GALLUDOXX 500 MG/G POWDER FOR USE IN DRINKING WATER/MILK REPLACER FOR CALVES, CHICKENS AND TURKEYS

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)

Fáanlegur frá:

Huvepharma NV

ATC númer:

QJ01AA02

INN (Alþjóðlegt nafn):

DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)

Skammtar:

500 mg/g

Lyfjaform:

Powder for use in drinking water

Gerð lyfseðils:

POM

Meðferðarhópur:

Bovine, Fowl - Chicken, Fowl - Turkey

Lækningarsvæði:

Doxycycline

Ábendingar:

Antibiotics

Leyfisstaða:

Authorised

Leyfisdagur:

2017-02-10

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GalluDoxx 500 mg/g powder for use in drinking water/milk replacer for
calves, chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Doxycycline hyclate 500 mg (equivalent to 433 mg doxycycline)
EXCIPIENT:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water/milk replacer.
Yellowish powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (pre-ruminant calves)
Chickens (broilers, breeders, replacement pullets) and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle (pre-ruminant calves)
For the treatment of:
- Pneumonia and shipping fever caused by_ Pasteurella_ spp and_
Mannheimia haemolytica_ infections.
Chickens (broilers, breeders, replacement pullets) and turkeys
For the treatment of:
- Ornithosis caused by_ Chlamydophila psittaci_ in turkeys;
- Colibacillosis caused by_ E. coli_ in chickens and turkeys;
- Chronic Respiratory Disease caused by_ Mycoplasma gallisepticum_ in
chickens and turkeys.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to tetracyclines or the
excipient.
Do not administer to animals with severe liver or kidney
insufficiency.
Do not use when tetracycline resistance has been detected in the
herd/flock due to the potential for cross resistance
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of medication by animals can be altered as a consequence of
illness. In case of insufficient uptake of
drinking water or medicated milk replacer, animals should be treated
parenterally. It is necessary to administer
medicated milk to calves on an individual basis.
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