Marbocyl P 80 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

80 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

marbofloxacin

Authorization status:

Authorised

Authorization date:

2004-04-19

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl P 80 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin 80 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Brown-beige spotted, circular divisible tablets.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbofloxacin tablet is indicated in the treatment of:
Skin and soft tissue infections (intertrigo, folliculitis, impetigo,
furunculosis, cellulitis) caused by susceptible strains.
Lower and upper urinary tract infections (UTI) associated or not with
prostatitis or epididymitis caused by susceptible strains.
Respiratory tract infections caused by susceptible strains.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.Do not use in dogs aged less than 12 months, or less
than 18 months for giant breeds of dogs.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Hypersensitivity (allergic) reactions may occur in treated animals.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 3
At the therapeutic recommended dosage, no severe side-effects are to
be expected in dogs. 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.
Mild side effects may occasionally occur such as vomiting, softening
of faeces, modification of thirst or transient increase in
activity. These signs cease spontaneously after treatment and do not
necessitate cessation of treatment.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Marbofloxacin may