Huvacillin 800 mg/g Powder for use in drinking water for chickens and pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Amoxicillin trihydrate

Dostopno od:

Huvepharma NV

Koda artikla:

QJ01CA04

INN (mednarodno ime):

Amoxicillin trihydrate

Farmacevtska oblika:

Powder for use in drinking water

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

amoxicillin

Datum dovoljenje:

2022-08-05

Lastnosti izdelka

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Huvacillin 800 mg/g Powder for use in drinking water for chickens and
pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram (g) contains:
ACTIVE SUBSTANCE:
Amoxicillin …………………………………697 mg
(equivalent to 800 mg of amoxicillin trihydrate).
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Sodium carbonate
Sodium citrate
Silica colloidal hydrated
Powder for use in drinking water.
White to slightly yellow powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens (for reproduction, broiler, pullet), pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In chickens:
Treatment of respiratory tract and gastrointestinal infections.
In pigs:
Treatment of respiratory tract, gastrointestinal and urogenital
infections, infections secondary to viral
diseases and septicaemia.
3.3
CONTRAINDICATIONS
Do not use in horses, rabbits, guinea pigs, hamsters, gerbils or any
other small herbivores given that
amoxicillin, as for all aminopenicillins, has a deleterious effect on
caecal bacteria.
Do not use in ruminants.
Do not use in animals with hypersensitivity to penicillins or other
ß-lactam antibiotics or to any of the
excipients.
Do not use in animals with renal disease including anuria or oliguria.
Do not use in the presence of ß-lactamase-producing bacteria, as the
veterinary medicinal product is
not effective against them.
3.4
SPECIAL WARNINGS
The uptake of medication by animals may be altered as a consequence of
illness. In case of insufficient
water/feed uptake, animals should be treated parenterally instead
using a suitable injectable veterinary
medicinal product prescribed by the veterinarian.
Cross-resistance has been shown between amoxicillin and other
penicillins, in particular amino-
penicillins in bacteria susceptible to amoxicillin. Use of the
veterinary medicinal product/amoxicillin
should be carefully considered when antimicrobial susceptibility
testing has shown resistance to
penicillins because its effectiveness may