natgillin/translations-raw huggingface dataset:
The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
Države članice se morajo o podrobnostih sistema nadzorovane distribucije dogovoriti z imetnikom dovoljenja za promet z zdravilom v skladu z nacionalnimi predpisi in sistemom zdravstvenega varstva ter zagotoviti njegovo izvajanje na nacionalnem nivoju tako, da imajo pred začetkom predpisovanja zdravila (in po presoji države članice, izdajanja zdravila) vsi zdravstveni delavci, ki bodo predpisovali (in kjer je primerno, izdajali) zdravilo Volibris na voljo naslednje:
• Product information (Summary of Product Characteristics (SPC) and Package Leaflet)
• podatke o zdravilu (Povzetek glavnih značilnosti zdravila (SmPC) in Navodilo za uporabo)
• Obligations of health care professionals in relation to the prescribing of Volibris: o That patients should be capable of complying with the requirements for the safe use of Volibris.
• Obveznosti zdravstvenih delavcev pri predpisovanju zdravila Volibris: o presoditi morajo, da so bolniki sposobni izpolnejvati zahteve glede varne uporabe zdravila Volibris.
• This should include key messages regarding the need for regular blood and pregnancy tests and provide spaces for the dates of appointments and the results of tests.
• Vključevati mora bistvene podatke o potrebnosti rednega izvajanja krvnih preiskav in testov za ugotavljanje nosečnosti ter imeti predviden prostor za vpisovanje terminov in rezultatov opravljenih preiskav.
• That the patient should not give Volibris to any other person.
• da bolnik zdravila Volibris ne sme dajati drugi osebi.
• Information booklets for patients
• informacijske brošure za bolnike
The healthcare professional information regarding Volibris should contain the following key elements:
Podatki o zdravilu Volibris za zdravstvene delavce morajo vključevati naslednje bistvene elemente:
The effect of Volibris on human testicular function and male fertility is not known.
Vpliv zdravila Volibris na delovanje mod pri človeku in plodnost moških ni znan.
o The need to provide comprehensive advice and counselling to patients.
o bolnikom morajo zagotoviti razumljiv nasvet in svetovanje.
For women with childbearing potential o Exclusion of pregnancy prior to treatment initiation and monthly pregnancy testing during treatment.
Za ženske v rodni dobi o Izključitev nosečnosti pred začetkom zdravljenja in mesečno izvajanje testov za ugotavljanje nosečnosti med zdravljenjem.
− The physician prescribing her contraception that she is taking Volibris
− zdravnika, ki ji je predpisal kontracepcijo o tem, da jemlje zdravilo Volibris
Booklet for male partners of women with childbearing potential The information for male partners of women with childbearing potential should include the following information:
Brošura za moške partnerje žensk v rodni dobi Podatki za moške partnerje žensk v rodni dobi morajo vključevati naslednje podatke:
• The need for the patient to discuss with her doctor if she is planning to become pregnant.
• da se mora bolnica posvetovati s svojim zdravnikom, če namerava zanositi.
• That if a women of childbearing potential needs to change or stop her method of contraception she should inform: o The physician prescribing her contraception that she is taking Volibris o The physician prescribing Volibris that she has changed or stopped her method of contraception
• da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije obvestiti: o zdravnika, ki ji je predpisal kontracepcijo o tem, da jemlje zdravilo Volibris o zdravnika, ki ji je predpisal zdravilo Volibris o tem, da je spremenila ali prenehala uporabljati dosedanjo metodo kontracepcije
o Definition of reliable contraception and the need to seek expert advice if unsure what is suitable for an individual patient.
o Opredeliti je treba zanesljivo metodo kontracepcije in v primeru negotovosti, kaj je primerno za posamezno bolnico, pridobiti mnenje specialista.
o That if a women of childbearing potential needs to change or stop her method of contraception she should inform:
o Da mora ženska v rodni dobi, ki mora spremeniti ali prenehati uporabljati dosedanjo metodo kontracepcije obvestiti:
o During therapy, monthly monitoring of ALT and AST is recommended.
o Med zdravljenjem je priporočljivo mesečno nadzirati vrednosti ALT in AST.
o The need to advise women (even if a woman has amenorrhoea) on the use of reliable contraception during treatment and for one month following permanent discontinuation of treatment.
o Ženskam (tudi ženskam z amenorejo) je treba svetovati, da morajo med zdravljenjem in še en mesec po trajni ukinitvi zdravljenja uporabljati zanesljivo metodo kontracepcije.
o The need to refer patients who become pregnant to a physician specialised or experienced in teratology and its diagnosis for evaluation and advice.
o Da je bolnico, ki je zanosila, treba napotiti k specialistu ali zdravniku z izkušnjami v teratologiji, ki mora izvesti diagnostične preiskave in podati svoje mnenje.
• That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury.
• da je zaradi možne okvare jeter in anemije treba redno izvajati krvne preiskave in da mora bolnik obvestiti svojega zdravnika, če se pojavi kakršenkoli simptom okvare jeter.
− The physician prescribing Volibris that she has changed or stopped her method of contraception.
− zdravnika, ki ji je predpisal zdravilo Volibris o tem, da je spremenila ali prenehala uporabljati dosedanjo metodo kontracepcije.
• That the patient should tell their doctor about any adverse event.
• da mora bolnik svojega zdravnika obvestiti o vsakem neželenem učinku.
o If tests show a clinically significant decrease in haemoglobin or haematocrit, and other causes have been excluded, consider reducing the dose of Volibris, or stopping treatment.
o Če preiskave pokažejo klinično pomembno znižanje vrednosti hemoglobina ali hematokrita in so drugi vzroki izključeni, je treba razmisliti o zmanjšanju odmerka zdravila Volibris ali o prekinitvi zdravljenja.
The Member States shall agree details of the implementation of the post-marketing surveillance study in each member state with the MAH and ensure that it is put in place prior to marketing of the product.
Države članice se morajo o podrobnostih izvedbe študije spremljanja zdravila po pridobitvi dovoljenja za promet dogovoriti z imetnikom dovoljenja za promet z zdravilom v vsaki posamezni državi članici in pred začetkom trženja zdravila zagotoviti njeno izvajanje.
• That Volibris is potentially hepatotoxic o Contraindication in patients with severe hepatic impairment (with or without cirrhosis) and in patients with baseline values of hepatic aminotransferases (AST and/or ALT) > 3X ULN.
• Da je zdravilo Volibris lahko hepatotoksično o Kontraindikacija pri bolnikih s hudo okvaro jeter (s cirozo ali brez) in pri bolnikih z izhodiščnimi vrednostmi jetrnih aminotransferaz (AST in/ali ALT) > 3X ZNM (“zgornje normalne meje”).
Health care Professional information
Podatki za zdravstvene delavce
• The need to ensure that women of child bearing potential are using reliable contraception and that patients should inform their doctors of any possibility of pregnancy before a new prescription is issued.
• da morajo ženske v rodni dobi uporabljati zanesljivo metodo kontracepcije in da morajo bolnice pred izdajo novega recepta svojega zdravnika obvestiti o vsaki možnosti zanositve.
o In subjects without clinical symptoms of hepatic injury or jaundice, reinitiation of ambrisentan may be considered following resolution of hepatic enzyme abnormalities.
o Pri osebah brez kliničnih simptomov okvare jeter ali zlatenice se o ponovni uvedbi zdravljenja z ambrisentanom lahko razmisli, ko nenormalnosti jetrnih encimov minejo.
• Information booklets for male partners of female patients with childbearing potential
• informacijske brošure za moške partnerje bolnic v rodni dobi
• Healthcare professional information regarding Volibris
• podatke o zdravilu Volibris za zdravstvene delavce
• That Volibris may cause liver injury.
• da lahko zdravilo Volibris povzroči okvaro jeter.
• That Volibris is teratogenic o Volibris is contraindicated in pregnancy and in women of child bearing potential who are not using reliable contraception.
• Da je zdravilo Volibris teratogeno o Uporaba zdravila Volibris je kontraindicirana med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo zanesljive metode kontracepcije.
Physician checklist
Kontrolni seznam za zdravnike
o That women receiving Volibris should be advised of the risk of foetal harm.
o Ženske, ki se zdravijo z zdravilom Volibris, je treba seznaniti s tveganjem za okvaro plodu.
o Patients taking Volibris should have their haemoglobin and/or haematocrit levels measured regularly.
o Pri bolnikih, ki jemljejo zdravilo Volibris, je treba redno nadzirati vrednosti hemoglobina in/ali hematokrita.
o Guidance for identifying women of child bearing potential and the actions the physician should take if unsure.
o Smernice za ugotovitev rodne dobe pri ženskah in ukrepe, ki jih morajo v primeru negotovosti izvesti zdravniki.
• That treatment with Volibris causes peripheral oedema and fluid retention o If a patient develops clinically significant peripheral oedema, with or without associated weight gain, carry out further evaluation to determine the cause and if appropriate consider discontinuation of Volibris.
• Zdravljenje z zdravilom Volibris je povezano s perifernim edemom in kopičenjem tekočin o Če se pri bolniku pojavi klinično pomemben periferni edem, s pridruženim povečanjem telesne mase ali brez, je za ugotovitev vzroka treba izvesti dodatne diagnostične postopke in po potrebi razmisliti o prekinitvi zdravljenja z zdravilom Volibris.
• That chronic administration of Volibris in animals has been linked to testicular tubular atrophy and impaired fertility.
• Da je bila dolgotrajna uporaba zdravila Volibris pri živalih povezana z atrofijo testikularnih tubulov in okvaro plodnosti.
• Pregnancy reporting forms
• obrazce za poročanje o nosečnosti
• That Volibris cannot be initiated if patient is pregnant.
• da se zdravljenje z zdravilom Volibris ne sme uvesti, če je bolnica noseča.
• That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia.
• Zdravljenje z zdravilom Volibris je pogosto povezano z znižanjem vrednosti hemoglobina in hematokrita o Pri bolnikih s klinično pomembno anemijo uvedba zdravljenja z zdravilom Volibris ni priporočljiva.
o The need to provide patients with the appropriate information booklet(s) and patient reminder card. o Should consider monthly prescription of 30 day supply to ensure that patients and key test results are reviewed prior to further prescription.
o presoditi morajo o mesečnem predpisovanju zdravila za 30-dnevno zalogo, da lahko pred nadaljnjim predpisovanjem pregledajo tako bolnika kot rezultate ključnih testov.
• That Volibris may cause serious birth defects in unborn babies conceived before, during, or within a month after stopping treatment.
• da lahko zdravilo Volibris povzroči resne okvare ploda, če ženska zanosi pred, med ali v enem mesecu po prekinitvi zdravljenja.
The physician pre-prescription checklist will highlight the contraindications to the use of ambrisentan and important pre-prescription assessments including:
V kontrolnem seznamu za zdravnike morajo biti posebej poudarjene kontraindikacije za uporabo ambrisentana in pomembna dejstva/preiskave, ki jih je treba poznati/izvesti pred začetkom zdravljenja, vključno s/z:
o That the patient should contact her doctor immediately if pregnancy is suspected and that alternative therapy should be initiated if pregnancy confirmed.
o Da mora bolnica, ki misli da je zanosila, o tem nemudoma obvestiti svojega zdravnika, in da je v primeru potrjene nosečnosti treba uvesti alternativno obliko zdravljenja.
• Information about the post marketing surveillance study
• podatke o študiji spremljanja zdravila po pridobitvi dovoljenja za promet
o That the safety database of Volibris is limited and physicians are encouraged to enrol patients in a post marketing surveillance study.
o seznaniti se morajo s celotno podatkovno bazo o varnosti zdravila Volibris in možnostjo vključitve bolnikov v študijo spremljanja zdravila po pridobitvi dovoljenja za promet.
o Discontinuation of ambrisentan therapy if patients develop sustained, unexplained clinically significant ALT and/or AST elevation or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice).
o Če se pri bolniku pojavi trdovratno, nepojasnjeno klinično pomembno zvišanje vrednosti ALT in/ali AST, ali če zvišanje vrednosti ALT in/ali AST spremljajo znaki ali simptomi okvare jeter (npr. zlatenica), je treba zdravljenje z ambrisentanom prekiniti.
• Women with childbearing potential must have a pregnancy test immediately prior to the first prescription and at monthly intervals whilst taking Volibris.
• da morajo ženske v rodni dobi neposredno pred začetkom zdravljenja z zdravilom Volibris opraviti test za ugotavljanje nosečnosti in ga nato med zdravljenjem opravljati v mesečnih intervalih.
• The need to ensure that women of child bearing potential are using reliable contraception.
• da morajo ženske v rodni dobi uporabljati zanesljivo metodo kontracepcije.
o To report suspected adverse reactions and pregnancy.
o poročati morajo o sumu na neželene učinke in o primerih nosečnosti.
o Hepatic aminotransferases (ALT and/or AST) should be evaluated prior to initiation of ambrisentan.
o Pred uvedbo zdravljenja z ambrisentanom je treba ovrednotiti vrednost jetrnih aminotransferaz (ALT in/ali AST).
• Adverse drug reaction reporting forms
• obrazce za poročanje o neželenih učinkih zdravila
• Pregnancy test if female patient with childbearing potential.
• testom za ugotavljanje nosečnosti pri bolnicah v rodni dobi.
Patient reminder card
Opozorilni kartonček za bolnika
• Determination of child bearing potential in female patients.
• določitvijo rodne dobe pri bolnicah.
• That Volibris should be initiated with caution in patients with severe renal impairment.
• Da je pri bolnikih s hudo okvaro ledvic treba zdravljenje z zdravilom Volibris uvesti previdno.
• That Volibris cannot be taken if a woman is or might become pregnant.
• da ženska, ki je ali bi lahko bila noseča, ne sme jemati zdravila Volibris.
• Patient reminder cards
• opozorilne kartončke za bolnika
• That hypersensitivity reactions, although uncommon, have been reported with Volibris.
• Da so pri uporabi zdravila Volibris občasno poročali o pojavu preobčutljivostnih reakcij.
In addition, an updated RMP should be submitted within a year.
Poleg tega je treba v enem letu predložiti posodobljen RMP.
Older people (over 65 years of age)
Starejši bolniki (stari 65 let in več)
Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 June 2013
Datum prve odobritve: 27. junij 2013
Symptoms may include catching or pain.
Simptomi lahko vključujejo zatikanje ali bolečine.
Microfracture N=72
Mikrofraktura N = 72
• the increased cells do not meet all the quality requirements.
• razmnožene celice ne izpolnjujejo zahtevanih kriterijev kakovosti.
Table 1: KOOS Response Rate*: Full Analysis Set n (%)
Preglednica 1: Stopnja odziva po lestvici KOOS*: Celovita analiza n (%)
Bleeding through the subchondral plate should be avoided, but if it occurs, it must be controlled.
Krvavitev skozi subhondralno ploščo je treba preprečiti, če pa se pojavi, jo je treba obvladati.
The implantation should be followed by an appropriate rehabilitation schedule (see section 4.4).
Vsaditvi mora slediti ustrezen rehabilitacijski postopek (glejte poglavje 4.4).
• the cells cannot be grown in the laboratory
• celic v laboratoriju ni mogoče vzgojiti,
• Details on how to recognise the signs and symptoms of important identified or potential risks of the product
• Podrobnosti o tem, kako prepoznati znake in simptome pomembnih ugotovljenih ali možnih
Your doctor may give you other medicines to help reduce any side effects (see section 2 “Warnings and precautions”).
Zdravnik vam lahko da druga zdravila, kar pomaga zmanjšati morebitne neželene učinke (glejte poglavje 2 „Opozorila in previdnostni ukrepi”).
Final sterility test results are not available at the time of shipping.
Končni testi sterilnosti v času pošiljanja niso na voljo.
Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
Ker vam bodo to zdravilo vsadili med operacijo kolena, je bolnišnično osebje odgovorno za pravilno shranjevanje zdravila pred in med uporabo kot tudi za ustrezno odstranitev.
Seventy-two patients received MACI, and 72 were treated with microfracture.
Dvainsedemdeset bolnikov je prejelo zdravilo MACI, 72 pa jih je bilo zdravljenih s postopkom mikrofrakture.
It is important that you closely follow the rehabilitation programme recommended by your doctor.
Pomembno je, da natančno upoštevate rehabilitacijski program, ki vam ga je priporočil zdravnik.
• The need to screen donors using patient questionnaires and laboratory tests for hepatitis C, hepatitis B, HIV and syphilis
• Potreba po presejanju darovalcev z uporabo vprašalnikov in laboratorijskih preskusov za hepatitis C, hepatitis B, HIV in sifilis.
The European Medicines Agency has deferred the obligation to submit the results of studies with MACI in paediatric patients from the closure of the femoral epiphyseal growth plate to less than 18 years of age.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij zdravila MACI pri pediatričnih bolnikih od zaprtja femoralne epifizne rastne plošče do starosti manj kot 18 let.
Please tell your doctor, surgeon or physical therapist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Obvestite zdravnika, kirurga ali fizioterapevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
Your surgeon or anaesthetist will explain to you the risks involved with the procedures as well as any additional specific risks that are applicable to you because of your medical history and current medical
Kirurg ali anestezist vam bosta razložila tveganja, povezana s postopki, ter morebitna dodatna tveganja, ki so pri vas možna zaradi vaše zdravstvene zgodovine ali trenutnega zdravstvenega stanja.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne
• the biopsy is of insufficient quality to produce MACI for you
• biopsija ni ustrezne kakovosti za izdelavo zdravila MACI za vas,
You may require more surgery to correct this
Morda bo potreben dodatni poseg, da se to popravi.
Return to sporting activity should be personalised in consultation with healthcare professionals.
Vrnitev k športnim aktivnostim je odvisna od vsakega posameznika v dogovoru z zdravstvenim osebjem.
There are no known risk groups or specific risk factors for graft hypertrophy in patients treated with MACI.
Ni znanih rizičnih skupin ali specifičnih dejavnikov tveganja za hipertofijo presadka pri bolnikih, zdravljenih z MACI.
Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic
Epinefrin ali fibrinsko lepilo (glejte poglavje 4.5), varčno naneseno neposredno na točke krvavitve, je primerno hemostatično
This should include specified or staged physical activity in order to minimise the likelihood of arthrofibrosis and graduated partial weight-bearing.
To naj vključuje specificirano ali vodeno fizično aktivnost, da se zmanjša verjetnost artrofibroze, in postopno delno obremenjevanje.
Keep MACI in the outer carton until ready to use.
Zdravilo MACI shranjujte v zunajni ovojnini, dokler ni pripravljeno na uporabo.
MACI N=72
Zdravilo MACI N = 72
• Patients with a femoral epiphyseal growth plate that is not fully closed.
• Bolniki s femoralno epifizo rastne ploščice, ki se še ni povsem zaprla.
• Educational material on the surgical procedures
• Izobraževalno gradivo o kirurških postopkih
Infective arthritis Wound infection Localised infection
Infekcijske in parazitske bolezni infekcijski artritis okužba rane lokalizirana okužba
• Cruciate ligament instability: the joint should not possess excessive laxity.
• Nestabilna križna vez: sklep ne sme biti pretirano ohlapen.
Please discuss with your doctor or physical therapist when to re-start specific physical activities.
Z zdravnikom ali fizioterapevtom se posvetujte, kdaj lahko ponovno začnete izvajati specifične fizične
Driving and using machines may be limited during the rehabilitation period, and the advice of your doctor, surgeon or physical therapist should be strictly followed during this period.
Vožnja in uporaba strojev sta lahko v obdobju rehabilitacije omejeni, v tem obdobju pa morate dosledno upoštevati nasvet zdravnika, kirurga ali fizioterapevta.
A small amount of blood (4 ml) will be taken by a qualified person for testing.
Usposobljena oseba vam bo odvzela majhno količino krvi (4 ml) za preiskave.
The use of MACI in this age group has not been studied.
Uporabe zdravila MACI v tej starostni skupini niso preučili.
In some cases, it may occur that source chondrocytes of the patient are not expandable or that the release criteria (see section 6.6) are not met due to poor biopsy quality, patient characteristics, or manufacturing failure.
V nekaterih primerih se lahko zgodi, da izvirnih hondrocitov bolnika ni mogoče razmnožiti, ali da kriteriji za sprostitev (glejte poglavje 6.6) niso izpolnjeni zaradi slabe kakovosti biopsije, značilnosti bolnika ali neuspelega postopka izdelave.
There are no data on possible effects of MACI treatment on fertility.
Podatkov o možnih učinkih zdravljenja z zdravilom MACI na plodnost ni.
What MACI is and what it is used for
Kaj je zdravilo MACI in za kaj ga uporabljamo
Complications may be related to MACI or to the surgical procedure, or both.
Zapleti so lahko povezani z zdravilom MACI ali s kirurškim postopkom ali z obema.
MACI should be used within 6 days after the date of release.
Zdravilo MACI morate porabiti v roku 6 dni od datuma sprostitve.
The use of MACI is not recommended in children and adolescents below 18 years.
Zdravilo MACI se ne priporoča za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Depending on your particular situation, your doctor or surgeon will advise you on whether or not to continue breast-feeding.
Glede na vašo individualno situacijo vam bo zdravnik ali kirurg svetoval, ali naj nadaljujete ali prekinete z dojenjem.
The Marketing Authorisation Holder (MAH) shall agree the content and the delivery of the Educational Program with the National Compentent Authority prior to the launch of MACI in that Member State.
Imetnik dovoljenja za promet z zdravilom (MAH) se mora glede vsebine in razdeljevanja izobraževalnega programa dogovoriti z nacionalnim pristojnim organom (NPO) pred začetkom uporabe zdravila MACI v tej državi članici.
Peri-operative complications related to surgical intervention of the knee:
Peri-operativni zapleti, povezani s kirurškim posegom na kolenu:
Patient: (name - date of birth {DD.Mmm.YYYY}) Biopsy: {biopsy number} Matrix: 1/1
Bolnik: (ime - datum rojstva {DD mmm LLLL})