natgillin/translations-raw huggingface dataset:
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or reproductive capacity in offspring of treated rats.
Izsledki reprodukcijskih raziskav na živalih kažejo, da rekombinantni interferon alfa- 2b ni teratogen za podgane in kunce in da ne vpliva negativno na nosečnost, razvoj ploda ali reprodukcijsko sposobnost potomcev zdravljenih podgan.
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.
Abortion was observed in all dose groups (7.5 million, 15 million and 30 million IU/kg), and was statistically 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).
180- kratnemu priporočenemu intramuskularnemu ali subkutanemu odmerku 2 milijona i. e. / m2).
High doses of other forms of interferons alpha and beta are known to produce dose- related anovulatory and abortifacient effects in rhesus monkeys.
Tudi za velike odmerke drugih oblik interferonov alfa in beta je znano, da povzročijo od odmerka odvisne učinke v smislu izgube ovulacije ali splava pri opicah rhesus.
Mutagenicity studies with interferon alfa-2b revealed no adverse events.
Raziskave mutagenosti interferona alfa- 2b niso pokazale nobenih neželenih dogodkov.
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 IntronA is to be administered in combination with ribavirin).
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 IntronA uporabljali v kombinaciji z ribavirinom, glejte poglavje 4. 4 in SPC za zdravilo Rebetol).
Glycine, Disodium phosphate anhydrous, Sodium dihydrogen phosphate monohydrate,
Glicin Brezvodni natrijev hidrogenfosfat Natrijev dihidrogen fosfat monohidrat Raztopina humanega albumina
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavje 6. 6.
An immediate use is recommended.
Po rekonstituciji: priporočena je takojšnja uporaba.
6.4 Special precautions for storage
21 6. 4 Posebna navodila za shranjevanje
Within its shelf-life, for the purpose of transport and/or to facilitate ambulatory use the non- reconstituted product can be kept at or below 25°C for a period up to four weeks before use.
V času roka uporabnosti pri prevozu in/ ali za lažjo ambulantno uporabo lahko nerekonstituirano zdravilo pred uporabo shranjujete pri temperaturi do vključno 25°C za čas do 4 tednov.
24 mg of powder (corresponding to 1 MIU) in a vial (type I glass), with a stopper (butyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene) and 1 ml water for injections in an ampoule (type I glass) with 1 injection syringe, 2 injection needles and 1 cleansing swab.
Velikosti pakiranj:
Pack sizes of 1 or 12.
1 komplet ali 12 kompletov.
Reconstitution of IntronA, powder for solution for injection or infusion, for parenteral administration:
Rekonstitucija zdravila IntronA, prašek za raztopino za injiciranje ali infundiranje za parenteralno uporabo:
IntronA is supplied as a powder at strengths of 1 million IU/ml for single-dose use.
Zdravilo IntronA je na voljo v obliki praška z jakostjo 1 milijon i. e. / ml za dajanje v enkratnem odmerku.
Using a sterilised injection syringe and injection needle, inject 1 ml water for injections into the vial of IntronA.
Z uporabo sterilizirane injekcijske brizge in injekcijske igle injicirajte 1 ml vode za injekcije v vialo zdravila IntronA.
As for all parenteral medicinal products, inspect the reconstituted solution visually for particulate matter and discolouration prior to administration.
Kot velja za vsa parenteralna zdravila, morate pred uporabo vizualno pregledati rekonstituirano raztopino in preveriti, da ne vsebuje delcev in da ni obarvana.
Detailed instructions for the subcutaneous use of the product are provided with the package leaflet (refer to “How to self inject IntronA”).
Natančna navodila za subkutano uporabo zdravila so opisana v navodilu za uporabo (nanaša se na "Kako si sami injicirate zdravilo IntronA").
 21 Preparation of IntronA for intravenous infusion:
Priprava zdravila IntronA za intravensko infundiranje:
The infusion must be prepared immediately prior to use.
Infuzijsko raztopino morate pripraviti tik pred uporabo.
The lyophilised powder form of IntronA is to be reconstituted by adding 1 ml of water for injections to the vial.
Zdravilo IntronA v obliki liofiliziranega praška rekonstituirajte z dodatkom 1 ml vode za injiciranje v vialo.
The calculated amount of interferon for the appropriate dose then is withdrawn from the vial(s), added to 100 ml of 9 mg/ml (0.9%) sodium chloride solution for injection and administered over 20 minutes.
Potem iz viale (vial) posesajte izračunano količino interferona za ustrezen odmerek, ga dodajte 100 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injekcije in ga dajte bolniku v 20 minutah.
Final concentration of interferon in sodium chloride solution must not be less than 1 x 105 IU/ml.
Končna koncentracija interferona v raztopini natrijevega klorida ne sme biti manjša od 1 x 105 i. e. / ml.
NO OTHER MEDICINAL PRODUCT CAN BE INFUSED CONCOMITANTLY WITH INTRONA.
SOČASNO Z ZDRAVILOM INTRONA NE SMETE INFUNDIRATI NOBENIH DRUGIH ZDRAVIL.
Any unused product must be discarded after withdrawal of the dose.
Neuporabljeno zdravilo ali odpadni material zavrzite skladno z lokalnimi predpisi.
SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
SP Europe 73, rue de Stalle B- 1180 Bruxelles Belgija
9 March 2000 Date of last renewal:
9. marec 2000 Datum podaljšanja dovoljenja za promet:
23 May 2005
23. maja 2005
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 /.
IntronA 3 million IU/ml powder and solvent for solution for injection or infusion
IntronA 3 milijoni i. e. / ml prašek in vehikel za raztopino za injiciranje ali infundiranje
One vial of powder contains 3 million IU of interferon alfa-2b produced in E.coli by recombinant DNA technology.
Ena viala s praškom vsebuje 3 milijone i. e. interferona alfa- 2b pridobljenega iz E. coli s tehnikami rekombinantne DNA tehnologije.
After reconstitution, 1 ml contains 3 million IU of interferon alfa-2b.
Po rekonstituciji 1 ml vsebuje 3 milijone i. e. interferona alfa- 2b.
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.
The best way to use IntronA in th is indication is in combination with ribavirin.
Pri tej indikaciji je zdravilo IntronA najbolje uporabljati v kombinaciji z ribavirinom.
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.
 23 Combination therapy:
24 Kombinirana terapija:
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.
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).
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 i.
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).
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).
25 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).
 24 (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.
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).
Genotype 2/3:
Genotip 2 or 3:
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.
Pri večini bolnikov z dlakastocelično levkemijo pride do normalizacije ene ali večih hematoloških vrednosti po 1 do 2
 25 Chronic Myelogenous Leukaemia:
Kronična mieloična levkemija:
The recommended dosage of IntronA is 4 to 5 million IU/m2 administered daily subcutaneously.
Priporočeni odmerek zdravila IntronA je 4 do 5 milijonov i. e. / m2 dnevno in se injicira subkutano.
Some patients have been shown to benefit from IntronA 5 million IU/m2 administered daily subcutaneously in association with cytarabine (Ara-C) 20 mg/m2 administered daily subcutaneously for 10 days per month (up to a maximum daily dose of 40 mg).
Pri nekaterih bolnikih so ugotavljali koristi pri subkutanem odmerku 5 milijonov i. e. / m2 zdravila IntronA dnevno, danem skupaj s citarabinom (Ara- C) v subkutanem odmerku 20 mg/ m2 dnevno, 10 dni na mesec (do največjega dnevnega odmerka 40 mg).
When the white blood cell count is controlled, administer the maximum tolerated dose of IntronA (4 to 5 million IU/m2 daily) to maintain haematological remission.
Ko bo število levkocitov pod nadzorom, dajte bolniku največji odmerek zdravila IntronA, ki ga še prenaša (4 do 5 milijonov i. e. / m2 na dan) za ohranjanje hematološke remisije.
In patients who are in the plateau phase (more than 50% reduction of myeloma protein) following initial induction chemotherapy, interferon alfa-2b may be administered as monotherapy, subcutaneously, at a dose of 3 million IU/m2 three times a week (every other day).
Pri bolnikih v fazi platoja (več kot 50% zmanjšanje količine mielomskega proteina) lahko po začetni indukcijski kemoterapiji dajete interferon alfa- 2b subkutano kot monoterapijo v odmerku 3 milijoni i. e. / m2 trikrat na teden (vsak drugi dan).
As induction therapy, interferon alfa-2b is administered intravenously at a dose of 20 million IU/m2 daily for five days a week for a four-week period; the calculated interferon alfa-2b dose is added to sodium chloride 9 mg/ml (0.9%) solution for injection and administered as a 20- minute infusion (see section 6.6).
Izračunani odmerek interferona alfa- 2b dodajte natrijevemu kloridu 9 mg/ ml (0, 9%) raztopini za injiciranje in ga dajte bolniku v 20- minutni infuziji (glejte poglavje 6. 6).
As maintenance treatment, the recommended dose is 10 million IU/m2 administered subcutaneously three days a week (every other day) for 48 weeks.
Za vzdrževalno zdravljenje je priporočeni odmerek 10 milijonov i. e. / m2, dan subkutano 3 dni na teden (vsak drugi dan) v času 48 tednov.
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to < 500/mm3 or alanine aminotransferase/aspartate aminotransferase (ALT/AST) rises to > 5 x upper limit of normal, discontinue treatment temporarily until the adverse event abates.
Če se med zdravljenjem z interferonom alfa- 2b pojavijo hudi neželeni dogodki, še posebej če število granulocitov pade na < 500/ mm3 ali če vrednost alanin- aminotransferaze/ aspartat- aminotransferaze (ALT/ AST) naraste na > 5- kratno zgornjo mejo normale, začasno prekinite zdravljenje, dokler se neželeni dogodek ne ublaži.
If intolerance persists after dose adjustment or if granulocytes decrease to < 250/mm3 or ALT/AST rises to > 10 x upper limit of normal, discontinue interferon alfa-2b therapy.
Če je intoleranca trdovratna tudi po prilagoditvi odmerka ali če število granulocitov upade na < 250/ mm3 ali se vrednost ALT/ AST zviša na > 10- kratno zgornjo mejo normale, prekinite terapijo z interferonom alfa- 2b.
- A history of severe pre-existing cardiac disease, e.g., uncontrolled congestive heart failure,
- Anamneza hude obstoječe srčne bolezni, npr. nekontrolirano kongestivno srčno popuščanje,
- Epilepsy and/or compromised central nervous system (CNS) function (see section 4.4).
- Epilepsija in/ ali moteno delovanje osrednjega živčevja (CŽS) (glejte poglavje 4. 4),
 26 Children and adolescents:
Otroci in mladostniki:
Acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) to interferon alfa-2b have been observed rarely during IntronA therapy.
Redko so med terapijo z zdravilom IntronA opažali akutne preobčutljivostne reakcije na interferon alfa- 2b (npr. urtikarijo, angioedem, bronhokonstrikcijo, anafilaktične reakcije).
While fever may be associated with the flu-like syndrome reported commonly during interferon therapy, other causes of persistent fever must be ruled out.
28 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.
IntronA 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 IntronA 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.
 27 Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Pri bolnikih, zdravljenih z interferonom alfa, vključno s tistimi, ki so zdravljeni z zdravilom IntronA, so redko opažali pljučne infiltrate, pnevmonitis in pljučnico, ki so občasno vodili celi do smrti bolnika.
Adult patients with a history of congestive heart failure, myocardial infarction and/or previous or current arrhythmic disorders, who require IntronA therapy, must be closely monitored.
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v pretekli anamnezi in/ ali s predhodnimi ali obstoječimi aritmijami, ki potrebujejo terapijo z zdravilom IntronA, morate skrbno spremljati.
It is recommended that those patients who have pre-existing cardiac abnormalities and/or are in advanced stages of cancer have electrocardiograms taken prior to and during the course of treatment.
Priporočamo, da pri bolnikih z obstoječimi srčnimi motnjami in/ ali tistih, ki so v napredovalih stadijih maligne bolezni, posnamete EKG pred in po terapiji.
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Vse bolnike z znaki ali simptomi, ki bi lahko kazali na avtoimunsko bolezen, morate skrbno pregledati in
If VKH syndrome is suspected, antiviral treatment should be withdrawn and corticosteroid therapy discussed (see section 4.8).
29 preiskati ter pri njih ponovno oceniti razmerje med koristmi in tveganji nadaljnje terapije z interferonom (glejte tudi t poglavji 4. 4 Kronični hepatitis C, monoterapija (ščitnične motnje) in 4. 8).
 28 Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived albumin.
Pri bolnikih, ki redno ali večkrat prejemajo albumin iz človeške plazme, po potrebi uvedite ustrezno cepljenje (hepatitis A in B).
Growth and Development:
30 Rast in razvoj:
A general reversal of these trends was noted during the 6 months follow-up post treatment.
V času 6- mesečnega spremljanja po zdravljenju so opazili splošni obrat teh trendov.
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Vendar pa je na podlagi vmesnih podatkov iz dolgoročne študije spremljanja bolnikov po zdravljenju imelo 12 (14%) od 84 otrok > 15 percentilno zmanjšanje hitrosti linearne rasti, od tega je imelo 5 (6%) otrok > 30 percentilno zmanjšanje kljub temu, da terapije niso prejemali že več kot 1 leto.
Therefore, the risk/benefit of the combined use of interferon alfa-2b and
Pri novorojenih podganjih mladičih, ki so jim dajali odmerke ribavirina, so ugotovili manjše, od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti (glejte poglavje 5. 3).
 29 ribavirin should be assessed in young children prior to the initiation of therapy.
Zato je treba pred začetkom zdravljenja oceniti razmerje med tveganji in koristmi kombinirane uporabe interferona alfa- 2b in ribavirina pri majhnih otrocih.
HCV/HIV Coinfection:
Sočasna okuženost s HCV/ HIV:
Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a result of the concomitantly administered medicinal product.
Uporaba zdravila IntronA skupaj z drugimi kemoterapevtiki (npr. citarabinom, ciklofosfamidom, doksorubicinom, tenipozidom) lahko poveča tveganje toksičnosti (tako jakost kot trajanje), ki je lahko smrtno nevarna ali povzroči celo smrt zaradi sočasno danega zdravila.
In patients treated for malignant melanoma, liver function and white blood cell (WBC) count and differential must be monitored weekly during the induction phase of therapy and monthly during the maintenance phase of therapy.
Pri bolnikih, ki se zdravijo zaradi malignega melanoma, morate enkrat na teden spremljati delovanje jeter in število levkocitov ter diferencialno krvno sliko ob uvedbi terapije, med vzdrževalnim zdravljenjem pa enkrat na mesec.
Effect on fertility:
31 Vpliv na plodnost:
This must be considered during concomitant therapy with medicinal products metabolised by this route, such as the xanthine derivatives
Interferoni lahko vplivajo na oksidativne presnovne procese, kar morate upoštevati med sočasno terapijo z zdravili, ki se presnovijo po tej poti, npr. s ksantinskima derivatoma teofilinom in aminofilinom.
Administration of IntronA in combination with other chemotherapeutic agents (e.g., Ara-C, cyclophosphamide, doxorubicin, teniposide) may lead to increased risk of toxicity (severity and duration) (see section 4.4).
Uporaba zdravila IntronA skupaj z drugimi kemoterapevtiki (npr. citarabinom, ciklofosfamidom, doksorubicinom, tenipozidom) lahko poveča tveganje toksičnosti zdravila (tako jakost kot trajanje) (glejte poglavje 4. 4).
4.8 Undesirable effects
32 4. 8 Neželeni učinki
In clinical trials conducted in a broad range of indications and at a wide range of doses (from 6 MIU/m2/week in hairy cell leukaemia up to 100 MIU/m2/week in melanoma), the most commonly reported undesirable effects were fever, fatigue, headache and myalgia.
V kliničnih raziskavah, opravljenih pri širokem razponu indikacij in širokem razponu odmerkov (od 6 mio i. e. / m2 na teden pri dlakastocelični levkemiji do največ 100 mio i. e. / m2 na teden pri melanomu), so bili najpogosteje opaženi neželeni učinki zvišana telesna temperatura, utrujenost, glavobol in mialgija.
The adverse reactions listed in Table 1 are based on experience from clinical trials and post-
Neželeni učinki, podani v Preglednici 1, so povzeti iz kliničnih preskušanj in iz postmarketinških izkušenj.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1,000, < 1/100); rarely (≥1/10,000, < 1/1,000); very rarely (< 1/10,000); not known.
V okviru razvrstitve po organskih sistemih so neželeni učinki dodatno navedeni po pogostnosti v naslednje kategorije: zelo pogosti (≥1/ 10), pogosti (≥1/ 100, < 1/ 10), občasni (≥1/ 1000, < 1/ 100), redki (≥1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000) oziroma pogostnost ni znana.
Very common:
Zelo redki: § Psihiatrične motnje Zelo pogosti: