natgillin/translations-raw huggingface dataset:
s 10 million IU doses administered subcutaneously, at 5 million IU/ m2 administered intramuscularly and as a
Srednja serumska koncentracija interferona po subkutanem injiciranju on
ori 30-minute intravenous infusion.
je bila podobna tisti po intravenskem injiciranju.
The elimination half-lives of interferon injections were approximately two
6 do 7 ur.
uth to three hours, and six to seven hours, respectively.
Serumske koncentracije so bile pod mejo detekcije 16 oz.
Serum levels were below the detection limit 16 and 24 hours, respectively, post-injection.
Tako uk
Both subcutaneous and intramuscular administration resulted in bioavailabilities greater than 100%.
pri subkutani uporabi kot pri intramuskularni uporabi je bila biološka uporabnost zdravila večja od 100%.
ra After intravenous administration, serum interferon levels peaked (135 to 273 IU/ ml) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration
Po intravenski uporabi so bile največje serumske koncentracije interferona (od 135 do 273 i. e. / ml) ks
ge of medicinal product, becoming undetectable four hours after the infusion.
dosežene ob koncu infuzije, potem pa so upadale nekoliko hitreje kot po subkutani ali intramuskularni uporabi zdravila in 4 ure po infuziji več niso bile merljive.
lon
Lie
Multiple-dose pharmacokinetic properties for Viraferon injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized no
Farmakokinetične lastnosti pri večkratnem odmerjanju zdravila Viraferon injekcije in kapsul ribavirina pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so
in Table 6.
202 povzete v Preglednici 6.
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin uc
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju zdravila Viraferon in kapsul ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C
capsules when administered to children or adolescents with chronic hepatitis C
ie Viraferon
Viraferon
Ribavirin
15 mg/ kg/ day as 2 divided
3 mio i. e. / m2 3- krat na teden
3 MIU/ m2 3 times a week
15 mg/ kg na dan v obliki
rod
ác
doses
2 deljenih odmerkov (n = 17)
(n = 17)
r
*AUC12 (ng. hr/ ml) for ribavirin; AUC0-24 (IU. hr/ ml) for Viraferon i
eg * AUC12 (ng x h/ ml) za ribavirin; AUC0- 24 (i. e. x h/ ml) za Viraferon
Schering-Plough monitored clinical trials.
ur bolnikih, ki so prejeli zdravilo Viraferon v kliničnih raziskavah, ki so potekale pod nadzorom družbe Schering- Plough.
The detectable titres are low in almost Me
Klinična incidenca nevtralizacijskih faktorjev, ki se pojavijo pri sistemsko
all cases and have not been regularly associated with loss of response or any other autoimmune phenomenon.
Merljivi titri so majhni skoraj v vseh primerih in jih niso redno povezovali s prenehanjem odziva ali s kakršnimkoli drugim avtoimunskim pojavom.
In patients with hepatitis, no loss of response was observed apparently due to the low titres.
Pri bolnikih s hepatitisom niso opažali prenehanja no odzivnosti, kar naj bi bilo posledica majhnih titrov.
5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti lat
Injections of human recombinant interferon alfa-2b for up to three months have shown no evidence of toxicity in mice, rats, and rabbits.
Po injiciranju človeškega rekombinantnega interferona alfa- 2b do 3 mesece niso up
192 for 3 months caused no remarkable toxicity.
opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
Toxicity was demonstrated in monkeys given 100 x 106 IU/ kg/ day for 3 months.
Raziskave pa so pokazale toksičnost interferona pri opicah, ki so prejemale 100 x 106 i. e. / kg na dan 3 mesece. no
In studies of interferon use in non-human primates, abnormalities of the menstrual cycle have been observed (see section 4.4).
V predkliničnih raziskavah uporabe interferona pri nečloveških primatih so opažali motnje menstrualnega ciklusa (glejte poglavje 4. 4). če
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats
Izsledki reprodukcijskih raziskav na živalih kažejo, da rekombinantni interferon alfa- 2b ni teratogen za on
Interferon alfa-2b has been shown to have abortifacient effects in Macaca mulatta (rhesus monkeys) at 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2.
180- krat večji od priporočenega intramuskularnega ali subkutanega odmerka 2 milijona i. e. / m2.
s Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/ kg), and was statistically
Splav so opažali v vseh skupinah po uk
ori significant versus control at the mid- and high-dose groups (corresponding to 90 and 180 times the recommended intramuscular or subcutaneous dose of 2 million IU/ m2).
velikosti odmerka (7, 5 milijonov, 15 milijonov in 30 milijonov i. e. / kg), in je bil v primerjavi s kontrolno skupino statistično značilno pogostejši pri skupinah s srednjimi in velikimi odmerki (ki so ustrezali 90 oz.
High doses of other forms of interferons alpha and beta are known to produce dose-related anovulatory and abortifacient effects in rhesus
Tudi za ks
uth monkeys.
Lie
Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov
ra No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa- 2b on growth, development, sexual maturation, and behaviour (see section 4.4 and Rebetol SPC if Viraferon
Študije za proučevanje učinkov zdravljenja z interferonom alfa- 2b na rast, razvoj, spolno zorenje in vedenje živali niso bile opravljene pri mladih živalih (če boste zdravilo Viraferon uporabljali v kombinaciji z ribavirinom, glejte poglavje 4. 4 in SPC za zdravilo Rebetol).
ge is to be administered in combination with ribavirin). lon 6.
203 6.
Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Edetate disodium, Sodium chloride, t uc
ie Brezvodni natrijev hidrogenfosfat Natrijev dihidrogen fosfat monohidrat
M-cresol, Polysorbate 80, Water for injections q. s. rod
ist Polisorbat 80 Voda za injekcije q. s.
6.2 Incompatibilities lp
eg 6. 2 Inkompatibilnosti
6.3 Shelf life
ur 6. 3 Rok uporabnosti
15 months i dic
sťo 15 mesecev
From a microbiological point of view, once opened, the product may be stored for a maximum of 27 days at 2ºC – 8ºC.
Z mikrobiološkega stališča lahko zdravilo po odpiranju shranjujete največ 27 dni pri temperaturi med 2 in no 8 ºC.
6.4 Special precautions for storage
Za čas shranjevanja in druge pogoje shranjevanja med uporabo je odgovoren uporabnik. lat 6. 4 Posebna navodila za shranjevanje
Store in a refrigerator (2°C – 8°C).
Shranjujte v hladilniku (2 °C - 8 °C). up
6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina no
193 1.2 ml of solution (corresponding to 18 MIU) in a pen made of a cartridge (type I glass) sealed at one end with an cap (aluminium) containing a liner (bromobutyl rubber) and at the other end by a plunger (bromobutyl rubber) with 12 injection needles and12 cleansing swabs Pack sizes of 1, 2 or 8 Not all pack sizes may be marketed.
1, 2 ml raztopine (kar ustreza 18 milijonom i. e.) v peresniku, ki sestoji iz vložka (iz stekla tipa I), zaprtega na enem koncu z zaporko (iz aluminija) z obrobo (iz bromobutilne gume) in na drugem z batom (iz bromobutilne gume), z 12 injekcijskimi iglami in 12 čistilnimi tamponi. če
ed The pen is designed to deliver its contents of 18 million IU in doses ranging from 1.5 to 6 million IU.
Peresnik je konstruiran tako, da svojo vsebino, to je 18 milijonov i. e., injicira v odmerkih od 1, 5 do 6 milijonov i. e.
The pen will deliver a maximum of 12 doses of 1.5 million IU over a period not to exceed 4 weeks.
biti daljši od 4 tednov.
s 6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za odstranjevanje ks
ori Not all dosage forms and strengths are appropriate for some indications.
Vse farmacevtske oblike in koncentracije niso primerne za vse indikacije.
uth Viraferon, solution for injection, multidose pen is injected subcutaneously after attaching an injection needle and dialing the prescribed dose.
Viraferon, raztopina za injiciranje v večodmernem peresniku, se injicira subkutano po pritrditvi injekcijske igle in nastavitvi predpisanega odmerka.
ra Remove the pen from the refrigerator approximately 30 minutes before administration to allow the injectable solution to reach room temperature (not more than 25°C).
Peresnik vzemite iz hladilnika približno 30 minut pred uporabo, da se bo raztopina za injiciranje lahko segrela na sobno temperaturo (na največ 25 C).
ge Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “ How to self inject Viraferon”). lon Each pen is intended for a maximum four-week use period and must then be discarded.
204 Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (nanaša se na "Kako si sami injicirate zdravilo Viraferon").
After each use, the injection needle must be discarded safely and the pen must be returned immediately to the refrigerator.
Po vsaki uporabi morate injekcijsko iglo zavreči na varen način in
A maximum of 48 hours (two days) of exposure to 25°C is no
V 4 tednih je peresnik lahko izpostavljen temperaturi 25 C skupaj največ 48 ur (dva dni), če ste ga nenamerno pozabili takoj vrniti v hladilnik.
permitted over the four-week use period to cover accidental delays in returning the pen to the refrigerator.
ác V pakiranju je dovolj igel in tamponov, da si lahko z uporabo peresnika Viraferon bolnik da tudi najmanjše še merljive odmerke.
Sufficient needles and swabs are provided to use the Viraferon pen for administering the smallest measurable doses.
Bolnika poučite, da mora vse odvečne igle in tampone, ki mu preostanejo
Instruct the patient that any extra needles and swabs that remain after the final dose has been taken from the pen, must be discarded appropriately and safely. t uc
r po dajanju končnega odmerka s peresnikom, zavreči na ustrezen in varen način.
As with all parenteral medicinal products, prior to administration inspect Viraferon, solution for injection, visually for particulate matter and discolouration.
ist Kot velja za vsa parenteralna zdravila, morate pred uporabo vizualno pregledati raztopino za injiciranje Viraferon in preveriti, da ne vsebuje delcev in da ni obarvana.
The solution should be clear and colourless. rod
Raztopina mora biti bistra in brezbarvna.
7.
eg 7.
MARKETING AUTHORISATION HOLDER lp
IMETNIK DOVOLJENJA ZA PROMET
B-1180 Bruxelles Belgium i dic
ur SP Europe 73, rue de Stalle
8.
sťo B- 1180 Bruxelles Belgija no 8.
EU/ 1/ 99/ 128/ 029 Me
EU/ 1/ 99/ 128/ 029 lat
EU/ 1/ 99/ 128/ 030 EU/ 1/ 99/ 128/ 031
EU/ 1/ 99/ 128/ 030 EU/ 1/ 99/ 128/ 031 up
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET no
23 May 2005
23. maja 2005 če
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE BESEDILA on
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 /. uk ks Lie
Viraferon 30 million IU solution for injection, multidose pen
Viraferon 30 milijonov i. e., raztopina za injiciranje, večodmerni peresnik
ed One cartridge contains 30 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1.2 ml.
ác En vložek vsebuje 30 milijonov i. e. rekombinantnega interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije v 1, 2 ml.
s One ml contains 25 million IU of interferon alfa-2b.
r ist En ml vsebuje 25 milijonov i. e. interferona alfa- 2b.
ori The pen is designed to deliver its contents of 30 million IU in doses ranging from 2.5 to 10 million IU.
Presnikje oblikovan tako, da njegovo vsebino 30 milijonov i. e., lahko odmerjamo v razponu od 2, 5 do 10
Multidose presentations must be for individual patient use only.
206 Večodmerna pakiranja so namenjena le za posamezne bolnike.
196 Not all dosage forms and strengths are appropriate for some indications.
Vse farmacevtske oblike in koncentracije niso primerne za vse indikacije.
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.
ie Če se v teku zdravljenja z zdravilom Viraferon za katerokoli od indikacij pojavijo neželeni dogodki,
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with Viraferon.
r bolezen napreduje, ukinite terapijo z zdravilom Viraferon.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens
Zdravnika lahko po lastni presoji bolniku
ed administered subcutaneously.
ist dovili, da si sam subkutano injicira vzdrževalni odmerek zdravila.
The recommended dosage is in the range 5 to 10 million IU administered
Priporočeni odmerek je v razponu od 5 do 10 milijonov i. e., injiciran subkutano
s subcutaneously three times a week (every other day) for a period of 4 to 6 months.
eg trikrat na teden (vsak drugi dan) v času 4 do 6 mesecev.
Treatment should be
Če se pojavijo hematološke motnje (število levkocitov < 1. 500/ mm3, število granulocitov < 1. 000/ mm3,
ra 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.
sťo 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.
ge 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. lon Children 3 years of age or older and adolescents:
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. lat
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). 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). t uc
Za bolnike, ki tehtajo < 47 kg ali ne morejo no
Relapse patients (adults):
Bolniki z relapsom bolezni (odrasli): če
Viraferon is given in combination with ribavirin. rod
Viraferon se uporablja v kombinaciji z ribavirinom.
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.
priporočamo, da te bolnike zdravite 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom.
Naïve patients: lp
Bolniki, ki še niso bili zdravljeni s tem zdravilom: uk
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is i
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 Lie
recommended that patients be treated with Viraferon in combination with ribavirin for at least 6 months. dic
ribavirinom.
high pre-treatment viral load.
207 Pri odločitvi o podaljšanju terapije na 12 mesecev upoštevajte tudi druge negativne prognostične dejavnike (starost > 40 let, moški spol, premostitvena fibroza).
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
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
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).
ie mejo detekcije 6 mesecev po prenehanju zdravljenja).
197 Viraferon alone:
ác Viraferon v monoterapiji:
The optimal duration of therapy with Viraferon alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Optimalna dolžina monoterapije z zdravilom Viraferon še ni bila dokončno ugotovljena, vendar
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.
ist Priporočamo, da bolnike zdravite z zdravilom Viraferon v monoterapiji najmanj 3 do 4 mesece, potem pa opravite preiskave na HCV- RNA.
Treatment should be continued in patients who exhibit negative
Pri tistih bolnikih, ki imajo negativen izvid na HCV- RNA, nadaljujte z
ed HCV-RNA.
eg zdravljenjem.
The efficacy and safety of Viraferon in combination with ribavirin has been
Varnost in učinkovitost zdravljenja s kombinacijo zdravila Viraferon in ribavirina
s studied in children and adolescents who have not been previously treated for chronic hepatitis C.
ur so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive
Pri bolnikih, ki niso dosegli virološkega odziva do
uth value 96%).
sťo 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
Genotype 2/ 3:
4. 3 Kontraindikacije up
ge 4.3 Contraindications lon
- Anamneza hude obstoječe srčne bolezni, npr. nekontrolirano kongestivno srčno popuščanje,
- Hypersensitivity to the active substance or to any of the excipients.
nedavni miokardni infarkt, hude aritmije, no
- A history of severe pre-existing cardiac disease, e. g., uncontrolled congestive heart failure, recent
- Huda ledvična ali jetrna insuficienca, vključno z insuficienco, ki nastane kot posledica metastaz,
myocardial infarction, severe arrhythmic disorders.
- Epilepsija in/ ali moteno delovanje osrednjega živčevja (CŽS) (glejte poglavje 4. 4),
- Severe renal or hepatic dysfunction; including that caused by metastases.
- Kronični hepatitis z dekompenzirano jetrno cirozo,
- Epilepsy and/ or compromised central nervous system (CNS) function (see section 4.4).
- Kronični hepatitis pri bolnikih, ki se zdravijo ali so se nedavno zdravili z imunosupresivi, razen
- Chronic hepatitis with decompensated cirrhosis of the liver.
kratkotrajne ukinitve kortikosteroidov,
- Chronic hepatitis in patients who are being or have been treated recently with immunosuppressive
- Avtoimunski hepatitis ali avtoimunska bolezen v pretekli anamnezi, imunosuprimirani bolniki po
- Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients.
transplantaciji,
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Viraferon therapy, and even after Me
Med terapijo z zdravilom Viraferon so pri nekaterih bolnikih opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo
treatment discontinuation mainly during the 6-month follow-up periodand in the follow-up period.
208 po ukinitvi zdravljenja, predvsem v 6- mesečnem obdobju spremljanja.
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.
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.
Patients should be closely monitored for any signs or symptoms of psychiatric disorders.
ie agresivnostjo (ki je včasih usmerjena proti drugim), zmedenostjo in spremembami duševnega statusa.
198 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
Patients with existence of or history of severe psychiatric conditions:
r poslabšajo ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z
The use of interferon alfa-2b in children and adolescents
ist 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).
Bolniki s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi:
s medication and institute appropriate medical therapy.
eg Če ocenite, da je potrebno zdravljenje z interferonom alfa- 2b pri odraslih bolnikih s hudimi psihiatričnimi 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
Acute hypersensitivity reactions (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon
ur mladostnikih s hudimi psihiatričnimi motnjami v sedanji ali pretekli anamnezi je kontraindicirana (glejte poglavje 4. 3).
If such a reaction develops, discontinue the medication and institute appropriate medical therapy.
sťo Redko so med terapijo z zdravilom Viraferon opažali akutne preobčutljivostne reakcije na interferon alfa - 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
Transient rashes do not necessitate interruption of treatment.
Če se takšna reakcija razvije, prekinite zdravljenje in uvedite ustrezno medikamentozno terapijo.
Any patient developing liver function abnormalities during treatment
Pri prehodnem izpuščaju ni potrebna prekinitev zdravljenja. no Pri zmernih do hudih neželenih učinkih je lahko potrebna prilagoditev režima odmerjanja, v nekaterih lat primerih pa tudi prekinitev terapije z zdravilom Viraferon.
ge 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, če se znaki in simptomi slabšajo. up
Hypotension may occur during Viraferon therapy or up to two days post-therapy and may require supportive lon treatment.
Med terapijo z zdravilom Viraferon ali do dva dni po prenehanju terapije lahko nastopi hipotenzija, zaradi katere je lahko potrebna podporna terapija. 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. 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 on
Caution must be observed also in patients with coagulation disorders (e. g., thrombophlebitis, rod
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 nagnjenostjo h ketoacidozi.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed lp
Etiologija teh motenj ni Lie
The aetiology has not been defined.
bila ugotovljena.