COLMYC 25 mg/ml ORAL SOLUTION for calves

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

现在购买

产品特点 产品特点 (SPC)
12-06-2017
公众评估报告 公众评估报告 (PAR)
29-09-2023

有效成分:

Enrofloxacin

可用日期:

SP Veterinaria, S.A.

ATC代码:

QJ01MA90

INN(国际名称):

Enrofloxacin

剂量:

25 milligram(s)/millilitre

药物剂型:

Oral solution

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Cattle

治疗领域:

enrofloxacin

疗效迹象:

Antibacterial

授权状态:

Authorised

授权日期:

2010-09-30

产品特点

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
COLMYC 25 mg/ml ORAL SOLUTION for calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In calves:
-
treatment of respiratory infections due to_ Pasteurella multocida_
and_ Mannheimia haemolytica_
-
treatment of gastro-intestinal infection due to_ Escherichia coli_.
To be used where clinical experience and/or sensitivity testing
indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use in cases of confirmed, or suspected, resistance to
quinolones.
Do not
use in cases of
known hypersensitivity to the active substance,
to other
(fluoro)quinolones or
to any of
excipients.
Do not
use in case of disturbances in growth of cartilage and/or during
injury of locomotory system particularly on
functionally loaded joints or due to body weight loaded joints.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
25.0 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
14.0 mg
For the full list of excipients, see section 6.1.
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4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not use for prophylaxis.
Of
                                
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