Introduction

Company name: Merial Animal Health Ltd

Address: PO Box 327

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

Telephone: Companion Animals 0870 6000123

Production Animals 0800 592699

Fax: 01279 775888

Email: ukenquiry@merial.com

Website: www.merial.com

Presentation

A sterile solution for injection containing 1% w/v ivermectin.

Uses

Cattle

For the treatment and control of gastro-intestinal roundworms, lungworms, eye worms, warbles, mites and lice of beef and non-lactating dairy cattle, as shown below.

PANOMEC Injection at the recommended dosage level of 200 micrograms ivermectin per kg bodyweight:

1. Provides effective treatment and control of the following parasites of cattle.

			Inhibited
CATTLE PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia lyrata	•	•
Ostertagia ostertagi	•	•	•
Cooperia oncophora	•	•
Cooperia pectinata	•	•
Cooperia punctata	•	•
Haemonchus placei	•	•
Trichostrongylus axei	•	•
Trichostrongylus colubriformis	•	•
Bunostomum phlebotomum	•	•
Oesophagostomum radiatum	•	•
Strongyloides papillosus	•
Nematodirus helvetianus	•
Nematodirus spathiger	•
Trichuris spp.	•
Lungworms:
Dictyocaulus viviparus	•	•
Eye Worms:
Thelazia spp.	•
Warbles:	Adult	Immature
Hypoderma bovis		•
H. lineatum		•
Mange Mites:
Psoroptes bovis	•	•
Sarcoptes scabiei var. bovis	•	•
Sucking Lice:
Linognathus vituli	•	•
Haematopinus eurysternus	•	•
Solenopotes capillatus	•	•

2. May also be used as an aid in the control of the mange mite Chorioptes bovis and biting lice (Damalinia bovis), but complete elimination may not occur.

When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with PANOMEC Injection given at the recommended dosage of 0.2 mg per kg bodyweight controls re-infection with:

	Prolonged activity
Lungworm- Dictyocaulus viviparus	up to 28 days
Brown stomach worm - Ostertagia ostertagi	up to 21 days
Nodular worm - Oesophagostomum radiatum	up to 21 days
Small intestinal worm - Cooperia spp.	up to 14 days
Hairworm - Trichostrongylus axei	up to 14 days
Barbers pole worm - Haemonchus placei	up to 14 days

To obtain optimal benefit from the persistent activity of PANOMEC Injection for grazing animals it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves are included in the programme and that no untreated cattle are added to the pasture.

Treated calves should always be monitored according to good husbandry practices.

Sheep

For the treatment and control of psoroptic mange (sheep scab), gastro-intestinal nematodes, lungworms and nasal bots of sheep.

PANOMEC Injection, at the recommended dosage level of 200 mcg ivermectin per kg bodyweight, effectively controls the following parasites of sheep:

			Inhibited
SHEEP PARASITE	Adult	L4	L4
Gastrointestinal Roundworms:
Ostertagia circumcincta	•	•	•
O. trifurcata	•	•
Haemonchus contortus	•	•	•
Trichostrongylus axei	•
T. colubriformis	•	•
T. vitrinus	•
Cooperia curticei	•	•
Oesophagostomum columbianum	•	•
O. venulosum	•
Nematodirus filicollis	•	•
Chabertia ovina	•	•
Trichuris ovis	•
Lungworms:
Dictyocaulus filaria	•	•
Protostrongylus rufescens	•
Nasal Bots:	Adult	Immature
Oestrus ovis		•
Mange Mites:
Psoroptes ovis*	•	•
*For the treatment and control of sheep scab, 2 injections with a seven day interval are required to treat clinical signs of scab and to eliminate mites.

Pigs

For the treatment and control of gastro-intestinal nematodes, lungworms, lice and mange mites of pigs.

PANOMEC Injection at the recommended dose rate of 300 mcg ivermectin per kg bodyweight provides effective control against the following parasites of pigs:

PIG PARASITE	Adult	L4
Gastrointestinal Roundworms:
Ascaris suum	•	•
Hyostrongylus rubidus	•	•
Oesophagostomum spp.	•	•
Strongyloides ransomi **	•
Lice:	Adult	Immature
Haematopinus suis	•	•
Mange Mites:
Sarcoptes scabiei var. suis	•	•
**Includes somatic larval stages

Dosage and administration

Cattle: Dosage

1 ml per 50 kg bodyweight (based on a recommended dosage level of 200 micrograms ivermectin per kg bodyweight).

Administration

Inject subcutaneously under the loose skin in front of or behind the shoulder. A sterile 17 gauge ½ inch needle is recommended.

Sheep: Dosage

0.5 ml per 25 kg bodyweight (based on a recommended level of 200 micrograms ivermectin per kg bodyweight).

Administration

For the treatment of gastro-intestinal roundworms, lungworms and nasal bots, inject once subcutaneously in the neck, using aseptic precautions; a sterile 17 gauge ½ inch needle is recommended. For the treatment and control of Psoroptes ovis (sheep scab), two injections with seven day interval are required to treat clinical signs of scab and to eliminate mites.

Pigs: Dosage

1 ml per 33 kg bodyweight (based on a recommended level of 300 mcg ivermectin per kg bodyweight).

Administration

The recommended route of administration is by subcutaneous injection into the neck using aseptic technique and a 17 gauge ½ inch needle.

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.

When treating groups of animals use only an automatic dosing device (with vented draw-off apparatus when using the 50 ml vial).

When treating individual sheep, a syringe not exceeding 2 ml and calibrated in increments of 0.1 ml should be used.

Each ml contains 10mg of ivermectin sufficient to treat 50kg of bodyweight of cattle and sheep and 33kg of bodyweight of pigs. The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of a 17 gauge x ½ inch needle is suggested.

Replace with a fresh sterile needle after every 10 to12 animals.

Injection of wet or dirty animals is not recommended.

PANOMEC Injection for Cattle, Sheep and Pigs can be administered to beef cows and ewes at any stage of pregnancy or lactation provided that the milk is not intended for human consumption, and to sows at any stage of pregnancy or lactation. It can be used in breeding ewes, rams, sows and boars and will not affect fertility. PANOMEC Injection for Cattle, Sheep and Pigs can be given to all ages of animals including young calves, lambs and piglets.When treating pigs and sheep of less than 16kg, seek veterinary advice regarding the use of 1ml disposable syringes graduated in increments of 0.1 ml.

Contra-indications, warnings, etc

For animal treatment only.

This product is not for intravenous or intramuscular use.

Do not smoke, eat or drink while handling the product.

Wash hands after use.

Take care to avoid self injection: the product may cause local irritation and/or pain at the site of injection. Read package leaflet before use.

PANOMEC injection for Cattle, Sheep and Pigs has been formulated specifically for use in those species. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

Cattle

Must not be treated within 35 days of slaughter for human consumption. Do not use in cattle producing milk for human consumption.

Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Sheep

Must not be slaughtered for human consumption until 42 days after the last treatment. Since no milk withholding period has been established, do not treat lactating ewes where milk is to be used for human consumption.

Treatment of psoroptic mange (sheep scab) with one injection is not recommended, because although a clinical improvement may be seen, elimination of all mites may not occur.

Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. Following treatment of infected sheep, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the sheep. It is important to ensure all sheep which have been in contact with infected sheep are treated. Contact between treated infected and non-treated, non-infected flocks must be avoided until at least 7 days after the last treatment.

Pigs

Must not be treated within 28 days of slaughter for human consumption.

Container disposal:

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate ponds, waterways or ditches with product or empty containers. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

This product does not contain an antimicrobial preservative.

Swab septum before removing each dose.

Use a dry sterile needle and syringe.

Protect from direct sunlight and store below 30° C.

Following withdrawal of the first dose, use the product within six months.

When using the 200 ml and 500 ml pack sizes, use only automatic syringe equipment.

Discard unused material.

Keep out of reach of children.

Legal category

POM-VPS

Packaging Quantities

50 ml containers.

Further information

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. Immediately following subcutaneous injection, activity suggesting pain, sometimes intense but usually transient, has been observed in some sheep. Mild and transient pain reactions may be seen in some pigs following subcutaneous injection. All of these reactions have disappeared without treatment.

In cattle, single doses of 4mg ivermectin per kg (20 x the usual level) given subcutaneously resulted in ataxia and depression. In sheep, dose levels up to 4mg per kg (20 x the usual level) given subcutaneously resulted in ataxia and depression. In pigs, a dose of 30mg ivermectin per kg (100 x the recommended dose) injected subcutaneously into pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency. No antidote has been identified, however, symptomatic therapy may be beneficial.

PANOMEC Injection has been used concurrently without adverse effects with clostridial vaccine, given at separate injection sites. Adequate vaccination of sheep against clostridial infections is strongly recommended.

Ivermectin belongs to the avermectin (3-AV) class of anthelmintic endectocides.

Marketing authorisation number

Vm 08327/4193.