natgillin/translations-raw huggingface dataset:
• If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in section 6). 
Zdravila Quofenix ne smete prejeti v naslednjih primerih: • Če ste alergični na delafloksacin ali katero koli sestavino tega zdravila (navedeno v poglavju
Quofenix is not recommended in patients with End Stage Renal Disease (ESRD). 
Zdravilo Quofenix ni priporočljivo pri bolnikih s končno ledvično odpovedjo.
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. 
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.
Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin. 
Ena viala vsebuje 300 mg delafloksacina v obliki megluminijevega delafloksacina.
Quofenix 450 mg tablets delafloxacin 
IME ZDRAVILA Quofenix 450 mg tablet delafloksacin
• Night sweat 
• nočno potenje
Sodium hydroxide (for pH-adjustment) Hydrochloric acid, concentrated (for pH-adjustment) 
6.1 Seznam pomoţnih snovi meglumin natrijev sulfobutilbetaciklodekstrin dinatrijev edetat natrijev hidroksid (za uravnavanje pH) koncentrirana klorovodikova kislina (za uravnavanje pH)
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 
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).
10 single-dose vials 
NALEPKA VIALE
This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial. 
Zdravilo Quofenix vsebuje ciklodekstrin To zdravilo vsebuje 2480 mg natrijevega sulfobutilbetaciklodekstrin na vialo.
If you get any side effects, talk to your doctor, pharmacist or nurse. 
Če opazite katerega koli izmed neţ elenih učinkov, se posvetujte z zdravnikom ali farmacevtom ali medicinsko sestro.
Meglumine 
Napihnjenost
The reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution. 
Po rekonstituciji viala z bistro raztopino rumene do jantarne barve vsebuje 300 mg na 12 ml delafloksacina.
Quofenix is not recommended in patients with ESRD. 
Uporaba zdravila Quofenix se ne priporoča pri bolnikih s končno odpovedjo ledvic.
Contact your doctor straight away if you have diarrhoea during or after your treatment. 
Če med zdravljenjem ali po njem dobite diarejo, o tem nemudoma obvestite svojega zdravnika.
Hallucination, auditory Anxiety 
Slušne halucinacije Anksioznost Nespečnost Nenavadne sanje
Constipation 
Utrujenost
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. 
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.
Contents of the pack and other information What Quofenix contains 
Shranjevanje zdravila Quofenix Vsebina pakiranja in dodatne informacije
• Abnormal dreams 
• nenormalno potenje
Skin and subcutaneous tissue disorders 
Bolezni koţe in podkoţ ja
Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis. 
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.
Hepatobiliary disorders 
Hipertransaminazemija
How to store Quofenix 
Shranjevanje zdravila Quofenix
• Sensations like numbness, tingling, pins and needles 
• občutek odrevenelosti, ščemenje, mravljinčenje
Magnesium stearate 
Okvarjeno delovanje jeter
Dizziness 
Izpuščaj
• Chills 
• srbenje
Vision blurred Dry eye 
Zamegljen vid Suhe oči
Susceptibility testing breakpoints 
Mejne vrednosti pri testiranju občutljivosti
Quofenix can make you feel dizzy and lightheaded. 
Vpliv na sposobnost upravljanja vozil in strojev Zaradi zdravila Quofenix se lahko počutite omotično in vrtoglavo.
• Fungal infection 
• mrzlica
Quofenix 300 mg powder for concentrate for solution for infusion delafloxacin 
IME ZDRAVILA IN POT(I) UPORABE Quofenix 300 mg prašek za koncentrat za raztopino za infundiranje delafloksacin
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
Fluoroquinolones form chelates with alkaline earth and transition metal cations. 
Kelacijske učinkovina: antacidi, sukralfat, kovinski kationi, multivitamini Fluorokinoloni tvorijo kelate z zemeljoalkalijskimi in prehodnimi kovinskimi kationi.
- The active substance is delafloxacin. 
Kaj vsebuje zdravilo - Učinkovina je delafloksacin.
Flatulence 
Omotica
No effects were detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed in humans. 
Pri izpostavljenosti, ki je bila pribliţ no 5-krat višja kot pri ljudeh, ni bilo ugotovljenih učinkov na plodnost samcev in samic.
Overall conclusion and benefit -risk balance 
Splošni zaključek ter razmerje med tveganji in koristmi
No bioequivalence is required for intravenous generic products and no such data was therefore submitted. 
Pri intravenskih generičnih zdravilih biološka enakovrednost ni potrebna, zato ti podatki niso bili predloženi.
Overall summary of the scientific evaluation of nicardipine-containing products for intravenous use (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil za intravensko uporabo, ki vsebujejo nikardipin (glejte Prilogo I)
Gastrointestinal intolerance such as nausea also occurs. 
Pojavlja se tudi gastrointestinalna intoleranca, kot je navzea (siljenje na bruhanje).
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. 
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.
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. 
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.
• The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data; 
• 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.
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. 
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.
Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations 
Znanstveni zaključki in razlogi za spremembo pogojev dovoljenj za promet z zdravili
• 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; 
• 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.
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. 
Odbor CHMP je pregledal široko indikacijo hipertenzije v perioperativnem obdobju, ki vključuje predoperacijsko fazo, čas med kirurškim posegom in pooperacijsko obdobje.
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. 
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.
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. 
Nikardipin je zaviralec kalcijevih kanalčkov dihidropiridinske vrste, ki primarno učinkuje prek periferne vazodilatacije v gladkih mišicah žil in ne v srčni mišici.
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. 
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.
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. 
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.
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. 
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.
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. 
Zaradi omejenih podatkov o učinkovitosti in splošnega varnostnega profila je odbor CHMP menil, da je treba indikacije hipertenzije umakniti iz informacij o zdravilu.
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. 
Odbor CHMP je menil, da uporaba intravenskega nikardipina pri indikaciji hipertenzije ni več ustrezna v okviru trenutne kirurške in anestetične prakse.
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. 
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.
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. 
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.
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. 
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.
• 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. 
• 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.
• 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; 
• Odbor je menil, da razpoložljivi podatki o učinkovitosti podpirajo uporabo intravenskega nikardipina pri zdravljenju akutne, smrtno nevarne hipertenzije in pooperacijske hipertenzije.
Grounds for the variation to the terms of the marketing authorisation Whereas 
Podlaga za spremembo pogojev dovoljenja za promet z zdravilom Ob upoštevanju naslednjega:
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. 
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.
The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting. 
Zaključil je, da razpoložljivi podatki podpirajo samo uporabo nikardipina pri indikaciji pooperacijske hipertenzije.
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. 
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.
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. 
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.
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. 
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.
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. 
nikardipina z injiciranjem bolusnega odmerka ali direktnim intravenskim dajanjem, saj obstaja morebitno povečano tveganje iatrogene hipotenzije, predvsem pri preeklampsiji.
The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective. 
Na podlagi predloženih podatkov, dokazov razširjene uporabe, strokovnih izjav in odsotnosti novih varnostnih težav pri populaciji bolnikov je odbor CHMP menil, da ima lahko intravenski nikardipin vlogo pri aortni disekciji, vendar je skladno z razpoložljivimi dokazi priporočil klinično uporabo kot zdravljenje druge izbire, kadar kratkodelujoči agonisti beta-adrenergičnih receptorjev niso primerni, ali v kombinaciji z agonistom beta-adrenergičnih receptorjev, kadar agonisti beta-adrenergičnih receptorjev v obliki monoterapije niso učinkoviti.
The CHMP therefore concluded that nicardipine for intravenous use should only be administered by continuous infusion and not by bolus dose administration, due to the abovementioned safety concerns. 
Odbor CHMP je zato sklenil, da se sme intravenski nikardipin zaradi zgoraj navedenih varnostnih težav uporabljati samo kot neprekinjeno infundiranje in ne z dajanjem bolusnega odmerka.
Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia. 
kardiovaskularni učinki ter učinki na živčevje, povezani s pričakovanimi vazodilatacijskimi učinki zdravila, predvsem glavobol, hipotenzija, vročinski oblivi, edem in tahikardija.
Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated. 
nikardipin v nekaterih državah članicah uporablja kot zdravljenje prve izbire, je odbor CHMP menil, da je za indikacijo preeklampsije nikardipin primeren kot zdravljenje druge izbire.
No suitable risk minimisation measures were identified to reduce the associated risks, given the nature of the patient population and the possible emergency setting in which IV nicardipine is used. 
nikardipin, niso ugotovili nobenih primernih ukrepov za zmanjševanje tveganja, ki bi lahko zmanjšali povezana tveganja.
It is a ‘hybrid medicine'. 
Je „hibridno zdravilo“.
The full EPAR and risk management plan summary for Neofordex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Neofordex sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death. 
To doseže tako, da medsebojno deluje z beljakovinama (nuklearnim dejavnikom kB in kaspazo 9), ki uravnavata celično smrt.
Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences). 
Multipli mielom je rak določene vrste belih krvnih celic, ki se imenujejo plazemske celice in so del imunskega sistema (naravne obrambe telesa).
This is a summary of the European public assessment report (EPAR) for Neofordex. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Neofordex.
This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength. 
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje isto zdravilno učinkovino, vendar je zdravilo Neofordex na voljo v večji jakosti.
What measures are being taken to ensure the safe and effective use of Neofordex? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Neofordex?
The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor je zato zaključil, da so koristi zdravila Neofordex večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression. 
Manj pogosti, a resni neželeni učinki vključujejo pljučnico (pljučno okužbo) ter druge okužbe in psihiatrične motnje, na primer depresijo.
A risk management plan has been developed to ensure that Neofordex is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Neofordex je bil pripravljen načrt obvladovanja tveganj.