European Union - English - EMA (European Medicines Agency)

plethora pharma solutions limited - lidocaine, prilocaine - premature ejaculation - anesthetics - senstend is indicated for the treatment of primary premature ejaculation in adult men.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - powder for injection - 1 mg - active: indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - powder for injection - 1 mg - active: indometacin sodium trihydrate 1.061mg equivalent to indomethacin 1 mg - indomethacin is indicated for the closure of patent ductus arteriosus in premature babies. clear-cut clinical evidence of a haemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin should only be used in a hospital under supervision of a specialist neonatologist.

Malta - English - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - solution for injection/infusion - dexamethasone sodium phosphate 4 mg/ml - corticosteroids for systemic use

Malta - English - Medicines Authority

medochemie limited 1-10 constantinoupleos street, 3011 limassol, cyprus - solution for injection/infusion - dexamethasone sodium phosphate 4 mg/ml - corticosteroids for systemic use

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

zydus pharmaceuticals usa inc. - indomethacin sodium (unii: 0imx38m2gg) (indomethacin - unii:xxe1cet956) - indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray. indomethacin for injection is contraindicated in: neonates with proven or suspected infection that is untreated; neonates who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; neonates with thrombocytopenia; neonates with coagulation defects; neonates with or who are suspected of having necrotizing enterocolitis; neonates with significant impairment of renal function; neonates with congenital heart disease in whom patency of the ductus arteriosus

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

pd-rx pharmaceuticals, inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l) - pentazocine 50 mg

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

keltman pharmaceuticals inc. - pentazocine hydrochloride (unii: a36bxo4ppx) (pentazocine - unii:rp4a60d26l), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - pentazocine hydrochloride 50 mg - pentazocine and naloxone hydrochlorides tablets are indicated for the relief of moderate to severe pain. pentazocine and naloxone hydrochlorides tablets are indicated for oral use only. pentazocine and naloxone hydrochlorides tablets should not be administered to patients who are hypersensitive to either pentazocine or naloxone. controlled substance. pentazocine and naloxone hydrochlorides tablets are a schedule iv controlled substance. there have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy. there have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse and rarely, in patients without such a history. abrupt discontinuance following the extended use of

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - hydrocortisone acetate 10.5%{relative} (includes 5 % excess) - foam - 10% w/w - active: hydrocortisone acetate 10.5%{relative} (includes 5 % excess) excipient: cetyl alcohol emulsifying wax methyl hydroxybenzoate polyoxyethylene stearyl ether propyl hydroxybenzoate propylene glycol purified water trolamine - colifoam rectal foam is indicated for topical treatment of inflammation occurring in the rectal mucosa, e.g. ulcerative colitis, proctosigmoiditis and granular proctitis.

Ireland - English - HPRA (Health Products Regulatory Authority)

mundipharma pharmaceuticals limited - prednisone - modified-release tablets - 1 milligram