FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Slovenian: Skupaj z zdravilom ZINPLAVA so bolniki prejemali standardno (SoC - standard of care) protibakterijsko zdravljenje za CDI.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic impairment and patients with normal hepatic function.
Slovenian: Med bolniki z okvaro ledvic in bolniki z normalnim delovanjem ledvic ni bilo klinično pomembnih razlik v izpostavljenosti bezlotoksumabu.
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
English: • shortness of breath
Slovenian: • siljenje na bruhanje
English: One 40 mL vial contains 1,000 mg of bezlotoxumab.
Slovenian: Ena 40-mililitrska viala vsebuje 1.000 mg bezlotoksumaba.
English: In the studies, the clinical cure rates of the presenting CDI episode were comparable between the treatment arms.
Slovenian: Med terapevtskima skupinama v študijah ni bilo razlik v deležu bolnikov, pri katerih je bila klinično ozdravljena trenutna epizoda CDI.
English: Each mL of concentrate contains 25 mg bezlotoxumab.
Slovenian: En mililiter koncentrata vsebuje 25 mg bezlotoksumaba.
English: Each mL contains 25 mg bezlotoxumab.
Slovenian: En mililiter vsebuje 25 mg bezlotoksumaba.
English: Hepatic impairment
Slovenian: Bolezni živčevja pogosti glavobol
English: Each 40 mL vial contains 1,000 mg bezlotoxumab.
Slovenian: Ena 40-ml viala vsebuje 1.000 mg bezlotoksumaba.
English: Each vial contains 1,000 mg bezlotoxumab.
Slovenian: Ena viala vsebuje 1.000 mg bezlotoksumaba.
English: Immune-related adverse reactions
Slovenian: Imunsko pogojeni neželeni učinki
English: ZINPLAVA with SoC Percent (n/m)
Slovenian: Placebo s SoC Odstotek (n/m)
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih pogosti z infundiranjem povezane reakcije†
English: How to store ZINPLAVA
Slovenian: Shranjevanje zdravila ZINPLAVA
English: Clear to moderately opalescent, colourless to pale yellow liquid.
Slovenian: koncentrat za raztopino za infundiranje bistra do zmerno opalescentna, brezbarvna do bledorumena raztopina
English: - Keep this leaflet.
Slovenian: Glejte navodilo.
English: • diarrhoea
Slovenian: • utrujenost
English: 7 May 2015
Slovenian: 7. maj 2015
English: The applicant requested a re-examination of the opinion.
Slovenian: Vlagatelj je zahteval ponoven pregled mnenja.
English: In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Slovenian: Poleg tega so obstajali pomisleki o tem, da je bila varnost zdravila v celoti dokazana, ter nerešeno vprašanje glede kakovosti.
English: As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Slovenian: Kot del svoje vloge je družba predstavila rezultate terenske študije na mačkah s krvnim tlakom 160 mmHg ali več.
English: After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Slovenian: Po preučitvi razlogov za to zahtevo je odbor CVMP ponovno pregledal prvotno mnenje in 7. maja 2015 potrdil zavrnitev vloge za pridobitev dovoljenja za promet.
English: Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Slovenian: Zdravilo Lodipressin naj bi se uporabljalo za zdravljenje mačk s sistemsko arterijsko hipertenzijo (visokim krvnim tlakom).
English: On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je v svojem negativnem mnenju z dne 15. januarja 2015 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Lodipressin, namenjenim zdravljenju sistemske arterijske hipertenzije pri mačkah.
English: At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
Slovenian: V času začetnega vrednotenja je odbor CVMP presodil, da so bile v načrtovanju in izvedbi terenske študije ter predstavitvi njenih rezultatov pomanjkljivosti.
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Lodipressin (amlodipin besilat) EMA/55773/2016
English: In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
Slovenian: V drugem delu je 23 mačk zdravilo Lodipressin prejemalo 16 tednov, skupine s placebom pa ni bilo.
English: This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Slovenian: Učinkovina zavira posebne kanalčke na površini celic, skozi katere v celico običajno vstopa kalcij.
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Lodipressin (amlodipin besilat)
English: The company that applied for authorisation is Le Vet Beheer B.V.
Slovenian: Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Le Vet Beheer B.V.
English: Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Slovenian: Zdravilo Lodipressin je zdravilo za uporabo v veterinarski medicini, ki vsebuje zdravilno učinkovino amlodipin besilat.
English: This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
Slovenian: To pomeni, da kljub nekaterim dokazom o učinkovitosti zdravila Lodipressin pri zniževanju krvnega tlaka ni bilo mogoče oblikovati trdnih zaključkov o njegovi učinkovitosti pri zdravljenju visokega krvnega tlaka pri mačkah.
English: The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
Slovenian: Odbor CVMP je zato obdržal priporočilo, da se dovoljenje za promet z zdravilom zavrne.
English: What is Lodipressin?
Slovenian: Kaj je zdravilo Lodipressin?
English: By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Slovenian: Amlodipin z zmanjševanjem pretoka kalcija v celice preprečuje krčenje žil in tako znižuje krvni tlak.
English: During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Slovenian: Pri ponovnem pregledu je odbor CVMP upošteval nasvet strokovne skupine za medicino mačk.
English: What were the CVMP's main concerns that led to the refusal?
Slovenian: Kateri so bili glavni zadržki, zaradi katerih je CVMP predlagal zavrnitev dovoljenja za promet?
English: The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Slovenian: Strokovna skupina je sporočila, da kljub nekaterim dokazom študije o zmanjšanju krvnega tlaka zaradi njenih številnih pomanjkljivosti ni bilo mogoče sklepati, da pri zdravljenju visokega krvnega tlaka pri mačkah koristi zdravila Lodipressin odtehtajo njegova tveganja.
English: What was Lodipressin expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Lodipressin uporabljalo?
English: How is Lodipressin expected to work?
Slovenian: Kako naj bi zdravilo Lodipressin delovalo?
English: When calcium enters the cells in the blood vessel walls this causes contraction.
Slovenian: Ko kalcij vstopi v celice v stenah žil, se te začnejo krčiti.
English: The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Slovenian: Od teh jih je bilo 11 zdravljenih z zdravilom Lodipressin, 8 pa jih je prejelo placebo (zdravilo brez zdravilne učinkovine).
English: Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika
English: These include (but are not limited to):
Slovenian: Ta zdravila vključujejo (a nanje niso omejena):
English: All patients were clinically cured.
Slovenian: Vsi bolniki so bili klinično ozdravljeni.
English: Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016
Slovenian: Datum prve odobritve: 27. oktober 2011 Datum zadnjega podaljšanja: 9. september 2016
English: − At the request of the European Medicines Agency.
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: It is not known whether these toxic effects are reversible.
Slovenian: Ni znano, ali so ti toksični učinki reverzibilni.
English: You or your child can drink water at any time.
Slovenian: Vi ali vaš otrok lahko kadar koli pijete vodo.
English: If this happens within:
Slovenian: Če se to zgodi:
English: Most of the side effects are not severe and normally disappear within a few days or weeks after treatment.
Slovenian: Večina neželenih učinkov ni resnih in običajno izginejo po nekaj dneh ali tednih zdravljenja.
English: Then take the third (last) dose approximately 24 hours after the second dose.
Slovenian: Nato vzemite tretji (zadnji) odmerek približno 24 ur po drugem odmerku.
English: Never take more than one dose on the same day to make up for a missed dose.
Slovenian: Nikoli ne vzemite več kot enega odmerka na isti dan, da bi nadomestili izpuščeni odmerek.
English: * see section 5.1
Slovenian: * Glejte poglavje 5.1.
English: The majority of paediatric experience is derived from African children aged 6 months to 5 years.
Slovenian: Večina pediatričnih izkušenj je izpeljanih iz afriških otrok, starih 6 mesecev do 5 let.
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Slovenian: NN: {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]>
English: Concomitant treatment with such medicinal products is not recommended.
Slovenian: Sočasno zdravljenje s temi zdravili se ne priporoča.
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital, taking this leaflet with you.
Slovenian: To takoj povejte svojemu zdravniku ali se odpravite na urgentni oddelek najbližje bolnišnice in vzemite to navodilo s seboj.
English: Do not use this medicine if you notice the blister is open.
Slovenian: Ne uporabljajte tega zdravila, če opazite, da je pretisni omot odprt.
English: The table in this section is for adult patients only.
Slovenian: Tabela v tem poglavju velja samo za odrasle bolnike.
English: • 31-60 minutes, half the dose must be taken again.
Slovenian: • 31-60 minut po uporabi, je treba ponovno vzeti polovico odmerka.
English: Via Ragazzi del '99, n. 5 40133 Bologna Italy
Slovenian: Via Ragazzi del '99, n. 5 40133 Bologna Italija
English: You or your child should take this medicine on an empty stomach.
Slovenian: Vi ali vaš otrok vzemite to zdravilo na prazen želodec.
English: The extent of interactions in the paediatric population is not known.
Slovenian: Obseg medsebojnega delovanja v pediatrični populaciji ni znan.
English: Your doctor may suggest special monitoring for you or your child because doses higher than those recommended may have an unwanted, severe effect on the heart (see also section 4).
Slovenian: Vaš zdravnik lahko predlaga poseben nadzor za vas ali vašega otroka, saj imajo lahko odmerki, višji od priporočenih, hud neželen učinek na srce (glejte tudi poglavje 4).
English: The main consequence of this interaction could be a reduction of efficacy of the co-administered medicinal products.
Slovenian: Glavna posledica tega medsebojnega delovanja bi lahko bila zmanjšanje učinkovitosti sočasno uporabljenih zdravil.
English: The concentration of artenimol may also be reduced.
Slovenian: Zmanjšajo se lahko tudi koncentracije artenimola.
English: No data are available for these paediatric subsets.
Slovenian: Podatki za ti pediatrični podskupini niso na voljo.
English: • is female, elderly (over 65 years) or vomiting;
Slovenian: • ste ženska, starejša oseba (nad 65 let) oziroma če bruhate;
English: • is in the 1st trimester of pregnancy or breastfeeding (see below);
Slovenian: • ste v 1. trimesečju nosečnosti ali dojite (glejte spodaj);
English: This can cause a life-threatening abnormality of the heart rhythm.
Slovenian: To lahko povzroči življenjsko nevarno nenormalnost srčnega ritma.
English: The elimination half-life of piperaquine is around 22 days for adult patients and around 20 days for paediatric patients.
Slovenian: Razpolovna doba izločanja piperakina je približno 22 dni za odrasle bolnike in približno 20 dni za pediatrične bolnike.
English: Consideration should be given to official guidance on the appropriate use of antimalarial medicinal products.
Slovenian: Upoštevati je treba uradna navodila glede ustrezne uporabe antimalarikov.
English: Examples are listed in the section “Other medicines and Eurartesim”.
Slovenian: Primeri so navedeni v poglavju „Druga zdravila in zdravilo Eurartesim“.
English: Artenimol is able to reach high concentrations within the parasitized erythrocytes.
Slovenian: Artenimol lahko dosega visoke koncentracije znotraj parazitiranih eritrocitov.
English: The results for the primary endpoint in the modified intent to treat (m-ITT) populations (defined as all randomised patients who received at least one dose of the study treatment, with the exclusion of those patients lost to follow up for unknown reasons) were as follows:
Slovenian: Rezultati primarnega končnega opazovanega dogodka za modificirane populacije z namenom zdravljenja (m-ITT - modified Intent to Treat) (opredeljene kot vsi randomizirani bolniki, ki so prejeli vsaj en odmerek študijskega zdravila, brez bolnikov, ki so bili izgubljeni za spremljanje zaradi neznanega razloga), so bili naslednji:
English: Compared to adult males, female patients and elderly patients have longer QTc intervals.
Slovenian: V primerjavi z odraslimi moškimi imajo ženske bolnice in starejši bolniki daljše intervale QTc.
English: • Certain antimicrobialmedicinal products, including medicinal products of the following classes:
Slovenian: • nekatera antimikrobna zdravila, vključno z zdravili naslednjih skupin:
English: The safety profile of these patients did not differ from that of patients receiving the recommended dose, with no patient reporting SAEs.
Slovenian: Varnostni profil teh bolnikov se ni razlikoval od tistega pri bolnikih, ki so prejeli priporočeni odmerek, pri čemer ni noben bolnik poročal o neželenih učinkih.
English: In both studies, the true treatment failure rate was below the 5% efficacy threshold set by WHO.
Slovenian: V obeh študijah je bila stopnja neuspešnosti zdravljenja pod 5-odstotnim pragom učinkovitosti, kot ga določa SZO.
English: Risk factors may include young age (children under 5 years old) and previous treatment with IV artesunate.
Slovenian: Dejavniki tveganja lahko vključujejo nizko starost (otroci, mlajši od 5 let) in predhodno zdravljenje z i.v.
English: Daily dose (mg)
Slovenian: Dnevni odmerek (mg)
English: Twenty-two of these patients were shown to be parasitic free at the last microscopic analysis of the blood sample; three patients did not complete parasitological blood analysis.
Slovenian: V tej študiji 22 bolnikov pri zadnji mikroskopski analizi krvnega vzorca ni imelo parazitov; 3 bolniki niso opravili parazitološke analize krvi.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Eurartesim are provided with a healthcare profession educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali ali uporabljali zdravilo Eurartesim, prejeli izobraževalno gradivo za zdravstvene delavce, ki vsebuje:
English: Vomiting when taking this medicine
Slovenian: Bruhanje po jemanju tega zdravila
English: The mixture should be used immediately after preparation.
Slovenian: Pripravljeno mešanico je treba takoj porabiti.
English: • is taking or has taken any other medicines for the treatment of malaria (other than those mentioned above);
Slovenian: • jemljete vi ali vaš otrok druga zdravila za zdravljenje malarije (razen zgoraj omenjenih);
English: Any effects are unlikely to persist beyond 24 hours after the last intake of artenimol.
Slovenian: Ni verjetno, da bi kateri od učinkov trajal dalj kot 24 ur po zadnji uporabi artenimola.
English: The daily dose depends on the patient's body weight.
Slovenian: Dnevni odmerek je odvisen od telesne mase bolnika.
English: Do not take this medicine after the expiry date which is stated on the package after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake "EXP".
English: These adverse reactions were seen in animals at exposure levels similar to clinical exposure levels, and with possible relevance to clinical use.
Slovenian: Te neželene učinke so opazili v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti in z možnim pomenom za klinično uporabo.
English: − and also pentamidine and saquinavir.
Slovenian: − ter tudi pentamidin in sakvinavir.
English: − Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Therefore, Eurartesim should be taken with water only as described in section 4.2.
Slovenian: Zato je treba zdravilo Eurartesim jemati z vodo, kot je opisano v poglavju 4.2.
English: A corresponding table for paediatric patients is presented in the specific section below.
Slovenian: Ustrezna tabela za pediatrične bolnike je predstavljena v specifičnem poglavju spodaj.
English: The elimination half-life of artenimol is approximately 1 hour.
Slovenian: Razpolovna doba izločanja artenimola je približno 1 ura.
English: If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Slovenian: Pri težavah s požiranjem tablet jih lahko zdrobite in zmešate z vodo; mešanico je treba spiti takoj.
English: The systemic exposure to artenimol was slightly lower following the last dose of Eurartesim (lower than after the first dose by up to 15%).
Slovenian: Sistemska izpostavljenost artenimolu je bila nekoliko nižja po zadnjem odmerku zdravila Eurartesim (nižja kot po prvem odmerku za do 15 %).
English: • has recently (for example within about one month) been treated for malaria with certain medicines or has taken certain medicines to prevent malaria.
Slovenian: - če ste se vi ali vaš otrok pred kratkim (na primer približno v roku enega meseca) zdravili zaradi malarije z določenimi zdravili ali jemali zdravila za preprečevanje malarije.
English: Both piperaquine and artenimol are highly bound to human plasma proteins: the protein binding observed in in vitro studies was 44-93% for artenimol and >99% for piperaquine.
Slovenian: Tako piperakin kot artenimol se močno vežeta na beljakovine v človeški plazmi: vezava na beljakovine, ki so jo opazili v študijah in vitro, je bila 44-93 % za artenimol in > 99 % za piperakin.
English: Contact your doctor urgently to obtain an alternative treatment for malaria.
Slovenian: Urgentno se posvetujte z zdravnikom, da dobite drugo zdravilo za malarijo.
English: Your doctor will advise you when these readings will be taken.
Slovenian: Zdravnik vam bo povedal, kdaj bo napravil posnetek.
English: The exposure of pregnant women during the 2nd and 3rd trimester was not associated with any harm of the unborn child.
Slovenian: Izpostavljenost nosečnic zdravilu v 2. in 3. trimesečju nosečnosti ni bila povezana s škodljivi vplivi na otroka.
English: Piperaquine, a highly lipophilic compound, is slowly absorbed.
Slovenian: Piperakin, visoko lipofilna spojina, se absorbira počasi.
English: The mean oral clearance was slightly higher for paediatric patients, however the differences were minor in magnitude (<20%).
Slovenian: Povprečni peroralni očistek je bil nekoliko višji za pediatrične bolnike, vendar so bile razlike po velikosti majhne (< 20 %).
English: PQP Artenimol
Slovenian: PKP Artenimol
English: For patients unable to swallow the tablets, such as infants and young children, Eurartesim may be crushed and mixed with water.
Slovenian: Za bolnike, ki tablet ne morejo pogoltniti, zlasti za dojenčke in majhne otroke, se lahko zdravilo Eurartesim zdrobi in zmeša z vodo.
English: A total of 15 (1.5%) subjects had serious ADRs in the study.
Slovenian: Skupaj 15 (1,5 %) oseb je imelo v študiji hude neželene učinke.
English: Drug-drug interaction studies have only been performed in adults.
Slovenian: Študije medsebojnega delovanja med zdravili so izvedli le pri odraslih.
English: The same comparison showed that piperaquine absorption rate constant and terminal half-life in children were predominantly similar to those seen in adults.
Slovenian: Enaka primerjava je pokazala, da je konstanta hitrosti absorpcije piperakina in končna razpolovna doba pri otrocih v glavnem podobna kot pri odraslih.
English: Dosing should be based on body weight as shown in the table below.
Slovenian: Odmerjanje naj temelji na telesni masi, kot je prikazano v spodnji tabeli:
English: • 30 minutes of taking Eurartesim, the whole dose must be taken again.
Slovenian: • 30 minut po uporabi zdravila Eurartesim, je treba ponovno vzeti ves odmerek;
English: • The ECG monitoring recommendations.
Slovenian: • Priporočila za spremljanje bolnikov z EKG.
English: The efficacy and safety of Eurartesim have been assessed in two large randomised, open-label clinical trials:
Slovenian: Učinkovitost in varnost zdravila Eurartesim so preskušali v dveh velikih odprtih randomiziranih kliničnih preskušanjih.
English: In clinical trials, nine patients received double the cumulative intended dose of Eurartesim.
Slovenian: V kliničnih preskušanjih je devet bolnikov prejelo dvojni kumulativni predvideni odmerek zdravila Eurartesim.
English: The most important potential cardiac effect was related to cardiac conduction.
Slovenian: Najpomembnejši možni srčni učinek je bil povezan s srčno prevodnostjo.
English: - Severe malaria according to WHO definition.
Slovenian: - Huda malarija po definiciji SZO.
English: You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.
Slovenian: Med jemanjem tega zdravila ne smete dojiti, ker zdravilo lahko prehaja z mlekom v vašega otroka.
English: If a patient vomits within 30 minutes of taking Eurartesim, the whole dose should be re-administered; if a patient vomits within 30-60 minutes, half the dose should be re-administered.
Slovenian: Če bolnik v 30 minutah po uporabi zdravila Eurartesim bruha, je treba odmerek dati ponovno; če bolnik bruha v 30-60 minutah, je treba ponovno dati polovico odmerka.
English: The Physician Leaflet should contain the following key messages:
Slovenian: Vodnik za zdravnika mora vsebovati naslednje ključne informacije: