Nuflor 40 mg/g Premix for Medicated Feeding Stuff for Swine

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Florfenicol

Tersedia dari:

Intervet Ireland Limited

Kode ATC:

QJ01BA90

INN (Nama Internasional):

Florfenicol

Dosis:

40 milligram(s)/gram

Bentuk farmasi:

Premix for medicated feeding stuff

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Pigs

Area terapi:

florfenicol

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2007-08-31

Karakteristik produk

Health Products Regulatory Authority
27 February 2018
CRN000WK7
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nuflor 40 mg/g Premix for Medicated Feeding Stuff for Swine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per gram:
​
​
ACTIVE SUBSTANCE:
QUANTITY:
​
Florfenicol
​40 mg
​
EXCIPIENTS:
​
​
Propylene Glycol (E1520)
10 mg
​
Ground Limestone
​qs to 1 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
White to off-white, free flowing powder with red and/or black grains
dispersed
throughout.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (Fattening pigs).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and metaphylaxis of swine respiratory disease caused
by
_Pasteurella multocida _susceptible to florfenicol in infected herds.
The presence of the
disease in the herd must be established before the product is used.
4.3 CONTRAINDICATIONS
Do not administer to boars intended for breeding.
Do not use in case of hypersensivity to the active substance or any of
the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Animals showing a decreased appetite and/or a poor general condition
should be
treated by the parenteral route.
Health Products Regulatory Authority
27 February 2018
CRN000WK7
Page 2 of 7
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 policy relating to the use of
antimicrobials.
This premix is intended for the manufacturing of solid medicated feed
and cannot be
used as it is; the incorporation rate of the premix in feed cannot be
lower than 5
kg/ton.
This premix contains ground limestone, which can lead to a decrease in
food
consumption and to a phosphorus calcium imbalance in feed intake. Care
should
therefore be taken to consider the calcium content of the final
medicated feed.
Treatment should not exceed 5 days.
In a field clinical study, within a wee