Target species
Cattle, Pigs
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, other (fluoro)quinolones or to any of the excipients.
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
Cross-resistance has been shown between enrofloxacin and other (fluoro)quinolones in target pathogens, e.g. Escherichia coli. Use of the veterinary medicinal product should be carefully considered when susceptibility testing has shown resistance to fluoroquinolones because its effectiveness may be reduced.
Special precautions for use
Special precautions for use in the target species:
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.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Narrow spectrum antibiotic therapy with a lower risk of antimicrobial resistance selection should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
The veterinary medicinal product should only be used in individual animals.
The feeding of waste milk containing residues of enrofloxacin to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
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.
Use of the veterinary medicinal product deviating from the instructions given in this 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.
Not for use for prophylaxis
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 veterinary medicinal 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)
Cattle and pigs:
Rare 1 to 10 animals / 10,000 animals treated): | Injection site reddening1, Injection site swelling1 Circulatory shock2 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Digestive tract disorders4,3 |
2With intravenous treatment in cattle.
3,4 In calves
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can 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.
Administration routes and dosage
Cattle:
Subcutaneous use (respiratory disease) or Intravenous use (E.coli mastitis).
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:
7.5ml of the veterinary medicinal product per 100kg 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 E.coli mastitis is 5 mg enrofloxacin per kg body weight (BW) by intravenous administration (i.v.).
This is equivalent to:
5ml of the veterinary medicinal product per 100kg BW and day |
The treatment of E.coli should be exclusively by intravenous application on 2 to 3 consecutive days.
Pigs:
Intramuscular use.
The dosage for respiratory tract infections is 7.5 mg enrofloxacin per kg body weight for a single treatment by intramuscular administration (i.m) into the neck muscles behind the ear.
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.
Repeated injections should be made at different injection sites.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The stopper may be safely punctured up to 20 times.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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
Pigs:
Meat and offal:
i.m: 12 days