natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
• 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. 
• 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.
EMA recommends aligning doses of metamizole medicines and their use during pregnancy and breastfeeding 
Evropska agencija za zdravila priporoča uskladitev odmerkov zdravil, ki vsebujejo metamizol, in njihove uporabe med nosečnostjo in dojenjem
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. 
Pri mlajših bolnikih se odmerki določijo na podlagi njihove telesne mase, vendar nekatera zdravila zaradi svoje jakosti za to niso primerna.
This summary was last updated in 04-2015. 
Povzetek je bil nazadnje posodobljen 04-2015.
Patients can inject themselves if they have been trained appropriately. 
Bolniki si lahko zdravilo injicirajo sami, če so bili za to ustrezno usposobljeni.
This medicine is the same as Neulasta, which is already authorised in the European Union (EU). 
To zdravilo je enako zdravilu Neulasta, ki je že odobreno v Evropski uniji (EU).
Other information about Ristempa 
Druge informacije o zdravilu Ristempa
What is Ristempa and what is it used for? 
Kaj je zdravilo Ristempa in za kaj se uporablja?
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. 
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.
What measures are being taken to ensure the safe and effective use of Ristempa? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ristempa?
It is not intended to provide practical advice on how to use Ristempa. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The European Commission granted a marketing authorisation valid throughout the European Union for Ristempa on 13 April 2015. 
Evropska komisija je dovoljenje za promet z zdravilom Ristempa, veljavno po vsej Evropski uniji, izdala 13. aprila 2015.
Filgrastim has been available in other medicines in the European Union (EU) for a number of years. 
Filgrastim je v Evropski uniji (EU) kot sestavina v drugih zdravilih na voljo že več let.
What benefits of Ristempa have been shown in studies? 
Kakšne koristi je zdravilo Ristempa izkazalo v študijah?
A risk management plan has been developed to ensure that Ristempa is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ristempa je bil pripravljen načrt obvladovanja tveganj.
The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy. 
Glavno merilo učinkovitosti je bilo trajanje hude nevtropenije med prvim ciklusom kemoterapije.
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. 
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.
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). 
Najpogostejši neželeni učinki zdravila Ristempa (opaženi pri več kot 1 bolniku od 10) so bolečine v kosteh in mišicah, glavobol in navzeja (slabost).
This is a summary of the European public assessment report (EPAR) for Ristempa. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ristempa.
It is given as a single 6 mg injection under the skin around 24 hours after the end of each cycle of chemotherapy. 
Zdravilo se daje kot enkratna 6-miligramska injekcija pod kožo približno 24 ur po koncu vsakega ciklusa kemoterapije.
What are the risks associated with Ristempa? 
Kakšna tveganja so povezana z zdravilom Ristempa?
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. 
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.
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. 
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.
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). 
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).
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. 
Ker je v učinkovini pegfilgrastim pegiliran, je izločanje zdravila iz telesa upočasnjeno, zaradi česar se lahko daje manj pogosto.
Why is Ristempa approved? 
Zakaj je bilo zdravilo Ristempa odobreno?
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. 
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.
For more information about treatment with Ristempa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
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.
Ristempa has been studied in two main studies involving 467 patients with breast cancer who were being treated with cytotoxic chemotherapy. 
Zdravilo Ristempa so proučevali v dveh glavnih študijah, v katerih je sodelovalo 467 bolnic z rakom dojke, ki so jih zdravili s citotoksično kemoterapijo.
Ristempa is a medicine used in cancer patients to help with some of the side effects of their treatment. 
Ristempa je zdravilo, ki se uporablja pri bolnikih z rakom za pomoč pri nekaterih neželenih učinkih njihovega zdravljenja.
The company that makes Neulasta has agreed that its scientific data can be used for Ristempa (‘informed consent'). 
Družba, ki izdeluje zdravilo Neulasta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Ristempa („uporaba dokumentacije s soglasjem“).
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). 
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).
In both studies, a single injection of Ristempa was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles. 
V obeh študijah so enkratno injekcijo zdravila Ristempa primerjali z večkratnimi dnevnimi injekcijami filgrastima med vsakim od štirih ciklusov kemoterapije.
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. 
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.
Ristempa was as effective as filgrastim in reducing the duration of severe neutropenia. 
Zdravilo Ristempa je bilo enako učinkovito kot filgrastim pri skrajšanju hude nevtropenije.
Filgrastim works by stimulating the bone marrow to produce more white blood cells, increasing white blood cell counts and treating neutropenia. 
Filgrastim deluje tako, da spodbuja kostni mozeg, da proizvaja več belih krvnih celic, s čimer poveča število belih krvnih celic in zdravi nevtropenijo.
Ristempa is available as a solution for injection in pre-filled syringes containing 6 mg pegfilgrastim. 
Zdravilo Ristempa je na voljo v obliki raztopine za injiciranje v napolnjenih injekcijskih brizgah, ki vsebujejo 6 mg pegfilgrastima.
For practical information about using Ristempa, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Ristempa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
How is Ristempa used? 
Kako se zdravilo Ristempa uporablja?
Ristempa cannot be used in patients with chronic myeloid leukaemia (a cancer of the white blood cells). 
Zdravilo Ristempa se ne sme uporabljati pri bolnikih s kronično mieloično levkemijo (rakom belih krvnih celic).
Ristempa is used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever). 
Zdravilo Ristempa se uporablja za skrajšanje nevtropenije ter zmanjšanje pojavljanja febrilne nevtropenije (nevtropenije s povišano telesno temperaturo).
Ristempa contains the active substance pegfilgrastim. 
Zdravilo Ristempa vsebuje zdravilno učinkovino pegfilgrastim.
Date of first authorisation: 6 July 2016 
Datum prve odobritve: 06. julij 2016
Up to 9 days from the date of manufacture. 
Do devet dni od dneva izdelave.
In some patients more than one cell line may be affected. 
Pri nekaterih bolnikih je lahko prizadeta več kot ena celična linija.
2 mL vial: EU/1/16/1105/001 10 mL vial: EU/1/16/1105/002 
2 ml viala: EU/1/16/1105/001 10 ml viala: EU/1/16/1105/002
Time points for measurements were 5 minutes, 1 hour, 12 hours, 2 days, 7 days and 28 days. 
Za meritve so bile uporabljene časovne točke 5 minut, 1 ura, 12 ur, 2 dneva, 7 dni in 28 dni.
The following information is intended for the specialist only: 
Naslednje informacije so namenjene samo specialistom:
- if you are pregnant or believe you may be pregnant. 
- če ste noseči ali menite, da bi lahko bili noseči.
Further precautions with respect to relatives, carers and hospital staff are provided in section 6.6. 
Več previdnostnih ukrepov v zvezi s sorodniki, negovalci in bolnišničnim osebjem je navedenih v poglavju 6.6.
This could potentially result in osteosarcomas. 
To lahko povzroči osteosarkome.
The use of television monitor systems to monitor the patients is recommended. 
Priporočljiva je uporaba sistemov s televizijskim zaslonom za spremljanje bolnikov.
Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation. 
Za njihovo sprejemanje, shranjevanje, uporabo, prenos in odstranjevanje veljajo predpisi in/ali ustrezna dovoljenja pristojnega organa.
Duration of the procedure 
Trajanje postopka
You will be asked to stop breast-feeding. 
Zaprošeni boste, da prenehate dojiti.
This leaflet was last revised in {month YYYY} Other sources of information 
Navodilo je bilo nazadnje revidirano dne {mesec LLLL} Drugi viri informacij
In most countries, the exposure limit for hospital staff is set the same as for the general public at 1 mSv/year. 
V večini držav je omejitev izpostavljenosti za bolnišnično osebje določena enako kot za splošno javnost, tj. pri 1 mSv/leto.
Withdrawals should be performed under aseptic conditions. 
Odvzem je treba izvajati v aseptičnih pogojih.
The generally accepted threshold for discharge of the treated patient from the hospital is 20 µSv/h. 
Splošno sprejeti prag za odpust zdravljenega bolnika iz bolnišnice je 20 µSv/h.
Most events are mild and transient. 
Večina dogodkov je blagih in prehodnih.
Your nuclear medicine doctor will inform you about the usual duration of the procedure. 
Zdravnik nuklearne medicine vas bo obvestil o običajnem trajanju postopka.
Most of these events are mild and only temporary. 
Večina dogodkov je blagih in samo začasnih.
Non carrier added (n.c.a.) 
Brez dodanega nosilca (non carrier added - n.c.a.)
It has to be used in combination with other medicines (carrier medicines). 
Uporabljati ga je treba skupaj z drugimi zdravili (nosilnimi zdravili).
Radiation Energy (keV)* Abundance (%) 
Sevanje Energija (keV)* Delež (%)
(GBq: GigaBecquerel is the unit in which radioactivity is measured). 
(GBq: gigabekerel je enota za merjenje radioaktivnosti.)
to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data). 
(< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
These are duplicates of those identified in the literature. 
Gre za iste primere, ki so že opredeljeni v literaturi.
Faecal and urinary elimination is slow. 
Odstranjevanje z blatom in urinom je počasno.
Activity may be measured using an ionisation chamber. 
Aktivnost je mogoče izmeriti z ionizacijsko celico.
All cases recovered with treatment. 
V vseh primerih je ob ustreznem zdravljenju prišlo do okrevanja.
Of course, the nuclear medicine staff is expected to wear standard radiation protection. 
Seveda se od osebja za nuklearno medicino pričakuje, da bo nosilo standardno zaščito pred sevanjem.
Observation of patients by overnight hospitalisation should be considered in some cases (e.g. patients with poor pharmacologic control of symptoms). 
V nekaterih primerih je treba razmisliti o opazovanju bolnikov s hospitalizacijo preko noči (npr. bolnikov s slabim farmakološkim nadzorom simptomov).
The surface dose rates and the accumulated dose depend on many factors. 
Površinske stopnje odmerka in nakopičeni odmerek so odvisni od več dejavnikov.
This radiation is used to treat certain diseases. 
S tem sevanjem se zdravijo določene bolezni.
Pack size: 1 vial 
Velikost pakiranja: 1 viala
Usual precautions regarding sterility and radioactivity should be respected. 
Upoštevati je treba običajne previdnostne ukrepe glede sterilnosti in radioaktivnosti.
It is recommended to perform individual radiation dosimetry assessments of specific organs, which may not be the target organ of therapy. 
Priporočljivo je izvesti individualne ocene dozimetrije sevanja za posamezne organe, ki morda niso ciljni organi zdravljenja.
Adequate shielding is mandatory. 
Ustrezna zaščitna oprema je obvezna.
The chelating efficacy is greatest immediately or within one hour of exposure when the radionuclide is circulating in or available to tissue fluids and plasma. 
Učinkovitost keliranja je največja takoj po izpostavljenosti ali v eni uri po njej, ko radionuklid kroži ali je v tkivni tekočini in plazmi.
The cases occurred in close temporal proximity to the RLT, alternative aetiologies were excluded and most cases either met or were close to meeting formal criteria of TLS definition. 
Primeri so se pojavili časovno blizu zdravljenja z RLT, alternativne etiologije so bile izključene in večina primerov je v celoti ali v veliki meri izpolnila formalna merila za diagnozo TLS.
In all cases, it is necessary to ensure that the risks of the radiation are less than from the disease itself. 
V vsakem primeru je treba zagotoviti, da so tveganja zaradi sevanja manjša od tveganj bolezni same.
The following nuclear reaction is ongoing in the irradiation: 
Pri obsevanju poteka naslednja jedrska reakcija:
Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines since they may interfere with the procedure. 
Obvestite zdravnika nuklearne medicine, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj bi ta zdravila lahko vplivala na postopek.
Store in the original package in order to avoid unnecessary radiation exposure. 
Shranjujte v originalni ovojnini, da se izognete nepotrebni izpostavljenosti sevanju.
Activity measurements using an ionization chamber are very sensitive to geometric factors and therefore should be performed only under geometric conditions which have been appropriately validated. 
Meritve aktivnosti z uporabo ionizacijske celice so zelo občutljive za geometrične faktorje in jih je zaradi tega treba izvajati samo pod geometričnimi pogoji,
The PRAC is of the view that although the number of identified cases is limited, the exposure to date is relatively low, and the association with tumour lysis syndrome is biologically plausible. 
Odbor PRAC kljub omejenemu številu prepoznanih primerov meni, da je izpostavljenost do danes relativno nizka, povezava s sindromom tumorske lize pa je biološko verjetna.
The PRAC therefore recommends that the Product Information should be updated accordingly. 
Odbor PRAC zato priporoča ustrezno posodobitev podatkov o zdravilu.
Measurements on the location and during work are critical and should be practiced for more precise and instructive determination of overall radiation dose to the staff. 
Meritve na lokaciji in med delom so ključnega pomena in jih je treba izvajati za natančnejšo in informativno določitev skupnega odmerka sevanja za osebje.
The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as indicated by the customer and can be within 0 to 7 days starting from the day of manufacture. 
Čas ART je ob 12:00 uri (opoldan) na predvideni dan radioaktivnega označevanja, ki ga določi stranka in lahko nastopi od 0 do 7 dni od dneva izdelave.
These persons will take special care for the safe use of this product and will keep you informed of their actions. 
Te osebe bodo posebno pozorne na varno uporabo radionuklidnega predhodnika in vas bodo sproti obveščale o svojem ravnanju.
For minimising radiation exposure resulting from repeated exposition there is no recommendation except the strict observance of the above ones. 
Za zmanjšanje izpostavljenosti sevanju, do katere prihaja ob ponavljajoči se izpostavljenosti, ni priporočil, z izjemo strogega upoštevanja zgoraj navedenih.
Any unused medicinal product or waste material must be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
For the next 28 days, further uptake of 177Lu can be observed in the bone, which is compensated in part by radioactive decay. 
V naslednjih 28 dneh je mogoče v kosteh opaziti nadaljnji privzem 177Lu, ki ga delno kompenzira radioaktivni razpad.
For each patient, the radiation exposure must be justifiable by the likely benefit. 
Pri vsakem bolniku je treba izpostavljenost sevanju upravičiti z verjetno koristjo.
Patients with a history of renal insufficiency and high tumour burden may be at greater risk and should be treated with increased caution. 
Pri bolnikih z anamnezo ledvične insuficience in velikim tumorskim bremenom je tveganje večje in jih je treba zdraviti previdneje.
This medicine is stored under the responsibility of the specialist in appropriate premises. 
Za shranjevanje tega zdravila v ustreznih prostorih je odgovoren specialist.
For this reason it is mandatory to use protective high quality (latex/nitrile) gloves in any direct contact with the radiopharmaceutical (vial/syringe) and with the patient. 
V ta namen je obvezna uporaba zaščitnih visokokakovostnih rokavic (lateks/nitril) pri vsakem neposrednem stiku z radiofarmakom (viala/brizga) in bolnikom.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznam EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Any other person in close vicinity of the treated patient should be informed about possibilities to reduce his/her exposure due to radiation emitted from the patient. 
Katero koli drugo osebo v neposredni bližini zdravljenega bolnika je treba obvestiti o tem, kako lahko zmanjša svojo izpostavljenost sevanju, ki ga oddaja bolnik.
The specific activity of the medicinal product at ART is indicated on the label and always greater than 3,000 GBq/mg. 
ART je navedena na ovojnini in je vedno višja od 3.000 GBq/mg.
For instructions on preparation of the medicinal product before administration, see section 12. 
Za navodila glede vnaprejšnje priprave zdravila pred dajanjem glejte poglavje 12.
This waiver does however not extend to any therapeutic uses of the product when linked to a carrier molecule (see section 4.2 for information on paediatric use). 
Vendar pa se ta odstop ne nanaša na nobeno terapevtsko uporabo zdravila, ko je povezano z nosilno molekulo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In any case, the blood parameters of the patient have to be monitored and the appropriate actions immediately taken if there is evidence of radiotoxicity. 
V vsakem primeru je treba spremljati krvne parametre bolnika in, če obstaja radiotoksičnost, takoj ustrezno ukrepati.
Pharmacotherapeutic group: Other therapeutic radiopharmaceuticals, ATC code: V10X 
Farmakoterapevtska skupina: drugi radioterapevtiki, oznaka ATC: V10X
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Če zdravilo ni porabljeno takoj, je za čas shranjevanja med uporabo in pogoje pred uporabo odgovoren uporabnik.
Absorbed dose per unit radioactivity administered (mSv/MBq) Adult (73.7 kg) 
Absorbirani odmerek na enoto dane radioaktivnosti (mSv/MBq) Odrasli (73,7 kg)
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Dose reduction may be necessary in affected patients. 
Pri prizadetih bolnikih bo morda odmerek treba zmanjšati.
In bone, the content increases from 0.01 %ID/g at 5 min to 0.23 %ID/g after 12 hours. 
V kosteh se vsebnost poveča z 0,01 % ID/g po 5 minutah na 0,23 % ID/g po 12 urah.
The radiation dose resulting from therapeutic exposure may result in higher incidence of cancer and mutations. 
Odmerek sevanja, ki izvira iz terapevtske izpostavljenosti, lahko povzroči povečano incidenco raka in mutacij.
- Nausea - Vomiting 
- navzea - bruhanje