FrancophonIA/ELRC3.0 huggingface dataset:
English: Egranli was investigated in a main study in 304 breast cancer patients receiving chemotherapy, in which it was compared with another medicine containing a different long-acting G-CSF called pegfilgrastim.
Slovenian: Zdravilo Egranli so proučevali v glavni študiji, v katero so bile vključene 304 bolnice z rakom dojke, ki so prejemale kemoterapijo, v okviru te študije pa so Egranli primerjali z drugim zdravilom, ki vsebuje drug dolgodelujoč G-CSF, imenovan pegfilgrastim.
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Egranli (balugrastim)
English: Based on the review of the data, at the time of the withdrawal the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Egranli for the reduction of the duration of neutropenia and of the occurrence of febrile neutropenia.
Slovenian: Na podlagi pregleda podatkov je Odbor v času umika izrazil pozitivno mnenje in priporočil izdajo dovoljenja za promet z zdravilom Egranli za skrajšanje trajanja nevtropenije in zmanjšanje pojavnosti febrilne nevtropenije.
English: Egranli was to be used to reduce the duration of neutropenia (abnormally low level of neutrophils, a type of white blood cell that fights infection) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy (medicines that treat cancer by killing cells).
Slovenian: Zdravilo Egranli naj bi se uporabljalo za skrajšanje trajanja nevtropenije (nenormalno nizke ravni nevtrofilcev, vrste belih krvničk, ki se bojujejo proti okužbam) in zmanjšanje pojavnosti febrilne nevtropenije (nevtropenije s povišano telesno temperaturo) pri odraslih bolnikih, ki prejemajo citotoksično kemoterapijo (zdravila za zdravljenje raka, ki ubijajo celice).
English: How is Egranli expected to work?
Slovenian: Kako naj bi zdravilo Egranli delovalo?
English: The G-CSF in Egranli is attached to another natural blood protein called albumin, which decreases the rate at which G-CSF is removed from the body and allows the medicine to have a longer duration of action and to be given less often.
Slovenian: G-CSF v zdravilu Egranli je vezan na drugo naravno beljakovino v krvi, albumin, kar zmanjšuje hitrost izločanja G-CSF iz telesa in omogoča daljše delovanje ter manj pogosto dajanje zdravila.
English: Withdrawal of the marketing authorisation application for Egranli (balugrastim) EMA/705109/2014
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Egranli (balugrastim) EMA/30243/2015
English: Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and to prevent febrile neutropenia (a sign of infection) in patients undergoing chemotherapy.
Slovenian: Balugrastim deluje na enak način kot naravno tvorjeni G-CSF, kar pomeni, da spodbuja tvorjenje nevtrofilcev in s tem pomaga skrajšati trajanje nevtropenije in preprečiti pojav fibrilne nevtropenije (znak okužbe) pri bolnikih, ki se zdravijo s kemoterapijo.
English: On 4 November 2014, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Egranli, for reduction in the duration of neutropenia and the occurrence of febrile neutropenia in adult cancer patients.
Slovenian: je dne 4. novembra 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za izdajo dovoljenja za promet z zdravilom Egranli, namenjenim skrajšanju trajanja nevtropenije in zmanjšanju pojavnosti febrilne nevtropenije pri odraslih onkoloških bolnikih.
English: The active substance in Egranli, balugrastim, is made up of ‘granulocyte-colony-stimulating factor' (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow.
Slovenian: Zdravilno učinkovino v zdravilu Egranli, balugrastim, predstavlja granulocitne kolonije spodbujajoči faktor (G-CSF), tj. beljakovina, ki je naravno prisotna v telesu in spodbuja tvorbo belih krvničk, vključno z nevtrofilci, v kostnem mozgu.
English: What is Egranli?
Slovenian: Kaj je zdravilo Egranli?
English: Moreover, the intended use does not require medical supervision.
Slovenian: Prav tako predvidena uporaba ne zahteva zdravniškega nadzora.
English: These combinations are not covered in this summary.
Slovenian: Ta povzetek teh kombinacij ne vključuje.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Slovenian: To pomeni, da je kljub nezadostnim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi o njihovi varni uporabi na navedeni način za vsaj 30 let (najmanj 15 let tudi v EU).
English: Although a possible effect in the temporary relief of symptoms of stress was observed, several shortcomings have been identified in these studies.
Slovenian: Čeprav so zabeležili možen učinek pri začasnem lajšanju simptomov, so v teh študijah ugotovili več pomanjkljivosti.
English: Arctic root medicines should only be used in adults over the age of 18 years and should not be taken for longer than two weeks without seeking medical advice.
Slovenian: Zdravila, ki vsebujejo rožni koren, se lahko uporabljajo samo pri odraslih, starejših od 18 let, in se lahko brez posvetovanja z zdravnikom uporabljajo največ dva tedna.
English: Arctic root
Slovenian: Rožni koren
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Slovenian: V času ocene odbora HMPC ni bilo poročil o neželenih učinkih teh zdravil.
English: This summary is not intended to provide practical advice on how to use medicines containing arctic root.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo rožni koren.
English: The HMPC concluded that, on the basis of its long-standing use, arctic root can be used for the temporary relief of symptoms of stress, such as fatigue and sensation of weakness.
Slovenian: Odbor HMPC je na osnovi dolgoletne uporabe zaključil, da se lahko rožni koren uporablja za začasno lajšanje simptomov stresa, na primer utrujenosti in občutka šibkosti.
English: Arctic root EMA/HMPC/289537/2012
Slovenian: Rožni koren EMA/HMPC/289537/2012
English: Arctic root is the common name for the underground stem (or rhizome) and root of the plant Rhodiola rosea L. The plant is cultivated or gathered to obtain the underground organs (root and rhizome) for medicinal use.
Slovenian: Rožni koren je splošno ime za podzemni del stebla (ali koreniko) in korenino rastline Rhodiola rosea L. Rastlina se goji in nabira za pridobivanje podzemnih delov (korenine in korenike) za medicinsko uporabo.
English: Arctic root preparations are obtained from the dried extracts prepared by ethanol extraction (a technique used to extract compounds from plant material by dissolving them in ethanol).
Slovenian: Pripravki rožnega korena se pridobijo iz suhih izvlečkov, pripravljenih z ekstrakcijo z etanolom (tehniko, ki se uporablja za ekstrakcijo snovi iz rastlinskega materiala z raztapljanjem v etanolu).
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of arctic root.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo rožnega korena.
English: Further information on the risks associated with arctic root 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 rožni koren, vključno z ustreznimi previdnostmi 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: In its assessment, the HMPC also considered clinical studies of small size that have been carried out to investigate the effects of arctic root medicines in adults suffering from stress and fatigue as compared with placebo (a dummy treatment).
Slovenian: Odbor HMPC je v sklopu ocene preučil tudi klinične študije, izvedene na manjšem številu ljudi, v katerih so preučevali učinke zdravil, ki vsebujejo rožni koren, pri odraslih, ki trpijo za stresom in utrujenostjo, v primerjavi s placebom (zdravilom brez zdravilne učinkovine).
English: What is arctic root?
Slovenian: Kaj je rožni koren?
English: Arctic root can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Rožni koren je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Information on the use and licensing of arctic root 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 rožni koren, 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 arctic root.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo rožni koren.
English: Any applications for the licensing of medicines containing arctic root 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 rožni koren, 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: How are arctic root medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo rožni koren, odobrena v EU?
English: Further information on the HMPC assessment of arctic root 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 rožni koren, 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: Other information about arctic root medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo rožni koren
English: The HMPC conclusions on the use of arctic root medicines are based on their ‘traditional use'.
Slovenian: Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo rožni koren, temeljijo na njihovi „tradicionalni uporabi“.
English: What evidence supports the use of arctic root medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo rožni koren?
English: Detailed instruction on how to take arctic root medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo rožni koren, in o tem, kdo jih lahko jemlje, so na voljo v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: Herbal medicines containing arctic root are usually available in solid forms to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo rožni koren, so navadno na voljo v trdnih oblikah, ki se jemljejo peroralno (zaužijejo skozi usta).
English: What are the risks associated with arctic root medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo rožni koren?
English: EMA/HMPC/289537/2012
Slovenian: EMA/HMPC/289537/2012 Odbor za zdravila rastlinskega izvora (HMPC)
English: For more information about treatment with arctic root 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 rožni koren, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using arctic root 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: Arctic root medicines are generally well tolerated.
Slovenian: Zdravila, ki vsebujejo rožni koren, bolniki običajno dobro prenašajo.
English: Therefore, the HMPC conclusions on the use of arctic root medicines are based on their long-standing use.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo rožni koren, zato temeljijo na njihovi dolgotrajni uporabi.
English: This usually takes between 15 and 30 minutes.
Slovenian: To običajno traja 15 do 30 minut.
English: Date of first authorisation: 28 August 2007 Date of latest renewal: 18 June 2012
Slovenian: Datum prve odobritve: 28 avgust 2007 Datum zadnjega podaljšanja: 18 junij 2012
English: At the final analysis, 1653 deaths were reported.
Slovenian: V končni analizi so poročali o 1.653 smrtnih primerih.
English: The symptoms are:
Slovenian: Simptomi so:
English: Do not use this medicine if you notice that
Slovenian: Ne uporabljajte tega zdravila, če opazite
English: It may affect other treatments or test results.
Slovenian: Vpliva lahko na druga zdravljenja ali rezultate preiskav.
English: Thus, the volume of distribution is slightly greater than the plasma space.
Slovenian: Zato je volumen porazdelitve nekoliko večji kot plazemski prostor.
English: Long-term carcinogenicity studies have not been carried out.
Slovenian: Dolgotrajne raziskave karcinogenosti zdravila niso bile opravljene.
English: Administer the amount required.
Slovenian: Uporabite potrebno količino.
English: • anaemia from other causes;
Slovenian: • anemijo zaradi drugih razlogov,
English: Total (N)b
Slovenian: Skupaj (N)b
English: • Or under the skin (subcutaneously).
Slovenian: • ali pod kožo (subkutano).
English: Adverse Reaction (Preferred Term Level)
Slovenian: Neželeni učinek (raven prednostnega izraza)
English: • if you are pregnant, or think you may be pregnant.
Slovenian: • če ste noseči ali menite, da bi lahko bili noseči, • če dojite.
English: If the medicinal product has not been used at the end of this period, it should be disposed of.
Slovenian: Če zdravila do konca tega obdobja ne porabite, ga je treba zavreči.
English: • Severe allergic reaction that may include:
Slovenian: • Huda alergijska reakcija, ki lahko vključuje:
English: • Allergic reaction.
Slovenian: • Alergijska reakcija.
English: - Uncontrolled hypertension.
Slovenian: - Nenadzorovana hipertenzija.
English: Adults donating their own blood
Slovenian: Odrasli bolniki, ki darujejo lastno kri
English: For subcutaneous and intravenous use.
Slovenian: Za subkutano in intravensko uporabo.
English: After approximately two months of therapy, virtually all patients were transfusion-independent.
Slovenian: Po približno dveh mesecih zdravljenja so bili praktično vsi bolniki neodvisni od transfuzije.
English: SI-1234 Menges Slovenia
Slovenian: SI-1234 Menges Slovenija
English: This does not affect normal operation of the syringe.
Slovenian: To na normalno uporabo brizge ne vpliva.
English: Your doctor will decide if it is right for you to take them.
Slovenian: Vaš zdravnik se bo odločil, ali je za vas dobro, da jih jemljete.
English: • have severe heart disease
Slovenian: • imate hudo srčno bolezen
English: • porphyria (a rare blood disorder).
Slovenian: • porfirijo (redko krvno bolezen).
English: Administer the dose as per standard protocol.
Slovenian: Odmerek aplicirajte po standardnem protokolu.
English: Administer over at least one to five minutes, depending on the total dose.
Slovenian: Dajanje naj traja vsaj eno do pet minut, odvisno od velikosti skupnega odmerka.
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Slovenian: Kot pri vseh rastnih dejavnikih tudi tu obstaja skrb, da bi epoetini lahko spodbujali rast tumorjev.
English: • if you have high blood pressure not properly controlled with medicines.
Slovenian: • če imate zvišan krvni tlak, ki ni ustrezno nadzorovan z zdravili
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Slovenian: EPO sodeluje v vseh fazah eritroidnega razvoja in ima svoj glavni učinek na raven eritroidnih prekurzorjev.
English: The cause of your anaemia is also a factor in your doctor deciding the correct dose.
Slovenian: Tudi vzrok vaše anemije je dejavnik, ki ga bo zdravnik upošteval pri določitvi pravilnega odmerka.
English: It is recommended that initial erythroid response be assessed 8 to 12 weeks following initiation of treatment.
Slovenian: Priporočljivo je, da se začetni eritroidni odziv oceni 8 do 12 tednov po začetku zdravljenja.
English: This requires urgent treatment.
Slovenian: Tako stanje je treba takoj zdraviti.
English: • Skin rashes, which may result from an allergic reaction.
Slovenian: • Kožni izpuščaj, ki je lahko posledica alergijske reakcije.
English: If you know you suffer, or have suffered, from:
Slovenian: Če veste, da imate ali ste imeli:
English: • Problem with the blood that may cause pain, dark coloured urine or increased sensitivity of the skin to sunlight (porphyria).
Slovenian: • Težave s krvjo, ki lahko povzročajo bolečino, temno obarvan urin ali povečano občutljivost kože na sončno svetlobo (porfirija).
English: As with any other injectable product, check that there are no particles in the solution or change in colour.
Slovenian: Kot pri vseh drugih zdravilih, ki se injicirajo, je treba preveriti, da v raztopini ni delcev ali da barva ni spremenjena.
English: Currently available data for subcutaneous use of epoetin alfa in these populations are described in section 5.1 but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki za subkutano uporabo epoetina alfa pri teh populacijah so opisani v poglavju 5.1, vendar priporočil o odmerjanju ni mogoče dati.
English: The median age of patients enrolled in the study was 11.6 years (range 0.5 to 20.1 years).
Slovenian: Mediana starost bolnikov, vključenih v študijo, je bila 11,6 let (razpon med 0,5 in 20,1 let).
English: Three were confirmed TVE and in the remaining case (sudden death), the thromboembolic event was not confirmed.
Slovenian: Potrjeni so bili trije TVE, v zadnjem primeru (nenadna smrt) pa trombembolični dogodek ni bil potrjen.
English: • the liquid is coloured or you can see particles floating in it,
Slovenian: • da je tekočina obarvana ali v njej vidite plavati delce,
English: Your doctor will decide this.
Slovenian: To bo odločil vaš zdravnik.
English: Raised blood pressure may require treatment with medicines (or adjustment to any medicines you already take for high blood pressure).
Slovenian: Zvišan krvni tlak bo morda treba zdraviti z zdravili (ali prilagoditi zdravilo, ki ga za visok krvni tlak že jemljete).
English: Haemoglobin levels should be monitored regularly.
Slovenian: Ravni hemoglobina je treba redno nadzirati.
English: A study of 7 preterm very low birth weight neonates and 10 healthy adults given i.v.
Slovenian: Študija s 7 novorojenci z zelo nizko porodno telesno maso in 10 zdravimi odraslimi, ki so prejemali i.v.
English: The pharmacokinetic profile of epoetin alfa in children and adolescents appears to be similar to that of adults.
Slovenian: Kaže, da je farmakokinetični profil epoetina alfa pri otrocih in mladostnikih podoben kot pri odraslih.
English: This temperature range should be closely maintained until administration to the patient.
Slovenian: Ta temperaturni razpon je treba natančno ohranjati do apliciranja zdravila bolniku.
English: Generally, children under 30 kg require higher maintenance doses than children over 30 kg and adults.
Slovenian: Otroci s telesno maso, manjšo od 30 kg, potrebujejo večje vzdrževalne odmerke kot otroci, ki so težji od 30 kg, in odrasli.
English: Additional supportive care should be provided as necessary.
Slovenian: Če je potrebno, zagotovimo dodatno podporno zdravljenje.
English: Your healthcare professional will always record the exact product you are using.
Slovenian: Vaš zdravnik bo vedno natančno zabeležil, katero zdravilo uporabljate.
English: If you have these symptoms during injection into the vein, a slower delivery of the injection may help to avoid them in the future.
Slovenian: Če te simptome opazite med injiciranjem v veno, jih lahko počasnejše dovajanje zdravila v prihodnje morda prepreči.
English: Monitoring of the blood pressure should be performed, particularly at the start of therapy (see section 4.4).
Slovenian: Potrebno je nadzirati krvni tlak, še zlasti na začetku zdravljenja (glejte poglavje 4.4).
English: Your doctor will use the lowest effective dose to control the symptoms of your anaemia.
Slovenian: Zdravnik bo uporabil najnižji učinkoviti odmerek za nadzor simptomov vaše anemije.
English: • Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP.
English: Tell your doctor or nurse immediately if you notice any of the effects in this list.
Slovenian: Zdravniku ali medicinski sestri takoj povejte, če opazite učinke, navedene na tem seznamu.
English: A less defined profile was observed for RBCs and haemoglobin.
Slovenian: Manj definiran profil so opazili za RKC in hemoglobin.
English: The apparent molecular weight of erythropoietin is 32,000 to 40,000 dalton.
Slovenian: Dejanska molekulska masa eritropoetina je od 32.000 do 40.000 daltonov.
English: • if you are allergic to epoetin alfa or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na epoetin alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: Treatment with Epoetin alfa HEXAL is divided into two stages - correction and maintenance phase.
Slovenian: Zdravljenje z zdravilom Epoetin alfa HEXAL poteka v dveh fazah - korekcijska in vzdrževalna faza.
English: Corresponding Presentations in Quantity/Volume for each Strength
Slovenian: Ustrezno pakiranje po količini/prostornini za vsako jakost
English: Target Hb
Slovenian: Ciljna koncentracija Hb
English: erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in healthy adults.
Slovenian: eritropoetin, kaže, da je bil volumen porazdelitve približno 1,5- do 2-krat večji pri novorojencih kot pri zdravih odraslih, očistek pa približno 3-krat večji pri novorojencih kot pri zdravih odraslih.
English: Patients should only be switched from one ESA to another under appropriate supervision.
Slovenian: Prehod z enega ESA na drugega mora potekati pod nadzorom.