BioFloxaVEt® D tablets for dogs (enrofloxacin 50 mg) 20 tablets

BioFloxaVEt® D tablets for dogs (enrofloxacin 50mg) 20 tablets

1. NAME  OF THE MARKETING AUTHORISATION HOLDER

Name: BIOVET

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

BioFloxaVEt® D

COMPOSITION

Content                               Biofloxavet® D

Enrofloxacin                            50 mg

Excipients                              Each tablet                                 

The product contains as excipients: lactose, wheat starch, hydroxypropylcellulose, microcrystalline cellulose, magnesium stearate and colloidal silica.

PHARMACOLOGICAL ACTION

Enrofloxacin is a synthetic broad-spectrum chemotherapeutic of the fluoroquinolones group.

Owing to the inhibition of the bacterial DNA-gyrase it causes a potent bactericidal effect against

Gram-negative, a wide range of Gram-positive bacteria and Mycoplasma spp. It is inactive

against anaerobic microorganisms. It is very well distributed in the tissues, possesses bactericidal

activity in small tissue concentrations, and is well tolerated by animals.

After oral administration of Biofloxavet® C tablet to cats and Biofloxavet® D tablets for dogs at a

dose of 5 mg enrofloxacin per kg b.w., enrofloxacin and absorbs quickly and almost completely

by the digestive tract thereby creating within a short period of time antimicrobial plasma

concentrations of enrofloxacin and its active metabolite ciprofloxacin higher than the MIC for

clinically important microbial agents which are maintained for 24 hours after the administration.

Enrofloxacin is well distributed within the organisms of cats. Its elimination from the organism

is primarily via the urine and bile/faeces.

INDICATIONS

For treatment of local and systemic infections in cats and dogs, caused by Gram-positive

bacteria: Staphylococcus and Streptococcus, Gram-negative bacteria: E.coli, Salmonella spp.,

Klebsiella spp., Proteus spp., Pseudomonas spp., Pasteurella spp., Haemophilus spp. as well as

Mycoplasma spp. – in primary and secondary infections of the gastrointestinal, respiratory and

urogenital systems; in skin, wound infections and infections of the external acoustic canal.

CONTRAINDICATIONS

Do not administer to pregnant and growing animals until the completion of the growth.

Do not give to pregnant and lactating animals.

MODE OF ADMINISTRATION

Orally.

TARGET SPECIES

Dogs.

DOSAGE

Biofloxavet D for dogs

The daily dose is 1 tablet per 10 kg body weight (=5 mg/kg b.w. enrofloxacin), applied a single time or separated on two portions with a 12-hour interval. A 3- to 5-day therapeutic course is usually sufficient but in case of more severe infections the treatment duration can be prolonged up to 10 consecutive days.

SIDE EFFECTS

On rare occasions, transitional gastrointestinal disorders may occur.

WITHDRAWAL PERIOD

Not applicable

STORAGE

In the original container in warehouse facilities protected from direct sunlight.

Keep out of the reach and sight of children.

PACKING

Cardboard box of 2 blisters with 10 tablets each.

WARNING

Do not eat, drink or smoke while handling the product. After use, wash hands with water and

soap.

Do not administer simultaneously with theophylline and non-steroidal anti-inflammatory drugs.

Substances containing magnesium and aluminum may decrease the absorption of enrofloxacin.

The simultaneous administration of enrofloxacin with chloramphenicol, tetracycline and

macrolides can result in an antagonistic effect.

The signs of acute toxicity may be referred to the neurointoxications – ataxia, tremor, tonic

convulsions, lethargy, dyspnea, ventral decubitus.