PERICOB Powder for solution for injection Ref.[115212] Active ingredients: Parecoxib

Posology

PERICOB 40 is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated. As the cardiovascular risk of PERICOB 40 may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. However, the relevance of these findings for the short-term use of PERICOB 40 in the post-operative setting has not been evaluated.

Safety and efficacy of PERICOB 40 have not been established for periods of use exceeding 96 hours.

Management of post-operative pain

The usual recommended dose is a single or initial 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. When given at the recommended doses for management of acute pain, the onset of analgesia was 7-14 minutes and reached a peak effect within 2 hours. After a single dose, the duration of analgesia was dose and clinical pain model dependent and ranged from 7 to greater than 24 hours.

Concomitant use with opioid analgesia

Opioid analgesia can be used concurrently with PERICOB 40 dosing as described in the paragraph above, for the management of post-operative pain for up to 48 hours. In a hip replacement surgery trial, the daily requirements for opioid were significantly reduced (20-40%) when co-administered with PERICOB 40. An optimal effect is achieved when PERICOB 40 is given at the end of hip replacement surgery, prior to opioid administration. In all clinical assessments PERICOB 40 was administered at a fixed time interval (i.e. 12 hourly), whereas the opioids were administered when needed (PRN basis).

Special populations

Elderly

Dosage adjustment in the elderly is not generally necessary, however, for elderly female patients weighing less than 50 kg, initiate treatment with half the usual recommended dose of PERICOB 40 and reduce the maximum daily dose to 40 mg.

Hepatic impairment

No dosage adjustment is generally necessary in patients with mild hepatic impairment (Child-Pugh scale 5-6). Introduce PERICOB 40 with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh scale 7-9) and reduce the maximum daily dose to 40 mg. There is no clinical experience in patients with severe hepatic impairment (Child-Pugh scale >9); therefore, its use is not recommended in these patients (see section 4.3).

Renal impairment

On the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate (creatinine clearance of 30-80 ml/min) renal impairment. In patients with severe (creatinine clearance <30 ml/min) renal impairment or patients who may be predisposed to fluid retention, PERICOB 40 should not be used (see section 4.3).

Children

PERICOB 40 has not been studied in patients under 18 years old. Therefore, its use is not recommended in these patients.

Method of administration

PERICOB 40 can be administered intravenously (IV) or intramuscularly (IM). The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle. For instructions on reconstitution of PERICOB 40 before administration and PERICOB 40 diluent incompatibilities, see sections 6.2 and 6.6.

Modes of administration other than IV or IM (e.g. intra-articular of intrathecal) have not been studies and should not be used.

Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib. In case of overdose, patients should be managed by symptomatic and supportive care. Valdecoxib is not removed by haemodialysis. Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.

36 months.

Chemical and physical in-use stability of the reconstituted solution, which should not be refrigerated or frozen, have been demonstrated for up to 24 hours at 25°C. Thus, 24 hours should be considered the maximum shelf life of the reconstituted product. However, due to the importance of microbiological infection risk for injectable medicines, the reconstituted solution should be used immediately unless reconstitution has taken place in controlled and validated aseptic conditions. Unless such requirements are met, in-storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 12 hours at 25°C.

Store at or below 30°C.

PERICOB 40 does not require any special storage conditions prior to reconstitution. For storage conditions of the reconstituted PERICOB 40 see section 6.3.

PERICOB 40 powder for solution for injection: 5 ml Type I glass vial with bromobutyl rubber stopper and an aluminium flip off seal.

Pack size: 10 × 5 ml vials.

For single use only. Any unused PERICOB 40 or waste material should be disposed of in accordance with local requirements.

Reconstitute PERICOB 40 with 2 ml sodium chloride solution (0,9% w/v) using aseptic technique. The only other acceptable solvents for reconstitution are 5% glucose intravenous infusion, 0,45% sodium chloride and 5% glucose injection. After reconstitution, PERICOB 40 should be inspected visually for particulate matter and discolouration prior to administration. The solution should not be used if discoloured or cloudy or if particulate matter is observed.