natgillin/translations-raw huggingface dataset:
In case of signs or symptoms suggestive of such injury, treatment should be stopped.
V primeru znakov ali simptomov, ki kažejo na tovrstno okvaro, je treba zdravljenje prekiniti.
While the review was ongoing, the PRAC had issued temporary recommendations that no new patients should start treatment.
Med potekom pregleda je odbor PRAC izdal začasna priporočila, po katerih zdravljenja ne sme začeti nobena nova bolnica.
In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.
Poleg tega je uporaba zdravila za več kot en ciklus zdravljenja omejena na ženske, ki niso primerne za kirurški poseg.
Although uncertainties around causality remain, the following measures to minimise a possible risk for liver injury will be introduced:
Čeprav negotovosti glede vzročne povezave ostajajo, so bili uvedeni naslednji ukrepi za zmanjšanje morebitnega tveganja za okvaro jeter:
− Liver function tests to be performed before starting each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated.
− Preiskave delovanja jeter je treba opravljati pred začetkom vsakega ciklusa zdravljenja, mesečno v prvih dveh ciklusih zdravljenja, nato pa, kot je klinično indicirano.
− Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN).
− Zdravilo Esmya se ne sme uvesti, če so ravni alanin-transaminaze (ALT) ali aspartataminotransferaze (AST) več kot dvakrat višje od zgornje meje normalne vrednosti (ULN).
• You will also have liver tests during treatment and after treatment has stopped.
• Jetrne preiskave boste imeli tudi med zdravljenjem in po prenehanju zdravljenja.
The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
Zdravilo je dokazano učinkovito pri zmanjševanju krvavenja in anemije, povezanih s to boleznijo, ter pri zmanjševanju velikosti leiomiomov.
• Esmya will not be prescribed to you if you have liver problems.
• Zdravila Esmya vam ne bodo predpisali, če imate težave z jetri.
Patients should be investigated immediately including liver function testing.
Bolnice morajo takoj opraviti preiskave, vključno s preiskavami delovanja jeter.
Certain women may start treatment with Esmya once the new measures are implemented.
Določene ženske se po uvedbi novih ukrepov lahko začnejo zdraviti z zdravilom Esmya.
No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.
Pri uporabi zdravila ellaOne niso poročali o primerih resne okvare jeter in trenutno ni zadržkov glede uporabe tega zdravila.
It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.
Priporočljiva je tudi izvedba študij za ugotavljanje učinkov zdravila Esmya na jetra in učinkovitosti novih ukrepov pri zmanjšanju tveganja.
The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury.
Ukrepi vključujejo: kontraindikacijo pri ženskah z znanimi težavami z jetri, jetrne preiskave pred uvedbo zdravljenja, med zdravljenjem in po koncu zdravljenja, kartico za bolnice, s katero se seznanijo o potrebi po spremljanju delovanja jeter in obveznosti, naj se obrnejo na zdravnika, če se pri njih pojavijo simptomi okvare jeter.
• Healthcare professionals prescribing Esmya in the EU will receive a letter with further details once a European Commission decision has been issued.
• Zdravstveni delavci, ki predpisujejo zdravilo Esmya v EU, so prejeli dopis z dodatnimi podrobnostmi.
• A card will be included in the package of the medicine with information on the risk of liver injury and the need for liver monitoring.
• Pakiranju zdravila bo priložena kartica z informacijami o tveganju za okvaro jeter in o potrebi po spremljanju delovanja jeter.
In 8 cases of serious liver injury, a role of Esmya in contributing to these cases is possible.
V osmih primerih resne poškodbe jeter obstaja možnost, da je k tem prispevalo zdravilo Esmya.
• Healthcare professionals should advise their patients about the signs and symptoms of liver injury and the action to take should they occur.
• Zdravstveni delavci morajo svojim bolnicam povedati, kakšni so znaki in simptomi okvare jeter, in jim svetovati, kako naj ukrepajo, če se ti pojavijo.
The PRAC's final recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Končna priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je sprejel končno mnenje.
The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines.
Pregled je opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
Since progesterone may promote the growth of fibroids, by preventing the effects of progesterone ulipristal acetate reduces the size of the fibroids.
Ker lahko progesteron spodbuja rast leiomiomov, ulipristalacetat s preprečevanjem njegovega učinka zmanjša velikost leiomiomov.
The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.1
Odbor PRAC je zaključil, da je zdravilo Esmya morda prispevalo k pojavu nekaterih primerov resne okvare jeter.1
Esmya: new measures to minimise risk of rare but serious liver injury
Zdravilo Esmya: novi ukrepi za zmanjšanje tveganja za redko, a resno okvaro jeter
Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Ulipristalacetat je učinkovina tudi v enoodmernem zdravilu ellaOne, odobrenem za nujno kontracepcijo.
− Restricted indication in the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: Esmya should only be used in women who are not eligible for surgical treatment.
− Omejitev indikacije na intermitentno zdravljenje zmernih do resnih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi: zdravilo Esmya se sme uporabljati samo pri ženskah, ki niso primerne za kirurško zdravljenje.
− Contraindication in patients with underlying liver disorders.
− Kontraindikacija pri bolnicah z osnovno boleznijo jeter.
The active substance in Esmya, ulipristal acetate, works by attaching to the targets on cells (receptors) that the hormone progesterone normally attaches to, preventing progesterone from having its effect.
Učinkovina v zdravilu Esmya, ulipristalacetat, deluje tako, da se na celicah veže na običajna prijemališča (receptorje) za vezavo hormona progesterona, kar prepreči učinek progesterona.
The review of Esmya was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation.
Pregled zdravila Esmya je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri agenciji EMA po poročilih o resni okvari jeter, vključno z odpovedjo jeter, zaradi katere je bila potrebna presaditev.
The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Mnenje odbora CHMP je bilo posredovano Evropski komisiji, ki je dne 26.07.2018 izdala končni pravno zavezujoč sklep, ki velja za vse države članice EU.
(Esmya continues to be indicated for one course (lasting up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.)
(Zdravilo Esmya je še naprej indicirano za en ciklus [ki traja največ tri mesece] predoperativnega zdravljenja zmernih do resnih simptomov materničnih leiomiomov pri odraslih ženskah v rodni dobi.)
• A liver test will be performed before you start treatment and if the test is abnormal, treatment with Esmya will not be started.
• Pred začetkom zdravljenja bodo opravili preiskavo jeter in v primeru nenormalnih izvidov zdravljenja z zdravilom Esmya ne bodo uvedli.
The PRAC's recommendations have now been endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP) and will be sent to the European Commission for a final legal decision.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je podprl priporočila odbora PRAC in jih poslal Evropski komisiji v sprejetje končnega pravnega sklepa.
A letter will be sent to doctors to inform them of the new conditions of use, which will become applicable after a Commission decision is issued.
Zdravnikom je bil poslan dopis, s katerim so bili seznanjeni z novimi pogoji uporabe.
The European Medicines Agency (EMA) has recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate).
Evropska agencija za zdravila (EMA) je 31. maja 2018 priporočila uvedbo ukrepov za zmanjšanje tveganja za redko, a resno okvaro jeter pri uporabi zdravila Esmya (ulipristalacetata).
• The medicine Esmya, used to treat uterine fibroids, has been reviewed because cases of serious liver problems have occurred in women taking the medicine, including four cases that resulted in liver transplantation.
• Zdravilo Esmya, ki se uporablja za zdravljenje materničnih leiomiomov, je bilo pregledano, ker so se pri ženskah, ki so jemale zdravilo, pojavili primeri resnih težav z jetri, vključno s štirimi primeri, pri katerih je bila potrebna presaditev jeter.
EMA concludes review of medicine for uterine fibroids
Agencija EMA zaključuje pregled zdravila za maternične leiomiome
Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are benign (non-cancerous) tumours of the womb, in women who have not reached the menopause.
Zdravilo Esmya je bilo leta 2012 odobreno za zdravljenje zmernih do hudih simptomov materničnih leiomiomov, tj. benignih (nerakavih) tumorjev maternice pri ženskah pred menopavzo.
− Treatment should be stopped in patients with ALT or AST levels more than 3 times ULN.
− Pri bolnicah z ravnmi ALT ali AST, ki so več kot trikrat višje od zgornje meje normalne vrednosti, je treba zdravljenje prekiniti.
• You should stop treatment and contact your doctor immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
• Če se pojavijo simptomi okvare jeter (kot so utrujenost, porumenelost kože, temno obarvan urin, siljenje na bruhanje in bruhanje), morate takoj prekiniti zdravljenje in se obrniti na zdravnika.
Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb).
Zdravilo Esmya uporablja za zdravljenje zmernih do hudih simptomov materničnih leiomiomov (benignih tumorjev maternice).
• If no liver problems are detected, a single course of Esmya can be used in women who are about to have surgery for their fibroids; Esmya can be used for more than one course only in women who cannot have surgery.
• Če ne odkrijejo nobenih težav z jetri, se pri ženskah, ki imajo načrtovan kirurški poseg zaradi leiomiomov, lahko opravi en ciklus zdravljenja z zdravilom Esmya.
• Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
• Pri bolnicah, zdravljenih z zdravilom Esmya (ulipristalacetatom), so poročali o štirih primerih resne okvare jeter, zaradi katere je bila potrebna presaditev, ter o dodatnih primerih okvare jeter.
ATCvet code: QI05AD02.
ATCvet oznaka: QI05AD02.
Date of first authorisation: 06/03/2003 Date of last renewal: 06/03/2013
Datum pridobitve dovoljenja za promet: 06/03/2003 Datum zadnjega podaljšanja dovoljenja za promet: 06/03/2013
10x1 ml (10 doses).
10x1ml (10 odmerkov)
EXP Use immediately after opening.
EXP Uporabite takoj po prvem odpiranju.
Do not use after the expiry date stated on the label.
Ne uporabljajte po pretečenem roku uporabnosti, navedenem na nalepki
In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
V izjemnih okoliščinah lahko pride do preobčutljivostne reakcije, ki jo je treba ustrezno simptomatično zdraviti.
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but at different sites and not mixed with MERIAL's inactivated vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno dati isti dan, vendar na različni mesti in ne zmešano z Merialovim inaktiviranim cepivom proti steklini.
4.6 Adverse reactions (frequency and seriousness)
Stranski učinki (pogostost in resnost)
The active substances being a principle of biological origin intended to produce active immunity are not within the scope of Regulation (EC) 470/2009.
Učinkovine biološkega izvora namenjene vzbujanju aktivne pasivne imunosti, niso vključene v Uredbo(ES) št. 470/2009.
* vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
* vCP vsebnost določena s celokupnim FAID50 (fluorescenčni test infektivnega odmerka 50 %) in qPCR razmerjem med vCP.
A slight increase in temperature (max. 1.5 °C) may occur for 1 day, exceptionally 2 days.
Rahlo povišanje temperature (največ 1,5 °C) lahko traja 1 dan, izjemoma 2 dni.
Manufacturer responsible for the batch release: MERIAL
Izdelovalec, odgovoren za sprostitev serije: MERIAL
• 5 months after primary vaccination course with ProteqFlu-Te.
• 5 mesecev po primarnem cepljenju s Proteqflu TE.
Active immunisation of horses of 4 months of age or older against equine influenza to reduce clinical signs and virus excretion after infection.
Aktivna imunizacija konj, starih 4 mesece ali več proti konjski influenci za ublažitev kliničnih znakov in zmanjšanje izločanja virusov po okužbi.
In exceptional circumstances, apathy and reduced appetite may be observed the day after vaccination.
V izjemnih okoliščinah se lahko dan po cepljenju pojavita apatičnosti in zmanjšan tek.
In rare occasions swelling can reach a diameter up to 15-20 cm, with duration up to 2-3 weeks, that may require symptomatic treatment.
V redkih primerih se lahko pojavi oteklina s premerom do 15-20 cm, ki traja do 2-3 tedne in lahko zahteva simptomatsko zdravljenje.
The excipients, including adjuvants, listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
SPC tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
Name and address of the manufacturers of the biological active substances
Ime in naslov proizvajalcev biološko aktivnih učinkovine
The vaccine stimulates active immunity against equine influenza.
Cepivo spodbuja aktivno imunost proti konjski influenci.
A transient swelling which usually regresses within 4 days may appear at the injection site.
Na mestu injiciranja se lahko pojavi prehodna oteklina, ki običajno izgine v 4 dneh.
Carbomer ........................................................................................................................................... 4 mg.
Karbomer .............................................................................................................................................. 4 mg
Pain, local hyperthermia and muscle stiffness can occur in rare cases.
V redkih primerih se lahko pojavijo bolečina, lokalno povišana temperatura in otrdelost mišic.
Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous Water for injections
Natrijev dihidrogenfosfat dihidrat Kalijev dihidrogenfosfat, brezvodni Voda za injekcije
In very rare occasions, abscessation may be observed.
V zelo redkih primerih se lahko pojavi absediranje.
Duration of immunity induced by the vaccination scheme: 5 months after primary vaccination course and 1 year after the third vaccination.
Čas trajanja imunosti, ki ga spodbudi predvideni razpored cepljenja: 5 mesecev po primarnem in eno leto po tretjem cepljenju.
Store and transport refrigerated (2 °C - 8 °C).
Shranjujte in prevažajte v hladilniku 2 °C 8 °C.
2nd scheme - vaccination against equine influenza and tetanus:
Shema 2 - cepljenje proti influenci konj in tetanusu:
As a consequence, these components induce immunity against equine influenza virus (H3N8).
ampak izražajo zaščitne proteine, ki spodbudijo imunost proti virusu konjske influence (H3N8).
- Revaccination: 5 months after primary vaccination course followed by annual booster injections.
- Revakcinacija: 5 mesecev po primarnem cepljenju, sledi letna revakcinacija.
After inoculation, the viruses do not multiply in the horse but express the protective proteins.
Po inokulaciji se virusi v konjih ne razmnožujejo,
In very rare occasions, abcessation may be observed.
V zelo redkih primerih se lahko pojavi abscediranje.
Carbomer ........................................................................................................................................... 4 mg. For the full list of excipients, see section 6.1.
Karbomer .............................................................................................................................................. 4 mg Celoten seznam pomožnih snovi, glej razdelek 6.1.
Onset of immunity: 14 days after primary vaccination course.
Nastop imunosti 14. dan po končanem primarnem cepljenju
The vaccine strains vCP2242 and vCP3011 are recombinant canarypox viruses expressing the haemagglutinin HA gene from the equine influenza virus strains A/eq/Ohio/03 (American strain, Florida sublineage clade 1) and A/eq/Richmond/1/07 (American strain, Florida sublineage clade 2), respectively.
Seva cepiva vCP3011 in vCP2242 sta rekombinantna canarypox virusa, ki izražata hemaglutinin HA gen sevov A/eq/Ohio/03 (ameriški sev, podvrsta Florida 1) oziroma A/eq/Richmond/1/07 (ameriški sev, podvrsta Florida 2) virusa konjske influence.
Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ............. ≥ 5.3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) .. ≥ 5.3 log10 FAID50*
Influenza A/eq/ Ohio/03 [H3N8] rekombinantni canarypox virus (vCP2242) ............. ≥ 5,3 log10 FAID50* Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni canarypox virus (vCP1533) .. ≥ 5,3 log10 FAID50*
1st scheme - vaccination against equine influenza:
Shema 1 - cepljenje proti influenci konj:
o against equine influenza: injection of 1 dose every year, alternatively with ProteqFlu or ProteqFlu-Te, respecting an interval of maximum 2 years for the tetanus component.
o Proti tetanusu: 1 odmerek Proteqflu TE največ na vsaki dve leti o Proti influenci konj: 1 odmerek vsako leto, izmenjaje Proteqflu in Proteqflu TE, upoštevajoč največ dve leti razmika za tetanus komponento.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK
Following the administration of overdoses of vaccine, no side-effects other than those described under “Adverse reactions” have been observed.
Po dajanju prevelikih odmerkov niso ugotovili nobenih drugih stranskih učinkov razen tistih,
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
- Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
ProteqFlu Suspension for injection for horses
ProteqFlu suspenzija za injiciranje za konje
In case of increased infection risk or insufficient colostrum intake, an additional initial injection of ProteqFlu can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 5-6 months of age and 4-6 weeks later followed by revaccination).
V primeru povečanega tveganja okužbe ali nezadostnega zaužitja kolostruma se lahko injicira dodaten začetni odmerek Proteqflu v starosti štirih mesecev, ki mu sledi popoln program cepljenja (prvi odmerek v starosti petih do šestih mesecev, drugi odmerek 4 do 6 tednov pozneje, sledi revakcinacija).
PACKAGE LEAFLET FOR: ProteqFlu suspension for injection for horses
NAVODILO ZA UPORABO ProteqFlu suspenzija za injiciranje za konje
Administer one dose (1 ml), by intramuscular injection, preferably in the neck region, according to the following schedule: - Primary vaccination course with ProteqFlu-Te: first injection from 5-6 months of age, second injection 4-6 weeks later.
Injicirajte 1 odmerek (1 ml Proteqflu) intramuskularno, priporočljivo v predel vratu, po naslednjem razporedu: - Primarno cepljenje: prvi odmerek pri starosti petih do šestih mesecev, drugi odmerek 4 do 6
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer package for 10 doses: 10 vials of 1 dose
Zunanja ovojnina za 10 odmerkov suspenzije
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Uporabite takoj po prvem odpiranju.
ProteqFlu suspension for injection for horses
ProteqFlu Suspenzija za injiciranje za konje.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
DODATEK II A IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIKDOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
• Followed by: o against tetanus: injection of 1 dose at an interval of maximum 2 years with ProteqFlu-Te.
o Proti tetanusu: 1 odmerek Proteqflu TE največ na vsaki dve leti o Proti influenci konj: 1 odmerek vsako leto, izmenjaje Proteqflu in Proteqflu TE,
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION 1st scheme - vaccination against equine influenza:
DAJANJA ZDRAVILA Shema 1 - cepljenje proti influenci konj:
Type I glass vial.
OVOJNINAH Viala
Following the administration of overdoses of vaccine, no side-effects other than those described under section 4.6 have been observed.
Pomožne snovi (vključno z dodatki), navedene v poglavju 6.1.
This needs point further discussion.
Ta točka zahteva nadaljnjo razpravo.
The mechanism of this syndrome is not understood.
Mehanizma tega sindroma ne poznamo.
Bioavailability is 65 to 70 %.
Biološka uporabnost znaša od 65 do 70 %.
The treatment should be discontinued one day prior to the surgery.
Zdravljenje morate prekiniti en dan pred operacijo.
Efficacy and safety of use in children has not been established.
Učinkovitosti in varnosti uporabe zdravila pri otrocih niso ugotavljali.
This effect is anticipated and is usually not a reason to discontinue treatment.
Učinek je pričakovan in običajno ni razlog za prekinitev zdravljenja.
This indication was endorsed by several CMS.
To indikacijo je odobrilo več zadevnih držav članic.
The dose adjustment should be based on the clinical response of the individual patient.
Prilagajanje odmerka mora temeljiti na kliničnem odzivu posameznega bolnika.
It is not known whether perindopril is excreted into human breast milk.
Ni znano, ali se perindopril pri ljudeh izloča v materino mleko.
• no untoward safety findings related to the extension of the indication have been identified.
• ugotovljene niso bile nikakršne neugodne ugotovitve v zvezi z varnostjo, povezane z razširitvijo indikacije,