MARBOXIL 100 inj

COMPOSITION

Each mL of product contains Marbofloxacin 100 mg.

TARGET SPECIES

Cattle and pigs

INDICATIONS

Cattle - In the treatment of respiratory infections caused by Pasteurella multocida, Mannheimia haemolytica, Mycoplasma bovis and in the treatment of acute mastitis caused by marbofloxacin-susceptible Escherichia coli, during lactation.

Pigs - In the treatment of mastitis, metritis and agalactia (MMA), produced by marbofloxacin-susceptible germs.

CONTRAINDICATIONS

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

ADVERSE REACTIONS

Intramuscular administration may cause transient local reactions (e.g., pain, swelling) at the injection site and even inflammatory lesions that persist for at least 12 days after administration.

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

Cattle - For the treatment of respiratory infections, the recommended dose is 2 mg marbofloxacin/kg body weight/day (1 mL product per 50 kg body weight), once daily, subcutaneously or intramuscularly, for 3 to 5 consecutive days.

For the treatment of acute mastitis, the recommended dose is 2 mg marbofloxacin/kg body weight/day (1 mL product per 50 kg body weight), once daily, subcutaneously or intramuscularly, for 3 consecutive days.

In cattle, the subcutaneous route of administration proved to be better tolerated than the intramuscular route.

Pigs - The recommended dose is 2 mg marbofloxacin/kg body weight/day (1 mL product per 50 kg body weight), once a day, intramuscularly, for 3 consecutive days.

The injection is made in the neck area.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

WITHDRAWAL PERIOD(S)

Meat and offal

Cattle (meat and offal) 6 days

Pigs (meat and offal) 3 days

Cattle (milk) 36 hours

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE

Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light.

SPECIAL WARNING(S)

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals. 

National and regional antimicrobial policies shall be observed when using the product. Using the product in violation of the instructions provided in the SmPC may increase the prevalence of fluoroquinolone-resistant bacteria and may decrease treatment effectiveness with other quinolones due to their potential cross-resistance. 

Studies also show low efficacy of the product in the treatment of acute mastitis caused by Gram-positive species.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

People with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product. In case of ingestion, accidental skin contact or self-injection, seek medical advice immediately and show the package leaflet or the label of the product. The person handling the veterinary medicinal product must wear protective equipment.

USE DURING PREGNANCY AND LACTATION

Use during gestation: laboratory studies in animals (rats, rabbits) did not indicate any teratogenic, embryotoxic or other maternal toxic effects of marbofloxacin. Product safety during pregnancy in cattle has been demonstrated. Use during lactation: the safety of the product in piglets and calves was demonstrated when the product was used in lactating sows and cows. 

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

No adverse reactions other than those mentioned for single dose administration were seen after a 3-fold higher dose than recommended. Overdosing may cause neurological disorders that will need to be treated symptomatically.

INCOMPATIBILITIES

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

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

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

PRESENTATION/PACKAGE 

100 mL brown polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.