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HSA Product

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

Product approved by Health Sciences Authority (SG)

Basic Information

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

INFUSION, SOLUTION

Regulatory Information

SIN16507P

June 3, 2022

Prescription Only

Therapeutic

INTRAVENOUS

August 10, 2023

June 3, 2025

XN02BE51

Company Information

APEX PHARMA MARKETING PTE. LTD.

APEX PHARMA MARKETING PTE. LTD.

Active Ingredients

Paracetamol

Strength: 1000mg/100ml

Detailed Information

Contraindications

**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).

Indication Information

**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.

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