Ypozane (3 - 7,5 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.
Dispensing
POM-V - Prescription Only Medicine – VeterinarianReferences
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
YPOZANE 1.875 mg tablets for dogsYPOZANE 3.75 mg tablets for dogs
YPOZANE 7.5 mg tablets for dogs
YPOZANE 15 mg tablets for dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate.
Excipients:
Qualitative composition of excipients and other constituents |
Lactose monohydrate |
Pregelatinised starch |
Carmellose calcium |
Maize starch |
Talc |
Magnesium stearate |
Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm or 12 mm diameter.
3. CLINICAL INFORMATION
3.1 Target species
Dogs (male).
3.2 Indications for use for each target species
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
3.3 Contraindications
None.
3.4 Special warnings
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
3.5 Special precautions for use
Special precautions for safe use in the target species:
A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration. Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism. The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash hands after administration.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. There was no clinical effect.
In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
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.
3.7 Use during pregnancy, lactation or lay
Not applicable.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
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.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QG04C X 4.2 Pharmacodynamics
Benign prostatic hypertrophy (BPH) is a natural consequence of ageing. Over 80% of male dogs above 5 years of age are affected. BPH is a development and enlargement of the prostate due to the male hormone testosterone. This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity. Also, the major metabolite of osaterone acetate (15β-hydroxylated osaterone acetate) has anti-androgenic activity. Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms. It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate.
No adverse effects on semen quality have been observed.
4.3 Pharmacokinetics
After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax about 2 hours) and undergoes a first-pass effect mainly in the liver. After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also
pharmacologically active. Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin. This binding is reversible and not affected by other substances known to specifically bind to albumin.
Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine. Elimination is slow with a mean half-life (T½) of about 80 hours. After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination. Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
Not applicable.
5.2 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
5.3 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
5.4 Nature and composition of immediate packaging
Carton box containing one aluminium/aluminium blister with 7 tablets.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
VIRBAC
7. MARKETING AUTHORISATION NUMBER(S)
EU/2/06/068/001
EU/2/06/068/002 EU/2/06/068/003 EU/2/06/068/004
8. DATE OF FIRST AUTHORISATION
Date of first authorisation: 11/01/2007
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
{MM/YYYY}
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).