Sheep.

Startect Dual Active is a broad spectrum anthelmintic for the treatment and control of mixed gastro-intestinal nematode infections and associated diseases of sheep. The spectrum of activity is as follows:

Haemonchus contortus (including inhibited larval stages)

Teladorsagia (Ostertagia) circumcincta (including inhibited larval stages)

Oesophagostomum venulosum (adult)

Dictyocaulus filaria (adult)

This product is effective against strains of parasites resistant to benzimidazoles, levamisole, macrocyclic lactones, and combinations of these.

Do not use in dogs as severe adverse reactions may occur.

Do not use in horses as severe adverse reactions, including fatalities, will occur.

Do not exceed the recommended dose rate.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

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:

- Underdosing, which may be due to underestimation of bodyweight, misadministration of the product or lack of calibration of the dosing device.

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

Assess bodyweight as accurately as possible before calculating dosage. Suspected clinical cases of resistance should be further investigated using the appropriate tests, e.g. (Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

The recommended dose of Startect Dual Active is 0.2 ml/kg; doses of 0.9 ml/kg and higher (4.5X the recommended dose) can cause signs of toxicity and may lead to fatalities.

If animals are batched for dosing it is very important that careful consideration be given to the weight range within each group, to avoid the risk of overdosing smaller animals. A representative sample of animals should be weighed before treatment.

Accuracy and proper functioning of the dosage device should be checked.

The safety of Startect Dual Active has not been established in sheep under six weeks of age or weighing less than 10 kg.

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

Personal protective equipment consisting of impermeable rubber gloves should be worn when handling the veterinary medicinal product.

Avoid ingestion, inhalation and eye and skin contact. Wash hands after handling the product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

In case of accidental eye or skin contact, wash affected areas immediately with clean running water and seek medical attention if irritation persists.

The product is toxic to dung insects. It is excreted mainly in faeces and it cannot be excluded that insects using dung excreted after treatment may be adversely affected. Using the product strictly in accordance with the SPC will keep this risk to a minimum.

None.

Sheep:

Very common (>1 animal / 10 animals treated):

coughing1

1Mild and transient.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Can be used in pregnant and lactating animals.

Can be used in breeding animals.

None known.

Startect Dual Active is a ready-to-use oral solution.

The dose for sheep is 2 mg derquantel and 0.2 mg abamectin per kg bodyweight. i.e. 1 ml of product per 5 kg bodyweight.

Drench sheep orally, using a drench gun with silicone sealed ‘o’ rings.

Check dose rates and the accuracy of the drench gun before treatment commences.

Do not under-or over-dose. To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly. Set the dosing gun to deliver the correct dose volume for the weight of sheep to be treated (see figure 1).

Figure 1

Gently place the nozzle of the drench gun over the back of the tongue and depress the trigger (see figure 2).

Figure 2

Doses of 0.9 ml/kg and higher have been associated with symptoms of toxicity. Signs of toxicity include dullness, depression, incoordination, weakness, decreased gastrointestinal motility and abnormal breathing pattern, recumbency and death. Non-fatal adverse events have been shown to be fully reversible. Supportive veterinary care is indicated; there is no known antidote.

Not applicable.

Meat and offal: 14 days.

Milk: Not authorised for use in animals producing milk for human consumption.