Amoxival 500 mg/g oral powder for pigs and chickens

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Amoxicillin (as amoxicillin trihydrate)

Διαθέσιμο από:

Ceva Santé Animale

Φαρμακολογική κατηγορία (ATC):

QJ01CA04

INN (Διεθνής Όνομα):

Amoxicillin (as amoxicillin trihydrate)

Δοσολογία:

500 milligram(s)/gram

Φαρμακοτεχνική μορφή:

Oral powder

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Chickens, Other Birds, Pigs

Θεραπευτική περιοχή:

amoxicillin

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-04-22

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxival 500 mg/g oral powder for pigs and chickens.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains
ACTIVE SUBSTANCE:
Amoxicillin.......................................................
500.00 mg
(as amoxicillin trihydrate 574.00 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral powder.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (pigs after weaning) and chickens (broilers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs (after weaning):
Treatment of swine pleuropneumonia due to_ Actinobacillus
pleuropneumoniae_ (susceptible to amoxicillin).
Broiler chickens:
Prevention at the group level, when disease is present, of respiratory
infections caused by_ Escherichia coli_ (susceptible
to amoxicillin).
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or
other substances of the ß-lactam group.
Do not use in animals with serious kidney malfunction including anuria
and oliguria.
Do not use in presence of
- lactamase producing bacteria.
Do not use in lagomorphs and rodents such as rabbits, guinea pigs,
hamsters or gerbils.
Do not use in ruminants or horses.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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