natgillin/translations-raw huggingface dataset:
transplant and are taking medicines that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts. ina
in jemljejo zdravilo za zaviranje delovanja imunskega sistema, • otrocih in mladostnikih z anamnezo hude duševne bolezni, še posebej hude depresije, rav
Because Viraferon can be associated with side effects such as depression, patients must be closely monitored during treatment. dic
Zd
The Committee for Medicinal Products for Human Use (CHMP) decided that Viraferon’ s benefits are greater than its risks for the treatment of chronic hepatitis B and C.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Viraferon pri zdravljenju kroničnega hepatitisa B in C večje od z njim povezanih tveganj.
Me
Odbor je priporočil, da se za zdravilo Viraferon odobri dovoljenje za promet.
Other information about Viraferon:
2/ 3 Druge informacije o zdravilu Viraferon:
2/ 3 This summary was last updated in 02-2008.
Povzetek je bil nazadnje posodobljen 02- 2008.
d se ori uth ra ge lon
t me p ro za nja lje vo do eā av nim ilo rav Zd
ed EU Number
et Številka EU
Invented Name
Izmišljeno
Content (Concentration)
Vsebina
or
m
is
ime
EU/ 1/ 99/ 128/ 001
ro EU/ 1/ 99/ 128/ 001
1.0 ml (1 million
1, 0 ml (1 milijon
th EU/ 1/ 99/ 128/ 002
p EU/ 1/ 99/ 128/ 002
1 vial + 1 ampoule + 1 injection set1
1 viala + 1 ampula + 1
g on EU/ 1/ 99/ 128/ 005
ol EU/ 1/ 99/ 128/ 005
l EU/ 1/ 99/ 128/ 006
v do EU/ 1/ 99/ 128/ 006
Powder and solvent for
Prašek in vehikel za
1 vial + 1 ampoule
1 viala + 1 ampula + 1 injekcijski set1
IU/ ml
i. e. / ml
+ 1 injection set1
milijonov i. e. / ml)
uc EU/ 1/ 99/ 128/ 008
v EU/ 1/ 99/ 128/ 008
d EU/ 1/ 99/ 128/ 009
a EU/ 1/ 99/ 128/ 009
ro IU/ 0.5ml
i. e. / 0, 5 ml
p EU/ 1/ 99/ 128/ 010
n 1 viala + 1 injekcijski set2 EU/ 1/ 99/ 128/ 010
3 million
3 milijoni i. e. / 0, 5 ml
0.5 ml (6 million IU/ ml)
0, 5 ml (6 milijonov i. e. / ml)
al IU/ 0.5ml EU/ 1/ 99/ 128/ 011
ilo EU/ 1/ 99/ 128/ 011
6 vials + 6 injection sets2
6 vial + 6 injekcijskih
in IU/ 0.5ml
i. e. / ml)
12 vials + 12 injection sets2
12 vial + 12 injekcijskih
ed EU/ 1/ 99/ 128/ 013
Zd EU/ 1/ 99/ 128/ 013
M EU/ 1/ 99/ 128/ 014
m 1 viala + 1 injekcijski set2 EU/ 1/ 99/ 128/ 014
Subcutaneous use
viala (steklena)
Vial (glass)
i. e. / 0, 5 ml
0.5 ml (10 million IU/ ml)
uporaba
1 vial + 1 injection set2
milijonov i. e. / ml)
1/ 3 IU/ 0.5ml
i. e. / 0, 5 ml
ed EU/ 1/ 99/ 128/ 016
za EU/ 1/ 99/ 128/ 016
or
i. e. / 0, 5 ml
is
uporaba
EU/ 1/ 99/ 128/ 017
a EU/ 1/ 99/ 128/ 017
th EU/ 1/ 99/ 128/ 018
lje 1 viala + 1 injekcijski set2 EU/ 1/ 99/ 128/ 018
u EU/ 1/ 99/ 128/ 019
o EU/ 1/ 99/ 128/ 019
a IU/ ml
i. e. / ml
EU/ 1/ 99/ 128/ 021
ā EU/ 1/ 99/ 128/ 021
on IU/ 3ml
i. e. / ml)
1 vial + 6 injection sets4
1 viala + 6 injekcijskih
no IU/ 3ml EU/ 1/ 99/ 128/ 023
im EU/ 1/ 99/ 128/ 023
18 million
18 milijonov i. e. / 3 ml
uc EU/ 1/ 99/ 128/ 024
n EU/ 1/ 99/ 128/ 024
d EU/ 1/ 99/ 128/ 025
v EU/ 1/ 99/ 128/ 025
25 million
25 milijonov i. e. / 2, 5 ml
p EU/ 1/ 99/ 128/ 026
ra EU/ 1/ 99/ 128/ 026
al IU/ 2.5ml EU/ 1/ 99/ 128/ 027
Z EU/ 1/ 99/ 128/ 027
in IU/ 2.5ml
Pot uporabe
ic EU/ 1/ 99/ 128/ 028
m EU/ 1/ 99/ 128/ 028
Solution for injection in a Subcutaneous use multidose pen
Raztopina za injiciranje
M EU/ 1/ 99/ 128/ 030
za peresniku EU/ 1/ 99/ 128/ 030
EU/ 1/ 99/ 128/ 031
a nj peresniku EU/ 1/ 99/ 128/ 031
Solution for injection in a Subcutaneous use
Raztopina za injiciranje
2/ 3
i. e.
IU
uporaba
multidose pen
milijonov i. e. / ml)
ed EU/ 1/ 99/ 128/ 032
o ov EU/ 1/ 99/ 128/ 032
or
i. e.
EU/ 1/ 99/ 128/ 033
d EU/ 1/ 99/ 128/ 033
th EU/ 1/ 99/ 128/ 034
v EU/ 1/ 99/ 128/ 034
u EU/ 1/ 99/ 128/ 035
im EU/ 1/ 99/ 128/ 035
60 million
60 milijonov
a
i. e.
er EU/ 1/ 99/ 128/ 036
ilo EU/ 1/ 99/ 128/ 036
EU/ 1/ 99/ 128/ 037
r Zd EU/ 1/ 99/ 128/ 037
g
Subkutana
on
i. e.
IU
v večodmernem peresniku
multidose pen
uporaba
l no 1 injection set = injection syringe + 2 injection needles + cleansing swab 2 injection set = injection syringe + injection needle + cleansing swab
milijonov i. e. / ml)
t uc 3 injection set = injection needle + cleansing swab 4 injection set = injection syringe + injection needle + 2 cleansing swabs
3/ 4 et 1 Injekcijski set = injekcijska brizga + 2 injekcijski igli + čistilni tampon 2 Injekcijski set = injekcijska brizga + injekcijska igla + čistilni tampon
3/ 3
m 3 Injekcijski set = injekcijska igla + čistilni tampon
ori uth ra ge lon ANNEX I
ie ác r ist eg ur sťo no DODATEK I
SUMMARY OF PRODUCT CHARACTERISTICS t no uc rod lp nai dic Me
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA lat up no če on uk ks Lie
Viraferon 1 million IU/ ml powder and solvent for solution for injection
Viraferon 1 milijon i. e. / ml prašek in vehikel za raztopino za injiciranje
ed One vial of powder contains 1 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
ác Ena viala s praškom vsebuje 1 milijon i. e. interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije.
After reconstitution, 1 ml contains 1 million IU of interferon alfa-2b.
r Po rekonstituciji 1 ml vsebuje 1 milijon i. e. interferona alfa- 2b.
s ori For a full list of excipients, see section 6.1.
ist Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
Powder and solvent for solution for injection
ur Prašek in vehikel za raztopino za injiciranje
ra White to cream coloured powder.
Prašek bele do krem barve.
Clear and colourless solvent.
sťo Bister in brezbarven vehikel.
CLINICAL PARTICULARS lon 4.1 Therapeutic indications
KLINIČNI PODATKI no 4. 1 Terapevtske indikacije lat
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B no
Zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki imajo znake replikacije virusa hepatitisa B (prisotnost HBV- DNA in HBeAg), povečano vrednost alanin- aminotransferaze (ALT) up
viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and histologically proven active liver inflammation and/ or fibrosis. t
in histološko dokazano aktivno vnetje in/ ali fibrozo jeter.
Chronic Hepatitis C: uc
Kronični hepatitis C:
Adult patients:
Odrasli bolniki: no
Viraferon is indicated for the treatment of adult patients with chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for serum HCV-RNA or anti-HCV (see rod
Viraferon je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki imajo povečane vrednosti transaminaz brez dekompenzacije jeter in pozitivne izvide za serumsko HCV- RNA ali anti- HCV (glejte poglavje 4. 4). če
The best way to use Viraferon in this indication is in combination with ribavirin. lp
Pri tej indikaciji je zdravilo Viraferon najbolje uporabljati v kombinaciji z ribavirinom. on
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and na
Zdravilo Viraferon je namenjeno uporabi v kombinirani terapiji z ribavirinom za zdravljenje otrok, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven uk
adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Odločitev za zdravljenje mora biti sprejeta za vsak primer posebej, ob upoštevanju morebitnih znakov napredovanja bolezni, npr. vnetja jeter in fibroze, pa tudi prognostičnih dejavnikov odziva, genotipa HCV in virusne obremenitve.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and i dic
Pri tem morate pretehtati pričakovano korist ks
The expected benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials (see sections 4.4, 4.8 and 5.1).
zdravljenja v primerjavi z izsledki o varnosti zdravila pri pediatričnih bolnikih v kliničnih preskušanjih (glejte poglavja 4. 4, 4. 8 in 5. 1).
2 If adverse events develop during the course of treatment with Viraferon for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
2 Če se v teku zdravljenja z zdravilom Viraferon za katerokoli od indikacij pojavijo neželeni dogodki, prilagodite odmerjanje zdravila ali začasno ukinite zdravljenje, dokler se neželeni dogodki ne ublažijo.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Zdravnika lahko po lastni presoji bolniku
The recommended dosage is in the range 5 to 10 million IU administered
ie dovili, da si sam subkutano injicira vzdrževalni odmerek zdravila.
ed subcutaneously three times a week (every other day) for a period of 4 to 6 months.
Priporočeni odmerek je v razponu od 5 do 10 milijonov i. e., injiciran subkutano trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white
r ist Če se pojavijo hematološke motnje (število levkocitov < 1. 500/ mm3, število granulocitov < 1. 000/ mm3, število trombocitov < 100. 000/ mm3), odmerek zmanjšajte za 50%.
Treatment should be
Zdravljenje ukinite v primeru hude levkopenije (< 1. 200/ mm3), hude nevtropenije (< 750/ mm3) ali hude trombocitopenije (< 70. 000/ mm3).
ori discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
eg Pri vseh bolnikih velja, da če po 3 do 4 mesecih zdravljenja ne ugotavljate nobenega izboljšanja serumske vrednosti HBV- DNA (ob največjem odmerku, ki ga bolnik še prenaša), morate terapijo z zdravilom
uth For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue Viraferon therapy.
ur Viraferon ukiniti.
ra Chronic Hepatitis C:
Kronični hepatitis C:
Viraferon is administered subcutaneously at a dose of 3 million IU three times a week (every other day) to adult patients, whether administered as monotherapy or in combination with ribavirin.
Zdravilo Viraferon dajemo subkutano v odmerku 3 milijoni i. e. trikrat na teden
ge Children 3 years of age or older and adolescents:
Otroci, stari 3 leta ali starejši in mladostniki:
Interferon alfa-2b 3 MIU/ m2 is administered subcutaneously 3 times a week (every other day) in combination with ribavirin capsules or oral solution administered orally in two divided doses daily with food (morning and evening). lon (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
Interferon alfa – 2b 3 milijoni i. e. / m2 dajemo subkutano no trikrat na teden (vsak drugi dan), v kombinaciji s kapsulami ali peroralno raztopino (zjutraj in zvečer).
For paediatric patients who weigh < 47 kg or cannot swallow capsules, see ribavirin oral solution SPC). no
Za bolnike, ki tehtajo < 47 kg ali ne morejo pogoltniti kapsul, glejte SPC za peroralno raztopino. up
Viraferon is given in combination with ribavirin. t uc
Viraferon se uporablja v kombinaciji z ribavirinom. no
Based on the results of clinical trials, in which data are available for 6 months of treatment, it is recommended that patients be treated with Viraferon in combination with ribavirin for 6 months. rod
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 6- mesečno zdravljenje, priporočamo, da te bolnike zdravite 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom. če
The efficacy of Viraferon is enhanced when given in combination with ribavirin.
Učinkovitost zdravila Viraferon je večja, če ga uporabljate v kombinaciji z ribavirinom.
Viraferon should be given alone mainly in case of intolerance or contraindication to ribavirin. lp
Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin. on
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is na
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 12- mesečno zdravljenje, uk
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months.
priporočamo, da te bolnike zdravite najmanj 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom. ks
negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and dic
Lie
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into Me
Pri odločitvi o podaljšanju terapije na 12 mesecev upoštevajte tudi druge negativne prognostične dejavnike (starost > 40 let, moški spol, premostitvena fibroza).
During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV- RNA below lower limit of detection) did not become sustained virologic responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
3 V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
3 The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
ie Optimalna dolžina monoterapije z zdravilom Viraferon še ni bila dokončno ugotovljena, vendar svetujemo, naj zdravljenje traja od 12 do 18 mesecev.
It is recommended that patients be treated with Viraferon alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
ác Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa
Treatment should be continued in patients who exhibit negative HCV-RNA.
Pri tistih bolnikih, ki imajo negativen izvid na HCV- RNA, nadaljujte z
ed Children and adolescents:
Otroci in mladostniki:
The efficacy and safety of Viraferon in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
eg so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
Patients who fail to achieve virological
Pri bolnikih, ki niso dosegli virološkega odziva do
ori response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
ur 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
uth Genotype 2/ 3:
sťo Genotip 2 or 3:
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 genotipe 2/ 3/ 4. no Zdravilo Viraferon lahko injicirate s steklenimi ali plastičnimi brizgami za enkratno uporabo. lat
ra 81% for genotype 2/ 3/ 4.
4. 3 Kontraindikacije up
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
- Anamneza hude obstoječe srčne bolezni, npr. nekontrolirano kongestivno srčno popuščanje,
myocardial infarction, severe arrhythmic disorders.
nedavni miokardni infarkt, hude aritmije,
- Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive
- Kronični hepatitis pri bolnikih, ki se zdravijo ali so se nedavno zdravili z imunosupresivi, razen
agents excluding short term corticosteroid withdrawal. t uc
kratkotrajne ukinitve kortikosteroidov,
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
- Avtoimunski hepatitis ali avtoimunska bolezen v pretekli anamnezi, imunosuprimirani bolniki po
Children and adolescents:
Otroci in mladostniki: uk
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
- Obstoječa huda duševna bolezen ali huda duševna bolezen v anamnezi, še posebej huda depresija,
ideation or suicide attempt. lp
samomorilne misli ali poskus samomora. ks
Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C. na
Lie
4.4 Special warnings and precautions for use i dic
4. 4 Posebna opozorila in previdnostni ukrepi
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Pri otrocih in mladostnikih so
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 follow-up after treatment.
4 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.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
ie Bolnike skrbno spremljajte, da ugotovite morebitne znake ali simptome psihiatričnih motenj.
If psychiatric
Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih
4 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.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z
Patients with existence of or history of severe psychiatric conditions:
r zdravilom Viraferon in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
ed with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
ist Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during Viraferon therapy.
Če ocenite, da je potrebno zdravljenje z interferonom alfa- 2b pri odraslih bolnikih s hudimi psihiatričnimi
s medication and institute appropriate medical therapy.
eg motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
Transient rashes do not necessitate interruption of
Uporaba interferona alfa- 2b pri otrocih in mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte
ori treatment.
ur poglavje 4. 3).
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 -
uth alfa-2b have been observed rarely during Viraferon therapy.
sťo 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
ra Moderate to severe adverse experiences may require modification of the patient's dosage regimen, or in some cases, termination of Viraferon therapy.
Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih primerih pa tudi prekinitev terapije z zdravilom Viraferon.
Any patient developing liver function abnormalities during treatment
Vse bolnike, pri katerih se med zdravljenjem z lat zdravilom Viraferon pojavijo motnje delovanja jeter, morate natančno spremljati in zdravljenje prekiniti, če se znaki in simptomi slabšajo. up
ge with Viraferon must be monitored closely and treatment discontinued if signs and symptoms progress.
Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija.
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
Pri bolnikih na terapiji z zdravilom Viraferon morate vzdrževati ustrezno hidracijo, saj so pri nekaterih no
Adequate hydration must be maintained in patients undergoing Viraferon therapy since hypotension related to fluid depletion has been seen in some patients.
bolnikih opažali hipotenzijo zaradi izgube tekočine.
Fluid replacement may be necessary. no
V tem primeru je lahko potrebno nadomeščanje tekočine. če
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out. t uc
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. on
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 ketoacidosis.
Zdravilo Viraferon morate uporabljati previdno pri bolnikih z izčrpujočimi boleznimi in motnjami, npr. pri uk
pulmonary embolism) or severe myelosuppression.
tistih s pljučno boleznijo v anamnezi (npr. kronična obstruktivna pljučna bolezen) ali sladkorna bolezen z nagnjenostjo h ketoacidozi.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Previdnost je potrebna tudi pri bolnikih z motnjami koagulacije (npr. tromboflebitisom, pljučno embolijo) ali hudo mielosupresijo. ks
rarely in interferon alpha treated patients, including those treated with Viraferon.
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.
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 Lie
dyspnea or other respiratory symptoms must have a chest X-ray taken.
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 i dic
Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so ga opažali tudi pri tistih z
hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
5 malignimi boleznimi, zdravljenimi z interferonom alfa.
Me
Videti je, da pljučni neželeni učinki minejo ob takojšnji ukinitvi interferona alfa in zdravljenju s kortikosteroidi.
Ocular adverse events (see section 4.8) including retinal haemorrhages, cotton wool spots, and retinal artery or vein obstruction have been reported in rare instance after treatment with alpha interferons.
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
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.
Vsi bolniki, ki tožijo o spremembah ostrine vida ali vidnega polja ali ki imajo druge oftalmološke simptome 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.
ác zdravilom Viraferon, morajo biti takoj poslani na celoten oftalmološki pregled.
Discontinuation of Viraferon should be considered in patients who develop new or worsening ophthalmological disorders.
Med zdravljenjem z zdravilom Viraferon priporočamo redne preglede vida, še posebej pri tistih z boleznimi, ki so lahko
5 More significant obtundation and coma, including cases of encephalopathy, have been observed in some patients, usually elderly, treated at higher doses.
r povezane z retinopatijo, npr. sladkorna bolezen ali hipertenzija.