Doxylin, 433 mg/g, Powder for Use in Drinking Water for Chickens and Turkeys

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Doxycycline

Available from:

Dopharma Research B.V.

ATC code:

QJ01AA02

INN (International Name):

Doxycycline

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Turkeys

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2015-05-29

Summary of Product characteristics

Revised: June 2020
AN: 01069/2019
PAGE 1 OF 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Doxylin, 433 mg/g, powder for use in drinking water for chickens and
turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram contains:
_ACTIVE SUBSTANCE:_
Doxycycline:
433.3 mg
(as doxycycline hyclate
500.0 mg)
_EXCIPIENTS_:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water.
Yellow, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers, broiler breeders) and turkeys (broilers,
breeders).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical respiratory infections associated with
_Mycoplasma _
_gallisepticum_ susceptible to doxycycline.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use when tetracycline resistance has been detected in the
herd/flock due
to the potential for cross resistance.
Do not use in animals with hepatic dysfunction.
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
Due to variability (time, geographical) in susceptibility of bacteria
for doxycycline,
bacteriological sampling and susceptibility testing of micro-organisms
from
diseased animals on farm are highly recommended.
Revised: June 2020
AN: 01069/2019
PAGE 2 OF 6
Use of the product deviating from the instructions given in the SPC
may increase
the prevalence of bacteria resistant to doxycycline and may decrease
effectiveness of treatment with tetracyclines due to the potential for
cross
resistance.
Use of the product should take into account official and local
antimicrobial
policies.
Avoid administration in oxidized drinking equipment.
As eradication of the target pathogens may not be achieved, medi