natgillin/translations-raw huggingface dataset:
Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with rifampin (a strong CYP3A and P-gp inducer) 600 mg twice daily for 11 days decreased larotrectinib Cmax and AUC by 71% and 81%, respectively.
Klinični podatki pri zdravih odraslih kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI s 600 mg rifampina (močan induktor CYP3A in P-gp) dvakrat na dan 11 dni, vrednosti Cmax in AUC larotrektiniba znižali za 71 % oziroma 81 %.
What VITRAKVI is and what it is used for What you need to know before you take VITRAKVI How to take VITRAKVI
Kaj morate vedeti, preden boste vzeli zdravilo VITRAKVI Kako jemati zdravilo VITRAKVI
Fertility studies with larotrectinib have not been conducted.
Študij karcenogenosti z larotrektinibom niso izvedli..
100 mL oral solution
100 ml peroralna raztopina
Aspartate aminotransferase (AST) increased
(ALT)a zvišane vrednosti aspartat aminotransferaze (AST)
VITRAKVI 100 mg hard capsules larotrectinib
VITRAKVI 100 mg trde kapsule larotrektinib
Therefore, larotrectinib is unlikely to be affected by pH-modifying agents.
Zato ni verjetno, da bi snovi, ki spreminjajo vrednost pH, vplivale na larotrektinib.
See “VITRAKVI contains” in section 2 for more information.
Za več informacij glejte poglavje 2, »Zdravilo VITRAKVI vsebuje«.
High density polyethylene (HDPE)-bottles with a child-resistant polypropylene (PP) cap with a polyethylene (PE) heat seal layer.
6.5 Vrsta ovojnine in vsebina Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko (PP) zaporko s polietilensko (PE) toplotno zavarjeno plastjo.
Dysgeusia
fenobarbital
Marketing Authorisation Holder
Pogojno dovoljenje za promet
VITRAKVI 25 mg hard capsules larotrectinib
VITRAKVI 25 mg trde kapsule larotrektinib
For volumes less than 1 mL use a 1 mL oral syringe with 0.1 mL graduation.
Za količine, manjše od 1 ml, je treba uporabiti 1-ml peroralno brizgo z oznakami za odmerjanje po 0,1 ml.
Patients should take the next dose at the next scheduled time.
Bolnik naj vzame naslednji odmerek kot običajno.
No effects on female reproductive organs were seen in the 3-months toxicity studies in rats and monkeys at doses corresponding to approximately 3-times (female rats) and 17-times (female monkeys) the human AUC at the recommended clinical dose.
V 3-mesečni študiji toksičnosti pri podganah in opicah niso opazili učinkov na reproduktivne organe samic pri odmerkih, ki ustrezajo približno 3-kratniku (pri podganjih samicah) in 17-kratniku (pri opičjih samich) AUC pri ljudeh po priporočenem kliničnem odmerku.
Ask your doctor about the best method of contraception for you.
Glede kontracepcijske metode, ki je za vas najbolj primerna, se posvetujte z zdravnikom.
Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with itraconazole (a strong CYP3A inhibitor and P-gp and BCRP inhibitor) 200 mg once daily for 7 days increased larotrectinib Cmax and AUC by 2.8-fold and 4.3-fold, respectively.
Klinični podatki pri zdravih odraslih osebah kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI z 200 mg itrakonazola (močan zaviralec CYP3A in zaviralec P-gp ter BCRP) enkrat na dan, 7 dni, vrednosti Cmax in AUC larotrektiniba zvišali za 2,8-krat oziroma 4,3-krat.
NSCLC (n=1)c Soft tissue sarcoma (n=1) Thyroid (n=1)
NDPR (n = 1)c sarkom mehkih tkiv (n = 1)
Patients with primary CNS tumours
Bolniki s primarnimi tumorji osrednjega živčevja
In a broad panel of purified enzyme assays, larotrectinib inhibited TRKA, TRKB, and TRKC with IC50 values between 5-11 nM.
V širšem naboru specifičnih encimskih testov je larotrektinib zaviral TRKA, TRKB in TRKC z vrednostmi IC50 med 5-11 nM. Edina druga aktivnost kinaze se je pojavila pri 100-krat večjih koncentracijah.
Lunga Melanomaa Colona
pljučaa melanoma debelo črevoa
Capsule shell: - Gelatin - Titanium dioxide (E 171) Printing ink: - Shellac - Indigo carmine aluminium lake (E 132) - Titanium dioxide (E 171) - Propylene glycol (E 1520) - Dimeticone
- šelak - barvilo indigotin (E 132) - titanov dioksid (E 171) - propilenglikol (E 1520) - dimetikon
glioblastoma and astrocytoma) with investigator tumour response assessment a GIST: gastrointestinal stromal tumour b brain metastases observed in one thyroid, one NSCLC, and one SCLC patient c NSCLC: non-small cell lung cancer d SCLC: small cell lung cancer
* 93 bolnikov z oceno odziva tumorja s strani neodvisnega odbora za pregled in 9 bolnikov s primarnimi tumorji osrednjega živčevja (vključno z gliomom, glioblastomom in astrocitomom) z raziskovalčevo oceno odziva tumorja a GIST: gastrointestinalni stromalni tumor b metastaze v možganih so opazili pri enem bolniku s tumorjem ščitnice, enem bolniku z NDPR in enem bolniku z DPR c NDPR: nedrobnocelični pljučni rak d DPR: drobnocelični pljučni rak
Median time on treatment was 12.1 months (range: 0.66 to 40.7 months) based on July 2018 cut-off. Fifty-two percent of patients had received VITRAKVI for 12 months or more and 30% had received VITRAKVI 18 months or more, with follow-up ongoing at the time of the analysis.
Dvainpetdeset odstotkov bolnikov je prejemalo zdravilo VITRAKVI 12 mesecev ali več, 30 % pa jih je prejemalo zdravilo VITRAKVI 18 mesecev ali več; v času analize je nadaljnje spremljanje bolnikov še trajalo.
The calculated dose volume should be rounded to the nearest 0.1 mL.
Količino izračunanega odmerka je treba zaokrožiti na odmerek, ki je najbližje 0,1 ml. - Za odmerke po 1 ml ali več je treba uporabiti 5-ml peroralno brizgo.
In order to further investigate the long-term toxicity and developmental effects of larotrectinib in paediatric patients, with particular focus on neurodevelopment including cognitive function, the MAH should submit the final report of study LOXO-TRK-15003 (SCOUT) including 5 year follow up data.
vključno s kognitivnimi funkcijami, mora imetnik dovoljenja za promet predložiti končno poročilo študije LOXO-TRK-15003 (SCOUT) vključno s podatki 5-letnega spremljanja.
Dizziness and fatigue have been reported in patients receiving larotrectinib, mostly Grade 1 and 2 during the first 3 months of treatment.
Pri bolnikih, ki so prejemali larotrektinib, so v prvih treh mesecih zdravljenja poročali o vrtoglavici in utrujenosti,
Do not eat grapefruit or drink grapefruit juice while taking VITRAKVI.
Med jemanjem zdravila VITRAKVI ne jejte grenivk niti ne pijte soka grenivk, ker lahko zviša koncentracijo zdravila VITRAKVI v vašem telesu.
Propylene glycol (E 1520) Potassium sorbate (E 202) Methyl parahydroxybenzoate (E 218) Citrus fruit flavour
- kalijev sorbat (E 202) - metil parahidroksibenzoat (E 218)
Nasogastric feeding tube - Use a suitable nasogastric feeding tube.
Nazogastrična sonda za hranjenje - Uporabite primerno nazogastrično sondo za hranjenje.
Very common Alanine aminotransferase (ALT) increased
Preiskave zelo pogosti zvišane vrednosti alanin aminotransferaze
Transaminase elevations
Zvišanja vrednosti ALT
Each capsule contains larotrectinib sulfate, equivalent to 25 mg of larotrectinib.
Ena trda kapsula vsebuje larotrektinibijev sulfat, kar ustreza 25 mg larotrektiniba.
Clinical data in healthy adult subjects indicate that co-administration of a single 100 mg VITRAKVI dose with a single dose of 600 mg rifampin (a P-gp and BCRP inhibitor) increased larotrectinib Cmax and AUC by 1.8-fold and 1.7-fold, respectively.
Klinični podatki pri zdravih odraslih osebah kažejo, da sta se ob sočasni uporabi enkratnega 100-mg odmerka zdravila VITRAKVI z enkratnim 600-mg odmerkom rifampina (zaviralec P-gp in BCRP) vrednosti Cmax in AUC larotrektiniba zvišali za 1,8-krat oziroma in 1,7-krat.
Soft tissue sarcoma (n=11) Primary CNS (n=5) Bone sarcoma (n=1) Congenital mesoblastic nephroma (n=1) Melanoma (n=1)
(n = 5) kostni sarkom (n = 1) kongenitalni mezoblastni nefrom (n = 1) melanom (n = 1)
White opaque hard gelatine capsule, size 0 (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on body of capsule.
VITRAKVI 100 mg trde kapsule bela, neprozorna, trda želatinasta kapsula, velikosti 0 (22 mm dolga x 7 mm široka), z modrim odtisnjenim znakom »BAYER« v obliki križa in napisom »LARO 100 mg« na telesu kapsule
The mean volume of distribution of larotrectinib in healthy adult subjects was 48 L following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose, indicating moderate distribution into tissues from the plasma.
mikrooznačevalca v povezavi s 100-mg peroralnim odmerkom, kar kaže zmerno porazdelitev iz plazme v tkiva.
Tube diameter for standard feeds
Premer sonde za standardno hrano
VITRAKVI is a clear yellow to orange oral solution.
Izgled zdravila VITRAKVI in vsebina pakiranja Zdravilo VITRAKVI je bistra, rumena do oranžna peroralna raztopina.
Each mL of oral solution contains 20 mg of larotrectinib (as sulfate).
1 ml peroralne raztopine vsebuje 20 mg larotrektiniba (v obliki sulfata).
Acquired resistance mutations after progression on TRK inhibitors have been observed.
Po prehodu na zaviralce TRK so opazili mutacije, ki povzročajo pridobljeno odpornost.
In cancer patients given VITRAKVI capsules, peak plasma levels (Cmax) of larotrectinib were achieved at approximately 1 hour after dosing.
larotrektiniba v plazmi dosežene približno 1 uro po odmerjanju.
Use a 1 mL syringe with 0.1 mL marks for doses less than 1 mL.
Za odmerke manjše od 1 ml uporabite 1 ml brizge z oznakami po 0,1 ml. Za odmerke 1 ml in več uporabite 5 ml-brizge z oznakami po 0,2 ml.
Myalgia Muscular weakness
- mišična šibkost
Larotrectinib Cmax was reduced by approximately 35% and there was no effect on AUC in healthy subjects administered VITRAKVI after a high-fat and high-calorie meal compared to the Cmax and AUC after overnight fasting.
V primerjavi z vrednostma Cmax in AUC zjutraj na tešče, pa zaužitje zdravila po obroku z visoko vsebnostjo maščob in kalorij ni imelo vpliva na vrednost
- VITRAKVI 25 mg is supplied as white opaque hard gelatine capsule, (18 mm long x 6 mm wide), with blue printing of BAYER-cross and “LARO 25 mg” on the body of the capsule - VITRAKVI 100 mg is supplied as white opaque hard gelatine capsule, (22 mm long x 7 mm wide), with blue printing of BAYER-cross and “LARO 100 mg” on the body of the capsule
VITRAKVI 25 mg trde kapsule bela, neprozorna, trda želatinasta kapsula, velikosti 2 (18 mm dolga x 6 mm široka), z modrim odtisnjenim znakom »BAYER« v obliki križa in napisom »LARO 25 mg« na telesu kapsule
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG
Very common Myalgia Muscular weakness
Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti mialgija mišična šibkost pogosti mialgija mialgija mišična šibkost
25 mg/m2 twice daily
25 mg/m2 dvakrat na dan
Effect of CYP3A and P-gp inducers on larotrectinib Co-administration of VITRAKVI with strong or moderate CYP3A and P-gp inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, or St. John's Wort) may decrease larotrectinib plasma concentrations and should be avoided (see section 4.4).
karbamazepin, fenobarbital, fenitoin, rifabutin, rifampin ali šentjanževka) se lahko zmanjšajo koncentracije larotrektiniba v plazmi, zato se ji je treba izogibati (glejte poglavje 4.4).
Resume at the next dose modification if resolution occurs within 4 weeks.
Če neželeni učinek izzveni v 4 tednih, nadaljujte s spremenjenim odmerkom.
Co-administration of larotrectinib with CYP2C8, CYP2C9 or CYP2C19 substrates (e.g. repaglinide, warfarin, tolbutamide or omeprazole) may decrease their exposure.
Pri sočasni uporabi larotrektiniba s substrati CYP2C8, CYP2C9 ali CYP2C19 (npr.
Neutrophil count decreased (Neutropenia)a Leukocyte count decreased (Leukopenia)
(nevtropenija)a zmanjšano število levkocitov (levkopenija)
Alanine aminotransferase (ALT) increased Aspartate aminotransferase (AST) increased Blood alkaline phosphatase increased
zvišane vrednosti alkalne fosfataze v krvi zvišane vrednosti alanin aminotransferaze
- VITRAKVI should not be mixed with feeding formulas, if administered via nasogastric feeding tube.
Količino izračunanega odmerka je treba zaokrožiti na odmerek, ki je najbližje 0,2 ml. - Zdravila VITRAKVI se ne sme mešati s formulami za hranjenje, če ga dajete z nazogastrično sondo za hranjenje.
Common (may affect up to 1 in 10 people): - change in how things taste (dysgeusia) - increased amount of “alkaline phosphatase” in blood tests (very common in children).
- zvišane vrednosti »alkalne fosfataze« v izvidih krvnih preiskav (zelo pogosto pri otrocih).
Nausea Vomiting
trebušna slinavkaa
Each mL of oral solution contains larotrectinib sulfate, equivalent to 20 mg of larotrectinib.
1 ml peroralne raztopine vsebuje larotrektinibijev sulfat, kar ustreza 20 mg larotrektiniba.
METHOD AND ROUTE(S) OF ADMINISTRATION Swallow whole.
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pogoltnite celo kapsulo.
- The recommended dose of VITRAKVI is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg),
Odrasli (starejši od 18 let) - Priporočeni odmerek zdravila VITRAKVI je 100 mg (1 kapsula po 100 mg ali 4 kapsule po
Package leaflet: Information for the patient VITRAKVI 25 mg hard capsules VITRAKVI 100 mg hard capsules larotrectinib This medicine is subject to additional monitoring.
VITRAKVI 100 mg trde kapsule larotrektinib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Alanine aminotransferase (ALT) increased Aspartate aminotransferase (AST) increased Weight increased (Abnormal weight gain) Blood alkaline phosphatase increased
pogosti zvišane vrednosti alkalne fosfataze v krvi zvišane vrednosti alanin aminotransferaze
- The maximum recommended dose is 100 mg (1 capsule of 100 mg or 4 capsules of 25 mg), two times a day.
- Največji priporočeni odmerek je 100 mg (1 kapsula po 100 mg ali 4 kapsule po 25 mg), dvakrat na dan. - Pediater vašega otroka bo preveril odmerek in ga po potrebi spremenil.
Neutrophil count decreased (Neutropenia) Leukocyte count decreased (Leukopenia)
zmanjšano število levkocitov (levkopenija)
VITRAKVI 25 mg hard capsules
Navodilo za uporabo VITRAKVI 25 mg trde kapsule
VITRAKVI 20 mg/mL oral solution
VITRAKVI 20 mg/ml peroralna raztopina
For Grade 3 or 4 adverse reactions: - VITRAKVI should be withheld until the adverse reaction resolves or improves to baseline or
- Uporabo zdravila VITRAKVI je treba opustiti, dokler neželeni učinek ne izzveni ali se izboljša na izhodiščno stanje ali 1. stopnjo.
75 mg/m2 twice daily
75 mg/m2 dvakrat na dan druga
4 weeks.
1,5-krat.
Partial response (PR)
Celokupni delež odziva
50 mg/m2 twice daily
50 mg/m2 dvakrat na dan tretja
Contents of the pack and other information What VITRAKVI contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo VITRAKVI Učinkovina je larotrektinib.
Complete response (CR) Surgical complete responsec
popolni odziv (CR) popoln odziv (CR) po kirurškem poseguc delni odziv (PR) čas do prvega odziva (mediana, meseci)
Efficacy across tumour types
»košarica« pri tumorjih
Alanine aminotransferase (ALT) increaseda Aspartate aminotransferase (AST) increased
zvišane vrednosti alanin aminotransferaze
Frequency Infants and toddlers (n=14)a
žleza slinavka (n = 14)
Dizziness Paraesthesia
Peroralna brizga
Analysis in solid tumours excluding primary CNS tumours (n=93)a
Analiza pri solidnih tumorjih brez primarnih tumorjev osrednjega živčevja
Purified water
Druge sestavine zdravila so: - očiščena voda
C.
AUC.
Nervous system disorders
zmanjšano število nevtrofilcev
Mean clearance (CL) of larotrectinib was approximately 34 L/h following intravenous administration of an IV microtracer in conjunction with a 100 mg oral dose of VITRAKVI.
mikrooznačevalca s 100-mg peroralnim odmerkom zdravila VITRAKVI je bil približno 34 l/h.
- Pull the plunger down to the graduation mark equal to the quantity in mL as prescribed.
- Povlecite bat navzdol do oznake, ki je enaka predpisani količini v ml. - Steklenico obrnite v pravilni položaj in odstranite peroralno brizgo z nastavka steklenice.
21 years with advanced cancer or with primary CNS tumours
≥ 12 let, z napredovalimi solidnimi tumorji s fuzijo genov NTRK
Soft tissue sarcomaa Salivary glanda Infantile fibrosarcomaa Thyroida
ritonavir, sakvinavir, rifabutin, efavirenz
Bone sarcoma (n=1) Pancreas (n=1)
dojke (n = 1) kostni sarkom (n = 1) trebušna slinavka (n = 1)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema zelo pogosti anemija zmanjšano število nevtrofilcev
Natural flavour
- naravna aroma
Paraesthesia Gait disturbance
Okvara ledvic
Very common Nausea Constipation Vomiting
Bolezni prebavil zelo pogosti občutek siljenja na bruhanje obstipacija bruhanje pogosti disgevzija občutek siljenja na bruhanje
Each capsule contains larotrectinib sulfate, equivalent to 100 mg of larotrectinib.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje larotrektinibijev sulfat, kar ustreza 100 mg larotrektiniba.
Grade 3
Vse stopnje
Sodium dihydrogen phosphate dihydrate (E 339) Citric acid (E 330)
- saharoza - hidroksipropilbetadeks - glicerol (E 422) - sorbitol (E 420) - natrijev citrat (E 331) - natrijev dihidrogenfosfat dihidrat (E 339) - citronska kislina (E 330) - propilenglikol (E 1520)
Capsule shell Gelatin
Ovojnica kapsule
How to store VITRAKVI
Pri odmerjanju zdravila VITRAKVI
Very common Dizziness Paraesthesia
Bolezni živčevja zelo pogosti vrtoglavica parestezija pogosti motnje hoje vrtoglavica parestezija
VITRAKVI 100 mg hard capsules
100 mg kapsule ali
Primary CNSb
Bayer Vital GmbH
Paediatric patients (n=37)
(n = 37)
Infantile fibrosarcoma (n=13)
žleza slinavka (n = 3)
This schedule can also be used in patients aged 16 to 21 years.
To shemo je mogoče uporabljati tudi pri bolnikih, starih od 16 do 21 let.
Most of these side effects were also very common in children.
Večina neželenih učinkov je bila zelo pogosta tudi pri otrocih.
Further information on Atriance can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
Dodatne informacije o zdravilu Atriance so na voljo na spletni strani agencije: https://www.ema.europa.eu/en/medicines/human/EPAR/atriance
The first study involved 70 children and young adults below 21 years of age.
Prva študija je vključevala 70 otrok in mladih odraslih, mlajših od 21 let.
What measures are being taken to ensure the safe and effective use of Atriance?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Atriance?
The European Medicines Agency decided that Atriance's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Atriance večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The dose and frequency of infusion depend on the patient's age and body surface area (calculated using the patient's height and weight).
Odmerek in pogostnost infuzije sta odvisna od bolnikove starosti in telesne površine (izračunane na podlagi bolnikove telesne višine in mase).
This means that because the diseases are rare, it has not been possible to obtain complete information about Atriance.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o zdravilu Atriance.
Atriance received a marketing authorisation valid throughout the EU on 22 August 2007.
Za zdravilo Atriance je bilo 22. avgusta 2007 izdano dovoljenje za promet, veljavno po vsej EU.
The most common side effects with Atriance in adults (which may affect more than 1 in 10 people) are infection, febrile neutropenia (low white blood cell counts with fever), neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), somnolence (sleepiness), peripheral neuropathy (damage to the nerves in the extremities), hypoaesthesia (a reduced sense of touch), paraesthesia (unusual sensations like pins and needles), dizziness, headache, dyspnoea (breathlessness), cough, diarrhoea, vomiting, constipation, nausea (feeling sick), myalgia (muscle pain), oedema (swelling), peripheral oedema (swelling in ankles and feet), pyrexia (fever), pain, tiredness and weakness.
Najpogostejši neželeni učinki zdravila Atriance pri odraslih (ki se lahko pojavijo pri več kot 1 bolniku od 10) so okužba, febrilna nevtropenija (nizko število belih krvnih celic s povišano telesno temperaturo), nevtropenija (nizko število belih krvnih celic), trombocitopenija (nizko število trombocitov), anemija (nizko število rdečih krvnih celic), somnolenca (zaspanost), periferna nevropatija (poškodba živcev v okončinah), hipestezija (zmanjšan občutek za dotik), parestezija (neobičajni občutki zbadanja), omotica, glavobol, dispneja (zasoplost), kašelj, driska, bruhanje, zaprtje, navzeja (siljenje na bruhanje), mialgija (bolečine v mišicah), edem (otekanje), periferni edem (otekanje gležnjev in stopal), pireksija (povišana telesna temperatura), bolečine, utrujenost in oslabelost.
This stops the production of DNA and thus slows down the growth and multiplication of cells.
To zaustavi nastajanje DNK, kar upočasni rast in množenje celic.
Of those whose cancer had not responded (28) five (18%) had a complete response to treatment.
Med njimi je pri tistih, ki se niso odzvali na zdravljenje (28), pet (18 %) bolnikov doseglo popoln odziv na zdravljenje.
Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.
Zdravljenje je treba prekiniti, če se pri bolniku pojavijo resni neželeni učinki, ki prizadenejo možgane ali živčni sistem.
In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine.
V obeh študijah so bolniki prejemali zdravilo Atriance, vendar njegovih učinkov niso primerjali z nobenim drugim zdravilom.
Other information about Atriance
Druge informacije o zdravilu Atriance
Atriance has been authorised under ‘exceptional circumstances'.
Zdravilo Atriance je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
The Agency noted that, due to the small number of patients with these diseases, the information to support the authorisation of Atriance is limited, but it agreed that the medicine could allow some patients to go on to receive bone-marrow transplantation, increasing their chances of survival.
Ugotovila je, da so zaradi majhnega števila bolnikov s tema boleznima informacije v podporo izdaji dovoljenja za zdravilo Atriance omejene, vendar se je strinjala, da bi zdravilo utegnilo nekaterim bolnikom omogočiti presaditev kostnega mozga in tako povečati njihove možnosti za preživetje.
These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly.
To sta vrsti raka, pri katerih se limfoblasti T (vrsta nezrelih belih krvnih celic) množijo prehitro.
In the second study, involving a total of 40 adults and adolescents above the age of 16.
Druga študija je vključevala 40 odraslih in mladostnikov, starejših od 16 let.
As for all medicines, data on the use of Atriance are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Atriance stalno spremljajo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atriance have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Atriance upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Atriance and why it is authorised in the EU
Pregled zdravila Atriance in zakaj je odobreno v EU
Side effects reported with Atriance are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Atriance, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Nelarabine is converted within cells into an analogue of guanine, one of the fundamental chemicals that make up DNA.
Nelarabin se v celicah pretvori v analog gvanina, ene od osnovnih kemičnih snovi, ki tvorijo DNK.
Why is Atriance authorised in the EU?
Zakaj je bilo zdravilo Atriance odobreno v EU?
What benefits of Atriance have been shown in studies?
Kakšne koristi zdravila Atriance so se pokazale v študijah?