FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Combivir 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) za zdravilo Combivir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Combivir on 18 March 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Combivir, veljavno po vsej Evropski uniji, izdala 18. marca 1998.
English: This is a summary of the European Public Assessment Report (EPAR) for Combivir.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Combivir.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Combivir's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Combivir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Because lamivudine and zidovudine have been available in the EU for a number of years, the company presented information from earlier studies of the two substances taken together.
Slovenian: Ker sta lamivudin in zidovudin v EU na voljo že vrsto let, je družba predložila podatke iz prejšnjih študij o jemanju teh dveh učinkovin skupaj.
English: CD4 cells (also called CD4 T cells) are white blood cells that are important for fighting infections, but they are killed by HIV.
Slovenian: Celice CD4 (imenovane tudi celice CD4 T) so bele krvne celice, ki so pomembne pri obrambi pred okužbami, vendar jih virus HIV uničuje.
English: In children (below 12 years of age) weighing between 14 and 30 kg, the dose depends on their weight.
Slovenian: Pri otrocih (mlajših od 12 let), ki tehtajo med 14 in 30 kg, je odmerek odvisen od njihove telesne mase.
English: The recommended dose of Combivir for patients over 12 years of age who weigh at least 30 kg is one tablet taken twice a day.
Slovenian: Priporočeni odmerek zdravila Combivir pri bolnikih, starejših od 12 let, ki tehtajo najmanj 30 kg, je ena tableta dvakrat na dan.
English: What are the risks associated with Combivir?
Slovenian: Kakšna tveganja so povezana z zdravilom Combivir?
English: What benefit of Combivir have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Combivir izkazalo v študijah?
English: Combivir is available as tablets containing lamivudine 150 mg and zidovudine 300 mg.
Slovenian: Zdravilo Combivir je na voljo v obliki tablet, ki vsebujejo 150 mg lamivudina in 300 mg zidovudina.
English: It is not intended to provide practical advice on how to use Combivir.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Combivir have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Combivir upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The company also compared Combivir to separate tablets of lamivudine and zidovudine in 75 patients aged over 12 years who had not taken treatment for HIV infection before.
Slovenian: Družba je prav tako primerjala jemanje zdravila Combivir z jemanjem ločenih tablet lamivudina in zidovudina pri 75 bolnikih, starejših od 12 let, ki pred tem še niso bili zdravljeni zaradi okužbe z virusom HIV.
English: Patients who cannot swallow tablets may crush the tablets, adding the powder to a small amount of food or drink and swallowing it immediately.
Slovenian: Bolniki, ki ne morejo pogoltniti cele tablete, jo lahko zdrobijo in dobljeni prašek zmešajo z manjšo količino hrane ali pijače, ki pa jo morajo takoj zaužiti.
English: The main measures of effectiveness were the change in viral load and CD4 cell counts in the blood.
Slovenian: Glavno merilo učinkovitosti je bila sprememba virusnega bremena in števila celic CD4 v krvi.
English: What is Combivir and what is it used for?
Slovenian: Kaj je zdravilo Combivir in za kaj se uporablja?
English: They work in similar ways by blocking the activity of reverse transcriptase, an enzyme made by the HIV virus that allows it to reproduce itself in the cells it has infected.
Slovenian: Delujeta podobno, in sicer tako da zavirata dejavnost reverzne transkriptaze, tj. encima, ki ga tvori virus HIV in ki mu omogoča, da se lahko razmnožuje v celicah, ki jih je okužil.
English: Combivir must not be used by patients with low neutrophil counts (a type of white blood cell) or anaemia (low red blood cell counts).
Slovenian: Zdravila Combivir ne smejo uporabljati bolniki z nizkim številom nevtrofilcev (vrste belih krvnih celic) v krvi ali anemijo (nizkim številom rdečih krvnih celic).
English: For more information about treatment with Combivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Combivir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It also presented information on the predicted blood levels of the two substances in children taking the two substances combined in one tablet.
Slovenian: Sočasno je predstavila podatke o predvidenih ravneh obeh učinkovin v krvi pri otrocih, ki obe učinkovini jemljejo kombinirano v eni tableti.
English: The company also compared how the body absorbed the Combivir combination tablet and the separate tablets.
Slovenian: Družba je prav tako primerjala, kako telo absorbira kombinirano tableto zdravila Combivir in ločeni tableti.
English: Combivir, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Combivir v kombinaciji z vsaj enim drugim protivirusnim zdravilom znižuje količino virusa HIV v krvi in jo zadržuje na nizki ravni.
English: Why is Combivir approved?
Slovenian: Zakaj je bilo zdravilo Combivir odobreno?
English: Combivir does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Combivir ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: Children taking Combivir should be closely monitored and the doctor may need to adjust the dose in case of side effects on their digestive system.
Slovenian: Otroke, ki prejemajo zdravilo Combivir, je treba skrbno spremljati, zdravnik pa bo morda moral v primeru pojava neželenih učinkov v prebavnem sistemu odmerek ustrezno prilagoditi.
English: The studies showed that the active substances taken together could reduce viral loads (the level of HIV in the blood) and allow CD4 cell counts to rise after up to one year of treatment.
Slovenian: Te študije so pokazale, da lahko jemanje obeh učinkovin skupaj zmanjša virusno breme (količino virusa HIV v krvi) in spodbudi zvišanje števila celic CD4 po enem letu zdravljenja.
English: The recommended doses of Combivir in children produced similar levels of the two active substances as in older patients.
Slovenian: Priporočeni odmerki zdravila Combivir pri otrocih povzročajo podobne ravni obeh zdravilnih učinkovin kot pri starejših bolnikih.
English: Treatment with Combivir should be started by a doctor who has experience in the management of HIV infection.
Slovenian: Zdravljenje z zdravilom Combivir lahko uvede le zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Combivir, an antiviral medicine, is used in combination with at least one other antiviral medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Combivir je protivirusno zdravilo, ki se uporablja v kombinaciji z vsaj enim drugim protivirusnim zdravilom za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: For practical information about using Combivir, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Combivir naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Both active substances in Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Slovenian: Obe zdravilni učinkovini v zdravilu Combivir, lamivudin in zidovudin, sta zaviralca nukleozidne reverzne transkriptaze (NRTI).
English: The most common side effects with Combivir (which may affect more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejša neželena učinka zdravila Combivir (opažena pri več kot 1 bolniku od 10) sta driska in navzeja (slabost).
English: The two groups also had similar rises in CD4 cell counts.
Slovenian: V obeh skupinah bolnikov je bilo zvišanje števila celic CD4 podobno.
English: To support its recommendations for Combivir doses in children, the company presented studies of the levels of lamivudine and zidovudine in the blood of children taking the medicines separately.
Slovenian: Družba je v podporo svojim priporočenim odmerkom zdravila Combivir pri otrocih predstavila študije ravni lamivudina in zidovudina v krvi otrok, ki so obe učinkovini jemali ločeno.
English: CHMP considered that combining the active ingredients in a single tablet may be of advantage because it can improve how well patients stick to the prescribed treatment and this can help to prevent HIV becoming resistant to treatment.
Slovenian: Menil je, da bi lahko bila združitev obeh zdravilnih učinkovin v eni tableti koristna, ker bolnike spodbuja k temu, da vztrajajo pri predpisanem zdravljenju, to pa posledično pripomore k preprečevanju razvoja odpornosti virusa HIV proti zdravilu.
English: Combivir was absorbed in the same way as the separate tablets.
Slovenian: Bolniki so zdravilo Combivir absorbirali enako kot ločeni tableti.
English: For the full list of all the side effects of Combivir and restrictions on its use, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev, o katerih so poročali pri uporabi zdravila Combivir, glejte navodilo za uporabo.
English: Patients taking Combivir and those taking the two active substances separately had similar falls in viral load.
Slovenian: Pri bolnikih, ki so jemali zdravilo Combivir, in tistih, ki so jemali obe zdravilni učinkovini v ločenih tabletah, je prišlo do podobnega znižanja virusnega bremena.
English: How is Combivir used?
Slovenian: Kako se zdravilo Combivir uporablja?
English: Combivir contains two active substances, lamivudine and zidovudine.
Slovenian: Zdravilo Combivir vsebuje dve zdravilni učinkovini, lamivudin in zidovudin.
English: How does Combivir work?
Slovenian: Kako zdravilo Combivir deluje?
English: The studies indicated that 1,8 cineole might have an effect in diseases of the airways.
Slovenian: Študije so pokazale, da lahko 1,8 cineol vpliva na bolezni dihalnih poti.
English: If symptoms persist for longer than a week, a doctor should be consulted.
Slovenian: Če simptomi po enem tednu ne izginejo, se je treba posvetovati z zdravnikom.
English: At the time of the HMPC assessment, no side effects had been reported with these medicines when used in the way described above.
Slovenian: V času ocene odbora HMPC ni bilo poročil o neželenih učinkih teh zdravil pri njihovi uporabi na zgoraj navedeni način.
English: Eucalyptus leaf is the common name for the whole or cut leaf of the tree Eucalyptus globulus Labill.
Slovenian: List evkaliptusa je splošno ime za cel ali narezan list drevesa Eucalyptus globulus Labill.
English: In its assessment, the HMPC considered the results of laboratory tests as well as studies in patients looking in particular at the effects of a component of eucalyptus leaf, called 1,8 cineole (also known as eucalyptol).
Slovenian: Odbor HMPC je v svoji oceni proučil rezultate laboratorijskih preskusov ter študij pri bolnikih, pri čemer se je osredotočal zlasti na učinke sestavine lista evkaliptusa, ki se imenuje 1,8 cineol (znan tudi pod imenom evkaliptol).
English: This summary is not intended to provide practical advice on how to use medicines containing eucalyptus leaf.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo list evkaliptusa.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eucalyptus leaf.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo lista evkaliptusa.
English: Further information on the risks associated with eucalyptus leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo list evkaliptusa, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC recommended that eucalyptus leaf medicines should not be used in children under 30 months of age because of the risk of laryngospasm (contraction of the vocal cords).
Slovenian: Odbor HMPC je priporočil, da se zdravil, ki vsebujejo list evkaliptusa, ne sme uporabljati pri otrocih, mlajših od 30 mesecev, zaradi tveganja za laringospazem (krč glasilk).
English: Comminuted preparations of eucalyptus leaf should only be used in adults and children over the age of 12 years, while tincture preparations should only be used in adults due to high content of ethanol (pure alcohol).
Slovenian: Zdrobljeni pripravki lista evkaliptusa se lahko uporabljajo samo pri odraslih in otrocih, starejših od 12 let, pripravki tinkture pa zaradi visoke vsebnosti etanola (čistega alkohola) samo pri odraslih.
English: Preparations from dried eucalyptus leaf are obtained by comminuting (reducing into tiny pieces) the dried leaves of older branches of the tree, or by using them to produce a tincture (an alcoholic extract of the plant material).
Slovenian: Pripravki iz posušenih listov evkaliptusa se pridobivajo z drobljenjem (zmanjšanjem na zelo majhne dele) suhih listov starejših vej drevesa ali pa se jih uporabi za izdelavo tinkture (alkoholnega izvlečka rastlinskega materiala).
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing eucalyptus leaf.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo list evkaliptusa.
English: The HMPC conclusions on the use of eucalyptus leaf medicines for the relief of cough associated with a cold are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo list evkaliptusa in se uporabljajo za lajšanje kašlja pri prehladu, temeljijo na njihovi tradicionalni uporabi pri tem stanju.
English: Herbal medicines containing eucalyptus leaf are usually available as comminuted herbal material for the preparation of a herbal tea to be drunk, an infusion to be inhaled or a liquid to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo list evkaliptusa, so navadno na voljo kot zdrobljen rastlinski material za pripravo zdravilnega čaja, ki se ga pije, prevretka, ki se ga inhalira, ali tekočine, ki se jo jemlje peroralno (zaužije skozi usta).
English: Any applications for the licensing of medicines containing eucalyptus leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo list evkaliptusa, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Information on the use and licensing of eucalyptus leaf medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo list evkaliptusa, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Further information on the HMPC assessment of eucalyptus leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo list evkaliptusa, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, eucalyptus leaf can be used for the relief of cough associated with a cold.
Slovenian: Odbor HMPC je na osnovi dolgoletne uporabe lista evkaliptusa zaključil, da se ga lahko uporablja za lajšanje kašlja pri prehladu.
English: For more information about treatment with eucalyptus leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo list evkaliptusa, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: How are eucalyptus leaf medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo list evkaliptusa, odobrena v EU?
English: Other information about eucalyptus leaf medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo list evkaliptusa
English: What evidence supports the use of eucalyptus leaf medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo list evkaliptusa?
English: What are the risks associated with eucalyptus leaf medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo list evkaliptusa?
English: What is eucalyptus leaf?
Slovenian: Kaj je list evkaliptusa?
English: For practical information about using eucalyptus leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Detailed instruction on how to take eucalyptus leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: uporabi zdravil, ki vsebujejo list evkaliptusa, in o tem, kdo jih lahko uporablja, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Eucalyptus leaf can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: List evkaliptusa je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.Ta povzetek teh kombinacij ne vključuje.
English: Committee on Herbal Medicinal Products (HMPC)
Slovenian: EMA/HMPC/300235/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: 1 bottle + 1 measuring spoon
Slovenian: 1 plastenka + merilna žlička
English: Package size mg/ml
Slovenian: EU/1/06/343/005 Baraclude 0,05 mg/ml Peroralna raztopina
English: You will hear a click.
Slovenian: Zaslišali boste klik.
English: 26 July 2018
Slovenian: 26. julij 2018
English: Both -2.5
Slovenian: obe -2,5
English: Elderly (aged 65 years and over)
Slovenian: Starejši (stari 65 let ali več)
English: There may be local regulations for disposal.
Slovenian: Morda obstajajo lokalni predpisi za odstranjevanje.
English: Of these, more than 1,300 patients were exposed for at least 12 months.
Slovenian: Med njimi je bilo več kot 1.300 bolnikov izpostavljenih zdravilu najmanj 12 mesecev.
English: The injection could take about 15 seconds.
Slovenian: Injiciranje naj traja približno 15 sekund.
English: - Then contact your doctor, who will tell you when you should schedule your next dose.
Slovenian: - Nato obvestite svojega zdravnika, ki vam bo povedal, za kdaj morate načrtovati naslednji odmerek.
English: Contact your doctor immediately.
Slovenian: Takoj obvestite zdravnika.
English: No safety data are available in these patients.
Slovenian: O teh bolnikih ni na voljo nobenih varnostnih podatkov.
English: The safety and efficacy of Aimovig in children below the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Aimovig pri otrocih, starih manj kot 18 let, še nista bili dokazani.
English: Press the start button.
Slovenian: Pritisnite sprožilni gumb.
English: Approximately 41% of patients in the study had medication overuse.
Slovenian: Približno 41 % bolnikov v študiji je prekomerno uporabljalo zdravila.
English: Biotransformation / Elimination
Slovenian: Biotransformacija/izločanje
English: Possible side effects are listed below.
Slovenian: Možni neželeni učinki so našteti spodaj.
English: 59% of patients completing the study achieved a 50% response in the last month of the study.
Slovenian: Med bolniki, ki so zaključili študijo, jih je 59 % doseglo 50-odstotni odziv v zadnjem mesecu študije.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije danega zdravila.
English: The injections can also be given by another individual who has been appropriately instructed.
Slovenian: Injekcije lahko bolniku daje tudi druga oseba, ki se je za to ustrezno usposobila.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of migraine.
Slovenian: Zdravljenje naj uvedejo zdravniki, ki imajo izkušnje z diagnostiko in zdravljenjem migrene.
English: Talk to your doctor or pharmacist about proper disposal.
Slovenian: Z zdravnikom ali farmacevtom se posvetujte o pravilnem odstranjevanju.
English: If you have not noticed any treatment effect after 3 months, tell your doctor who will decide whether you should continue treatment.
Slovenian: Če po treh mesecih ne opazite nobenega učinka zdravljenja, povejte zdravniku, ki bo odločil, ali je z zdravljenjem treba nadaljevati ali ne.
English: Less than 2% of patients in these studies discontinued due to adverse events.
Slovenian: V teh študijah je manj kot 2 % bolnikov prekinilo zdravljenje zaradi neželenih učinkov.
English: Evaluation of the need to continue treatment is recommended regularly thereafter.
Slovenian: Po preteku tega obdobja je priporočeno redno ocenjevanje potrebe po nadaljnjem zdravljenju.
English: It has biological activity in cynomolgus monkeys, but this species is not an appropriate model for evaluation of tumorigenic risk.
Slovenian: Biološko aktivnost izkazuje pri opicah cinomolgus, vendar ta vrsta ne predstavlja ustreznega modela za oceno tveganja za tumorigenost.
English: Do not use Aimovig: - if you are allergic to erenumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Aimovig: - če ste alergični na erenumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: See section “Injection site reactions” below.
Slovenian: Glejte poglavje “Reakcije na mestu injiciranja” spodaj.