FrancophonIA/ELRC3.0 huggingface dataset:
English: Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
Slovenian: Filgrastim je indiciran za skrajšanje trajanja nevtropenije in pri nastanku febrilne nevtropenije pri bolnikih, zdravljenih z uveljavljeno citotoksično kemoterapijo zaradi malignoma (z izjemo kronične mieloične levkemije in mielodisplastičnih sindromov), ter za skrajšanje trajanja nevtropenije pri bolnikih, ki se zdravijo z mieloablativnim zdravljenjem, ki mu sledi presaditev kostnega mozga, pri katerih obstaja tveganje za pojav daljše hude nevtropenije.
English: Filgrastim had no observed effect on the fertility of male or female rats.
Slovenian: Filgrastim ni imel vpliva na plodnost podganjih samčkov ali samic.
English: As a result of the potential to receive higher doses or a greater number of these medications with filgrastim therapy, the patient may be at higher risk of developing thrombocytopenia and anaemia.
Slovenian: Ker obstaja možnost, da bo bolnik ob zdravljenju s filgrastimom prejemal večje odmerke ali večje število teh zdravil, je lahko bolnik izpostavljen večjemu tveganju za nastanek trombocitopenije in anemije.
English: Nivestim is a biosimilar medicinal product.
Slovenian: Zdravilo Nivestim je biološko podobno zdravilo.
English: Within its shelf-life and for the purpose of ambulatory use, the patient may remove the product from the refrigerator and store it at room temperature (not above 25°C) for one single period of up to 15 days.
Slovenian: Znotraj roka uporabnosti lahko pri ambulantni uporabi bolnik vzame zdravilo iz hladilnika in ga hrani pri sobni temperaturi (do 25 °C) do največ 15 dni.
English: Do not use the Nivestim syringe if the liquid has particles floating in it or any of the liquid has leaked out of the syringe.
Slovenian: Brizge zdravila Nivestim ne smete uporabiti, če v tekočini plavajo delci ali če je iz brizge izteklo nekaj tekočine.
English: Pseudogout (chondrocalcinosis pyrophosphate)
Slovenian: Psevdoprotin (pirofosfatna hondrokalcinoza)
English: Physicians should use caution when prescribing filgrastim in patients with sickle cell trait or sickle cell disease.
Slovenian: Zdravniki morajo biti previdni, ko predpisujejo filgrastim pri bolnikih z genetsko predispozicijo za srpaste celice ali z anemijo srpastih celic.
English: • swelling and/or fluid in the lungs (pulmonary oedema)
Slovenian: • oteklina in/ali tekočina v pljučih (pljučni edem)
English: Diluted filgrastim may be adsorbed to glass and plastic materials unless it is diluted in 5% glucose solution (see section 6.6).
Slovenian: Razredčen filgrastim se lahko adsorbira na steklo in plastične materiale, razen če je razredčen s 5odstotno raztopino glukoze (glejte poglavje 6.6).
English: • plum-coloured, raised, painful sores on the limbs and sometimes the face and neck with a fever
Slovenian: • boleče izbočene razjede slivnate barve na okončinah in včasih na obrazu in vratu, skupaj z vročino (Sweetov sindrom)
English: • tingling or numbness of the hands or feet (paraesthesia)
Slovenian: • mravljinčenje ali odrevenelost dlani ali stopal (parestezija)
English: Adverse events with higher incidence in filgrastim patients compared to placebo and associated with the sequelae of the underlying malignancy or cytotoxic chemotherapy.
Slovenian: Neželeni učinki z večjo pojavnostjo pri bolnikih, ki so prejemali filgrastim, v primerjavi s placebom in povezani s posledicami osnovne maligne bolezni ali citotoksične kemoterapije.
English: • get left upper belly (abdominal) pain, pain below the left rib cage or at the tip of your left shoulder (these may be symptoms of an enlarged spleen (splenomegaly), or possibly rupture of the spleen).
Slovenian: • imate bolečine v zgornjem levem delu trebuha, bolečine pod levo stranjo prsnega koša ali na vrhu leve rame (to so lahko simptomi povečane vranice (splenomegalija) ali možnega pretrganja vranice).
English: - if you have a combination of any of the following symptoms: o fever, or shivering, or feeling very cold, high heart rate, confusion or disorientation, shortness of breath, extreme pain or discomfort and clammy or sweaty skin.
Slovenian: - če se vam pojavi kombinacija katerihkoli izmed naslednjih neželenih učinkov: o vročina ali drhtenje ali hudo mrazenje, hiter srčni utrip, zmedenost ali dezorientiranost, kratka sapa, izjemna bolečina ali nelagodje ter lepljiva ali znojna koža.
English: Please tell your doctor immediately during treatment with Nivestim, if you:
Slovenian: Med zdravljenjem z zdravilom Nivestim takoj obvestite zdravnika, če:
English: Dose adjustment: Filgrastim should be administered daily by subcutaneous injection until the neutrophil count has reached and can be maintained at more than 1.5 x 10
Slovenian: Prilagoditev odmerka: filgrastim je treba bolniku dajati vsak dan v obliki subkutane injekcije, dokler število nevtrofilcev ne doseže vrednosti 1,5 x 10
English: Analysis includes patients receiving BM transplant during this period.
Slovenian: Analiza je vključevala bolnike, ki so jim v tem času presadili kostni mozeg.
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 ločeni retrospektivni mednarodni študiji pri bolnikih z akutno in kronično mieloično levkemijo niso opazili nobenega učinka na tveganje za pojav reakcij presadka proti gostitelju, z zdravljenjem povezane umrljivosti in za umrljivost.
English: Congenital neutropenia: the recommended starting dose is 1.2 MU (12 µg)/kg/day as a single dose or in divided doses.
Slovenian: Prirojena nevtropenija: priporočeni začetni odmerek je 1,2 M e. (12 µg)/kg/dan v obliki enkratnega odmerka ali deljenih odmerkov.
English: Therefore, in patients with reduced precursors neutrophil response may be diminished (such as those treated with extensive radiotherapy or chemotherapy, or those with bone marrow infiltration by tumour).
Slovenian: Zaradi tega je pri bolnikih z zmanjšanim številom predhodnikov nevtrofilcev (na primer pri tistih, ki se zdravijo z obsežno radioterapijo ali kemoterapijo, oziroma pri tistih s tumorsko infiltracijo kostnega mozga) odziv števila nevtrofilcev lahko manjši.
English: • pain in your mouth and throat (oropharyngeal pain)
Slovenian: • bolečina v ustih in žrelu (orofaringealna bolečina)
English: There is insufficient data to evaluate filgrastim use in geriatric subjects for other approved filgrastim indications.
Slovenian: Pri starejših preiskovancih ni dovolj podatkov za oceno uporabe filgrastima pri drugih odobrenih indikacijah za filgrastim.
English: For the mobilisation of PBPCs in patients undergoing myelosuppressive or myeloablative therapy followed by autologous PBPC transplantation
Slovenian: Za mobilizacijo PBPC pri bolnikih, zdravljenih z mielosupresivno ali mieloablativno terapijo, ki ji sledi avtologna presaditev PBPC.
English: • high blood pressure (hypertension)
Slovenian: • visok krvni tlak (hipertenzija)
English: There have been reports of GvHD and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.4 and 5.1).
Slovenian: Obstajajo poročila o GvHD in o smrtnih primerih pri bolnikih, ki so prejemali G-CSF po alogenski presaditvi kostnega mozga (glejte poglavji 4.4 in 5.1).
English: In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section
Slovenian: V kliničnih raziskavah in v obdobju trženja zdravila so poročali o primerih neželenih učinkov na pljuča, vključno z intersticijsko boleznijo pljuč, pljučnim edemom in pljučno infiltracijo, pri čemer je v nekaj primerih prišlo do odpovedi dihanja ali sindroma akutne dihalne stiske (ARDS - Acute Respiratory Distress Syndrome), ki je lahko smrten (glejte poglavje 4.4).
English: Filgrastim is not recommended during pregnancy.
Slovenian: Uporaba filgrastima med nosečnostjo ni priporočljiva.
English: There are no or limited amount of data from the use of filgrastim in pregnant women.
Slovenian: Podatkov o uporabi filgrastima pri nosečnicah ni oziroma so omejeni.
English: Recipients of allogeneic PBPCs mobilised with filgrastim experienced significantly more rapid haematological recovery, leading to a significant decrease in time to unsupported platelet recovery when compared with allogeneic bone marrow transplantation.
Slovenian: Pri prejemnikih alogenskih PBPC, mobiliziranih s filgrastimom, je bilo opaziti bistveno hitrejše hematološko okrevanje, pri čemer je bilo za ponovno tvorbo trombocitov brez podpornega zdravljenja potrebno znatno manj časa, v primerjavi z alogensko presaditvijo kostnega mozga.
English: Nivestim has not been tested in pregnant or breast-feeding women.
Slovenian: Uporabe zdravila Nivestim pri nosečnicah in doječih ženskah niso preskušali.
English: cells re-infused and the rate of platelet recovery after high-dose chemotherapy indicates a complex but continuous relationship.
Slovenian: + in hitrostjo vračanja števila trombocitov na normalo po kemoterapiji v velikih odmerkih je pokazala zapleteno, a stalno medsebojno odvisnost.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE GLEDE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care (see section 4.8).
Slovenian: Zanj so značilni hipotenzija, hipoalbuminemija, edemi in hemokoncentracija.Bolnike, ki se jim pojavijo simptomi sindroma kapilarne prepustnosti, je treba skrbno spremljati, prejeti pa morajo tudi standardno simptomatsko zdravljenje, ki lahko vključuje potrebo po intenzivni negi (glejte poglavje 4.8).
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih transfuzijska reakcija
English: The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Slovenian: Varnost in učinkovitost filgrastima sta podobni pri odraslih in otrocih, ki so prejemali citotoksično kemoterapijo.
English: Myelodysplastic syndrome or Chronic myeloid leukaemia
Slovenian: Mielodisplastični sindrom ali kronična mieloična levkemija
English: added.
Slovenian: uporabi.
English: MDS and leukaemias are natural complications of the disease and are of uncertain relation to filgrastim therapy.
Slovenian: Mielodisplastični sindromi in levkemija so običajni zapleti pri tem obolenju, njihova povezanost z uporabo filgrastima pa ni potrjena.
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Slovenian: Povedati morate tudi, če vaš otrok ne more več uživati sladke hrane ali pijače, ker mu je po njej slabo, bruha ali ima težave, kot so napihnjenost, želodčni krči ali driska.
English: The recommended dose of filgrastim for PBPC mobilisation after myelosuppressive chemotherapy is 0.5 MU (5 µg)/kg/day from the first day after completion of chemotherapy until the expected neutrophil nadir is passed and the neutrophil count has recovered to the normal range.
Slovenian: Priporočeni odmerek filgrastima za mobilizacijo krvotvornih matičnih celic v periferno kri po mielosupresivni kemoterapiji je 0,5 M e. (5 µg)/kg/dan, od prvega dne po zaključku kemoterapije in dokler se število nevtrofilcev ne premakne s pričakovane najnižje vrednosti in se povrne v območje normalnih vrednosti.
English: 30 MU (300 µg)/day on 1 to 7 days per week was required to maintain the ANC > 2.0 x 10
Slovenian: V kliničnih študijah je bilo potrebno odmerjanje po 30 M e. (300 µg)/dan v obdobju 1 do 7 dni na teden za ohranjanje vrednosti ANC > 2,0 x 10
English: Store and transport refrigerated (2°C to 8°C).
Slovenian: Zdravilo shranjujte in prevažajte na hladnem (2 °C do 8 °C).
English: It can also be given as a daily slow injection into the vein (known as an intravenous infusion).
Slovenian: Prav tako ga je mogoče dajati kot vsakodnevno počasno injekcijo v žilo (temu pravimo intravenska infuzija)Običajni odmerek je odvisen od vaše bolezni in telesne mase.
English: It is better to change the injection site every day to avoid the risk of soreness at any one site.
Slovenian: Najbolje je, da si zdravilo vsak dan injicirate na drugo mesto, da ne bo eno mesto postalo preveč boleče.
English: The most commonly reported adverse reactions are pyrexia, musculoskeletal pain (which includes bone pain, back pain, arthralgia, myalgia, pain in extremity, musculoskeletal pain, musculoskeletal chest pain, neck pain), anaemia, vomiting, and nausea.
Slovenian: Neželeni učinki, o katerih so najpogosteje poročali, so pireksija, mišično-skeletna bolečina (ki vključuje bolečino v kosteh, bolečino v hrbtu, artralgijo, mialgijo, bolečino v okončinah, mišičnoskeletno bolečino, mišično-skeletno bolečino v prsnem košu, bolečino v vratu), anemija, bruhanje in navzea.
English: Store and transport refrigerated (2°C - 8°C).
Slovenian: Zdravilo shranjujte in prevažajte na hladnem (2 °C - 8 °C).
English: Regular monitoring of platelet count and haematocrit is recommended.
Slovenian: Priporočljivo je redno spremljanje števila trombocitov in hematokrita.
English: 9/L after the expected nadir, filgrastim should be discontinued immediately.
Slovenian: 9/l, je treba takoj prenehati z dajanjem filgrstima.
English: Treatment with filgrastim significantly reduces the durations of febrile neutropenia, antibiotic use and hospitalisation after induction chemotherapy for acute myelogenous leukaemia or myeloablative therapy followed by bone marrow transplantation.
Slovenian: Zdravljenje s filgrastimom značilno skrajša trajanje febrilne nevtropenije, čas uporabe antibiotikov in hospitalizacijo po indukcijski fazi kemoterapije pri akutni mieloični levkemiji ali mieloablativni terapiji, ki ji sledi presaditev kostnega mozga.
English: • injection site reaction
Slovenian: • reakcija na mestu injiciranja
English: - if you get left upper belly (abdominal) pain, pain below the left rib cage or pain at the tip of your shoulder, as there may be a problem with your spleen (enlargement of the spleen (splenomegaly) or rupture of the spleen).
Slovenian: - če imate bolečine v zgornjem levem delu trebuha, bolečine pod levo stranjo prsnega koša ali na vrhu rame, saj gre lahko za težave z vranico (povečana vranica (splenomegalija) ali pretrganje vranice).
English: Filgrastim should not be administered to patients with severe congenital neutropenia who develop leukaemia or have evidence of leukaemic evolution.
Slovenian: Filgrastima se ne sme uporabljati pri bolnikih s hudo prirojeno nevtropenijo, pri katerih se pojavi levkemija ali ki kažejo znake razvoja levkemije.
English: Agents such as melphalan, carmustine (BCNU), and carboplatin, when administered over prolonged periods prior to attempts at progenitor mobilisation may reduce progenitor yield.
Slovenian: Dolgotrajnejša uporaba zdravil, kot so melfalan, karmustin (BCNU) in karboplatin pred poskusom mobilizacije krvotvornih matičnih celic lahko zmanjša pričakovani delež teh celic.
English: • pain when passing urine (dysuria)
Slovenian: • bolečine pri uriniranju (disurija)
English: There is insufficient data to further evaluate filgrastim use in paediatric subjects.
Slovenian: Za nadaljnjo oceno uporabe filgrastima pri pediatričnih preiskovancih ni dovolj podatkov.
English: The incidence of fever and documented infections were not reduced in either setting.
Slovenian: V nobenem izmed primerov se ni zmanjšala incidenca zvišane telesne temperature in dokumentiranih okužb.
English: There have been reports of graft versus host disease (GvHD) and fatalities in patients receiving G-CSF after allogeneic bone marrow transplantation (see sections 4.8 and 5.1).
Slovenian: Obstajajo poročila o reakcijah presadka proti gostitelju (»Graft versus Host Disease« - GvHD) in o smrtnih primerih pri bolnikih, ki so prejemali G-CSF po alogenski presaditvi kostnega mozga (glejte poglavji 4.8 in 5.1).
English: Established cytotoxic chemotherapy
Slovenian: Uveljavljena citotoksična kemoterapija
English: Nivestim stimulates the bone marrow to produce new white cells quickly.
Slovenian: Zdravilo Nivestim spodbuja kostni mozeg k hitremu proizvajanju novih belih krvničk.
English: The pre-filled syringe has an UltraSafe Needle Guard attached in order to protect from needle stick injury.
Slovenian: Napolnjena injekcijska brizga ima zaščito za iglo UltraSafe zaradi zaščite pred vbodnimi poškodbami igle.
English: The dosage recommendations in paediatric patients are the same as those in adults receiving myelosuppressive cytotoxic chemotherapy.
Slovenian: Priporočila za odmerjanje zdravila pri pediatričnih bolnikih so enaka kot za odrasle, ki prejemajo mielosupresivno citotoksično kemoterapijo.
English: Use of filgrastim for the mobilisation of PBPCs in normal donors prior to allogeneic PBPC transplantation
Slovenian: Uporaba filgrastima za mobilizacijo PBPC pri normalnih darovalcih pred alogensko presaditvijo PBPC
English: Special precautions in normal donors undergoing PBPC mobilisation
Slovenian: Posebni previdnostni ukrepi pri normalnih darovalcih, pri katerih poteka mobilizacija PBPC
English: Infusion of PBPC accelerates haematopoietic recovery reducing the duration of risk for haemorrhagic complications and the need for platelet transfusions.
Slovenian: Infuzija matičnih celic iz periferne krvi pospeši hematopoetično okrevanje in tako skrajša trajanje tveganja za hemoragične zaplete in zmanjša potrebo po transfuziji trombocitov.
English: Special care should be taken in the diagnosis of SCNs to distinguish them from other haematopoietic disorders such as aplastic anaemia, myelodysplasia, and myeloid leukaemia.
Slovenian: Pri diagnostiki SCN je potrebna posebna pozornost, da bi razlikovali od drugih bolezni krvotvornih celic, na primer aplastične anemije, mielodisplazije in mieloične levkemije.
English: If leucocyte counts exceed 50 x 10
Slovenian: Če po doseženem pričakovanem najnižjem številu levkocitov le-to potem preseže 50 x 10
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 µg) should be given with 0.2 ml of 20% human albumin solution Ph. Eur.
Slovenian: Primer: Če je končni volumen injiciranja 20 ml, je treba skupne odmerke filgrastima, ki so manjši od 30 M e. (300 µg) dati z dodatkom 0,2 ml 20 % raztopine humanega albumina Ph. Eur.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: Filgrastim may be given as a daily subcutaneous injection or as a daily intravenous infusion diluted in 5% glucose solution given over 30 minutes (see section 6.6).
Slovenian: Filgrastim lahko dajemo dnevno v obliki subkutane injekcije ali v obliki 30-minutne intravenske infuzije zdravila, razredčenega s 5-odstotno raztopino glukoze (glejte poglavje 6.6).
English: Use of Active UltraSafe Needle Guard for Nivestim 12 MU/0.2 ml solution for injection/infusion
Slovenian: Uporaba aktivne varnostne zaščite za iglo UltraSafe za zdravilo Nivestim 12 M e./0,2 ml raztopino za injiciranje/infundiranje
English: • low blood pressure (hypotension)
Slovenian: • nizek krvni tlak (hipotenzija)
English: Leucocytosis (WBC > 50 x 10
Slovenian: Levkocitozo (število belih krvničk > 50 x 10
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima podobni pri odraslih in otrocih, ki prejemajo citotoksično kemoterapijo.
English: Data from clinical studies in paediatric patients indicate that the safety and efficacy of filgrastim are similar in both adults and children receiving cytotoxic chemotherapy suggesting no age-related differences in the pharmacokinetics of filgrastim.
Slovenian: Podatki iz kliničnih študij pri pediatričnih bolnikih kažejo, da sta varnost in učinkovitost filgrastima podobna pri odraslih in otrocih, ki prejemajo citotoksično kemoterapijo, kar kaže, da v farmakokinetiki filgrastima ni starostno pogojenih razlik.
English: Nivestim is a clear colourless solution for injection/infusion in a glass pre-filled syringe with an injection needle (stainless steel) with a needle guard.
Slovenian: Zdravilo Nivestim je bistra in brezbarvna raztopina za injiciranje/infundiranje v steklenih napolnjenih brizgah z injekcijsko iglo (iz nerjavečega jekla) in z varnostno zaščito.
English: Patients having a bone marrow transplant after chemotherapy:
Slovenian: Bolniki, ki imajo po kemoterapiji presaditev kostnega mozga:
English: Depress the plunger while grasping the finger flange until the entire dose has been given.
Slovenian: Spuščajte bat, medtem ko držite prirobnice s prstom in injicirajte celotni odmerek.
English: cells/kg recipient bodyweight.
Slovenian: + celic/kg telesne mase prejemnika.
English: Example: In a final injection volume of 20 ml, total doses of filgrastim less than 30 MU (300 g) should be given with 0.2 ml of 200 mg/ml (20%) human albumin solution added.
Slovenian: Primer: Če je končni volumen injiciranja 20 ml, je treba skupne odmerke filgrastima, ki so manjši od 30 M e. (300 µg) dati z dodatkom 0,2 ml 200 mg/ml (20 %) raztopine humanega albumina.
English: Leucocytosis
Slovenian: Levkocitoza
English: • upper respiratory tract infection
Slovenian: • okužba zgornjih dihal
English: Haematuria was common and proteinuria occurred in a small number of patients.
Slovenian: Pri majhnem številu bolnikov je bila pogosta hematurija in pojavila se je proteinurija.
English: To give yourself a subcutaneous injection you will need the following items:
Slovenian: Za subkutano injiciranje zdravila boste potrebovali naslednje stvari: • novo napolnjeno brizgo zdravila Nivestim,
English: Nivestim 48 MU/0.5 ml
Slovenian: Nivestim 48 M e./0,5 ml
English: If the ANC decreases to < 1.0 x 10
Slovenian: Če se med zdravljenjem vrednost ANC zmanjša na < 1,0 x 10
English: The first dose of filgrastim should be administered at least 24 hours following cytotoxic chemotherapy and at least 24 hours after bone marrow infusion.
Slovenian: Prvi odmerek filgrastima se sme uporabiti vsaj 24 ur po citotoksični kemoterapiji in vsaj 24 ur po infundiranju kostnega mozga.
English: The duration of fever was not reduced in patients undergoing myeloablative therapy followed by bone marrow transplantation.
Slovenian: Tudi trajanje zvišane telesne temperature ni bilo krajše pri bolnikih, ki so prejemali mieloablativno terapijo, čemur je sledila presaditev kostnega mozga.
English: In patients with known bone marrow infiltrating infections or malignancy, consider appropriate therapy for treatment of the underlying condition, in addition to administration of filgrastim for treatment of neutropenia.
Slovenian: Pri bolnikih z znano infiltracijo okužbe ali malignim obolenjem kostnega mozga je treba, poleg dajanja filgrastima za zdravljenje nevtropenije, razmisliti o uvedbi primernega zdravljenja za osnovno bolezen.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila : http://www.ema.europa.eu.