natgillin/translations-raw huggingface dataset:
Once you have completed the 2 treatment courses over 2 years, your doctor will continue to monitor your health for another 2 years, in which you do not need to take the medicine.
Ko boste zaključili 2 ciklusa zdravljenja v 2 letih, bo zdravnik vaše zdravje spremljal še nadaljnji 2 leti, v katerih vam ne bo treba jemati zdravila.
Swallow them without chewing.
Pogoltnite jih brez žvečenja.
Grade 4 lymphopenia was seen in less than 1% of the patients.
Limfopenijo 4. stopnje so opazili pri manj kot 1 % bolnikov.
Re-initiation of therapy after year 4 has not been studied.
Ponovne uvedbe zdravljenja po 4. letu niso preučili.
Fructose intolerance
Fruktozna intoleranca
When you receive your supply of medicine, check that you have the correct number of tablets.
Ko boste prejeli zalogo zdravil, preverite, ali imate pravo število tablet.
Oral herpes, dermatomal herpes zoster.
oralni herpes, dermatomalni herpes zoster
Wash your hands thoroughly with soap and water.
Roke si temeljito umijte z milom in vodo.
Live or live attenuated vaccines
Živa ali živa oslabljena cepiva
• 2 and 6 months after start of treatment in each treatment year.
• 2 in 6 mesecev po začetku zdravljenja v vsakem letu zdravljenja.
Concomitant treatment is not recommended.
Sočasno zdravljenje ni priporočljivo.
Take the tablet(s) at about the same time each day.
Tableto(i) vzemite vsak dan ob približno istem času.
Example: if you weigh 85 kg and are about to start treatment week 1, you will be given 8 tablets.
Primer: če tehtate 85 kg in boste začeli s 1. tednom zdravljenja, boste dobili 8 tablet.
- certain types of vaccines (live and live attenuated vaccines).
- nekaterimi vrstami cepiv (na primer živa ali živa oslabljena cepiva).
If your daily dose is 2 tablets, take them at the same time.
Če sta vaš dnevni odmerek 2 tableti, ju vzemite istočasno.
Push the tray back into the carton.
Nosilec potisnite nazaj v škatlo.
Infection with human immunodeficiency virus (HIV).
Okužba z virusom humane imunske pomanjkljivosti (HIV).
- if you are pregnant or breast-feeding (see also 'Pregnancy and breast-feeding').
- če ste noseči ali dojite (glejte tudi 'Nosečnost in dojenje').
If you miss a dose and do not remember it until the following day
Če izpustite odmerek in se tega ne spomnite do naslednjega dne
1 tablet 4 tablets 5 tablets 6 tablets 7 tablets 8 tablets
1 tableta 4 tablete 5 tablet 6 tablet 7 tablet 8 tablet
Push (text to indicate the two hooks that have to be pressed for opening) QR code to be included www.mavenclad-instructions.com
Pritisnite (besedilo, ki označuje dva zatiča, ki ju je treba pritisniti, da se nosilec odpre) Vključi se koda QR www.mavenclad-instructions.com
• Additional risk minimisation measures
• • Dodatni ukrepi za zmanjševanje tveganj
Harderian gland tumours are not considered to be of clinical relevance, as humans do not have comparable anatomical structures.
Tumorji Harderjeve žleze ne veljajo za klinično pomembne, saj ljudje nimajo primerljivih anatomskih struktur.
An effect on disability progression could not be shown in either subgroup.
Učinka na napredovanje prizadetosti ni bilo možno prikazati v nobeni podskupini.
You will need to wait between 4 and 6 weeks for the vaccination to take effect.
Morali boste počakati od 4 do 6 tednov, da bo cepivo začelo učinkovati.
OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic: Handle with caution.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično: ravnajte previdno.
Contact with skin should be limited.
Stik s kožo morate omejiti.
Talk to your doctor if you have previously had cancer.
Povejte zdravniku, če ste imeli raka.
Use of MAVENCLAD is not recommended in patients below the age of 18 years, because it has not been investigated in this age group.
Uporaba zdravila MAVENCLAD se ne priporoča pri bolnikih, mlajših od 18 let, ker v tej starostni skupini ni bila raziskana.
• Guidance for patient's monitoring during the treatment;
• vodnik za spremljanje bolnika med zdravljenjem;
- if you have moderate or severe kidney problems.
- če imate zmerne ali hude težave z ledvicami.
MS is a disease in which inflammation destroys the protective sheath around the nerves.
MS je bolezen, pri kateri vnetje uniči zaščitni ovoj okoli živcev.
• patients with 2 or more relapses in the previous year, whether on DMD treatment or not.
• bolnike z 2 recidivoma ali več v preteklem letu, bodisi zdravljenih z DMD ali ne.
How to take your medicine
Kako jemati to zdravilo
The estimated terminal half-life for a typical patient from the population pharmacokinetic analysis is approximately 1 day.
Ocenjena končna razpolovna doba za običajnega bolnika iz populacijske farmakokinetične analize je približno 1 dan.
Have a glass of water ready and make sure your hands are clean and dry before taking the tablet(s).
Pripravite kozarec vode in se prepričajte, da imate čiste in suhe roke, preden vzamete tableto(-i).
Consultation with a haematologist is advised.
Priporočljivo se je posvetovati s hematologom.
Patients with hereditary problems of fructose intolerance should not take this medicinal product.
Bolniki z dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
500 cells/mm³, it should be actively monitored until values increase again.
500 celic/mm³, je treba število limfocitov aktivno spremljati, dokler vrednost znova ne zraste.
Careful monitoring of haematological parameters is recommended in such cases.
V teh primerih se priporoča skrbno nadziranje hematoloških parametrov.
(3) Pull the tray out until it stops.
(3) Izvlecite nosilec, dokler se ne zaustavi.
Very rare side effect - may affect up to 1 in 10,000 people - tuberculosis
Zelo redki neželeni učinki - pojavijo se lahko pri največ 1 od 10.000 bolnikov - tuberkuloza
If such signs and symptoms occur, antiinfective treatment should be initiated as clinically indicated.
Če se pojavijo takšni znaki in simptomi, je treba uvesti zdravljenje okužbe glede na klinično indikacijo.
Make sure you know how many tablets are contained in the package.
Prepričajte se, da veste, koliko tablet vsebuje pakiranje.
Patients were required to have at least 1 relapse in the previous 12 months.
Bolniki so morali imeti vsaj 1 recidiv v zadnjih 12 mesecih.
If you have taken more tablets than you should, contact your doctor immediately.
Če ste vzeli več tablet kot bi smeli, takoj obvestite zdravnika.
Effects on the kidneys were also seen in mice.
Učinke na ledvice so opazili tudi pri miših.
Example: if you have to take 8 tablets, you would take 2 tablets on Day 1, Day 2, Day 3, then 1 tablet on Day 4 and Day 5.
Primer: če morate vzeti 8 tablet, bi vzeli 2 tableti 1. dan, 2. dan, 3. dan, in nato 1 tableto 4. dan in 5. dan.
Rash, alopecia.
izpuščaj, alopecija
Clinically relevant interactions with inhibitors of P-gp are not expected.
Klinično pomembne interakcije z inhibitorji P-gp niso pričakovane.
Vaccination with live or attenuated live vaccines should be avoided during and after cladribine treatment as long as the patient's white blood cell counts are not within normal limits.
Cepljenju z živimi ali živimi oslabljenimi cepivi se moramo med in po zdravljenju s kladribinom izogibati, dokler bolnikovo število belih krvnih celic ni znotraj normalnih meja.
Concomitant use of other oral medicinal products
Sočasna uporaba drugih peroralnih zdravil
Patients with secondary progressive MS were excluded in the CLARITY study.
Bolniki s sekundarno progresivno MS so bili izključeni iz študije CLARITY.
Pack sizes of 1, 4, 5, 6, 7 or 8 tablets.
Velikosti pakiranja 1, 4, 5, 6, 7 ali 8 tablet.
These may be the symptoms of a rare brain disorder caused by infection and called progressive multifocal leukoencephalopathy (PML).
Lahko gre za simptome redke bolezni možganov, povzročene z okužbo, ki se imenuje progresivna multifokalna levkoencefalopatija (PML).
In the left column of the table below find the row that fits your body weight (in kg), and then check the number of tablets that should be in the pack(s) for the treatment week you will be starting.
V levem stolpcu spodnje preglednice poiščite vrstico, ki ustreza vaši telesni masi (v kg), in nato preverite število tablet, ki mora biti v pakiranju(-jih) za teden zdravljenja, ki ga boste začeli.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila posvetujte z zdravnikom.
If a daily dose consists of two tablets, both tablets are taken together as a single dose.
Če sestavljata dnevni odmerek dve tableti, se obe tableti vzameta skupaj, kot en odmerek.
The bioavailability of 10 mg oral cladribine was approximately 40%.
Biološka uporabnost 10 mg peroralnega kladribina je bila približno 40 %.
• A reminder to carefully consider data on blood count monitoring and screening for latent infections before starting the treatment;
• opomnik, da je treba natančno upoštevati podatke o spremljanju krvne slike in presejalnem pregledu zaradi latentnih okužb pred začetkom zdravljenja;
- Thoroughly wash your hands after handling the tablets.
- Temeljito si operite roke, potem ko ste rokovali s tabletami.
In the overall study population, the median age was 39 years (range 18 to 65), and the female to male ratio was approximately 2:1.
V celotni preiskovani populaciji je bila mediana starosti 39 let (razpon 18 do 65), pri čemer je bilo razmerje med ženskami in moškimi približno 2:1.
Your immune system must have recovered before you can be vaccinated, and blood tests will check this.
Vaš imunski sistem mora najprej okrevati, preden ste lahko cepljeni, in da se to ugotovi, je potrebna krvna preiskava.
Place your hand under the blister pack and push 1 or 2 tablet(s) into your hand, according to your prescribed dose.
Roko namestite pod pretisni omot in potisnite 1 ali 2 tableti v dlan, skladno s predpisanim odmerkom.
Because of these expression levels, cells of the innate immune system are less affected than cells of the adaptive immune system.
Zaradi teh ekspresijskih ravni so celice naravnega imunskega sistema prizadete manj kot celice prilagojenega imunskega sistema.
There is no known specific antidote to an overdose of cladribine.
Ni znanega specifičnega antidota za preveliko odmerjanje kladribina.
Pharmacotherapeutic group: Selective Immunosuppressants, ATC code: L04AA40
Farmakoterapevtska skupina: Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA40
Particular attention is recommended for patients who have no history of exposure to varicella zoster virus.
Posebna pozornost se priporoča pri bolnikih, ki v anamnezi nimajo izpostavljenosti virusu varicella zoster.
Although cladribine may have a potential for genotoxicity, long-term data in mice and monkeys did not provide any evidence of a relevant increased carcinogenicity risk in humans.
Čeprav je kladribin potencialno genotoksičen, dolgoročni podatki pri miših in opicah niso dali nobenih dokazov o relevantnem povečanem tveganju za rakotvornost pri ljudeh.
Each pack contains 1, 4, 5, 6, 7 or 8 tablets in a blister, sealed in a cardboard wallet and fixed in a child-resistant carton.
Vsako pakiranje vsebuje 1, 4, 5, 6, 7 ali 8 tablet v pretisnem omotu, zaprtem v kartonski zgibanki in pritrjenem v za otroke varni škatli.
As a precautionary measure, you should follow standard cancer screening recommendations, as advised by your doctor.
Zato morate kot previdnostni ukrep upoštevati standardne smernice glede presejalnih pregledov za raka, ki vam jih svetuje vaš zdravnik.
The following definitions apply to the frequency terminology used hereafter:
V nadaljevanju se uporabljajo naslednje navedbe pogostnosti:
A small study in cancer patients has shown a cerebrospinal fluid/plasma concentration ratio of approximately 0.25.
Majhna študija na bolnikih z rakom je pokazala razmerje koncentracije v cerebrospinalni tekočini/plazmi približno 0,25.
- Do not leave your tablet(s) exposed on surfaces, for example on a table, or handle the tablet longer than necessary.
- Tablet(e) ne puščajte izpostavljenih(e) na površini, na primer na mizi, in s tableto ne rokujte dlje časa, kot je to potrebno.
If this is not possible, dose reduction to the minimum mandatory dose of medicinal products containing these compounds, separation in the timing of administration and careful patient monitoring is recommended.
Če to ni možno, se priporoča zmanjšanje odmerka na najmanjši potrebni odmerek zdravila, ki vsebuje te spojine, časovni razmik med dajanjem enega in drugega zdravila in skrbno nadziranje bolnika.
A population kinetic analysis did not show any effect of age (range 18 to 65 years) or gender on cladribine pharmacokinetics.
Populacijske analize kinetike niso pokazale nikakršnih znakov vpliva starosti (razpon od 18 do 65 let) ali spola na farmakokinetiko kladribina.
Latent infections may be activated, including tuberculosis or hepatitis.
Aktivirajo se lahko latentne okužbe, vključno s tuberkulozo ali hepatitisom.
Your doctor will tell you the number of tablets to take
Zdravnik bo določil število tablet, ki jih morate jemati
The prescriber / patient guide should include information about the following safety concerns:
Vodnik za zdravnika, ki bo zdravilo predpisoval/bolnika, naj vključuje informacije o naslednjih pomislekih glede varnosti:
- if you are allergic to cladribine or any of the other ingredients of MAVENCLAD (listed in section 6).
- če ste alergični na kladribin ali katero koli sestavino zdravila MAVENCLAD (navedeno v poglavju 6).
Raise the blister pack by pushing your finger through the hole in the tray.
Dvignite pretisni omot, tako da prst potisnete skozi luknjo v nosilcu.
You may have to have the blood irradiated to prevent complications.
Morda bo treba za preprečitev zapletov kri obsevati.
Safety and efficacy in patients with moderate or severe renal impairment have not been established.
Varnost in učinkovitost pri bolnikih z zmerno ali hudo ledvično okvaro nista bili dokazani.
However, net effects in terms of potential cladribine exposure alterations are difficult to predict.
Vendar je dejanske učinke v smislu možnih sprememb izpostavljenosti kladribinu težko napovedati.
In the clinical study data base of cladribine in MS (1,976 patients, 8,650 patient years) no case of PML has been reported.
V podatkovni bazi klinične študije s kladribinom pri MS (1.976 bolnikov, 8.650 bolnikov-let) niso poročali o nobenem primeru PML.
Clinical studies with oral cladribine in MS did not include patients over 65 years of age; therefore, it is not known whether they respond differently from younger patients.
V klinične študije s peroralnim kladribinom pri MS niso bili vključeni bolniki starejši od 65 let, zato ni znano, ali je njihov odziv drugačen kot pri mlajših bolnikih.
Dose and time dependence
Odvisnost od odmerka in časa
The most important side effect is a reduction in the number of white blood cells called lymphocytes (lymphopenia), which is very common (may affect more than 1 in 10 people) and may be severe.
Najpomembnejši neželeni učinek je zmanjšanje števila belih krvnih celic, imenovanih limfociti (limfopenija), ki je zelo pogost (pojavi se lahko pri več kot 1 od 10 bolnikov) in je lahko resen.
Patients with lymphocyte counts below 500 cells/mm³ should be actively monitored for signs and symptoms suggestive of infections, in particular herpes zoster.
Bolnike s številom limfocitov pod 500 celic/mm³ je treba aktivno nadzirati glede znakov in simptomov, ki nakazujejo okužbe, še posebno s herpesom zosterjem.
It is recommended that the daily cladribine doses in each treatment week be taken at intervals of 24 hours at approximately the same time each day.
Priporoča se, da se dnevni odmerki kladribina v vsakem tednu zdravljenja jemljejo v 24-urnih časovnih presledkih, vsak dan ob približno enakem času.
Patients who had completed the CLARITY study could be enrolled in CLARITY Extension.
Bolniki, ki so zaključili študijo CLARITY, so se lahko vključili v podaljšano študijo (CLARITY Extension).
If you get pregnant more than 6 months after the last dose in year 1, no safety risk is expected but this will mean that you cannot receive treatment with MAVENCLAD while you are pregnant.
Če zanosite več kot 6 mesecev po zadnjem odmerku v prvem letu, ni pričakovati nobenega tveganja glede varnosti, vendar to pomeni, da med nosečnostjo ne morete prejemati zdravljenja z zdravilom MAVENCLAD.
Cladribine can reduce the body's immune defence and may increase the likelihood of infections.
Kladribin lahko zmanjša imunsko obrambo telesa in zviša možnost okužb.
If necessary, the treatment course in year 2 can be delayed for up to 6 months to allow for recovery of lymphocytes.
Če je potrebno, se lahko cikel zdravljenja v 2. letu preloži za do 6 mesecev, da se omogoči izboljšanje števila limfocitov.
Short-term corticosteroids can be used when advised by your doctor.
Kratkotrajna uporaba kortikosteroidov je možna, če tako svetuje vaš zdravnik.
If you require blood transfusions, tell the doctor that you are taking MAVENCLAD.
Če potrebujete transfuzijo krvi, povejte zdravniku, da jemljete zdravilo MAVENCLAD.
Do not store the tablets in a different container.
Tablet ne shranite v drug vsebnik.
MAVENCLAD is a medicine used to treat multiple sclerosis (MS) in adults.
Zdravilo MAVENCLAD se uporablja za zdravljenje multiple skleroze (MS) pri odraslih.
Tell your doctor immediately if you have symptoms of shingles such as a 'band' of severe pain and blistering rash, typically on one side of the upper body or the face.
Nemudoma povejte zdravniku, če imate simptome pasovca, kot na primer 'pas' hude bolečine in mehurjastega izpuščaja, običajno na eni strani zgornjega dela trupa ali obraza.
See also 'Other medicines and MAVENCLAD'.
Glejte tudi 'Druga zdravila in zdravilo MAVENCLAD'.
Secondary progressive MS with relapses
Sekundarna progresivna MS z recidivi
Histologically, testicular degeneration was only seen in one male monkey in a 1-year subcutaneous toxicity study.
Histološko so testikularno degeneracijo opazili samo pri enem opičjem samcu v 1-letni študiji toksičnosti ob subkutani uporabi.
These included
Vključevale so
As the tablets are uncoated, they must be swallowed immediately once removed from the blister and not be left exposed on surfaces or handled for any period of time greater than that required for dosing.
Ker tablete niso obložene, jih je treba pogoltniti takoj, ko se odstranijo iz pretisnega omota, da ne ostanejo izpostavljene na površinah in da se z njimi ne rokuje dlje časa, kot je to potrebno za odmerjanje.
The patient's hands must be dry when handling the tablets and washed thoroughly afterwards.
Bolnikove roke morajo biti suhe, ko rokuje s tabletami, nato pa jih mora temeljito oprati.
Example: If you forget to take the Day 3 dose and do not remember it until Day 4, take the Day 3 dose on Day 4, and extend the total number of days in the treatment week by 1 day.
Primer: Če pozabite vzeti odmerek za 3. dan in se tega ne spomnite do 4. dne, boste odmerek za 3. dan vzeli 4. dan in skupno število dni v tednu zdravljenja podaljšali za en dan.
If this recovery takes more than 6 months, the patient should not receive MAVENCLAD anymore.
Če je za izboljšanje potrebnih več kot 6 mesecev, bolnik ne sme več prejemati zdravila MAVENCLAD.
Do not take MAVENCLAD if you are pregnant or trying to become pregnant.
Ne jemljite zdravila MAVENCLAD, če ste noseči ali želite zanositi.
Before you start a treatment course, your doctor will do a blood test to check that the levels of lymphocytes (a type of white blood cells) are in an acceptable range.
Preden boste lahko začeli s ciklusom zdravljenja, bo zdravnik opravil krvne preiskave, da preveri, ali so ravni limfocitov (vrsta belih krvnih celic) v sprejemljivem razponu.
- if you have a weakened immune system due to medical conditions or because you are taking other medicines that weaken your immune system or reduce the production of blood cells in your bone marrow.
- če imate oslabljen imunski sistem zaradi bolezni ali ker jemljete zdravila, ki slabijo vaš imunski sistem ali zmanjšajo proizvodnjo krvnih celic v vašem kostnem mozgu.
(2) Push in the hooks on the sides of the carton simultaneously with your index finger and thumb, and keep hooks pushed.
(2) Zatiča ob straneh škatle s palcem in kazalcem istočasno pritisnite noter in ju držite pritisnjena.
Keep your tablets in the blister until your next dose.
Tablete hranite v pretisnem omotu do naslednjega odmerka.
Active chronic infection (tuberculosis or hepatitis).
Aktivna kronična okužba (tuberkuloza ali hepatitis).
Read the 'Step-by-Step Guide' at the end of this package leaflet on how to handle the childresistant package and how to take the tablets included in the pack.
Preberite 'Navodilo po korakih' na koncu tega navodila o tem, kako ravnati z za otroke varno ovojnino in kako jemati tablete, ki so v pakiranju.
• patients with 1 relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions,
• bolnike z 1 recidivom v preteklem letu in vsaj 1 lezijo T1 Gd+ ali z 9 ali več lezijami T2 med zdravljenjem z drugimi DMD,
Each treatment week consists of 4 or 5 days on which a patient receives 10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body weight.
Vsak teden zdravljenja je sestavljen iz 4 ali 5 dni, ko bolnik prejme 10 mg ali 20 mg (eno ali dve tableti) kot enkratni dnevni odmerek, odvisno od telesne mase.
Progressive multifocal leukoencephalopathy (PML) If you believe your MS is getting worse or if you notice any new symptoms, for example changes in mood or behaviour, memory lapses, speech and communication difficulties, talk to your doctor as soon as possible.
Če imate občutek, da se vaša MS slabša ali opazite nove simptome, na primer spremembe v razpoloženju ali vedenju, izgubo spomina, težave z govorom in komuniciranjem, se čim prej pogovorite z zdravnikom.
The incidence of affected mouse foetuses in this study was in the same range of spontaneous incidence of amelia and phocomelia in this strain of mice.
Pogostnost prizadetih mišjih zarodkov v tej študiji je bila v istem razponu kot spontana pogostnost amelije in fokomelije v tem rodu miši.
If your doctor believes that MAVENCLAD is essential for you, your doctor will advise you to stop breast-feeding.
Če zdravnik meni, da je zdravilo MAVENCLAD za vas bistvenega pomena, vam bo svetoval, da nehate dojiti.
Do not use MAVENCLAD together with other medicines for MS unless specifically advised by your doctor.
Ne uporabljajte zdravila MAVENCLAD skupaj z drugimi zdravili za MS, razen če vam tega ni posebej svetoval zdravnik.
Cladribine and/or its phosphorylated metabolites are substantially accumulated and retained in human lymphocytes.
Kladribin in/ali njegovi fosforilirani presnovki se v veliki meri kopičijo in zadržujejo v človeških limfocitih.
Patients with current active malignancies must not receive Mavenclad treatment;
se bolniki z obstoječimi aktivnimi malignostmi ne smejo zdraviti z zdravilom Mavenclad;
Treatment with MAVENCLAD should not be initiated within 4 to 6 weeks after vaccination with live or attenuated live vaccines because of a risk of active vaccine infection.
Zdravljenja z zdravilom MAVENCLAD se ne sme uvesti v roku 4 do 6 tednov po cepljenju z živimi ali oslabljenimi živimi cepivi zaradi tveganja okužbe z aktivnim cepivom.
Tablets must be swallowed whole and not chewed or allowed to dissolve in your mouth.
Tablete morate pogoltniti cele in jih ne smete žvečiti ali pustiti, da se razpustijo v ustih.
The Patient Guide should include an introduction to Mavenclad treatment, its side effects, potential risks and information on pregnancy prevention.
Vodnik za bolnika naj vključuje uvod v zdravljenje z zdravilom Mavenclad, njegove neželene učinke, možna tveganja in informacije o preprečevanju nosečnosti.
The distribution of cladribine across biological membranes is facilitated by various transport proteins, including ENT1, CNT3 and BCRP.
Porazdelitev kladribina preko bioloških membran olajšajo različne transportne beljakovine, vključno z ENT1, CNT3 in BCRP.
Only traces of other metabolites could be found in plasma and in urine.
Druge presnovke je mogoče najti v plazmi in v urinu le v sledeh.