FrancophonIA/ELRC3.0 huggingface dataset:
English: They all work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Slovenian: Učinkovine podobno zavirajo delovanje reverzne transkriptaze, tj. encima, ki ga tvori virus HIV, da lahko okuži celice ter tvori še več virusov.
English: All three active substances in Trizivir, abacavir, lamivudine, and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Slovenian: Vse tri zdravilne učinkovine v zdravilu Trivizir, abakavir, lamivudin in zidovudin, so nukleozidni zaviralci reverzne transkriptaze (NRTI-ji).
English: For the full list of all side effects reported with Trizivir, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Trizivir, glejte navodilo za uporabo.
English: Why has Trizivir been approved?
Slovenian: Zakaj je bilo zdravilo Trizivir odobreno?
English: What is Trizivir used for?
Slovenian: Za kaj se zdravilo Trizivir uporablja?
English: How has Trizivir been studied?
Slovenian: Kako je bilo zdravilo Trizivir raziskano?
English: How is Trizivir used?
Slovenian: Kako se zdravilo Trizivir uporablja?
English: What is Trizivir?
Slovenian: Kaj je zdravilo Trizivir?
English: Treatment with Trizivir should be stopped promptly if the patient has a hypersensitivity reaction.
Slovenian: Če se pri bolniku pojavijo preobčutljivostne reakcije, je treba zdravljenje z zdravilom Trizivir takoje prekiniti.
English: Repeatability was 97%.
Slovenian: Ponovljivost je bila 97-odstotna.
English: If this happens, do not drive or use machines.
Slovenian: Če se to zgodi, ne vozite in upravljajte strojev.
English: In the event of an overdose, symptomatic and supportive measures should be employed.
Slovenian: V primeru prevelikega odmerjanja moramo uvesti simptomatske in podporne ukrepe.
English: During the test, the patient needs to stay fasted until the end of the blood sampling.
Slovenian: Med preiskavo mora bolnik ostati tešč do konca vzorčenja krvi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1337/001
Slovenian: ŠTEVILKA(ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1337/001
English: You need to stop such treatment at least 1 month before the test.
Slovenian: Takšno zdravljenje morate prekiniti vsaj 1 mesec pred preiskavo.
English: For oral use after reconstitution.
Slovenian: Za peroralno uporabo po rekonstituciji.
English: Step 5 Have the patient drink the entire content of the drinking glass within 30 seconds.
Slovenian: 5. korak Bolnik naj popije celotno vsebino kozarca v 30 sekundah.
English: It is unknown whether such potential interactions may also affect QTc (see above).
Slovenian: Ni znano, ali lahko takšne potencialne interakcije vplivajo tudi na interval QTc (glejte zgoraj).
English: It is unknown whether this may affect QTc.
Slovenian: Ni znano, ali lahko to vpliva na interval QTc.
English: Stir the suspension gently for 2 minutes (a small amount of undissolved particles will remain giving a slightly turbid suspension).
Slovenian: Nežno mešajte suspenzijo 2 minuti (zaradi majhne količine neraztopljenih delcev bo suspenzija vedno rahlo motna).
English: Transfer the measured amount to a drinking glass.
Slovenian: Izmerjeno količino prenesite v kozarec.
English: Read all of this leaflet carefully before you take this medicine because it contains important information for you.
Slovenian: Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: It is used when your doctor thinks that you may not have enough growth hormone (adult growth hormone deficiency).
Slovenian: Uporablja se, če vaš zdravnik meni, da morda nimate dovolj rastnega hormona (pomanjkanje rastnega hormona pri odraslih).
English: If you are a woman able to have children, you must use effective contraceptive methods to ensure you are not pregnant at the time of the test.
Slovenian: Če ste ženska v rodni dobi, morate uporabljati učinkovite kontracepcijske metode, da zagotovite, da v času preiskave ne zanosite.
English: In case a patient should be reporting dizziness as side effect, the patient should be instructed to neither drive nor use machines.
Slovenian: Če bolnik poroča o omotici kot neželenem učinku, mu je treba naročiti, naj ne vozi ali upravlja strojev.
English: If occurring, such changes would be timely limited and not last long.
Slovenian: Če se takšne spremembe pojavijo, so kratkotrajne.
English: Results
Slovenian: Rezultati
English: The median age was 41 years (range: 18 - 66 years) and body mass index 27.5 kg/m2 (range: 16 - 40 kg/m2).
Slovenian: Mediana starosti je bila 41 let (razpon: 18-66 let), indeksa telesne mase pa 27,5 kg/m2 (razpon: 16-40 kg/m2).
English: The suspension should be stirred again, when some particles settle at the bottom of the container for example after the suspension is left standing for some time.
Slovenian: Suspenzijo morate premešati še enkrat, ko se delci usedejo na dno posode, na primer ko suspenzijo pustite stati nekaj časa.
English: In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point.
Slovenian: V starostni skupini od 60 do 65 let omejeni razpoložljivi podatki ne kažejo potrebe po specifični mejni vrednosti za preiskavo.
English: Reconstituted suspension
Slovenian: Rekonstituirana suspenzija
English: The mechanism for the observed QTcF prolongation is unknown.
Slovenian: Mehanizem opaženega podaljšanja intervala QTcF ni znan.
English: Store in the original package, in order to protect from light and moisture.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: Preclinical data from safety pharmacology, repeated dose toxicity and genotoxicity studies reveal no specific hazard for humans.
Slovenian: Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Pharmacotherapeutic group: Diagnostic agents, Tests for pituitary function, ATC code: V04CD06
Slovenian: Farmakoterapevtska skupina: diagnostiki, testi za ugotavljanje hipofiznega delovanja, oznaka ATC: V04CD06
English: This is not a treatment for patients who do not have enough growth hormone.
Slovenian: Ne uporablja se za zdravljenje bolnikov, ki nimajo dovolj rastnega hormona.
English: • Physical exercise - avoid strenuous physical activity 24 hours before the test.
Slovenian: • Telesna vadba - 24 ur pred preiskavo se izogibajte naporni telesni dejavnosti.
English: There are no data available on animal (see section 5.3) or human male and female fertility.
Slovenian: Ni podatkov iz poskusov na živalih (glejte poglavje 5.3) ali glede plodnosti pri moških in ženskah.
English: Tell your doctor if you are taking medicines that can alter your heart rhythm, such as:
Slovenian: Obvestite zdravnika, če jemljete zdravila, ki lahko spremenijo srčni ritem, kot so:
English: The shelf life of a sachet is 4 years.
Slovenian: Neodprta vrečica Rok uporabnosti vrečice je 4 leta.
English: Based on current understanding, this is unlikely to decrease the specificity of the test.
Slovenian: Na podlagi trenutnega razumevanja je malo verjetno, da bi to zmanjšalo specifičnost testa.
English: Any suspension that remains must not be stored and must be discarded.
Slovenian: Dela suspenzije, ki ostane, ne smete shraniti,
English: Only limited pharmacokinetic data are available in the elderly.
Slovenian: Pri starejših bolnikih je na voljo malo farmakokinetičnih podatkov.
English: All three dose levels studied showed a similar magnitude of QTcF prolongation in the Thorough QT study, suggesting an absence of dose dependent changes.
Slovenian: Vse tri ravni odmerka so pokazale podobno podaljšanje intervala QTcF v temeljiti študiji QT, kar kaže na odsotnost sprememb, odvisnih od odmerka.
English: Potential for false negative test results in recent onset hypothalamic disease
Slovenian: Možnost lažno pozitivnih rezultatov testa pri nedavnem pojavu hipotalamične bolezni
English: No specific recommendations after overdose are given.
Slovenian: Posebnih priporočil za primer prevelikega odmerjanja ni.
English: No studies to assess carcinogenicity and effects on reproduction and development have been conducted.
Slovenian: Študije za oceno kancerogenega potenciala ter vpliva na sposobnost razmnoževanja in razvoja niso bile izvedene.
English: • any other medicines that can prolong the QT interval or inducing torsades de pointes
Slovenian: • katera koli druga zdravila, ki lahko podaljšajo interval QT ali povzročijo torsades de pointes.
English: SPECIAL STORAGE CONDITIONS Reconstituted suspension:
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Rekonstituirana suspenzija:
English: Each cardboard box contains 1 sachet.
Slovenian: Ena kartonska škatla vsebuje 1 vrečico.
English: • The active substance is macimorelin.
Slovenian: • Učinkovina je macimorelin.
English: Growth hormone secretion normally decreases with age.
Slovenian: Izločanje rastnega hormona se običajno zmanjšuje s starostjo.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should take this medicinal product only if the expected benefit of the test clearly outweighs the potential risk associated with an intake of maximum 1,691.8 mg lactose per sachet.
Slovenian: Bolniki z redko dedno intoleranco za galaktozo, popolnim pomanjkanjem laktaze ali malabsorpcijo glukoze-galaktoze lahko uporabijo to zdravilo samo, če pričakovana korist preiskave jasno odtehta morebitno tveganje, povezano z vnosom do 1.691,8 mg laktoze na vrečico.
English: Macimorelin was eliminated with a mean terminal half-life (T1/2) of 4.1 hours.
Slovenian: Macimorelin se izloča s povprečno končno razpolovno dobo (T1/2) 4,1 ure.
English: A decision must be made whether to discontinue breast-feeding or to abstain from macimorelin, taking into account the benefit of breast-feeding for the child and the benefit of the test for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja ali opustitvijo uporabe macimorelina, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti preiskave za mater.
English: These side effects are mostly mild, do not last long, and usually go away quickly without treatment.
Slovenian: Ti neželeni učinki so večinoma blagi in kratkotrajni ter običajno hitro izzvenijo brez zdravljenja.
English: Four groups of individuals were evaluated: three groups of adult patients with different pre-test probability of growth hormone deficiency (Group A (high likelihood), Group B (intermediate likelihood), Group C (low likelihood) and healthy control subjects (Group D)).
Slovenian: Ovrednotili so štiri skupine preiskovancev: tri skupine odraslih bolnikov z različnimi verjetnostmi pomanjkanja rastnega hormona pred testiranjem (skupina A (velika verjetnost), skupina B (vmesna verjetnost), skupina C (majhna verjetnost) in zdrave kontrolne preiskovance (skupina D)).
English: The suspension should be stirred until it is slightly turbid without particles at the bottom of the container.
Slovenian: Suspenzijo morate mešati, dokler ni rahlo motna, na dnu pa ni delcev.
English: Reconstituted suspension:
Slovenian: Rekonstituirana suspenzija:
English: You have to drink the complete test dose within 30 seconds.
Slovenian: Celotni odmerek za preiskavo morate spiti v 30 sekundah.
English: Prepare plasma or serum samples and send to a laboratory for growth hormone determination.
Slovenian: Vzorce plazme ali seruma pripravite in jih pošljite v laboratorij za določanje rastnega hormona.
English: The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2.
Slovenian: Varnost in diagnostična uspešnost macimorelina nista bili dokazani pri bolnikih z ITM > 40 kg/m2.
English: Measure the required volume using a 50 mL graduated syringe without a needle.
Slovenian: Izmerite zahtevani volumen s 50-ml graduirano brizgo brez igle.
English: The description in this leaflet is for your information on the testing procedure.
Slovenian: Opis v tem navodilu je namenjen vam, da se seznanite s potekom preiskave.
English: Plasma protein binding decreases with increasing concentrations from 78% at 0.1 µM to 62% at 10 µM.
Slovenian: Vezava na beljakovine v plazmi upada pri višjih koncentracijah, pri čemer je 78-odstotna pri 0,1 μM in 62-odstotna pri 10 μM.
English: The pharmacodynamics of macimorelin was not sufficiently evaluated in the elderly population aged > 65 years.
Slovenian: Farmakodinamika macimorelina ni bila dovolj ovrednotena pri osebah, starih > 65 let.
English: As with all GH stimulation tests, also the macimorelin test results should always be interpreted on basis of the outcome of all examinations within the diagnostic work-up for a patient.
Slovenian: Kot pri vseh preiskavah stimulacije rastnega hormona moramo rezultate preiskave z macimorelinom vedno razlagati z upoštevanjem rezultatov vseh preiskav v okviru diagnostične obravnave bolnika.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per sachet that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vrečico, kar pomeni, da je v bistvu „brez natrija“.
English: No drug-drug interaction studies have been performed in humans.
Slovenian: Študij medsebojnega delovanja med zdravili pri ljudeh niso izvedli.
English: One hundred and fifty-seven (157) subjects underwent at least one of the two tests in this study, 59% were male, 41% female and 86% of white origin.
Slovenian: Od 157 preiskovancev, ki so v tej študiji opravili vsaj eno od preiskav, je bilo 59 % moških, 41 % žensk in 86 % belcev.
English: It is a test that helps your doctor to diagnose this condition.
Slovenian: Uporablja se za preiskavo, ki zdravniku pomaga diagnosticirati omenjeno bolezen.
English: There are no data for the use of macimorelin in pregnant women.
Slovenian: Podatkov o uporabi macimorelina pri nosečnicah ni.
English: Any remaining suspension must be discarded by your doctor or nurse according to local regulations.
Slovenian: Morebitni ostanek suspenzije mora zdravnik ali medicinska sestra zavreči v skladu z lokalnimi predpisi.
English: If either of these conditions is not met, the growth hormone stimulation test must be re-scheduled for a new test day.
Slovenian: Če kateri koli od teh pogojev ni izpolnjen, je treba preiskavo stimulacije rastnega hormona odložiti.
English: Sufficient washout time (five elimination half-lives) of medicinal products prior to administration of macimorelin is recommended.
Slovenian: Priporočljivo je dovolj dolgo obdobje izpiranja (pet razpolovnih dob izločanja) zdravil pred dajanjem macimorelina.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before this medicine is given to you.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: • Fasting - you must not eat for at least 8 hours before the test, and during the test.
Slovenian: • Teščost - vsaj 8 ur pred preiskavo in med njo ne smete jesti.
English: Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need.
Slovenian: Na splošno so poročali o neželenih učinkih, ki so bili večinoma blagi in kratkotrajni brez posebne potrebe po zdravljenju.
English: One LDPE/Alu/LDPE/paper sachet containing 1,817 mg granules placed in cardboard box.
Slovenian: Ena vrečica iz LDPE/Al/LDPE/papirja, ki vsebuje 1.817 mg zrnc, pakirana v kartonski škatli.
English: Add required volume of water in a graduated glass or transparent plastic container.
Slovenian: Nalijte zahtevano količino vode v graduirano stekleno ali prozorno plastično posodo.
English: To ensure that the test results are reliable, you need to follow the rules below:
Slovenian: Upoštevajte naslednja pravila, da zagotovite zanesljive rezultate preiskave:
English: During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions.
Slovenian: Med kliničnim razvojem so pri enem preiskovancu opazili dve prehodni nepravilnosti na EKG in ju poročali kot resna morebitna neželena učinka.
English: If you are breast-feeding or intend to breast-feed, a risk to the suckling child cannot be excluded.
Slovenian: Če dojite ali nameravate dojiti, tveganja za dojenega otroka ni mogoče izključiti.
English: • cystic fibrosis (lumacaftor)
Slovenian: • cistične fibroze (lumakaftor);
English: Paediatric population The safety and efficacy of macimorelin in children and adolescents below 18 years have not yet been established (see also section 5.2).
Slovenian: Pediatrična populacija Varnost in učinkovitost macimorelina pri otrocih ter mladostnikih, starih do 18 let, še nista bili dokazani (glejte poglavje 5.2).
English: No studies have been conducted to evaluate the pharmacokinetics of macimorelin in paediatric patients or in patients with renal or hepatic impairment.
Slovenian: Študije za oceno farmakokinetike macimorelina pri pediatričnih bolnikih ali pri bolnikih z okvaro ledvic ali jeter niso bile izvedene.
English: Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.
Slovenian: Rekonstituirano suspenzijo damo peroralno bolnikom, ki so vsaj 8 ur tešči in ki niso izvajali napornih telesnih vaj 24 ur pred preiskavo, saj lahko oboje vpliva na raven rastnega hormona.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Women of childbearing potential must use adequate contraceptive methods at the time when macimorelin will be administered.
Slovenian: Ženske v rodni dobi morajo v času dajanja macimorelina uporabljati ustrezne kontracepcijske metode.
English: In such a situation, a repetition of the test may be required.
Slovenian: V takšnem primeru bo morda treba preiskavo ponoviti.
English: Growth hormone medicinal products should be discontinued at least 1 month before administering macimorelin.
Slovenian: Uporabo zdravil z rastnim hormonom moramo prekiniti vsaj 1 mesec pred dajanjem macimorelina.
English: Macimorelin Aeterna Zentaris can cause changes in the ECG (electrocardiogram) including QT prolongation that are associated with an increased risk for arrhythmias.
Slovenian: Zdravilo Macimorelin Aeterna Zentaris lahko povzroči spremembe na EKG (elektrokardiogramu), vključno s podaljšanjem intervala QT, kar je povezano s povečanim tveganjem za aritmije.
English: It is unknown whether macimorelin or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se macimorelin ali njegovi presnovki izločajo v materino mleko.
English: Both co-primary endpoints as pre-defined in Study 052 (lower limit of the 95% CI for negative agreement ≥ 75%, lower limit of the 95% CI for positive agreement ≥ 70%) are met when using an ITT cut-off point of 3.0 ng/mL and the pre-defined cut-off point for the MAC of 2.8 ng/mL.
Slovenian: Oba opazovana dogodka, kot sta bila predhodno določena v študiji 052 (spodnja meja 95-odstotnega IZ za negativno ujemanje ≥ 75 %, spodnja meja 95-odstotnega IZ za pozitivno ujemanje ≥ 70 %), sta izpolnjena, če uporabljamo mejno točko za ITT pri 3,0 ng/ml in vnaprej določeno mejno točko za
English: The dose is calculated based on the patient´s body weight.
Slovenian: Odmerek je odvisen od bolnikove telesne mase.
English: The oral bioavailability may be limited (among others) by first pass metabolism via CYP3A4 (see section 4.5).
Slovenian: Peroralna biološka uporabnost je lahko omejena (med drugim) s presnovo prvega prehoda prek CYP3A4 (glejte poglavje 4.5).
English: A healthcare professional must supervise the preparation and use of Macimorelin Aeterna Zentaris.
Slovenian: Zdravstveni delavec mora nadzorovati pripravo in uporabo zdravila Macimorelin Aeterna Zentaris.
English: GH levels were determined centrally with the IDS-iSYS assay (Immunodiagnostic Systems Ltd., UK).
Slovenian: Ravni rastnega hormona so bile izmerjene v osrednji ustanovi s testom IDS-iSYS (Immunodiagnostic Systems Ltd., Velika Britanija).
English: • you have recently been treated for Cushing's disease (disorder which results in high levels of the hormone cortisol) or if you are receiving a high dose of hydrocortisone medicine, the test may lead to false positive test results.
Slovenian: • Če ste se nedavno zdravili zaradi Cushingove bolezni (motnje, ki povzroča visoko raven hormona kortizola) ali če prejemate velik odmerek zdravila, imenovanega hidrokortizon, saj lahko test da lažno pozitivne rezultate.
English: Macimorelin Aeterna Zentaris granules are to be reconstituted with water and must be used within 30 minutes after preparation.
Slovenian: Zdravilo Macimorelin Aeterna Zentaris rekonstituiramo z vodo in ga uporabimo v 30 minutah po pripravi.
English: Therefore, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin (see also section 4.4).
Slovenian: Zato je lahko indicirana kontrola z EKG pred dajanjem macimorelina ter 1 uro, 2 uri, 4 ure in 6 ur po dajanju macimorelina (glejte tudi poglavje 4.4).
English: Further possible undesirable effects in case of overdosing could include headache, nausea, vomiting and diarrhoea.
Slovenian: Dodatni morebitni neželeni učinki v primeru prevelikega odmerjanja lahko vključujejo glavobol, navzeo, bruhanje in drisko.
English: Based on current understanding, this potential is unlikely to decrease the specificity of the test.
Slovenian: Na podlagi trenutnega razumevanja to tveganje verjetno ne zmanjša specifičnosti preiskave.
English: • infections (antibiotics such as rifabutin, rifampicin)
Slovenian: • okužb (antibiotiki, kot sta rifabutin, rifampicin);
English: Macimorelin was absorbed rapidly and the maximum plasma macimorelin concentrations (Cmax) were observed approximately 30 minutes to 1 hour and 10 minutes after oral administration of 0.5 mg/kg macimorelin after fasting for at least 8 hours.
Slovenian: Macimorelin se je hitro absorbiral in največje koncentracije macimorelina (Cmax) v plazmi so ugotovili približno od 30 minut do 1 ure in 10 minut po peroralnem dajanju macimorelina v odmerku 0,5 mg/kg osebam, ki so bile tešče vsaj 8 ur.
English: The number of test sachets needed is based on body weight.
Slovenian: Število potrebnih vrečic zdravila je odvisno od telesne mase.
English: Agreement between the result of the first test and the second test was observed in 31 cases (91.2%).
Slovenian: Ponovljivost je bila preverjena v podskupini 34 preiskovancev, za katere so izvedli dva testa MAC. Ujemanje med rezultatom prvega in drugega testa je bilo ugotovljeno v 31 primerih (91,2 %).
English: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases.
Slovenian: Podaljšanje intervala QT lahko privede do razvoja ventrikularne tahikardije vrste torsades de pointes, pri čemer se tveganje z naraščanjem podaljšanja intervala QT povečuje.
English: • cancer (dabrafenib, enzalutamide)
Slovenian: • raka (dabrafenib, enzalutamid).
English: Determine the volume of suspension needed for the recommended macimorelin dose of 0.5 mg/kg.
Slovenian: Določite količino suspenzije, ki jo potrebujete za priporočeni odmerek macimorelina 0,5 mg/kg.