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

etailer limited - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic, hand sanitizer decreases bacteria on skin. - in children less than 2 months of age - on open skin wounds - if you are allergic to any of the ingredients stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.

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

legacy biotechnologies inc. - eriodictyon (unii: 2y7tiq135h) (eriodictyon - unii:2y7tiq135h), eucalyptus globulus leaf (unii: s546ylw6e6) (eucalyptus globulus leaf - unii:s546ylw6e6), inula (unii: e55smd6da8) (inula - unii:e55smd6da8), sambucus nigra flower (unii: 07v4dx094t) (sambucus nigra flower - unii:07v4dx094t), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37), magnesium phosphate (unii: 453cof7817) (magnesium cation - unii:t6v3l - eriodictyon 3 [hp_x] - uses for relief of symptoms of chills, body aches and pains, fever, runny nose and cough associated with the flu.

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

ensobretados y derivados s.a. de c.v. - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic hand sanitizing to decrease bacteria on the skin.

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

stanvac prime private limited - alcohol (unii: 3k9958v90m) (alcohol - unii:3k9958v90m) - antiseptic hand sanitizer to help reduce bacteria that potentially can cause disease.

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

مستودع البتراء للمواد الطبية - petra drug store - gentamicin 300.000 iu/100ml - 300.000 iu/100ml

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

theramex australia pty ltd - estradiol hemihydrate, quantity: 1 mg; progesterone, quantity: 100 mg - capsule, soft - excipient ingredients: mono- and di- glycerides; gelatin; glycerol; purified water; lauroyl macrogolglycerides; hydrolysed gelatin; allura red ac; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400 - bijuva 1/100 is indicated for use during continuous combined hormone replacement therapy (hrt) for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses.

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - iopromide 623 mg/ml equivalent to iodine 300 mg/ml - solution for infusion - 300 mg/ml - active: iopromide 623 mg/ml equivalent to iodine 300 mg/ml excipient: hydrochloric acid as 10% solution sodium calcium edetate trometamol water for injection - for intravascular use and use in body cavities. contrast enhancement in computerised tomography (ct), arteriography and venography, intravenous/intra-arterial digital subtraction angiography (dsa), intravenous urography, use for ercp, arthrography and examination of other body cavities. ultravist 240: also for intrathecal use. ultravist 370: especially for angiocardiography. ultravist 300/370: not for intrathecal use.

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

mylan institutional llc - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 5 mg in 1 ml - levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy. levetiracetam in sodium chloride injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. levetiracetam in sodium chloride injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. levetiracetam in sodium chloride injection is contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.3)]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam, during pregnancy. encourage women who are taking levetiracetam injection during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see human data]. in animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see animal data]. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. levetiracetam blood levels may decrease during pregnancy [see warnings and precautions (5.8)]. physiological changes during pregnancy may affect levetiracetam concentration. decrease in levetiracetam plasma concentrations has been observed during pregnancy. this decrease is more pronounced during the third trimester. dose adjustments may be necessary to maintain clinical response. while available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. when levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (mrhd) of 3000 mg on a body surface area (mg/m2 ) basis. oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. the no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the mrhd on a mg/m2 basis. oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. there was no evidence of maternal toxicity. the no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the mrhd on a mg/m2 basis oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the mrhd on a mg/m2 basis). levetiracetam is excreted in human milk. there are no data on the effects of levetiracetam on the breastfed infant, or the effects on milk production. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for levetiracetam and any potential adverse effects on the breastfed infant from levetiracetam or from the underlying maternal condition. safety and effectiveness of levetiracetam injection in patients below the age of 16 years have not been established. there were 347 subjects in clinical studies of levetiracetam that were 65 years old and over. no overall differences in safety were observed between these subjects and younger subjects. there were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam in these patients. levetiracetam 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 [see clinical pharmacology (12.3)] . clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see clinical pharmacology (12.3)] . dosage adjustment is recommended for patients with impaired renal function and supplemental doses should be given to patients after dialysis [see dosage and administration (2.5)] .

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

bluepoint laboratories - metoprolol succinate (unii: th25pd4ccb) (metoprolol - unii:geb06nhm23) - metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.  many patients will require more than 1 drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.  the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hyper-tension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. metoprolol succinate extended-release tablets may be administered with other anti-hypertensive agents. metoprolol succinate extended-release tablets are indicated in the long-term treatment of angina pectoris, to reduce angina attacks and to improve exercise tolerance. metoprolol succinate extended-release tablets are indicated to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. metoprolol succinate extended-release tablets are contraindicated in severe bradycardia, second- or third-degree heart block, cardiogenic shock, decompensated heart failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. risk summary untreated hypertension and heart failure during pregnancy can lead to adverse outcomes for the mother and the fetus (see clinical considerations). available data from published observational studies have not demonstrated a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with metoprolol use during pregnancy. however, there are inconsistent reports of intrauterine growth restriction, preterm birth, and perinatal mortality with maternal use of beta blockers, including metoprolol, during pregnancy (see data). in animal reproduction studies, metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, approximately 24 times the daily dose of 200 mg in a 60-kg patient on a mg/m2 basis. 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. clinical consideration disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and postpartum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. there is a risk for preterm birth with pregnant women with chronic heart failure in 3rd trimester of pregnancy. fetal/neonatal adverse reactions metoprolol crosses the placenta. neonates born to mothers who are receiving metoprolol during pregnancy, may be at risk for hypotension, hypoglycemia, bradycardia, and respiratory depression. observe neonates and manage accordingly. data human data data from published observational studies did not demonstrate an association of major congenital malformations and use of metoprolol in pregnancy. the published literature has reported inconsistent findings of intrauterine growth retardation, preterm birth, and perinatal mortality with maternal use of metoprolol during pregnancy; however, these studies have methodological limitations hindering interpretation. methodological limitations include retrospective design, concomitant use of other medications, and other unadjusted confounders that may account for the study findings including the underlying disease in the mother. these observational studies cannot definitively establish or exclude any drug-associated risk during pregnancy. animal data metoprolol has been shown to increase post-implantation loss and decrease neonatal survival in rats at oral dosages of 500 mg/kg/day, i.e., 24 times, on a mg/m2 basis, the daily dose of 200 mg in a 60-kg patient. no fetal abnormalities were observed when pregnant rats received metoprolol orally up to a dose of 200 mg/kg/day, i.e., 10 times, the daily dose of 200 mg in a 60-kg patient. risk summary limited available data from published literature report that metoprolol is present in human milk. the estimated daily infant dose of metoprolol received from breastmilk ranges from 0.05 mg to less than 1 mg. the estimated relative infant dosage was 0.5% to 2% of the mother’s weight adjusted dosage (see data). no adverse reactions of metoprolol on the breastfed infant have been identified. there is no information regarding the effects of metoprolol on milk production. clinical consideration monitoring for adverse reactions monitor the breastfed infant for bradycardia and other symptoms of beta-blockade such as listlessness (hypoglycemia). data based on published case reports, the estimated infant daily dose of metoprolol received from breast milk range from 0.05 mg to less than 1 mg. the estimated relative infant dosage was 0.5% to 2% of the mother’s weight-adjusted dosage. in two women who were taking unspecifi ed amount of metoprolol, milk samples were taken after one dose of metoprolol. the estimated amount of metoprolol and alpha-hydroxy metoprolol in breast milk is reported to be less than 2% of the mother’s weight-adjusted dosage. in a small study, breast milk was collected every 2 to 3 hours over one dosage interval, in three mothers (at least 3 months postpartum) who took metoprolol of unspecified amount. the average amount of metoprolol present in breast milk was 71.5 mcg/day (range 17.0 to 158.7). the average relative infant dosage was 0.5% of the mother’s weight-adjusted dosage. risk summary based on the published literature, beta blockers (including metoprolol) may cause erectile dysfunction and inhibit sperm motility. no evidence of impaired fertility due to metoprolol was observed in rats [see nonclinical toxicology (13.1)]. one hundred forty-four hypertensive pediatric patients aged 6 to 16 years were randomized to placebo or to one of three dose levels of metoprolol succinate extended-release tablets. (0.2, 1.0 or 2.0 mg/kg once daily) and followed for 4 weeks. the study did not meet its primary endpoint (dose response for reduction in sbp). some pre-specified secondary endpoints demonstrated effectiveness including: - dose-response for reduction in dbp, - 1.0 mg/kg vs. placebo for change in sbp, and - 2.0 mg/kg vs. placebo for change in sbp and dbp. the mean placebo corrected reductions in sbp ranged from 3 to 6 mmhg, and dbp from 1 to 5 mmhg. mean reduction in heart rate ranged from 5 to 7 bpm but considerably greater reductions were seen in some individuals [see dosage and administration (2.1)] . no clinically relevant differences in the adverse event profile were observed for pediatric patients aged 6 to 16 years as compared with adult patients. safety and effectiveness of metoprolol succinate extended-release tablets have not been established in patients < 6 years of age. clinical studies of metoprolol succinate extended-release tablets in hypertension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience in hypertensive patients has not identified differences in responses between elderly and younger patients. of the 1,990 patients with heart failure randomized to metoprolol succinate extended-release tablets in the merit-hf trial, 50% (990) were 65 years of age and older and 12% (238) were 75 years of age and older. there were no notable differences in efficacy or the rate of adverse reactions between older and younger patients. in general, use a low initial starting dose in elderly patients given their greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. no studies have been performed with metoprolol succinate extended-release tablets in patients with hepatic impairment. because metoprolol succinate extended-release tablets is metabolized by the liver, metoprolol blood levels are likely to increase substantially with poor hepatic function. therefore, initiate therapy at doses lower than those recommended for a given indication; and increase doses gradually in patients with impaired hepatic function. the systemic availability and half-life of metoprolol in patients with renal failure do not differ to a clinically significant degree from those in normal subjects. no reduction in dosage is needed in patients with chronic renal failure [see clinical pharmacology (12.3)] .

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

aft pharmaceuticals pty ltd - paracetamol, quantity: 1000 mg; ibuprofen sodium dihydrate, quantity: 385 mg (equivalent: ibuprofen, qty 300 mg) - injection, intravenous infusion - excipient ingredients: mannitol; dibasic sodium phosphate dihydrate; cysteine hydrochloride monohydrate; hydrochloric acid; sodium hydroxide; water for injections - maxigesic iv is indicated in adults for the relief of mild to moderate pain and the reduction of fever, where an intravenous route of administration is considered clinically necessary.