MARBOCYL 2 % SOLUTION FOR INJECTION VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MARBOFLOXACIN

متاح من:

ELIEZER LINEVITZ LTD.

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

MARBOFLOXACIN 2 %W/V

طريقة التعاطي:

I.M, I.V, S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

VETOQUINOL, FRANCE

الخصائص العلاجية:

In pre-ruminant and ruminant calves:Treatment of respiratory infections caused by susceptible strains of Pasteurella multocida, Mannheimia (Pasteurella) haemolytica and Mycoplasma bovis.In pigs:Treatment of respiratory infections caused by susceptible strains of Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae and Pasteurella multocida.The product should only be used when strain susceptibility has been tested.

تاريخ الترخيص:

2023-10-31

نشرة المعلومات

CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE
MARBOCYL 2% SOLUTION FOR INJECTION VETERINARY
2.
ACTIVE INGREDIENT and its quantity in a dose unit
One ml solution contains:
Marbofloxacin 20 mg
Inactive excipients: Disodium edetate 0.1 mg/ml, Thioglycerol 0.5
mg/ml, m-
cresol 2 mg/ml. For a full list of excipients see section 13 below.
3.
WHAT IS THE MEDICINE INTENDED FOR
IN PRE-RUMINANT AND RUMINANT CALVES:
- Treatment of respiratory infections caused by susceptible strains of
_Pasteurella _
_multocida, Mannheimia (Pasteurella) haemolytica_ _and Mycoplasma
bovis._
IN PIGS:
- Treatment of respiratory infections caused by susceptible strains of
_Actinobacillus _
_pleuropneumoniae, Mycoplasma hyopneumoniae_ and _Pasteurella
multocida._
The product should only be used when strain susceptibility has been
tested.
Therapeutic group: fluoroquinolone antibiotics for systemic use
.
4.
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.
5.
SIDE EFFECTS
Administration by subcutaneous and intramuscular route may cause
temporary
swelling.
Administration by intramuscular route may cause pain and inflammatory
lesions at
the injection site. Inflammatory lesions can last for 6 days in pigs
and 12 days in
calves.
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 reporting
side effects.
Alternatively you can use the following link:
https://sideeffects.health.gov.il
_ _
_ _
6.
TARGET SPECIES
Bovines and porcines during fatting.
7.
DOSAGE AND ADMINISTRATION
In preruminant and ruminant calves:
2 mg marbofloxacin per kg live weight, i.e. 1 ml of solutio

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 2% SOLUTION FOR INJECTION VETERINARY
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance(s):
Marbofloxacin…………………………………………….
20.0 mg
Excipient(s):
Disodium edetate………………………………………….
0.1 mg
Thioglycerol………………………………………………......
0.5 mg
m-cresol
.......................................…………….……….…..
2.0 mg
For a full list of excipients, see section ‘List of excipients’.
3. PHARMACEUTICAL FORM
Solution for injection.
Yellow green to yellow brown aqueous solution.
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES
Bovines and porcines during fatting.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In pre-ruminant and ruminant calves:
- Treatment of respiratory infections caused by susceptible strains of
_Pasteurella multocida, _
_Mannheimia (Pasteurella) haemolytica_ _and Mycoplasma bovis._
In pigs:
- Treatment of respiratory infections caused by susceptible strains of
_Actinobacillus _
_pleuropneumoniae, Mycoplasma hyopneumoniae_ and _Pasteurella
multocida._
The product should only be used when strain susceptibility has been
tested.
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 only be used to treat clinical disorders not
responding sufficiently to other
antibiotic classes, or when it is expected they will not respond
sufficiently to other antibiotic classes.
Bacterial sensitivity tests to antibiotics should be carried out
before using fluoroquinolones
whenever possible, and should take account of official and local
antibiotic use policies
Off-label use of the prod