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

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Doxycycline Hyclate

Disponible depuis:

Ceva Animal Health Ltd

Code ATC:

QJ01AA02

DCI (Dénomination commune internationale):

Doxycycline Hyclate

forme pharmaceutique:

Powder for use in drinking water

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Chickens, Pigs

Domaine thérapeutique:

Antimicrobial

Statut de autorisation:

Expired

Date de l'autorisation:

2011-09-06

Résumé des caractéristiques du produit

Revised: July 2016
AN: 01402/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxyval 500 mg/g powder for use in drinking water for pigs and
chickens
Sogedoxy 500 mg/g powder for use in drinking water for pigs and
chickens (CZ)
Doxyval Vet (DK)
Doxyval 433 mg/g powder for use in drinking water for pigs and
chickens (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per gram:
ACTIVE SUBSTANCE:
Doxycycline hyclate
500 mg
(equivalent to 433 mg doxycycline base)
EXCIPIENTS:
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Powder for use in drinking water
Yellow to pale yellow powder
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and chickens (broiler, pullet, breeder).
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 case of hypersensitivity to the active substance or to
any of excipients.
Do not use in animals with an impaired liver function.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES.
None.
Revised: July 2016
AN: 01402/2015
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due
to
likely
variability
(time,
geographical)
in
susceptibility
of
bacteria
for
doxycycline, especially susceptibility of _A. pleuropneumoniae _and
_O. rhinotracheale _
may differ from country to country and even farm to farm,
bacteriological sampling
and susceptibility testing are recommended. Use of the product should
be based on
culture and sensitivity of micro-organisms from diseased cases on