Forcyl 16% 160 mg Solution for injection

Cattle

Pigs (fattening pigs, weaned piglets, sows)

Indications for use, specifying the target species

Cattle: Therapeutic treatment of respiratory infections caused by sensitive strains of Pasteurella multocida and Mannheimia haemolytica. In lactating cows: Treatment of acute mastitis caused by sensitive strains of Escherichia coli

Pigs: In fattening pigs: Treatment of respiratory tract infections caused by susceptible strains of Actinobacillus pleuropneumoniae and Pasteurella multocida. In weaned piglets: Treatment of intestinal infections caused by susceptible strains of E. coli. In post-partum sows: Treatment of Metritis-Mastitis-Agalactiae syndrome (form of postpartum dysgalactiae syndrome, PPDS) caused by susceptible strains of E. coli

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

Cattle: Therapeutic treatment of respiratory infections: 10 mg/kg body weight i.e., 10 ml/160 kg body weight in a single intramuscular injection - Treatment of acute mastitis caused by sensitive strains of Escherichia coli: 10 mg/kg body weight i.e., 10 ml/160 kg body weight in a single intramuscular or intravenous injection

If the volume to be injected in more than 20 ml, it should be divided between two or more injection sites.

Pigs: The recommended dose is 8 mg/kg body weight i.e., 1 ml/20 kg body weight in a single intramuscular injection in the side of the pig neck.

• Do no use in animals with known hypersensitivity to fluoroquinolones or to any of the excipients
• Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance)

Special warnings < for each target species >

Piglets: To limit development of resistance, do not use fluoroquinolones as prophylaxis or metaphylaxis during weaning

Lactating cows: The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria

Special precautions for use

i) Special precautions for use in animals

Official and local antimicrobial policies should be considered when this 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. Wherever possible, use of the product should only be based on susceptibility testing.

Use of the product deviating from the instructions given in this PI 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.

ii) Special precautions to be taken by the person administering the veterinary medicine

People with known hypersensitivity to fluoroquinolones and benzyl alcohol should avoid any contact with the product. Wash hands after use. Avoid contact of the skin and eyes with the product. If the product comes into contact with the skin or eyes, rinse with copious amounts of water. Care should be taken to avoid accidental self-injection. In the event of accidental self-administration, the user should immediately seek professional medical care. Accidental self-injection can induce a slight irritation.

None known

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:

• 10 mg/kg has not been determined in pregnant cows or in suckling calves when used in cows.
• 8 mg/kg in pregnant sows or in suckling piglets when used in sows.

Use only according to the benefit/risk assessment by the responsible veterinarian.

In Cattle: Very rare cases (less than 1 animal in 10,000 animals, including isolated reports), of administration by the intramuscular route may cause transient local reactions such as pain and swelling at the injection site which may persist up to 7 days after injection. In very rare cases, anaphylactic-type reactions with a potentially fatal outcome might occur. Fluoroquinolones are known to induce arthropathies. In cattle, such lesions were observed after a three day treatment with the 16% marbofloxacin solution. These lesions did not induce clinical signs and should be reversible, particularly if they were to be observed after a single administration.

In Pigs: Local reactions can be observed at the injection site, which disappear within 36 days. Pain at the injection site has been commonly reported (more than 1 but less than 10 animals in 100 animals).

In Cattle: Lesions of the joint cartilage were observed in some animals treated at 10 mg/kg or 30 mg/kg for three times the recommended treatment duration but did not induce clinical signs. Moreover, no other signs of overdosage was observed throughout this study.

In Pigs: Lesions of the joint cartilage, potentially leading to difficulties in movement, were observed in some animals treated at three times the recommended dose and treatment duration.