FrancophonIA/ELRC3.0 huggingface dataset:
English: If you want more information on the HMPC conclusions, read the Community list entry on this herbal medicine.
Slovenian: Če želite več podatkov o zaključkih HMPC, si oglejte vpis v seznam Skupnosti za to zdravilo rastlinskega izvora.
English: vulgare var. dulce (Miller) Thellung is provided in the HMPC Assessment Report, overview of comments received during the public consultation period and other related documents which can be found here.
Slovenian: vulgare var. dulce (Miller) Thellung so na voljo v poročilu HMPC o oceni zdravila, pregledu pripomb, prejetih med javnim posvetovalnim obdobjem, in drugih povezanih dokumentih, ki jih lahko najdete tukaj.
English: The HMPC came to these conclusions after assessment of the bibliographic data available on sweet fennel fruit preparations.
Slovenian: HMPC je do teh zaključkov prišel na podlagi ocene razpoložljivih bibliografskih podatkov o pripravkih iz plodov sladkega navadnega komarčka.
English: Many components have been identified in preparations containing sweet fennel fruit and it is not possible to define precisely the action of each component.
Slovenian: V pripravkih, ki vsebujejo plodove sladkega navadnega komarčka, je bilo odkritih veliko sestavin, zato ni mogoče natančno določiti delovanja vsake posamezne sestavine.
English: The botanical Latin name of the plant is Foeniculum vulgare Miller subsp.
Slovenian: Botanično latinsko ime rastline je Foeniculum vulgare Miller subsp.
English: The justification for the use of these preparations is found in their traditional use as herbal medicines.
Slovenian: Uporaba teh pripravkov je utemeljena z njihovo tradicionalno uporabo kot zdravil rastlinskega izvora.
English: This image is not intended to encourage collection from the wild.
Slovenian: Njen namen ni spodbuditi nabiranja rastline v naravi.
English: The most common side effects with sweet fennel fruit medicines are related to allergic reactions, affecting the skin or the respiratory system.
Slovenian: Najpogostejši neželeni učinki zdravil iz plodov sladkega navadnega komarčka so povezani z alergičnimi reakcijami, ki prizadenejo kožo ali dihalni sistem.
English: The Commission decision establishing the Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products can be found here.
Slovenian: Odločba Komisije o vzpostavitvi seznama rastlinskih snovi, pripravkov in kombinacij iz njih za uporabo v tradicionalnih zdravilih rastlinskega izvora je na voljo tukaj.
English: There are few studies looking at the safety of sweet fennel fruit preparations, but the many years of experience of their use in man indicate that they are sufficiently safe.
Slovenian: Študij o varnosti pripravkov iz plodov sladkega navadnega komarčka je malo, vendar dolgoletne izkušnje z njihovo uporabo pri človeku kažejo, da so dovolj varni.
English: VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS FENNEL FRUIT, SWEET HMPC Assessment Report Summary for the Public
Slovenian: VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS PLOD SLADKEGA NAVADNEGA KOMARČKA Povzetek poročila odbora HMPC o oceni zdravila
English: Further information on the HMPC assessment on Foeniculum vulgare Miller subsp.
Slovenian: Dodatne informacije o oceni HMPC o Foeniculum vulgare Miller subsp.
English: Community list entries are authorised by the European Commission further to the scientific opinion of the HMPC and describe the herbal medicines, including their content, how they are used, what they are used for, how they work and how they can be used safely.
Slovenian: Vpise v seznam Skupnosti odobri Evropska komisija na podlagi znanstvenega mnenja HMPC, vsebujejo pa opis zdravil rastlinskega izvora, vključno s podatki o njihovi sestavi, načinu in namenu uporabe, načinu delovanja in zagotovitvi varne uporabe zdravila.
English: Sweet fennel fruit medicines are available in various forms to be taken by mouth, such as herbal tea, tablets, capsules.
Slovenian: Zdravila iz plodov navadnega sladkega komarčka so na voljo v različnih oblikah, ki jih zaužijemo peroralno, npr. v obliki zeliščnega čaja, tablet ali kapsul.
English: It was has been observed that a number of compounds detected in fennel fruit inhibit the growth of pathogenic bacteria and fungi.
Slovenian: Opazili so, da številne sestavine ploda navadnega komarčka zavirajo rast patogenih bakterij in gliv.
English: Sweet fennel fruit medicines can be used from the age of 4 years.
Slovenian: Zdravila iz plodov sladkega navadnega komarčka se lahko uporabljajo od 4. leta starosti dalje.
English: Clinical trials on sweet fennel fruit medicines are limited, but pharmacological data support the plausibility of the traditional medicinal use.
Slovenian: Klinična preskušanja zdravil iz sladkega navadnega komarčka so omejena, vendar pa farmakološki podatki podpirajo verodostojnost tradicionalne medicinske uporabe zdravila.
English: Studies on isolated components of these medicines could not fully explain the activity of the medicines, so it is thought that several components in sweet fennel fruit preparations work together to bring about their effects.
Slovenian: Študije posameznih sestavin teh zdravil niso v celoti pojasnile delovanja teh zdravil, zato se domneva, da je učinek pripravkov posledica skupnega delovanja več sestavin sladkega navadnega komarčka.
English: Other information about sweet fennel fruit medicines The medicinal use of sweet fennel fruit is part of traditional European Phytotherapy.
Slovenian: Druge informacije o zdravilih iz plodov sladkega navadnega komarčka Uporaba plodov sladkega navadnega komarčka v medicini je del tradicionalne evropske fitoterapije.
English: The plant is cultivated to obtain the fruits (also commonly called fennel seeds) for medicinal use (herbal substance).
Slovenian: Gojijo jo za pridelavo plodov (splošno znanih kot semena navadnega komarčka) za uporabo v medicini (rastlinska snov).
English: Furthermore, the secretolytic and expectorant effect of two main components of sweet fennel fruit (anethole and estragole) observed in a study conducted in rabbits, could also support the plausibility of the traditional use of fennel in cough associated with colds.
Slovenian: Sekretolitični in ekspektorantski učinki obeh glavnih sestavin sladkega navadnega komarčka (anetol in estragol), opaženi v študiji pri kuncih, prav tako podpirajo verodostojnost tradicionalne uporabe navadnega komarčka pri zdravljenju kašlja, povezanega s prehladi.
English: Sweet fennel fruit medicines should not be used in people who may be hypersensitive (allergic) to sweet fennel.
Slovenian: Zdravil iz plodov sladkega navadnega komarčka ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) sladki navadni komarček.
English: Detailed instructions can be found in the package leaflet that comes with each medicinal product.
Slovenian: Podrobnejši napotki so na voljo v navodilu za uporabo, ki je priloženo vsakemu zdravilu.
English: Because there have been no tests looking at the effects of sweet fennel fruit medicines during pregnancy or lactation, they should not be used in women who are pregnant or breast-feeding as a general precaution.
Slovenian: Ker preskušanja učinkov zdravil iz plodov sladkega navadnega komarčka niso bila izvedena v obdobju nosečnosti in dojenja, se kot splošni previdnosti ukrep odsvetuje uporaba teh zdravil pri nosečnicah in doječih materah.
English: Sweet fennel fruit medicines are generally well tolerated.
Slovenian: Zdravila iz plodov sladkega navadnega komarčka se na splošno dobro prenašajo.
English: The dose of sweet fennel fruit medicines and how often they are used depends on what they are being used for and the formulation of the medicine being used.
Slovenian: Odmerek in pogostost uporabe zdravil iz plodov sladkega navadnega komarčka sta odvisna od namena uporabe in formulacije uporabljenega zdravila.
English: Important information on the use of a traditional herbal medicine can be found in the package leaflet that comes with each individual product.
Slovenian: Za pomembne informacije o uporabi tradicionalnih zdravil rastlinskega izvora glejte navodilo za uporabo, ki je priloženo vsakemu posameznemu zdravilu.
English: Preparations made from sweet fennel fruit can also be found in combination with other herbal substances.
Slovenian: Pripravki iz plodov sladkega navadnega komarčka lahko vsebujejo tudi druge rastlinske snovi.
English: A relaxing effect on isolated contracted smooth muscles of alcoholic extracts of fennel and fennel essential oil has been reported.
Slovenian: Poročali so o sproščujočem učinku alkoholnih ekstraktov iz navadnega komarčka in eteričnega olja iz navadnega komarčka na posamezne skrčene gladke mišice.
English: The relaxing and anti-inflammatory effects together with the antimicrobial action of their constituents may contribute to the traditional use of sweet fennel medicines in the treatment of minor spasmodic gastro-intestinal complaints and in the treatment of cough associated with colds.
Slovenian: Sproščujoči in protivnetni učinki skupaj s protimikrobnim delovanjem sestavin lahko pojasnijo tradicionalno uporabo zdravil iz sladkega navadnega komarčka pri zdravljenju blažjih prebavnih težav s krči in zdravljenju kašlja, povezanega s prehladom.© EMEA 2010
English: Sweet fennel fruit medicines are traditionally used for: - symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
Slovenian: Zdravila iz plodov sladkega navadnega komarčka se tradicionalno uporabljajo za: - simptomatsko zdravljenje blagih prebavnih težav s krči, vključno z napenjanjem in vetrovi; - simptomatsko zdravljenje blažjih krčev, povezanih z menstruacijo; - kot ekspektorans (zdravilo za lažje izkašljevanje) pri kašlju, povezanem s prehladom.
English: For further information, see section ‘Specified posology of the Community list entry on sweet fennel fruit.
Slovenian: Za več informacij si preberite poglavje „Odmerjanje“ v vpisu v seznam Skupnosti za plod sladkega navadnega komarčka.
English: What are the risks associated with sweet fennel fruit medicines?
Slovenian: Kakšna tveganja so povezana z zdravili iz plodov sladkega navadnega komarčka?
English: This document is a summary of the assessment report adopted by the Committee on Herbal Medicinal Products (HMPC) that describes the data available on the medicinal use of a herbal substance and the conclusions after evaluating these data.
Slovenian: Ta dokument je povzetek poročila o oceni zdravila, ki ga je sprejel Odbor za zdravila rastlinskega izvora (HMPC).
English: What studies were conducted with sweet fennel fruit medicines?
Slovenian: Katere študije so bile izvedene z zdravili iz plodov sladkega navadnega komarčka?
English: The full list of all side effects reported for a given sweet fennel fruit medicine is found in its package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri zadevnem zdravilu iz plodov sladkega navadnega komarčka, glejte navodilo za uporabo.
English: Sweet fennel fruit medicines contain the fruit of the sweet fennel plant.
Slovenian: Zdravila iz plodov sladkega navadnega komarčka vsebujejo plodove sladkega navadnega komarčka.
English: Moreover an anti-inflammatory effect has been reported following oral administration to rats.
Slovenian: Poročali so tudi o protivnetnem učinku pri peroralni uporabi zdravila pri podganah.
English: How do sweet fennel fruit medicines work?
Slovenian: Kako zdravila iz plodov sladkega navadnega komarčka delujejo?
English: What are sweet fennel fruit medicines used for?
Slovenian: Za kaj se zdravila iz plodov sladkega navadnega komarčka uporabljajo?
English: How are sweet fennel fruit medicines used?
Slovenian: Kako se zdravila iz plodov sladkega navadnega komarčka uporabljajo?
English: The marketing authorisation application (MAA) for Myoson was submitted under Article 10(1) of Directive 2001/83/EC (i.e. a generic application), vis-à-vis the reference medicinal product Mydeton (Gedeon Richter Plc).
Slovenian: Vloga za pridobitev dovoljenja za promet z zdravilom Myoson je bila predložena v skladu s členom 10(1) Direktive 2001/83/ES (tj. generična vloga) in je temeljila na referenčnem zdravilu Mydeton (Gedeon Richter Plc).
English: • The Committee reviewed the responses submitted by the applicant to address the issues raised with regard to the bioequivalence of Myoson with respect to the reference medicinal product;
Slovenian: • odbor je pregledal odgovore, ki jih je predložil predlagatelj, da bi razrešil odprta vprašanja v zvezi z biološko enakovrednostjo zdravila Myoson in referenčnega zdravila;
English: The CHMP has recommended the granting of the marketing authorisation for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group, for Myoson and associated names (see Annex I).
Slovenian: je odbor CHMP priporočil odobritev dovoljenja za promet z zdravilom, katerega povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo ostanejo enaki kot zadnje različice, dogovorjene med postopkom Usklajevalne skupine, za zdravilo Myoson in povezana imena (glejte Prilogo I).
English: The active substance of Myoson is tolperisone hydrochloride, which is a centrally acting muscle relaxant indicated for the symptomatic treatment of post-stroke spasticity in adults.
Slovenian: Zdravilna učinkovina v zdravilu Myoson je tolperizonijev klorid, mišični relaksant, ki deluje na osrednje živčevje in je indiciran za simptomatsko zdravljenje spastičnosti, ki je posledica možganske kapi, pri odraslih.
English: • Therefore, the Committee concluded by majority that the bioequivalence studies conducted in the fasting state give sufficient evidence to conclude on the bioequivalence also in the fed state since Myoson contains a highly soluble and highly permeable active substance, and pharmacokinetic principles and convincing experimental evidence suggest that the food effect of this active substance is formulation independent.
Slovenian: • odbor je zato z večino zaključil, da sta bioekvivalenčni študiji, izvedeni v pogojih na tešče, zagotovili zadostne dokaze, da je mogoče sklepati o biološki enakovrednosti tudi v pogojih na poln želodec, saj zdravilo Myoson vsebuje lahko topno in zelo permeabilno zdravilno učinkovino, načela farmakokinetike in prepričljivi eksperimentalni dokazi pa kažejo, da vpliv hrane na to zdravilno učinkovino ni odvisen od formulacije;
English: Since the summary of product characteristics (SmPC) of the reference medicinal product did not make any recommendations regarding food and did not mention a food effect, the MAA that was submitted for Myoson included two bioequivalence studies with 50 and 150 mg tolperisone film-coated tablets conducted under fasting conditions with 52 volunteers each.
Slovenian: Povzetek glavnih značilnosti zdravila za referenčno zdravilo ni vseboval nobenih priporočil glede hrane niti navedbe o vplivu hrane, zato sta bili k vlogi za pridobitev dovoljenja za promet z zdravilom, ki je bila predložena za Myoson, priloženi dve bioekvivalenčni študiji s 50- in 150-miligramskimi filmsko obloženimi tabletami tolperizona, ki so ju izvedli v pogojih na tešče, v vsaki pa je sodelovalo 52 prostovoljcev.
English: • The Committee was of the view that results of the submitted bioequivalence studies showed that Myoson 50 and 150 mg tablets was bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets under fasting conditions;
Slovenian: • odbor CHMP je menil, da so rezultati predloženih bioekvivalenčnih študij pokazali, da so 50- in 150-miligramske tablete zdravila Myoson biološko enakovredne 50- in 150-miligramskim tabletam referenčnega zdravila Mydeton v pogojih na tešče;
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Myoson 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Slovenian: Člani odbora CHMP so se na podlagi rezultatov predloženih bioekvivalenčnih študij strinjali, da so 50- in 150-miligramske tablete zdravila Myoson biološko enakovredne 50- in 150-miligramskim tabletam referenčnega zdravila Mydeton (Gedeon Richter Plc) v pogojih na tešče.
English: You may need medical treatment.
Slovenian: Morda boste potrebovali zdravljenje.
English: · Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganja (RMP)
English: Often these are colds, but there have been cases of more severe infections.
Slovenian: Pogosto so to prehladi, zabeležili pa so tudi hujše okužbe.
English: These can be complemented with other appropriate markers as per local guidelines.
Slovenian: To je mogoče dopolniti z drugimi ustreznimi označevalci v skladu z lokalnimi smernicami.
English: No specific dose recommendations can be made.
Slovenian: Specifičnih priporočil za odmerjanje ni mogoče dati.
English: Any additional guidelines according to standard practice should be followed.
Slovenian: Dodatno je treba upoštevati morebitne dodatne smernice v skladu s standardno prakso.
English: Stage 1a
Slovenian: Faza 1a
English: The affected “B-lymphocytes” multiply too quickly and live too long.
Slovenian: Prizadeti limfociti B se množijo prehitro in živijo predolgo.
English: Additional safety information from clinical studies experience
Slovenian: Dodatne informacije o varnosti iz izkušenj v kliničnih študijah
English: 82377 Penzberg GERMANY
Slovenian: 82377 Penzberg
English: Antibodies work by attaching themselves to specific targets in your body.
Slovenian: Protitelesa delujejo tako, da se vežejo na specifične tarče v telesu.
English: Based on your disease status after the initial treatment cycles your doctor will decide whether you will receive treatment in the maintenance phase.
Slovenian: Glede na status vaše bolezni po začetnih ciklih zdravljenja se bo vaš zdravnik odločil, ali boste v vzdrževalni fazi prejemali zdravljenje.
English: Each cycle lasts 28 days.
Slovenian: Vsak cikel traja 28 dni.
English: Bendamustine N=166
Slovenian: Bendamustin n = 166
English: Your doctor/nurse will monitor you carefully for infusion related reactions.
Slovenian: Zdravnik/medicinska sestra vas bosta skrbno nadzirala glede reakcij, povezanih z infuzijo.
English: A risk for interactions with other concomitantly used medicinal products cannot be excluded.
Slovenian: Tveganja za medsebojno delovanje z drugimi sočasno uporabljenimi zdravili ni mogoče izključiti.
English: Worsening of pre-existing cardiac conditions
Slovenian: Poslabšanje obstoječih srčnih bolezni
English: This is because small amounts of the medicine may pass into your breast milk.
Slovenian: Majhna količina zdravila namreč lahko pride v materino mleko.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2014
Slovenian: Datum prve odobritve: 23. julij 2014 Datum zadnjega podaljšanja:
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Slovenian: Za čim boljšo učinkovitost tega zdravila je namreč pomembno, da upoštevate razpored odmerjanja.
English: A typical schedule is shown below.
Slovenian: Tipičen razpored je prikazan spodaj.
English: Hypersensitivity symptoms can occur after previous exposure and very rarely with the first infusion.
Slovenian: Simptomi preobčutljivosti se lahko pojavijo po predhodni izpostavljenosti in zelo redko ob prvi infuziji.
English: Any signs of concomitant infection should be treated as appropriate.
Slovenian: Morebitne znake sočasne okužbe je treba zdraviti, kot je primerno.
English: The diluted solution should not be shaken or frozen.
Slovenian: Razredčene raztopine se ne sme stresati ali zamrzniti.
English: Results of subgroup analyses
Slovenian: Rezultati analiz podskupin
English: These reactions are more likely to happen with the first infusion.
Slovenian: Te reakcije so bolj verjetne med prvo infuzijo.
English: Size of PVC or non-PVC polyolefin infusion bag
Slovenian: Velikost PVC ali ne-PVC poliolefinske infuzijske vrečke
English: Patients requiring premedication
Slovenian: Bolniki, ki potrebujejo premedikacijo
English: A post hoc analysis was performed 8 months after the primary analysis data cut.
Slovenian: Analizo post-hoc so izvedli 8 mesecev po zaključku zajema podatkov za primarno analizo.
English: These reactions led to unscheduled termination of 6/36 animals treated with obinutuzumab during dosing and recovery phases; these changes were partially reversible.
Slovenian: Te reakcije so povzročile nenačrtovano prekinitev pri 6/36 živali, ki so prejemale obinutuzumab med fazo odmerjanja in okrevanja; spremembe so bile delno reverzibilne.
English: · A typical schedule is shown below.
Slovenian: • Tipičen razpored je prikazan spodaj.
English: This is because treatment with Gazyvaro may affect yours or the baby's health.
Slovenian: Zdravljenje z zdravilom Gazyvaro namreč lahko vpliva na vaše ali otrokovo zdravje.
English: followed by 48 hours (including infusion time) at ≤ 30°C.
Slovenian: 8 °C, čemur sledi 48 ur (vključno s časom infundiranja) pri temperaturi ≤ 30 °C.
English: When these symptoms go away, or improve, the infusion can be continued.
Slovenian: Ko ti simptomi minejo ali se izboljšajo, je infundiranje mogoče nadaljevati.
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba pripravljeno raztopino za infundiranje uporabiti takoj.
English: The majority of the patients in study GAO4753g had FL (81.1%).
Slovenian: Večina bolnikov v študiji GAO4753g je imela FL (81,1 %).
English: However, if you get an infusion related reaction, (see section 4), do not drive, cycle or use any tools or machines until the reaction stops.
Slovenian: Če pa se vam pojavi reakcija, povezana z infuzijo (glejte poglavje 4), ne upravljajte vozil, ne kolesarite in ne uporabljajte kakršnih koli orodij ali strojev, dokler reakcija ne mine.
English: Patients should continue to receive repeated prophylaxis prior to each subsequent infusion, if deemed appropriate.
Slovenian: Bolniki morajo nadaljevati z jemanjem ponovnih profilaks pred vsako nadaljnjo infuzijo, če se smatra, da je to primerno.
English: Do not increase the infusion rate.
Slovenian: Ne povečajte hitrosti infundiranja.
English: · you are allergic to obinutuzumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na obinutuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Gastro-Intestinal Perforation
Slovenian: Gastro-intestinalne perforacije
English: However, no notable differences in quality of life during follow up have been identified to date.
Slovenian: Vendar do zdaj med spremljanjem niso ugotovili pomembnih razlik v kakovosti življenja.
English: Clearly label each infusion bag.
Slovenian: Obe infuzijski vrečki jasno označite.
English: Due to the open label design the patient reported outcomes should be interpreted with caution.
Slovenian: Zaradi odprte zasnove študije je treba izide po navedbi bolnika razlagati previdno.
English: If treatment is necessary it should be administered in accordance with local guidelines and the administration of granulocyte-colony stimulating factors (G-CSF) should be considered.
Slovenian: Če je potrebno zdravljenje, ga je treba uporabiti v skladu z lokalnimi smernicami in razmisliti o uporabi granulocitne kolonije stimulirajočih faktorjev (granulocyte-colony stimulating factor - G-CSF).
English: In addition these patients should be hydrated with caution in order to prevent a potential fluid overload.
Slovenian: Poleg tega je treba pri teh bolnikih hidracijo izvajati previdno, da bi preprečili možno preobremenitev s tekočino.
English: Antibodies are mostly cleared by catabolism.
Slovenian: Protitelesa se večinoma odstranijo s katabolizmom.
English: While the clinical significance of HAHA is not known, a potential correlation between HAHA and clinical course cannot be ruled out.
Slovenian: Čeprav klinični pomen protiteles HAHA ni znan, možne povezave med protitelesi HAHA in kliničnim potekom ni mogoče izključiti.
English: There are no data from the use of obinutuzumab in pregnant women.
Slovenian: Podatkov o uporabi obinutuzumaba pri nosečnicah ni.