Marbocyl P 5 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:

5 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 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl P 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin 5 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 and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Dogs
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
In Cats
Marbofloxacin tablet is indicated in the treatment of skin and soft
tissue infections (wounds, abscesses, phlegmons) and upper
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. Not recommended for use in
cats aged less than 16 weeks.
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.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Hypersensitivity (allergic) reactions may occur in treated animals.
At the therapeutic recommended dosage, no severe side-effects are to
be expected in dogs and cats. 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