Ireland - English - HPRA (Health Products Regulatory Authority)

medac gesellschaft fur klinische spezialpraparate - levofolinic acid sodium hydroxide - solution for inj/inf - 50 micromol

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - erysipelothrix rhusiopathiae; whole cell e. coli including fimbrial antigens k88, k99; leptospira interrogans serovar pomona; formaldehyde; thiomersal - misc. vaccines or anti sera - erysipelothrix rhusiopathiae vaccine-general active 0.0 u; whole cell e. coli including fimbrial antigens k88, k99 vaccine-microbial active 0.0 u; leptospira interrogans serovar pomona vaccine-microbial active 0.0 u; formaldehyde aldehyde other 0.3 mg/ml; thiomersal mercury other 0.1 mg/ml - immunotherapy - pig - piglet | pigs | boar | gilt | neonatal piglet | new born pig | piglet | sow | sucker pig | swine - erysipelas infection | escherichia coli scours | leptospirosis - leptospira pomona | l. interrogans serovar pomona | leptospira pomona infection | white scours

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - whole cell e. coli including fimbrial antigens k88, k99 - parenteral liquid/solution/suspension - whole cell e. coli including fimbrial antigens k88, k99 vaccine-microbial active 0.0 p - immunotherapy - cow - pregnant | heifer (before calving) | bovine | pregnant cow - bovine neonatal colibacillosis | escherichia coli scours | white scours

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - e.coli - parenteral liquid/solution/suspension - e.coli vaccine-microbial active 0.0 p - immunotherapy - pig weaner - escherichia coli scours | vaccine | equine rotavirus | white scours

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - whole cell e. coli including fimbrial antigens k88, k99; formaldehyde; thiomersal - parenteral liquid/solution/suspension - whole cell e. coli including fimbrial antigens k88, k99 vaccine-microbial active 0.0 p; formaldehyde aldehyde other 1.2 mg/ml; thiomersal mercury other 0.1 mg/ml - immunotherapy - pig - piglet | neonatal piglet | new born pig | sucker pig - escherichia coli (e. coli) | scours - neonatal | vaccine | equine rotavirus | including b-lactamase producin

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

merck sharp & dohme llc - tedizolid phosphate (unii: o7drj6r4dw) (tedizolid - unii:97hlq82ngl) - tedizolid phosphate 200 mg - sivextro® is an oxazolidinone-class antibacterial indicated in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (absssi) caused by susceptible isolates of the following gram-positive microorganisms: staphylococcus aureus (including methicillin-resistant [mrsa] and methicillin-susceptible [mssa] isolates), streptococcus pyogenes , streptococcus agalactiae , streptococcus anginosus group (including streptococcus anginosus , streptococcus intermedius , and streptococcus constellatus ), and enterococcus faecalis . to reduce the development of drug-resistant bacteria and maintain the effectiveness of sivextro and other antibacterial drugs, sivextro should be used only to treat absssi 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 epidemio

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

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

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

alexion pharmaceuticals inc. - eculizumab (unii: a3ulp0f556) (eculizumab - unii:a3ulp0f556) - eculizumab 300 mg in 30 ml - soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (pnh) to reduce hemolysis. soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (ahus) to inhibit complement-mediated thrombotic microangiopathy. limitation of use soliris is not indicated for the treatment of patients with shiga toxin e. coli related hemolytic uremic syndrome (stec-hus). soliris is indicated for the treatment of generalized myasthenia gravis (gmg) in adult patients who are anti-acetylcholine receptor (achr) antibody positive. soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (nmosd) in adult patients who are anti-aquaporin-4 (aqp4) antibody positive. soliris is contraindicated for initiation in patients with unresolved serious neisseria meningitidis infection [see warnings and precautions (5.1)] . risk summary limited data on outcomes of pregnancies that have occurred following soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus) in pregnancy (see clinical considerations ). animal studies using a mouse analogue of the soliris molecule (murine anti-c5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see data ). the estimated background risk of major birth defects and miscarriage for the indicated populations 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 defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or fetal/neonatal risk pnh in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. ahus in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (iugr), fetal death and low birth weight. data human data a pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to soliris have not suggested safety concerns. however, these data cannot definitively exclude any drug-associated risk during pregnancy, because of the limited sample size. animal data animal reproduction studies were conducted in mice using doses of a murine anti-c5 antibody that approximated 2-4 times (low dose) and 4-8 times (high dose) the recommended human soliris dose, based on a body weight comparison. when animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. when maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose; however, the exposure did not increase fetal loss or neonatal death. when maternal exposure to the antibody occurred in the time period from implantation through weaning, a higher number of male offspring became moribund or died (1/25 controls, 2/25 low dose group, 5/25 high dose group). surviving offspring had normal development and reproductive function. risk summary although limited published data does not report detectable levels of eculizumab in human milk, maternal igg is known to be present in human milk. available information is insufficient to inform the effect of eculizumab on the breastfed infant. there are no data on the effects of eculizumab on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition. safety and effectiveness of soliris for the treatment of pnh, gmg, or nmosd in pediatric patients have not been established. the safety and effectiveness of soliris for the treatment of ahus have been established in pediatric patients. use of soliris in pediatric patients for this indication is supported by evidence from four adequate and well-controlled clinical studies assessing the safety and effectiveness of soliris for the treatment of ahus. the studies included a total of 47 pediatric patients (ages 2 months to 17 years). the safety and effectiveness of soliris for the treatment of ahus appear similar in pediatric and adult patients [see adverse reactions (6.1), and clinical studies (14.2) ]. administer vaccinations for the prevention of infection due to neisseria meningitidis , streptococcus pneumoniae and haemophilus influenzae type b (hib) according to acip guidelines [see warnings and precautions (5.1, 5.3)] . fifty-one patients 65 years of age or older (15 with pnh, 4 with ahus, 26 with gmg, and 6 with nmosd) were treated with soliris in clinical trials in the approved indications. although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

intervet australia pty limited - erysipelothrix rhusiopathiae; e. coli strain - o20:k88; e. coli strain - o149:k88; e. coli strain - o64:k99; e. coli strain - o9:987p; porcine parvo virus; formaldehyde; thiomersal - parenteral liquid/solution/suspension - erysipelothrix rhusiopathiae vaccine-general active 0.0 u; e. coli strain - o20:k88 vaccine-microbial active 0.0 u; e. coli strain - o149:k88 vaccine-microbial active 0.0 u; e. coli strain - o64:k99 vaccine-microbial active 0.0 u; e. coli strain - o9:987p vaccine-microbial active 0.0 u; porcine parvo virus vaccine-viral active 0.0 u; formaldehyde aldehyde other 1.2 mg/ml; thiomersal mercury other 0.1 mg/ml - immunotherapy - pig - piglet | pigs | boar | gilt | neonatal piglet | new born pig | piglet | sow | sucker pig | swine - erysipelas infection | escherichia coli scours | leptospirosis - leptospira pomona | parvovirus | l. interrogans serovar pomona | leptospira pomona infection | white scours

European Union - English - EMA (European Medicines Agency)

zoetis belgium sa - live aroa gene deleted escherichia coli, type 078, strain ec34195 - immunologicals for aves, live bacterial vaccines - chicken; turkeys - for active immunisation of broiler chickens and future layers / breeders in order to reduce mortality and lesions (pericarditis, perihepatitis, airsacculitis) associated with escherichia coli serotype o78.