natgillin/translations-raw huggingface dataset:
Annex II Scientific conclusions and grounds for amendment of the summaries of product characteristics and package leaflets presented by the EMA
Dodatek II Znanstveni zaključki in podlaga za dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo, ki jih je predstavila Evropska agencija za zdravila
The task force of the American Society for Bone and Mineral Research (ASBMR) on atypical subtrochanteric and diaphyseal femoral fractures have defined major and minor features of atypical femoral fracture (Shane et al, 20103) and recommend that for a case to be considered an atypical femoral fracture all major features need to be present, whereas the minor features have commonly been described in cases of atypical femoral fractures, but are not present in all patients.
Delovna skupina ameriškega združenja za raziskovanje kosti in mineralov (ASBMR) za atipične subtrohanterne in diafizne zlome stegnenice je opredelila glavne in manj pomembne značilnosti atipičnih zlomov stegnenice (Shane et al., 20103) in priporočila, da morajo biti za določitev primera kot atipičnega zloma stegnenice prisotne vse glavne značilnosti, medtem ko so po drugi strani pri primerih atipičnih zlomov stegnenice pogosto opisane manj pomembne značilnosti, ki pa niso prisotne pri vseh bolnikih.
Based on the small number of spontaneous reports of comminuted atypical femoral fracture in association with bisphosphonates, one published case report (Schneider, 20064), as well as preliminary data presented at the October meeting of the ASBMR (Nitche et al, 20105), the CHMP for the purpose of its assessment agreed on a modified case definition that lists ‘noncomminuted' as a minor feature rather than a major feature of atypical femur femoral fracture.
Na podlagi majhnega števila spontanih poročil o zdrobljenih atipičnih zlomih stegnenice v zvezi z difosfonati, enega objavljenega poročila o primeru (Schneider, 20064) in predhodnih podatkov, predstavljenih na oktobrskem srečanju združenja ASBMR (Nitche et al., 20105), je CHMP za namen postopka vrednotenja potrdil spremenjeno opredelitev primera, ki navaja „zdrobljene“ zlome kot manj pomembno značilnost in ne glavno značilnost atipičnih zlomov stegnenice.
However not all preclinical studies have found adverse effects of alendronic acid on bone (Burr et al2).
Vendar pa se neželeni učinki alendronske kisline na kosti niso pokazali pri vseh predkliničnih študijah (Burr et al.2).
Other than osteoporosis the most prevalent co-morbid conditions in patients with atypical femur fracture were found to be chronic obstructive pulmonary disease or asthma, rheumatoid arthritis and diabetes.
Poleg osteoporoze so bile pri bolnikih z atipičnimi zlomi stegnenice kot najpogostejše sočasne bolezni ugotovljene kronična obstruktivna pljučna bolezen ali astma, revmatoidni artritis in diabetes.
While some epidemiology studies suggest that subtrochanteric and femoral shaft fractures may be normal osteoporotic fractures (Abrahamsen et al, 20096, Abrahamsen, 20107, Vestergaard et al, 20108) other studies suggest that long-term bisphosphonate use may increase the risk of subtrochanteric and femoral shaft fractures (Park-Wyllie et al, 20119, Wang & Bhattacharyya, 201110).
Medtem ko nekatere epidemiološke študije kažejo, da so subtrohanterni zlomi in zlomi stegnenice lahko običajni zlomi zaradi osteoporoze (Abrahamsen et al., 20096; Abrahamsen, 20107; Vestergaard et al., 20108), druge študije kažejo, da dolgotrajna uporaba difosfonatov lahko poveča tveganje za subtrohanterne zlome in zlome stegnenice (Park-Wyllie et al., 20119; Wang in Bhattachayya, 201110).
Glucocorticoids and proton pumps inhibitor (PPI) have been identified as possible important risk factors for atypical femur fracture.
Glukokortikoidi in zaviralec protonske črpalke so bili ugotovljeni kot možni pomembni dejavniki tveganja za atipične zlome stegnenice.
The number of post-marketing reports of possible atypical femur fracture suspected to be associated with bisphosphonates has increased since the 2008 PhVWP review.
Število poročil v obdobju trženja o možnih atipičnih zlomih stegnenice, ki naj bi bili povezani z difosfonati, se je od pregleda delovne skupine za farmakovigilanco v letu 2008 povečalo.
• Addition of atypical femoral fracture to section 4.8 (Undesirable effects) of the SmPC accompanied by a statement that this adverse effect is a class attribution of all bisphosphonates.
• Vključitev atipičnega zloma stegnenice v poglavje 4.8 (Neželeni učinki) povzetka glavnih značilnosti zdravila, ki naj bo dopolnjeno z izjavo, da je ta neželeni učinek posledica uporabe vseh difosfonatov.
The long-term use of bisphosphonates is thought to be the main risk factor for atypical femoral fractures.
Dolgotrajna uporaba difosfonatov naj bi bila najpomembnejši dejavnik tveganja za atipične zlome stegnenice.
The mechanism(s) for the development of atypical fractures in patients taking bisphosphonates is not known.
Mehanizmi za razvoj atipičnih zlomov pri bolnikih, ki jemljejo difosfonate, niso znani.
Other studies with radiographic evidence have also reported an increased incidence of atypical femoral fractures in patients treated with bisphosphonates compared to non-exposed patients, which may increase with duration of bisphosphonate treatment (Dell et al, 201013, Schilcher et al, 200914).
Tudi v drugih študijah z rentgenskimi dokazi so poročali o povečani pojavnosti atipičnih zlomov stegnenice pri bolnikih, zdravljenih z difosfonati, v primerjavi z bolniki, ki niso bili izpostavljeni difosfonatom, pri čemer se lahko ta pojavnost poveča glede na trajanje zdravljenja z difosfonati (Dell et al., 201013; Schilcher et al., 200914).
Although pre-clinical studies have provided limited information on the risk of atypical fractures with bisphosphonates, some of them have demonstrated that suppression of bone turnover by bisphosphonates may increase microdamage accumulation and the accumulation of advanced glycation end-products resulting in changes in the biomechanical properties of bone (Brennan et al, 2011, Hofstaetter et al, 2010, Mashiba et al, 2000, O'Neal et al, Tang et al, 20091).
Čeprav so informacije iz predkliničnih študij glede tveganja za pojavljanje atipičnih zlomov kosti pri uporabi difosfonatov omejene, so nekatere izmed njih pokazale, da lahko zaviranje kostne presnove zaradi difosfonatov poveča kopičenje mikropoškodb in kopičenje končnih produktov pospešene glikacije, kar lahko povzroči spremembe biomehanskih lastnosti kosti (Brennan et al., 2011; Hofstaetter et al., 2010; Mashiba et al., 2000; O'Neal et al.; Tang et al., 20091).
The lack of evidence may be due to a lack of recognition and reporting of atypical fractures at sites other than the femur with bisphosphonate use or it is possible that the unique characteristics of the femur as the major weight bearing bone in the body mean that atypical fractures only occur at this site.
Pomanjkanje dokazov je lahko posledica pomanjkljivega prepoznavanja in poročanja o atipičnih zlomih pri uporabi difosfonatov na drugih mestih kot na stegnenici, možno pa je tudi, da se atipični zlomi pojavljajo samo na stegnenici zaradi njenih edinstvenih lastnosti, saj nosi večino telesne mase.
• The Committee concluded that the Product Information of all bisphopshonates should include a warning in section 4.4 on the risk of atypical fractures of the femur and this adverse reaction should also be listed in section 4.8 of the SPCs.
• Odbor je sklenil, da morajo informacije o zdravilih, ki vsebujejo difosfonate, v poglavju 4.4 vključevati opozorilo o atipičnih zlomih stegnenice, ta neželeni učinek pa mora biti naveden tudi v poglavju 4.8 povzetkov glavnih značilnosti zdravil.
Casecontrol studies have reported a significant association between atypical femur fracture pattern and bisphosphonate use (Lenart et al, 200911, Isaacs et al, 201012).
V študijah primerov in kontrol so poročali o pomembni povezavi med vzorci atipičnih zlomov stegnenice in uporabo difosfonatov (Lenart et al., 200911; Isaacs et al., 201012).
Osteoporosis Int 2009; 20: 887-894 2 Burr DB et al Effects of one to three years treatment with alendronate on mechanical properties of the femoral shaft in a canine model: implications for subtrochanteric femoral fracture risk.
2 Burr DB et al Effects of one to three years treatment with alendronate on mechanical properties of the femoral shaft in a canine model: implications for subtrochanteric femoral fracture risk.
Definition of atypical fracture of the femur
Opredelitev atipičnih zlomov stegnenice
A number of possible risk factors have been proposed for atypical femoral fractures in association with bisphosphonate use.
Predlagana je bila vrsta možnih dejavnikov tveganja za atipične zlome stegnenice v zvezi z uporabo difosfonatov.
Grounds for amendment of the summaries of product characteristics and package leaflets
Podlaga za dopolnilo povzetkov glavnih značilnosti zdravila in navodil za uporabo
However a number of possible mechanisms of atypical fracture in association with bisphosphonate use have been postulated.
Vendar pa je bilo opredeljenih več možnih mehanizmov atipičnih zlomov, ki bi lahko bili povezani z uporabo difosfonatov.
Date of first authorisation: 21 February 2008 Date of first renewal: 19 November 2012
Datum prve odobritve: 21. februar 2008 Datum zadnjega podaljšanja: 19. november 2012
• Do you need to receive vaccines (live vaccines)?
• Ali morate prejeti cepivo (živo cepivo)?
Not known (frequency cannot be estimated from the available data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
• changes in different laboratory parameters
• spremembe različnih laboratorijskih parametrov
• serious infection which may affect the whole body
• resna okužba, ki lahko vpliva na celo telo
Influenza vaccination may be of value.
Cepiva proti gripi so lahko koristna.
Information concerning the following antibiotics is available:
Na voljo so podatki v povezavi z naslednjimi antibiotiki:
Talk to your doctor immediately,
Nemudoma se pogovorite s svojim zdravnikom:
Do not take this medicine if any of the above applies to you.
Ne jemljite tega zdravila, če kar koli izmed naštetega velja za vas.
There are limited safety and efficacy data in children below the age of 2°years.
O varnosti in učinkovitosti pri otrocih, mlajših od dveh let, je na voljo premalo podatkov.
Talk to a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Takoj obvestite zdravnika, če opazite katerega koli od naslednjih resnih neželenih učinkov - morda boste potrebovali nujno medicinsko pomoč:
Children and adolescents (aged 2 to 18)
Otroci in mladostniki (stari od 2 do 18 let)
If you forget to take your medicine at any time, take it as soon as you remember, then continue to take it at the usual times.
Če ste pozabili vzeti zdravilo, ga vzemite takoj, ko se spomnite, in nato nadaljujte kot običajno.
Hepatic transplant patients were followed for at least 1°year, but less than 3°years.
Bolnikom z jetrnim presadkom so sledili vsaj 1 leto, vendar pa manj kot 3 leta.
Your doctor will decide the most appropriate dose based on body surface area (height and weight).
Zdravnik bo določil najbolj ustrezen odmerek glede na telesno površino (višina in telesna masa).
Your doctor will have to advise you what is indicated for you.
Zdravnik vam bo svetoval, kaj je primerno za vas.
The dose given will vary depending on the size of the child.
Dani odmerek bo odvisen od velikosti otroka.
50 tablets 150 tablets 50 x 1 tablets
50 tablet 150 tablet 50 x 1 tableta
Your treatment is started and monitored by a doctor who is specialised in transplants.
Zdravljenje bo začel in spremljal zdravnik, ki je specializiran za presaditve.
The proportion of patients with CMV viraemia/syndrome was 13.5%.
Delež bolnikov s sindromom CMV/viremijo je znašal 13,5 %.
You can take them with or without food.
Tablete lahko vzamete s hrano ali brez.
• if you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
• če ne uporabljate učinkovite kontracepcije (glejte Nosečnost, kontracepcija in dojenje),
Talk to your doctor about the most suitable contraception for you.
S svojim zdravnikom se pogovorite o izbiri metode kontracepcije, ki je za vas najbolj primerna.
These may be signs of bleeding in the stomach or intestines.
To so lahko znaki krvavitve v želodec ali prebavila.
• you have black or bloody stool or if you vomit blood or dark particles that look like coffee grounds.
• imate črno ali krvavo blato ali bruhate kri ali temne delce, ki izgledajo kot kavna usedlina.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
Zdi se, da je tveganje bolj odvisno od intenzivnosti in trajanja imunosupresije kot od specifičnosti učinkovin.
In addition there have been isolated reports of the following malformations:
Dodatno so zabeležili posamezna poročila o naslednjih malformacijah:
The health professional educational material should contain:
Izobraževalno gradivo za zdravstvene delavce mora vsebovati:
Treatment will continue for you as long as you need immunosuppression to prevent your body from rejecting your transplanted organ.
Vaše zdravljenje se bo nadaljevalo, dokler boste potrebovali imunosupresive, ki preprečujejo, da bi vaše telo zavrnilo presajeni organ.
• too much acid in the body
• preveč kisline v telesu
Avoid contact with any powder that spills out from damaged capsules.
Izogibajte se stiku s praškom, ki ga vsebujejo poškodovane kapsule.
If any powder gets into your eyes or mouth, rinse thoroughly with plenty of plain, fresh water.
Če prašek zaide v oči ali usta, jih sperite z zadostno količino sveže vode.
• insufficient production of red blood cells
• nezadostno nastajanje rdečih krvnih celic
Do not crush the tablets.
Tablet ne drobite.
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: 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), not known (cannot be estimated from the available data).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Neželeni učinki so znotraj organskih sistemov razvrščeni po pogostnosti v naslednje skupine: 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), z neznano pogostnostjo (iz podatkov, ki so na voljo določitev ni mogoča).
• change of the shape of certain white blood cells
• sprememba oblike nekaterih belih krvnih celic
• inflammation of the tissue that lines the inner wall of the abdomen and covers most of the abdominal organs
• vnetje tkiva, ki obdaja notranjo trebušno steno in pokriva večino trebušnih organov
• decrease in the number of all blood cells, increase in the number of white blood cells
• zmanjšanje števila vseh krvnih celic, zvišanje števila belih krvnih celic
The usual way to take Myfenax is as follows:
Običajen način jemanja zdravila Myfenax je naslednji:
Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Pri 3,6 % bolnikov so opazili nemelanomski kožni rak, druge vrste malignosti pa so se pojavile pri 1,1 % bolnikov.
• Congenital heart disease such as atrial and ventricular septal defects;
• kongenitalna bolezen srca, kot sta atrijski in ventrikularni septum defekt,
The patient information pack should contain:
Gradivo za bolnike mora vsebovati:
Do not stop taking your medicine unless you have discussed this with your doctor first.
Ne prenehajte z jemanjem zdravila, ne da bi se prej o tem posvetovali s svojim zdravnikom.
• An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
• Uvod v obeh vodnikih bo informiral bralca, da je namen vodnika pojasniti, da se je treba izogibati izpostavljenosti ploda in kako kar najbolj zmanjšati tveganje za prirojene okvare in spontani splav, povezane z uporabo mofetilmikofenolata.
If a capsule breaks open accidentally, wash any powder from your skin with soap and water.
Če se kapsula po nesreči odpre, sperite prašek s kože z milom in vodo.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete nosečnost, se pred jemanjem tega zdravila posvetujte z zdravnikom ali farmacevtom.
It is recommended, however, to administer Myfenax at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Vseeno je priporočljivo, da dajemo zdravilo Myfenax vsaj eno uro pred ali tri po dajanju sevelamerja, zato da zmanjšamo vpliv na absorpcijo mikofenolne kisline.
What Myfenax is and what it is used for
Kaj je zdravilo Myfenax in za kaj ga uporabljamo
Potential interaction
Možne interakcije
Patients taking Myfenax should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
Med zdravljenjem z zdravilom Myfenax moramo napraviti preiskave celotne krvne slike enkrat na teden prvi mesec, dvakrat mesečno v drugem in tretjem mesecu in nato enkrat mesečno v prvem letu.
• high level of potassium in the blood, low level of potassium, magnesium, calcium and/or phosphate in the blood
• visoka raven kalija v krvi, nizka raven kalija, magnezija, kalcija in/ali fosfata v krvi
• Olfactory nerve agenesis.
• agenezija olfaktornega živca.
In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
V nekaj od teh primerov je zamenjava mofetilmikofenolat za drugi imunosupresiv povzročila izboljšanje respiratornih simptomov.
The MAH shall ensure that in each MS where Myfenax is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myfenax are provided with the following educational package:
Imetnik dovoljenja za promet mora zagotoviti, da v vseh državah članicah, kjer je zdravilo Myfenax na tržišču, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo Myfenax, prejeli naslednja izobraževalna gradiva:
• severe reduction in the number of certain white blood cells (possible symptoms are fever, sore throat, frequent infections) (agranulocytosis)
• hudo zmanjšanje števila nekaterih belih krvnih celic (možni simptomi so zvišana telesna temperatura, vneto grlo, pogoste okužbe) (agranulocitoza)
MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
selektivni, nekompetitivni in reverzibilni zaviralec inozin-monofosfat-dehidrogenaze in tako zavira de novo sintezo gvanozinskih nukleotidov, brez vključevanja v DNA.
Talk to your doctor if you develop a persistent cough or breathlessness.
Pogovorite se z zdravnikom, če kašelj ali kratka sapa vztraja.
Treatment with Myfenax should be initiated and maintained by appropriately qualified transplant specialists.
Zdravljenje z zdravilom Myfenax mora vpeljati in voditi ustrezen specialist za presaditve.
In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes.
V primerih trajne klinično pomembne hipogamaglobulinemije je treba razmisliti o primernem kliničnem ukrepu, upoštevajoč močan citostatični učinek, ki ga ima mikofenolna kislina na limfocite T in B.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive
Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants.
O primerih hepatitisa zaradi reaktivacije hepatitisa B ali C so poročali pri bolnikih nosilcih, ki so se zdravili z imunosupresivi.
These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Ti so nezadostni za navodila o priporočenem odmerjanju, zato uporaba zdravila v tej starostni skupini ni priporočljiva.
However, at high MPAG plasma concentrations (>°100 µg/mL), small amounts of MPAG are removed.
Pri visokih koncentracijah mikofenolglukuronida v plazmi (> 100 µg/ml) se majhne količine mikofenolglukuronida vendarle odstranijo.
MPA AUC values across age groups were similar in the early and late post-transplant period.
Vrednosti AUC mikofenolne kisline so bile v starostnih skupinah podobne v začetnem in poznejšem obdobju po presaditvi.
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23-27%) in the unborn baby.
Mikofenolat zelo pogosto povzroči spontani splav (50 %) in hude prirojene napake (23 - 27 %) pri nerojenih otrocih.
• serious disease of the central nervous system (JC virus associated progressive multifocal leucoencephalopathy)
• resna bolezen centralnega živčnega sistema (progresivna multifokalna levkoencefalopatija, povezana z virusom JC)
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Zdravilo Myfenax je zaviralec inozin-monofosfat-dehidrogenaze (IMPDH).
• bowel blockage
• blokada črevesja
EU/1/07/438/003 (50 tablets) EU/1/07/438/004 (150 tablets) EU/1/07/438/005 (50 x 1 tablets)
EU/1/07/438/003 (50 tablet) EU/1/07/438/004 (150 tablet) EU/1/07/438/005 (50 x 1 tablet)
• serious inflammation of the heart and its valves
• resno vnetje srca in njegovih zaklopk
It is recommended to monitor MPA exposure levels and to adjust Myfenax doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Priporočljivo je spremljanje ravni izpostavljenosti mikofenolni kislini in prilagoditev odmerkov zdravila Myfenax za ohranitev klinične učinkovitosti, kadar sočasno dajemo rifampicin.
Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, oznaka ATC: L04AA06.
See also further information in this section under “Warnings and precautions” and “Pregnancy, contraception and breast-feeding”.
"Opozorila in previdnostni ukrepi" in "Nosečnost, kontracepcija in dojenje".
• proliferation of the lymphatic tissue, including malignant tumours
• rast limfatičnega tkiva, vključno z malignimi tumorji
Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Bolnikom, ki prejemajo zdravilo Myfenax, je treba naročiti, da morajo takoj poročati o kakršnem koli znaku okužbe, nepričakovani modrici, krvavitvi ali drugih znakih depresije kostnega mozga.
Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Nasvet o postopku, če se nosečnost pojavi (ali sumi nanjo) med ali kmalu po zdravljenju z mofetilmikofenolatom.
• high level of cholesterol and/or lipids in the blood
• visoka raven holesterola in/ali lipidov v krvi
In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) of 18% to 70%.
Pri bolnikih, ki ne jemljejo tudi ciklosporina, je sočasno mofetilmikofenolata in rifampicina povzročilo zmanjšanje izpostavljenosti mikofenolni kislini (AUC0-12h) za 18 do 70 %.