Generic medicinal product of the Ciblor Nourrisson
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
Powder for oral suspension
Box of 1 vial (+ syringe for oral administration) of 30 ml
They arise from the antibacterial activity and pharmacokinetic characteristics of this drug. They take into account both the clinical studies it has given and its place in the range of antibacterial products currently available.
They are limited to infections due to known sensitive organisms, especially in certain situations where the bacterial species responsible for the infection can be multiple and / or resistant to the currently available antibiotics.
This dosage is indicated for infants under 30 months of age in:
· Acute otitis media,
· Low respiratory infections,
· Urinary tract infections.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
Dosage AMOXICILLIN / AC CLAV BIOGAR N 100 mg / 12.5 mg / mL Powder for oral suspension Box of 1 vial (+ syringe for oral administration) of 30 ml
Dosages expressed as amoxicillin
80 mg / kg / day in three doses. The three doses are recommended in order to obtain sufficient serum concentrations during the nycthemeron.
This medicine is administered orally.
The administration is done with the graduated oral syringe in kg of body weight.
The dose per dose is indicated, based on the weight of the child, on the plunger of the graduated oral syringe in kg. The dose is therefore read directly on the graduations of the syringe for oral administration. Thus, the indicated weight corresponds to the dose for a catch.Three taken per day are necessary.
For example, graduation # 5 is the dose to be taken per dose for a child of 5 kg, three times a day.
Take the medicine preferably at the beginning of the meal.
This medicine MUST NEVER BE USED in case of:
· Allergy to beta-lactam antibiotics (penicillins, cephalosporins): take into account the risk of cross-allergy with cephalosporin antibiotics,
· Allergy to any component of the drug,
· History of liver injury associated with amoxicillin / clavulanic acid;
· Phenylketonuria, due to the presence of aspartame (E951).
This medicine is usually not recommended for use with methotrexate (see section 4.5 ).
Adverse effects Amoxicillin / AC Clav Biogar N
· Digestive manifestations: nausea, vomiting, possibility of gastrointestinal overinfections with Candida, diarrhea, loose stools, dyspepsia and abdominal pain. Some cases of pseudo-membranous colitis and haemorrhagic colitis have been reported.
· Allergic manifestations: including urticaria, eosinophilia, angioedema, respiratory discomfort, serum sickness, vasculitis, exceptionally anaphylactic shock.
· Maculopapular rash of allergic origin or not.
Very occasionally, some cases of Lyell's syndrome and Stevens-Johnson, erythema multiforme, and exfoliative dermatitis have been reported.
These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia.
Very rare cases of acute generalized exanthematous pustulosis (see Warnings and precautions for use ).
· Other events have been reported more rarely:
o Cases of hepatitis, usually cholestatic or mixed, have occasionally been reported. These cases seem to be more likely to occur in elderly and male patients, and for more than 10 days of treatment and especially for treatments longer than 15 days. Symptoms, including jaundice that appears consistent, occur during or at the end of treatment, but may occur a few weeks after stopping. Histopathological examination of the liver usually reveals centrilobular cholestasis. The evolution is generally favorable but can be prolonged by a few weeks.
Some extremely rare cases of fatal evolution have been observed.
o moderate and asymptomatic increases in ASAT, ALT or alkaline phosphatase;
o acute interstitial nephritis;
o leukopenia, neutropenia, agranulocytosis, hemolytic anemia, reversible thrombocytopenia.
· Cases of seizures have been reported exceptionally (see Warnings and Precautions section ).
· Very rare cases of superficial dental stains, usually reversible after brushing, have been reported with forms for oral suspension.