MARBOCYL 20MG TABLETS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

MARBOFLOXACIN

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01MA93

Dosage:

20 Milligram

Pharmaceutical form:

Tablets

Therapeutic group:

Antibacterial

Therapeutic area:

Canine

Authorization date:

1995-12-19

Summary of Product characteristics

                                IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10983/028/002
Case No: 7003107
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to:
VETOQUINOL IRELAND LIMITED
WILTON PLACE, DUBLIN 2, IRELAND
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
MARBOCYL 20MG TABLETS
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/03/2007_
_CRN 7003107_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 20 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance
Marbofloxacin
20 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
White, 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 epididymit
                                
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