FrancophonIA/ELRC3.0 huggingface dataset:
English: abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence, discoloured faeces
Slovenian: • vnetje sluznice ţelodca, vnetje ustne sluznice, bolečina v trebuhu, neprijeten občutek v trebuhu/bolečina ali slaba prebava, suha usta, nabiranje plinov v ţ elodcu in črevesju,
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Slovenian: Pri bolnikih s pozitivno druţ insko anamnezo anevrizme ali pri bolnikih, ki so jim postavili diagnozo obstoječe aortne anevrizme in/ali aortne disekcije, ali v prisotnosti drugih dejavnikov tveganja ali stanj, ki so predispozicija za aortno anevrizmo in disekcijo (npr. Marfanov sindrom, vaskularna oblika Ehlers-Danlosovega sindroma, Takayasujev arteritis, velikocelični arteritis, Behçetova bolezen, hipertenzija, znana ateroskleroza), se smejo zato fluorokinoloni uporabljati le po natančni oceni razmerja med koristmi in tveganji ter razmisleku o drugih moţ nostih zdravljenja.
English: Myositis
Slovenian: Miozitis
English: • The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
Slovenian: • Rekonstituirano raztopino je treba nato pred uporabo redčiti v 250 ml vrečo za intravensko infudiranje (0,9 % raztopina natrijevega klorida za injiciranje ali D5W).
English: Serious bullous skin reactions
Slovenian: Resne bulozne koţ ne reakcije
English: Quofenix 300mg
Slovenian: PODATKI V BRAILLOVI PISAVI Quofenix 300 mg
English: Breast-feeding is contraindicated during treatment with delafloxacin.
Slovenian: Med zdravljenjem z delafloksacinom je dojenje kontraindicirano.
English: - If you get any side effects, talk to your doctor, or pharmacist or nurse.
Slovenian: - Če opazite kateri koli neţeleni učinek, se posvetujte z zdravnikom, ali farmacevtom ali medicinsko sestro.
English: The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
Slovenian: Rekonstituirano raztopino je treba nato pred uporabo razredčiti v 250 ml vrečko za intravensko infudiranje (0,9 % natrijevega klorida ali D5W).
English: Quofenix 450 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Quofenix 450 mg
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Slovenian: Pri bolnikih, ki so prejemali kinolone in fluorokinolone, so, neodvisno od njihove starosti in obstoječih dejavnikov tveganja, poročali o zelo redkih primerih dolgotrajnih (več mesecev ali let), onesposabljajočih in potencialno nepopravljivih neţ elenih učinkov, ki so vplivali na različne organske sisteme, včasih na več hkrati (mišično-skeletni sistem, ţ ivčevje, duševno zdravje in čutila).
English: • Insomnia
Slovenian: • tesnoba
English: No genotoxicity hazard was identified in vitro and it was negative in vivo at the highest possible dose
Slovenian: Nevarnost genotoksičnosti in vitro ni bila ugotovljena in rezultat in vivo je bil na podlagi AUC negativen pri najvišjem moţ nem odmerku, ≥ 15-krat izpostavljenost ocenjena v plazmi pri ljudeh.
English: • If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Quofenix ne smete prejeti v naslednjih primerih: • Če ste alergični na delafloksacin ali katero koli sestavino tega zdravila (navedeno v poglavju
English: Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).
Slovenian: Zdravilo Quofenix ni priporočljivo pri bolnikih s končno ledvično odpovedjo.
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Slovenian: Z uporabo kinolonskih in fluorokinolonskih antibiotikov, v nekaterih primerih ne glede na obstoječe dejavnike tveganja, so povezani zelo redki primeri dolgotrajnih (več mesecev ali let trajajočih) ali trajnih neţ elenih učinkov, kot so vnetje kit, pretrganje tetiv, bolečine v sklepih, bolečine v okončinah, teţ ave pri hoji, nenormalna občutenja, kot so mravljinčenje, ščemenje, ţ gečkanje, ţ arenje, odrevenelost ali bolečina (nevropatija), depresija, utrujenost, motnje spanja, motnje spomina, pa tudi okvara sluha, vida, okusa in voha.
English: Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin.
Slovenian: Ena viala vsebuje 300 mg delafloksacina v obliki megluminijevega delafloksacina.
English: Quofenix 450 mg tablets delafloxacin
Slovenian: IME ZDRAVILA Quofenix 450 mg tablet delafloksacin
English: • Night sweat
Slovenian: • nočno potenje
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid, concentrated (for pH-adjustment)
Slovenian: 6.1 Seznam pomoţnih snovi meglumin natrijev sulfobutilbetaciklodekstrin dinatrijev edetat natrijev hidroksid (za uravnavanje pH) koncentrirana klorovodikova kislina (za uravnavanje pH)
English: Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section
Slovenian: V povezavi z uporabo kinolonov in fluorokinolonov, v nekaterih primerih ne glede na obstoječe dejavnike tveganja so poročali o zelo redkih primerih dolgotrajnih (več mesecev ali let), onesposabljajočih in potencialno nepovratnih resnih neţ elenih učinkih, ki so vplivali na različne organske sisteme, včasih na več hkrati, ter občutke (vključno z neţ elenimi učinki kot je tendinitis, ruptura tetive, artralgija, bolečina v okončinah, motnje hoje, nevropatije povezane s parestezijo, depresija, utrujenost, okvare spomina, motnje spanca in okvara sluha, vida, okusa ter vonja) (glejte poglavje 4.4).
English: 10 single-dose vials
Slovenian: NALEPKA VIALE
English: This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.
Slovenian: Zdravilo Quofenix vsebuje ciklodekstrin To zdravilo vsebuje 2480 mg natrijevega sulfobutilbetaciklodekstrin na vialo.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neţ elenih učinkov, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
English: Meglumine
Slovenian: Napihnjenost
English: The reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution.
Slovenian: Po rekonstituciji viala z bistro raztopino rumene do jantarne barve vsebuje 300 mg na 12 ml delafloksacina.
English: Quofenix is not recommended in patients with ESRD.
Slovenian: Uporaba zdravila Quofenix se ne priporoča pri bolnikih s končno odpovedjo ledvic.
English: Contact your doctor straight away if you have diarrhoea during or after your treatment.
Slovenian: Če med zdravljenjem ali po njem dobite diarejo, o tem nemudoma obvestite svojega zdravnika.
English: Hallucination, auditory Anxiety
Slovenian: Slušne halucinacije Anksioznost Nespečnost Nenavadne sanje
English: Constipation
Slovenian: Utrujenost
English: However, no such effects and no other developmental abnormalities occurred in the progeny of mothers exposed up to a level about 2-fold higher than observed in humans.
Slovenian: Vendar pa pri potomcih samic, ki so bile izpostavljene do 2-krat višji koncentraciji, kot bi jo aplicirali ljudem, takšnih učinkov ali drugih razvojnih nepravilnosti ni bilo opaziti.
English: Contents of the pack and other information What Quofenix contains
Slovenian: Shranjevanje zdravila Quofenix Vsebina pakiranja in dodatne informacije
English: • Abnormal dreams
Slovenian: • nenormalno potenje
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni koţe in podkoţ ja
English: Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
Slovenian: V obdobju po prihodu na trg je bila uporaba fluorokinolonov pri bolnikih z miastenijo gravis povezana z resnimi neţ elenimi učinki, vključno s smrtjo in potrebo po dihalni podpori.
English: Dyspepsia
Slovenian: Disglikemija
English: Hepatobiliary disorders
Slovenian: Hipertransaminazemija
English: How to store Quofenix
Slovenian: Shranjevanje zdravila Quofenix
English: • Sensations like numbness, tingling, pins and needles
Slovenian: • občutek odrevenelosti, ščemenje, mravljinčenje
English: Magnesium stearate
Slovenian: Okvarjeno delovanje jeter
English: Dizziness
Slovenian: Izpuščaj
English: • Chills
Slovenian: • srbenje
English: Vision blurred Dry eye
Slovenian: Zamegljen vid Suhe oči
English: Susceptibility testing breakpoints
Slovenian: Mejne vrednosti pri testiranju občutljivosti
English: Quofenix can make you feel dizzy and lightheaded.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Quofenix se lahko počutite omotično in vrtoglavo.
English: • Fungal infection
Slovenian: • mrzlica
English: Quofenix 300 mg powder for concentrate for solution for infusion delafloxacin
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Quofenix 300 mg prašek za koncentrat za raztopino za infundiranje delafloksacin
English: A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
English: Fluoroquinolones form chelates with alkaline earth and transition metal cations.
Slovenian: Kelacijske učinkovina: antacidi, sukralfat, kovinski kationi, multivitamini Fluorokinoloni tvorijo kelate z zemeljoalkalijskimi in prehodnimi kovinskimi kationi.
English: - The active substance is delafloxacin.
Slovenian: Kaj vsebuje zdravilo - Učinkovina je delafloksacin.
English: Flatulence
Slovenian: Omotica
English: No effects were detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed in humans.
Slovenian: Pri izpostavljenosti, ki je bila pribliţ no 5-krat višja kot pri ljudeh, ni bilo ugotovljenih učinkov na plodnost samcev in samic.
English: Overall conclusion and benefit -risk balance
Slovenian: Splošni zaključek ter razmerje med tveganji in koristmi
English: No bioequivalence is required for intravenous generic products and no such data was therefore submitted.
Slovenian: Pri intravenskih generičnih zdravilih biološka enakovrednost ni potrebna, zato ti podatki niso bili predloženi.
English: Overall summary of the scientific evaluation of nicardipine-containing products for intravenous use (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za intravensko uporabo, ki vsebujejo nikardipin (glejte Prilogo I)
English: Gastrointestinal intolerance such as nausea also occurs.
Slovenian: Pojavlja se tudi gastrointestinalna intoleranca, kot je navzea (siljenje na bruhanje).
English: In view of the identified divergences in the nationally approved product information, the CHMP also considered it to be of community interest to harmonise the product information across the EU.
Slovenian: Glede na ugotovljena neskladja v nacionalno odobrenih informacijah o zdravilu je odbor CHMP prav tako menil, da je v interesu skupnosti, da se informacije o zdravilu uskladijo po celotni EU.
English: Regarding the treatment of severe hypertension in pregnancy, the CHMP took into account the limited study data, the lack of long-term study data on morbidity and mortality and the recommendations of current guidelines.
Slovenian: Pri zdravljenju hude hipertenzije med nosečnostjo je odbor CHMP upošteval omejene podatke iz študij, pomanjkanje podatkov o obolevnosti ter umrljivosti iz dolgotrajnih študij in priporočila trenutnih smernic.
English: • The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data;
Slovenian: • Odbor je pregledal vse razpoložljive podatke, vključno z odzivi, ki so jih predložili imetniki dovoljenj za promet z zdravilom, objavljenimi študijami in podatki iz obdobja trženja.
English: The RMS therefore decided to suspend the DCP procedure at day 210 and triggered a procedure under Article 31 of Directive 2001/83/EC, requesting the Committee for Medicinal Products for Human Use (CHMP) to review the benefit-risk of all intravenous nicardipine-containing products for intravenous use and to clarify the data supporting the licensing of these products.
Slovenian: Zato se je referenčna država članica odločila, da 210. dan prekine decentralizirani postopek in sprožila postopek v skladu s členom 31 Direktive 2001/83/ES, s katerim je Odbor za zdravila za uporabo v humani medicini (CHMP) zaprosila, da pregleda razmerje med tveganji in koristmi za vsa intravenska zdravila, ki vsebujejo nikardipin, in pojasni podatke, ki podpirajo dovoljenja za promet s temi zdravili.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Slovenian: Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili
English: • The Committee considered that in view of the identified serious limitations of the efficacy data and the overall safety profile of nicardipine, the benefits were no longer considered to outweigh the risks for some indications, which should therefore be removed;
Slovenian: • Odbor je menil, da zaradi ugotovljenih resnih omejitev podatkov o učinkovitosti in splošnega varnostnega profila nikardipina koristi niso več večje od tveganj pri nekaterih indikacijah, zato je te treba odstraniti.
English: The CHMP reviewed the broad indication for hypertension in the peri-operative period, which includes the pre-operative phase, the time of surgery itself and the post-operative period.
Slovenian: Odbor CHMP je pregledal široko indikacijo hipertenzije v perioperativnem obdobju, ki vključuje predoperacijsko fazo, čas med kirurškim posegom in pooperacijsko obdobje.
English: The CHMP considered all data available in its assessment, including published studies, article and guideline reviews, expert statements, user surveys, national guidelines as well as safety data from post-marketing and marketing authorisation holder databases.
Slovenian: Odbor CHMP je pri svoji oceni upošteval vse razpoložljive podatke, vključno z objavljenimi študijami, pregledi člankov in smernic, strokovnimi izjavami, anketami pri uporabnikih, nacionalnimi smernicami ter varnostnimi podatki iz obdobja trženja in podatkovnih zbirk imetnikov dovoljenj za promet z zdravilom.
English: Nicardipine is a calcium channel blocker of the dihydropyridine type which is primarily effective via peripheral vasodilatation in vascular smooth muscle rather than cardiac muscle.
Slovenian: Nikardipin je zaviralec kalcijevih kanalčkov dihidropiridinske vrste, ki primarno učinkuje prek periferne vazodilatacije v gladkih mišicah žil in ne v srčni mišici.
English: These adverse effects are consistent with other dihydropyridine calcium channel blockers and were not considered to impact negatively on the benefit-risk balance of IV nicardipine.
Slovenian: Ti neželeni učinki so skladni z drugimi dihidropiridinskimi zaviralci kalcijevih kanalčkov in se niso obravnavali kot negativen vpliv na razmerje med tveganji in koristmi intravenskega nikardipina.
English: The CHMP also made significant revisions to the posology section of the product information, including bringing the recommendations in special populations in line with current knowledge of the use of intravenous nicardipine.
Slovenian: Odbor CHMP je prav tako temeljito pregledal poglavje o odmerjanju v informacijah o zdravilu, vključno z uskladitvijo priporočil za posebne skupine bolnikov skladno s trenutnim znanjem o uporabi intravenskega nikardipina.
English: Intravenous nicardipine can also continue to be used in malignant arterial hypertension/hypertensive encephalopathy; however, due to the risk of intracranial pressure elevation, the CHMP recommended the addition of a warning on this risk.
Slovenian: Intravenski nikardipin se lahko še naprej uporablja pri maligni arterijski hipertenziji/hipertenzivni encefalopatiji, vendar je odbor CHMP zaradi tveganja zvišanja intrakranialnega tlaka priporočil, da se doda opozorilo o tem tveganju.
English: Considering the limited efficacy data and overall safety profile, the CHMP therefore considered that the indications in hypotension should be removed from the product information.
Slovenian: Zaradi omejenih podatkov o učinkovitosti in splošnega varnostnega profila je odbor CHMP menil, da je treba indikacije hipertenzije umakniti iz informacij o zdravilu.
English: With regards to hypotension, the CHMP considered that the use of intravenous nicardipine for this indication is no longer relevant in the context of current surgical and anaesthetic practice.
Slovenian: Odbor CHMP je menil, da uporaba intravenskega nikardipina pri indikaciji hipertenzije ni več ustrezna v okviru trenutne kirurške in anestetične prakse.
English: The Committee, as a consequence, concluded that the benefit-risk balance of nicardipine-containing medicinal products for intravenous use remains positive under normal conditions of use, taking into account the changes to the product information agreed.
Slovenian: Odbor je posledično zaključil, da je razmerje med tveganji in koristmi intravenskih zdravil, ki vsebujejo nikardipin, še naprej pozitivno pri normalnih pogojih uporabe, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
English: The Committee, as a consequence, concluded that the benefit-risk balance of intravenous nicardipinecontaining medicinal products remains positive, taking into account the restrictions, warnings and other changes to the product information.
Slovenian: Odbor je posledično zaključil, da je razmerje med tveganji in koristmi intravenskih zdravil, ki vsebujejo nikardipin, še naprej pozitivno, če se upoštevajo omejitve, opozorila in druge spremembe informacij o zdravilu.
English: The CHMP considered that overall, sufficient evidence is available on the safety and efficacy of nicardipine containing medical products for IV use in the treatment of post-operative hypertension and treatment of acute life-threatening hypertension in specific settings, with appropriate specialist intervention and monitoring and when used by specialists.
Slovenian: Odbor CHMP je menil, da so v splošnem na voljo zadostni podatki o varnosti in učinkovitosti zdravil za intravensko uporabo, ki vsebujejo nikardipin, pri zdravljenju pooperacijske hipertenzije in zdravljenju akutne, smrtno nevarne hipertenzije v določenih okoliščinah, pri čemer mora intervencijo ter spremljanje opraviti specialist.
English: • The Committee considered that the product information should be updated, including with regard to the therapeutic indications and advised that nicardipine should only be administered by continuous infusion and not by bolus dose administration, due to safety concerns.
Slovenian: • Odbor je menil, da je treba posodobiti informacije o zdravilu, vključno s terapevtskimi indikacijami, in zaradi varnostnih zadržkov priporočiti, naj se nikardipin uporablja samo z neprekinjenim infundiranjem in ne z dajanjem bolusnega odmerka.
English: • The Committee considered that the available efficacy data is supportive of the use of nicardipine for intravenous use in the treatment of acute life-threatening hypertension and post-operative hypertension;
Slovenian: • Odbor je menil, da razpoložljivi podatki o učinkovitosti podpirajo uporabo intravenskega nikardipina pri zdravljenju akutne, smrtno nevarne hipertenzije in pooperacijske hipertenzije.
English: Grounds for the variation to the terms of the marketing authorisation Whereas
Slovenian: Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Ob upoštevanju naslednjega:
English: There are safety concerns associated with the use of nicardipine in patients with left ventricular heart failure as well as in patients with suspected coronary artery disease and therefore nicardipine should no longer be used for acute severe hypertension with accompanying left ventricular decompensation and pulmonary oedema.
Slovenian: Pri uporabi nikardipina pri bolnikih s popuščanjem levega prekata in bolnikih s sumom na koronarno bolezen so prisotni varnostni zadržki, zato se nikardipin ne sme več uporabljati pri akutni hudi hipertenziji s sočasno dekompenzacijo levega prekata ter pljučnim edemom.
English: The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting.
Slovenian: Zaključil je, da razpoložljivi podatki podpirajo samo uporabo nikardipina pri indikaciji pooperacijske hipertenzije.
English: In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Slovenian: Poleg tega je referenčna država članica odkrila tudi pomembna neskladja med predloženimi podatki in podatki o odmerjanju ter varnosti v predlaganem povzetku glavnih značilnosti zdravila.
English: Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
Slovenian: uporabo, ki vsebuje nikardipin (10 mg/10 ml raztopina za injiciranje), in oceni dokumentacije, priložene vlogi, je referenčna država članica, Združeno kraljestvo, menila, da predloženi klinični podatki niso zadostni za določitev učinkovitosti, varnosti ter razmerja med tveganji in koristmi i.v.
English: In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Slovenian: Na podlagi razpoložljivih dokazov in trenutnega medicinskega znanja o uporabi intravenskega nikardipina ter upoštevajoč morebitno resne neželene učinke, povezane z uporabo nikardipina, je odbor CHMP menil, da je razmerje med tveganji in koristmi i.v.
English: Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
Slovenian: nikardipina z injiciranjem bolusnega odmerka ali direktnim intravenskim dajanjem, saj obstaja morebitno povečano tveganje iatrogene hipotenzije, predvsem pri preeklampsiji.