FrancophonIA/ELRC3.0 huggingface dataset:
English: o Information provided regarding - In all cases where further investigation of change in neurological status or change in brain MRI is indicated, TYSABRI must be suspended and not restarted until non MS pathology has been confidently excluded.
Slovenian: o Zagotovitev informacij - V vseh primerih, kjer je indicirano slikanje z magnetno resonanco za nadaljnje preiskave sprememb nevrološkega statusa ali sprememb v možganih, je treba zdravljenje z zdravilom TYSABRI prekiniti in se ga ne sme ponovno uvesti do prepričljive izključitve patologije MS. Ne pričakuje se, da bi kratkotrajna prekinitev zdravljenja z zdravilom TYSABRI (nekaj dni ali tednov) ogrozila terapevtsko učinkovitost, ki temelji na farmakodinamiki zdravila.
English: Common side effects that may affect up to 1 in 10 people:
Slovenian: Pogosti neželeni učinki, ki lahko prizadenejo največ 1 od 10 bolnikov:
English: o Description of PML and incidence.
Slovenian: o Opis in incidenca PML.
English: In anti-JCV antibody positive patients, extended interval dosing of TYSABRI (average dosing interval of approximately 6 weeks) is suggested to be associated with a lower PML risk compared to approved dosing.
Slovenian: Pri bolnikih, ki so pozitivni na protitelesa proti JCV, se predvideva, da je podaljšan interval odmerjanja zdravila TYSABRI (povprečni interval odmerjanja je bil približno 6 tednov) povezan s klinično pomembnim in statistično značilnim nižjim tveganjem za PML v primerjavi z odobrenim odmerjanjem.
English: Genesis Pharma SA Τηλ: +30 210 8771500
Slovenian: Τηλ: +30 210 8771500
English: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Slovenian: natrijev dihidrogenfosfat monohidrat; natrijev hidrogenfosfat heptahidrat; natrijev klorid; polisorbat 80 (E433); voda za injekcije
English: o A stratification of the risk of developing PML based on the identified risk factors and presentation of the PML risk in a given time interval of treatment as well as the cumulative PML risk o PML risk estimates algorithm summarizes PML risk by anti- John Cunningham virus (JCV) antibody status, prior IS use and duration of treatment (by year of treatment) and stratifies this risk by index value when applicable.
Slovenian: o Algoritem za oceno tveganja za razvoj PML povzema tveganja za PML na podlagi statusa protiteles proti virusu John Cunningham (JCV), predhodne uporabe imunosupresivov (IS) in trajanja zdravljenja (v letih zdravljenja) ter razvršča tveganje glede na vrednost indeksa, če se uporablja.
English: For further information, refer to the Physician Information and Management Guidelines.
Slovenian: Za nadaljnje informacije glejte Informacije za zdravnike in smernice za zdravljenje bolezni.
English: • Reminder no to take any other long-term medicines for MS while receiving Tysabri
Slovenian: • Opomnik, da med prejemanjem zdravila Tysabri ni dovoljeno jemati drugih zdravil za dolgotrajno zdravljenje MS.
English: • You may not be able to use TYSABRI if you are currently receiving or have previously received medicines that affect your immune system
Slovenian: • Če trenutno jemljete ali ste predhodno prejemali zdravila, ki vplivajo na imunski sistem, morda ne boste mogli uporabljati zdravila TYSABRI.
English: The treatment discontinuation form • Inform patient that PML has been reported up to 6 months after stopping Tysabri
Slovenian: • Seznanitev bolnika, da so o PML poročali še do šest mesecev po prekinitvi zdravljenja z zdravilom Tysabri.
English: Patients who have experienced a hypersensitivity reaction must be permanently discontinued from treatment with TYSABRI.
Slovenian: Pri bolnikih, ki so doživeli preobčutljivostno reakcijo, je treba zdravljenje z zdravilom TYSABRI
English: The pharmacokinetics of natalizumab in paediatric MS patients has not been established.
Slovenian: Farmakokinetika natalizumaba pri otrocih, obolelih za MS, ni bila ugotovljena.
English: EDSS-baseline, median (range)
Slovenian: Izhodišče na EDSS, mediana
English: o TYSABRI increases the risk of developing encephalitis, meningitis and acute retinal necrosis (ARN) caused by herpes simplex and varicella zoster viruses o Guidance on screening for ARN.
Slovenian: o Zdravilo TYSABRI poveča tveganje za razvoj encefalitisa, meningitisa in akutne retinalne nekroze (ARN), ki jih povzročata virusa herpes simplex in varicella zoster.
English: In studies conducted in mice, growth and metastasis of melanoma and lymphoblastic leukaemia tumour cells was not increased by the administration of natalizumab.
Slovenian: Pri študijah na miših dajanje natalizumaba ni vplivalo na rast in zasevke celic tumorja melanoma in limfoblastne levkemije.
English: Immunosuppressant treatment prior to the use of TYSABRI
Slovenian: zdravljenje z imunosupresivi pred začetkom uporabe zdravila TYSABRI.
English: Relapse rate derived variables / MRI-derived variables
Slovenian: Napredovanje po EDSS Sekundarni opazovani dogodki Iz stopnje recidivov izpeljane spremenljivke/iz MRT-izpeljane spremenljivke
English: o If treatment is to be continued for longer than 24 months, the need to inform patients about the increased risk of PML and provide them with a copy of the treatment continuation form o Description of Immune Reconstitution Inflammatory Syndrome (IRIS) is provided
Slovenian: o Če bo zdravljenje trajalo več kot 24 mesecev, je treba bolnike seznaniti s povečanim tveganjem za PML in jim zagotoviti kopijo obrazca za nadaljevanje zdravljenja.
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Slovenian: Razmerje stopnje 0,33 IZ95 % 0,26; 0,41
English: Cases of JCV GCN have also been reported during postmarketing use of TYSABRI.
Slovenian: V obdobju trženja zdravila TYSABRI so poročali tudi o primerih JCV GCN.
English: Concurrent treatment with immunosuppressants
Slovenian: Sočasno zdravljenje z imunosupresivi
English: In post marketing experience, serious, life-threatening, and sometimes fatal cases of encephalitis and meningitis caused by herpes simplex or varicella zoster have been reported in multiple sclerosis patients receiving TYSABRI.
Slovenian: V izkušnjah v obdobju trženja zdravila so pri bolnikih z multiplo sklerozo, zdravljenih z zdravilom TYSABRI, poročali o resnih, življenjsko nevarnih in včasih smrtnih primerih encefalitisa in meningitisa, ki ju povzročajo virusi herpes simplex ali virusi varicella zoster.
English: • Summary of Product Characteristics and Package Leaflet
Slovenian: • Povzetek glavnih značilnosti zdravila in Navodilo za uporabo
English: The active substance is natalizumab.
Slovenian: Učinkovina je natalizumab.
English: − differentiation between PML and MS
Slovenian: − diferenciacija PML in multiple skleroze,
English: During extended pre-registration trials, two cases of PML were reported in MS patients and a full safety evaluation revealed one further case in a clinical trial patient with Crohn's Disease.
Slovenian: Razprava o PML pri bolnikih, ki so se zdravili z zdravilom TYSABRI V podaljšanih preskušanjih pred pridobitvijo dovoljenja za promet z zdravilom so poročali o dveh primerih PML pri bolnikih z MS, popolna ocena varnosti pa je razkrila še en primer pri bolniku s
English: Patients with a treatment history of immunosuppressant medications are at increased risk for PML.
Slovenian: Predhodno zdravljenje z imunosupresivnimi ali imunomodulatornimi terapijami Pri bolnikih, ki so v preteklosti jemali imunosupresive, je tveganje za PML večje.
English: Therefore, following PLEX or IA, periodic clinical monitoring of patients, including MRI monitoring, may be useful for the early detection of IRIS.
Slovenian: PLEX ali IA, bo zato morda koristno redno klinično spremljanje bolnikov, vključno s slikanjem z magnetno resonanco.
English: • Reminder to show the card to any doctor involved with their treatment
Slovenian: Opozorilna kartica za bolnika • Navodilo, da je treba kartico pokazati vsem zdravnikom, ki so vključeni v zdravljenje.
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: • 15 ml koncentrata za raztopino za infundiranje dodajte 100 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
English: Within 3 months prior to starting TYSABRI Annually during treatment with TYSABRI More frequent MRIs (e.g. on a 3 to 6 monthly basis) for patients at high risk for PML.
Slovenian: enkrat letno med zdravljenjem z zdravilom TYSABRI, pogostejša MRS (npr. vsake 3 do 6 mesecev) za bolnike z velikim tveganjem za PML, ob prvih znakih kakršnih koli simptomov, ki kažejo na možnost pojava PML.
English: Diluted solution:
Slovenian: Razredčena raztopina:
English: Some cases have occurred in patients with central nervous system (CNS) herpes infections (e.g. herpes meningitis and encephalitis).
Slovenian: Nekateri primeri so se pojavili pri bolnikih z okužbami osrednjega živčnega sistema s herpesom
English: Diluted solution After dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, immediate use is recommended.
Slovenian: Priporoča se, da z natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje razredčeno raztopino takoj uporabite.
English: • Patients with a high anti-JCV antibody index who have received more than 2 years of
Slovenian: • Bolnike z visokim indeksom protiteles proti JCV, ki so se z zdravilom TYSABRI
English: The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Slovenian: Neželeni učinki so navedeni z izrazi, ki jih priporoča MedDRA, in glede na MedDRA organske sisteme.
English: • Reminder of the approved dosing; cross reference to EU SmPC
Slovenian: Informacije o podaljšanem intervalu odmerjanja (PIO) • Opomnik glede odobrenega odmerka; navzkrižno sklicevanje na EU povzetek glavnih značilnosti zdravila.
English: Persistent anti-natalizumab antibodies (one positive test reproducible on retesting at least
Slovenian: Pri približno 6 % bolnikov so se razvila obstojna proti-natalizumabna protitelesa (en pozitivni test, potrjen pri ponovnem testiranju vsaj 6 tednov kasneje).
English: Serious adverse events were evaluated in 621 MS paediatric patients included in a meta-analysis (see also Section 5.1).
Slovenian: Pediatrična populacija Pri 621 pediatričnih bolnikih z MS, vključenih v metaanalizo, so ocenjevali resne neželene učinke
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Slovenian: Biogen Netherlands B.V.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila TYSABRI Vsebina pakiranja in dodatne informacije
English: and IRIS
Slovenian: Zaradi reakcije IRIS
English: Presence of anti-JC virus antibodies Level of the antibody response (index) for patients without a history of immunosuppressant treatment
Slovenian: Drugi dejavniki, povezani s povečanim tveganjem za razvoj PML: prisotnost protiteles proti JCV, raven odziva protiteles (indeks) za bolnike brez zdravljenja z imunopresivi v anamnezi,
English: Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI (see also section
Slovenian: Zdravnik mora potrditi ustrezno odpornost pri bolnikih, preden začnejo zdravljenje z zdravilom TYSABRI (glejte tudi poglavje 4.4).
English: This includes:
Slovenian: UPORABNO DO:
English: Spontaneous serious adverse reactions of liver injury have been reported during the post marketing phase.
Slovenian: V obdobju trženja zdravila so poročali o spontanih hudih neželenih reakcijah okvare jeter.
English: TYSABRI contains sodium
Slovenian: Zdravilo TYSABRI vsebuje natrij.
English: - Keep this leaflet and the Patient Alert Card. You may need to read them again.
Slovenian: - Navodilo in opozorilno kartico za bolnika shranite.
English: virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Slovenian: Virus JC lahko povzroči tudi bolezen, imenovano JCV GCN (JCV nevropatija zrnatih celic), o kateri so poročali pri nekaterih bolnikih, zdravljenih z zdravilom TYSABRI.
English: • Reminder to read the package leaflet carefully before starting Tysabri
Slovenian: • Navodilo, da je treba pred začetkom jemanja zdravila Tysabri skrbno prebrati navodilo za uporabo.
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a higher risk of PML.
Slovenian: Pri bolnikih z vsemi tremi dejavniki tveganja za PML (tj. so pozitivni na protitelesa proti JCV, so se več kot dve leti zdravili z zdravilom TYSABRI in so jih predhodno zdravili z imunosupresivi) obstaja večje tveganje za razvoj PML.
English: Efficacy as monotherapy has been evaluated in one randomised, double-blind, placebo-controlled study lasting 2 years (AFFIRM study) in relapsing-remitting MS patients who had experienced at least 1 clinical relapse during the year prior to entry and had a Kurtzke Expanded Disability Status Scale (EDSS) score between 0 and 5.
Slovenian: 1 leto pred vključitvijo vsaj en klinični recidiv in po lestvici prizadetosti EDSS (Kurtzke Expanded Disability Status Scale) med 0 in 5 točkami.
English: After the infusion is complete, flush the intravenous line with sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Po končanem infundiranju sperite intravensko linijo z natrijevim kloridom 9 mg/ml (0,9 %)
English: • Prescriber name, signature and date
Slovenian: • ime, podpis zdravnika, ki predpisuje zdravilo, in datum.
English: Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy) have a significantly higher risk of PML.
Slovenian: PML (tj. so pozitivni na protitelesa proti JCV in so se z zdravilom TYSABRI zdravili več kot 2 leti in so pred tem prejemali imunosupresive), je tveganje za PML značilno večje.
English: o Management of PML o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Slovenian: o Bolnike je treba seznaniti s koristmi in tveganji zdravila TYSABRI ter jim posredovati naslednje:
English: o That the risk of PML increases with increasing duration of treatment and that treatment beyond 24 months carries additional risk and other factors associated with an increased risk for the development of PML
Slovenian: o Tveganje PML narašča s trajanjem zdravljenja in zdravljenje, ki traja dlje kot
English: Talk to your doctor before using TYSABRI.
Slovenian: Pred začetkom uporabe zdravila TYSABRI se posvetujte z zdravnikom.
English: Caution regarding potential concomitant immune effects is required when switching patients from teriflunomide to TYSABRI.
Slovenian: Pri prehajanju bolnikov s teriflunomida na zdravilo TYSABRI je potrebna previdnost glede možnih sočasnih imunskih učinkov.
English: Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Slovenian: 43,5 % bolnikov, zdravljenih z natalizumabom, poročalo o neželenih učinkih zdravila
English: • Keep alert card with the them after discontinuation • Reporting of side effects
Slovenian: • Po prekinitvi zdravljenja morajo imeti pri sebi opozorilno kartico.
English: • Yellowing of your skin or the whites of your eyes • Unusual darkening of the urine.
Slovenian: • porumenelost kože ali beločnice
English: In anti-JCV antibody positive TYSABRI treated patients who have not used prior immunosuppressants the level of anti-JCV antibody response (index) is associated with the level of risk for PML (i.e. the risk is greater in those with a high antibody index compared to those with a low index).
Slovenian: JCV (indeks) povezana s stopnjo tveganja za razvoj PML (tako je tveganje večje pri bolnikih z visokim indeksom protiteles v primerjavi z bolniki z nizkim indeksom).
English: Your doctor may switch you directly from another medicine for MS to TYSABRI if there are no signs of abnormalities caused by your previous treatment.
Slovenian: Če ni nobenih bolezenskih znakov, ki bi jih povzročilo vaše predhodno zdravljenje, vam lahko zdravnik drugo zdravilo za MS neposredno zamenja z zdravilom TYSABRI.
English: Hepatic events
Slovenian: Farmakodinamični učinki
English: Discussion of PML in TYSABRI Treated Patients
Slovenian: V opazovalnih študijah v obdobju trženja zdravila so pri bolnikih, zdravljenih z zdravilom Tysabri,
English: Speak to your doctor or nurse immediately if you notice any of the following Symptoms of serious infections including:
Slovenian: Če opazite kar koli od naslednjega, se takoj posvetujte z zdravnikom ali medicinsko sestro.
English: The interim analysis showed a lower risk of PML in patients treated with EID (hazard ratio = 0.06 95% CI of hazard ratio = 0.01- 0.22).
Slovenian: PIO (razmerje tveganja= 0,06; 95-% IZ razmerja tveganja = 0,01-0,22).
English: In 2-year controlled clinical trials in MS patients, the rate of infection was approximately 1.5 per patient-year in both natalizumab- and placebo-treated patients.
Slovenian: 1,5 na bolnika-leto, tako pri bolnikih zdravljenih z natalizumabom, kot pri bolnikih, zdravljenih s placebom.
English: 1 ≥106.3 and ≤ 108.3 CFU of live Bordetella bronchiseptica bacteria strain B-C2 per dose
Slovenian: ≥ 106,3- ≤ 108,3 CFU živih bakterij Bordetella bronchiseptica, sev B-C2, na odmerek
English: Vial (type I glass) in plastic box
Slovenian: Viala (steklo tip I) In plastična škatla
English: Vial (type I glass) in carton box
Slovenian: Viala (steklo tip I) in zloženka
English: Pack size l t o r
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja o č
English: Invented nameStrength Pharmaceutical Form
Slovenian: Izmišljeno ime Jakost
English: The results of these pre-specified analyses are as follows:
Slovenian: Rezultati teh vnaprej določenih analiz so naslednji:
English: • you are pregnant.
Slovenian: • če ste noseči.
English: Summarised below are PFS results:
Slovenian: Spodaj so povzeti rezultati PFS:
English: • epidemiological studies/non-interventional or observational studies,
Slovenian: • v epidemioloških študijah/neinterventnih ali opazovalnih študijah ali,
English: Currently available data are described in sections 4.8, 5.1 and 5.2, but no recommendation on a posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
English: Overall survival (final analysis)***
Slovenian: Celokupno preživetje (končna analiza)***
English: Observed in paediatric population only.
Slovenian: Opaženo samo pri pediatrični populaciji.
English: Interferon alfa-2a 9 MIU 3x/week.
Slovenian: a interferon alfa-2a 9 mio 3x/teden.
English: • spontaneous reporting,
Slovenian: • pri spontanem poročanju,
English: Further details on the study and the results are provided below.
Slovenian: Dodatne podrobnosti o preskušanju in rezultati so navedeni spodaj.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2018
Slovenian: Datum prve odobritve: 15. januar 2018
English: Blinded independent review (protocol-defined primary analysis).
Slovenian: Slepi neodvisni pregled (primarna analiza, določena s protokolom).
English: • loss of appetite,
Slovenian: • izgubo apetita,
English: • abnormal urine test (protein in the urine),
Slovenian: • nenormalen urinski test (beljakovine v seču),
English: Patients older than 65 years have an increased risk of experiencing the following side effects:
Slovenian: Pri bolnikih, starejših od 65 let, je večje tveganje za naslednje neželene učinke:
English: • or through an evaluation of individual case reports.
Slovenian: • s presojo poročil posameznih primerov.
English: ** Primary analysis at clinical cut-off 31 January 2006.
Slovenian: ** Primarna analiza kliničnih podatkov zbranih do 31. januarja 2006.
English: MVASI may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo MVASI lahko povzroči tudi spremembe rezultatov laboratorijskih testov, ki jih izvaja vaš zdravnik.
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Slovenian: Termini predstavljajo skupino neželenih učinkov, ki opisujejo medicinski pojem namesto posameznega stanja ali prednostni izraz po MedDRA (Medical Dictionary for Regulatory Activites).
English: • your doctor will decide when you should be given your next dose of MVASI.
Slovenian: • bo vaš zdravnik odločil o tem, kdaj boste prejeli naslednji odmerek tega zdravila.
English: • lack of energy,
Slovenian: • pomanjkanje energije,
English: Elderly patients: No dose adjustment is required in the elderly.
Slovenian: Starejši bolniki: za starejše bolnike prilagajanje odmerka ni potrebno.
English: • any severe bleeding.
Slovenian: • kakršna koli huda krvavitev.
English: Subject to a p-value boundary of 0.0116.
Slovenian: Odvisna od meje p-vrednosti, ki je 0,0116.
English: • you may develop a severe migraine.
Slovenian: • lahko dobite hudo migreno.
English: *** The final analysis of overall survival was performed when 266 deaths, which account for 73.7% of enrolled patients, were observed.
Slovenian: *** Končna analiza celokupnega preživetja je bila opravljena, ko je nastopilo 266 smrti, kar je predstavljalo 73,7 % vključenih bolnic.
English: Kaplan-Meier estimates.
Slovenian: Ocena po metodi Kaplan-Meier.
English: • post-authorisation safety studies,
Slovenian: • v varnostnih študijah po pridobitvi dovoljenja za promet,
English: Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason.
Slovenian: Posvetujte se s svojim zdravnikom, če ste vi ali vaša družina nagnjeni k težavam zaradi krvavitev ali če jemljete zdravila za redčenje krvi iz kakršnih koli razlogov.
English: Based on a substudy from NSABP C-08 with 295 patients.
Slovenian: Na podlagi podštudije NSABP C-08 z 295 bolnicami.
English: Severe side effects of unknown frequency (frequency cannot be estimated from the available data), include:
Slovenian: Hudi neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti), vključujejo:
English: However two of the randomised patients discontinued the study before receiving any study treatment.
Slovenian: Dva izmed randomiziranih bolnikov sta bila iz študije izključena, preden sta prejela katero koli zdravljenje, uporabljeno v študiji.
English: • if you undergo surgery.
Slovenian: • če boste operirani.
English: Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Slovenian: Ocene tumorjev in vrednotenje odzivov so določili raziskovalci z uporabo kriterijev GOG RECIST (revidiranih smernic RECIST (verzija 1.1).
English: • problems with the eyes (including increased production of tears),
Slovenian: • težave z očmi (vključno s povečanim solzenjem),
English: Final analysis
Slovenian: Končna analiza.
English: Name and address of the manufacturer of the biological active substance Amgen Inc
Slovenian: Ime in naslov izdelovalca biološke učinkovine Amgen Inc
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Slovenian: • nenormalno visok krvni tlak v krvnih žilah pljuč, zaradi česar mora desna stran srca delati močneje kot navadno,
English: Approximate 95% CI for difference of two rates using Hauck-Anderson method.
Slovenian: Približni 95-% interval zaupanja za razliko dveh deležev z uporabo Hauck-Andersonove metode.
English: MVASI use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Slovenian: Uporaba zdravila MVASI ni priporočena pri otrocih in mladostnikih, mlajših od 18 let, ker varnosti in koristi zdravila pri tej populaciji niso dokazali.
English: Please discuss with your doctor if you noticed this previously.
Slovenian: Pogovorite se s svojim zdravnikom, če ste to že kdaj opazili.