Ypozane (osaterone acetate) – Summary of product characteristics - QG04CX90

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

Excipients:

For a full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Tablet

Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.

4.CLINICAL PARTICULARS

4.1Target species

Dogs (male)

4.2Indications for use, specifying the target species

Treatment of benign prostatic hypertrophy (BPH) in male dogs.

4.3Contraindications

None.

4.4Special warnings

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 child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.

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.

Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane.

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

Not applicable.

4.8Interaction with other medicinal products and other forms of interaction

None known.

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:

Dog’s weight

YPOZANE tablets to be

Number of tablets per

Treatment duration

 

administered

day

 

 

 

 

 

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.

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)

Not applicable.

5.PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.

ATC vet code : QG04C X

Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).

5.1Pharmacodynamic properties

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.

5.2Pharmacokinetic particulars

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 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.PHARMACEUTICAL PARTICULARS

6.1List of excipients

Lactose monohydrate

Pregelatinised starch

Carmellose calcium

Maize starch

Talc

Magnesium stearate

6.2Incompatibilities

Not applicable.

6.3Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

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.

6.6 Special 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

VIRBAC S.A.

1ère avenue – 2065 m – LID

06516 Carros France

8.MARKETING AUTHORISATION NUMBER(S)

EU/2/06/068/001

EU/2/06/068/002

EU/2/06/068/003

EU/2/06/068/004

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

Not applicable.

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