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

ucb australia pty ltd t/a ucb pharma division of ucb australia - lacosamide, quantity: 10 mg - solution - excipient ingredients: glycerol; sodium chloride; carmellose sodium; sorbitol solution (70 per cent) (crystallising); macrogol 4000; citric acid; acesulfame potassium; sodium methyl hydroxybenzoate; purified water; flavour - vimpat (lacosamide) tablets and oral solution are indicated as:,? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.,? add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.,? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - 13912 - swab - alcohol swab to clean area prior to injecting.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - rotigotine -

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - lacosamide -

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 1000 mg - tablet, film coated - excipient ingredients: macrogol 6000; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 500 mg - tablet, film coated - excipient ingredients: magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; macrogol 6000; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

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

ucb australia pty ltd t/a ucb pharma division of ucb australia - levetiracetam, quantity: 250 mg - tablet, film coated - excipient ingredients: magnesium stearate; croscarmellose sodium; macrogol 6000; colloidal anhydrous silica; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - keppra (film coated tablets and oral solution) is indicated for - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation, - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. - add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (jme), and - add on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (ige). keppra concentrate solution for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Irlanda - engleză - HPRA (Health Products Regulatory Authority)

ucb (pharma) ireland limited - cetirizine dihydrochloride - film-coated tablet - 10 milligram(s) - piperazine derivatives; cetirizine - piperazine derivatives - in adults and paediatric patients 6 years and above: cetirizine is indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. cetirizine is indicated for the relief of symptoms of chronic idiopathic urticaria.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

ucb, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - keppra xr® is indicated for the treatment of partial-onset seizures in patients 12 years of age and older. keppra xr is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including keppra xr, during pregnancy. encourage women who are taking keppra xr 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 prolonged experience with keppra in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data] . in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations keppra xr levels may decrease during pregnancy [see warnings and precautions (5.10)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. data human data while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. animal data when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal developmental in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis. oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). risk summary levetiracetam is excreted in human milk. there are no data on the effects of keppra xr 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 keppra xr and any potential adverse effects on the breastfed infant from keppra xr or from the underlying maternal condition. safety and effectiveness in patients 12 years of age and older have been established based on pharmacokinetic data in adults and adolescents using keppra xr and efficacy and safety data in controlled pediatric studies using immediate-release keppra [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14.1)]. safety and effectiveness in pediatric patients below the age of 12 have not been established. a 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release keppra as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (keppra n=64; placebo n=34). the target dose of immediate-release keppra was 60 mg/kg/day. neurocognitive effects were measured by the leiter-r attention and memory (am) battery, which assesses various aspects of a child's memory and attention. although no substantive differences were observed between the placebo- and keppra-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo. the achenbach child behavior checklist (cbcl/6-18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. an analysis of the cbcl/6-18 indicated a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with keppra [see warnings and precautions (5.1)] . juvenile animal toxicity data studies of levetiracetam in juvenile rats (dosed on postnatal days 4 through 52) and dogs (dosed from postnatal weeks 3 through 7) at doses of up to 1800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not demonstrate adverse effects on postnatal development. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of keppra xr in these patients. it is expected that the safety of keppra xr in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate-release keppra tablets. there were 347 subjects in clinical studies of immediate-release keppra that were 65 and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of immediate-release keppra in these patients. levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse 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)] . the effect of keppra xr on renally impaired patients was not assessed in the controlled study. however, it is expected that the effect on keppra xr-treated patients would be similar to the effect seen in controlled studies of immediate-release keppra tablets. clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dose adjustment is recommended for patients with impaired renal function [see dosage and administration (2.2)] .

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

ucb, inc. - fenfluramine (unii: 2ds058h2cf) (fenfluramine - unii:2ds058h2cf) - fintepla is indicated for the treatment of seizures associated with dravet syndrome (ds) and lennox-gastaut syndrome (lgs) in patients 2 years of age and older. fintepla is contraindicated in patients with: - hypersensitivity to fenfluramine or any of the excipients in fintepla [see description (11)] - concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome [see warnings and precautions (5.7)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fintepla, during pregnancy. encourage women who are taking fintepla during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no data on fintepla use in pregnant women. available data from epidemiologic studies with fenfluramine or dexfenfluramine are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. fintepla can cause decreased appetite and decreased weight [see warnings and precautions (5.3)]; monitor for adequate weight gain during pregnancy. in animal studies, administration of fenfluramine throughout organogenesis (rat and rabbit) or throughout gestation and lactation (rat) resulted in adverse effects on development (fetal malformations, embryofetal and offspring mortality and growth impairment) in the presence of maternal toxicity at clinically relevant maternal plasma levels of fenfluramine and its major active metabolite (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 oral administration of fenfluramine (0, 4.5, 8.6, or 34.6 mg/kg/day) to pregnant rats during organogenesis resulted in decreased fetal body weights and marked increases in fetal malformations (external, visceral, and skeletal) at the highest dose tested, which was associated with maternal toxicity. at the no-effect dose (8.6 mg/kg/day) for adverse effects on embryofetal development in rats, maternal plasma exposures (auc) of fenfluramine and norfenfluramine (the major metabolite) were approximately 2 and 5 times, respectively, those in humans at the maximum recommended human dose (mrhd) of 26 mg/day. oral administration of fenfluramine (0, 4.3, 8.6, 13.0 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in increased embryofetal mortality at all doses and increases in fetal malformations (external and skeletal) at the highest dose tested, which was associated with maternal toxicity. a no-adverse-effect dose for adverse effects on embryofetal development in rabbits was not identified. at the lowest dose tested in rabbits (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were lower than those in humans at the mrhd. oral administration of fenfluramine (0, 4.3, 8,6, or 34.6 mg/kg/day) to female rats throughout gestation and lactation resulted in marked increases in stillborn pups and neonatal offspring deaths at the highest dose tested and delayed growth and reflex development during the pre- weaning period at all doses. maternal body weight gain was decreased at all doses during pregnancy and at the two highest doses during lactation. a no-effect dose for adverse effects on pre- and postnatal development in rats was not determined. at the lowest dose tested in rats (4.3 mg/kg/day), maternal plasma exposures of fenfluramine and norfenfluramine were approximately 0.5 and 3 times, respectively, those in humans at the mrhd. risk summary there are no data on the presence of fenfluramine or its metabolites in human milk, 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 fintepla and any potential adverse effects on the breastfed infant from fintepla or from the underlying maternal condition. infertility in animal studies, oral administration of fenfluramine resulted in adverse reproductive effects in males and females at clinically relevant doses in the presence of parental toxicity [see nonclinical toxicology (13.1)] . the safety and effectiveness of fintepla for the treatment of seizures associated with ds and lgs have been established in patients 2 years of age and older. use of fintepla for the treatment of seizures associated with ds in patients 2 years of age and older is supported by two randomized, double-blind, placebo-controlled trials in 202 patients 2 to 18 years of age. use of fintepla for the treatment of seizures associated with lgs is supported by a randomized, double-blind, placebo-controlled study in 263 patients aged 2 to 35 years, including 187 patients less than 18 years [see boxed warning, warnings and precautions (5), adverse reaction (6.1), and clinical studies (14)]. fintepla can cause decreases in appetite and weight. the growth of pediatric patients treated with fintepla should be carefully monitored. safety and effectiveness in patients less than 2 years of age have not been established. juvenile animal data oral administration of fenfluramine (0, 3.0, 7,8, or 17.3 mg/kg/day) to young rats for 10 weeks starting on postnatal day 7 resulted in reduced body weight and neurobehavioral changes (decreased locomotor activity and learning and memory deficits) at all doses tested. neurobehavioral effects persisted after dosing was discontinued. bone size was decreased at the mid and high doses; brain size was decreased at the highest dose. partial or complete recovery was seen for these endpoints. a no-effect dose for postnatal developmental toxicity was not identified. the lowest dose tested (3.0 mg/kg/day) was associated with plasma fenfluramine exposures (auc) less than that in humans at the maximum recommended human dose (mrhd) of 26 mg/day and norfenfluramine (metabolite) exposures (auc) approximately 2 times that in humans at the mrhd. clinical studies of fintepla for the treatment of ds or lgs did not include patients 65 years of age and over to determine whether they respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with estimated glomerular filtration rate (egfr) 15 to 29 ml/min/1.73m2 , do not exceed the maximum daily dosage of fintepla of 20 mg. in patients with egfr 15 to 29 ml/min/1.73m2 and concomitant stiripentol use, do not exceed the maximum daily dosage of fintepla of 17 mg [see dosage and administration (2.4) and clinical pharmacology (12.3)]. fintepla has not been studied in patients with egfr < 15 ml/min/1.73m2 . combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (child-pugh class a, b, and c), necessitating a dosage adjustment in these patients [see dosage and administration (2.5) and clinical pharmacology (12.3)] . be sure that you read, understand, and follow these instructions before you start using fintepla oral solution and each time you get a refill. there may be new information. this instructions for use contains information on how to take fintepla. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. what is included with fintepla? the following items are included to prepare and give an oral dose of fintepla: - 1 bottle of fintepla oral solution (2.2 mg/ml) - 2 reusable oral syringes 1 bottle of fintepla oral solution (2.2 mg/ml)    2 oral syringes call the pharmacist at 1-844-288-5007 if you did not receive the items listed above, or if you need help using them. important information about fintepla - fintepla is an oral medicine (taken by mouth) and is given 2 times each day . follow your healthcare provider's instructions for taking or giving doses of fintepla. - if you have questions about how to prepare or give fintepla, contact your healthcare provider or call your pharmacist. - always use the oral syringes provided with fintepla to make sure the right dose is given. if you need a new syringe contact your pharmacist. do not use a household teaspoon or tablespoon. oral syringes provided with fintepla by the pharmacy. with fintepla you will receive 2 reusable oral syringes. call the pharmacist at 1-844-288-5007 if you have any questions about the syringes provided with fintepla. - the bottle of fintepla oral solution, and - a clean, dry reusable oral syringe that was provided with fintepla. - do not use the medicine if the "throw away" (discard) date has passed. - if the date is near, contact your pharmacy or healthcare provider to get a refill or new prescription. - if the date has passed, dispose of any unused fintepla. - set the cap aside (do not throw away). - if the bottle does not have an adapter, contact the pharmacist. - always leave the adapter in place in the bottle of medicine. - use the other oral syringe provided, or - contact the pharmacist to get a new one. - if you draw out too much medicine: leave the oral syringe in the adapter. push the plunger slowly back into the syringe until you reach the prescribed dose. - leave the oral syringe in the adapter. - push the plunger slowly back into the syringe until you reach the prescribed dose. - if you see air bubbles in the medicine: leave the oral syringe in the adapter. pull the plunger further down. allow the bubbles to rise to the tip of the syringe. push the plunger in all the way. slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - leave the oral syringe in the adapter. - pull the plunger further down. - allow the bubbles to rise to the tip of the syringe. - push the plunger in all the way. - slowly pull the plunger out to the prescribed dose. note: very small bubbles in the liquid are normal. - put the syringe back into adapter. - see steps 9 to 11 to adjust the dose, as needed. - do not squirt or forcefully push the medicine into the back of the throat. this may cause choking. - always leave the adapter in place in the bottle - the cap will fit over it. - rinse the oral syringe with clean tap water and allow it to air dry after each use. - make sure you rinse the inside of the syringe and the plunger. - pull clean tap water into the syringe with the plunger and push it out several times to clean the syringe. - remove the plunger from the barrel of the oral syringe - rinse both parts under tap water - make sure the syringe and plunger are completely dry before the next use. - the syringe is also safe to clean in the dishwasher. how should i store fintepla? - store fintepla at room temperature between 68°f to 77°f (20°c to 25°c). - do not refrigerate or freeze. - keep the cap tightly closed and the bottle upright. - store the fintepla bottle and syringe together in a clean area. - throw away (discard) any unused fintepla 3 months after first opening the bottle or if the discard after date on the package or bottle has passed. whichever one comes first. - keep fintepla and all medicines out of the reach of children. manufactured for: ucb, inc., smyrna, ga 30080 fintepla® is a registered trademark of the ucb group of companies. ©2023. all rights reserved. this instructions for use has been approved by the u.s. food and drug administration. revised: 9/2023