Sør-Afrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

pharmacare limited û woodmead - tablet - see ingredients - each tablet contains sodium valproate 333,0 mg valproic acid 145,0 mg

Sør-Afrika - engelsk - South African Health Products Regulatory Authority (SAHPRA)

pharmacare limited û woodmead - tablet - see ingredients - each tablet contains sodium valproate 133,2 mg valproic acid 58,0 mg

USA - engelsk - NLM (National Library of Medicine)

northstar rxllc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride extended-release tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets are contraindicated in patients with: ·   severe renal impairment (egfr below 30 ml/minute/1.73 m2 ) [see warnings and precautions (5.1)] . ·   known hypersensitivity to metformin. ·   acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects w

USA - engelsk - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies (

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate is contraindicated in patients with bowel obstruction. sevelamer carbonate is contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. data animal data in pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, occurred in mid and

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

mylan health pty ltd - mesalazine -

USA - engelsk - NLM (National Library of Medicine)

cardinal health - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium extended-release tablets, usp are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical stud

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - busulfan 2mg (milled) - film coated tablet - 2 mg - active: busulfan 2mg (milled) excipient: lactose magnesium stearate opadry white oy-s-7322 pregelatinised maize starch purified water

Irland - engelsk - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - enrofloxacin - tablet - 15 mg/tablet - enrofloxacin - cats, dogs - antibacterial

Irland - engelsk - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - enrofloxacin - tablet - 150 mg/tablet - enrofloxacin - dogs - antibacterial