MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Florfenicol

Dostępny od:

SP Veterinaria, S.A.

Kod ATC:

QJ01BA90

INN (International Nazwa):

Florfenicol

Dawkowanie:

300 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Cattle, Pigs

Dziedzina terapeutyczna:

florfenicol

Wskazania:

Antibacterial

Status autoryzacji:

Authorised

Data autoryzacji:

2011-12-21

Charakterystyka produktu

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
MYCOFLOR, 300 mg/ml solution for injection for cattle and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Florfenicol 300 mg
EXCIPIENTS:
N-methyl pyrrolidone 200 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear, light yellow to yellow solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle: Treatment of respiratory tract infections due to strains of _
Mannheimia haemolytica, _
_Pasteurella multocida _and _Histophilus somni_ susceptible to
florfenicol_. _
Pigs:
Treatment
of
acute
outbreaks
of
swine
respiratory
disease
caused
by
strains
of
_Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_
susceptible to florfenicol.
4.3 CONTRAINDICATIONS
Do not use in adult bulls and boars intended for breeding purposes.
Do not use in piglets of less than 2 kg.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not administer intravenously.
Do not use in known cases of resistance to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product should be used in conjunction with susceptibility testing
and take into account
official and local antimicrobial policies.
The stopper must be cleaned before removing each dose. Use a dry,
sterile syringe and needle.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence
of bacteria resistant to florfenicol_ _ and may decrease the
effectiveness of treatment with other
antimicrobials, due to the potential for cross-resistance.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
Care should be taken to avoid accidental self-injection. In case of
accidental self-injection, seek
medical advice immediately and show the package leaflet or the labe