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DOLIMEX PERF is indicated for the short-term treatment of moderate pain, particularly in the post-operative period, and for the short-term treatment of fever, when the intravenous route is clinically justified by the urgency of treating pain or hyperthermia and/or when other routes of administration are not possible.

Intravenous route.
Dosage :
The dosage is calculated according to the patient’s weight (see table below).

Patient’s weight Dose per dose Volume per outlet Maximum volume of DOLIMEX PERF (10 mg/ml) per dose, based on upper group weight limits (ml) Maximum daily dose**.
≤ 10 kg*  7,5 mg/kg  0,75 ml/kg  7,5 ml  30 mg/kg 
> 10 kg à ≤ 33 kg  15 mg/kg  1,5 ml/kg  49,5 ml  60 mg/kg Without exceeding 2 g 
> 33 kg à £ 50 kg  15 mg/kg  1,5 ml/kg  75 ml  60 mg/kg Without exceeding3 g 
> 50 kg With additional risk factors for hepatotoxicity  1 g  100 ml  100 ml  3 g 
> 50 kg Without additional risk factors for hepatotoxicity  1 g  100 ml  100 ml  4 g 

* Premature neonates: there are no efficacy and safety data available in premature neonates (see section 5.2). 

** Maximum daily dose: The maximum daily dose presented in the table above is for patients not receiving other paracetamol-containing products and should be adjusted accordingly taking into account these products. 

*** Smaller patients should be given smaller volumes. 

The minimum interval between doses should be at least 4 hours.

The minimum dosing interval in patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be at least 6 hours.

Do not administer more than 4 doses in 24 hours.

In adult patients with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione stores) or dehydration, the maximum daily dose should not exceed 3 g (see section 4.4).

Method of administration

Take care when prescribing and administering DOLIMEX PERF 10 mg/ml, solution for infusion, to avoid errors in dosing due to confusion between milligrams (mg) and millilitres (ml), which could lead to accidental overdose and death. Ensure that the correct dose is communicated and administered. When prescribing, it is recommended that the dose in mg and the corresponding volume be indicated. Ensure that the dose is accurately measured and administered.

Paracetamol solution is given as a 15-minute intravenous infusion.

The paracetamol solution may be diluted in 0.9% sodium chloride solution or 5% glucose solution up to a factor of 10. In this case, the diluted solution should be used within 2 hours of its preparation (including the infusion time). However, from a microbiological point of view, the product must be used immediately.

Before administration, the product should be visually checked. Do not use DOLIMEX PERF if particles or yellowing are observed.

Patients ≤ 10kg:

– The bag of DOLIMEX PERF 10 mg/ml, solution for infusion should not be hung as an infusion due to the small volume of drug to be administered in this population.

– The volume to be administered should be drawn from the bag and may be administered as is, or diluted (in a volume of 1 to 9) in 0.9% sodium chloride solution or 5% glucose solution, and should be administered over 15 minutes.

– A 5 or 10 ml syringe should be used to measure the appropriate dose for the child’s weight and the desired volume. However, the volume should never exceed 7.5 ml per dose.

– The user should refer to the dosing recommendations in the summary of product characteristics.

This medicine should be administered by a healthcare professional.

Patients ≤ 10kg : 

– La poche de DOLIMEX PERF 10 mg/ml, solution pour perfusion ne doit pas être suspendue comme une perfusion étant donné le petit volume de médicament à administrer dans cette population. 

– Le volume à administrer doit être prélevé de la poche et peut être administré en l’état, ou dilué (dans un volume de 1 à 9) dans une solution de chlorure de sodium 0,9% ou une solution de glucose à 5%, et doit être administré en plus de 15 minutes. 

– Une seringue de 5 ou 10 ml doit être utilisée pour mesurer la dose appropriée au poids de l’enfant et le volume souhaité. Cependant, ce dernier ne doit jamais dépasser 7,5 ml par dose. 

– L’utilisateur doit se référer aux recommandations posologiques du résumé des caractéristiques du produit. 

Ce médicament doit être administré par un professionnel de santé.