Ypozane (osaterone acetate) – Summary of product characteristics - QG04CX90
Updated on site: 09-Feb-2018
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
YPOZANE 1.875 mg tablets for dogs
YPOZANE 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
For a full list of excipients, see section 6.1.
Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
4.2Indications for use, specifying the target species
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
4.5 Special precautions for use
Special precautions for use in animals
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. post- operative) 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 the case of accidental ingestion by a person, 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
4.6Adverse reactions (frequency and seriousness)
Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare).
Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly. Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases.
A transient reduction in plasma cortisol occurs in most treated animals.
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
4.7Use during pregnancy, lactation or lay
4.8Interaction with other medicinal products and other forms of interaction
4.9Amounts 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:
YPOZANE tablets to be
Number of tablets per
3 to 7.5 kg*
1.875 mg tablet
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
4.11 Withdrawal period(s)
Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.
ATC vet code : QG04C X
Osaterone is a steroid
Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen
No adverse effects on semen quality have been observed.
After oral administration with food in dogs, osaterone acetate is rapidly absorbed (Tmax about 2 hours) and undergoes a
Osaterone acetate is converted to its main,
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
administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 3- 4 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.
6.1List of excipients
6.4.Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5Nature and composition of immediate packaging
Carton box containing one aluminium/aluminium blister with 7 tablets.
6.6Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7.MARKETING AUTHORISATION HOLDER
1ère avenue – 2065 m – LID
06516 Carros France
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11/01/2007
Date of latest renewal: 19/12/2011
10 DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
PROHIBITION OF SALE, SUPPLY AND/OR USE