Medicinal Products

AMOXICILLIN / AC CLAV EG N 100 mg / 12.5 mg / mL

Generic medicinal product of the Ciblor Nourrisson
Therapeutic class: Infectiology - Parasitology
active ingredients: Amoxicillin, Clavulanic acid
laboratory: EG Labo

Powder for oral suspension
Box of 1 vial (+ syringe for oral administration) of 30 ml
All forms

Indication

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 EG 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

INFANTS

80 mg / kg / day in three doses. The three doses are recommended in order to obtain sufficient serum concentrations during the nycthemeron.

Administration mode

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 takes a day are needed.

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.

Against indications

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.

This medicine is usually not recommended for use with methotrexate (see section 4.5 ).

Adverse effects Amoxicillin / AC Clav EG N

Infections and infestations

Frequent:

Cutaneous and mucosal candidiasis.

Blood and lymphatic system disorders
Cases of eosinophilia have been reported.

Rare:

Leukopenia (neutropenia), agranulocytosis, thrombocytopenia and reversible haemolytic anemia.

Immune system disorders
Allergic manifestations including urticaria, angioedema, respiratory discomfort, very rare anaphylaxis (including anaphylactic shock), serum sickness, hypersensitivity vasculitis.

Nervous system disorders

Rare:

Vertigo, headache.

Very rare:

Convulsions.

Gastrointestinal disorders

Frequent:

Diarrhea, loose stools, nausea, vomiting.

Rare:

Dyspepsia and abdominal pain.

Very rare:

Pseudo-membranous colitis and hemorrhagic colitis.
Superficial dental stains, usually reversible after brushing, have been reported very rarely in children with oral suspension forms.

Hepatobiliary disorders

Rare:

Moderate and asymptomatic increase in ASAT, ALT or alkaline phosphatase.

Very rare:

Jaundice and / or cholestatic or mixed hepatitis.
These cases seem to occur more often in elderly and male patients and during prolonged treatment (more than 10 days and in particular for treatments longer than 15 days).
These effects occur during treatment, but in some cases may occur only several 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. Very rare cases of fatal evolution have been observed.

Skin and subcutaneous tissue disorders

Rare:

Rash, pruritus and urticaria.

Rare:

Erythema multiforme

Very rare:

Stevens-Johnson syndrome, Lyell's syndrome, bullous or exfoliative dermatitis, and generalized acute exanthematous pustulosis (see Warnings and Precautions for Special Warnings section). These skin manifestations may be more frequent and / or more intense in patients with infectious mononucleosis or evolving lymphoid leukemia.

Renal and urinary disorders

Cases of acute interstitial nephritis, crystalluria have been reported.

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