Marbocyl 10 % Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1997-10-31

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 10 % Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Marbofloxacin
100 mg
Excipients:
m-Cresol
2.0 mg
Monothioglycerol
1.0 mg
Disodium Edetate
0.1 mg
Excipient Q.S.
1 ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow to green/brown solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Cattle
Marbofloxacin 10% injection is indicated in the treatment of
respiratory infections caused by susceptible strains of organisms. It
is also indicated in the treatment of acute _E.coli_ mastitis.
In Pigs
Marbofloxacin 10% injection is indicated in the treatment of Metritis
Mastitis Agalactia syndrome caused by susceptible strains
of organisms
4.3 CONTRAINDICATIONS
None known
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
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 increase the prevalence of bacteria resistant to
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the potential for cross
resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No severe side-effects to be expected at doses up to 3 to 5 times the
recomme