PARACETAMOL ALTAN

Intravenous use. The 100 ml bag is restricted to adults, adolescents and children weighing more than 33 kg (approximately 11 years of age). The 50 ml bag is adapted to term newborn infants, infants, toddlers and children weighing less than 33 kg.

2). ** Patients weighing less will require smaller volumes. The minimum interval between each administration must be at least 4 hours. No more than 4 doses to be given in 24 hours. The minimum interval between each administration in patients with severe renal insufficiency must be at least 6 hours.

*** Maximum daily dose: The maximum daily dose as presented in the table above is for patients that are not receiving other paracetamol containing products and should be adjusted accordingly taking such products into account. 2). 4).

Method of administration Take care when prescribing and administering PARACETAMOL ALTAN to avoid dosing errors due to confusion between milligram (mg) and milliliter (ml), which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed.

When writing prescriptions, include both the total dose in mg and the total dose in volume. The paracetamol solution is administered as an intravenous infusion. The paracetamol solution is administered slowly, with an infusion time that must never be less than 15 minutes.

Patients weighing ≤ 10 kg: • The plastic bag of Paracetamol ALTAN should not be hung as an infusion due to the small volume of the medicinal product to be administered in this population. 9% sodium chloride solution or 5% glucose solution and administered in 15-minute.

Use the diluted solution within the hour following its preparation (infusion time included). • A 5 or 10 ml syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume. 5ml per dose. • The user should be referred to the product information for dosing guidelines.

8 mm needle (21 gauge needle) and vertically perforate the stopper at the spot specifically indicated. As for all solutions for infusion presented in plastic bags, 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. 9% sodium chloride solution or 5% glucose solution (from one to nine volumes diluent). In this case, use the diluted solution within the hour following its preparation (infusion time included).

As with all products containing paracetamol, the adverse reactions are rare (≥1/10000, <1/1000) or very rare (<1/10000) and are listed below. Organ system Rare ≥1/10000, <1/1000 Very rare <1/10000 General Malaise Hypersensitivity reaction Cardiovascular Hypotension Liver Increased hepatic transaminase levels.

Platelet/blood Thrombocytopaenia, leucopenia, neutropenia, Frequent adverse reactions at injection site have been reported during clinical trials (pain and burning sensation). Very rare cases of hypersensitivity reactions ranging from simple skin rash or urticaria to anaphylactic shock have been reported and require discontinuation of treatment.

Cases of erythema, flushing, pruritus and tachycardia have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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2). It is recommended to use an oral analgesic treatment as soon as this route of administration is possible. To avoid the risk of overdose, check that other medicinal products administered do not contain paracetamol. Doses higher than those recommended carry a risk of very serious liver damage.

Clinical signs and symptoms of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) are usually seen after two days of drug administration with a peak seen usually after 4 - 6 days.

9). 2). 2). g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. 4 mg) sodium per 100 mL, which should be taken into account by patients on a low salt diet.

30 g glucose per 100 mL, which should be taken into consideration when treating patients with diabetes mellitus.

Paracetamol ALTAN is contraindicated in: - patients with hypersensitivity to paracetamol, propacetamol hydrochloride (product of paracetamol) or to any of the excipients. - cases of severe hepatocellular insufficiency.