Ypozane (7.5 - 15 kg)
Active substance
ATC code
Species
Dogs (male).
Indications
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Dose to be administered and administration route
For oral use.
Administer 0.25 – 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Dog’s weight | Strength of tablet to be administered | Number of tablets per day | Treatment duration |
3 to 7.5 kg* | 1.875 mg tablet | 1 tablet | 7 days |
7.5 to 15 kg | 3.75 mg tablet | ||
15 to 30 kg | 7.5 mg tablet | ||
30 to 60 kg | 15 mg tablet |
*No data are available for dogs less than 3 kg bodyweight
Tablets can be given either directly into the mouth or with food. The maximum dose should not be exceeded.
The onset of clinical response to treatment is usually seen within 2 weeks. The clinical response persists for at least 5 months after treatment.
Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product. If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Adverse reactions
Dogs (male):
Very common (>1 animal / 10 animals treated): | Increased appetite1 Hypocortisolaemia1 |
Common (1 to 10 animals / 100 animals treated): | Behavioural disorders (e.g., hyperactivity, decreased activity or more social behaviour)1 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Vomiting and/or diarrhoea1 Polydipsia1, lethargy1 Polyuria1 Mammary hyperplasia |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Decreased appetite1 Galactorrhoea2 Changes in hair coat (e.g., hair loss or hair modification)1 |
1 Transient.
2 Associated with mammary hyperplasia.
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
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.
