natgillin/translations-raw huggingface dataset:
Pregnancy Prevention Programme information Definition of women of childbearing potential (WCBP) and actions the prescriber should take if childbearing status is unclear Information on what is effective contraception Safety advice for WCBP • Need to avoid foetal exposure • Pregnancy prevention requirement, definition and need for adequate contraceptive methods
spremenila svojo kontracepcijsko metodo • zahteve testa nosečnosti o Nasvete o ustreznih testih o Pogostnost (pred pričetkom, mesečno med zdravljenjem in po končanem zdravljenju) • opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene • opozorilo, da je treba v primeru suma na nosečnost, o tem nemudoma obvestiti zdravnika, ki vodi zdravljenje Varnostne nasvete za moške • 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 med zdravljenjem in še en teden po prekinitvi jemanja talidomida ne sme darovati sperme
17
17 podatke bolnika, podpis in datum ime zdravnika, ki je zdravilo predpisal, podpis in datum namen dokumenta, tj. kot je zabeleženo v PPN:
That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception
„ Cilj obrazca za začetek zdravljenja je zaščititi bolnike in morebitne plode tako, da se zagotovi popolna obveščenost in razumevanje bolnikov glede tveganja teratogenosti in drugih neželenih učinkov, povezanih z uporabo talidomida.
• Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment) • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men • 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 using effective contraception • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse • That he should not donate semen during therapy and for one week after discontinuation of thalidomide
Obrazci za začetek zdravljenja za ženske bolnice v rodni dobi morajo vsebovati tudi o naslednje elemente: potrdilo, da se je zdravnik pogovoril o naslednjem: • treba je preprečiti izpostavljenost ploda • če je ženska noseča ali načrtuje nosečnost, ne sme jemati zdravila Thalidomide Celgene • potrebna je učinkovita kontracepcija brez prekinitev, 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter 4 tedne po koncu zdravljenja • če želi ženska spremeniti ali zamenjati svojo kontracepcijsko metodo, mora obvestiti
o
- zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid
Pregnancy reporting requirements Stop Thalidomide Celgene immediately upon suspicion of pregnancy Refer patient to physician specialised or experienced in dealing with teratology for advice and evaluation Complete pregnancy reporting form as provided in the “Educational Healthcare Professional’s Kit” Local contact details for reporting of any suspected pregnancy
- zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali
• Pregnancy initial and outcome reporting forms • Post-marketing and compliance assessment (as applicable to a Member State) • Neuropathy and adverse reaction reporting forms
spremenila svojo kontracepcijsko metodo • potrebno je izvesti teste nosečnosti pred zdravljenjem, vsake 4 tedne med zdravljenjem in po zdravljenju • takoj po sumu na nosečnost mora prenehati uporabljati zdravilo Thalidomide Celgene • če sumi, da je noseča, mora o tem takoj obvestiti svojega zdravnika • svojega zdravila ne sme dajati nikomur drugemu • med zdravljenjem in še en teden po prekinitvi jemanja talidomida ne sme darovati krvi • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
• Treatment initiation forms o There should be 3 types of treatment initiation forms:
Obrazci za začetek zdravljenja za ženske bolnice, ki ne morejo zanositi, morajo o vsebovati tudi:
Female patient of childbearing potential Female patient of non-childbearing potential Male patient
Potrdilo, da se je zdravnik pogovoril o naslednjem: • svojega zdravila ne sme dajati nikomur drugemu • med zdravljenjem in še en teden po prekinitvi jemanja talidomida ne sme darovati krvi • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
o
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 • med zdravljenjem in še en teden po prekinitvi jemanja talidomida ne sme darovati krvi ali sperme • svojega zdravila ne sme dajati nikomur drugemu • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu
All Treatment Initiation Forms should contain the following elements:
• Kartice za bolnike in/ ali ustrezno orodje:
Teratogenicity warning Date of counselling Affirmation of patient understanding regarding the risk of thalidomide and the PPP measures Patient details, signature and date Prescriber name, signature and date Aim of this document i.e. as stated in the PPP: “The aim of the treatment initiation form is to protect patients and any possible foetuses by ensuring that patients are fully informed of and understand the risk of teratogenicity and other adverse reactions associated with the use of thalidomide.
18 potrdilo o ustreznem svetovanju o dokumentacijo o statusu plodnosti o kontrolno okence (ali podobno) kjer zdravnik potrdi, da bolnik uporablja učinkovito o kontracepcijo (za ženske v rodni dobi) potrdilo o začetnem negativnem testu nosečnosti pred začetkom zdravljenja (za o ženske v rodni dobi) datume testov nosečnosti in izide o
Treatment initiation forms for female patients with childbearing potential should also include:
• Izobraževalne brošure za bolnike: o brošure so lahko treh vrst ali pa v obliki ene same brošure za bolnike, ki kombinira 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
C onfirmation that the physician has discussed the following: • The need to avoid foetal exposure • That if she is pregnant or plans to be, she must not take Thalidomide Celgene • The need for effective contraception, without interruption, 4 weeks before starting treatment, throughout the entire duration of treatment, and 4 weeks after the end of treatment • That if she needs to change or stop using her method of contraception she should inform: - the physician prescribing her contraception that she is on thalidomide - the physician prescribing thalidomide that she has stopped or changed her method of contraception • The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment • The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy • The need to contact their doctor immediately upon suspicion of pregnancy • That she should not share the treatment with any other person • That she should not donate blood during therapy and for one week following discontinuation of thalidomide • That she should return the capsules to the pharmacist at the end of 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, ki se izdaja da se zdravila Thalidomide Celgene ne sme dati nikomur drugemu da bolniki ne smejo darovati krvi da morajo bolniki svojega zdravnika obvestiti o vseh neželenih učinkih da je treba ob koncu zdravljenja vse preostale kapsule vrniti farmacevtu
C onfirmation that the physician has discussed the following: • That she should not share the treatment with any other person • That she should not donate blood during therapy and for one week following discontinuation of thalidomide • That she should return the capsules to the pharmacist at the end of treatment
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
Treatment initiation forms for male patients should also include:
- zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali
Confirmation 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
spremenila svojo kontracepcijsko metodo • potreba po testih nosečnosti, in sicer 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
• 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)
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 med zdravljenjem in še en teden po koncu zdravljenja ne sme darovati sperme
19
19 • DRUGI POGOJI
B ooklet for women of childbearing potential and their partners Booklet for women patients who are not of childbearing potential Booklet for male patients
Farmakovigilančni sistem Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je farmakovigilančni sistem, kot je opisan v različici 5. 1, ki je predstavljena v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v prometu.
All b ooklets 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 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
Načrt o obvladovanju tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v farmakovigilančnem načrtu, sprejetem v različici 6. 0 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih spremembah načrta za obvladovanje tveganja, ki jih bo odobril Odbor za zdravila za uporabo v humani medicini (CHMP).
The following information should also be provided in the appropriate booklets:
Skladno s smernico CHMP o sistemih za obvladovanje tveganja pri zdravilih za humano uporabo mora biti posodobljeni načrt za obvladovanje tveganja predložen sočasno s periodičnim poročilom o varnosti (PSUR)
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
Poleg tega je treba posodobljeni načrt za obvladovanje tveganja predložiti • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na trenutno varnostno specifikacijo, farmakovigilančni načrt ali dejavnosti za zmanjševanje tveganja, • v 60 dneh, potem ko je dosežen pomemben mejnik (pri farmakovigilanci ali zmanjševanju tveganja), • na zahtevo Evropske agencije za zdravila (EMEA).
20 The MAH must ensure that the system of pharmacovigilance, as described in version 5.1 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
20 DODATEK III
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 6.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
OZNAČEVANJE IN NAVODILO ZA UPORABO
LABELLING
22 PODATKI NA ZUNANJI OVOJNINI
Lactose.
Vsebuje tudi laktozo.
See the package leaflet for further information.
Za več informacij glejte navodila za uporabo.
May cause drowsiness, if affected do not drive or operate machines.
Če ste prizadeti, ne smete voziti avta ali upravljati s stroji.
Unused medicinal product should be returned to your pharmacist.
23 Neuporabljeno zdravilo morate vrniti farmacevtu.
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA United Kingdom
Celgene Europe Ltd Riverside House Riverside Walk Windsor SL4 1NA Velika Britanija
25 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
24 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
PACKAGE LEAFLET
26 NAVODILO ZA UPORABO:
Thalidomide Celgene 50 mg hard capsules Thalidomide
Thalidomide Celgene 50 mg trde kapsule Talidomid
WARNING Thalidomide causes birth defects and foetal death.
OPOZORILO Talidomid povzroča prirojene okvare in smrt zarodka.
Do not take thalidomide if you are pregnant or could become pregnant.
Ne jemljite talidomida, če ste noseči, ali bi lahko zanosili.
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Pred začetkom jemanja natančno preberite navodilo. • Navodilo shranite.
Never pass it on to others.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom. • Zdravilo je bilo predpisano vam osebno in ga nikoli ne smete dajati drugim.
It may harm them, even if their symptoms are the same as yours • If any of your side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
Before you take Thalidomide Celgene 3.
3.
WHAT THALIDOMIDE CELGENE IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO THALIDOMIDE CELGENE IN ZA KAJ GA UPORABLJAMO
What Thalidomide Celgene is:
Kaj je zdravilo Thalidomide Celgene:
Thalidomide Celgene contains an active substance called thalidomide.
Thalidomide Celgene vsebuje zdravilno učinkovino, ki se imenuje talidomid.
This belongs to a group of medicines known as ‘immunosuppressive’ medicines.
Slednje spada v skupino zdravil, znano kot imunosupresivna zdravila.
These work by acting on the cells involved in your immune system.
Ta zdravila delujejo tako, da učinkujejo na celice, ki so dejavne v vašem imunskem sistemu.
The immune system is part of the body’s defence which helps to fight illness and infection.
Imunski sistem je del obrambe telesa, ki pomaga pri boju proti boleznim in okužbam.
What Thalidomide Celgene is used for:
Za kaj zdravilo Thalidomide Celgene uporabljamo:
Thalidomide Celgene is used to treat multiple myeloma, a cancer of the bone marrow.
Zdravilo Thalidomide Celgene se uporablja za zdravljenje mieloma, raka kostnega mozga.
It is used in combination with two other medicines, melphalan and prednisone, for the first line treatment of multiple myeloma in patients ≥ 65 years or those who cannot receive high dose chemotherapy.
Uporablja se v kombinaciji z dvema drugima zdraviloma, melfalanom in prednizonom, za primarno zdravljenje multiplega mieloma pri bolnikih, starih ≥ 65 let, ali pri bolnikih, pri katerih zdravljenje z visokimi odmerki kemoterapije ni primerno.
In the principal clinical trial, this combination was associated with a prolongation of the survival time by an average of 18 months.
V glavnem kliničnem preizkušanju je bila ta kombinacija povezana s podaljšanim časom preživetja, ki je znašal približno 18 mesecev.
To find out more about these medicines, please ask your doctor or read the Package Leaflet that comes with these medicines.
Če želite izvedeti več o tem zdravilu, vprašajte svojega zdravnika ali preberite navodilo za uporabo, ki je priloženo temu zdravilu.
BEFORE YOU TAKE THALIDOMIDE CELGENE You will have been given specific instructions by your doctor, p articularly on the effects of thalidomide on unborn babies (outlined in the Thalidomide Celgene Pregnancy Prevention Programme).
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO THALIDOMIDE CELGENE
You will have been given a patient card or any other relevant document by your doctor.
Od svojega zdravnika boste prejeli kartico za bolnika in vse druge pomembne informacije.
Read it carefully and follow the related instructions.
Pozorno jih preberite in upoštevajte vsa navodila.
28 If you do not fully understand these instructions, please ask your doctor to explain them again before you take thalidomide.
27 Če teh navodil ne razumete v celoti, prosite svojega zdravnika, da vam jih ponovno razloži, preden vzamete talidomid.
See also further information in this section under “Take special care with Thalidomide Celgene” and “Pregnancy”.
Glejte tudi dodatne informacije v tem poglavju pod „ Bodite posebno pozorni pri jemanju zdravila Thalidomide Celgene “ in „ Nosečnost “.
"What Thalidomide Celgene contains:”).
Ne jemljite zdravila Thalidomide Celgene: • če ste noseči ali domnevate, da bi lahko bili noseči ali načrtujete zanositev, saj povzroča zdravilo Thalidomide Celgene prirojene okvare in smrt zarodka, • če lahko zanosite, toda niste sposobni slediti potrebnim ukrepom za preprečevanje nosečnosti (opisanih v programu Thalidomide Celgene za preprečevanje nosečnosti), • če ste alergični na (preobčutljivi za) talidomid ali katerokoli drugo sestavino zdravila Thalidomide Celgene (navedene so spodaj v poglavju 6 „ Kaj vsebuje zdravilo Thalidomide Celgene “).
Do not take Thalidomide Celgene if any of the above applies to you.
Ne jemljite zdravila Thalidomide Celgene, če karkoli od zgoraj navedenega velja za vas.
If you are not sure, talk to your doctor or pharmacist before taking Thalidomide Celgene.
Če ste negotovi, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete zdravilo Thalidomide Celgene.
Take special care with Thalidomide Celgene:
Bodite posebno pozorni pri uporabi zdravila Thalidomide Celgene:
Talk to your doctor before taking this medicine in the following situations:
Preden vzamete to zdravilo se posvetujte s svojim zdravnikom v naslednjih primerih:
For all patients taking Thalidomide Celgene Check with your doctor before taking this medicine if: • You are at high risk of a blood clot developing in your veins (deep vein thrombosis) or in your lungs (pulmonary embolism). • You do not understand the contraception advice given to you by your doctor or if you do not feel able to follow this advice. • You have nerve damage, such as numbness, tingling or pain in your hands or feet.
Posvetujte se s svojim zdravnikom, preden vzamete to zdravilo, če: • imate visoko tveganje za razvoj krvnih strdkov v vaših žilah (globoko vensko trombozo) ali vaših pljučih (pljučno embolijo), • ne razumete nasvetov za kontracepcijo, ki vam jih da vaš zdravnik, ali se ne čutite sposobne slediti tem nasvetom, • imate okvaro živcev, kot je otrplost, ščemenje ali bolečine v rokah ali nogah.
For women taking Thalidomide Celgene Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely.
Za ženske, ki jemljejo zdravilo Thalidomide Celgene Pred pričetkom zdravljenja morate vprašati svojega zdravnika, ali lahko zanosite, tudi če mislite, da to ni verjetno.
If you are able to become pregnant: • Your doctor will make sure that you have pregnancy tests o before treatment o every 4 weeks during treatment o 4 weeks after stopping treatment • You must use one effective method of contraception: o for 4 weeks before starting treatment o during treatment o until 4 weeks after stopping treatment Your doctor will tell you what method of contraception to use.
Če lahko zanosite: • Bo vaš zdravnik poskrbel, da boste opravili teste nosečnosti o pred zdravljenjem o na vsake 4 tedne med zdravljenjem o 4 tedne po koncu zdravljenja • Uporabljati morate eno učinkovito kontracepcijsko metodo: o 4 tedne pred začetkom zdravljenja o med zdravljenjem o 4 tedne po koncu zdravljenja Vaš zdravnik vam bo povedal, katero metodo kontracepcije uporabiti.
Therefore do not have unprotected intercourse. • Pregnancy and any exposure during pregnancy must be avoided.
Za moške, ki jemljejo zdravilo Thalidomide Celgene Talidomid prehaja v spermo, zato ne imejte nezaščitenih spolnih odnosov. • Preprečite nosečnost ali izpostavljenost med nosečnostjo.
Always use a condom: o during treatment o for 1 week after stopping treatment • You must not donate semen: o during treatment o for 1 week after stopping treatment
Vedno uporabljajte kondom: o med zdravljenjem o 1 teden po koncu zdravljenja • Ne smete darovati sperme: o med zdravljenjem o 1 teden po koncu zdravljenja
Donating Blood:
Darovanje krvi:
29 If you are not sure if any of the above apply to you, talk to your doctor before taking Thalidomide Celgene.
28 Če ste negotovi, ali se karkoli od zgoraj naštetega nanaša na vas, se posvetujte s svojim zdravnikom, preden vzamete zdravilo Thalidomide Celgene.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines since other medicines could interfere with the effect of thalidomide.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, saj lahko vpliva na učinke talidomida.
This includes medicines obtained without a prescription, including herbal medicines.
To vključuje tudi zdravila, ki ste jih dobili brez recepta, vključno z zdravili zeliščnega izvora.