FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose depends on the patient's body weight, on the condition being treated and on whether Herzuma is given weekly or three-weekly.
Slovenian: Priporočeni odmerek je odvisen od telesne mase bolnika, od zdravljene bolezni in od tega, ali se zdravilo Herzuma daje vsak teden ali vsake tri tedne.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Slovenian: • zgodnjega raka dojke (kadar se je rak razširil znotraj dojke ali v podpazdušne žleze, ne pa na druge dele telesa) po kirurškem posegu, kemoterapiji (zdravljenju z zdravili proti raku) in radioterapiji (zdravljenju z obsevanjem), če je to smiselno.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Herzuma has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Herzuma po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Herceptin.
English: What benefits of Herzuma have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Herzuma izkazalo v študijah?
English: Patients were given either Herzuma or Herceptin with other cancer medicines before surgery to remove the cancer, and then the same medicine on its own every three weeks for 1 year.
Slovenian: Bolnice so zdravilo Herzuma ali zdravilo Herceptin skupaj z drugimi zdravili proti raku prejele pred operacijo za odstranitev raka, nato pa so isto zdravilo samostojno prejemale še eno leto vsake tri tedne.
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma is used before surgery in combination with chemotherapy and then again after surgery on its own;
Slovenian: Pri lokalno napredovalih tumorjih (vključno z vnetnimi tumorji) ali tumorjih, širših od 2 cm, se zdravilo Herzuma pred kirurškim posegom uporablja v kombinaciji s kemoterapijo, po kirurškem posegu pa kot samostojno zdravilo;
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Slovenian: Pri zgodnjem raku dojke zdravljenje poteka eno leto ali dokler se bolezen ne ponovi, pri metastatskem raku dojke in raku želodca pa traja, dokler je še učinkovito.
English: The active substance in Herzuma, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein.
Slovenian: Zdravilna učinkovina v zdravilu Herzuma, trastuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino HER2 in se veže nanjo.
English: Herzuma can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Herzuma je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravili proti raku.
English: Why is Herzuma approved?
Slovenian: Zakaj je bilo zdravilo Herzuma odobreno?
English: For practical information about using Herzuma, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Herzuma naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is used on its own in patients in whom previous treatments have failed.
Slovenian: Pri bolnikih, pri katerih je bilo predhodno zdravljenje neuspešno, se uporablja kot samostojno zdravilo.
English: Because Herzuma is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Herzuma.
Slovenian: Zdravilo Herzuma je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Herzuma ni treba ponavljati.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Slovenian: • metastatskega raka želodca, in sicer v kombinaciji s cisplatinom in bodisi kapecitabinom bodisi fluorouracilom (drugima zdraviloma proti raku).
English: It is not intended to provide practical advice on how to use Herzuma.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The reference medicine for Herzuma is Herceptin.
Slovenian: Referenčno zdravilo za zdravilo Herzuma je zdravilo Herceptin.
English: Studies have also shown that giving Herzuma produces similar levels of the active substance in the body to giving Herceptin.
Slovenian: Študije so pokazale tudi, da zdravilo Herzuma ustvari podobne ravni zdravilne učinkovine v telesu kot zdravilo Herceptin.
English: Herzuma is a ‘biosimilar medicine'.
Slovenian: Zdravilo Herzuma je „podobno biološko zdravilo“.
English: Laboratory studies comparing Herzuma with Herceptin have shown that the active substance in Herzuma is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Herzuma primerjali z zdravilom Herceptin, so pokazale, da je zdravilna učinkovina v zdravilu Herzuma po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini v zdravilu Herceptin.
English: How is Herzuma used?
Slovenian: Kako se zdravilo Herzuma uporablja?
English: How does Herzuma work?
Slovenian: Kako zdravilo Herzuma deluje?
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Herzuma should be given marketing authorisation.
Slovenian: Zato je menila, da njegove koristi enako kot pri zdravilu Herceptin odtehtajo znana tveganja.
English: Herzuma can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells.
Slovenian: To pomeni, da na površini tumorskih celic v velikih količinah nastaja beljakovina, imenovana HER2.
English: 56 ampoules x 1 administration device
Slovenian: 56 ampul x 1 pripomoček za aplikacijo
English: 170 mg Nebuliser solution Inhalation use ampoule (PE)
Slovenian: za inhaliranje ampula (PE)
English: Further information about the EU-wide safety review:
Slovenian: Dodatne informacije o analizi varnosti, opravljeni v EU:
English: • Parents who have any questions or concerns should speak to the treating doctor or other healthcare professional.
Slovenian: • Starši, ki imajo kakršna koli vprašanja ali skrbi, naj se posvetujejo z lečečim zdravnikom ali drugim zdravstvenim delavcem.
English: Information to parents and carers
Slovenian: Informacije za starše in negovalce
English: The CMDh is a medicines regulatory body representing the EU Member States.
Slovenian: Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice EU.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: Pregled je izvedel Odbor za oceno tveganja na področju farmakovigilance (PRAC).
English: This should be done in accordance with routine clinical practice and the clinical needs of the individual patient.
Slovenian: Pri tem morajo upoštevati vsakdanjo klinično prakso in klinične potrebe posameznega bolnika.
English: References:
Slovenian: Referenčna literatura:
English: This report was confounded by the fact that additional magnesium may have been given.
Slovenian: Vendar pa je to poročilo nezanesljivo zaradi dejstva, da je bil morda uporabljen dodaten magnezij.
English: However, healthcare professionals should be aware of the potential risk for hypermagnesaemia.
Slovenian: Vendar pa se morajo zdravstveni delavci zavedati možnega tveganja za hipermagneziemijo.
English: Numeta G13%E and Numeta G16%E have been authorised since 2011 via national procedures in the following Member States: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom.
Slovenian: Zdravili Numeta G13%E in Numeta G16%E sta po nacionalnih postopkih odobreni od leta 2011 v naslednjih državah članicah: v Avstriji, Belgiji, Češki republiki, na Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Irskem, v Italiji, Luksemburgu, na Malti, Nizozemskem, Norveškem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu.
English: Stakeholders were also invited to submit any relevant information to support the assessment, and the Agency's Paediatric Committee (PDCO) was consulted for advice.
Slovenian: Prav tako je pozval zainteresirane strani k predložitvi kakršnih koli pomembnih informacij, ki bi bile v pomoč pri oceni, in se posvetoval z Odborom za zdravila za pediatrično uporabo (PDCO) pri agenciji.
English: They contain nutrients such as glucose (sugar), lipids (fats), aminoacids and other important substances including magnesium.
Slovenian: Vsebujejo hranilne snovi, kot so glukoza (sladkor), lipidi (maščobe), aminokisline in druge pomembne snovi, med katerimi je tudi magnezij.
English: The review of Numeta G13%E and Numeta G16%E was initiated on 13 June 2013 at the request of Sweden, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Slovenian: Pregled zdravil Numeta G13%E in Numeta G16%E se je začel 13. junija 2013 na zahtevo Švedske, v skladu s členom 107i Direktive 2001/83/ES, znanim tudi kot nujni postopek Unije.
English: • Severe hypermagnesaemia is rare but can have adverse clinical consequences.
Slovenian: • Huda hipermagneziemija je redka, vendar ima lahko neželene klinične posledice.
English: As the review only covers nationally authorised medicines, the PRAC recommendation was forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Slovenian: Ker so bila pregledana samo zdravila, odobrena na nacionalni ravni, je bilo priporočilo odbora PRAC predloženo Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela dokončni sklep.
English: As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Slovenian: Ker je skupina CMDh soglasno podprla priporočila odbora PRAC, jih bodo odslej neposredno izvajale vse države članice v skladu z dogovorjenim časovnim razporedom.
English: Magnesium levels mainly ranged from 1.025 mmol/L to > 1.5 mmol/L and no clinical signs or symptoms were reported for any of the cases.
Slovenian: Koncentracije magnezija so bile večinoma v razponu od 1,025 mmol/l do > 1,5 mmol/l, v nobenem primeru pa niso poročali o kliničnih znakih ali simptomih.
English: Because the CMDh position was agreed by consensus, the agreement will be directly implemented by the Member States where the medicines are authorised.
Slovenian: Ker je skupina CMDh soglasno sprejela sklep, ga bodo neposredno izvajale države članice, v katerih sta zdravili odobreni.
English: Clinical signs may not be identifiable unless hypermagnesaemia is severe.
Slovenian: Kliničnih znakov včasih ni mogoče prepoznati, če hipermagneziemija ni huda.
English: Although this is within the recommendations reported in the literature as a whole, it is slightly more than suggested by some recognised guidelines1,2,3 (0.15-0.25 mmol/kg/day and 0.2 mmol/kg/day for term infant to one year of age, 0.15-0.25 mmol/kg/day and 0.1 mmol/kg/day for children from one year to two years of age).
Slovenian: Čeprav je ta vrednost znotraj priporočil, ki se na splošno pojavljajo v literaturi1,2,3, nekoliko presega vrednost, ki jo priporočajo nekatere priznane smernice (0,15-0,25 mmol/kg/dan in 0,2 mmol/kg/dan za donošenčke do 1. leta starosti, 0,15-0,25 mmol/kg/dan in 0,1 mmol/kg/dan za otroke od prvega do drugega leta starosti).
English: • The appropriate parenteral magnesium intake in preterm infants is uncertain.
Slovenian: • Kakšen je ustrezen parenteralni vnos magnezija pri nedonošenčkih, ni povsem jasno.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed by consensus the recommendation to suspend the marketing authorisation of Numeta G13%E because of a risk of hypermagnesaemia (high blood levels of magnesium).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), je soglasno podprla priporočilo, da se začasno umakne dovoljenje za promet z zdravilom Numeta G13%E zaradi tveganja za hipermagneziemijo (visoke koncentracije magnezija v krvi).
English: Parenteral nutrition is necessary in premature neonates and in some full-term babies in order to prevent complications such as growth retardation and breathing complications and to promote the normal development of the brain.
Slovenian: Parenteralno hranjenje je potrebno pri nedonošenčkih in nekaterih donošenčkih, da se preprečijo zapleti, kot sta zaostajanje v rasti in težave z dihanjem, ter spodbudi normalen razvoj možganov.
English: The product information should be revised accordingly and healthcare professionals should be informed in writing of the potential risk of hypermagnesaemia, which is increased in patients with impaired kidney function and those whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimise this risk.
Slovenian: Informacije o zdravilu je treba ustrezno spremeniti, zdravstvene delavce pa je treba pisno obvestiti o možnem tveganju za hipermagneziemijo, ki se poveča pri bolnikih z okvarjenim delovanjem ledvic in pri tistih, katerih matere so pred porodom dobivale dodaten magnezij, ter o ukrepih, ki jih je treba sprejeti za zmanjšanje tega tveganja.
English: Safe Practices for Parenteral Nutrition JPEN 2004; 28: S 39 - S 70
Slovenian: Mirtallo in sod., „Varna praksa parenteralnega hranjenja“, JPEN, št. 28, 2004, str. S 39-S 70.
English: This risk is increased in patients with reduced renal function, and in newborn infants of mothers who were receiving supplemental magnesium prior to delivery.
Slovenian: Tveganje je večje pri bolnikih z zmanjšanim delovanjem ledvic in pri novorojenčkih mater, ki so pred porodom dobivale dodaten magnezij.
English: For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product.
Slovenian: V zvezi z zdravilom Numeta G16%E je zaključil, da bi vsebnost magnezija sicer lahko povzročila vnos količin magnezija, ki so nekoliko večje od tistih, ki jih priporočajo nekatere smernice, vendar predlagani ukrepi, med katerimi sta tudi posodobitev informacij o zdravilu in dodatna študija, zadostujejo za zagotovitev varne uporabe tega zdravila.
English: Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN), and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR).
Slovenian: Koletzko, B., Goulet, O., Hunt, J., Krohn, K., Shamir, R., „Smernice za parenteralno prehrano otrok Evropskega združenja za pediatrično gastroenterologijo, hepatologijo in prehrano (ESPGHAN) in Evropskega združenja za klinično prehrano in metabolizem (ESPEN), ki jih je podprlo Evropsko združenje za pediatrične raziskave (ESPR)“, J Pediatric Gastroenterology Nutrition, št. 41, 2005, str. S1-S87.
English: In addition, the PRAC noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium.
Slovenian: Poleg tega je ugotovil, da bi bilo to tveganje še večje pri nedonošenčkih, ker so njihove ledvice še nerazvite in zato težje izločijo magnezij iz telesa.
English: Numeta G13%E and Numeta G16%E (glucose, lipids, aminoacids and electrolytes) are parenteral nutrition solutions.
Slovenian: Numeta G13%E in Numeta G16%E (glukoza, lipidi, aminokisline in elektroliti) sta parenteralni hranilni raztopini.
English: The PRAC also noted the difficulty in identifying symptoms of hypermagnesaemia in premature newborns, which means that hypermagnesaemia may not be detected until it causes serious complications.
Slovenian: Ugotovil je tudi, da je težko prepoznati simptome hipermagneziemije pri nedonošenčkih, kar pomeni, da hipermagneziemije včasih ne odkrijejo, dokler ne povzroči resnih zapletov.
English: In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.
Slovenian: Poleg tega je odbor PRAC priporočil, da se opravi študija, v kateri bi nadalje ocenili koncentracije magnezija v krvi, opažene pri donošenčkih in otrocih do drugega leta starosti po uporabi zdravila Numeta G16%E.
English: • Doctors should also monitor patients for signs and symptoms of hypermagnesaemia such as nausea, vomiting and flushing, generalized weakness, respiratory failure, hypotension and arrhythmias.
Slovenian: • Zdravniki morajo bolnike spremljati tudi glede znakov in simptomov hipermagneziemije, kot so slabost, bruhanje in zardevanje, splošna oslabelost, odpoved dihal, hipotenzija in aritmije.
English: • The company identified one case of hypermagnesaemia associated with Numeta G16%E.
Slovenian: • Družba je zabeležila en primer hipermagneziemije, povezane z zdravilom Numeta G16%E.
English: For another nutrition preparation given into a vein, Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive, provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient.
Slovenian: Za drugi prehranski pripravek, ki se daje v veno, tj. Numeta G16%E, ki se uporablja pri donošenčkih in otrocih do 2. leta starosti, se je skupina CMDh strinjala, da je razmerje med tveganji in koristmi še vedno pozitivno, če zdravstveni delavci preverijo koncentracijo magnezija v krvi bolnikov, preden jim dajo pripravek in v rednih razmikih po tem, pri čemer morajo upoštevati vsakdanjo klinično prakso in klinične potrebe posameznega bolnika.
English: The review of Numeta G13%E and Numeta G16%E was carried out by the the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia (without clinical symptoms) in preterm infants.
Slovenian: Pregled zdravil Numeta G13%E in Numeta G16%E je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, potem ko so poročali o več primerih hipermagneziemije (brez kliničnih simptomov) pri nedonošenčkih.
English: Having considered available guidelines and relevant literature and considering the magnesium content of Numeta, the PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia.
Slovenian: Potem ko je odbor PRAC proučil razpoložljive smernice in zadevno literaturo ter pregledal vsebnost magnezija v zdravilu Numeta, je zaključil, da bi se lahko pri uporabi zdravila Numeta G13%E povečalo tveganje za hipermagneziemijo.
English: As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU.
Slovenian: Izdelovalec se je odločil za previdnostni ukrep in prostovoljno odpoklical zdravilo Numeta G13%E s trgov EU.
English: • The benefit-risk balance of the nutrition preparation Numeta G16%E, used in full-term newborns and children up to 2 years, remains positive.
Slovenian: • Razmerje med tveganji in koristmi za prehranski pripravek Numeta G16%E, ki se uporablja pri donošenčkih in otrocih do 2. leta starosti, je še naprej pozitivno.
English: • The maximum total amount of magnesium that can be delivered to term infants using Numeta G16%E according to its product information is 0.3 mmol/kg/day.
Slovenian: • Največja skupna količina magnezija, ki jo lahko pri uporabi zdravila Numeta G16%E prejmejo donošenčki, glede na navedeno v informacijah o zdravilu znaša 0,3 mmol/kg/dan.
English: • The company marketing Numeta identified 14 case reports of hypermagnesaemia with Numeta G13%E.
Slovenian: • Družba, ki trži zdravilo Numeta, je zabeležila 14 poročil o primerih hipermagneziemije pri uporabi zdravila Numeta G13%E.
English: The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines.
Slovenian: Odbor PRAC je ocenil razpoložljive podatke o tveganju za hipermagneziemijo pri uporabi pripravkov Numeta G13%E in Numeta G16%E, ki so na voljo iz kliničnih študij, poročil v obdobju trženja in objavljene literature, ter proučil razpoložljive smernice za zdravljenje.
English: In patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.
Slovenian: Pri bolnikih, pri katerih se pojavijo zvišane koncentracije magnezija v krvi ali znaki hipermagneziemije, je treba prekiniti dajanje zdravila Numeta G16%E ali zmanjšati hitrost infundiranja.
English: Numeta preparations are given to provide nutritional support in children who cannot be fed by mouth or with a feeding tube.
Slovenian: Pripravki Numeta se dajejo za prehransko podporo pri otrocih, ki jih ni mogoče hraniti skozi usta ali po sondi za hranjenje.
English: • The nutrition preparation Numeta G16%E can continue to be used in full-term newborns and children up to 2 years, however the doctor will monitor the levels of magnesium in the child's blood before giving the preparation and at appropriate intervals thereafter.
Slovenian: • Prehranski pripravek Numeta G16%E se lahko še naprej uporablja pri donošenčkih in otrocih do 2. leta starosti, vendar morajo zdravniki preveriti koncentracije magnezija v krvi otroka, preden mu dajo pripravek in v ustreznih razmikih po tem.
English: The maximum total licensed amount of magnesium that can be delivered to preterm infants using Numeta G13%E is 0.55 mmol/kg/day which is above this recommended intake.
Slovenian: Največja skupna odobrena količina magnezija, ki jo lahko pri uporabi zdravila Numeta G13%E prejmejo nedonošenčki, je 0,55 mmol/kg/dan, kar je več od priporočenega vnosa.
English: • In case of hypermagnesaemia, the infusion of Numeta G16%E should be stopped or infusion rate reduced and alternative fluids, nutrition and electrolytes prescribed as deemed clinically appropriate.
Slovenian: • Če se pojavi hipermagneziemija, je treba prekiniti ali upočasniti infundiranje zdravila Numeta G16%E in predpisati druge tekočine, hranilne snovi in elektrolite, kot je klinično ustrezno.
English: However, widelyrecognised guidelines 1,2 recommend a parenteral magnesium intake of 0.15 - 0.25 mmol/kg/day.
Slovenian: Parenteralni vnos magnezija, ki ga priporočajo splošno priznane smernice1,2, je od 0,15-0,25 mmol/kg/dan.