FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary is not intended to provide practical advice on how to use medicines containing primula flower.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo cvet jegliča.
English: Primula flower is the common name for the flowers of the plant Primula veris L. and/or Primula elatior (L.) Hill.
Slovenian: Cvet jegliča je splošno ime za cvetove rastline Primula veris L. in/ali Primula elatior (L.) Hill.
English: No clinical studies have been carried out with primula flower.
Slovenian: Klinične študije s cvetom jegliča niso bile izvedene.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of primula flower.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo cveta jegliča.
English: The HMPC conclusions only cover primula flower preparations which are obtained by comminuting (reducing into tiny pieces) the flowers or using a technique to extract compounds by putting the plant material in a solvent (such as ethanol) to dissolve compounds and form a liquid extract.
Slovenian: Zaključki odbora HMPC zajemajo samo pripravke s cvetom jegliča, ki se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) cvetov ali z uporabo tehnike, s katero se spojine ekstrahirajo tako, da se rastlinski material najprej namoči v topilo (npr. etanol), v katerem se raztopijo spojine in se pridobi tekoči ekstrakt.
English: Further information on the risks associated with these primula flower 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 s temi zdravili, ki vsebujejo cvet jegliča, 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 conclusions on the use of these primula flower medicines for coughs are based on their ‘traditional use' .
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo cvet jegliča, za zdravljenje kašlja temeljijo na njihovi „tradicionalni uporabi“.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing primula flower.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo cvet jegliča.
English: Primula flower medicines must not be used in patients who are allergic to primula flower or to other plants of the primula species.
Slovenian: Zdravila, ki vsebujejo cvet jegliča, se ne smejo uporabljati pri bolnikih, ki so alergični na cvet jegliča ali druge rastline iz vrst jegličev.
English: Herbal medicines containing these primula flower preparations are usually available as herbal tea to be drunk and in liquid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo te pripravke s cvetom jegliča, so navadno na voljo kot zdravilni čaj, ki se popije, in v tekoči obliki za jemanje skozi usta.
English: How are primula flower medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo cvet jegliča, odobrena v EU?
English: Further information on the HMPC assessment of primula flower 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 cvet jegliča, 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: Any applications for the licensing of medicines containing primula flower 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 cvet jegliča, 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 primula flower medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in registraciji zdravil, ki vsebujejo cvet jegliča, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: Primula flower preparations may also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Pripravki s cvetom jegliča so v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Other information about primula flower medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo cvet jegliča
English: What evidence supports the use of primula flower medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo cvet jegliča?
English: In its assessment, the HMPC considered laboratory studies which showed primula flower increased production of airway secretions, making phlegm less thick and easier to expel.
Slovenian: V svoji oceni je odbor HMPC upošteval študije z laboratorijskimi preskusi, ki so pokazale, da je cvet jegliča povečal izločanje sluzi v dihalih, zaradi česar je bila sluz manj gosta in jo je bilo laže izkašljati.
English: The HMPC concluded that, on the basis of its long-standing use, these primula flower primula flower preparations can be used as an expectorant (a medicine that helps bring up phlegm) for coughs associated with colds.
Slovenian: Odbor HMPC je na podlagi dolgotrajne uporabe zaključil, da se lahko ti pripravki, ki vsebujejo cvet jegliča, uporabljajo kot ekspektoransi (zdravila za lažje izkašljevanje sluzi) pri kašlju, povezanem s prehladom.
English: What are the risks associated with primula flower medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo cvet jegliča?
English: For more information about treatment with primula flower 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 cvet jegliča, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using primula flower 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 instructions on how to take primula flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: zdravil, ki vsebujejo cvet jegliča, in o tem, kdo sme ta zdravila jemati, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: The company that applied for authorisation is Teva B.V.
Slovenian: Podjetje, ki je zaprosilo za dovoljenje, je Teva B.V.
English: To support this claim, the company referred to published data and provided an expert opinion.
Slovenian: V podporo tej trditvi se je podjetje sklicevalo na objavljene podatke in predložilo strokovno mnenje.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Slovenian: V 15 dneh od prejema uradnega obvestila o negativnem mnenju lahko zahteva ponovno proučitev mnenja.
English: Data from clinical studies also showed differences in the safety profile of the two active substances.
Slovenian: Podatki iz kliničnih študij so pokazali tudi razlike v varnostnem profilu učinkovin.
English: Furthermore, patients receiving cabazitaxel are exposed to the unchanged substance plus two active breakdown products, which are not formed when docetaxel is given.
Slovenian: Poleg tega so bolniki, ki prejemajo kabazitaksel, izpostavljeni nespremenjeni učinkovini in dvema aktivnima produktoma razgradnje, ki pri dajanju docetaksela ne nastajata.
English: Additionally, laboratory data suggest that cabazitaxel can be effective at treating cancer that is resistant to docetaxel.
Slovenian: Poleg tega laboratorijski podatki kažejo, da je kabazitaksel lahko učinkovit pri zdravljenju raka, ki je odporen proti docetakselu.
English: On 26 April 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Cabazitaxel Teva, intended for the treatment of prostate cancer.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 26. aprila 2019 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Cabazitaxel Teva, namenjenim zdravljenju raka prostate.
English: The company informed the CHMP that there are no ongoing clinical trials with Cabazitaxel Teva in the EU.
Slovenian: Podjetje je odbor CHMP obvestilo, da v EU trenutno ne poteka nobeno klinično preskušanje z zdravilom Cabazitaxel Teva.
English: The company made reference to two medicines, Jevtana (containing cabazitaxel) and Taxotere (containing docetaxel, see below for more details).
Slovenian: Podjetje se je sklicevalo na dve zdravili, in sicer zdravilo Jevtana (ki vsebuje kabazitaksel) in zdravilo Taxotere (ki vsebuje docetaksel; za več podrobnosti glejte spodaj).
English: Based on these findings, the CHMP was of the opinion that it cannot be concluded that cabazitaxel and docetaxel do not differ significantly with regard to safety and effectiveness.
Slovenian: Odbor CHMP je na podlagi teh ugotovitev menil, da ni mogoče zaključiti, da se kabazitaksel in docetaksel glede varnosti in učinkovitosti ne razlikujeta bistveno.
English: Because Cabazitaxel Teva was developed as a hybrid medicine, the company presented data from the published literature to demonstrate that it is similar to Jevtana.
Slovenian: Ker je bilo zdravilo Cabazitaxel Teva razvito kot hibridno zdravilo, je podjetje predložilo podatke iz objavljene literature kot dokaz, da je podobno zdravilu Jevtana.
English: The applicant also made reference to another medicine, Taxotere, which contains docetaxel.
Slovenian: Predlagatelj se je skliceval še na zdravilo Taxotere, ki vsebuje docetaksel.
English: The CHMP did not agree that the data presented by the company were sufficient to support the claim that cabazitaxel and docetaxel should be considered the same active substance.
Slovenian: Odbor CHMP se ni strinjal, da podatki, ki jih je predložilo podjetje, zadoščajo kot podpora trditvi, da je treba kabazitaksel in docetaksel obravnavati kot enaki učinkovini.
English: This means that Cabazitaxel Teva was intended to be similar to a ‘reference medicine' containing the same active substance and already authorised in the European Union.
Slovenian: To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki vsebuje enako učinkovino in je že odobreno v Evropski uniji.
English: Cabazitaxel works by blocking the ability of cancer cells to break down their internal ‘skeleton' that allows them to divide and multiply.
Slovenian: Deluje tako, da zavira sposobnost rakavih celic za razgradnjo njihovega notranjega „ogrodja“, ki jim omogoča, da se delijo in množijo.
English: Cabazitaxel also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.
Slovenian: Kabazitaksel učinkuje tudi na nerakave celice, kot so krvne ali živčne celice, kar lahko povzroči neželene učinke.
English: The company claimed that cabazitaxel is a derivative of docetaxel, and that the active substances do not differ significantly in their safety and effectiveness.
Slovenian: Podjetje je trdilo, da je kabazitaksel derivat docetaksela in da se učinkovini glede varnosti in učinkovitosti ne razlikujeta bistveno.
English: Cabazitaxel Teva was developed as a ‘hybrid medicine'.
Slovenian: Zdravilo Cabazitaxel Teva je bilo razvito kot „hibridno zdravilo“.
English: Cabazitaxel Teva was to be used when the cancer had spread to other parts of the body (metastatic) despite treatments to prevent the production of testosterone or after surgical removal of the testes (castration).
Slovenian: Zdravilo Cabazitaxel Teva naj bi se uporabljalo, kadar se je rak razširil na druge dele telesa (metastaziral) kljub zdravljenjem za zaviranje tvorjenja testosterona ali po kirurški odstranitvi mod (kastraciji).
English: Refusal of the marketing authorisation for Cabazitaxel Teva (cabazitaxel)
Slovenian: Zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Cabazitaxel Teva (kabazitaksel)
English: Cabazitaxel Teva was expected to be used to treat men with prostate cancer, a cancer that affects the prostate gland (which produces the liquid in semen).
Slovenian: Zdravilo Cabazitaxel Teva naj bi se uporabljalo za zdravljenje moških z rakom prostate, tj. rakom, ki prizadene žlezo prostato (ki proizvaja tekočino v spermi).
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: There was no need for ‘bioequivalence' studies to investigate whether Cabazitaxel Teva is absorbed similarly to Jevtana to produce the same level of the active substance in the blood.
Slovenian: Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Cabazitaxel Teva absorbira podobno kot zdravilo Jevtana in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
English: This is because Cabazitaxel Teva is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Slovenian: Zdravilo Cabazitaxel Teva se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
English: Cabazitaxel belongs to the group of cancer medicines known as ‘taxanes'.
Slovenian: Kabazitaksel spada v skupino zdravil za zdravljenje raka, imenovanih „taksani“.
English: Cabazitaxel Teva is a cancer medicine that contains the active substance cabazitaxel.
Slovenian: Cabazitaxel Teva je zdravilo za zdravljenje raka, ki vsebuje učinkovino kabazitaksel.
English: Cabazitaxel Teva was to be used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).
Slovenian: Uporabljalo naj bi se v kombinaciji s prednizonom ali prednizolonom (protivnetnima zdraviloma) pri bolnikih, ki so se že zdravili z docetakselom (drugim zdravilom za zdravljenje raka).
English: Cabazitaxel Teva is expected to work in the same way as the reference medicine, Jevtana.
Slovenian: Zdravilo Cabazitaxel Teva naj bi delovalo na enak način kot referenčno zdravilo Jevtana.
English: What is Cabazitaxel Teva?
Slovenian: Kaj je zdravilo Cabazitaxel Teva?
English: What was Cabazitaxel Teva expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Cabazitaxel Teva uporabljalo?
English: How does Cabazitaxel Teva work?
Slovenian: Kako zdravilo Cabazitaxel Teva deluje?
English: Thus Taxotere cannot be used to support the application for Cabazitaxel Teva and the CHMP recommended that Cabazitaxel Teva be refused marketing authorisation.
Slovenian: Zato zdravila Taxotere ni mogoče uporabiti v podporo vlogi za zdravilo Cabazitaxel Teva.
English: Although cabazitaxel is a derivative of docetaxel, laboratory studies have shown that cabazitaxel and docetaxel have different properties, for example cabazitaxel can cross the blood-brain barrier while docetaxel cannot.
Slovenian: Čeprav je kabazitaksel derivat docetaksela, so laboratorijske študije pokazale, da imata kabazitaksel in docetaksel drugačne lastnosti.
English: Egg production may also be affected.
Slovenian: Prizadeta je lahko tudi proizvodnja jajc.
English: If another course of treatment is required, the interval between the two courses of treatment should be at least 3 months.
Slovenian: Če je potreben še en cikel zdravljenja, mora interval med obema zdravljenjema znašati vsaj tri mesece.
English: The duration of effectiveness was between 6 weeks and 8 months, depending on the length of the production cycle and how effectively the farms prevented re-introduction of new mites into their houses.
Slovenian: Učinkovitost je trajala od 6 tednov do 8 mesecev, odvisno od dolžine proizvodnega ciklusa in tega, kako učinkovito so farme preprečevale ponovni vnos pršic v svoje hleve.
English: While handling the product people must not eat, drink or smoke.
Slovenian: Pri ravnanju z zdravilom se ne sme jesti, piti ali kaditi.
English: The full EPAR for Exzolt can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Exzolt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Exzolt.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Sufficient Exzolt is added to ensure the required dose is present in the volume of water that the chickens will consume in one day.
Slovenian: Doda se dovolj zdravila Exzolt, da se zagotovi potreben odmerek v količini vode, ki jo bodo piščanci zaužili v enem dnevu.
English: This means it kills parasites such as mites that feed on the skin of animals.
Slovenian: To pomeni, da ubija parazite, kot so pršice, ki se hranijo na koži živali.
English: Exzolt reduced the number of mites by more than 99% in pullets and breeders and more than 98% in layers.
Slovenian: Zdravilo Exzolt je število pršic zmanjšalo za več kot 99 % pri jarkicah in matičnih jatah ter za več kot 98 % pri nesnicah.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Exzolt's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Exzolt večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for Exzolt.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Exzolt.
English: Exzolt has been studied in a field study involving 9 farms with poultry red mite infestation, each with two similar houses with 550 to 100,000 chickens per house.
Slovenian: Zdravilo Exzolt so raziskovali v terenski raziskavi, v katero je bilo vključenih devet farm, na katerih je prišlo do infestacije z rdečimi pršicami perutnine, vsaka pa je imela dva podobna hleva s 550 do 100 000 piščanci na hlev.
English: What are the risks associated with Exzolt?
Slovenian: Kakšna tveganja so povezana z zdravilom Exzolt?
English: Fluralaner kills mites by acting on their nervous system after they have ingested the chicken's blood.
Slovenian: Fluralaner ubija pršice tako, da deluje na njihov živčni sistem, potem ko so zaužile kri piščanca.
English: It works by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the mites.
Slovenian: Deluje tako, da ovira pot, po kateri potujejo signali med živčnimi celicami v živčnem sistemu zajedavcev, kar povzroči paralizo in pogin pršic.
English: What benefits of Exzolt have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Exzolt izkazalo v študijah?
English: Why is Exzolt approved?
Slovenian: Zakaj je bilo zdravilo Exzolt odobreno?
English: Since the veterinary medicine may be slightly irritating to skin and/or eyes, contact with skin, eyes and mucous membranes (moist body surfaces, such as the lining of the mouth) should be avoided.
Slovenian: Ker je zdravilo za uporabo v veterinarski medicini lahko rahlo dražilno za kožo in/ali oči, se je treba izogibati stiku s kožo, očmi in sluznicami (vlažnimi telesnimi površinami, kot je ustna sluznica).
English: Exzolt is a veterinary medicine used to treat poultry red mite (Dermanyssus gallinae) infestation in pullets (young female chickens), breeders and layer hens.
Slovenian: Exzolt je zdravilo za uporabo v veterinarski medicini, ki se uporablja za zdravljenje infestacij z rdečimi pršicami perutnine (Dermanyssus gallinae) pri jarkicah (mladih piščancih ženskega spola), matičnih jatah in kokoših nesnicah.
English: Poultry red mite is a parasite that feeds on the blood of hens.
Slovenian: Rdeča pršica perutnine je parazit, ki se hrani s krvjo kokoši.
English: Red mite infestations can cause irritation and restlessness of the bird, feather pecking and anaemia (low red blood cell counts).
Slovenian: Infestacije z rdečimi pršicami lahko povzročijo razdraženost in nemir ptičev, kljuvanje perja in anemijo (nizko število rdečih krvnih celic).
English: Exzolt is added to drinking water on two occasions, seven days apart.
Slovenian: Zdravilo Exzolt se v pitno vodo doda dvakrat v razmiku sedmih dni.
English: What is Exzolt and what is it used for?
Slovenian: Kaj je zdravilo Exzolt in za kaj se uporablja?
English: The withdrawal period for eggs from chickens treated with Exzolt is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za jajca piščancev, zdravljenih z zdravilom Exzolt, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: Hands and contacted skin should be washed after use of the medicine.
Slovenian: Roke in kožo, ki je prišla v stik z zdravilom, je treba po uporabi zdravila sprati.
English: The withdrawal period for meat from chickens treated with Exzolt is 14 days.
Slovenian: Karenca za meso piščancev, zdravljenih z zdravilom Exzolt, je 14 dni.
English: One of the houses on each of the farms was treated with Exzolt, the other house was left untreated.
Slovenian: V enem od hlevov na vsaki farmi so bile živali zdravljene z zdravilom Exzolt, v drugem hlevu pa niso bile zdravljene.
English: The active substance in Exzolt, fluralaner, acts as an ‘ectoparasiticide'.
Slovenian: Zdravilna učinkovina v zdravilu Exzolt, fluralaner, deluje kot ektoparaziticid.
English: Other information about Exzolt?
Slovenian: Druge informacije o zdravilu Exzolt
English: Exzolt is available as a solution for use in drinking water and can only be obtained with a prescription.
Slovenian: Zdravilo Exzolt je na voljo v obliki raztopine za dajanje v vodo za pitje, njegovo predpisovanje in izdaja pa je le na recept.
English: Exzolt contains the active substance fluralaner.
Slovenian: Zdravilo Exzolt vsebuje zdravilno učinkovino fluralaner.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Exzolt, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Slovenian: V povzetek glavnih značilnosti zdravila Exzolt in navodilo za njegovo uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
English: For more information about treatment with Exzolt, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Exzolt naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: The European Commission granted a marketing authorisation valid throughout the EU for Exzolt on 18 August 2017.
Slovenian: Evropska komisija je izdala dovoljenje za promet z zdravilom Exzolt, veljavno po vsej Evropski uniji