KERAL Solution for injection/infusion Ref.[110025] Active ingredients: Dexketoprofen

Posology

Adults

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. Keral solution for injection/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 (see section 4.4). In case of moderate to severe postoperative pain, Keral solution for injection/infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults (see section 5.1).

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 (see section 4.4).

Hepatic impairment

The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate (ChildPugh score 5-9) hepatic impairment and hepatic function should be closely monitored (see section 4.4). Keral solution for injection/infusion should not be used in patients with severe hepatic impairment (Child-Pugh score 10-15) (see section 4.3).

Renal impairment

The dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60–89 ml/min) (see section 4.4). Keral solution for injection/infusion should not be used in patients with moderate to severe renal impairment (creatinine clearance <59 ml/min) (see section 4.3).

Paediatric population

Keral has not been studied in children and adolescents. Therefore the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescents.

Method of administration

Keral solution for injection/infusion can be administered either by intramuscular or by intravenous route:

• Intramuscular use: the content of one ampoule (2 ml) of Keral solution for injection/infusion should be administered by slow injection deep into the muscle.
• Intravenous use:
  • Intravenous infusion: the diluted solution, prepared as described in section 6.6, 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 Keral solution for injection/infusion can be administered in a slow intravenous bolus over no less than 15 seconds.

Instructions on handling the product:

When Keral solution for injection/infusion is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the coloured ampoule (see also sections 6.2 and 6.6).

For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight (see also sections 6.3 and 6.6). For instructions on dilution of the medicinal product before administration, see section 6.6.

The symptomatology following overdose is not known. Similar medicinal products have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.

In case of accidental or excessive intake or administration, immediately institute symptomatic therapy according to the patient’s clinical condition.

Dexketoprofen trometamol may be removed by dialysis.

4 years.

After dilution according to directions given in Section 6.6., the diluted solution, provided it is adequately protected from natural daylight, has been shown to be chemically stable for 24 hours, when stored at 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Keep the ampoules in the outer carton in order to protect it from the light.

For storage conditions after dilution of the medicinal product, see section 6.3.

Type I glass coloured ampoules containing 2 ml of Solution for injection/infusion.

Packs containing: 1, 5, 6, 10, 20, 50 or 100 ampoules. Not all pack sizes may be marketed.

Keral solution for injection/infusion has shown to be compatible when mixed in small volumes (e.g. in a syringe) with injectable solutions of heparin, lidocaine, morphine and theophylline.

For administration as intravenous infusion the content of one ampoule (2 ml) of Keral solution for injection/infusion should be diluted in a volume of 30 to 100 ml of normal saline, glucose or Ringer lactate solution. The solution should be diluted aseptically and protected from natural daylight (see also section 6.3). The diluted solution is a clear solution.

Keral solution for injection/infusion, diluted in a volume of 100 ml of normal saline or glucose solution has shown to be compatible with the following medicinal products: dopamine, heparin, hydroxyzine, lidocaine, morphine, pethidine and theophylline.

No sorption of the active ingredient has been found when diluted solutions of Keral solution for injection/infusion have been stored in plastic bags or administration devices made of Ethyl Vinyl Acetate (EVA), Cellulose Propionate (CP), Low Density PolyEthylene (LDPE) and PolyVinyl Chloride (PVC).

Keral solution for injection/infusion is for single use only and any unused solution should be discarded. Prior to administration, the solution should be inspected visually to make sure it is clear and colourless: it should not be used if particulate matter is observed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.