FLORFENIKEL 300 mg/ml solution for injection for cattle and pigs

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Florfenicol

Доступна с:

Kela n.v.

код АТС:

QJ01BA90

ИНН (Международная Имя):

Florfenicol

дозировка:

300 milligram(s)/millilitre

Фармацевтическая форма:

Solution for injection

Тип рецепта:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтическая группа:

Cattle, Pigs

Терапевтические области:

florfenicol

Терапевтические показания :

Antibacterial

Статус Авторизация:

Authorised

Дата Авторизация:

2012-02-24

Характеристики продукта

Page 2 of 17
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
FLORFENIKEL 300 mg/ml solution for injection for cattle and pigs (BE,
BG, CY, CZ, DE, FR, HU, IE,
IT, LU, NL, PT, RO, SK, UK)
KELAFLOR 300 mg/ml solution for injection for cattle and pigs (DK, ES,
PL)
FLORIKEL 300 mg/ml solution for injection for cattle and pigs (EL)
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.
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 case of hypersensitivity to florfenicol or to any of the
excipients.
Do not use in case of resistance to the active substance.
Do not administer intravenously.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The stopper must be cleaned before removing each dose. Use a dry,
sterile syringe and needle.
Page 3 of 17
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 increase the prevalence of bacteria
resistant to florf