Marbocare 20 mg/ml solution for injection for cattle and pigs

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Marbofloxacin

可用日期:

Animalcare Limited

ATC代码:

QJ01MA93

INN（国际名称）:

Marbofloxacin

剂量:

20 milligram(s)/millilitre

药物剂型:

Solution for injection

处方类型:

POM: Prescription Only Medicine as defined in relevant national legislation

治疗组:

Cattle, Pigs

治疗领域:

marbofloxacin

疗效迹象:

Antibacterial

授权状态:

Authorised

授权日期:

2013-01-11

产品特点

Health Products Regulatory Authority
22 December 2017
CRN000VG6
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocare 20 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
EACH ML CONTAINS:
​
​
ACTIVE SUBSTANCE:
​
​
Marbofloxacin
​
20.0 mg
​
EXCIPIENTS
​
​
Metacresol
​
2.0 mg
​
Monothioglycerol
​
0.5 mg
​
Disodiumedetate
​
0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
- Cattle: pre-ruminants up to 100 kg b.w.
- Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pre-ruminant calves:
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella _
_multocida, Mannheimia haemolytica _and _Mycoplasma bovis_.
Pigs:
Treatment of respiratory infections caused by sensitive strains of
_Actinobacillus _
_pleuropneumoniae_, _Mycoplasma hyopneumoniae _and _Pasteurella
multocida._
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to marbofloxacin or
to any other
quinolone or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other
Health Products Regulatory Authority
22 December 2017
CRN000VG6
Page 2 of 6
fluoroquinolones (cross resistance).
Do not use in case of disturbance in growth of cartilage and/or during
injury of the
locomotion system particularly on functionally loaded joints.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when the
product is used. Fluoroquinolones should be reserved for the treatment
of clinical
conditions which have responded poorly, or are expected to respond
poorly, to other
classes of antimicrobials. Whenever possible, fluoroquinolones should
only be used
based on susceptibility testing. Use of the product deviating from the
instructions
given in the SPC may i