natgillin/translations-raw huggingface dataset:
Prior to initiation of Viraferon therapy, TSH levels must be evaluated and any thyroid abnormality detected at that time must be treated with conventional therapy.
Pred uvedbo terapije z zdravilom Viraferon morate ovrednotiti vrednost TSH in morebitne motnje v delovanju ščitnice, ki jih ugotovite v tem času, zdraviti z ustaljeno terapijo.
Detailed instructions for subcutaneous administration are provided with this leaflet (see HOW TO SELF INJECT VIRAFERON at the end of the leaflet).
Podrobna navodila za podkožno injiciranje so priložena temu navodilu (glejte poglavje KAKO SI SAMI INJICIRATE ZDRAVILO VIRAFERON - na koncu navodil).
Diagram Q
Slika Q
While being treated with Viraferon, your doctor may want you to drink extra fluids to help prevent low blood pressure.
Uporaba zdravila Viraferon skupaj s hrano in pijačo Medtem, ko prejemate zdravilo Viraferon vam bo vaš zdravnik lahko naročil, naj pijete več tekočine, da bi preprečili nizek krvni tlak.
Viraferon may be administered using either glass or plastic disposable injection syringes.
Zdravilo Viraferon lahko injicirate s steklenimi ali plastičnimi brizgami za enkratno uporabo.
To dissolve the white contents, swirl the Viraferon vial with a gentle rotary motion leaving the syringe needle in the vial, until the contents are completely dissolved.
Da se bo bela vsebina viale zdravila Viraferon raztopila, le-to nežno obračajte, pri čemer naj igla z brizgo ostane v viali, dokler se vsebina viale popolnoma ne raztopi.
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.
In clinical trials using Viraferon therapy, 2.8 % patients overall developed thyroid abnormalities.
V kliničnih raziskavah terapije z zdravilom Viraferon so se pri 2,8 % vseh bolnikov pojavile ščitnične motnje.
Response rates in these trials were increased with compliance.
Pogostnosti odziva v teh raziskavah so se povečevale z boljšim sodelovanje bolnika.
Females of childbearing potential and their partners must each use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Tako ženske v rodni dobi kot njihovi partnerji morajo uporabljati učinkovito kontracepcijo med zdravljenjem in še 4 mesece po zaključku zdravljenja.
Clear and colourless solvent.
Bister in brezbarven vehikel.
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 Viraferon 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 Viraferon v kombinaciji z ribavirinom.
If the product is not used during the seven-day period, it should be discarded.
Če zdravila v teh 7 dneh ne uporabite, ga morate zavreči.
You and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 4 months after stopping treatment.
Tako vi kot vaš partner morata uporabljati učinkovito kontracepcijo v času jemanja ribavirina in še 4 mesece po zaključku zdravljenja.
Other negative prognostic factors (age > 40 years, male gender, bridging fibrosis) should be taken into account in order to extend therapy to 12 months.
Pri odločitvi o podaljšanju terapije na 12 mesecev upoštevajte tudi druge negativne prognostične dejavnike (starost > 40 let, moški spol, premostitvena fibroza).
The pharmacokinetics of Viraferon were studied in healthy volunteers following single 5 million IU/m2 and 10 million IU doses administered subcutaneously, at 5 million IU/m administered intramuscularly and as a
Farmakokinetiko zdravila Viraferon so raziskovali pri zdravih prostovoljcih po enkratnih subkutanih odmerkih po 5 milijonov i.e./m2 in 10 milijonov i.e., po intramuskularnem dajanju 5 milijonov i.e./m2 in po 30-minutni intravenski infuziji.
The abnormalities were controlled by conventional therapy for thyroid dysfunction.
Te so lahko nadzorovali s konvencionalno terapijo motenj delovanja ščitnice.
Take the pen out of the refrigerator about one-half hour before administering the dose so that the solution in the pen is at room temperature when it is injected.
Peresnik vzemite iz hladilnika približno pol ure pred injiciranjem, da bo raztopina v njem ob injiciranju na sobni temperaturi.
Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Viraferon in combination with ribavirin.
Zdravljenje z ribavirinom je kontraindicirano pri nosečnicah, zato je potrebna posebna previdnost v izogib nosečnosti pri bolnicah ter tudi pri partnerkah bolnikov, ki jemljejo zdravilo Viraferon v kombinaciji z ribavirinom.
If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment.
Če ste moški, morata tako vi kot vaša partnerka uporabljati učinkovito kontracepcijsko sredstvo v času jemanja ribavirina in še 7 mesecev po zaključku zdravljenja.
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.
Na podlagi poročil iz kliničnih raziskav, v katerih so navedeni podatki za 6-mesečno zdravljenje, priporočamo, da te bolnike zdravite 6 mesecev z zdravilom Viraferon v kombinaciji z ribavirinom.
Psychiatric disorders
Psihiatrične motnje§
If you are receiving HAART, the addition of Viraferon and ribavirin may increase your risk of lactic acidosis and of liver failure.
Če prejemate HAART, lahko dodatek zdravila Viraferon z ribavirinom tej terapiji poveča tveganje za nastanek laktoacidoze in jetrne odpovedi.
Change your injection site each time.
Pri vsakem injiciranju menjavajte injekcijsko mesto.
Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord) has been reported with Viraferon use.
Poleg tega so pri uporabi zdravila Viraferon poročali tudi o pojavu sindroma Vogt-Koyanagi-Harada (avtoimunska vnetna bolezen, ki prizadene oči, kožo in ušesne membrane ter ovojnice možgan in hrbtenjače).
12 multiple dose vials
12 vial z večkratnimi odmerki
Viraferon was administered at a dose of 3 MIU 3 times a week as monotherapy or in combination with ribavirin.
Zdravilo Viraferon so dajali bolnikom v odmerku 3 mio i.e. trikrat na teden, v monoterapiji ali v kombinaciji z ribavirinom.
Viraferon is presented as a solution for injection
Viraferon je na voljo kot raztopina za injiciranje
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Pri bolnikih, ki so okuženi tudi z virusom HIV in imajo napredovano cirozo ter prejemajo terapijo HAART, je lahko povečano tveganje za jetrno dekompenzacijo in smrt.
Hold the Viraferon vial upright without touching the cleaned top of the vial with your hands.
Držite vialo zdravila Viraferon pokončno, ne da bi se pri tem z rokami dotaknili očiščenega vrha viale.
No studies have been conducted in juvenile animals to examine the effects of treatment with interferon alfa2b on growth, development, sexual maturation, and behaviour ((see section 4.4 and Rebetol SPC if Viraferon 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 Viraferon uporabljali v kombinaciji z ribavirinom, glejte poglavje 4.4 in SPC za zdravilo Rebetol).
To set the required dose, hold the pen horizontally by the barrel with one hand.
Potrebni odmerek nastavite tako, da z eno roko držite peresnik vodoravno za telo.
However, during the 6 months after treatment, this trend was generally reversed, although a few children did not return to their previous rate of growth within the first year after completing treatment.
V času enoletnega zdravljenja mnogi otroci niso zrasli ali pridobili na telesni masi toliko, kot bi pričakovali, vendar se je v 6 mesecih po zdravljenju ta trend običajno obrnil, pri nekaj otrocih, pa se rast ni vrnila na običajni nivo tudi eno leto po prenehanju zdravljenja.
The pen can only be fully capped when the triangle on the cap scale is aligned with the dosage indicator on the barrel.
Peresnik lahko do konca pokrijete s pokrovčkom le, če je trikotnik na lestvici pokrovčka poravnan s kazalnikom odmerkov na telesu peresnika.
1 multiple dose vial
1 viala z večkratnimi odmerki
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.
Mean (% CV) multiple-dose pharmacokinetic parameters for Viraferon and ribavirin capsules when administered to children or adolescents with chronic hepatitis C Parameter
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju zdravila Viraferon in kapsul ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C Parameter
Remove the protective cap from the Viraferon vial.
Snemite zaščitno kapico z viale.
Very rarely, seizures have occurred with high doses of Viraferon.
Zelo redko so pri uporabi velikih odmerkov zdravila Viraferon nastopile konvulzije.
Chronic 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.
Kronični hepatitis C: 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.
Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
glavobol, omotica hiperkinezija, tremor, disfonija, parestezije, hipoestezija, hiperestezija, zmanjšana koncentracija, somnolenca
PHARMACEUTICAL PARTICULARS 6.1 List of excipients Glycine,
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Brezvodni natrijev hidrogenfosfat
Endocrine disorders Very common:
Bolezni endokrinega sistema Pogosti:
Chronic hepatitis B: 5 to 10 million IU 3 times a week (every other day) injected subcutaneously (under the skin).
Kronični hepatitis B: 5 do 10 milijonov i.e. 3-krat na teden (vsak drugi dan) s subkutano (podkožno) injekcijo.
Vertigo, tinnitus Hearing loss, hearing disorder
vrtoglavica, tinitus izguba sluha, motnje sluha
Remove the protective tab from the injection needle.
Snemite ščitnik z injekcijske igle.
Diagram R
Slika R
Measuring the dose of Viraferon from the reconstituted powder for injection Turn the vial and the syringe upside down in one hand.
Merjenje odmerka zdravila Viraferon iz rekonstituranega praška za injiciranje Obrnite vialo in brizgo narobe in ju držite v eni roki.
d p value b
Vrednost pb
Patients treated with Viraferon and ribavirin combination therapy and zidovudine could be at increased risk of developing anaemia.
Pri bolnikih zdravljenih z zdravilom Viraferon v kombinaciji z ribavirinom in zidovudinom, se lahko poveča verjetnost za razvoj anemije.
Viraferon is presented as a powder and solvent for solution for injection The white to cream coloured powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.
Viraferon je na voljo kot prašek in vehikel za raztopino za injiciranje Prašek bele do krem barve je v 2 ml stekleni viali, bister in brezbarven vehikel pa v 2 ml stekleni ampuli.
§, virilism Hyperthyroidism
hipertiroidizem§, virilizem
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia§
faringitis*, virusna okužba* bronhitis, sinusitis, herpes simpleks (rezistenca), rinitis pljučnica§
p value a pegylated interferon alfa-2b (100 or 150c µg/week)
Vrednost p a pegiliran interferon alfa-2b (100 ali 150c µg/
(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.
Keep the outer injection needle cap for later use.
Shranite zunanji pokrovček injekcijske igle za kasneje.
The best way to use Viraferon in this indication is in combination with ribavirin.
Pri tej indikaciji je zdravilo Viraferon najbolje uporabljati v kombinaciji z ribavirinom.
Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with Viraferon.
Pri bolnikih, zdravljenih z interferonom alfa, vključno z zdravilom Viraferon, so redko opažali pljučne infiltrate, pnevmonitis in pljučnico, ki so občasno vodili celo do smrti bolnika.
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 decompensation, and who are positive for serum HCV-RNA.
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 izvid na serumsko HCV RNA.
Combination therapy with ribavirin: Also see ribavirin SPC if interferon alfa-2b is to be administered in combination with ribavirin in patients with chronic hepatitis C.
Kombinirana terapija z ribavirinom: Glejte tudi SPC za ribavirin, če uporabljate interferon alfa-2b v kombinaciji z ribavirinom pri bolnikih s kroničnim hepatitisom C.
Monotherapy: Infrequently, adult patients treated for chronic hepatitis C with Viraferon developed thyroid abnormalities, either hypothyroidism or hyperthyroidism.
Monoterapija: V redkih primerih so se pri odraslih bolnikih, zdravljenih z zdravilom Viraferon zaradi kroničnega hepatitisa C, pojavile ščitnične motnje, bodisi hipotiroza ali hipertiroza.
Cases of Vogt-Koyanagi-Harada (VKH) syndrome have been reported in patients with chronic hepatitis C treated with interferon.
Pri bolnikih s kroničnim hepatitisom C, ki so se zdravili z interferonom, so poročali o primerih sindroma Vogt-Koyanagi-Harada (VKH).
With the other hand, turn the cap in a clockwise direction indicated by the arrow in Diagram M. You will observe the push button rising, indicating the dose set.
Z drugo roko obrnite pokrovček v smeri urnega kazalca, kot kaže puščica na sliki M. Videli boste, da se je pritisni gumb dvignil, kar pomeni nastavljanje odmerka.
Chemical and physical in-use stability has been demonstrated for 27 days at 2ºC - 8ºC.
Med uporabo je zdravilo kemično in fizikalno stabilno 27 dni pri temperaturi med 2 in 8 ºC.
If thyroid abnormalities are detected, the patient's thyroid status should be evaluated and treated as clinically appropriate.
Če ugotovite motnje v delovanju žleze ščitnice, ovrednotite bolnikov ščitnični status in ga zdravite, kot je klinično ustrezno.
Cap scale
Lestvica na pokrovčku
Immune system disorders Very rarely:
Bolezni imunskega sistema§ Zelo redki:
Diagram N
Slika N
Hold the Viraferon, solution for injection, multidose pen with the injection needle point upwards.
Držite Viraferon raztopino za injiciranje v večodmernem peresniku z injekcijsko iglo navzgor.
1 single dose vial
1 viala z enkratnim odmerkom
Pack sizes of 1.
Velikost pakiranja: 1 komplet.
Myocardial infarction, cardiac ischaemia Arrhythmia
palpitacije, tahikardija kardiomiopatija miokardni infarkt, ishemija srca aritmije
Diagram D
Slika D
pegylated interferon alfa-2b (1.5 µg/kg/ week) + ribavirin (800 mg)
pegiliran interferon alfa-2b (1,5 µg/kg/ teden) + ribavirin (800 mg)
Amenorrhea, breast pain, dysmenorrhea, menorrhagia, menstrual disorder, vaginal disorder
amenoreja, bolečine v dojkah, dismenoreja, menoragija, motnje menstruacije, bolezni nožnice
Adverse reactions reported during clinical trials or following the marketing use of Viraferon alone or in combination with ribavirin
Neželeni učinki, o katerih so poročali med kliničnimi preskušanji ali v okviru postmarketinških izkušenj z uporabo zdravila Viraferon,
Urine levels of interferon were below the detection limit following each of the three routes of administration.
Koncentracija interferona v seču je bila pod mejo detekcije pri vseh treh omenjenih načinih uporabe zdravila.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pen label
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Pack sizes of 6
Velikost pakiranja: 6 kompletov.
Replace the needle guard and place the syringe with the needle on a flat surface.
Vrnite zaščitni pokrovček na iglo in odložite brizgo z iglo na ravno površino.
Therefore, the risk/benefit of the combined use of interferon alfa-2b and 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.
Hypothyroidism
hipotiroidizem§
Current treatment guidelines should be consulted as to whether a liver biopsy is needed prior to commencing treatment.
Pri odločanju, ali je pred začetkom zdravljenja potrebna biopsija jeter, poglejte v tekoče smernice za zdravljenje.
Diagram G
Slika G
These three main classes are themselves not homogeneous and may contain several different molecular species of interferon.
Ugotovili so tri poglavitne razrede interferonov: alfa, beta in gama, ki pa tudi sami niso homogeni in lahko vsebujejo več različnih vrst interferonskih molekul.
Diagram P
Slika P
Diagram S
Slika S
Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or Viraferon (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Bolnike so naključno razporedili bodisi v skupino, ki je prejemala pegiliran interferon alfa-2b (v odmerku 1,5 µg/kg/teden) z ribavirinom (v odmerku 800 mg/dan) ali pa v skupino, ki je prejemala zdravilo Viraferon (3 mio i.e. trikrat na teden) z ribavirinom (v odmerku 800 mg/dan), v času 48 tednov, z nadaljnjim 6-mesečnim obdobjem spremljanja bolnikov.
Diagram F
Slika F
Common: Very rarely:
Pogosti: Zelo redki:
Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
Otroci in mladostniki: Obstoječa huda duševna bolezen ali huda duševna bolezen v anamnezi, še posebej huda depresija, samomorilne misli ali poskus samomora.
Cardiomyopathy, that may be reversible upon discontinuation of interferon alpha, has been reported rarely in patients without prior evidence of cardiac disease (see section 4.4).
V redkih primerih so poročali po ukinitvi interferona alfa o prehodni reverzibilni kardiomiopatiji pri bolnikih, ki niso imeli nikakršnih znakov srčne bolezni (glejte poglavje 4.4).
Viraferon 3 MIU/m2 3 times a week (n = 54)
Viraferon 3 mio i.e./m2 3-krat na teden
Carefully replace the outer injection needle cap (See Diagram Q).
Previdno postavite zunanji pokrovček injekcijske igle nazaj na iglo (glejte sliko Q).
• chest pain or persistent and severe cough; irregular or rapid heartbeat; shortness of breath, confusion, difficulty remaining alert, numbness or tingling sensation or pain in hands or feet; seizure (convulsions); trouble sleeping, thinking or concentrating; altered mental state; suicidal thoughts, suicide attempt, changed behaviour or aggressive behaviour (sometimes directed against others), hallucinations; severe stomach pain; black or tar like stools; blood in stool or urine, severe nosebleed; waxy pallor, high sugar level in blood, fever or chills beginning after a few weeks of treatment, lower back or side pain, difficult urination, problems with your eyes or your eyesight or hearing, loss of hearing, severe or painful reddening or sores on your skin or mucous membrane.
• bolečine v prsih ali trdovraten in hud kašelj; neredno ali hitro bitje srca; težko dihanje, težava ostati buden, odrevenelost, mravljinci ali bolečina v dlaneh ali stopalih; epileptični napadi (konvulzije); težave z vidom, mišljenjem ali zbranostjo; spremenjeno duševno stanje; samomorilne misli ali poskus samomora, spremenjeno obnašanje ali agresivno obnašanje (včasih odkrito proti drugim), halucinacije; močne želodčne bolečine; črno ali smolnato blato; kri v blatu in seču, huda krvavitev iz nosu; voskasta bledica, visoka raven sladkorja v krvi, zvišana telesna temperatura ali mrzlica, ki nastopi po nekaj tednih zdravljenja, bolečina v spodnjem delu hrbta ali ob strani, težave z uriniranjem, težave z očmi ali vidom ali sluhom, izguba sluha, huda ali boleča pordelost ali ranice na koži ali sluznicah.
Viraferon is used in combination with ribavirin in children and adolescents 3 years of age and older who have previously untreated chronic hepatitis C.
Zdravilo Viraferon je namenjeno uporabi v kombinirani terapiji z ribavirinom za zdravljenje otrok in mladostnikov, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C.
The activity of Viraferon is expressed in terms of IU, with 1 mg of recombinant interferon alfa-2b protein corresponding to 2.6 x l08 IU.
Aktivnost zdravila Viraferon izražamo v i.e., pri čemer 1 mg rekombinantne beljakovine interferona alfa2b ustreza 2,6 x 108 i.e.
HOW TO USE VIRAFERON
KAKO UPORABLJATI ZDRAVILO VIRAFERON
Chronic hepatitis C: Adults - 3 million IU 3 times a week (every other day) injected subcutaneously (under the skin) in combination with ribavirin or alone.
Kronični hepatitis C: Odrasli - 3 miljoni i.e.3 krat na teden (vsak drugi dan) s subkutano (podkožno) injekcijo v kombinaciji z ribavirino mali sam.
Treatment should be continued in patients who exhibit negative HCV-RNA.
Pri tistih bolnikih, ki imajo negativen izvid na HCV-RNA, nadaljujte z zdravljenjem.
Remove the needle from the vial and check for air bubbles in the syringe.
Izvlecite iglo iz viale in preverite, ali so v brizgi morda zračni mehurčki.
Pharyngitis*, infection viral* Bronchitis, sinusitis, herpes simplex (resistance), rhinitis Pneumonia
faringitis*, virusna okužba* bronhitis, sinusitis, herpes simpleks (rezistenca), rinitis
18 million IU/3 ml solution for injection
18 milijonov i.e./3 ml raztopina za injiciranje
Remove the needle guard.
Snemite zaščitni pokrovček z igle.
Diagram B
Slika B
Sustained virological response based on genotype after Viraferon in combination with ribavirin versus pegylated interferon alfa-2b in combination with ribavirin in HCV/HIV co-infected patients
Preglednica 4 Trajni virološki odziv glede na genotip po uporabi zdravila Viraferon v kombinaciji z ribavirinom, v primerjavi z uporabo pegiliranega interferona alfa-2b v kombinaciji z ribavirinom pri bolnikih, ki so bili sočasno okuženi z virusoma HCV in HIV
Note that the rear portion of the injection needle is revealed once the protective tab is removed (see Diagram D).
Po odstranitvi ščitnika se pokaže zadnji del injekcijske igle (glejte sliko D).
Table 2 Adverse reactions very commonly and commonly reported in paediatric clinical trials Very common (≥1/10) - Common (≥1/100, <1/10)
Neželeni učinki, o katerih so v pediatričnih kliničnih preskušanjih poročali zelo pogosto (≥ 1/10) ali pogosto (≥ 1/100, < 1/10) Razporeditev po organskih sistemih
Decreased serum estradiol and progesterone concentrations have been reported in women treated with human leukocyte interferon.
Pri ženskah, zdravljenih s humanim levkocitnim interferonom, so poročali o zmanjšanih serumskih koncentracijah estradiola in progesterona.