natgillin/translations-raw huggingface dataset:
In CML, more patients who received IntronA with cytarabine were still alive after 3 years than patients who only received IntronA.
Pri CML je bilo po 3 letih še vedno živih več bolnikov, ki so prejemali zdravilo IntronA v kombinaciji s citabirinom, kot bolnikov, ki so prejemali samo zdravilo IntronA.
IntronA was also shown to have a benefit in children with chronic hepatitis B.
Zdravilo IntronA je izkazalo koristi tudi pri otrocih s kroničnim hepatitisom B.
IntronA, with or without ribavirin, was shown to be effective in treating hepatitis C in both treatment- naïve and relapsed adults.
Zdravilo IntronA v kombinaciji z ribavirinom ali brez njega je bilo učinkovito pri zdravljenju hepatitisa C pri predhodno nezdravljenih odraslih in odraslih s ponovitvijo bolezni.
It was also effective in children, when used with ribavirin, with 46% of the children having responded to treatment at the 6-month follow up visit following 1-year treatment.
V kombinaciji z ribavirinom je bilo učinkovito tudi pri otrocih, saj je bilo ob pregledu po 6 mesečnem obdobju spremljanja, ki je sledilo enoletnemu zdravljenju, ugotovljeno, da se je na zdravljenje odzvalo 46% otrok.
The most common side effects with IntronA (generally reported in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), anxiety, emotional lability (mood swings), headache, impaired concentration, dizziness, cough, dyspnoea (difficulty breathing), nausea (feeling sick), diarrhoea, abdominal (tummy) pain, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), rigors (shaking chills), fever, flu-like symptoms, asthenia (weakness), irritability and weight loss.
Najpogostejši neželeni učinki zdravila IntronA (o katerih so na splošno poročali pri več kot 1 od 10 bolnikov) so virusne okužbe, faringitis (vneto žrelo), anoreksija (izguba teka), depresija, nespečnost (težave s spanjem), anksioznost, čustvena labilnost (nihanje razpoloženja), glavobol, motnje koncentracije, omotica, kašelj, dispneja (oteženo dihanje), navzeja (občutek slabosti), driska, bolečine v trebuhu, alopecija (izpadanje las), pruritus (srbenje), suha koža, izpuščaji, mialgija (bolečine v mišicah), artralgija (bolečine v sklepih), mišičnoskeletne bolečine (bolečine v mišicah in kosteh), reakcije na mestu injiciranja, vključno z vnetjem, utrujenost, mrzlica (drgetanje), povišana telesna temperatura, gripi podobni simptomi, astenija (šibkost), razdražljivost in izguba telesne mase.
For the full list of all side effects reported with IntronA, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila IntronA, glejte Navodilo za uporabo.
IntronA should not be used in people who may be hypersensitive (allergic) to interferon alfa-2b or any of the other ingredients.
Zdravila IntronA se ne sme uporabljati pri ljudeh, ki utegnejo biti preobčutljivi za (alergični na) interferon alfa- 2b ali katero koli drugo sestavino.
IntronA should not be used in: • patients with severe heart disease, • patients with severe kidney or liver disease including that caused by cancer, • patients with epilepsy or other central nervous system problems, • patients with thyroid disease unless it is controlled, • hepatitis patients with liver cirrhosis or who have recently received medicines that affect the immune system, • patients with a history of certain disorders of the immune system, or have had an organ transplant and are taking medicine that suppress immune system • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
Zdravila IntronA se ne sme uporabljati pri: • bolnikih s hudimi obolenji srca, • bolnikih s hudo boleznijo ledvic ali jeter, vključno s takšno, ki jo povzroča rak, • bolnikih z epilepsijo ali drugimi motnjami delovanja centralnega živčnega sistema, • bolnikih z boleznijo ščitnice, razen če je obvladana,
For a list of all restrictions with IntronA, see the Package Leaflet.
Za celoten seznam omejitev za zdravilo IntronA glejte Navodilo za uporabo.
The Committee for Medicinal products for Human Use (CHMP) decided that IntronA’ s benefits are greater than its risks for the treatment of chronic hepatitis B and C, hairy cell leukaemia, CML, multiple myeloma, follicular lymphoma, carcinoid tumour and malignant melanoma.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Viraferon pri zdravljenju kroničnega hepatitisa B in C, dlakastocelične levkemije, CML, multiplega mieloma, folikularnega limfoma, karcinoidnega tumorja in malignih melanomov večje od z njim povezanih tveganj.
The Committee recommended that IntronA be given marketing authorisation.
Odbor je priporočil, da se za zdravilo IntronA odobri dovoljenje za promet.
Other information about IntronA:
Druge informacije o zdravilu IntronA:
The European Commission granted a marketing authorisation valid throughout the European Union, for IntronA to SP Europe on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom IntronA, veljavno po vsej Evropski uniji, odobrila družbi SP Europe dne 9. marca 2000.
The full EPAR for IntronA is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo IntronA je na voljo tukaj.
1 million IU/ ml
1 milijon
Powder and solvent for solution for injection or infusion
Prašek in vehikel za
1.0 ml (1 million IU/ ml)
1, 0 ml (1 milijon
3 million IU/ ml
3 milijoni
1.0 ml (3 million IU/ ml)
1, 0 ml (3 milijoni
3 million IU/ ml
3 milijoni i. e. / ml
Powder and solvent for solution for injection or infusion
Prašek in vehikel za raztopino za injiciranje ali infundiranje
1.0 ml (3 million IU/ ml)
1, 0 ml (3 milijoni i. e. / ml)
5 million IU/ ml
5 milijonov
1.0 ml (5 million IU/ ml)
1, 0 ml (5 milijonov
5 million IU/ ml
5 milijonov i. e. / ml
1.0 ml (5 million IU/ ml)
1, 0 ml (5 milijonov i. e. / ml)
10 million IU/ ml
10 milijonov
1.0 ml (10 million IU/ ml)
1, 0 ml (10 milijonov
10 million IU/ ml
10 milijonov i. e. / ml
1.0 ml (10 million IU/ ml)
1, 0 ml (10 milijonov i. e. / ml)
10 vials + 10 ampoules + 10 injection sets1
10 vial + 10 ampul + 10 injekcijskih setov1
18 million IU/ ml
18 milijonov
1.0 ml (18 million IU/ ml)
1, 0 ml (18 milijonov
30 million IU/ ml
30 milijonov
1.0 ml (30 million IU/ ml)
1, 0 ml (30 milijonov
3 million IU/ 0.5ml
3 milijoni i. e. / 0, 5 ml
Vial (glass)
viala (steklena)
0.5 ml (6 million IU/ ml)
0, 5 ml (6 milijonov i. e/ ml)
3 million IU/ 0.5ml
3 milijoni
Solution for injection or infusion
Raztopina za injiciranje
0.5 ml (6 million IU/ ml)
0, 5 ml (6 milijonov
12 vials + 12 injection sets2
12 vial + 12 injekcijskih setov2
5 million IU/ 0.5ml
5 milijonov i. e. / 0, 5 ml
0.5 ml (10 million IU/ ml)
0, 5 ml (10 milijonov i. e. / ml)
5 million IU/ 0.5ml
5 milijonov
0.5 ml (10 million IU/ ml)
0, 5 ml (10 milijonov
18 million IU/ 3ml
18 milijonov i. e. / 3 ml
3.0 ml (6 million IU/ ml)
3, 0 ml (6 milijonov i. e. / ml)
18 million IU/ 3ml
18 milijonov
3.0 ml (6 million IU/ ml)
3, 0 ml (6 milijonov
1 vial + 6 injection sets4
1 viala + 6 injekcijskih setov4
25 million IU/ 2.5ml
25 milijonov i. e. / 2, 5 ml
2.5 ml (10 million IU/ ml)
2, 5 ml (10 milijonov i. e. / ml)
25 million IU/ 2.5ml
25 milijonov
2.5 ml (10 million IU/ ml)
2, 5 ml (10 milijonov
18 million IU
18 milijonov
Solution for injection in a multidose pen
Raztopina za injiciranje
Cartridge (glass) in multidose pen
vložek (steklen) v
1.2 ml (15 million IU/ ml)
1, 2 ml (15 milijonov
1 pen + 12 injection sets3
1 peresnik + 12 injekcijskih setov3
2 pens + 24 injection sets3
2 peresnika + 24 injekcijskih setov3
8 pens + 96 injection sets3
8 peresnikov + 96 injekcijskih setov3
30 million IU
30 milijonov
1.2 ml (25 million IU/ ml)
1, 2 ml (25 milijonov
1 pen +12 injection sets3
1 peresnik + 12 injekcijskih setov3
60 million IU
60 milijonov
1.2 ml (50 million IU/ ml)
1, 2 ml (50 milijonov
12 vials + 12 ampoules + 12 injection sets1
12 vial + 12 ampul + 12 injekcijskih setov1
Strength
i. e. / ml
Pharmaceutical Form
raztopino za injiciranje ali infundiranje
Route of administration
intravenska uporaba
Content (Concentration)
topilo: ampula (steklena)
Package size
i. e. / ml)
2 vials + 12 injection sets4
2 viali + 12 injekcijskih setov4
12 vials + 72 injection sets4
12 vial + 72 injekcijskih setov4
1 injection set = injection syringe + 2 injection needles + cleansing swab 2 injection set = injection syringe + injection needle + cleansing swab 3 injection set = injection needle + cleansing swab 4 injection set = injection syringe + injection needle + 2 cleansing swabs
1 Injekcijski set = injekcijska brizga + 2 injekcijski igli + čistilni tampon 2 Injekcijski set = injekcijska brizga + injekcijska igla + čistilni tampon 3 Injekcijski set = injekcijska igla + čistilni tampon 4 Injekcijski set = injekcijska brizga + injekcijska igla + 2 čistilna tampona
IntronA 1 million IU/ ml powder and solvent for solution for injection or infusion
IntronA 1 milijon i. e. / ml prašek in vehikel za raztopino za injiciranje ali infundiranje
One vial of powder contains 1 million IU of interferon alfa-2b produced in E. coli by recombinant DNA technology.
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.
Po rekonstituciji 1 ml vsebuje 1 milijon i. e. interferona alfa- 2b.
White to cream coloured powder.
Prašek bele do krem barve.
Chronic Hepatitis B:
Kronični hepatitis B:
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 histologically proven active liver inflammation and/ or fibrosis.
Zdravljenje odraslih bolnikov s kroničnim hepatitisom B, ki imajo znake replikacije virusa hepatitisa B (prisotnost HBV- DNA in HBeAg), povečano vrednost alanin - aminotransferaze (ALT) in histološko dokazano aktivno vnetje in/ ali fibrozo jeter.
IntronA 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).
IntronA 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).
IntronA 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 decompensation, and who are positive for serum HCV-RNA.
Zdravilo IntronA 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 izvid na serumsko HCV RNA.
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).
Pri tem morate pretehtati pričakovano korist zdravljenja v primerjavi z izsledki o varnosti zdravila pri pediatričnih bolnikih v kliničnih preskušanjih (glejte poglavja 4. 4, 4. 8 in 5. 1).
Hairy Cell Leukaemia:
Dlakastocelična levkemija:
Chronic Myelogenous Leukaemia:
Kronična mieloična levkemija:
Treatment of adult patients with Philadelphia chromosome or bcr/ abl translocation positive chronic myelogenous leukaemia.
Zdravljenje odraslih bolnikov s kromosomom Philadelphia ali kronično mieloično levkemijo s pozitivnim izvidom na translokacijo bcr/ abl.
Clinical experience indicates that a haematological and cytogenetic major/ minor response is obtainable in the majority of patients treated.
Klinične izkušnje kažejo, da je možno pri večini zdravljenih bolnikov doseči večji ali manjši hematološki in citološki odziv.
A major cytogenetic response is defined by < 34% Ph+ leukaemic cells in the bone marrow, whereas a minor response is  34%, but < 90% Ph+ cells in the marrow.
Večji citološki odziv je opredeljen kot < 34% Ph+ levkemičnih celic v kostnem mozgu, manjši pa kot  34%, vendar z < 90% Ph+ celic v kostnem mozgu.
 2 Combination therapy:
2 Kombinirana terapija:
The combination of interferon alfa-2b and cytarabine (Ara-C) administered during the first 12 months of treatment has been demonstrated to significantly increase the rate of major cytogenetic responses and to significantly prolong the overall survival at three years when compared to interferon alfa-2b monotherapy.
Raziskave so pokazale, da kombiniranje interferona alfa- 2b in citarabina (Ara - C), danega v prvih 12 mesecih zdravljenja, bistveno poveča pogostnost večjega citološkega odziva in bistveno podaljša skupno dolžino preživetja po 3 letih v primerjavi z monoterapijo z interferonom alfa- 2b.
Multiple Myeloma:
Multipli mielom:
As maintenance therapy in patients who have achieved objective remission (more than 50% reduction in myeloma protein) following initial induction chemotherapy.
Zdravilo se pri tej indikaciji uporablja za vzdrževalno zdravljenje pri bolnikih, pri katerih je bila dosežena objektivna remisija (več kot 50% zmanjšanje količine mielomskega proteina) po uvedbi začetne kemoterapije.
Current clinical experience indicates that maintenance therapy with interferon alfa-2b prolongs the plateau phase; however, effects on overall survival have not been conclusively demonstrated.
Sedanje klinične izkušnje kažejo, da vzdrževalno zdravljenje z interferonom alfa- 2b podaljša fazo platoja, vendar učinek na celotno preživetje ni bil dokončno dokazan.
Follicular Lymphoma:
Folikularni limfom:
Treatment of high tumour burden follicular lymphoma as adjunct to appropriate combination induction chemotherapy such as a CHOP-like regimen.
Zdravljenje folikularnega limfoma z veliko tumorsko obremenitvijo kot adjuvantna terapija ob ustrezni kombinirani začetni kemoterapiji, npr. podobno shemi CHOP.
High tumour burden is defined as having at least one of the following: bulky tumour mass (> 7 cm), involvement of three or more nodal sites (each > 3 cm), systemic symptoms (weight loss > 10%, fever > 38°C for more than 8 days, or nocturnal sweats), splenomegaly beyond the umbilicus, major organ obstruction or compression syndrome, orbital or epidural involvement, serous effusion, or leukaemia.
Velika tumorska obremenitev je opredeljena s tem, da ima bolnik najmanj enega od naslednjih znakov: obsežno tumorsko maso (> 7 cm), prizadetost treh ali več skupin bezgavk (vsaka > 3 cm), sistemski simptomi (hujšanje > 10%, zvišana telesna temperatura > 38°C več kot 8 dni, nočno znojenje), splenomegalija, ki sega pod popek, sindrom obstrukcije ali kompresije pomembnih organov, prizadetost orbite ali epiduralnih struktur, serozni izliv ali levkemija.
Carcinoid Tumour:
Karcinoidni tumor:
Treatment of carcinoid tumours with lymph node or liver metastases and with "carcinoid syndrome".
Zdravljenje karcinoidnih tumorjev z metastazami v bezgavkah ali jetrih in s “ karcinoidnim sindromom ”.
Malignant Melanoma:
Maligni melanom:
As adjuvant therapy in patients who are free of disease after surgery but are at high risk of systemic recurrence, e. g., patients with primary or recurrent (clinical or pathological) lymph node involvement.
Za adjuvantno terapijo pri bolnikih, ki po kirurškem posegu nimajo več bolezni, vendar obstaja pri njih še vedno veliko tveganje za sistemsko ponovitev bolezni, npr. pri bolnikih s primarno ali ponavljajočo prizadetostjo bezgavk (klinično ali patološko).
Treatment must be initiated by a physician experienced in the management of the disease.
Zdravljenje mora uvesti zdravnik z izkušnjami pri obvladovanju bolezni.
If adverse events develop during the course of treatment with IntronA for any indication, modify the dosage or discontinue therapy temporarily until the adverse events abate.
Če se v teku zdravljenja z zdravilom IntronA za katerokoli od indikacij pojavijo neželeni dogodki, prilagodite odmerjanje ali začasno ukinite zdravljenje, dokler se neželeni dogodki ne ublažijo.
If persistent or recurrent intolerance develops following adequate dosage adjustment, or disease progresses, discontinue treatment with IntronA.
Če po ustrezni prilagoditvi odmerka ugotavljate trdovratno ali ponavljajočo intoleranco za zdravilo ali če bolezen napreduje, ukinite terapijo z zdravilom IntronA.
At the discretion of the physician, the patient may self-administer the dose for maintenance dosage regimens administered subcutaneously.
Zdravnik lahko po lastni presoji bolniku dovili, da si sam subkutano injicira vzdrževalni odmerek zdravila.
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 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 blood cells < 1,500/ mm3, granulocytes < 1,000/ mm3, thrombocytes < 100,000/ mm3).
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 discontinued in case of severe leukopaenia (< 1,200/ mm3), severe neutropaenia (< 750/ mm3) or severe thrombocytopaenia (< 70,000/ mm3).
Zdravljenje ukinite v primeru hude levkopenije (< 1. 200/ mm3), hude nevtropenije (< 750/ mm3) ali hude trombocitopenije (< 70. 000/ mm3).
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 IntronA therapy.
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 IntronA ukiniti.
IntronA 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 IntronA 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.
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).
3 Otroci, stari 3 leta ali starejši in mladostniki: 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).
 3 (See ribavirin capsule SPC for dose of ribavirin capsules and dosage modification guidelines for combination therapy.
(Glede odmerjanja kapsul ribavirina in smernic za prilagoditev odmerka pri kombinirani terapiji glejte v povzetek glavnih značilnosti zdravila (SPC) za ribavirin.
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 IntronA in combination with ribavirin for 6 months.
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 6- mesečno zdravljenje, priporočamo, da te bolnike zdravite 6 mesecev z zdravilom IntronA v kombinaciji z ribavirinom.
Naïve patients:
Bolniki, ki še niso bili zdravljeni s tem zdravilom:
IntronA in combination with ribavirin:
IntronA v kombinaciji z ribavirinom:
Based on the results of clinical trials, in which data are available for 12 months of treatment, it is recommended that patients be treated with IntronA in combination with ribavirin for at least 6 months.
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 IntronA v kombinaciji z ribavirinom.
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.
Pri bolnikih z negativnim izvidom HCV- RNA po 6 mesecih, virusnim genotipom 1 (kar se določi na vzorcu, odvzetem pred terapijo) ter veliko virusno obremenitvijo pred začetkom zdravljenja le- tega podaljšajte še za 6 mesecev (t. j. skupaj 12 mesecev).
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).
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).
IntronA alone:
IntronA v monoterapiji:
The optimal duration of therapy with IntronA alone is not yet fully established, but a therapy of between 12 and 18 months is advised.
Optimalna dolžina monoterapije z zdravilom IntronA še ni bila dokončno ugotovljena, vendar svetujemo, naj zdravljenje traja od 12 do 18 mesecev.
It is recommended that patients be treated with IntronA alone for at least 3 to 4 months, at which point HCV-RNA status should be determined.
Priporočamo, da bolnike zdravite z zdravilom IntronA v monoterapiji najmanj 3 do 4 mesece, potem pa opravite preiskave na HCV- RNA.
Treatment should be continued in patients who exhibit negative HCV-RNA.
Pri tistih bolnikih, ki imajo negativen izvid na HCV- RNA, nadaljujte z zdravljenjem.
The efficacy and safety of IntronA in combination with ribavirin has been studied in children and adolescents who have not been previously treated for chronic hepatitis C.
Varnost in učinkovitost zdravljenja s kombinacijo zdravila IntronA in ribavirina so ocenjevali pri otrocih in mladostnikih, ki jih predhodno še niso zdravili za hepatitis C.
The recommended duration of treatment is one year.
Priporočena dolžina zdravljenja je 1 leto.
Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96%).
Pri bolnikih, ki niso dosegli virološkega odziva do 12. tedna, je zelo majhna verjetnost, da bodo postali stalno virološko odzivni (negativna napovedna vrednost 96%).
Virological response is defined as absence of detectable HCV-RNA at Week 12.
Virološki odziv je opredeljen kot odsotnost merljive vrednosti HCV- RNA v 12. tednu zdravljenja.
Genotype 2/ 3:
Genotip 2 or 3:
The recommended duration of treatment is 24 weeks.
Priporočena dolžina zdravljenja je 24 tednov.
Virological responses after 1 year of treatment and 6 months of follow-up were 36% for genotype 1 and 81% for genotype 2/ 3/ 4.
Virološki odziv je po enem letu zdravljenja in 6 mesecih spremljanja 36% za genotip 1 in 81% za genotipe 2/ 3/ 4.
The recommended dosage is 2 million IU/ m2 administered subcutaneously three times a week (every other day) for both splenectomised and non-splenectomised patients.
Priporočeni odmerek je 2 milijona i. e. / m2, injicirano subkutano trikrat na teden (vsak drugi dan), tako za splenektomirane kot za nesplenektomirane bolnike.
For most patients with Hairy Cell Leukaemia, normalisation of one or more haematological variables occurs within one to two months of IntronA treatment.
4 mesecih terapije z zdravilom IntronA.
Improvement in all three haematological variables (granulocyte count, platelet count and haemoglobin level) may require six months or more.
Za izboljšanje vseh treh hematoloških vrednosti (število granulocitov, število trombocitov in vrednost hemoglobina) pa je lahko potrebnih 6 mesecev ali več.