natgillin/translations-raw huggingface dataset:
The company informed the CHMP that it will continue to provide the medicine to all patients currently enrolled in clinical trials or compassionate use programmes.
Družba je obvestila odbor CHMP, da bo še naprej zagotavljala zdravila za vse bolnike, ki so trenutno vključeni v klinična preskušanja ali programe sočutne uporabe.
It was to be available as a concentrate to be made up into a solution for infusion.
Na voljo naj bi bilo v obliki koncentrata za pripravo raztopine za infundiranje.
However, insufficient safety data are available to properly assess its overall risks and the committee still had concerns about the medicine's benefits and manufacturing controls.
Vendar ni na voljo dovolj podatkov o varnosti zdravila, da bi lahko ustrezno ocenili njegova skupna tveganja, zato je odbor še vedno imel pomisleke o njegovih koristih in kontrolah pri njegovi proizvodnji.
During the re-examination, the Committee was reassured that no commonly reported side effects appear to be directly linked to this medicine.
Med ponovnim pregledom so odboru zagotovili, da noben neželeni učinek, o katerem so občasno poročali, ni bil neposredno povezan s tem zdravilom.
Lastly, there were inadequate controls of the manufacturing process to ensure the medicine would have the same quality as the product used in clinical trials.
Ne nazadnje niso bile opravljene ustrezne kontrole proizvodnega postopka, ki bi zagotovile, da bo zdravilo imelo enako kakovost kot zdravilo, ki se je uporabilo v kliničnih preskušanjih.
The company presented results of a main study in 333 patients looking at the effects of this medicine on lean body mass (body weight excluding fat) and quality of life.
Družba je predstavila rezultate glavne študije pri 333 bolnikih o učinkih zdravila na pusto telesno maso (telesno maso brez maščob) in kakovost življenja.
Such symptoms include cachexia, a form of muscle wasting with significant weight loss.
Ti simptomi vključujejo kaheksijo, tj. obliko izgube mišic z znatno izgubo telesne mase.
The medicine was expected to be used for treating debilitating symptoms of advanced colorectal cancer (cancer of the large intestine).
Zdravilo naj bi se uporabljajo za zdravljenje izčrpavajočih simptomov napredovalega kolorektalnega raka (raka debelega črevesa).
The medicine was compared with placebo (a dummy treatment).
Zdravilo so primerjali s placebom (zdravilom brez zdravilne učinkovine).
The CHMP therefore maintained its opinion that the benefits of this medicine did not outweigh its risks and recommended that it be refused marketing authorisation.
Zato je še vedno vztrajal pri svojem mnenju, da koristi zdravila ne odtehtajo z njim povezanih tveganj, in priporočil, da se dovoljenje za promet z njim zavrne.
By blocking the actions of human interleukin-1 alpha, the medicine was expected to slow down the growth of the cancer, thus relieving patients' symptoms.
Zdravilo zavira delovanje humanega interlevkina-1 alfa, zato naj bi upočasnilo rast raka ter lajšalo simptome pri bolnikih.
On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech', intended for intended for treating debilitating symptoms of advanced colorectal cancer.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 18. maja 2017 priporočil zavrnitev vloge za pridobitev dovoljenja za promet s humanim monoklonskim protitelesom IgG1, specifičnim za humani interlevkin-1 alfa XBiotech, namenjenim zdravljenju izčrpavajočih simptomov napredovalega raka debelega črevesa.
The company that applied for authorisation is XBiotech Germany GmbH.
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba XBiotech Germany GmbH.
growth and spread of cancer cells.
dejavnostih v telesu, vključno s pospeševanjem rasti in širjenjem rakavih celic.
What is Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech?
Kaj je zdravilo humano monoklonsko protitelo IgG1, specifično za humani interlevkin1 alfa XBiotech?
This is a medicine containing the active substance human IgG1 monoclonal antibody specific for human interleukin-1 alpha.
To je zdravilo, ki vsebuje zdravilno učinkovino humano monoklonsko protitelo IgG1, specifično za humani interlevkin-1 alfa.
The active substance is a protein that attaches to and blocks the actions of another protein called human interleukin-1 alpha, which is involved in many activities in the body including some that aid the
Zdravilna učinkovina je beljakovina, ki se veže na drugo beljakovino, imenovano humani interlevkin-1 alfa, in zavira njeno delovanje.
Tablets can be given either directly into the mouth or with food.
Tablete lahko daste neposredno v gobec ali s hrano.
There was no clinical effect.
Kliničnega učinka ni bilo.
Over 80% of male dogs above 5 years of age are affected.
Prizadene več kot 80% psov samcev nad 5 letom starosti.
No adverse effects on semen quality have been observed.
Škodljivi vplivi na kakovost semena niso bili opaženi.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja za promet mora obvestiti Evropsko komisijo o načrtih za trženje zdravila, ki ga dovoljuje ta odločitev.
REGARD TO SAFE AND EFFECTIVE USE
VARNE IN UČINKOVITE UPORABE
This binding is reversible and not affected by other substances known to specifically bind to albumin.
Vezava je reverzibilna in nanjo ne vplivajo druge snovi, za katere je znano, da se specifično vežejo na albumin.
1 tablet
1 tablete
If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Če je klinični odgovor na zdravljenje znatno krajši od pričakovanega, je treba ponovno oceniti postavljeno diagnozo.
Dog's weight
Teža psa
The maximum dose should not be exceeded.
Največjega odmerka ne smete preseči.
ATC vet code : QG04C X
oznaka ATC vet: QG04C X
This veterinary medicinal product does not require any special storage conditions.
To zdravilo ne potrebuje nobenih posebnih pogojev za shranjevanje.
This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.
To lahko privede do več nespecifičnih kliničnih znakov, kot so bolečina v trebuhu, težave pri iztrebljanju in uriniranju, kri v urinu in motnje gibanja.
Elimination is slow with a mean half-life (T½) of about 80 hours.
Izločanje je počasno s srednjim razpolovnim časom (T½) okoli 80 ur.
It competitively prevents the binding of androgens to their prostatic receptors and blocks the transport of testosterone into the prostate.
Kompetitivno preprečuje vezavo androgenov na njihove prostatične receptorje in blokira prenos testosterona v prostato.
*No data are available for dogs less than 3 kg bodyweight
*Za pse lažje od 3 kilogramov ni podatkov.
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy.
V kliničnih preizkusih zdravljenje s tem zdravilom ni bilo prekinjeno, vsi psi pa so okrevali brez posebne terapije.
Fifteen days after the last administration, the mean plasma concentration is about 6.5 µg/l.
Petnajst dni po zadnjem odmerku je srednja plazemska koncentracija okoli 6,5 µg/l.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Natančne informacije o tem izdelku veterinarske medicine so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Dogs (male)
Psi (samci)
Osaterone acetate
Osateronijev acetat
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.
Študija prevelikega odmerjanja (do 1,25 mg/kg telesne teže za 10 dni s ponovitvijo čez en mesec) ni pokazala neželenih učinkov razen znižanja koncentracije plazemskega kortizola.
Osaterone is eliminated within 14 days, mainly in faeces via biliary excretion (60%) and to a lesser extent (25%) in urine.
Osateron se izloči v 14 dneh v glavnem skozi blato preko izločanja žolča (60%) in v manjši meri (25%) preko urina.
ANNEX II A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE D. STATEMENT OF THE MRLs
DODATEK II A. IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE VARNE IN UČINKOVITE UPORABE D. NAVEDBA NAJVIŠJIH DOVOLJENIH ZAOSTANKOV ZDRAVILA (MRL)
Wash hands after administration.
Po dajanju zdravila si umijte roke.
Tablet Round, white, biconvex tablet of 5.5 mm, 7 mm, 9 mm and 12 mm.
Tablete Okrogla, bela, bikonveksna tablete velikosti 5,5 mm, 7 mm, 9 mm in 12 mm.
REGARDING SUPPLY OR USE
OSKRBE IN UPORABE
Do not use after the expiry date stated on the blister after “EXP”
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini za "EXP"
PHARMACEUTICAL FORM Tablet.
FARMACEVTSKA OBLIKA Tablete.
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.
Prehodni stranski učinki v spremembi dlake, kot so izguba ali sprememba dlake so bili po uporabi Ypozane opaženi le zelo redko.
Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur.
Veterinar naj naredi ponovno oceno 5 mesecev po zdravljenju ali prej, če se klinični znaki ponovijo.
Osaterone acetate and its metabolite are bound to plasma proteins (around 90% and 80% respectively), mainly to albumin.
Osateronijev acetat in njegov metabolit sta vezana na plazemske proteine (prvi okoli 90% in slednji okoli 80%) v glavnem na albumin.
PACKAGE SIZE 7 tablets.
VELIKOST PAKIRANJA 7 tablet.
Benign prostatic hypertrophy (BPH) is a natural consequence of ageing.
Benigna hipertrofija prostate (BHP) je naravna posledica staranja.
After repeated administration of osaterone acetate at 0.25 mg/kg/day for 7 days, the factor of accumulation is about 34 without change in the rates of absorption or elimination.
Po ponovljenem odmerjanju osateronijevega acetata z 0,25 mg/kg/dan za 7 dni je akumulacijski faktor okoli 3-4 brez spremembe v hitrosti absorpcije ali izločanja.
The clinical response persists for at least 5 months after treatment.
Klinični odgovor traja vsaj 5 mesecev po zdravljenju.
Osaterone acetate inhibits the effects of an excess of male hormone (testosterone) through various mechanisms.
Osateronijev acetat inhibira učinke presežka moškega hormona (testosterona) preko več mehanizmov.
Osaterone acetate is converted to its main, 15β-hydroxylated metabolite, which is also pharmacologically active.
Osateronijev acetat se pretvori v glavni 15β-hidroksiliran metabolit, ki je prav tako farmakološko aktiven.
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.
Pri psih se po peroralnem dajanju s hrano osateronijev acetat hitro absorbira (Tmax okoli 2 uri) in je v glavnem v jetrih izpostavljen učinku prvega prehoda.
BPH is a development and enlargement of the prostate due to the male hormone testosterone.
BHP je razvoj in povečanje prostate zaradi moškega hormona testosterona.
Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Odmerite 0,25 - 0,5 mg osateronijevega acetata na kilogram telesne teže enkrat na dan 7 dni na naslednji način:
The onset of clinical response to treatment is usually seen within 2 weeks.
Nastop kliničnega odgovora na zdravljenje opazite v 2 tednih.
After a dose of 0.25 mg/kg/day, the mean maximum concentration (Cmax) in plasma is about 60 µg/l.
Po odmerku 0,25 mg/kg/dan je srednja največja koncentracija (Cmax) v plazmi okoli 60 µg/l.
MANUFACTURER'S BATCH NUMBER Batch {number}
IZDELOVALČEVA ŠTEVILKA SERIJE Serija {številka}
Osaterone acetate is a steroid chemically related to progesterone, and as such it has potent progestagen and potent anti-androgen activity.
Osateronijev acetat je steroid, ki je kemijsko podoben progesteronu in ima zato močno progestagensko in močno protiandrogeno delovanje.
All these adverse reactions are reversible without any specific treatment.
Vsi neželeni učinki izginejo brez specifičnega zdravljenja.
EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003 EU/2/06/068/004
EU/2/06/068/001 EU/2/06/068/002 EU/2/06/068/003
Behavioural changes such as modification of dog's activity or more social behaviour are common.
Pogoste so spremembe vedenja, na primer spremenjena dejavnost psa ali bolj družabno vedenje.
Transient modifications of appetite can be observed, either increased (very common) or decreased (very rare).
Zelo pogosto se pojavi prehodna sprememba apetita, bodisi povečanega (zelo pogosto) ali zmanjšanega (zelo redko).
Osaterone is a steroid anti-androgen, which inhibits the effects of an excess production of male hormone (testosterone).
Osateron je steroidni antiandrogen, ki inhibira učinke presežne proizvodnje moškega hormona (testosterona).
Also, the major metabolite of osaterone acetate (15β-hydroxylatedosaterone acetate) has anti-androgenic activity.
Tudi glavni metabolit osateronijevega acetata (15β-hidroksiliran osateronijev acetat) ima protiandrogeno delovanje.
Number of tablet per day
Število tablet na dan Trajanje zdravljenja
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.
Odločitev o ponovnem zdravljenju v tem ali kasnejšem trenutku mora temeljiti na veterinarskem pregledu upoštevajoč tveganje in koristi izdelka.
Pharmacotherapeutic group: drugs used in benign prostatic hypertrophy.
Farmakoterapevtska skupina: zdravila, ki se uporabljajo pri benigni hipertrofiji prostate.
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Pri psih z BHP povezano s prostatitisom lahko zdravilo uporabljamo sočasno s protimikrobnimi zdravili.
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.
Odločitev o ponovnem zdravljenju v tem ali kasnejšem trenutku mora temeljiti na veterinarskem pregledu upoštevajoč tveganje in koristi zdravila.
The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Tudi odgovor na test stimulacije adrenokortikotropnega hormona (ACTH) je lahko zmanjšan še nekaj tednov po zaužitju osaterona.
Date of first authorisation: 11/01/2007 Date of latest renewal: 19/12/2011
Datum podaljšanja dovoljenja za promet: 19/12/2011
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE
The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare).
Najpogosteje opaženi neželeni učinki so blaga in prehodna sprememba apetita, bodisi povečanega (zelo pogosto) ali zmanjšanega (zelo redko).
The onset of clinical response to treatment is usually seen within 2 weeks and persists for at least 5 months after treatment.
Prvi klinični odgovor na zdravljenje se pojavi v 2 tednih in traja vsaj 5 mesecev po zdravljenju.
Use with caution in dogs with a history of liver disease.
Pri psih s podatki o bolezni jeter uporabljajte previdno.
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.
Enkraten peroralno zaužiti odmerek 40 mg osateronijevega acetata pri moških je v posameznih primerih povzročil znižanje koncentracije FSH, LH in testosterona, ki se je vrnila v običajno po 16
Transient behavioural changes such as increased or decreased activity, or more sociable behaviour, are common.
Pogoste so prehodne spremembe vedenja, na primer povečana ali zmanjšana dejavnost ali bolj družabno vedenje.
To be supplied only on veterinary prescription
Izdaja zdravila je le na veterinarski recept
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.
Enkraten peroralno zaužiti odmerek 40 mg osateronijevega acetata pri moških je v posameznih primerih povzročil znižanje koncentracije spolnih hormonov, ki se je vrnila v običajno po 16 dneh.
Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate Excipients:
Vsaka tablete vsebuje 1,875 mg, 3,75 mg, 7,5 mg ali 15 mg osateronijevega acetata
In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
Če kdo nenamerno zaužije zdravilo, mora takoj poiskati zdravniško pomoč in zdravniku pokazati navodila za uporabo ali oznako na ovojnini.
The enlargement of mammary glands occurs less commonly and can be associated with lactaction in very rare cases.
Povečanje mlečnih žlez se pojavlja le občasno in jo v zelo redkih primerih lahko spremlja laktacija.
15 mg tablet
15 mg tablete
Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly.
Drugi neželeni učinki kot so prehodno bruhanje in/ali driska, povečana žeja, otrplost ali povečane mlečne žleze se pojavljajo redko.
1.875 mg tablet
1,875 mg tablete
Other adverse reactions, including transient vomiting and/or diarrhoea, polyuria/polydipsia or lethargy occur uncommonly.
Drugi neželeni učinki, kot so prehodno bruhanje in/ali driska, poliurija/polidipsija ali letargija se pojavljajo redko.
- 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).
- zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
6.5 Nature and composition of immediate packaging Carton box containing one aluminium/aluminium blister with 7 tablets.
Zloženka, ki vsebuje pretisni omot (aluminij/aluminij) s 7 tabletami.
YPOZANE tablets to be administered
Tablete YPOZANE, ki jih je treba uporabiti
Mammary gland hyperplasia occurs uncommonly and can be associated with lactation in very rare cases.
Hiperplazija mlečnih žlez se pojavlja le občasno in jo v zelo redkih primerih lahko spremlja laktacija.
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)
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Ženske v plodni dobi naj se torej pri dajanju zdravila izogibajo stiku z njim, oziroma nosijo rokavice za enkratno uporabo.
Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Ženske v plodni dobi naj se torej pri dajanju zdravila izogibajo stiku z njim oziroma nosijo rokavice za enkratno uporabo.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism.
Pojavi se lahko prehodno znižanje koncentracije kortizola v plazmi, ki se lahko nadaljuje še nekaj tednov po zaužitju zdravila Psi pod stresom (npr. po operaciji) ali tisti s hipoadrenokorticizmom morajo biti pod ustreznim nadzorom.
INDICATION(S) Treatment of benign prostatic hypertrophy in male dogs.
INDIKACIJA(E) Zdravljenje benigne hipertrofije prostate pri psih samcih.
3.75 mg tablet
3,75 mg tablete
D. STATEMENT OF THE MRLs Not applicable
D. NAVEDBA NAJVIŠJIH DOVOLJENIH ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
7.5 mg tablet
7,5 mg tablete
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA ODGOVOREN
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 1.875 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 1,875 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 15 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 15 mg
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Zdravljenje benigne hipertrofije prostate (BHP) pri psih samcih.
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 1.875 mg osaterone acetate.
NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 1,875 mg osateronijevega acetata.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Virbac S.A.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Virbac S.A.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 7.5 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 7,5 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX - 3.75 mg
PODATKI NA ZUNANJI OVOJNINI ŠKATLA - 3,75 mg
Name and address of the manufacturer responsible for batch release Virbac S.A.
(ODGOVORNI) ZA SPROŠČANJE SERIJE Ime in naslov izdelovalca zdravila, odgovornega za sproščanje serije Virbac S.A.
VIRBAC S.A.1ère avenue 2065 m - LID06516 CarrosFrance
VIRBAC S.A.1ère avenue 2065 m - LID06516 Carros Francija
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.
Pri psih s podatki o bolezni jeter uporabljajte previdno, saj pri teh psih varnost uporabe zdravila še ni raziskana.
3 to 7.5 kg
3 do 7,5 kg
RESTRICTIONS REGARDING SUPPLY AND USE, if applicable For animal treatment only - to be supplied only on veterinary prescription.
Samo za živali - oskrba le na podlagi veterinarskega recepta.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
BESEDILO “SAMO ZA ŽIVALI” IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
Treatment of benign prostatic hypertrophy in male dogs.
Zdravljenje benigne hipertrofije prostate pri psih samcih.
A transient reduction in plasma cortisol occurs in most treated animals.
Pri večini zdravljenih živali pride zaradi reverzibilnega antiglukokortikoidnega učinka osaterona do prehodnega zmanjšanja plazemskega kortizola.
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 7.5 mg osaterone acetate
NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 7,5 mg osateronijevega acetata
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 1.875 mg tablets for dogs Osaterone acetate
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 1,875 mg tablete za pse
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 15 mg tablets for dogs Osaterone acetate
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 15 mg tablete za pse
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 3.75 mg osaterone acetate
NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 3,75 mg osateronijevega acetata
STATEMENT OF ACTIVE SUBSTANCES Each tablet contains 15 mg osaterone acetate
NAVEDBA UČINKOVIN(E) Vsaka tablete vsebuje 15 mg osateronijevega acetata.
NAME OF THE VETERINARY MEDICINAL PRODUCT Ypozane 7.5 mg tablets for dogs Osaterone acetate
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Ypozane 7,5 mg tablete za pse
1ère avenue - 2065 m - LID 06516 Carros France
VIRBAC S.A. 1ère avenue - 2065 m - LID 06516 Carros Francija