FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Laboratorijska ispitivanja u kojima su uspoređivani lijekovi Herzuma i Herceptin pokazala su da je djelatna tvar u lijeku Herzuma vrlo slična djelatnoj tvari u lijeku Herceptin u pogledu strukture, čistoće i biološke aktivnosti.
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Herzuma should be given marketing authorisation.
Croatian: Stoga je mišljenje Agencije da, kao i kod lijeka Herceptin, koristi nadmašuju utvrđene rizike te je preporučila davanje odobrenja za stavljanje lijeka Herzuma u promet.
English: For practical information about using Herzuma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Herzuma bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Why is Herzuma approved?
Croatian: Zašto je lijek Herzuma odobren?
English: Studies have also shown that giving Herzuma produces similar levels of the active substance in the body to giving Herceptin.
Croatian: Ispitivanja su dokazala i da se primjenom lijeka Herzuma stvaraju slične razine djelatne tvari u tijelu kao i primjenom lijeka Herceptin.
English: How is Herzuma used?
Croatian: Kako se Herzuma koristi?
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.
Croatian: Djelatna tvar u lijeku Herzuma, trastuzumab, monoklonsko je protutijelo (vrsta bjelančevine) namijenjeno prepoznavanju i vezivanju na bjelančevinu HER2.
English: How does Herzuma work?
Croatian: Kako djeluje Herzuma?
English: What benefits of Herzuma have been shown in studies?
Croatian: Koje su koristi lijeka Herzuma utvrđene u ispitivanjima?
English: Herzuma contains the active substance trastuzumab.
Croatian: Herzuma sadržava djelatnu tvar trastuzumab.
English: 56 ampoules x 1 administration device
Croatian: 56 ampula x 1 naprava za raspršivanje
English: Strength Pharmaceutical
Croatian: Jačina Farmaceutski oblik
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Izmišljeno) ime
English: 170 mg Nebuliser solution Inhalation use ampoule (PE)
Croatian: Za inhalaciju ampula (PE)
English: References:
Croatian: Reference:
English: 20 September 2013 EMA/564255/2013
Croatian: 20. rujna 2013. EMA/564255/2013
English: Further information about the EU-wide safety review:
Croatian: Za više informacija o sigurnosnom pregledu na razini EU-a:
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Kontaktirajte s našim djelatnicima za medije Monika Benstetter ili Martin Harvey
English: The CMDh is a medicines regulatory body representing the EU Member States.
Croatian: CMDh je regulatorno tijelo za lijekove koje predstavlja države članice EU.
English: • Parents who have any questions or concerns should speak to the treating doctor or other healthcare professional.
Croatian: • Bolesnici koji imaju pitanja ili su zabrinuti moraju se obratiti svojem liječniku koji vodi liječenje ili drugim zdravstvenim djelatnicima.
English: This should be done in accordance with routine clinical practice and the clinical needs of the individual patient.
Croatian: Ovo se mora provoditi u skladu s rutinskom kliničkom praksom i ovisno o kliničkim potrebama pojedinog bolesnika.
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.
Croatian: Lijekovi Numeta G13%E i Numeta G16%E odobreni su 2011. godine putem nacionalnih postupaka u sljedećim državama članicama: Austrija, Belgija, Češka Republika, Danska, Finska, Francuska, Njemačka, Grčka, Irska, Italija, Luksemburg, Malta, Nizozemska, Norveška, Poljska, Portugal, Španjolska, Švedska, Ujedinjeno Kraljevstvo.
English: Information to parents and carers
Croatian: Informacije bolesnicima i skrbnicima
English: However, healthcare professionals should be aware of the potential risk for hypermagnesaemia.
Croatian: No, zdravstveni djelatnici moraju biti svjesni mogućeg rizika od hipermagnezemije.
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.
Croatian: Od pripadnika interesne skupine također je zatraženo da dostave sve bitne informacije u prilog ocijeni, te je konzultirano Pedijatrijsko povjerenstvo (PDCO) pri Agenciji.
English: Clinical signs may not be identifiable unless hypermagnesaemia is severe.
Croatian: Klinički znakovi ne mogu se identificirati osim ako hipermagnezemija nije ozbiljna.
English: This report was confounded by the fact that additional magnesium may have been given.
Croatian: Na ovu prijavu je utjecao zbunjujući čimbenik da je možda dodan dodatni magnezij.
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.
Croatian: Razine magnezija su uglavnom u rasponu od 1,025 mmol/L do > 1,5 mmol/L, te nikakvi klinički znakovi ili simptomi nisu prijavljeni za bilo koji slučaj.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Povjerenstvo za procjenu rizika na području farmakovigilancije (PRAC) provelo je pregled.
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.
Croatian: S obzirom da su pregledom pokriveni samo nacionalno odobreni lijekovi, preporuka PRAC-a proslijeđena je Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je usvojila konačni stav.
English: As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU.
Croatian: Kao mjeru opreza, proizvođač je odlučio dobrovoljno opozvati lijek Numeta G13%E u EU.
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.
Croatian: S obzirom da je CMDh konsenzusom potvrdio preporuke PRAC-a, one će se sada izravno primijeniti u svim državama članicama prema dogovorenom rasporedu.
English: They contain nutrients such as glucose (sugar), lipids (fats), aminoacids and other important substances including magnesium.
Croatian: Sadrže nutrijente poput glukoze (šećera), lipida (masti), aminokiselina i drugih važnih tvari poput magnezija.
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.
Croatian: Pregled pripravaka Numeta G13%E i Numeta G16%E započet je dana 13. lipnja 2013. na zahtjev Švedske, sukladno članku 107.i Direktive 2001/83/EC, poznat pod nazivom hitan postupak Unije.
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).
Croatian: Iako je ova vrijednost u cijelosti unutar preporuka prijavljenih u literaturi, ona je malo viša od predložene vrijednosti u pojedinim priznatim smjernicama1,2,3 (0,15-0,25 mmol/kg/danu i 0,2 mmol/kg/danu za donesenu novorođenčad do jedne godine starosti, 0,15-0,25 mmol/kg/danu i 0,1 mmol/kg/danu za djecu u dobi od jedne do dvije godine starosti).
English: • Severe hypermagnesaemia is rare but can have adverse clinical consequences.
Croatian: • Ozbiljna hipermagnezemija je iznimno rijetka i može imati neželjene kliničke posljedice.
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.
Croatian: Nadalje, PRAC je naveo da se rizik još više povećava u nedonoščadi s obzirom da su njihovi bubrezi nezreli i manje su sposobni za čišćenje tijela od magnezija.
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).
Croatian: Koordinacijska skupina za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), regulatorno tijelo koje predstavlja države članice Europske unije (EU), konsenzusom je potvrdilo preporuku za suspenziju odobrenja za stavljanje u promet lijeka Numeta G13%E zbog rizika od hipermagnezemije (povećane razine magnezija u krvi).
English: • The appropriate parenteral magnesium intake in preterm infants is uncertain.
Croatian: • Odgovarajući parenteralni unos magnezija u nedonoščadi nije siguran.
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.
Croatian: PRAC je također naveo poteškoće s identificiranjem simptoma hipermagnezemije u nedonoščadi, što znači da se hipermagnezemija ne može detektirati sve dok uzrokuje ozbiljne komplikacije.
English: While Numeta G13%E is suspended, healthcare professionals should use alternative nutrition solutions which may include authorised standardised or individually prepared solutions.
Croatian: S obzirom da je pripravak Numeta G13%E suspendiran, zdravstveni djelatnici moraju koristiti alternativna nutritivna rješenja koja mogu uključivati ovlaštene standardizirane ili individualno pripremljene otopine.
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.
Croatian: Parenteralno hranjenje potrebno je u nedonoščadi i u pojedinim slučajevima donesene novorođenčadi kako bi se spriječile komplikacije poput retardiranosti rasta i komplikacije disanja te se potaknuo normalan razvoj mozga.
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.
Croatian: Informacije o proizvodu moraju se revidirati primjereno, a zdravstveni djelatnici trebaju se informirati pismenim putem o mogućem riziku hipermagnezemije, koji je povećan u bolesnika s oštećenom funkcijom bubrega i onih čije majke su primale dodatni magnezij prije poroda, te o mjerama koje je potrebno poduzeti za smanjivanje ovog rizika.
English: Because the CMDh position was agreed by consensus, the agreement will be directly implemented by the Member States where the medicines are authorised.
Croatian: S obzirom da je stav CMDh-a usuglašen konsenzusom, države članice u kojima su lijekovi odobreni izravno implementiraju dogovor.
English: • The company identified one case of hypermagnesaemia associated with Numeta G16%E.
Croatian: • Tvrtka je identificirala jedan slučaj hipermagnezemije povezan s pripravkom Numeta G16%E.
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.
Croatian: U slučaju pripravka Numeta G16%E, PRAC je zaključio da iako udjel magnezija može rezultirati unosom magnezija koji je tek neznatno veći od preporučenog u pojedinim smjernicama, predložene mjere, uključujući i obnavljanje informacija o proizvodu, kao i provođenje daljnjih ispitivanja, dostatni su da osiguraju sigurnu uporabu ovog proizvoda.
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.
Croatian: • Maksimalna ukupna količina magnezija koja se može dati donesenoj novorođenčadi pripravkom Numeta G16%E u skladu s informacijama o proizvodu iznosi 0,3 mmol/kg/danu.
English: However, widelyrecognised guidelines 1,2 recommend a parenteral magnesium intake of 0.15 - 0.25 mmol/kg/day.
Croatian: No, širom priznate smjernice1,2 preporučile su unos magnezija od 0,15 - 0,25 mmol/kg/danu.
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.
Croatian: Nadalje, PRAC je preporučio provođenje ispitivanja sa svrhom daljnjeg ocjenjivanja razina magnezija u krvi koje su uočene u donesene novorođenčadi i djece do 2 godine starosti nakon primjene pripravka Numeta G16%E.
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.
Croatian: Ovaj se rizik povećava u bolesnika sa smanjenom funkcijom bubrega, i u novorođenčadi majki koje su primale dodani magnezij prije poroda.
English: Parenteral nutrition is the providing of nutrients and fluids through a vein in patients who cannot be fed by mouth or by enteral nutrition (the use of a feeding tube passed directly into the gut).
Croatian: Parenteralnim hranjenjem u tijelo se unose hranjive tvari i tekućine kroz venu bolesnika koji se ne može hraniti peroralnim ili eneteralnim hranjenjem (uporabom cjevčice za hranjenje koja se uvodi izravno u crijeva).
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.
Croatian: Nakon razmatranja dostupnih smjernica i relevantne literature, te razmatranja udjela magnezija u pripravcima Numeta, PRAC je zaključio da primjena pripravka Numeta G13%E može uzrokovati visoki rizik od hipermagnezemije.
English: Numeta G13%E and Numeta G16%E (glucose, lipids, aminoacids and electrolytes) are parenteral nutrition solutions.
Croatian: Numeta G13%E i Numeta G16%E (glukoza, lipidi, aminokiseline i elektroliti) su parenteralne prehrambene otopine.
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.
Croatian: • U slučaju hipermagnezemije, infuzija pripravka Numeta G16%E mora se prekinuti ili se brzina infuzije mora smanjiti, a alternativne tekućine, prehrana i elektroliti smatraju se klinički primjerenima.
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.
Croatian: U bolesnika čije su razine magnezija u krvi povišene ili su identificirani znakovi hipermagnezemije, uzimanje lijeka Numeta G16%E mora se prekinuti ili se brzina infuzije mora smanjiti.
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.
Croatian: • Omjer koristi i rizika prehrambenog pripravka Numeta G16%E, koji se koristi u donesene novorođenčadi i djece do starosti od 2 godine, ostaje pozitivan.
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.
Croatian: Maksimalna ukupna dozvoljena količina magnezija koja se može dati nedonoščadi pripravkom Numeta G13%E iznosi 0,55 mmol/kg/danu, što je više od preporučenog unosa.
English: Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Croatian: Hipermagnezemija je ozbiljno stanje, a simptomi mogu uključivati slabost, mučninu i povraćanje, poteškoće s disanjem, hipotenziju (niski krvni tlak) i aritmije (nepravilne otkucaje srca).
English: The doctor will stop giving Numeta G16%E if magnesium levels are high, or will give Numeta at a slower rate.
Croatian: Liječnik će prekinuti davanje lijeka Numeta G16%E, ako su razine magnezija previsoke ili će usporiti davanje pripravka Numeta.
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.
Croatian: U slučaju drugog prehrambenog pripravka koji se daje u venu, Numeta G16%E, a koji se koristi kod donesene novorođenčadi i djece do dobi od 2 godine, CMDh je suglasan da omjer koristi i rizika ostaje pozitivan, pod uvjetom da zdravstveni djelatnici prate razine magnezija u krvi svojih bolesnika prije davanja pripravka i u odgovarajućim intervalima, stoga u skladu s rutinskom kliničkom praksom i kliničkim potrebama pojedinačnog bolesnika.
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.
Croatian: PRAC je ocijenio dostupne podatke o riziku od hipermagnezemije s pripravcima Numeta G13%E i Numeta G16%E iz kliničkih ispitivanja, prijave nakon stavljanja lijeka u promet i objavljene literature, te je razmotrio dostupne smjernice za liječenje.
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.
Croatian: • Prehrambeni pripravak Numeta G16%E može se i dalje koristiti u donesene novorođenčadi i djece do dvije godine starosti, no liječnik treba nadzirati razine magnezija u dječjoj krvi prije davanja pripravka i u odgovarajućim intervalima nakon toga.
English: • When giving Numeta G16%E, doctors should monitor serum magnesium levels, along with other electrolyte levels at baseline and at appropriate intervals thereafter.
Croatian: • Prilikom davanja pripravka Numeta G16%E, liječnici moraju pratiti razine magnezija u serumu, zajedno s razinama elektrolita u početnoj vrijednosti i u odgovarajućim intervalima nakon toga.
English: • The company marketing Numeta identified 14 case reports of hypermagnesaemia with Numeta G13%E.
Croatian: • Tvrtka koja stavlja u promet pripravak Numeta identificirala je 14 prijava slučaja hipermagnezemije s pripravkom Numeta G13%E.
English: Numeta preparations are given to provide nutritional support in children who cannot be fed by mouth or with a feeding tube.
Croatian: Numeta daju se sa svrhom pružanja potpore prehrani u djece koja se ne mogu hraniti peroralno ili pomoću cjevčice za hranjenje.
English: • Following several reports of hypermagnesaemia in preterm infants, the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Croatian: • Nakon nekoliko prijava hipermagnezemije u nedonoščadi, nutritivan pripravak Numeta G13%E suspendiran je sve dok ponovno formuliran pripravak ne bude dostupan.
English: Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a re-formulated preparation is made available.
Croatian: Za lijek Numeta G13%E, koji se daje u venu nedonoščadi kako bi se pružila potpora prehrani (intravenska prehrana ili parenteralna prehrana), suspenzija ostaje na snazi sve do odobravanja reformuliranog pripravka.
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.
Croatian: • Liječnici moraju pratiti bolesnike kako bi uočili znakove i simptome hipermagnezemije poput mučnine, povraćanja i crvenila, općenite slabosti, respiratornih problema, hipotenzije i aritmija.
English: Doctors will monitor newborns and children who are receiving Numeta G16%E for symptoms of hypermagnesaemia such as weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).
Croatian: Liječnici će pratiti novorođenčad i djecu koja primaju pripravak Numeta G16%E kako bi uočili simptome hipermagnezemije poput slabosti, mučnine i povraćanja, poteškoća sa disanjem, hipotenzije (niskog krvnog tlaka) i aritmije (nepravilnih otkucaja srca).
English: • Because of the risk of hypermagnesaemia (high blood levels of magnesium), the nutrition preparation Numeta G13%E has been suspended until a re-formulated preparation is made available.
Croatian: • Zbog rizika od hipermagnezemije (visokih razina magnezija u krvi), prehrambeni pripravak Numeta G13%E suspendiran je sve do odobrenja reformuliranog pripravka.
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.
Croatian: Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) pri Europskoj agenciji za lijekove provelo je pregled lijekova Numeta G13%E i Numeta G16%E nakon nekoliko prijava hipermagnezemije (bez kliničkih simptoma) u nedonoščadi.
English: Numeta G13%E is given into a vein to provide nutritional support in premature babies who cannot be fed by mouth or with a feeding tube.
Croatian: Pripravak Numeta G13%E daje se u venu da bi se omogućila potpora prehrani u nedonoščadi koja se ne može hraniti peroralno ili na cjevčicu za hranjenje.
English: These improvements were not statistically significant.
Croatian: Ovo poboljšanje nije bilo statistički značajno.
English: The higher than approved dose used in the study did not fully explain these findings.
Croatian: Viša doza lijeka od odobrene korištena u ispitivanju nije u potpunosti objasnila ove rezultate.
English: Other side effects have also been reported:
Croatian: Druge nuspojave su također zabilježene:
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Dostupni su podaci opisani u dijelovima 5.1 i 5.2 ali ne mogu se dati preporuke za doziranje.
English: United Kingdom EX31 3UD
Croatian: Ujedinjeno Kraljevstvo EX31 3UD
English: Hazard ratio [95% CI]
Croatian: [95% CI]
English: Date of latest renewal:
Croatian: Datum posljednje obnove:.
English: Applicable only for the outer packaging component: PC:
Croatian: Primjenjivo samo na vanjsko pakiranje: PC:
English: 2900 Komárom Hungary
Croatian: 2900 Komárom Mađarska
English: Children and adolescents Ivabradine JensonR is not intended for use in children and adolescents younger than 18 years.
Croatian: Djeca i adolescenti Ivabradine JensonR nije namijenjen djeci ni adolescentima mlađima od 18 godina.
English: Barnstaple, Devon, United Kingdom EX31 3UD
Croatian: Barnstaple, Devon, Ujedinjeno Kraljevstvo EX31 3UD