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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Emdoka

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

marbofloxacin

Authorization status:

Authorised

Authorization date:

2013-01-11

Summary of Product characteristics

Health Products Regulatory Authority
14 September 2020
CRN009V48
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbodug 20 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
EACH ML CONTAINS:
​
​
ACTIVE SUBSTANCE:
​
​
Marbofloxacin
​
20.0 mg
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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
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.
Health Products Regulatory Authority
14 September 2020
CRN009V48
Page 2 of 4
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 in