Flubenol 5% w/w Premix for Medicated Feeding Stuff

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Flubendazole

Available from:

Eli Lilly and Company Limited

ATC code:

QP52AC12

INN (International Name):

Flubendazole

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

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

Therapeutic group:

Pigs

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

1985-09-17

Summary of Product characteristics

Revised: June 2012
AN: 00170/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubenol 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
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Flubendazole is a broad spectrum anthelmintic for oral administration,
active
against mature and immature stages of the following nematodes of the
gastro-
intestinal tract of the pig:
_Ascaris suum_ (large roundworm)
_Hyostrongylus rubidus_ (red stomach worm)
_Oesophagostomum dentatum_ (nodular worm)
_Trichuris suis_ (whip worm)
_Strongyloides ransomi_ (threadworm) (adult).
_Metastrongylus apri _(lungworm).
Flubendazole is ovicidal.
4.3
CONTRA-INDICATIONS
Not applicable.
4.4
SPECIAL WARNINGS FOR TARGET SPECIES
None.
Page 1 of 6
Revised: June 2012
AN: 00170/2012
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
INTERACTION WITH OTH