natgillin/translations-raw huggingface dataset:
ra A wide variety of autoimmune and immune-mediated disorders have been reported with alpha interferons including thyroid disorders, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), idiopathic and thrombotic thrombocytopenic purpura, vasculitis, neuropathies including mononeuropathies
ie že poslabšan), idiopatski in trombotični trombocitopenični purpuri, vaskulitisu ter nevropatijah, vključno z mononevropatijami (glejte tudi poglavje 4. 4).
ge (see also section 4.4).
r večjih od 10 milijonov i. e. na dan, sodijo zmanjšanje števila granulocitov in levkocitov, zmanjšanje
Clinically significant laboratory abnormalities, most frequently occurring at doses greater than 10 million IU lon daily, include reduction in granulocyte and white blood cell counts; decreases in haemoglobin level and platelet count; increases in alkaline phosphatase, LDH, serum creatinine and serum urea nitrogen levels.
ist vrednosti hemoglobina in števila trombocitov, povečanje vrednosti alkalne fosfataze, LDH, serumskega kreatinina in dušičnih retentov iz sečnine v serumu.
Paediatric population t
eg kroničnim hepatitisom B, in je sovpadalo z očistkom virusne DNAp.
Children and adolescents – Chronic Hepatitis C uc
Pediatrični bolniki
In clinical trials of 118 children or adolescents 3 to 16 years of age, 6% discontinued therapy due to adverse events.
ur Otroci in mladostniki – Kronični hepatitis C V kliničnih preskušanjih pri 118 otrocih in mladostnikih, starih od 3 do 16 let, so pri 6% ukinili terapijo
height (mean percentile decrease of growth velocity of 9%) and weight (mean percentile decrease of 13%) percentile were observed during treatment (see section 4.4).
Na splošno je bil profil neželenih dogodkov v omejeni pediatrični populaciji, ki je bila vključena v študije, podoben profilu pri odraslih, se je pri njih pojavila dodatna skrb glede zaviranja rasti, saj so med zdravljenjem opažali zmanjšanje percentila telesne višine (srednje percentilno zmanjšanje hitrosti rasti za 9%) in telesne mase (srednje percentilno zmanjšanje za 13%) (glejte poglavje no 4. 4).
Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% vs 1%) during treatment and during the 6 month lp
Poleg tega so pri pediatričnih bolnikih pogosteje poročali o samomorilnih mislih ali poskusih samomora kot pri odraslih bolnikih (2, 4% v primerjavi z 1%) med zdravljenjem in v 6- mesečnem obdobju spremljanja bolnikov po zdravljenju.
As in adult patients, children and adolescents also experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence) (see section 4.4).
druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje 4. 4).
In addition, injection site disorders, fever, anorexia, vomiting, and emotional lability occurred more frequently in children and na
Poleg tega so se pri otrocih in mladostnikih pogosteje kot pri odraslih bolnikih pojavile težave na mestu up
adolescents compared to adult patients.
injiciranja, zvišana telesna temperatura, anoreksija, bruhanje in čustvena labilnost.
Dose modifications were required in 30% of patients, most commonly for anaemia and neutropaenia. i dic
Prilagoditev odmerka je bila potrebna pri 30% bolnikov, najpogosteje zaradi anemije in nevtropenije.
The adverse reactions listed in Table 2 are based on experience from paediatric clinical trials.
Neželeni učinki, ki so navedeni v Preglednici 2, so povzeti iz pediatričnih kliničnih preskušanj. no
Viral infection, pharyngitis Fungal infection, bacterial infection, pulmonary infection, otitis
Infekcijske in parazitske bolezni virusna okužba, faringitis Zelo pogosti: glivična okužba, bakterijska okužba, pljučna okužba, vnetje Pogosti: ks
Blood and lymphatic system
srednjega ušesa, zobni absces, herpes simpleks, okužba sečil, vaginitis, gastroenteritis Benigne, maligne in Lie
ed disorders Very common:
Bolezni krvi in limfatičnega sistema anemija, nevtropenija Zelo pogosti:
Common:
136 Pogosti:
ori Very common:
Bolezni endokrinega sistema Zelo pogosti:
Hypothyroidism§, Hyperthyroidism§, virilism
trombocitopenija, limfadenopatija hipotiroidizem§ hipertiroidizem§, virilizem
Common:
ie Presnovne in prehranske motnje
ra Psychiatric disorders§ Very common:
r Psihiatrične motnje§
Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour
ist depresija, čustvena nestabilnost, nespečnost Zelo pogosti: samomorilne misli, agresivne reakcije, zmedenost, vedenjske Pogosti: motnje, vznemirjenost, somnambulizem, tesnoba, živčnost,
ge disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy Nervous system disorders§ lon Very common:
eg motnje spanja, nenormalne sanje, apatija Bolezni živčevja§ Zelo pogosti:
Headache, dizziness Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence no
hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, zmanjšana koncentracija, somnolenca
Raynaud’ s disease, flushing, pallor t
Bolezni dihal, prsnega koša in mediastinalnega prostora
Respiratory, thoracic and uc
no Raynaudova bolezen, zardevanje, bledica lat
mediastinal disorders Common:
Pogosti:
Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal
dispneja, tahipneja, epistaksa, kašelj, zamašen nos, draženje nosne sluznice, rinoreja, kihanje up
quadrant pain, dyspepsia, glossitis, gastroesophogeal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, na
driska, bruhanje, navzea, trebušne bolečine Zelo pogosti: razjede v ustih, ulcerozni stomatitis, stomatitis, bolečine v Pogosti: desnem zgornjem kvadrantu trebuha, dispepsija, glositis, gastroezofagealni refluks, bolezni rektuma, bolezen prebavil, no
toothache, tooth disorder Hepatobiliary disorders Common:
zaprtje, vodeno blato, zobobol, zobne bolezni Bolezni jeter, žolčnika in žolčevodov če
Hepatic function abnormal
Pogosti:
Skin and subcutaneous tissue dic
Bolezni kože in podkožja on
disorders Very common:
motnje delovanja jeter
Alopecia, rash Photosensitivity reaction, maculopapular rash, eczema, acne, skin
alopecija, izpuščaj Zelo pogosti: preobčutljivostne reakcije na svetlobo, makulopapulozni Pogosti: izpuščaj, ekcem, akne, kožne bolezni, bolezni nohtov, obarvanje uk
Reproductive system and
Motnje reprodukcije in Lie
Injection site inflammation, injection site reaction, fatigue, rigors, fever§, influenza-like symptoms§, malaise, irritability
dojk ženske: amenoreja, menoragija, motnje menstruacije, bolezni Pogosti: vagine moški: bolečine v modih Splošne težave in spremembe na mestu 137 aplikacije vnetje na mestu injiciranja, reakcija na mestu injiciranja, Zelo pogosti: utrujenost, mrzlica, zvišana telesna temperatura§, gripi podobni simptomi§, splošno slabo počutje, razdražljivost, Pogosti: bolečine v prsih, astenija, edem, bolečine na mestu injiciranja
s Investigations
ie Preiskave Zelo pogosti:
Injury and poisoning
zmanjšana rast (premajhna telesna višina in/ ali masa glede na
Common:
r Pogosti:
uth § See section 4.4
ist § glejte poglavje 4. 4
However, as for any pharmacologically active compound, symptomatic treatment with frequent monitoring of vital signs and close
ur znakov in natančnim opazovanjem bolnika.
ge observation of the patient is indicated. lon 5.
sťo 5.
5.1 Pharmacodynamic properties no
Farmakodinamične lastnosti
L03A B05 t
L03A B05 lat
Viraferon is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA uc
Viraferon je sterilna, stabilna formulacija visokoprečiščenega interferona alfa- 2b, ki ga izdelujemo s tehnikami rekombinantne DNA.
techniques.
maso približno 19. 300 daltonov.
recombinant interferon alfa-2b with the activity of the international reference preparation of human leukocyte interferon established by the World Health Organisation. na
Število mednarodnih enot se določi s primerjavo aktivnosti rekombinantnega interferona alfa- 2b z aktivnostjo mednarodnega referenčnega pripravka interferona iz človeških levkocitov, ki ga je uvedla Svetovna zdravstvena organizacija. če
Three major classes of interferons have been identified: alpha, beta and gamma. i dic
Interferoni so skupina majhnih beljakovinskih molekul z molekulsko maso približno 15. 000 do on
These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
Izdelujejo in izločajo jih telesne celice v odziv na virusno okužbo ali različne sintetične ali biološke induktorje.
131 The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Izsledki številnih raziskav kažejo, da sproži interferon po vezavi na celično membrano zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo nekaterih encimov.
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 virus-infected 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 zavoro replikacije virusov v celicah 138 okuženih z virusi, supresijo celične proliferacije in različnimi oblikami imunomodulacijskega delovanja, kot je npr. okrepitev fagocitne aktivnosti makrofagov in povečanje specifične citotoksičnosti limfocitov za tarčne celice.
Response rates in these trials were increased with compliance.
139 Pogostnosti odziva v teh raziskavah so se povečevale z boljšim sodelovanje bolnika.
dic
140
133 All Genotype 1, 4
Genotipa 1,
multicentre trials and received Viraferon 3 MIU/ m2 3 times a week plus ribavirin 15 mg/ kg per day for 1 year followed by 6 months follow-up after-treatment.
Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami HCV RNA (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT- PCR), so bili vključeni v dve multicentrični preskušanji in so zdravilo Viraferon prejemali v odmerku 3 mio i. e. / m2 trikrat na teden skupaj z ribavirinom v odmerku 15 mg/ kg na dan v času enega leta, čemur je sledilo 6 - 141 mesečno spremljanje po zdravljenju.
(n = 17)
142 (n = 17)
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride, t uc
143 Natrijev dihidrogen fosfat monohidrat Natrijev edetat Natrijev klorid M- krezol Polisorbat 80
136 1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip- off seal (aluminium) with a bonnet (polypropylene) Pack sizes of 1
1 ml raztopine (kar ustreza 10 milijonom i. e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena) up
1 ml of solution (corresponding to 10 MIU) in a vial (type I glass), with a stopper (halobutyl rubber) in a flip-
1 ml raztopine (kar ustreza 10 milijonom i. e.) v viali (iz stekla tipa I), z zamaškom (iz halobutilne gume) in zaporko s ploščico (iz aluminija) s pokrovčkom (iz polipropilena), z 1 injekcijsko brizgo, 1 injekcijsko iglo in 1 čistilnim tamponom. če
ed off seal (aluminium) with a bonnet (polypropylene) with 1 injection syringe, 1 injection needle and 1 cleansing swab.
Velikosti pakiranj:
Packs sizes of 1, 6 or 12
1 komplet, 6 kompletov ali 12 kompletov.
EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 EU/ 1/ 99/ 128/ 020 i dic
eg EU/ 1/ 99/ 128/ 018 EU/ 1/ 99/ 128/ 019 EU/ 1/ 99/ 128/ 020
137 Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /. up no če on uk ks Lie
138 1.
145 1.
Viraferon 18 million IU/ 3 ml solution for injection
Viraferon 18 milijonov i. e. / 3 ml raztopina za injiciranje
ed One vial of Viraferon solution for injection, multiple dose vial, contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 3 ml of solution.
ác Ena viala zdravila Viraferon, raztopina za injiciranje, v viali z večimi odmerki vsebuje 18 milijonov i. e. rekombinantnega interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije
s One ml of solution contains 6 million IU of interferon alfa-2b.
ist En ml raztopine vsebuje 6 milijonov i. e. interferona alfa - 2b
ori For a full list of excipients, see section 6.1.
eg Za celoten seznam pomožnih snovi glejte poglavje 6. 1.
ra Solution for injection Solution is clear and colourless.
Raztopina za injiciranje.
4.1
sťo Raztopina je bistra in brezbarvna.
CLINICAL PARTICULARS Therapeutic indications
KLINIČNI PODATKI no 4. 1 Terapevtske indikacije lat
Treatment of adult patients with chronic hepatitis B associated with evidence of hepatitis B viral replication (presence of HBV-DNA and HBeAg), elevated alanine aminotransferase (ALT) and 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
histologically proven active liver inflammation and/ or fibrosis.
in histološko dokazano aktivno vnetje in/ ali fibrozo jeter.
Chronic Hepatitis C: t
Kronični hepatitis C:
Adult patients: uc
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 section 4.4). 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
Viraferon is intended for use, in a combination regimen with ribavirin, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver 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
decompensation, and who are positive for serum HCV-RNA.
izvid na serumsko HCV RNA.
The expected benefit of i dic
Pri tem morate pretehtati pričakovano korist ks
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).
Lie
4.2 Posology and method of administration Me
4. 2 Odmerjanje in način uporabe
Not all dosage forms and strengths are appropriate for some indications.
146 Vse farmacevtske oblike in koncentracije niso primerne za vse indikacije.
If persistent or recurrent intolerance
Če
139 develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
ie po ustrezni prilagoditvi odmerka ugotavljate trdovratno ali ponavljajočo intoleranco za zdravilo ali če bolezen napreduje, ukinite terapijo z zdravilom Viraferon.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
ác dovili, da si sam subkutano injicira vzdrževalni odmerek zdravila.
Chronic Hepatitis B:
r Kronični hepatitis B:
The recommended dosage is in the range 5 to 10 million IU administered 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
ed The administered dose should be reduced by 50% in case of occurrence of haematological disorders (white blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
ist trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
Treatment should be discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe
Če se pojavijo hematološke motnje (število levkocitov < 1. 500/ mm3, število granulocitov < 1. 000/ mm3,
s thrombocytopaenia (< 70,000/ mm3).
Zdravljenje ukinite v primeru hude levkopenije (< 1. 200/ mm3), hude nevtropenije (< 750/ mm3) ali hude trombocitopenije (< 70. 000/ mm3).
ori 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 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 Viraferon ukiniti.
uth Chronic Hepatitis C:
sťo 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 (vsak drugi dan) za odrasle bolnike, ne glede na to, ali zdravilo uporabljate v monoterapiji ali v kombinirani terapiji z ribavirinom. no 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
Interferon alfa – 2b 3 milijoni i. e. / m2 dajemo subkutano trikrat na teden (vsak drugi dan), v kombinaciji s kapsulami ali peroralno raztopino (zjutraj in zvečer). lat
ge administered orally in two divided doses daily with food (morning and evening).
(Glede odmerjanja kapsul ribavirina in smernic za prilagoditev odmerka pri kombinirani terapiji glejte v up
(See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination lon therapy.
povzetek glavnih značilnosti zdravila (SPC) za ribavirin.
Relapse patients (adults): no
Bolniki z relapsom bolezni (odrasli): no
Naïve patients:
Bolniki, ki še niso bili zdravljeni s tem zdravilom: on
Viraferon should be rod
Učinkovitost zdravila Viraferon je večja, če ga uporabljate v kombinaciji z ribavirinom.
given alone mainly in case of intolerance or contraindication to ribavirin.
Zdravilo Viraferon uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin. uk
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is lp
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 12- mesečno zdravljenje, priporočamo, da te bolnike zdravite najmanj 6 mesecev z zdravilom Viraferon v kombinaciji z ks
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. na
Pri bolnikih z negativnim izvidom HCV- RNA po 6 mesecih, virusnim genotipom 1 (kar se določi na Lie
Treatment should be continued for another 6-month period (i. e., a total of 12 months) in patients who exhibit negative HCV-RNA at month 6, and with viral genotype 1 (as determined in a pre-treatment sample) and high pre-treatment viral load. i dic
vzorcu, odvzetem pred terapijo) ter veliko virusno obremenitvijo pred začetkom zdravljenja le- tega podaljšajte še za 6 mesecev (t. j. skupaj 12 mesecev).
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).
147 V kliničnih raziskavah tisti bolniki, ki po 6 mesecih zdravljenja niso pokazali virološkega odziva (HCV - RNA pod spodnjo mejo detekcije), tudi kasneje niso postali virološko odzivni (HCV- RNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
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.
140 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
Patients who fail to achieve virological 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%).
ori Genotype 2/ 3:
sťo Genotip 2 or 3:
ra 4.3 Contraindications
4. 3 Kontraindikacije up
myocardial infarction, severe arrhythmic disorders. lon
nedavni miokardni infarkt, hude aritmije,
no
če
ideation or suicide attempt. rod
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. lp
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
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 Me
148 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.
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 se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih
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.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z
141 Patients with existence of or history of severe psychiatric conditions:
ist 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.
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).
eg motnjami v sedanji ali pretekli anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
ed medication and institute appropriate medical therapy.
ur poglavje 4. 3).
ori alfa-2b have been observed rarely during Viraferon therapy.
sťo 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
uth 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.
ra 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.