Moxapulvis 500 mg/g Powder for Use in Drinking Water

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Amoxicillin

Tersedia dari:

VMD NV

Kode ATC:

QJ01CA04

INN (Nama Internasional):

Amoxicillin

Bentuk farmasi:

Powder for use in drinking water

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Chickens, Duck, Pigs, Turkeys

Area terapi:

Antimicrobial

Status otorisasi:

Authorized

Tanggal Otorisasi:

2018-03-13

Karakteristik produk

Unlimited renewal: April 2023
AN: 03899/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MOXAPULVIS 500 mg/g powder for use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate 574 mg
(equivalent to Amoxicillin 500 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water
Homogeneous, fine, white to creamy-white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens, ducks, turkeys, pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in chickens, turkeys and ducks caused by
bacteria
susceptible to amoxicillin.
Pigs: For the treatment of pasteurellosis caused by _Pasteurella
multocida_ susceptible
to amoxicillin.
4.3
CONTRAINDICATIONS
Do not use in rabbits, hamsters, gerbils and guinea pigs, or to birds
producing eggs
intended for human consumption.
Not effective against beta-lactamase producing organisms.
Do not use in known cases of hypersensitivity to penicillin or other
substances of the
beta-lactam group or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Pigs: The uptake of medication by animals can be altered as a
consequence of
illness. In case of insufficient uptake of water, animals should be
treated parenterally.
Unlimited renewal: April 2023
AN: 03899/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not effective against beta-lactamase producing organisms. 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 SPC
may increase the
prevalence of bacteria resis