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M-Amoxicilline - Vial IP 1g



Leaflet;indication

FORM AND PRESENTATION :
Micro crystalline white powder for injection.
7ml sealed vial.

COMPOSITION FOR ONE VIAL :
Amoxicillin (INN)      1g
(As amoxicillin sodium BP)

PROPERTIES:
Bacterial antibiotic of the betalactamine family.
Activity linked to inhibition of protein synthesis of microbial wall cells.
Active on Streptococcus, Gonococcus, Colibacille, Shigelle, Samonelle, Hemophylus.

INDICATIONS:
Respiratory, ENT (Ear,Nose and Throat) or stomatologic infections.
Endocardite, meningitis and septicemy.
Kidney, urogenital or gynecologic infections.
Lime disease treatment in primary phase.
Prophylaxy of bacterial endocardite.

DOSAGE :
Intramuscular route :
Adult : 2g/day, or one injection of 1g two times per day.
Child and infant : 50mg per kg of weight per day in two injections per day.
Intraveinous route :
Adult : 2 to  12g/day.
Child and Infant (1 month to 15 years of age) : 100mg to 200mg per kg of weight per day.
Newborn (0 to 1 month) :
Premature 0 to 7day: 100mg/Kg of weight /day Direct  IV route 7 to  30 day 100mg to 150mg/Kg of weight/day min.
New born  0 to 7day: 100mg to 150mg/Kg of weight/day 3 to 4 full term pregnancy  7 to 30 days: 100mg to 200mg/Kg of weight/day min.Lime disease :
Adult : Strictly isolated chronic migrant erythem : 4g per day, however the dose may be adjusted to up to 6g perday in case there is  a suspicion of Borrelia burgdorferi.
Children : Strictly isolated chronic migrant erythem: 50mg per Kg of weight per day, however the dose may be adjusted to up to 100mg per Kg of weight perday in case there is a suspicion of Borrelia burgdorferi.
The treatment should last from 15 to 21 days.

Prophylaxy of  bacterial endocardite :
Adult : 2g in  IV (perf. of 30 min.) within the hour which precedes the risk, followed by an injection of 1g 6 hours later.
Children : 50mg/ Kg of weight/day in IV (perf. of 30 min.) within the hour which precedes the risk, followed by a treatment per os of M-Amoxicillin sirup, of 25mg per Kg 6 hours later.

METHOD OF ADMINISTRATION :
Intramuscular route : Do not inject more than 1 g of amoxicillin at a time for the adult and more that 25mg per kg of weight at a time for the child.

Intraveinous route : This medicine may be administered either in :
Direct IV Injection, slow IV injection over 3 to 4 min :
- For the adult : do not inject more than 1 g of amoxicillin at a time, diluted in 20 ml of water for injection.
- For the child, the infant and the newborn : do not inject more than 25 mg per kg of weight at time.

Discontinued quick perfusion, 30 to 60 min :
- For the adult : do not inject more than 2 g of amoxicillin at a time,
- For the child and the newborn : do not inject more than 50 mg/kg of weight at a time.

CONTRAINDICATION :
Allergy to penicillins and to cephalosporins.
Infectious mononucleose.

INTERACTIONS :
Avoid association with methotrexate or allopurinol : risk of cutaneous accidents.

PRECAUTIONS AND WARNINGS :
Before any treatment, confirm the absence of allergy to penicillins and to cephalosporins.

ADVERSE EFFECTS :
Allergic accidents.