MARBOCYL 10 % SOLUTION FOR INJECTION VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MARBOFLOXACIN

Available from:

ELIEZER LINEVITZ LTD.

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MARBOFLOXACIN 100 MG/ML

Administration route:

S.C, I.V, I.M

Prescription type:

Required

Manufactured by:

VETOQUINOL, FRANCE

Therapeutic indications:

In cattle:Treatment of respiratory infections with susceptible strains of Pasteurella multocida, Mannheimia (Pasteurella) haemolytica and Mycoplasma bovis.- Treatment of acute Escherichia coli mastitis susceptible to marbofloxacin during the lactation period.In sows:- Treatment of Metritis-Mastitis-Agalactic Syndrome with bacterial strains sensitive to marbofloxacin.

Authorization date:

2014-07-31

Patient Information leaflet

Page 1 of
CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
MARBOCYL 10% SOLUTION FOR INJECTION VETERINARY
2.
ACTIVE INGREDIENT and quantity in a single dose:
Marbofloxacin 100 mg/ml
EXCIPIENTS – each ml contains:
m-cresol (2 mg), Thioglycerol ( 1 mg), Disodium edetate (0.1 mg)
For a full list of excipients, see section 13: "additional
information".
3.
WHAT IS THE MEDICINE INTENDED FOR
IN CATTLE:
-Treatment of respiratory infections with susceptible strains of
Pasteurella multocida,
Mannheimia (Pasteurella) haemolytica and Mycoplasma bovis.
-Treatment of acute Escherichia coli mastitis susceptible to
marbofloxacin during the
lactation period. IN SOWS:
Treatment of Metritis-Mastitis-Agalactic Syndrome with bacterial
strains sensitive to
marbofloxacin.
Therapeutic group: fluoroquinolone.
4.
CONTRA-INDICATIONS
Do not administer in the event of bacteria resistant to other
fluoroquinolones (cross-
resistance).
Do not administer to an animal with known hypersensitivity to
marbofloxacin or to another
quinolone.
5.
SIDE EFFECTS
Administration by the intramuscular route may cause transient local
reactions such as pain
and swelling at the injection site and inflammatory lesions which
persist at least 12 days
after injection.
However, in cattle, subcutaneous route was shown to be better
tolerated locally than
intramuscular route. Therefore, the subcutaneous route is recommended
in adult cattle. For
the injections, the neck should be preferred in cattle and pigs.
No other undesirable effects have been observed in cattle and pigs.
Side effects can be reported to the Ministry of Health by clicking on
the link "Adverse
Drug Reactions Repot" that appears on the home page of the Ministry of
Health web site
(www.health.gov.il), which leads to an online form for reporting side
effects. Alternatively
you can use the following link: HTTPS://SIDEEFFECTS.HEALTH.GOV.IL/
6.
TARGET ANIMALS: Cattl

Summary of Product characteristics

This leaflet format has been determined by the Ministry of Health and
the content has been checked
and approved in
1
.20
20
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 10%
SOLUTION FOR INJECTION VETERINARY
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance(s):
Marbofloxacin…………………………………………….
100.0 mg
Excipient(s):
Disodium edetate………………………………………….
0.1 mg
Thioglycerol………………………………………………......
1.0 mg
m-cresol
.......................................…………….……….…..
2.0 mg
For a full list of excipients, see section ‘List of excipients’.
3. PHARMACEUTICAL FORM
Solution for injection.
For IM, IV or SC injection.
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES
Cattle and sows
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN CATTLE:
Treatment of respiratory infections with susceptible strains of
Pasteurella multocida, Mannheimia
(Pasteurella) haemolytica and Mycoplasma bovis
.
Treatment of acute Escherichia coli mastitis susceptible to
marbofloxacin during the lactation period
.
IN SOWS:
Treatment of Metritis-Mastitis-Agalactic Syndrome with bacterial
strains sensitive to marbofloxacin.
4.3. CONTRAINDICATIONS
Do not administer in the event of bacteria resistant to other
fluoroquinolones (cross-resistance).
Do not administer to an animal with known hypersensitivity to
marbofloxacin or to another
quinolone.
4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5. SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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 official and
local antimicrobial policies should be taken into account when the
product is used.
Use of the product deviating from the instr