FrancophonIA/ELRC3.0 huggingface dataset:
English: Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur: - Girl or woman of childbearing age:
Slovenian: Tako bolnice kot bolniki morajo biti posebno previdni pri spolnih odnosih, če obstaja kakršna koli možnost za zanositev: - Dekle ali ženska v rodni dobi:
English: Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Slovenian: Rebetol kapsule so pakirane v pretisne omote iz polivinilklorida (PVC)/polietilena (PE)/polivinilidenklorida (PVdC).
English: Hard capsule (capsule)
Slovenian: trda kapsula (kapsula)
English: SVR % (n/N) 99 % CI
Slovenian: SVR % (n/N) 99 % IZ
English: In this subgroup, there was a 56 % (463/823) sustained virological response rate.
Slovenian: V tej podskupini je bila stopnja trajnega virološkega odziva 56 % (463/823).
English: Genotype 2, 3**
Slovenian: Genotip 2, 3**
English: If you forget to take Rebetol
Slovenian: Če ste pozabili vzeti zdravilo Rebetol
English: Your doctor will recommend the best course of therapy.
Slovenian: Zdravnik bo predlagal optimalno zdravljenje.
English: What you need to know before you use Rebetol
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Rebetol
English: The syringe should be rinsed with water after each use to avoid stickiness.
Slovenian: Brizgo sperite z vodo po vsaki uporabi, da ne postane lepljiva.
English: Reminder: Your doctor may have changed the amount based on recent test results.
Slovenian: Opozorilo: Zdravnik vam bo lahko spremenil količino glede na zadnje izvide.
English: Growth rate decrease (height and/or weight decrease for age)
Slovenian: zmanjšana rast (zmanjšana telesna višina in/ali telesna masa glede na starost)
English: METAVIR Fibrosis score F2
Slovenian: METAVIR Ocena fibroze F2
English: Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Slovenian: Prosimo, glejte navodilo za uporabo (peg)interferona alfa za podrobnejše informacije o teh varnostnih vprašanjih.
English: D. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe.
Slovenian: D. Brizgo za peroralno odmerjanje vzemite iz stekleničke in preverite, ali na dnu brizge vidite pravilno količino raztopine.
English: Each capsule contains a small amount of lactose.
Slovenian: Vsaka kapsula vsebuje majhno količino laktoze.
English: Ribavirin plus interferon
Slovenian: Ribavirin in interferon
English: Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
Slovenian: 24 % bolnikov je imelo mostno fibrozo ali cirozo (Knodell 3/4).
English: No sustained Response
Slovenian: Ni trajnega odziva
English: Try not to let the oral syringe touch the inside of the mouth.
Slovenian: Pazite, da se s peroralno brizgo ne boste dotaknili notranjosti ust.
English: Take/administer the missed dose as soon as possible during the same day.
Slovenian: Vzemite/dajte pozabljeni odmerek čimprej še isti dan.
English: (%)) in previously untreated children and adolescents by genotype and treatment duration -All subjects n = 107
Slovenian: (%)) pri predhodno nezdravljenih otrocih in mladostnikih po genotipu in dolžini zdravljenja - vsi preiskovanci n = 107
English: Furthermore, 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.
Slovenian: Poleg tega so pri pediatričnih bolnikih pogosteje poročali o samomorilnih mislih ali poskusih samomora kot pri odraslih bolnikih (2,4 % v primerjavi z 1 %) med zdravljenjem in v 6-mesečnem obdobju spremljanja bolnikov po zdravljenju.
English: 1 capsule in the morning and 2 capsules in the evening
Slovenian: 1 kapsula zjutraj in 2 kapsuli zvečer
English: Of these, sixty-three were sustained responders.
Slovenian: Triinšestdeset od teh bolnikov je imelo trajni odziv.
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Slovenian: - Nosečnost (glejte poglavja 4.4, 4.6 in 5.3).
English: Do not take Rebetol Do not take Rebetol if any of the following apply to you or the child you are caring for.
Slovenian: Ne jemljite zdravila Rebetol, če se kar koli od navedenega nanaša na vas ali otroka, za katerega skrbite.
English: Rebetol accumulates intracellularly and is cleared from the body very slowly.
Slovenian: Zdravilo Rebetol se namreč kopiči intracelularno in se iz telesa izloča zelo počasi.
English: The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy.
Slovenian: Izrazit varnostni problem pri zdravilu Rebetol je hemolitična anemija, ki se pojavi v prvih tednih zdravljenja.
English: Genotype 1 (n = 92) Genotype 2/3/4 (n = 26)
Slovenian: Genotip 1 (n = 92) Genotip 2/3/4 (n = 26)
English: See leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo.
English: Caution should be exercised when both medicines are co-administered.
Slovenian: Pri sočasni uporabi obeh zdravil je potrebna previdnost.
English: Mitochondrial toxicity
Slovenian: Mitohondrijska toksičnost
English: In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
Slovenian: V kliničnem preskušanju C/I98-580 je 1.530 predhodno nezdravljenih bolnikov leto dni prejemalo enega od naslednjih kombiniranih režimov zdravljenja:
English: All patients were to be followed for 24 weeks post-treatment.
Slovenian: Vse bolnike so spremljali še 24 tednov po zdravljenju.
English: • are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na ribavirin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: Genotype 1, 4 17 % (21/125) 6 % (8/129) 0.006 38 % (12/32) 7 % (2/27) 0.007 Genotype 2, 3 44 % (35/80) 43 % (33/76) 0.88 53 % (10/19) 47 % (7/15) 0.730
Slovenian: Genotip 1, 4 17 % (21/125) 6 % (8/129) 0,006 38 % (12/32) 7 % (2/27) 0,007 Genotip 2, 3 44 % (35/80) 43 % (33/76) 0,88 53 % (10/19) 47 % (7/15) 0,730
English: In this subgroup, there was a 92 % (89/97) sustained virological response rate.
Slovenian: V tej podskupini bolnikov je bila stopnja trajnega virološkega odziva 92 % (89/97).
English: 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.
Slovenian: Konvencionalne študije kancerogenosti pri glodalcih 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.
English: Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Slovenian: Ribavirin (zdravilo Rebetol) je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
English: 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).
Slovenian: Ribavirin se hitro absorbira po zaužitju enkratnega odmerka (srednji Tmax = 1,5 ure), čemur sledita hitra faza porazdelitve in faza podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku je 0,05, 3,73 in 79 ur).
English: Limited historical data indicate that treatment for 48 weeks might be associated with a higher sustained response rate (11/11) and with a lower risk of relapse (0/11 as compared to 7/96 following 24 weeks of treatment).
Slovenian: Majhna količina predhodnih podatkov kaže, da je lahko zdravljenje, ki traja 48 tednov, povezano z večjo stopnjo trajnega virološkega odziva (11/11) in z manjšim tveganjem za ponovitev bolezni (0/11 v primerjavi s 7/96 po 24. tednih zdravljenja).
English: Response at Treatment Week
Slovenian: Odziv v tednu zdravljenja
English: This medicine is a white, opaque, hard capsule imprinted with blue ink.
Slovenian: To zdravilo so bele, neprozorne, trde kapsule, znatisnjenim napisom z modrim črnilom.
English: Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Slovenian: Dodatno zdravljenje s samim alfa interferonom ali v kombinaciji z ribavirinom lahko namreč poveča tveganje pri tej podskupini bolnikov.
English: Women of childbearing potential/contraception in males and females
Slovenian: Ženske v rodni dobi/kontracepcija za moške in ženske
English: It is unknown whether the Rebetol that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Slovenian: Ni znano, ali ima zdravilo Rebetol iz sperme potencialne teratogene ali genotoksične učinke na človeški zarodek ali plod.
English: Predictive Value
Slovenian: Pozitivna napovedna vrednost
English: It is not known whether Rebetol is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Rebetol pri ljudeh izloča v materino mleko.
English: There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection.
Slovenian: Lahko obstajajo dodatne omejitve zdravljenja, glede na to, ali ste bili predhodno že zdravljeni zaradi kronične okužbe s hepatitisom C ali ne.
English: Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take: - azathioprine is a medicine that suppresses your immune system, using this medicine in combination with Rebetol may increase your risk of developing severe blood disorders.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali otrok, za katerega skrbite, jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati: - azatioprin je zdravilo, ki zavira delovanje vašega imunskega sistema; njegova uporaba v kombinaciji z zdravilom Rebetol lahko poveča tveganje za nastanek hudih krvnih bolezni.
English: 4 capsules Refer to adult dose recommendations
Slovenian: 4 kapsule Glejte priporočila za odmerke za odrasle
English: 2, rue Louis Pasteur 14200 Hérouville-Saint-Clair France
Slovenian: 2, rue Louis Pasteur 14200 Hérouville-Saint-Clair Francija
English: Although data on approximately 300 prospectively followed pregnancies with paternal exposure to Rebetol have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, either male patients or their female partners of childbearing age must be advised to use an effective contraceptive during treatment with Rebetol and for seven months after treatment.
Slovenian: Čeprav podatki o približno 300 prospektivno spremljanih nosečnostih z izpostavljenostjo očeta zdravilu Rebetol niso pokazali ne povečanega tveganja za pojav malformacij v primerjavi s splošno populacijo, ne specifičnega vzorca malformacij, morate moškim bolnikom ali njihovim partnerkam v rodni dobi svetovati, naj med zdravljenjem z zdravilom Rebetol in še sedem mesecev po koncu zdravljenja uporabljajo učinkovito kontracepcijo.
English: Name and address of the manufacturer responsible for batch release for the hard capsules
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij za trde kapsule
English: For children or adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available.
Slovenian: Za otroke in mladostnike, ki ne morejo pogoltniti trde kapsule, je na voljo peroralna raztopina tega zdravila.
English: For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Slovenian: Za pediatrične bolnike (otroke in mladostnike), ki tehtajo manj kot 47 kg, je na voljo peroralna raztopina.
English: Men whose partners are pregnant must be instructed to use a condom to minimise delivery of Rebetol to the partner.
Slovenian: Moškim z nosečo partnerko naročite, naj uporabljajo kondom, da se čim bolj zmanjša prehajanje zdravila Rebetol v partnerko.
English: b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
Slovenian: b: n = število preiskovancev, ki so se odzvali na zdravljenje, in število preiskovancev z danim genotipom virusa ter določena dolžina zdravljenja.
English: There does not appear to be a significant age-related effect on the pharmacokinetics of Rebetol.
Slovenian: Ni videti, da bi starost pomembno vplivala na farmakokinetiko zdravila Rebetol.
English: Measured Dose (Morning / Evening) 2 mL / 2 mL
Slovenian: Izmerjeni odmerek (zjutraj / zvečer) 2 ml / 2 ml
English: White, opaque and imprinted with blue ink.
Slovenian: bele, neprozorne in z natisnjenim napisom z modrim črnilom
English: The overall sustained response rate after a 24-week treatment duration was 50 %.
Slovenian: Skupna stopnja trajnega virološkega odziva po 24-tedenskem zdravljenju je bila 50 %.
English: Adult:  12 g/dL (females);  13 g/dL (males) Children and adolescents:  11 g/dL (females);  12 g/dL (males)
Slovenian: Odrasli:  12 g/dl (ženske);  13 g/dl (moški) Otroci in mladostniki:  11 g/dl (ženske);  12 g/dl (moški)
English: These include: - Severe psychiatric and central nervous system effects (such as depression, suicidal ideation,
Slovenian: Med njimi so: - hudi psihiatrični učinki in učinki na osrednje živčevje (kot so depresija, samomorilne misli,
English: These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Slovenian: Za navedene časovne točke (4. teden zdravljenja in 12. teden zdravljenja) so pokazali, da napovedujejo trajni virološki odziv (preglednica 10).
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Slovenian: Med 480 bolniki z zmanjšanjem količine virusa za > 2 log vrednosti, vendar še vedno z merljivo količino virusa v krvi v 12. tednu zdravljenja, je z zdravljenjem nadaljevalo skupaj 188 bolnikov.
English: If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped.
Slovenian: Če vaša partnerka trenutno ni noseča, a je v rodni dobi, mora opraviti test nosečnosti vsak mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
English: Prior to initiation of treatment with Rebetol the physician must comprehensively inform both male and female patients of the teratogenic risk of Rebetol, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with Rebetol (see section 4.6).
Slovenian: Pred uvedbo zdravljenja z zdravilom Rebetol mora zdravnik bolnike in bolnice izčrpno seznaniti s teratogenim tveganjem zdravila Rebetol, potrebo po učinkoviti in stalni kontracepciji, možnostjo za neuspešnost kontracepcije ter možnimi posledicami nosečnosti, če se ta pojavi med zdravljenjem ali po zdravljenju z zdravilom Rebetol (glejte poglavje 4.6).
English: *AUC12 (ng.hr/mL) for Rebetol; AUC0-24 (IU.hr/mL) for interferon alfa-2b
Slovenian: *AUC12 (ng.h/ml) za zdravilo Rebetol; AUC0-24 (i.e. h/ml) za interferon alfa-2b
English: Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
Slovenian: Bolniki, ki so imeli negativen izvid na HCV-RNA v 12. tednu zdravljenja, pa so nadaljevali z zdravljenjem še 48 tednov, po zdravljenju pa so jih spremljali še 24 tednov.
English: Preclinical data - Fertility: In animal studies, Rebetol produced reversible effects on spermatogenesis (see section 5.3).
Slovenian: Predklinični podatki - Plodnost: V študijah na živalih je zdravilo Rebetol povzročilo reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
English: Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Slovenian: Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo zdravljenja z zdravilom Rebetol pri otrocih in mladostnikih:
English: Rebetol should be administered orally with food.
Slovenian: Zdravilo Rebetol je treba uporabljati peroralno s hrano.
English: Rebetol dose (mg/kg)
Slovenian: Odmerek zdravila Rebetol (mg/kg)
English: Rebetol must be used in combination with other medicinal products (see section 5.1).
Slovenian: Zdravilo Rebetol je treba uporabljati v kombinaciji z drugimi zdravili (glejte poglavje 5.1).
English: 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.
Slovenian: Prehajanje ribavirina v neplazemskih prostorih so najobsežneje proučevali na eritrocitih in ugotovili, da poteka predvsem preko ekvilibracijskega nukleozidnega prenašalca tipa es.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Slovenian: Tako kot odrasli bolniki so tudi otroci in mladostniki imeli še druge psihiatrične neželene učinke (npr. depresijo, čustveno labilnost in zaspanost) (glejte poglavje 4.4).
English: This Package Leaflet contains information for the paediatric patient (child or adolescent, 3 through 17 years of age), or for his or her parent or caregiver.
Slovenian: To navodilo za uporabo vsebuje informacije za pediatrične bolnike (otroke in mladostnike v starosti od 3 do 17 let ) oziroma za njihove starše ali skrbnike.
English: The mechanism by which Rebetol in combination with other medicinal products exerts its effects against HCV is unknown.
Slovenian: Mehanizem delovanja, preko katerega zdravilo Rebetol v kombinaciji z drugimi zdravili deluje proti HCV, ni znan.
English: The majority of adverse reactions reported in the study were mild or moderate in severity.
Slovenian: Neželeni učinki o katerih so poročali v tej študiji, so bili po jakosti večinoma blagi ali zmerni.
English: If you take more Rebetol than you should Tell your doctor or pharmacist as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Rebetol, kot bi smeli Čimprej obvestite zdravnika ali farmacevta.
English: Treatment with Rebetol in combination with peginterferon alfa-2b was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Slovenian: Zdravljenje z zdravilom Rebetol v kombinaciji s peginterferonom alfa-2b je bilo povezano z zmanjšanjem absolutnega števila celic CD4+ v prvih 4 tednih, brez zmanjšanja odstotka celic CD4+.
English: In clinical studies performed in this population, Rebetol was used in doses of 15 mg/kg/day (Table 1).
Slovenian: V kliničnih preskušanjih pri tej populaciji bolnikov se je zdravilo Rebetol uporabljalo v odmerku 15 mg/kg na dan (preglednica 1).
English: Rebetol does not inhibit cytochrome P450 enzymes.
Slovenian: Zdravilo Rebetol ne zavira encimov citokroma P450.
English: Rebetol oral solution is administered orally in two divided doses (morning and evening) with food.
Slovenian: Rebetol peroralna raztopina se uporablja peroralno v dveh deljenih odmerkih (zjutraj in zvečer) s hrano.
English: Pharmacotherapeutic group: antivirals for systemic use, antivirals for treatment of HCV infections, ATC code: J05AP01.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje virusnih infekcij, zdravila za zdravljenje infekcij z virusom hepatitisa C, oznaka ATC: J05AP01.
English: Dose modification for adults
Slovenian: Prilagoditev odmerka pri odraslih
English: Rebetol in combination with Direct Antiviral Agent (DAA):
Slovenian: Zdravilo Rebetol v kombinaciji z neposredno delujočimi protivirusnimi zdravili (DAA - direct antiviral agent)):
English: Sustained Response
Slovenian: Trajni odziv
English: Use in children and adolescents If the child is weighing less than 47 kg or unable to swallow an oral solution of Rebetol is available.
Slovenian: Uporaba pri otrocih in mladostnikih Če otrok tehta manj kot 47 kg ali ne more požirati, je na voljo peroralna raztopina zdravila Rebetol.
English: 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).
Slovenian: 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).
English: Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Rebetol.
Slovenian: Zato je priporočljivo pred uvedbo zdravila Rebetol pri vseh bolnikih ovrednotiti delovanje ledvic.
English: If you are not sure, talk to your doctor or pharmacist before taking Rebetol.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Rebetol.
English: C. Pull the rod out until you can read the correct number of mL for the dose you are measuring.
Slovenian: C. Bat izvlecite toliko, da boste lahko prebrali pravilno število mililitrov za odmerek, ki ga želite dati bolniku.
English: This medicine is available in different pack sizes containing 84, 112, 140 or 168 capsules of 200 mg to be swallowed.
Slovenian: To zdravilo je na voljo v različnih velikostih pakiranja, ki vsebujejo 84, 112, 140 ali 168kapsul po 200mg, za peroralno uporabo.
English: Excipients with known effect Rebetol contains 142 mg of sorbitol and 300 mg of sucrose per mL.
Slovenian: Pomožne snovi z znanim učinkom Zdravilo Rebetol vsebuje 142 mg sorbitola in 300 mg saharoze na ml.
English: Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
Slovenian: zaradi možnosti pojava laktacidoze (kopičenja mlečne kisline v telesu) in pankreatitisa, uporaba ribavirina z didanozinom ni priporočljiva, uporabi ribavirina in stavudina pa se je treba izogibati.
English: Rebetol must be used in combination therapy as described in section 4.1.
Slovenian: Zdravilo Rebetol je treba uporabljati v kombinaciji z drugimi zdravili, kot je opisano v poglavju 4.1.
English: Do not chew the hard capsules.
Slovenian: Trdih kapsul ne smete žvečiti.
English: Because of the potential for adverse reactions in breast-fed infants, breast-feeding must be discontinued prior to initiation of treatment.
Slovenian: Zaradi možnosti za pojav neželenih učinkov pri dojenih otrocih je treba dojenje ukiniti pred pričetkom zdravljenja.
English: However, in a population pharmacokinetic study, age was not a key factor in the kinetics of ribavirin; renal function is the determining factor.
Slovenian: Specifičnih farmakokinetičnih raziskav pri starostnikih niso opravljali, vendar v populacijski farmakokinetični raziskavi starost ni bila ključni dejavnik kinetike ribavirina; odločilni dejavnik je delovanje ledvic.
English: Patients whose dose of Rebetol is reduced to 600 mg daily receive one 200 mg capsule in the morning and two 200 mg capsules in the evening.
Slovenian: Bolniki, katerih odmerek zdravila Rebetol je zmanjšan na 600 mg na dan, naj prejmejo po eno 200 mg kapsulo zjutraj in dve 200 mg kapsuli zvečer.
English: Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “Laboratory tests” and section 4.8).
Slovenian: Čeprav bi lahko pri večini teh bolnikov zmanjšali odmerek, je pri tej skupini bolnikov potrebno skrbno spremljanje hematoloških parametrov (glejte poglavje 4.2, "Laboratorijske preiskave" v nadaljevanju in poglavje 4.8).