FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose of Temozolomide Sun depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Slovenian: Odmerek zdravila Temozolomide Sun je odvisen od telesne površine (izračunane glede na telesno višino in maso bolnika) in znaša od 75 do 200 mg na kvadratni meter, enkrat na dan. Odmerek in število odmerkov sta odvisna od vrste zdravljenega tumorja ter od tega, ali je bil bolnik že zdravljen, ali se zdravilo Temozolomide Sun uporablja samostojno ali skupaj z drugimi zdravljenji in kako se bolnik odziva na zdravljenje.
English: Temozolomide Sun is a medicine that contains the active substance temozolomide.
Slovenian: Temozolomide Sun je zdravilo, ki vsebuje zdravilno učinkovino temozolomid.
English: Why has Temozolomide Sun been approved?
Slovenian: Zakaj je bilo zdravilo Temozolomide Sun odobreno?
English: Temozolomide Sun is used on its own in these patients.
Slovenian: Pri teh bolnikih se zdravilo Temozolomide Sun uporablja samostojno.
English: What is Temozolomide Sun?
Slovenian: Kaj je zdravilo Temozolomide Sun?
English: How has Temozolomide Sun been studied?
Slovenian: Kako je bilo zdravilo Temozolomide Sun raziskano?
English: What is Temozolomide Sun used for?
Slovenian: Za kaj se zdravilo Temozolomide Sun uporablja?
English: Patients may also need to take medicines to prevent vomiting before taking Temozolomide Sun. Temozolomide Sun should be used with caution in patients with severe liver problems or with kidney problems.
Slovenian: Pri bolnikih, ki imajo hude težave z jetri ali ledvicami, je treba zdravilo Temozolomide Sun uporabljati previdno.
English: How is Temozolomide Sun used?
Slovenian: Kako se zdravilo Temozolomide Sun uporablja?
English: How does Temozolomide Sun work?
Slovenian: Kako zdravilo Temozolomide Sun deluje?
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Slovenian: *Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
English: The Member States shall ensure that the following key elements are included in the appropriate material:
Slovenian: Države članice bodo zagotovile, da zajema ustrezno gradivo naslednje ključne elemente:
English: • Post-marketing and compliance assessment (as applicable to a Member State)
Slovenian: • ocenitev pomarketinških izkušenj in skladnosti (kot velja v državi članici)
English: The Dear Healthcare Professional letter will consist of two parts:
Slovenian: Pismo za zdravstvene delavce bo sestavljeno iz dveh delov:
English: It is not a contract and does not absolve anybody from his/her responsibilities with regard to the safe use of the product and prevention of foetal exposure.”
Slovenian: To ni pogodba in nikogar ne odvezuje njegovih odgovornosti v zvezi z varno uporabo zdravila in preprečevanjem izpostavljenosti ploda temu zdravilu.”
English: The Member States should agree the local implementation of the patient card system
Slovenian: Države članice bodo dorekle lokalni način izvajanja sistema kartice za bolnika.
English: CONDITIONS OR RESTRICTION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Slovenian: POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA, KI JIH IZVAJAJO DRŽAVE ČLANICE
English: • The need for effective contraception
Slovenian: • opozorilo, da je potrebna učinkovita kontracepcija
English: The Member States must ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da so izpolnjeni vsi pogoji in omejitve v zvezi z varno in učinkovito uporabo zdravila, opisani v nadaljevanju:
English: Dear Healthcare Professional letter
Slovenian: Pismo za zdravstvene delavce
English: The Member States shall ensure that the MAH implements a pregnancy prevention programme (PPP) within their territory.
Slovenian: Države članice bodo zagotovile, da imetnik dovoljenja za promet z zdravilom na svojih ozemljih izvaja program za preprečevanje nosečnosti (PPN).
English: Details of how the PPP will be implemented should be agreed with the Marketing Authorisation Holder and put in place prior to the marketing of the product.
Slovenian: Podrobnosti o izvajanju PPN bodo dogovorjene z imetnikom dovoljenja za promet z zdravilom in uveljavljene pred začetkom trženja zdravila.
English: • Need to avoid foetal exposure
Slovenian: • treba je preprečiti izpostavljenost ploda
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o procedures to ensure that all appropriate measures have been performed prior to thalidomide being dispensed
Slovenian: • posebnih zahtev posameznih držav po dogovoru s pristojnim nacionalnim organom glede: o distribucije zdravila o postopkov za zagotovitev izvedbe vseh ustreznih ukrepov pred začetkom izdajanja talidomida.
English: The Member States shall put into place measures to ensure that: o The maximum treatment duration for one prescription shall be 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Prescriptions can only be dispensed within 7 days of the date of the prescription
Slovenian: Države članice bodo uvedle ukrepe, s katerimi bodo zagotovile: o Najdaljši čas zdravljenja za eno predpisano obdobje bo 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o Zdravilo na recept je možno izdati le v roku 7 dni od datuma na receptu
English: • 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
Slovenian: • potrebna je učinkovita kontracepcija brez prekinitev, 4 tedne pred pričetkom zdravljenja, med celotnim trajanjem zdravljenja ter 4 tedne po koncu zdravljenja
English: • That if she is pregnant or plans to be, she must not take Thalidomide Celgene
Slovenian: • če je ženska noseča ali načrtuje nosečnost, ne sme jemati zdravila Thalidomide Celgene
English: The Member States shall report to the EMEA the following information at 6 monthly intervals following the Commission Decision: o The status of implementation of the PPP within their MS o Estimates of usage in their MS
Slovenian: Država članica bo Evropsko agencijo za zdravila (EMEA) v 6-mesečnih časovnih presledkih po sklepu Komisije obveščala o naslednjem: o statusu izvajanja PPN v državi članici o ocenjeni rabi v državi članici
English: • Pregnancy testing requirements o Advice on suitable tests o Frequency (before commencing, monthly during treatment and after finishing treatment)
Slovenian: • zahteve testa nosečnosti o nasvete o ustreznih testih o pogostnost (pred pričetkom, mesečno med zdravljenjem in po končanem zdravljenju)
English: Educational healthcare professional's kit The Educational healthcare professional's kit shall contain the following elements:
Slovenian: Izobraževalni paket za zdravstvene delavce Izobraževalni paket za zdravstvene delavce naj vsebuje naslednje elemente:
English: The Member State should agree with the Marketing Authorisation Holder prior to the launch of the product: o The most appropriate strategies to monitor the off label use within national territory o The collection of detailed data with at least patient demographics and indication in order to monitor closely the off-label use within national territory o The set-up of national measures to assess the effectiveness of and compliance with the PPP.
Slovenian: Države članice se bodo z imetnikom dovoljenja za promet z zdravilom pred uvedbo zdravila na trg dogovorile o: o najustreznejših strategijah za nadzor nenamenske uporabe zdravila znotraj nacionalnega območja, o zbiranju podrobnih podatkov z vsaj demografijo in indikacijo bolnika, da bi skrbno nadzorovali nenamensko uporabo znotraj nacionalnega območja, o vzpostavitvi nacionalnih ukrepov za določanje učinkovitosti in skladnosti s PPN.
English: The Member States should ensure that the MAH provides the educational materials to the national patients' organisations for review or if such an organisation does not exist or can not be involved, to a relevant patients group.
Slovenian: Države članice bodo zagotovile, da bo imetnik dovoljenja za promet z zdravilom zagotovil izobraževalno gradivo za nacionalne organizacije za bolnike, ki jih pregledajo, oziroma če te ne obstajajo ali če ne morejo sodelovati, zadevnim skupinam bolnikov, ki še niso bili zdravljeni s talidomidom.
English: • Pregnancy initial and outcome reporting forms
Slovenian: • obrazce za poročanje o začetku in izidu nosečnosti
English: • That she should not share the treatment with any other person
Slovenian: • svojega zdravila ne sme dajati nikomur drugemu
English: • 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
Slovenian: • 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
English: • Neuropathy and adverse reaction reporting forms
Slovenian: • nevropatija in obrazci za poročanje neželenih učinkov
English: • 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
Slovenian: • če želi ženska spremeniti ali zamenjati svojo kontracepcijsko metodo, mora obvestiti - zdravnika, ki je kontracepcijo predpisal, da jemlje talidomid - zdravnika, ki je talidomid predpisal, da je prenehala uporabljati ali spremenila svojo kontracepcijsko metodo
English: • The need for pregnancy tests i.e. before treatment, every 4 weeks during treatment and after treatment
Slovenian: • potrebno je izvesti teste nosečnosti pred zdravljenjem, vsake 4 tedne med zdravljenjem in po zdravljenju
English: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority using the forms provided in the “Educational Healthcare Professional's Kit” (if applicable to a Member State)
Slovenian: • Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobreno, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom na obrazcu v „Izobraževalnem paketu za zdravstvene delavce“ (če je primerno za državo članico)
English: • That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for male patients should also include: Confirmation that the physician has discussed the following:
Slovenian: • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu o Obrazci za začetek zdravljenja za moške bolnike morajo vsebovati tudi naslednje elemente: potrdilo, da se je zdravnik pogovoril o naslednjem:
English: • Need to tell treating doctor immediately upon suspicion of pregnancy Safety advice for men
Slovenian: • opozorilo, da je v primeru suma na nosečnost, o tem treba nemudoma obvestiti zdravnika, ki vodi zdravljenje varnostne nasvete za moške
English: • That he should not donate semen during therapy and for one week following discontinuation of thalidomide o 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”
Slovenian: • Opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida o Zahteve poročanja nosečnosti opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene napotitev k zdravniku specialistu za teratologijo ali zdravniku z izkušnjami v teratologiji na svetovanje in oceno izpolnitev obrazca o poročanju nosečnosti, ki se nahaja v „Izobraževalnem paketu za zdravstvene delavce“ lokalne kontaktne podrobnosti za poročanje kakršnegakoli suma na nosečnost
English: The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and must implement such programme nationally to ensure that: o Prior to launch, all doctors and pharmacists who intend to prescribe or dispense Thalidomide Celgene receive a Dear Healthcare Professional letter as described below.
Slovenian: Države članice se morajo z imetnikom dovoljenja za promet z zdravilom dogovoriti o podrobnostih za nadzorovani sistem distribucije v skladu z nacionalno ureditvijo in zdravstvenim sistemom in izvajati ta program na nacionalni ravni ter tako zagotoviti naslednje: o Pred uvedbo zdravila na trg morajo vsi zdravniki in farmacevti, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, prejeti Pismo za zdravstvene delavce, kot je opisano spodaj o Pred predpisovanjem vsi zdravstveni delavci, ki nameravajo predpisovati (in v skladu z dogovorom s pristojnimi nacionalnimi organi izdajati) zdravilo Thalidomide Celgene, prejmejo izobraževalni paket za zdravstvene delavce, ki vsebuje naslednje: Brošura za zdravstvene delavce Brošure za paciente Kartice za bolnike Povzetek glavnih značilnosti zdravila, navodilo za uporabo in označevanje.
English: • That she should return the capsules to the pharmacist at the end of treatment o Treatment initiation forms for female patients with no childbearing potential should also include: Confirmation that the physician has discussed the following:
Slovenian: • ob koncu zdravljenja mora preostale kapsule vrniti farmacevtu o Obrazci za začetek zdravljenja za ženske bolnice, ki ne morejo zanositi, morajo vsebovati tudi: potrdilo, da se je zdravnik pogovoril o naslednjem:
English: • 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
Slovenian: • 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
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom
Slovenian: • če partnerica zanosi, mora o tem takoj obvestiti zdravnika, ki ga zdravi, in vedno uporabljati kontom
English: • That he should not donate blood or semen during therapy and for one week following discontinuation of thalidomide
Slovenian: • ne sme darovati krvi ali sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
English: • That she should not donate blood during therapy and for one week following discontinuation of thalidomide
Slovenian: • ne sme darovati krvi med zdravljenjem in še en teden po prekinitvi jemanja talidomida
English: • That if his partner becomes pregnant he should inform his treating doctor immediately and always use a condom during intercourse
Slovenian: • Opozorilo, da je treba v primeru zanositve partnerice nemudoma obvestiti zdravnika, ki vodi zdravljenje, in vedno med odnosom uporabljati kondom
English: • 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
Slovenian: • talidomid je prisoten v spermi, zato mora pri spolni partnerici, ki je noseča ali v rodni dobi in ne uporablja učinkovite kontracepcije, uporabiti kondom
English: • The need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Slovenian: • opozorilo, da je v primeru suma na nosečnost treba takoj prekiniti zdravljenje z zdravilom Thalidomide Celgene
English: • That he should not donate semen during therapy and for one week following discontinuation of thalidomide.
Slovenian: • opozorilo, da ne sme darovati sperme med zdravljenjem in še en teden po prekinitvi jemanja talidomida
English: • Need to stop Thalidomide Celgene immediately upon suspicion of pregnancy
Slovenian: • takoj po sumu na nosečnost mora prenehati uporabljati zdravilo Thalidomide Celgene
English: 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.
Slovenian: • Obrazce za začetek zdravljenja o Obstajajo naj 3 vrste obrazcev za začetek zdravljenja: bolnica v rodni dobi bolnica, ki ne more zanositi moški bolnik o Vsi obrazci za začetek zdravljenja naj vsebujejo naslednje elemente: opozorilo o teratogenosti datum svetovanja potrdilo o bolnikovem razumevanju v zvezi s tveganjem talidomida in ukrepi PPN podatke bolnika, podpis in datum ime zdravnika, ki je zdravilo predpisal, podpis in datum namen dokumenta, tj. kot je zabeleženo v PPN : „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.
English: 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 o The following information should also be provided in the appropriate booklet Female patient of childbearing potential
Slovenian: o obstajajo lahko tri vrste brošur ali ena sama brošura 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 o Vse brošure morajo zajemati naslednje informacije 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 Ustrezne brošure naj vsebujejo tudi naslednje podatke bolnica v rodni dobi:
English: Not to donate blood during treatment and for one week after treatment ends o Algorithm for Pregnancy Prevention Plan implementation This shall assist with patient categorisation, and determination of required pregnancy prevention and testing measures.
Slovenian: o Varnostne nasvete, pomembne za vse bolnike opis in upravljanje trombembolitičnih in kardiovaskularnih dogodkov in periferna nevropatija napotke za odstranjevanje odvečnega zdravila opozorilo, da bolniki ne smejo darovati krvi med zdravljenjem in en teden po koncu zdravljenja o Algoritem za izvajanje programa za preprečevanje nosečnosti ta naj pomaga pri razvrstitvi bolnikov in določanju zahtevanega preprečevanja nosečnosti in merilih testiranja o Podatke programa za preprečevanje nosečnosti opredelitev žensk v rodni dobi (ŽRD) in ukrepov za zdravnika, ki zdravilo predpiše, če status rodnosti ni jasen informacije o učinkoviti kontracepciji varnostne nasvete za ŽRD
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Slovenian: • opozorilo, da mora v primeru suma na nosečnost o tem nemudoma obvestiti svojega zdravnika
English: Confirmation that the physician has discussed the following:
Slovenian: o Obrazci za začetek zdravljenja za ženske bolnice v rodni dobi morajo vsebovati tudi naslednje elemente: Potrdilo, da se je zdravnik pogovoril o naslednjem:
English: If such a reaction occurs, appropriate treatment should be administered without delay.
Slovenian: Če se pojavi takšna reakcija, je potrebno nemudoma pričeti z ustreznim zdravljenjem.
English: In very rare cases transient hyperthermia may occur for up to 2 days.
Slovenian: Zelo redko se lahko pojavi prehodna hipertermija, ki traja do 2 dni.
English: Vaccination may interfere with existing sero-epidemiological surveys.
Slovenian: Cepljenje lahko ovira obstoječe sero-epidemiološke postopke.
English: It is therefore recommended not to vaccinate foals of less than 6 months of age.
Slovenian: Zato ni priporočljivo cepiti žrebet, mlajših od 6 mesecev.
English: • Revaccination: a sufficient degree of protection should be achieved after an annual booster injection with a single 1 ml dose although this schedule has not been fully validated.
Slovenian: • Revakcinacija: zadostna stopnja zaščite je dosežena po letni vzdrževalni injekciji enega 1 ml odmerka cepiva, čeprav ta program ni popolnoma validiran.
English: The vaccine stimulates active immunity against West Nile virus.
Slovenian: Cepivo stimulira aktivno imunost proti virusu West Nile.
English: • Primary vaccination course: first injection from 6 months of age, second injection 3-5 weeks later.
Slovenian: • Prvi krog cepljenja: prva injekcija od 6 meseca starosti, druga injekcija 3-5 tednov kasneje.
English: SP oil
Slovenian: SP olje
English: As a consequence, it cannot be excluded that transient immunodepression that may be observed during pregnancy could interfere with vaccine uptake.
Slovenian: Zato ni mogoče izključiti, da prehodna imunodepresija, ki se lahko pojavi med brejostjo, interferira z učinkovitostjo cepiva.
English: b) The disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: b) Bolezen, za katero se z zdravilom pridobi imunost, na zadevnem območju skoraj ni prisotna