Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - felodipine; ramipril - modified-release tablet - 5mg ; 5mg

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - felodipine; ramipril - modified-release tablet - 2.5mg ; 2.5mg

Irlande - anglais - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - paracetamol; pseudoephedrine hydrochloride - tablet - 500/30 milligram(s) - anilides; paracetamol; sympathomimetics; pseudoephedrine

Australie - anglais - Department of Health (Therapeutic Goods Administration)

southern cross pharma pty ltd - ephedrine hydrochloride, quantity: 30 mg - injection, solution - excipient ingredients: water for injections - ephedrine hydrochloride injection is indicated in the treatment of hypotension secondary to spinal anaesthesia.

Malte - anglais - Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - cetirizine dihydrochloride, pseudoephedrine hydrochloride - prolonged-release tablet - cetirizine dihydrochloride 5 mg pseudoephedrine hydrochloride 120 mg - nasal preparations

Kenya - anglais - Pharmacy and Poisons Board

bayer consumer care ag peter merian strasse 84,4052 p.o. box 4002 - loratidine & pseudoephedrine sulphate - prolonged-release tablet - 5 mg & 120 mg - nasal decongestants for systemic use:

Jordanie - anglais - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع أدوية سليمان طنوس وأولاده - suleiman tannous & sons co. ltd - pseudoephedrine hcl 120 mg, cetirizine dihydrochloride 5 mg - 120 mg, 5 mg

Malte - anglais - Medicines Authority

glaxosmithkline consumer healthcare (ireland) limited 12, riverwalk, citywest business campus, dublin 24, ireland - ibuprofen, pseudoephedrine hydrochloride - coated tablet - ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg - antiinflammatory and antirheumatic products

Singapour - anglais - HSA (Health Sciences Authority)

organon singapore pte. ltd. - (ir layer) desloratadine, micronized; (sr layer) pseudoephedrine sulfate - tablet, delayed release - 2.5mg - (ir layer) desloratadine, micronized 2.5mg; (sr layer) pseudoephedrine sulfate 120.0mg

États-Unis - anglais - NLM (National Library of Medicine)

endo usa, inc. - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. none r isk summary limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. however, there are clinical considerations [see clinical considerations] . animal reproduction studies have not been conducted with ephedrine sulfate. 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. c linical considerations fetal/neonatal adverse reactions cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. these reports describe umbilical artery ph of ≤7.2 at the time of delivery [see clinical pharmacology 12.3] . monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible. r isk summary limited published literature reports that ephedrine is present in human milk. however, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ephedrine sulfate injection and any potential adverse effects on the breastfed child from ephedrine sulfate injection or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and 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. this drug 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. ephedrine and its metabolite are excreted in urine. in patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. monitor patients with renal impairment carefully after the initial bolus dose for adverse events.