Malta - Inggris - Medicines Authority

ucb pharma sa 60 allee de la recherche, b-1070 brussels, belgium - cetirizine dihydrochloride, pseudoephedrine hydrochloride - prolonged-release tablet - cetirizine dihydrochloride 5 mg pseudoephedrine hydrochloride 120 mg - nasal preparations

Malta - Inggris - Medicines Authority

reckitt benckiser healthcare (uk) limited 103-105 bath road slough sl1 3uh, united kingdom - ibuprofen, pseudoephedrine hydrochloride - modified-release capsule - ibuprofen 300 mg pseudoephedrine hydrochloride 45 mg - antiinflammatory and antirheumatic products

Amerika Serikat - Inggris - 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.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

ucb, inc. - acrivastine (unii: a20f9xai7w) (acrivastine - unii:a20f9xai7w), pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - capsule - 8 mg - semprex-d capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. semprex-d capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see clinical pharmacology). the efficacy of semprex-d capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials. semprex-d capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold. semprex-d capsules are contraindicated in patients with a known sensitivity to acrivastine, other alkylamine antihistamines (e.g., triprolidine), pseudoephedrine, other sympathomimetic amines (e.g., phenylpropanolamine), or to any other components of the formulation. semprex-d capsules are contraindicated in patients with severe hypertension or severe coronary arter

Amerika Serikat - Inggris - NLM (National Library of Medicine)

nexus pharmaceuticals inc - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injectionn, usp is indicated in the treatment of allergic disorders, such as bronchial asthma the drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotensionn frequently ooccurs. in stokes-adams syndromeme with complete heart block, ephedrine has a value similar to that of epinephrine. it is indicated as a central nervous system stimulant in narcolepsy and depressive states. it is also used in myasthenia gravis. allergic reactions to ephedrine sulfate are rare. the hypersensitivity, if known, is a specific contraindication. patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate. prolonged abuse of ephedrine sulfate injection, usp can lead to symptoms of paranoid schizophrenia. when this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils. some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. t

Amerika Serikat - Inggris - NLM (National Library of Medicine)

akorn - ephedrine sulfate (unii: u6x61u5zeg) (ephedrine - unii:gn83c131xs) - ephedrine sulfate 50 mg in 1 ml - ephedrine sulfate injection, usp is indicated in the treatment of allergic disorders, such as bronchial asthma the drug has long been used as a pressor agent, particularly during spinal anesthesia when hypotension frequently occurs. in stokes-adams syndrome with complete heart block, ephedrine has a value similar to that of epinephrine. it is indicated as a central nervous system stimulant in narcolepsy and depressive states. it is also used in myasthenia gravis. allergic reactions to ephedrine sulfate are rare. the hypersensitivity, if known, is a specific contraindication. patients hypersensitive to other sympathomimetics may also be hypersensitive to ephedrine sulfate. prolonged abuse of ephedrine sulfate injection, usp can lead to symptoms of paranoid schizophrenia. when this occurs, patients exhibit such physical signs as tachycardia, poor nutrition and hygiene, fever, cold sweat and dilated pupils. some measure of tolerance may develop with prolonged or excessive use but addiction does not occur. tempor

Amerika Serikat - Inggris - NLM (National Library of Medicine)

sandoz 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 risk summary available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, there are clinical considerations due to underlying conditions (see clinical considerations ). in animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (mrhd) of 50 mg/day). no malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the mrhd, respectively [see data ]. the estimated

Malta - Inggris - Medicines Authority

glaxosmithkline consumer health-care uk trading limited 980 great west road, brentford, middlesex, tw8 9gs, united kingdom - pholcodine, paracetamol, pseudoephedrine hydrochloride - oral solution - pholcodine 10/30 mg/ml paracetamol 1000 mg pseudoephedrine hydrochloride 60/30 mg/ml - analgesics

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

sanofi-aventis healthcare pty ltd t/a sanofi consumer healthcare - pseudoephedrine hydrochloride, quantity: 120 mg; fexofenadine hydrochloride, quantity: 60 mg - tablet, modified release - excipient ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; pregelatinised maize starch; carnauba wax; colloidal anhydrous silica; stearic acid; macrogol 8000; hypromellose; macrogol 400 - for the relief of the symptoms of seasonal allergic rhinitis with nasal congestion when both the antiallergic properties of fexofenadine hydrochloride and the decongestant activity of pseudoephedrine hydrochloride are required.

Amerika Serikat - Inggris - NLM (National Library of Medicine)

cvs pharmacy, inc. - pseudoephedrine hydrochloride (unii: 6v9v2ryj8n) (pseudoephedrine - unii:7cuc9ddi9f) - purpose nasal decongestant - temporarily relieves sinus congestion and pressure  - temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies