Medicinal Products

DOLIPRANE s / s 2.4%

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Sanofi-Aventis France

Oral suspension
Bottle (+ syringe for oral administration) of 100 ml
All forms

Indication

Symptomatic treatment of mild to moderate pain and / or febrile conditions.

Dosage DOLIPRANE s / s 2.4% Oral suspension Bottle (+ syringe for oral administration) of 100 ml

Administration mode

Oral way.

The suspension can be drunk pure or diluted in a small amount of drink (eg water, milk, fruit juice).

Dosage

This presentation is reserved for children from 3 to 26 kg (approximately from birth to 9 years).

In children, it is imperative to respect the dosages defined according to the weight of the child and therefore to choose a suitable presentation. Approximate ages by weight are given for information.

The recommended daily dose of paracetamol is approximately 60 mg / kg / day, to be divided into 4 or 6 doses, ie approximately 15 mg / kg every 6 hours.

The oral syringe, graduated per half kilogram, allows to administer 15 mg / kg / dose. The dose to be administered for a catch is thus obtained by pulling the piston up to the graduation corresponding to the weight of the child. This dose can be renewed if necessary after 6 hours, without exceeding 4 doses per day.

Examples:

· For a child weighing 3.5 kg, the dose per dose is from a syringe for oral administration filled up to 3.5 kg graduation.

· For a child weighing 13 kg, the dose per dose is from a filled oral syringe to the 13 kg graduation.

· For a 15 kg child, the dose per dose is from a filled oral syringe up to the 10 kg mark, and from a filled oral syringe to the 5 kg mark.

For information, a graduation kg corresponds to 0.625 ml of suspension.

The maximum graduation of "13 kg" corresponds to 8.13 ml of suspension, ie approximately 195 mg of paracetamol.

Maximum recommended doses: see section Warnings and precautions for use .

Frequency of administration

Systematic catches prevent pain or fever oscillations:

· In children, they should be regularly spaced, including at night, preferably 6 hours and at least 4 hours.

Renal failure

In cases of severe renal impairment (creatinine clearance less than 10 ml / min), the interval between two doses should be increased to at least 8 hours.

The lowest effective daily dose should be considered, not to exceed 60 mg / kg / day (not to exceed 3 g / day) in the following situations:

· Adults under 50 kg

· Mild to moderate hepatocellular insufficiency

· Chronic alcoholism

· Chronic malnutrition

· Dehydration

Against indications

· Hypersensitivity to paracetamol or any of the other ingredients

· Hepatocellular insufficiency,

Side effects Doliprane S / S

· Few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this drug and related drugs.

· Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.

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