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

hope pharmaceuticals pty ltd - sodium thiosulfate pentahydrate, quantity: 12.5 g - solution - excipient ingredients: water for injections; potassium chloride; boric acid; sodium hydroxide - hope pharmaceuticals sodium thiosulfate injection is indicated as an antidote in the treatment of cyanide poisoning. it is frequently used in conjunction with sodium nitrite.,sodium thiosulfate is also indicated to prevent sodium nitroprusside induced cyanide poisoning.

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

hope pharmaceuticals pty ltd - sodium nitrite, quantity: 300 mg - solution - excipient ingredients: water for injections - sodium nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

Malta - English - Medicines Authority

vale pharmaceuticals limited 3 anglesea street, clonmel, co. tipperary, e91 d6c5, ireland - clopidogrel - film-coated tablet - clopidogrel 75 mg - antithrombotic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

centrient pharmaceuticals netherlands b.v - amoxicillin (as trihydrate) - capsule, hard - 500 milligram(s) - penicillins with extended spectrum; amoxicillin

Ireland - English - HPRA (Health Products Regulatory Authority)

zaphyr pharmaceuticals ireland limited - anastrozole - film-coated tablet - 1 milligram(s) - aromatase inhibitors; anastrozole

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

cameron pharmaceuticals, llc - chlordiazepoxide hydrochloride (unii: mfm6k1xwdk) (chlordiazepoxide - unii:6rz6xez3cr), clidinium bromide (unii: 91zqw5jf1z) (clidinium - unii:bo76jf850n) - chlordiazepoxide hydrochloride 5 mg - chlordiazepoxide hcl/clidinium bromide is indicated to control emotional and somatic factors in gastrointestinal disorders. chlordiazepoxide hcl/clidinium bromide may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. chlordiazepoxide hcl/clidinium bromide is contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. it is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide. withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of chlordiazepoxide. the more severe withdrawal symptoms have usually been limited to tho

Ireland - English - HPRA (Health Products Regulatory Authority)

essential pharmaceuticals limited - clobazam - oral suspension - 1 milligram(s)/millilitre - clobazam

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

azurity pharmaceuticals, inc. (formerly arbor pharmaceuticals) - gabapentin enacarbil (unii: 75ocl1spbq) (gabapentin - unii:6cw7f3g59x) - gabapentin enacarbil 300 mg - horizant® is indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls) in adults. horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night. horizant is indicated for the management of postherpetic neuralgia (phn) in adults. none. risk summary there are no adequate data on the developmental risk associated with the use of horizant in pregnant women. in nonclinical studies in rats and rabbits, administration of gabapentin enacarbil was developmentally toxic when administered to pregnant animals at doses and gabapentin exposures greater than those used clinically [see data] . in the us 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when pregnant rats were administered gabapentin enacarbil (oral d

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

oceanside pharmaceuticals - primidone (unii: 13afd7670q) (primidone - unii:13afd7670q) - primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. it may control grand mal seizures refractory to other anticonvulsant therapy. primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see actions ).

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

alembic pharmaceuticals limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. additional pediatric use information is approved for novartis pharmaceuticals corporation’s jadenu® (deferasirox) tablets. however, due to novartis pharmaceuticals corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: • estimated gfr less than 40 ml/min/1.73 m2 [see dosage and administration (2.5), warnings and precautions (5.1)]; • poor performance status [see warnings and precautions (5.1, 5.3)]; • high-risk myelodysplastic syndromes (this patient population was not studied and is not expected to benefit from chelation therapy); • advanced malignancies [see warnings and precautions (5