SIMPARICA is a chewable and palatable tablet readily consumed by dogs when offered by the owner. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The tablets should not be divided.
Tablets can be administered with or without food. The product should be administered at a dose of 2–4 mg/kg body weight in accordance with the following table:
|Body weight (kg)||Tablet strength (mg sarolaner)||Number of tablets to be administered|
|1.3 – 2.5||5||One|
|> 2.5 – 5||10||One|
|> 5 – 10||20||One|
|> 10 – 20||40||One|
|> 20 – 40||80||One|
|> 40 – 60||120||One|
|> 60.0||Appropriate combination of tablets||Appropriate combination of tablets|
If not all strengths are marketed, use appropriate combination of available strengths to achieve the recommended dose 2–4 mg/kg.
For optimal control of tick and flea infestations, the product should be administered at monthly intervals. Treatment with SIMPARICA chewable tablets may begin at any time of the year and based on local epidemiological situations should continue without interruption in areas where fleas and ticks are common year-round.
FOR ANIMAL USE ONLY
INDICATIONS FOR USE:
For the treatment of tick infestations on dogs. The product has immediate and persistent tick killing activity for at least 5 weeks. For the treatment and prevention of flea infestations on dogs. The product has immediate and persistent flea killing activity against new infestations for 5 weeks. The product may be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Consult your veterinarian. The product kills fleas before they can lay eggs. Fleas and ticks must attach to the host and commence feeding to be exposed to the active substance. For fleas, the onset of effect is within 8 hours of attachment. For ticks, the onset of effect is within 12 hours of attachment.
Sarolaner starts killing fleas 3 hours after administration; adequate treatment effect is achieved within 8 hours. Sarolaner starts killing ticks 8 hours after administration; adequate treatment effect is achieved within 12 hours (24 hours for ticks on the animal prior to administration). The product kills fleas before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
Active substance: Sarolaner 5 mg; 10 mg; 20 mg; 40 mg; 80 mg and 120 mg per chewable tablet. Mottled brown coloured, square shaped chewable tablets with rounded edges.
• Do not treat puppies less than 8 weeks of age and/or dogs weighing less than 1,3 kg.
• Do not treat pregnant and lactating dogs. IMPORTANT: Consult your veterinarian as the safety of this product has not been established during pregnancy and lactation. Use only as directed by your veterinarian according to a benefit/risk assessment by the responsible veterinarian.
• Only one chewable tablet at a time should be removed from the blister to prevent children from accessing the product. The blister should be returned into the carton and kept out of reach of children, uninformed persons and animals.
• Although this remedy has been extensively tested under a large variety of conditions, failure thereof may ensue because of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.
• Wash hands after handling the product.
• Dispose of any containers, disposable equipment and any other waste after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
Interaction with other medicinal products and other forms of interaction - None known.
Consult your veterinarian if you intend dosing SIMPARICA with other medications.
DIRECTIONS FOR USE:
Use only as directed
Tick and flea preparations should always be used with caution in animals suffering from or prone to seizures. Please contact your veterinary healthcare provider in this case, or if you are at all unsure regarding the safety and use of this product.