MAXIGESIC IV SOLUTION FOR INFUSION 1000MG/300MG PER 100ML VIAL

4.1 Therapeutic indications

Maxigesic® IV is indicated in adults for the relief of moderate pain and the reduction of fever, where an intravenous route of administration is considered clinically necessary.

4.3 Contraindications

Maxigesic® IV is contraindicated:

• in patients with hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information;
• in patients with active alcoholism, as chronic excessive alcohol ingestion may predispose patients to paracetamol hepatoxicity (due to the paracetamol component);
• in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);
• for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);
• in patients with impaired kidney function, impaired liver function, heart problems or heart failure;
• in patients with active gastrointestinal bleeding, peptic ulceration or other stomach disorders;
• in patients with spinal cord injuries;
• during pregnancy or in patients planning to become pregnant;
• during breastfeeding.

It is recommended to use a suitable analgesic oral treatment as soon as this administration route is possible.

In order to avoid the risk of overdose, check that other medicines administered do not contain paracetamol.

Doses higher than the recommended entail a risk of very serious liver damage. Clinical symptoms and signs of liver damage are usually seen first after two days with a maximum usually after 4 to 6 days. Treatment with antidote should be given as soon as possible (see section 4.2).

4.2 Dose and method of administration

Dose

Administer one vial (100 mL) Maxigesic® IV as a 15-minute infusion every 6 hours, as necessary. Do not exceed a total daily dose of 4000 mg (4 g) paracetamol.

Special populations

Paediatric population

The safety and efficacy of Maxigesic® IV in children aged under 18 years have not been established.

Elderly

Clinical studies of Maxigesic® IV did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently to younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients are at increased risk for serious GI adverse events (see section 4.4, Gastrointestinal effects – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

Caution is also recommended in patients with pre-existing renal disease. No information is available from controlled clinical studies regarding the use of Maxigesic® IV in patients with advanced renal disease. If Maxigesic® IV therapy must be initiated in patients with advanced renal disease, closely monitor the patient’s renal function.

Hepatic impairment

The use of paracetamol at higher than recommended doses can lead to hepatotoxicity and even hepatic failure and death.

A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ibuprofen. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), Maxigesic® IV should be discontinued.

Adverse gastrointestinal events

To minimise the potential risk for an adverse GI event in patients treated with a NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected.

This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

Method of administration

Maxigesic® IV should be administered as a 15-minute intravenous infusion.

Visually inspect Maxigesic® IV for particulate matter and discolouration prior to administration, whenever solution and container permit. If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used.

Maxigesic® IV should be used in one patient on one occasion only. It contains no antimicrobial preservative. Unused solution should be discarded.

As for all solutions for infusion presented in glass vials, it should be remembered that close monitoring is needed notably at the end of the infusion, regardless of administration route. This monitoring at the end of the perfusion applies particularly for central route infusion, in order to avoid air embolism.

It is recommended that for the administration of Maxigesic® IV a syringe or giving set with a diameter equal to or below 0.8 mm should be used for solution sampling. In addition, it is recommended that the bung is pierced at the location specifically designed for needle introduction (where the thickness of the bung is the lowest). If these recommendations are not adhered to the likelihood of bung fragmentation or the bung being forced into the vial is increased.

To facilitate administration, the label attached to the vials of Maxigesic® IV allow for hanging.