FrancophonIA/ELRC3.0 huggingface dataset:
English: In other studies, PRES was reported in patients treated with monotherapy ZALTRAP (0.5 %) and in combination with other chemotherapies (see section 4.4).
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES) V ključni študiji III. faze pri bolnikih mKRR niso zabeležili primerov PRES. PRES je bil opisan pri bolnikih, ki so prejemali monoterapijo z zdravilom ZALTRAP (0,5 %) in v kombinaciji z drugimi kemoterapijami (glejte poglavje 4.4).
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of fistula (all grades) was 1.1 % for patients treated with ZALTRAP and 0.2 % for patients treated with placebo.
Slovenian: V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca fistul (vseh stopenj) med prejemniki zdravila ZALTRAP 1,1 % in med prejemniki placeba 0,2 %.
English: • 8 ml of concentrate in a 10 ml clear borosilicate glass vial (type I) sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Slovenian: • 8 ml koncentrata v 10-ml enoodmerni viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.
English: Cardiac failure
Slovenian: Srčne bolezni Občasni srčno popuščanje
English: Aflibercept treatment should be discontinued in patients who develop fistula (see section 4.2).
Slovenian: Pri bolnikih, ki se jim pojavi fistula, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
English: • 4 ml of concentrate in a 5 ml clear borosilicate glass vial (type I), sealed by a flanged stopper with flip-off cap and inserted coated sealing disc.
Slovenian: • 4 ml koncentrata v 5-ml enoodmerni viali iz prozornega borosilikatnega stekla (tipa I), zaprti s prirobljenim zamaškom s snemno zaporko in vstavljeno prevlečeno tesnilno ploščico.
English: Rectal haemorrhage Fistula (1) Aphthous stomatitis Haemorrhoids Proctalgia Toothache
Slovenian: Pogosti krvavitev iz danke fistula (1) aftozni stomatitis hemoroidi proktalgija zobobol bolečine v trebuhu bolečine v zgornjem delu trebuha
English: A higher incidence of severe diarrhoea has been observed in patients treated with the ZALTRAP/FOLFIRI regimen (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih s shemo ZALTRAP/FOLFIRI, so opažali večjo incidenco hude driske (glejte poglavje 4.8).
English: General disorders and administration site conditions Very common
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti astenična stanja astenična stanja
English: Skin and subcutaneous tissue disorders Very common
Slovenian: Bolezni kože in podkožja Zelo pogosti sindrom palmarno-plantarne eritrodizestezije
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of compromised wound healing (all grades) was 0.5 % for patients treated with ZALTRAP and 0.4 % for patients treated with placebo.
Slovenian: V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca slabšega celjenja ran (vseh stopenj) med prejemniki zdravila ZALTRAP 0,5 % in med prejemniki placeba 0,4 %.
English: Across the three Phase III placebo-controlled clinical studies (colorectal, pancreatic, and lung cancer populations), the incidence of nephrotic syndrome was 0.5 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Slovenian: Pri enem prejemniku sheme ZALTRAP/FOLFIRI, ki je imel proteinurijo in hipertenzijo, so postavili diagnozo trombotične mikroangiopatije (TMA) V treh s placebom kontroliranih kliničnih študijah III. faze (populacije s kolorektalnim rakom, rakom pankreasa in pljučnim rakom) je bila incidenca nefrotskega sindroma med prejemniki zdravila ZALTRAP 0,5 % in med prejemniki placeba 0,1 % (glejte poglavje 4.4).
English: Aflibercept treatment should be discontinued in patients who experience GI perforation (see section 4.2).
Slovenian: Pri bolnikih, ki se jim pojavi perforacija prebavil, je treba zdravljenje z afliberceptom prekiniti (glejte poglavje 4.2).
English: Grade 3 compromised wound healing was reported in 2 patients (0.3 %) treated with the ZALTRAP/FOLFIRI regimen and in none of the patients treated with the placebo/FOLFIRI regimen.
Slovenian: Slabše celjenje ran 3. stopnje se je pojavilo pri 2 (0,3 %) prejemnikih sheme ZALTRAP/FOLFIRI, med prejemniki sheme placebo/FOLFIRI pa se ni pojavilo.
English: Talk to your doctor for advice if you plan to have or father a child.
Slovenian: Če nameravate zanositi oz. zaploditi otroka, se posvetujte s svojim zdravnikom.
English: • you have illnesses where your gut is inflamed, such as an infected section of the bowel wall (also called ‘diverticulitis'), stomach ulcers or colitis.
Slovenian: • če imate bolezni, ki jih spremlja vnetje v prebavilih, na primer divertikulitis, želodčno razjedo ali kolitis- zdravilo ZALTRAP namreč lahko poveča tveganje za predrtje stene prebavil.
English: Fistula formation involving GI and non-GI sites has occurred in patients treated with ZALTRAP.
Slovenian: Bolnikom, zdravljenim z zdravilom ZALTRAP, so se pojavile fistule na gastrointestinalnih in negastrointestinalnih mestih.
English: Grade 3-4 fistula occurred in 0.2 % of patients treated with ZALTRAP and 0.1 % of patients treated with placebo (see section 4.4).
Slovenian: Fistule 3. do 4. stopnje so se pojavile pri 0,2 % prejemnikov zdravila ZALTRAP in pri 0,1 % prejemnikov placeba (glejte poglavje
English: Dysphonia Oropharyngeal pain
Slovenian: Občasni dispneja epistaksa disfonija orofaringealna bolečina
English: Compromised wound healing
Slovenian: Slabše celjenje ran
English: Decreased appetite Weight loss
Slovenian: Redki zmanjšan iztisni delež
English: Method of administration
Slovenian: NAČIN UPORABE
English: Performance status and co-morbidities
Slovenian: Stanje zmogljivosti bolnika in sočasne bolezni:
English: Deutschland Sanofi-Aventis Deutschland GmbH
Slovenian: Nederland sanofi-aventis Netherlands B.V.
English: Each infusion will take approximately 4 hours.
Slovenian: Vsaka infuzija traja približno 4 ure.
English: In addition, an updated RMP should be submitted:
Slovenian: Poleg tega je treba predložiti posodobljen RMP:
English: Date of latest renewal: 26 January 2011
Slovenian: Datum zadnjega podaljšanja: 26. januar 2011
English: The final study report under this CSP will be submitted by 31 July 2020.
Slovenian: Končno poročilo o študiji v okviru tega CSP bo predloženo do 31 julija 2020.
English: There are also links to other websites about rare diseases and treatments.
Slovenian: Kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Module 5 - Clinical
Slovenian: Modul 5 - Klinični
English: If you forget to take this medicine
Slovenian: Če ste pozabili vzeti to zdravilo
English: Risk Management Plan
Slovenian: Načrt obvladovanja tveganja
English: Your doctor may also give you additional medicines to manage any allergic reactions.
Slovenian: Zdravnik vam tudi lahko uvede dodatna zdravila za obvladovanje vseh alergičnih reakcij.
English: Currently available data are described in section 5.1.
Slovenian: Razpoložljivi podatki so navedeni v poglavju 5.1.
English: Improved hearing was noted in at least one ear for all four subjects.
Slovenian: Izboljšan sluh na vsaj enem ušesu je bil zabeležen pri vseh štirih preiskovancih.
English: Water for injections
Slovenian: Voda za injekcije.
English: Genotoxic and carcinogenic potential are not expected.
Slovenian: Genotoksični in karcinogeni potencial zdravila ni pričakovan.
English: Unopened vials: 3 years.
Slovenian: Neodprte viale: 3 leta
English: Urinary GAG levels decreased by more than 70%, consistent with results in older patients.
Slovenian: Vrednosti GAG v urinu so se zmanjšale za več kot 70%, kar je skladno z rezultati pri starejših bolnikih.
English: As a result, these substances do not get broken down and processed by the body as they should.
Slovenian: Posledica tega je, da telo teh snovi ne razgrajuje in ne presnavlja, kot bi jih moralo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 January 2006
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja: 24. januar 2006
English: The expiry date refers to the last day of that month.
Slovenian: do: Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Substudies will be conducted within the CSP that will:
Slovenian: V okviru CSP se bodo izvajale podštudije z namenom:
English: Detailed clinical status information will be collected at study entry and on an annual basis for at least 15 years.
Slovenian: Podatki o podrobnem kliničnem statusu se bodo zbirali ob vključitvi v študijo in na letni podlagi vsaj 15 let.
English: What this medicine is and what it is used for
Slovenian: Kaj je to zdravilo in za kaj ga uporabljamo
English: What this medicine is and what it is used for What you need to know before you are given this medicine How this medicine is given
Slovenian: Kaj je to zdravilo in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli to zdravilo Kako se daje to zdravilo
English: - If you have an allergic reaction your doctor may slow down, or stop, your infusion.
Slovenian: - Če imate alergijsko reakcijo, lahko vaš zdravnik upočasni ali prekine infuzijo.
English: This medicine contains a recombinant enzyme called galsulfase.
Slovenian: To zdravilo vsebuje rekombinantni encim, ki se imenuje galsulfaza.
English: Specific Obligations:
Slovenian: Posebne zahteve:
English: Other side effects with an unknown frequency:
Slovenian: Drugi neželeni učinki z neznano pogostnostjo:
English: Growth rate remained normal over this limited follow-up period.
Slovenian: V omejenem obdobju spremljanja je bila stopnja rasti normalna.
English: This can replace the natural enzyme which is lacking in MPS VI patients.
Slovenian: Ta lahko nadomesti naravni encim, ki bolnikom z boleznijo MPS VI primanjkuje.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: What you need to know before you are given this medicine
Slovenian: Kaj morate vedeti, preden boste prejeli to zdravilo
English: As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease.
Slovenian: Kot pri vseh lizosomskih genetskih motnjah je zlasti pri težjih oblikah primarnega pomena, da se zdravljenje začne čim prej, še preden se pojavijo nereverzibilne klinične manifestacije bolezni.
English: The current medical standards for emergency treatment are to be observed.
Slovenian: Upoštevati je treba veljavne standarde za nudenje nujne medicinske pomoči.
English: Several measures will be implemented to assess the Naglazyme dose.
Slovenian: Uvedeni bodo številni ukrepi za oceno odmerka zdravila Naglazyme.
English: The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction.
Slovenian: Večina bolnikov (42/59; 71 %) je poročala o vsaj enem neželenem učinku na zdravilo.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Slovenian: • v roku 60 dni po dosegu pomembnega farmakovigilančnega mejnika ali mejnika zmanjševanja tveganja);
English: Although limited by the very small number of patients that were enrolled, the conclusions that can be drawn from this study are the following:
Slovenian: Kljub omejitvi zaradi izredmo majhnega števila vklučenih bolnikov, lahko iz te raziskave potegnemo naslednje zaključke:
English: Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2).
Slovenian: Izločanje skozi ledvice velja za manj pomembno pot za očistek galsulfaze (glejte poglavje 4.2).
English: - This medicine has not been tested in patients with kidney or liver problems.
Slovenian: - Tega zdravila pri bolnikih z ledvičnimi ali jetrnimi težavami niso preizkušali.
English: Samples for total antibody will be collected at specific intervals.
Slovenian: Vzorci za skupna protitelesa se bodo jemali na določen interval.
English: As there is little experience on resumption of treatment following prolonged interruption, caution is to be used due to the theoretical increased risk of hypersensitivity reaction.
Slovenian: Ker obstaja le malo izkušenj o ponovnem pričetku zdravljenja po daljši prekinitvi, je treba posvetiti posebno pozornost teoretično povečanemu tveganju za razvoj preobčutljivostne reakcije.
English: Consequently, impaired liver function is not expected to affect the pharmacokinetics of galsulfase in a clinically significant way.
Slovenian: Posledično se ne pričakuje, da bi okvarjeno delovanje jeter vplivalo na farmakokinetiko galsulfaze v klinično pomembni obliki.
English: A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study.
Slovenian: Ključni namen je zdraviti mlade bolnike pred dopolnjenim petim letom starosti, ki trpijo za težko obliko bolezni, čeprav bolniki, mlajši od 5 let, niso bili vključeni v ključno klinično raziskavo faze III.
English: The molecule contains 6 N-linked oligosaccharide modification sites.
Slovenian: Molekula vsebuje 6 na N vezanih oligosaharidnih modifikacijskih mest.
English: If you get any of these symptoms, or other symptoms not listed in this leaflet, tell your doctor immediately.
Slovenian: Če opazite kateri koli simptom ali simptome, ki niso navedeni v tem navodilu, to takoj povejte svojemu zdravniku.
English: Sodium chloride
Slovenian: Natrijev klorid,
English: Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks).
Slovenian: Farmakokinetični parametri pri bolnikih, ki so sodelovali v kliničnih raziskavah faze I so ostali stabilni dolgo časa (skozi najmanj 194 tednov).
English: This leaflet was last revised in MM/YYYY
Slovenian: Navodilo je bilo nazadnje revidirano dne MM/YYYY
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kakor vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: As with any intravenous protein medicinal product, severe allergic-type hypersensitivity reactions are possible.
Slovenian: Kot pri vseh beljakovinskih zdravilih za intravensko uporabo so možne resne preobčutljivostne reakcije alergijskega tipa.
English: Pack sizes: 1 and 6 vials.
Slovenian: Velikosti pakiranj: 1 ali 6 vial.
English: Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy.
Slovenian: Višje ravni protiteles (≥ 65610 frakcije redčenja (DF - dilution fraction)) bodo primerjane z vrednostmi GAG v urinu tega bolnika z namenom oceniti morebitni vpliv na učinkovitost.
English: The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24.
Slovenian: Povprečni (SD) razpolovni čas izločanja (t1/2) v tednu 24 je bil 22,8 ( 10,7) minut.
English: This medicine may improve the symptoms of MPS VI.
Slovenian: To zdravilo lahko izboljša simptome MPS VI.
English: Management of infusion-associated reactions
Slovenian: Obvladovanje z infundiranjem povezanih reakcij
English: The CSP data will be analysed at yearly intervals and results will be submitted as annual reports.
Slovenian: Podatki CSP se bodo analizirali v letnih intervalih, rezultati pa bodo predloženi kot letna poročila.
English: The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation.
Slovenian: Osnovni princip encimskega nadomestnega zdravljenja je ponovno vzpostaviti nivo encimske aktivnosti, ki je zadostna za hidrolizo nakopičenega substrata in preprečitev nadaljnjega kopičenja.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem izdelku so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks.
Slovenian: Reakcije na infuzije so se lahko začele že v 1. tednu ali šele v 146. tednu zdravljenja z zdravilom Naglazyme, pojavile pa so se med več infundiranji, čeprav ne vedno v zaporednih tednih.
English: Based on data obtained during Naglazyme clinical trials, the majority of patients are expected to develop IgG antibodies to galsulfase within 4-8 weeks of treatment initiation.
Slovenian: Na osnovi podatkov, pridobljenih v času kliničnih preizkušanj Naglazyma, se za večino bolnikov pričakuje, da bodo razvili IgG protitelesa na galsulfazo v 4 - 8 tednih po pričetku zdravljenja.
English: See leaflet for further information.
Slovenian: Glejte navodila za nadaljnje informacije
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Slovenian: V skladu s smernicami CHMP glede sistema obvladovanja tveganja za zdravila za uporabo v humani medicini, mora biti vsak posodobljen RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila(PSUR).
English: Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”.
Slovenian: Neželeni učinki, o katerih so poročali v obdobju po začetku trženja, so zajeti v kategoriji pogostnosti »neznana pogostnost«.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance.
English: This medicine contains Sodium
Slovenian: To zdravilo vsebuje natrij
English: If you are given more Naglazyme than you should Naglazyme is administered under the supervision of a nurse or doctor, he or she will check that the correct dose has been given and act accordingly if necessary.
Slovenian: Če ste prejeli večji odmerek zdravila Naglazyme, kot bi smeli Naglazyme se daje pod nadzorom sestre ali zdravnika; eden ali drugi bo preveril, da ste prejeli pravilni odmerek in ustrezno ukrepal, če bo potrebno.
English: It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding.
Slovenian: Zdravljenje ni preprečilo napredovanja skeletne displazije in razvoja hernij ter ni preprečilo napredovanja motnjave roženice.
English: Limited data are available in patients < 1 year of age (see section 5.1).
Slovenian: Pri bolnikih, mlajših od 1 leta, je na razpolago le malo podatkov (glejte poglavje 5.1).
English: They accumulate in many tissues in the body, which causes the symptoms of MPS VI.
Slovenian: Zaradi tega se nabirajo v mnogih telesnih tkivih, kar povzroča simptome MPS VI.
English: Due to the small patient population, an adverse reaction in a single patient is classified as common.
Slovenian: Zaradi majhne populacije bolnikov je neželen učinek pri enem bolniku razvrščen med pogoste.
English: 46 Galli Drive, Novato, CA 94949 United States of America
Slovenian: BioMarin Pharmaceutical Inc., 46 Galli Drive, Novato, CA 94949 Združene države Amerike
English: In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol should be considered.
Slovenian: V primeru posamezne hude IAR, je treba infuzijo prekiniti, dokler simptomi ne izzvenijo in razmisliti o zdravljenju z antihistaminiki in paracetamolom.
English: - Please talk to your doctor if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems as these may be caused by pressure on your spinal cord.
Slovenian: - Povejte svojemu zdravniku, če imate mišične bolečine, otrplost rok ali nog ali težave s črevesjem ali mehurjem, saj jih morda povzroča pritisk na vašo hrbtenjačo.
English: When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.
Slovenian: Pri uporabi vsebnikov s 100 ml se lahko volumen zdravila Naglazyme dodaja neposredno v infuzijsko vrečko.
English: You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics).
Slovenian: Morda boste morali vzeti dodatna zdravila, ki bodo preprečila alergijsko reakcijo (npr. antihistaminiki in/ali kortikosteroidi) ali znižala povišano telesno temperaturo (antipiretiki).
English: Any unused product or waste material is to be disposed of in accordance with local requirements.
Slovenian: Vsa neporabljena količina zdravila ali odpadni material morata biti odstranjena v skladu z lokalnimi predpisi.
English: Very Common
Slovenian: zelo pogosti
English: If these reactions occur, immediate discontinuation of Naglazyme is recommended and appropriate medical treatment should be initiated.
Slovenian: V primeru takšne reakcije je priporočljivo takoj prekiniti aplikacijo Naglazyma in uvesti ustrezno zdravljenje.
English: Final CSP Study Report: 31 July activities.
Slovenian: Končno študijsko poročilo CPS: 31. julij 2020
English: Warnings and precautions - If you are treated with Naglazyme, you may develop infusion-associated reactions.
Slovenian: Opozorila in previdnostni ukrepi - Če se zdravite z Naglazymom, se lahko pri vas razvijejo z infundiranjem zdravila povezano reakcije.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje pred in med prisotnostjo zdravila na trgu.
English: Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation.
Slovenian: Zbirali se bodo tudi podatki o kliničnem statusu, neželenih učinkih, ocenitvi imunogenosti in možnih učinkov na nastajanje protiteles.
English: 6.6 Special precautions for disposal and other handling Each vial of Naglazyme is intended for single use only.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsaka viala Naglazymaz je namenjena samo za enkratno uporabo.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal raziskave in dodatne farmakovigilančne aktivnosti, podrobno opredeljene v farmakovigilančnem načrtu, sprejetem v različici 002 Načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Peri- and post-natal toxicity has not been investigated.
Slovenian: Obporodna in poporodna toksičnost nista bili raziskani.