SELECTAN 300 mg/ml solution for injection for cattle and swine

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Florfenicol

Dostupno od:

Laboratorios Hipra S.A.

ATC koda:

QJ01BA90

INN (International ime):

Florfenicol

Doziranje:

300 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Cattle, Pigs

Područje terapije:

florfenicol

Terapijske indikacije:

Antibacterial

Status autorizacije:

Authorised

Datum autorizacije:

2008-02-15

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SELECTAN
300 mg/ml solution for injection for cattle and swine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
Active substance
Florfenicol
……………………………………………………………………………
300 mg
Excipient
N-methyl pyrrolidone
……………………………………………...…………………
308 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A slightly yellowish and clear solution.
4.
CLINICAL PARTICULARS
4.1. TARGET SPECIES
Cattle and swine.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by florfenicol susceptible bacteria:
Cattle:
Therapeutic treatment of respiratory tract infections in cattle due to
_ Mannheimia haemolytica, _
_Pasteurella_
_multocida,_
and
_ Histophilus somni. _
Swine:
Treatment of acute outbreaks of respiratory disease caused by strains
of
_Actinobacillus _
_pleuropneumoniae _
and
_ Pasteurella multocida_
.
4.3. CONTRAINDICATIONS
Do not administer to adult bulls or boars intended for breeding
purposes.
Do not administer to animals with known hypersensitivity to the active
substance or to any of the
excipients.
4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5. SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use in piglets of less than 2 kg.
Swab the septum before removing each dose.
Use a dry, sterile syringe and needle.
Use of the veterinary medicinal product should be based on
susceptibility testing and take into
account official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of
bacteria resistant to the florfenicol and may decrease the
effectiveness of treatment with other
amfenicols, due to the potential for crossresistance.
_ _
SPECIAL PRECAUTION TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental