Marbocyl 10% Solution for Injection

国: イギリス

言語: 英語

ソース: VMD (Veterinary Medicines Directorate)

即購入

ダウンロード 製品の特徴 (SPC)
21-09-2023

有効成分:

Marbofloxacin

から入手可能:

Vetoquinol UK Ltd

ATCコード:

QJ01MA93

INN(国際名):

Marbofloxacin

医薬品形態:

Solution for injection

処方タイプ:

POM-V - Prescription Only Medicine – Veterinarian

治療群:

Cattle, Pigs

治療領域:

Antimicrobial

認証ステータス:

Authorized

承認日:

1997-02-14

製品の特徴

                                Revised: September 2023
AN: 00689/2023
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 10% Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marbofloxacin
10.0g
Monothioglycerol
0.1g
Metacresol
0.2g
Disodium edetate
0.01g
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle & pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle: Indicated in the treatment of respiratory infections caused
by susceptible
strains of organisms. It is also indicated in the treatment of acute
E. coli mastitis.
In pigs: Indicated in the treatment of Metritis Mastitis Agalactia
syndrome caused by
susceptible strains of organisms.
4.3
CONTRA-INDICATIONS
Do not use in cases of resistance to other fluoroquinolones
(cross-resistance).
Do not use in cases of hypersensitivity to the active substance, to
any other quinolone or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Revised: September 2023
AN: 00689/2023
Page 2 of 5
Official and local antimicrobial policies should be taken into account
when the
product is used. 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,
fluoroquinolones
should only be used 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.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
People with known hypersensitivity to (fluoro)quinolones should avoid
using this
product.
In case of contact with skin or eyes, rinse wi
                                
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