Florkem 300 mg/ml Solution for Injection for Cattle and Pigs

Country: Велика Британија

Језик: Енглески

Извор: VMD (Veterinary Medicines Directorate)

Активни састојак:

Florfenicol

Доступно од:

Ceva Animal Health Ltd

АТЦ код:

QJ01BA90

INN (Међународно име):

Florfenicol

Фармацеутски облик:

Solution for injection

Тип рецептора:

POM-V - Prescription Only Medicine – Veterinarian

Терапеутска група:

Cattle, Pigs

Терапеутска област:

Antimicrobial

Статус ауторизације:

Authorized

Датум одобрења:

2009-08-25

Карактеристике производа

Revised: September 2022
AN: 01506/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Florkem 300 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol ............................................. 300 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Colourless to yellow clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
Treatment of respiratory tract infections due to _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 or boars intended for breeding purposes.
Do not administer in cases of hypersensitivity to the active
ingredient or any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2022
AN: 01506/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Wipe the stopper before removing each dose. Use a dry, sterile needle
and syringe.
Do not use in piglets of less than 2 kg.
Under field conditions, approximately 30% of treated pigs presented
with pyrexia
(40°C) associated with either moderate depression or moderate
dyspnoea a week or
more after administration of the second dose.
Use of product should be based on susceptibility testing of the
bacteria isolated from
the animal. If this is not possible, therapy should be based on local
(regional, farm
level) epidemiological information about susceptibility of the target
bacteria.
Official national and regional antimicrobial policies should be taken
into account when
the product is used.
Use of the product deviating from the instructions given in the SPC
may