HYDRODOXX 500 MG/G POWDER FOR USE IN DRINKING WATER FOR CHICKENS AND PIGS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
31-01-2015
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Active ingredient:
DOXYCYCLINE HYCLATE
Available from:
Huvepharma NV
ATC code:
QJ01AA02
INN (International Name):
DOXYCYCLINE HYCLATE
Dosage:
500 mg/g
Pharmaceutical form:
Powder for Oral Solution
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
Doxycycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2009-05-15
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HydroDoxx 500 mg/g Powder for use in drinking water for chickens and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram contains:
Active substance:
Doxycycline (as doxycycline hyclate)
500 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
Yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers)
Pigs (Fattening pigs)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens (broilers) : Prevention and treatment of Chronic Respiratory Disease (CRD) caused by _Mycoplasma_
_gallisepticum _susceptible to doxycycline.
Fattening pigs: prevention and treatment of clinical respiratory infection caused by strains of _Pasteurella multocida_
susceptible to doxycycline.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not
possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the
target bacteria.
The presence of the clinical disease in the herd should be established before preventive treatment is started.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to other tetracyclines or to any excipient. Do not use in
animals with hepatic disorders.
Do not use in animals with renal disorders
See section 4.7.
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, animals should be treated parenterally.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 16/01/201
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