PACKAGE LEAFLET YPOZANE

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

   THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

   
   

   Marketing authorisation holder and manufacturer:

   
   

   VIRBAC S.A. –

   1ère avenue 2065 m – LID–

   06516 Carros –

   France

   
   

2. 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

   
   

   Osaterone acetate

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

   
   

   Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate

   
   

4. INDICATION(S)

   
   

   Treatment of benign prostatic hypertrophy in male dogs.

   
   

5. CONTRAINDICATIONS

   
   

   None.

   
   

6. ADVERSE REACTIONS

   
   

   The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare). Behavioural changes such as modification of dog’s activity or more social behaviour are common. Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly. The enlargement of mammary glands occurs less commonly and can be associated with lactaction 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.

   All these adverse reactions are reversible without any specific treatment.

   
   

   The frequency of adverse reactions is defined using the following convention:

   • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

   • common (more than 1 but less than 10 animals in 100 animals treated )

   • uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

   • rare (more than 1 but less than 10 animals in 10,000 animals treated)

   • very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

   
   

7. TARGET SPECIES

   
   

   Dogs (male)

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   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 administered	Number of tablet 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 – 60 kg	15 mg tablet

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Tablets can be given either directly into the mouth or with food. The onset of clinical response to treatment is usually seen within 2 weeks and 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 medicine.

   
   

   If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.

   
   

   The maximum dose should not be exceeded.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Not applicable.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the reach and sight of children.

    This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date stated on the blister after “EXP”

12. SPECIAL WARNING(S)

    
    

    Use with caution in dogs with a history of liver disease. 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 of sexual hormones, 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.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED :

    
    

    ).

    
    

15. OTHER INFORMATION

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.

België/Belgique/Belgien

VIRBAC BELGIUM NV

Esperantolaan 4 BE-3001 Leuven

Tél/Tel : +32-(0)16 387 260

Luxembourg/Luxemburg

VIRBAC BELGIUM NV

Esperantolaan 4 BE-3001 Leuven Belgique / Belgien

Tél/Tel: +32-(0)16 387 260

Česká republika

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros Francie

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding Tlf: +45 75521244

Magyarország

VIRBAC HUNGARY KFT

Szent Istvàn krt.11.II/21. HU-1055 Budapest

Tel: +36703387177

Malta

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Franza

Tel: 33 (0) 4 92 08 73 00

Deutschland

VIRBAC Tierarzneimittel GmbH Rögen 20

DE-23843 Bad Oldesloe Tel: 49 (4531) 805 111

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

NL-3771 ND-Barneveld Tel: 31 (0) 342 427 127

Eesti

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Prantsusmaa

Tel: +33-(0)4 92 08 73 00

Norge

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding Tel: + 45 75521244

Ελλάδα

VIRBAC HELLAS A.E.

13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση Τηλ: +30 210 6219520

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27 A-1180 Wien

Tel: 43 (0) 1 21 834 260

España

VIRBAC ESPAÑA, S.A.

Angel Guimerá 179-181

ES-08950 - Esplugues de Llobregat (Barcelona)

Tel: + 34 (0) 93 470 79 40

Polska

VIRBAC Sp. o.o.

ul. Puławska 314

PL 02-819 Warszawa

Tel.: + 48 22 855 40 46

France

VIRBAC

13ème rue LID

FR-06517 Carros

Tél : +33-(0)805 05 55 55

Portugal

VIRBAC DE Portugal LABORATÓRIOS LDA

R.do Centro Empresarial Ed13-Piso 1- Esc.3

Quinta da Beloura PT-2710-693 Sintra

Tel: 00 351 219 245 020

Ireland

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

France

Tel: + 33 (0) 4 92 08 73 00

Slovenija

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francija

Tel: 33 (0) 4 92 08 73 00

Ísland

VIRBAC S.A.

1ère avenue 2065 m LID FR-06516 Carros

Frakkland

Simi: 33 (0) 4 92 08 73 00

Slovenská republika

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francúzsko

Tel: 33 (0) 4 92 08 73 00

Italia

VIRBAC SRL

Via Ettore Bugatti, 15 IT-20142 Milano

Tel: +39 02 40 92 47 1

Suomi/Finland

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Puh/Tel: 33 (0) 4 92 08 73 00

Κύπρος

VIRBAC HELLAS Α.Ε.

13o χλμ Ε.Ο. Αθηνών - Λαμίας

Sverige

VIRBAC Danmark A/S Filial Sverige

c/o Incognito AB

EL-14452, Μεταμόρφωση Τηλ.: +30 2106219520

Box 1027

SE-171 21 Solna

Tel: +45 75521244

Latvija

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros Francjia

Tel: +33-(0)4 92 08 73 00

United Kingdom (Northern Ireland)

VIRBAC

1ère avenue 2065m LID FR-06516 Carros France

Tel: + 33-(0)4 92 08 73 00

Lietuva

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Prancūzija

Tel: +33-(0)4 92 08 73 00

Република България

VIRBAC S.A.

1ère avenue 2065 m LID FR-06516 Carros

Франция

Teл: 33 (0) 4 92 08 73 00

România

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Franţa

Tel: 33 (0) 4 92 08 73 00

Hrvatska

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francuska

Tel: 33 (0) 4 92 08 73 00