FrancophonIA/ELRC3.0 huggingface dataset:
English: In the course of the meeting, it became clear that there would be neither a qualified majority in support of a draft Commission decision following the opinion of the CHMP nor a qualified majority against it.
Slovenian: Med sestankom je postalo jasno, da osnutka Odločbe Komisije na podlagi mnenja CHMP ne bo podprla kvalificirana večina, prav tako pa kvalificirana večina ne bo proti njemu.
English: This approach is strengthened by the fact that a full risk-benefit assessment is to be conducted in the framework an Article 31 procedure, where the risks of nimesulide will be weighted vis-à-vis the gastrointestinal risks of other products.
Slovenian: Ta pristop krepi dejstvo, da je treba celovito oceno tveganja in koristi izvesti v okviru postopka iz člena 31, med katerim se bodo tveganja v zvezi z nimesulidom obravnavala glede na gastrointestinalna tveganja drugih proizvodov.
English: A significant number of members of the Committee expressed however a divergent opinion, sustaining that the benefit/risk profile of these products should be considered negative and that the marketing authorisations should rather be revoked.
Slovenian: Precejšnje število članov odbora pa je kljub temu nasprotno menilo, da je treba lastnosti glede koristi/tveganja teh proizvodov obravnavati negativno in da je treba dovoljenja za promet ukiniti.
English: Upon recommendation from the CHMP, given that an assessment of the gastrointestinal toxicity of nimesulide was outside the scope of the review procedure under Article 107, the Commission will initiate a referral under Article 31 of Directive 2001/83/EC, under which a full risk-benefit assessment will be undertaken.
Slovenian: Glede na to, da je bila ocena gastrointestinalne toksičnosti nimesulida zunaj obsega revizijskega postopka iz člena 107, bo Komisija na podlagi priporočila CHMP začela postopek iz člena 31 Direktive 2001/83/ES, v okviru katerega se bo izvedla celovita ocena tveganja in koristi.
English: It also appeared that a fundamental disagreement persisted among Member States competent authorities on whether risk minimisation measures were capable of addressing the risk of hepatotoxicity of the product.
Slovenian: Izkazalo se je tudi, da pri pristojnih organih držav članic ostaja temeljno nesoglasje o tem, ali je bilo z ukrepi za zmanjševanje tveganj mogoče odpraviti tveganje jetrne toksičnosti proizvoda.
English: • Nimesulide presents a risk of hepatotoxicity, including risk of fulminant hepatic failure.
Slovenian: • nimesulid povzroča tveganje za jetrno toksičnost, vključno s fulminantno jetrno odpovedjo,
English: Therefore, an increase in gastrointestinal toxicity events may occur if nimesulide ceases to be available.
Slovenian: Če nimesulid ne bi bil več na voljo, se lahko poveča število pojavov gastrointestinalne toksičnosti,
English: This is a summary of the European public assessment report (EPAR) for Tolucombi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tolucombi.
English: The full EPAR for Tolucombi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Tolucombi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tolucombi on 13 March 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tolucombi, veljavno po vsej Evropski uniji, odobrila dne 13. marca 2013.
English: What measures are being taken to ensure the safe and effective use of Tolucombi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tolucombi?
English: This means that Tolucombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu MicardisPlus.
English: The Committee recommended that Tolucombi be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Tolucombi odobri za uporabo v EU.
English: Tolucombi telmisartan / hydrochlorothiazide
Slovenian: Tolucombi telmisartan/hidroklorotiazid
English: Because Tolucombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Tolucombi generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Other information about Tolucombi
Slovenian: Druge informacije o zdravilu Tolucombi
English: Tolucombi is a ‘generic medicine'.
Slovenian: Zdravilo Tolucombi je „generično zdravilo“.
English: A risk management plan has been developed to ensure that Tolucombi is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Tolucombi je bil izdelan načrt obvladovanja tveganj.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tolucombi, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Tolucombi vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Tolucombi is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Slovenian: Zdravilo Tolucombi je na voljo v obliki tablet (40 mg ali 80 mg telmisartana in 12,5 mg hidroklorotiazida; 80 mg telmisartana in 25 mg hidroklorotiazida), ki se zaužijejo peroralno enkrat dnevno skupaj s tekočino.
English: What are the benefits and risks of Tolucombi?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Tolucombi?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tolucombi has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Tolucombi primerljivo raven kakovosti kot zdravilo MicardisPlus ter da mu je biološko enakovredno.
English: For more information about treatment with Tolucombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Tolucombi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Because Tolucombi is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Slovenian: Ker je zdravilo Tolucombi generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu MicardisPlus.
English: For practical information about using Tolucombi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Tolucombi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: What is Tolucombi and what is it used for?
Slovenian: Kaj je zdravilo Tolucombi in za kaj se uporablja?
English: The dose of Tolucombi to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Slovenian: Odmerek zdravila Tolucombi je odvisen od odmerka telmisartana, ki ga je bolnik jemal pred tem: bolniki, ki so prejemali 40 mg telmisartana, morajo jemati tablete po 40/12,5 mg, tisti, ki pa so prejemali 80 mg telmisartana, pa morajo jemati tablete po 80/12,5 mg. Tablete po 80/25 mg se dajejo bolnikom, pri katerih se krvni tlak ne uravna z jemanjem tablet po 80/12,5 mg ali pri katerih se je krvni tlak stabiliziral z uporabo dveh zdravilnih učinkovin, ki so ju jemali ločeno, preden so prešli na zdravilo Tolucombi.
English: Tolucombi is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: Tolucombi je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: Why is Tolucombi approved?
Slovenian: Zakaj je bilo zdravilo Tolucombi odobreno?
English: Tolucombi contains two active substances, telmisartan and hydrochlorothiazide.
Slovenian: Zdravilo Tolucombi vsebuje dve zdravilni učinkovini, telmisartan in hidroklorotiazid.
English: It is not intended to provide practical advice on how to use Tolucombi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How has Tolucombi been studied?
Slovenian: Kako je bilo zdravilo Tolucombi raziskano?
English: How does Tolucombi work?
Slovenian: Kako zdravilo Tolucombi deluje?
English: How is Tolucombi used?
Slovenian: Kako se zdravilo Tolucombi uporablja?
English: 4.8 Undesirable effects a.Summary of the safety profile
Slovenian: 4.8 Neželeni učinki a. Povzetek varnostnega profila
English: Tell your doctor or pharmacist if you are using have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The needle safety guard will rapidly move to cover the needle (see picture 7).
Slovenian: Varnostni pripomoček se bo hitro premaknil, da bo pokril iglo (glejte sliko 7).
English: - osteoporosis (bone disease).
Slovenian: - osteoporozo (bolezen kosti).
English: Date of first authorisation: 15 September 2008.
Slovenian: Datum prve odobritve: 15. september 2008 Datum zadnjega podaljšanja: 19. julij 2013
English: Congenital, idiopathic or cyclic neutropenia:
Slovenian: Prirojena, idiopatska ali ciklična nevtropenija:
English: Do not warm Tevagrastim in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: Zdravila Tevagrastim ne smete segrevati na kak drug način (na primer v mikrovalovni pečici ali v vroči vodi).
English: Your doctor may want to monitor you closely , see section 4 of the package leaflet.
Slovenian: Zdravnik vas bo morda želel pozorno spremljati, glejte poglavje 4 v teh navodilih za uporabo.
English: Do not release the pressure on the plunger!
Slovenian: Ne popustite pritiska na bat!
English: Before you inject Tevagrastim you must do the following:
Slovenian: Pred injiciranjem zdravila Tevagrastim morate narediti naslednje:
English: TEVA GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Slovenian: Graf-Arco-Straße 3 89079 Ulm
English: Push the plunger up to the number (mL) on the syringe that matches the dose of Tevagrastim that your doctor prescribed.
Slovenian: Bat potisnite navzgor do številke (ml), ki se sklada z odmerkom zdravila Tevagrastim, ki vam ga je predpisal vaš zdravnik.
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Slovenian: Če je razredčeno v raztopini glukoze 50 mg/ml (5 %) za infundiranje, je zdravilo Tevagrastim kompatibilno s steklom in vrsto plastičnih snovi, med katerimi so PVC, poliolefin (kopolimer polipropilena in polietilena) in polipropilen.
English: If you develop or are likely to develop cancers of the blood, you should not use Tevagrastim, unless instructed by your doctor.
Slovenian: Če se pri vas razvije krvni rak ali je verjetno, da se bo, zdravila Tevagrastim ne smete uporabljati, razen če vam tega ne naroči vaš zdravnik.
English: Following established chemotherapy for solid tumours, lymphomas and lymphoid leukaemias, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Slovenian: Po uveljavljeni kemoterapiji za čvrste tumorje, limfome in pri limfoidini levkemiji se pričakuje, da bo trajanje zdravljenja, če želimo doseči zahtevane kriterije, do 14 dni.
English: Teva UK Limited Tel: +44 1977 628500
Slovenian: United Kingdom Teva UK Limited Tel: +44 1977 628500
English: b. Tabulated summary of adverse reactions
Slovenian: b. Tabelarični povzetek neželenih učinkov
English: Tevagrastim contains sorbitol (E420).
Slovenian: Zdravilo Tevagrastim vsebuje sorbitol (E420).
English: If you are a patient with severe chronic neutropenia, you may be at risk of developing cancer of the blood (leukaemia, myelodysplastic syndrome [MDS]).
Slovenian: Če ste bolnik s hudo kronično nevtropenijo, lahko pri vas obstaja tveganje za nastanek krvnega raka (levkemija, mielodisplastični sindrom (MDS - myelodisplastic syndrome)).
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Tevagrastim was comparable to that of the reference product after subcutaneous and intravenous administration.
Slovenian: Randomizirane, enojno slepe navzkrižne študije z enkratnim odmerkom pri 196 zdravih prostovoljcih so pokazale, da je farmakokinetičen profil zdravila Tevagrastim primerljiv s profilom referenčnega zdravila po subkutanem in intravenskem apliciranju.
English: The results of flow cytometric analysis of CD34+ cell numbers vary depending on the precise methodology used and recommendations of numbers based on studies in other laboratories need to be interpreted with caution.
Slovenian: Rezultati meritev števila celic CD34+ s pretočno citometrijo se med seboj razlikujejo glede na dejansko uporabljeno metodologijo, zato je treba priporočila o številu celic, ki temeljijo na študijah v drugih laboratorijih, interpretirati previdno.
English: How long will I have to take Tevagrastim?
Slovenian: Koliko časa bom moral jemati zdravilo Tevagrastim?
English: Check again to make sure the correct dose of Tevagrastim is in the syringe.
Slovenian: Še enkrat preverite, če je v brizgi ustrezen odmerek zdravila Tevagrastim.
English: The efficacy and safety of Tevagrastim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Slovenian: Učinkovitost in varnost zdravila Tevagrastim sta bili ocenjeni v randomiziranih in nadzorovanih študijah faze III pri bolnikih z rakom dojk, rakom na pljučih in Ne-Hodkinovim limfomom.
English: if you are being treated for severe chronic neutropenia and you have blood in your urine (haematuria).
Slovenian: - če vas zdravijo zaradi hude kronične nevtropenije in imate kri v urinu (hematurija).
English: This section contains information on how to give yourself an injection of Tevagrastim.
Slovenian: To poglavje vsebuje podatke o tem, kako si sami injicirate zdravilo Tevagrastim.
English: Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Slovenian: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG,
English: Timing of leukapheresis: 1 or 2 leukapheresis on days 5 and 6 are often sufficient.
Slovenian: Časovna razporeditev levkaferez: običajno zadostujeta 1 do 2 levkafrezi 5. in 6. dan.
English: What should I do before I give myself a subcutaneous injection of Tevagrastim?
Slovenian: Kaj moram narediti, preden si dam subkutano injekcijo zdravila Tevagrastim?
English: Tevagrastim is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines called cytokines.
Slovenian: Zdravilo Tevagrastim je rastni faktor za bele krvničke (granulocitne kolonije stimulirajoči faktor) in spada v skupino zdravil, imenovanih citokini.
English: Assessment of progenitor cell yields
Slovenian: Ocena donosa matičnih celic
English: You will need to take Tevagrastim until your white blood cell count is normal.
Slovenian: Zdravilo Tevagrastim boste morali jemati, dokler ne bo število belih krvničk v vaši krvi normalno.
English: Teva Finland Oy Puh/Tel: +358 20 180 5900
Slovenian: Suomi/Finland Teva Finland Oy Puh/Tel: +358 20 180 5900
English: Nevertheless, a risk of promotion of a malignant myeloid clone can not be excluded.
Slovenian: Tveganja za napredovanje mieloidnega rakastega klona ni možno izključiti.
English: If you use more Tevagrastim than you should, contact your doctor or pharmacist as soon as possible.
Slovenian: Če ste uporabili večji odmerek zdravila Tevagrastim, kot bi smeli, se čimprej posvetujte z zdravnikom ali farmacevtom.
English: To give yourself a subcutaneous injection you will need: - a pre-filled syringe of Tevagrastim; - alcohol wipes or similar.
Slovenian: Za subkutano samoinjiciranje boste potrebovali: - napolnjeno injekcijsko brizgo z zdravilom Tevagrastim, - alkoholne krpice ali podobno,
English: Tevagrastim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Slovenian: Zdravilo Tevagrastim običajno dajemo vsakodnevno v obliki injekcije v tkivo tik pod kožo (temu pravimo subkutana injekcija).
English: There were no relevant differences between Tevagrastim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Slovenian: Med zdravilom Tevagrastim in referenčnim zdravilom ni bilo očitne razlike v zvezi s trajanjem hude nevtropenije in nastanka febrilne nevtropenije.
English: Take your Tevagrastim pre-filled syringe out of the refrigerator.
Slovenian: Vzemite napolnjeno injekcijsko brizgo z zdravilom Tevagrastim iz hladilnika.
English: In randomised clinical trials, a subcutaneous dose of 23 MIU (230 μg)/m2/day (4.0 to 8.4 μg/kg/day) was used.
Slovenian: V randomiziranih kliničnih preskušanjih so uporabljali subkutani odmerek 23 milijonov i.e. (230 μg)/m2/dan (4,0 do 8,4 μg/kg/dan).
English: Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Slovenian: Razkužite mesto injiciranja z alkoholno krpico in primite kožo s palcem in kazalcem, ne da bi jo stiskali (glejte sliko 5).
English: A subset of approximately 12 % of patients who had normal cytogenetic evaluations at baseline was subsequently found to have abnormalities, including monosomy 7, on routine repeat evaluation.
Slovenian: Pri podskupini približno 12 % bolnikov, ki so imeli na začetku normalen citogenetski izvid, so pri poznejšem ponovnem rutinskem pregledu ugotovili nepravilnosti, vključno z monosomijo 7.
English: Because of the potential of receiving higher doses of chemotherapy (e.g., full doses on the prescribed schedule) the patient may be at greater risk of thrombocytopenia and anaemia.
Slovenian: Zaradi možnosti prejemanja večjih odmerkov kemoterapije (npr. polnih odmerkov po predpisani shemi), je lahko bolnik bolj ogrožen zaradi trombocitopenije in anemije.
English: White blood cell counts of 100 x 109/L or greater have been observed in less than 5 % of patients receiving filgrastim at doses above 0.3 MIU/kg/day (3 μg/kg/day).
Slovenian: Število belih krvničk 100 x 109/l ali več so ugotovili pri manj kot 5 % bolnikov z rakom, ki so prejemali filgrastim v odmerkih, večjih od 0,3 M i.e./kg/dan (3 μg/kg/dan).
English: Other medicines and Tevagrastim
Slovenian: Druga zdravila in zdravilo Tevagrastim
English: TEVA GmbH Tel: +49 731 402 08
Slovenian: Deutschland TEVA GmbH Tel: +49 731 402 08
English: Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Slovenian: Zdravilo Tevagrastim se uporablja za zdravljenje dolgotrajne nevtropenije (ANC manjše ali enako 1,0 x 109/l) pri bolnikih z napredovalo okužbo HIV, z namenom zmanjšanja tveganja bakterijskih okužb, ko druge oblike zdravljenja nevtropenije niso primerne.
English: If you forget to use Tevagrastim
Slovenian: Če ste pozabili uporabiti zdravilo Tevagrastim
English: Contents of the pack and other information What Tevagrastim contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Tevagrastim
English: Offspring of rats administered filgrastim during the peri-natal and lactation periods, exhibited a delay in external differentiation and growth retardation (≥ 20 µg/kg/day) and slightly reduced survival rate (100 µg/kg/day).
Slovenian: Pri potomcih podgan, ki so jim dali filgrastim v času poroda ali obdobju laktacije, so opazili zamudo v zunanji diferenciaciji in zastoj rasti (≥ 20 µg/kg/dan) in nekoliko zmanjšano stopnjo preživetja
English: Pre-filled syringe (type I glass) with injection needle (stainless steel), with or without a needle safety guard.
Slovenian: Napolnjena injekcijska brizga (steklo tipa I) z injekcijsko iglo (iz nerjavečega jekla), z varnostno zaščito za iglo ali brez nje.
English: A common side effect of Tevagrastim use is pain in your muscles or bones (musculoskeletal pain), which could be relieved by taking standard pain relief medicines (analgesics).
Slovenian: Pogost neželeni učinek uporabe zdravila Tevagrastim so bolečine v mišicah in kosteh (mišičnoskeletne bolečine), ki jih je mogoče lajšati s standardnimi protibolečinskimi zdravili (analgetiki).
English: Using the pre-filled syringe without a needle safety guard Administer the dose as per standard protocol.
Slovenian: Uporaba napolnjene injekcijske brizge brez varnostne zaščite za iglo Odmerek aplicirajte po standardnem protokolu.
English: Tevagrastim is a solution for injection/infusion in a pre-filled syringe.
Slovenian: Zdravilo Tevagrastim je raztopina za injiciranje/infundiranje v napolnjeni injekcijski brizgi.
English: In view of the possible risk of microbial contamination, Tevagrastim syringes are for single use only.
Slovenian: Ker obstaja tveganje mikrobne kontaminacije so z zdravilom Tevagrastim napolnjene brizge namenjene izključno enkratni uporabi.
English: One retrospective European study evaluating the use of G-CSF after allogeneic bone marrow transplantation in patients with acute leukaemias suggested an increase in the risk of GvHD, treatment related mortality (TRM) and mortality when G-CSF was administered.
Slovenian: Ena retrospektivna evropska študija, v kateri so ocenili uporabo G-CSF po alogenski presaditvi kostnega mozga pri bolnikih z akutno levkemijo, je pokazala zvišanje tveganja za GvHD, z zdravljenjem povezano smrtnostjo (treatment related mortality - TRM) in smrtnost pri uporabi
English: In a separate retrospective international study in patients with acute and chronic myelogenous leukaemias, no effect on the risk of GvHD, TRM and mortality was seen.
Slovenian: V drugi retrospektivna mednarodna študija pri bolnikih z akutnimi in kroničnimi mielogenimi levkemijami niso opazili tveganja za GvHD, TRM in smrtnost.
English: While maintaining pressure on the plunger, remove the syringe from the patient.
Slovenian: Medtem ko še vedno vzdržujete pritisk na bat, odstranite iglo iz bolnika.
English: Based on reported data for another filgrastim product similar to the reference product, comparable findings plus increased foetal malformations were observed at 100 µg/kg/day, a maternally toxic dose which corresponded to a systemic exposure of approximately 50-90 times the exposures observed in patients treated with the clinical dose of 5 µg/kg/day.
Slovenian: Na osnovi podatkov za drugo zdravilo, ki vsebuje filgrastim in je podobno referenčnem zdravilu, so primerljive ugotovitve ter zvečano število malformacij ploda opazili pri 100 µg/kg/dan, pri odmerku, ki je bil toksičen za mater in ustreza približno 50-90-krat večji sistemski izpostavljenosti kot je izpostavljenost bolnikov, ki se zdravijo s kliničnimi odmerki 5 μg/kg/dan.