Ypozane

Glavna informacija

  • Trgovački naziv:
  • Ypozane
  • Koristi za:
  • Životinje
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Ypozane
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • psi
  • Područje terapije:
  • Urologicals
  • Terapijske indikacije:
  • Liječenje benigne hipertrofije prostate (BPH) kod muških pasa.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/V/C/000112
  • Datum autorizacije:
  • 11-01-2007
  • EMEA koda:
  • EMEA/V/C/000112
  • Zadnje ažuriranje:
  • 24-02-2018

Uputu o lijeku

B. UPUTA O VMP

UPUTA O VMP

YPOZANE

1.

NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I

NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE

PROIZVODNE SERIJE

Nositelj odobrenja za stavljanje u promet i proizvođač

VIRBAC S.A. –

1ère avenue

2065 m – LID–

06516 Carros –

Francuska

2.

NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA

YPOZANE 1,875 mg tablete za pse

YPOZANE 3,75 mg tablete za pse

YPOZANE 7,5 mg tablete za pse

YPOZANE 15 mg tablete za pse

Osateron acetat

3.

NAVOĐENJE DJELATNE(IH) TVARI I DRUGIH SASTOJAKA

Svaka tableta sadrži: 1,875 mg, 3,75 mg, 7,5 mg ili 15 mg osateron acetata

4.

INDIKACIJE

Liječenje benigne hipertrofije prostate (BPH) u muških pasa.

5.

KONTRAINDIKACIJE

Nema

6.

NUSPOJAVE

Vrlo često dolazi do prolaznih promjena u apetitu, bilo da je riječ o povećanju apetita (jako često) ili o

smanjenju apetita (jako rijetko).

Prolazne promjene ponašanja poput povišene ili umanjene aktivnosti ili izrazitije društvenosti su česte.

Druge nuspojave uključujući prolazno povraćanje i/ili proljev, poliuriju/polidipsiju, letargiju nisu

toliko česte. Feminizacijski sindrom s hiperplazijom mliječne žlijezde povezan s laktacijom, nije tako

čest.

Prolazne nuspojave se mogu javiti u vidu promjena na krznu, gubitak dlake ili promjene na dlakama

koje se javljaju jako rijetko nakon primijene Ypozana.

Sve ove nuspojave nestaju bez ikakvog specifičnog liječenja.

Ako zamijetite ozbiljne nuspojave ili druge nuspojave koje nisu opisane u uputi o VMP, molimo da se

javite veterinaru.

7.

CILJNE VRSTE ŽIVOTINJA

Psi (muški)

8.

DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI)

PRIMJENE

Za peroralnu primjenu

Aplicirati 0,25 - 0,5 mg osateron acetata po kilogramu tjelesne mase, jednom dnevno, tokom 7 dana

kao što slijedi:

Tjelesna masa psa

tablete YPOZANE za

primjenu

Broj tableta na dan

Trajanje terapije

3 do 7,5 kg*

1,875 mg tableta

1 tableta

7 dana

7,5 do 15 kg

3,75 mg tableta

15 do 30 kg

7,5 mg tableta

30 do 60 kg

15 mg tableta

9.

SAVJETI ZA ISPRAVNU PRIMJENU

Tablete se mogu dati ili direktno u usta ili s hranom. Početak kliničkog odgovora se obično uočava

unutar 2 tjedna. Klinički odgovor traje najmanje 5 mjeseci nakon kraja primjene.

Veterinar treba napraviti ponovnu procjenu 5 mjeseci poslije zadnje primjene ili ranije, ukoliko se

klinički znakovi vrate. Odluka o ponovnoj primjeni u tom trenutku ili kasnije trebala bi biti donijeta na

osnovu veterinarskog pregleda i procjene rizika i dobiti u odnosu na proizvod. Ukoliko je klinički

odgovor značajno kraći od očekivanog, potrebna je ponovna procjena postavljene dijagnoze.

Najviša doza ne smije biti prekoračena.

10.

KARENCIJA

Nije primjenljivo

11.

POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE

Čuvati izvan dosega i pogleda djece.

Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjete čuvanja.

Ne koristiti poslije isteka roka valjanosti naznačenog na blisteru poslije {EXP}

12.

POSEBNO(A) UPOZORENJE(A)

Koristiti uz oprez u pasa koji u anamnezi imaju oboljenje jetre.

Oprati ruke nakon aplikacije

U slučaju da se nehotice proguta, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili

etiketu.

Jednokratna peroralna doza od 40 mg osateron acetata u muškaraca bila je praćena mjestimičnim

umanjenjem FSH, LH i testosterona što je vraćeno za 16 dana. Nije bilo kliničkih učinaka.

U ženki laboratorijskih životinja osateron acetat je uzrokovao ozbiljne nuspojave na reprodukcijske

funkcije. Stoga se ženama u plodnom razdoblju savjetuje da izbjegavaju kontakt sa proizvodom ili da

tijekom njegove aplikacije nose rukavice za jednokratnu primjenu.

13.

POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENOG

PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA

Pitajte vašeg veterinara kako odlagati proizvod koji vam više nisu potrebni. Te mjere pomažu zaštiti

okoliša.

14.

DATUM KADA JE UPUTA O VMP ZADNJI PUTA ODOBRENA

Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske

agencije za lijekove http://www.ema.europa.eu/

15.

OSTALE INFORMACIJE

Benigna hipertrofija prostate (BPH) je prirodna posljedica starenja. Javlja se u preko 80% muških pasa

preko

godina

starosti.

razvoj

povećanje

prostate

uzrokovana

muškim

hormonom

testosteronom. Dovodi do mnoštva ne specifičnih kliničkih znakova kao što su bol u abdomenu,

poteškoće pri defekaciji ili mokrenju, pojave krvi u urinu ili motoričkih poremećaja.

België/Belgique/Belgien

VIRBAC BELGIUM S.A.

Rue de la station 17

B-1300 WAVRE

Tel: 32 (0) 10 47 06 35

Luxembourg/Luxemburg

VIRBAC BELGIUM S.A.

Rue de la station 17

B-1300 WAVRE

Tel: 32 (0) 10 47 06 35

Република България

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

Česká republika

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Malta

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

Nederland

VIRBAC NEDERLAND BV

Hermesweg 15

NL-3771 ND-Barneveld

Tel: 31 (0) 342 427 100

Deutschland

VIRBAC Tierarzneimittel GmbH

West Rögen 20

D-23843 Bad Oldesloe

Tel: 49 (4531) 805 555

Norge

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Eesti

OÜ ZOOVETVARU

Pärnasalu 31

ET -76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27

A-1180 Wien

Tel: 43 (0) 1 21 834 260

Ελλάδα

Polska

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

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

España

VIRBAC ESPAÑA S.A.

ES-8950 Esplugues de Llobregat (Barcelona).

Tél. : + 34 93 470 79 40

Portugal

VIRBAC DE Portugal

LABORATÓRIOS LDA

P-2080 Almeirim

Tel: (351) 243 570 500

France

VIRBAC

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

E-mail: dar@virbac.fr

România

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Ireland

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: 44 (0) 1359 243243

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 dei Gracchi 30

I-20146 Milano

Tel: 39 02 48 53 541

Suomi/Finland

VIRBAC S.A.

ère

avenue 2065 m – L.I.D

F-06516 Carros

Tel: 33 (0) 4 92 08 73 00

Κύπρος

GEO. PAVLIDES & ARAOUZOS LTD

25-27 Dimostheni Severi, 1080

CY-1080 Nicosia - CYPRUS

Τηλ: + 357 22456117

E-mail: theodosiou.vet@gpa.com.cy

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

Pärnasalu 31

ET - 76505 Saue/Harjumaa, ESTONIA

Tel: + 372 6 709 006

E-mail: margus@zoovet.ee

VIRBAC Ltd

UK-Suffolk IP30 9 UP

Tel: 44 (0) 1359 243243

Lietuva

OÜ ZOOVETVARU

Pärnasalu 31

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

Hrvatska

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

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

15-3-2018

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Health Canada

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

29-8-2018

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Active substance: Ulipristal Acetate) - Centralised - Authorisation - Commission Decision (2018)5779 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/5017

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety