Solubenol » 100mg/g Oral Solution Poultry Wormer

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Elanco Animal Health
Address: Eli Lilly and Company Limited
Lilly House
Priestley Road, Basingstoke
Hampshire, RG24 9NL
Telephone: 01256 353131
Fax: 01256 779510
Email: elancouk@lilly.com
Website: www.elanco.com
 
Company name: Elanco Companion Animal Health
Address: Eli Lilly and Company Limited
Lilly House
Priestley Road, Basingstoke
Hampshire, RG24 9NL
Telephone: 01256 353131
Technical & Academic Services (24 hr response 01256 779956)
Fax: 01256 779510
Email: elancoCAH.UK@lilly.com
Website: www.elanco.com
 

Presentation

Oral emulsion. A white homogeneous viscous liquid. Each g contains 100 mg flubendazole as active ingredient for administration in drinking water.
Excipients include: 4 mg/g propyl parahydroxybenzoate (E216), 4 mg/g methyl parahydroxybenzoate (E218), 0.2 mg/g butylhydroxytoluene (E321) and 50 mg/g propylene glycol
 

Uses

For pigs and chickens (laying hens, breeders and pullets).
For treatment of worm infestations caused by:
Chickens (laying hens, breeders and pullets)
Ascaridia galli (adult stages)
Heterakis gallinarum (adult stages)
Capillaria spp (adult stages)
Pigs
Ascaris suum (adult and intestinal larval stages)
 

Dosage and administration

Chickens (laying hens, breeders and pullets)
1.43 mg flubendazole per kg body weight daily via oral administration, i.e. 1 g of the product per 70 kg body weight daily for 7 days.
Pigs
a. Treatment of mature stages and intestinal larval stages of Ascaris suum in piglets, finishers and gestating sows
1 mg flubendazole (= 10 mg product) per kg body weight daily via oral administration during 5 days, i.e. 1 g of the product per 100 kg body weight daily for 5 days
b. Treatment of mature stages of Ascaris suum in piglets and finishers
2.5 mg flubendazole (= 25 mg product) per kg body weight daily via oral administration during 2 days, i.e. 2.5 g of the product per 100 kg body weight daily for 2 days.
In pigs, ensure animals to be treated are grouped by weight. Dose to the heaviest animal in the group. This will avoid overdosing smaller pigs which may lead to residue violations. Calculate the dosage accurately with the following formula:

This will result in a concentration of flubendazole between 20 and 200 mg per litre
Administration in drinking water
1) The required quantity of the product is a function of the estimated body weight of the total group of animals (see table below for guidance).

2) Each day prepare a predilution containing the daily required dose of the product mixed in 10 to 100 times its weight in water (depending on the distribution system). For example: 500 g of the product can be added to between 5 and 50 litres of water.
3) Squeeze the sachet gently before use and then empty the contents into the predilution container.
4) Stir the predilution vigorously with a manual mixer (whisk) for at least 3 minutes to obtain a white milky homogenous mixture.
5) This predilution must be distributed via the general water supply system:
Tanks: add the predilution to the quantity of water usually consumed by the animals over a period of 4 hours, homogenize the contents of the reservoir at least every 30 minutes with an electric or manual mixer.
Dosing pumps: adjust the flow rate of the pump to distribute the predilution over a period of 4 hours. Homogenize the predilution every 30 minutes with an automatic mixer or manually.
In order to ensure administration of the correct dose, a substantial water flow must be present in the drinking water system and mixing of the solution in the delivery system (tank or dosing pump) is essential during application. Administration of the product over a period of up to 4 hours on each treatment day, at times when water consumption is likely to be highest, prevents precipitation of flubendazole in the water delivery system and allows washing out of the drinking water system within a 24 hour period after the period of drug administration is finished.
6) Prior to and after the period of treatment make sure the water distribution system is cleaned.
7) Make sure that all animals in the group receive enough drinking water containing the product. Withhold drinking water for 2 hours before treatment to stimulate thirst.
8) The corresponding dose must always be distributed when the water consumption of the animals is highest.
 

Contra-indications, warnings, etc

Do not use in case of hypersensitivity to active ingredient or to any of the excipients.
Special precautions for use
Development disorders of the feathers cannot be fully excluded after the administration of flubendazole when administered in chickens, pigeons and parrots. In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the maintenance of the cages.
Adverse reactions
No undesirable effects have been demonstrated after administration of the therapeutic dose in pigs or in chickens.
Use during pregnancy, lactation or lay
The safety of the product has been demonstrated in laying hens. The product can be administered to these animals.
At the dose regimen of 1mg flubendazole/kg/day for 5 days the product can be used in pregnant sows. The safety of the product has not been demonstrated at the dose regimen of 2.5 mg flubendazole for 2 days. Do not use in pregnant sows at this dose regimen.
The safety of the product has not been assessed in lactating sows. The use of the product during the lactation should be subject to benefit/risk ratio assessment by the responsible veterinarian.
Withdrawal Periods
Chickens
Meat and offal: 4 days
Eggs: (0) zero days
Pigs
Meat and offal: 4 days
Other special precautions
Due to concerns for the environment when the product is used in free range poultry or pigs, animals must be kept indoors during the treatment period and for 1 day after last treatment.
Overdose
In chickens, no undesirable effects have been observed after administration of up to 4 times the recommended dose for 14 days. Even at doses 4 times the recommended dose, egg quality is not altered. Only a reduction in egg weight and a slight decrease in egg production may be observed with doses of twice the recommended dose and over. Egg weight returns to normal when treatment is discontinued.
In pigs, no undesirable effects have been observed at the highest dose: 5 x 2.5 mg per kg body weight during 3 x 2 consecutive days (or 12.5 mg during 6 consecutive days). In the event of a massive overdose, mild transient diarrhoea may occur by the 2nd day of treatment, possibly lasting for 7 to 12 days without affecting the behaviour or performance of the animals.
User Safety Warnings
Direct contact with the product should be avoided. It is advisable to wear gloves when handling the product. Wash hands after use.
People with known hypersensitivity to flubendazole should avoid contact with the product.
In the event of eye contact, rinse thoroughly with water and if conjunctival redness persists, seek medical advice.
Disposal advice
Any unused product or waste material should be disposed of in accordance with national requirements.
For animal treatment only. Keep out of the reach and sight of children.
 

Pharmaceutical precautions

This veterinary medicinal product does not require any special storage conditions.
Shelf-life after dilution: 1 day. Do not use after the expiry date stated on the carton.
Do not mix with any other veterinary medicinal product
 

Legal category

POM-VPS
 

Packaging Quantities

Box containing 5 sachets of 100 g
 

Further information

Nil
 

Marketing authorisation number

Vm 00242/4063.