FrancophonIA/ELRC3.0 huggingface dataset:
English: Caraway oil is the common name for the essential oil obtained from the fruit of the plant Carum carvi L. The plant is cultivated or gathered to obtain the oil for medicinal use.
Slovenian: Eterično olje navadne kumine je splošno ime za eterično olje, ki se pridobiva iz plodu rastline Carum carvi L. Rastlina se goji ali nabira za pridobivanje olja za medicinsko uporabo.
English: Further information on the risks associated with caraway oil 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 eterično olje navadne kumine, 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: Caraway oil medicines must not be used in people who are hypersensitive (allergic) to caraway oil or other plants of the same Apiaceae (Umbelliferae) family (e.g. fennel, anise, celery, coriander and dill).
Slovenian: Eterično olje navadne kumine se ne sme uporabljati pri posameznikih, ki so preobčutljivi za (alergični na) eterično olje navadne kumine ali za druge rastline iz družine kobulnic - Apiaceae (Umbelliferae) (navadni komarček, janež, zelena, koriander in navadni koper).
English: The HMPC conclusions on the use of caraway oil medicines in the relief of digestive problems such as bloating and flatulence are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC glede uporabe zdravil, ki vsebujejo eterično olje navadne kumine, za lajšanje težav s prebavili, kot so napenjanje in vetrovi, temeljijo na njihovi „tradicionalni uporabi“.
English: Any applications for the licensing of medicines containing caraway oil 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 eterično olje navadne kumine, 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 caraway oil 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 eterično olje navadne kumine, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing caraway oil.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo eterično olje navadne kumine.
English: For further information, see the HMPC assessment report.
Slovenian: Za podrobnejše informacije o študijah, ki jih je ocenil odbor HMPC, glejte njegovo poročilo o oceni zdravila.
English: Herbal medicines containing caraway oil preparations are usually available in liquid forms to be taken by mouth and in semi-solid forms (such as ointments) to be applied to the skin.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo pripravke z eteričnim oljem navadne kumine, so navadno na voljo v tekoči obliki, ki se jemlje peroralno (uživajo skozi usta), ali v poltrdni obliki (kot so mazila), ki se nanaša na kožo.
English: Further information on the HMPC assessment of caraway oil 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 eterično olje navadne kumine, 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: What evidence supports the use of caraway oil medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo eterično olje navadne kumine?
English: What are the risks associated with caraway oil medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo eterično olje navadne kumine?
English: For more information about treatment with caraway oil 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 eterično olje navadne kumine, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using caraway oil 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: The HMPC concluded that, on the basis of its long-standing use, caraway oil medicines can be used for the relief of problems of the digestive system such as bloating and flatulence.
Slovenian: Odbor HMPC je na podlagi dobro uveljavljene uporabe eteričnega olja navadne kumine zaključil, da se lahko zdravila, ki vsebujejo eterično olje navadne kumine, uporabljajo za lajšanje težav s prebavili, kot so napenjanje in vetrovi.
English: Detailed instructions on how to take caraway oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: o jemanju zdravil, ki vsebujejo eterično olje navadne kumine, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Other information about caraway oil medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo eterično olje navadne kumine
English: Caraway oil is obtained by a current of steam through the dried fruit.
Slovenian: Eterično olje navadne kumine se pridobiva s pomočjo toka pare skozi posušene plodove.
English: What is caraway oil?
Slovenian: Kaj je eterično olje navadne kumine?
English: How are caraway oil medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo eterično olje navadne kumine, odobrena v
English: Contraception, in press.
Slovenian: Contraception, v tisku.
English: However this may not be realistic in all situations.
Slovenian: To pa morda ni vedno realistično.
English: A relevant summary of the conclusions is presented below.
Slovenian: Spodaj je predstavljen povzetek zaključkov.
English: The Concerned Member States (CMS) were: Austria, Belgium, Czech Republic, Germany, Greece, Spain, France, Ireland, Iceland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal and Sweden.
Slovenian: Zadevne države članice so bile: Avstrija, Belgija, Češka, Nemčija, Grčija, Španija, Francija, Irska, Islandija, Italija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska in Švedska.
English: (iii) Management options - Dose increase / alternative treatment
Slovenian: (iii) Možnosti obvladovanja - povečanje odmerka/nadomestno zdravljenje
English: The type II variation started on 17 September 2014.
Slovenian: Postopek za spremembo tipa II se je začel 17. septembra 2014.
English: As no agreement could be reached, the procedure was referred to the CHMP.
Slovenian: Ker ni bilo mogoče doseči dogovora, so postopek napotili na odbor CHMP.
English: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 pages
Slovenian: Infectious Diseases in Obstetrics and Gynecology, 2012:137192, 4 strani.
English: The reasons for the under-reporting are not known but may be due to an expectation of lower efficacy compared to other contraceptives.
Slovenian: Razlogi za nezadostno poročanje niso znani, vendar so morda posledica pričakovanja nižje učinkovitosti v primerjavi z drugimi kontracepcijskimi sredstvi.
English: inducers.
Slovenian: uporabljati.
English: The CMDh 60 day procedure was initiated on 3 August 2015.
Slovenian: 60-dnevni rok za izvedbo postopka skupine CMDh je začel teči 3. avgusta 2015.
English: Taken together, this suggests that the magnitude of the efavirenz effect has been reliably estimated1.
Slovenian: Skupaj to kaže, da je bila velikost učinka efavirenza zanesljivo ocenjena1.
English: Specialist clinics are not necessarily aware of the importance of the interactions and women rely on specialist clinical advice.
Slovenian: Specialistične klinike morda niso seznanjene s pomenom medsebojnega delovanja, ženske pa se zanašajo na nasvet kliničnega specialista.
English: Day 60 of the CMDh procedure was on 1 October 2015, when a final position was reached by most MSs except Italy (IT).
Slovenian: 60. dan postopka skupine CMDh je bil 1. oktober 2015, ko je večina držav članic, razen Italije, sprejela dokončno stališče.
English: Fitting a Cu-IUD is a skilled procedure and this option may not be available, suitable or acceptable for all women.
Slovenian: Namestitev materničnega vložka z bakrom je strokoven poseg, in ta možnost morda ni na voljo, ni primerna ali ni sprejemljiva za vse ženske.
English: In order to assess the effectiveness and readability of this advice in the product information, a consultation was undertaken with patient and consumer groups and relevant healthcare professionals, with responses from across the EU.
Slovenian: Da bi ocenili učinkovitost in berljivost tega opozorila v informacijah o zdravilu, so opravili posvetovanje s skupinami bolnic in potrošnic ter ustreznimi zdravstvenimi delavci, odzive pa so prejeli iz vse EU.
English: • The Committee took also into account written consultations of consumers, patients and healthcare professionals before recommending the agreed changes to the product information.
Slovenian: • odbor CHMP je upošteval tudi pisna posvetovanja s potrošnicami, bolnicami in zdravstvenimi delavci, preden je priporočil dogovorjene spremembe informacij o zdravilu;
English: The currently licensed dose of 1500mcg was not included in either of the contraceptive efficacy studies, so direct comparison of efficacy is not possible.
Slovenian: Trenutno odobreni odmerek 1 500 μg ni bil vključen v nobeno od navedenih študij učinkovitosti, tako da neposredna primerjava učinkovitosti ni mogoča.
English: The scope of this procedure is limited to Levonelle and associated names which are authorised in the European Union (EU) as emergency hormonal contraceptives (EHC).
Slovenian: Ta postopek je omejen samo na zdravilo Levonelle in povezana imena, ki so odobrena v Evropski uniji (EU) kot nujna hormonska kontracepcijska sredstva.
English: • The Committee considered the referral under Article 13(2) of Regulation No 1234/2008.
Slovenian: • odbor CHMP je obravnaval napotitev v skladu s členom 13(2) Uredbe št. 1234/2008;
English: It is considered that specific training is not needed for healthcare professionals, rather a Dear healthcare professional communication (DHPC) should be issued to highlight the change in prescribing advice.
Slovenian: Meni se, da za zdravstvene delavce ni potrebno posebno usposabljanje, treba je izdati le sporočilo za zdravstvenega delavca (DHPC), v katerem je treba opozoriti na spremembo glede predpisovanja.
English: For that reason the CHMP has discussed the key elements for communication to healthcare professionals and patients to facilitate the communication at national level.
Slovenian: Zato je odbor CHMP razpravljal o ključnih elementih, ki jih je treba sporočiti zdravstvenim delavcem in bolnicam za lažje sporočanje na nacionalni ravni.
English: Thus the CHMP concluded that there is a need for timely and clear advice for clinically relevant interactions.
Slovenian: Zato je odbor CHMP zaključil, da obstaja potreba po pravočasnem in jasnem opozorilu o klinično pomembnem medsebojnem delovanju.
English: There is a need to educate healthcare professionals and patients about the interaction concerns and the related recommendations.
Slovenian: Zdravstvene delavce in bolnice je treba izobraziti o pomislekih zaradi medsebojnega delovanja in povezanih priporočilih.
English: Exposure to 400mcg LNG represented the largest group, with 2801 patients studied, 71% for >6 months and 48% for > 12 months.
Slovenian: Izpostavljenost levonorgestrelu v odmerku 400 μg je predstavljala največjo skupino z 2801 preučevano bolnico, 71 % > 6 mesecev in 48 % > 12 mesecev.
English: This is recognised in clinical guidance and in the product information of hormonal contraceptives which advise use of additional or alternative contraception.
Slovenian: To je priznano tudi v kliničnih navodilih in informacijah o zdravilu za hormonska kontracepcijska sredstva, v katerih se svetuje uporaba dodatne ali druge kontracepcije.
English: The CHMP considered the possibility that a double dose may not be adequate to fully compensate the effects of strong enzyme inducers.
Slovenian: Odbor CHMP je preučil možnost, da dvojni odmerek morda ne zadošča za popolno nadomestitev učinkov močnih encimskih induktorjev.
English: Although this study was not in association with enzyme inducers, it suggests that linearity of Cmax is maintained up to 3mg LNG.
Slovenian: Čeprav ta študija ni bila povezana z encimskimi induktorji, kaže, da se linearnost Cmax ohranja do 3 mg levonorgestrela.
English: Thus safety concerns related to the over compensation of less strong enzyme inducers would also seem unlikely.
Slovenian: Pomisleki o varnosti, povezani s čezmernim nadomeščanjem manj močnih encimskih induktorjev, se torej prav tako zdijo manj verjetni.
English: Conversely, a double dose may over compensate the effects of less strong enzyme inducers.
Slovenian: Nasprotno pa lahko dvojni odmerek nadomesti učinke manj močnih encimskih induktorjev.
English: Although this possibility does exist, a double dose would still result in higher plasma LNG levels than under the current posology and thus reduce the risk of contraceptive failure.
Slovenian: Čeprav ta možnost res obstaja, dvojni odmerek še vedno povzroči višje ravni levonorgestrela v plazmi kot pri trenutnem odmerjanju in tako zmanjša tveganje za odpoved kontracepcije.
English: In addition, the CHMP considered that instructions for an amended dose for users of enzyme inducers should be part of the package leaflet and should also be highlighted on the product outer carton labelling as the information should be available prior or during the purchase of the medicinal products to get the appropriate number of packs.
Slovenian: Poleg tega je odbor CHMP menil, da morajo biti navodila za prilagojeni odmerek pri uporabnicah encimskih induktorjev del navodila za uporabo in poudarjena tudi na oznaki na zunanji škatli zdravila, saj morajo biti informacije na voljo pred ali med nakupom zdravila, da lahko stranka kupi dovolj pakiranj.
English: However in this case, the exposure to LNG would be less than that for a woman taking a double dose (i.e. 3 mg LNG) whilst not using a concomitant enzyme inducer.
Slovenian: Vendar bi bila v tem primeru izpostavljenost levonorgestrelu manjša kot pri ženski, ki vzame dvojni odmerek (tj. 3 mg levonorgestrela), a hkrati ne uporablja encimskega induktorja.
English: This is important as contraceptive efficacy of LNG EHC diminishes with time since UPSI: from 95% within 24 hours to 58% if started between 48 and 72 hours.
Slovenian: To je pomembno, saj se kontracepcijska učinkovitost levonorgestrela kot nujnega hormonskega kontracepcijskega sredstva zmanjšuje s časom po nezaščitenem spolnem odnosu; od 95 % v 24 urah do 58 %, če se vzame med 48 in 72 urami po njem.
English: Secondly, AUC, the main measure of exposure, has generally been found2 to be dose-proportional.
Slovenian: Poleg tega so ugotovili2, da je AUC, glavno merilo izpostavljenosti, v splošnem odvisen od odmerka.
English: Finally the decision on whether a Cu-IUD is appropriate or not for a woman should be a clinical decision that considers her individual circumstances.
Slovenian: Končno mora biti odločitev o ustreznosti materničnega vložka z bakrom pri določeni ženski klinična odločitev, ki upošteva njene dejanske okoliščine.
English: On 17 September 2014, Gedeon Richter Plc submitted an application for Levonelle and associated names through a mutual recognition procedure (MRP) type II variation (UK/H/0803/001/II/022) with the United Kingdom acting as a Reference Member State (RMS).
Slovenian: Družba Gedeon Richter Pic je 17. septembra 2014 predložila vlogo za spremembo tipa II (UK/H/0803/001/II/022) za zdravilo Levonelle in povezana imena po postopku z medsebojnim priznavanjem, pri čemer je bilo Združeno kraljestvo določeno kot referenčna država članica.
English: Moreover, to access this, a woman needs first to be aware of the risks associated with medicines interacting with LNG.
Slovenian: Poleg tega se mora ženska najprej zavedati tveganj, povezanih z zdravili, ki medsebojno delujejo z levonorgestrelom.
English: (ii) Clinical significance of reduced plasma LNG levels
Slovenian: (ii) Klinični pomen zmanjšanih ravni levonorgestrela v plazmi
English: All Member States (MSs) supported the existence of a clinically relevant interaction however a few remained unsure about the advice on how to manage the interaction.
Slovenian: Vse države članice so se strinjale, da obstaja klinično pomembno medsebojno delovanje, vendar nekatere od njih niso vedele, kakšen nasvet bi bil potreben za njegovo obvladovanje.
English: In that way the CHMP wanted to ensure that the instructions on dosing are as clear as possible on the outer carton labelling and the package leaflet, in order to maintain the non-prescription supply without increasing the risk of medication errors.
Slovenian: Tako je odbor CHMP želel zagotoviti, da so navodila za odmerjanje na oznaki zunanje škatle in navodilu za uporabo čim jasnejša, s čimer se ohrani izdaja brez recepta brez povečanega tveganja za napake pri uporabi zdravila.
English: The CHMP reviewed all data available from clinical studies, published literature, post-marketing experience, including responses submitted by the MAH in writing, as well as the results of a written consultation with patients and consumers, and healthcare professionals across the EU.
Slovenian: Odbor CHMP je pregledal vse razpoložljive podatke iz kliničnih študij, objavljene literature, izkušenj iz obdobja trženja, vključno z odgovori, ki jih je predložil imetnik dovoljenja za promet z zdravilom, in rezultate pisnih posvetovanj z bolnicami in potrošnicami ter zdravstvenimi delavci iz EU.
English: In this respect, the CHMP recommended that the national competent authorities (NCAs) should outline the amendments to the SmPC and the reasons for the change through their normal means of communication with healthcare professionals.
Slovenian: V zvezi s tem je odbor CHMP priporočil, naj pristojni nacionalni organi spremembe povzetka glavnih značilnosti zdravila in razloge za spremembo sporočijo po svojih običajnih komunikacijskih kanalih z zdravstvenimi delavci.
English: Also, decreases in exposure of the LNG component of combined hormonal contraceptives have been noted with several enzyme inducers: LNG AUC was reduced by 36 to 47% reductions with oxcarbazepine; 40 to 46% with carbamazepine; 42% with phenytoin; 37% with eslicarbazepine; and 40% with perampanel.
Slovenian: Pri več encimskih induktorjih so opazili tudi zmanjšano izpostavljenost levonorgestrelu kot komponenti kombiniranih hormonskih kontracepcijskih sredstev: AUC levonorgestrela se je z okskarbazepinom zmanjšal od 36 do 47 %, karbamazepinom od 40 do 46 %, fenitoinom za 42 %, eslikarbamazepinom za 37 % in perampanelom za 40 %.
English: Reduction in plasma levels with efavirenz and other enzyme inducers
Slovenian: (i) Zmanjšanje ravni v plazmi ob sočasnem jemanju efavirenza in drugih encimskih induktorjev
English: Currently two other forms of emergency contraception are available, ulipristal acetate and Cu-IUDs.
Slovenian: Trenutno sta na voljo dve drugi obliki nujne kontracepcije, in sicer ulipristal acetat in maternični vložek z bakrom.
English: On 1 October 2015, the United Kingdom (UK) as RMS triggered a referral under Article 13(2) of the Commission Regulation (EC) No 1234/2008.
Slovenian: Združeno kraljestvo je kot referenčna država članica 1. oktobra 2015 sprožila napotitev v skladu s členom 13(2) Uredbe Komisije (ES) št. 1234/2008.
English: To the extent that other 750mcg and 1500mcg LNG-containing medicinal products indicated in emergency contraception not included in this assessment but are currently authorised in the EU, or are subject to future authorisation procedures by the Member States, the CHMP recommends that the concerned member states take due consideration of these scientific conclusions.
Slovenian: Če so za nujno kontracepcijo indicirana tudi druga zdravila, ki vsebujejo levonorgestrel 750 μg ali 1 500 μg in ki niso vključena v to oceno, vendar so trenutno odobrena v EU, ali če bodo taka zdravila v prihodnje predmet postopkov za pridobitev dovoljenja v državah članicah, odbor CHMP priporoča, da zadevne države članice upoštevajo te znanstvene zaključke.
English: Concerns have been raised by the CHMP of potential for medication errors related to non-prescription supply (i.e. targeted patients not using the double dosing as unaware).
Slovenian: Odbor CHMP je izrazil pomisleke o možnosti za napake pri uporabi zdravila, povezane z izdajo zdravila brez recepta (tj. ciljne bolnice ne uporabljajo dvojnega odmerka, ker s tem niso seznanjene).
English: There were 75 pregnancies in the 400mcg LNG treated group, yielding a failure rate of 3.52% and a method failure rate of 1.69%.
Slovenian: V skupini, zdravljeni s 400 μg levonorgestrela, je bilo 75 nosečnosti, kar pomeni 3,52-odstotno stopnjo neuspeha in 1,69-odstotno stopnjo neuspeha metode.
English: In that regards, the CHMP recommended that to improve the delivery of the information, the effect of the enzyme inducers should be included directly after the usual dosage instructions on the same side of the carton.
Slovenian: Glede tega je priporočil, da je treba za boljše posredovanje informacij učinek encimskih induktorjev vključiti neposredno po navodilih za običajno odmerjanje, na isti strani škatle.
English: • The CHMP concluded that in view of the available data for Levonelle 1500mcg and associated names, information should be available on the effect of efavirenz and other hepatic enzyme inducers when taken concomitantly, or for 4 weeks after cessation of treatment with all enzyme inducers.
Slovenian: • odbor CHMP je zaključil, da morajo biti glede na razpoložljive podatke za zdravilo Levonelle 1 500 μg in povezana imena na voljo informacije o učinku efavirenza in drugih induktorjev jetrnih encimov, če se jemlje sočasno ali štiri tedne po prenehanju zdravljenja z vsemi encimskimi induktorji.
English: Cu-IUDs can be used up to 5 days following UPSI but this may not be an option for all women on medical grounds (e.g. following recent expulsion or perforation, recurrent vaginal infections, and increased risk of bleeding is undesirable for female HIV patients), due to access issues (lack of availability of appropriately skilled HCPs) or due to personal choice (e.g. for women not in long term relationships at the time of UPSI).
Slovenian: Maternični vložki z bakrom se lahko uporabljajo do pet dni po nezaščitenem spolnem odnosu, vendar to morda ni možnost, primerna za vse ženske, bodisi iz medicinskih razlogov (npr. po nedavnem iztisu ali predrtju, zaradi ponavljajočih se nožničnih okužb in povečanega tveganja za krvavitev, kar je pri bolnicah z okužbo z virusom HIV nezaželeno), zaradi težav z dostopom (pomanjkanje ustrezno usposobljenih zdravstvenih delavcev) ali zaradi osebne izbire (npr. pri ženskah, ki v času nezaščitenega spolnega odnosa niso v dolgotrajnem razmerju).
English: Levonelle 1500mcg and associated names consists of a single tablet.
Slovenian: Zdravilo Levonelle 1 500 μg in povezana imena je na voljo v obliki posamezne tablete.