natgillin/translations-raw huggingface dataset:
lymphatic system disorders decreased, haematocrit decreased, white blood cell count decreased coagulopathy, leukopaenia, eosinophil count increased, platelet count decreased, platelet count increased, lymphocyte count decreased, white blood cell count increased, neutrophil count decreased
Bolezni krvi in limfatičnega sistema znižanje hemoglobina, znižanje hematokrita, zmanjšano število levkocitov anemija, trombocitopenija, motnje strjevanja krvi, levkopenija, povečano število eozinofilcev, zmanjšano število trombocitov, povečano število trombocitov, zmanjšano število limfocitov, povečano število levkocitov, zmanjšano število nevtrofilcev
What Cancidas contains
Kaj vsebuje zdravilo Cancidas
CANCIDAS for transfer to intravenous bag or bottle
Prostornina koncentrata zdravila CANCIDAS, ki ga je treba vbrizgati v infuzijsko vrečko ali steklenico
c. CANCIDAS is formulated to provide the full labeled vial dose (50 mg) when 10 ml is withdrawn from the vial.
c. Zdravilo CANCIDAS je pripravljeno tako, da zagotavlja polni, na viali označeni odmerek (50 mg), če iz viale potegnete 10 ml.
The first study, which enrolled 82 patients between 2 to 17 years of age, was a randomized, doubleblind study comparing caspofungin (50 mg/m
Prva študija je bila randomizirana, dvojno slepa študija z 82 bolniki, starimi od 2 do 17 let.
Cancidas contains sucrose
Zdravilo Cancidas vsebuje saharozo
CANCIDAS 70 mg powder for concentrate for solution for infusion Each vial contains 70 mg caspofungin (as acetate).
CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 70 mg kaspofungina (v obliki acetata).
A reduction of the daily dose to 35 mg is recommended for adults with moderate hepatic impairment.
Odraslim bolnikom z zmerno jetrno okvaro je priporočljivo dnevni odmerek zmanjšati na 35 mg. Kliničnih izkušenj pri odraslih bolnikih s hudo jetrno okvaro in pri pediatričnih bolnikih s katero koli stopnjo jetrne okvare nimamo.
Among patients with candidaemia, favourable response rates at the end of IV study therapy were comparable for caspofungin (72 % [66/92]) and amphotericin B (63 % [59/94]) in the primary efficacy analysis (MITT analysis) [% difference 10.0 (95.0 % CI -4.5, 24.5)].
Med bolniki s kandidemijo sta bila deleža ugodnega odziva na koncu intravenskega raziskovanega zdravljenja v analizi primarne učinkovitosti (analiza MITT) pri kaspofunginu (72 % [66/92]) in amfotericinu B (63 % [59/94]) podobna [% razlike
When co-administering inducers of metabolic enzymes, an increase in the daily dose of caspofungin to 70 mg, following the 70 mg loading dose, should be considered in adult patients (see section 4.2).
Pri sočasnem zdravljenju z induktorji presnovnih encimov moramo pri odraslih bolnikih razmisliti o povečanju dnevnega odmerka kaspofungina na 70 mg, po 70 mg uvajalnem odmerku (glejte poglavje 4.2).
CANCIDAS 50 mg powder for concentrate for solution for infusion Each vial contains 50 mg caspofungin (as acetate).
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 50 mg kaspofungina (v obliki acetata).
In young children and toddlers (ages 12 to 23 months) receiving caspofungin at 50 mg/m2 daily (maximum 70 mg daily), the caspofungin plasma AUC0-24 hr after multiple doses was comparable to that seen in adults receiving caspofungin at 50 mg daily and to that in older children (2 to 11 years of age) receiving the 50 mg/m2 daily dose.
Pri malih otrocih (starih od 12 do 23 mesecev), ki so dobivali kaspofungin v odmerku 50 mg/m 2 na dan (največ 70 mg na dan), je bila AUC0-24h kaspofungina v plazmi po večkratnih odmerkih primerljiva kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan, in kot pri starejših otrocih (starih od 2 do 11 let), ki so dobivali dnevni odmerek 50 mg/m
35 mg for moderate hepatic impairment (from one 70 mg vial)
35 mg pri zmerni jetrni okvari (iz ene viale po 70 mg)
Aseptically transfer this volume (ml)
To količino (ml)
Do not mix with diluents containing glucose, as CANCIDAS is not stable in diluents containing glucose.
Ne mešajte z vehikli, ki vsebujejo glukozo, ker zdravilo CANCIDAS v njih ni stabilno.
DO NOT USE ANY DILUENTS CONTAINING GLUCOSE, as CANCIDAS is not stable in diluents containing glucose.
NE UPORABLJAJTE VEHIKLOV, KI VSEBUJEJO GLUKOZO, ker zdravilo CANCIDAS v njih ni stabilno.
35 mg for moderate hepatic impairment (from one 50 mg vial)
35 mg pri zmerni jetrni okvari (iz ene viale po 50 mg)
INSTRUCTIONS FOR USE IN ADULT PATIENTS (70 mg vial)
NAVODILA ZA UPORABO PRI ODRASLIH BOLNIKIH (viala po 70 mg)
What Cancidas is
Kaj je zdravilo Cancidas
35 mg for moderate hepatic impairment (from one 50 mg vial) at reduced volume
35 mg pri zmerni jetrni okvari (iz ene viale po 50 mg) / zmanjšana prostornina infuzije
Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.
Cancidas 70 mg prašek za koncentrat za raztopino za infundiranje Ena viala zdravila Cancidas vsebuje 70 mg kaspofungina.
INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial)
NAVODILA ZA UPORABO PRI ODRASLIH BOLNIKIH (viala po 50 mg)
CANCIDAS 50 mg powder for concentrate for solution for infusion CANCIDAS 70 mg powder for concentrate for solution for infusion
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje
Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.
Nedovzetnost pomeni, da po najmanj 7 dneh prejemanja terapevtskih odmerkov učinkovitega protiglivnega zdravila okužba še vedno napreduje ali se stanje ne izboljša.
INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (50 mg vial)
NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH (viala po 50 mg)
In neonates and infants (<3 months) receiving caspofungin at 25 mg/m2 daily (corresponding mean daily dose of 2.1 mg/kg), caspofungin peak concentration (C1 hr) and caspofungin trough concentration (C24 hr) after multiple doses were comparable to that seen in adults receiving caspofungin at 50 mg daily.
Pri novorojenčkih in dojenčkih (starih <3 mesece), ki so dobivali kaspofungin v odmerku 25 mg/m (kar ustreza povprečnemu dnevnemu odmerku 2,1 mg/kg), sta bili največja koncentracija kaspofungina (C1 h) in koncentracija kaspofungina tik pred naslednjim odmerkom (C24 h) po večkratnih odmerkih podobni kot pri odraslih, ki so dobivali 50 mg kaspofungina na dan. Prvi dan je bila C1 h pri teh novorojenčkih in dojenčkih primerljiva, C24 h pa zmerno večja (36 %) v primerjavi z odraslimi.
INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (70 mg vial)
NAVODILA ZA UPORABO PRI PEDIATRIČNIH BOLNIKIH (viala po 70 mg)
Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses.
Če je to iz zdravstvenih razlogov potrebno, lahko za 50 mg ali 35 mg dnevne odmerke pripravite manjšo prostornino infuzije - 100 ml. Raztopine ne uporabite, če je motna ali če je nastala oborina.
Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin.
Cancidas 50 mg prašek za koncentrat za raztopino za infundiranje Ena viala zdravila Cancidas vsebuje 50 mg kaspofungina.
Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.
Če ste noseči ali dojite ali menite, da ste noseči, se posvetujte z zdravnikom, preden dobite to zdravilo.
• Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)
• spremembe nekaterih laboratorijskih izvidov krvi (vključno z motnjami strjevanja krvi,
Before reconstitution, the powder is a white to off-white-compact, powder.
prašek za koncentrat za raztopino za infundiranje Pred pripravo je prašek bel do skoraj bel kompakten prašek.
50 mg/m2 and the 50 mg dose, respectively, while in one 6-month old child receiving the 50 mg/m dose, the AUC0-24 hr was somewhat higher.
Farmakokinetični podatki so pri enem 10-mesečnem otroku, ki je dobival 50 mg/m2 na dan, pokazali AUC0-24h v enakem območju, kot je bila pri starejših otrocih med uporabo 50 mg/m2 in odraslih med uporabo 50-mg odmerka, pri enem 6-mesečnem otroku, ki je dobival 50 mg/m2, pa je bila AUC0-24h nekoliko večja.
CANCIDAS 70 mg powder for concentrate for solution for infusion Caspofungin
CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje kaspofungin
CANCIDAS 50 mg powder for concentrate for solution for infusion Caspofungin
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje kaspofungin
CANCIDAS 50 mg powder for concentrate for solution for infusion
CANCIDAS 50 mg prašek za koncentrat za raztopino za infundiranje
CANCIDAS 70 mg powder for concentrate for solution for infusion
CANCIDAS 70 mg prašek za koncentrat za raztopino za infundiranje
and 50 mg/m 2 daily in young children (3 to 11 months of age) can be considered (see section 5.2).
Malo podatkov nakazuje, da pride pri novorojenčkih in dojenčkih (starih manj kot 3 mesece) v poštev zdravljenje s kaspofunginom v odmerku 25 mg/m2 na dan, pri majhnih otrocih (starih od 3 do 11 mesecev) pa v odmerku 50 mg/m 2 na dan (glejte poglavje 5.2).
Caspofungin acetate inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of many filamentous fungi and yeast.
glukana, ki je bistvena sestavina celične stene številnih filamentoznih gliv in kvasovk.
Very common
Ni priporočljivo
Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 50-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Priprava infuzije 50 mg/m za pediatrične bolnike, stare > 3 mesece (z uporabo viale po 50 mg) Dejanski dnevni vzdrževalni odmerek za pediatričnega bolnika določite na podlagi njegove telesne površine (izračunane, kot je prikazano zgoraj) po naslednji enačbi: Telesna površina (m2) X 50 mg/m2 = dnevni vzdrževalni odmerek
Development of in vitro resistance to caspofungin by Aspergillus species has been identified.
Pri Aspergillus sp. so in vitro ugotovili razvoj odpornosti proti kaspofunginu.
Empirical Therapy in Febrile, Neutropaenic Adult Patients: A total of 1,111 patients with persistent fever and neutropaenia were enrolled in a clinical study and treated with either caspofungin 50 mg once daily following a 70 mg loading dose or liposomal amphotericin B 3.0 mg/kg/day.
Empirično zdravljenje febrilnih, nevtropeničnih odraslih bolnikov: Klinična študija je zajela skupno 1.111 bolnikov s trdovratno zvišano telesno temperaturo in nevtropenijo.
• Chills, fever
• mrzlica, zvišana telesna temperatura
Class
Višina
Preparation of the 50 mg/m infusion for paediatric patients >3 months of age (using a 70-mg vial) Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose
Priprava infuzije 50 mg/m za pediatrične bolnike, stare >3 mesece (z uporabo viale po 70 mg) Dejanski dnevni vzdrževalni odmerek za pediatričnega bolnika določite na podlagi njegove telesne površine (izračunane, kot je prikazano zgoraj) po naslednji enačbi: Telesna površina (m2) X 50 mg/m2 = dnevni vzdrževalni odmerek
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Sočasna uporaba z induktorji presnovnih encimov
• Inflammation of the vein
• zvišana telesna temperatura
50 mg / 100 mg
50 mg/100 mg filmsko obložena tableta peroralna uporaba pretisni omot (alu/alu)
Oral use blister (alu/alu)
Pot uporabe Stična ovojnina Velikost pakiranja
It is available as capsules (100 and 400 mg) and tablets (100 and 400 mg) and is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut.
Na voljo je v obliki kapsul (100 in 400 mg) in tablet (100 in 400 mg) in se jemlje peroralno ob obroku z velikim kozarcem vode za zmanjšanje draženja želodca in črevesja.
What measures are being taken to ensure the safe and effective use of Imatinib Teva?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Imatinib Teva?
The European Commission granted a marketing authorisation valid throughout the European Union for Imatinib Teva on 8 January 2013.
Evropska komisija je dovoljenje za promet z zdravilom Imatinib Teva, veljavno po vsej Evropski uniji, izdala 8. januarja 2013.
It is also used in adults and children in the ‘chronic phase' of the disease if it is not responding to interferon alpha (another cancer medicine), and in more advanced phases of the disease (‘accelerated phase' and ‘blast crisis');
Uporablja se tudi pri odraslih in otrocih v kronični fazi bolezni, če se ta ne odziva na interferon alfa (drugo zdravilo za zdravljenje raka), ter v napredovalih fazah bolezni (pospešeni fazi in blastni krizi);
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imatinib Teva have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
These enzymes can be found in certain receptors in cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably.
Ti encimi se nahajajo v določenih receptorjih v rakavih celicah, vključno z receptorji, ki spodbujajo celice, da se nenadzorovano delijo.
The dose depends on the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day.
Odmerek je odvisen od starosti bolnika, njegovega bolezenskega stanja in odziva na zdravljenje, vendar ne sme presegati 800 mg na dan. Za več informacij glejte navodilo za uporabo.
This means that Imatinib Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Glivec.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Glivec.
This is a summary of the European public assessment report (EPAR) for Imatinib Teva.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Imatinib Teva.
This means that it blocks some specific enzymes known as tyrosine kinases.
To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin kinaze.
It is also used alone in adults to treat Ph+ ALL that has returned following previous treatment, or is not responding to other medicines;
Uporablja se tudi samostojno pri odraslih za zdravljenje Ph+ ALL, ki se je po predhodnih zdravljenjih ponovno pojavila ali se ne odziva na druga zdravljenja;
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Imatinib Teva has been shown to have comparable quality and to be bioequivalent to Glivec.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Imatinib Teva primerljivo raven kakovosti kot zdravilo Glivec ter da mu je biološko enakovredno.
Other information about Imatinib Teva
Druge informacije o zdravilu Imatinib Teva
By blocking these receptors, Imatinib Teva helps to control cell division.
Z zaviranjem teh receptorjev zdravilo Imatinib Teva pomaga pri nadzoru deljenja celic.
What are the benefits and risks of Imatinib Teva?
Kakšne so koristi in tveganja, povezani z zdravilom Imatinib Teva?
Because Imatinib Teva 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.
Ker je zdravilo Imatinib Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
This means that some of their genes have re-arranged themselves to form a special chromosome called the Philadelphia chromosome.
To pomeni, da so se nekateri geni prerazporedili in tvorijo poseben kromosom Philadephia.
The full EPAR for Imatinib Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information about treatment with Imatinib Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Imatinib Teva preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Imatinib Teva is used to treat adults with DFSP that cannot be removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Zdravilo Imatinib Teva se uporablja za zdravljenje odraslih z (DFSP), ki ga ni mogoče odstraniti s kirurškim posegom ter pri odraslih, ki niso primerni za kirurški poseg po ponovnem pojavu raka po zaključenem zdravljenju ali pri razširitvi na druge dele telesa.
Imatinib Teva is used to treat adults with HES or CEL who have a specific re-arrangement of two genes called FIP1L1 and PDGFRα;
Zdravilo Imatinib Teva se uporablja za zdravljenje odraslih s HES ali CEL, ki imajo posebno preureditev dveh genov, imenovanih FIP1L1 in PDGFRα;
What is Imatinib Teva and what is it used for?
Kaj je zdravilo Imatinib Teva in za kaj se uporablja?
For practical information about using Imatinib Teva, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Imatinib Teva naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Because Imatinib Teva is a generic medicine, studies in patients have been limited to tests to determine that the tablets and capsules are bioequivalent to the reference medicine, Glivec.
Ker je zdravilo Imatinib Teva generično zdravilo, so bile študije pri bolnikih omejene na preskuse za ugotavljanje, ali so tablete in kapsule biološko enakovredne referenčnemu zdravilu Glivec.
Therefore, the CHMP's view was that, as for Glivec, the benefit outweighs the identified risk.
Zato je menil, da njegove koristi enako kot pri zdravilu Glivec odtehtajo znana tveganja.
The active substance in Imatinib Teva, imatinib, is a protein-tyrosine kinase inhibitor.
Zdravilna učinkovina v zdravilu Imatinib Teva, imatinib, je zaviralec beljakovine tirozin kinaze.
The Committee recommended that Imatinib Teva be given marketing authorisation.
Priporočil je, da se za zdravilo Imatinib Teva izda dovoljenje za promet.
Imatinib Teva is used in combination with other cancer medicines in adults and children who have been newly diagnosed with Ph+ ALL.
Zdravilo Imatinib Teva se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka pri odraslih in otrocih z novo ugotovljeno Ph+ ALL.
• myelodysplastic or myeloproliferative diseases (MD/MPD), a group of diseases in which the body produces large numbers of abnormal blood cells.
• mielodisplastične ali mieloproliferativne bolezni (MDS/MPD), skupine bolezni, pri katerih telo proizvaja velike količine nenormalnih krvnih celic.
• dermatofibrosarcoma protuberans (DFSP), a type of cancer (sarcoma) in which cells in the tissue beneath the skin divide uncontrollably.
• protuberantnega dermatofibrosarkoma (DFSP), vrste raka (sarkoma), pri kateri se celice pod kožo nenadzorovano delijo.
Imatinib Teva can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood.
Predpisovanje in izdaja zdravila Imatinib Teva je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem krvnega raka.
Imatinib Teva is used to treat adults with MD/MPD who have re-arrangements of the gene for platelet-derived growth factor receptor (PDGFR);
Zdravilo Imatinib Teva se uporablja za zdravljenje odraslih z MDS/MPD v povezavi s preureditvijo genov za receptor za rastni faktor iz trombocitov (PDGFRplatelet derived growth factor receptor);
• Ph+ acute lymphoblastic leukaemia (ALL), a type of cancer in which lymphocytes (another type of white blood cell) multiply too quickly.
• Ph+ akutne limfoblastne levkemije (ALL), vrste raka, pri kateri se limfociti (druga vrsta belih krvnih celic) prehitro množijo.
Why is Imatinib Teva approved?
Zakaj je bilo zdravilo Imatinib Teva odobreno?
Imatinib Teva is a cancer medicine.
Zdravilo Imatinib Teva je zdravilo za zdravljenje raka.
Imatinib Teva is used when the patients are ‘Philadelphia chromosome positive' (Ph+).
Zdravilo Imatinib Teva se uporablja pri bolnikih s prisotnim kromosomom Philadelphia (Ph+).
• advanced hypereosinophilic syndrome (HES) or chronic eosinophilic leukaemia (CEL), diseases in which eosinophils (another type of white blood cell) start growing out of control.
• napredovalega hipereozinofilnega sindroma (HES) ali kronične eozinofilne levkemije (CEL), bolezni, pri katerih eozinofilci (druga vrsta belih krvnih celic) začnejo nenadzorovano rasti.
Imatinib Teva is used in adults and children who have been newly diagnosed with Ph+ CML and who are not eligible for a bone marrow transplant.
Zdravilo Imatinib Teva se uporablja pri odraslih in otrocih, pri katerih je bila Ph+ KML na novo ugotovljena in niso primerni za presaditev kostnega mozga.
It is not intended to provide practical advice on how to use Imatinib Teva.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
• chronic myeloid leukaemia (CML), a cancer of the white blood cells in which granulocytes (a type of white blood cell) start growing out of control.
• kronične mieloidne levkemije (KML), raka belih krvnih celic, pri katerem začnejo granulociti (vrsta belih krvnih celic) nenormalno rasti.
Imatinib Teva contains the active substance imatinib.
Zdravilo Imatinib Teva vsebuje zdravilno učinkovino imatinib.
How has Imatinib Teva been studied?
Kako je bilo zdravilo Imatinib Teva raziskano?
How is Imatinib Teva used?
Kako se zdravilo Imatinib Teva uporablja?
How does Imatinib Teva work?
Kako zdravilo Imatinib Teva deluje?
EU - Number Invented name
EU - številka Izmišljeno ime Jakost
This summary was last updated in 09-2012.
Povzetek je bil nazadnje posodobljen 09-2012.
This prevents the cells from dividing.
To celicam preprečuje, da bi se delile.
It is available as an oral suspension.
Na voljo je v obliki peroralne suspenzije.
The European Commission granted a marketing authorisation valid throughout the European Union for Xaluprine on 9 March 2012.
Evropska komisija je dovoljenje za promet z zdravilom Xaluprine, veljavno po vsej Evropski uniji, odobrila dne 9. marca 2012.
The CHMP also noted that the risks of using the medicine are well known.
Ugotovil je tudi, da so tveganja pri uporabi zdravila dobro znana.
Treatment with this medicine should be supervised by a healthcare professional experienced in treating patients with ALL.
Zdravljenje s tem zdravilom mora nadzorovati zdravstveni delavec, ki ima izkušnje z zdravljenjem bolnikov z ALL.
The dose is determined for each patient mainly by body surface area and may be adjusted according to its effects in the blood.
Odmerek se določi za vsakega bolnika posebej, v glavnem na podlagi telesne površine, in se lahko prilagaja glede na njegove učinke v krvi.
The effectiveness of 6-mercaptopurine in slowing down the progression of ALL is already well known since it has been used for many years.
Učinkovitost 6-merkaptopurina pri upočasnitvi napredovanja ALL je že znana, saj se uporablja že vrsto let.
It must also not be used at the same time as patients are having a yellow fever vaccination.
Prav tako ga bolniki ne smejo uporabljati sočasno s cepljenjem proti rumeni mrzlici.
The medicine is taken by mouth, using the syringe provided in the pack, once per day in the evening.
Zdravilo se jemlje peroralno s pomočjo brizge, ki je priložena v pakiranju, enkrat na dan, zvečer.
EPAR summary for the public mercaptopurine
Povzetek EPAR za javnost merkaptopurin