New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - avian reovirus (live) - avian reovirus (live) 0 vaccine - vaccine

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - chicken anaemia virus - live - chicken anaemia virus - live 0 vaccine - vaccine

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - turkey herpes virus (attenuated); marek's disease virus (attenuated) - turkey herpes virus (attenuated) 0 vaccine; marek's disease virus (attenuated) 0 vaccine - diluent

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

avkare - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - naproxen tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea naproxen is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] risk summary use of nsaids, including naproxen, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including naproxen, in pregnant women starting at 30 weeks of gestation (third trimester). there are no adequate and well-controlled studies of naproxen in pregnant women. data from observational studies regarding potential embryofetal risks of nsaid use in women in the first or second trimesters of pregnancy are inconclusive. in the general u.s. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. in animal reproduction studies in rats, rabbits, and mice no evidence of teratogenicity or fetal harm when naproxen was administered during the period of organogenesis at doses 0.13, 0.26, and 0.6 times the maximum recommended human daily dose of 1,500 mg/day, respectively [see data] . based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre- and post-implantation loss. clinical considerations labor or delivery there are no studies on the effects of naproxen during labor or delivery. in animal studies, nsaids, including naproxen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. data human data there is some evidence to suggest that when inhibitors of prostaglandin synthesis are used to delay preterm labor, there is an increased risk of neonatal complications such as necrotizing enterocolitis, patent ductus arteriosus, and intracranial hemorrhage. naproxen treatment given in late pregnancy to delay parturition has been associated with persistent pulmonary hypertension, renal dysfunction, and abnormal prostaglandin e levels in preterm infants. because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly starting at 30-weeks of gestation, or third trimester) should be avoided. an imal data reproduction studies have been performed in rats at 20 mg/kg/day (0.13 times the maximum recommended human daily dose of 1,500 mg/day based on body surface area comparison), rabbits at 20 mg/kg/day (0.26 times the maximum recommended human daily dose, based on body surface area comparison), and mice at 170 mg/kg/day (0.6 times the maximum recommended human daily dose based on body surface area comparison) with no evidence of impaired fertility or harm to the fetus due to the drug. based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. in animal studies, administration of prostaglandin synthesis inhibitors such as naproxen, resulted in increased pre- and post-implantation loss. r isk summary the naproxen anion has been found in the milk of lactating women at a concentration equivalent to approximately 1% of maximum naproxen concentration in plasma. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for naproxen and any potential adverse effects on the breastfed infant from the naproxen or from the underlying maternal condition. i n f ertility f emales based on the mechanism of action, the use of prostaglandin-mediated nsaids, including naproxen, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. small studies in women treated with nsaids have also shown a reversible delay in ovulation. consider withdrawal of nsaids, including naproxen, in women who have difficulties conceiving or who are undergoing investigation of infertility. safety and effectiveness in pediatric patients below the age of 2 years have not been established. pediatric dosing recommendations for polyarticular juvenile idiopathic arthritis are based on well-controlled studies [see dosage and administration (2)] . there are no adequate effectiveness or dose-response data for other pediatric conditions, but the experience in polyarticular juvenile idiopathic arthritis and other use experience have established that single doses of 2.5 to 5 mg/kg as naproxen suspension, , with total daily dose not exceeding 15 mg/kg/day, are well tolerated in pediatric patients over 2 years of age. the hepatic and renal tolerability of long-term naproxen administration was studied in two double-blind clinical trials involving 586 patients. of the patients studied, 98 patients were age 65 and older and 10 of the 98 patients were age 75 and older. naproxen was administered at doses of 375 mg twice daily or 750 mg twice daily for up to 6 months. transient abnormalities of laboratory tests assessing hepatic and renal function were noted in some patients, although there were no differences noted in the occurrence of abnormal values among different age groups. elderly patients, compared to younger patients, are at greater risk for nsaid-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. if the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [see warnings and precautions (5.1, 5.2,  5.3, 5.6, 5.13)]. studies indicate that although total plasma concentration of naproxen is unchanged, the unbound plasma fraction of naproxen is increased in the elderly. the clinical significance of this finding is unclear, although it is possible that the increase in free naproxen concentration could be associated with an increase in the rate of adverse events per a given dosage in some elderly patients. caution is advised when high doses are required and some adjustment of dosage may be required in elderly patients. as with other drugs used in the elderly, it is prudent to use the lowest effective dose. experience indicates that geriatric patients may be particularly sensitive to certain adverse effects of nonsteroidal anti-inflammatory drugs. elderly or debilitated patients seem to tolerate peptic ulceration or bleeding less well when these events do occur. most spontaneous reports of fatal gi events are in the geriatric population [see warnings and precautions (5.2)] . naproxen 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 clinical pharmacology (12.3)] . geriatric patients may be at a greater risk for the development of a form of renal toxicity precipitated by reduced prostaglandin formation during administration of nonsteroidal anti-inflammatory drugs [see warnings and precautions (5.6)] . caution is advised when high doses are required and some adjustment of dosage may be required in these patients. it is prudent to use the lowest effective dose [see clinical pharmacology (12.3)] . naproxen-containing products are not recommended for use in patients with moderate to severe and severe renal impairment (creatinine clearance <30 ml/min) [see warnings and precautions (5.6), clinical pharmacology (12.3)] . to report suspected adverse reactions contact avkare, inc. at 1-855-361-3993; email drugsafety@avkare.com; or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

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

avkare - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - ketorolac tromethamine 10 mg - carefully consider the potential benefits and risks of ketorolac tromethamine tablets usp and other treatment options before deciding to use ketorolac tromethamine tablets usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and administrati

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

avkare, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 375 mg - carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings). naproxen delayed-release tablets are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see clinical pharmacology and dosage and administration). naproxen delayed-release tablets are contraindicated in patients with known hypersensitivity to naproxen. naproxen delayed-release

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

avkare - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see wa

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

avkare - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see wa

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

avkare - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. additional pediatric use information is approved for ucb, inc.’s vimpat ® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. none.  pregnancy exposure registry  there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as lacosamide, during pregnancy. encourage women who are taking lacosamide during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.  risk summary  there are no adequate data on the developmental risks associated with the use of lacosamide in pregnant women.  lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. these effects were observed at doses associated with clinically relevant plasma exposures  (see data) .  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. the background risk of major birth defects and miscarriage for the indicated population is unknown.  animal data  oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. however, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. these doses were associated with maternal plasma lacosamide exposures (auc) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (mrhd) of 400 mg/day. in two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. the no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide auc similar to that in humans at the mrhd.  oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide auc less than that in humans at the mrhd.  in vitro data  lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential adverse effects on cns development related to this activity cannot be ruled out.  risk summary  there are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production. studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk.  the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition.  partial-onset seizures safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see adverse reactions (6.1),  clinical pharmacology (12.3) and  clinical studies (14.1, 14.2)] . safety and effectiveness in pediatric patients below 1 month of age have not been established. animal data  lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (crmp-2), a protein involved in neuronal differentiation and control of axonal outgrowth. potential related adverse effects on cns development cannot be ruled out. administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). the no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (auc) less than that in humans at the maximum recommended human dose of 400 mg/day.  additional pediatric use information is approved for ucb, inc.’s vimpat ® (lacosamide) tablets. however, due to ucb, inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. there were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. no lacosamide dose adjustment based on age is necessary. in elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy  [see dosage and administration (2.1,  2.3,  2.4)  and   clinical pharmacology (12.3)] .  based on data in adults, no dose adjustment is necessary in adult and pediatric patients with mild to moderate renal impairment (cl cr ≥30 ml/min). in adult and pediatric patients with severe renal impairment (cl cr <30 ml/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended  [see dosage and administration (2.3)  and   clinical pharmacology (12.3)] .  in all patients with renal impairment, dose titration should be performed with caution.  lacosamide is effectively removed from plasma by hemodialysis. dosage supplementation of up to 50% following hemodialysis should be considered.  based on data in adults, for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. patients with mild to moderate hepatic impairment should be observed closely during dose titration  [see dosage and administration (2.4),  clinical pharmacology (12.3)] . the pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. lacosamide use is not recommended in patients with severe hepatic impairment.  lacosamide is a schedule v controlled substance. in a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a schedule iv drug. the duration of the euphoria-type responses following lacosamide was less than that following alprazolam. a high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). however, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%.  abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. however, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. 

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

bob martin (australia) pty ltd - malathion; liquid hydrocarbon - topical solution/suspension - malathion organophosphorus-dithiophospha active 200.0 g/l; liquid hydrocarbon solvent other 640.0 g/l - parasiticides - bird cage, cabinet, loft or aviary | cat - over 6 months old | dog - with exclusions see label | cat - over 24 weeks old - bird louse | flea | fowl tick | louse - felicola spp. | louse - trichodectes spp. | paralysis tick | poultry red mite | sarcoptic mange | tick - rhipicephalus spp. | australian paralysis tick | ctenocephalides spp. | ground fleas | red mite | scrub tick