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

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)

Boleh didapati daripada:

Huvepharma NV

Kod ATC:

QJ01AA02

INN (Nama Antarabangsa):

DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)

Dos:

500 mg/g

Borang farmaseutikal:

Powder for use in drinking water

Jenis preskripsi:

POM

Kumpulan terapeutik:

Bovine, Fowl - Chicken, Fowl - Turkey

Kawasan terapeutik:

Doxycycline

Tanda-tanda terapeutik:

Antibiotics

Status kebenaran:

Authorised

Tarikh kebenaran:

2017-02-10

Ciri produk

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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__