Doxatib 500 mg/g Powder for Use in Drinking Water for Pigs and Chickens

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Doxycycline Hyclate

MAH:

Krka d.d., Novo Mesto

ATC_code:

QJ01AA02

INN:

Doxycycline Hyclate

pharmaceutical_form:

Powder for use in drinking water

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Chickens, Pigs

therapeutic_area:

Antimicrobial

authorization_status:

Authorized

authorization_date:

2016-09-08

SPC

Revised: September 2021
AN: 01652/2020 & 01663/2020
Page 1 of 7
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
Each 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.
Do not use when tetracycline resistance has been detected in the
herd/flock due to
the potential for cross resistance.
Revised: September 2021
AN: 01652/2020 & 01663/2020
Page 2 of 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.
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 the