natgillin/translations-raw huggingface dataset:
This suggested that the measures recommended in September 2007, including the changes to the prescribing information, were appropriate to reduce the risk of liver problems associated with nimesulide.
To pomeni, da so bili ukrepi, priporočeni septembra 2007, vključno s spremembami navodil za predpisovanje, primerni za zmanjšanje tveganje težav z jetri, povezanih z nimesulidom.
Based on the additional information reviewed, the CHMP has not changed its conclusions from September 2007, namely that the benefits of systemic formulations of nimesulide still outweigh their risks, provided that the use of these medicines is restricted to ensure that the risk of patients developing liver problems is kept to a minimum.
Na podlagi dodatnih pregledanih informacij CHMP ni spremenil svojih sklepov iz septembra 2007, namreč da koristi sistemskih formulacij nimesulida še vedno odtehtajo z njimi povezana tveganja, če je uporaba teh zdravil omejena tako, da so tveganja za nastanek težav z jetri pri bolnikih zmanjšana na najmanjšo možno mero.
Nimesulide was reviewed by the CHMP in 2007 because of concerns with liver injury.
CHMP je leta 2007 pregledal nimesulid glede zadržkov zaradi okvar jeter.
In the latest review, the CHMP has looked at all the reports of side effects affecting the liver in patients taking nimesulide reported since April 2007, including those from Ireland.
V zadnjem pregledu je CHMP proučil vsa poročila o neželenih učinkih na jetra pri bolnikih, ki prejemajo nimesulid, prejeta od aprila 2007, vključno s poročili iz Irske.
The restriction was therefore added into the prescribing information for nimesulide-containig medicines.
Omejitev je bila tako dodana navodilom za predpisovanje zdravil, ki vsebujejo nimesulid.
This study used existing reports of the rate of side effects with all NSAIDs to simulate the possible effect that a suspension of nimesulide would have on the rates of side effects affecting the stomach and gut.
V študiji so bila uporabljena obstoječa poročila o stopnji neželenih učinkov pri vseh nesteroidnih protivnetnih zdravilih za okrepitev morebitnega učinka, ki bi ga imel začasen umik nimesulida na stopnjo neželenih učinkov na želodec in črevesje.
The European Commission noted that, in some Members States, nimesulide was restricted to second-line treatment.
Evropska komisija je opozorila, da se v nekaterih državah članicah nimesulid uporablja šele kot zdravilo druge izbire.
The Committed has also looked at whether Member States took additional measures to those proposed by the CHMP in September 2007, in order to minimise the risk of liver problems in patients using nimesulide-containing medicines.
Odbor je pregledal tudi, ali so države članice sprejele dodatne ukrepe k ukrepom, ki jih je CHMP predlagal septembra 2007, da se zmanjša tveganje težav z jetri pri bolnikih, ki prejemajo zdravila, ki vsebujejo nimesulid.
Invented name Strength Pharmaceutical Form Route of administration
Izmišljeno ime Jakost
Further information on EndolucinBeta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Nadaljnje informacije o zdravilu EndolucinBeta so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
These tumours affect hormonesecreting cells in many parts of the body, including the pancreas, intestine, stomach and lungs.
Ti tumorji prizadenejo celice, ki izločajo hormone, v številnih delih telesa, vključno s trebušno slinavko, črevesjem, želodcem in pljuči.
EndolucinBeta received a marketing authorisation valid throughout the EU on 6 July 2016.
Za zdravilo EndolucinBeta je bilo 6. julija 2016 izdano dovoljenje za promet, veljavno po vsej EU.
The most common side effects with EndolucinBeta (which may affect more than 1 in 10 people) are anaemia (low red blood cell counts), thrombocytopenia (low blood platelet counts), leucopenia (low white blood cell counts), lymphopenia (low levels of lymphocytes, a particular type of white blood cell), nausea (feeling sick), vomiting and mild and temporary hair loss.
Najpogostejši neželeni učinki zdravila EndolucinBeta (ki se lahko pojavijo pri več kot 1 bolniku od 10) so anemija (nizko število rdečih krvnih celic), trombocitopenija (nizko število trombocitov), levkopenija (nizko število belih krvnih celic), limfopenija (nizko število limfocitov, posebne vrste belih krvnih celic), navzeja (slabost), bruhanje in blago, začasno izpadanje las.
However, the quantity of EndolucinBeta to be used is very small and therefore these risks are considered low.
Kljub temu je količina zdravila EndolucinBeta, ki jo je treba uporabiti, zelo majhna, zato je tudi to tveganje majhno.
EndolucinBeta (lutetium (177Lu) chloride) EMA/554249/2018
EndolucinBeta (lutecijev [177Lu] klorid) EMA/554249/2018
What measures are being taken to ensure the safe and effective use of EndolucinBeta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila EndolucinBeta?
EndolucinBeta is never given to a patient on its own.
Zdravilo EndolucinBeta se bolniku nikoli ne daje samostojno.
The doctor will ensure that the expected benefit to the patients of using EndolucinBeta outweigh the risks linked to the radioactivity.
Zdravnik bo poskrbel, da bodo pričakovane koristi uporabe zdravila EndolucinBeta za bolnike večje od tveganj, povezanih z radioaktivnostjo.
When a medicine radiolabelled with EndolucinBeta is given to a patient, it carries the radiation to where it is needed in the body, either to kill cancer cells (when used for treatment) or to obtain images on a screen (when used for diagnosis).
Ko se zdravilo, radioaktivno označeno z zdravilom EndolucinBeta, da bolniku, to prenese sevanje v tiste dele telesa, kjer je potrebno, da uniči rakave celice (kadar se uporablja za zdravljenje) ali da se pridobijo slike na zaslonu (kadar se uporablja za diagnostične namene).
The Agency concluded that the benefits of EndolucinBeta outweigh the risks and it can be authorised for use in the EU.
Agencija je zaključila, da so koristi zdravila EndolucinBeta večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of EndolucinBeta have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila EndolucinBeta upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Radiolabelling with EndolucinBeta takes place in a laboratory.
Radiooznačevanje z zdravilom EndolucinBeta poteka v laboratoriju.
Side effects reported with EndolucinBeta are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu EndolucinBeta, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency considered that the use of lutetium (177Lu) for radiolabelling medicines was well documented in the scientific literature.
Evropska agencija za zdravila je menila, da je uporaba lutecija (177Lu) za radiooznačevanje zdravil dobro dokumentirana v znanstveni literaturi.
The radiolabelled medicine is then given to the patient according to the instructions in that medicine's product information.
Nato bolnik prejme radioaktivno označeno zdravilo v skladu z navodili iz informacij o označenem zdravilu.
Other information about EndolucinBeta
Druge informacije o zdravilu EndolucinBeta
An overview of EndolucinBeta and why it is authorised in the EU
Pregled zdravila EndolucinBeta in zakaj je odobreno v EU
As for all medicines, data on the use of EndolucinBeta are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila EndolucinBeta stalno spremljajo.
Medicines radiolabelled with EndolucinBeta must not be used in women unless pregnancy has been ruled out.
Zdravila, radiooznačena z zdravilom EndolucinBeta, se ne smejo uporabljati pri nosečnicah ali ženskah, ki bi lahko bile noseče.
Why is EndolucinBeta authorised in the EU?
Zakaj je bilo zdravilo EndolucinBeta odobreno v EU?
What is EndolucinBeta and what is it used for?
Kaj je zdravilo EndolucinBeta in za kaj se uporablja?
What benefits of EndolucinBeta have been shown in studies?
Kakšne koristi zdravila EndolucinBeta so se pokazale v študijah?
EndolucinBeta is only used by specialists who have experience in radiolabelling.
Zdravilo EndolucinBeta smejo uporabljati samo zdravniki specialisti, ki imajo izkušnje na področju radiooznačevanja.
Information on how to minimise the risks is included in the product information for EndolucinBeta.
Navodila, kako zmanjšati tveganja, so vključena v informacije o zdravilu EndolucinBeta.
The active substance in EndolucinBeta, lutetium (177Lu) chloride, is a radioactive compound that mainly releases beta radiation, with small amounts of gamma radiation.
Učinkovina v zdravilu EndolucinBeta, lutecijev (177Lu) klorid, je radioaktivna spojina, ki predvsem oddaja sevanje beta, skupaj z majhnimi količinami sevanja gama.
EndolucinBeta itself is radioactive, and as with any other radioactive product, its use may carry a risk of developing cancer and defects that are passed on to children.
Zdravilo EndolucinBeta je radioaktivno, zato pri njegovi uporabi, enako kot pri uporabi katerega koli drugega radioaktivnega zdravila, obstaja tveganje za nastanek raka in dednih okvar.
Information on restrictions that apply specifically to medicines radiolabelled with EndolucinBeta can be found in the package leaflets of those medicines.
Informacije o omejitvah, ki veljajo posebej za zdravila, radioaktivno označena z zdravilom EndolucinBeta, bodo na voljo v navodilih za uporabo teh zdravil.
What are the risks associated with EndolucinBeta?
Kakšna tveganja so povezana z zdravilom EndolucinBeta?
The side effects with EndolucinBeta depend largely on the medicine it is used with and are described in that medicine's package leaflet.
Neželeni učinki zdravila EndolucinBeta so odvisni predvsem od zdravila, s katerim se uporablja, in so opisani v navodilu za uporabo tega zdravila.
EndolucinBeta contains the radioactive compound lutetium (177Lu) chloride and is used for radiolabelling other medicines.
Zdravilo EndolucinBeta vsebuje radioaktivno spojino lutecijev (177Lu) klorid in se uporablja za radiooznačevanje drugih zdravil.
EndolucinBeta is to be used to radiolabel medicines that have been specifically developed for use with lutetium (177Lu) chloride.
Zdravilo EndolucinBeta je namenjeno samo radiooznačevanju tistih zdravil, ki so bila razvita posebej za uporabo z lutecijevim (177Lu) kloridom.
As with all radiolabelling materials for medicines, there are risks linked to radiation exposure from EndolucinBeta.
Tako kot pri uporabi drugih snovi za radiooznačevanje zdravil tudi pri uporabi zdravila EndolucinBeta obstajajo tveganja, povezana z izpostavljenostjo njegovemu sevanju.
For the list of all side effects and restrictions with EndolucinBeta, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila EndolucinBeta glejte navodilo za uporabo.
How well EndolucinBeta works will largely depend on the medicine that it is used to radiolabel.
Učinkovitost delovanja zdravila EndolucinBeta je predvsem odvisna od zdravila, za radiooznačevanje katerega se uporabi.
How is EndolucinBeta used?
Kako se zdravilo EndolucinBeta uporablja?
How does EndolucinBeta work?
Kako zdravilo EndolucinBeta deluje?
Lu) chloride)
EndolucinBeta (lutecijev [177Lu] klorid)
The company responded to these points on 20 May 2005.
Podjetje je na te točke odgovorilo 20. maja 2005.
It is currently marketed in the entire European Union and world-wide in more than 10 countries, including USA and Japan.
Trenutno je na voljo na celotnem tržišču Evropske unije in v več kot 10 državah po vsem svetu, vključno z ZDA in Japonsko.
The final opinion was converted into a Decision by the European Commission on 7 November 2005.
Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 7. novembra 2005.
International Non-Proprietary Name (INN): Perindopril
Mednarodno nelastniško ime (INN): Perindopril
The arbitration procedure was discussed and initiated by the CHMP at its plenary meeting in April 2005, and a Rapporteur (Dr Gonzalo Calvo Rojas) and Co-Rapporteur (Dr. Gottfried Kreutz) were appointed.
Arbitražni postopek je CHMP obravnaval in začel na svojem plenarnem zasedanju aprila 2005, ko sta bila imenovana poročevalec (dr. Gonzalo Calvo Rojas) in soporočevalec (dr. Gottfried Kreutz).
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI MNENJE NA PODLAGI NAPOTITVE IZ ČLENA 6(12)
It is licensed in the EU through the Mutual Recognition Procedure (MRP) and was first marketed in France in 1988 as Coversyl 2 and 4 mg.
V Evropi je odobren po postopku medsebojnega priznavanja in je bil najprej v prodaji v Franciji leta 1988 kot Coversyl 2 in 4 mg.
Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 27 July
Opombe: Informacije, podane v tem dokumentu in v Dodatkih odražajo samo mnenje CHMP z dne 27. julija
This Referral procedure relates to a request for Arbritation concerning a type II variation for a new indication in the “reduction of risk of cardiovascular events in patients with stable coronary artery disease”.
Ta napotitveni postopek se nanaša na zahtevo po arbitraži v zvezi z variacijo tipa II za novo indikacijo pri “zmanjšanju tveganj kardiovaskularnih dogodkov pri bolnikih s stabilno koronarno arterijsko boleznijo”.
Coversyl and associated names contain perindopril, a well-known, potent angiotensin converting enzyme inhibitor (ACE-I), currently indicated for the treatment of hypertension and symptomatic heart failure.
Coversyl in povezana imena vsebujejo perindopril, zelo znan, močan inhibitor angiotenzinske konvertaze (ACE-I), ki je trenutno indiciran za zdravljenje hipertenzije in simptomatske odpovedi srca.
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
Zmanjšanje tveganj kardioloških zapletov pri bolnikih, ki so doživeli miokardni infarkt in/ali revaskularizacijo.
Based on the evaluation of the currently available data and the (Co-)Rapporteurs' assessment reports, the CHMP adopted an opinion on 27 July 2005 recommending the variation of the Marketing Authorisations for the addition of the following new indication:
Na podlagi vrednotenja trenutno dosegljivih podatkov ter poročevalčevega in soporočevalčevega poročila o oceni, je CHMP dne 27. julija 2005 sprejel mnenje, s katerim je priporočil dopolnitev dovoljenja za promet z zdravilom za vključitev nove indikacije:
The questions identified pertained to the inclusion of a specific group of revascularised patients in the proposed indication, the justification of the beneficial effect of perindopril beyond a mere reduction of myocardial infarction, and an overall justification of the claimed indication based on the results of relevant published literature on other ACE-Is in terms of patients to be included and goals of therapy.
Obravnavana vprašanja so se nanašala na vključitev posebne skupine revaskulariziranih bolnikov v predlagano indikacijo, utemeljitev, da korist uporabe perindoprila presega zgolj zmanjšanje miokardnega infarkta, ter na splošno utemeljitev zahtevane indikacije na podlagi rezultatov iz ustrezne objavljene literature o drugih inhibitorjih ACE, kar se tiče bolnikov, ki bi jih vključili v zdravljenje ter ciljev terapije.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II and the amended Summary of Product Characteristics in Annex III.
Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, in dopolnjen Povzetek glavnih značilnosti zdravila v Dodatku III.
At the end of the MRP procedure there was a discrepancy between different MS regarding the wording of the indication that adequately reflects the clinical data submitted by the company, and an official referral for arbitration according to Article 6(12) of Commission Regulation EC No 1084/2003, as amended, was notified by the Netherlands to the CHMP on 17.03.2005.
O uradni napotitvi na arbitražo v skladu s členom 6(12) Uredbe Komisije ES št. 1084/2003, kot je bila spremenjena, je Nizozemska obvestila CHMP dne 17.3.2005.
Date of first authorisation: 22 May 2017
Datum prve odobritve: 22. maj 2017
Activity in the brain is low.
Aktivnost v možganih je majhna.
It will be the smallest quantity necessary to get the desired information.
To bo najmanjša količina, ki je potrebna za pridobitev želenih podatkov.
This medicinal product must not be mixed with other medicinal products except those mentioned in sections 6.6 and 12.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavjih 6.6 in 12.
It might be helpful to estimate the effective dose that was applied.
Morda bi bilo koristno oceniti uporabljeni efektivni odmerek.
However, in the case of an overdose, you will receive the appropriate treatment.
Vendar boste v primeru prevelikega odmerjanja prejeli ustrezno zdravljenje.
One injection is usually sufficient to conduct the test that your doctor needs.
Ena injekcija običajno zadostuje za izvedbo preiskave, ki jo potrebuje zdravnik.
Individual benefit/risk justification
Utemeljitev koristi/tveganja pri posamezniku
Histopathology standard of truth data was available for 99 of the 115 subjects.
Histopatološki podatki, določeni kot standard resnice, so bili na voljo za 99 od 115 preiskovancev.
Appropriate aseptic precautions should be taken.
Sprejeti je treba ustrezne aseptične previdnostne ukrepe.
These persons will take special care for the safe use of this medicine and will keep you informed of their actions.
To osebje bo posebej pazilo na varno uporabo tega zdravila in vas obveščalo o svojih ukrepih.
Axumin is not intended for use in children and adolescents aged under 18 years.
Zdravilo Axumin ni namenjeno uporabi pri otrocih in mladostnikih, mlajših od 18 let.
This medicine is stored under the responsibility of the specialist in appropriate premises.
Zdravilo se shranjuje na odgovornost specialista v ustreznih prostorih.
The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
Aplicirana aktivnost mora biti v vsakem primeru tako nizka, kot jo je razumno mogoče doseči za pridobitev zahtevanih diagnostičnih podatkov.
Axumin will only be used in specially controlled areas.
Zdravilo Axumin se uporablja samo na posebej nadzorovanih območjih.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se ne uporabi takoj, je za čas in pogoje shranjevanja med uporabo odgovoren uporabnik.
The major route of elimination is via the renal pathway.
Glavna pot izločanja je skozi ledvice.
Typical total scan time is between 20-30 minutes.
Običajni skupni čas slikanja je 20-30 minut.
The Healthcare professionals self-training material shall contain the following key elements:
Gradivo za samostojno usposabljanje zdravstvenih delavcev mora vsebovati ključne elemente:
Washout of activity from most organs and tissues (with the exception of the pancreas) is slow.
Izpiranje aktivnosti iz večine organov in tkiv (razen trebušne slinavke) je počasno.
From a microbiological point of view, unless the method of opening/ dose withdrawal/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Z mikrobiološkega stališča, če način odprtja/odvzema odmerka/razredčitve ne izključi nevarnosti mikrobiološke kontaminacije, je treba zdravilo uporabiti takoj.
Withdrawals should be performed under aseptic conditions.
Odvzem odmerkov je treba opraviti v aseptičnih pogojih.
The solution should be inspected visually prior to use.
Raztopino je treba pred uporabo vizualno pregledati.
In clinical studies side effects were reported by less than 1 in 100 patients given the medicine.
V kliničnih študijah so poročali o pojavu neželenih učinkov pri manj kot 1 od 100 bolnikov, ki so prejeli zdravilo.
- Pain or rash at the site of injection, altered taste in the mouth, altered sense of smell.
- Bolečina ali izpuščaj na mestu injiciranja, spremenjen okus v ustih, spremenjen čut za vonj.
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
Specialist nuklearne medicine vas bo obvestil o običajnem trajanju postopka.
Urinary excretion is slow, reaching approximately 3% of administered radioactivity within 4 hours and 5% within 24 hours.
Izločanje z urinom je počasno; v 4 urah doseže približno 3 % aplicirane radioaktivnosti in v 24 urah 5 %.
Paediatric population For information on use in the paediatric population, see section 4.2.
Pediatrična populacija Za informacije o uporabi pri pediatrični populaciji glejte poglavje 4.2.
Effective dose
Efektivni odmerek
Increasing the duration of acquisition over the pelvis may increase the sensitivity of detection of disease.
Podaljšanje časa slikanja nad predelom medenice lahko poveča občutljivost za odkrivanje bolezni.
Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
Vrednosti so bile izračunane iz podatkov biološke porazdelitve pri ljudeh ob uporabi programske opreme OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling).
The patient should be positioned supine with arms above the head.
Bolnik mora ležati na hrbtu z rokami nad glavo.
This medicinal product is not intended for regular or continuous administration.
To zdravilo ni namenjeno za redno ali neprekinjeno uporabo.
This medicine is not indicated for use in women.
To zdravilo ni namenjeno za uporabo pri ženskah.
Histological assessment of extraprostatic sites (either regional lymph nodes or distant sites) was only conducted for sites with positive image findings.
Histološko oceno lokacij zunaj prostate (bodisi regionalnih bezgavk ali oddaljenih lokacij) so izvedli samo na lokacijah s pozitivnimi ugotovitvami na slikah.
Long-term carcinogenicity studies have not been carried out.
Dolgotrajne študije karcinogenosti zdravila niso bile opravljene.
If the injection volume is between 0.5 and 1 mL, only syringes of an appropriate size (1 mL) should be used.
Če je volumen injiciranja med 0,5 in 1 ml, se smejo uporabiti samo brizge ustrezne velikosti (1 ml).
- not eat or drink for at least 4 hours before the scan (you can take your usual medicines with small amounts of water).
- jesti ali piti vsaj 4 ure pred slikanjem (vendar lahko vzamete običajna zdravila z majhno količino vode).
The nuclear medicine doctor supervising the procedure will decide on the quantity of Axumin to be used in your case.
Specialist nuklearne medicine, ki bo nadzoroval postopek, bo določil količino zdravila Axumin, ki bo uporabljena v vašem primeru.
Your doctor and the nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of being exposed to radiation.
Vaš zdravnik in specialist nuklearne medicine sta presodila, da korist tega postopka z radiofarmakom odtehta tveganje zaradi izpostavljenosti sevanju.
For the limitations in the interpretation of a positive scan, see section 4.4 and 5.1.
Za omejitve pri razlaganju pozitivnega rezultata slikanja glejte poglavji 4.4 in 5.1.
For instructions on dilution of the medicinal product before administration, see section 12.
Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 12.
Advanced Accelerator Applications 3 rue Charles Lauer 92210 Saint Cloud France
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Table 3: Estimated radiation absorbed doses for adults receiving Axumin Organ/Tissue
Preglednica 3: Ocenjeni absorbirani odmerki sevanja pri odraslih, ki so prejeli zdravilo Axumin Organ/tkivo