natgillin/translations-raw huggingface dataset:
Palynziq must not be used in patients who have had an allergic reaction to pegvaliase, to any of the other components of Palynziq or to any other pegylated medicine. 
Zdravilo Palynziq se ne sme uporabljati pri bolnikih, ki so imeli alergijsko reakcijo na pegvaliazo, katero koli drugo sestavino zdravila Palynziq ali katero koli drugo pegilirano zdravilo.
Throughout the study, patients were required to maintain a constant level of dietary protein intake, to ensure that changes in blood phenylalanine levels could be attributed to treatment rather than to changes in protein intake. 
V študiji so morali bolniki ohranjati stalno raven vnosa beljakovin v prehrani, da bi lahko spremembe ravni fenilalanina v krvi pripisali zdravljenju, ne pa spremembam vnosa beljakovin.
Other information about Palynziq 
Druge informacije o zdravilu Palynziq
It was shown that for the majority of patients continued treatment with Palynziq for 18 months was effective at keeping blood phenylalanine levels under control (below 600 micromoles per litre). 
Dokazano je bilo, da je bilo za večino bolnikov 18-mesečno nadaljevanje zdravljenja z zdravilom Palynziq učinkovito pri uravnavanju ravni fenilalanina v krvi pod nadzorom (pod 600 mikromolov na liter).
What are the risks associated with Palynziq? 
Kakšna tveganja so povezana z zdravilom Palynziq?
Eighty-six patients who responded to treatment (i.e. whose blood phenylalanine levels were reduced by at least 20%) where then either kept on the same dose of Palynziq or were given placebo (a dummy treatment). 
Šestinosemdeset bolnikov, ki so se odzvali na zdravljenje (tj. pri katerih so se ravni fenilalanina v krvi zmanjšale za najmanj 20 %), je nato bodisi še naprej prejemalo enak odmerek zdravila Palynziq bodisi so prejeli placebo (zdravilo brez učinkovine).
After 8 weeks of treatment, blood phenylalanine levels remained under control in patients taking Palynziq but they returned to pre-treatment levels in patients on placebo, showing that Palynziq was more effective than placebo in reducing blood phenylalanine levels and keeping them within an acceptable range. 
Po osmih tednih zdravljenja so ravni fenilalanina v krvi ostale pod nadzorom pri bolnikih, ki so jemali zdravilo Palynziq, vendar so se pri bolnikih, ki so prejemali placebo, vrnili na ravni pred zdravljenjem, kar kaže, da je bilo zdravilo Palynziq pri zniževanju ravni fenilalanina v krvi učinkovitejše od placeba in jih ohranja v sprejemljivem razponu.
The active substance in Palynziq, pegvaliase, is a bacterial enzyme that can break down phenylalanine, thereby stopping phenylalanine from building up in the body and helping to relieve the symptoms of phenylketonuria. 
Učinkovina v zdravilu Palynziq, pegvaliaza, je bakterijski encim, ki lahko razgrajuje fenilalanin, s čimer preprečuje kopičenje fenilalanina v telesu in pomaga ublažiti simptome fenilketonurije.
Palynziq is used in patients whose blood levels of phenylalanine have not been adequately controlled with other treatments. 
Zdravilo Palynziq se uporablja pri bolnikih, pri katerih ravni fenilalanina v krvi niso bile ustrezno uravnane z drugimi oblikami zdravljenja.
Patients with this genetic disease cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system. 
Bolniki s to dedno boleznijo ne morejo razgraditi aminokisline fenilalanin, ki je prisotna v beljakovinah v hrani, zaradi česar se ta kopiči v krvi in dosega neobičajno visoko raven, kar povzroča težave z živčnim sistemom.
Palynziq contains the active substance pegvaliase. 
Zdravilo Palynziq vsebuje učinkovino pegvaliaza.
Palynziq was shown to be effective at reducing levels of blood phenylalanine and keeping them under control. 
Dokazano je bilo, da je zdravilo Palynziq učinkovito pri zniževanju ravni fenilalanina v krvi in jih ohranja pod nadzorom.
The main study investigating Palynziq in patients with PKU consisted of different parts. 
Glavna študija, v kateri so zdravilo Palynziq proučevali pri bolnikih s fenilketonurijo, je bila sestavljena iz dveh delov.
In the extension phase of the study patients received an individual optimized dose of Palynziq. 
V podaljšanem obdobju študije so bolniki prejemali odmerek zdravila Palynziq, prilagojen vsakemu posamezniku.
Phenylalanine blood levels must be measured before starting treatment. 
Pred začetkom zdravljenja je treba izmeriti ravni fenilalanina v krvi.
How is Palynziq used? 
Kako se zdravilo Palynziq uporablja?
How does Palynziq work? 
Kako zdravilo Palynziq deluje?
For the full list of side effects of Palynziq, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Palynziq, glejte navodilo za uporabo.
They must also not be used in patients who are allergic to aniseed or to plants of the Apiaceae family (Umbelliferae) (caraway, celery, coriander, dill, fennel) or anethole. 
Prav tako se ne smejo uporabljati pri bolnikih, ki so alergični na janež, rastline iz družine Apiaceae (Umbelliferae) (kumino, zeleno, koriander, koper, komarček) ali anetol.
Aniseed oil medicines must not be used in children and adolescents under 18 years. 
Zdravila, ki vsebujejo eterično olje janeža, se ne smejo uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
Anise oil medicines should only be used in adults and should not be taken for longer than two weeks. 
Zdravila, ki vsebujejo eterično olje janeža, se smejo uporabljati samo pri odraslih in se ne smejo uporabljati več kot dva tedna.
In addition they can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds. 
Poleg tega se lahko uporabljajo kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
This summary is not intended to provide practical advice on how to use medicines containing anise oil. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo eterično olje janeža.
Anise oil is the common name for the essential oil obtained from the dry ripe fruits of the plant Pimpinella anisum L. 
Eterično olje janeža je splošno ime za eterično olje, ki se pridobiva iz suhih zrelih plodov rastline Pimpinella anisum L.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of anise oil. 
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo eteričnega olja janeža.
Herbal medicines containing these anise oil preparations are usually available in solid or liquid forms to be taken by mouth. 
Zdravila rastlinskega izvora, ki vsebujejo te pripravke z eteričnim oljem janeža, so navadno na voljo v trdni ali tekoči obliki za jemanje skozi usta.
Further information on the risks associated with these anise oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o tveganjih, povezanih s temi zdravili, ki vsebujejo eterično olje janeža, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
What is anise oil? 
Kaj je eterično olje janeža?
In its assessment, the HMPC considered studies in laboratory tests which showed anise oil to have a relaxing effect on the muscle of the gut and airways. 
V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so pokazale, da ima eterično olje janeža relaksacijski učinek na mišice črevesja in dihalnih poti.
Allergic reactions to aniseed oil that affect the skin or airways may occur. 
Lahko se pojavijo alergijske reakcije na eterično olje janeža, ki prizadenejo kožo ali dihalne poti.
The HMPC conclusions on the use of these anise oil medicines for indigestion complaints and coughs are based on their ‘traditional use' . 
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo eterično olje janeža, za zdravljenje prebavnih težav in kašlja temeljijo na njihovi „tradicionalni uporabi“.
Further information on the HMPC assessment of anise oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use. 
Dodatne informacije o oceni zdravil, ki vsebujejo eterično olje janeža, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
Information on the use and licensing of anise oil medicines in EU Member States should be obtained from the relevant national authorities. 
Za informacije o uporabi in registraciji zdravil, ki vsebujejo eterično olje janeža, v državah članicah EU se obrnite na pristojni nacionalni organ.
Any applications for the licensing of medicines containing anise oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC. 
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo eterično olje janeža, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Anise oil preparations may also be found in combination with other herbal substances in some herbal medicines. 
Pripravki z eteričnim oljem janeža so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
The HMPC conclusions only cover anise oil preparations which are obtained by steam distillation of the dry ripe fruits. 
Zaključki odbora HMPC zajemajo samo pripravke z eteričnim oljem janeža, ki se pridobivajo z destilacijo suhih zrelih plodov.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing anise oil. 
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje janeža.
How are anise oil medicines approved in the EU? 
Kako so zdravila, ki vsebujejo eterično olje janeža, odobrena v EU?
The HMPC concluded that, on the basis of its long-standing use, these anise oil preparations can be used for treating symptoms of mild indigestion complaints including bloating and flatulence. 
Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo eterično olje janeža, uporabljajo za zdravljenje simptomov blagih prebavnih težav, vključno z napihnjenostjo in napenjanjem.
What evidence supports the use of anise oil medicines? 
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje janeža?
Detailed instructions on how to take anise oil medicines and who can use them can be found in the package leaflet that comes with the medicine. 
Podrobna navodila o jemanju zdravil, ki vsebujejo eterično olje janeža, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Other information about anise oil medicines 
Druge informacije o zdravilih, ki vsebujejo eterično olje janeža
For more information about treatment with anise oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravili, ki vsebujejo eterično olje janeža, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with anise oil medicines? 
Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje janeža?
For practical information about using anise oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist. 
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
If symptoms last or get worse during the use of the medicine, a doctor or a qualified healthcare practitioner should be consulted. 
treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
Healthy people should not use Eporatio. 
Zdravi ljudje ne smejo uporabljati zdravila Eporatio.
Do not warm Eporatio in any other way (for example, do not warm it in a microwave or in hot water). 
Zdravila Eporatio ne grejte na noben drug način (na primer ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
Do not increase the dose your doctor has given you. 
Ne povečajte odmerka, ki vam ga je predpisal zdravnik.
Do not use it if the date has passed the last day of the month shown. 
Ne uporabite, če je ta pretekel zadnji dan navedenega meseca.
Date of latest renewal: 11 September 2014. 
Datum prve odobritve: 29. oktober 2009 Datum zadnjega podaljšanja: 11. september 2014
The safety and efficacy of Eporatio in children and adolescents aged up to 17 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Eporatio pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani.
PRCA means that the body has stopped or reduced the production of red blood cells which causes severe anaemia. 
PRCA pomeni, da je telo prenehalo ali zmanjšalo tvorbo rdečih krvničk, kar povzroča hudo anemijo.
Do not attempt to give this medicine to yourself without this training. 
Zdravila Eporatio si ne poskušajte dati sami brez usposabljanja.
Eporatio has not been tested in pregnant women. 
Zdravila Eporatio niso preizkusili pri nosečnicah.
If your doctor suspects or confirms that you have this condition, you must not be treated with Eporatio or another epoetin. 
Če zdravnik sumi na to stanje ali ga potrdi, se ne smete zdraviti z zdravilom Eporatio ali drugim epoetinom.
Other medicines and Eporatio 
Druga zdravila in zdravilo Eporatio
Eporatio is used for the treatment of anaemia accompanied by symptoms (for example fatigue, weakness and shortness of breath). 
Zdravilo Eporatio se uporablja za zdravljenje anemije s simptomi (na primer utrujenost, šibkost in kratka sapa).
Treatment with Eporatio is normally a long-term therapy. 
Zdravljenje z zdravilom Eporatio je navadno dolgotrajno.
If you do not respond adequately to Eporatio, your doctor will check your dose and will inform you if you need to change doses of Eporatio. 
Če se na zdravilo Eporatio ne odzovete ustrezno, bo zdravnik vaš odmerek preveril in vas obvestil, ali je treba odmerke zdravila Eporatio zamenjati.
You will usually receive Eporatio until 1 month after the end of chemotherapy. 
Zdravilo Eporatio boste navadno prejemali do enega meseca po koncu kemoterapije.
As a precautionary measure, it is preferable to avoid the use of Eporatio during pregnancy. 
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Eporatio bolje izogibati.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eporatio therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Eporatio, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Contents of the pack and other information What Eporatio contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Eporatio
Check again to make sure the correct dose of Eporatio is in the syringe. 
Ponovno preverite, ali je v brizgi ustrezen odmerek zdravila Eporatio.
If you are a patient with chronic renal failure, and particularly if you do not respond properly to Eporatio, your doctor will check your dose of Eporatio because repeatedly increasing your dose of Eporatio if you are not responding to treatment may increase the risk of having a problem of the heart or the blood vessels and could increase risk of myocardial infarction, stroke and death. 
Če imate kronično ledvično odpoved, in še zlasti, če se na zdravilo Eporatio niste ustrezno odzvali, bo zdravnik večkrat preverjal vaš odmerek zdravila Eporatio, saj lahko, če se na zdravljenje ne odzivate, stalno povečevanje odmerka zdravila Eporatio poveča možnost za težave s srcem ali krvnimi žilami in lahko poveča tveganje za srčni infarkt, možgansko kap ali smrt.
Push the plunger up to the number (IU) on the syringe that matches the dose of Eporatio that your doctor prescribed. 
Bat potisnite do številke (i.e.), ki ustreza odmerku zdravila Eporatio, ki ga je predpisal zdravnik.
If PRCA is diagnosed, therapy with epoetin theta must be discontinued and patients should not be switched to another recombinant epoetin (see section 4.4). 
Če se postavi diagnoza PRCA, je treba zdravljenje z epoetinom theta prekiniti, bolniki pa ne smejo preiti na drug rekombinantni epoetin (glejte poglavje 4.4).
If you think you are having this type of reaction, you must stop your Eporatio injection and get medical help immediately. 
Če menite, da imate to vrsto reakcije, morate prenehati injicirati zdravilo Eporatio in takoj poiskati zdravniško pomoč.
If you think you have injected more Eporatio than you should, contact your doctor. 
Če menite, da ste si injicirali večji odmerek zdravila Eporatio, kot bi smeli, se obrnite na zdravnika.
Check the appearance of Eporatio. 
Preverite videz zdravila Eporatio.
Do not use any Eporatio that is left in the syringe. 
Ne uporabite zdravila Eporatio, ki je ostalo v brizgi.
If you stop using Eporatio 
Če ste prenehali uporabljati zdravilo Eporatio
Eporatio is a clear and colourless solution for injection in pre-filled syringe along with an injection needle. 
Zdravilo Eporatio je bistra in brezbarvna raztopina za injiciranje v napolnjeni injekcijski brizgi z injekcijsko iglo.
This section contains information on how to give yourself an injection of Eporatio under the skin. 
To poglavje vsebuje informacije o samostojnem injiciranju zdravila Eporatio pod kožo.
Eporatio contains sodium 
Zdravilo Eporatio vsebuje natrij
It may also be necessary to reduce your dose of Eporatio or to stop the treatment with Eporatio for a short period of time. 
Morda bo treba zmanjšati odmerek zdravila Eporatio ali začasno prekiniti jemanje zdravila Eporatio.
What Eporatio looks like and contents of the pack 
Izgled zdravila Eporatio in vsebina pakiranja
If you are receiving Eporatio as an injection under the skin, your doctor may suggest that you learn how to inject yourself this medicine. 
Če vam zdravilo Eporatio injicirajo pod kožo, bo morda zdravnik predlagal, da se naučite samostojnega iniciranja zdravila.
If you forget to use Eporatio 
Če ste pozabili uporabiti zdravilo Eporatio
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of epoetin theta, treatment with epoetin theta must not be restarted in this patient at any time. 
Če je pri bolniku zaradi uporabe epoetina theta prišlo do hude kožne reakcije, kot sta SJS ali TEN, zdravljenja z epoetinom theta ni dovoljeno ponovno začeti.
If you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions, tell your doctor immediately. 
če se pojavijo glavoboli, predvsem nenadni, zbadajoči glavoboli, podobni migreni, zmedenost, motnje govora, nestabilna hoja, epileptični napadi, to takoj povejte zdravniku.
EU/1/09/573/025 EU/1/09/573/026 EU/1/09/573/027 EU/1/09/573/028 EU/1/09/573/040 EU/1/09/573/041 EU/1/09/573/042 
EU/1/09/573/024 EU/1/09/573/025 EU/1/09/573/026 EU/1/09/573/027 EU/1/09/573/028 EU/1/09/573/040 EU/1/09/573/041 EU/1/09/573/042
If you develop a serious rash or another of these skin symptoms, stop using Eporatio and contact your doctor or seek medical attention immediately. 
Če se je pri vas pojavil hud izpuščaj ali eden od teh kožnih simptomov, prenehajte z uporabo zdravila Eporatio in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
If you use more Eporatio than you should 
Če ste uporabili večji odmerek zdravila Eporatio, kot bi smeli
Epoetins are growth factors that primarily stimulate red blood cell production. 
Učinek na rast tumorja Epoetini so rastni faktorji, ki primarno stimulirajo tvorbo rdečih krvničk.
Do not use this medicine after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in napolnjeni injekcijski brizgi poleg oznake Uporabno do. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
What you need to know before you use Eporatio Do NOT use Eporatio 
Kaj morate vedeti, preden boste uporabili zdravilo Eporatio NE uporabljajte zdravila Eporatio
This medicine contains less than 1 mmol sodium (23 mg) per pre-filled syringe, i.e. essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na napolnjeno injekcijsko brizgo, kar v bistvu pomeni ‘brez natrija‘.
If you are being treated with Eporatio, the dose of the anticoagulant medicine may have to be increased. 
Če se zdravite z zdravilom Eporatio, bo morda treba povečati odmerek zdravila proti strjevanju krvi.
Eporatio 10,000 IU/1 ml, Eporatio 20,000 IU/1 ml and Eporatio 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution. 
Eporatio 10.000 i.e./1 ml, Eporatio 20.000 i.e./1 ml in Eporatio 30.000 i.e./1 ml: ena napolnjena injekcijska brizga vsebuje 1 ml raztopine.
If you have any further questions on the use of this medicine , ask your doctor, pharmacist or nurse. 
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Eporatio 1,000 IU/0.5 ml, Eporatio 2,000 IU/0.5 ml, Eporatio 3,000 IU/0.5 ml, Eporatio 4,000 IU/0.5 ml and Eporatio 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution. 
Eporatio 1000 i.e./0,5 ml, Eporatio 2000 i.e./0,5 ml, Eporatio 3000 i.e./0,5 ml, Eporatio 4000 i.e./0,5 ml in Eporatio 5000 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 0,5 ml raztopine.
To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Eporatio, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab, - a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely. 
- alkoholni čistilni robček, - košček povoja iz gaze ali sterilno vatno blazinico, - vsebnik, odporen proti vbodom (plastični vsebnik, ki ga dobite v bolnišnici ali lekarni), da lahko varno zavržete uporabljene brizge.
How to use Eporatio 
Kako uporabljati zdravilo Eporatio
What Eporatio is and what it is used for 2. 
Kaj je zdravilo Eporatio in za kaj ga uporabljamo Kaj je zdravilo Eporatio
Stop using Eporatio if you develop these symptoms and contact your doctor or seek medical attention immediately. 
Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo Eporatio in se takoj posvetujte z zdravnikom ali poiščite zdravniško pomoč.
The dose of Eporatio (expressed in International Units or IU) depends on your disease condition, your body weight and the way the injection is given (under the skin [subcutaneous injection] or into a vein [intravenous injection]). 
telesne mase in načina injiciranja (pod kožo [subkutano injiciranje] ali v veno [intravensko injiciranje]).