natgillin/translations-raw huggingface dataset:
C onfirmation that the physician has discussed the following: • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide • That he should not share the treatment with any other person • That he should return the capsules to the pharmacist at the end of treatment
Obrazci za začetek zdravljenja za moške bolnike morajo vsebovati tudi naslednje o elemente: potrdilo, da se je zdravnik pogovoril o naslednjem: • treba je preprečiti izpostavljenost ploda • talidomid je prisoten v spermi, zato mora pri spolni partnerici, ki je noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije, uporabiti kondom • če partnerica zanosi, mora o tem takoj obvestiti zdravnika, ki ga zdravi, in vedno uporabljati kontom • ne sme darovati krvi ali sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida • svojega zdravila ne sme dajati nikomur drugemu • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
• Patient cards and/or equivalent tools: o verification that appropriate counselling has taken place o documentation of childbearing status potential o check box (or similar) which physician ticks to confirm that patient is using effective contraception (if female with childbearing potential) o verification of initial negative pregnancy test prior to start of treatment (if female with childbearing potential) o pregnancy test dates and results
• Kartice za bolnike in/ ali ustrezno orodje o potrdilo o ustreznem svetovanju o dokumentacijo o statusu plodnosti o kontrolno okence (ali podobno) kjer zdravnik potrdi, da bolnik uporablja učinkovito kontracepcijo (za ženske v rodni dobi) o potrdilo o začetnem negativnem testu nosečnosti pred začetkom zdravljenja (za ženske v rodni dobi) o datume testov nosečnosti in izide
Booklet for women of childbearing potential and their partners Booklet for women patients who are not of childbearing potential
• Izobraževalne brošure za bolnike:
5 Booklet for male patients
5 obstajajo lahko tri vrste brošur ali ena sama brošura za bolnike, ki kombinira o informacije za vsak razred bolnikov: brošure za ženske v rodni dobi in njihove partnerje brošure za ženske, ki ne morejo zanositi brošure za moške bolnike
o All booklets should contain the following information That Thalidomide Celgene is teratogenic That Thalidomide Celgene may cause thromboembolism, cardiovascular events and neuropathy Description of the patient card and its use in the individual Member State National or other applicable specific arrangements for a prescription for thalidomide to be dispensed That Thalidomide Celgene must not be given to any other person That the patient should not donate blood during therapy and for one week following discontinuation of thalidomide That the patient should tell their doctor about any adverse events That any unused capsules should be returned to the pharmacist at the end of the treatment
Vse brošure morajo zajemati naslednje informacije o da je zdravilo Thalidomide Celgene teratogeno da lahko zdravilo Thalidomide Celgene povzroči trombembolizem, kardiovaskularne dogodke in nevropatijo opis kartice za bolnika in njeno uporabo v posameznih državah članicah nacionalne ali druge veljavne posebne dogovore za predpisovanje in izdajo talidomida da se zdravila Thalidomide Celgene ne sme dajati nikomur drugemu da bolniki ne smejo darovati krvi ali sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida da morajo bolniki svojega zdravnika obvestiti o vseh neželenih učinkih da je treba ob koncu zdravljenja vse preostale kapsule vrniti farmacevtu
o The following information should also be provided in the appropriate booklet Female patient of childbearing potential • The need to avoid foetal exposure • The need for effective contraception • That if she needs to change or stop using her method of contraception she should inform:
Ustrezne brošure naj vsebujejo tudi naslednje podatke o bolnica v rodni dobi: • opozorilo, da je treba preprečiti izpostavljenost ploda • opozorilo, da je potrebna učinkovita kontracepcija • opozorilo, da mora ženska, če želi spremeniti ali zamenjati svojo kontracepcijsko metodo, obvestiti
- the physician prescribing thalidomide that she has stopped or
- zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid
changed her method of contraception
- zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali
The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
spremenila svojo kontracepcijsko metodo • potreba po testih nosečnosti, t. j. pred zdravljenjem, vsake 4 tedne med samim zdravljenjem in po zdravljenju • opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene • opozorilo, da mora v primeru suma na nosečnost o tem nemudoma obvestiti svojega zdravnika
Male patients • The need to avoid foetal exposure • That thalidomide is found in semen and the need to use condoms if sexual partner is pregnant or is a women with childbearing potential not on effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom • That he should not donate semen during therapy and for one week following discontinuation of thalidomide.
Moški bolniki • opozorilo, da je treba preprečiti izpostavljenost ploda • opozorilo, da je talidomid prisoten v spermi in o potrebi zaščite s kondomom, če je spolna partnerica noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije • opozorilo, da je treba v primeru zanositve partnerice nemudoma obvestiti zdravnika, ki vodi zdravljenje, in vedno med odnosom uporabljati kondom • opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with melphalan and prednisone (anticancer medicines) in patients who have not been treated for multiple myeloma before.
Zdravilo Thalidomide Celgene se uporablja za zdravljenje multiplega mieloma (raka kostnega mozga) v kombinaciji z melfalanom in prednizonom (zdraviloma proti raku) pri bolnikih s predhodno nezdravljenim multiplim mielomom.
It is used in patients aged over 65 years, and in younger patients if they cannot be treated with high-dose chemotherapy (anticancer treatments).
Uporablja se pri bolnikih, starejših od 65 let, ter pri mlajših bolnikih, če zdravljenje s kemoterapijo (protirakavim zdravljenjem) v visokih odmerkih ni mogoče.
Because the number of patients with multiple myeloma is low, the disease is considered ‘ rare’, and Thalidomide Celgene was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 20 November 2001.
Ker je število bolnikov z multiplim mielomom majhno, velja ta bolezen za redko, zato je bilo zdravilo Thalidomide Celgene 20. novembra 2001 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Treatment with Thalidomide Celgene must be started and monitored under the supervision of a doctor who is skilled in using medicines that modulate the immune system or anticancer medicines.
Zdravljenje z zdravilom Thalidomide Celgene se mora uvesti in spremljati pod nadzorom zdravnika, ki ima strokovno znanje in izkušnje z uporabo zdravil, ki spreminjajo imunsko odzivnost, ali zdravil proti raku.
The doctor must also understand the risks of thalidomide and the ways in which the use of the medicine must be monitored.
Zdravnik mora prav tako popolnoma poznati tveganja, povezana z zdravljenjem s talidomidom, ter kako je treba uporabo zdravila spremljati.
The recommended dose of Thalidomide Celgene is four capsules a day, taken at the same time, preferably at bedtime.
Priporočeni odmerek zdravila Thalidomide Celgene je štiri kapsule dnevno, vzete sočasno, po možnosti pred spanjem.
The capsules can be taken with or without food.
Kapsule se lahko jemljejo s hrano ali brez nje.
Thalidomide Celgene can be used for a maximum of 12 treatment cycles, with each cycle lasting six weeks.
Zdravilo Thalidomide Celgene se lahko uporablja največ 12 ciklov zdravljenja po 6 tednov.
The doctor may delay, reduce or stop doses if the patient experiences certain side effects, including blood clots, nerve damage, rash, low heart rate, fainting or sleepiness.
Zdravnik sme odložiti, zmanjšati ali ustaviti odmerke, če se pri bolniku pojavijo nekateri neželeni učinki, kot npr. krvni strdki, poškodbe živčevja, izpuščaji, počasen utrip srca, omedlevica ali zaspanost.
Each patient should also receive an anticoagulant (a medicine to prevent the formation of blood clots) for at least the first five months of treatment, after careful assessment of the patient ’ s individual risk.
Vsak bolnik mora po natančni oceni njegovega individualnega tveganja najmanj prvih pet mesecev zdravljenja prejemati tudi antikoagulant (zdravilo, ki preprečuje tvorbo krvnih strdkov).
Patients who have severe problems with their kidneys or liver should be carefully monitored for side effects.
Pri bolnikih, ki imajo resne težave z ledvicami ali jetri, je treba skrbno spremljati morebitno pojavljanje neželenih učinkov.
Thalidomide Celgene is not recommended for use in patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Uporaba zdravila Thalidomide Celgene pri bolnikih, mlajših od 18 let, zaradi pomanjkanja informacij o varnosti in učinkovitosti v tej skupini ni priporočljiva.
The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the development of cancer cells, and by stimulating some of the specialised cells of the immune system (the body’ s defence mechanism) to attack the cancer cells.
Zdravilna učinkovina zdravila Thalidomide Celgene, talidomid, naj bi učinkovala tako, da zavira razvoj rakavih celic ter stimulira nekatere specifične celice v imunskem sistemu (obrambnem sistemu telesa), da napadejo rakave celice.
The effects of Thalidomide Celgene were first tested in experimental models before being studied in humans.
Učinki zdravila Thalidomide Celgene so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The effectiveness of Thalidomide Celgene was studied in one main study involving 447 patients with multiple myeloma.
Zdravilo Thalidomide Celgene so proučevali v eni glavni študiji, ki je vključevala 447 bolnikov z multiplim mielomom.
The study compared the effect of melphalan and prednisone, with or without Thalidomide Celgene, on survival times.
V študiji so primerjali učinek melfalana in prednizona v kombinaciji z zdravilom Thalidomide Celgene oziroma brez njega glede na čase preživetja.
The company also presented the results of a study looking at the combination of Thalidomide Celgene and dexamethasone as ‘ induction’ treatment for multiple myeloma for use before high-dose chemotherapy.
Družba je predstavila tudi rezultate študije, v kateri so proučevali kombinacijo zdravila Thalidomide Celgene in deksametazona kot „ indukcijskega “ zdravljenja multiplega mieloma, namenjenega za uporabo pred kemoterapijo z visokimi odmerki.
However, it withdrew this application during the assessment of the medicine.
Vendar pa je družba to vlogo med vrednotenjem zdravila umaknila.
Survival times were longer in the patients receiving Thalidomide Celgene in addition to melphalan and prednisone.
Časi preživetja so bili daljši pri bolnikih, ki so poleg melfalana in prednizona prejemali zdravilo Thalidomide Celgene.
Patients receiving melphalan and prednisone survived for an average of 33.2 months from the start of the study, compared with 51.6 months when the treatment also included Thalidomide Celgene.
Bolniki, ki so prejemali melfalan in prednizon, so v povprečju preživeli še 33, 2 meseca od začetka študije, v primerjavi z 51, 6 meseca pri zdravljenju, ki je vključevalo tudi zdravilo Thalidomide Celgene.
The most common side effects (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (nerve damage causing tingling, pain and numbness in the hands and feet), tremor (shaking), dizziness, paraesthesia (unusual sensations like pins and needles), dysaesthesia (reduced sense of touch), somnolence (sleepiness), constipation and peripheral oedema (swelling, usually in the legs).
Najpogostejši neželeni učinki (opaženi pri več kot 1 bolniku izmed 10) so nevtropenija (nizka raven nevtrofilov, vrste belih krvničk), levkopenija (nizka raven belih krvničk), anemija (nizka raven rdečih krvničk), limfopenija (nizka raven limfocitov, druga vrsta belih krvničk), trombocitopenija (nizka raven krvnih ploščic), periferna nevropatija (poškodba živcev, ki povzroči mravljinčenje, bolečino in odrevenelost rok in nog), tremor, omotica, parestezija (neobičajnimi občutki zbadanja), disestezija (zmanjšana občutljivost za dotik), zaspanost, zaprtje in periferni edemi (otekanje, običajno nog).
For the full list of all side effects reported with Thalidomide Celgene, see the Package Leaflet.
Za celoten seznam vseh neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Thalidomide Celgene, glejte navodilo za uporabo.
Thalidomide is a powerful human ‘ teratogen’, meaning that it has a harmful effect on the unborn child, causing severe and life-threatening birth defects.
Talidomid je močan humani teratogen, kar pomeni, da škodljivo učinkuje na nerojenega otroka ter povzroča resne in smrtno nevarne prirojene okvare.
The strict conditions put in place to prevent pregnancies and the exposure of unborn children to thalidomide must be met by all men and women taking the medicine.
Vsi moški in ženske, ki jemljejo zdravilo, morajo izpolnjevati stroge pogoje, določene za preprečevanje nosečnosti in izpostavljanja nerojenih otrok talidomidu.
Thalidomide Celgene must never be used by the following groups:  women who are pregnant;  women who could become pregnant, unless they take all of the necessary steps to ensure that they are not pregnant before treatment and that they do not become pregnant during or soon after treatment;  patients who are unable to follow or to comply with the requirement to use contraceptives.
Zdravila Thalidomide Celgene ne smejo v nobenem primeru jemati naslednje skupine:  nosečnice;  ženske, ki bi lahko zanosile, razen če storijo vse potrebno za zagotovitev, da ne bodo zanosile pred zdravljenjem, kakor tudi da ne bi zanosile med samim zdravljenjem ali kmalu po njem;  bolniki, ki niso zmožni upoštevati zahtev po uporabi kontracepcijskih sredstev ali se ravnati v skladu z njimi.
Thalidomide Celgene should also not be used in people who may be hypersensitive (allergic) to thalidomide or any of the other ingredients.
Zdravila Thalidomide Celgene prav tako ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) talidomid ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, provided that very strict measures are put in place to avoid exposure of unborn children to thalidomide, Thalidomide Celgene’ s benefits are greater than its risks, in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged greater than or equal to 65 years or ineligible for high dose chemotherapy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Thalidomide Celgene, če se s strogimi ukrepi prepreči izpostavljenost nerojenih otrok talidomidu, v kombinaciji z melfalanom in prednizonom kot zdravljenjem prve izbire za bolnike z nezdravljenim multiplim mielomom, starih 65 let ali več, ali bolnikov, pri katerih zdravljenje s kemoterapijo v visokih odmerkih ni primerno, večje od z njim povezanih tveganj.
The Committee recommended that Thalidomide Celgene be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Thalidomide Celgene odobri dovoljenje za promet.
Which measures are being taken to ensure the safe use of Thalidomide Celgene?
2/ 3 Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Thalidomide Celgene?
The company that makes Thalidomide Celgene will set up a pregnancy prevention programme in each Member State.
Družba, ki izdeluje zdravilo Thalidomide Celgene, bo v vsaki državi članici organizirala program za preprečevanje nosečnosti.
It will provide a letter and educational kits for healthcare workers and brochures for 2/ 3 patients, detailing the steps that need to be taken for the medicine to be used safely.
Priskrbela bo dopis in izobraževalni paket za zdravstvene delavce ter brošure za bolnike, kjer bodo natančno opisani postopki, ki jih je treba upoštevati za varno jemanje zdravila.
It will also supply cards for patients to ensure that all appropriate safety measures have been taken by each patient.
Prav tako bo družba priskrbela kartice za bolnike, da bi tako zagotovila, da vsak bolnik izpolnjuje vse ustrezne varnostne ukrepe.
The company will also collect information on whether the medicine is used outside its approved indication.
Družba bo tudi zbirala informacije o tem, ali se zdravilo uporablja zunaj odobrene indikacije.
Other information about Thalidomide Celgene:
Druge informacije o zdravilu Thalidomide Celgene:
The European Commission granted a marketing authorisation valid throughout the European Union for Thalidomide Pharmion on 16 April 2008.
Evropska komisija je dovoljenje za promet z zdravilom Thalidomide Pharmion, veljavno po vsej Evropski uniji, odobrila dne 16. aprila 2008.
The summary of opinion of the Committee for Orphan Medicinal Products for Thalidomide Celgene is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Thalidomide Celgene je na voljo tukaj.
The full EPAR for Thalidomide Celgene can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Thalidomide Celgene je na voljo tukaj.
EU number EU/ 1/ 08/ 443/ 001
Številka EU EU/ 1/ 08/ 443/ 001
Name Thalidomide Celgene
Ime Thalidomide Celgene
Strength 50 mg
Jakost 50 mg
Pharmaceutical Form Capsule, hard
Farmacevtska oblika Kapsule, trde
Packaging Blister (PVC/ PE/ Aclar/ Alu)
Ovojnina Pretisni omot (PVC/ PE/ Aclar/ aluminij)
Package size 28 capsules
Velikost pakiranja 28 kapsul
Each capsule contains 257.2 mg of anhydrous lactose.
Ena kapsula vsebuje 257, 2 mg brezvodne laktoze.
White opaque capsules marked “ Thalidomide 50 mg Celgene”.
Kapsule, motno bele barve, z oznako "Thalidomide 50 mg Celgene"
Thalidomide Celgene in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged ≥ 65 years or ineligible for high dose chemotherapy.
Zdravilo Thalidomide Celgene v kombinaciji z melfalanom in prednizonom za primarno zdravljenje bolnikov z nezdravljenim multiplim mielomom, starih ≥ 65 let ali za bolnike, pri katerih zdravljenje z visokimi odmerki kemoterapije ni primerno.
Thalidomide Celgene is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).
Zdravilo Thalidomide Celgene se predpisuje in izdaja v skladu s programom Thalidomide Celgene za preprečevanje nosečnosti (glejte poglavje 4. 4).
Recommended posology in adults:
Priporočeno odmerjanje pri odraslih:
The recommended oral dose is 200 mg per day.
Priporočljiv peroralni odmerek je 200 mg na dan.
A maximum number of 12 cycles of 6 weeks should be used.
Dovoljenih je največ 12 ciklov po 6 tednov.
Thalidomide Celgene can be taken with or without food.
Zdravilo Thalidomide Celgene se lahko jemlje s hrano ali brez.
Patients should be monitored for: thromboembolic events; peripheral neuropathy; rash/ skin reactions; bradycardia, syncope and somnolence (see sections 4.4 and 4.8).
Bolnike je treba nadzorovati za: trombembolične dogodke, periferno nevropatijo, izpuščaje/ kožne reakcije, bradikardijo, sinkopo in somnolenco (glejte poglavji 4. 4 in 4. 8).
Dose delay, reduction or discontinuation, dependent upon the NCI CTC grade, may be necessary.
Glede na stopnjo CTC (splošna merila toksičnosti) inštituta NCI (Nacionalni institut za raka) bo morda potrebna odložitev, zmanjšanje odmerka ali prekinitev zdravljenja.
Thromboembolic events:
Trombembolični dogodki:
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’ s underlying risk factors (see sections 4.4, 4.5 and 4.8).
O uvajanju zaščitnih ukrepov proti trombozi se morate odločiti po skrbni oceni dejavnikov tveganja pri posameznem bolniku (glejte poglavja 4. 4, 4. 5 in 4. 8).
2 and any complications of the thromboembolic event have been managed, the thalidomide treatment may be restarted at the original dose dependent upon a benefit risk assessment.
2 Če se pri bolniku pojavijo katerikoli trombembolični dogodki, morate zdravljenje prekiniti in pričeti s standardno antikoagulacijsko terapijo.
The patient should continue anticoagulation therapy during the course of thalidomide treatment.
Ko se bolnika stabilizira z antikoagulacijskim zdravljenjem in so odpravljeni vsi zapleti trombemboličnega dogodka, se lahko ponovno prične zdravljenje s talidomidom v prvotnem odmerku, odvisno od ocenitve tveganja in koristi.
Dose modifications due to peripheral neuropathy are described in Table 1.
Spremembe odmerka zaradi periferne nevropatije so opisane v Tabeli 1.
Recommended dose modifications for Thalidomide Celgene related neuropathy in first line treatment of multiple myeloma.
Priporočene spremembe odmerkov za nevropatijo, povezano z zdravilom Thalidomide Celgene za primarno zdravljenje multiplega mieloma
Severity of neuropathy Grade 1 (paraesthesia, weakness and/ or loss of reflexes) with no loss of function
Resnost nevropatije 1. stopnja (parestezija, slabotnost in/ ali izguba refleksov) brez izgube funkcij
Modification of dose and regimen Continue to monitor the patient with clinical examination.
Sprememba odmerka in režima Nadaljujte z nadzorovanjem bolnika s kliničnimi pregledi.
However, dose reduction is not necessarily followed by improvement of symptoms.
Premislite o zmanjšanju odmerka, če se simptomi poslabšajo, vendar pa ni nujno, da se bodo simptomi po zmanjšanju odmerka izboljšali.
If no improvement or continued worsening of the neuropathy, discontinue treatment.
Če ni izboljšanja ali se nevropatija nenehno slabša, prekinite zdravljenje.
If the neuropathy resolves to Grade 1 or better, the treatment may be restarted, if the benefit/ risk is favourable.
Če se nevropatija izboljša do 1. ali stopnje ali še bolj, se lahko prične s ponovnim zdravljenjem, če je razmerje med koristjo in tveganjem ugodno.
Discontinue treatment
Prekinite zdravljenje.
No specific dose adjustments are recommended for the elderly.
Ni priporočil o posebnem prilagajanju odmerkov za starejše osebe.
Patients with renal or hepatic impairment:
Bolniki z ledvično ali jetrno okvaro:
Patients with severe organ impairment should be carefully monitored for adverse reactions.
Bolnike s hudo okvaro organov je treba skrbno nadzirati v zvezi z neželenimi učinki.
Thalidomide Celgene is not recommended for use in children below 18 years of age as safety and efficacy have not been established.
Uporaba zdravila Thalidomide Celgene pri otrocih pod 18 let starosti ni priporočljiva, saj varnost in učinkovitost nista bili ugotovljeni.