natgillin/translations-raw huggingface dataset:
Progression free survival (PFS) as assessed by IRC according to International Workshop on CLL (IWCLL) criteria indicated an 84% statistically significant reduction in the risk of death or progression in the IMBRUVICA arm. Efficacy results for Study PCYC-1115-CA are shown in Table 4 and the Kaplan-Meier curves for PFS and OS are shown in Figures 2 and 3, respectively.
Podatki o preživetju brez napredovanja bolezni (PFS- Progression free survival), ki jih je ocenila IRC glede na kriterije mednarodnega seminarja za KLL (IWCLL - International Workshop on CLL) so pokazali 84% statistično značilno zmanjšanje tveganja za smrt ali napredovanje bolezni v skupini, ki je prejemala zdravilo IMBRUVICA.
Also tell your doctor if you take any of the following medicines - The effects of IMBRUVICA or other medicines may be influenced if you take IMBRUVICA together with any of the following medicines:
Poleg tega zdravniku povejte, če jemljete katero od naslednjih zdravil - na učinke zdravila IMBRUVICA ali drugih zdravil lahko vpliva sočasno jemanje zdravila IMBRUVICA s katerim koli od naslednjih zdravil: - zdravila, ki jih imenujemo antibiotiki in jih uporabljamo za zdravljenje bakterijskih okužb klaritromicin, telitromicin, ciprofloksacin, eritromicin ali rifampicin - zdravila proti glivičnim okužbam - posakonazol, ketokonazol, itrakonazol, flukonazol ali vorikonazol - zdravila, ki jih uporabljamo pri okužbi z virusom humane imunske pomanjkljivosti (HIV)
Hepatic impairment
Huda bolezen srca
Swallow the tablet whole.
Tablete je treba pogoltniti cele z vodo.
Analysis of OS demonstrated a 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA arm. Efficacy results for Study PCYC-1112-CA are shown in Table 7.
Analiza OS je pri bolnikih v skupini z zdravilom IMBRUVICA pokazala 57-odstotno statistično značilno znižanje tveganja za smrt.
Very common Haemorrhage Bruising Hypertension
Presnovne in prehranske motnj pogosti sindrom razpada tumorja hiperurikemija
• blood thinners such as warfarin, heparin or other medicines for blood clots
Mednje sodijo: - acetilsalicilna kislina in nesteroidna protivnetna zdravila, kot sta ibuprofen in naproksen - zdravila, ki zavirajo strjevanje krvi, kot so varfarin, heparin in druga zdravila, ki delujejo proti nastanku krvnih strdkov - prehranski nadomestki, ki lahko povečajo možnost krvavitve, kot so ribje olje, vitamin E ali laneno seme
Uncommon Angioedema Panniculitis
pogosti urtikarija eritem lomljenje nohtov občasni angioedem panikulitis*
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
peroralna uporaba Pred uporabo preberite priloženo navodilo!
MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Velikost pakiranja pretisni omot (alu/alu)
1 bottle + 1 oral syringe 10 ml
1 steklenička + 1 peroralna brizga 10 ml
EU Number
Številka EU Izmišljeno ime Jakost
This overview was last updated in 07-2018.
Pregled je bil nazadnje posodobljen 07-2018.
Histamine is a substance occurring naturally in the body that is involved in many processes.
Histamin je snov, ki je naravno prisotna v telesu, in je vpletena v številne procese.
This means that it changes the activity of the immune system (the body's natural defences).
To pomeni, da spreminja delovanje imunskega sistema (naravnega obrambnega mehanizma telesa).
The European Medicines Agency decided that Ceplene'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 Ceplene večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
It is used during the patients' first ‘remission' (a period without symptoms of the disease after the first course of treatment).
Uporablja se pri bolnikih med „prvo remisijo“ (obdobjem brez simptomov bolezni po prvem krogu zdravljenja).
This can increase the length of time the patient stays in remission.
S tem se podaljša čas, ko bolnik ostane v remisiji.
What measures are being taken to ensure the safe and effective use of Ceplene?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ceplene?
Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Za zdravilo Ceplene je bilo 7. oktobra 2008 izdano dovoljenje za promet, veljavno po vsej EU.
It is available as a solution for injection under the skin.
Na voljo je v obliki raztopine za injiciranje pod kožo.
Other information about Ceplene
Druge informacije o zdravilu Ceplene
An overview of Ceplene and why it is authorised in the EU
Pregled zdravila Ceplene in zakaj je odobreno v EU
Ceplene must not be used in patients who have severe heart problems or in women who are pregnant or breastfeeding.
Zdravilo Ceplene se ne sme uporabljati pri bolnikih, ki imajo resne težave s srcem, ali pri ženskah, ki so noseče ali dojijo.
As for all medicines, data on the use of Ceplene are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ceplene stalno spremljajo.
AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
AML je redka bolezen, zdravilo Ceplene pa je bilo 11. aprila 2005 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Ceplene has been authorised under ‘exceptional circumstances'.
Zdravilo Ceplene je pridobilo dovoljenje za promet „v izjemnih okoliščinah“.
Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije za zdravilo Ceplene so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Ceplene and what is it used for?
Kaj je zdravilo Ceplene in za kaj se uporablja?
Depending on the patient's response to treatment and side effects, the treatment may have to be suspended or the dose adjusted.
Glede na bolnikov odziv na zdravljenje in neželene učinke se lahko zdravljenje prekine ali pa se odmerek prilagodi.
Between each cycle there should be a treatment-free period of 3 weeks.
En cikel traja 3 tedne, med vsakim ciklom pa mora biti obdobje 3 tednov brez zdravljenja.
Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ceplene, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefit of Ceplene have been shown in studies?
Kakšne koristi zdravila Ceplene so se pokazale v študijah?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ceplene 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 Ceplene upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Priporočeni odmerek zdravila Ceplene je ena injekcija dvakrat dnevno, od ene do treh minut po injekciji interlevkina-2.
What are the risks associated with Ceplene?
Kakšna tveganja so povezana z zdravilom Ceplene?
For more information about using Ceplene, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ceplene glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Učinkovitost zdravila Ceplene so preučevali v eni glavni študiji, v kateri je sodelovalo 320 odraslih bolnikov z AML, ki so bili v remisiji po zdravljenju levkemije.
This is because it has not been possible to obtain complete information about Ceplene due to the rarity of the disease.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Ceplene (histamine dihydrochloride)
Ceplene (histaminijev diklorid)
The company that markets Ceplene will provide yearly updates on the safety and effectiveness of Ceplene in combination with interleukin-2 in AML patients in first remission.
Podjetje, ki trži zdravilo Ceplene, bo zagotovilo letne posodobitve glede varnosti in učinkovitosti zdravila Ceplene v kombinaciji z interlevkinom-2 pri bolnikih z AML v prvi remisiji.
Why has Ceplene been approved?
Zakaj je bilo zdravilo Ceplene odobreno?
Ceplene can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in the treatment of AML.
Predpisovanje in izdaja zdravila Ceplene je le na recept, dajati pa ga je treba pod nadzorom zdravnika z izkušnjami z zdravljenjem AML.
For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Kombinacija zdravila Ceplene in interlevkina-2 je bila pri bolnikih v prvi remisiji v primerjavi z bolniki brez zdravljenja učinkovitejša pri podaljšanju časa, ko se bolezen AML ponovi ali bolnik iz katerega koli razloga umre: povprečni čas brez bolezni se je podaljšal z 291 dni (brez zdravljenja) na 450 dni (po zdravljenju z zdraviloma Ceplene in interlevkin-2).
When Ceplene is first given, the patient's blood pressure, heart rate and lung function must be checked.
Ob prvi uporabi zdravila Ceplene je treba spremljati bolnikov krvni tlak, srčni utrip in delovanje pljuč.
Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Zdravilo Ceplene je zdravilo, ki se uporablja v kombinaciji z interlevkinom-2 (zdravilom za zdravljenje raka) za vzdrževalno zdravljenje pri odraslih bolnikih z akutno mieloično levkemijo (AML), vrsto raka, ki prizadene bele krvničke.
What information is still awaited for Ceplene?
Katere informacije o zdravilu Ceplene še pričakujemo?
It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Prav tako se ne sme uporabljati pri bolnikih, ki so jim presadili kostni mozeg, prejet od darovalca, ali ki jemljejo sistemske steroide (zdravila za ublažitev ali preprečevanje vnetij, prejete peroralno ali z injekcijo), klonidine (zdravila za zniževanje povišanega krvnega tlaka) ali zaviralce histaminskega receptorja H2 (zdravila za zdravljenje želodčnih razjed, slabe prebave ali zgage).
This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
To poveča učinkovitost interlevkina2, zdravila, ki spodbuja imunski sistem k uničevanju rakavih celic.
The most common side effects with Ceplene (seen in more than 1 patient in 10) are flushing (reddening), headache, tiredness, fever and inflammation or redness at the injection site.
Najpogostejši neželeni učinki zdravila Ceplene (opaženi pri 1 od 10 bolnikov) so zardevanje, glavobol, utrujenost, povišana telesna temperatura in vnetje ali rdečina na mestu injiciranja.
Ceplene and interleukin-2 are given for 10 cycles.
Zdravili Ceplene in interlevkin-2 se dajeta v 10 ciklih zdravljenja.
Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (belly).
Vsak odmerek zdravila Ceplene je treba injicirati počasi, in sicer v 5-15 minutah, na mesto, ki se razlikuje od mesta injiciranja interlevkina-2, po možnosti v stegno ali abdomen (trebuh).
Every year, the Agency will review any new information that may become available and this summary will be updated as necessary.
Agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo.
When Ceplene is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Če se zdravilo Ceplene daje skupaj z interlevkinom-2, pomaga imunskemu sistemu ubijati levkemične celice, ki ostanejo v telesu med remisijo.
In the treatment of AML, it is thought to work by protecting immune system cells from damage.
Domneva se, da histamin pri zdravljenju AML pomaga z zaščito celic imunskega sistema pred poškodbami.
Ceplene was given in combination with interleukin-2 and compared with no treatment.
Zdravilo je bilo dano v kombinaciji z interlevkinom-2, zdravljenje pa so primerjali s stanjem brez zdravljenja.
How does Ceplene work?
Kako zdravilo Ceplene deluje?
For the full list of side effects of Ceplene, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Ceplene glejte navodilo za uporabo.
The active substance in Ceplene, histamine dihydrochloride, is an immune modulator.
Učinkovina v zdravilu Ceplene, histaminijev diklorid, je imunomodulator.
How is Ceplene used?
Kako se zdravilo Ceplene uporablja?
Ceplene contains the active substance histamine dihydrochloride.
Zdravilo Ceplene vsebuje učinkovino histaminijev diklorid.
No effect of Ceplene and interleukin-2 was seen in patients in second or later remission.
Pri bolnikih v drugi ali poznejši remisiji ni bilo opaznega učinka zdravila Ceplene in interlevkina-2.
Hence no safety margin could be calculated.
Posledično ni bilo mogoče izračunati nobenega varnostnega faktorja.
• four cases of spontaneous abortion,
• štiri primere spontanega splava;
This DUS should be conducted over a three year period.
Študija mora trajati tri leta.
Carcinogenicity is an important potential risk.
Rakotvornost je pomembno možno tveganje.
Clinical Safety
Klinična varnost
A relevant summary is presented hereinafter.
Povzetek pregleda je predstavljen v nadaljevanju.
• Teratogenicity is classified as an important identified risk.
• Teratogenost je opredeljena kot pomembno znano tveganje.
However it is still controversial if aneuploidy is a contributing cause or merely a consequence of neoplastic transformation.
Še vedno pa je sporno vprašanje, ali je anevploidija eden od vzrokov za neoplastično transformacijo ali zgolj njena posledica.
Post marketing experience
Izkušnje v obdobju trženja
The CHMP was asked to give its opinion on whether the indication of TCC containing medicinal products should be restricted and/or other regulatory measures should be taken.
CHMP so zaprosili, naj poda svoje mnenje o tem, ali bi bilo treba omejiti indikacijo zdravil, ki vsebujejo tiokolhikozid, in/ali sprejeti druge ureditvene ukrepe.
The package size should be adapted to new recommended treatment-days.
Velikost pakiranja je treba spremeniti v skladu s priporočenim številom dni zdravljenja;
The CHMP also recommended further changes to the product information including information on fertility.
CHMP je priporočil tudi dodatne spremembe informacij o zdravilu, vključno z informacijami v zvezi s plodnostjo;
Subsequent safety assessments focusing on genotoxic potential were issued in 20012 and 20033 .
Leta 20012 in 20033 so bile objavljene naknadne ocene varnosti, ki so se osredotočile na genotoksični potencial.
• The CHMP also agreed on the need of a RMP.
• prav tako se je CHMP strinjal, da je potreben načrt za obvladovanje tveganja.
The CHMP also noted that the limited number of cases of malformations/embryo-foetal toxicities may be due to the fact that, in most of the Member States, the medicine is contraindicated in pregnancy.
CHMP je upošteval tudi, da bi majhno število primerov malformacij/embriofetalne toksičnosti lahko bilo posledica dejstva, da je v večini držav članic zdravilo v nosečnosti kontraindicirano.
In addition, the lack of evidence for the correlation between the use of TCC and cancer could be due to the difficulty of establishing a causal relationship between the medicine and the effect, which may occur years after intake.
Poleg tega bi lahko bilo pomanjkanje dokazov o povezavi med uporabo tiokolhikozida in rakom posledica dejstva, da je težko dokazati vzročno razmerje med zdravilom in učinkom, ki se lahko pojavi več let po jemanju.
Muscle relaxants are one of the many treatments currently employed in the management of non-specific low back pain.
Mišični relaksanti so ena od številnih vrst zdravljenja, ki se trenutno uporabljajo za obvladovanje nespecifične bolečine v križu.
In view of the above, on 15 February 2013, Italy requested the CHMP, under Article 31 of Directive 2001/83/EC, to assess the above concerns regarding aneuploidy and its impact on the benefit-risk balance for TCC containing medicinal products for systemic use.
Na podlagi zgoraj navedenega je Italija dne 15. februarja 2013 v skladu s členom 31 Direktive 2001/83/ES zaprosila odbor CHMP, da oceni omenjene zadržke v zvezi z anevploidijo in njen vpliv na razmerje med tveganji in koristmi zdravil za sistemsko uporabo, ki vsebujejo tiokolhikozid.
Case review reports from 2004 up to 29 April 2013 from the second database reported 23 cases secondary to exposure during pregnancy and / or exposition in utero:
Poročila o pregledu primerov med letom 2004 in 29. aprilom 2013 iz druge zbirke podatkov navajajo 23 primerov, ki so bili posledica izpostavljenosti med nosečnostjo in/ali intrauterine izpostavljenosti:
Overall summary of the scientific evaluation of thiocolchicoside containing medicinal products for systemic use (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil za sistemsko uporabo, ki vsebujejo tiokolhikozid (glejte Prilogo I)
• Lastly, evidence for carcinogenicity of aneugens is limited.
• Dokazov o rakotvornosti anevgenov je malo.
Postmarketing spontaneous cases were collected based on the reports recorded in two MAHs' global pharmacovigilance databases (cut-off dates of 15 February 2013 and 29 April 2013 respectively).
Spontane primere v obdobju trženja so zbrali na podlagi poročil, ki so jih zabeležili v dveh zbirkah podatkov farmakovigilance po vsem svetu dveh imetnikov dovoljenja za promet z zdravilom (presečna datuma sta bila 15. februar 2013 oziroma 29. april 2013).
Taking the totality of data into account, the CHMP considered that causality cannot be excluded and that aneuploidy should be considered as a cancer risk factor on theoretical grounds.
Potem ko je proučil vse podatke, je CHMP menil, da vzročnosti ni mogoče izključiti in da bi morala anevploidija na podlagi teoretičnih spoznanj veljati za dejavnik tveganja za raka.
For the purpose of the review of this risk, the MAHs provided an analysis of this genotoxic potential for each systemic route of administration, together with an analysis of possible risk factors, including relevant criteria such as dose and duration of treatment.
Da bi omogočili pregled tega tveganja, so imetniki dovoljenja za promet z zdravilom predložili analizo genotoksičnega potenciala za vsako sistemsko pot uporabe, skupaj z analizo možnih dejavnikov tveganja, v katero so vključili pomembne faktorje, kot sta odmerek in trajanje zdravljenja.
• one case of threat of premature delivery.
• en primer grozečega prezgodnjega poroda.
In most cases the treatment is for short-term use and not associated with the perception of increased cancer risk for both physicians and patients, therefore a causal relationship between cancer occurrence and treatment is difficult to establish.
V večini primerov je zdravilo namenjeno kratkotrajni uporabi in ga zdravniki ter bolniki ne povezujejo s povečanim tveganjem za raka, tako da je vzročno razmerje med pojavom raka in zdravljenjem težko dokazati.
In the first database, 11 cases secondary to exposure during pregnancy were reported:
V prvi zbirki podatkov so zabeležili 11 primerov, ki so bili posledica izpostavljenosti med nosečnostjo:
• The Committee considered also that thiocolchicoside containing medicinal products for systemic use should be contraindicated during the entire pregnancy period.
• odbor je menil tudi, da je treba zdravila za sistemsko uporabo, ki vsebujejo tiokolhikozid, kontraindicirati med celotnim obdobjem nosečnosti.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for thiocolchicoside containing medicinal products for systemic use (see annex I).
• odbor je obravnaval napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES za zdravila za sistemsko uporabo, ki vsebujejo tiokolhikozid (glejte Prilogo I);
Grounds for the maintenance of the marketing authorisations
Podlaga za ohranitev dovoljenj za promet z zdravili
A risk management plan (RMP) will be submitted to national competent authorities in accordance with agreed timelines and periodic safety update reports (PSURs) will be submitted every 3 years.
Pristojnim nacionalnim organom se bo v dogovorjenih rokih predložil načrt za obvladovanje tveganja (RMP) in vsaka 3 leta tudi redno posodobljena poročila o varnosti zdravila (PSUR).
However, whether the exposure to M2 would be below a threshold of aneugenicity (including a sufficient safety margin) is unknown since M2 has not been analysed in the available clinical kinetic studies.
Vendar ni znano, ali bi bila izpostavljenost presnovku M2 pod mejno vrednostjo za anevgenost (ob upoštevanju zadostnega varnostnega faktorja), saj M2 v razpoložljivih kliničnih kinetičnih študijah niso analizirali.
Given the treatment conditions with TCC (short-term, potentially aneugenic at maximum doses) effects on male fertility will be low and a rapid recover to normal levels can be expected.
Glede na pogoje zdravljenja s tiokolhikozidom (kratkotrajno, potencialno anevgeno pri največjih odmerkih) bodo učinki na plodnost pri moških majhni, pričakuje pa se tudi hitra povrnitev normalnih ravni.
It was concluded that M1 (SL18.0740) is devoid of mutagenic (gene mutations) and clastogenic (structural chromosome damage) potential, but is able to induce aneuploidy (numerical chromosome damage).
Ugotovili so, da M1 (SL18.0740) nima mutagenega (mutacije genov) in klastogenega (strukturne poškodbe kromosomov) potenciala, lahko pa povzroči anevploidijo (številčne poškodbe kromosomov).
No case was registered for neonatal effects related to exposure occurred in late pregnancy or during childbirth.
Primerov neželenih učinkov na novorojenčke, povezanih z izpostavljenostjo v pozni nosečnosti ali med porodom, niso zabeležili.
Aneuploidy is a common characteristic of cancer cells.
Anevploidija je skupna lastnost rakavih celic.
Therefore, on the basis of the above-mentioned available data, the CHMP considered the safety margins and benefit/risk for TCC and SL18.0740 (M1) acceptable.
CHMP je zato na podlagi zgoraj omenjenih razpoložljivih podatkov menil, da so varnostni faktorji ter razmerje med tveganji in koristmi za tiokolhikozid in presnovek SL18.0740 (M1) sprejemljivi.
These products should also be contraindicated in women of childbearing potential not using contraception and during lactation.
Prav tako jih je treba kontraindicirati pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije, in med dojenjem.
The study protocol should be provided within the RMP.
Protokol za študijo mora biti predložen v okviru načrta za obvladovanje tveganja.
Genotoxic mechanisms, such as aneuploidy, involving cell division and non-DNA targets, are known to occur above a certain threshold of exposure.
Genotoksični mehanizmi, kot je anevploidija, ki vključujejo delitev celic in tarčna mesta, ki niso DNA, se dokazano pojavijo nad določeno mejno vrednostjo izpostavljenosti.
In addition males and females showed only a slight gender difference in exposure.
Poleg tega so pri samcih in samicah zabeležili zelo majhne razlike v izpostavljenosti glede na spol.
However a follow-up study (in vivo micronucleus test) defined a no-effect level of 39.6 mg/kg.
Vendar pa je nadaljnja študija (mikronukleusni preskus in vivo) pokazala, da je odmerek do 39,6 mg/kg brez učinka.