natgillin/translations-raw huggingface dataset:
- have ever had a heart attack or a heart problem.
- ste kdaj imeli srčni infarkt ali težave s srcem.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
To povzroči hudo anemijo, med njene simptome pa sodita neobičajna utrujenost in pomanjkanje energije.
Ninety-four of 107 subjects enrolled in the 5 year long-term follow-up trial.
Štiriindevetdeset od 107 preiskovancev je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
Alopecia, pruritus
alopecija, pruritus
Before reconstitution, this medicine may appear either as a white tablet-shaped solid that is whole or in pieces, or as a white powder.
Pred rekonstitucijo je to zdravilo videti bodisi kot bela trdna snov v obliki tablete, ki je cela ali v koščkih, ali kot bel prašek.
Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.
Zlasti pri bolnikih na velikih odmerkih metadona je treba upoštevati tveganje podaljšanja intervala QTc.
Monitoring of lipid levels is, therefore, recommended.
Priporočljivo je torej spremljanje koncentracije lipidov.
• TSH level must be within normal limits
mora biti v okviru normalnih meja
Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Takoj se posvetujte z zdravnikom ali poiščite nujno medicinsko pomoč, če kažejo neobičajne simptome vedenja, se počutijo depresivno ali če želijo škodovati sebi ali drugim.
This medicine is injected into your body to work with your immune system.
To zdravilo se injicira v vaše telo in nato deluje na vaš imunski sistem.
- are taking medicine that suppresses (weakens) your immune system.
- jemljete zdravila, ki zavirajo (slabijo) imunski sistem.
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection.
Ne skušajte si injicirati zdravila, če niste prepričani, da razumete postopek in vse zahteve za samoinjiciranje.
327 patients completed at least 5 years of long-term follow-up and only 3 out of 366 sustained responders relapsed during the study.
327 bolnikov je zaključilo najmanj 5-letno dolgoročno spremljanje in le 3 od 366 bolnikov s trajnim virološkim odzivom so imeli ponoven izbruh bolezni v času te študije.
- have autoimmune hepatitis or any other problem with your immune system.
- imate avtoimunski hepatitis ali kakršne koli druge težave z imunskim sistemom.
• DO NOT SHAKE TO MIX.
• NE STRESAJTE, DA BI PREMEŠALI.
Whenever possible the child should be treated after the pubertal growth spurt, in order to reduce the risk of growth inhibition.
Kadar je le mogoče, je treba zdravljenje pri otroku uvesti po obdobju intenzivne rasti v puberteti, da bi zmanjšali tveganje za zastoj rasti.
The clinical significance of this finding is unknown; however, patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression.
Klinični pomen tega izsledka ni znan, vendar je treba bolnike spremljati glede znakov in simptomov okrepljenega sedativnega učinka, kot tudi morebitnega pojava depresije dihanja.
Do not use this medicine if you notice discolouration of the powder, which should be white.
Ne uporabljajte tega zdravila, če opazite spremembo barve praška, ki mora biti bele barve.
- have had severe heart problems.
- ste kdaj imeli hude težave s srcem.
You are ready to inject
Pripravljeni ste za injiciranje
Growth and development (children and adolescents):
Rast in razvoj (otroci in mladostniki):
Patients with severe renal impairment, including those on hemodialysis, should be closely monitored.
Bolnike s hudo ledvično okvaro, vključno s tistimi na hemodializi, morate natančno spremljati.
No sustained response
Ni trajnega odziva
Interferons are made by your body's immune system to help fight infections and severe diseases.
Interferone izdeluje vaš telesni imunski sistem za pomoč pri premagovanju okužb in hudih bolezni.
You may develop a dry mouth or vomiting, both of which can damage your teeth.
Pojavijo se lahko suha usta ali bruhanje, kar lahko poškoduje vaše zobe.
Acceptable baseline values that may be considered as a guideline prior to initiation of ViraferonPeg therapy are:
Sprejemljive začetne vrednosti, ki vam lahko služijo kot smernica pred uvedbo terapije z zdravilom ViraferonPeg, so naslednje:
The decision to treat should be made on a case by case basis (see section 4.4).
Odločitev za zdravljenje mora biti sprejeta za vsak primer posebej (glejte poglavja 4.4).
- pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
- pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
Contact your doctor immediately if you notice any of the following serious side effects occurring during treatment:
Takoj se posvetujte z zdravnikom, če med zdravljenjem opazite katerega od naslednjih resnih neželenih učinkov:
This includes adults also infected with clinically stable HIV (Human Immunodeficiency Virus).
To vključuje odrasle osebe, ki imajo sočasno klinično stabilno okužbo z virusom HIV (virus humane imunske pomanjkljivosti).
The average molecular mass is approximately 31,300 daltons of which the protein moiety constitutes approximately 19,300.
Povprečna molekulska masa je približno 31.300 daltonov, od tega je 19.300 daltonov za beljakovinski del.
There was no improvement in terms of fibrosis observed in this study.
V tej študiji niso opazili izboljšanja fibroze.
In Study 1 (see section 5.1), decrease in absolute neutrophil count levels below 500 cells/mm
V študiji 1 (glejte poglavje 5.1) so opazili zmanjšanje absolutnega števila nevtrofilcev pod 500 celic/mm
Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code: L03AB10.
Farmakoterapevtska skupina: Imunostimulansi, Interferoni, oznaka ATC: L03AB10.
The potency of this product should not be compared to that of another pegylated or non-pegylated protein of the same therapeutic class (see section 5.1).
Jakosti tega zdravila se ne sme primerjati z jakostjo drugih pegiliranih ali nepegiliranih beljakovin iz istega terapevtskega razreda (glejte poglavje 5.1).
# Calculated from urine data collected over an interval of 48-hours ## Calculated from urine data collected over an interval of 24-hours
# izračunano iz podatkov analize urina, zbranega v obdobju 48 ur ## izračunano iz podatkov analize urina, zbranega v obdobju 24 ur
Do not massage the injection site.
Injekcijskega mesta ne masirajte.
In this subgroup, there was a 56 % (463/823) sustained virological response rate.
V tej podskupini je bil delež trajnega virološkega odziva 56 % (463/823).
Moreover, the safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.
Poleg tega varnost in učinkovitost uporabe telbivudina v kombinaciji z interferoni za zdravljenje kroničnega hepatitisa B nista bili dokazani.
In studies in pregnant animals, interferons have sometimes caused miscarriage.
V študijah na brejih živalih so interferoni včasih povzročili splav.
- have severe medical conditions that leave you very weak.
- imate kakšno hujšo bolezen, zaradi katere se počutite zelo šibki.
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
Ti učinki so običajno reverzibilni, vendar je pri nekaj bolnikih trajalo do tri tedne, da so popolnoma minili.
Patients should be closely monitored during therapy and even after treatment discontinuation.
Bolnike je treba natančno spremljati med zdravljenjem in celo po ukinitvi zdravljenja.
Disposal of the injection materials
Odstranitev materiala za injiciranje
Although not all of these side effects may occur, they may need medical attention if they do.
Čeprav ni nujno, da se bodo pojavili vsi navedeni neželeni učinki, boste morda potrebovali zdravniško pomoč, če se pojavijo.
Treatment with ViraferonPeg in combination with ribavirin was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Zdravljenje z zdravilom ViraferonPeg v kombinaciji z ribavirinom je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
You may develop gum disease, which could lead to loss of teeth.
Lahko se vam razvijejo bolezni dlesni, kar lahko pripelje do izgube zob.
Other medicines and ViraferonPeg Please tell your doctor or pharmacist if you, or the child you are caring for: - are taking or have recently taken any other medicines or vitamins/nutritional supplements, including medicines obtained without a prescription.
Druga zdravila in zdravilo ViraferonPeg Obvestite zdravnika ali farmacevta, če vi ali otrok, za katerega skrbite: - jemljete ali ste pred kratkim jemali katero koli zdravilo ali vitamine/prehranska dopolnila, vključno z zdravili, ki ste jih dobili brez recepta.
If you have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressure), you should receive regular eye exams during therapy.
Če vaše zdravstveno stanje lahko v prihodnje vodi do težav z očmi (npr. sladkorna bolezen ali visok krvni tlak), morate imeti med zdravljenjem redne preglede oči.
In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Poleg tega otroci in mladostniki ne smejo uporabljati tega zdravila, če so kdaj imeli resno bolezen živčevja ali resno duševno bolezen, kot na primer hudo depresijo ali misli na samomor.
Prepare the dose just before you intend to inject it and use it immediately.
Odmerek si pripravite, tik preden ga nameravate injicirati, in ga uporabite takoj.
Do not use this medicine after the expiry date which is stated on the carton, after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP.
Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Bolniki, katerih odmerek ribavirina je zmanjšan na 600 mg na dan, naj prejmejo po eno 200 mg kapsulo zjutraj in dve 200 mg kapsuli zvečer.
The decrease in CD4+ cell counts was reversible upon dose reduction or cessation of therapy.
Zmanjšanje števila celic CD4+ je bilo reverzibilno po zmanjšanju odmerka ali po prekinitvi terapije.
Insert the needle into the pinched skin at an angle of approximately 45°.
Zabodite iglo v stisnjeno kožo pod kotom približno 45.
This may occur in particular in patients with risk factors such as HIV infection or severe liver problems (cirrhosis).
Pojavi se lahko zlasti pri bolnikih z dejavniki tveganja, kot so okužba z virusom HIV ali hude težave z jetri (ciroza).
All patients in the selected chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i.e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Vsi bolniki iz izbranih študij kroničnega hepatitisa C so imeli pred vključitvijo v študijo jetrno biopsijo, vendar je v določenih primerih (tj. pri bolnikih z genotipom 2 in 3) zdravljenje možno brez histološke potrditve.
ViraferonPeg is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Zdravilo ViraferonPeg lahko med nosečnostjo uporabljate le, če potencialne koristi upravičijo potencialno tveganje za plod.
Mechanism of action is unknown, but it is considered that both medicines have bone marrow depressive effects.
Mehanizem delovanja ni znan, vendar velja, da obe zdravili zavirata delovanje kostnega mozga.
Cmax (90% CI)
Cmax (90 % IZ)
Table 15 Sustained virological response rates (n a,b
Preglednica 15 Deleži trajnega virološkega odziva (n a,b
This should be discussed with your doctor.
O tem se morate pogovoriti z zdravnikom.
Description of selected adverse reactions in adults
Opis izbranih neželenih učinkov pri odraslih
Negative predictive value
Negativna napovedna vrednost
Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
Opažali so hipertrigliceridemijo in poslabšanje hipertrigliceridemije, ki je včasih hudo.
All patients should have a baseline eye examination.
Vsi bolniki morajo opraviti osnovni pregled oči.
Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
24 % bolnikov je imelo premostitveno fibrozo ali cirozo (Knodell 3/4).
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
HCV genotip in virusno breme na začetku sta prognostična dejavnika, za katera je znano, da vplivata na stopnjo odziva.
o With zidovudine or stavudine, it is not certain if ribavirin will change the way these medicines work.
o Pri jemanju skupaj z zidovudinom ali stavudinom ni gotovo, če ribavirin spremeni delovanje teh zdravil.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Histological response: Liver biopsies were obtained before and after treatment in Study 1 and were available for 210 of the 412 subjects (51 %).
V študiji 1 so biopsijo jeter opravili pred in po zdravljenju - na voljo so bili podatki za 210 od 412 preiskovancev (51 %).
Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Omejena količina predhodnih podatkov kaže, da je lahko zdravljenje, ki traja 48 tednov, povezano z večjo stopnjo trajnega virološkega odziva (11/11) in z manjšim tveganjem za ponovitev bolezni (0/11 v primerjavi s 7/96 po 24 tednih zdravljenja).
If you have kidney disease, your dose may be lower, depending upon your kidney function.
Če imate ledvično bolezen, bo vaš odmerek lahko manjši, odvisno od delovanja ledvic.
Administer once weekly (ml)
Enkrat na teden (ml)
The most frequently reported adverse reactions were mostly mild to moderate in severity and were manageable without the need for modification of doses or discontinuation of therapy.
Najpogosteje poročani neželeni učinki so bili po jakosti večinoma blagi do zmerni in so jih lahko obvladali brez prilagoditve odmerka ali ukinitve zdravljenja.
This medicine is used for the treatment of chronic hepatitis C, a viral infection of the liver.
To zdravilo se uporablja za zdravljenje kroničnega hepatitisa C, ene od virusnih okužb jeter.
If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.
Če je za vaše zdravstveno stanje uporaba ribavirina nevarna ali če ste že imeli težave pri uporabi ribavirina, vam bo zdravnik najverjetneje predpisal samo to zdravilo.
If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Če ni uporabljeno takoj, je za čas shranjevanja in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne sme presegati 24 ur pri temperaturi od 2 °C do 8 °C.
Paediatric population (bitherapy only) - Duration of treatment
Pediatrična populacija (samo dvojna terapija) - trajanje zdravljenja
The best sites for injection are tissues with a layer of fat between skin and muscle.
Najprimernejša mesta za injiciranje so predeli, kjer je med kožo in mišicami plast maščobnega tkiva.
Do not aim the stream directly at the white solid or powder, or inject the liquid quickly, as this causes a greater amount of bubbles.
Curka ne smete usmeriti naravnost v belo trdno snov oz. prašek ali tekočine vbrizgati hitro, saj bi to povzročilo več mehurčkov.
You should tell your doctor before starting treatment if you, or the child you are caring for: - are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in section 6).
Pred začetkom zdravljenja morate povedati zdravniku, če za vas ali otroka, za katerega skrbite, velja kaj od naštetega: - ste alergični na peginterferon alfa-2b ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
While being treated with ViraferonPeg, your doctor may advise to drink extra fluids to help prevent low blood pressure.
Med zdravljenjem z zdravilom ViraferonPeg vam bo zdravnik morda svetoval, da pijte več tekočine, da bi preprečili pojav nizkega krvnega tlaka.
Organ transplant recipients
Prejemniki presajenih organov
Any patient complaining of ocular symptoms, including loss of visual acuity or visual field must have a prompt and complete eye examination.
Vsak bolnik, ki toži o očesnih simptomih, vključno z zmanjšanjem ostrine vida ali vidnega polja, potrebuje takojšen in celoten oftalmološki pregled.
- are diabetic or have high blood pressure, your doctor may ask you, or the child you are caring for to have an eye examination.
- imate sladkorno bolezen ali visok krvni tlak; zdravnik bo vas ali otroka, za katerega skrbite, morda napotil na pregled oči.
Side effects of unknown frequency (frequency cannot be estimated from the available data): - pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells).
Neznana (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - aplazija rdečih krvnih celic (stanje, pri katerem telo preneha ali zmanjša izdelovanje rdečih krvnih celic).
** For patients > 120 kg, the ViraferonPeg dose should be calculated based on the individual patient weight.
** Za bolnike, ki so težji od 120 kg, mora biti odmerek izračunan individualno glede na telesno maso bolnika.
Treatment should be initiated and monitored only by a physician experienced in the management of patients with hepatitis C.
Zdravljenje s tem zdravilom lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hepatitisom C.
Look at the date printed on the carton after EXP to make sure that the expiration date has not passed.
Preverite datum, ki je natisnjen na škatli poleg oznake EXP, in se tako prepričajte, da se rok uporabnosti zdravila še ni iztekel.
Patients may self-inject ViraferonPeg if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki si lahko zdravilo ViraferonPeg injicirajo sami, če njihov zdravnik odloči, da je to primerno, in jih po potrebi spremlja.
The appropriate dose can then be withdrawn with a sterilised injection syringe and injected.
Ustrezen odmerek lahko potem izvlečete s sterilno injekcijsko brizgo in ga injicirate.
Discontinue combination therapy if:
Ukinite kombinirano terapijo v primeru:
As adherence might be of importance for outcome of therapy, the dose of ViraferonPeg and ribavirin should be kept as close as possible to the recommended standard dose.
Ker je privrženost terapiji pomembna za njeno uspešnost, mora biti odmerek zdravila ViraferonPeg in ribavirina čim bliže standardnemu priporočenemu odmerku.
Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of ViraferonPeg in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Zaradi poročil, da lahko interferon alfa poslabša obstoječo psoriazo in sarkoidozo je uporaba zdravila ViraferonPeg pri bolnikih s psoriazo ali sarkoidozo priporočena le, če možne koristi zdravljenja odtehtajo morebitno tveganje.
You must not use ViraferonPeg if any of the conditions above should apply to you, or the child you are caring for.
Zdravila ViraferonPeg ne smete uporabljati, če katero od zgoraj naštetih stanj velja za vas ali otroka, za katerega skrbite.
It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.
Pomembno je, da si temeljito ščetkate zobe dvakrat na dan, če bruhate, da si temeljito sperete usta, in da redno hodite na pregled k zobozdravniku.
Although data are limited, no evidence of long-term effects on sexual maturation was noted in the 5-year observational follow-up study.
Podatkov je sicer malo, a med 5-letno opazovalno spremljevalno študijo ni bilo dokazov o dolgoročnih učinkih na spolno dozorevanje.
Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.
Zaradi nevarnosti neželenih učinkov pri dojenih dojenčkih naj matere dojenje prekinejo pred začetkom zdravljenja.
Once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Po vezavi na celično membrano interferon sproži kompleksno zaporedje znotrajceličnih reakcij, ki vključujejo indukcijo določenih encimov.
This activity could potentiate the risk of lactic acidosis induced by purine nucleoside analogs (e.g. didanosine or abacavir).
Takšno delovanje lahko poveča tveganje za pojav laktacidoze, ki jo povzročajo analogi purinskih nukleozidov (npr. didanozin ali abakavir).
If it cannot be used immediately, the solution may be refrigerated for up to 24 hours.
Če je ne morete uporabiti takoj, lahko raztopino hranite v hladilniku do 24 ur.
Medicines
Zdravila
Steatosis was significantly improved in patients infected with HCV Genotype 3.
Steatoza se je pri bolnikih, okuženih z genotipom 3 virusa HCV, pomembno izboljšala.
The Kaplan-Meier estimate for continued sustained response over 5 years for all patients is 99 % (95 % CI: 98-100 %).
Kaplan-Meierjeva ocena ohranitve trajnega virološkega odziva v obdobju 5 let je pri vseh bolnikih znašala 99 % (95 % IZ: 98-100 %).
Side effects in children and adolescents The following effects have occurred in children and adolescents:
Neželeni učinki pri otrocih in mladostnikih Pri otrocih in mladostnikih so se pojavili naslednji neželeni učinki:
Do not attempt to administer an injection until you are sure you understand how to use the pre-filled pen.
Ne poskušajte si injicirati zdravila, dokler niste prepričani, da razumete, kako se napolnjeni injekcijski peresnik uporablja.
A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Skupaj so zdravili 107 bolnikov, od tega je bilo 52 % žensk, 89 % belcev, 67 % jih je imelo HCV genotipa 1 in 63 % jih je bilo starih < 12 let.
It is thought that this process, at least in part, is responsible for the various cellular responses to interferon, including inhibition of virus replication in virusinfected cells, suppression of cell proliferation and such immunomodulating activities as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells.
Menijo, da je ta proces vsaj deloma odgovoren za različne celične odzive na interferon, vključno z zaviranjem razmnoževanja virusa v okuženih celicah, supresijo celične proliferacije in imunomodulatornimi učinki, kot je okrepitev fagocitozne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
Note: The pre-filled pen will make a clicking sound for up to 10 seconds - depending on your dose.
Opomba: Napolnjeni injekcijski peresnik bo klikal do 10 sekund - odvisno od vašega odmerka.
Decrease in mean height percentile at year 1 of long-term follow-up was most prominent in prepubertal age children.
Znižanje srednjega percentila telesne višine po 1 letu po začetku spremljanja je bilo najbolj izrazito pri otrocih pred puberteto.
Water for injection and ViraferonPeg powder are provided in separate ampoules.
Voda za injekcije in ViraferonPeg prašek sta na voljo v ločenih ampulah.