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

prasco laboratories - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - ibuprofen lysine is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. ibuprofen lysine is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infants with thrombocytopenia; - preterm infants with coagulation defects; - preterm infants with or who are suspected of having necrotizing enterocolitis; - preterm infants with significant impairment of renal function. safety and effectiveness have only been established in premature infants.

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

xgen pharmaceuticals djb, inc. - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - ibuprofen lysine injection is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. ibuprofen lysine injection is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infants with thrombocytopenia; - preterm infants with coagulation defects; - preterm infants with or who are suspected of having necrotizing enterocolitis; - preterm infants with significant impairment of renal function. safety and effectiveness have only been established in premature infants.

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

recordati rare diseases inc. - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - neoprofen is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. neoprofen is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infant

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle medical - ibuprofen lysine - capsule, soft - 200 milligram(s) - propionic acid derivatives; ibuprofen

Ireland - English - HPRA (Health Products Regulatory Authority)

chanelle medical - ibuprofen lysine - capsule, soft - 400 milligram(s) - propionic acid derivatives; ibuprofen

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

the boots company plc - ibuprofen lysine - oral tablet - 342mg

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

reckitt benckiser (healthcare) sa-nv - ibuprofen lysine 342 mg - eq. ibuprofen 200 mg - film-coated tablet - 200 mg - ibuprofen lysine 342 mg - ibuprofen

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - ibuprofen lysine - film coated tablet - 200 milligram - propionic acid derivatives

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd t/a gerard laboratories - ibuprofen lysine - film coated tablet - 400 milligram - propionic acid derivatives

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

viatris gx bv-srl - ibuprofen lysine 342 mg - eq. ibuprofen 200 mg - film-coated tablet - ibuprofen