Elanco Gastro Dectomax Injection

Introduction

Company name: Elanco Animal Health

Address: Eli Lilly and Company Limited

Lilly House

Priestley Road, Basingstoke

Hampshire, RG24 9NL

Telephone: 01256 353131

Veterinary Education & Technical Services (24 hr response 01256 353131 option 1)

Fax: 01256 779510

Email: [email protected]

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

Veterinary Education & Technical Services (24 hr response 01256 353131 option 1)

Fax: 01256 779508

Email: [email protected]

Website: www.elanco.com

Presentation

Dectomax solution for injection is a ready-to-use, clear colourless to pale yellow, sterile solution containing 1% w/v doramectin (10 mg/ml).

Each 1ml contains:

Active ingredient - Doramectin 10.00mg

Excipients - ethyl oleate 218.00mg

Uses

Cattle

For the treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, eyeworms, warbles, lice and mange mites.

Gastrointestinal roundworms (adults and fourth stage larvae)

Ostertagia ostertagi (incl. inhibited larvae)

O. lyrata1

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C.pectinata1

C.punctata

C.surnabada (syn. mcmasteri)

Nematodirus spathiger1

Bunostomum phlebotomum1

Strongyloides papillosus1

Oesophagostomum radiatum

Trichuris spp.1

Lungworms (adults and fourth stage larvae)

Dictyocaulus viviparus

Eyeworms (adults)

Thelazia spp.

Warbles (parasitic stages)

Hypoderma bovis, H.lineatum

Sucking lice

Haematopinus eurysternus. Linognathus vituli, Solenopotes capillatus

Mange mites

Psoroptes bovis, Sarcoptes scabiei

1 adults only

Dectomax solution for injection may also be used as an aid in the control of Nematodirus helvetianus, biting lice (Damalinia bovis) and the mange mite Chorioptes bovis.

The pharmacokinetics of Dectomax solution for injection allow protection of cattle against infection or re-infection with the following parasites for the period indicated:

To obtain optimal benefit from the action of Dectomax solution for injection, it is recommended that cattle which are set-stocked should be treated at turnout and eight weeks later. Studies have demonstrated that, used in this way, Dectomax will reduce the build-up of infective larvae on pasture and can protect animals from parasitic gastro-enteritis and parasitic bronchitis throughout the grazing season. To obtain these results, all animals must be included in the programme and untreated cattle must not be introduced on the pasture. Treated cattle should always be monitored according to good husbandry practices. Treatment with Dectomax solution for injection at turnout and eight weeks later of cattle set-stocked for the grazing season can protect against clinical disease caused by lungworm and may allow the development of naturally acquired immunity. However, due to the unpredictable nature of lungworm epidemiology, clinical signs of lungworm disease may on occasion be seen, particularly towards the end of the grazing season, if the season is long. If this occurs, cattle should be further treated with an anthelmintic effective against lungworm.

Sheep

For the treatment and control of Psoroptes ovis (sheep scab mite) and for the treatment and control of gastrointesinal roundworms and nasal bots

Mange mites

Porsoptes ovis

Gastrointestinal roundworms (Adults and fourth stage larvae(L4) unless otherwise indicated)

Chabertia ovina (adults only)

Cooperia curticei (L4 only)

C. oncophora

Gaigeria pachyscelis

Haemonchus contortus

Nematodirus battus (L4 only)1

Oesophagostomum columbianum

Ostertagia (Teladorsagia) circumcincta *

Strongyloides papillosus

Trichostrongylus axei

T. colubriformis

T. vitrinus

Trichuris spp. (adults only)

* Inhibited larval stages (L4) including strains that are benzimidazole resistant, are also controlled.

1 For effective treatment and control of both adults and L4 larvae of Nematodirus battus a dose rate of 300 mcg/kg is required.

Lungworm

Dictyocaulus filaria (adults only)

Nasal bots (1st, 2nd and 3rd instar larvae)

Oestrus ovis

Dosage and administration

Dectomax is a clear, sterile solution. In common with other non-aqueous formulations the product contains no antimicrobial preservative. Dry, sterile equipment and aseptic procedures should therefore be used when administering Dectomax to animals. Swab the septum before removing the dose. When the temperature of the formulation is below 5°C, syringeability may be improved by gently warming the injecting equipment and product.

When treating groups of animals, use only the Dectomax automatic dosing device and vented draw-off apparatus. When treating individual animals syringes must be filled from the vial through a dry, sterile draw-off needle that has been placed in the vial stopper. Vial stoppers must not be broached more than 20 times.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Cattle

A single treatment of 1ml (10mg doramectin) per 50kg bodyweight, equivalent to 200mcg/kg bodyweight, administered in the region of the neck by subcutaneuous injection.

Sheep

A single treatment of 1ml 10mg doramectin) per 33kg bodyweight, equivalent to 300 mcg/kg bodyweight, administered by intramuscular injection for the treatment and control of Psoroptes ovis (sheep scab mite) and adult Nematodirus battus. In addition, adequate bio-security measures should be implemented to prevent re-infestation. Ensure that all sheep which have been in contact with infested sheep are treated. After treatment contact between treated infected and untreated uninfected flocks must be avoided for at least 14 days.

Suggested dose rates for Psoroptes ovis (sheep scab mite) and Nematodirus battus: 1 ml/33 kg bodyweight (300 mcg/kg). Sheep over 16 kg bodyweight:

In young lambs of less than 16 kg bodyweight seek veterinary advice regarding the use of appropriate sized needles and of 1 ml disposable syringes graduated in increments of 0.1 ml or less. Suggested dose rates at 1 ml/33 kg bodyweight (300 mcg/kg) in young lambs:

For treatment of gastro-intestinal roundworms, lungworms and nasal bots, administer Dectomax solution for injection once at a dosage of 200 mcg doramectin per kilogram of bodyweight by the intramuscular route. Each ml contains 10 mg of doramectin, sufficient to treat 50 kg of bodyweight.

Contra-indications, warnings, etc

Do not use in dry dairy cows including pregnant dairy heifers within 60 days of calving.

Extra label use in dogs should be avoided, as severe adverse reactions may occur. In common with other avermectins, certain breeds of dog, such as collies, are especially sensitive to doramectin and particular care should be taken to avoid accidental consumption of the product.

Operator warnings

Do not eat, drink or smoke while handling the product. Wash hands after use.

Take care to avoid accidental self administration - seek medical attention should any specific signs be noticed

Advice to Medical Practitioners: In cases of accidental self injection specific symptoms have rarely been observed and therefore any cases should be treated symptomatically.

Withdraw Period

Animals must not be slaughtered for human consumption during treatment.

Cattle

Meat and Offal: 56 days

Milk: Not permitted for use in lactating cows used to produce milk for human consumption.

Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving.

Sheep

Meat and offal: 63 days

Milk: Not permitted for use in dairy ewes producing milk for human consumption.

Disposal advice

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

EXTREMELY DANGEROUS to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or used container.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

•Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

•Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintics belonging to another pharmacological class and having a different mode of action should be used.

Resistance to doramectin (an avermectin) has been reported in Teladorsagia and Haemonchus in sheep within the EU. Therefore the use of this product should be based on a local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Pharmaceutical precautions

Store below 30°C. Do not freeze or refrigerate. Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Dispose of unused material safely.

This product does not contain an antimicrobial preservative. Swab septum before removing each dose. Use sterile equipment and follow aseptic procedures.

For animal treatment only.

Keep out of reach of children.

Legal category

POM-VPS

Packaging Quantities

Multi-dose vials of 50 ml, 200 ml and 500ml in rubbed capped amber glass vials. Not all pack sizes may be merketed.

Further information

Sheep scab (caused by Psoroptes ovis) is an extremely contagious disease. In view of scab control requirements in the UK, treatment with 300 mcg doramectin per kg bodyweight is recommended to ensure elimination of all mites. In addition, where possible, adequate bio-security measures should be implemented to prevent re-infestation. Ensure that all sheep which have been in contact with infested sheep are treated. After treatment, contact between treated infected and untreated uninfected flocks must be avoided for at least 14 days. When used for scab treatment in sheep, Dectomax solution for injection is also effective against certain gastro-intestinal roundworms, and this treatment may form part of a worm control programme in the flock.

Anthelmintics class

3-AV

Marketing authorisation number

Vm 00006/4121.

GTIN (Global Trade Item No)

Dectomax 10mg/ml Injection for Cattle & Sheep 50ml

05014602800253

Dectomax 10mg/ml Injection for Cattle & Sheep 250ml

05014602800260

Dectomax 10mg/ml Injection for Cattle & Sheep 500ml

05014602800284