Ypozane (osaterone acetate) – Package leaflet - QG04CX90

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.

If you notice any serious effects or other effects not mentioned in this leaflet, 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

Number of tablet per

Treatment duration

 

administered

day

 

 

 

 

 

3 to 7.5 kg

1.875 mg tablet

 

 

 

 

 

 

7.5 to 15 kg

3.75 mg tablet

1 tablet

7 days

 

 

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

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 :

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

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

Luxembourg/Luxemburg

VIRBAC BELGIUM S.A.

VIRBAC BELGIUM S.A.

B-3001 Leuven

B-3001 Leuven

Tel: 32 (0) 10 47 06 35

Tel: 32 (0) 10 47 06 35

Česká republika

Magyarország

VIRBAC S.A.

VIRBAC S.A.

1ère avenue 2065 m – L.I.D

1ère avenue 2065 m – L.I.D

F-06516 Carros

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Tel: 33 (0) 4 92 08 73 00

Danmark

Malta

VIRBAC Danmark A/S

VIRBAC S.A.

Profilvej 1

1ère avenue 2065 m – L.I.D

6000 Kolding

F-06516 Carros

Tel: 45 2219 1733

Tel: 33 (0) 4 92 08 73 00

Deutschland

Nederland

VIRBAC Tierarzneimittel GmbH

VIRBAC NEDERLAND BV

Rögen 20

Postbus 313

D-23843 Bad Oldesloe

NL-3771 AH-Barneveld

Tel: 49 (4531) 805 111

Tel: 31 (0) 342 427 100

Eesti

Norge

OÜ ZOOVETVARU

VIRBAC S.A.

Uusaru 5

1ère avenue 2065 m – L.I.D

ET - 76505 Saue/Harjumaa, ESTONIA

F-06516 Carros

Tel: + 372 6 709 006

Tel: 33 (0) 4 92 08 73 00

E-mail: margus@zoovet.ee

 

Ελλάδα

Österreich

VIRBAC HELLAS A.E.

VIRBAC Österreich GmbH

23 rd Klm National Road Athens-Lamia

Hildebrandgasse 27

145 65 Agios Stefanos

A-1180 Wien

Athens

Tel: 43 (0) 1 21 834 260

GREECE

 

Tel: +30 210 6219520

 

E-mail: info@virbac.gr

 

España

Polska

VIRBAC ESPAÑA, S.A.

VIRBAC Sp. o.o.

E-08950 - Esplugues de Llobregat (Barcelona)

ul. Puławska 314

Tel: + + 34 93 470 79 40

02-819 Warszawa

France

Portugal

VIRBAC

VIRBAC DE Portugal

13ème rue – L.I.D – BP 27

LABORATÓRIOS LDA

F-06517 Carros

Ed13-Piso 1- Esc.3

 

Quinta da Beloura

 

2710-693 Sintra

 

00 351 219 245 020

Ireland

Slovenija

VIRBAC Ltd

VIRBAC S.A.

UK-Suffolk IP30 9 UP

1ère avenue 2065 m – L.I.D

Tel: 44 (0) 1359 243243

F-06516 Carros

 

Tel: 33 (0) 4 92 08 73 00

Ísland

Slovenská republika

VIRBAC S.A.

VIRBAC S.A.

1ère avenue 2065 m – L.I.D

1ère avenue 2065 m – L.I.D

F-06516 Carros

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Tel: 33 (0) 4 92 08 73 00

Italia

Suomi/Finland

VIRBAC SRL

VIRBAC S.A.

Via Caldera, 21

1ère avenue 2065 m – L.I.D

I-20153 Milano

F-06516 Carros

Tel: +39 02 40 92 47 1

Tel: 33 (0) 4 92 08 73 00

Κύπρος

Sverige

Panchris Feeds (Veterinary) Ltd

VIRBAC S.A.

Industrial Area Aradippou, 7100, Larnaca, Cyprus

1ère avenue 2065 m – L.I.D

(P.O.Box 40261, 6302 Larnaca, Cyprus)

F-06516 Carros

Tel: +357 24813333

Tel: 33 (0) 4 92 08 73 00

Latvija

United Kingdom

OÜ ZOOVETVARU

VIRBAC Ltd

Uusaru 5

UK-Suffolk IP30 9 UP

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: 44 (0) 1359 243243

Tel: + 372 6 709 006

 

E-mail: margus@zoovet.ee

 

Lietuva

Република България

OÜ ZOOVETVARU

VIRBAC S.A.

Uusaru 5

1ère avenue 2065 m – L.I.D

ET - 76505 Saue/Harjumaa, ESTONIA

F-06516 Carros

Tel: + 372 6 709 006

Tel: 33 (0) 4 92 08 73 00

E-mail: margus@zoovet.ee

 

România

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Hrvatska

VIRBAC S.A.

1ère avenue 2065 m – L.I.D F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

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