FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered that metoclopramide is associated with a risk of serious adverse events, including neurological adverse events such as extrapyramidal symptoms and irreversible tardive dyskinesia.
Slovenian: • odbor je menil, da je metoklopramid povezan s tveganjem za resne neželene dogodke, vključno z nevrološkimi neželenimi dogodki, kot so ekstrapiramidni simptomi in trajna tardivna diskinezija.
English: − parenteral formulations with concentration higher than 5mg/ml
Slovenian: − parenteralne pripravke s koncentracijo, večjo od 5 mg/ml,
English: Based on data submitted, when administered for highly emetic chemotherapy, metoclopramide appears to be effective by intravenous route at doses ranging from 6 to 10 mg/kg/day.
Slovenian: Predloženi podatki kažejo, da je metoklopramid po močno emetogeni kemoterapiji učinkovit, če se uporabi po intravenski poti v odmerku od 6 do 10 mg/kg/dan.
English: Limited data exists on the onset of action of oral liquid formulations in comparison with tablets.
Slovenian: O začetku delovanja tekočih pripravkov za peroralno uporabo v primerjavi s tabletami so na voljo omejeni podatki.
English: While endorsing the conclusions of the previous assessment, the CHMP also took note of the fact that, in particular for the treatment of delayed CINV which can be quite a debilitating condition, there are limited alternative treatments available for the paediatric population.
Slovenian: CHMP se je strinjal z ugotovitvami iz prejšnje ocene, vendar je prav tako upošteval, da so zlasti za zapoznelo slabost in bruhanje zaradi kemoterapije, ki sta lahko precej izčrpavajoča, na voljo omejene možnosti zdravljenja za pediatrično populacijo.
English: Nausea and vomiting of other origins
Slovenian: Slabost in bruhanje zaradi drugih vzrokov
English: If however risk minimisation measures are put in place to allow accurate dosing and address the risk of overdose, oral liquid formulations remain an important and suitable alternative for the paediatric population.
Slovenian: Kljub temu bi tekoči pripravki za peroralno uporabo ob sprejetju ukrepov za zmanjšanje tveganja, ki bi zagotovili natančno odmerjanje in zmanjšali tveganje za preveliko odmerjanje, lahko drugi pomembna in ustrezna možnost zdravljenja za pediatrično populacijo.
English: • Adjuvant to surgical and radiological procedures
Slovenian: • dodatek pri kirurških in radioloških posegih.
English: • Nausea and vomiting of other origins
Slovenian: • slabost in bruhanje zaradi drugih vzrokov;
English: The MAH disagreed with the CHMP recommendation for revocation of oral liquid formulations with concentration higher than 1 mg/ml.
Slovenian: Imetnik dovoljenja za promet z zdravilom se ni strinjal s priporočilom odbora CHMP za razveljavitev dovoljenj za promet s tekočimi pripravki za peroralno uporabo s koncentracijo, večjo od 1 mg/ml.
English: o Is not favourable for ‘gastrointestinal motility disorders, including gastroparesis'
Slovenian: o ni ugodno za indikacijo „motnje gibljivosti prebavil, vključno z gastroparezo“;
English: • In view of the available data the Committee concluded, subject to the amendments to the product information and implementation of the risk minimisation measures, that the benefitrisk balance of metoclopramide-containing products:
Slovenian: • na podlagi razpoložljivih podatkov je odbor zaključil, da je pod pogojem, da se upoštevajo spremembe informacij o zdravilu in uvedejo ukrepi za zmanjšanje tveganja, razmerje med tveganji in koristmi zdravil, ki vsebujejo metoklopramid:
English: Very limited information exists to support the efficacy of metoclopramide in the paediatric population, in the majority of the indications.
Slovenian: Obstoječi podatki, ki naj bi dokazovali učinkovitost metoklopramida pri pediatrični populaciji, so za večino indikacij zelo omejeni.
English: Therefore the Committee considered that the benefit-risk balance of metoclopramide in these indications is negative.
Slovenian: Zato je odbor menil, da je razmerje med tveganji in koristmi metoklopramida pri teh indikacijah negativno.
English: The Committee noted this proposal from the MAH, but it also took note of the fact that, even if not specifically approved for paediatric use, high concentration oral liquid formulations are associated with risks in this population.
Slovenian: Odbor je upošteval ta predlog imetnika dovoljenja za promet z zdravilom, vendar hkrati tudi dejstvo, da so zelo koncentrirani tekoči pripravki za peroralno uporabo povezani s tveganji pri pediatričnih bolnikih, četudi niso posebej odobreni za pediatrično uporabo.
English: Oral liquid formulations shall be supplied with an appropriate measuring device such as a graduated oral syringe.
Slovenian: Tekočim pripravkom za peroralno uporabo mora biti priložen primeren odmerni pripomoček, kot je na primer graduirana brizga za peroralno dajanje.
English: o Is favourable in adults for ‘prevention of radiotherapy induced nausea and vomiting' (parenteral, oral and rectal routes)
Slovenian: o ugodno pri odraslih za indikacijo „preprečevanje slabosti in bruhanja zaradi radioterapije“ (parenteralna, peroralna in rektalna uporaba);
English: o Is not favourable for ‘prevention of acute chemotherapy induced nausea and vomiting'
Slovenian: o ni ugodno za indikacijo „preprečevanje akutne slabosti in bruhanja zaradi kemoterapije“;
English: o Is favourable in adults for ‘prevention of post-operative nausea and vomiting' (parenteral route only)
Slovenian: o ugodno pri odraslih za indikacijo „preprečevanje slabosti in bruhanja po operaciji“ (samo parenteralna uporaba);
English: Both the 50% and the 75% dose reductions recommended, respectively, in hepatic and renal impairment are easily achievable with the 1 mg/ml liquid formulations.
Slovenian: S tekočimi pripravki s koncentracijo 1 mg/ml je mogoče preprosto doseči 50-odstotno in 75-odstotno zmanjšanje odmerka, ki je priporočeno pri okvari jeter oziroma ledvic.
English: − oral liquid formulations with concentration higher than 1mg/ml
Slovenian: − tekoče pripravke za peroralno uporabo s koncentracijo, večjo od 1 mg/ml,
English: Thus, for both treatment of established post-operative nausea and vomiting and prevention of delayed CINV in children, the use of metoclopramide should be reserved as a second line option.
Slovenian: Metoklopramid mora biti torej za zdravljenje nastale slabosti in bruhanja po operaciji in za preprečevanje zapoznele CINV pri otrocih na voljo kot zdravilo druge izbire.
English: Post-operative nausea and vomiting
Slovenian: Slabost in bruhanje po operaciji
English: o Is favourable in children between 1 and 18 years of age for ‘treatment of established post-operative nausea and vomiting, as second line option' (parenteral route only)
Slovenian: o ugodno pri otrocih, starih od 1 do 18 let, za indikacijo „zdravilo druge izbire za zdravljenje nastale slabosti in bruhanja po operaciji“ (samo parenteralna uporaba);
English: A paediatric worksharing procedure under Article 45 of Regulation (EC) No 1901/20061 to assess information from paediatric studies with metoclopramide has been concluded in 2010 with a recommendation that Member States should introduce the following changes to the product information:
Slovenian: Leta 2010 se je zaključil pediatrični postopek delitve dela v skladu s členom 45 Uredbe (ES) št. 1901/20061, namenjen oceni podatkov iz študij uporabe metoklopramida pri pediatrični populaciji.
English: • Gastroesophageal reflux disease (GORD) and dyspepsia
Slovenian: • motnje gibljivosti prebavil, vključno z gastroparezo; • gastroezofagealna refluksna bolezen (GERB) in dispepsija;
English: o Is favourable in adults for ‘prevention of delayed chemotherapy induced nausea and vomiting' (oral and rectal routes)
Slovenian: o ugodno pri odraslih za indikacijo „preprečevanje zapoznele slabosti in bruhanja zaradi kemoterapije“ (peroralna in rektalna uporaba);
English: o Is favourable in children between 1 and 18 years of age for ‘prevention of delayed chemotherapy induced nausea and vomiting, as second line option' (parenteral and oral routes)
Slovenian: o ugodno pri otrocih, starih od 1 do 18 let, za indikacijo „zdravilo druge izbire za preprečevanje zapoznele slabosti in bruhanja zaradi kemoterapije“ (parenteralna in peroralna uporaba);
English: Very limited data exists in support of the efficacy of metoclopramide in this indication, and the existing data is not consistent.
Slovenian: Učinkovitost metoklopramida pri tej indikaciji podpira zelo omejeno število podatkov, ki poleg tega niso dosledni.
English: The data presented is indicative of the efficacy of metoclopramide in acute migraine induced nausea and vomiting based on its anti-emetic properties.
Slovenian: Predloženi podatki kažejo, da je metoklopramid zaradi svojih antiemetičnih lastnosti učinkovit pri zdravljenju slabosti in bruhanja zaradi akutne migrene.
English: In this population, and based on the studies submitted, the clearance of metoclopramide has shown to be significantly impaired.
Slovenian: Pri tej populaciji je, tudi glede na predložene študije, očistek metoklopramida znatno manjši, zato bi bilo treba odmerek zmanjšati za 75 %.
English: Radiotherapy induced nausea and vomiting
Slovenian: Slabost in bruhanje zaradi radioterapije
English: Therefore, for these indications the Committee considered the benefitrisk balance to be positive.
Slovenian: Zato je odbor menil, da je razmerje med tveganji in koristmi pri teh indikacijah pozitivno.
English: It was noted by the Committee that a formulation of suppositories dosed at 20mg is currently approved in some Member States.
Slovenian: Odbor je upošteval, da so v nekaterih državah članicah trenutno odobrene svečke v odmerku 20 mg. Kot je že bilo navedeno zgoraj, ni dokazov, da bi bili odmerki nad 10 mg učinkovitejši.
English: Very limited high quality data exists in support of the efficacy of metoclopramide in the majority of the indications authorised in the European Union.
Slovenian: Učinkovitost metoklopramida pri večini indikacij, ki so odobrene v Evropski uniji, dokazuje zelo malo visokokakovostnih podatkov.
English: In respect of dose adjustment for renal and hepatic impairment, while it is correct that oral liquid formulations offer advantage over solid pharmaceutical forms, higher concentrations (such as 4
Slovenian: Čeprav drži, da so tekoči pripravki za peroralno uporabo primernejši od trdnih farmacevtskih oblik, kadar je potrebno prilagajanje odmerka zaradi okvare ledvic in jeter, pa večje koncentracije (kot je 4 mg/ml) ne nudijo dodatnih prednosti v primerjavi s predlagano koncentracijo 1 mg/ml.
English: Suppositories
Slovenian: Svečke
English: Chemotherapy induced nausea and vomiting
Slovenian: Slabost in bruhanje zaradi kemoterapije
English: Oral liquid formulations
Slovenian: Tekoči pripravki za peroralno uporabo
English: Limited data exists on the efficacy of metoclopramide in the different therapeutic indications authorised in the European Union; however, when taken together, it is indicative of the efficacy of the product in the management of nausea and vomiting of different origins.
Slovenian: O učinkovitosti metoklopramida pri različnih terapevtskih indikacijah, odobrenih v Evropski uniji, so na voljo omejeni podatki.
English: 31 January 2020
Slovenian: 31. januar 2020
English: Such reactions may be allergic.
Slovenian: Te reakcije so lahko alergijske.
English: The majority of these events occurred in the first 4 cycles.
Slovenian: Večina teh dogodkov se je pojavila v prvih 4 ciklih.
English: The pain can last from few days to up to 200 days.
Slovenian: Bolečina lahko traja od nekaj do 200 dni.
English: You should tell your doctor about any of the following:
Slovenian: Svojega zdravnika morate obvestiti o čemer koli od naslednjega:
English: Other subtypes were infrequently represented.
Slovenian: Drugi podtipi so bili redko zastopani.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Slovenian: Zdravnik se bo o tem z vami pogovoril in vam pojasnil morebitna tveganja in koristi vašega zdravljenja.
English: Your doctor will discuss this with you.
Slovenian: O tem se bo z vami pogovoril zdravnik.
English: The drip lasts about 60 minutes.
Slovenian: Infuzija traja približno 60 minut.
English: The study met its primary endpoint (PFS).
Slovenian: Študija je dosegla svoj primarni cilj (PFS).
English: This leaflet was last revised in < {month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano v < { mesecu leta LLLL}>.
English: No data are available.
Slovenian: Na voljo ni nobenih podatkov.
English: The following information is intended for healthcare professionals only
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju.
English: The safety and efficacy of olaratumab in children aged 0 to 18 years of age have not yet been established.
Slovenian: Varnost in učinkovitost olaratumaba pri otrocih, starih od 0 do 18 let, nista bili dokazani.
English: Management recommendations (any occurrence)
Slovenian: Priporočeni ukrepi (kateri koli dogodek)
English: 28108 Madrid
Slovenian: 28108 Madrid Španija
English: Frequency overall Grade 3/4 frequency
Slovenian: Pogostnost stopnje 3/4
English: Other symptoms may occur as well (see section 2 “Warnings and precautions”).
Slovenian: Pojavijo se lahko tudi drugi simptomi (glejte poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Below is a list of some typical symptoms associated with infusion reactions:
Slovenian: Tu so navedeni nekateri tipični simptomi, povezani z infuzijskimi reakcijami:
English: Lartruvo should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Slovenian: Zdravila Lartruvo se ne sme dajati bolnikom, mlajšim od 18 let, saj podatki o njegovem delovanju pri tej starostni skupini niso na voljo.
English: Doxorubicin alone (n = 67)
Slovenian: Samo doksorubicin (n = 67)
English: Efficacy results are shown in Table 3 and Figures 1 and 2.
Slovenian: Rezultati učinkovitosti so prikazani v preglednici 3 ter na grafih 1 in 2.
English: White blood cells are important for fighting infection.
Slovenian: Bele krvne celice so pomembne za obrambo pred okužbami.
English: - If you have any further questions, ask your doctor.
Slovenian: − Če imate dodatna vprašanja, se posvetujte z zdravnikom.
English: de la Industria 30
Slovenian: de la Industria 30 Alcobendas
English: PFS according to a post-hoc, blinded, independent assessment was 8.2 months vs 4.4 months; HR = 0.670; p = 0.1208.
Slovenian: PFS v skladu s post-hoc, slepo, neodvisno oceno je bil 8,2 meseca v primerjavi s 4,4 meseca; HR = 0,670; p = 0,1208.
English: The number of infusions that you receive will depend on how well and for how long treatment with Lartruvo works and how well you feel.
Slovenian: Število infuzij, ki jih boste prejeli, je odvisno od tega, kako dobro in koliko časa bo delovalo zdravljenje z zdravilom Lartruvo, in vašega počutja.
English: • Monitor patient for worsening of condition.
Slovenian: • Spremljajte bolnike glede možnega poslabšanja stanja.
English: Infusion solution: After dilution and preparation, the medicine must be used immediately.
Slovenian: Raztopina za infuzijo: Po redčenju in pripravi je treba zdravilo nemudoma uporabiti.
English: Date of latest renewal: 21 September 2017
Slovenian: Datum prve odobritve: 9. november 2016 Datum zadnjega podaljšanja: 21. september 2017
English: Data on very elderly patients (> 75 years) are very limited (see sections 4.8 and 5.1).
Slovenian: Starejši (> 65 let) Podatki o zelo starih bolnikih (> 75 let) so zelo omejeni (glejte poglavji 4.8 in 5.1).
English: From a microbiological point of view the prepared dosing solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba pripravljeno raztopino nemudoma uporabiti.
English: The main analysis was performed in the following two subgroups: Leiomyosarcoma (LMS) and non-LMS (other).
Slovenian: Glavna analiza je bila opravljena v naslednjih dveh podskupinah: leiomiosarkom (LMS) in ne-LMS (drugo).
English: Immunogenicity As with all therapeutic proteins, there is the potential for immunogenicity.
Slovenian: Imunogenost Kot pri vseh terapevtskih beljakovinah obstaja možnost imunogenosti.
English: • Once the reaction has resolved, resume infusion at a 50 %
Slovenian: • Ko je reakcija obvladana, infuzijo nadaljujte s 50 % manjšo
English: Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznake »EXP«.
English: Due to frequent occurrence of fatigue, patients should be advised to use caution when driving or operating machinery.
Slovenian: Ker so bolniki pogosto utrujeni, jim je treba svetovati previdnost pri vožnji in upravljanju strojev.
English: Clearance and volume of distribution had a positive correlation with body weight.
Slovenian: Očistek in prostornina porazdelitve sta pozitivno korelirala s telesno maso.
English: • For subsequent infusions, please see premedication section.
Slovenian: • Za nadaljnje infuzije glejte poglavje o premedikaciji.
English: Musculoskeletal pain
Slovenian: Mišično-skeletna bolečina
English: Based on its mechanism of action (see section 5.1), olaratumab has the potential to cause foetal harm.
Slovenian: Glede na mehanizem delovanja (glejte poglavje 5.1) bi olaratumab potencialno lahko škodoval plodu.
English: No dose reductions other than those recommended for the general patient population are necessary.
Slovenian: Odmerka ni treba zmanjševati, razen skladno s priporočili, ki veljajo za splošno populacijo bolnikov.
English: FOR THE CONDITIONAL MARKETING AUTHORISATION This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: In the majority of patients the pain was related to the patients' underlying cancer or metastases or pre-existing or concomitant conditions.
Slovenian: Pri večini bolnikov je bila bolečina povezana z rakom ali zasevki pri bolniku in že obstoječimi ali sočasnimi boleznimi.
English: Detailed instructions for your doctor or your nurse on how to prepare Lartruvo infusion are included at the end of this package leaflet (see ‘Handling instructions').
Slovenian: Podrobna navodila o pripravi infuzije zdravila Lartruvo za vašega zdravnika ali medicinsko sestro so navedena na koncu tega navodila za uporabo (glejte »Navodilo za ravnanje z zdravilom«).
English: Olaratumab therapy must be initiated and supervised by physicians experienced in oncology.
Slovenian: Zdravljenje z olaratumabom morajo začeti in spremljati zdravniki z izkušnjami v onkologiji.
English: Doxorubicin can cause cardiotoxicity.
Slovenian: Doksorubicin je lahko kardiotoksičen.
English: Severe IRRs, also including a fatal case (see section 4.4) were reported in 3.1 % of patients and mainly presented with shortness of breath, loss of consciousness and hypotension.
Slovenian: O hudih IRR, vključno s smrtnim primerom (glejte poglavje 4.4), so poročali pri 3,1 % bolnikov; kazale so se predvsem kot pomanjkanje sape, izguba zavesti in hipotenzija.
English: Subgroups analysis of OS is shown in figure 2.
Slovenian: Analiza OS po podskupinah je prikazana na grafu 2.
English: Human IgG is excreted in human milk, therefore breast-feeding is not recommended during treatment with olaratumab and for at least 3 months following the last dose.
Slovenian: Humani IgG se izloča v materino mleko, zato se dojenje v času zdravljenja z olaratumabom in še vsaj tri mesece po zadnjem odmerku ne priporoča.
English: What Lartruvo is and what it is used for 2.
Slovenian: Kaj je zdravilo Lartruvo in za kaj ga uporabljamo 2.
English: If you get any symptoms that affect your ability to concentrate and react, such as tiredness, do not drive or use machines until the effect goes away.
Slovenian: Če se pojavijo simptomi, ki vplivajo na zbranost in reagiranje, kot je utrujenost, do prenehanja učinka ne vozite in ne upravljajte strojev.
English: IRRs were reported in 12.5 % of patients and mainly present as chills, fever or dyspnoea.
Slovenian: O IRR so poročali pri 12,5 % bolnikov; kazale so se predvsem kot mrzlica, vročina ali dispneja.
English: c Infusion-related reactions includes anaphylactic reactions/anaphylactic shock.
Slovenian: c Reakcije, povezane z infuzijo, vključujejo anafilaktične reakcije/anafilaktični šok.
English: The current wording of the Package leaflet is considered sufficient to communicate this risk.
Slovenian: Odbor meni, da trenutno besedilo navodila za uporabo ustrezno navaja to tveganje.
English: Patients had received 0-4 previous lines of therapy for treatment of advanced disease but had not previously received treatment with anthracyclines.
Slovenian: Bolniki so predhodno prejeli od 0 do 4 linije zdravljenja za napredovalo bolezen, niso pa bili zdravljeni z antraciklini.
English: Other non-haematology toxicities
Slovenian: Druge vrste nehematološke toksičnosti
English: In severe cases, you may experience very low blood pressure, feel faint, and experience breathing distress caused by narrowing of the airways, which could be life-threatening.
Slovenian: V hudih primerih se lahko pojavijo zelo nizek krvni tlak, občutek omedlevice in dihalna stiska, ki jo povzroči zoženje dihalnih poti in je lahko življenjsko nevarna.
English: You must not be given Lartruvo - if you are allergic to olaratumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: − če ste alergični na olaratumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This corresponds to a mean terminal half-life of approximately 11 days.
Slovenian: Olaratumab ima povprečni končni razpolovni čas približno 11 dni.
English: The majority of these reactions occurred during or following the first olaratumab infusion.
Slovenian: Te reakcije so se večinoma pojavile med prvo infuzijo olaratumaba ali po njej.
English: Doxorubicin is given on day 1 of each cycle following the Lartruvo infusion.
Slovenian: Doksorubicin se daje 1. dan vsakega cikla po infuziji zdravila Lartruvo.
English: DO NOT dilute with other solutions or co-infuse with other electrolytes or medicines.
Slovenian: NE redčite z drugimi raztopinami in ne mešajte z drugimi elektroliti ali zdravili.
English: Your doctor may consider slowing the Lartruvo infusion or interrupting it to manage these symptoms.
Slovenian: Zdravnik bo morda premislil o upočasnitvi infuzije zdravila Lartruvo ali prekinitvi zdravljenja z njim, da bi obvladal te simptome.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC27
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), monoklonska protitelesa, oznaka ATC:L01XC27
English: Storage times include the duration of infusion.
Slovenian: V obdobje hranjenja spada tudi čas infuzije.
English: Patients with gastrointestinal stromal tumours (GIST) or Kaposi sarcoma were not enrolled.
Slovenian: Bolniki z gastrointestinalnim stromalnim tumorjem (GIST) ali s Kaposijevim sarkomom v študijo niso bili vključeni.
English: The risk of cardiac toxicity rises with increasing cumulative doses of anthracyclines, including doxorubicin.
Slovenian: Tveganje kardiotoksičnosti se povečuje z rastjo kumulativnih odmerkov antraciklinov, vključno z doksorubicinom.
English: if you are receiving any treatment for heart disease or liver disease
Slovenian: - če se zdravite zaradi bolezni srca ali jeter.
English: The PopPK model-based mean (CV %) clearance for olaratumab was 0.56 L/day (33 %).
Slovenian: Povprečen (CV %) očistek olaratumaba, ocenjen z modelom PopPK, je bil 0,56 l/dan (33 %).