New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - iopromide 498.72 mg/ml equivalent to 240 mg iodine - solution for infusion - 240 mg/ml - active: iopromide 498.72 mg/ml equivalent to 240 mg iodine excipient: hydrochloric acid as 10% solution sodium calcium edetate, hydrate 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)

denton pharma, inc. dba northwind pharmaceuticals - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram hbr is indicated for the treatment of depression. the efficacy of citalopram hbr in the treatment of depression was established in 4-6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.the antidepressant action of citalopram in hospitalized depressed patients has not been adequately studied. the efficacy of citalo

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

proficient rx lp - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: pregnancy category b there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine tablets not be initiated during pregnancy. oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12× to 23× the maximum recommended human dose (mrhd), in rabbits and rats, respectively, based on body surface area (bsa) comparisons] and have revealed no evidence of impaired

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

rising health, llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 1 mg - warfarin sodium tablets are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - pregnancy warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembo

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

rebel distributors - tizanidine hydrochloride (unii: b53e3nmy5c) (tizanidine - unii:6ai06c00gw) - tizanidine 2 mg - tizanidine is a short-acting drug for the management of spasticity. because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see dosage and administration ). tizanidine is contraindicated in patients with known hypersensitivity to tizanidine hydrochloride or its ingredients. geriatric use tizanidine should be used with caution in elderly patients because clearance is decreased four-fold. pediatric use there are no adequate and well-controlled studies to document the safety and efficacy of tizanidine in children. abuse potential was not evaluated in human studies. rats were able to distinguish tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam, or phenobarbital to tizanidine. monkeys were shown to self-administer tizanidine in a dose-dependent manner, and abrupt cessation of tizanidine produced transie

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

sciegen pharmaceuticals inc - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson’s disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexo

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

proficient rx lp - clindamycin hydrochloride (unii: t20oq1yn1w) (clindamycin - unii:3u02el437c) - clindamycin 300 mg - clindamycin hydrochloride capsules, usp are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.   clindamycin hydrochloride capsules, usp are also indicated in the treatment of seri‑ous infections due to susceptible strains of streptococci, pneumococci, and staphylococci. its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. because of the risk of colitis, as described in the warning box, before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).   anaerobes: serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastroin‑testinal tract);

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

pd-rx pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin tablets are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic

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

avkare, inc. - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 50 mg

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

biocomp pharma, inc. - ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), iron pentacarbonyl (unii: 6wq62taq6z) (ferrous cation - unii:gw89581owr), docusate sodium (unii: f05q2t2ja0) (docusate - unii:m7p27195ag), ferrous gluconate (unii: u1b11i423z) (ferrous cation - unii:gw89581owr), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - ascorbic acid 138 mg - bioferr™ 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. these include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, post-surgical convalescence, and dietary needs. hypersensitivity to any of the ingredients. hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.