Amoxy Active CTD 697 mg/g Powder for Use in Drinking Water for Chickens, Turkeys and Ducks

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Amoxicillin

Dostopno od:

Dopharma Research B.V.

Koda artikla:

QJ01CA04

INN (mednarodno ime):

Amoxicillin

Farmacevtska oblika:

Powder for use in drinking water

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Chickens, Duck, Turkeys

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2019-02-14

Lastnosti izdelka

Unlimited renewal: July 2023
AN: 00743/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMOXY ACTIVE CTD 697 mg/g powder for use in drinking water for
chickens, turkeys
and ducks
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
_ACTIVE SUBSTANCE:_
Amoxicillin
697 mg
as amoxicillin trihydrate
800 mg
_EXCIPIENTS:_
For the full list of excipients, see section 6.1.
3.
PHARMAPEUTICAL FORM
Powder for use in drinking water.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broiler, pullet, breeder), turkeys, ducks (broiler,
breeder).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens, turkeys and ducks: treatment of infections caused by
bacteria
susceptible to amoxicillin.
4.3
CONTRAINDICATIONS
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other
small
herbivores.
Do not use in animals with known hypersensitivity to penicillins or
other
substances from the beta-lactam group or to any of the excipients.
Do not use in ruminants or horses.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Unlimited renewal: July 2023
AN: 00743/2023
Page 2 of 6
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
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.
Use of the product deviating from the instructions given in the
product literature
may increase the prevalence of bacteria resistant to the amoxicillin
and may
decrease the effectiveness of the treatment.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicillins may cause hypersensitivity (allergy) following injection