Amoxy Active 697 mg/g Oral Powder for Pigs and Chickens

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

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下载 产品特点 (SPC)
10-01-2024

有效成分:

Amoxicillin

可用日期:

Dopharma Research B.V.

ATC代码:

QJ01CA04

INN(国际名称):

Amoxicillin

药物剂型:

Oral powder

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Chickens, Pigs

治疗领域:

Antimicrobial

授权状态:

Authorized

授权日期:

2014-06-27

产品特点

                                Revised: January 2024
AN: 01621/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxy Active, 697 mg/g, oral powder for pigs and chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin
697 mg
as amoxicilline trihydrate
800 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White to off-white oral powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and chickens (broilers, pullets, chickens for reproduction).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
Treatment of respiratory tract infections, gastro-intestinal tract
infections,
urogenital infections, secondary infections following viral infections
and septicaemia caused by micro-organisms susceptible to amoxicillin.
Chickens: Treatment of respiratory tract infections and
gastro-intestinal tract infections
caused by micro-organisms susceptible to amoxicillin.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to penicillin or other
substances of the beta-lactam
group or to any of the excipients.
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in lagomorphs and rodents such as guinea pigs, hamsters or
gerbils.
Do not use in animals with serious kidney malfunction including anuria
and oliguria.
Do not use in ruminants or horses.
Revised: January 2024
AN: 01621/2023
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Sick animals have an altered drinking behaviour and should be
medicated parenterally
where applicable.
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
veterinary medicinal product is used. Use of the veterinary medicinal
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 ta
                                
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