Flubenvet 5 % w/w Premix for Medicated Feeding Stuff

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Flubendazole

Tilgængelig fra:

Kernfarm B.V.

ATC-kode:

QP52AC12

INN (International Name):

Flubendazole

Lægemiddelform:

Premix for medicated feeding stuff

Recept type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Terapeutisk gruppe:

Chickens, Goose, Partridge, Pheasants, Turkeys

Terapeutisk område:

Anthelmintic

Autorisation status:

Authorized

Autorisation dato:

2017-01-24

Produktets egenskaber

Unlimited Renewal: February 2022
AN: 02329/2021
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubenvet 5 % w/w Premix for Medicated Feeding Stuff
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Flubendazole
50 mg
EXCIPIENT:
Titanium dioxide
20 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
White to slightly yellow powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pheasant, partridge, chicken, goose, and turkey.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Flubendazole is a broad spectrum anthelmintic, effective against
mature and
immature stages and eggs of the following nematodes of chickens,
turkeys,
geese, partridges and pheasants:
In the gastrointestinal tract:
_Ascaridia galli, Heterakis gallinarum, _
_Capillaria _spp_., Amidostomum anseris _and
_Trichostrongylus tenuis._
In the respiratory tract:
_Syngamus trachea_
4.3
CONTRAINDICATIONS
None known
Unlimited Renewal: February 2022
AN: 02329/2021
Page 2 of 5
4.4
SPECIAL WARNINGS FOR TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
None.
i.
Special precautions for use in animals
None.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental ingestion by humans should be avoided. May cause
sensitisation by skin contact. May cause skin and eye irritation.
Avoid
direct skin contact. Wear overalls, safety glasses and impervious
gloves
when mixing and handling the product. Wash affected parts if skin
contact
occurs. If accidental eye contact occurs, immediately rinse thoroughly
with
water. If the operations involve potential exposure to dust, wear
either a
disposable filter and half-mask respirator conforming to European
Standard EN149, or a non-disposable respirator to European Standard
EN140 fitted with a filter to EN143.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8
INTER