Lapizole® 20 mg/ml Suspension for Oral Administration

Introduction

Company name: Dechra Veterinary Products Limited

Address: (A business unit of Dechra Pharmaceuticals PLC)

Sansaw Business Park

Hadnall, Shrewsbury

Shropshire SY4 4AS

Telephone: 01939 211200

Fax: 01939 211201

Email: info.uk@dechra.com

Website: www.dechra.com

Small Animal Exemption Scheme (SAES) product

Qualitative and quantitative composition

1 ml suspension contains: Active substance:

Fenbendazole 20 mg

Palatable aniseed flavour.

Pharmaceutical form

Suspension for oral administration.

Clinical particulars

Target species

Rabbits, birds, reptiles and ferrets.

Indications for use

Lapizole is a broad-spectrum, oral anti-parasiticide for administration in the prevention and treatment of infections caused by internal parasites of rabbits, ferrets, birds, reptiles, including Encephalitozoon cuniculi.

Contraindications

Lapizole is only for use in rabbits, birds, reptiles and ferrets. Do not use in animals other than those indicated.

Do not use in pregnant animals.

Do not overdose.

Special warnings for each target species

In birds, fenbendazole can cause intestinal problems and inhibit bone marrow production. Do not use in nestlings/growing birds or those in moult. In some mammalian species, high doses of fenbendazole can lead to bone marrow suppression, gastrointestinal tract irritation and problems in pregnancy. Do not overdose. As with all veterinary medicines, occasional instances of allergic response due to prior sensitisation, drug intolerance and idiosyncratic reactions may occur.

Special precautions for use

For animal treatment only. If you are uncertain about the condition of your pet, consult a veterinary surgeon. If symptoms persist, consult a veterinary surgeon.

Special precautions to be taken by the person administering the product to animals

Avoid contact with the skin. Wash hands with soap and water following treatment.

Use during pregnancy and lactation

No data available. Do not use in pregnant animals.

Interactions

None known.

Amounts to be administered and administration route

Suspension for oral administration.

Weigh animal carefully before administration to accurately assess the appropriate dose.

Shake the bottle well before each daily administration. Using the easy dose syringe:

Remove the cap and peel off the foil bottle covering.

Place the plastic plug into the neck of the bottle.

Push the syringe firmly into the plug (hole) in the neck of the bottle.

Turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger, drawing the liquid to the correct mark on the syringe.

Turn the bottle the right way up and remove the syringe from the plug by gently twisting the syringe.

After use, replace the cap. Wash the syringe in warm water and allow to dry.

(Please refer to dosing guide).

Dosing Guide for Lapizole

Species/

Indication

Amount of

Lapizole to

administer

Equivalent

fenbendazole dose rate

Rabbits:

treatment/

prevention

E. Cuniculi

1 ml/kg daily for 28 days

20 mg/kg

Rabbits:

routine

worming

1 ml/kg daily for 5 days

Repeat every 3 months

20 mg/kg

Ferrets:

routine

worming

1 ml/kg daily for 5 days

Repeat every 3 months

20 mg/kg

Pigeons:

routine

worming

0.5 ml per bird for 3 days

10 mg per bird

Exotic birds -

all species:

routine

worming

1 ml/kg: mix in a small quantity feed then add to daily ration daily for 7 days

20 mg/kg

Reptiles -

lizards and

snakes

2.5 ml/kg daily for 7 days

50 mg/kg

Reptiles -

tortoises

De-worm after faecal screening for parasites. 1 ml/kg (20 mg/kg)

once per week for up to 4 weeks

20 mg/kg

Withdrawal period

Not applicable. For pet animals only. Do not use in animals intended for human consumption. Do not eat the eggs of treated birds.

Pharmaceutical particulars

Incompatibilities

None known.

Special precautions for storage

Do not store above 25°C. Do not freeze. Keep out of direct sunlight. Keep out of the reach and sight of children.

Immediate packaging

Polypropylene container containing 100 ml of suspension and a dosing syringe.

Disposal

After use dispose of empty container with domestic refuse.

Wholesaler dealer's authorisation number

WDA 1732.

Further information

Encephalitozoon cuniculi is a protozoal parasite of rabbits which affects the nervous and urinary systems and can cause a number of clinical signs. These include, but are not limited to, head tilt, hind limb paralysis or weakness, eye problems and death. It is a common parasite which is frequently sub-clinical, but in one study over 50% of rabbits in the UK were shown to have been infected.

Encepalitozoon cuniculi may be passed on to humans and presents a potential risk to individuals who may have deficiencies to the immune system.

Published data on the efficacy of fenbendazole in the treatment and prevention of Encepalitozoon cuniculi in rabbits indicate that a minimum treatment period of 28 consecutive days at 20 mg/kg body weight is required for adequate control.

Date of last review: April 2012

Legal category

SAES

GTIN (Global Trade Item No)

Lapizole 20 mg/ml Suspension for Oral Administration 100 ml:

05060019580639

Significant Changes