Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - mycophenolate mofetil -

Ավստրալիա - անգլերեն - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ensystex australasia pty ltd - bifenthrin - suspension concentrate - bifenthrin pyrethroid active 100.0 g/l - insecticide - carnation | commercial building/structure - external | commercial building/structure-internal | commercial turf grass | commerci - african black beetle | ants (except red imported fire ant) | aphid | argentine stem weevil | bill bug | biting midge | black or black house ant | caterpillar | coastal brown ant | cockroach | corn earworm | cutworm | flea | fly | funnel ant | geranium plume moth | lawn armyworm | light brown apple moth | looper | mealy bug | meat ant | mosquito | native budworm or bollworm | paper nest wasp | plague thrips | poinsettia whitefly | sod webworm | spider | stinging ant | subterranean termite | sugar ant | tick - except paralysis tick | two spotted mite | whitefly | adult mosquitoes | banded sugar ant | billbug | budworm | cotton bollworm | cotton whitefly | ctenocephalides spp. | grass caterpillar | grass grub | ground fleas | heliothis | la plata weevil | large cockroach | lawn caterpillar | looper | looper caterpillars | madeira ant | mealybug | native bollworm | ochetellus glaber | papernest wasps | red spider mite | silverleaf whitefly | small cockroach | spider mite | tobacco budworm | tomato grub | two-spot

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mdd us operations llc, a subsidiary of supernus pharmaceuticals, inc. - safinamide mesylate (unii: ys90v3dtx0) (safinamide - unii:90enl74sig) - safinamide 50 mg - xadago is indicated as adjunctive treatment to levodopa/carbidopa in patients with parkinson's disease (pd) experiencing "off" episodes. xadago is contraindicated in patients with: - concomitant use of other drugs in the monoamine oxidase inhibitor (maoi) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. the combination may result in increased blood pressure, including hypertensive crisis [see warnings and precautions (5.1) and drug interactions (7.1)] . - concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol); serotonin-norepinephrine reuptake inhibitors (snris), tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or st john's wort. concomitant use could result in life-threatening serotonin syndrome [see warnings and precautions (5.2) and drug interactions (7.2, 7.3, 7.5)] . - concomitant use of dextromethorphan. the combination of maois and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior [see drug interactions (7.4)] . - a history of a hypersensitivity to safinamide. reactions have included swelling of the tongue and oral mucosa, and dyspnea. - severe hepatic impairment (child-pugh c: 10-15) [see use in specific populations (8.6)] . risk summary there are no adequate data on the developmental risk associated with the use of xadago in pregnant women. in animals, developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses. developmental toxicity was observed at doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa. the 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. data animal data in an embryofetal development study in rats, oral administration of safinamide (0, 50, 100, or 150 mg/kg/day) throughout organogenesis resulted in dose-related increases in fetal abnormalities (primarily urogenital malformations) at all doses. a no-effect dose for adverse effects on embryofetal development was not established. the lowest dose tested (50 mg/kg/day) is approximately 5 times the maximum recommended human dose (mrhd) of 100 mg on a body surface area (mg/m 2 ) basis. in a combination embryofetal development study of safinamide and levodopa (ld)/carbidopa (cd) in rats (80/20 mg/kg/day ld/cd in combination with 0, 25, 50, or 100 mg/kg/day safinamide or 100 mg/kg/day safinamide alone), increased incidences of fetal visceral and skeletal malformations and variations were observed at all doses of safinamide in combination with cd/ld and with safinamide alone. the lowest dose of safinamide tested (25 mg/kg/day) is approximately 2 times the mrhd on a mg/m 2 basis. in embryofetal development studies in rabbits, no developmental toxicity was observed at up to the highest oral dose of safinamide tested (100 mg/kg/day). however, when safinamide (0, 4, 12, or 40 mg/kg/day) was administered throughout organogenesis in a combination study of safinamide with ld/cd (80/20 mg/kg/day ld/cd), there was an increased incidence of embryofetal death and cardiac and skeletal malformations, compared to ld/cd alone. a no-effect dose for safinamide was not established; the lowest effect dose of safinamide tested (4 mg/kg/day) is less than the mrhd on a mg/m 2 basis. in a rat pre- and postnatal development study, oral administration of safinamide (0, 4, 12.5, or 37.5 mg/kg/day) throughout pregnancy and lactation resulted in skin discoloration of the offspring, presumed to be due to hepatobiliary toxicity, at the mid and high doses and decreased body weight and increased postnatal mortality in offspring at the highest dose tested. the no-effect dose (4 mg/kg/day) for adverse developmental effects is less than the mrhd on a mg/m 2 basis. risk summary there is no information regarding the presence of xadago 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 mothers' clinical need for xadago and any potential adverse effects on the breastfed infant from xadago or from the underlying maternal condition. data animal data skin discoloration, presumed to be caused by hyperbilirubinemia resulting from hepatobiliary toxicity, was observed in rat pups indirectly exposed to safinamide through the milk during the lactation period. safety and effectiveness in pediatric patients have not been established. of the 1516 subjects exposed to xadago in clinical studies, 38% were 65 and over, while 4% were 75 and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. xadago plasma concentrations are increased in patients with hepatic impairment [see clinical pharmacology (12.3)] . in patients with moderate hepatic impairment (child-pugh b: 7-9), the maximum recommended dosage of xadago is 50 mg once daily [see dosage and administration (2.2)] . xadago has not been studied in patients with severe hepatic impairment (child-pugh c: 10-15), and is contraindicated in these patients. if patients progress from moderate to severe hepatic impairment, treatment with xadago should be stopped.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

haleon us holdings llc - nicotine (unii: 6m3c89zy6r) (nicotine - unii:6m3c89zy6r) - nicotine 2 mg - stop smoking aid - reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

llc federal solutions - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 100 mg in 1 ml - indication and usage levetiracetam is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. levetiracetam is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. contraindications this product should not be administered to patients who have previously exhibited hypersensitivity to levetiracetam or any of the inactive ingredients in levetiracetam oral solution. drug abuse and dependence the abuse and dependence potential of levetiracetam has not been evaluated in human studies.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

haleon us holdings llc - loratadine (unii: 7ajo3bo7qn) (loratadine - unii:7ajo3bo7qn) - loratadine 10 mg - antihistamine temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: - runny nose - sneezing - itchy, watery eyes - itching of the nose or throat

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

haleon us holdings llc - loratadine (unii: 7ajo3bo7qn) (loratadine - unii:7ajo3bo7qn), pseudoephedrine sulfate (unii: y9dl7qpe6b) (pseudoephedrine - unii:7cuc9ddi9f) - loratadine 5 mg - antihistamine nasal decongestant

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

haleon us holdings llc - potassium nitrate (unii: ru45x2jn0z) (nitrate ion - unii:t93e9y2844), sodium fluoride (unii: 8zyq1474w7) (fluoride ion - unii:q80vpu408o) - potassium nitrate 50 mg in 1 g - antihypersensitivity anticavity - builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. - aids in the prevention of dental cavities.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mdd us operations, llc - apomorphine hydrochloride (unii: f39049y068) (apomorphine - unii:n21far7b4s) - apomorphine hydrochloride 30 mg in 3 ml - apokyn (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced parkinson's disease. apokyn has been studied as an adjunct to other medications [see clinical studies (14)] . apokyn is contraindicated in patients: - using concomitant drugs of the 5ht 3 antagonist class including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see drug interactions (7.1)] . there have been reports of profound hypotension and loss of consciousness when apokyn was administered with ondansetron. - with hypersensitivity/allergic reaction to apomorphine or to any of the excipients of apokyn, including a sulfite (i.e., sodium metabisulfite). angioedema or anaphylaxis may occur [see warnings and precautions (5.13)]. risk summary there are no adequate data on the developmental risk associated with use of apokyn in pregnant women. in animal reproduction studies, apomorphine had adverse developmental effects in rats (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. these doses were also associated with maternal toxicity [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. data animal data no adverse developmental effects were observed when apomorphine (0.3, 1, or 3 mg/kg/day) was administered by subcutaneous injection to pregnant rats throughout organogenesis; the highest dose tested is 1.5 times the maximum recommended human dose (mrhd) of 20 mg/day on a mg/m 2 basis. administration of apomorphine (0.3, 1, or 3 mg/kg/day) by subcutaneous injection to pregnant rabbits throughout organogenesis resulted in an increased incidence of malformations of the heart and/or great vessels at the mid and high doses; maternal toxicity was observed at the highest dose tested. the no-effect dose for adverse developmental effects is less than the mrhd on a mg/m 2 basis. apomorphine (0.3, 1, or 3 mg/kg/day), administered by subcutaneous injection to females throughout gestation and lactation, resulted in increased offspring mortality at the highest dose tested, which was associated with maternal toxicity. there were no effects on developmental parameters or reproductive performance in surviving offspring. the no-effect dose for developmental toxicity (1 mg/kg/day) is less than the mrhd on a mg/m 2 basis. risk summary there are no data on the presence of apomorphine in human milk, the effects of apomorphine on the breastfed infant, or the effects of apomorphine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for apokyn and any potential adverse effects on the breastfed infant from apokyn or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. in the apokyn clinical development program, there were 239 patients less than age 65 treated with apokyn and 311 patients who were age 65 or older. confusion and hallucinations were reported more frequently with patients age 65 and older compared to patients with less than age 65. serious adverse reactions (life-threatening events or events resulting in hospitalization and/or increased disability) were also more common in patients age 65 and older. patients age 65 and older were more likely to fall (experiencing bone and joint injuries), have cardiovascular events, develop respiratory disorders, and have gastrointestinal events. patients age 65 and above were also more likely to discontinue apokyn treatment as a result of one or more adverse reactions. the starting apokyn dose should be reduced in patients with mild or moderate renal impairment because the concentration and exposure (c max and auc) are increased in these patients. studies in subjects with severe renal impairment have not been conducted [see dosage and administration (2.4) and clinical pharmacology (12.3)] . caution should be exercised when administrating apokyn to patients with mild and moderate hepatic impairment because of the increased c max and auc in these patients. closely monitor patients with mild and moderate hepatic impairment. studies of subjects with severe hepatic impairment have not been conducted [see clinical pharmacology (12.3)] . in premarketing clinical experience, apokyn did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. however, there are rare postmarketing reports of abuse of medications containing apokyn or levodopa. in general, these reports consist of patients taking increasing doses of medication in order to achieve a euphoric state. designed to be used only with 3 ml apokyn ® (apomorphine hydrochloride injection) cartridges for more information, call your specialty pharmacy provider or 1-877-7apokyn (727-6596). apokyn ® (apomorphine hydrochloride injection) apokyn pen - apokyn ® (apomorphine hydrochloride injection) is for under the skin (subcutaneous) injection only. - do not inject apokyn into a vein. - do not use the apokyn ® pen unless you and your care partner have been taught the right way to use it and both of you understand all of the instructions. - the apokyn pen is for use only with 3 ml apokyn ® (apomorphine hydrochloride injection) cartridges. - the apokyn pen is only for use by 1 patient and should not be shared. read first: important safety information - the apokyn pen is a medicine delivery device. it is very important that you or your care partner read this instructions for use and follow the instructions for using the apokyn pen correctly to receive the correct apokyn dose. - always perform a flow check (prime) before every injection and after loading a new cartridge. - the liquid in the apokyn cartridge can cause irritation if it gets on your skin or in your eyes. flush your eyes with cold water and wash the liquid off your skin right away if this happens. - the bd pen needle unit is sterile. avoid contaminating the needle after opening. do not place it on a surface or touch other items with the needle. - do not dial the dose or try to correct a dialing error with the pen needle in the skin. you could receive the wrong dose. - be careful when removing the needle. accidental needle sticks can transmit serious infections. never store or carry the apokyn pen with a pen needle attached. - air enter the cartridge - medicine leak out the apokyn pen should only be used with pen needles (29g × 1/2"). these needles are available through your specialty pharmacy provider or your local pharmacy. how to use the apokyn pen preparing (priming) the apokyn pen for use storage information –store apokyn cartridges at room temperature, 68°f to 77°f (20°c to 25°c) excursions permitted between 59 to 86°f (15 to 30°c) [see usp controlled room temperature] proper disposal - put your used needles and syringes in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have an fda-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out upright and stable during use leak-resistant properly labeled to warn of hazardous waste inside the container - made of a heavy-duty plastic - able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out - upright and stable during use - leak-resistant - properly labeled to warn of hazardous waste inside the container - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. care and storage the apokyn pen can now be stored in its carrying case. never store or carry the apokyn pen with a pen needle attached. you must store and care for your pen the right way: - avoid exposure to dust, moisture, and cold or hot temperatures. - never wash the pen in water or use strong disinfectants. only a clean, damp cloth should be used for cleaning. - do not try to repair the pen if it is damaged or if you cannot solve a problem shown in the following "troubleshooting" section. - do not use pen for more than 1 year after the first use or after the expiration date on the carton. for more information, call your specialty pharmacy provider or 1-877-7apokyn (727-6596). troubleshooting

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

cardinal health - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg