Ireland - English - HPRA (Health Products Regulatory Authority)

intervet ireland limited - cefalexin sodium - suspension for injection - 18 percent weight/volume - cefalexin - cattle, dogs, cats - antibacterial

Ireland - English - HPRA (Health Products Regulatory Authority)

intervet ireland limited - fenbendazole - oral paste - 18.75 percent weight/weight - fenbendazole - horses - endoparasiticide

Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - levodopa, quantity: 75 mg; carbidopa monohydrate, quantity: 20.25 mg (equivalent: carbidopa, qty 18.75 mg); entacapone, quantity: 200 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose; hyprolose; povidone; colloidal anhydrous silica; magnesium stearate; hypromellose; titanium dioxide; glycerol; iron oxide yellow; polysorbate 80; iron oxide red - lecteva (levodopa/carbidopa/entacapone) is indicated for the management of patients with parkinson?s disease who are experiencing motor fluctuations.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - indometacin sodium trihydrate -

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

zydus pharmaceuticals (usa) inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablet is indicated in adult patients 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 clinical studies (14.1)] .   levofloxacin tablet is indicated in adult patients 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, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see dosage and administration (2.1) and clinical studies (14.2)] . mdrsp isolat

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

apotheca inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 750 mg - levofloxacin tablets, usp 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, usp are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see clinical studies ( 14.1) ]. levofloxacin tablets, usp are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus , streptococcus pneumoniae (including multidrug-resistant

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

medi-physics, inc. dba ge healthcare - flutemetamol f-18 (unii: l49m066s0o) (flutemetamol f-18 - unii:l49m066s0o) - flutemetamol f-18 4.05 mci in 1 ml - vizamyl is indicated for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer's disease (ad) and other causes of cognitive decline. a negative vizamyl scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of ad at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to ad. a positive vizamyl scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with ad, but may also be present in patients with other types of neurologic conditions as well as in older people with normal cognition. vizamyl is an adjunct to other diagnostic evaluations. limitations of use: - a positive vizamyl scan does not establish a diagnosis of ad or other cognitive disorder. - safety and effe

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

eli lilly and company - florbetapir f-18 (unii: 6w15z5r0ru) (florbetapir f-18 - unii:6w15z5r0ru) - florbetapir f-18 51 mci in 1 ml - amyvid is indicated for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer's disease (ad) and other causes of cognitive decline. a negative amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of ad at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to ad. a positive amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with ad, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. amyvid is an adjunct to other diagnostic evaluations. limitations of use: - a positive amyvid scan does not establish a diagnosis of ad or other cognitive disorder. - safety and effectivenes

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

life molecular imaging, ltd - florbetaben f-18 (unii: tla7312toi) (florbetaben f-18 - unii:tla7312toi) - florbetaben f-18 135 mci in 1 ml - neuraceq is indicated for positron emission tomography (pet) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for alzheimer’s disease (ad) and other causes of cognitive decline. a negative neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of ad at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to ad. a positive neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with ad, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. neuraceq is an adjunct to other diagnostic evaluations. limitations of use • a positive neuraceq scan does not establish the diagnosis of ad or any other cognitive disorder. • safety and effectiveness of neuraceq have not been established for:    o predicting development of dementia or other neurologic conditions;    o monitoring responses to therapies. none risk summary there are no available data on neuraceq use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  animal reproduction studies have not been conducted with neuraceq. all radiopharmaceuticals, including neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. if considering neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. 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. risk summary there are no data on the presence of florbetaben f 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben f 18 injection on milk production. exposure of neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for neuraceq and any potential adverse effects on the breastfed child from neuraceq or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk for 24 hours after administration of neuraceq. neuraceq is not indicated for use in pediatric patients. of the 872 subjects in clinical studies of neuraceq, 603 (69%) were 65 years or over, while 304 (35%) were 75 years or over. no overall differences in safety were observed between these subjects and younger subjects.

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

glaxosmithkline llc - rosiglitazone maleate (unii: kx2339dp44) (rosiglitazone - unii:05v02f2kdg) - rosiglitazone 2 mg - avandia is a thiazolidinedione antidiabetic agent indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. important limitations of use: risk summary limited data with avandia in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal reproduction studies, no adverse developmental effects were observed when rosiglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 4 times the maximum recommended human dose (mrhd) of 8 mg daily (see data). the estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20% to 25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the