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Dexketoprofen Trometamol

Ketofenax

Non-Steroidal Anti-Inflammatory / Antirheumatic Product (Propionic Acid Derivative)

CONTENTS:

  • Each ampoule of 2mL contains 50mg dexketoprofen (as dexketoprofen trometamol).

  • Each mL of the solution contains 25mg dexketoprofen (as dexketoprofen trometamol).​

  • Each mL of the solution contains 100mg ethanol (96%) and 0.08 mmol sodium.

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INDICATIONS:

​Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain.

PHP 2250 / box of 5 vials

DOSAGE:

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.

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Dexketoprofen Rompharm 50mg/2ml 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 2 days). Patients should be switched to an oral analgesic treatment when possible.

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Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

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In case of moderate to severe postoperative pain, Dexketoprofen Rompharm 50mg/2ml 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.

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Hepatic dysfunction

The dosage should be reduced to 50mg total daily dose in patients with mild to moderate (Child-Pugh score 5-9) hepatic impairment and hepatic function should be closely monitored. Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10-15).

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Renal dysfunction

The dosage should be reduced to 50mg total daily dose in patients with mildly impaired renal function (creatinine clearance 50-80ml /min). Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50ml/min).

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Elderly

No dosage adjustment is generally necessary in elderly 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 / min).

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Pediatric population 

The safety and efficacy of Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion have not been established and therefore should not be used in children and adolescents. 

CONTRAINDICATIONS:

​Dexketoprofen Rompharm 50mg/2ml solution for injection or concentrate for solution for infusion must not be administered in the following cases:

  • Hypersensitivity to the active substance or to any of the excipients

  • Patients in whom substances with a similar action (e.g. acetylsalicylic acid and other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.

  • Patients with active or suspended peptic ulcer/hemorrhage or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) or chronic dyspepsia.

  • Patients who have gastrointestinal bleeding or other active bleeding disorders

  • Patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy

  • Patients with Crohn’s disease or ulcerative colitis

  • Patients with severe heart failure

  • Patients with moderate to severe renal dysfunction (creatinine clearance <50 ml/min)

  • Patients with severely impaired hepatic function (Child-Pugh score 10-15)

  • Patients with hemorrhage diathesis and other coagulation disorders

  • During the third trimester of pregnancy and lactation period

  • For neuraxial (intrathecal or epidural) administration due to its ethanol content

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