NEOMARBOFLOX

Description

NEOMARBOFLOXACIN (CURRENTLY IN REGISTRATION PROCESS)

 

COMPOSITION:
Active substance
Marbofloxacin 100 miligrams

Excipients:
Monothioglycerol
Metacresol
Disodium edetate
Glucanolactone 
Water for injection

 

INDICATION

In cattle: Therapeutic treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni. It is also indicated in the treatment of acute E. coli mastitis.

In pigs: Indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms.

CONTRAINDICATION
Do not use in animals with known hypersensitivity to fluoroquinolones.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).

TARGET SPECIES
Cattle and pigs

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Cattle
For the treatment of acute E.coli mastite the recommended dosage is 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular, subcutaneous or intravenous routes during 3-5 days.
For the treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni:
2mg/kg/day (1ml/50kg)
or 8 mg/kg body weight i.e. 2 ml /25kg body weight in a single intramuscular injection
If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.

Swine
Treatment of Metritis Mastitis Agalactia syndrome caused by susceptible strains of organisms: 2mg/kg/day (1ml/50kg) in a single daily injection by intramuscular routes during 3 days.

ADVICE ON CORRECT ADMINISTRATION
To avoid excessive broaching of the septum, the use of a draw-off needle is recommended.

WITHDRAWAL PERIOD

Cattle
At dose of 2 mg/kg bw during 3 do 5 days (i.m., s.c., i.v.)
Meat: 6 days
Milk 36 hours
At dose of 8 mg/kg bw once (i.m.)
Meat: 3 days
Milk 72 hours

Pigs : 4 days

SPECIAL STORAGE PRECAUTIONS
Keep the bottle in the outer carton in order to protect from light.
Do not store above 25°C.
Keep out of the sight and reach of children.
Shelf life after first opening the container: 28 days.

SPECIAL WARNING(S)

Special warnings for each target species
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 the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.
For Animal Treatment Only
Official and local antimicrobial policies should be taken into account when the product is used.

Special precautions for use in animals
People with known hypersensitivity to fluoroquinolones should avoid using this product. Wash hands after use.

Use during pregnancy/ lactation
Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin. Safety of the product at 8 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use only accordingly to the benefit/risk assessment by the responsible veterinarian. Marbofloxacin may be used in pregnant and lactating cows and sows.

Overdose (symptoms, emergency procedures, antidotes), if necessary
No severe side-effects are to be expected at doses up to 3 or 5 times the recommended dose in cattle and pigs respectively. In particular, no lesions of the articular joints are encountered.

Incompatibilites
Do not mix with other medicinal products.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Nature and composition of packaging: Type II amber glass vials of 100 ml. The vials are closed with a bromobutyl stopper and an aluminum cap.

Conditions or restrictions regarding supply and use: On veterinary prescription only.

ATC-vet code: QJ01MA93