Bioamoxi 50
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
05-01-2012
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Active ingredient:
amoxicillin trihydrate 500 mg
Available from:
Laboratoires Biove Arques
ATC code:
QJ01CA04
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
amoxicillin
Therapeutic area:
Chicken Broilers
Authorization date:
2010-01-19
Summary of Product characteristics
11604 BIOAMOXI
Final renewal SPC September 2008
SPC Bioamoxi
March 2008
p. 1 / 6
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
BIOAMOXI 500 mg/g powder for oral solution for chicken
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin as amoxicillin trihydrate .....500 mg
Excipient ................................................QS 1 g
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for oral solution.
_Fine, almost white, homogenous powder. _
4. CLINICAL PARTICULARS
_4.1. TARGET SPECIES _
Broiler chickens.
_ _
_ _
_4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _
_ _
In broiler chickens:
- At the group level where disease is present: prevention of clinical colibacillosis due to _Escherichia _
_coli_ susceptible to amoxicillin.
_4.3. CONTRAINDICATIONS _
Do not use in animals known for their susceptibility to penicillin or other substances of the
-lactam
group.
Do not use in lagomorphs such as rabbits, guinea-pigs, hamsters and gerbils.
Do not use in ruminants and horses.
Do not use in case of
-lactam-resistance in _Escherichia coli_.
_4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES _
See section 4.11.
_4.5. SPECIAL PRECAUTIONS FOR USE _
_4.5.I) SPECIAL PRECAUTION FOR USE IN ANIMALS: _
Penicillins and cephalosporins may cause hypersensitivity following administration. Allergic
reactions to these substances may occasionally be serious.
11604 BIOAMOXI
Final renewal SPC September 2008
SPC Bioamoxi
March 2008
p. 2 / 6
The use of BIOAMOXI should be based on susceptibility testing because of reported resistance
(up to 50 %) in _Escherichia
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