FrancophonIA/ELRC3.0 huggingface dataset:
English: Two of the studies compared Ambirix with other vaccines against hepatitis A and B. The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.
Slovenian: V dveh študijah so zdravilo Ambirix primerjali z drugimi cepivi proti hepatitisu A in B. Glavno merilo učinkovitosti je bil delež cepljenih otrok, katerih število protiteles je bilo en mesec po zadnjem injiciranju dovolj veliko za ustrezno zaščito.
English: The additional study showed that the levels of protection with Ambirix were similar with a six- and a 12-month gap between injections.
Slovenian: Dodatna študija je pokazala, da so bile ravni zaščite s cepivom Ambirix podobne pri šestmesečnem in dvanajstmesečnem intervalu med obema odmerkoma.
English: For the full list of all side effects reported with Ambirix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ambirix, glejte navodilo za uporabo.
English: Individuals who receive the first injection should complete the course with Ambirix.
Slovenian: Osebe, ki prejmejo prvo injekcijo cepiva Ambirix, morajo dokončati postopek cepljenja s prejemom druge injekcije tega cepiva.
English: Ambirix is given as two injections six to 12 months apart into the muscle of the upper arm, or into the thigh in very young children.
Slovenian: Zdravilo Ambirix se daje z dvema injekcijama, med katerima mora biti šest- do dvanajstmesečni interval, in sicer v mišico nadlakti, pri zelo majhnih otrocih pa je možno tudi injiciranje v stegno.
English: Ambirix is a vaccine that contains inactivated (killed) hepatitis A virus and parts of the hepatitis B virus as active substances.
Slovenian: Ambirix je cepivo, ki kot zdravilno učinkovino vsebuje inaktivirani (uničeni) virus hepatitisa A in dele virusa hepatitisa B. Na voljo je v obliki suspenzije za injiciranje.
English: Ambirix is used as a two-dose schedule and protection against hepatitis B may not be obtained until after the second dose.
Slovenian: Shema cepljenja s cepivom Ambirix je sestavljena iz dveh odmerkov, pri čemer se zaščita proti virusu hepatitisa B zna pojaviti šele po prejemu drugega odmerka.
English: Why has Ambirix been approved?
Slovenian: Zakaj je bilo zdravilo Ambirix odobreno?
English: Where a booster dose of hepatitis A or B is desired, Ambirix, or a separate hepatitis A or B vaccine may be given.
Slovenian: Če je zaželen obnovitveni odmerek cepiva proti hepatitisu A ali B, lahko zdravnik injicira bodisi cepivo Ambirix ali pa ločeno cepivo proti hepatitisu A oziroma hepatitisu B.
English: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Slovenian: Ambirix cepivo proti hepatitisu A, inaktivirano, in hepatitisu B, rekombinantno (HAB), adsorbirano
English: How has Ambirix been studied?
Slovenian: Kako je bilo zdravilo Ambirix raziskano?
English: Ambirix was as effective as other vaccines against hepatitis A and B once the full vaccination course had been completed.
Slovenian: Po končanem celotnem postopku cepljenja je bilo cepivo Ambirix proti hepatitisu A in B enako učinkovito kot druga cepiva.
English: How is Ambirix used?
Slovenian: Kako se zdravilo Ambirix uporablja?
English: How does Ambirix work?
Slovenian: Kako zdravilo Ambirix deluje?
English: What is Ambirix used for?
Slovenian: Za kaj se zdravilo Ambirix uporablja?
English: When a child is given the vaccine, the immune system recognises the viruses and surface antigens as ‘foreign' and makes antibodies against them., The immune system will then be able to make antibodies more quickly when exposed to the viruses again.
Slovenian: Imunski sistem bo tako ob ponovni izpostavitvi virusom sposoben hitreje tvoriti protitelesa.
English: Ambirix contains small amounts of inactivated hepatitis A viruses and the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Slovenian: Cepivo Ambirix vsebuje majhno količino inaktiviranih virusov hepatitisa A in „površinski antigen” (beljakovine s površine) virusa hepatitisa B. Ko otrok prejme cepivo, imunski sistem prepozna viruse in površinske antigene kot tuje in začne proti njim tvoriti protitelesa.
English: What is Ambirix?
Slovenian: Kaj je zdravilo Ambirix?
English: 1 In the context of a referral procedure under Article 31 of Directive 2001/83/EC.
Slovenian: 1 V okviru napotitvenega postopka v skladu s členom 31 Direktive 2001/83/ES.
English: The average dose used was 600 to 800 mg per day.
Slovenian: Povprečni uporabljeni odmerek je bil od 600 do 800 mg na dan.
English: The patient's liver function should also be checked weekly for one month when the dose is increased.
Slovenian: Delovanje jeter pri bolniku je treba prav tako preverjati enkrat tedensko en mesec, kadar se poveča odmerek.
English: The most serious side effects are liver problems which can be detected early through regular monitoring.
Slovenian: Najresnejši neželeni učinki so težave z jetri, ki jih je z rednim spremljanjem mogoče odkriti zgodaj.
English: The usual treatment dose is between 400 mg and 1,200 mg per day taken in two or three divided doses.
Slovenian: Običajni odmerek zdravila je med 400 mg in 1 200 mg na dan, vzeti pa ga je treba v dveh ali treh ločenih odmerkih.
English: Regarding its safety the CHMP considered that the risk of liver problems can be managed through appropriate measures.
Slovenian: Kar zadeva varnost zdravila, je CHMP menil, da je tveganje težav z jetri mogoče obvladati z ustreznimi ukrepi.
English: Ketoconazole treatment was shown to normalise urine cortisol levels in 43 to 80% of patients.
Slovenian: Pokazano je bilo, da zdravljenje s ketokonazolom normalizira raven kortizola pri 43 do 80 % bolnikov.
English: It must also not be used in pregnant or breastfeeding women or patients who have QTc prolongation (disruption of the electrical activity of the heart).
Slovenian: Prav tako se ne sme uporabljati pri nosečnicah, doječih materah in bolnikih s podaljšanim intervalom QTc (motnjo električne aktivnosti srca).
English: The dose is adjusted according to the levels of cortisol in the body, which is measured by regular checks of the urine or blood.
Slovenian: Odmerek zdravila je treba prilagajati glede na raven kortizola v telesu, ki se meri z rednimi pregledi urina ali krvi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ketoconazole HRA on 19 November 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ketokonazol HRA, veljavno po vsej Evropski uniji, izdala 19. novembra 2014.
English: The main measure of effectiveness in these literature studies was the level of cortisol in the urine.
Slovenian: V teh študijah, objavljenih v literaturi, je bila glavno merilo učinkovitosti raven kortizola v urinu.
English: Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease.
Slovenian: Zaviranje tvorbe kortizola pomaga pri zmanjševanju ravni kortizola v telesu in tako lajša simptome bolezni.
English: If liver enzyme levels in the blood increase beyond three times the normal maximum (a sign of possible liver problems) or in case of symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain (stomach ache) or dark urine that may suggest a liver problem, treatment must be stopped.
Slovenian: V primeru povečanja vrednosti jetrnih encimov, večjega od trikratne zgornje meje normalnih vrednosti (znak morebitnih težav z jetri), ali v primeru pojave simptomov, kot so pomanjkanje teka, slabost, bruhanje, utrujenost, zlatenica, bolečina v trebuhu ali temen urin, ki lahko nakazujejo težave z jetri, je treba zdravljenje prekiniti.
English: However, oral formulations (used by mouth) for the treatment of fungal infections were suspended in July 2013 because of the risk of liver injury.1
Slovenian: Dovoljenje za peroralne farmacevtske oblike zdravila (za vnos skozi usta) za zdravljenje glivičnih okužb pa je bilo julija 2013 zaradi tveganja okvare jeter začasno umaknjeno.1
English: In addition the CHMP considered that additional treatment options are needed for this rare disease.
Slovenian: Poleg tega je menil, da so za to redko bolezen potrebne druge možnosti zdravljenja.
English: The company will also set up a registry of patients treated with Ketoconazole HRA in order to monitor the safety and effectiveness of the medicine.
Slovenian: Družba bo prav tako vzpostavila register bolnikov, zdravljenih z zdravilom Ketokonazol HRA, da bi spremljala varnost in učinkovitost zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ketoconazole HRA's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ketokonazol HRA večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Ketoconazole HRA.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ketokonazol HRA.
English: What measures are being taken to ensure the safe and effective use of Ketoconazole HRA?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ketokonazol HRA?
English: ketoconazole
Slovenian: ketokonazol
English: Ketoconazole HRA is available as tablets (200 mg).
Slovenian: Ketokonazol HRA je na voljo v obliki tablet (200 mg).
English: Because ketoconazole is a well-known substance, and its use in Cushing's syndrome is well established, the applicant presented data from the published literature on more than 800 patients with Cushing's syndrome who were treated with ketoconazole either alone or in combination with other treatments.
Slovenian: Ker je ketokonazol dobro znana učinkovina, njena uporaba za zdravljenje Cushingovega sindroma pa uveljavljena, je predlagatelj predložil podatke iz objavljene literature o več kot 800 bolnikih s Cushingovim sindromom, ki so se zdravili s ketokonazolom, in sicer bodisi samo z njim ali v kombinaciji z drugimi zdravili.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Ketokonazol HRA je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Ketoconazole blocks the activity of a group of enzymes in the adrenal glands involved in the production of cortisol, such as 17 alpha-hydroxylase or 11β-hydroxylase.
Slovenian: Ketokonazol zavira dejavnost skupine encimov v nadledvičnih žlezah, ki sodelujejo pri nastajanju kortizola, kot sta 17α-hidroksilaza in 11β-hidroksilaza.
English: Because the number of patients with Cushing's syndrome is low, the disease is considered ‘rare', and Ketoconazole HRA was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 April 2012.
Slovenian: Ker je bolnikov s Cushingovim sindromom malo, velja ta bolezen za redko, zato je bilo 23. aprila 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The CHMP considered that the use of Ketoconazole HRA to treat Cushing's syndrome was well established in medical practice and documented in the scientific literature.
Slovenian: CHMP je menil, da je uporaba zdravila Ketokonazol HRA za zdravljenje Cushingovega sindroma ustaljena v klinični praksi in dokumentirana v znanstveni literaturi.
English: The most common side effects with Ketoconazole HRA are adrenal insufficiency (too low a level of the hormones produced by the adrenal gland), nausea (feeling sick), vomiting, abdominal pain (stomach ache), diarrhoea, pruritus (itching), rash and increase in blood levels of liver enzymes.
Slovenian: Najpogostejši neželeni učinki zdravila Ketokonazol HRA so adrenalna insuficienca (prenizka raven hormonov, ki jih tvorijo nadledvične žleze), navzeja (slabost), bruhanje, bolečina v trebuhu, driska, srbenje, izpuščaj in povečanje ravni jetrnih encimov v krvi.
English: Ketoconazole HRA must not be used in patients with liver disease or whose blood levels of liver enzymes are above a certain level.
Slovenian: Zdravilo Ketokonazol HRA se ne sme uporabljati pri bolnikih z jetrno boleznijo ali bolnikih, katerih raven jetrnih encimov v krvi presega določeno raven.
English: It can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in treating patients with Cushing syndrome who has access to appropriate facilities to assess the patient's response.
Slovenian: Izdaja zdravila je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem Cushingovega sindroma, ki ima na voljo ustrezno opremo za spremljanje bolnikovega odziva.
English: A risk management plan has been developed to ensure that Ketoconazole HRA is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ketokonazol HRA je bil pripravljen načrt obvladovanja tveganj.
English: Ketoconazole HRA must also not be used together with certain medicines that may increase the risk of serious side effects.
Slovenian: Zdravilo Ketokonazol HRA se ne sme uporabljati skupaj z določenimi zdravili, ki lahko povečajo tveganje resnih neželenih učinkov.
English: The active substance in Ketoconazole HRA, ketoconazole, is a well known substance that has been authorised for several decades for the treatment of fungal infections.
Slovenian: Zdravilna učinkovina v zdravilu Ketokonazol HRA, ketokonazol, je dobro znana učinkovina, ki je že več desetletij odobrena za zdravljenje glivičnih okužb.
English: The full EPAR and risk management plan summary for Ketoconazole HRA can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ketokonazol HRA sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ketoconazole can still be found in topical medicines (medicines applied to the skin) to treat fungal infections.
Slovenian: Ketokonazol se še vedno uporablja v zdravilih za lokalno uporabo (zdravilih, ki se nanašajo na kožo) za zdravljenje glivičnih okužb.
English: Ketoconazole HRA is a medicine used to treat adults and children above the age of 12 years with Cushing's syndrome.
Slovenian: Ketokonazol HRA je zdravilo, ki se uporablja za zdravljenje odraslih in mladostnikov, starejših od 12 let, s Cushingovim sindromom.
English: For the full list of all side effects and restrictions with Ketoconazole HRA, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri zdravilu Ketokonazol HRA glejte navodilo za uporabo.
English: For more information about treatment with Ketoconazole HRA, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ketokonazol HRA preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The company that makes Ketoconazole HRA will also provide doctors who will use Ketoconazole HRA with a letter containing information regarding the risks of side effects, particularly of liver injury, and how to use the medicine properly.
Slovenian: Družba, ki izdeluje zdravilo Ketokonazol HRA, bo zdravnikom, ki ga bodo uporabljali, zagotovila tudi dopis z informacijami o tveganjih neželenih učinkov, zlasti okvare jeter, in o pravilni uporabi zdravila.
English: Ketoconazole can also block the production of other hormones produced by the adrenal gland which are often raised in Cushing's syndrome.
Slovenian: Ketokonazol lahko zavira tudi tvorbo drugih hormonov, ki jih proizvajajo nadledvične žleze in katerih raven je pri Cushingovem sindromu pogosto povečana.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ketoconazole HRA, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Ketokonazol HRA in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: What are the risks associated with Ketoconazole HRA?
Slovenian: Kakšna tveganja so povezana z zdravilom Ketokonazol HRA?
English: Ketoconazole HRA
Slovenian: Ketokonazol HRA
English: What benefits of Ketoconazole HRA have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ketokonazol HRA izkazalo v študijah?
English: What is Ketoconazole HRA and what is it used for?
Slovenian: Kaj je zdravilo Ketokonazol HRA in za kaj se uporablja?
English: For practical information about using Ketoconazole HRA, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ketokonazol HRA naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Slovenian: Cushingov sindrom je bolezen, pri kateri nadledvične žleze (dve žlezi, ki se nahajata nad ledvicami) tvorita prekomerne količine hormona kortizola.
English: The active substance in Ketoconazole HRA is ketoconazole.
Slovenian: Zdravilna učinkovina v zdravilu Ketokonazol HRA je ketokonazol.
English: The patient's liver function should be checked with blood tests before treatment is started and regularly for the following 6 months.
Slovenian: Pred uvedbo zdravljenja in nato redno naslednjih 6 mesecev je treba s preiskavami krvi preverjati delovanje jeter pri bolniku.
English: Other information about Ketoconazole HRA
Slovenian: Druge informacije o zdravilu Ketokonazol HRA
English: Why is Ketoconazole HRA approved?
Slovenian: Zakaj je bilo zdravilo Ketokonazol HRA odobreno?
English: It is not intended to provide practical advice on how to use Ketoconazole HRA.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How is Ketoconazole HRA used?
Slovenian: Kako se zdravilo Ketokonazol HRA uporablja?
English: How does Ketoconazole HRA work?
Slovenian: Kako zdravilo Ketokonazol HRA deluje?
English: The cough may last for 1-2 months or longer.
Slovenian: Kašelj lahko traja 1-2 meseca ali dlje.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Slovenian: • POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
English: The incidences are presented below:
Slovenian: Incidenca je prikazana spodaj:
English: Vaccination is the best way to protect against these diseases.
Slovenian: Cepljenje je najboljši način za zaščito pred temi boleznimi.
English: If not, your child may not be fully protected against the diseases.
Slovenian: V nasprotnem primeru je možno, da vaš otrok ni popolnoma zaščiten pred boleznimi.
English: Frequencies are defined as follows:
Slovenian: Pogostnost je definirana kot:
English: N° of symptom checklists Local symptoms (%)
Slovenian: Število zabeleženih simptomov Lokalni simptomi (%)
English: Temperature of ≥ 40.0 C within 48 hours, not due to another identifiable cause.
Slovenian: Temperatura ≥ 40,0 ºC v 48 urah, ki ni bila posledica drugega ugotovljenega vzroka.
English: None of the components in the vaccine are infectious.
Slovenian: Nobena izmed komponent v cepivu ni kužna.
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA)
English: This does not constitute a sign of
Slovenian: To ni znak kvarjenja.
English: Date of latest renewal: 19 July 2006.
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet:19. julij 2006
English: Persistent crying lasting ≥ 3 hours, occurring within 48 hours.
Slovenian: Vztrajno jokanje, ki je trajalo ≥ 3 ure in se je pojavilo v 48 urah.
English: Such reactions may occur before leaving the doctor's surgery.
Slovenian: Te reakcije se lahko pojavijo še preden zapustite ambulanto.
English: * reported by the parents as adversely affecting the child's daily activities For both vaccination groups, the majority of the reactions were short lasting.
Slovenian: *poročila staršev o vplivu na dnevno aktivnost otroka Pri obeh skupinah je bila večina reakcij po cepljenju kratkotrajnih.
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Slovenian: Vrednotenja farmakokinetičnih lastnosti predpisi pri cepivih ne zahtevajo.
English: B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU
English: If your child misses a scheduled injection, talk to your doctor and arrange another visit.
Slovenian: Če vaš otrok ni prejel po shemi načrtovanega odmerka, se pogovorite z zdravnikom in dogovorite za drug obisk.
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Slovenian: Možne so določene okoliščine, na primer visoka incidenca oslovskega kašlja, ko potencialne koristi prevladajo nad možnim tveganjem.
English: Extensive tests have demonstrated that these particles display the characteristic properties of the natural HBsAg.
Slovenian: Obširne raziskave so pokazale, da ti delci kažejo značilne lastnosti naravnega HBsAg.
English: 2-4-6 months; 3-4-5 months and 3-4½-6 months
Slovenian: 6-10-14 tednov 2-4-6 mesecev; 3-4-5 mesecev in 3-4½-6 mesecev
English: • if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
Slovenian: • če ima vaš otrok nediagnosticirano ali napredujočo bolezen možganov ali neurejeno epilepsijo.
English: Please tell your doctor if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Slovenian: Obvestite svojega zdravnika, če vaš otrok jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section
Slovenian: Cepiva ne smemo mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
English: • if your child has a severe infection with a high temperature (over 38°C).
Slovenian: • če ima hudo okužbo z visoko vročino (nad 38 ºC).
English: not less than 30 IU not less than 60 IU not less than 4 IU 10 micrograms
Slovenian: ne manj kot 30 i.e. ne manj kot 60 i.e.
English: Upon storage, a white deposit and clear supernatant can be observed.
Slovenian: Med shranjevanjem se lahko pojavita bela usedlina in bister supernatant.
English: When using a multidose vial, each dose should be taken with a sterile needle and syringe.
Slovenian: Pri uporabi večodmerne viale morate vsak odmerek odvzeti s sterilno injekcijsko iglo in brizgo.