natgillin/translations-raw huggingface dataset:
Your doctor will monitor you for signs and symptoms of these conditions. 
Zdravnik bo spremljal vaše znake in simptome teh stanj.
Please check with your doctor and follow the recommended duration of treatment. 
Prosimo, preverite z vašim zdravnikom in sledite priporočenemu trajanju zdravljenja.
● the needle-shield may not have locked. 
• je možno, da se ščitnik za iglo ni zaklenil.
The average molecular mass is approximately 60,000 of which the protein moiety constitutes approximately 20,000. 
Povprečna molekulska masa je približno 60.000, od tega predstavlja beljakovinski del približno 20.000.
 The viewing window will now be completely red. 
 Okence bo postalo popolnoma rdeče.
< 12 g/dl despite 4 weeks at reduced dose 
< 12 g/dl kljub 4-tedenskemu zmanjšanemu odmerku
The risk of developing anaemia is higher in the female population. 
Tveganje za pojav anemije je večje pri ženski populaciji.
Date of latest renewal: 20 June 2007 
Datum prve odobritve: 20. junij 2002 Datum zadnjega podaljšanja: 20. junij 2007
The instructions below should be used as a general guide for proper disposal: Recapping is not required. 
Spodnja navodila naj služijo kot splošna navodila za primerno odstranjevanje: Pokrovčka ni treba ponovno pritrditi.
 A "click" sound will indicate the start of the injection. 
 Zvok “klik” naznanja začetek injiciranja.
Consideration for early treatment discontinuation should be evaluated in the context of a particular clinical situation. 
Razlog za zgodnjo prekinitev zdravljenja je treba oceniti v okviru posamezne klinične situacije.
● the expiration date has passed. 
• je rok uporabnosti potekel.
 The red indicator will move down in the viewing window as the injection is ongoing. 
 Rdeči indikator se bo pomikal navzdol po okencu, ko bo injekcija tekla.
● if the patient is a child less than 3 years old. 
• je bolnik otrok, mlajši od treh let,
● expose to excessive forces or shock. 
• izpostavljajte ga prekomernim silam ali udarcem;
Haematological tests should be repeated after 2 and 4 weeks and biochemical tests should be performed at 4 weeks. 
Hematološke preiskave moramo ponoviti po 2 in 4 tednih, biokemične preiskave pa po 4 tednih.
A return to original dosing is not recommended. 
Vrnitev na prvotni odmerek ni priporočljiva.
It is important to note that ribavirin should never be given as monotherapy. 
Pomembno je, da se ribavirina nikoli ne da kot monoterapijo.
● a container for the waste material 
• vsebnik za odpadni material.
All patients who completed the phase III studies were eligible for entry into a long-term follow-up study (WV16866). 
Vsi bolniki, ki so zaključili fazo III študij, so bili primerni za vključitev v dolgotrajno študijo sledenja (WV16866).
**Scheduled treatment duration was 48 weeks regardless of the genotype 
**Program zdravljenja je trajal 48 tednov, ne glede na genotip
You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour. 
Mogoče boste želeli prositi člana vaše družine ali prijatelja, da bi bila skupaj pozorna na znake depresije ali spremembe vašega vedenja.
Predictability of response Please refer to section 4.2, in Table 2. 
Predvidljivost odziva Prosimo, glejte poglavje 4.2, preglednica 2.
Take your next doses at 5 day intervals until you return to your regularly scheduled day of the week. 
Naslednje odmerke vzemite v 5-dnevnih intervalih, dokler se ne vrnete na vaš določeni dan v tednu.
This is normal. 
To je normalen pojav.
Predictability of response 
Predvidljivost odziva
Increased alanine aminotransferase (ALT) 
Zvišane vrednosti alaninaminotransferaze (ALT)
For spontaneous reports of undesirable effects from post-marketing experience, the frequency is not known (cannot be estimated from the available data). 
Za spontana poročila o neželenih učinkih v obdobju po prihodu zdravila na trg pogostnost ni znana (je ni mogoče oceniti iz razpoložljivih podatkov).
Change your injection site each time. 
Mesto injiciranja vsakič spremenite.
● the medicine contains particles 
• zdravilo vsebuje delce;
• A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months (see section 4.4) 
• anamneza težkega srčnega obolenja, vključno z nestabilnim ali nekontroliranim srčnim obolenjem v predhodnih 6 mesecih (glejte poglavje 4.4),
The extent of available data is not sufficient to conclude that growth inhibition due to Pegasys exposure is always reversible. 
Obseg razpoložljivih podatkov ni dovolj velik, da bi zaključili, da je zastoj rasti zaradi izpostavljenosti zdravilu Pegasys vedno reverzibilen.
If necessary, the dose may be changed during treatment. 
Če bo potrebno, bo zdravnik odmerek med zdravljenjem spremenil.
● Do contact your healthcare provider. 
• Obrnite se na zdravstvenega delavca.
The potency of this medicinal product should not be compared to the one of another pegylated or nonpegylated protein of the same therapeutic class. 
Jakosti tega zdravila ne smete primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda.
Efficacy results were similar to those reported in adults. 
Izsledki o učinkovitosti so podobni tistim, ki so jih opazili pri odraslih.
Pegasys must not be given to children below the age of 3 years because it contains benzyl alcohol and may cause toxic reactions and allergic reactions in these children. 
Zdravila Pegasys ne smemo dajati otrokom, mlajšim od 3 let, ker vsebuje benzilalkohol in lahko pri teh otrocih povzroči toksične reakcije in alergije.
The study efficacy results for these patients are summarised in Table 25. 
Podatki učinkovitosti študije za te bolnike so povzeti v preglednici 25.
Additional testing should be performed periodically during therapy (including glucose monitoring). 
Med zdravljenjem moramo periodično opravljati dodatne preiskave (vključno s spremljanjem ravni glukoze).
Interferon is a protein that modifies the response of the body's immune system to help fight infections and severe diseases. 
Interferon je beljakovina, ki spremeni imunski odgovor organizma, tako da se telo lahko brani pred okužbami in težkimi boleznimi.
As an example: Your regular weekly Pegasys injection is on Monday. 
Primer: vaš običajni dan injiciranja injekcije zdravila Pegasys je ponedeljek.
Most of the adverse reactions reported in the study were mild or moderate in severity. 
Večina neželenih učinkov, o katerih so poročali v študiji, je bila po izraženosti blagih ali zmernih.
Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery. 
Bolnike, pri katerih se pojavi omotičnost, zmedenost, somnolenca ali utrujenost, moramo opozoriti, naj se izogibajo vožnji ali upravljanju strojev.
You remember on Friday that you forgot to take your injection on Monday (4 days late). 
V petek se spomnite, da ste si v ponedeljek pozabili dati svojo injekcijo (4 dni pozneje).
All patients should be closely monitored for any signs or symptoms of psychiatric disorders. 
Pri vseh bolnikih je treba skrbno spremljati kakršne koli znake ali simptome psihiatričnih motenj.
- Adequately controlled thyroid function (TSH and T4) 
- ustrezno nadzirano delovanje ščitnice (TSH in T4).
Progressive decreases after 8 weeks of therapy were infrequent. 
Progresivno zmanjšanje po 8 tednih zdravljenja je bilo redko.
NOTE: Do not yet attempt to press the activation button. 
OPOMBA: Ne poskušajte še pritisniti gumba.
Pegasys is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. 
Zdravilo Pegasys se lahko uporablja med nosečnostjo samo, če potencialna korist upravičuje potencialno tveganje za plod.
Study ML17131 
Študija ML17131
Within 24 hours, about 80% of the peak serum concentration is reached. 
V 24 urah dosežemo 80 % največje plazemske koncentracije.
While most children returned to their projected height within two years after completing treatment, and the majority of the remaining children within six years after completing treatment, it remains possible that Pegasys may affect the final adult height. 
Čeprav je večina otrok dosegla njihovo pričakovano višino v dveh letih po zaključku zdravljenja, večina preostalih otrok pa v šestih letih po zaključku zdravljenja, ostaja možnost, da zdravilo Pegasys vpliva na končno višino v odrasli dobi.
Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition. 
Kadar koli je le mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
Predictive Value 
Napovedna vrednost
The dose reduction levels are provided in Table 8. 
Nivoji zmanjšanja odmerka so navedeni v preglednici 8.
● Slowly pull back the plunger to withdraw a bit more than the dose prescribed by your doctor into the syringe. 
● Bat počasi potegnite nazaj in v brizgo zajemite malo več kot odmerek, ki vam ga je predpisal zdravnik.
55% (21 of 38) of subjects who completed the original study enrolled in the long-term follow up extending up to 6 years post-treatment. 
55 % (21 od 38) preizkušancev, ki so zaključili prvotno študijo, je bilo vključenih v dolgoročno spremljanje, ki je trajalo do šest let po zdravljenju.
Operating characteristics of these biomarkers are presented in Table 11. 
Značilnosti teh bioloških označevalcev so predstavljene v preglednici 11.
• If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4). 
• Če ima vaš otrok psihične motnje ali jih je kadar koli imel, se posvetujte z zdravnikom, ki bo spremljal vašega otroka glede pojava znakov ali simptomov depresije (glejte poglavje 4).
It is not yet known whether they will return to their projected height and weight after completing treatment. 
Ni še znano, ali bodo po zaključku zdravljenja dosegli svojo pričakovano višino in maso.
Response rates in groups A and B at the end of 24 weeks follow-up are presented in Table 22. 
Deleži odzivov skupin A in B ob koncu 24-tedenskega spremljanja so predstavljeni v preglednici 22.
There are no data on long-term effects on sexual maturation. 
Podatkov o dolgotrajnih učinkih na spolno dozorevanje ni na voljo.
● if you have been withdrawn from previous therapy for Hepatitis C because of anaemia or low blood count. 
• če ste prejšnje zdravljenje hepatitisa C prekinili zaradi anemije ali nizkega števila krvnih celic.
After the Week 24 follow-up visit, patients from group A, B and C entered a long-term follow-up period (lasting for 5 years after end of treatment). 
Po obisku v 24. tednu spremljanja so bolnike iz skupin A, B in C vključili v dolgoročno obdobje spremljanja (s trajanjem 5 let po koncu zdravljenja).
A full listing of adverse reactions reported in this treatment group (n=55) is provided in Table 10. 
Celoten seznam poročanih neželenih učinkov iz te zdravljene skupine (n=55) je naveden v preglednici 10.
For more information, see section 5.1. 
Za dodatne informacije glejte poglavje 5.1.
● the medicine is any colour besides colourless to light yellow 
• je zdravilo kakršne koli druge barve razen brezbarvno do rahlo rumeno;
Patients who also have HIV infection: Tell your doctor if you are taking anti-HIV therapy. 
Bolniki, okuženi z virusom HIV: obvestite svojega zdravnika, da jemljete zdravila proti virusu HIV.
Wash your hands well using soap and water. 
Z milom in vodo si dobro umijte roke.
Your next injection will be on the Monday, 5 days later after the Wednesday injection. 
Vaš naslednji odmerek bo v ponedeljek, 5 dni po sredini injekciji.
HBV genotype A B 
HBV genotipa A B
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination. 
Vsak bolnik, pri katerem se pojavi poslabšanje ali izguba vida, mora na takojšen in celovit pregled oči.
Thus, the lower the BSA of the child, the lower the clearance of the drug and the higher the resultant exposure. 
Nižja kot je telesna površina otroka, nižji je očistek zdravila in tako je večja izpostavljenost zdravilu.
*Grading according to Trey, Burns and Saunders (1966) 
* stopnja po Treyu, Burnsu in Saundersu (1966)
The syringe, needle and all injection materials are intended for single use and must be discarded after the injection. 
Injekcijska brizga, igla in vsi injekcijski materiali so namenjeni enkratni uporabi in morajo biti po injiciranju uničeni.
● if you have diabetes or high blood pressure, your doctor may ask you to have an eye examination. 
• če imate sladkorno bolezen ali visok krvni tlak, da vas bo zdravnik morda napotil na pregled oči,
Psychiatric evaluation abnormal 
Preiskave nenormalna psihiatrična ocena
Patients should brush their teeth thoroughly twice daily and have regular dental examinations. 
Bolniki si morajo dvakrat na dan temeljito umiti zobe in imeti redne preglede pri zobozdravniku.
Haematological (see also Table 3) 
Hematološki (glejte tudi preglednico 3)
Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established. 
Razen tega korist kombinacije telbivudina in interferona alfa (pegiliranega ali standardnega) trenutno ni dokazana.
 You might hear a second “click” as the activation button pops back up. 
 Lahko zaslišite drugi “klik”, ko se sprožilni gumb vrne na prvotno mesto.
Must not be given to premature babies or neonates. 
Predčasno rojenim otrokom in novorojenčkom ga ne smemo dajati.
Do not attempt to administer an injection until you are sure that you understand how to use the pre-filled pen. 
Ne poskušajte si dati injekcije, dokler niste prepričani, kako uporabljati napolnjeni injekcijski peresnik.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Pulmonary changes 
Pulmonalne spremembe
Preliminary and limited safety data demonstrated no obvious departure from the known safety profile of the combination in adults with chronic HCV infection, but, importantly, the potential impact on growth has not been reported. 
Preliminarni in omejeni podatki o varnosti niso pokazali očitne razlike glede na znan varnostni profil te kombinacije pri odraslih s kronično okužbo s HCV, pomembno pa je, da niso poročali o potencialnem vplivu na rast.
Response rates at the end of follow-up for the two studies are presented in Table 12. 
Deleži odzivov po koncu obdobja sledenja bolnikom za ti dve študiji so predstavljeni v preglednici 12.
The difference between treatment regimens was in general not influenced by presence/absence of cirrhosis; therefore treatment recommendations for genotype 1, 2 or 3 are independent of this baseline characteristic. 
Prisotnost ali odsotnost ciroze v splošnem na razlike med shemami zdravljenja ni imela vpliva, zato so priporočila za zdravljenje za genotipe 1, 2 ali 3 neodvisna od te osnovne značilnosti.
HBeAg negative / anti-HBe positive Study WV16241 
HBeAg negativni / anti-HBe pozitivni študija WV16241
No data is available on long-term follow-up posttreatment in these patients (see section 4.4). 
Podatkov o dolgoročnem spremljanju po zdravljenju pri teh bolnikih ni na voljo (glejte poglavje 4.4).
The ribavirin dose should be administered with food. 
Odmerek ribavirina je treba zaužiti s hrano.
• When receiving Pegasys, your child may have slower growth and development (see section 4). 
• Ob prejemanju zdravila Pegasys sta lahko rast in razvoj vašega otroka upočasnjena (glejte poglavje 4).
If you see any bubbles, pull the plunger slightly back. 
Če vidite mehurčke, počasi potegnite bat nazaj.
If you have the impression that the effect of Pegasys is too strong or too weak, talk to your doctor or pharmacist. 
Če menite, da je učinek zdravila Pegasys premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Prior to beginning Pegasys therapy, standard haematological and biochemical laboratory tests are recommended for all patients. 
Pred začetkom zdravljenja z zdravilom Pegasys so za vse bolnike priporočljive standardne hematološke in biokemične laboratorijske preiskave.
Patients who initiate treatment prior to their 18th birthday should maintain paediatric dosing through the completion of therapy. 
Bolniki, ki z zdravljenjem začnejo pred svojim 18. rojstnim dnevom, morajo odmerjanje za pediatrične bolnike ohraniti do zaključka zdravljenja.
1) Visually check the pre-filled pen 2) Allow the pre-filled pen to adjust to room temperature 3) Clean your hands 
1) Vizualno preglejte napolnjeni injekcijski peresnik 2) Pustite, da se napolnjeni injekcijski peresnik ogreje na sobno temperaturo 3) Umijte si roke
The percentage of patients with cirrhosis who withdrew from treatment was similar to that of the overall population in each treatment group. 
Delež bolnikov s cirozo, ki so prenehali z zdravljenjem, je bil podoben deležu pri celotni populaciji v vsaki zdravljeni skupini.
The study demonstrated that the post-treatment recovery in growth at 2 years post-treatment was maintained to 6 years post-treatment. 
Študija je dokazala, da se je izboljšanje rasti dve leti po zdravljenju ohranilo tudi šest let po zdravljenju.
If ALT increase is progressive or persistent, the dose should be reduced initially to 135 micrograms. 
Če je zvečanje koncentracij ALT progresivno ali vztrajno, odmerek v začetku zmanjšamo na 135 mikrogramov.
The duration of combination treatment varies from 4 to 18 months depending on the type of virus you are infected with, on treatment response and whether you have been treated before. 
Kombinirano zdravljenje lahko traja od 4 do 18 mesecev, odvisno od tipa virusa, s katerim ste okuženi, odziva na zdravljenje in od tega, če ste se zdravili že prej.
With your other hand hold the syringe as you would a pencil. 
Z drugo roko primite injekcijsko brizgo, kakor bi držali svinčnik.
None of these patients experienced unusual, serious or treatment-limiting events. 
Pri teh bolnikih se ni pojavil nobeden od nenavadnih, resnih ali drugih učinkov, ki bi omejeval zdravljenje.
Pegasys has minor or moderate influence on the ability to drive and use machines. 
Zdravilo Pegasys ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Keep the pre-filled pen pressed on the skin for 10 seconds for injection to complete. 
Pustite napolnjeni injekcijski peresnik pritisnjen na kožo 10 sekund, da se injiciranje zaključi.
Excipient with known effect: Benzyl alcohol (10 mg/ 1 ml) 
Pomožna snov z znanim učinkom: benzilalkohol (10 mg/1 ml)
The interaction between theophylline and Pegasys is likely to be maximal after more than 4 weeks of Pegasys therapy. 
Interakcija med teofilinom in zdravilom Pegasys je verjetno največja po več kot 4 tednih zdravljenja z zdravilom Pegasys.
The mechanism behind these events is not known; thus, co-treatment with telbivudine and other interferons (pegylated or standard) may also entail an excess risk. 
Mehanizem za razvoj le-te ni znan; sočasno zdravljenje s telbivudinom in drugimi interferoni (pegiliranimi ali standardnimi) torej lahko ravno tako predstavlja čezmerno tveganje.
● if you have advanced liver disease and your liver does not work properly (e.g. your skin has become yellow). 
• imate napredovano jetrno bolezen in vaša jetra ne delujejo pravilno (npr. če je vaša koža postala rumena),
You should brush your teeth thoroughly twice daily and have regular dental examinations. 
Zobe si morate temeljito umiti dvakrat na dan in redno hoditi na pregled k zobozdravniku.
Very rare Frequency not known 
Zelo redki Pogostnost neznana
Patients and caregivers must not attempt to break the 200 mg tablets. 
Bolniki in njihovi skrbniki 200-mg tablet ne smejo prelamljati.
Disposal of the injection materials 
Odstranjevanje injekcijskih materialov
As with other interferons, a higher incidence of neutralising antibodies was seen in CHB. 
Kot pri drugih interferonih so pri CHB opazili višjo incidenco nevtralizirajočih protiteles.
Response Parameter 
Parameter odziva
If there is bleeding, cover with an adhesive bandage. 
Če pride do krvavitve, pokrijte z obližem.
Multiple regression and pooled group analyses evaluating the influence of treatment duration and use of induction dosing clearly identified treatment duration for 72 weeks as the primary driver for achieving a sustained virological response. 
Multipla regresija in skupna analiza skupin, s katerima so ocenjevali vpliv trajanja zdravljenja in uporabe indukcijskega odmerjanja, je jasno pokazala, da je 72-tedensko zdravljenje primarno gonilo za dosego trajnega virološkega odziva.
All patients were followed up for 24 weeks post-treatment (groups A and C), or post-principal observation period (group B). 
Vse bolnike so spremljali do 24 tednov po koncu zdravljenja (skupini A in C) ali po glavnem obdobju opazovanja (skupina B).
Patients with cirrhosis were not enrolled in this study. 
Bolnikov s cirozo v to študijo niso vključili.
Dispose of the pre-filled pen and use another if: 
Zavrzite napolnjeni injekcijski peresnik in uporabite drugega, če:
The probability for sustained virological response varied depending upon the previous treatment regimen; see Table 20. 
Verjetnost trajnega virološkega odziva je bila različna glede na prejšnjo shemo zdravljenja (glejte preglednico 20).
For CHB patients, transient flares of ALT levels sometimes exceeding 10x ULN are not uncommon, and may reflect immune clearance. 
Pri bolnikih s CHB prehodna nihanja vrednosti ALT, ki včasih presegajo 10-kratno ULN, niso redka in lahko odražajo imunsko čiščenje.
Overdoses involving between two injections on consecutive days (instead of weekly interval) up to daily injections for 1 week (i.e., 1260 micrograms/week) have been reported. 
Poročali so o prevelikih odmerjanjih, ki so se pojavila med dvema injekcijama v zaporednih dnevih (namesto tedenskega intervala) in pri dnevnih injekcijah do 1 tedna (to je 1260 mikrogramov na teden).
A duration of therapy less than 48 weeks has not been adequately studied. 
Zdravljenja, krajšega od 48 tednov, niso zadostno proučevali.
All HCV genotypes** HCV genotype 1 
Vsi HCV genotipi** HCV genotipa 1
Although no teratogenic effects were seen in the offspring delivered at term, adverse effects in humans cannot be excluded. 
Čeprav pri mladičih, ki so se skotili v normalnem času, niso opazili teratogenih učinkov, pri ljudeh neželenih učinkov ne moremo izključiti.
● Visually inspect the solution prior to administration: do not use if it is discoloured or if particles are present. 
● Pred injiciranjem preglejte raztopino: ne uporabljajte raztopine, če je obarvana ali če so prisotni delci.
The terminal half-life after subcutaneous administration in patients is longer with a mean value of 160 hours (84 to 353 hours). 
Končna razpolovna doba po subkutanem dajanju je pri bolnikih daljša, s srednjo vrednostjo 160 ur (84 do 353 ur).
In CHB, unlike CHC, disease exacerbations during therapy are not uncommon and are characterised by transient and potentially significant increases in serum ALT. 
Pri CHB, v nasprotju s CHC, poslabšanja bolezni med zdravljenjem niso redka in so opisana kot prehodna in potencialno pomembna zvišanja ALT v serumu.
The negative predictive value for sustained response in patients treated with Pegasys in monotherapy was 98%. 
Negativna napovedna vrednost trajnega odziva pri bolnikih, zdravljenih z zdravilom Pegasys pri samostojnem zdravljenju, je bila 98 %.
 The needle-shield will automatically move out and lock to prevent needle injuries. 
 Ščitnik za iglo se bo avtomatsko pomaknil navzven in se zaklenil, da ne bi prišlo do poškodb.
Your doctor or his/her assistant will instruct you on how to give the injections. 
Vaš zdravnik ali njegov pomočnik vas bosta natančno poučila o tem.
Use of alfa interferons has been associated with exacerbation or provocation of psoriasis and sarcoidosis. 
Uporaba interferonov alfa je bila povezana s poslabšanjem ali pojavom psoriaze in sarkoidoze.
In addition some patients may experience vomiting. 
Pri nekaterih bolnikih se lahko pojavi tudi bruhanje.