MARBONOR 100 MGML VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MARBOFLOXACIN

Available from:

COMEX LTD., ISRAEL

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MARBOFLOXACIN 100 MG / 1 ML

Administration route:

I.V, S.C, I.M

Prescription type:

Required

Manufactured by:

NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND

Therapeutic indications:

In cattle: treatment of respiratory infections caused by sensitive strains of Pasteurella multocida, pasteurella haemolytica bovis.In sows: treatment of metritis mastitis agalactia syndrome caused by bacterial strains sensitive to marbofloxacin.Treatment in both species should be given only after the sensitivity of the bacteria has been proven and it has been found that there is no alternative treatment (proven resistance to other agents).

Authorization date:

2022-08-31

Patient Information leaflet

THIS LEAFLET HAS BEEN REVIEWED AND APPROVED 9/2017
SUMMARY OF PRODUCT CHARACTERISTICS
VETERINARY USE ONLY - PRESCRIPTION ONLY MEDICINE
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbonor 100 mg/ml Veterinary Solution for injection
I.M, I.V, S.C injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxaciח
100 mg
For a full list of excipients, see section 13 “further
information”
3.
INDICATIONS FOR USE
CATTLE
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella multocida, _
_Psteurella heamolytica bovis._
SOWS
Treatment of Metritis Mastitis Agalactia Syndrome (postpartum
dysgalactia syndrome, PDS)
caused by bacterial strains sensitive to marbofloxacin
_Treatment in both species should be given only after the sensitivity
of the bacteria has been _
_proven and it has been found that there is no alternative treatment
(proven resistance to _
_other agents). _
PHARMACOTHERAPEUTIC GROUP:
Antibacterials, Flouroquinolones
4.
CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross
resistance).
Do not use in animals with known hypersensitivity to fluoroquinolones
or to
any of the excipients.
5.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Administration by the intramuscular route may cause transient local
reactions such as pain and
swelling at the injection site and inflammatory lesions which may
persist for at least 12 days
after injection.
In cattle subcutaneous route was shown to be better tolerated locally
than
intramuscular route.
Therefore, the subcutaneous route is recommended in heavy cattle.
Side effects can be reported to the Ministry of Health by clicking on
the link "Reporting
adverse events due to drug treatment" found on the home page of the
Ministry of Health
website (www.health.gov.il) which refers to the online form for
reporting adverse events, or by
entering the link:
_https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=Ad_
_versEffectMedic_
[e-mail] _
_