Medicinal Products

DAFALGAN PEDIATRIC 3%

Generic drug of the therapeutic class: Analgesics
active ingredients: Paracetamol
laboratory: Bristol Myers Squibb

Drinkable solution
Bottle (+ dosage system graduated in kg) of 90 ml
All forms

Indication

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

Dosage DAFALGAN PEDIATRIC 3% Oral solution Bottle (+ measuring system graduated in kg) of 90 ml

Administration mode

Oral way.

The solution 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 4 to 32 kg (about 1 month to 12 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 dosing system is graduated in kg, with a weight of 4-6-8-10-12-14-16 kg. The other graduations correspond to intermediate weights 3-5-7-9-11-13-15 kg.

Fill the dosing system according to the weight of the child and adjust the level of liquid at the graduation.

· From 4 kg to 16 kg: use the dosing system up to the graduation corresponding to the weight of the child or to that closest to it.
For example, from 4 kg up to 5 kg: fill the dosing system up to 4 kg graduation. The plug is to be renewed if necessary after 6 hours.

· From 16 kg to 32 kg: first fill the dosing system and complete by filling the dosing system a second time until the weight of the child is reached.
For example, from 18 to 19 kg: first fill the dosing system up to the 10 kg graduation and then fill a second time up to the graduation 8 kg. The plug is to be renewed if necessary after 6 hours.

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.

Renal failure

In case of severe renal insufficiency (creatinine clearance less than 10 ml / min), the interval between two doses will be at least 8 hours.

Against indications

· Hypersensitivity to paracetamol or any of the other ingredients

· Hepatocellular insufficiency.

Adverse effects Dafalgan Pediatric

· 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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