natgillin/translations-raw huggingface dataset:
• The data from SIGNIFY did not demonstrate a beneficial effect for Corlentor/Procoralan on cardiovascular outcomes in coronary artery patients without clinical heart failure. 
• Podatki iz študije SIGNIFY ne kažejo, da bi imelo zdravilo Corlentor/Procoralan koristen učinek na kardiovaskularne izide pri bolnikih s koronarno arterijsko boleznijo brez kliničnega srčnega popuščanja.
Doctors should consider stopping treatment if there is no improvement in angina symptoms after 3 months, or if the improvement is only limited. 
Zdravniki bi morali razmisliti o ukinitvi zdravljenja, če v 3 mesecih ni opaziti izboljšanja simptomov angine pektoris ali če je to izboljšanje le omejeno.
• Corlentor/Procoralan should be discontinued if the symptoms of angina do not improve within 3 months. 
• Zdravljenje z zdravilom Corlentor/Procoralan je treba ukiniti, če se simptomi angine pektoris v 3 mesecih ne izboljšajo.
The data also indicated a higher risk of bradycardia with Corlentor/Procoralan compared with placebo (17.9% vs. 
Podatki poleg tega kažejo na večje tveganje za bradikardijo ob uporabi zdravila Corlentor/Procoralan v primerjavi s placebom (17,9 % proti 2,1 %).
• Your doctor will stop treatment with Corlentor/Procoralan if your symptoms of angina (such as shortness of breath) do not improve within 3 months or if the improvement is only limited. 
• Zdravnik bo ukinil zdravljenje z zdravilom Corlentor/Procoralan, če se vaši simptomi angine pektoris (kot je zasoplost) v 3 mesecih ne izboljšajo ali če je izboljšanje le omejeno.
• Your doctor will start treatment with Corlentor/Procoralan at a dose of up to 5 mg twice daily and increase it if necessary to a maximum of 7.5 mg twice daily. 
• Zdravnik vam bo na začetku zdravljenja z zdravilom Corlentor/Procoralan predpisal odmerek do 5 mg dvakrat dnevno in ga po potrebi povečal na največ 7,5 mg dvakrat dnevno.
• The concomitant use of Corlentor/Procoralan with verapamil or diltiazem is now contraindicated. 
• Sočasna uporaba zdravila Corlentor/Procoralan z zdravilom verapamil ali diltiazem je sedaj kontraindicirana.
Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). 
V priporočilih je navedeno tudi, da zdravniki ne smejo predpisovati zdravila Corlentor/Procoralan skupaj z zdraviloma verapamil ali diltiazem, ki znižujeta srčni utrip, ter da bi morali preverjati, ali se je pri bolnikih morebiti pojavila atrijska fibrilacija (nepravilno, hitro krčenje preddvorov srca).
Corlentor/Procoralan is also used in patients with long-term heart failure (when the heart cannot pump enough blood to the rest of the body). 
Zdravilo Corlentor/Procoralan se uporablja tudi pri bolnikih s kroničnim srčnim popuščanjem (kadar srce ni zmožno prečrpati dovolj krvi v druge dele telesa).
Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina. 
Ker se zdravilo Corlentor/Procoralan ni izkazalo za učinkovito pri zmanjševanju tveganja za srčni infarkt ali kardiovaskularno smrt (smrt zaradi težav s srcem), se lahko uporablja le za lajšanje simptomov angine pektoris.
Patients in the SIGNIFY study were started on a higher than recommended dose of Corlentor/Procoralan and received up to 10 mg twice a day, which is higher than the currently authorised maximum daily dose (7.5 mg twice a day). 
Začetni odmerek zdravila Corlentor/Procoralan pri bolnikih v študiji SIGNIFY je bil večji od priporočenega, saj so ti prejemali do 10 mg dvakratno dnevno, kar presega trenutno odobren največji dnevni odmerek (7,5 mg dvakrat dnevno).
• The starting dose of Corlentor/Procoralan should not exceed 5 mg twice daily and the maintenance dose of Corlentor/Procoralan should not exceed 7.5 mg twice daily. 
• Začetni odmerek zdravila Corlentor/Procoralan ne sme presegati 5 mg dvakrat dnevno, vzdrževalni odmerek pa ne sme presegati 7,5 mg dvakrat dnevno.
Corlentor/Procoralan is used to treat symptoms of long-term stable angina (chest pain due to problems with the blood flow to the heart) in adults with coronary heart disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle) who have a normal heart rhythm. 
Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov kronične stabilne angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) pri odraslih s koronarno srčno boleznijo (boleznijo srca, ki jo povzroča zapora krvnih žil, ki dovajajo kri v srčno mišico), ki imajo normalen srčni utrip.
These recommendations are based on the EMA's review of the final data from the SIGNIFY study1, which showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates). 
V študiji so pri podskupini bolnikov s simptomatsko angino pektoris zabeležili majhno, vendar značilno povečanje kombiniranega tveganja za kardiovaskularno smrt ali nesmrten srčni infarkt ob uporabi zdravila Corlentor/Procoralan v primerjavi s placebom (letna stopnja pojavnosti je znašala 3,4% proti 2,9 %).
• In the symptomatic treatment of patients with chronic stable angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is above or equal to 70 beats per minute (bpm). 
• Za simptomatsko zdravljenje bolnikov s kronično stabilno angino pektoris se zdravljenje z zdravilom Corlentor/Procoralan lahko uvede le, če bolnikov srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
• Your doctor will only start Corlentor/Procoralan if your resting heart rate is at least 70 beats per minute (bpm). 
• Vaš zdravnik bo zdravljenje z zdravilom Corlentor/Procoralan uvedel le, če vaš srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
However, the Agency reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day. 
EMA je menila, da večji odmerek, uporabljen v študiji, ne pojasnjuje v celoti ugotovitev, kljub temu pa je ponovno opozorila, da začetni odmerek za angino pektoris ne sme presegati 5 mg dvakrat dnevno in da največji odmerek ne sme presegati 7,5 mg dvakrat dnevno.
• The risk of developing atrial fibrillation is increased in patients treated with Corlentor/Procoralan. 
• Pri bolnikih, ki se zdravijo z zdravilom Corlentor/Procoralan, je tveganje za razvoj atrijske fibrilacije povečano.
When used for angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is at least 70 beats per minute (bpm). 
Pri angini pektoris se zdravljenje z zdravilom Corlentor/Procoralan lahko uvede le, če bolnikov srčni utrip v mirovanju znaša vsaj 70 utripov na minuto.
• Corlentor/Procoralan is a medicine used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure. 
• Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) in za zdravljenje srčnega popuščanja.
Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure. 
Zdravilo Corlentor/Procoralan se uporablja za zdravljenje simptomov angine pektoris (bolečine v prsnem košu zaradi težav z dotokom krvi v srce) in za zdravljenje srčnega popuščanja.
In its evaluation the EMA also assessed additional data on the safety and effectiveness of Corlentor/Procoralan which showed that the risk of atrial fibrillation is increased in patients treated with Corlentor/Procoralan compared with controls (4.9% vs 4.1%). 
Evropska agencija za zdravila je v okviru svojega ocenjevanja pregledala tudi dodatne podatke o varnosti in učinkovitosti zdravila Corlentor/Procoralan, ki izkazujejo večje tveganje za atrijsko fibrilacijo
SE = standard error. 
SE = standardna napaka.
Some of these patients have been under 50 years of age. 
Nekateri od teh bolnikov so bili mlajši od 50 let.
Key results of studies 2, 3 and 4 are shown below. 
Ključni rezultati študij 2, 3 in 4 so prikazani spodaj.
This is due to air pressure and should not be of concern. 
Do tega pride zaradi zračnega pritiska, to naj vas ne skrbi.
• Wash your hands thoroughly. 
Temeljito si umijte roke.
(It may be helpful to keep notes on the location of the previous injections.) 
(Morda vam bo v pomoč, če si boste beležili mesta predhodnih injekcij.)
Serious allergic reactions are rare. 
Resne alergijske reakcije so redke.
Immediate use is then recommended. 
Nato priporočamo takojšnjo uporabo.
Date of first authorisation: 13 February 2017 Date of last renewal: {DD month YYYY} 
Datum prve odobritve: 13. februar 2017 Datum zadnjega podaljšanja: {DD. mesec LLLL}
Wait until all the powder dissolves (usually less than 10 minutes). 
Počakajte, da se ves prašek raztopi (običajno v manj kot 10 minutah).
From a microbiological point of view, the reconstituted medicinal product should be used immediately. 
Z mikrobiološkega stališča je treba rekonstituirano zdravilo uporabiti takoj.
This benefit was maintained in Year 2 of this study. 
To koristno delovanje se je ohranjalo tudi v drugem letu te študije.
c: Remission is defined as DAS <1.6. 
c: Remisija je definirana kot DAS < 1,6.
Frequency Not Known (Cannot be Estimated from Available Data) 
Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov)
The half-life is long, approximately 70 hours. 
Njegova razpolovna doba je dolga in znaša približno 70 ur.
Very Rare 
Zelo redki
Long-term studies to assess the safety of the combination are ongoing. 
Dolgoročne študije za oceno varnosti te kombinacije zdravil še potekajo.
Wash your hands with soap and warm water. 
Umijte si roke z milom in s toplo vodo.
Always have the outer carton of the medicine with you, even if it is empty. 
Vedno vzemite s seboj škatlo zdravila, tudi če je prazna.
The powder is white. 
Prašek je bele barve.
Paediatric population See Summary of the safety profile, above. 
Pediatrična populacija Glejte Povzetek varnostnega profila zgoraj.
The healthcare professional's educational material should contain the following key elements: 
Izobraževalno gradivo za zdravstvene delavce mora vsebovati naslednje ključne sestavine:
See section 4.4 for vaccination advice. 
Glejte poglavje 4.4 za nasvete o cepljenju.
Gather the items that you will need for your injection, and place them on the chosen surface: 
Zberite predmete, ki jih boste potrebovali za injekcijo, in jih položite na izbrano površino:
Clear or almost clear defined as 0 or 1 on a 0 to 5 scale. 
"Čisto" ali "skoraj čisto" definirano kot 0 ali 1 na lestvici od 0 do 5.
• The risk of opportunistic infections and tuberculosis (TB) 
• tveganje za oportunistične okužbe in tuberkulozo
On pressing the centre of the button, you will hear a click. 
Ob pritisku sredine gumba boste slišali klik.
Do not warm in any other way. 
Ne segrevajte na noben drug način.
Do not warm LIFMIOR in any other way (for example, do not warm it in a microwave or in hot water). 
Zdravila LIFMIOR ne segrevajte na noben drug način (npr. ne segrevajte ga v mikrovalovni pečici ali topli vodi).
Check the expiry date (month/year) on the pen. 
Preverite datum izteka roka uporabnosti (mesec/leto) na peresniku.
These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). 
To so redki ali občasni neželeni učinki, ki pa so resni (nekateri od njih so v redkih primerih lahko smrtni).
b: Values for Disease Activity Score (DAS) are means. 
b: Vrednosti za oceno aktivnosti bolezni (DAS - Disease Activity Score) so povprečne vrednosti.
Please read the instructions carefully and follow them step by step. 
Navodilo skrbno preberite in sledite napotkom korak za korakom.
With continued therapy, responses were maintained up to 48 weeks. 
Ob nadaljevanju zdravljenja so se odzivi ohranili do 48 tednov.
LIFMIOR N=103 to 105* 
LIFMIOR n = 103 do 105*
Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. 
Zdravnik vam bo pomagal pri odločitvi, ali so koristi zdravljenja večje od možnega tveganja za vašega dojenčka.
Do not be concerned, as you will remove the air in a later step. 
To naj vas ne skrbi, ker ga boste kasneje odstranili.
D-88397 Biberach an der Riss 
D-88397 Biberach an der Riss Nemčija
The safety profile was consistent with that observed in other JIA studies. 
Varnostni profil je bil podoben kot v drugih študijah JIA.
These antibodies have all been non-neutralising and are generally transient. 
Protitelesa niso bila nevtralizirajoča in so na splošno prehodna.
The 2 year data did not reveal any new safety findings. 
Podatki, zbrani v 2 letih, niso pokazali novih dognanj o varnosti.
Double-Blind Clinical Responses at Week 12 
Dvojno slepi klinični odzivi po 12 tednih
LIFMIOR can be taken with or without food or drink. 
Zdravilo LIFMIOR se lahko uporablja skupaj s hrano ali pijačo ali brez njiju.
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. 
Priporočeni so redni pregledi kože pri vseh bolnikih, še posebno pri tistih, ki imajo dejavnike tveganja za kožnega raka.
CORRECT INCORRECT 
PRAVILNO NEPRAVILNO
Etanercept is cleared slowly from the body. 
Etanercept se počasi odstranjuje iz telesa.
Significant improvement was also observed for the ASAS partial remission and BASDAI 50. 
Pomembno izboljšanje so opazili tudi pri delni remisiji ASAS in BASDAI 50.
LIFMIOR is recommended for use in patients as defined in section 4.1. 
Uporaba zdravila LIFMIOR je priporočena pri bolnikih, kot je opredeljeno v poglavju 4.1.
Consequently, the choice of intermittent or continuous therapy should be based upon physician judgment and individual patient needs. 
Zato naj izbira zdravljenja v presledkih ali stalnega zdravljenja temelji na presoji zdravnika in potrebah posameznega bolnika.
Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the green button again. 
Opozorilo - Če ne morete začeti injiciranja, kakor je opisano, peresnik močneje pritisnite ob kožo in nato znova pritisnite zeleni gumb.
Dosing for adult patients (aged 18 years or over) 
Odmerjanje pri odraslih bolnikih (starih 18 let ali več)
• The pen should be used once only - it should never be re-used. 
• Peresnik je namenjen le za enkratno uporabo - nikoli ga ne smete ponovno uporabiti.
Undesirable effects in adults 
Neželeni učinki pri odraslih
The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies. 
Učinke etanercepta na izide nosečnosti so preučevali v 2 opazovalnih kohortnih študijah.
Do not use this medicine if you notice the solution is not clear or contains particles. 
Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali vsebuje delce.
(Note: After you have completed these steps, a small amount of liquid may remain in the vial. 
(Opozorilo: Tudi če ste postopek izvedli pravilno, lahko v viali ostane malo tekočine.
• Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen 
• učni pripomoček za olajšanje poučevanja bolnikov o varni uporabi napolnjenega peresnika
Some white foam may remain in the vial - this is normal. 
V viali lahko ostane nekaj bele pene - to je normalno.
Store in a refrigerator (2° - 8°C). 
Shranjujte v hladilniku (2 C - 8 C).
The observed rates and incidences in these clinical trials were similar to those expected for the population studied. 
Ugotovljene stopnje in pojavnosti v teh kliničnih preskušanjih so bile podobne tistim, ki so jih pričakovali za raziskovano populacijo.
The appropriate dose and frequency of dosing for the child or adolescent will depend on body weight and disease. 
Ustrezen odmerek in pogostnost odmerjanja za otroka ali mladostnika sta odvisna od njegove telesne mase in bolezni.
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%). 
Bolniki so bili prej zdravljeni z NSAID (86 %), DMARD (80 %) in kortikosteroidi (24 %).
Read all (both sides) of this leaflet carefully before you start using this medicine because it contains important information for you. 
Pred začetkom uporabe zdravila natančno preberite navodilo (obe strani), ker vsebuje za vas pomembne podatke!
The powder must be dissolved before use. 
Prašek morate pred uporabo raztopiti.
These reactions were generally transient and did not recur with treatment. 
Te reakcije so bile običajno prehodne in se med zdravljenjem niso ponavljale.
The clinical significance of this is unknown. 
Klinični pomen tega ni znan.
On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6). 
Ko zaslišite drugi klik (ali, če ne zaslišite drugega klika, ko bo minilo 10 sekund), bo injiciranje končano (glejte sliko 6).
In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. 
V nekaterih primerih določenih glivičnih in drugih oportunističnih okužb niso prepoznali, zaradi česar je prišlo do zakasnitve ustreznega zdravljenja in včasih bolnikove smrti.
Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy. 
Izboljšanja z zdravjem povezane kakovosti življenja in telesne funkcije so se prav tako vzdrževala med celotnim 2-letnim zdravljenjem.
Do not try to use the pen again, and do not try to use another pen without agreement from your nurse or pharmacist. 
Ne poskušajte ponovno uporabiti peresnika in ne poskušajte uporabiti drugega peresnika brez dovoljenja medicinske sestre ali farmacevta.
Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1). 
Za nekatere odrasle bolnike bo morda primerno stalno zdravljenje, daljše od 24 tednov (glejte poglavje 5.1).
Long-term experience with LIFMIOR was generally comparable to the original 48-week study and did not reveal any new safety findings. 
Dolgoročne izkušnje z zdravilom LIFMIOR so v splošnem primerljive s prvotno 48-tedensko študijo in niso pokazale novih dognanj o varnosti.
Injection site reactions usually occurred in the first month. 
Reakcije na mestu injiciranja so se običajno pojavljale v prvem mesecu.
With the other hand, hold the syringe like a pencil. 
Z drugo roko držite brizgo, kot bi držali svinčnik.
Mean duration was approximately 3 to 5 days. 
Povprečno trajanje tovrstnih reakcij je bilo 3 do 5 dni.
• Infections/monitoring: Tell your doctor of any recent travel outside the European region. 
Okužbe/spremljanje: Povejte zdravniku za morebitno nedavno potovanje izven Evrope.
The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults. 
Pri najmlajših bolnikih (4 leta) so opazili zmanjšan očistek (povečan, če je bil normaliziran s težo) v primerjavi s starejšimi otroki (12 let) in odraslimi.
If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgotten dose. 
Če se pozabljenega odmerka spomnite šele na dan, ko je že čas za naslednjo injekcijo, ne uporabite dvojnega odmerka (dveh odmerkov v istem dnevu), da bi nadomestili pozabljeni odmerek.
The clinical significance of this interaction is unknown. 
Klinični pomen te interakcije ni znan.
This appearance is normal for LIFMIOR. 
Tak izgled je normalen za zdravilo LIFMIOR.
Follow the directions given by the doctor. 
Upoštevajte navodila zdravnika.
The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria. 
Rezultate tega nadzorovanega preskušanja so prikazali kot odstotek izboljšanja revmatoidnega artritisa po kriterijih odziva ACR (American College of Rheumatology).
LIFMIOR should only be used during pregnancy if clearly needed. 
Zdravilo LIFMIOR lahko med nosečnostjo uporabljamo le, če je to nujno potrebno.
The clinical impact of this is unknown, however, infants may be at increased risk of infection. 
Klinični učinek tega ni znan, vendar pa lahko pri dojenčkih obstaja povečano tveganje za razvoj okužbe.
The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience. 
Spodnji seznam neželenih učinkov temelji na izkušnjah iz kliničnih preskušanj pri odraslih ter na izkušnjah iz obdobja trženja.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. 
Ta pregled mora zajeti natančno medicinsko anamnezo z osebno anamnezo tuberkuloze ali možnim predhodnim stikom s tuberkulozo in predhodnim in/ali sedanjim imunosupresivnim zdravljenjem.
It blocks the activity of another protein in the body that causes inflammation. 
V telesu zavre delovanje neke druge beljakovine, ki povzroča vnetje.
Injection advice: 
Nasvet za injiciranje:
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years. 
Na koncu dvojno slepe študije so se bolniki lahko vključili v dolgoročno odprto podaljšano študijo, ki je v celoti trajala do 2 leti.
Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose. 
Etanercept se počasi absorbira z mesta subkutane injekcije in doseže največjo koncentracijo po enkratnem odmerku po približno 48 urah.
It is important that you tell the baby's doctors and other healthcare professionals about the use of LIFMIOR during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”). 
Pomembno je, da o uporabi zdravila LIFMIOR med nosečnostjo obvestite dojenčkovega zdravnika in ostale zdravstvene delavce, preden dojenček prejme katerokoli cepivo (za več informacij glejte poglavje 2 “Cepljenja”).
Etanercept contains 934 amino acids and has an apparent molecular weight of approximately 150 kilodaltons. 
Etanercept vsebuje 934 aminokislin in ima navidezno molekulsko maso približno 150 kilodaltonov.
ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively. 
Odziva ASAS 50 in 70 sta bila definirana po istih kriterijih, le da je šlo za 50 % oziroma 70 % izboljšanje.
This study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy. 
Ta študija prav tako ni pokazala povečanih tveganj za manjše prirojene napake, prezgodnji porod, mrtvorojenost ali okužbe v prvem letu življenja pri dojenčkih, katerih matere so bile v času nosečnosti izpostavljene etanerceptu.
In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered. 
Pri pregledovanju bolnikov glede okužb moramo upoštevati bolnikovo tveganje za relevantne oportunistične okužbe (npr. izpostavljenost endemičnim mikozam).
Worsening of hepatitis C 
Poslabšanje hepatitisa C
Psoriatic Arthritis Response n = 104 
Odziv psoriatičnega artritisa n = 104
Inject slowly, at an angle of 45° to 90° to the skin. 
Injicirajte počasi, pod kotom 45 do 90 stopinj proti koži.