Each ml contains:

Marbofloxacin 100.0 mg

For the full list of excipients, see Pharmaceutical particulars.

Solution for injection. Clear yellow solution.

Cattle and pigs (sows).

Cattle:

Therapeutic treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, Mannheimia haemolytica and Histophilus somni.

Therapeutic treatment of acute mastitis caused by E. coli strains sensitive to marbofloxacin during the lactation period.

Sows:
Treatment of Metritis Mastitis Agalactia Syndrome caused by bacterial strains sensitive to marbofloxacin.

Do not use in case of known hypersensitivity to the active substance or other (fluoro)quinolones or to any of the excipients.

Do not use in case of confirmed or suspected resistance to fluoroquinolones (cross resistance).

None.

Use of the product should be based on susceptibility testing and has to take into account official and local antimicrobial policies.

It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics.

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.

As the vial cannot be broached more than 45 times, the user should choose the most appropriate vial size according to the target species to treat.
For the injections, the neck should be preferred in cattle and pigs.

People with known hypersensitivity to (fluoro)quinolones should avoid any contact with the product.

If the product comes into contact with the skin or eyes, rinse with copious amounts of water.

Take care to avoid accidental self-injection since it can induce a slight irritation.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician.

Wash hands after use.

Administration by the intramuscular route may cause in cattle transient local reactions such as pain at the injection site and slight muscular inflammatory lesions (resulting in fibrosis). The process of cicatrisation starts rapidly (varying from fibrosis to synthesis of extracellular matrice and collagen) and may persist for at least 15 days after injection.

Administration by the subcutaneous route may induce slight to moderate oedema at the injection site. A moderate pain on palpation of the injection site occurred in some animals.

In pigs, administration by the intramuscular route may induce very transient slight oedema and mild inflammatory lesions at the injection site persisting for 12 days after injection.

Studies in laboratory animals (rats, rabbits) did not show any evidence of a teratogenic, embryotoxic or maternotoxic effect associated with the use of marbofloxacin.

Safety of the product at 2 mg/kg has been shown in cows during gestation and in suckling pigs and calves when used in sows and cows.

Safety of the product at 8 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows. Use therefore according to the benefit/risk assessment carried out by the responsible veterinarian.

None known.

Cattle:

Intramuscular use:- Respiratory infections: The recommended dosage is 8 mg/kg bodyweight i.e. 2 ml/25 kg bodyweight in a single injection.
If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.

Subcutaneous use:- Acute mastitis: The recommended dosage is 2 mg/kg i.e. 1 ml/50 kg bodyweight in a single daily injection, for 3 days.
The first injection may also be given by the intravenous route.

Sows:

Intramuscular use:- The recommended dosage is 2 mg/kg i.e. 1 ml/50 kg bodyweight in a single daily injection by intramuscular route, for 3 days.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing.

No sign of overdosage has been observed in cattle after administration of 3 times the recommended dose.

Overdosage may cause signs such as acute neurological disorders which should be treated symptomatically.

Cattle:
Intramuscular: Meat and offal: 3 days - Milk: 72 hours
Subcutaneous: Meat and offal: 6 days - Milk: 36 hours

Sows:
Intramuscular: Meat and offal: 4 days

Pharmacotherapeutic group: Anti-infectives for systemic use, fluoroquinolones class. ATCvet code: QJ01MA93

Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to the fluoroquinolone group, which acts by inhibition of DNA gyrase. It has a broad-spectrum activity in vitro against Gram-negative bacteria (Pasteurella multocida, Mannheimia haemolytica, Histophilus somni, E. coli) and against Gram-positive bacteria (in particular Staphylococcus).
Resistance to Streptococcus may occur.

Strains with MIC ≤ 1 µg/ml are sensitive to marbofloxacin whereas strains with MIC > 2 µg/ml are resistant to marbofloxacin.

Resistance to fluoroquinolones occurs by chromosomal mutation with three mechanisms: decrease of the bacterial wall permeability, expression of efflux pump or mutation of enzymes responsible for molecule binding.

Cattle- Intramuscular route:

After a single intramuscular administration at the recommended dose of 8 mg/kg, the maximum plasma concentration of marbofloxacin (Cmax) is 8 µg/ml reached in approximatively 1 hour (Tmax). Marbofloxacin is eliminated slowly (terminal T1/2 = 9.5 h), predominantly in the active form in urine and faeces.

Cattle- Subcutaneous route:

After subcutaneous administration at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.7 µg/ml in approximately 1 hour. The terminal elimination half-life (t½) of marbofloxacin is 5.6 hours.

Pigs- Intramuscular route:

After intramuscular administration at the recommended dose of 2 mg/kg, marbofloxacin is readily absorbed and reaches maximal plasma concentrations of 1.7 µg/ml in approximately 1 hour. The terminal elimination half-life (t½) of marbofloxacin is 8.7 hours.

Its bioavailability is close to 100 %.

Marbofloxacin is weakly bound to plasma proteins (less than 10% in pigs and 30 % in cattle), extensively distributed and in most tissues (liver, kidney, skin, lung, bladder, uterus) it achieves higher concentrations than in plasma. Marbofloxacin is eliminated predominantly in the active form in urine and faeces.

Glucono-delta-lactone, Water for injections.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first opening the immediate packaging: 28 days.

Keep the container in the outer carton in order to protect from light.

Primary packaging:

Amber PP/Ethylene vinyl alcohol/PP multi-layer plastic vials.
Type II chlorobutyl rubber stopper
Aluminium and plastic flip capsule.

Pack size:

Cardboard box containing one 50 ml vial
Cardboard box containing one 100 ml vial
Cardboard box containing one 250 ml vial
Cardboard box containing one 500 ml vial

Not all pack sizes may be marketed.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

UK: Vm 15052/4048

10 November 2010

October 2022

Nil