Numelvi® tablets for dogs, (PER TABLET) POM/V

Product Description

Numelvi® tablets for dogs

Target species

Dogs.

Indications for use

For the treatment of pruritus associated with allergic dermatitis including atopic dermatitis in dogs.

For the treatment of clinical manifestations of atopic dermatitis in dogs.

Contraindications

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

Special warnings

None.

Special precautions for safe use in the target species

Safety of this veterinary medicinal product has not been investigated in dogs younger than 6 months of age or weighing less than 3 kg bodyweight. Use of the veterinary medicinal product in younger animals or animals with a lower bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.

It is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections (e.g., flea, Demodex mites), as well as any underlying causes (e.g., flea allergy, contact allergy, food allergy) of allergic and atopic dermatitis.

The safety of the veterinary medicinal product has not been investigated in dogs with evidence of immune suppression, such as uncontrolled primary hypothyroidism or rickettsial disease, or with evidence of progressive malignant neoplasia.

Therefore, the use in such cases should be based on a benefit-risk assessment by the responsible veterinarian.

Operator warnings

Wash hands thoroughly with soap and water immediately after use of the veterinary medicinal product.

Special precautions for the protection of the environment

Not applicable.

Adverse Events

Dogs:

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 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 and lactation or in breeding dogs.

Pregnancy and lactation:

The use is not recommended during pregnancy and lactation.

Laboratory studies in rats and rabbits have shown effects on prenatal development, inherent to the class of JAK inhibitors.

Fertility:

The use is not recommended in breeding animals.

Laboratory studies in male rats showed an effect on sperm counts and sperm motility.

Interactions

None known. No drug interactions were observed in field studies where the veterinary medicinal product was administered concomitantly with other veterinary medicinal products such as antimicrobials (including topicals), ecto- and endoparasiticides (isoxazolines, milbemycins, avermectins, pyrethrins and pyrethroids), nutritional supplements, topical skin and ear cleansers that did not contain glucocorticoids, as well as medicated shampoos.

There was no impact on immune response to vaccination. The veterinary medicinal product was well-tolerated with no adverse clinical effects related to treatment when used concomitantly with vaccination. An adequate immune response (serology) to modified live Canine Adenovirus type-2 (CAV), modified live Canine Distemper Virus (CDV), modified live Canine Parvovirus (CPV), and inactivated Rabies Virus (RV) vaccination was achieved when 6-month-old vaccine naïve puppies were administered the veterinary medicinal product at 3.6 mg/kg atinvicitinib (3 times the maximum recommended dose) once daily for 84 days.

Amounts to be administered and administration route

Oral use.

The veterinary medicinal product should be administered once daily, at or around the time of feeding, in accordance with the following dosing table (corresponding to a dose of 0.8 - 1.2 mg atinvicitinib/kg bodyweight within one weight band):

The tablets are breakable along the score line.

Dogs outside the listed weight bands (see “Special precautions for use” section) can be dosed with a combination of full and/or half tablets of appropriate tablet strengths to achieve a target dose of 0.8 - 1.2 mg atinvicitinib/kg bodyweight.

The available tablet strengths do not allow for accurate dosing of dogs weighing less than 2 kg bodyweight.

The intensity and duration of signs of allergic dermatitis including atopic dermatitis are variable. The need for long-term treatment should be based on an individual benefit-risk assessment.

Overdose

For atinvicitinib a high selectivity of JAK1 was shown, limiting the potential for adverse effects mediated via other JAK family enzymes.

Consequently, the veterinary medicinal product was well tolerated when administered orally to healthy 6-months-old puppies treated with overdoses of up to 5 times the maximum recommended dose once daily over a period of 6 months.

At significant overdoses, treatment with the veterinary medicinal product may lead to a higher susceptibility of dogs for development of bacterial, fungal and/or parasitic skin disease.

In case of adverse effects following an overdose, the dog should be treated symptomatically.

Withdrawal periods

Not applicable.

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