FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Namuscla are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Namuscla, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Namuscla must also not be used in patients with various heart problems, or together with certain medicines.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z različnimi težavami s srcem ali sočasno z določenimi zdravili.
English: For more information about using Namuscla, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Namuscla glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Namuscla
Slovenian: Druge informacije o zdravilu Namuscla
English: Myotonic disorders are rare, and Namuscla was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 November 2014.
Slovenian: Miotonične motnje so redke, zato je bilo zdravilo Namuscla 19. novembra 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: What is Namuscla and what is it used for?
Slovenian: Kaj je zdravilo Namuscla in za kaj se uporablja?
English: What are the risks associated with Namuscla?
Slovenian: Kakšna tveganja so povezana z zdravilom Namuscla ?
English: Patients with non-dystrophic myotonic disorders experience muscle stiffness and pain because their muscles are slow to relax after contraction.
Slovenian: Pri bolnikih z nedistrofičnimi miotoničnimi motnjami se pojavljajo otrdelost mišic in bolečine, ker se njihove mišice po krčenju prepočasi sproščajo.
English: Namuscla must not be used in patients who are hypersensitive (allergic) to the active substance, mexiletine, to any other ingredients of the medicine, or to local anaesthetics (medicines that block out sensation used to prevent pain in a part of the body).
Slovenian: Zdravilo Namuscla se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) učinkovino meksiletin, katero koli drugo sestavino zdravila ali lokalne anestetike (zdravila, ki zavirajo zaznavanje občutka bolečine v delu telesa).
English: By blocking them, the medicine helps to reduce the stiffness that occurs when the contractions are prolonged.
Slovenian: Zdravilo z zaviranjem kanalčkov pomaga zmanjšati otrdelost, ki se pojavi pri podaljšanem krčenju.
English: The active substance in Namuscla, mexiletine, works by blocking channels in muscle cells that allow sodium ions (electrically charged particles) to pass in and out.
Slovenian: Učinkovina v zdravilu Namuscla, meksiletin, deluje tako, da zavira kanalčke v mišicah, ki omogočajo prehajanje natrijevih ionov (električno nabitih delcev).
English: These sodium channels play a role in the contraction and relaxation of muscles and are hyperactive in patients with myotonic disorders, causing excessive contractions and stiffness.
Slovenian: Ti natrijevi kanalčki povzročajo krčenje in sproščanje mišic in so pri bolnikih z miotoničnimi motnjami hiperaktivni, kar povzroča čezmerno krčenje in otrdelost.
English: Namuscla was shown to be effective at easing the symptoms of myotonia in patients with nondystrophic myotonic disorders, thus improving their quality of life.
Slovenian: Zdravilo Namuscla se je izkazalo za učinkovito pri lajšanju simptomov miotonije pri bolnikih z nedistrofičnimi miotoničnimi motnjami, s čimer se je izboljšala njihova kakovost življenja.
English: The most common side effects with Namuscla (which may affect more than 1 in 10 people) are abdominal (belly) pain and insomnia (difficulty sleeping).
Slovenian: Najpogostejši neželeni učinki zdravila Namuscla (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so bolečine v trebuhu in nespečnost.
English: Namuscla is a medicine used to treat symptoms of myotonia (muscle stiffness) in patients with nondystrophic myotonic disorders, a group of inherited muscle disorders.
Slovenian: Namuscla je zdravilo, ki se uporablja za zdravljenje simptomov miotonije (otrdelosti mišic) pri bolnikih z nedistrofičnimi miotoničnimi motnjami, tj. skupino podedovanih mišičnih obolenj.
English: In one study involving 25 patients with non-dystrophic myotonia, Namuscla was shown to be more effective than placebo (a dummy treatment) at reducing muscle stiffness.
Slovenian: Zdravilo Namuscla se je v eni študiji, ki je vključevala 25 bolnikov z nedistrofičnimi miotoničnimi motnjami, pri zmanjševanju otrdelosti mišic izkazalo za učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
English: Non-dystrophic means no muscle wasting occurs in patients affected by the condition.
Slovenian: Nedistrofična pomeni, da pri bolnikih, ki jih je bolezen prizadela, ne pride do izgube mišic.
English: Namuscla is available as capsules to be taken by mouth.
Slovenian: Zdravilo Namuscla je na voljo v obliki kapsul, ki se jemljejo peroralno.
English: How is Namuscla used?
Slovenian: Kako se zdravilo Namuscla uporablja?
English: For the full list of side effects of Namuscla, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Namuscla, glejte navodilo za uporabo.
English: How does Namuscla work?
Slovenian: Kako zdravilo Namuscla deluje?
English: Namuscla can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Namuscla je le na recept.
English: Muscle stiffness was self-assessed by each patient before and after treatment, and scored on a scale running from 0 to 100 (most severe).
Slovenian: Otrdelost mišic je vsak bolnik ocenil sam pred zdravljenjem in po njem z oceno na lestvici od 0 do 100 (najhujša).
English: (see section 4.2).
Slovenian: (glejte poglavje 4.2).
English: Appropriate supportive treatment should be given.
Slovenian: Potrebno je ustrezno podporno zdravljenje.
English: Both key secondary endpoints were also met.
Slovenian: Dosežena sta bila tudi oba ključna sekundarna cilja opazovanja.
English: Date of first authorisation: 23 August 2012 Date of latest renewal: 24 April 2017
Slovenian: Datum prve odobritve: 23. avgust 2012 Datum zadnjega podaljšanja: 24. april 2017
English: Follow all the doctor's instructions carefully.
Slovenian: Skrbno se držite zdravnikovih navodil.
English: Long-term safety:
Slovenian: Dolgoročna ocena varnosti:
English: Effects of age, gender or race
Slovenian: Vpliv starosti, spola ali rase
English: Frequency is based on laboratory values.
Slovenian: Pogostnost temelji na laboratorijskih vrednostih.
English: This medicine is not intended for use by children or adolescents aged below 18 years because it has not been studied in this age group.
Slovenian: To zdravilo ni namenjeno uporabi pri otrocih in mladostnikih, ki so stari manj kot 18 let, ker v tej starostni skupini uporaba ni bila preučevana.
English: Patients should be assessed for the risk of developing serious infections.
Slovenian: Pri bolnikih je treba oceniti tveganje za razvoj resnih okužb.
English: - if you have or have ever had any liver problems.
Slovenian: - če imate ali ste imeli kdaj prej kakršne koli težave z jetri.
English: if you have ever had tuberculosis.
Slovenian: - če ste že kdaj imeli tuberkulozo.
English: The majority of patients (68.4%) were treated for at least 9 months.
Slovenian: Večina bolnikov (68,4 %) se je zdravila najmanj 9 mesecev.
English: - if you are taking other medicines (see section “Other medicines and Jakavi”).
Slovenian: - če jemljete druga zdravila (glejte poglavje “Druga zdravila in zdravilo Jakavi”).
English: (64.2% versus 38.5%).
Slovenian: (64,2 % v primerjavi z 38,5 %).
English: Your doctor will tell you if you should take one or two doses and how many tablets to take for each dose.
Slovenian: Zdravnik vam bo povedal, ali morate vzeti en odmerek ali dva in koliko tablet morate vzeti pri vsakem odmerku.
English: It is important that you tell your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Slovenian: Pomembno je, da zdravniku poveste, če ste že kdaj imeli tuberkulozo ali če ste bili v tesnem stiku s kom, ki ima ali je imel tuberkulozo.
English: The safety and efficacy of Jakavi in children and adolescents aged up to 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Jakavi pri otrocih in mladostnikih, starih do 18 let, nista bili dokazani.
English: Unchanged parent substance accounted for less than 1% of the excreted total radioactivity.
Slovenian: Nespremenjena matična učinkovina je predstavljala manj kot 1 % vseh izločenih radioaktivnih snovi.
English: Your doctor will also regularly check the level of lipids (fat) in your blood.
Slovenian: Poleg tega bo zdravnik redno pregledoval koncentracije lipidov (maščob) v vaši krvi.
English: - if you have ever had skin cancer.
Slovenian: - če ste že kdaj imeli kožnega raka.
English: depending on your blood cell count.
Slovenian: odvisno od vaše krvne slike.
English: Comparative data regarding long-term survival and incidence of disease complications is missing.
Slovenian: Podatkov o primerjavi dolgotrajnega preživetja in pogostnosti zapletov pri tej bolezni ni.
English: You should take Jakavi every day at the same time, either with or without food.
Slovenian: Zdravilo Jakavi morate jemati vsak dan ob istem času, bodisi s hrano ali brez nje.
English: Treatment may be continued as long as the benefit-risk remains positive.
Slovenian: Z zdravljenjem je mogoče nadaljevati, dokler razmerje med koristmi in tveganji ostaja pozitivno.
English: The median age was 60 years (range 33 to 90 years).
Slovenian: Mediana starost bolnikov je bila 60 let (od 33 do 90 let).
English: Dose proportionality was demonstrated in the single and multiple dose studies.
Slovenian: Sorazmernost velikosti odmerka so dokazali v študijah tako enkratnih kot večkratnih odmerkov.
English: Uncommon (may affect up to 1 in 100 people): - tuberculosis
Slovenian: Občasni (lahko se pojavijo pri največ 1 od 100 bolnikov): - tuberkuloza
English: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Slovenian: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Španija
English: Treatment with Jakavi should not be started until active serious infections have resolved.
Slovenian: Zdravila Jakavi se ne sme uvesti, dokler aktivne resne okužbe niso odpravljene.
English: Your doctor will regularly monitor your condition to make sure that the treatment is having the desired effect.
Slovenian: Zdravnik bo redno spremljal vaše stanje, da se bo prepričal, ali zdravilo učinkuje v skladu s pričakovanji.
English: Frequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755)
Slovenian: Pogostnost temelji na vseh bolnikih, ki so bili izpostavljeni ruksolitinibu v kliničnih študijah (N=4755).
English: This may require further observation, as certain types of skin cancer (non-melanoma) have been reported.
Slovenian: V tem primeru bo potrebno nadaljnje opazovanje, saj so poročali o določenih vrstah kožnega raka (o nemelanomskem kožnem raku).
English: Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Slovenian: Pred začetkom zdravljenja je treba pri bolnikih v skladu z lokalnimi priporočili preveriti prisotnost aktivne in neaktivne (latentne) tuberkuloze.
English: Your doctor may perform tests to see if you have tuberculosis or any other infections.
Slovenian: Zdravnik bo morda pri vas izvedel preiskave, da ugotovi, ali imate tuberkulozo ali katero drugo okužbo.
English: Haematopoietic growth factors
Slovenian: Hematopoetski rastni dejavniki
English: It is important that you tell your doctor if you have ever had hepatitis B. - if you have any kidney problems.
Slovenian: Pomembno je, da zdravniku poveste, če ste že kdaj imeli okužbo z virusom hepatitisa B. - če imate težave z ledvicami.
English: Patients developing anaemia may require blood transfusions.
Slovenian: Bolniki, pri katerih pride do anemije, lahko potrebujejo transfuzije krvi.
English: Two major and active metabolites are present in plasma representing 25% and 11% of parent AUC.
Slovenian: V plazmi sta prisotna dva glavna aktivna presnovka, ki predstavljata 25 % in 11 % AUC matične učinkovine.
English: One patient (0.3%) discontinued treatment because of anaemia.
Slovenian: En bolnik (0,3 %) je zaradi anemije prekinil zdravljenje.
English: Increased systolic blood pressure
Slovenian: Zvišan sistolični krvni tlak
English: It is particularly important that you mention any of the following medicines containing any of the following active substances, as your doctor may need to adjust the Jakavi dose for you.
Slovenian: Posebno pomembno je, da zdravniku poveste za naslednja zdravila, ki vsebujejo katero od naslednjih učinkovin, saj vam bo moral zdravnik morda prilagoditi odmerek zdravila Jakavi.
English: Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs).
Slovenian: Zdravniki naj bodo še posebej pozorni na simptome, ki kažejo na PML in jih bolniki sami morda ne opazijo (na primer na kognitivne, nevrološke ali psihiatrične simptome oziroma znake).
English: Final CSR: December 2019
Slovenian: Zaključno poročilo klinične študije: december 2019
English: If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Slovenian: Če bolnik izpusti odmerek, kasneje ne sme vzeti dodatnega odmerka, ampak mora vzeti le naslednji predpisani odmerek.
English: Elderly patients (≥65 years) No additional dose adjustments are recommended for elderly patients.
Slovenian: Starejši bolniki (≥65 let) Pri starejših bolnikih ni potrebno dodatno prilagajanje odmerjanja.
English: COMFORT-II was an open-label, randomised study in 219 patients.
Slovenian: COMFORT-II je bila odprta, randomizirana študija z 219 bolniki.
English: What Jakavi is and what it is used for
Slovenian: Kaj je zdravilo Jakavi in za kaj ga uporabljamo
English: Ruxolitinib was not carcinogenic in the Tg.rasH2 transgenic mouse model.
Slovenian: Ruksolitinib prav tako ni bil kancerogen v modelu Tg.rasH2 transgenskih miši.
English: Your doctor may need to prescribe a different dose of Jakavi.
Slovenian: Zdravnik vam bo morda moral predpisati drugačen odmerek zdravila Jakavi.
English: Subsequent doses should be adjusted based on careful monitoring of safety and efficacy.
Slovenian: Nadaljnje odmerke je treba prilagajati na podlagi skrbnega spremljanja varnosti in učinkovitosti.
English: Treatment benefit perception was measured by the Patient Global Impression of Change (PGIC) questionnaire.
Slovenian: Zaznavanje koristi zdravljenja so ocenjevali z vprašalnikom Bolnikova globalna ocena razlike (PGICPatient Global Impression of Change).
English: This pattern was observed in patients regardless of whether they had received transfusion during therapy.
Slovenian: Opisan potek so opažali pri bolnikih ne glede na to, ali so med zdravljenjem prejeli transfuzijo ali ne.
English: During the treatment your doctor may recommend a lower or higher dose to you if the results of blood tests show that this is necessary, if you have problems with your liver or kidneys, or if you also need treatment with certain other medicines.
Slovenian: Med zdravljenjem vam zdravnik lahko svetuje nižji ali višji odmerek, če izvidi krvnih preiskav kažejo, da je to potrebno, če imate težave z jetri ali ledvicami ali če potrebujete zdravljenje z določenimi drugimi zdravili.
English: The safety and effectiveness of Jakavi in paediatric patients have not been established (see section 5.1, “Paediatric population”).
Slovenian: Varnost in učinkovitost zdravila Jakavi pri pediatričnih bolnikih nista bili dokazani (glejte poglavje 5.1, “Pediatrična populacija”).
English: Your doctor will always tell you exactly how many Jakavi tablets to take.
Slovenian: Zdravnik vam bo vedno natančno povedal, koliko tablet zdravila Jakavi morate vzeti.
English: Frequency is based on adverse event data.
Slovenian: Pogostnost temelji na podatkih o neželenih dogodkih.
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Slovenian: Znotraj vsakega organskega sistema so neželeni učinki zdravila razvrščeni po pogostnosti, pri čemer so najbolj pogosti neželeni učinki navedeni najprej.
English: Your doctor may need to adjust the dose or stop treatment.
Slovenian: Zdravnik vam bo morda moral prilagoditi ali prekiniti odmerjanje.
English: Single doses up to 200 mg have been given with acceptable acute tolerability.
Slovenian: Enkratne odmerke do 200 mg so osebe akutno sprejemljivo prenašale.
English: 168 tablets (3x56)
Slovenian: 168 tablet (3 x 56)
English: Effects of ruxolitinib on other medicinal products
Slovenian: Vpliv ruksolitiniba na druga zdravila
English: Best available therapy (N=72)
Slovenian: najboljše razpoložljivo zdravljenje (N=72)
English: Before you start treatment with Jakavi, your doctor will perform blood tests to determine the best starting dose for you.
Slovenian: Preden se boste začeli zdraviti z zdravilom Jakavi, vas bo zdravnik napotil na krvne preiskave, da bi lahko določil, kateri začetni odmerek bo za vas najboljši.
English: The cumulative frequency of adverse events in these studies increased proportionally to the increase in the follow-up time.
Slovenian: Kumulativna pogostnost neželenih učinkov v teh študijah se je povečevala sorazmerno s časom spremljanja bolnikov.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures:
Slovenian: • Obveznosti izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe:
English: Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Slovenian: Bolnike s kronično okužbo z virusom hepatitisa B je treba zdraviti in spremljati v skladu s kliničnimi smernicami.
English: Doses may be titrated based on safety and efficacy.
Slovenian: Odmerke je mogoče titrirati glede na njihovo varnost in učinkovitost.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Razvrstitev posameznega neželenega učinka zdravila v ustrezno kategorijo pogostnosti temelji na naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: In lactating rats, ruxolitinib and/or its metabolites were excreted into the milk with a concentration that was 13-fold higher than the maternal plasma concentration.
Slovenian: Pri doječih podganah so se ruksolitinib in/ali njegovi presnovki izločali v mleko v koncentraciji, ki je bila 13-krat višja od koncentracije v plazmi samic.
English: The study met its primary objective and a higher proportion of patients in the Jakavi group achieved the primary composite endpoint and each of its individual components.
Slovenian: V študiji je bil dosežen primarni cilj in v skupini z zdravilom Jakavi je večji delež bolnikov dosegel primarni sestavljeni cilj opazovanja in vsakega od obeh posameznih ciljev.
English: Most patients (>80%) had received at least two phlebotomies in the last 24 weeks prior to screening.
Slovenian: Pri večini bolnikov (>80 %) so že najmanj dvakrat v zadnjih 24 tednih pred presejalnim (screening) obiskom opravili flebotomijo.
English: Thus, medicinal products inhibiting these enzymes can give rise to increased ruxolitinib exposure.
Slovenian: Zdravila, ki zavirajo delovanje teh encimov, lahko torej povzročijo povečano izpostavljenost ruksolitinibu.
English: Your doctor will measure the amount of blood cells in your body and find the best dose for you, particularly if you have liver or kidney problems.
Slovenian: Zdravnik bo pregledal količino krvnih celic v vašem telesu in določil za vas najbolj primeren odmerek, zlasti če imate še okvaro jeter ali ledvic.
English: Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening d
Slovenian: Skupni terminološki kriteriji za neželene dogodke (CTCAE) različica 3.0; stopnja 1 = blaga, stopnja 2 = zmerna, stopnja 3 = huda, stopnja 4 = življenjsko nevarna d
English: Jakavi can help reduce the risk of serious blood or vascular complications.
Slovenian: Zdravilo Jakavi lahko prispeva k zmanjševanju tveganja za resne krvne ali žilne zaplete.
English: Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started.
Slovenian: Zdravila Jakavi se v obdobju dojenja ne sme uporabljati (glejte poglavje 4.3), zato je treba ob začetku zdravljenja z dojenjem prenehati.
English: Most of the side effects of Jakavi are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Slovenian: Večina neželenih učinkov zdravila Jakavi je blago do zmerno izraženih in večinoma izzvenijo po nekaj dneh do nekaj tednih zdravljenja.
English: If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Jakavi.
Slovenian: Če kaj od navedenega velja za vas, povejte zdravniku, ki bo odločil, ali lahko začnete jemati zdravilo Jakavi.
English: Jakavi treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Slovenian: Zdravljenje z zdravilom Jakavi sme uvesti samo zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
English: The sum total of all active metabolites contributes to 18% of the overall pharmacodynamics of ruxolitinib.
Slovenian: Vsi aktivni presnovki skupaj prispevajo 18 % skupne farmakodinamične aktivnosti ruksolitiniba.
English: Table 1 Frequency category of adverse drug reactions reported in the phase 3 studies (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
Slovenian: Preglednica 1: Kategorije pogostnosti neželenih učinkov, o katerih so poročali v študijah faze 3 (COMFORT-I, COMFORT-II, RESPONSE in RESPONSE 2)
English: This is a long-term treatment.
Slovenian: Zdravljenje s tem zdravilom je dolgotrajno.
English: Warnings and precautions Talk to your doctor or pharmacist before taking Jakavi - if you have any infections.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Jakavi se posvetujte z zdravnikom ali farmacevtom: - če imate kakršno koli okužbo.
English: It is not known whether the Janus Associated Kinase (JAK) inhibition by ruxolitinib reduces the efficacy of the haematopoietic growth factors or whether the haematopoietic growth factors affect the efficacy of ruxolitinib (see section 4.4).
Slovenian: Ni znano, ali ruksolitinib z zaviranjem Janus kinaz (JAK) zmanjšuje učinkovitost hematopoetskih rastnih dejavnikov oziroma ali hematopoetski rastni dejavniki vplivajo na učinkovitost ruksolitiniba (glejte poglavje 4.4).
English: The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals.
Slovenian: V prvih štirih tednih zdravljenja se začetnega odmerka ne sme zviševati, kasneje pa je odmerke mogoče zviševati v presledkih najmanj 2 tednov.
English: Other than bone development, the effects of ruxolitinib in juvenile rats were similar to those in adult rats.
Slovenian: Razen vpliva na razvoj kosti so bili učinki ruksolitiniba pri podganjih mladičih podobni kot pri odraslih podganah.
English: Additional analyses from the RESPONSE study to assess durability of response were conducted at week 80 only in the Jakavi arm.
Slovenian: Nadaljnje analize podatkov iz študije RESPONSE za oceno trajanja odziva po 80 tednih zdravljenja so opravili samo v skupini z zdravilom Jakavi.
English: There are no data from the use of Jakavi in pregnant women.
Slovenian: Podatkov o uporabi zdravila Jakavi pri nosečnicah ni.