natgillin/translations-raw huggingface dataset:
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and
Virološki odziv je po enem letu zdravljenja in 6 mesecih spremljanja 36% za genotip 1 in 81% za
uth 81% for genotype 2/ 3/ 4.
sťo genotipe 2/ 3/ 4.
Viraferon may be administered using either glass or plastic disposable injection syringes.
Zdravilo Viraferon lahko injicirate s steklenimi ali plastičnimi brizgami za enkratno uporabo. no 4. 3 Kontraindikacije
ra 4.3 Contraindications
- Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov,
ge
lat
myocardial infarction, severe arrhythmic disorders. lon
nedavni miokardni infarkt, hude aritmije, up
agents excluding short term corticosteroid withdrawal.
kratkotrajne ukinitve kortikosteroidov,
- Pre-existing thyroid disease unless it can be controlled with conventional treatment.
transplantaciji, če
t uc
- Obstoječa bolezen ščitnice, razen če jo je mogoče nadzirati s konvencionalno terapijo.
Children and adolescents:
Otroci in mladostniki: on
ideation or suicide attempt. rod
samomorilne misli ali poskus samomora. uk
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Glejte tudi SPC za ribavirin, če uporabljate interferon alfa- 2b v kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C. ks
4.4 Special warnings and precautions for use na
4. 4 Posebna opozorila in previdnostni ukrepi
For all patients:
Lie
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after i dic
Med terapijo z zdravilom Viraferon so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6- mesečnem obdobju spremljanja.
treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
Pri otrocih in mladostnikih so pogosteje poročali o samomorilnih mislih ali poskusu samomora kot pri odraslih (2, 4% v primerjavi z 1%) med zdravljenjem in v času 6- mesečnega spremljanja bolnikov po zdravljenju.
Among children and adolescents treated with Viraferon in combination with ribavirin, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6-month Me
Tako kot pri odraslih bolnikih so tudi pri otroci in mladostniki opazili druge psihiatrične neželene dogodke (npr. depresijo,
follow-up after treatment.
88 čustveno labilnost in zaspanost).
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Če psihiatrični simptomi ne prenehajo ali se celo
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Viraferon be discontinued, and the patient followed, with psychiatric intervention as appropriate.
ie poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Viraferon in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
84 Patients with existence of or history of severe psychiatric conditions:
ác Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
If a treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
r Če ocenite, da je potrebno zdravljenje z interferonom alfa- 2b pri odraslih bolnikih s hudimi psihiatričnimi
The use of interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
ist motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy.
Uporaba interferona alfa- 2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte
ed medication and institute appropriate medical therapy.
eg poglavje 4. 3).
s Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
Redko so med terapijo z zdravilom Viraferon opažali akutne preobčutljivostne reakcije na interferon alfa -
ori alfa-2b have been observed rarely during Viraferon therapy.
ur 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
Any patient developing liver function abnormalities during treatment
sťo Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom Viraferon.
ra with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Vse bolnike, pri katerih se med zdravljenjem z zdravilom Viraferon pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, no če se znaki in simptomi slabšajo. lat Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija. up
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related lon to fluid depletion has been seen in some patients.
Pri bolnikih na terapiji z zdravilom Viraferon morate vzdrževati ustrezno hidracijo, saj so pri nekaterih bolnikih opažali hipotenzijo zaradi izgube tekočine.
Fluid replacement may be necessary.
V tem primeru je lahko potrebno nadomeščanje tekočine. no
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. no
Četudi je zvišana telesna temperatura lahko povezana z gripoznim sindromom, ki je pogost med zdravljenjem z interferonom, morate najprej izključiti druge vzroke za trdovratno zvišanje telesne temperature. če
Viraferon must be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e. g., chronic obstructive pulmonary disease) or diabetes mellitus prone to t
Zdravilo Viraferon morate uporabljati previdno pri bolnikih z izčrpujočimi boleznimi in motnjami, npr. pri tistih s pljučno boleznijo v anamnezi (npr. kronična obstruktivna pljučna bolezen) ali sladkorna bolezen z on
ketoacidosis.
nagnjenostjo h ketoacidozi.
pulmonary embolism) or severe myelosuppression.
Previdnost je potrebna tudi pri bolnikih z motnjami koagulacije (npr. tromboflebitisom, pljučno embolijo) ali hudo mielosupresijo. uk
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.5).
O teh simptomih so poročali pogosteje pri sočasni uporabi kitajskega zeliščnega ks
dyspnea or other respiratory symptoms must have a chest X-ray taken.
pripravka shosaikoto in interferona alfa (glejte poglavje 4. 5).
If the chest X-ray shows pulmonary infiltrates or there is evidence of pulmonary function impairment, the patient is to be monitored closely, and, if appropriate, discontinue interferon alpha.
Pri vseh bolnikih, ki dobijo zvišano telesno temperaturo, kašelj, dispnejo ali kakšne druge simptome dihal, morate opraviti rentgensko slikanje prsnega koša.
While this has been reported more often in patients with chronic na
Če rentgenogram pokaže pljučne infiltrate ali znake motenosti pljučne funkcije, morate Lie
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so ga opažali tudi pri tistih z malignimi boleznimi, zdravljenimi z interferonom alfa.
Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events. i dic
Videti je, da pljučni neželeni učinki minejo ob takojšnji ukinitvi interferona alfa in zdravljenju s kortikosteroidi.
All patients Me
89 V redkih primerih so po zdravljenju z alfa interferoni poročali o očesnih neželenih dogodkih (glejte poglavje 4. 8), npr. krvavitvah v mrežnico, bombažu podobnih lisah in zamašitvi mrežnične arterije ali vene.
should have a baseline eye examination.
Pri vseh bolnikih je potreben oftalmološki pregled na začetku zdravljenja.
Any patient complaining of changes in visual acuity or visual fields, or reporting other ophthalmologic symptoms during treatment with Viraferon, must have a prompt and complete eye examination.
Med zdravljenjem z
Periodic visual examinations during Viraferon therapy are recommended particularly in patients with disorders that may be associated with retinopathy, such as diabetes mellitus or hypertension.
Pri bolnikih, pri katerih se pojavijo nove
Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
ác oftalmološke motnje ali se obstoječe poslabšajo, premislite o prekinitvi zdravljenja z zdravilom Viraferon.
85 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
r Pri nekaterih bolnikih so ugotavljali močnejšo otopelost in komo, vključno s primeri encefalopatije,
While these effects are generally reversible, in a few patients full resolution took up to three weeks.
ist običajno pri starostnikih, zdravljenih z večjimi odmerki.
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders, who require Viraferon therapy, must be closely monitored.
eg Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom Viraferon, morate skrbno
ed electrocardiograms taken prior to and during the course of treatment.
Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of Viraferon therapy.
Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar je pri njih lahko potrebna
s ori Hypertriglyceridemia and aggravation of hypertriglyceridemia, sometimes severe, have been observed.
sťo ukinitev terapije z zdravilom Viraferon.
Monitoring of lipid levels is, therefore, recommended.
Ni podatkov otrocih in mladostnikih s srčno boleznijo v anamnezi.
uth Due to reports of interferon alpha exacerbating pre-existing psoriatic disease and sarcoidosis, use of Viraferon in patients with psoriasis or sarcoidosis is recommended only if the potential benefit justifies the potential risk.
Opisali so hipertrigliceridemijo in poslabšanje hipertrigliceridemije, ki je bilo včasih hudo, zato priporočamo spremljanje lipidov v krvi. no Zaradi poročil, da je interferon alfa poslabšal obstoječo psoriazo in sarkoidozo, priporočamo, da pri bolnikih s psoriazo in sarkoidozo to zdravilo uporabljate le, če njegove morebitne koristi odtehtajo možno lat
ra Preliminary data indicates that interferon alpha therapy may be associated with an increased rate of kidney graft rejection.
Preliminarni podatki kažejo, da je lahko zdravljenje z interferonom alfa povezano z večjo pogostnostjo zavrnitve ledvičnega presadka.
ge The development of auto-antibodies and autoimmune disorders has been reported during treatment with alpha interferons.
Bolniki, no
Patients predisposed to the development of autoimmune disorders may be at increased risk. lon Patients with signs or symptoms compatible with autoimmune disorders should be evaluated carefully, and the benefit-risk of continued interferon therapy should be reassessed (see also section 4.4 Chronic hepatitis C, Monotherapy (thyroid abnormalities) and section 4.8).
Vse bolnike z znaki ali simptomi, ki bi lahko kazali na avtoimunsko bolezen, morate skrbno pregledati in preiskati ter pri njih oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi poglavji 4. 4 če
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C no
Pri bolnikih s kroničnim hepatitisom C, ki so se zdravili z interferonom, so poročali o primerih sindroma Vogt- Koyanagi- Harada (VKH).
treated with interferon.
ovojnice in kožo.
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8). t uc
Če sumite na sindrom VKH, morate bolniku ukiniti protivirusno zdravljenje in se posvetovati glede uvedbe kortikosteroidne terapije (glejte poglavje 4. 8). uk
Discontinue treatment with Viraferon in patients with chronic hepatitis who develop prolongation of coagulation markers which might indicate liver decompensation. rod
Pri bolnikih s kroničnim hepatitisom, pri katerih ugotavljate podaljšanje parametrov koagulacije, ki bi lahko kazalo na jetrno dekompenzacijo, prekinite terapijo z zdravilom Viraferon. ks
Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C. lp
Lie
Current na
Pri vseh bolnikih, vključenih v raziskave kroničnega hepatitisa C, so pred vključitvijo v raziskavo opravili jetrno biopsijo, vendar je v določenih primerih (npr. pri bolnikih z genotipoma 2 in 3), zdravljenje možno tudi brez histološke potrditve.
treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment. i
Pri odločanju, ali je pred začetkom zdravljenja potrebna biopsija jeter, poglejte v tekoče smernice za zdravljenje.
Monotherapy:
90 Monoterapija:
Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid dic
V redkih primerih so se pri odraslih bolnikih, zdravljenih z zdravilom Viraferon zaradi kroničnega hepatitisa C, pojavile ščitnične motnje, bodisi hipotiroza ali hipertiroza.
Prior to Me
Pred uvedbo terapije z zdravilom Viraferon za zdravljenje
initiation of Viraferon therapy for the treatment of chronic hepatitis C, evaluate serum thyroid-stimulating hormone (TSH) levels.
ie kroničnega hepatitisa C določite serumsko koncentracijo tirotropnega hormona (TSH).
Viraferon treatment may be initiated if TSH levels can be maintained in the normal range by medication.
ác lahko začnete, če je koncentracijo TSH mogoče z zdravili ohranjati v normalnem razponu vrednosti.
Determine TSH levels if, during the course of Viraferon therapy, a patient develops symptoms consistent with possible thyroid dysfunction.
V primeru motenj delovanja žleze ščitnice lahko
In the presence of thyroid dysfunction, Viraferon treatment may be continued if TSH levels can be maintained in the normal range by medication.
ist terapijo z zdravilom Viraferon nadaljujete, če boste lahko z zdravili ohranjali koncentracijo TSH v normalnem razponu vrednosti.
Discontinuation of Viraferon therapy has not reversed thyroid dysfunction occurring during treatment (also see Children and adolescents, Thyroid monitoring).
Motnje delovanja žleze ščitnice, ki so se pojavile med terapijo z zdravilom Viraferon, niso minile ob prekinitvi terapije (glejte tudi Otroci in mladostniki, Spremljanje delovanja
86 Supplemental monitoring specific for children and adolescents Thyroid Monitoring:
Dodatno spremljanje delovanja posebej za otroke in mladostnike
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Pred uvedbo terapije z zdravilom Viraferon morate ovrednotiti vrednost TSH in morebitne motnje v delovanju
Viraferon therapy may be initiated if TSH levels can be maintained in the normal range by medication.
sťo ščitnice, ki jih ugotovite v tem času, zdraviti z ustaljeno terapijo.
Thyroid dysfunction during treatment with interferon alfa-2b and ribavirin has
Terapijo z zdravilom Viraferon lahko uvedete, če boste lahko z zdravili ohranjali vrednost TSH v normalnem razponu.
If thyroid abnormalities are detected, the patient’ s thyroid status should be evaluated and treated as clinically appropriate.
Med zdravljenjem z interferonomom alfa- 2b in ribavirinom so opažali motnje delovanja žleze ščitnice.
Children and adolescents should be monitored every 3 months for evidence of thyroid dysfunction (e. g.
Če ugotovite motnje v delovanju žleze ščitnice, ovrednotite bolnikov ščitnični status in ga zdravite, kot je klinično ustrezno. no Otroke in mladostnike morate spremljati na vsake 3 mesece glede morebitnih znakov motenj delovanja žleze ščitnice (npr.
s ori Growth and Development:
Rast in razvoj:
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
V času 1- letne terapije je prišlo do zmanjšanja hitrosti linearne rasti (srednje percentilno zmanjšanje 9%) in zmanjšanja hitrosti pridobivanja telesne mase (srednje percentilno zmanjšanje 13%). up
However,
Pri novorojenih no
uth based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
podganjih mladičih, ki so jim dajali odmerke ribavirina, so ugotovili manjše, od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti (glejte poglavje 5. 3).
In addition, preclicinal juvenile toxicity results have demonstrated a minor,
Zato je treba pred začetkom zdravljenja oceniti razmerje med če
Therefore, the risk/ benefit of the combined use of interferon alfa-2b and ribavirin should be assessed in young children prior to the initiation of therapy.
tveganji in koristmi kombinirane uporabe interferona alfa- 2b in ribavirina pri majhnih otrocih.
Physicians are advised to monitor the growth of children taking ribavirin in
Zdravnikom torej svetujemo, naj spremljajo rast otrok, ki jemljejo ribavirin v kombinaciji z interferonom alfa- 2b.
HCV/ HIV Coinfection:
Ni podatkov o dolgoročnih učinkih na rast in razvoj ter spolno dozorevanje bolnikov. on
lon receiving Highly Active Anti-Retroviral Therapy
Sočasna okuženost s HCV/ HIV:
(HAART) may be at increased risk of developing lactic acidosis.
Pri bolnikih, ki so okuženi tudi z virusom HIV in prejemajo visokoaktivno protivirusno terapijo Highly Active Anti- Retroviral Therapy (HAART), je lahko tveganje za nastanek uk
Caution should be used when adding Viraferon and ribavirin to HAART therapy (see ribavirin SPC).
laktacidoze povečano, zato svetujemo previdnost pri dodatku zdravila Viraferon in ribavirina terapiji HAART (glejte SPC za ribavirin).
Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia. no
Pri bolnikih zdravljenih z zdravilom Viraferon v kombinaciji z ribavirinom in zidovudinom, se lahko poveča verjetnost za razvoj anemije. ks
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset. t uc
Lie
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the rod
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila Viraferon in ribavirina imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
Patients should brush their teeth thoroughly twice daily and have regular dental examinations.
91 na dan in redno hoditi na preglede k zobozdravniku.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards. lp
Če pride do te reakcije, naj si potem temeljito sperejo usta.
Standard haematological tests and blood chemistries (complete blood count and differential, platelet count, na
Standardne hematološke preiskave in biokemične preiskave krvi (celotna krvna slika in diferencialna
electrolytes, liver enzymes, serum protein, serum bilirubin and serum creatinine) are to be conducted in all patients prior to and periodically during systemic treatment with Viraferon. i dic
ie krvna slika, število trombocitov, določanje elektrolitov, jetrnih encimov, serumskih beljakovin, bilirubina v serumu in serumskega kreatinina) morate opraviti pri vseh bolnikih, in sicer pred terapijo z zdravilom
During treatment for hepatitis B or C the recommended testing schedule is at weeks 1, 2, 4, 8, 12, 16, and every other month, thereafter, throughout treatment.
r Med zdravljenjem hepatitisa B ali C je priporočljivo, da preiskave opravite v 1., 2., 4., 8., 12. in 16. tednu,
During ALT flare, liver function tests:
Med povečanjem vrednosti
bilirubin must be monitored at two-week intervals.
eg ALT morate na vsaka dva tedna opravljati naslednje preiskave delovanja jeter: določanje vrednosti ALT, protrombinskega časa, alkalne fosfataze, albumina in bilirubina.
Effect on fertility:
ur Vpliv na plodnost:
Narcotics, hypnotics or sedatives must be administered with caution when used concomitantly with Viraferon.
sťo Narkotike, hipnotike ali sedative morate uporabljati previdno pri sočasni uporabi z zdravilom Viraferon.
87 Interactions between Viraferon and other medicinal products have not been fully evaluated.
Interakcij med zdravilom Viraferon in drugimi zdravili še niso v celoti ovrednotili.
Caution must be exercised when administering Viraferon in combination with other potentially myelosuppressive agents.
Pri sočasni uporabi no zdravila Viraferon in drugih potencialno mielosupresivnih snovi priporočamo previdnost.
Interferons may affect the oxidative metabolic process.
Interferoni lahko vplivajo na oksidativne presnovne procese, kar morate upoštevati med sočasno terapijo z lat
This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives theophylline or aminophylline.
zdravili, ki se presnovijo po tej poti, npr. s ksantinskima derivatoma teofilinom in aminofilinom.
During concomitant therapy with xanthine agents, serum theophylline levels must be
Med sočasno terapijo s ksantinskimi snovmi morate spremljati serumsko koncentracijo teofilina in po potrebi up
ed monitored and dosage adjusted if necessary.
prilagoditi odmerek zdravila.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed
Pri bolnikih, zdravljenih z interferonom alfa, vključno z zdravilom Viraferon, so redko opažali pljučne infiltrate, pnevmonitis in pljučnico, ki so občasno vodili celo do smrti bolnika.
The aetiology has not been
Etiologija teh motenj ni no
ori defined.
bila ugotovljena.
These symptoms have been reported more frequently when shosaikoto, a Chinese herbal medicine, is administered concomitantly with interferon alpha (see section 4.4).
O teh simptomih so poročali pogosteje pri sočasni uporabi kitajskega zeliščnega pripravka shosaikoto z interferonom alfa (glejte poglavje 4. 4). če
uth (Also see ribavirin SPC if Viraferon is to be administered in combination with ribavirin in patients with chronic hepatitis C).
(Če boste zdravilo Viraferon uporabljali v kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C, glejte tudi SPC za ribavirin). on
ra 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
Viraferon must be
Zdravilo Viraferon uk
ge used with caution in fertile men.
uporabljajte previdno pri plodnih moških.