natgillin/translations-raw huggingface dataset:
In order to maintain renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs and cats during sevoflurane anaesthesia. 
Zaradi vzdrževanja krvnega pretoka skozi ledvice se moramo pri psih in mačkah pod sevofluransko anestezijo izogibati dolgotrajnim epizodam hipotenzije (srednji arterijski tlak pod 60 mmHg).
Sevoflurane degradation in soda lime has been shown to increase with temperature. 
Dokazali so, da se degradacija sevoflurana v zmesi kalcijevega hidroksida z natrijevim ali kalijevim hidroksidom zvečuje s temperaturo.
PHARMACEUTICAL FORM Inhalation vapour, liquid. 
FARMACEVTSKA OBLIKA Para za inhaliranje, tekočina.
PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code: QN 01AB08 
Oznaka ATCvet: QN 01AB08.
PACKAGE LEAFLET: SevoFlo 100% Inhalation vapour, liquid for dogs and cats 
NAVODILO ZA UPORABO SevoFlo, 100 % para za inhaliranje, tekočina za pse in mačke
Bradycardia can be reversed by the administration of anticholinergics. 
Bradikardijo lahko odpravimo z uporabo antiholinergikov.
The nephrotoxic potential of certain NSAIDs, when used in the perioperative period, may be exacerbated by hypotensive episodes during sevoflurane anaesthesia. 
Epizode hipotenzije med sevofluransko anestezijo lahko poslabšajo nefrotoksični potencial nekaterih nesteroidnih protivnetnih zdravil (NSAID), če jih uporabljamo v perioperativnem obdobju.
During maintenance of anaesthesia, increasing the concentration of sevoflurane produces a dosedependent decrease in blood pressure. 
Med vzdrževanjem anestezije povzroči zviševanje koncentracije sevoflurana od odmerka odvisno znižanje krvnega tlaka.
For operator warnings - read the package leaflet before use. 
Pred uporabo preberite navodilo za uporabo.
In cats, transient increases in AST and ALT may occur with sevoflurane, however, hepatic enzymes tend to remain within the normal range. 
Pri mačkah se lahko pri sevofluranu pojavi prehodno zvišanje aspartatne aminotransferaze (AST), alaninske aminotransferaze (ALT), medtem, ko jetrni encimi ostanejo v normalnem območju.
In order to minimise exposure to sevoflurane vapour, the following recommendations are made: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Da bi kar najbolj zmanjšali izpostavitev hlapom sevoflurana, priporočamo naslednje:
The possibility of sevoflurane triggering episodes of malignant hyperthermia in susceptible dogs and cats cannot be ruled out. 
Čeprav ne poročajo o primerih maligne hipertermije pri psih pod anestezijo s sevofluranom, ni mogoče izključiti možnosti, da bi sevofluran pri dovzetnih psih in mačkah sprožil epizode maligne hipertermije.
Induction of anaesthesia: 
Uvod v anestezijo:
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, ki nastanejo pri uporabi teh zdravil
As a result, renal blood flow falls in a linear fashion with increasing hypotension in sevoflurane anaesthetised dogs and cats. 
Kot posledica se pri psih in mačkah, anesteziranih s sevofluranom, pretok krvi skozi ledvice zmanjšuje linearno z naraščajočo hipotenzijo.
Longduration, low-flow sevoflurane anaesthesia should be avoided due to the risks of Compound A accumulation. 
Zaradi nevarnosti kopičenja spojine A se je treba dolgotrajni nizkopretočni sevofluranski anesteziji izogibati.
4.2 Indications for use, specifying the target species 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Za uvod v anestezijo in vzdrževanje anestezije.
Symptoms of human overexposure (inhalation) to sevoflurane vapour include respiratory depression, hypotension, bradycardia, shivering, nausea and headache. 
Neželeni škodljivi učinki, povezani z uporabo SevoFlo, o katerih najpogosteje poročajo, so bile hipotenzija, nato pa tahipneja, mišična napetost, razdraženost, apneja, mišične fascikulacije in bruhanje.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE BOTTLE 
PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI STEKLENICA
22 November 2012 EMA/393905/2006 Rev. 2 
22. novembra 2012 EMA/393905/2006 Rev. 2
Regulatory authorities may also perform an inspection of these monitoring systems. 
Regulativni organi lahko opravijo pregled teh sistemov spremljanja.
However, this can only be done as long as it does not affect the medicine's activity. 
Vendar je to dovoljeno le, če ne vpliva na delovanje zdravila.
Each company is required to set up systems to monitor the safety of all medicines that it markets. 
Vsaka družba mora vzpostaviti sistem spremljanja varnosti vseh zdravil, ki jih trži.
Generic medicines are manufactured according to the same quality standards as all other medicines. 
Generična zdravila se izdelujejo po enakih standardih kakovosti kot vsa druga zdravila.
They may also decide to develop a medicine with a slightly different indication, such as a limited indication that will allow the medicine to be used without a prescription. 
Lahko se odločijo tudi za razvoj zdravila z nekoliko drugačno indikacijo, na primer omejeno indikacijo, ki bi omogočala uporabo zdravila brez recepta.
This protection applies to new uses of the medicine, such as new indications. 
To varstvo se lahko uveljavlja za vse nove uporabe zdravila, na primer za nove indikacije.
This type of generic medicine is called a ‘hybrid' medicine, because its authorisation relies in part on the results of tests trials on the reference medicine and in part on new data. 
Tovrstna generična zdravila se imenujejo „hibridna“ zdravila, saj je njihova odobritev delno odvisna od rezultatov testnih preskušanj referenčnega zdravila, delno pa od novih podatkov.
If the medicine is a hybrid, additional tests may be required, such as the results of clinical trials that test the efficacy of the medicine. 
Če je zdravilo hibrid, se lahko zahtevajo dodatni testi, na primer rezultati kliničnih preskušanj, s katerimi se testira učinkovitost zdravila.
However, the name of the medicine, its appearance (such as colour or shape) and its packaging can be different from those of the reference medicine. 
Vendar pa so lahko ime, videz (npr. barva in oblika) in ovojnina zdravila drugačni kot pri referenčnem zdravilu.
Bioequivalence studies are only needed for medicines that are absorbed by the body before being released into the bloodstream, such as medicines that are taken by mouth. 
Študije biološke enakovrednosti so potrebne samo za zdravila, ki jih telo absorbira, preden se sprostijo v krvni obtok, na primer peroralna zdravila.
A generic manufacturer may choose to use a different form of the active substance, for example the manufacturer can decide to use a ‘hydrochloride' salt of the active substance because this form is more stable. 
Izdelovalec generičnega zdravila lahko izbere drugačno obliko zdravilne učinkovine; lahko se na primer odloči, da bo uporabil „hidrokloridno“ sol zdravilne učinkovine, ker je ta oblika obstojnejša.
Specifically, a company producing a generic medicine needs to provide information on the quality of the medicine. 
Družba, ki proizvaja generično zdravilo, mora predložiti predvsem podatke o kakovosti zdravila.
As for all medicines, the safety of generic medicines continues to be monitored after authorisation. 
Kot pri vseh zdravilih se varnost generičnih zdravil spremlja tudi po odobritvi.
Until the expiry of the use patent, generic medicines can only be marketed for indications that are not patented. 
Dokler veljavnost patenta za uporabo ne poteče, se lahko generično zdravilo trži samo za indikacije, ki niso patentirane.
Generic medicines that are administered directly into the bloodstream, such as those given directly into a vein by injection or infusion (drip), do not need to be tested for bioequivalence against the reference medicine. 
Generičnih zdravil, ki se dajejo neposredno v krvni obtok, na primer zdravil, ki se injicirajo ali infundirajo (kapalno) v veno, ni treba testirati, ali so biološko enakovredna referenčnemu zdravilu.
As the reference medicine will have been authorised for several years, information is already available on the efficacy and safety of the active substance(s) it contains. 
Ker so referenčna zdravila odobrena že nekaj let, so na voljo podatki o učinkovitosti in varnosti zdravilne(ih) učinkovine (učinkovin), ki jo (jih) zdravilo vsebuje.
In most cases, it will also need to supply data from a bioequivalence study to show that the generic medicine produces the same levels of the active substance in the body (whether human or animal) as the reference medicine. 
V večini primerov mora predložiti tudi podatke iz študije biološke enakovrednosti, s katero mora dokazati, da se ob jemanju generičnega zdravila v (človekovem ali živalskem) telesu tvori enaka raven zdravilne učinkovine kot pri referenčnem zdravilu.
The innovator company benefits from data and market exclusivity under pharmaceutical legislation (typically 10 years from the date of first authorisation). 
V skladu s farmacevtsko zakonodajo je družba, ki je razvila inovativno zdravilo, upravičena do podatkovne in tržne zaščite (običajno 10 let od datuma prve odobritve zdravila).
When can a generic medicine be developed? 
Kdaj se lahko razvije generično zdravilo?
A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised (the ‘reference medicine'). 
Generično zdravilo je zdravilo, ki je zasnovano tako, da je enako že odobrenemu zdravilu („referenčnemu zdravilu“).
The pharmaceutical legislation defines the tests that must be carried out to demonstrate that the generic medicine is comparable to the reference medicine so that it can receive a marketing authorisation. 
Farmacevtska zakonodaja določa teste, ki se morajo izvesti in s katerimi mora biti dokazana primerljivost generičnega zdravila z referenčnim zdravilom, da lahko generično zdravilo pridobi dovoljenje za promet.
If specific safety precautions have to be considered when taking the reference medicine, the same precautions will generally also be required for the generic medicine. 
Če so pri jemanju referenčnega zdravila potrebni posebni previdnostni ukrepi, je treba običajno enake previdnostne ukrepe upoštevati tudi pri jemanju generičnega zdravila.
The inactive ingredients, or ‘excipients', may differ between the generic medicine and its reference. 
Neaktivne sestavine ali „pomožne snovi“ se lahko pri generičnem in referenčnem zdravilu razlikujejo.
The active substance of a medicine is what gives it its therapeutic effect. 
Zdravilna učinkovina zdravila je snov, ki zagotavlja terapevtski učinek zdravila.
The only differences relate to any differences in excipients and any patented indications. 
Odstopanja se pojavijo le v primeru razlik v zvezi z uporabljenimi pomožnimi snovmi in patentiranimi indikacijami.
If the reference medicine is benefiting from patent protection for some indications, these cannot appear in the product information of the generic medicine. 
Če so bile pri referenčnem zdravilu s patentnim varstvom zaščitene nekatere indikacije, se te indikacije ne smejo pojaviti v informacijah o generičnem zdravilu.
Generic manufacturers can also choose to develop a generic medicine that is based on a reference medicine, but is presented as a different strength or with a different route of administration to the reference medicine. 
Izdelovalci generičnih zdravil se lahko odločijo tudi za razvoj generičnega zdravila, ki je osnovano na referenčnem zdravilu, vendar ima drugačno jakost ali drugačno pot uporabe kot referenčno zdravilo.
If a generic medicine contains a different salt of the active substance to the salt used in the reference medicine, regulatory authorities will consider whether additional tests are needed for the medicine to be granted a marketing authorisation. 
Če generično zdravilo vsebuje drugačno sol zdravilne učinkovine kot referenčno zdravilo, regulativni organi odločijo, ali so potrebni dodatni testi za pridobitev dovoljenja za promet s tem zdravilom.
As for other medicines, regulatory authorities perform periodic inspections of the manufacturing site(s), to ensure that good manufacturing practices are in place. 
Kot pri vseh drugih zdravilih regulativni organi izvajajo občasne preglede proizvodnih obratov in tako zagotavljajo proizvodnjo v skladu z dobro proizvodno prakso.
Once the generic medicine is authorised, the same information will appear in the ‘product information' of the generic medicine (the summary of product characteristics, the labelling and the package leaflet) as in the product information of the reference medicine. 
Po odobritvi generičnega zdravila so v informacijah o tem zdravilu (povzetku glavnih značilnosti zdravila, označevanju in navodilu za uporabo) navedeni enaki podatki kot v informacijah o referenčnem zdravilu.
How is the safety of generic medicines monitored? 
Kako se spremlja varnost generičnih zdravil?
As for all medicines, generic medicines must obtain a marketing authorisation before they can be marketed. 
Kot vsa druga zdravila morajo tudi generična zdravila pred trženjem pridobiti dovoljenje za promet.
While this ‘use patent' protection is in place, a generic medicine cannot be marketed for the protected indication, even if the period of exclusivity on the reference medicine has expired. 
Med veljavnostjo „patenta za uporabo“ se generično zdravilo ne sme tržiti za zaščiteno indikacijo, tudi če je obdobje zaščite za referenčno zdravilo že poteklo.
Innovator companies can use patent law to obtain further protection for an innovative medicine. 
Družbe, ki razvijejo inovativna zdravila, lahko ta dodatno zaščitijo s patentnim varstvom.
Marketing authorisations are granted after a regulatory authority, such as the European Medicines Agency, has conducted a scientific evaluation of the medicine's efficacy (how well it works as measured in clinical studies), safety and quality. 
Evropska agencija za zdravila, izvede znanstveno vrednotenje učinkovitosti (kako učinkovito je zdravilo glede na rezultate kliničnih študij), varnosti in kakovosti zdravila.
A company can only develop a generic medicine for marketing once the period of ‘exclusivity' on the reference medicine has expired. 
Družba lahko generično zdravilo za trženje razvije šele po izteku „zaščite“ za referenčno zdravilo.
A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s) as the reference medicine. 
Generično zdravilo vsebuje enako(e) zdravilno(e) učinkovino(e) kot referenčno zdravilo in se v enakem odmerku uporablja za zdravljenje enake(ih) bolezni kot referenčno zdravilo.
This period of exclusivity is given by law to the company that developed the innovative medicine on which the generic medicine is based. 
Obdobje zaščite je za družbo, ki razvije inovativno zdravilo, na podlagi katerega se zasnuje generično zdravilo, določeno z zakonom.
A generic medicine contains the same quantity of active substance(s) as the reference medicine. 
Generično zdravilo vsebuje enako količino zdravilne(ih) učinkovine (učinkovin) kot referenčno zdravilo.
If precautions are necessary because of an excipient, they will be described both on the label and in the package leaflet of the generic medicine. 
Če so zaradi določene pomožne snovi potrebni previdnostni ukrepi, bodo ti opisani na ovojnini in v navodilu za uporabo generičnega zdravila.
Questions and answers on generic medicines 
Vprašanja in odgovori o generičnih zdravilih EMA/393905/2006 Rev 2
What is a generic medicine? 
Kaj je generično zdravilo?
How are generic medicines authorised? 
Kako se generična zdravila odobrijo?
How are generic medicines manufactured? 
Kako se generična zdravila izdelujejo?
What does a generic medicine contain? 
Kaj generično zdravilo vsebuje?
How are generic medicines evaluated? 
Kako se generična zdravila vrednotijo?
2 pre-filled syringes 
2 napolnjena injekcijska peresnika
The PRAC issued its final recommendations on 17 May 2018, replacing the temporary measures. 
Odbor PRAC je 17. maja 2018 izdal končna priporočila, ki nadomeščajo začasne ukrepe.
The review of Esmya was initiated at the request of European Commission on 30 November 2017, under Article 20 of Regulation (EC) No 726/2004. 
Pregled zdravila Esmya se je začel 30. novembra 2017 na zahtevo Evropske komisije v skladu s členom 20 Uredbe (ES) št. 726/2004.
It is estimated that around 765,000 patients have been treated with Esmya to date. 
Ocenjuje se, da se je do zdaj z zdravilom Esmya zdravilo približno 765 000 bolnic.
The PRAC therefore recommended that use of the medicine should be restricted. 
Odbor PRAC je zato priporočil, da je treba uporabo zdravila omejiti.
• If you have any questions or concern about your treatment, speak to your doctor or pharmacist. 
• Če imate kakršna koli vprašanja ali pomisleke glede zdravljenja, se posvetujte z zdravnikom ali farmacevtom.
Liver testing also to be performed again 2-4 weeks after stopping treatment. 
Preiskave delovanja jeter je treba ponovno opraviti 2-4 tedne po prenehanju zdravljenja.
More information on Esmya can be found here. 
Več informacij o zdravilu Esmya je na voljo tukaj.
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.