FORCYL 160 MGML SOLUTION FOR INJECTION FOR CATTLE VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MARBOFLOXACIN

Available from:

ELIEZER LINEVITZ LTD.

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MARBOFLOXACIN 160 MG/ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

VETOQUINOL S.A., FRANCE

Therapeutic indications:

Therapeutic treatment of respiratory infections in cattle caused by sensitive strains of Pasteurella multocida and Manneimia haemolytica.In lactating cows: treatment of acute mastitis caused by sensitive strains of Escherichia coli

Authorization date:

2019-04-30

Patient Information leaflet

1
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
Forcyl 160 mg/mL solution for injection for cattle veterinary
2.
ACTIVE INGREDIENT and its quantity in a dose unit
Marbofloxacin 160 mg/mL
INACTIVE EXCIPIENTS: Each mL contains:
Benzyl alcohol 15 mg
For the full list of inactive excipients, see Section 13: " Additional
information."
3.
WHAT IS THE MEDICINE INTENDED FOR
IN CATTLE: Therapeutic treatment of respiratory infections in cattle
caused by
sensitive strains of Pasteurella multocida and Mannheimia haemolytica.
IN LACTATING COWS:
Treatment of acute mastitis caused by strains of Escherichia coli
sensitive to
Marbofloxacin
Therapeutic group: Fluoroquinolone
4.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient, to
any other fluoroquinolones or to any of the product inactive
excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
5.
SIDE EFFECTS
In very rare cases (may occur in less than 1 of 10,000 treated
animals),
administration by the intramuscular route may cause transient local
reactions
such as pain and swelling at the injection site which may persist up
to 7 days
after injection.
Fluoroquinolones are known to induce arthropathies. In cattle, such
lesions
were observed after a three days treatment with the 16% marbofloxacin
2
solution. These lesions did not induce clinical signs and should be
reversible,
particularly if they were to be observed after a single
administration.
In very rare cases (may occur in less than 1 of 10,000 treated
animals),
anaphylactic-type (allergic) reactions with a potentially fatal
outcome might
occur.
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Report" that appears on the home page of the
Ministry of Health web site (www.health.gov.il), which leads to an
online form
for
rep

Summary of Product characteristics

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forcyl 160 mg/ml solution for injection for cattle veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE INGREDIENT(S):
Marbofloxacin ....................... 160 mg
EXCIPIENTS:
Benzyl alcohol ………………... 15 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow greenish to yellow brownish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Therapeutic treatment of respiratory infections caused by sensitive
strains of _Pasteurella _
_multocida_ and _Mannheimia haemolytica_.
In lactating cows:
- Treatment of acute mastitis caused by_ _sensitive strains of
_Escherichia coli._
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones
or to any of the
excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones
(cross resistance).
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS
The efficacy of the product has not been tested on mastitis caused by
Gram positive
bacteria.
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when this 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.
Wherever possible, use of the product should only be based on
susceptibility testing.
Use of the product deviating from the instructions given in this 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.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINA