NAM PHUC THINH TRADING CO., LTD

BOFLOX

Composition: 1 ml contains: Marbofloxacin, 100 mg.

Dosage form: injectable solution

Target species: cattle and pigs (sows)

Indications for use, specifying the target species:

Cattle:

• Treatment of respiratory infections caused by strains of Histophilus somni, Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida susceptible to marbofloxacin.
• Treatment of acute mastitis caused by strains of Escherichia coli susceptible to marbofloxacin during the lactation period.

Pigs: Treatment of Postpartum Dysgalactia Syndrome –PDS- (Metritis Mastitis Agalactia syndrome) caused by bacterial strains susceptible to marbofloxacin.

Contraindications:

• Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
• Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the excipients.

Adverse reactions (frequency and seriousness):

• Transitory inflammatory lesions can occur at the injection site, without clinical impact, when administered via the intra-muscular or subcutaneous route.
• Administration by the intramuscular route in cattle may cause transient local reactions such as pain and swelling at the injection site and inflammatory lesions which may persist for at least 12 days after injection.
• However, in cattle, subcutaneous route was shown to be better tolerated locally than intramuscular route. Therefore, the subcutaneous route is recommended in heavy cattle.
• If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Route of administration: intramuscular route or subcutaneous route.

Dosage for each species, routes and method of administration:

Cattle:

Respiratory infections:

The recommended dosage is 8 mg marbofloxacin/kg body weight (2 ml product/25 kg body weight) in a single injection by intramuscular route. If the volume to be injected is more than 20 ml, it should be divided between two or more injection sites.

In cases of respiratory infections caused by Mycoplasma bovis, the recommended dose is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight), in a single daily injection for 3 to 5 consecutive days, by intramuscular or subcutaneous route. The first injection may be given by the intravenous route.

Acute mastitis: (Intramuscular or subcutaneous use).

The recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight) in a single daily injection, for 3 consecutive days.

The first injection may also be given by the intravenous route.

Pigs (sows): (Intramuscular use)

The recommended dosage is 2 mg marbofloxacin/kg body weight (1 ml product/50 kg body weight) in a single daily injection, for 3 consecutive days.

To ensure administration of a correct dose, body weight should be determined as accurately as possible, to avoid underdosing.

In cattle and pig, the preferred injection site is the neck area.

The cap may be safely punctured up to 30 times. The user should choose the most appropriate vial size according to the target species to treat.

Withdrawal period:

Cattle:

8 mg/kg on a single occasion (IM): Meat and offal: 3 days; Milk: 72 hours.

2 mg/kg for 3 to 5 days (IV/SC/IM): Meat and offal: 6 days; Milk: 36 hours.

Pig (sows): Meat and offal: 4 days.

Storage precautions: Store in the original package in order to protect from light.

Special warnings:

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 the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced by gram-positive bacteria.

User warnings:

People with known hypersensitivity to (fluoro) quinolones should avoid contact with the veterinary medicinal product. Care should be taken to avoid accidental self-injection as it can induce a slight irritation.

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

In case of contact with skin or eyes, rinse with plenty of water.

Wash hands after use.

Using during pregnancy, lactation or lay:

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Safety of the product at 2 mg/kg body weight has been established in pregnant cows and sucking calves and piglets when used in cows and sows. Can be used during pregnancy and lactation.

Safety of the product at 8 mg/kg body weight has not been established in pregnant cows or in sucking calves when used in cows. Therefore, this dose regimen should be used only accordingly to the benefit/risk assessment by the responsible veterinarian.

In case of use in lactating cow, see section “Withdrawal period”.

Interaction with other medicinal products and other forms of interaction: None known.

Overdose (symptoms, emergency procedures, and antidotes):

No signs of overdose have been observed after administration of 3 times the recommended dose.

Signs as acute neurological disorders may occur when the dose is exceeded.  This signs should be treated symptomatically. Do not exceed the recommended dose.

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

Disposal:

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

Presentations: Vials of 100 ml and 250 ml. Vials are individually packed in a carton box. Six, ten or twelve vials are grouped as a clinical pack. Not all pack sizes may be marketed.

Shelf-life: 3 years from the manufacturing date and 28 days from the first opening.

FOR VETERINARY USE ONLY

Keep out of the reach of children

 

Invesa

Industrial Veterinaria, S.A.

a LIVISTO company

Esmeralda, 19

08950 Esplugues de Llobregat

(Barcelona) Spain