Butox®50

This summary of product characteristics (SPC) is specific to the European Union. Please note that Butox® 50 may not be licensed for use in your country or the product's data sheet may be different depending on local regulations. For more information please contact your local MSD Animal Health representative.

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

1.       NAME OF THE VETERINARY MEDICINAL PRODUCT

Butox 50 mg/mL concentrate for cutaneous solution for cattle and sheep

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:       Deltamethrin 50 mg/mL
For a full list of excipients, see section 6.1.

3.       PHARMACEUTICAL FORM

Concentrate for cutaneous solution

4.         CLINICAL PARTICULARS

4.1       Target species
Cattle, sheep

4.2       Indications for use, specifying the target species
Butox® 50 is used as a dip or spray solution for the prevention and the treatment of ectoparasitic infestations in cattle and sheep caused by the following parasites: mange mites, lice, ticks and flies.

4.3       Contraindications
None.

4.4     Special warnings for each target species
None.

4.5       Special precautions for use

Special precautions for use in animals
Do not treat the animals during very hot weather.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not spray facing the wind.
Do not eat, drink or smoke while using the product.
In case of contact with eyes and skin, wash immediately with water.
In the event of medical ingestion, seek medical advice immediately.
Wear protective gloves when applying the product or handling recently treated animals.
If clothing becomes heavily contaminated remove and wash before re-use.

4.6     Adverse reactions (frequency and seriousness)
None known.
The emergence of adverse reactions should be communicated to the competent authority.

4.7     Use during pregnancy, lactation or lay
Can be administered to animals at any stage of pregnancy and lactation.

4.8     Interaction with other medicinal products and other forms of interaction
Some organo-phosphorous insecticides can reduce metabolism rate and thus enhance deltamethrin toxicity. Therefore, avoid the simultaneous use of such organo-phosphorous insecticides.

    1. Amounts to be administered and administration route

For external use only.               

 

Indications

Quantity of Butox® 50 needed for 100 litres of water

Spray treatment

Plunge dip treatment

Charging

Topping up

Mange mites

100 ml

100 ml

150 ml

Lice

25 ml

25 ml

37.5 ml

Flies/Ticks

50 ml

50 ml

75 ml

Frequency of treatment recommended:
Mange mites: For curative treatment, two treatments at an interval of ten days should be made. For routine treatment, a single treatment every six months is recommended.
Lice: Usually, a single treatment provides protection against lice, depending on the infestation degree. 
Ticks: Treatment should be repeated depending on the level of infestation.
Flies: A single application provides protection against flies for 6 to 8 weeks depending on the infestation degree, fly species and weather conditions.           
Use:          
Plunge dips:     
a) Charging:
A pre-mix with Butox® 50 is made by adding a small quantity of water to the required quantity of Butox® 50. This pre-mix is distributed along the length of the dip and stirred thoroughly before the remaining quantity of water is added. By passing through the dip, the first 20 animals will mix the dip and therefore need to be treated twice.
b) Topping up:
After the treatment of a herd or when the dip volume has fallen by 10% of its initial volume, topping up should be carried out, adding the necessary quantity of water and Butox® 50.
c) General instructions:
Before starting the dip treatment, stir thoroughly. Ensure that the animals are neither tired nor thirsty before treatment. Do not treat the animals during very hot weather.

Sprays:
A pre-mix with Butox® 50 is made by adding a small quantity of water to the required quantity of Butox® 50. This pre-mix is stirred thoroughly before the remaining quantity of water is added.
Each treatment should use a minimum quantity of 3 litres of diluted product per animal, paying particular attention to the preferential sites of parasites.
For treatment of mange mites, a preliminary brushing is recommended.

4.10   Overdose (symptoms, emergency procedures, antidotes)
Not applicable.

4.11   Withdrawal periods
Edible tissues:   0 days (cattle)
                                    4 days (sheep)
Milk:                            0 days
                                    (Do not use milk from treated sheep for human consumption)

5.       PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: pyrethroid ectoparasiticide for topical use
 ATCvet code: QP53AC11

5.1     Pharmacodynamic properties
Butox® 50 is an ectoparasiticide whose active ingredient deltamethrin belongs to the synthetic pyrethroids class. Its mode of action affects the neurotransmission in the target parasite.

    1. Pharmacokinetic particulars

After dermal application, deltamethrin is slightly absorbed and remains available to the target ectoparasite. The main route of excretion in the target animal is by faeces.
 
Environmental properties
Dangerous to aquatic life.

6.       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Citric acid monohydrate
Calcium dodecylphenylsulfonate
Polyethoxylated tri-tert-butylphenol
2-Methoxyethyl acetate
C9 Aromatic solvent

6.2     Incompatibilities
None known.

6.3     Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years

6.4.    Special precautions for storage
Do not store above 25°C. Protect from direct sunlight. Keep out of the reach of children, away from food, drink and animal feeding stuffs.

6.5     Nature and composition of immediate packaging
250 mL or 1000 mL aluminium bottle closed by a screw polypropylene cap fitted internally with a polyethylene/aluminium composite joint.

6.6     Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with the national requirements. Dangerous to aquatic life. Do not contaminate ponds waterways or ditches with the product or used containers.

7.       MARKETING AUTHORISATION HOLDER

Intervet International B.V.
Wim de Körverstr. 35
5831 AN Boxmeer
The Netherlands

8.         MARKETING AUTHORISATION NUMBERS

9.         DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10        DATE OF REVISION OF THE TEXT

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.
butox 50