Skylocalm 3.6 mg Film-coated Tablets for 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 its local representative or the national
competent authority via the national reporting system. See also the last section of
the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay.
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation, or in breeding male dogs, therefore its use is not
recommended during pregnancy, lactation or in dogs intended for breeding.
4.8 Interaction with other medicinal products and other forms of interaction
No drug interactions were observed in field studies where oclacitinib was
administered concomitantly with veterinary medicinal products such as endo- and
ectoparasiticides, antimicrobials and anti-inflammatories.
The impact of oclacitinib administration on vaccination with modified live vaccines,
canine parvovirus (CPV), canine distemper virus (CDV) and canine parainfluenza
(CPI) and inactivated rabies vaccine (RV), on 16 week old vaccine naïve puppies
has been studied. An adequate immune response (serology) to CDV and CPV
vaccination was achieved when puppies were administered oclacitinib at 1.8 mg/kg
bodyweight (bw) twice daily for 84 days. However, the findings of this study indicated
a reduction in serological response to vaccination with CPI and RV in puppies being
treated with oclacitinib compared to untreated controls. The clinical relevance of
these observed effects for animals vaccinated while being administered oclacitinib
(in accordance with the recommended dosing regimen) is unclear.
4.9 Amount(s) to be administered and administration route
For oral use.
Dosage and treatment schedule:
The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight,
administered orally, twice daily for up to 14 days.
For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight)
should then be administered only once a day. The requirement for long-term
maintenance therapy should be based on an individual benefit-risk assessment.
These tablets can be administered with or without food.

Revised: April 2024AN: 02338/2023
The dosing table below shows the number of tablets required. The tablets are
breakable along the score line.
Strength and number of tablets to be administered:Bodyweight
(kg) of dog
Skylocalm 3.6 mg
tablets
Skylocalm 5.4 mg
tablets
Skylocalm 16 mg
tablets
3.0–4.4½4.5–5.9½