natgillin/translations-raw huggingface dataset:
In addition, the CHMP requested the MAH to provide a clear rationale for having slightly different description of pharmacodynamic section in Sandimmun (both oral and injection) vs Sandimmun Neoral versions of SmPCs.
CHMP je zahteval tudi, da imetnik dovoljenja za promet z zdravilom jasno utemelji, zakaj je opis v poglavju o farmakodinamičnih lastnostih v povzetku glavnih značilnosti zdravila za zdravilo Sandimmun (tako za peroralno uporabo kot injiciranje) nekoliko drugačen kot v povzetku glavnih značilnosti zdravila za zdravilo Sandimmun Neoral.
The CHMP was of the opinion that a general message about the value of monitoring to guide posology was missing.
CHMP je menil, da manjka splošno opozorilo o pomembnosti spremljanja bolnika pri določanju odmerka.
In conclusion, based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon and adopted harmonised sets of PI documents for the various presentations of Sandimmun Neoral and associated names.
Po preučitvi predlogov imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj in seznam odprtih vprašanj ter razpravi znotraj odbora je CHMP odobril in sprejel usklajene dokumente z informacijami o zdravilu za različne oblike zdravila Sandimmun Neoral in povezanih imen.
Transplantation indications:
Indikaciji, povezani s presaditvijo:
Thus, the harmonized label for the safety section of the SmPC proposed by the MAH was based on the agreed CSP and enhanced with some newly added information from the full review of the MAH's labels (CDSs).
Usklajeno besedilo za poglavje o varnosti v povzetku glavnih značilnosti zdravila, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je torej temeljilo na odobrenem CSP, ki so mu dodali nekatere nove informacije iz natančnega pregleda dokumentov imetnika dovoljenja za promet z zdravilom (krovnih dokumentov).
The MAH agreed to correct this and proposed a wording for Sandimmum and Sandimmum Neoral which was acceptable to the CHMP.
Imetnik dovoljenja za promet z zdravilom je odpravil neskladja in predlagal besedilo za zdravili Sandimmun in Sandimmun Neoral, ki ga je CHMP odobril.
To achieve a harmonized SmPC, the MAH used the wording that is common to national SmPCs in the majority of MSs and the MAH's Core Data Sheet (CDS) for Sandimmun Neoral (dated 13 February 2012), as well as submitted legacy studies and literature references.
Imetnik dovoljenja za promet z zdravilom je za uskladitev povzetka glavnih značilnosti zdravila uporabil besedilo, ki se uporablja v večini držav članic in v krovnem dokumentu (Core Data SheetCDS) za zdravilo Sandimmun Neoral (z dne 13. februarja 2012), ter predložil starejše študije in referenčno literaturo.
Similarly to the section 4.2, wordings for each of the sub-sections for the different non-transplantation indications were discussed and agreed between the CHMP and MAH.
Podobno kot pri poglavju 4.2 sta se odbor CHMP in imetnik dovoljenja za promet z zdravilom dogovorila tudi o besedilih za vsakega od podpoglavij za različne indikacije, ki niso povezane s presaditvijo.
The efficacy of Sandimmun (oil based formulation of ciclosporin) has been demonstrated in 4 randomized controlled and 5 uncontrolled studies.The clinical results from these 9 clinical studies were analyzed using a pooling of data from all studies (controlled and uncontrolled).
Klinične rezultate iz teh 9 kliničnih študij so analizirali po združitvi podatkov iz vseh študij (nadzorovanih in nenadzorovanih).
The MAH's proposed indication wording for rheumatoid arthritis is approved in 13 EU countries.
Besedilo za indikacijo revmatoidni artritis, ki ga je predlagal imetnik dovoljenja za promet z zdravilom, je odobreno v 13 državah EU.
The MAH proposed a wording accordingly to include these recommendations, as requested by the CHMP.
Imetnik dovoljenja za promet z zdravilom je predlagal ustrezno besedilo, v katero je vključil priporočila, ki jih je zahteval odbor CHMP.
Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the non-transplantations indications.
Po preučitvi predloga imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj (LoQ) in seznam odprtih vprašanj (LoOI) ter razpravi znotraj odbora je CHMP odobril ustrezno usklajeno besedilo poglavja 4.2 za indikacije, ki niso povezane s presaditvijo.
• Solid organ transplantation
• Presaditev parenhimskih organov
Concerning the sub-sections on infections, renal toxicity and hepatotoxicity, monitoring ciclosporin levels in transplant patients, hypertension, blood lipids increased, live-attenuated vaccines and interactions, wordings were proposed by the MAH and intensively discussed and revisited as per CHMP requests.
Prav tako je imetnik dovoljenja za promet z zdravilom v skladu z zahtevami odbora CHMP predlagal, podrobno obravnaval in ponovno preučil besedila za podpoglavja o infekcijah, toksičnosti za ledvice in jetra, spremljanju koncentracij ciklosporina pri bolnikih po presaditvi, hipertenziji, zvišanih vrednostih lipidov v krvi, živih oslabljenih cepivih in medsebojnem delovanju z drugimi zdravili.
The CHMP was in agreement with the MAH's proposal.
CHMP se je s predlogom strinjal.
The MAH agreed with the CHMP's opinion and hence revised the wording of the posology in the solid organ transplantation indication accordingly.
Imetnik dovoljenja za promet z zdravilom se je strinjal z mnenjem odbora CHMP in ustrezno spremenil besedilo o odmerjanju pri indikaciji presaditev parenhimskih organov.
In that context, a thorough comparison of the Feb 2011 agreed CSP information and the safety sections of the newly released CDSs was performed by the MAH.
Na osnovi tega je imetnik dovoljenja za promet z zdravilom natančno primerjal informacije v CSP, ki je bil odobren februarja 2011, in poglavja o varnosti v najnovejših krovnih dokumentih.
The MAH agreed with the CHMP's opinion and a wording was agreed accordingly.
Imetnik dovoljenja za promet z zdravilom se je strinjal z mnenjem odbora CHMP, zato je bilo besedilo ustrezno usklajeno.
With regards to the paragraphs concerning Medical supervision, Lymphomas and other malignancies, Geriatrics, Hyperkalaemia, Hypomagnesemia and Hyperuricaemia, Special excipients, the MAH proposed the CSP wording as the harmonised SmPC text.
Imetnik dovoljenja za promet z zdravilom je predlagal, da se za uskladitev besedila odstavkov v poglavjih povzetka glavnih značilnosti zdravila Zdravniški nadzor, Limfomi in druge maligne spremembe, Geriatrija, Hiperkaliemija, Hipomagneziemija in Hiperurikemija ter Posebne pomožne snovi, uporabi besedilo iz CSP. CHMP se je s predlaganim besedilom strinjal.
Based on the assessment of the MAH's proposal, the responses to the LoQ, LoOI and following the discussions of the committee, the CHMP agreed upon a harmonised wording of the section 4.2 accordingly for the special populations.
Po preučitvi predloga imetnika dovoljenja za promet, njegovih odgovorov na seznam vprašanj in seznam odprtih vprašanj ter razpravi znotraj odbora je CHMP odobril ustrezno usklajeno besedilo poglavja 4.2 za posebne skupine bolnikov.
Transplantation indications
Indikaciji, povezani s presaditvijo
Hence, this supports the lower doses proposed for Sandimmun Neoral in the proposed SmPC.
To kaže na to, da so manjši odmerki, ki so bili v predlaganem povzetku glavnih značilnosti zdravila predlagani za zdravilo Sandimmun Neoral, upravičeni.
A revised wording was proposed by the MAH accordingly and endorsed by the CHMP.
Imetnik dovoljenja za promet z zdravilom je nato predlagal spremenjeno besedilo, ki ga je CHMP odobril.
The CHMP was of the view that the proposed text is relevant to include and therefore the CHMP agreed with the wordings as proposed by the MAH.
Ta dva odstavka nista bila vključena v CSP. CHMP je menil, da je vključitev predlaganega besedila smiselna, zato je odobril besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
A wording was agreed accordingly.
Besedilo je bilo ustrezno usklajeno.
All MS except Norway have the indication bone marrow transplantation and GVHD approved.
Indikacija presaditev kostnega mozga in GVHD je odobrena v vseh državah članicah, razen na Norveškem.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Sandimmum and associated names (see Annex I).
je odbor CHMP priporočil spremembo dovoljenj za promet z zdravilom Sandimmun in povezanimi imeni (glejte Prilogo I), za katerega so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo opredeljeni v Prilogi III.
The proposed wording was acceptable to the CHMP.
CHMP je menil, da je predlagano besedilo sprejemljivo.
” This wording was endorsed by the CHMP.
CHMP je to besedilo odobril.
The MAH agrees with the CHMP's view.
CHMP se je strinjal s tem mnenjem.
Section 6.3 - Shelf life
Poglavje 6.3 - Rok uporabnosti
The MAH accepted the proposal to amend the ADRs as highlighted by the CHMP.
Imetnik dovoljenja za promet z zdravilom se je strinjal s spremembo podatkov o neželenih učinkih, ki jo je predlagal CHMP.
The MAH proposed to harmonise the SmPC text along with the agreed CSP.
Imetnik dovoljenja za promet z zdravilom je predlagal, da se besedilo povzetka glavnih značilnosti zdravila uskladi v skladu z odobrenim CSP. CHMP se je s predlaganim besedilom strinjal.
The CHMP therefore agreed with the approach taken by the MAH.
CHMP se je zato strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
The daily doses of Neoral should always be given in two divided doses.” The MAH's statement “The dose ranges given for oral administration are intended to serve as guidelines only” is endorsed by the CHMP.
CHMP je odobril stavek imetnika dovoljenja „razpone odmerkov za peroralno uporabo je treba upoštevati zgolj kot smernice“.
The CHMP was in agreement with the approach taken by the MAH.
CHMP se je strinjal s pristopom imetnika dovoljenja za promet z zdravilom.
This point was addressed by the MAH and a wording was agreed.
Imetnik dovoljenja za promet je obravnaval ta predlog, nato pa je bilo besedilo usklajeno.
Thus, a wording was proposed by the MAH and agreed by the CHMP to address this matter.
Imetnik dovoljenja za promet z zdravilom je zato v zvezi s tem predlagal ustrezno besedilo, ki ga je CHMP odobril.
• Bone marrow transplantation
• Presaditev kostnega mozga
The recommended dose is…
Priporočeni odmerek je …
It is unlikely to be serious.
Ni verjetno, da bo šlo za resno težavo.
It needs to be treated at once.
To je treba zdraviti takoj.
End of 7 days period at room temperature: __/__/____
Konec sedemdnevnega obdobja na sobni temperaturi: __/__/____
This can help to provide more information on the safety of medicines like this one.
To pomaga zagotoviti več informacij o varnosti zdravila, kot je to.
Find a comfortable, well-lit place.
Pojdite na udobno in dobro osvetljeno mesto.
cannot be estimated from the available data.
ni mogoče oceniti iz razpoložljivih podatkov.
Please use as follows:
Uporabljajte na naslednji način:
Proper treatment of your disease, however, requires close and constant co-operation with your doctor.
Kljub temu pa ustrezno zdravljenje vaše bolezni zahteva pozorno in stalno sodelovanje z zdravnikom.
This medicine may not be suitable for the following patients.
To zdravilo morda ne bo primerno za naslednje bolnike.
Furthermore, deaths were more frequent in this patient group compared to younger patients.
Poleg tega so bile smrti v tej skupini pogostejše kot pri mlajših bolnikih.
It acts as a mitosis-stimulating factor and differentiation hormone.
Deluje kot mitozo stimulirajoči dejavnik in diferenciacijski hormon.
- if you have high blood pressure that cannot be controlled.
- če imate visok krvni tlak, ki ga ni mogoče nadzorovati.
Even at very high blood levels, no symptoms of poisoning have been observed.
Celo pri zelo visokih ravneh v krvi niso opazili nobenih simptomov zastrupitve.
b) Maintaining sufficient red blood cell levels
b) Vzdrževanje zadostnega števila rdečih krvničk
Approximately 9% of patients can be expected to experience an adverse reaction.
Pri približno 9 % bolnikov se pričakuje, da se bo pojavil neželeni učinek.
These symptoms could indicate that your treatment with this medicine is ineffective.
Ti simptomi lahko kažejo, da je zdravljenje s tem zdravilom neučinkovito.
Please discuss this with your doctor.
O tem se pogovorite z zdravnikom.
- Uncontrolled hypertension.
- nenadzorovana hipertenzija.
Do not warm Biopoin in any other way (for example, do not warm it in a microwave or in hot water).
Zdravila Biopoin ne grejte na noben drug način (na primer ne segrevajte ga v mikrovalovni pečici ali vroči vodi).
Red blood cells are very important for distributing oxygen within your body.
Rdeče krvničke so zelo pomembne za porazdelitev kisika v telesu.
Healthy people should not use Biopoin.
Zdravi ljudje ne smejo uporabljati zdravila Biopoin.
Your healthcare professional will always record the exact product you are using.
Zdravstveni delavec bo vedno natančno zabeležil, katero zdravilo uporabljate.
Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.
Tega zdravila ne dajajte otrokom in mladostnikom, starim manj kot 18 let, saj ni podatkov o varnosti in učinkovanju zdravila pri tej starostni skupini.
It works in exactly the same way as erythropoietin.
Deluje popolnoma enako kot eritropoetin.
Your doctor will work out the right dose for you.
Zdravnik bo določil pravi odmerek za vas.
● Risk Management Plan (RMP)
ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
Very rare: Not known:
Zelo redki: Neznana:
The extent of absorption (AUC) was slightly greater after injection in the abdomen in comparison to the other sites.
Obseg absorpcije (AUC) je bil rahlo večji po injiciranju v abdomen kot na drugih dveh mestih.
It is important to tell your doctor if you are pregnant, think you may be pregnant or plan to get pregnant, as the doctor may decide that you should not use this medicine.
Pomembno je, da zdravniku poveste, če ste noseči, menite, da bi lahko bili noseči ali načrtujete nosečnost, saj se lahko odloči, da tega zdravila ne smete uporabljati.
Epoetins are not indicated for use in this patient population.
Epoetini niso indicirani za uporabo pri tej skupini bolnikov.
The safety of epoetin theta has been evaluated based on results from clinical studies including 972 patients.
Varnost epoetina theta so ocenili na podlagi rezultatov kliničnih študij, ki so vključile 972 bolnikov.
- Severely elevated blood pressure:
- Hudo zvišan krvni tlak:
Anaemia occurs when your blood does not contain enough red blood cells.
Anemija se pojavi, kadar kri ne vsebuje dovolj rdečih krvničk.
It is recommended that haemoglobin be monitored every two weeks until levels have stabilised and periodically thereafter.
Priporočeno je, da se vrednost hemoglobina spremlja vsaka dva tedna, dokler se ravni ne stabilizirajo, potem pa občasno.
If necessary, your doctor will increase your dose at monthly intervals.
Po potrebi bo zdravnik odmerek povečeval v mesečnih presledkih.
Date of latest renewal: 26 August 2014.
Datum prve odobritve: 23. oktober 2009 Datum zadnjega podaljšanja: 26. avgust 2014
The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established.
Pediatrična populacija Varnost in učinkovitost zdravila Biopoin pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani.
The solution should be visually inspected prior to use.
Pred uporabo je treba raztopino vizualno pregledati.
Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of epoetins and should therefore be corrected.
Pomanjkanje železa, folne kisline ali vitamina B12 zmanjša učinkovitost epoetinov, zato ga je treba popraviti.
Before you stop using this medicine, talk to your doctor.
Preden prenehate uporabljati to zdravilo, se pogovorite z zdravnikom.
Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.
Receptorji eritropoetina so lahko izraženi na površini različnih tumorskih celic.
For instructions on handling of the medicinal product before administration, see section 6.6.
Za navodila glede ravnanja z zdravilom pred dajanjem, glejte poglavje 6.6.
Maintenance phase
Vzdrževalna faza
A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Opravili so tudi sistematični pregled, ki je vključil več kot 9000 bolnikov z rakom, ki so sodelovali v 57 kliničnih preskušanjih.
- Do not put the cover back on used needles.
- Pokrovčka ne dajajte nazaj na uporabljene igle.
Your doctor or nurse will give you instructions on how to do this.
Zdravnik ali medicinska sestra vam bosta dala navodila.
If your iron level is too low, your doctor may also prescribe you an iron preparation.
Če je raven železa prenizka, vam bo zdravnik morda predpisal tudi pripravek železa.
- if you are allergic to epoetin theta, another epoetin or any of the other ingredients of this medicine (listed in section 6);
- če ste alergični na epoetin theta, drug epoetin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
Biopoin has not been tested in pregnant women.
Zdravila Biopoin niso preizkusili pri nosečnicah.
Your doctor will carry out regular blood tests in order to monitor various blood components and their levels.
Zdravnik bo opravil običajne krvne preiskave, da bo spremljal različne krvne elemente in njihove ravni.
Factors that should be considered in this assessment should include the type of tumour and its stage, the degree of anaemia, life-expectancy, the environment in which the patient is being treated, and patient preference (see section 5.1).
Dejavniki, ki jih je treba pretehtati v tej oceni, morajo vključevati vrsto tumorja in njegov stadij, stopnjo anemije, pričakovano življenjsko dobo, okolje, v katerem se bolnik zdravi, in bolnikovo prednostno izbiro (glejte poglavje 5.1).
The maximum concentration is reached after an average of 10 to 14 hours and the average terminal half-life ranges from approximately 22 to 41 hours.
Največja koncentracija se v povprečju doseže po 10 do 14 urah, povprečni končni razpolovni čas pa se giba med 22 in 41 ur.
At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Ko se bolnikom predpiše zdravilo, jim je treba svetovati glede znakov in simptomov ter jih skrbno spremljati glede kožnih reakcij.
Epoetin theta is a protein produced by biotechnology.
Epoetin theta je beljakovina, ki se izdeluje z biotehnologijo.
These may be signs of severely elevated blood pressure, even if your blood pressure is usually normal or low.
To so lahko znaki hudo zvišanega krvnega tlaka, tudi če je vaš krvni tlak navadno normalen ali nizek.
Do not remove the needle cover from the syringe until you are ready to inject.
Pokrovčka za iglo ne odstranite, dokler niste pripravljeni na injiciranje.
It is better to change the injection site every day to avoid the risk of soreness at any one site.
Najbolje je, da mesto injiciranja menjate vsak dan, da se izognete tveganju bolečine na nekem mestu.
If you are a cancer patient you should be aware that this medicine may act as a blood cell growth factor and in some circumstances may have a negative impact on your cancer.
Če imate raka, morate vedeti, da lahko to zdravilo deluje kot rastni faktor za krvničke in lahko v nekaterih primerih negativno vpliva na raka.
In the four placebo-controlled studies the hazard ratios for overall survival ranged between 1.25 and 2.47 in favour of controls.
V štirih s placebom nadzorovanih študijah je bilo razmerje tveganja za splošno preživetje od 1,25 do 2,47 v korist kontrolnih skupin.
The target haemoglobin concentration in two studies was > 13 g/dl; in the remaining three studies it was 12-14 g/dl.
Ciljna koncentracija hemoglobina v dveh študijah je bila > 13 g/dl, v drugih treh pa 12-14 g/dl.
This may be associated with life-threatening cardiovascular complications.
To je lahko povezano s smrtno nevarnimi kardiovaskularnimi zapleti.
Do not use any Biopoin that is left in the syringe.
Ne uporabite zdravila Biopoin, ki je ostalo v brizgi.
If severe polycythaemia occurs, conventional methods (phlebotomy) may be indicated to reduce the haemoglobin level.
Če se pojavi huda policitemija, so lahko indicirane konvencionalne metode (flebotomija) za znižanje ravni hemoglobina.
Epoetin theta has no or negligible influence on the ability to drive and use machines.
Epoetin theta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Your doctor will carry out blood tests regularly and adjust the dosage or suspend the treatment if necessary.
Zdravnik bo redno opravljal krvne preiskave in prilagodil odmerek ali po potrebi prekinil zdravljenje.
Therapy should be continued up to 4 weeks after the end of chemotherapy.
Zdravljenje je treba nadaljevati do 4 tedne po končani kemoterapiji.
During the studies, mortality was lower in the epoetin theta group (6.9%) compared to placebo (10.3%).
Med temi študijami je bila umrljivost manjša v skupini, ki je prejemala epoetin theta, (6,9odstotna) kot v skupini, ki je prejemala placebo (10,3-odstotna).
After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase.
Po uporabi epoetina theta se število eritrocitov, vrednosti hematokrita in število retikulocitov povečajo.
Effect on tumour growth
Učinek na rast tumorja
To ensure effective erythropoiesis, iron status has to be evaluated for all patients prior to and during treatment.
Da se zagotovi učinkovita eritrocitopoeza, je treba pri vseh bolnikih pred zdravljenjem in med njim oceniti stanje železa.
Other medicines and Biopoin
Druga zdravila in zdravilo Biopoin
Hypertension can be treated with appropriate medicinal products (see section 4.4).
Zdravi se lahko z ustreznimi zdravili (glejte poglavje 4.4).
The initial dose is 20,000 IU.
Začetni odmerek je 20.000 i.e.
In order to improve the traceability of epoetins, the name of the administered epoetin should be clearly recorded in the patient file.
Za izboljšanje sledljivosti epoetinov je treba v bolnikovo kartoteko jasno zabeležiti ime uporabljenega epoetina.
Your treatment with this medicine is being initiated by a doctor who is experienced in the above-mentioned indications.
Zdravljenje s tem zdravilom bo uvedel zdravnik z izkušnjami z zgoraj navedenimi indikacijami.
This is known as a subcutaneous injection.
To se imenuje subkutano injiciranje.
Particular attention should be paid to sudden sharp migraine-like headaches as a possible warning signal.
Posebej je treba paziti na pojav nenadnih, zbadajočih glavobolov, podobnih migreni, ki so morebitni opozorilni znak.
Adverse reactions listed below in table 1 are classified according to System Organ Class.
Navedeni neželeni učinki so razvrščeni v spodnji preglednici 1 glede na organske sisteme.
You will usually receive Biopoin until 1 month after the end of chemotherapy.
Zdravilo Biopoin boste navadno prejemali do enega meseca po koncu kemoterapije.
If a dose adjustment is required to maintain the desired haemoglobin level, it is recommended that the dose be adjusted by approximately 25%.
Če je za vzdrževanje želene ravni hemoglobina treba prilagoditi odmerek, se priporoča, da se odmerek prilagodi za približno 25 %.
In clinical trials, patients over 75 years of age had a higher incidence of serious and severe adverse events irrespective of a causal relationship to treatment with epoetin theta.
V kliničnih preskušanjih so imeli bolniki, starejši od 75 let, večjo incidenco resnih in hudih neželenih dogodkov, ne glede na vzročno povezanost z zdravljenjem z epoetinom theta.
*See subsection “Description of selected adverse reactions” below
*Glejte spodnje podpoglavje "Opis izbranih neželenih učinkov"