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

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

New Zealand - English - Medsafe (Medicines Safety Authority)

reckitt benckiser (new zealand) limited - ibuprofen lysine 342mg equivalent to 200 mg ibuprofen;   - film coated tablet - 342 mg - active: ibuprofen lysine 342mg equivalent to 200 mg ibuprofen   excipient: hypromellose magnesium stearate opacode black s-1-277001 opaspray white m-1-7111b povidone purified talc sodium starch glycolate

New Zealand - English - Medsafe (Medicines Safety Authority)

reckitt benckiser (new zealand) limited - ibuprofen lysine 342mg equivalent to 200 mg ibuprofen;   - film coated tablet - 342 mg - active: ibuprofen lysine 342mg equivalent to 200 mg ibuprofen   excipient: hypromellose magnesium stearate opacode black s-1-277001 opaspray white m-1-7111b povidone purified talc sodium starch glycolate

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

viatris bv-srl - ibuprofen lysine 342 mg - eq. ibuprofen 200 mg - capsule, soft - 200 mg - ibuprofen lysine 342 mg - ibuprofen

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

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

johnson & johnson consumer sa-nv - ibuprofen lysine 342 mg - eq. ibuprofen 200 mg - film-coated tablet - 200 mg - ibuprofen lysine 342 mg - ibuprofen

New Zealand - English - Medsafe (Medicines Safety Authority)

merck sharp & dohme (new zealand) limited - ibuprofen lysine 342mg equivalent to 200 mg ibuprofen - tablet - 200 mg - active: ibuprofen lysine 342mg equivalent to 200 mg ibuprofen excipient: hyprolose hypromellose magnesium stearate microcrystalline cellulose povidone purified water titanium dioxide

New Zealand - English - Medsafe (Medicines Safety Authority)

reckitt benckiser (new zealand) limited - ibuprofen lysine 342mg equivalent to 200 mg ibuprofen;   - film coated tablet - 200 mg - active: ibuprofen lysine 342mg equivalent to 200 mg ibuprofen   excipient: hypromellose magnesium stearate opacode black s-1-277001 opaspray white m-1-7111b povidone purified talc sodium starch glycolate - for the temporary relief of pain and/or inflammation associated with: headache, migraine headache, tension headache, muscular pain, cold & flu symptoms, period pain, dental pain, sinus pain, back pain, arthritic pain. reduces fever.