natgillin/translations-raw huggingface dataset:
The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Priporočila Evropske agencije za zdravila temeljijo na pregledu Odbora za zdravila za uporabo v humani medicini (CHMP), ki je preučil razpoložljive podatke o koristih peroralnega ketokonazola in tveganju hepatotoksičnosti iz predkliničnih ter kliničnih študij, spontanih poročil o primerih v obdobju trženja, epidemioloških študij in znanstvene literature.
The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Odbor CHMP je mnenje predložil Evropski komisiji, ki ga je potrdila in dne 11. oktobra 2013 sprejela končni pravno zavezujoči sklep, veljaven v celotni EU.
Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Upoštevajoč povečano število poškodb jeter in dostopnost drugih antimikotičnih terapij je odbor CHMP sklenil, da koristi ne odtehtajo tveganj.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Mnenje odbora CHMP je bilo poslano Evropski komisiji, ki je izdala končni pravno zavezujoči sklep, veljaven po celotni EU.
The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Pregled peroralnega ketokonazola je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila, pristojnemu za vsa vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Peroralni (z zaužitjem skozi usta) ketokonazol je v EU odobren od leta 1980, pozneje pa je sledila še odobritev topičnih (kožnih) formulacij, kot so kreme, mazila in zdravilni šamponi.
Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
Zdravniki ne smejo več predpisovati peroralnega ketokonazola in morajo ponovno proučiti možnosti zdravljenja bolnikov.
The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.
Odbor CHMP je sklenil, da je tveganje poškodbe jeter večje od koristi pri zdravljenju glivičnih okužb.
Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Ketokonazol je antimikotik, ki se uporablja za zdravljenje okužb, ki jih povzročajo dermatofiti in kvasovke.
The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Evropska agencija za zdravila se zaveda, da se ketokonazol uporablja za zdravljenje bolnikov s Cushingovim sindromom, za kar ni indiciran.
Consequently, the French agency asked the EMA to carry out a full assessment of the benefitrisk balance of oral ketoconazole-containing medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Posledično je francoska agencija Evropsko agencijo za zdravila zaprosila za popolno oceno razmerja med tveganji in koristmi peroralnih zdravil, ki vsebujejo ketokonazol, ter izdajo mnenja o tem, ali naj se dovoljenja za promet z zdravilom obdržijo, spremenijo, začasno umaknejo ali ukinejo.
• Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
• Peroralni (z zaužitjem skozi usta) ketokonazol se je začasno umaknil iz prometa po pregledu podatkov, ki je pokazal veliko jetrno toksičnost pri tem zdravilu v primerjavi z drugimi antimikotiki (zdravili proti glivicam).
• Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents.1 Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.
• Čeprav je morebitna hepatotoksičnost učinek razreda azolnih antimikotikov, je ocena podatkov pokazala, da sta incidenca in resnost hepatotoksičnosti večji pri ketokonazolu kot pri drugih antimikotikih.1 Poročani primeri hepatotoksičnosti so vključevali hepatitis, cirozo in jetrno odpoved s smrtnimi izidi ali potrebo po presaditvi jeter.
Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections
Korist peroralnega ketokonazola ne odtehta tveganja jetrne poškodbe pri glivičnih okužbah
• If you are taking topical formulations of ketoconazole (such as creams, ointments and shampoos), you can continue your treatment, as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
• Če jemljete topične formulacije ketokonazola (kot so kreme, mazila in zdravilni šamponi), lahko nadaljujete zdravljenje, saj je količina ketokonazola, ki se absorbira po telesu, v teh formulacijah zelo majhna.
Topical formulations of ketoconazole (such as creams, ointments and shampoos) can continue to be used as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Topične formulacije ketokonazola (kot so kreme, mazila in zdravilni šamponi) se lahko še naprej uporabljajo, saj je količina ketokonazola, ki se absorbira po telesu, v teh formulacijah zelo majhna.
The French medicine agency, the National Agency for the Safety of Medicine and Health Products (ANSM), concluded that the benefit-risk balance of oral ketoconazole was negative because of a high level of liver injury associated with the medicine and in view of the currently available alternative treatments, which are deemed to be safer.
Francoska agencija za zdravila, Nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM), je sklenila, da je razmerje med tveganji in koristmi peroralnega ketokonazola negativno zaradi velikega deleža poškodb jeter, povezanih z zdravilom, in glede na trenutno razpoložljive druge oblike zdravljenja, ki so varnejše.
The EU-wide review of oral ketoconazole was triggered by the suspension of the medicine in France.
Pregled peroralnih zdravil, ki vsebujejo ketokonazol, po celotni EU je povzročil začasni umik zdravila v Franciji.
In June 2011, the French medicines agency concluded that the benefit-risk balance of oral ketoconazole was negative and suspended the existing marketing authorisations in France.
Francoska agencija za zdravila je junija 2011 sklenila, da je razmerje med tveganji in koristmi peroralnega ketokonazola negativno in začasno umaknila dovoljenja za promet z zdravilom v Franciji.
• As oral ketoconazole is no longer recommended, doctors should review patients being treated with this medicine for fungal infections, with a view of stopping treatment or choosing an appropriate alternative treatment.
• Ker peroralni ketokonazol ni več priporočljiv, naj zdravniki preučijo bolnike, ki se zdravijo s tem zdravilom zaradi glivične okužbe, in se odločijo, ali prekiniti zdravljenje ali izbrati drugo ustrezno obliko zdravljenja.
• Pharmacists should refer patients with a prescription of oral ketoconazole for fungal infections to their treating doctor.
• Farmacevti naj bolnike z receptom za peroralni ketokonazol proti glivičnim okužbam napotijo k njihovemu zdravniku.
Suspension of marketing authorisations for oral ketoconazole
Začasen umik dovoljenj za promet s peroralnimi zdravili,
Having assessed the available data on the risks with oral ketoconazole, the CHMP concluded that, although liver injury such as hepatitis is a known side effect of antifungal medicines, the incidence and the seriousness of liver injury with oral ketoconazole were higher than with other antifungals.
Na podlagi ocene razpoložljivih podatkov o tveganjih pri peroralnem ketokonazolu je odbor CHMP sklenil, da čeprav je okvara jeter, kot je hepatitis, znani neželeni učinek antimikotikov, sta incidenca in resnost okvar jeter pri peroralnem ketokonazolu večji kot pri drugih antimikotikih.
Patients currently taking oral ketoconazole for fungal infections should make a non-urgent appointment with their doctor to discuss suitable alternative treatments.
Bolniki, ki se zaradi glivičnih okužb trenutno zdravijo s peroralnim ketokonazolom, naj se neurgentno naročijo na obisk pri zdravniku, s katerim bosta pretehtala druge ustrezne oblike zdravljenja.
• If you are currently taking oral ketoconazole for fungal infections, you should speak to your doctor at a routine appointment to discuss suitable alternative treatments.
• Če jemljete peroralni ketokonazol za zdravljenje glivičnih okužb, se ob rednem obisku z zdravnikom posvetujte o drugih ustreznih oblikah zdravljenja.
There are also inadequate data to support the efficacy of ketoconazole when other treatments have failed or are not tolerated, or resistance has been detected.
• Študije učinkovitosti peroralnega ketokonazola so omejene in se niso izvedle skladno z najsodobnejšimi smernicami.2 Prav tako ni zadostnih podatkov, ki bi podprli učinkovitost ketokonazola, kadar druge oblike zdravljenja niso uspešne, jih bolnik ne prenaša ali pa se je ugotovila rezistenca.
** RED80: Rabbit effective dose in 80% of the animals (serology).
* RED60: efektivni odmerek za zajca v 60 % živali (serologija) ** RED80: efektivni odmerek za zajca v 80 % živali (serologija)
• The prescription should include all of the following details:
• Recept mora vključevati vse naslednje podrobnosti:
Information for parents and carers
Informacije za starše in skrbnike
More information on Amglidia can be found on the Agency's website: ema.europa.eu/Find medicine.
Več informacij o zdravilu Amglidia je na voljo na spletni strani agencije: ema.europa.eu/Find medicine.
Guide will increase awareness on the different medicine presentations and help avoid medication errors
Navodila bodo povečala ozaveščenost o različnih oblikah zdravila in pripomogla k zmanjševanju napak pri uporabi zdravila
Dosing errors may occur due to confusion between milligram (mg) and millilitre (ml), or use of incorrect strength or size of syringe and how the dose is measured, which may result in too high or too low blood sugar levels.
Napake pri odmerjanju se lahko pojavijo zaradi zamenjave miligramov (mg) in mililitrov (ml) ali uporabe nepravilne jakosti ali velikosti brizge ter načina odmerjanja, kar lahko privede do previsoke ali prenizke ravni sladkorja v krvi.
Once Amglidia is started, it is usually possible to reduce and even stop the dose of insulin the patient is already receiving.
Po uvedbi zdravila Amglidia je običajno mogoče zmanjšati in nato ukiniti odmerek insulina, ki ga bolnik že prejema.
All healthcare professionals who are expected to prescribe Amglidia (glibenclamide oral suspension) will be provided with a guide to help ensure that the medicine is prescribed and used correctly.
Vsi zdravstveni delavci, ki naj bi predpisovali zdravilo Amglidia (peroralno suspenzijo glibenklamida), bodo prejeli navodila, ki jim bodo pomagala zagotavljati pravilno predpisovanje in uporabo zdravila.
• The choice of the oral syringe depends on the volume per dose:
• Izbira peroralne brizge je odvisna od volumna na odmerek:
Amglidia is effective in patients with specific genetic mutations (beta-cell ATP-sensitive potassium channel and chromosome 6q24).
Zdravilo Amglidia je učinkovito pri bolnikih z določenimi genetskimi mutacijami (od ATP odvisen kalijev kanalček celic beta in kromosom 6q24).
It works on insulin-producing cells in the pancreas and attaches to special channels on their surface called ATP-sensitive potassium channels (KATP channels), through which potassium ions normally enter the cells and trigger the release of insulin.
Deluje na celice trebušne slinavke, ki tvorijo insulin, in se veže na posebne kanalčke na njihovi površini, imenovane od ATP odvisni kalijevi kanalčki (kanalčki KATP), skozi katere kalijevi ioni običajno vstopijo v celice ter sprožijo sproščanje insulina.
− size of the oral syringe to be used.
− velikost peroralne brizge, ki jo je treba uporabiti.
− how many doses are given each day,
− število odmerkov na dan;
To avoid medication errors, prescribers will be given a guide specifying which strength and presentation to use and what details to include on each prescription.
Da bi se izognili napakam pri uporabi zdravila, bodo predpisovalci prejeli navodila, v katerih bo določeno, katero jakost in obliko uporabiti ter katere podatke navesti na posameznem receptu.
Glibenclamide's effect on the KATP channel restores the cells' ability to release insulin into the blood.
Učinek glibenklamida na kanalček KATP obnovi sposobnost celic za sproščanje insulina v kri.
− daily dose of Amglidia in ml,
− dnevni odmerek zdravila Amglidia v ml;
When prescribing the medicine, the doctor will also specify the strength of Amglidia and the correct size of the oral syringe to give this dose accurately.
Pri predpisovanju zdravila bo zdravnik določil tudi jakost zdravila Amglidia in pravilno velikost peroralne brizge za točno dajanje tega odmerka.
• Parents and carers should always use Amglidia as advised by the doctor.
• Starši in skrbniki naj zdravilo Amglidia vedno uporabljajo tako, kakor je priporočil zdravnik.
Healthcare professionals should also explain that the dose is to be given with the oral syringe graduated in ml, provided in the pack.
Zdravstveni delavci morajo tudi pojasniti, da je treba odmerek dati s priloženo peroralno brizgo, graduirano v ml.
• If the patient is switched to a different strength or a different oral syringe is appropriate, the prescriber should highlight to the parent or carer the packaging differences and carefully explain how to measure the new dose.
• Če je treba pri bolniku zamenjati jakost ali peroralno brizgo, mora predpisovalec starše ali skrbnika opozoriti na razliko v pakiranju in natančno razložiti, kako odmeriti novi odmerek.
− If the volume per dose is equal to or less than 1 ml, the 1-ml oral syringe should be prescribed;
− če je volumen na odmerek enak 1 ml ali manjši, je treba predpisati 1-mililitrsko peroralno brizgo;
Parents and carers should speak to a doctor or pharmacist if they have any questions about the treatment.
Če imajo starši in skrbniki kakršno koli vprašanje o zdravljenju, naj se o tem pogovorijo z zdravnikom ali farmacevtom.
− If the volume per dose is more than 1 ml, the 5-ml oral syringe should be prescribed.
− če je volumen na odmerek večji od 1 ml, je treba predpisati 5-mililitrsko peroralno brizgo.
− strength of Amglidia,
− jakost zdravila Amglidia;
It is important that only the syringe provided with the pack is used to measure Amglidia.
Pomembno je, da se za odmerjanje zdravila Amglidia uporablja samo priložena brizga.
Guide to be given to prescribers to ensure Amglidia is used correctly
Navodila za predpisovalce, da se zagotovi pravilna uporaba zdravila Amglidia
• Parents and carers will be advised by their healthcare professional on how to draw up the medicine into the oral syringe and give a dose to the child.
• Staršem in skrbnikom bo njihov zdravstveni delavec svetoval, kako povleči zdravilo v peroralno brizgo in dati odmerek otroku.
The active substance in Amglidia, glibenclamide, is a diabetes medicine that belongs to the class of sulfonylureas.
Učinkovina v zdravilu Amglidia, glibenklamid, je zdravilo za zdravljenje sladkorne bolezni, ki spada v skupino sulfonilsečnin.
• Healthcare professionals should explain to the parent or carer that the dose of Amglidia is prescribed in ml according to the patient's body weight.
• Zdravstveni delavci morajo staršem ali skrbniku razložiti, da je zdravilo Amglidia predpisano v mililitrih (ml), skladno z bolnikovo telesno maso.
It is a liquid to be given by mouth and is available in two strengths: 0.6 mg/ml and 6 mg/ml.
Gre za tekočino, ki se daje skozi usta in je na voljo v dveh jakostih: 0,6 mg/ml in 6 mg/ml.
Each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe (see picture below).
Vsaka jakost je na voljo v dveh oblikah: bodisi z 1-mililitrsko peroralno brizgo ali s 5-mililitrsko peroralno brizgo (glejte sliko spodaj).
• Amglidia is used to treat neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
• Zdravilo Amglidia se uporablja za zdravljenje neonatalnega diabetesa, oblike sladkorne bolezni, ki se pojavi v prvih šestih mesecih življenja.
• Pharmacists should ensure that the correct strength of Amglidia and the correct size of oral syringe are dispensed.
• Farmacevti morajo poskrbeti, da izdajo zdravilo Amglidia ustrezne jakosti in z ustrezno velikostjo peroralne brizge.
Amglidia is a diabetes medicine used for neonatal diabetes, a form of diabetes that occurs in the first 6 months of life and that requires treatment with insulin.
Zdravilo Amglidia je zdravilo, ki se uporablja za zdravljenje neonatalnega diabetesa, oblike sladkorne bolezni, ki se pojavi v prvih šestih mesecih življenja in zahteva zdravljenje z insulinom.
• Amglidia is an oral suspension available in two strengths: 0.6 mg/ml and 6 mg/ml.
• Zdravilo Amglidia je peroralna suspenzija, ki je na voljo v dveh jakostih: 0,6 mg/ml in 6 mg/ml.
Amglidia is a medicine used for the treatment of neonatal diabetes, a form of diabetes that occurs in the first 6 months of life.
Zdravilo Amglidia je zdravilo, ki se uporablja za zdravljenje neonatalnega diabetesa, tj. oblike sladkorne bolezni, ki se pojavi v prvih šestih mesecih življenja.
There are two presentations for each strength: one with an oral syringe of 1 ml and one with an oral syringe of 5 ml (see picture above).
Vsaka jakost je na voljo v dveh oblikah: z 1-mililitrsko peroralno brizgo in s 5-mililitrsko peroralno brizgo (glejte sliko zgoraj).
Amglidia is available as an oral suspension in two strengths: 0.6 mg/ml and 6 mg/ml, and each strength is available in two presentations: either with a 1-ml oral syringe or with a 5-ml oral syringe.The strength and the size of the oral syringe to be used depends on the dose prescribed.
Zdravilo Amglidia je na voljo v obliki peroralne suspenzije v dveh jakostih: 0,6 mg/ml in 6 mg/ml, vsaka jakost pa je na voljo v dveh oblikah: bodisi z 1-mililitrsko peroralno brizgo ali s 5-mililitrsko peroralno brizgo.
− volume in ml to be given for each dose,
− volumen posameznega odmerka v ml;
The dose is prescribed in millilitre (ml) according to body weight.
• Zdravilo Amglidia se daje dvakrat na dan. Odmerek se predpisuje v mililitrih (ml) glede na telesno maso.
Amglidia 6 mg/ml should be used for doses higher than 0.6 mg/kg daily.
Pri odmerkih, večjih od 0,6 mg/kg na dan, je treba uporabiti zdravilo Amglidia v jakosti 6 mg/ml.
• Amglidia 0.6 mg/ml strength should only be used for doses up to 0.6 mg/kg daily.
• Zdravilo Amglidia v jakosti 0,6 mg/ml se sme uporabljati samo za odmerke do 0,6 mg/kg na dan. S tem se omejuje izpostavljenost pomožni snovi natrijev benzoat.
• Only the oral syringe provided with the package should be used to measure the dose of Amglidia.
• Zdravilo Amglidia se sme odmerjati samo s priloženo peroralno brizgo.
• Parents and carers should use only the oral syringe provided with the package to measure the dose of Amglidia.
• Za odmerjanje zdravila Amglidia naj starši in skrbniki uporabljajo samo peroralno brizgo, ki je priložena zdravilu.
Date of first authorisation: 31st August 2018
Datum prve odobritve: 31. avgust 2018
In this population, efficacy has not been demonstrated.
Pri tej populaciji učinkovitost ni bila dokazana.
Do not use in children under 18 years of age.
Ne uporabljajte pri otrocih in mladostnikih, mlajših od 18 let.
(see Section 4.4).
(Glejte poglavje 4.4.)
Approximately 75% of patients were re-consented for extended follow-up beyond 24 months.
Približno 75 % bolnic je ponovno privolilo v razširjeno spremljanje po 24 mesecih.
- Take all the tablets with water, at about the same time each day, preferably in the morning.
- Vse tablete vzemite skupaj z vodo, približno ob istem času vsak dan, po možnosti zjutraj.
Talk to your doctor if:
Z zdravnikom se posvetujte, če:
• Any grade with complicated features†
• Vsaka stopnja s kompliciranimi značilnostmi†.
The course of treatment is one year.
Zdravljenje traja eno leto.
Effect of race
Učinek rase
- Take the tablets with food.
- Tablete vzemite skupaj s hrano.
There is no data in patients ≥85 years of age.
Ni podatkov o bolnikih, starih ≥ 85 let.
Take the medicine pack with you.
S seboj vzemite pakiranje zdravila.
Observations with missing data were censored at the last date of assessment.
Ugotovitve z manjkajočimi podatki so bile izključene zadnji dan ocenjevanja.
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt France
Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne-Billancourt Francija
The excretion was rapid and complete, with the majority of the radioactivity (61%) recovered within 96 hours and 98% recovered after 10 days.
Izločanje je bilo hitro in popolno, pri čemer je bila večina radioaktivnosti (61 %) odstranjena v 96 urah, 98 % pa v 10 dneh.
Median time from the last adjuvant trastuzumab treatment to randomization was 4.5 months.
Povprečen čas od zadnjega adjuvantnega zdravljenja s trastuzumabom do randomizacije je znašal 4,5 meseca.
- you are having diarrhoea that does not go away - they can advise how to control your diarrhoea.
- imate drisko, ki ne izgine - lahko vam svetuje, kako jo nadzorovati;
You must also have previously been treated with trastuzumab.
Prav tako mora za vas veljati, da ste se že zdravili s trastuzumabom.
No fertility studies in women or men have been conducted.
Študij plodnosti pri ženskah ali moških niso izvedli.
In the event of an overdose, administration should be withheld and general supportive measures undertaken.
Pri prevelikem odmerjanju je treba dajanje odložiti in izvesti splošne podporne ukrepe.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „EXP“.
While the treatment benefit of Nerlynx over placebo was maintained at five years, the effect size cannot be reliably estimated.
Čeprav je bila korist zdravila Nerlynx v primerjavi s placebom po petih letih ohranjena, obsega učinka ni mogoče zanesljivo oceniti.
Patients should initiate treatment within 1 year after completion of trastuzumab therapy.
Bolniki morajo zdravljenje začeti v enem letu po zaključku zdravljenja s trastuzumabom.
Tests and checks for liver problems
Testi in pregledi za odkrivanje težav z jetri
Clinical studies with BCRP substrates have not been conducted.
Kliničnih študij s substrati za BCRP niso izvedli.
The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of breast carcinoma.
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za vse podskupine pediatrične populacije za zdravljenje raka dojke.
Nerlynx with food and drink
Zdravilo Nerlynx skupaj s hrano in pijačo
The primary endpoint of the study was invasive disease-free survival (iDFS).
Primarni cilj študije je bilo preživetje brez invazivne bolezni (iDFS).
This helps to stop the cells from dividing and growing.
S tem pripomore k zaustavitvi delitve in rasti celic.
>=4 Positive Nodes
>= 4 pozitivne bezgavke
Nerlynx has minor or moderate influence on the ability to drive and use machines.
Zdravilo Nerlynx ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
It helps control how a healthy breast cell grows.
Pomaga nadzorovati rast zdravih celic dojk.