Ypozane

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  • Ypozane
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  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Dogs
  • Lækningarsvæði:
  • UROLOGICALS
  • Ábendingar:
  • Treatment of benign prostatic hypertrophy (BPH) in male dogs.,
  • Vörulýsing:
  • Revision: 3

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/V/C/000112
  • Leyfisdagur:
  • 10-01-2007
  • EMEA númer:
  • EMEA/V/C/000112
  • Síðasta uppfærsla:
  • 27-03-2019

Opinber matsskýrsla

European Medicines Agency

Veterinary Medicines

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 47

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

EMEA

2006

Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

EMEA/V/C/112

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

YPOZANE

EPAR summary for the public

This document is a summary of the European Public Assessment Report. Its purpose is to explain

how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP)

on the basis of the documentation provided, led to the recommendations on the conditions of use.

This document cannot replace a face-to-face discussion with your veterinarian. If you need more

information about your animal’s medical condition or treatment, contact your veterinarian. If you

want more information on the basis of the CVMP recommendations, read the Scientific

Discussion (also part of the EPAR).

What is Ypozane?

Ypozane are round, white tablets that contain osaterone acetate as the active substance. The

medicine is available as 1.875 mg, 3.75 mg, 7.5 mg or 15 mg tablets, which can be used for

dogs of different weights (small, medium sized, large or very large dogs).

What is Ypozane used for?

Ypozane is used in male dogs for the treatment of “benign prostatic hypertrophy”, which

means an increase of the size of the prostate gland that is not related to cancer (benign). The

prostate is a gland that produces a fluid that is part of the semen. When it is enlarged, it can

lead to abdominal pain, constipation and difficulties in urinating in the dogs affected.

Ypozane is given daily for 7 days. Its effect can be seen within about 2 weeks, and lasts for

5 months.

How does Ypozane work?

Osaterone acetate is a hormone that is chemically related to progesterone, and as such it has

anti-androgen and progestagen activity. In male dogs, it blocks the transport of the male

hormone testosterone into the prostate. By inhibiting testosterone, Ypozane helps the prostate

to shrink back to its normal size.

How has Ypozane been studied?

Data were provided on the pharmaceutical quality of the product, the tolerance of Ypozane in

dogs and the safety of the tablets when handled by humans.

The effectiveness of osaterone acetate was investigated in a large study undertaken in a

number of veterinary practices across Europe. Dogs with enlarged prostates from various

breeds, age groups and weights, were either treated with Ypozane or with another product,

which is already authorised in the EU for this indication. The dogs received once a day for 7

days, one Ypozane tablet appropriate for their size to correspond to a daily dose of 0.25 –

0.5 mg osaterone acetate per kilogram bodyweight.

Page 2/2

EMEA 2006

What benefit has Ypozane shown during the studies?

Treatment with Ypozane was effective in the treatment of benign prostatic hypertrophy. A

clinical response to treatment (reduction of prostate volume) was seen within 14 days, which

lasted for at least 5 months. After this time, the dog should be re-examined by a veterinarian

and treatment might be repeated. Ypozane has no adverse effects on semen quality.

What is the risk associated with Ypozane?

Ypozane should be used with caution in dogs which have had liver problems.

The most common side effects are a transient increase in appetite, and changes in the

behaviour of the dog (changes in activity levels, more sociable behaviour). Some dogs might

also

show

vomiting,

diarrhoea

increased

thirst,

might

develop

“feminisation

syndrome”. This is when male dogs suddenly become attractive to other male dogs or the size

of their mammary glands increases. All these effects disappear after a while without specific

treatment.

What are the precautions for the person who gives the medicine or comes into contact with the

animal?

This veterinary medicine has been developed especially for dogs and is not for use in humans.

If a person accidentally takes the medicine, seek medical advice immediately and show the

package leaflet or the label to a doctor. Wash hands after administration.

In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive

functions.

Therefore,

women

child-bearing

should

avoid

contact

with,

wear

disposable gloves, when handling the tablets.

Why has Ypozane been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the

benefits of Ypozane exceed its risks for the treatment of benign prostatic hypertrophy (BPH)

in male dogs and recommended that Ypozane be given a marketing authorisation. The benefit-

risk balance may be found in module 6 of this EPAR.

Other information about Ypozane:

The European Commission granted a marketing authorisation valid throughout the European

Union, for Ypozane to Virbac S.A. on 11.01.2007. Information on the prescription status of

this product may be found on the label/outer package.

This summary was last updated on 11.01.2007.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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

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 :

Detailed information on this veterinary medicinal 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

VIRBAC BELGIUM S.A.

B-3001 Leuven

Tel: 32 (0) 10 47 06 35

Luxembourg/Luxemburg

VIRBAC BELGIUM S.A.

B-3001 Leuven

Tel: 32 (0) 10 47 06 35

Česká republika

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Magyarország

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

6000 Kolding

Tel: 45 2219 1733

Malta

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Deutschland

VIRBAC Tierarzneimittel GmbH

Rögen 20

Nederland

VIRBAC NEDERLAND BV

Postbus 313

D-23843 Bad Oldesloe

Tel: 49 (4531) 805 111

NL-3771 AH-Barneveld

Tel: 31 (0) 342 427 100

Eesti

OÜ ZOOVETVARU

Uusaru 5

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

Norge

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Ελλάδα

VIRBAC HELLAS A.E.

23 rd Klm National Road Athens-Lamia

145 65 Agios Stefanos

Athens

GREECE

Tel: +30 210 6219520

E-mail: info@virbac.gr

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27

A-1180 Wien

Tel: 43 (0) 1 21 834 260

España

VIRBAC ESPAÑA, S.A.

E-08950 - Esplugues de Llobregat (Barcelona)

Tel: + + 34 93 470 79 40

Polska

VIRBAC Sp. o.o.

ul. Puławska 314

02-819 Warszawa

France

VIRBAC

ème

rue – L.I.D – BP 27

F-06517 Carros

Portugal

VIRBAC DE Portugal

LABORATÓRIOS LDA

Ed13-Piso 1- Esc.3

Quinta da Beloura

2710-693 Sintra

00 351 219 245 020

Ireland

VIRBAC

1ère avenue 2065 m LID

06516 Carros

France

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

Slovenija

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Ísland

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Slovenská republika

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Italia

VIRBAC SRL

Via Caldera, 21

I-20153 Milano

Tel: +39 02 40 92 47 1

Suomi/Finland

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Κύπρος

Panchris Feeds (Veterinary) Ltd

Industrial Area Aradippou, 7100, Larnaca, Cyprus

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

Tel: +357 24813333

Sverige

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Latvija

OÜ ZOOVETVARU

Uusaru 5

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

United Kingdom

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: 44 (0) 1359 243243

Lietuva

OÜ ZOOVETVARU

Uusaru 5

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

Република България

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

România

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Hrvatska

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00