Dalyx Dosage/Direction for Use

Posology: The recommended dose is 50 mg every 8-12 hours. If necessary, the administration can be repeated 6 hours apart. The total daily dose should not exceed 150 mg.
Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion is intended for short term use and the treatment must be limited to the acute symptomatic period (no more than two days). Patients should be switched to an oral analgesic treatment when possible.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
In case of moderate to severe postoperative pain, Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults.
Elderly: No dosage adjustment is generally necessary in older patients. However because of the physiological decline in renal function in elderly patients a lower dose is recommended in case of mild renal function impairment: 50 mg total daily dose.
Hepatic impairment: The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate (Child-Pugh score 5-9) hepatic impairment and hepatic function should be closely monitored. Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10-15).
Renal impairment: The dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 50-80 mL/min). Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min).
Pediatric population: Dalyx has not been studied in children and adolescent. Therefore the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescent.
Method of administration: Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion can be administered either by intramuscular or by intravenous route.
Intramuscular use: the content of one ampoule (2 mL) of Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion should be administered by slow injection deep into the muscle.
Intravenous use: Intravenous infusion: the diluted solution, prepared as described in Special precautions for disposal & other handling, should be administered as a slow intravenous infusion, lasting 10 to 30 min. The solution must be always protected from natural daylight.
Intravenous bolus: if necessary, the content of one ampoule (2 mL) of Dexketoprofen 50 mg/2 mL solution for injection or concentrate for solution for infusion can be administered in a slow intravenous bolus over no less than 15 seconds.
Instructions on handling the product: When Dalyx solution for injection/infusion is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the coloured ampoule. For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight.