Target species
Dogs (5mg, 20mg and 80mg)
Cats (5mg only)
Indications for use for each target species
In dogs
Marbofloxacin is indicated in the treatment of:
•skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis) caused by susceptible strains of organisms.
•urinary tract infections (UTI) associated or not with prostatitis caused by susceptible strains of organisms.
•respiratory tract infections caused by susceptible strains of organisms.
In cats
Marbofloxacin is indicated in the treatment of skin and soft tissue infections (wounds, abscesses, phlegmons) and upper respiratory tract infections caused by susceptible strains of organisms.
Contraindications
Do not use in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briard, Bernese Bonvier and Mastiffs, with a longer growth period.
Do not use in cats aged less than 16 weeks.
Do not use in cases of hypersensitivity to fluoroquinolones or any of the excipients.
Do not use in cases of resistance against quinolones since (almost) complete cross-resistance exists against other fluoroquinolones.
Do not use for infections resulting from strict anaerobes, yeast or fungi.
For Marbocyl 20mg and 80mg, do not use in cats. For the treatment of this species, a 5 mg tablet is available.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals.
Fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.
A low urinary pH could have an inhibitory effect on the activity of marbofloxacin.
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, use of fluoroquinolones should be 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to fluoroquinolones should avoid using this product.
In case of accidental ingestion seek medical attention and show the package leaflet or the label to the physician. Wear gloves when handling or dividing tablets. Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Marbocyl P 5 mg
Dogs and cats:
Rare (1 to 10 animals / 10 000 animals treated): | Vomiting1,2, soft stool1,2 Hyperactivity1,2,3 Excessive thirst1,2 Allergic skin reaction3,4 Neurological disorder (ataxia, convulsion) Joint pain Aggression Depression |
At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate
1 Mild
2 These signs cease spontaneously and do not require discontinuation of treatment
3 Transient
4 Due to the release of histamine
Marbocyl P 20 mg and 80 mg
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Joint pain Neurological disorder (ataxia, seizure) Depression Aggression |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Allergic skin reaction1,2 Vomiting3,4, loose stool3,4 Excessive thirst3,4 Hyperactivity2,3,4 |
At the therapeutic recommended dosage, no severe side-effects are to be expected in dogs and cats. In particular, no lesions of the articular joints were encountered in clinical studies at the recommended dose rate.
1 Due to histamine release
2 Transient
3 Mild
4 These signs cease spontaneously after treatment and do not necessitate cessation of treatment
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
Studies in pregnant rats and rabbits showed no side effects on pregnancy. However no specific studies have been carried out in pregnant cats and dogs.
Interaction with other medicinal products and other forms of interaction
Fluoroquinolones are known to interact with orally administered cations (Aluminium, Calcium, Magnesium, Iron). In such cases, the bioavailability may be reduced.
Administration routes and dosage
To ensure a correct dosage, body weight should be determined as accurately as possible.
For oral administration.
The recommended dose rate is 2 mg/kg/d in single daily administration.
1 tablet for 2.5 kg per day - 5mg
1 tablet for 10 kg per day - 20mg
1 tablet for 40 kg per day - 80mg
Dogs:
•in skin and soft tissue infections, treatment duration is at least 5 days. Depending on the course of the disease, it may be extended up to 40 days.
•in urinary tract infections, treatment duration is at least 10 days. Depending on the course of the disease, it may be extended up to 28 days.
•in respiratory infections, treatment duration is at least 7 days and depending on the course of the disease, it may be extended up to 21 days.
Cats: (5mg only)
•for skin and soft tissue infections (wounds, abscesses, phlegmons) treatment duration is 3 to 5 days.
•for upper respiratory infections treatment duration is 5 days.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdosage may cause acute signs in the form of neurological disorders, which should be treated symptomatically.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.