natgillin/translations-raw huggingface dataset:
Children and adolescents are particularly prone to develop depression when being treated with IntronA and ribavirin.
Otroci in mladostniki so še bolj nagnjeni k depresiji, kadar se zdravijo z zdravilom IntronA in ribavirinom.
If such symptoms appear, the potential seriousness of these undesirable effects must be borne in mind by the prescribing physician and the need for adequate therapeutic management should be considered.
Če se pojavijo takšni simptomi, mora zdravnik, ki predpiše zdravilo, upoštevati potencialno resnost teh neželenih učinkov in razmisliti o potrebi po primernih terapevtskih ukrepih.
Cardiac arrhythmias (primarily supraventricular) usually respond to conventional therapy but may require discontinuation of IntronA therapy.
Srčne aritmije (predvsem supraventrikularne) se običajno odzovejo na konvencionalno terapijo, vendar je pri njih lahko potrebna ukinitev terapije z zdravilom IntronA.
Children and adolescents: - if you have had serious nervous or mental problems, such as severe depression or thoughts of suicide.
Otroci in mladostniki: - če ste kdaj imeli resno bolezen živčevja ali duševne težave, kot so huda depresija ali samomorilne misli.
This regimen must be maintained unless the disease progresses rapidly or severe intolerance is manifested.
Ta režim zdravljenja vzdržujte, razen če bolezen hitro napreduje ali če bolnik zelo slabo prenaša zdravljenje.
Carcinoid tumour 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”.
If this reaction occurs, they should be advised to rinse out their mouth thoroughly afterwards.
Če pride do te reakcije, naj si potem temeljito sperejo usta.
if you are also being treated for HIV (see section “Other medicines and IntronA”).
če se zdravite tudi zaradi okužbe s HIV (glejte poglavje “Druga zdravila in zdravilo IntronA”).
Before initiating treatment with IntronA, consideration should be given to the results from clinical trials comparing IntronA with pegylated interferon (see section 5.1).
Preden začnete zdravljenje z zdravilom IntronA, upoštevajte rezultate kliničnih preskušanj, ki so primerjala zdravilo IntronA s pegiliranim interferonom (glejte poglavje 5.1).
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 (števila granulocitov, števila trombocitov in vrednosti hemoglobina) pa je lahko potrebnih 6 mesecev ali več.
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 of medicinal product, becoming undetectable four hours after the infusion.
Po intravenski uporabi so bile največje serumske koncentracije interferona (od 135 do 273 i.e./ml) dosežene ob koncu infuzije, potem pa so upadale nekoliko hitreje kot po subkutani ali intramuskularni uporabi zdravila in 4 ure po infuziji niso bile več merljive.
Moderate and usually reversible pancytopenia has been reported.
Poročali so o zmerni in navadno reverzibilni pancitopeniji.
Relapse patients (adults)
Bolniki z relapsom bolezni (odrasli)
The best sites for injection are tissues with a layer of fat between skin and muscle: thigh, outer surface of the upper arm (you may need the assistance of another person to use this site), abdomen (except the navel or waistline).
Najboljša mesta za injiciranje so tkiva s plastjo maščevja med kožo in mišicami: stegno, zunanja površina nadlakti (tu boste morda potrebovali pomoč druge osebe), trebuh (razen popka ali pasu).
This enhancement in efficacy included loss of serum HCV (< 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Ta okrepitev učinkovitosti je vključevala odsotnost HCV v serumu (< 100 kopij/ml pri PCR), izboljšanje vnetja jeter in normalizacijo ALT in je bila še ohranjena ob merjenju 6 mesecev po koncu terapije.
The relative benefit of combination therapy with IntronA + ribavirin is particularly significant in the most difficult to treat subgroup of patients (genotype 1 and high virus load) (Table 3).
Relativna korist kombinirane terapije z zdravilom IntronA in ribavirinom je še posebej pomembna za podskupino bolnikov, ki jih je najtežje zdraviti (genotip 1 in velika virusna obremenitev) (Preglednica 3).
Be sure to tell your doctor if you are taking the Chinese herbal medicine shosaikoto.
Zdravniku morate povedati tudi, če jemljete kitajski zeliščni pripravek shosaikoto.
§, pneumonitis Pulmonary fibrosis, pulmonary arterial hypertension
§, pnevmonitis pljučna fibroza, pljučna arterijska hipertenzija
If there is bleeding, cover with an adhesive bandage.
Če pride do krvavitve, mesto pokrijte s samolepilnim obližem.
Push up the plunger slowly back to the correct dose.
Bat počasi potisnite nazaj do pravilnega odmerka.
Superior efficacy has been demonstrated with the combination of pegylated interferon with ribavirin (sustained response rate of 61 % achieved in a study performed in naïve patients with a ribavirin dose > 10.6 mg/kg, p < 0.01).
Boljša učinkovitost pa se je pokazala pri uporabi pegiliranega interferona v kombinaciji z ribavirinom (trajen virološki odziv 61 %, dosežen v študiji, opravljeni pri bolnikih, ki se prej še niso zdravili, z odmerkom ribavirina > 10,6 mg/kg, p < 0,01).
The undesirable effects seen with hepatitis C are representative of those reported when IntronA is administered in other indications, with some anticipated dose-related increases in incidence.
Neželeni učinki, ki so jih opažali pri hepatitisu C, so skladni s tistimi, o katerih so poročali pri uporabi zdravila IntronA za druge indikacije, z nekaterimi pričakovanimi povečanji pojavnosti v odvisnosti od odmerka zdravila.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rarely (≥1/10,000 to <1/1,000); very rarely (<1/10,000); not known.
V posameznih organskih sistemih so neželeni učinki razvrščeni po pogostnosti v naslednje kategorije: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) oziroma pogostnost ni znana.
Daily dosing of cynomolgus monkeys with 20 x 10
Vsakodnevno odmerjanje zdravila pri opicah vrste cynomolgus v odmerku 20 x 10
IntronA (3 MIU 3 times a week) I/R IntronA (3 MIU 3 times a week) + ribavirin (1,000/1,200 mg/day)
IntronA (3 mio i.e. trikrat na teden) I/R IntronA (3 mio i.e. trikrat na teden) + ribavirin (1.000/1.200 mg/dan)
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).
Splav so opažali v vseh skupinah po 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. 180-kratnemu priporočenemu intramuskularnemu ali subkutanemu odmerku 2 milijona i.e./m2).
If severe adverse events develop during interferon alfa-2b treatment, particularly if granulocytes decrease to < 500/mm
Če se med zdravljenjem z interferonom alfa-2b pojavijo hudi neželeni učinki, še posebej če število granulocitov pade na < 500/mm
Patients with substance use/abuse:
Bolniki, ki uživajo/zlorabljajo opojne substance:
Genotype 2,
Genotipa 2,
This risk should be weighed against the disease characteristics of the child, such as evidence of disease progression (notably fibrosis), co-morbidities that may negatively influence the disease progression (such as HIV co-infection), as well as prognostic factors of response, (HCV genotype and viral load).
To tveganje je treba pretehtati glede na značilnosti bolezni pri otroku, na primer glede na znake napredovanja bolezni (predvsem fibrozo), druge sočasne bolezni, ki bi lahko negativno vplivale na napredovanje bolezni (npr. sočasno okužbo s HIV), pa tudi prognostične dejavnike odziva na zdravljenje (genotip HCV in virusno breme).
IntronA can be put back in the refrigerator at any time during this seven-day period.
Zdravilo IntronA lahko kadar koli v tem 7 dnevnem obdobju vrnete nazaj v hladilnik.
HCV genotype and baseline virus load are prognostic factors which are known to affect response rates.
HCV genotip in virusna obremenitev na začetku zdravljenja sta znana prognostične dejavnika, ki vplivata na delež odziva.
Pyrexia and fatigue were often reversible within 72 hours of interruption or cessation of treatment.
Zvišana telesna temperatura in utrujenost sta pogosto izginila v roku 72 ur po prekinitvi ali ukinitvi zdravljenja.
If you are injecting IntronA yourself, please be sure that the dose that has been prescribed for you is clearly provided with the package of medicine you receive.
Če si zdravilo IntronA injicirate sami, se prepričajte, da je predpisani odmerek jasno napisan na pakiranju zdravila, ki ga prejmete.
Patients with existence of, or history of severe psychiatric conditions:
Bolniki, ki imajo ali so kdaj imeli hude psihiatrične motnje:
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 več hematoloških vrednosti v 1 do 2 mesecih terapije z zdravilom IntronA.
IntronA should be given alone mainly in case of intolerance or contraindication to ribavirin.
Zdravilo IntronA uporabljajte samostojno predvsem v primeru intolerance ali kontraindikacij za ribavirin.
The results of several studies suggest that, once bound to the cell membrane, interferon initiates a complex sequence of intracellular events that include the induction of certain enzymes.
Izsledki številnih raziskav kažejo, da interferon po vezavi na celično membrano sproži zapleteno kaskado znotrajceličnih procesov, med drugim indukcijo določenih encimov.
The longer term data available in children treated with the combination therapy with standard interferon/ribavirin are also indicative of substantial growth retardation (> 15 percentile decrease in height percentile as compared to baseline) in 21 % of children (n=20) despite being off treatment for more than 5 years.
Dolgoročnejši podatki, ki so na voljo za otroke, zdravljene s kombinirano terapijo s standardnim interferonom in ribavirinom, tudi kažejo znatno zaostajanje v rasti (zmanjšanje telesne višine za > 15 percentilov v primerjavi z osnovno vrednostjo) pri 21 % otrok (n=20) kljub temu, da se ti že več kot 5 let niso zdravili s tem zdravilom.
The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Namen študije je bil opravljati letne ocene trajanja trajnega virološkega odziva (SVR - sustained virologic response) in oceniti vpliv nadaljnjega negativnega izvida navzočnosti virusa na klinični izid zdravljenja pri bolnikih, ki so pokazali trajni virološki odziv 24 tednov po 48-tedenskem zdravljenju z interferonom alfa-2b in ribavirinom.
Intravenous infusion:
Intravensko infundiranje:
While this has been reported more often in patients with chronic hepatitis C treated with interferon alpha, it has also been reported in patients with oncologic diseases treated with interferon alpha.
Četudi so o tem pojavu poročali pogosteje pri bolnikih s kroničnim hepatitisom C, zdravljenih z interferonom alfa, so o njem poročali tudi pri bolnikih z malignimi boleznimi, zdravljenih z interferonom alfa.
For user convenience, the needle protection device can be rotated for ease of injection (Diagram B).
Za lažje injiciranje lahko pripomoček za zaščito igle obrnete (slika B).
Case by case benefit/risk assessment in children The expected benefit of treatment should be carefully weighed against the safety findings observed for children and adolescents in the clinical trials (see sections 4.8 and 5.1).
Individualna ocena razmerja med koristmi in tveganji pri otrocih Pričakovano korist zdravljenja je treba skrbno pretehtati glede na znane izsledke iz kliničnih preskušanj glede varnosti zdravila pri otrocih in mladostnikih (glejte poglavji 4.8 in 5.1).
During the one year of treatment with IntronA in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected.
V času enoletnega zdravljenja z zdravilom IntronA v kombinaciji z ribavirinom nekateri otroci in mladostniki niso zrasli in niso pridobili na telesni masi v tolikšni meri, kot bi pričakovali.
If treatment with interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Če ocenite, da je zdravljenje z interferonom alfa-2b potrebno pri odraslih bolnikih, ki imajo ali so kdaj imeli hude psihiatrične motnje, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatričnega stanja.
If you are self-administering treatment, or if you are the caregiver of a child taking IntronA in combination with ribavirin, inject the recommended dose as soon as you remember and continue treatment as usual.
Če si sami injicirate zdravilo IntronA ali ga dajete otroku v kombinaciji z ribavirinom, injicirajte priporočeni odmerek takoj, ko se spomnite, in nadaljujte z zdravljenjem kot običajno.
- if you have psoriasis, it may get worse during treatment with IntronA.
- če imate luskavico, saj se ta lahko poslabša med zdravljenjem z zdravilom IntronA.
Tell your doctor if you have ever had a heart attack or a heart problem; if you have a history of breathing irregularities or pneumonia, problems with blood clotting, liver condition, thyroid problems, diabetes, or high or low blood pressure.
Zdravniku povejte, če ste kdaj imeli srčni napad ali težave s srcem, ali če ste imeli v preteklosti kdaj motnje dihanja ali pljučnico, težave s strjevanjem krvi, jetrno bolezen, težave s ščitnico, sladkorno bolezen ali visok ali nizek krvni tlak.
If psychiatric symptoms persist or worsen, or suicidal or homicidal ideation is identified, it is recommended that treatment with IntronA be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo ali če ugotovite, da ima bolnik samomorilne ali morilske misli, priporočamo, da zdravljenje z zdravilom IntronA prekinete in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
IntronA is also used in adult patients for the treatment of chronic hepatitis B or C, which are viral infections of the liver.
Zdravilo IntronA se pri odraslih bolnikih uporablja tudi za zdravljenje kroničnega hepatitisa B ali C, ki sta virusni okužbi jeter.
Obtundation, coma and encephalopathy
Otopelost, koma in encefalopatija
CHOP-like regimens are advised, but clinical experience is available only with CHVP (combination of cyclophosphamide, doxorubicin, teniposide and prednisolone).
Svetujemo uporabo sheme, podobne CHOP zdravljenju, klinične izkušnje pa so na voljo le za shemo CHVP (kombinacija ciklofosfamida, doksorubicina, tenipozida in prednizolona).
Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded (see ribavirin SPC).
Moški bolniki ali njihove partnerke morajo učinkovito kontracepcijo uporabljati med zdravljenjem in še 7 mesecev po zaključku zdravljenja (glejte SPC za ribavirin).
Final adult height was available for 14 of those children and demonstrated that 12 continued to show height deficits > 15 percentiles, 10 to 12 years after the end of treatment.
Za 14 od teh otrok je bila na voljo končna telesna višina in pokazalo se je, da se je pri 12-ih še naprej kazalo zmanjšanje telesne višine za > 15 percentilov 10 do 12 let po končanem zdravljenju.
A total of 107 patients received treatment of whom 52 % were female, 89 % Caucasian, 67 % with HCV Genotype 1 and 63 % < 12 years of age.
Zdravilo se je skupno 107 bolnikov, od tega je bilo 52 % žensk, 89 % belcev, 67 % jih je imelo HCV genotipa 1 in 63 % jih je bilo starih < 12 let.
Appropriate dose form and strength must be selected.
Pozorno morate izbrati primerno obliko in jakost.
§, asthenia,
§, manija,
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.
What IntronA is and what it is used for
Kaj je zdravilo IntronA in zakaj ga uporabljamo
The study results are summarized in Table 6.
Povzetek izsledkov študije je podan v Preglednici 6.
Treatment should be discontinued in case of severe leukopaenia (< 1,200/mm 3), severe neutropaenia (< 750/mm or severe thrombocytopaenia (< 70,000/mm
Zdravljenje ukinite v primeru hude levkopenije (< 1.200/mm 3), hude nevtropenije (< 750/mm 3) ali hude trombocitopenije
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 (HCVRNA below lower limit of detection six months after withdrawal of treatment).
Bolniki, pri katerih v kliničnih preskušanjih po 6 mesecih zdravljenja ni prišlo do virološkega odziva (HCV-RNA pod spodnjo mejo detekcije), tudi kasneje niso dosegli trajnega virološkega odziva (HCVRNA pod spodnjo mejo detekcije 6 mesecev po prenehanju zdravljenja).
If you take telbivudine with a pegylated interferon alfa-2a or any type of injectable interferon product, your risk of developing peripheral neuropathy (numbness, tingling and/or burning sensations in the arms and/or legs) is higher.
Če jemljete telbivudin s pegiliranim interferonom alfa-2a ali katerim koli interferonskim zdravilom za injiciranje, imate povečano tveganje za nastanek periferne nevropatije (odrevenelost, mravljinci in/ali pekoč občutek v rokah in/ali nogah).
Your doctor may prescribe a different dose of IntronA alone or in combination with other medicines (e.g., cytarabine, ribavirin).
Zdravnik vam lahko predpiše tudi drugačen odmerek zdravila IntronA, samega ali skupaj z drugimi zdravili (npr. s citarabinom, ribavirinom).
Contact your doctor or pharmacist if needed.
Po potrebi se posvetujte z zdravnikom ali farmacevtom.
Hold the IntronA vial upright without touching the cleaned top of the vial with your hands.
Vialo zdravila IntronA držite pokončno, ne da bi se pri tem z rokami dotaknili očiščenega vrha viale.
Because of the risk of increased toxicity, careful adjustments of doses are required for IntronA and for the concomitant chemotherapeutic agents (see section 4.5).
Zaradi nevarnosti povečane toksičnosti je potrebno skrbno prilagajanje odmerkov zdravila IntronA in sočasno uporabljenih kemoterapevtikov (glejte poglavje 4.5).
In Table 1 the frequency of patients reporting (treatment related) undesirable effects is presented from clinical trials in naïve patients treated for one year.
V Preglednici 1 je podana pogostnost (z zdravljenjem povezanih) neželenih učinkov, o katerih so poročali pri predhodno nezdravljenih bolnikih v kliničnih preskušanjih, v katerih so se zdravili eno leto.
- if you are being treated with telbivudine (see section "Other medicines and IntronA").
- če se zdravite s telbivudinom (glejte poglavje "Druga zdravila in zdravilo IntronA").
Your doctor will test your blood to ensure that your white blood cell (cells that fight infection) and red blood cell (cells that carry iron and oxygen) counts, platelets (blood clotting cells) and other laboratory values are at acceptable levels.
Zdravnik bo opravil preiskave krvi, da zagotovi, da so število levkocitov (celice, ki se bojujejo proti okužbi), število eritrocitov (celice, ki prenašajo železo in kisik), število trombocitov (celice za strjevanje krvi) pa tudi drugi vaši laboratorijski izvidi sprejemljivi.
Within the 5 years follow-up post-treatment period, the children had a mean height of th percentile, which was below the median of the normative population and less than their mean baseline height (48
V obdobju 5-letnega spremljanja bolnikov po zaključku zdravljenja je bila srednja višina otrok v 44. percentilu, kar je pod mediano vrednostjo normativne populacije in manj od srednje vrednosti njihove višine na začetku zdravljenja (48. percentil).
- when receiving IntronA, you may temporarily have a greater risk of getting an infection.
- med prejemanjem zdravila IntronA ste lahko začasno bolj nagnjeni k okužbam.
Tell your doctor if you have ever been treated for depression or any other psychiatric disorder; confusion; unconsciousness; thoughts of suicide or attempted suicide, or have a history of substance abuse (e.g., alcohol or drugs).
Zdravniku povejte, če ste se kdaj zdravili zaradi depresije ali katere koli druge duševne motnje, zmedenosti, nezavesti, samomorilnih misli ali poskusa samomora ali ste v preteklosti zlorabljali opojne substance (npr. alkohol ali droge).
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 humanega rekombinantnega interferona alfa-2b do 3 mesece niso opažali nobenih znakov toksičnosti zdravila pri miših, podganah in kuncih.
Combination therapy with ribavirin Ribavirin therapy is contraindicated in women who are pregnant.
Kombinirana terapija z ribavirinom Zdravljenje z ribavirinom je kontraindicirano pri nosečnicah.
- if you are being treated for mental illness or had treatment in the past for any other nervous or mental disorder, including depression (such as feelings of sadness, dejection) or suicidal or homicidal behaviour (see section 4 “Possible side effects”).
- če se zdravite zaradi duševne bolezni ali ste se v preteklosti zdravili zaradi katere koli bolezni živčevja ali duševne motnje, vključno z depresijo (kot je občutek žalosti, potrtosti) ali s samomorilnim ali morilskim vedenjem (glejte poglavje 4.
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.
Kot dodatno zdravljenje pri bolnikih, ki so po kirurškem posegu ozdravljeni, vendar pri njih še vedno obstaja veliko tveganje za sistemsko ponovitev bolezni, npr. pri bolnikih s primarno ali ponavljajočo prizadetostjo bezgavk (klinično ali patološko).
During concomitant therapy with xanthine agents, serum theophylline levels must be monitored and dose adjusted if necessary.
Med sočasno terapijo s ksantinskimi učinkovinami morate spremljati serumsko koncentracijo teofilina in po potrebi prilagoditi odmerek zdravila.
Your doctor or his/her assistant will instruct you how to selfinject IntronA.
Zdravnik ali medicinska sestra vas bosta poučila, kako si sami injicirate zdravilo IntronA.
Some children have had a decrease in their rate of growth (height and weight).
Pri nekaterih otrocih se je upočasnila rast (telesna višina in masa).
For short term travelling, the solution can be kept out of the refrigerator at or below 25°C for a period up to seven days before use.
Za kratkotrajen prevoz lahko raztopino shranjujete zunaj hladilnika pri temperaturi do vključno 25 °C, do 7 dni pred uporabo.