DOXATIB 500 MG/G POWDER FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-09-2016
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Active ingredient:
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
Available from:
Krka, d.d., Novo mesto
ATC code:
QJ01AA02
INN (International Name):
DOXYCYCLINE HYCLATE (EQUIVALENT TO DOXYCYCLINE)
Dosage:
500 mg/g
Pharmaceutical form:
Powder for use in drinking water
Prescription type:
POM
Therapeutic group:
Fowl - Chicken, Porcine
Therapeutic area:
Doxycycline
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2016-09-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxatib 500 mg/g powder for use in drinking water for pigs and chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of powder contains:
ACTIVE SUBSTANCE:
Doxycycline hyclate 500 mg
(corresponding to 433 mg of doxycycline)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
Pale yellow to yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and chickens (broilers, pullets, broiler breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by _Actinobacillus_
_pleuropneumoniae, Pasteurella multocida _and _Mycoplasma hyopneumoniae _susceptible to doxycycline.
Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce
lesions due to Pasteurellosis caused by _Pasteurella multocida _or to reduce morbidity and lesions in respiratory
infections caused by _Ornithobacterium rhinotracheale _(ORT).
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to tetracyclines or to any of the excipients.
Do not use in animals with an impaired liver function.
Do not use in animals with renal disorders.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/09/2016_
_CRN 7021913_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in
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