Ireland - English - HPRA (Health Products Regulatory Authority)

famy care europe ltd - levonorgestrel ethinylestradiol - coated tablets - 100/20 microgram

Ireland - English - HPRA (Health Products Regulatory Authority)

famy care europe ltd - levonorgestrel ethinylestradiol - coated tablets - 100/20 microgram

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

besins healthcare (uk) ltd - progesterone - vaginal capsule - 200mg

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

aries pharmaceuticals inc - rifamycin (unii: du69t8zzpa) (rifamycin - unii:du69t8zzpa) - aemcolo is indicated for the treatment of travelers' diarrhea (td) caused by non-invasive strains of escherichia coli in adults. limitations of use aemcolo is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of escherichia coli [see warnings and precautions (5), clinical studies (14)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of aemcolo and other antibacterial drugs, aemcolo should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial age

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

redhill biopharma ltd - rifamycin (unii: du69t8zzpa) (rifamycin - unii:du69t8zzpa) - aemcolo is indicated for the treatment of travelers' diarrhea (td) caused by non-invasive strains of escherichia coli in adults. limitations of use aemcolo is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of escherichia coli [see warnings and precautions (5), clinical studies (14)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of aemcolo and other antibacterial drugs, aemcolo should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. aemcolo is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents (e.g. rifaximin), or any of the components in aemcolo. risk summary there are no available data on aemcolo use in pregnant women to inform any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. systemic absorption of aemcolo in humans is negligible following oral administration of the recommended dose of aemcolo [see clinical pharmacology (12.3)] . due to the negligible systemic exposure, it is not expected that maternal use of aemcolo will result in fetal exposure to the drug. in animal reproduction studies, no malformations were observed in pregnant rats or rabbits at exposures 25,000 and 500 times (based on auc), respectively, the human exposure achieved with the recommended clinical dose of aemcolo. treatment of pregnant rats with aemcolo at more than 1,000 times the maximum plasma concentration (cmax ) and 25,000 times the systemic exposure (based on auc) during the period of organogenesis resulted in maternal toxicity, decreased fetal weight, and variations in diaphragm formation. similarly, treatment of pregnant rabbits with aemcolo at more than 10 times the maximum human plasma concentration (cmax ), resulted in maternal toxicity, decreased fetal weight, and slightly delayed fetal ossifications [see data] . all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. advise pregnant women of the potential risk to a fetus. animal data embryofetal toxicity studies in rats and rabbits did not show malformations up to the maximum tested doses of 855 and 85.5 mg/kg, (25,000 and 500 times greater plasma exposure based on auc), respectively, of rifamycin given orally during the period of organogenesis (gestational days 6-17/18). in rats, the high dose of 855 mg/kg/day caused reduction in maternal food consumption, reduced fetal weight and a higher number of fetuses with thin tendinous diaphragm. in rabbits, the high dose of 85.5 mg/kg/day caused a reduction in food consumption and bodyweight gain in pregnant dams, as well as reduced fetal weights and slight delay in ossification, including slightly higher incidences of fetuses with skull suture bone variations, enlarged skull fontanelle and incompletely ossified digit 5 medial phalanx of both forelimbs. no adverse fetal effects were observed in rats and rabbits administered lower doses of oral rifamycin. risk summary there is no information regarding the presence of aemcolo in human milk, the effects on the breastfed infant, or the effects on milk production. systemic absorption of aemcolo in humans is negligible following oral administration of the recommended dose of aemcolo; therefore, exposure to a breastfed infant through breastmilk is expected to be negligible [see clinical pharmacology (12.3)] . there are no animal lactation data following oral rifamycin administration. following single intravenous injection of rifamycin to lactating ewes, rifamycin has been shown to pass into milk.1 the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for aemcolo and any potential adverse effects on the breast-fed infant from aemcolo or from the underlying maternal condition. the safety and effectiveness of aemcolo has not been established in pediatric patients less than 18 years of age with travelers' diarrhea. clinical studies with aemcolo for travelers' diarrhea did not include sufficient numbers of patients aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. the pharmacokinetics of aemcolo in patients with impaired renal function has not been studied. given the minimal systemic exposure of rifamycin (taken as aemcolo) and minor role of renal excretion in elimination of rifamycin, renal impairment is not expected to have a clinically meaningful effect on rifamycin systemic exposure necessitating a dose adjustment. the pharmacokinetics of aemcolo in patients with impaired hepatic function has not been studied. given the minimal systemic exposure of rifamycin (taken as aemcolo) hepatic impairment is not expected to have a clinically meaningful effect on rifamycin systemic exposure necessitating a dose adjustment.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sanofi belgium sa-nv - rifamycin sodium - eq. rifamycin 50 mg/ml - solution for injection - 500 mg - rifamycin sodium - rifamycin

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - prednisolone - oral tablet - 25mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

alliance healthcare (distribution) ltd - dexamethasone - oral tablet - 2mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

phoenix healthcare distribution ltd - dexamethasone - oral tablet - 2mg