natgillin/translations-raw huggingface dataset:
Hexacima is given by deep injection into a muscle, normally in the upper thigh or the shoulder.
Cepivo Hexacima se daje običajno z injekcijo globoko v stegensko ali ramensko mišico.
Hexacima is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, the hepatitis B virus, and inactivated polioviruses.
Zdravilo Hexacima je cepivo, ki vsebuje zdravilne učinkovine, pridobljene iz bakterij davice, tetanusa, oslovskega kašlja in Haemophilus influenzae tipa b, virusa hepatitisa B in neaktiviranih poliovirusov.
The CHMP noted that Hexacima has been shown to produce protective antibody levels against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b infections in children between six weeks and two years of age regardless of ethnicity.
Ugotovil je, da je bilo dokazano, da cepivo Hexacima ustvari zaščitne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, virusu hepatitisa B, otroški paralizi in okužbam, ki jih povzročajo bakterije H. influenzae tipa b pri otrocih, starih od šest mesecev do dveh let, ne glede na njihovo etnično pripadnost.
The immune system will then be able to produce antibodies quickly when the person is naturally exposed to the bacteria or viruses.
Posledično bo imunski sistem ob ponovni izpostavitvi bakterijam ali virusom sposoben hitro tvoriti protitelesa.
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Hexacima konjugirano (adsorbirano) cepivo proti davici, tetanusu, oslovskemu kašlju (acelularno, komponentno), hepatitisu B (rDNK), otroški paralizi (inaktivirano) in bakteriji Haemophilus influenzae tipa b
How does Hexacima work?
Kako zdravilo Hexacima deluje?
How is Hexacima used?
Kako se zdravilo Hexacima uporablja?
A subsequent study involving 455 children looked at the longer-term persistence of protective antibodies up to 3 years after a booster dose with Hexacima, and another study in 1,336 children evaluated the response to different lots of the vaccine and what happened when it was given with vaccines for infections caused by the bacterium Streptococcus pneumoniae (Prevenar) and rotavirus (Rotarix).
V drugi študiji so pri 1 336 otrocih proučevali odziv na različne skupine cepiv in kaj se zgodi, če se cepivo daje sočasno s cepivi za okužbe, ki jih povzročata bakterija Streptococcus pneumoniae (Prevenar) in rotavirus (Rotarix).
In the study, children who received Hexacima produced a similar antibody response to those who received a comparator vaccine (Infanrix hexa), when given as a two-dose schedule followed by a booster 6 months later.
Študija je pokazala, da so se pri otrocih, ki so prejeli cepivo Hexacima v dveh odmerkih, ki mu je čez šest mesecev sledil obnovitveni odmerek, ustvarile primerljive ravni protiteles, kot pri tistih, ki so prejeli primerjalno cepivo (Infanrix hexa).
• pertussis (whooping cough);
• oslovskemu kašlju;
1 morning, 2 evening 2 morning, 2 evening
1 zjutraj, 2 zvečer 2 zjutraj, 2 zvečer
Overall Population*
Celotna populacija*
This should be discussed with your doctor.
O tem se pogovorite z zdravnikom.
In those patients the SVR was 12 %.
Pri teh bolnikih je vrednost SVR znašala 12 %.
Male patients and their female partners
Moški bolniki in njihove partnerke
Overall Response a (n = 118)
Skupni odziv a (n = 118)
3 years After first opening: the medicinal product should be used within one month.
3 leta Po prvem odprtju: Zdravilo porabite v roku enega meseca.
If you have too much or too little, try again until you have the correct amount.
Če imate v brizgi preveč ali premalo raztopine, poskusite ponovno, dokler ne boste imeli pravilne količine raztopine.
Date of first authorisation: 25 January 2005 Date of latest renewal: 23 April 2009
Datum prve odobritve: 25. januar 2005 Datum zadnjega podaljšanja: 23. april 2009
This medicine can be very damaging to your unborn baby (embryo).
To zdravilo je lahko zelo škodljivo za nerojenega otroka (plod).
Date of first authorisation: 07 May 1999 Date of latest renewal: 23 April 2009
Datum prve odobritve: 07. maj 1999 Datum zadnjega podaljšanja: 23. april 2009
• had a serious heart problem during the past 6 months.
• če ste imeli resne težave s srcem v zadnjih 6 mesecih,
Response week 12 % (n/N)
Odziv v 12. tednu % (n/N)
This should be discussed with your doctor (see section “Do not take Rebetol”).
O tem se pogovorite z zdravnikom (glejte poglavje "Ne jemljite zdravila Rebetol").
If you are pregnant, you must not take this medicine.
Če ste noseči, ne smete jemati tega zdravila.
A patient may be missing or have had a different result for week 4 or week 12.
Možno je, da manjka en bolnik oziroma da je imel v 4. tednu in v 12. tednu različna rezultata.
If the syringe has touched the inside of the mouth, rinse it with water before inserting it in the bottle again.
Če se brizga vseeno dotakne notranjosti ust, brizgo sperite z vodo, preden jo boste spet vstavili v stekleničko.
Paediatric population No data are available in children below 3 years of age.
Pediatrična populacija Podatkov pri otrocih, mlajših od 3 let, ni na voljo.
The use of Rebetol is contraindicated during pregnancy.
Uporaba zdravila Rebetol je kontraindicirana med nosečnostjo.
Talk to your doctor if you or the child you are caring for:
Zdravniku povejte, če ste vi ali otrok, za katerega skrbite:
If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Če se poslabša, se bo zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Rebetol ali ne.
Reduce Rebetol dose* if:
Odmerek zdravila Rebetol zmanjšajte*, če:
What Rebetol is and what it is used for
Kaj je zdravilo Rebetol in za kaj ga uporabljamo
Long-term efficacy data - Adults
Dolgoročni podatki o učinkovitosti - Odrasli bolniki
Elderly patients ( 65 years of age)
Starejši bolniki ( 65 let starosti)
In all three treatment groups, sustained virologic response rates were similar.
V vseh treh terapevtskih skupinah so bile pogostnosti trajnega virološkega odziva podobne.
Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Štiriindevetdeset od 107 otrok je bilo vključenih v 5-letno dolgoročno spremljevalno preskušanje.
Although not all of these unwanted effects may occur, they may need medical attention if they do occur.
Čeprav ni nujno, da se bodo pojavili vsi ti neželeni učinki, če pa se, boste morda potrebovali zdravniško pomoč.
If an entire day has gone by, check with your doctor.
Če je minil že ves dan, se posvetujte z zdravnikom.
Once the bottle has been opened, the oral solution can be used for 1 month.
Po odprtju stekleničke lahko peroralno raztopino uporabljate 1 mesec.
The side effect profile was also similar at the lower incidences.
Profil neželenih učinkov je bil podoben tudi pri nižjih pojavnostih.
Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines.
Odvisno od genotipa virusa hepatitisa C, ki ga imate, bo zdravnik morda izbral zdravljenje s kombinacijo tega zdravila z drugimi zdravili.
Caucasian patients had a higher sustained virologic response rate compared to the African Americans.
Kavkazijci so imeli večje pogostnosti trajnega virološkega odziva kot Afroameričani.
- Depending upon the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are caring for take, prescribe a different pack size of this medicine, and/or change the length of time to take this treatment.
- Glede na izvide teh preiskav bo zdravnik lahko spremenil/prilagodil število trdih kapsul, ki jih vi ali otrok, za katerega skrbite, jemljete, in vam predpisal drugo velikost pakiranja tega zdravila in/ali spremenil dolžino zdravljenja.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can also help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
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:
Tako bolnice kot bolniki morajo biti posebno previdni pri spolnih odnosih, če obstaja kakršna koli možnost za zanositev: - Dekle ali ženska v rodni dobi:
Rebetol capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC).
Rebetol kapsule so pakirane v pretisne omote iz polivinilklorida (PVC)/polietilena (PE)/polivinilidenklorida (PVdC).
Hard capsule (capsule)
trda kapsula (kapsula)
SVR % (n/N) 99 % CI
SVR % (n/N) 99 % IZ
In this subgroup, there was a 56 % (463/823) sustained virological response rate.
V tej podskupini je bila stopnja trajnega virološkega odziva 56 % (463/823).
If you forget to take Rebetol
Če ste pozabili vzeti zdravilo Rebetol
Your doctor will recommend the best course of therapy.
Zdravnik bo predlagal optimalno zdravljenje.
What you need to know before you use Rebetol
Kaj morate vedeti, preden boste uporabili zdravilo Rebetol
The syringe should be rinsed with water after each use to avoid stickiness.
Brizgo sperite z vodo po vsaki uporabi, da ne postane lepljiva.
Reminder: Your doctor may have changed the amount based on recent test results.
Opozorilo: Zdravnik vam bo lahko spremenil količino glede na zadnje izvide.
Growth rate decrease (height and/or weight decrease for age)
zmanjšana rast (zmanjšana telesna višina in/ali telesna masa glede na starost)
METAVIR Fibrosis score F2
METAVIR Ocena fibroze F2
Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.
Prosimo, glejte navodilo za uporabo (peg)interferona alfa za podrobnejše informacije o teh varnostnih vprašanjih.
D. Take the oral syringe out of the bottle and check to see that the correct amount appears in the bottom of the syringe.
D. Brizgo za peroralno odmerjanje vzemite iz stekleničke in preverite, ali na dnu brizge vidite pravilno količino raztopine.
Each capsule contains a small amount of lactose.
Vsaka kapsula vsebuje majhno količino laktoze.
Ribavirin plus interferon
Ribavirin in interferon
Twenty-four % had bridging fibrosis or cirrhosis (Knodell 3/4).
24 % bolnikov je imelo mostno fibrozo ali cirozo (Knodell 3/4).
No sustained Response
Ni trajnega odziva
Try not to let the oral syringe touch the inside of the mouth.
Pazite, da se s peroralno brizgo ne boste dotaknili notranjosti ust.
Take/administer the missed dose as soon as possible during the same day.
Vzemite/dajte pozabljeni odmerek čimprej še isti dan.
(%)) in previously untreated children and adolescents by genotype and treatment duration -All subjects n = 107
(%)) pri predhodno nezdravljenih otrocih in mladostnikih po genotipu in dolžini zdravljenja - vsi preiskovanci n = 107
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.
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.
1 capsule in the morning and 2 capsules in the evening
1 kapsula zjutraj in 2 kapsuli zvečer
Of these, sixty-three were sustained responders.
Triinšestdeset od teh bolnikov je imelo trajni odziv.
- Pregnancy (see sections 4.4, 4.6 and 5.3).
- Nosečnost (glejte poglavja 4.4, 4.6 in 5.3).
Do not take Rebetol Do not take Rebetol if any of the following apply to you or the child you are caring for.
Ne jemljite zdravila Rebetol, če se kar koli od navedenega nanaša na vas ali otroka, za katerega skrbite.
Rebetol accumulates intracellularly and is cleared from the body very slowly.
Zdravilo Rebetol se namreč kopiči intracelularno in se iz telesa izloča zelo počasi.
The salient safety issue of Rebetol is haemolytic anaemia occurring within the first weeks of therapy.
Izrazit varnostni problem pri zdravilu Rebetol je hemolitična anemija, ki se pojavi v prvih tednih zdravljenja.
See leaflet for further information.
Za dodatne informacije glejte navodilo.
Caution should be exercised when both medicines are co-administered.
Pri sočasni uporabi obeh zdravil je potrebna previdnost.
In clinical trial C/I98-580, 1,530 naïve patients were treated for one year with one of the following combination regimens:
V kliničnem preskušanju C/I98-580 je 1.530 predhodno nezdravljenih bolnikov leto dni prejemalo enega od naslednjih kombiniranih režimov zdravljenja:
All patients were to be followed for 24 weeks post-treatment.
Vse bolnike so spremljali še 24 tednov po zdravljenju.
• are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na ribavirin ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
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
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
In this subgroup, there was a 92 % (89/97) sustained virological response rate.
V tej podskupini bolnikov je bila stopnja trajnega virološkega odziva 92 % (89/97).
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 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.
Ribavirin (Rebetol) is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Ribavirin (zdravilo Rebetol) je sintetični nukleozidni analog, ki je pokazal aktivnost proti nekaterim RNA in DNA virusom in vitro.
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 faza podaljšanega izločanja (razpolovna doba absorpcije, porazdelitve in izločanja po enkratnem odmerku je 0,05, 3,73 in 79 ur).
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).
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).
Response at Treatment Week
Odziv v tednu zdravljenja
This medicine is a white, opaque, hard capsule imprinted with blue ink.
To zdravilo so bele, neprozorne, trde kapsule, znatisnjenim napisom z modrim črnilom.
Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Dodatno zdravljenje s samim alfa interferonom ali v kombinaciji z ribavirinom lahko namreč poveča tveganje pri tej podskupini bolnikov.
Women of childbearing potential/contraception in males and females
Ženske v rodni dobi/kontracepcija za moške in ženske
It is unknown whether the Rebetol that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Ni znano, ali ima zdravilo Rebetol iz sperme potencialne teratogene ali genotoksične učinke na človeški zarodek ali plod.
Predictive Value
Pozitivna napovedna vrednost
It is not known whether Rebetol is excreted in human milk.
Ni znano, ali se zdravilo Rebetol pri ljudeh izloča v materino mleko.
There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection.
Lahko obstajajo dodatne omejitve zdravljenja, glede na to, ali ste bili predhodno že zdravljeni zaradi kronične okužbe s hepatitisom C ali ne.
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.
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.
4 capsules Refer to adult dose recommendations
4 kapsule Glejte priporočila za odmerke za odrasle
2, rue Louis Pasteur 14200 Hérouville-Saint-Clair France
2, rue Louis Pasteur 14200 Hérouville-Saint-Clair Francija
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.
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.
Name and address of the manufacturer responsible for batch release for the hard capsules
Ime in naslov izdelovalca, odgovornega za sproščanje serij za trde kapsule
For children or adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available.
Za otroke in mladostnike, ki ne morejo pogoltniti trde kapsule, je na voljo peroralna raztopina tega zdravila.
For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available.
Za pediatrične bolnike (otroke in mladostnike), ki tehtajo manj kot 47 kg, je na voljo peroralna raztopina.
Men whose partners are pregnant must be instructed to use a condom to minimise delivery of Rebetol to the partner.
Moškim z nosečo partnerko naročite, naj uporabljajo kondom, da se čim bolj zmanjša prehajanje zdravila Rebetol v partnerko.
b: n = number of responders/number of subjects with given genotype, and assigned treatment duration.
b: n = število preiskovancev, ki so se odzvali na zdravljenje, in število preiskovancev z danim genotipom virusa ter določena dolžina zdravljenja.
There does not appear to be a significant age-related effect on the pharmacokinetics of Rebetol.
Ni videti, da bi starost pomembno vplivala na farmakokinetiko zdravila Rebetol.
Measured Dose (Morning / Evening) 2 mL / 2 mL
Izmerjeni odmerek (zjutraj / zvečer) 2 ml / 2 ml
White, opaque and imprinted with blue ink.
bele, neprozorne in z natisnjenim napisom z modrim črnilom
The overall sustained response rate after a 24-week treatment duration was 50 %.
Skupna stopnja trajnega virološkega odziva po 24-tedenskem zdravljenju je bila 50 %.
Adult:  12 g/dL (females);  13 g/dL (males) Children and adolescents:  11 g/dL (females);  12 g/dL (males)
Odrasli:  12 g/dl (ženske);  13 g/dl (moški) Otroci in mladostniki:  11 g/dl (ženske);  12 g/dl (moški)
These include: - Severe psychiatric and central nervous system effects (such as depression, suicidal ideation,
Med njimi so: - hudi psihiatrični učinki in učinki na osrednje živčevje (kot so depresija, samomorilne misli,
These time points (treatment week 4 and treatment week 12) have been shown to be predictive for sustained response (Table 10).
Za navedene časovne točke (4. teden zdravljenja in 12. teden zdravljenja) so pokazali, da napovedujejo trajni virološki odziv (preglednica 10).
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 vrednosti, vendar še vedno z merljivo količino virusa v krvi v 12. tednu zdravljenja, je z zdravljenjem nadaljevalo skupaj 188 bolnikov.
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.
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.
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).
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).
*AUC12 (ng.hr/mL) for Rebetol; AUC0-24 (IU.hr/mL) for interferon alfa-2b
*AUC12 (ng.h/ml) za zdravilo Rebetol; AUC0-24 (i.e. h/ml) za interferon alfa-2b
Patients who were HCV-RNA negative at Treatment week 12 continued treatment for 48 weeks and were followed for 24 weeks post-treatment.
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.
Preclinical data - Fertility: In animal studies, Rebetol produced reversible effects on spermatogenesis (see section 5.3).
Predklinični podatki - Plodnost: V študijah na živalih je zdravilo Rebetol povzročilo reverzibilne učinke na spermatogenezo (glejte poglavje 5.3).
Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy in children and adolescents:
Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo zdravljenja z zdravilom Rebetol pri otrocih in mladostnikih:
Rebetol should be administered orally with food.
Zdravilo Rebetol je treba uporabljati peroralno s hrano.
Rebetol dose (mg/kg)
Odmerek zdravila Rebetol (mg/kg)
Rebetol must be used in combination with other medicinal products (see section 5.1).
Zdravilo Rebetol je treba uporabljati v kombinaciji z drugimi zdravili (glejte poglavje 5.1).
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.
Prehajanje ribavirina v neplazemskih prostorih so najobsežneje proučevali na eritrocitih in ugotovili, da poteka predvsem preko ekvilibracijskega nukleozidnega prenašalca tipa es.
As in adult patients, children and adolescents also experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence) (see section 4.4).
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).