FrancophonIA/ELRC3.0 huggingface dataset:
English: Corticosteroid or ACTH treatment of relapses for periods of up to 28 days has been well tolerated in patients receiving Extavia.
Slovenian: Bolniki, ki so dobivali zdravilo Extavia, so dobro prenašali zdravljenje recidivov s kortikosteroidi oz. ACTH, ki je trajalo do 28 dni.
English: Urticaria, Pruritus, Alopecia
Slovenian: Bolezni kože in podkožja urtikarija, srbenje, alopecija razbarvanje kože
English: 4 - Peel back and remove the cover from the vial adapter packaging.
Slovenian: 4 - Odtrgajte in odstranite zaščito z ovojnine adapterja.
English: ► If you have more than one sore injection sites (multiple lesions) you must stop using Extavia until your skin has healed.
Slovenian: ► morate prenehati uporabljati zdravilo Extavia, dokler se koža ne zaceli, če imate več poškodovanih mest injiciranja (multiple lezije).
English: As for other beta interferons, cases of severe hepatic injury, including hepatic failure, have been reported in patients treated with Extavia.
Slovenian: Tako kot pri drugih interferonih beta so bili tudi pri bolnikih, ki so jih zdravili z zdravilom Extavia, opisani primeri hude okvare jeter, vključno s primeri odpovedi jeter.
English: Skin and subcutaneous tissue disorders Skin disorder
Slovenian: Bolezni kože in podkožja kožne motnje izpuščaj
English: Hepatobiliary disorders Alanine aminotransferase increased (SGPT >5 times baseline)
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišane vrednosti alanin aminotransferaze (SGPT >5-kratna izhodiščna vrednost)
English: 1 ml contains 250 microgram (8.0 million IU) interferon beta-1b when reconstituted.
Slovenian: 1 ml vsebuje 250 mikrogramov (8,0 milijonov i.e.) interferona beta-1b po rekonstituciji.
English: This may suggest an inflammation of the pancreas (pancreatitis), which has been reported with Extavia use.
Slovenian: Morda to kaže na vnetje trebušne slinavke (pankreatitis), o katerem poročajo pri bolnikih, ki jemljejo zdravilo Extavia.
English: See “Warnings and precautions” in section 2 for more information and what to do if you experience an injection site reaction.
Slovenian: Opozorila in previdnostni ukrepi za več informacij in ravnanje v tem primeru.
English: LABEL OF PRE-FILLED SYRINGE
Slovenian: NALEPKA NA NAPOLNJENI INJEKCIJSKI BRIZGI
English: - If you have ever had seizures or if you are taking medicines to treat epilepsy (antiepileptics), you doctor will monitor your treatment carefully (see also “Other medicines and Extavia” and section 4, “Possible side effects”).
Slovenian: - če ste imeli epileptične napade ali jemljete zdravila proti epilepsiji (antiepileptike), bo zdravnik skrbno nadzoroval vaše zdravljenje.
English: Powder - white to off-white in colour.
Slovenian: Prašek - bele do belkaste barve.
English: - infection, abscess - reduced number of white blood cells, swollen lymph glands (lymphadenopathy) - decrease in the amount of sugar in the blood (hypoglycaemia) - depression, anxiety - headache, dizziness, sleeplessness, migraine, numbness or tingling feeling (paraesthesia) - eye inflammation (conjunctivitis), abnormal vision - ear pain - irregular, rapid beating or pulsation of the heart (palpitation) - redness and/or facial flushing due to widening of blood vessels(vasodilation), increased blood pressure (hypertension) - runny nose, cough, hoarseness due to infection of the upper respiratory tract, sinusitis, cough increased, shortness of breath (dyspnoea) - diarrhoea, constipation, nausea, vomiting, abdominal pain - rises in the blood levels of liver enzymes (will show up in blood tests) - skin disorder, rash - muscle stiffness (hypertonia), painful muscles (myalgia), muscular debility (myasthenia), back pain, pain in extremities such as fingers and toes - holding urine (urinary retention), protein in the urine (will show up in urine tests), urinary frequency, inability to hold back urination (urinary incontinence), urinary urgency
Slovenian: - okužba, ognojek - zmanjšanje števila belih krvnih celic, otekanje bezgavk (limfadenopatija) - znižanje vrednosti sladkorja v krvi (hipoglikemija) - depresija, tesnoba - glavobol, omotica, nespečnost, migrena, otrplost ali občutek ščemenja (parestezija) - vnetje očesne veznice (konjunktivitis), motnje vida - bolečina v ušesu - nepravilno, hitro bitje ali utripanje srca (palpitacija) - rdečica in/ali zardevanje obraza zaradi širjenja žil (vazodilatacija), zvišan krvni tlak
English: If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
Slovenian: Če so težave hude, bo morda moral zdravnik odstraniti tujke in mrtvo tkivo (čiščenje).
English: Follow the sequence described in the schedule at the end of the Annex (see Part II “Rotating injection sites”) and you will come back to your first injection site area after 8 injections (16 days).
Slovenian: Upoštevajte vrstni red, opisan v razporedu na koncu Dodatka (glejte Del II Menjavanje mest injiciranja).
English: However, this did not seem to be associated with a reduction in clinical efficacy (with regard to time to clinically definite multiple sclerosis (CDMS), time to confirmed EDSS progression and relapse rate).
Slovenian: V tem obdobju je bil razvoj nevtralizacijske aktivnosti povezan s pomembnim povečanjem novo aktivnih lezij in prostornine lezij T2 pri slikanju z magnetno resonanco, ni pa kazalo, da bi bil povezan z zmanjšanjem klinične učinkovitosti (glede na čas do klinično dokončne multiple skleroze (clinically definite multiple sclerosis (CDMS), čas do potrjenega napredovanja na lestvici EDSS in pogostnost recidivov).
English: Powder: Human albumin, mannitol.
Slovenian: Prašek: humani albumin, manitol Vehikel: natrijev klorid, voda za injekcije
English: Snap off and discard the tip of the syringe.
Slovenian: Odlomite vrh brizge in ga zavrzite.
English: Problems with your small blood vessels (capillaries) may develop (systemic capillary leak syndrome) when using medicines like Extavia.
Slovenian: Pri uporabi zdravil kot je Extavia se lahko pojavijo težave z majhnimi žilami (kapilarami) (sindrom sistemske kapilarne krvavitve).
English: Rare (1/10,000 to
Slovenian: Organski sistem zelo pogosti pogosti (1/100 do občasni (1/1.000 do redki (1/10.000 do pogostnost neznana
English: ** Class label for interferon products, see below “Pulmonary arterial hypertension”.
Slovenian: * neželeni učinki, o katerih so poročali samo v obdobju trženja zdravila označevanje razreda zdravil, ki vsebujejo interferon beta (glejte poglavje 4.4) ** velja za skupino zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj
English: No benefit, attributable to Extavia, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Slovenian: Po merilih ocene sposobnosti pri multipli sklerozi (FAMS - Functional Assessment of MS) niso opažali izboljšanja kakovosti življenja, ki bi ga lahko pripisali zdravilu Extavia.
English: Do not remove the vial adapter from its packaging.
Slovenian: Adapter za vialo pustite v njegovi ovojnini.
English: - the number of red cells in the blood may fall (anaemia), - the thyroid gland does not work properly (too little hormone is produced) (hypothyroidism), - weight increase or decrease, - confusion, - abnormally rapid heartbeat (tachycardia), - a reddish yellow pigment (bilirubin), which is produced by your liver, may rise (this will show up in blood tests),
Slovenian: - lahko se zmanjša število rdečih krvnih celic (anemija) - motnje delovanja ščitnice (proizvaja se premalo hormona) (hipotiroidizem) - povečanje ali zmanjšanje telesne mase - zmedenost - nenormalno hitro bitje srca (tahikardija) - poveča se količina rdečkasto rumenega pigmenta (bilirubina), ki nastaja v jetrih (to pokažejo krvne preiskave) - običajno srbeči in otekli predeli na koži ali sluznicah (urtikarija) - srbenje (pruritus) - izpadanje las (alopecija) - motnje menstruacije (menoragija)
English: It can cause temporary disability, such as difficulty walking.
Slovenian: Pri napadu MS (relapsu) se lahko pojavijo spremembe v OŽ, ki lahko povzročijo začasno prizadetost, na primer težave pri hoji.
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 42 (3x14) pre-filled syringes containing solvent.
Slovenian: 3-mesečno skupno pakiranje, ki vsebuje 42 (3x14) vial interferona beta-1b in 42 (3x14) napolnjenih brizg, ki vsebujejo vehikel
English: 9 - Hold the syringe-vial assembly at a slight angle.
Slovenian: 9 - Sestavo brizge in viale držite nekoliko pod kotom.
English: After reconstitution, each millilitre contains 250 microgram (8.0 million IU) interferon beta-1b.
Slovenian: Po rekonstituciji en mililiter raztopine vsebuje 250 mikrogramov (8.0 milijonov i.e.) interferona beta-1b.
English: ► Uncommon (may affect up to 1 in 100 people):
Slovenian: ► Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Hyperthyroidism, Thyroid disorders
Slovenian: Bolezni endokrinega sistema hipotiroidizem hipertiroidizem, motnje ščitnice
English: 3-month multipack containing 45 (3x15) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Slovenian: 3-mesečno skupno pakiranje, ki vsebuje 45 (3x15) vial interferona beta-1b in 45 (3x15) napolnjenih brizg, ki vsebujejo vehikel
English: 14 vials with powder and 14 pre-filled syringes with 1.2 ml solvent.
Slovenian: 14 vial s praškom in 14 napolnjenih injekcijskih brizg z 1,2 ml vehikla.
English: What Extavia is
Slovenian: Kaj je zdravilo Extavia
English: ► Flu-like symptoms such as fever, chills, painful joints, malaise, sweating, headache, or muscular pain.
Slovenian: Najpogostejši neželeni učinki so: ► Gripi podobni simptomi, kot so zvišana telesna temperatura, mrzlica, bolečine v sklepih, splošno slabo počutje, potenje, glavobol ali bolečine v mišicah.
English: Talk to your doctor before using Extavia:
Slovenian: Pred začetkom uporabe zdravila Extavia se posvetujte z zdravnikom:
English: The PSUR cycle of Extavia is aligned with the cross-referred product, Betaferon, until otherwise specified.
Slovenian: Ciklus rednih posodobljenih poročil o varnosti zdravila Extavia je usklajen z izdajo rednih posodobljenih poročil o varnosti referenčnega zdravila Betaferon, dokler ni določeno drugače.
English: Bronchospasm* Pulmonary arterial hypertension**
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora bronhospazem* pljučna arterijska hipertenzija**
English: 3-month multipack containing 42 (3x14) vials of interferon beta-1b and 45 (3x15) pre-filled syringes containing solvent.
Slovenian: 3-mesečno skupno pakiranje, ki vsebuje 42 (3x14) vial interferona beta-1b in 45 (3x15) napolnjenih brizg, ki vsebujejo vehikel
English: Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Slovenian: Pri uporabi interferona beta pri bolnikih s hudo ledvično odpovedjo, je treba biti previden, bolnike pa pozorno spremljati.
English: After reconstitution, each ml contains 250 microgram (8.0 million IU) of recombinant interferon beta1b.
Slovenian: Po rekonstituciji vsebuje en ml 250 mikrogramov (8,0 milijonov i.e.) rekombinantnega interferona beta-1b.
English: 14 vials of interferon beta-1b and 14 pre-filled syringes containing solvent.
Slovenian: 14 vial interferona beta-1b in 14 napolnjenih brizg, ki vsebujejo vehikel (raztopina natrijevega klorida)
English: Musculoskeletal and connective tissue disorders Hypertonia°
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija z zdravili povzročen eritematozni lupus
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Rekonstituirano raztopino je treba injicirati subkutano vsak drugi dan. Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
English: 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Slovenian: 15 vial s praškom in 15 napolnjenih injekcijskih brizg z 1,2 ml vehikla.
English: - If you have severe kidney problems, your doctor may monitor your kidney function during treatment.
Slovenian: Med zdravljenjem lahko vaš zdravnik spremlja delovanje ledvic.
English: After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 microgram Extavia.
Slovenian: Za odmerjanje 250 mikrogramov zdravila Extavia, je treba po rekonstituciji potegniti 1,0 mililiter raztopine iz viale v brizgo.
English: You should rotate the injection site at every injection.
Slovenian: Vsak odmerek si injicirajte na drugo mesto.
English: Rotation schedule
Slovenian: POSTOPEK UPORABE
English: Each vial contains 300 microgram (9.6 million IU) interferon beta-1b per vial.
Slovenian: Ena viala vsebuje 300 mikrogramov (9,6 milijona i.e.) interferona beta-1b.
English: 3-month multipack: 45 (3 packs of 15) vials with powder and 45 (3 packs of 15) pre-filled syringes with 1.2 ml solvent.
Slovenian: 3-mesečno skupno pakiranje: 45 (3 pakiranja po 15) vial s praškom in 45 (3 pakiranja po 15) napolnjenih injekcijskih brizg z 1,2 ml vehikla 3-mesečno skupno pakiranje: 42 (3 pakiranja po 14) vial s praškom in 45 (3 pakiranja po 15) napolnjenih injekcijskih brizg z 1,2 ml vehikla
English: The titration period may be adjusted, if any significant adverse reaction occurs.
Slovenian: Če se pojavijo resni neželeni učinki, se lahko obdobje titracije prilagodi.
English: Cardiomyopathy*
Slovenian: Srčne bolezni
English: The medicinal product should be discarded before use if it contains particulate matter or is discoloured.
Slovenian: Če zdravilo vsebuje delce ali je obarvano, se ga ne sme uporabiti, temveč ga je treba zavreči.
English: Extavia contains 300 microgram (9.6 million IU) of recombinant interferon beta-1b per vial*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilo Extavia vsebuje 300 mikrogramov (9,6 milijonov i.e.) rekombinantnega interferona beta-1b na vialo*.
English: Extavia contains sodium
Slovenian: Shranjevanje zdravila Extavia
English: ► Very common (may affect more than 1 in 10 people): - painful joints (arthralgia).
Slovenian: ► Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: 14 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
Slovenian: 14 vial s praškom in 15 napolnjenih injekcijskih brizg z 1,2 ml vehikla.
English: Your doctor also needs to know the following whilst you are using Extavia:
Slovenian: Med uporabo zdravila Extavia morate vašega zdravnika obvestiti tudi:
English: 15 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Slovenian: 15 vial interferona beta-1b in 15 napolnjenih brizg, ki vsebujejo vehikel (raztopina natrijevega klorida)
English: 14 vials of interferon beta-1b and 15 pre-filled syringes containing solvent.
Slovenian: 14 vial interferona beta-1b in 15 napolnjenih brizg, ki vsebujejo vehikel (raztopina natrijevega klorida)
English: Withdrawal of Extavia should be considered if the levels significantly increase or if they are associated with clinical symptoms such as jaundice.
Slovenian: Če se transaminaze pomembno zvišajo ali če jih spremljajo klinični simptomi zlatenice, je treba premisliti o prekinitvi zdravljenja z zdravilom Extavia.
English: Chills
Slovenian: Absces
English: * Significantly associated with Extavia treatment for RRMS, p <0.05 ° Significantly associated with Extavia treatment for SPMS, p <0.05 § Injection site reaction (various kinds) comprises all adverse events occurring at the injection site, i.e. the following terms: injection site haemorrhage, injection site hypersensitivity, injection site inflammation, injection site mass, injection site necrosis, injection site pain, injection site reaction, injection site oedema, and injection site atrophy & “Flu-like symptom complex” denotes flu syndrome and/or a combination of at least two adverse events from fever, chills, myalgia, malaise, sweating.
Slovenian: naslednji učinki: krvavitev na mestu injiciranja, preobčutljivost na mestu injiciranja, vnetje na mestu injiciranja, masa na mestu injiciranja, nekroza na mestu injiciranja, bolečina na mestu injiciranja, reakcija na mestu injiciranja, edem na mestu injiciranja in atrofija na mestu injiciranja & “kompleks gripi podobnih simptomov” pomeni sindrom gripe in/ali kombinacijo vsaj dveh izmed naslednjih neželenih učinkov: povišana telesna temperatura, mrzlica, mialgija, občutek neugodja,
English: CARTON FOR UNIT PACK
Slovenian: ŠKATLA POSAMIČNEGA PAKIRANJA
English: ► Common (may affect up to 1 in 10 people):
Slovenian: ► Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: At the present time, it is not known for how long the patient should be treated.
Slovenian: Trenutno ni znano, kako dolgo naj traja zdravljenje (glejte poglavje 5.1).
English: Pain in extremity
Slovenian: - bolečine v sklepih (artralgija)
English: Use the packaging to handle the vial adapter.
Slovenian: Adapter za vialo primite skupaj z njegovo ovojnino.
English: This forms the syringe-vial assembly.
Slovenian: Tako dobite sestavo brizge in viale.
English: ROTATION SCHEDULE:
Slovenian: NAČRT MENJAVANJA MEST INJICIRANJA:
English: Subcutaneous use
Slovenian: Pomožne snovi
English: Gastrointestinal disorders Diarrhoea
Slovenian: Žilne bolezni vazodilatacija hipertenzija °
English: Abdominal pain °
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Chest pain °
Slovenian: Leva stran trebuha
English: This means that it has been used for many years and that there was sufficient information on its effectiveness and safety.
Slovenian: To pomeni, da se uporablja že mnogo let in da je na voljo dovolj informacij o njeni učinkovitosti in varnosti.
English: Because thiotepa has been used for many years in the EU, the company presented data from the published literature.
Slovenian: Ker se tiotepa v EU uporablja že več let, je družba predstavila podatke iz objavljene literature.
English: Tepadina thiotepa
Slovenian: Tepadina tiotepa
English: It must be given as an infusion into a large vein lasting two to four hours.
Slovenian: Zdravilo je treba dajati kot infuzijo v veliko veno, ki traja dve do štiri ure.
English: What measures are being taken to ensure the safe and effective use of Tepadina?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tepadina?
English: This included 109 studies involving around 6,000 adults and 900 children with blood diseases or solid tumours, who were having a transplant of blood-making cells.
Slovenian: To je vključevalo 109 študij s približno 6 000 odraslimi in 900 otroki s krvnimi boleznimi ali čvrstimi tumorji, pri katerih so izvedli presaditev krvotvornih celic.
English: It must also not be used together with the vaccine against yellow fever or vaccines containing live viruses or bacteria.
Slovenian: Zdravilo se ne sme uporabljati skupaj s cepivom proti rumeni mrzlici ali cepivi, ki vsebujejo žive viruse ali bakterije.
English: In children, the daily dose ranges from 125 to 350 mg/m2 given for up to three days before transplantation.
Slovenian: Pri otrocih je dnevni odmerek od 125 do 350 mg/m2 in se daje do največ tri dni pred presaditvijo.
English: This allows new cells to be transplanted, by creating space for the new cells and reducing the risk of rejection.
Slovenian: To omogoča presaditev novih celic, saj se ustvari prostor za nove celice in zmanjša tveganje zavrnitve.
English: This means that they kill cells, especially cells that multiply rapidly, such as cancer or progenitor (or ‘stem') cells (cells that can develop into different types of cell).
Slovenian: To pomeni, da ubijajo celice, zlasti tiste, ki se hitro množijo, kot so rakave ali matične (ali „izvorne“) celice (celice, ki se lahko razvijejo v različne vrste celic).
English: Tepadina is used in combination with chemotherapy (medicines to treat cancer) in two ways:
Slovenian: Zdravilo Tepadina se uporablja v kombinaciji s kemoterapijo (zdravili za zdravljenje raka) na dva načina:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tepadina on 15 March 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Tepadina, veljavno po vsej Evropski uniji, izdala 15. marca 2010.
English: What benefit has Tepadina shown during the studies?
Slovenian: Kakšne koristi je zdravilo Tepadina izkazalo med študijami?
English: Because the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, Tepadina was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 January 2007.
Slovenian: Ker je v Evropski uniji (EU) bolnikov, pri katerih se izvaja tovrstno kondicioniranje in presaditev, malo, je bilo zdravilo Tepadina dne 29. Januarja 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: In adults, the daily dose ranges from 120 to 481 mg per square metre (m2) given for up to five days before transplantation.
Slovenian: Pri odraslih je dnevni odmerek od 120 do 481 mg na kvadratni meter (m2), ki se daje do največ pet dni pred presaditvijo.
English: Thiotepa has been used to prepare patients for transplantation of blood-making cells in the European Union (EU) since the late 1980s.
Slovenian: Z zdravilno učinkovino tiotepa pripravljajo bolnike na presaditev krvotvornih celic v Evropski uniji (EU) od konca 80. let 20. stoletja.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tepadina can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Tepadina je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is a summary of the European Public Assessment Report (EPAR) for Tepadina.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Tepadina.
English: Other information about Tepadina
Slovenian: Druge informacije o zdravilu Tepadina
English: The studies looked at the number of patients with successful transplantations, how long it took for the diseases to come back and how long the patients survived.
Slovenian: V študijah so proučevali število bolnikov z uspešno presaditvijo, čas do ponovitve bolezni in čas preživetja bolnikov.
English: What is the risk associated with Tepadina?
Slovenian: Kakšna tveganja so povezana z zdravilom Tepadina?
English: A risk management plan has been developed to ensure that Tepadina is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Tepadina je bil pripravljen načrt obvladovanja tveganj.
English: Tepadina treatment must be supervised by a doctor who has experience in treatments given before transplantation.
Slovenian: Zdravljenje z zdravilom Tepadina mora nadzorovati zdravnik, ki ima izkušnje z zdravili, ki jih je bolnik prejemal pred presaditvijo.
English: It helps to destroy the patient's existing blood-making cells, resulting in the successful transplantation of new cells, improved survival and a reduced risk of the diseases coming back.
Slovenian: Pomaga uničiti bolnikove obstoječe krvotvorne celice, kar se kaže v uspešni presaditvi novih celic, daljšem preživetju in zmanjšanem tveganju ponovitve bolezni.
English: The dose of Tepadina depends on the type of blood disease or solid tumour that the patient has and the type of transplantation to be carried out.
Slovenian: Odmerek zdravila Tepadina je odvisen od vrste krvne bolezni ali čvrstega tumorja, ki ga ima bolnik, in od vrste presaditve, ki se bo izvedla.
English: The full EPAR for Tepadina 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 Tepadina je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • as a ‘conditioning' (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Slovenian: • kot pripravljalno zdravilo (kondicioniranje) pred presaditvijo krvotvornih matičnih celic (celic, ki tvorijo krvne celice).