natgillin/translations-raw huggingface dataset:
66.8 (129/ 193) 20
66, 8 (129/ 193)
57.7 (45/ 78)
(45/ 78)
29.2 (191/ 653)
29, 2 (191/ 653)
58.1, 75.6
58, 1, 75, 6
43.3, 72.1
43, 3, 72, 1
24.7, 33.8
24, 7, 33, 8
62.6 (102/ 163) 52.8, 72.3
62, 6 (102/ 163) 52, 8, 72, 3
51.3 (40/ 78) 36.7, 65.9
32, 4 (78/ 241) 51, 3 (40/ 78) 36, 7, 65, 9
21.9 (147/ 672) 17.8, 26.0
21, 9 (147/ 672) 17, 8, 26, 0
44.8 (52/ 116) 32.9, 56.7
29, 7 (116/ 390) 44, 8 (52/ 116) 32, 9, 56, 7
16.5 (159/ 966) 13.4, 19.5
16, 5 (159/ 966) 13, 4, 19, 5
Baseline Viral Load HVL (> 600,000 IU/ ml)
Virusno breme na začetku HVL (> 600. 000 i. e. / ml)
56.1 (157/ 280) 48.4, 63.7
56, 1 (157/ 280) 48, 4, 63, 7
41.4 (63/ 152) 31.2, 51.7
41, 4 (63/ 152) 31, 2, 51, 7
16.6 (239/ 1,441) 14.1, 19.1
16, 6 (239/ 1. 441) 14, 1, 19, 1
LVL (≤ 600,000 IU/ ml)
LVL (≤600. 000 i. e. / ml)
62.8 (169/ 269) 55.2, 70.4
62, 8 (169/ 269) 55, 2, 70, 4
61.0 (72/ 118) 49.5, 72.6
61, 0 (72/ 118) 49, 5, 72, 6
30.2 (256/ 848) 26.1, 34.2
30, 2 (256/ 848) 26, 1, 34, 2
Non-responder defined as serum/ plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Bolniki brez odziva na zdravljenje so bili opredeljeni kot tisti s pozitivnim izvidom na serumsko RNA- HCV v serumu oz. plazmi ob koncu najmanj 12- tedenskega zdravljenja.
Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory *Intent to treat population includes 7 patients for whom at least 12 weeks of prior therapy could not be confirmed.
Vrednost serumske RNA- HCV v plazmi so merili z raziskovalnim kvantitativnim testom polimerazne verižne reakcije, ki ga je opravljal osrednji laboratorij. * Populacija, ki so jo nameravali zdraviti, je vključevala 7 bolnikov brez predhodno potrjenega vsaj 12- tedenskega zdravljenja.
Overall, approximately 36% (821/ 2,286) of patients had undetectable plasma HCV-RNA levels at Week 12 of therapy measured using a research-based test (limit of detection 125 IU/ ml).
Skupaj je imelo v 12. tednu zdravljenja približno 36% (821/ 2. 286) bolnikov nezaznavne koncentracije serumske RNA- HCV v plazmi, kar so merili z raziskovalnim testom (meja detekcije 125 i. e. / ml).
In this subgroup, there was a 56% (463/ 823) sustained virological response rate.
V tej podskupini je bila stopnja stalnega virološkega odziva 56% (464/ 823).
Among 480 patients with > 2 log viral reduction but detectable virus at Week 12, altogether 188 patients continued therapy.
Med 480 bolniki z zmanjšanjem količine virusa za > 2- log, vendar s še zaznavnim virusom v 12. tednu, je skupaj 118 bolnikov nadaljevalo z zdravljenjem.
In those patients the SVR was 12%.
Pri teh bolnikih je znašala ocenjena stopnja stalnega virološkega odziva 12%.
28.6%).
Pri bolnikih, ki se niso odzvali na predhodno zdravljenje s pegiliranim interferonom alfa in ribavirinom, je bila verjetnost, da se bodo 12. teden odzvali na ponovno zdravljenje, manjša kot pri tistih, ki se niso odzvali na zdravljenje z nepegiliranim interferonom alfa in ribavirinom (12, 4% v primerjavi z 28, 6%).
However, if a Week 12 response was achieved, there was little difference in SVR regardless of prior treatment or prior response.
Če pa so se v 12. tednu odzvali na zdravljenje, je bila razlika v stalnem virološkem odzivu glede na predhodno zdravljenje ali predhodni odziv majhna.
Retreatment of relapse patients with Ribavirin and interferon alfa-2b combination treatment Two trials examined the use of Ribavirin and interferon alfa-2b combination treatment in relapse patients (C95-144 and I95-145); 345 chronic hepatitis patients who had relapsed after previous interferon treatment were treated for six months with a six month follow-up.
Ponovno zdravljenje bolnikov s ponovitvijo bolezni z ribavirinom in interferonom alfa- 2b v kombinirani terapiji V dveh preskušanjih so raziskovali uporabo kombinacije ribavirina in interferona alfa- 2b pri bolnikih s ponovitvijo bolezni (C95- 144 in I95- 145); 345 bolnikov s kroničnim hepatitisom, pri katerih se je bolezen ponovila po predhodnem zdravljenju z interferonom, so zdravili šest mesecev, in jih nato spremljali še šest mesecev.
Combination therapy with Ribavirin and interferon alfa-2b resulted in a sustained virological response that was ten-fold higher than that with interferon alfa-2b alone (49% vs 5%, p < 0.0001).
Pri kombinirani terapiji z ribavirinom in interferonom alfa- 2b je bil trajen virološki odziv kar desetkrat večji kot pri monoterapiji z interferonom alfa- 2b (49% proti 5%, p < 0, 0001).
Long-term efficacy data Two large long-term follow-up studies enrolled 1,071 patients and 567 patients after treatment in prior studies with nonpegylated interferon alfa-2b (with or without ribavirin) and pegylated interferon alfa- 2b (with or without ribavirin), respectively.
Dolgoročni podatki o učinkovitosti V dve veliki, dolgoročni študiji spremljanja bolnikov po zdravljenju v prejšnjih študijah so vključili skupaj 1071 bolnikov po končanem zdravljenju z nepegiliranim interferonom alfa- 2b (z ali brez ribavirina) ter 567 bolnikov po končanem zdravljenju s pegiliranim interferonom alfa- 2b (z ali brez ribavirina).
The purpose of the studies was to evaluate the durability ofsustained virologic response (SVR) and assess the impact of continued viral negativity on clinicaloutcomes.
Namen teh študij je bil oceniti dolžino trajnega virološkega odziva (SVR- sustained virologic response) in tudi vpliv nadaljnjega negativnega izvida testov na prisotnost virusa na klinični izid bolezni.
12 out of 492 sustained responders and only 3 out of 366 sustainedresponders relapsed, respectively, in the studies.
22 skupine in le pri 3 od 366 bolnikov s trajnim virološkim odzivom iz druge skupine, ki so bili vključeni v študijo.
95-99%) for patients receiving nonpegylated interferon alfa-2b (with or without ribavirin), and is 99% (95% CI:
95- 99%) pri bolnikih, ki so prejemali nepegiliran interferon alfa- 2b (z ali brez ribavirina), oziroma 99% (95% IZ:
98-100%) for patients receiving pegylated interferon alfa-2b (with or without ribavirin).
98- 100%) pri tistih, ki so prejemali pegiliran interferon alfa- 2b (z ali brez ribavirina).
SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and nonpegylated, with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical'cure 'from chronic HCV.
SVR po zdravljenju kronične okužbe z virusom hepatitisa C z interferonom alfa- 2b (pegiliranim ali nepegiliranim, z ali brez ribavirina) vodi do dolgotrajnega očistka virusa ter tako odpravi jetrno okužbo in omogoči klinično » ozdravitev « kronične okužbe z virusom hepatitisa C.
21 Ribavirin clinical trials in children and adolescents:
Klinična preskušanja ribavirina pri otrocih in mladostnikih:
Children and adolescents 3 to 16 years of age with compensated chronic hepatitis C and detectable HCV-RNA (assessed by a central laboratory using a research-based RT-PCR assay) were enrolled in two multicentre trials and received Ribavirin 15 mg/ kg per day plus interferon alfa-2b 3 MIU/ m 3
Otroci in mladostniki, stari od 3 do 16 let in s kompenziranim kroničnim hepatitisom C in merljivimi količinami serumske RNA- HCV (kar je ocenil osrednji laboratorij z uporabo raziskovalnega testa RT - PCR), so bili vključeni v dve multicentrični preskušanji in so ribavirin prejemali v odmerku 15 mg/ kg na dan skupaj z interferonom alfa- 2b v odmerku 3 mio i. e. / m2 trikrat na teden v času enega leta, čemur je sledilo 6- mesečno spremljanje po zdravljenju.
Sustained virological response rates in children and adolescents were similar to those in adults.
Delež trajnega virološkega odziva pri otrocih in mladostnikih je bil podoben tistemu pri odraslih.
Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/ risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
(glejte poglavja 4. 1, 4. 4 in 4. 8).
Study results are summarized in Table 11.
Povzetek izsledkov študije je podan v preglednici 11.
Table 11.
Preglednica 11
Virological response in previously untreated children and adolescents Ribavirin 15 mg/ kg/ day + interferon alfa-2b 3 MIU/ m2 3 times a week
Virološki odziv pri predhodno nezdravljenih otrocih in mladostnikih ribavirina 15 mg/ kg/ dan + interferon alfa- 2b 3 mio i. e. / m2 3- krat na teden
* Number (%) of patients
* Število (%) bolnikov
Defined as HCV-RNA below limit of detection using a research based RT-PCR assay at end of treatment and during follow-up period
Opredeljeno kot vrednost serumske RNA- HCV pod mejo detekcije koncu zdravljenja in v obdobju spremljanja bolnikov.
Ribavirin is absorbed rapidly following oral administration of a single dose (mean Tmax= 1.5 hours), followed by rapid distribution and prolonged elimination phases (single dose half-lives of absorption, distribution and elimination are 0.05, 3.73 and 79 hours, respectively).
Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1, 5 ure), čemur sledita hitra faza porazdelitve in faze podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku so 0, 05; 3, 73 in 79 ur).
Ribavirin has been shown to produce high inter- and intra-subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30% for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
To je lahko posledica obsežne presnove pri prvem prehodu skozi jetra in porazdelitve znotraj in zunaj krvnega prostora.
Ribavirin transport in non-plasma compartments has been most extensively studied in red cells, and has been identified to be primarily via an es-type equilibrative nucleoside transporter.
23 Prehajanje ribavirina v neplazemske prostore so najobsežneje proučevali na eritrocitih in ugotovili, da poteka predvsem preko ekvilibracijskega nukleozidnega prenašalca tipa es.
The ratio of whole blood: plasma ribavirin concentrations is approximately 60:1; the excess of ribavirin in whole blood exists as ribavirin nucleotides sequestered in erythrocytes.
Razmerje koncentracij ribavirina v polni krvi proti plazmi je približno 60 proti 1; prebitek ribavirina v polni krvi pa je v obliki ribavirinskih nukleotidov, sekvestriranih v eritrocitih.
22 Upon multiple dosing, ribavirin accumulates extensively in plasma with a six-fold ratio of multiple- dose to single-dose AUC12hr.
Po večkratnem odmerjanju se ribavirin obsežno kopiči v plazmi, s šestkratnim razmerjem med vrednostima AUC12 ur za večkratno in za enkratno odmerjanje.
Following oral dosing with 600 mg BID, steady-state was reached by approximately four weeks, with mean steady state plasma concentrations approximately 2,200 ng/ ml.
Po peroralnem odmerjanju ribavirina 600 mg dvakrat na dan je bilo stanje dinamičnega ravnovesja doseženo v približno štirih tednih; srednja plazemska koncentracija v stanju dinamičnega ravnovesja je bila približno 2. 200 ng/ ml.
Single-dose ribavirin pharmacokinetics were altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 ml/ minute).
Pri bolnikih z motnjami delovanja ledvic je bila farmakokinetika ribavirina po enkratnem odmerku spremenjena (povečanje AUCtf in Cmax) glede na kontrolno skupino (očistek kreatinina > 90 ml/ minuto).
However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Specifičnih farmakokinetičnih raziskav pri starostnikih niso opravljali, vendar v populacijski farmakokinetični študiji starost ni bila ključni dejavnik kinetike ribavirina, odločilni dejavnik je delovanje ledvic.
For males, clearance was approximately 20% higher than for females.
Pri moških je bil očistek približno 20% večji kot pri ženskah.
Multiple-dose pharmacokinetic properties for Ribavirin capsules and interferon alfa-2b in children and adolescents with chronic hepatitis C between 5 and 16 years of age are summarized in Table 12.
Farmakokinetične lastnosti pri večkratnem odmerjanju kapsul zdravila Ribavirin Teva in interferona alfa- 2b pri otrocih in mladostnikih s kroničnim hepatitisom C v starosti od 5 do 16 let so povzete v preglednici 12.
The pharmacokinetics of Ribavirin and interferon alfa-2b (dose- normalized) are similar in adults and children or adolescents.
Farmakokinetika zdravila Ribavirin Teva in interferona alfa- 2b (z normaliziranim odmerkom) je podobna pri odraslih in otrocih ali mladostnikih.
Mean (% CV) multiple-dose pharmacokinetic parameters for interferon alfa-2b and ribavirin when administered to children or adolescents with chronic hepatitis C
Srednja vrednost (% CV) farmakokinetičnih parametrov pri večkratnem odmerjanju interferona alfa- 2b in ribavirina otrokom ali mladostnikom s kroničnim hepatitisom C
15 mg/ kg/ day as 2 divided doses (n = 17)
deljenih odmerkov (n = 17)
5.9 (36)
5. 9 (36)
clearance l/ hr/ kg
Navidezni očistek l/ hr/ kg
*AUC12 (ng. hr/ ml) for Ribavirin; AUC0-24 (IU. hr/ ml) for interferon alfa-2b
* AUC12 (ng. hr/ ml) za zdravilo Ribavirin Teva; AUC0- 24 (i. e. x h/ ml) za interferon alfa- 2b
23 In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/ kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
V študiji toksičnosti zdravila za podganje mladiče so pri mladičih, ki so jim od 7. do 63. dne po rojstvu dajali odmerke 10, 25 in 50 mg/ kg ribavirina, so ugotovili od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti.
In 3- and 6-month studies in mice to investigate ribavirin-induced testicular and sperm effects, abnormalities in sperm, occurred at doses of 15 mg/ kg and above.
V 3 - in 6- mesečni študiji na miših za proučevanje učinkov ribavirina na testise in spermo so se anomalije sperme, pojavile pri odmerku 15 mg/ kg in več.
Ribavirin was active in the Balb/ 3T3 in vitro Transformation Assay.
Ribavirin se je izkazal za aktivnega v transformacijskem testu na celicah Balb/ 3T3 in vitro.
Genotoxic activity was observed in the mouse lymphoma assay, and at doses of 20-200 mg/ kg in a mouse micronucleus assay.
Njegovo genotoksično delovanje so beležili tudi v testu na celicah mišjega limfoma in pri odmerkih od 20 do 200 mg/ kg v testu na mišjih mikronukleusih.
Conventional carcinogenicity rodent studies with low exposures compared to human exposure under therapeutic conditions (factor 0.1 in rats and 1 in mice) did not reveal tumorigenicity of ribavirin.
Konvencionalne študije kancerogenosti pri glodavcih z majhnimi izpostavljenostmi v primerjavi z izpostavljenostjo pri človeku v terapevtskih pogojih (faktor 0, 1 pri podganah in 1 pri miših) niso pokazale nobene tumorogenosti ribavirina.
In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/ -) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/ kg (plasma exposure factor approximately 2.5 compared to human exposure).
Poleg tega v 26- tedenski študiji kancerogenosti z uporabo heterozigotnega mišjega modela p53 (+ / -) ribavirin ni povzročil nastanka tumorjev pri največjem odmerku, ki so ga živali še prenašale, 300 mg/ kg (faktor plazemske izpostavljenosti približno 2, 5- večji od izpostavljenosti pri človeku).
Ribavirin plus interferon alfa-2b:
Ribavirin + interferon alfa- 2b:
Calcium hydrogen phosphate Croscarmellose sodium Povidone Magnesium stearate
Vsebina kapsule: kalcijev hidrogenfosfat premrežen natrijev karmelozat povidon magnezijev stearat
Titanium dioxide (E171) Gelatin
Ovojnica kapsule: titanov dioksid (E171) želatina
Shellac Titanium dioxide (E171) Indigo carmine
Napis na kapsuli: šelak titanov dioksid (E171) indigotin
Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/ polyethylene (PE)/ polyvinylidene chloride (PVdC)-aluminium blister packs
Kapsule zdravila Ribavirin Teva so pakirane v pretisne omote iz polivinilklorida (PVC) / polietilena (PE) / polivinilidenklorida (PVdC) – pakiranja v aluminijasti pretisni omot.
Packs of 84, 112, 140 and 168 capsules Not all pack sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
6.6 Special precautions for disposal
6. 6 Posebni varnostni ukrepi za shranjevanje
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 Evropskega agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI) IN IMETNIK( I) DOVOLJENJA (DOVOLJENJ) ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI IN IMETNIKI DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13 H-4042 Debrecen Hungary
TEVA Pharmaceutical Works Private Limited Company Pallagi út 13, 4042 Debrecen Madžarska
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82 H-2100 Gödöllo Hungary
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82 Madžarska
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne East Sussex, BN22 9AG Velika Britanija
Swensweg 5, 2031 GA Haarlem The Netherlands
Swensweg 5 2031 GA Haarlem Nizozemska
TEVA Santé SA Rue Bellocier, 89107 Sens France
TEVA Santé SA Rue Bellocier 89107 Sens Francija
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 dated November 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 4. 0 z novembra 2007, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
27 Risk Management Plan
Načrt za obvladovanje tveganja
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
29 Vloga temelji na referenčnem zdravilu za katereganiso niso bile ugotovljene varnostna vprašanja, ki bi zahtevale dodatne aktivnosti za zmanjšanje tveganja.
PSURs The PSUR submission schedule should follow the PSUR schedule for the reference product.
Časovnica za predložitev PSUR mora slediti časovnici oddajanja PSUR za referenčno zdravilo.
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 PODATKI NA ZUNANJI OVOJNINI
What Ribavirin Teva is and what it is used for 2.
Kaj je zdravilo Ribavirin Teva in za kaj ga uporabljamo 2.
Before you take Ribavirin Teva 3.
Kaj morate vedeti, preden boste vzeli zdravilo Ribavirin Teva 3.
How to take Ribavirin Teva 4.
Kako jemati zdravilo Ribavirin Teva 4.
How to store Ribavirin Teva 6.
Shranjevanje zdravila Ribavirin Teva 6.
WHAT RIBAVIRIN TEVA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO RIBAVIRIN TEVA IN ZA KAJ GA UPORABLJAMO
Ribavirin Teva is a medicine that can inhibit the multiplication of some viruses.
Ribavirin Teva je zdravilo, ki zavira razmnoževanje nekaterih virusov.
Ribavirin Teva is used in adults, in combination with either peginterferon alfa-2b or interferon alfa-2b, to treat patients who have chronic hepatitis C.
Zdravilo Ribavirin Teva se uporablja za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, in sicer v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b.
The situations where Ribavirin Teva can be used with adults are listed below:
Primeri kjer se zdravilo Ribavirin Teva lahko uporablja pri odraslih bolnikih so navedeni spodaj:
In combination with either interferon alfa-2b or peginterferon alfa-2b in adults who have not previously been treated for chronic hepatitis C or who have previously responded to treatment with an alpha interferon, but whose condition has recurred.
V kombinaciji bodisi z interferonom alfa- 2b ali peginterferonom alfa- 2b pri odraslih bolnikih, ki prej niso bili zdravljeni za kronični hepatitis C ali ki so se predhodno odzvali na zdravljenje z intereferonom alfa, vendar se je pri njih obolenje ponovilo.
In combination with peginterferon alfa-2b in adults who have been not previously been treated for chronic hepatitis C and who are co-infected with clinically stable HIV.
V kombinaciji s peginterferonom alfa- 2b pri odraslih bolnikih, ki prej niso bili zdravljeni za kronični hepatitis C in, ki so okuženi tudi s klinično stabilnim virusom HIV.
In combination with peginterferon alfa-2b in adults who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy.
V kombinaciji s peginterferonom alfa- 2b pri odraslih bolnikih, pri katerih je bilo predhodno zdravljenje z interferonom alfa (pegeliranim ali nepegeliranim) in kombinirano terapijo z ribavirinom ali samostojno terapijo z interferonom alfa neuspešno.
Ribavirin Teva can also be used in combination with interferon alfa-2b in children and adolescents 3 years of age and older, who have previously untreated chronic hepatitis C.
Zdravilo Ribavirin Teva, v kombinaciji s interferonom alfa- 2b, se lahko uporablja za zdravljenje otrok in mladostnikov starih 3 leta ali več, pri katerih kronični hepatitis C še ni bil zdravljen.
Ribavirin Teva should not be used on its own.
Zdravila Ribavirin Teva ne smete uporabljati samostojno.
2.
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO RIBAVIRIN 2.
BEFORE YOU TAKE RIBAVIRIN TEVA
TEVA
You must read the patient leaflet for peginterferon alfa -2b or interferon alfa-2b before you start treatment with Ribavirin Teva and either peginterferon alfa-2b or interferon alfa-2b.
Preden boste uporabili zdravilo Ribavirin Teva ter peginterferon alfa- 2b ali interferon alfa- 2b, morate prebrati navodilo za uporabo peginterferona alfa- 2b ali interferona alfa- 2b.
Do not take Ribavirin Teva
Ne jemljite zdravila Ribavirin Teva
- if you are allergic (hypersensitive) to ribavirin or any of the other ingredients of Ribavirin Teva
- če ste alergični (preobčutljivi) na ribavirin ali katerokoli sestavino zdravila Ribavirin Teva
Capsules (see section 6, further information)
(glejte poglavje 6, Dodatne informacije),
Ribavirin Teva can harm both the embryo
Zdravilo Ribavirin Teva lahko škoduje plodu (nerojenemu
(unborn baby) and the male sperm.
otroku) in spermi moškega.
Female patients of childbearing age must produce a negative pregnancy test immediately prior to treatment.
Bolnice v rodni dobi morajo tik pred pričetkom zdravljenja opraviti test nosečnosti, ki mora biti negativen.
It is essential that Routine pregnancy tests should also be performed monthly during treatment and for four months after treatment has stopped.
Pomembno je, da bolnice opravijo test nosečnosti vsak mesec v času zdravljenja ter še štiri mesece po zaključenem zdravljenju.
Female partners of male patients should also have routine pregnancy tests monthly during treatment, and for seven months after treatment has stopped.
Partnerke bolnikov morajo med njihovim zdravljenjem ter še sedem mesecev po zaključenem zdravljenju, prav tako mesečno opravljati teste nosečnosti.
- if you have any severe medical conditions that leave you very weak, including severe kidney
- če imate kakšno resno bolezen, zaradi katere se počutite zelo šibki, npr. hudo ledvično bolezen,
- if you are breast-feeding
- če dojite,
- if you have had any previous severe heart problems, or have had any problems with the heart in
- če ste imeli kakršnokoli resno srčno bolezen v preteklosti ali če ste imeli težave s srcem v
the last six months.
zadnjih šestih mesecih,
- if you have had severe liver problems, which are not related to hepatitis C
- če imate resno bolezen jeter, ki ni povezana s hepatitisom C,