen and progestin in oral contraceptives. based on these findings, hormonal contraceptives (including oral, injectable, transdermal, and implantable contraceptives) may be less effective for preventing pregnancy in patients using tracleer and should not be used as a patient's only contraceptive method [see drug interactions (7.2)] . females of reproductive potential using tracleer must use two acceptable methods of contraception during treatment and for 1 month after treatment with tracleer. patients may choose one highly effective form of contraception (intrauterine devices (iud) or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). if a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must be used along with this method. counsel patients on pregnancy planning and prevention, including emergency contraception, or designate counseling by another healthcare provider trained in contraceptive counseling [see boxed warning] . infertility males decreased sperm counts have been observed in patients receiving tracleer. based on these findings and findings in animals, tracleer may impair fertility in males of reproductive potential. it is not known whether effects on fertility would be reversible [see warnings and precautions (5.6), adverse reactions (6.1), nonclinical toxicology (13.1)] . the efficacy of tracleer in patients <18 years is supported by data from an uncontrolled trial in which 19 pediatric patients were treated with tracleer. in this study, cardiopulmonary hemodynamic improvements were similar to those seen in adults treated with tracleer [see pulmonary arterial hypertension (14.1)] . safety in pediatric patients is supported by data from 100 pediatric patients treated with tracleer for a median of 17 months [see clinical studies experience (6.1), pulmonary arterial hypertension (14.1)] . juvenile animal toxicity data in a juvenile rat toxicity study, rats were treated from day 4 postpartum to adulthood (day 69 postpartum). decreased body weights, absolute weights of testes and epididymides, and reduced number of sperm in epididymides were observed after weaning. no effect on testis histology or sperm morphology and function was seen. the noael was 4 times (at day 4 postpartum) and 2 times (day 69 postpartum) the human therapeutic exposure, respectively. no effects on general development, sensory, cognitive function and reproductive performance were detected at the highest dose tested in juvenile rats, 7 times the therapeutic exposure in children with pah. clinical studies of tracleer did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects. because there is in vitro and in vivo evidence that the main route of excretion of bosentan is biliary, liver impairment could be expected to increase exposure (c max and auc) of bosentan. the pharmacokinetics of tracleer have not been evaluated in patients with severe liver impairment (child-pugh class c). in patients with moderate hepatic impairment (child-pugh class b), the systemic exposures to bosentan and its active metabolite increased significantly. tracleer should generally be avoided in patients with moderate or severe liver impairment. pharmacokinetics of bosentan were not altered in patients with mild impairment of hepatic function (child-pugh class a) [see dosage and administration (2.6), warnings and precautions (5.1), pharmacokinetics (12.3)] . the effect of renal impairment on the pharmacokinetics of bosentan is small and does not require dosing adjustment [see pharmacokinetics (12.3)] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

18-21mmhg) panty closed toe lymphoedema garment long extra large caramel (sigvaris britain ltd -

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

23-32mmhg) thigh length open toe with knobbed grip top lymphoedema garment normal extra small plus black (sigvaris britain ltd -

United States - English - NLM (National Library of Medicine)

astrazeneca pharmaceuticals lp - anifrolumab (unii: 38rl9ae51q) (anifrolumab - unii:38rl9ae51q) - saphnelo (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (sle), who are receiving standard therapy [see clinical studies (14)] . limitations of use the efficacy of saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. use of saphnelo is not recommended in these situations.                                                                 saphnelo is contraindicated in patients with a history of anaphylaxis with anifrolumab-fnia [see warnings and precautions (5.2)] . pregnancy exposure registry a pregnancy exposure registry monitors pregnancy outcomes in women exposed to saphnelo during pregnancy. for more information about the registry or to report a pregnancy while on saphnelo, contact astrazeneca at 1‑877‑693‑9268. risk summary the limited human data with saphnelo use in pregnant women are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. monoclonal igg antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumab-fnia exposure to the fetus may be greater during the third trimester of pregnancy. in an enhanced pre- and post-natal development study with pregnant cynomolgus monkeys that received intravenous administration of anifrolumab-fnia, there was no evidence of embryotoxicity or fetal malformations with exposures up to approximately 28‑times the exposure at the maximum recommended human dose (mrhd) on an area under curve (auc) basis (see data) . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the estimated 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. clinical considerations disease-associated maternal and/or embryo/fetal risk : pregnant women with sle are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. data animal data : in an enhanced pre- and post-natal development study, pregnant cynomolgus monkeys received anifrolumab-fnia at intravenous doses of 30 or 60 mg/kg once every 2 weeks from confirmation of pregnancy at gestation day 20, throughout the gestation period, and continuing until 1‑month post-partum (approximately lactation day 28). there was no evidence of anifrolumab-fnia related maternal toxicity, embryo-fetal toxicity, or post-natal developmental effects. no anifrolumab-fnia related effect on t-cell-dependent antibody response in the infants was noted up to day 180 after birth. the no observed adverse effect level (noael) for maternal and developmental toxicity was identified as 60 mg/kg (approximately 28‑times the mrhd on an auc basis). in the infants, mean serum concentrations of anifrolumab‑fnia on day 30 after birth increased with dose and were approximately 4.2% to 9.7% of the respective maternal concentrations. the anifrolumab-fnia concentrations in the infant serum were up to approximately 22‑times the concentrations in the maternal milk, suggesting that anifrolumab-fnia had transferred via the placenta. risk summary no data are available regarding the presence of saphnelo in human milk, the effects on the breastfed child, or the effects on milk production. anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. due to species-species differences in lactation physiology, animal data may not reliably predict drug levels in humans. maternal igg is known to be present in human milk. if anifrolumab-fnia is transferred into human milk, the effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to anifrolumab-fnia are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for anifrolumab-fnia and any potential adverse effects on the breast-fed child from anifrolumab-fnia or from the underlying maternal condition. the safety and efficacy of saphnelo in pediatric patients less than 18 years of age have not been established. of the 664 patients with sle exposed to anifrolumab-fnia in clinical trials, 3% (n=20) were 65 and over. the number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.