FrancophonIA/ELRC3.0 huggingface dataset:
English: • as an infusion or as a tablet to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone);
Slovenian: • kot infuzija ali tableta za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali zapletov s kostmi, pri katerih je potrebno zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh
English: These included spine fractures, fractures outside the spine and any bone complications that needed treatment with radiotherapy or surgery.
Slovenian: Ti so vključevali zlome hrbtenice, zlome na drugih mestih in vse z okostjem povezane zaplete, pri katerih je bilo potrebno obsevanje ali kirurški poseg.
English: Bondronat is a medicine that contains the active substance ibandronic acid.
Slovenian: Bondronat je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
English: Why has Bondronat been approved?
Slovenian: Zakaj je bilo zdravilo Bondronat odobreno?
English: where tap water contains a lot of dissolved calcium, bottled water with a low mineral content may be used).
Slovenian: Tableto mora vzeti s polnim kozarcem navadne vode (na območjih s trdo vodo, kjer voda iz pipe vsebuje veliko raztopljenega kalcija, se lahko uporabi ustekleničena voda z nizko vsebnostjo mineralov).
English: For the full list of all side effects and restrictions reported with Bondronat, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Bondronat, glejte navodilo za uporabo.
English: The most common side effects with Bondronat infusions are a rise in body temperature, hypocalcaemia (low blood calcium levels), asthenia (weakness) and headache.
Slovenian: Najpogostejši neželeni učinki pri infuzijah zdravila Bondronat so povišana telesna temperatura, hipokalciemija (nizke ravni kalcija v krvi), astenija (šibkost) in glavobol.
English: By preventing the breakdown of bones, Bondronat also helps to reduce the amount of calcium released into the blood.
Slovenian: Zdravilo Bondronat s preprečevanjem razgradnje kosti pripomore tudi k znižanju ravni kalcija, ki se sprosti v kri.
English: The patient should not lie down for one hour after taking the tablet.
Slovenian: Vsaj eno uro po zaužitju tablete ne sme leči.
English: The active substance in Bondronat, ibandronic acid, is a bisphosphonate.
Slovenian: Zdravilna učinkovina v zdravilu Bondronat, ibandronska kislina, je difosfonat.
English: Bondronat was also effective in treating hypercalcaemia caused by tumours.
Slovenian: Zdravilo je bilo učinkovito tudi pri zdravljenju tumorsko povzročene hiperkalciemije.
English: The most common side effects with the tablets are hypocalcaemia and dyspepsia (heartburn).
Slovenian: Najpogostejša neželena učinka pri jemanju tablet sta hipokalciemija in dispepsija (zgaga).
English: The tablet should be taken after the patient has not eaten anything for at least six hours overnight and at least 30 minutes before the first food or drink of the day.
Slovenian: Pri preprečevanju z okostjem povezanih dogodkov se zdravilo Bondronat daje kot 6-miligramska infuzija v trajanju najmanj 15 minut vsake tri do štiri tedne ali kot ena tableta enkrat na dan. Tableto mora bolnik vedno vzeti zjutraj na tešče, ko ni jedel vsaj šest ur, in vsaj 30 minut pred prvim obrokom ali pijačo.
English: How has Bondronat been studied?
Slovenian: Kako je bilo zdravilo Bondronat raziskano?
English: What is Bondronat used for?
Slovenian: Za kaj se zdravilo Bondronat uporablja?
English: How is Bondronat used?
Slovenian: Kako se zdravilo Bondronat uporablja?
English: How does Bondronat work?
Slovenian: Kako zdravilo Bondronat deluje?
English: What is Bondronat?
Slovenian: Kaj je zdravilo Bondronat?
English: Intravenous use vial (glass) 12 (12x1) vials (multipack)
Slovenian: 12 (12 × 1) vial (skupno pakiranje)
English: (Invented) name Strength Pharmaceutical form
Slovenian: Jakost Farmacevtska oblika
English: Convincing data to identify a patient population in which the benefits of meprobamate clearly outweigh its identified risks.
Slovenian: prepričljive podatke z opredelitvijo populacije bolnikov, v kateri koristi meprobamata jasno odtehtajo opredeljena tveganja.
English: Annex III Conditions for lifting the suspension of the marketing authorisations
Slovenian: Dodatek III Pogoji za odpravo začasnega umika dovoljenj za promet z zdravilom
English: For the suspension to be lifted, the Marketing Authorisation Holders would need to provide the National Competent Authorities with the following:
Slovenian: Za odpravo začasnega umika morajo imetniki dovoljenja za promet z zdravilom pristojnim nacionalnim organom predložiti naslednje:
English: MA (EU) number (Invented) name
Slovenian: Številka (EU) dovoljenja za promet
English: 2 sets of constituents
Slovenian: Za infundiranje Steklene viale 2 kompleta sestavin
English: 1 set of constituents
Slovenian: Za infundiranje Steklene viale 1 komplet sestavin
English: However, the following efficacy and safety issues were addressed:
Slovenian: Vendar pa so bili obravnavani naslednji vidiki učinkovitosti in varnosti:
English: Results continuously improved with increasing experience over the course of 11 years.
Slovenian: Rezultati so se v teku 11 let s povečevanjem izkušenj nenehno izboljševali.
English: The three studies demonstrated similar survival rates.
Slovenian: Te tri študije so pokazale podobne deleže preživetja.
English: To date, no other relevant epidemiological data are available.
Slovenian: Doslej ni na voljo drugih pomembnih epidemioloških podatkov.
English: You should keep in regular contact with your doctor.
Slovenian: Redno morate biti v stiku s svojim zdravnikom.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Slovenian: Približno 2 % radioaktivnosti sta se izločila v urinu.
English: Belgium, Luxembourg, The Netherlands.
Slovenian: Belgija, Luksemburg, Nizozemska.
English: The divergences identified at the start of the referral have been resolved.
Slovenian: Razhajanja, ugotovljena na začetku napotitvenega postopka, so bila odpravljena.
English: Your doctor will tell you exactly how many capsules to take and how often.
Slovenian: Zdravnik vam bo natančno povedal, koliko kapsul morate jemati in kako pogosto.
English: Austria, Cyprus, Czech Republic, Denmark, Germany, Greece, Spain, Finland, France, Hungary, Ireland, Italy, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden,United Kingdom.
Slovenian: Avstrija, Ciper, Češka republika, Danska, Nemčija, Grčija, Španija, Finska, Francija, Madžarska, Irska, Italija, Norveška, Poljska, Portugalska, Slovaška, Slovenija, Švedska, Velika Britanija.
English: The course of preexisting infections may be aggravated.
Slovenian: Potek obstoječih okužb se lahko poslabša.
English: Efficacy results of the largest studies in each indication are summarised below.
Slovenian: Rezultati o učinkovitosti iz največjih študij za vsako indikacijo so povzeti spodaj.
English: The use of live attenuated vaccines should be avoided.
Slovenian: Izogniti se je treba uporabi živih oslabljenih cepiv.
English: The recommended initial dosages presented below are intended to act solely as a guideline.
Slovenian: Spodaj navedeni priporočeni začetni odmerki so namenjeni le kot smernice.
English: Section on contraindications (4.3) remained unchanged.
Slovenian: Poglavje o kontraindikacijah (4.3) je ostalo nespremenjeno.
English: 1640 Nicosia
Slovenian: 1640 Nikosia
English: Your doctor will advise you on the best course of action.
Slovenian: Zdravnik vam bo svetoval, kako je najbolje ravnati.
English: 28223 Pozuelo de Alarcón (Madrid) Spain
Slovenian: 28223 Pozuelo de Alarcón (Madrid) Španija
English: The capsules should be swallowed whole with a glass of water.
Slovenian: Kapsule morate zaužiti cele, s kozarcem vode.
English: In addition, synergistic/additive nephrotoxic effects can occur.
Slovenian: Poleg tega se lahko pojavijo sinergistični/aditivni nefrotoksični učinki.
English: 2600 Glostrup Denmark
Slovenian: 2600 Glostrup Danska
English: Box 25676
Slovenian: P.O. Box 25676
English: Intravenous therapy should not be continued for more than 7 days.
Slovenian: Intravensko zdravljenje ne sme trajati več kot 7 dni.
English: Your dose depends on your general condition and on which other immunosuppressive medication you are taking.
Slovenian: Vaš odmerek je odvisen od vašega splošnega stanja in od tega, katera druga imunosupresivna zdravila jemljete.
English: Possible side effects are listed according to the following categories:
Slovenian: Možni neželeni učinki so našteti po naslednjih skupinah:
English: Do not stop your treatment unless your doctor tells you to do so.
Slovenian: Ne prekinjajte zdravljenja, če vam tega ne naroči zdravnik.
English: Both generalised and localised infections can occur.
Slovenian: Pojavijo se lahko generalizirane in lokalizirane okužbe.
English: Classification and terminology were amended according to the MedDRA system organ class.
Slovenian: Klasifikacija in terminologija sta bili dopolnjeni v skladu s klasifikacijo organov v sistemu MedDRA.
English: • Safety issues
Slovenian: • Varnostni vidiki
English: The long-term safety profile of tacrolimus has not been systematically studied.
Slovenian: Dolgoročni varnostni profil takrolimusa ni bil sistematično raziskan.
English: 2350 AC Leiderdorp The Netherlands
Slovenian: 2350 AC Leiderdorp Nizozemska
English: Distribution and elimination
Slovenian: Porazdelitev in izločanje
English: Many of the adverse drug reactions stated below are reversible and/or respond to dose reduction.
Slovenian: Številne spodaj navedene neželene reakcije na zdravilo so reverzibilne in/ali se odzovejo na zmanjšanje odmerka.
English: Based on these data the efficacy of tacrolimus appears to be well established.
Slovenian: Na podlagi teh podatkov je učinkovitost takrolimusa dobro potrjena.
English: 114 rue Victor Hugo 92300 Levallois Perret France
Slovenian: 114 rue Victor Hugo 92300 Levallois Perret Francija
English: Most of the data supporting this indication are as expected retrospective.
Slovenian: Večina podatkov, ki podpirajo to indikacijo, je v skladu s pričakovanji retrospektivna.
English: Benefit/Risk considerations
Slovenian: Razmerje med koristmi in tveganji
English: Middlesex TW18 3AZ United Kingdom
Slovenian: Middlesex, TW18 3AZ Združeno kraljestvo
English: If you have forgotten to take your <Invented name> capsules, wait until it is time for the next dose, and then continue as before.
Slovenian: Če ste pozabili vzeti kapsule <(Lastniško) ime zdravila>, počakajte, da bo čas za naslednji odmerek, in potem nadaljujte kot prej.
English: insufficient function of your transplanted organ
Slovenian: nezadostno delovanje presajenega organa
English: The ISHLT's annual report therefore adds important information to the use of heart transplantation in children.
Slovenian: Zato letno poročilo ISHLT nudi pomembne dodatne informacije o uporabi zdravila pri presaditvi srca pri otrocih.
English: Astellas Farma Limitada Edifício Cinema Rua José Fontana, n° 1, 1° andar 2770-101 Paço de Arcos Portugal
Slovenian: Astellas Farma Limitada Edifício Cinema Rua José Fontana, n°1, 1° andar 2770-101 Paço de Arcos Portugalska
English: Clinically significant interactions have also been observed with phenobarbital.
Slovenian: Klinično pomembne interakcije so opažali tudi s fenobarbitalom.
English: But in a scenario where re-transplantation or death is a likely outcome a more liberal attitude toward the indication is in place.
Slovenian: Vendar pa je pri scenariju, pri katerem je verjeten rezultat ponovna presaditev ali smrt, upravičeno bolj liberalno stališče v povezavi s to indikacijo.
English: If overdosage occurs, general supportive measures and symptomatic treatment should be conducted.
Slovenian: Če pride do prevelikega odmerjanja, je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
English: The safety database for tacrolimus is fragmented and uncertain.
Slovenian: Baza podatkov o varnosti takrolimusa je fragmentarna in nezanesljiva.
English: There is no evidence currently available to indicate that dosing should be adjusted in elderly patients.
Slovenian: Trenutno ni dokazov, da bi bila pri starejših bolnikih potrebna prilagoditev odmerjanja.
English: toxic epidermal necrolysis (Lyell's syndrome)
Slovenian: toksična epidermalna nekroliza (Lyellov sindrom)
English: During treatment, careful monitoring with EBV-PCR is recommended.
Slovenian: Med zdravljenjem je potrebno natančno nadziranje z EBV-PCR.
English: There is a risk for premature delivery (<37 week) as well as for hyperkalaemia in the newborn, which, however, normalizes spontaneously.
Slovenian: Obstaja tveganje za prezgoden porod (< 37 tednov) in za hiperkaliemijo pri novorojenčku, ki pa se normalizira sama od sebe.
English: The frequency of blood level monitoring should be based on clinical needs.
Slovenian: Pogostnost nadziranja koncentracije v krvi mora temeljiti na kliničnih potrebah.
English: very rare:
Slovenian: zelo redki:
English: Due to the fact that the original product Prograf and associated names does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union and due to divergent national decisions, a harmonisation of the SPC for Prograf and associated names, throughout Europe became necessary.
Slovenian: Ker originalni proizvod Prograf in z njim povezana imena nima istega Povzetka glavnih značilnosti zdravila (SPC) v vseh državah članicah EU in ker se posamezne nacionalne odločitve medsebojno razlikujejo, se je pojavila potreba bo uskladitvi Povzetka glavnih značilnosti zdravila Prograf in z njim povezanih imen po celotni Evropi.
English: Dosage adjustments in specific patient populations Patients with liver impairment
Slovenian: Prilagoditve odmerjanja pri specifičnih populacijah bolnikov Bolniki z okvaro jeter
English: Adverse drug reactions are listed below in descending order by frequency of occurrence: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000, including isolated reports).
Slovenian: Neželene reakcije na zdravilo so naštete spodaj v padajočem zaporedju pogostnosti pojavljanja: zelo pogoste (> 1/10), pogoste (> 1/100, < 1/10), občasne (> 1/1.000, < 1/100), redke (> 1/10.000, < 1/1.000), zelo redke (< 1/10.000, vključno s posameznimi primeri).
English: United Kingdom Astellas Pharma Ltd. Lovett House, Lovett Road Staines
Slovenian: Astellas Pharma Ltd. Lovett House, Lovett Road Staines
English: Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Slovenian: Zdravnik vam bo redno naročil preiskave krvi, da bo določil pravi odmerek in da ga bo od časa do časa prilagodil.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Slovenian: Tako kot pri drugih močnih imunosupresivih tudi pri tem zdravilu tveganje za sekundarnega raka ni znano (glejte poglavje 4.8).
English: Severe effects have been reported, including allergic and anaphylactic reactions.
Slovenian: Poročali so o hudih učinkih, vključno z alergijskimi in anafilaktičnimi reakcijami.
English: You will receive <Invented name> as a continuous 24-hour infusion and never as a short injection.
Slovenian: <(Lastniško) ime zdravila> boste dobili kot stalno 24-urno infuzijo, nikoli kot hitro vbrizgano injekcijo.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Slovenian: Pozitivna EBV-PCR lahko traja še mesece in sama po sebi ne nakazuje limfoproliferativne bolezni ali limfoma.
English: The consequences of long-term immunosuppression, infections and tumour formation, are likely to increase with time, but this issue was not addressed.
Slovenian: Posledice dolgotrajne imunosupresije, okužbe in tvorbe tumorjev, se s časom povečujejo, vendar pa to vprašanje ni bilo obravnavano.
English: Corresponding data based on whole blood averaged 47.6 l.
Slovenian: Ustrezni podatek na podlagi polne krvi je povprečno 47,6 l.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Slovenian: Začetni odmerek za preprečitev zavrnitve presajenega organa bo določil zdravnik na podlagi vaše telesne mase.
English: If you have previously had such a problem, please inform your doctor.
Slovenian: Če ste kdaj prej imeli takšne težave, morate o tem obvestiti zdravnika.
English: If signs of toxicity are noted (e.g. pronounced adverse reactions - see section 4.8) the dose of <Invented name> may need to be reduced.
Slovenian: Če se pojavijo znaki toksičnosti (npr. izrazite neželene reakcije - glejte poglavje 4.8), utegne biti potrebno zmanjšanje odmerka <(Lastniško) ime zdravila>.
English: • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: • je so bili Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi posredovane dokumentacije in znanstvene razprave znotraj Odbora,
English: Section on undesirable effects (4.8) was brought in line with the guideline on summary of product characteristics.
Slovenian: Poglavje o neželenih učinkih (4.8) je bilo usklajeno s smernico o povzetku glavnih značilnosti zdravila.
English: Astellas Pharma S.A Paseo del Club Deportivo n°1, Bloque 14
Slovenian: Paseo del Club Deportivo n° 1, Bloque 14
English: • the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
Slovenian: • je bil namen napotitve uskladitev Povzetkov glavnih značilnosti zdravila,
English: This is quite normal and will help your doctor to decide on the most appropriate dose of <Invented name> for you.
Slovenian: To je povsem običajno in bo zdravniku pomagalo, da izbere odmerek zdravila <(Lastniško) ime zdravila>, ki bo za vas najprimernejši.
English: The concentrate should be used for intravenous infusion only after it is diluted with suitable carrier media (see section 6.6).
Slovenian: Koncentrat smete uporabiti za intravensko infundiranje, šele ko je razredčen s primernim vehiklom (glejte poglavje 6.6).
English: This should be dealt with as a follow-up request.
Slovenian: To vprašanje bo potrebno rešiti z zahtevo po spremljanju zdravljenja.
English: Only anecdotal descriptions of isolated patients or small numbers of patients in differing organ transplant indications were provided.
Slovenian: Podani so bili le anekdotični opisi izoliranih primerov bolnikov ali manjšega števila bolnikov z različnimi presajenimi organi.
English: - If you need to have any vaccinations, please inform your doctor beforehand.
Slovenian: - Če morate opraviti kakšno cepljenje, o tem predhodno obvestite svojega zdravnika.
English: One pitfall for the renal paediatric indication is, however, the lack of longterm data.
Slovenian: Pomanjkljivost v indikaciji za zdravljenje ledvic pri pediatričnih bolnikih pa je odsotnost dolgoročnih podatkov.
English: Inconsistencies between section 4.6 (Pregnancy and lactation) and section 5.3 (Preclinical safety data) have been corrected and more information has been included on male fertility.
Slovenian: Neskladnosti med poglavjema 4.6 (Nosečnost in dojenje) ter 5.3 (Predklinični podatki o varnosti) so bile odpravljene, vključenih je bilo tudi več podatkov o moški plodnosti.
English: This approach was reserved for patients without organ dysfunction (e.g. renal dysfunction).
Slovenian: Ta način je pridržan za bolnike brez motene funkcije organov (npr. motenega delovanja ledvic).
English: Your doctor will then prescribe <Invented name> capsules for you instead.
Slovenian: Potem vam bo zdravnik namesto tega predpisal kapsule <(Lastniško) ime zdravila>.
English: Data on cardiac transplantation in children are sparse due to the low number of transplantations performed each year.
Slovenian: Podatki o presaditvah srca pri otrocih so skromni, kar je posledica majhnega števila letno izvedenih presaditev.
English: If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist for advice before taking any medicine.
Slovenian: Če nameravate zanositi ali mislite, da ste noseči, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
English: Patients should be converted from intravenous to oral medication as soon as individual circumstances permit.
Slovenian: Bolnik mora preiti z intravenskega na peroralno zdravilo, čim to dopuščajo individualne okoliščine.
English: <Invented name> therapy requires careful monitoring by adequately qualified and equipped personnel.
Slovenian: Zdravljenje s <(Lastniško) ime zdravila> mora natančno nadzorovati ustrezno usposobljeno in opremljeno osebje.
English: Take special care with <Invented name> - You will need to take <Invented name> every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Slovenian: Bodite posebno pozorni pri jemanju zdravila <(Lastniško) ime zdravila> - <(Lastniško) ime zdravila> boste morali jemati vsak dan, dokler potrebujete imunosupresijo za preprečitev zavrnitve presajenega organa.
English: Metabolism and biotransformation
Slovenian: Presnova in biotransformacija
English: Consequently, your body will not be as good as usual at fighting infections.
Slovenian: Zaradi tega telo ne more premagovati okužb tako dobro kot ponavadi.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Slovenian: Kontroliranje najmanjše koncentracije v polni krvi zato omogoča dobro oceno sistemske izpostavljenosti.
English: Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Slovenian: Imunosupresivi lahko poslabšajo odziv na cepljenje in cepljenje je med zdravljenjem s takrolimusom lahko manj učinkovito.
English: In practice, <Invented name> therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Slovenian: V praksi so zdravljenje s <(Lastniško) ime zdravila> začenjali od 12 do 24 ur po prekinitvi ciklosporina.
English: Heart transplantation in paediatric patients:
Slovenian: Presaditev srca pri pediatričnih bolnikih:
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Slovenian: V sistemskem obtoku je v majhni koncentraciji prisoten le eden od neaktivnih presnovkov.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PROGRAF / PROGRAFT HARD CAPSULES AND CONCENTRATE FOR INFUSION
Slovenian: SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVILA PROGRAF / PROGRAFT TRDE KAPSULE IN KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
English: Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG preand post-transplant (e.g. initially at three months and then at 9-12 months).
Slovenian: Glede na to je treba zelo ogrožene bolnike, zlasti mlade otroke in tiste, ki prejemajo precejšnjo imunosupresijo, nadzorovati s preiskavami, kot sta ehokardiografija ali EKG, in sicer pred presaditvijo in po njej (npr. uvodoma po 3 mesecih in potem pri 9 - 12 mesecih).
English: Pharmacotherapeutic group: Macrolide immunosuppressant, ATC code: L04A A05
Slovenian: Farmakoterapevtska skupina: Zdravila za selektivno zaviranje imunske odzivnosti, Oznaka ATC: L04A A05
English: In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
Slovenian: V takšnem primeru so uporabili začetni peroralni odmerek takrolimusa od 2 do 4 mg na dan v kombinaciji z mofetilmikofenolatom in kortikosteroidi ali v kombinaciji s sirolimusom in kortikosteroidi.