Marbosyva 100 mg/ml solution for injection for cattle and pigs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Marbofloxacin

זמין מ:

Laboratorios SYVA, S.A.U

קוד ATC:

QJ01MA93

INN (שם בינלאומי):

Marbofloxacin

כמות:

100 milligram(s)/millilitre

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Cattle, Pigs

איזור תרפויטי:

marbofloxacin

סממני תרפויטית:

Antibacterial

מצב אישור:

Authorised

תאריך אישור:

2012-11-23

מאפייני מוצר

Health Products Regulatory Authority
17 November 2017
CRN000V8D
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbosyva 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
​
ACTIVE SUBSTANCE:
​
Marbofloxacin
​
100 mg
EXCIPIENTS:
​
Metacresol
​
2 mg
​
Monothioglycerol
​
1 mg
Disodium edetate
​
0.1 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, yellowish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Treatment of respiratory infections caused by
marbofloxacin-susceptible strains of
_Histophilus somni_, _Mannheimia haemolytica_, _Pasteurella multocida
_and _Mycoplasma _
_bovis_.
- Treatment of acute forms of mastitis induced by
marbofloxacin-susceptible
_Escherichia coli_ strains, during lactation.
In pigs (sows):
- Treatment of Postpartum Dysgalactiae Syndrome, PDS (Metritis
Mastitis Agalactia
Syndrome) caused by marbofloxacin-susceptible bacterial strains.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Health Products Regulatory Authority
17 November 2017
CRN000V8D
Page 2 of 7
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
Special precautions for use in animals
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 fluoroquinol