न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - lenograstim 33.6 miu - powder for injection - 33.6 miu - active: lenograstim 33.6 miu excipient: arginine hydrochloric acid mannitol methionine phenylalanine polysorbate 20

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

apotheca inc. - phendimetrazine tartrate (unii: 6985ip0t80) (phendimetrazine - unii:ab2794w8kv) - phendimetrazine tartrate 35 mg - phendimetrazine tartrate tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m 2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. weight height (feet, inches) (pounds) 5'0" 5'3" 5'6" 5'9" 6'0" 6'3" 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31 phendimetrazine tartrate is indicated

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

mckesson corporation dba sky packaginng - valganciclovir hydrochloride (unii: 4p3t9qf9nz) (ganciclovir - unii:p9g3ckz4p5) - valganciclovir 450 mg - treatment of cytomegalovirus (cmv) retinitis:   valganciclovir tablets are indicated for the treatment of cmv retinitis in patients with acquired immunodeficiency syndrome (aids) [see clinical studies (14.1)] . prevention of cmv disease:   valganciclovir tablets are indicated for the prevention of cmv disease in kidney, heart, and kidney-pancreas transplant patients at high risk (donor cmv seropositive/recipient cmv seronegative [d+/r-]) [see clinical studies (14.1)] . prevention of cmv disease: valganciclovir tablets are indicated for the prevention of cmv disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see clinical studies (14.2)] . valganciclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation [see adverse reactions (6.1)].  risk summary after oral administration, valganciclovir (prodrug) is converted to ganciclovir (active drug) and, therefore, valganciclovir hydrochloride is expected to have reproductive toxicity effects similar to ganciclovir. in animal studies, ganciclovir caused maternal and fetal toxicity and embryo-fetal mortality in pregnant mice and rabbits as well as teratogenicity in rabbits at exposures two-times the human exposure. there are no available human data on use of valganciclovir hydrochloride or ganciclovir in pregnant women to establish the presence or absence of drug-associated risk. the background risk of major birth defects and miscarriage for the indicated populations is unknown. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and the risk of miscarriage is 15 to 20% of clinically recognized pregnancies. advise pregnant women of the potential risk to the fetus [see warnings and precautions (5.3), use in specific populations (8.3)]. clinical considerations disease-associated maternal and/or embryo/fetal risk most maternal cmv infections are asymptomatic or they may be associated with a self-limited mononucleosis-like syndrome. however, in immunocompromised patients (i.e., transplant patients or patients with aids) cmv infections may be symptomatic and may result in significant maternal morbidity and mortality. the transmission of cmv to the fetus is a result of maternal viremia and transplacental infection. perinatal infection can also occur from exposure of the neonate to cmv shedding in the genital tract. approximately 10% of children with congenital cmv infection are symptomatic at birth. mortality in these infants is about 10% and approximately 50 to 90% of symptomatic surviving newborns experience significant morbidity, including mental retardation, sensorineural hearing loss, microcephaly, seizures, and other medical problems. the risk of congenital cmv infection resulting from primary maternal cmv infection may be higher and of greater severity than that resulting from maternal reactivation of cmv infection. data animal data doses resulting in two-times the human exposure of ganciclovir (based on the human auc following a single intravenous infusion of 5 mg per kg of ganciclovir) resulted in maternal and embryo-fetal toxicity in pregnant mice and rabbits as well as teratogenicity in the rabbits. fetal resorptions were present in at least 85% of rabbits and mice. rabbits showed increased embryo-fetal mortality, growth retardation of the fetuses and structural abnormalities of multiple organs of the fetuses including the palate (cleft palate), eyes (anophthalmia/microphthalmia), brain (hydrocephalus), jaw (brachygnathia), kidneys and pancreas (aplastic organs). increased embryo-fetal mortality was also seen in mice. daily intravenous doses of approximately 1.7 times the human exposure (based on auc) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the male offspring, as well as pathologic changes in the nonglandular region of the stomach. data from an ex-vivo human placental model showed that ganciclovir crosses the human placenta. the transfer occurred by passive diffusion and was not saturable over a concentration range of 1 to 10 mg/ml. risk summary no data are available regarding the presence of valganciclovir (prodrug) or ganciclovir (active drug) in human milk, the effects on the breastfed infant, or the effects on milk production. animal data indicate that ganciclovir is excreted in the milk of lactating rats. the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. advise nursing mothers that breastfeeding is not recommended during treatment with valganciclovir hydrochloride because of the potential for serious adverse events in nursing infants and because of the potential for transmission of hiv [see boxed warning, warnings and precautions (5.1, 5.3, 5.4, 5.5), nonclinical toxicology (13.1)] . pregnancy testing females of reproductive potential should undergo pregnancy testing before initiation of valganciclovir hydrochloride [see use in specific populations (8.1)] . contraception females because of the mutagenic and teratogenic potential of valganciclovir hydrochloride, females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with valganciclovir hydrochloride [see dosage and administration (2.6), warnings and precautions (5.4, 5.5), nonclinical toxicology (13.1)] . males because of its mutagenic potential, males should be advised to use condoms during and for at least 90 days following, treatment with valganciclovir hydrochloride [see dosage and administration (2.6), warnings and precautions (5.3 , 5.5) , nonclinical toxicology (13.1) ] . infertility valganciclovir hydrochloride at the recommended doses may cause temporary or permanent female and male infertility [see warnings and precautions (5.3 ) , nonclinical toxicology (13.1) ] . data human data in a small, open-label, non-randomized clinical study, adult male renal transplant patients receiving valganciclovir hydrochloride for cmv prophylaxis for up to 200 days post-transplantation were compared to an untreated control group. patients were followed-up for six months after valganciclovir hydrochloride discontinuation. among 24 evaluable patients in the valganciclovir hydrochloride group, the mean sperm density at the end of treatment visit decreased by 11 million/ml from baseline; whereas, among 14 evaluable patients in the control group the mean sperm density increased by 33 million/ml. however, at the follow-up visit among 20 evaluable patients in the valganciclovir hydrochloride group the mean sperm density was comparable to that observed among 10 evaluable patients in the untreated control group (the mean sperm density at the end of follow-up visit increased by 41 million/ml from baseline in the valganciclovir hydrochloride group and by 43 million/ml in the untreated group). valganciclovir for oral solution and tablets are indicated for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age and in pediatric heart transplant patients 1 month to 16 years of age at risk for developing cmv disease [see indications and usage (1.2), dosage and administration (2.3)]. the use of valganciclovir for oral solution and tablets for the prevention of cmv disease in pediatric kidney transplant patients 4 months to 16 years of age is based on two single-arm, open-label, non-comparative studies in patients 4 months to 16 years of age. study 1 was a safety and pharmacokinetic study in pediatric solid organ transplant patients (kidney, liver, heart, and kidney/pancreas). valganciclovir hydrochloride was administered once daily within 10 days of transplantation for a maximum of 100 days post-transplantation. study 2 was a safety and tolerability study where valganciclovir hydrochloride was administered once daily within 10 days of transplantation for a maximum of 200 days post-transplantation in pediatric kidney transplant patients. the results of these studies were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1) , clinical pharmacology (12.3) , clinical studies (14.2) ] . the use of valganciclovir for oral solution and tablets for the prevention of cmv disease in pediatric heart transplant patients 1 month to 16 years of age is based on two studies (study 1 described above and study 3) and was supported by previous demonstration of efficacy in adult patients [see clinical pharmacology (12.3) , clinical studies (14.2) ] . study 3 was a pharmacokinetic and safety study of valganciclovir hydrochloride in pediatric heart transplant patients less than 4 months of age who received a single dose of valganciclovir oral solution on each of two consecutive days. a physiologically based pharmacokinetic (pbpk) model was developed based on the available pharmacokinetic data from pediatric and adult patients to support dosing in heart transplant patients less than 1 month of age. however, due to uncertainty in model predictions for neonates, valganciclovir hydrochloride is not indicated for prophylaxis in this age group. the safety and efficacy of valganciclovir for oral solution and tablets have not been established in children for prevention of cmv disease in pediatric liver transplant patients, in kidney transplant patients less than 4 months of age, in heart transplant patients less than 1 month of age, in pediatric aids patients with cmv retinitis, and in infants with congenital cmv infection. a pharmacokinetic and pharmacodynamic evaluation of valganciclovir for oral solution was performed in 24 neonates with congenital cmv infection involving the central nervous system. all patients were treated for 6 weeks with a combination of intravenous ganciclovir 6 mg per kg twice daily or valganciclovir for oral solution at doses ranging from 14 mg per kg to 20 mg per kg twice daily. the pharmacokinetic results showed that in infants greater than 7 days to 3 months of age, a dose of 16 mg per kg twice daily of valganciclovir for oral solution provided ganciclovir systemic exposures (median auc 0-12h = 23.6 [range 16.8 to 35.5] mcg ∙ h/ml; n = 6) comparable to those obtained in infants up to 3 months of age from a 6 mg per kg dose of intravenous ganciclovir twice daily (auc 0-12h = 25.3 [range 2.4 to 89.7] mcg ∙ h/ml; n = 18) or to the ganciclovir systemic exposures obtained in adults from a 900 mg dose of valganciclovir tablets twice daily. however, the efficacy and safety of intravenous ganciclovir and of valganciclovir have not been established for the treatment of congenital cmv infection in infants and no similar disease occurs in adults; therefore, efficacy cannot be extrapolated from intravenous ganciclovir use in adults. studies of valganciclovir for oral solution or tablets have not been conducted in adults older than 65 years of age. clinical studies of valganciclovir hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. valganciclovir hydrochloride is known to be substantially excreted by the kidneys, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because renal clearance decreases with age, valganciclovir hydrochloride should be administered with consideration of their renal status. renal function should be monitored and dosage adjustments should be made accordingly [see dosage and administration (2.5), warnings and precautions (5.2), use in specific populations (8.6), clinical pharmacology (12.3)] . dose reduction is recommended when administering valganciclovir hydrochloride to patients with renal impairment [see dosage and administration (2.5),  warnings and precautions (5.2),  clinical pharmacology (12.3)] . for adult patients on hemodialysis (crcl less than 10 ml/min), valganciclovir tablets should not be used. adult hemodialysis patients should use ganciclovir in accordance with the dose-reduction algorithm cited in the cytovene ® -iv complete product information section on dosage and administration: renal impairment [see  dosage and administration (2.5) and clinical pharmacology (12.3)]. the safety and efficacy of valganciclovir hydrochloride have not been studied in patients with hepatic impairment.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. pregnancy category b. there are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant women. oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. risk summary based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. animal data reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. it is not known whether oxybutynin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride extended-release tablets are administered to a nursing woman. the safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. patients were aged 6 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. study results demonstrated that administration of oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 ml to 136 ml, an increase from baseline in mean urine volume after morning awakening from 148 ml to 189 ml, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. urodynamic results were consistent with clinical results. administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 ml to 254 ml, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm h 2 o to 33 cm h 2 o , and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm h 2 o) from 60% to 28%. the pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see clinical pharmacology ( 12.3)] . oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6. the rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. the pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). there were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment. there were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

hanul trading co., ltd. - levomenthol (unii: bz1r15mtk7) (levomenthol - unii:bz1r15mtk7), camphor (synthetic) (unii: 5tjd82a1et) (camphor (synthetic) - unii:5tjd82a1et), diphenhydramine (unii: 8gts82s83m) (diphenhydramine - unii:8gts82s83m), .alpha.-tocopherol, dl- (unii: 7qwa1rio01) (.alpha.-tocopherol, dl- - unii:7qwa1rio01), methyl salicylate (unii: lav5u5022y) (salicylic acid - unii:o414pz4lpz), peppermint oil (unii: av092ku4jh) (peppermint - unii:v95r5kmy2b), nonivamide (unii: s846b891or) (nonivamide - unii:s846b891or) - levomenthol 2.769 mg in 0.2832 g - [purpose] topical analgesic [indications] anti-inflammatory effect to following symptoms: bruise, wrick, muscle pain, arthralgia, backache, shoulder pain, neuralgia, and rheumatic pain.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

hangzhou haorun technology co.,ltd. - benzalkonium chloride (unii: f5um2km3w7) (benzalkonium - unii:7n6jud5x6y) - benzalkonium chloride 0.13 g in 100 g - for hand washing to decrease bacteria on skin

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

ethypharm - fentanyl - sublingual tablet - 67 microgram(s) - phenylpiperidine derivatives; fentanyl

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

hospira, inc. - propofol (unii: yi7vu623sf) (propofol - unii:yi7vu623sf) - propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: limitations of use propofol injectable emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see pediatric use (8.4)] . safety, effectiveness and dosing guidelines for propofol injectable emulsion have not been established for mac sedation in the pediatric population; therefore, it is not recommended for this use [see pediatric use (8.4)] . propofol injectable emulsion is not indicated for use in pediatric icu sedation since the safety of this regimen has not been established [see pediatric use (8.4)] . propofol injectable emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of propofol injectable emulsion components. propofol injectable emulsion is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products. data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. there are reports of neonatal depression in infants exposed to propofol during delivery (see clinical considerations) . in animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. in pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (gestation day 7), offspring that were allowed to mate had increased post implantation losses. the pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block nmda receptors and/or potentiate gaba activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. there are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see data, warnings and precautions (5.3), and use in specific populations (8.4)] . the clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical 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 2–4% and 15–20%, respectively. clinical considerations fetal/neonatal adverse reactions propofol injectable emulsion crosses the placenta and may be associated with neonatal depression. monitor neonates for hypotonia and sedation following maternal exposure to propofol. pregnant rats were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.3, 0.65, and 1 times the human induction dose of 2.5 mg/kg based on body surface area) during organogenesis (gestational days 6–15). propofol did not cause adverse effects to the fetus at exposures up to 1 times the human induction dose despite evidence of maternal toxicity (decreased weight gain in all groups). pregnant rabbits were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.65, 1.3, 2 times the human induction dose of 2.5 mg/kg based on body surface area comparison) during organogenesis (gestation days 6–18). propofol treatment decreased total numbers of corpora lutea in all treatment groups but did not cause fetal malformations at any dose despite maternal toxicity (one maternal death from anesthesia-related respiratory depression in the high dose group). pregnant rats were administered propofol intravenously at 0, 10, and 15 mg/kg/day (0.65 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from late gestation through lactation (gestation day 16 to lactation day 22). decreased pup survival was noted at all doses in the presence of maternal toxicity (deaths from anesthesia- induced respiratory depression). this study did not evaluate neurobehavioral function including learning and memory in the pups. pregnant rats were administered propofol intravenously at 0, 10, or 15 mg/kg/day (0.3 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from 2 weeks prior to mating to gestational day 7. pup (f1) survival was decreased on day 15 and 22 of lactation at maternally toxic doses of 10 and 15 mg/kg/day. when f1 offspring were allowed to mate, postimplantation losses were increased in the 15 mg/kg/day treatment group. in a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on gestation day 122 increased neuronal apoptosis in the developing brain of the fetus. in other published studies, administration of either isoflurane or propofol for 5 hours on gestation day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. with respect to brain development, this time period corresponds to the third trimester of gestation in the human. the clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see warnings and precautions (5.3), pediatric use (8.4), and animal toxicology and/or pharmacology (13.2)] . risk summary based on data from published studies, propofol is present in human milk. variable concentrations have been reported in human milk with administration of propofol to nursing mothers in the early post-partum period. available data have not shown adverse reactions in breastfed infants. there are no data on the effects of propofol on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for propofol injectable emulsion and any potential adverse effects on the breastfed infant form propofol injectable emulsion or from the underlying maternal condition. the safety and effectiveness of propofol injectable emulsion have been established for induction of anesthesia in pediatric patients aged 3 years and older and for the maintenance of anesthesia aged 2 months and older. in pediatric patients, administration of fentanyl concomitantly with propofol injectable emulsion may result in serious bradycardia [see warnings and precautions (5.4)] . propofol injectable emulsion is not indicated for use in pediatric patients for icu sedation or for mac sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. there have been anecdotal reports of serious adverse events and death in pediatric patients with upper respiratory tract infections receiving propofol injectable emulsion for icu sedation. in one multicenter clinical trial of icu sedation in critically ill pediatric patients that excluded patients with upper respiratory tract infections, the incidence of mortality observed in patients who received propofol injectable emulsion (n=222) was 9%, while that for patients who received standard sedative agents (n=105) was 4%. while causality was not established in this study, propofol injectable emulsion is not indicated for icu sedation in pediatric patients until further studies have been performed to document its safety in that population [see clinical pharmacology (12.3) and dosage and administration (2.1 and 2.2)] . however, propofol infusions are routinely used to provide safe sedation to critically ill pediatric patients in icus. in pediatric patients, abrupt discontinuation of propofol injectable emulsion following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. increased incidences of bradycardia (5%), agitation (4%), and jitteriness (9%) have also been observed. published juvenile animal studies demonstrate that the administration of anesthetic and sedation drugs, such as propofol injectable emulsion, that either block nmda receptors or potentiate the activity of gaba during the period of rapid brain growth or synaptogenesis, results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately 3 years of age in humans. in primates, exposure to 3 hours of ketamine that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer of isoflurane increased neuronal cell loss. data from isoflurane-treated rodents and ketamine-treated primates suggest that the neuronal and oligodendrocyte cell losses are associated with prolonged cognitive deficits in learning and memory. the clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates, and young children who require procedures with the potential risks suggested by the nonclinical data [see warnings and precautions (5.3) , pregnancy (8.1), and animal toxicology and/or pharmacology (13.2)] . benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. the “gasping syndrome,” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth weight neonates. additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity. practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. the effect of age on induction dose requirements for propofol was assessed in an open-label study involving 211 unpremedicated patients with approximately 30 patients in each decade between the ages of 16 and 80. the average dose to induce anesthesia was calculated for patients up to 54 years of age and for patients 55 years of age or older. the average dose to induce anesthesia in patients up to 54 years of age was 1.99 mg/kg and in patients above 54 it was 1.66 mg/kg. subsequent clinical studies have demonstrated lower dosing requirements for subjects greater than 60 years of age. a lower induction dose and a slower maintenance rate of administration of propofol injectable emulsion should be used in elderly patients. in this group of patients, rapid (single or repeated) bolus administration should not be used in order to minimize undesirable cardiorespiratory depression. all dosing should be titrated according to patient condition and response [see dosage and administration (2) and clinical pharmacology (12.3)] . the long-term administration of propofol injectable emulsion to patients with hepatic insufficiency has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic hepatic cirrhosis compared to adults with normal hepatic function. the effects of acute hepatic failure on the pharmacokinetics of propofol have not been studied. the long-term administration of propofol injectable emulsion to patients with renal failure has not been evaluated. the pharmacokinetics of propofol do not appear to be different in people with chronic renal impairment compared to adults with normal renal function. the effects of acute renal failure on the pharmacokinetics of propofol have not been studied. there are reports of the abuse of propofol for recreational and other improper purposes, which have resulted in fatalities and other injuries. instances of self-administration of propofol injectable emulsion by health care professionals have also been reported, which have resulted in fatalities and other injuries. inventories of propofol injectable emulsion should be stored and managed to prevent the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting.

आयरलैंड - अंग्रेज़ी - HPRA (Health Products Regulatory Authority)

lexon (uk) ltd - triamcinolone acetonide - nasal spray, suspension - 55 microgram(s)/dose - triamcinolone

जॉर्डन - अंग्रेज़ी - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

الشركة المتحدة لصناعة الأدوية - united pharmaceutical manufacturing co. ltd. - amorolfine hcl 55.74 mg/ml - 55.74 mg/ml