FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP also concluded that a fuller review of nimesulide was needed, that would look at all of the potential risks of the medicine, especially the risk of side effects affecting the stomach and the gut, which were outside the scope of the original review.
Slovenian: CHMP je tudi zaključil, da je potreben obsežnejši pregled nimesulida, ki bo upošteval vsa možna tveganja, povezana z zdravilom, zlasti tveganja neželenih učinkov na želodec in črevesje, ki so bila izključena iz prvotnega pregleda.
English: The Committee considered that the use of systemic nimesulide for the treatment of painful osteoarthritis, which is a chronic condition, will increase the risk of the medicines being used for long-term treatment with a consequent increase in the risk of liver injury.
Slovenian: Meni, da bo uporaba sistemskega nimesulida za zdravljenje bolečega osteoartritisa, ki je kronično obolenje, povečala možnost, da bi se zdravila uporabljala za dolgotrajno zdravljenje, kar bi povečalo tveganje za okvaro jeter.
English: It issued a recommendation that it should no longer be used for the treatment of painful osteoarthritis.
Slovenian: Izdal je priporočilo, da zdravilo ni več primerno za zdravljenje bolečega osteoartritisa.
English: • Patient currently receiving systemic nimesulide for painful osteoarthritis should consult their doctor in order to arrange alternative treatment.
Slovenian: • Bolniki, ki boleči osteoartritis trenutno zdravijo s sistemskim nimesulidom, naj se posvetujejo s svojim zdravnikom o uvedbi nadomestnega zdravljenja.
English: The CHMP is now recommending, as a further restriction, that systemic nimesulide should no longer be used for treating painful osteoarthritis.
Slovenian: Kot dodatno omejitev sedaj priporoča, da se sistemski nimesulid ne uporablja več za zdravljenje bolečega osteoartritisa.
English: • Prescribers should no longer prescribe systemic nimesulide for treating painful osteoarthritis.
Slovenian: • Zdravniki naj prenehajo predpisovati sistemski nimesulid za zdravljenje bolečega osteoartritisa.
English: • primary dysmenorrhoea (period pains).
Slovenian: • bolečega osteoartritisa (otekanja sklepov), primarne dismenoreje (boleče menstruacije).
English: In terms of safety, the Committee noted that nimesulide has the same risk of causing stomach and gut problems as other NSAIDs.
Slovenian: Z vidika varnosti je opozoril, da nimesulid pomeni enako tveganje za nastanek težav z želodcem in črevesjem kot druga neselektivna nesteroidna protivnetna zdravila.
English: A summary of the recommended changes will be published on the EMA website.
Slovenian: Povzetek vseh priporočenih sprememb bo objavljen na spletišču agencije.
English: Metamizole-containing medicines are available in Austria, Belgium, Bulgaria, Croatia, Czech Republic, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Slovenian: Zdravila, ki vsebujejo metamizol, so na voljo v Avstriji, Belgiji, Bolgariji, na Hrvaškem, v Češki republiki, na Finskem, v Nemčiji, na Madžarskem, v Italiji, Latviji, Litvi, Luksemburgu, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji in Španiji.
English: They are marketed under a variety of names including Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin and Tempimet.
Slovenian: Tržijo se pod različnimi imeni, in sicer: Algifen, Algifen Neo, Algi-Mabo, Algoblock, Algocalmin, Algopyrin, Algozone, Alindor, Alkagin, Alvotor, Amizolmet, Analgin, Benalgin, Benlek, Berlosin, Buscapina Compositum, Dialgin, Dolocalma, Flamborin, Freshalgin, Gardan, Generalgin, Hexalgin, Litalgin, Locamin, Metagelan, Metalgial, Metamilan, Metamistad, Metapyrin, Metarapid, Nevralgin, Nodoryl, Nolotil, Novalgin, Novalgina, Novalgine, Novaminsulfon, Novocalmin, Panalgorin, Parakofdal, Piafen, Piralgin, Proalgin, Pyralgin, Pyralgina, Quarelin, Scopolan Compositum, Spasmalgon, Spasmoblok, Tempalgin in Tempimet.
English: The review of metamizole was initiated on 31 May 2018 at the request of Poland, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled metamizola se je začel 31. maja 2018 na zahtevo Poljske v skladu s členom 31 Direktive 2001/83/ES.
English: • Patients who have any concerns about their medication should consult their doctor or pharmacist.
Slovenian: • Bolniki, ki imajo kakršna koli vprašanja o svojem zdravljenju, naj se posvetujejo z zdravnikom ali farmacevtom.
English: Treatment should start at the lowest recommended dose and only be increased if needed.
Slovenian: Zdravljenje se začne z najnižjim priporočenim odmerkom, ki se sme povečati le, če je to potrebno.
English: 20 March 2019 EMA/191666/2019
Slovenian: 20. marec 2019 EMA/191666/2019
English: The review has been carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's opinion.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP), odgovoren za vprašanja v zvezi z zdravili za uporabo v humani medicini, ki je sprejel mnenje agencije.
English: • Updated summaries of product characteristics (information for healthcare professionals) and package leaflets for patients which contain the new recommendations will be available nationally following the final legal decision issued by the European Commission.
Slovenian: • Posodobljeni povzetki glavnih značilnosti zdravila (informacije za zdravstvene delavce) in navodila za uporabo za bolnike, ki vsebujejo nova priporočila, bodo na nacionalni ravni na voljo po sprejetju končnega pravnega sklepa, ki ga bo izdala Evropska komisija.
English: Metamizole (also known as dipyrone) is an analgesic medicine (painkiller) that can also relieve fever and muscle spasm.
Slovenian: Metamizol (znan tudi kot dipiron) je analgetik (zdravilo za lajšanje bolečin), ki lahko ublaži tudi povišano telesno temperaturo in mišične krče.
English: E M A /191666/2019
Slovenian: EMA/191666/2019
English: The review was carried out by EMA's human medicines committee (CHMP) at the request of Poland, which was concerned by the substantial differences in the recommendations on the use of metamizole in different EU countries, given that it is known the medicine may occasionally cause severe side effects, such as effects on the blood.
Slovenian: Pregled je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila na zahtevo Poljske, ki je izrazila zaskrbljenost zaradi znatnih razlik v priporočilih glede uporabe metamizola v različnih državah EU, saj je znano, da lahko zdravilo občasno povzroči resne neželene učinke, na primer na kri.
English: The Agency reviewed the available information on the way the medicine is distributed in the body, how it works and the limited data on its effects on the unborn child or breast-fed infant.
Slovenian: Agencija je pregledala vse razpoložljive informacije o načinu, kako se zdravilo porazdeli po telesu in kako deluje, ter omejene podatke o njegovem vplivu na nerojenega otroka ali dojenčka, dojenega z materinim mlekom.
English: The review found little to suggest problems in early pregnancy, and single doses in the first 6 months might be acceptable if other analgesics cannot be used.
Slovenian: V pregledu so ugotovili le malo pokazateljev na težave v zgodnji nosečnosti, zato bi lahko bili enkratni odmerki v prvih šestih mesecih nosečnosti sprejemljivi, kadar se drugi analgetiki ne morejo uporabljati.
English: Although metamizole has been on the market for nearly a century, evidence of its effects in pregnancy and breastfeeding is scarce.
Slovenian: Čeprav je metamizol na trgu že skoraj celo stoletje, so podatki o njegovih učinkih med nosečnostjo in dojenjem skopi.
English: As a precaution, metamizole should not be used during breastfeeding because the infant may receive high amounts of the medicine in the milk relative to the infant's weight.
Slovenian: Kot previdnostni ukrep se metamizol ne sme uporabljati med dojenjem, saj bi lahko dojenček prek materinega mleka prejel velike količine zdravila glede na njegovo telesno maso.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20 March 2019.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 20. marca 2019 izdala končni pravno zavezujoči sklep, ki velja za vse države članice EU.
English: EMA's recommendations include setting a maximum single dose by mouth of 1,000 mg, taken up to 4 times daily (a maximum daily dose of 4,000 mg), in patients from 15 years of age.
Slovenian: V priporočilih je agencija EMA določila, da je pri bolnikih, starejših od 15 let, največji enkratni peroralni odmerek 1 000 mg, ki se lahko vzame do štirikrat na dan (največji dnevni odmerek torej znaša 4 000 mg).
English: EMA's recommendations were forwarded to the European Commission, which issued a final legally binding decision valid across the EU on 20 March 2019.
Slovenian: Priporočila Evropske agencije za zdravila so bila predložena Evropski komisiji, ki je 20. marca 2019 izdala končni pravno zavezujoči sklep, ki velja po vsej EU.
English: However, there was some evidence of effects on the kidneys and circulation of the fetus if the medicine were used in the last 3 months of pregnancy, and the medicine should therefore not be used in this period.
Slovenian: Našli pa so nekaj dokazov o učinkih na ledvice in krvni obtok zarodka, kadar so se zdravila uporabljala v zadnjem tromesečju nosečnosti, zato se ta zdravila v tem obdobju nosečnosti ne smejo uporabljati.
English: • EMA has recommended changes to the product information of metamizole, to ensure that advice on the maximum daily doses and warnings not to use the medicine during the last 3 months of pregnancy or during breastfeeding are consistent across the EU.
Slovenian: • Agencija EMA je priporočila spremembo informacij o zdravilu za metamizol, da bi zagotovila skladnost navodil o največjih dnevnih odmerkih in opozoril, da se zdravilo ne sme uporabljati v zadnjem tromesečju nosečnosti ali med dojenjem, po vsej EU.
English: On 13 December 2018, following a review of medicines containing the painkiller metamizole, EMA recommended that the maximum daily dose of the medicine and the contraindications to its use in pregnancy or women who are breastfeeding should be harmonised for all products on the EU market.
Slovenian: Po pregledu zdravil, ki vsebujejo učinkovino za lajšanje bolečin, metamizol, je agencija 13. decembra 2018 priporočila, da je treba za vsa zdravila na trgu EU uskladiti največji dnevni odmerek in kontraindikacije za uporabo teh zdravil med nosečnostjo in dojenjem.
English: It has been used for many decades in the EU by mouth, as suppositories or by injection, to treat severe pain and fever that cannot be controlled with other treatments.
Slovenian: V EU se v obliki peroralnih zdravil, svečk ali injekcij uporablja že več desetletij za lajšanje hude bolečine in povišane telesne temperature, ki ju ni mogoče uspešno obvladati z drugimi zdravili.
English: The recommendation addressed inconsistencies in the product information for metamizole medicines, which are marketed in many EU member states to treat severe pain and fever that cannot be controlled with other treatments.
Slovenian: Priporočilo se nanaša na neskladnosti v informacijah o zdravilu za vsa zdravila, ki vsebujejo metamizol in se tržijo v številnih državah članicah EU za lajšanje hude bolečine in povišane telesne temperature, ki ju ni mogoče uspešno obvladati z drugimi zdravili.
English: • EMA has completed a review of the painkiller metamizole, used in many EU countries to treat severe pain and fever that cannot be controlled with other treatments.
Slovenian: • Agencija EMA je zaključila pregled učinkovine za lajšanje bolečin, metamizola, ki se uporablja v številnih državah EU za lajšanje hude bolečine in povišane telesne temperature, ki ju ni mogoče uspešno obvladati z drugimi zdravili.
English: EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding
Slovenian: Evropska agencija za zdravila priporoča uskladitev odmerkov zdravil, ki vsebujejo metamizol, in njihove uporabe med nosečnostjo in dojenjem
English: If given by injection the total daily dose should not exceed 5,000 mg. Doses in younger patients should be based on their body weight but some products may be unsuitable because of their strength.
Slovenian: Pri mlajših bolnikih se odmerki določijo na podlagi njihove telesne mase, vendar nekatera zdravila zaradi svoje jakosti za to niso primerna.
English: This summary was last updated in 04-2015.
Slovenian: Povzetek je bil nazadnje posodobljen 04-2015.
English: Patients can inject themselves if they have been trained appropriately.
Slovenian: Bolniki si lahko zdravilo injicirajo sami, če so bili za to ustrezno usposobljeni.
English: This medicine is the same as Neulasta, which is already authorised in the European Union (EU).
Slovenian: To zdravilo je enako zdravilu Neulasta, ki je že odobreno v Evropski uniji (EU).
English: Other information about Ristempa
Slovenian: Druge informacije o zdravilu Ristempa
English: What is Ristempa and what is it used for?
Slovenian: Kaj je zdravilo Ristempa in za kaj se uporablja?
English: The full EPAR and risk management plan summary for Ristempa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Ristempa sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Ristempa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ristempa?
English: It is not intended to provide practical advice on how to use Ristempa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ristempa on 13 April 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ristempa, veljavno po vsej Evropski uniji, izdala 13. aprila 2015.
English: Filgrastim has been available in other medicines in the European Union (EU) for a number of years.
Slovenian: Filgrastim je v Evropski uniji (EU) kot sestavina v drugih zdravilih na voljo že več let.
English: What benefits of Ristempa have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ristempa izkazalo v študijah?
English: A risk management plan has been developed to ensure that Ristempa is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Ristempa je bil pripravljen načrt obvladovanja tveganj.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Slovenian: Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije med prvim ciklusom kemoterapije.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ristempa'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 humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ristempa večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The most common side effects with Ristempa (seen in more than 1 in 10 patients) are bone and muscle pain, headache and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Ristempa (opaženi pri več kot 1 bolniku od 10) so bolečine v kosteh in mišicah, glavobol in navzeja (slabost).
English: This is a summary of the European public assessment report (EPAR) for Ristempa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ristempa.
English: It is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy.
Slovenian: Zdravilo se daje kot enkratna 6-miligramska injekcija pod kožo približno 24 ur po koncu vsakega ciklusa kemoterapije.
English: What are the risks associated with Ristempa?
Slovenian: Kakšna tveganja so povezana z zdravilom Ristempa?
English: Ristempa can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Slovenian: Izdaja zdravila Ristempa je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka ali bolezni krvi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ristempa, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The active substance in Ristempa, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF), that has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: Zdravilna učinkovina v zdravilu Ristempa, pegfilgrastim, je sestavljena iz filgrastima, ki je zelo podoben človeški beljakovini, imenovani granulocitne kolonije spodbujajoči faktor (G-CSF), ki je bil „pegiliran“ (vezan na kemično spojino, imenovano polietilenglikol).
English: Because it is pegylated in pegfilgrastim, the rate at which the medicine is removed from the body is decreased, allowing the medicine to be given less often.
Slovenian: Ker je v učinkovini pegfilgrastim pegiliran, je izločanje zdravila iz telesa upočasnjeno, zaradi česar se lahko daje manj pogosto.
English: Why is Ristempa approved?
Slovenian: Zakaj je bilo zdravilo Ristempa odobreno?
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle, compared with around five to seven days when neither medicine is used.
Slovenian: V obeh študijah je huda nevtropenija pri bolnicah med prvim ciklusom kemoterapije trajala približno 1,7 dneva, kadar ni bilo uporabljeno nobeno zdravilo, pa približno pet do sedem dni.
English: For more information about treatment with Ristempa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ristempa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Ristempa has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy.
Slovenian: Zdravilo Ristempa so proučevali v dveh glavnih študijah, v katerih je sodelovalo 467 bolnic z rakom dojke, ki so jih zdravili s citotoksično kemoterapijo.
English: Ristempa is a medicine used in cancer patients to help with some of the side effects of their treatment.
Slovenian: Ristempa je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nekaterih neželenih učinkih njihovega zdravljenja.
English: The company that makes Neulasta has agreed that its scientific data can be used for Ristempa (‘informed consent').
Slovenian: Družba, ki izdeluje zdravilo Neulasta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Ristempa („uporaba dokumentacije s soglasjem“).
English: It also cannot be used in patients with myelodysplastic syndromes (a disease in which too many white blood cells are produced, which can develop into leukaemia).
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z mielodisplastičnim sindromom (boleznijo, pri kateri nastaja preveč belih krvnih celic in ki se lahko razvije v levkemijo).
English: In both studies, a single injection of Ristempa was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Slovenian: V obeh študijah so enkratno injekcijo zdravila Ristempa primerjali z večkratnimi dnevnimi injekcijami filgrastima med vsakim od štirih ciklusov kemoterapije.
English: Chemotherapy (medicines to treat cancer) that is cytotoxic (cell-killing) also kills white blood cells, which can lead to neutropenia (low levels of neutrophils, a type of white blood cell that fights infections) and the development of infections.
Slovenian: Kemoterapija (zdravila za zdravljenje raka), ki je citotoksična (uničuje celice), uniči tudi bele krvne celice, kar lahko povzroči nevtropenijo (nizke ravni nevtrofilcev, vrste belih krvnih celic, ki se borijo proti okužbam) ter razvoj okužb.
English: Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia.
Slovenian: Zdravilo Ristempa je bilo enako učinkovito kot filgrastim pri skrajšanju hude nevtropenije.
English: Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia.
Slovenian: Filgrastim deluje tako, da spodbuja kostni mozeg, da proizvaja več belih krvnih celic, s čimer poveča število belih krvnih celic in zdravi nevtropenijo.
English: Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg pegfilgrastim.
Slovenian: Zdravilo Ristempa je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah, ki vsebujejo 6 mg pegfilgrastima.
English: For practical information about using Ristempa, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ristempa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How is Ristempa used?
Slovenian: Kako se zdravilo Ristempa uporablja?
English: Ristempa cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells).
Slovenian: Zdravilo Ristempa se ne sme uporabljati pri bolnikih s kronično mieloično levkemijo (rakom belih krvnih celic).
English: Ristempa is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Slovenian: Zdravilo Ristempa se uporablja za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
English: Ristempa contains the active substance pegfilgrastim.
Slovenian: Zdravilo Ristempa vsebuje zdravilno učinkovino pegfilgrastim.
English: Date of first authorisation: 6 July 2016
Slovenian: Datum prve odobritve: 06. julij 2016
English: Up to 9 days from the date of manufacture.
Slovenian: Do devet dni od dneva izdelave.
English: In some patients more than one cell line may be affected.
Slovenian: Pri nekaterih bolnikih je lahko prizadeta več kot ena celična linija.
English: 2 mL vial: EU/1/16/1105/001 10 mL vial: EU/1/16/1105/002
Slovenian: 2 ml viala: EU/1/16/1105/001 10 ml viala: EU/1/16/1105/002
English: Time points for measurements were 5 minutes, 1 hour, 12 hours, 2 days, 7 days and 28 days.
Slovenian: Za meritve so bile uporabljene časovne točke 5 minut, 1 ura, 12 ur, 2 dneva, 7 dni in 28 dni.
English: The following information is intended for the specialist only:
Slovenian: Naslednje informacije so namenjene samo specialistom:
English: - if you are pregnant or believe you may be pregnant.
Slovenian: - če ste noseči ali menite, da bi lahko bili noseči.
English: Specific activity:
Slovenian: Specifična aktivnost: