FrancophonIA/ELRC3.0 huggingface dataset:
English: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé film-coated tablet Oral use
Slovenian: RISEDRONATE WINTHROP 35 mg, comprimé pelliculé
English: BE - Belgium Merck Sharp & Dohme B.V. Clos du Lynx, 5- 1200
Slovenian: NO - Norveška Merck Sharp and Dohme B.V., Postbus 581,
English: 90MG/VIAL POWDER AND SOLUTION FOR INFUSION
Slovenian: 90MG/VIAL prašek in vehikel za raztopino za infundiranje
English: Risedronate Teva 35 mg filmomhulde tabletten film-coated tablets
Slovenian: Risedronate Teva 35 mg filmomhulde tabletten
English: Alendronat "Ranbaxy"
Slovenian: Alendronat "Ranbaxy" 70 mg
English: DE - Germany Volkspharma GmbH August-Wessels-Str. 5
Slovenian: Volkspharma GmbH August-Wessels-Str. 5 D-86154 Augsburg
English: ISUS - Produtos Farmacêuticos e Cosméticos, S.A. Rua António Quadros, 9GEscritório 3, 1600-875 Lisboa Portugal
Slovenian: Cosméticos, S.A. Rua António Quadros, 9GEscritório 3,
English: Prenteral
Slovenian: Avestra
English: ACTONEL 30 mg, comprimé pelliculé film-coated tablet Oral use
Slovenian: ACTONEL 30 mg, comprimé pelliculé
English: Actonel® 75 mg, filmomhulde tabletten filmcoated tablets Oral use
Slovenian: Actonel® 75 mg, filmomhulde tabletten
English: Neridronic acid containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo neridronsko kislino in so pridobila dovoljenje za promet v Evropski uniji
English: Risedronaatnatrium Mylan Wekelijks 35 mg filmcoated tablets Oral use
Slovenian: Risedronaatnatrium Mylan Wekelijks 35 mg
English: DK - Denmark Pharmathen S.A., 6, Dervenakion str., GR-15351
Slovenian: Pharmathen S.A., 6, Dervenakion str., GR-15351 Pallini Attiki, Greece
English: AREDIA DRY POWDER 30 mg
Slovenian: AREDIA DRY POWDER 30 mg prašek za raztopino za injiciranje
English: SE - Sweden Hexal A/S Kanalholmen 8-12
Slovenian: Hexal A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark
English: PT - Portugal
Slovenian: Lisboa Portugal
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira,
Slovenian: PT - Portugalska Farmoz - Sociedade Técnico Medicinal, S.A. Rua da
English: DE - Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Slovenian: ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen
English: Natriumrisedronaat Ceft 5 mg filmcoated tablets Oral use
Slovenian: Natriumrisedronaat Ceft 5 mg
English: Alendronat Sandoz 70
Slovenian: ALENDRONAT SANDOZ 70 mg
English: Natriumrisedronaat Sandoz® wekelijks 35 mg filmcoated tablets Oral use
Slovenian: Natriumrisedronaat Sandoz® wekelijks 35 mg
English: 70mg film-coated tablets
Slovenian: 30 mg filmsko obložena tableta
English: The CHMP considered that this information does not impact the safety and efficacy profile of MACI but that in the absence of an authorised manufacturing site, the requirements laid down in Article 41 of Directive 2001/83/EC are no longer met.
Slovenian: Odbor CHMP je menil, da ta podatek ne vpliva na profil varnosti in učinkovitosti zdravila MACI, vendar ker odobrenega mesta proizvodnje ni, niso več izpolnjene zahteve, opredeljene v členu 41 Direktive
English: • The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
Slovenian: • odbor CHMP je zaključil, da zaradi neobstoja odobrenega mesta za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij niso več izpolnjene zahteve, opredeljene v
English: For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Slovenian: Za preklic začasnega umika dovoljenja za promet z zdravilom mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje
English: Ref. EMEA/477488/2008
Slovenian: EMEA/548389/2008
English: International non-proprietary name (INN): dalbavacin
Slovenian: Mednarodno nelastniško ime (INN): dalbavacin
English: This kills the bacteria causing the infection.
Slovenian: To ubije bakterije, ki povzročajo okužbo.
English: The main measure of effectiveness was the number of patients whose infection was treated successfully and who did not need further treatment with any other antibiotics.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, katerih okužbe so bile uspešno ozdravljene in niso potrebovali nadaljnjega zdravljenja z drugimi antibiotiki.
English: The company presented the results of one main study that compared the effects of EXULETT with those of linezolid (another antibiotic) in 873 adults.
Slovenian: Družba je predstavila izsledke ene glavne študije, v kateri so primerjali učinke zdravila EXULETT z učinki linezolida (drugega antibiotika) pri 873 odraslih bolnikih.
English: These bacteria include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Slovenian: Med temi bakterijami sta tudi Staphylococcus aureus (vključno z obliko, odporno na meticilin, znano kot „MRSA“) in Streptococcus pyogenes.
English: Questions and answers on the withdrawal of the marketing application for EXULETT
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom EXULETT
English: The effects of EXULETT were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila EXULETT so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The patients included in this study were required to have complicated skin and soft tissue infections (such as abscesses or wound infections) that were due to Gram-positive bacteria.
Slovenian: Bolniki, vključeni v to študijo, so morali imeti zapletene okužbe kože in mehkega tkiva (kot so ognojki ali okužbe ran), ki so jih povzročile Gram pozitivne bakterije.
English: In addition, the CHMP was concerned over the relevance of the results of the main study, since not all of the patients included in the study seemed to have an infection that was severe enough to need antibiotic treatment given by infusion into a vein.
Slovenian: Poleg tega je imel CHMP pomisleke tudi glede ustreznosti izsledkov glavne študije, saj se je zdelo, da niso imeli vsi bolniki, vključeni v študijo, dovolj hude okužbe, ki bi zahtevala antibiotično zdravljenje s kapalno infuzijo v veno.
English: There were also concerns over whether EXULETT could be manufactured with consistent good quality.
Slovenian: Pojavili so se tudi dvomi ali bi bilo izdelovanje zdravila EXULETT vedno enako kakovostno.
English: The CHMP was concerned that the results of the single main study were too limited to support the approval of the medicine because of the way the study had been carried out, and was of the opinion that another study would be needed to confirm the results.
Slovenian: CHMP je izrazil zaskrbljenost, da morda izsledki ene same glavne študije ne zadostujejo za podporo odobritvi zdravila, zlasti zaradi načina, na katerega je bila študija izvedena, in da bi bilo treba za potrditev izsledkov opraviti novo študijo.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Slovenian: Zapletene okužbe so takšne okužbe, ki jih je težko zdraviti, ker so razširjene v tkiva globoko pod kožo, ker je morda potrebna operacija ali ker ima bolnik še druga stanja, ki utegnejo vplivati na zdravljenje.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with EXULETT?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila EXULETT?
English: The active substance in EXULETT, dalbavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Slovenian: Zdravilna učinkovina zdravila EXULETT, dalbavancin, je antibiotik, ki spada v skupino glikopeptidov.
English: On 9 September 2008, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for EXULETT, for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Slovenian: Družba Pfizer Limited je dne 9. septembra 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom EXULETT , namenjenim zdravljenju zapletenih kožnih okužb in okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
English: EXULETT is a powder that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo EXULETT je prašek za pripravo raztopine za infundiranje (dajanje v veno).
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that EXULETT could not have been approved for the treatment of complicated skin and soft tissue infections in adults when known or suspected to be caused by susceptible Gram-positive bacteria.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila EXULETT ni mogoče odobriti za zdravljenje zapletenih okužb kože ali okužb mehkih tkiv pri odraslih, kjer je znano ali obstaja sum, da jih povzročajo občutljive Gram pozitivne bakterije.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of EXULETT.
Slovenian: Družba je CHMP obvestila, da umik vloge za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila EXULETT, nima posledic.
English: It is expected to work by stopping the bacteria making their cell walls.
Slovenian: Zdravilo naj bi preprečilo bakterijam gradnjo celičnih sten.
English: EXULETT was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive' and that would be killed by the medicine.
Slovenian: Zdravilo EXULETT naj bi se uporabljalo samo, kadar je znano ali domnevano, da so okužbo povzročile bakterije, znane kot Gram pozitivne bakterije, ki bi jih zdravilo ubilo.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of EXULETT had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je zato v času umika menil, da koristi zdravila EXULETT niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: How is EXULETT expected to work?
Slovenian: Kako naj bi zdravilo EXULETT delovalo?
English: EXULETT was to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Slovenian: Zdravilo EXULETT naj bi se uporabljalo za zdravljenje odraslih z zapletenimi okužbami kože in podkožnih mehkih tkiv.
English: What was EXULETT expected to be used for?
Slovenian: Za kaj naj bi se zdravilo EXULETT uporabljalo?
English: What is EXULETT?
Slovenian: Kaj je zdravilo EXULETT?
English: (Best response rates)
Slovenian: (Najboljše odzivnosti)
English: In addition, children have been treated in two phase I studies and one phase II study.
Slovenian: Poleg tega so zdravili otroke v dveh študijah prve faze in eni študiji druge faze.
English: • Risk Management Plan (RMP) Not applicable.
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: Molecular response**
Slovenian: Molekularni odziv**
English: Return to chronic phase (RTC)
Slovenian: vrnitev v kronično fazo (RTC)
English: • Slowing of growth in children and adolescents.
Slovenian: • upočasnjena rast pri otrocih in mladostnikih.
English: % of patients (CI95%)
Slovenian: % bolnikov (IZ95 %)
English: A limited number of patients were enrolled in phase I studies (n=10).
Slovenian: Omejeno število bolnikov so vključili v študije prve faze (n=10).
English: A major response (0-35%) combines both complete and partial responses.
Slovenian: Pomemben odziv (0-35 %) združuje popolni in delni odziv.
English: A complete haematological response was achieved in 95% of patients.
Slovenian: Popoln hematološki odziv je bil dosežen pri 95 % bolnikov.
English: In all clinical studies 38-40% of patients were ≥ 60 years of age and 10-12% of patients were ≥ 70 years of age.
Slovenian: V vseh kliničnih študijah je bilo 38-40 % bolnikov starih ≥ 60 let, 10-12 % bolnikov pa je bilo starih ≥ 70 let.
English: If you think you may be allergic but are not sure, ask your doctor for advice.
Slovenian: Če mislite, da bi bili lahko alergični, a niste prepričani, se posvetujte z zdravnikom.
English: Other adverse reactions were reported with lower or equal frequency.
Slovenian: Pri drugih neželenih reakcijah so poročali o manjši ali enaki pogostnosti.
English: • Stir with a spoon until the tablets have completely dissolved.
Slovenian: • Mešajte z žlico, dokler se tablete popolnoma ne raztopijo.
English: (Of note, out of the 411 patients, 353 were treated in an expanded access program without primary response data collected.)
Slovenian: od 411 bolnikov jih je bilo 353 zdravljenih v programu razširjenega dostopa brez zbranih podatkov o primarnem odzivu.)
English: Capsule, hard
Slovenian: kapsula, trda
English: The annual rate of progression to accelerated phase or blast crisis decreased with time on therapy and was less than 1% annually in the fourth and fifth years.
Slovenian: Letna stopnja napredovanja v pospešeno fazo ali blastno krizo je upadala s trajanjem zdravljenja in je bila v četrtem in petem letu manj kot 1 % letno.
English: • Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Slovenian: • ponovitev (reaktivacija) okužbe s hepatitisom B, če ste imeli hepatitis B v preteklosti (okužba jeter).
English: - Swallow the capsules whole with a large glass of water.
Slovenian: Kapsule pogoltnite cele z velikim kozarcem vode.
English: The amount of Imatinib Teva given will depend on your child's condition, body weight and height.
Slovenian: Potrebna količina zdravila Imatinib Teva bo odvisna od otrokovega stanja, telesne mase in višine.
English: PVC/PE/PVdC/PE/PVC//Al blisters OPA/Al/PVC//Al blisters
Slovenian: PVC/PE/PVdC/PE/PVC//Al pretisni omoti OPA/Al/PVC//Al pretisni omoti
English: Date of latest renewal: 18 September 2017
Slovenian: Datum prve odobritve: 8. januar 2013 Datum zadnjega podaljšanja: 18. september 2017
English: • Once the tablet has dissolved, drink everything in the glass straight away.
Slovenian: • Ko se tableta raztopi, takoj popijte celotno vsebino kozarca.
English: Pericarditis*, cardiac tamponade*
Slovenian: perikarditis*, tamponada srca*
English: If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.
Slovenian: Če imate kakšna vprašanja glede tega, kako zdravilo Imatinib Teva deluje ali zakaj vam je bilo predpisano to zdravilo, vprašajte svojega zdravnika.
English: The duration of imatinib therapy can vary with the treatment programme selected, but generally longer exposures to imatinib have yielded better results.
Slovenian: Trajanje zdravljenja z imatinibom je lahko različno glede na izbrani program zdravljenja, vendar pa je na splošno daljša izpostavljenost imatinibu prinesla boljše rezultate.
English: The median duration of therapy in study B2225 was 6.2 months, with a maximum duration of 24.3 months.
Slovenian: Mediano trajanje zdravljenja v študiji B2225 je bilo 6,2 meseca z najdaljšim trajanjem 24,3 meseca.
English: - If you are being treated for Ph-positive ALL:
Slovenian: Če se zdravite zaradi Ph pozitivne ALL:
English: Your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Slovenian: Zdravnik vam lahko predpiše večji ali manjši odmerek, odvisno od tega, kako se odzivate na zdravljenje.
English: In this study, 31% of patients achieved a haematological response (36% in previously untreated patients and 22% in previously treated patients).
Slovenian: V tej študiji je 31 % bolnikov doseglo hematološki odziv (36 % pri predhodno nezdravljenih bolnikih in 22 % pri predhodno zdravljenih bolnikih).
English: Response data are shown in Table 2.
Slovenian: Podatke o odzivnosti kaže preglednica 2.
English: Do not take Imatinib Teva - if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Imatinib Teva če ste alergični na imatinib ali katero koli sestavino tega zdravila (navedeno v poglavju
English: A confirmed haematological response was achieved in 71.5% of patients (Table 3).
Slovenian: Potrjeni hematološki odziv je bil dosežen pri 71,5 % bolnikov (preglednica 3).
English: 235 adult patients with accelerated phase disease were enrolled.
Slovenian: Pospešena faza Vključili so 235 odraslih bolnikov s pospešeno fazo bolezni.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John's Wort).
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta (na primer paracetamol), vključno z zdravili rastlinskega izvora (na primer šentjanževka).
English: Thrombosis/embolism*
Slovenian: tromboza/embolija*
English: Chronic phase, Interferon failure
Slovenian: Kronična faza, neuspeh z interferonom
English: Study 0109 40.5-month data Accelerated phase (n=235)
Slovenian: Študija 0109 podatki pri 40,5 meseca pospešena faza (n = 235)
English: Ki values in human liver microsomes were 27, 7.5 and 7.9 µmol/l, respectively.
Slovenian: Vrednosti Ki v mikrosomih človeških jeter so bile 27; 7,5 oziroma 7,9 μmol/l.
English: Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.
Slovenian: Zdravnik se bo pogovoril z vami o možnih nevarnostih jemanja zdravila Imatinib Teva v nosečnosti.
English: While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working.
Slovenian: Med jemanjem zdravila Imatinib Teva bo zdravnik redno spremljal, ali zdravilo deluje.
English: Some children and adolescents taking Imatinib Teva may have slower than normal growth.
Slovenian: Pri nekaterih otrocih in mladostnikih, ki jemljejo zdravilo Imatinib Teva, je lahko rast počasnejša od normalne.
English: Hepatitis B reactivation
Slovenian: reaktivacija hepatitisa B
English: The content of the capsule is white to light yellow granulated powder.
Slovenian: Vsebina kapsule je bel do svetlo rumen prašek.
English: The yearly rates of progression of any type for imatinib also decreased over time.
Slovenian: Tudi letne stopnje kakršnegakoli napredovanja bolezni za imatinib so se sčasoma zmanjševale.
English: After 42 months of follow-up, 11 patients experienced a confirmed loss (within 4 weeks) of their cytogenetic response.
Slovenian: Po 42 mesecih spremljanja je bila potrjena izguba (v 4 tednih) citogenetičnega odziva pri 11 bolnikih.
English: 260 patients with myeloid blast crisis were enrolled.
Slovenian: Vključili so 260 bolnikov z mieloidno blastno krizo.
English: Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
Slovenian: Zdravilo Imatinib Teva vam lahko zmanjša število belih krvnih celic, zato lahko laže pride do okužbe,
English: Mean absolute bioavailability for imatinib is 98%.
Slovenian: Povprečna absolutna biološka uporabnost imatiniba je 98 %.
English: There were 59% males and 41% females; 89.9% caucasian and 4.7% black patients.
Slovenian: Moških je bilo 59 %, žensk pa 41 %; 89,9 % je bilo belcev, 4,7 % pa črncev.
English: Imatinib pharmacokinetics has not been specifically studied in the elderly.
Slovenian: Farmakokinetike imatiniba pri starejših niso posebej proučili.
English: Median age was 51 years (range 18-70 years), with 21.9% of patients ≥ 60 years of age.
Slovenian: Povprečna starost je bila 51 let (razpon 18-70 let), 21,9 %
English: 12 Gy in 8 fractions for all patients that are CNS1 and CNS2 at diagnosis
Slovenian: 12 Gy v 8 frakcijah za vse bolnike, ki imajo ob postavitvi diagnoze CNS1 in CNS2
English: Investigations Very common
Slovenian: Preiskave zelo pogosti:
English: • Blood clots in small blood vessels (thrombotic microangiopathy).
Slovenian: • krvni strdki v majhnih krvnih žilah (trombotična mikroangiopatija).
English: Major response at 12 months (%)
Slovenian: pomemben odziv pri 12 mesecih (%)
English: Your doctor has prescribed Imatinib Teva because you suffer from a serious condition.
Slovenian: Zdravnik vam je predpisal zdravilo Imatinib Teva, ker imate resno bolezen.
English: Imatinib should not be used during pregnancy unless clearly necessary.
Slovenian: Imatinib ne smete uporabljati pri nosečnicah, razen če je nujno potrebno.
English: The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Slovenian: Varnost in učinkovitost imatiniba pri otrocih, ki imajo MDS/MPD, DFSP in HES/CEL in so stari manj kot 18 let, nista bili dokazani v kliničnih preskušanjih.
English: The suspension should be administered immediately after complete disintegration of the tablet(s).
Slovenian: Suspenzijo je treba zaužiti takoj, ko tableta (tablete) popolnoma razpade (razpadejo).
English: Table 2 Response in newly diagnosed CML Study (84-month data)
Slovenian: Preglednica 2 Odziv v študiji na novo diagnosticirane KML (podatki pri 84 mesecih)
English: Because of known increased risks of bleeding in conjunction with the use of imatinib (e.g. haemorrhage), patients who require anticoagulation should receive low-molecular-weight or standard heparin, instead of coumarin derivatives such as warfarin.
Slovenian: Zaradi znanega povečanega tveganja za krvavitve v povezavi z uporabo imatiniba (na primer hemoragija), naj bolniki, pri katerih je potrebna antikoagulantna terapija, dobivajo nizkomolekularni ali standardni heparin namesto kumarinskih derivatov, kot je varfarin.
English: Major response at 24 months (%)
Slovenian: pomemben odziv pri 24 mesecih (%)
English: Acute respiratory failure11*, interstitial lung disease*
Slovenian: akutna respiratorna odpoved11*, intersticijska pljučna bolezen*
English: Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.
Slovenian: Zdravilo Imatinib Teva vam lahko predpiše samo zdravnik, ki ima izkušnje z zdravili za zdravljenje krvnih rakov ali solidnih tumorjev.
English: Mogilska 80, 31-546 Krakow Poland
Slovenian: Mogilska 80, 31-546 Krakow Poljska
English: Studies in two breast-feeding women revealed that both imatinib and its active metabolite can be distributed into human milk.
Slovenian: Študiji pri dveh doječih materah sta pokazali, da se tako imatinib kot njegov aktivni presnovek pri človeku lahko izločata v materino mleko.
English: - Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby.
Slovenian: Uporaba zdravila Imatinib Teva v nosečnosti ni priporočena, če to ni nujno potrebno, saj lahko škoduje vašemu otroku.
English: There is no experience in children with CML below 2 years of age and with Ph+ALL below 1 year of age (see section 5.1).
Slovenian: Izkušenj pri otrocih s KML, mlajših od 2 let, in pri otrocih s Ph+ALL, mlajših od 1 leta, ni (glejte poglavje 5.1).
English: Constitutive activation of the PDGF receptor or the Abl protein tyrosine kinases as a consequence of fusion to diverse partner proteins or constitutive production of PDGF have been implicated in the pathogenesis of MDS/MPD, HES/CEL and DFSP.
Slovenian: Konstitutivna aktivacija receptorja za PGDF ali Abl protein-tirozin-kinaze kot posledica združitve različnih sodelujočih proteinov ali konstitutivna tvorba PDGF sta vpleteni v patogenezo MDS/MPD, HES/CEL in DFSP.