Target species
Dogs
Indications for use, specifying the target species
For use in dogs with, or at risk from, mixed infestations/infections by ticks, fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm.
This veterinary medicinal product is only indicated for use when treatment against ticks/fleas/mites and gastrointestinal nematodes or the treatment against ticks/fleas/mites and prevention of heartworm disease/angiostrongylosis is indicated at the same time.
Ectoparasites
For the treatment of tick (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus and I. hexagonus) and flea (Ctenocephalides felis and C. canis) infestations in dogs.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for ticks and fleas.
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
For the treatment of demodicosis (caused by Demodex canis).
Gastrointestinal Nematodes
Treatment of gastrointestinal nematodes: hookworm (L4, immature adult (L5) and adult Ancylostoma caninum), roundworms (L4, immature adult (L5) and adult Toxocara canis, and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).
Heartworm
Prevention of heartworm disease (Dirofilaria immitis).
Lungworm
Prevention of angiostrongylosis by reduction of the level of infection with immature adult (L5) and adult stages of Angiostrongylus vasorum (lungworm) with monthly administration.
Contraindications
Do not use in cases of hypersensitivity to the active substances, or to any of the excipients.
Special warnings for each target species
The possibility that other animals in the same household can be a source of re-infection with ticks, fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm should be considered, and these should be treated as necessary with an appropriate product.
The product should be used in dogs with, or at risk from, mixed infestations of ectoparasites (ticks, fleas or mites) and endoparasites (gastrointestinal nematodes and/or for prevention of heartworm/lungworm). In the absence of risk of co-infestation by external and internal parasites, a narrow spectrum product should be used.
Ticks and fleas must attach to the host and commence feeding in order to be exposed to the active substance; therefore the risk of the transmission of tick/flea-borne diseases cannot be excluded.
For the treatment of infections with gastrointestinal nematodes the need for, and the frequency of, re-treatment as well as the choice of the treatment (monosubstance or combination product) should be evaluated by the prescribing veterinarian.
Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis prevention, therefore, to minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each heartworm season prior to starting monthly preventive treatments. The product is not effective against adult D. immitis and is not indicated for microfilariae clearance.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infection/infestation based on its epidemiological features, for each individual animal.
Special precautions for use
Special precautions for use in animals
All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.4 kg of bodyweight and greater. Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.4 kg of bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
The recommended dose should be strictly observed in MDR1 mutant (-/-) dogs with a non-functional P-glycoprotein, which may include Collies and related breeds.
Prior to first administration, dogs in heartworm endemic areas or who have visited heartworm endemic areas must be tested for existing heartworm infection. At the discretion of the veterinarian, infected dogs should be treated with an adulticide to kill adult heartworms.
Administration of products containing milbemycin oxime (such as this product) to dogs with a high number of circulating microfilariae is not recommended in order to avoid hypersensitivity reactions associated with the release of proteins from dead or dying microfilariae.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental ingestion may cause gastrointestinal disturbances. In order to prevent access by children, keep the chewable tablets in the blister packs until required and keep the blister packs in the outer carton out of the reach of children.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Wash hands after handling the tablets.
Adverse events
Dogs
Uncommon (1 to 10 animals / 1 000 animals treated): | Behavioural disorder 1,2 Diarrhoea2, Vomiting2 Muscle tremor2 Pruritis2 Anorexia2, Lethargy2 |
Very rare (<1 animal / 10 000 animals treated, including isolated reports): | Ataxia3, Convulsion3, Muscle tremor3 |
1 Changes in behaviour.
2 Generally self-limiting and of short duration.
3 These signs typically resolve without treatment.
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 the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation or in breeding dogs.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not yet been established during pregnancy or lactation. Laboratory studies in rats have not produced any evidence of teratogenic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.
Fertility:
The safety of the veterinary medicinal product has not been established in breeding dogs. Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Lotilaner and milbemycin oxime have been shown to be a substrate for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (e.g. digoxin, doxorubicin) or other macrocyclic lactones. Therefore, concomitant treatment with other P-gp substrates could lead to enhanced toxicity.
Amounts to be administered and administration route
Oral use
The veterinary medicinal product should be administered in accordance with the dosage table to ensure a dose of 20 to 41 mg lotilaner/kg bodyweight and 0.75 to 1.53 mg milbemycin oxime/kg bodyweight.
Dosage Table |
Dog Bodyweight | Strength and number of Credelio Plus chewable tablets to be administered |
| 56.25 mg/2.11 mg | 112.5 mg/4.22 mg | 225 mg/8.44 mg | 450 mg/16.88 mg | 900 mg/33.75 mg |
1.4-2.8 kg | 1 | | | | |
>2.8-5.5 kg | | 1 | | | |
>5.5-11 kg | | | 1 | | |
>11-22 kg | | | | 1 | |
>22-45 kg | | | | | 1 |
>45 kg | Appropriate combinations of tablets |
Use an appropriate combination of available strengths to achieve the recommended dose of 20‒41 mg lotilaner/kg and 0.75‒1.53 mg milbemycin oxime/kg for animals > 45 kg bodyweight. Underdosing could result in ineffective use and may favour resistance development. To ensure a correct dosage, body weight should be determined as accurately as possible.
For infestations/infections with parasites, the need for any frequency of re-treatment should be based on professional advice and should take into account the local epidemiological situation and the animal's lifestyle. If based on the veterinarian’s opinion the dog requires re-administration(s) of the product, any subsequent administration(s) must follow the 1 month interval schedule.
Method of administration:
The veterinary medicinal product is a palatable chewable flavoured tablet. Administer the chewable tablet(s) with or after food.
Dogs living in non-heartworm endemic areas:
The veterinary medicinal product can be used as part of the seasonal treatment of ticks and/or fleas in dogs with diagnosed, or at risk from, concurrent gastrointestinal nematode infections or at risk of lungworm. A single treatment is effective for the treatment of gastrointestinal nematodes.
Dogs living in heartworm endemic areas:
Prior to treatment with the veterinary medicinal product the advice in sections 'Special warnings for each target species' and 'Special precautions for use' should be considered.
For the prevention of heartworm disease and the concurrent treatment of tick and/or flea infestations, the veterinary medicinal product must be given at regular monthly intervals during the time of the year when mosquitoes, ticks and/or fleas are present. The first dose of the veterinary medicinal product may be given after first possible exposure to mosquitoes, but not more than one month after this exposure.
When the veterinary medicinal product is used to replace another heartworm preventive product, the first dose of the product must be given within a month of the last dose of the former medication.
Dogs travelling to a heartworm region should start medication within a month after arrival there.
Heartworm prevention treatment should be continued monthly, with the last administration being given 1 month after the dog has left the region.
Lungworm:
In endemic areas, monthly administration of the veterinary medicinal product will reduce the level of infection with immature adults (L5) and adults of Angiostrongylus vasorum in the heart and lungs. It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails.
Seek veterinary advice regarding information on the optimal time to start treatment with this veterinary medicinal product.
For the treatment of demodicosis (caused by Demodex canis):
Monthly administration of the product for two consecutive months is efficacious and leads to a marked improvement of clinical signs. Treatment should be continued until two negative skin scrapings are obtained one month apart. Severe cases may require prolonged monthly treatments. As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse reactions, other than those listed in the adverse reaction section, were observed in puppies (starting at 8 - 9 weeks of age) after administering up to 5 times the maximum recommended dose over 1 - 5 days (consecutive daily dosing) at monthly intervals on 9 occasions; or in adult dogs (starting at 11 months of age) after administering up to 5 times the maximum recommended dose over 1 - 5 days (consecutive daily dosing) at monthly intervals on 7 occasions; or in adult dogs (approximately 12 months old) after administration up to 6 times the maximum recommended dose as a bolus on a single occasion.
After administration of 5 times the maximum recommended dose to MDR1 mutant (-/-) dogs with a non-functional P-glycoprotein, transient depression, ataxia, tremors, mydriasis and/or excessive salivation were observed.
Withdrawal period(s)
Not applicable.