Target species
Cattle, Pig
Indications for use, specifying the target species
Cattle:
For the treatment of respiratory tract infections caused by enrofloxacin-sensitive Histophilus somni, Mannheimia haemolytica, Pasteurella multocida and Mycoplasma spp.
For the treatment of mastitis caused by enrofloxacin-sensitive E. coli.
Pig:
For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive Actinobacillus pleuropneumoniae, Pasteurella multocida and complicated by Haemophilus parasuis as a secondary pathogen in pigs.
Contraindications
Do not use for prophylaxis.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in known cases of resistance to other (fluoro)quinolones due to the potential for cross-resistance.
Do not use in animals with central nervous system-associated seizure disorders.
Do not use in the presence of existing disorders of cartilage development or musculoskeletal damage around functionally significant or weight-bearing joints.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
For repeated injection or for injection volumes exceeding 15 ml (cattle) or 7.5 ml (pigs, calves) in divided doses, a new site must be chosen for each injection.
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.
Enrofloxacin is eliminated renally. As with all fluoroquinolones, delayed excretion can therefore be expected in the presence of existing renal damage.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Direct contact with the skin should be avoided due to sensitisation, contact dermatitis and possible hypersensitivity reactions.
People with known hypersensitivity to (fluoro)quinolones should avoid contact with the product.
Wash hands after use.
In the event of accidental splash into the eye, rinse with large amounts of clean water. If irritation occurs, seek medical advice.
Do not eat, drink or smoke while handling the product.
Take care to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the physician.
Adverse reactions (frequency and seriousness)
In rare cases, transitory inflammatory reactions (swelling, redness) can occur at the injection site. These regress within a few days without further therapeutic measures.
In rare cases, intravenous treatment can cause shock reactions in cattle, probably as a result of circulatory disturbances.
Gastrointestinal disturbances may occur in isolated cases during treatment of calves.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay
May be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction
Antagonist effects due to concurrent administration of macrolides and tetracyclines may occur. Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.
Amounts to be administered and administration route
Cattle:
The dosage for respiratory disease is 7.5 mg enrofloxacin per kg body weight (BW) for a single treatment by subcutaneous administration (s.c.).
This is equivalent to
7.5 ml of the product per 100 kg BW and day
Do not administer more than 15 ml (cattle) or 7.5 ml (calf) per injection site (s.c.).
In case of serious or chronic respiratory disease a second injection may be required after 48 hours.
The dosage for the treatment of colimastitis is 5 mg enrofloxacin per kg body weight (BW) by intravenous administration (i.v.).
This is equivalent to
5 ml of the product per 100 kg BW and day
The treatment of colimastitis should be exclusively by intravenous application on 2 to 3 consecutive days.
Pig:
The dosage for respiratory tract infections is 7.5 mg enrofloxacin per kg body weight for a single treatment by intramuscular administration (i.m.).
This is equivalent to
0.75 ml of the product per 10 kg BW and day
Do not administer more than 7.5 ml per injection site (i.m.). In cases of serious or chronic respiratory disease a second injection may be required after 48 hours.
Method of administration:
Repeated injections should be made at different injection sites.
Cattle:
For subcutaneous injection (respiratory disease) or for intravenous injection (colimastitis).
Pig:
For intramuscular injection into the neck muscles behind the ear.
To ensure administration of the correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The stopper may be safely punctured up to 20 times.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle a dose of 25 mg/kg bodyweight administered by the subcutaneous route for 15 consecutive days is tolerated without any clinical symptoms. Higher doses in cattle and doses of around 25 mg/kg and above in pigs may cause lethargy, lameness, ataxia, slight salivation and muscle tremors.
Do not exceed the recommended dose. In accidental overdose there is no antidote and treatment should be symptomatic.
Withdrawal period(s)
Cattle:
Meat and offal:
s.c.: 14 days
i.v.: 7 days
Milk:
s.c.: 120 hours
i.v.: 72 hours
Pig:
Meat and offal: 12 days