DISCLAIMER
This information summarizes the current status of our knowledge and may differ from the legally binding, country specific use instructions provided with the product. Novartis Animal Health Inc. is not liable for damages or injury caused by the use of its products different from those specified on the pack label.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Each ml contains 125 mg pyriprole as a colourless to yellow, clear solution. Each pipette of Prac-tic delivers the following:
|
|
Unit dose |
Pyriprole |
|
Prac-tic for very small dogs |
0.45 ml |
56.25 mg |
|
Prac-tic for small dogs |
1.1 ml |
137.5 mg |
|
Prac-tic for medium dogs |
2.2 ml |
275 mg |
|
Prac-tic for large dogs |
5.0 ml |
625 mg |
The solution also contains 0.1 % Butylhydroxytoluene (E321)
INDICATIONS
Treatment and prevention of flea infestation (Ctenocephalides canis and C. felis.). Prac-tic is effective against new infestations with fleas for a minimum duration of 4 weeks. The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Treatment and prevention of tick infestation (Ixodes ricinus, Ixodes scapularis, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus, Amblyomma americanum ). Prac-tic has a persistent effect for 4 weeks against ticks.
CONTRAINDICATIONS
Do not use in dogs less than 8 weeks of age or weighing less than 2 kg.
Do not use in case of known hypersensitivity to phenylpyrazole class compounds or to any of the excipients.
Do not use in sick or convalescent animals.
This product is specifically developed for dogs. Do not use on cats, as this could lead to overdosing.
Do not use on rabbits.
ADVERSE REACTIONS
The following local reactions may be observed at the application site: fur discoloration, local alopecia or pruritus. Local cosmetic effects at the application site, such as a greasy appearance or clumpiness of hair are common. However, those signs disappear within 24 hours of the application. A brief period of hypersalivation may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
TARGET SPECIES
Dog
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For spot-on use.
The recommended minimum dose is 12.5 mg/kg bodyweight pyriprole, equivalent to 0.1 ml/kg bodyweight of the veterinary medicinal product. Within each weight band the entire contents of the correct size pipette should be used.
|
Weight of dog (kg) |
Pipette size to be used |
Volume of 12.5% (w/v)
solution (ml) |
Pyriprole (mg/kg bw) |
|
2 - 4.5 kg |
Very small dog |
0.45 |
12.5 - 28.1 |
|
> 4.5 - 11 kg |
Small dog |
1.1 |
12.5 - 30.6 |
|
> 11 - 22 kg |
Medium dog |
2.2 |
12.5 - 25.0 |
|
> 22 - 50 kg |
Large dog |
5.0 |
12.5 - 28.4 |
|
More than 50 kg |
The appropriate combination of pipettes
|
Flea treatment and prevention
Pyriprole kills fleas within 24 hours post exposure. One treatment prevents future flea infestation for 4 weeks. The veterinary medicinal product should be administered at monthly intervals when used as part of a treatment strategy for flea allergy dermatitis.
Tick treatment and prevention
Pyriprole kills ticks within 48 hours post-exposure. One treatment has efficacy duration of 4 weeks.
ADVICE ON CORRECT ADMINISTRATION
For external use only.
Remove one pipette from the package. Then hold it in an upright position. Tap the narrow part of the pipette to ensure the contents remain within the widest part. Break the top of the snap-off top along the scored line. Part the coat on the back of the animal between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze it gently several times at one or two spots to empty the contents onto the skin. Apply the 5 ml pipette to 2-3 spots down the backline of large dogs so as to prevent run-off. When administering the product, try to avoid wetting the fur as this will lead to a clogged appearance. However, should this happen it will disappear within 1 day. In cases of heavy infestation with fleas prior to treatment, the dog’s surroundings should be vacuumed and treated with a suitable insecticide.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the pipette after “EXP”.
Do not remove the pipette from the packaging until ready to use.
Do not store above 30ºC.
SPECIAL WARNING(S)
People with known allergies to the phenylpyrazole class of compounds or either of the excipients should avoid contact with the veterinary medicinal product. Avoid the contents coming into contact with your fingers. Wash your hands after use and wash off any product in contact with your skin with soap and water. If the veterinary medicinal product accidentally gets in your eyes, rinse them carefully with water. If you or anybody else accidentally swallows this veterinary medicinal product, seek medical advice immediately and show this leaflet or the label to your doctor. Do not smoke, eat or drink while handling the veterinary medicinal product. As a precautionary measure, direct contact with the treated animals should be avoided and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended to treat animals in the evening. Recently treated animals should not be allowed to sleep in the same bed as their owners, especially children. This veterinary medicinal product is for skin application on dogs only, do not put it in your dog’s mouth. Take care to avoid the veterinary medicinal product coming into contact with your dog’s eyes.
Apply the dose to an area where the dog cannot lick it off and do not allow your dog or other animals to lick each other following treatment.
Dogs should not be bathed or shampooed from 48 hours before treatment. If you want to wash
your dog, leave at least one day between treatment and shampooing.
If you suspect your dog may be pregnant or if your bitch is nursing puppies or if you want to
treat a breeding dog, contact your veterinarian for advice before use.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the local requirements. The veterinary medicinal product should not be allowed to enter surface water, as it may be harmful for aquatic organisms. Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
;)
