This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
- What is Stronghold?
Stronghold is a spot-on solution that contains the active substance selamectin, which belongs to a class of medicines having an antiparasitic action. Stronghold is available in two different concentrations (6% and 12%) and in tubes of various strengths (15, 30, 45, 60, 120 and 240 mg). The concentration and the strength to use depend on the weight and species of the animal being treated.
- What is Stronghold used for?
Stronghold is used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body. It is used in the following ways:
- to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs. It can also be used as part of treatment for flea allergy dermatitis (skin inflammation) and to help control existing flea infestations, by killing eggs and larvae in the areas to which the animal has access, so breaking the flea life-cycle;
- to prevent heartworm disease in cats and dogs;
- to treat ear mites in cats and dogs;
- to treat adult intestinal roundworms and intestinal hookworms in cats;
- to treat adult intestinal roundworms in dogs;
- to treat biting lice in dogs and cats;
- to treat sarcoptic mange (scabies) in dogs.
The contents of the tube are squeezed onto the skin after parting the fur between the shoulder blades. This small volume of liquid is absorbed through the skin and has an effect throughout the animal’s body. The strength used and the number of administrations depend on the weight and species of the animal being treated, and the type of parasite. See the package leaflet for further information.
- How does Stronghold work?
Stronghold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin’ class. Selamectin activates special proteins called ‘chloride channels’ on the surface of nerve and muscle cells, disrupting their normal electrical activity. This causes the paralysis or death of the parasites.
- How has Stronghold been studied?
Stronghold has been studied in the treatment of a wide range of breeds of dog and cat for the parasitic infestations listed above.
- What benefit has Stronghold shown during the studies?
Stronghold treatment was found to be effective after a single administration or repeated treatments at monthly intervals, depending on the type of infestation it was being used to treat or prevent.
In field studies, it reduced the flea comb counts by up to 98% in cats and 99% in dogs 90 days after treatment, as well as preventing flea eggs from hatching, and killing and preventing the development of flea larvae. Field studies also showed that Stronghold was 100% effective in preventing heart worm disease in dogs and cats. It is also effective in treating ear mites in cats and dogs. In the treatment of sarcoptic mange in dogs, two treatments given 30 days apart were required to completely eliminate the mites in dogs. Stronghold was also effective in the treatment of adult intestinal hookworms in cats, adult intestinal roundworms in cats and dogs, and biting lice in dogs and cats.
Shampooing or soaking the animal two hours or more after treatment did not affect the medicine’s effectiveness.
- What is the risk associated with Stronghold?
In rare cases, Stronghold causes temporary alopecia (hair loss) at the application site in cats. Very rarely, there is also temporary irritation at the application site.
On rare occasions, Stronghold may produce clumping of the hair at the application site or the appearance of a small quantity of a white powder. This does not affect the safety or effectiveness of the medicine.
Stronghold must not be used in animals under six weeks of age. It must also not be used in cats that are suffering from another disease or that are debilitated and underweight for their size and age.
- What are the precautions for the person who gives the medicine or comes into contact with the animal?
The package leaflet should be read before use. Because it is highly flammable, Stronghold should be kept away from heat, sparks, any open flame or other sources of ignition. Do not smoke, eat or drink while handling Stronghold. Wash hands after use and wash off any product in contact with the skin immediately with soap and water. If Stronghold gets into the eyes, flush the eyes immediately with water and seek medical attention.
Keep treated animals away from fires and other sources of ignition for at least 30 minutes or until the hair coat is dry. Do not touch treated animals until the application area is dry. Keep children away from treated animals for at least 30 minutes or until the hair coat is dry. People with sensitive skin or known allergy to products of this type should handle Stronghold with caution.
- Why has Stronghold been approved?
The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Stronghold exceed the risks for the treatment and prevention of parasitic infestations in cats and dogs. The Committee recommended that Stronghold be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.
- Other information about Stronghold
The European Commission granted a marketing authorisation valid throughout the European Union for Stronghold to Pfizer Ltd. on 25 November 1999. The marketing authorisation was renewed on 25 November 2004. Information on the prescription status of this product may be found on the label / outer package.
This EPAR was last updated on 20/11/2012 .
14/09/2012 Stronghold -EMEA/V/C/000050 -IB/0043
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Cats and dogs: treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea-allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Cats and dogs: prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.
Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals six months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly. This product is not effective against adult D. immitis.
Cats and dogs: treatment of ear mites (O. cynotis).
Cats: treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme).
Cats: treatment of biting lice infestations (Felicola subrostratus).
Dogs: treatment of biting lice infestations (Trichodectes canis).
Dogs: treatment of sarcoptic mange (caused by S. scabiei).
Dogs: treatment of adult intestinal roundworms (Toxocara canis).
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Stronghold : EPAR - Procedural steps taken and scientific information after authorisation||(English only)||22/01/2010||20/11/2012|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Stronghold : EPAR - Scientific Discussion||(English only)||03/08/2006|
|Stronghold : EPAR - Procedural steps taken before authorisation||(English only)||03/08/2006|
This medicine is approved for use in the European Union