natgillin/translations-raw huggingface dataset:
What is Purevax RCP FeLV? 
Kaj je zdravilo Purevax RCP FeLV?
What is Purevax RCP FeLV used for? 
Za kaj se zdravilo Purevax RCP FeLV uporablja?
How does Purevax RCP FeLV work? 
Kako zdravilo Purevax RCP FeLV deluje?
You and your doctor will decide if you can continue treatment or if you need to take another type of antibiotic. 
Skupaj z zdravnikom se boste odločili, ali lahko nadaljujete zdravljenje ali morate jemati drugo vrsto antibiotika.
• If you have any questions or concerns about your medicines, speak to your doctor or pharmacist. 
• Če imate kakršna koli vprašanja ali pomisleke glede svojih zdravil, se posvetujte z zdravnikom ali farmacevtom.
The review of fluoroquinolones and quinolones was initiated on 9 February 2017 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC. 
Pregled fluorokinolonov in kinolonov se je začel 9. februarja 2017 na zahtevo nemške agencije za zdravila (BfArM) v skladu s členom 31 Direktive 2001/83/ES.
The CHMP confirmed that the use of the remaining fluoroquinolone antibiotics should be restricted. 
Odbor CHMP je potrdil, da je treba omejiti uporabo preostalih fluorokinolonskih antibiotikov.
• to treat mild or moderate bacterial infections unless other antibacterial medicines commonly recommended for these infections cannot be used. 
• zdravljenje blagih ali zmernih bakterijskih okužb, razen če ne bo mogoča uporaba drugih antibakterijskih zdravil, ki se običajno priporočajo za tovrstne okužbe.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. 
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj o zdravilih za uporabo v humani medicini.
Restrictions on the use of fluoroquinolone antibiotics will mean that they should not be used: 
Omejitev uporabe fluorokinolonskih antibiotikov bo pomenila, da jih ne bo dovoljeno uporabljati za:
The final PRAC recommendations were adopted on 4 October 2018 and then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion. 
Odbor PRAC je 4. oktobra 2018 sprejel končna priporočila in jih poslal Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ta pa je nato sprejel končno mnenje agencije.
National authorities will enforce this decision for the fluoroquinolone and quinolone medicines authorised in their countries and they will also take other appropriate measures to promote the correct use of these antibiotics. 
Nacionalni organi bodo izvrševali navedeni sklep za fluorokinolonska in kinolonska zdravila, odobrena v posameznih državah, sprejeli pa bodo tudi dodatne ustrezne ukrepe, s katerimi bodo spodbujali pravilno uporabo teh antibiotikov.
Fluoroquinolones are of value in certain infections, including some life-threatening ones, where alternative antibiotics are not sufficiently effective. 
Fluorokinoloni so koristni pri določenih okužbah, vključno z življenjsko nevarnimi, pri katerih uporaba drugih antibiotikov ni dovolj učinkovita.
• to treat infections that might get better without treatment or are not severe (such as throat infections); 
• zdravljenje okužb, ki se lahko pozdravijo brez zdravljenja ali niso resne (na primer okužb grla);
o at the first sign of tendon injury, such as tendon pain or swelling - rest the painful area; 
o ob prvem znaku poškodbe kite, kot je bolečina ali zatekanje - spočijte boleče območje;
The review concerned only medicines given systemically (by mouth or injection) and inhaled medicines. 
Upoštevana so bila samo zdravila za sistemsko uporabo (za peroralno uporabo ali injiciranje) in zdravila za inhaliranje.
The review incorporated the views of patients, healthcare professionals and academics presented at EMA's public hearing on fluoroquinolone and quinolone antibiotics in June 2018. 
V pregled so bila vključena mnenja bolnikov, zdravstvenih delavcev in znanstvenikov, predstavljena na javni razpravi agencije EMA o fluorokinolonskih in kinolonskih antibiotikih junija 2018.
• The benefits and risks of fluoroquinolones will be monitored continuously and a drug utilisation study will evaluate the effectiveness of the new measures to reduce inappropriate use of fluoroquinolones by investigating changes in prescribing behaviour. 
• Koristi in tveganja fluorokinolonov se bodo redno spremljali, s študijo o uporabi zdravil, v kateri bodo proučevali spremembe pri predpisovanju, pa bo ocenjena učinkovitost novih ukrepov za zmanjšanje neustrezne uporabe fluorokinolonov.
They should be used with special caution in the elderly, patients with kidney disease and those who have had an organ transplantation because these patients are at a higher risk of tendon injury. 
Posebno pozornost je treba nameniti njihovi uporabi pri starejših bolnikih, bolnikih z boleznijo ledvic in tistih s presajenim organom, saj so ti bolniki bolj izpostavljeni tveganju za poškodbo kit.
You may be especially prone to tendon damage if you are taking a corticosteroid and a fluoroquinolone medicine at the same time. 
K poškodbi kit ste lahko še posebno nagnjeni, če hkrati jemljete kortikosteroid in fluorokinolonsko zdravilo.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision on 14 February 2019 for Quinsair and on 11 March 2019 for other quinolone and fluoroquinolone antibiotics given by mouth and by injection, which is applicable in all EU countries. 
Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je 14. februarja 2019 izdala končni pravno zavezujoči sklep za zdravilo Quinsair in 11. marca 2019 za druge kinolonske in fluorokinolonske antibiotike za peroralno uporabo ali injiciranje, veljaven v vseh državah članicah EU.
EMA's human medicines committee (CHMP) endorsed the recommendations of EMA's safety committee (PRAC) and concluded that the marketing authorisation of medicines containing cinoxacin, flumequine, nalidixic acid, and pipemidic acid should be suspended. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA je odobril priporočila Odbora agencije za ocenjevanje tveganja na področju farmakovigilance (PRAC) in zaključil, da se začasno umaknejo dovoljenja za promet z zdravili, ki vsebujejo cinoksacin, flumekin, nalidiksno kislino in pipemidno kislino.
Concomitant treatment with a fluoroquinolone and a corticosteroid should be avoided. 
Treba se je izogibati sočasnemu zdravljenju s fluorokinolonom in kortikosteroidom.
Fluoroquinolones and quinolones are a class of broad-spectrum antibiotics that are active against bacteria of both Gram-negative and Gram-positive classes. 
Fluorokinoloni in kinoloni so vrsta antibiotikov širokega spektra, ki učinkujejo proti gramnegativnim in grampozitivnim bakterijam.
• Tendon swelling and injury may occur within 2 days of starting treatment with a fluoroquinolone but may even occur several months after stopping treatment. 
• Zatekanje in poškodbe kit se lahko pojavijo v dveh dneh po začetku zdravljenja s fluorokinolonom, lahko pa tudi več mesecev po prenehanju zdravljenja.
Since the use of a corticosteroid with a fluoroquinolone also increases this risk, combined use of these medicines should be avoided. 
Omenjeno tveganje prav tako povečuje uporaba kortikosteroida s fluorokinolonom, zato se je treba izogibati kombinirani uporabi teh zdravil.
• Stop taking a fluoroquinolone medicine and contact your doctor at once in the following cases: 
• V naslednjih primerih prenehajte jemati fluorokinolonsko zdravilo in se nemudoma posvetujte z zdravnikom:
• to treat non-bacterial infections, e.g. non-bacterial (chronic) prostatitis; 
• zdravljenje nebakterijskih okužb, na primer nebakterijskega (kroničnega) vnetja prostate;
• Tendon damage (especially to Achilles tendon but also other tendons) can occur within 48 hours of starting fluoroquinolone treatment but the damage may be delayed several months after stopping treatment. 
• Do poškodbe kite (zlasti Ahilove, pa tudi drugih kit) lahko pride v 48 urah po začetku zdravljenja s fluorokinolonom, poškodba pa se lahko pojavi tudi šele več mesecev po prenehanju zdravljenja.
The review covered medicines containing the following fluoroquinolone and quinolone antibiotics: cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin. 
V pregled so bila vključena zdravila z naslednjimi fluorokinolonskimi in kinolonskimi antibiotiki: cinoksacin, ciprofloksacin, flumekin, levofloksacin, lomefloksacin, moksifloksacin, nalidiksna kislina, norfloksacin, ofloksacin, pefloksacin, pipemidna kislina, prulifloksacin in rufloksacin.
• Patients who are older, have renal impairment or have had solid organ transplantation and those being treated with a corticosteroid are at higher risk of tendon damage. 
• Starejši bolniki, bolniki z okvaro ledvic ali presajenim organom in tisti, ki se zdravijo s kortikosteroidom, so bolj izpostavljeni tveganju za poškodbo kit.
• Speak with your doctor if you are taking a corticosteroid (medicines such as hydrocortisone and prednisolone) or need to have treatment with a corticosteroid. 
• Če jemljete kortikosteroid (zdravila, kot sta hidrokortizon in prednizolon) ali potrebujete zdravljenje s kortikosteroidom, se posvetujte z zdravnikom.
• Fluoroquinolones are associated with prolonged (up to months or years), serious, disabling and potentially irreversible drug reactions affecting several, sometimes multiple, systems, organ classes and senses. 
• Fluorokinoloni so povezani z dolgotrajnimi (do nekaj mesecev ali let trajajočimi) resnimi neželenimi učinki, ki povzročajo nezmožnost ali nesposobnost in so lahko nepopravljivi ter prizadenejo več sistemov, organov in čutil, včasih tudi hkrati.
• Fluoroquinolone treatment should be discontinued at the first sign of tendon pain or inflammation and patients should be advised to stop treatment with a fluoroquinolone and speak with the doctor in case of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness so as to prevent development of potentially irreversible condition. 
• Fluorokinolonsko zdravljenje je treba prekiniti ob prvem znaku bolečine v kiti ali njenem vnetju, prav tako pa je treba bolnikom svetovati, naj prenehajo zdravljenje s fluorokinolonom in se posvetujejo z zdravnikom v primeru znakov nevropatije, kot so bolečina, pekoča bolečina, ščemenje, odrevenelost ali šibkost, da se prepreči razvoj posledic, ki so lahko nepopravljive.
In addition, the prescribing information for healthcare professionals and information for patients will describe the disabling and potentially permanent side effects and advise patients to stop treatment with a fluoroquinolone antibiotic at the first sign of a side effect involving muscles, tendons or joints and the nervous system. 
Poleg tega bodo informacije za zdravstvene delavce glede predpisovanja zdravila in informacije za bolnike vključevale opis neželenih učinkov, ki povzročajo nezmožnost ali nesposobnost in so lahko trajni, in nasvet bolnikom glede prekinitve zdravljenja s fluorokinolonskimi antibiotiki ob prvem znaku neželenega učinka, ki prizadene mišice, kite ali sklepe in živčni sistem.
Importantly, fluoroquinolones should generally be avoided in patients who have previously had serious side effects with a fluoroquinolone or quinolone antibiotic. 
Pomembno je, da se je treba uporabi fluorokinolonov na splošno izogibati pri bolnikih, ki so v preteklosti že imeli resne neželene učinke zaradi uporabe fluorokinolonskih ali kinolonskih antibiotikov.
• Fluoroquinolones should generally not be used in patients who have had serious adverse reactions associated with the use of quinolone or fluoroquinolone medicines. 
• Fluorokinoloni se na splošno ne smejo uporabljati pri bolnikih, ki so imeli v preteklosti resne neželene učinke, povezane z uporabo kinolonskih ali fluorokinolonskih zdravil.
• for preventing traveller's diarrhoea or recurring lower urinary tract infections (urine infections that do not extend beyond the bladder); 
• preprečevanje potovalne driske ali ponavljajočih se okužb spodnjih sečil (okužb, ki prizadenejo sečnico in mehur);
o if you get swelling in the shoulder, arms or legs, have walking difficulty, feel tired or depressed or have problems with your memory or with sleeping or you notice changes with your vision, taste, smell or hearing. 
o če vam zatečejo ramena, roke ali noge, težko hodite, se počutite utrujene ali depresivne ali imate težave s pomnjenjem ali spanjem ali če opazite spremembe vida, okusa, voha ali sluha.
• Fluoroquinolone medicines (which contain ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, prulifloxacin and rufloxacin) can cause long-lasting, disabling and potentially permanent side effects involving tendons, muscles, joints and the nervous system. 
• Fluorokinolonska zdravila (ki vsebujejo ciprofloksacin, levofloksacin, lomefloksacin, moksifloksacin, norfloksacin, ofloksacin, pefloksacin, prulifloksacin in rufloksacin) lahko povzročijo dolgotrajne neželene učinke, ki povzročajo nezmožnost ali nesposobnost in so lahko trajni ter ki med drugim prizadenejo kite, mišice, sklepe in živčni sistem.
On 15 November 2018, EMA finalised a review of serious, disabling and potentially permanent side effects with quinolone and fluoroquinolone antibiotics given by mouth, injection or inhalation. 
Agencija EMA je 15. novembra 2018 zaključila pregled resnih neželenih učinkov kinolonskih in fluorokinolonskih antibiotikov za peroralno uporabo, injiciranje ali inhaliranje, ki povzročajo nezmožnost ali nesposobnost in so lahko trajni.
o if you get pain, feel pins and needles, tingling, tickling, numbness or burning, or weakness especially in the legs or arms; 
o če začutite bolečine, mravljinčenje ali zbadanje, ščemenje, draženje, odrevenelost ali pekočo bolečino ali šibkost, zlasti v nogah in rokah;
• The serious side effects include tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impaired hearing, vision, taste and smell. 
• Med resne neželene učinke spadajo tendonitis, pretrganje kite, artralgija, bolečine v okončinah, motnje pri hoji, nevropatije, povezane s parestezijo, depresija, utrujenost, slabše pomnjenje, težave s spanjem ter okvare sluha, vida, okusa in voha.
• You should not take a fluoroquinolone medicine if you have ever had a serious side effect with a fluoroquinolone or a quinolone medicine and you should speak with your doctor immediately. 
• Če ste v preteklosti že imeli resne neželene učinke zaradi uporabe fluorokinolonskega ali kinolonskega zdravila, ne smete jemati fluorokinolonskega zdravila in se morate nemudoma posvetovati z zdravnikom.
• You may be more prone to joint pain or swelling or tendon damage if you are aged over 60 years, your kidneys do not work well or you have received organ transplantation. 
• Če ste starejši od 60 let, vaše ledvice slabo delujejo ali imate presajen organ, ste lahko dovzetnejši za bolečine ali otekline sklepov ali poškodbe kit.
• These serious side effects include inflamed or torn tendon, muscle pain or weakness, and joint pain or swelling, walking difficulty, feeling pins and needles, burning pain, tiredness, depression, problems with memory, sleeping, vision and hearing, and altered taste and smell. 
• Med resne neželene učinke spadajo vneta ali strgana kita, bolečine v mišicah ali šibkost mišic, bolečine v sklepih ali zatekanje sklepov, težave s hojo, občutek mravljinčenja in zbadanja, pekoča bolečina, utrujenost, depresija, težave s pomnjenjem, spanjem, vidom in sluhom ter spremenjen okus in voh.
• Up-to-date summary of product characteristics should be consulted for authorised indications when considering treatment with a fluoroquinolone medicine. 
• Pri razmisleku o uporabi zdravljenja s fluorokinolonskim zdravilom je treba upoštevati odobrene indikacije v posodobljenem povzetku glavnih značilnosti zdravila, saj so bile indikacije za ta zdravila omejene.
The doctor will consider stopping treatment if the condition does not show any improvement after 16 weeks. 
Zdravnik bo razmislil o prenehanju zdravljenja, če se stanje po 16 tednih ne izboljša.
Patientsor their carers may inject the medicine themselves if their doctor or nurse considers it appropriate. 
Bolniki ali njihovi skrbniki lahko zdravilo sami injicirajo, če zdravnik ali medicinska sestra meni, da je to zanje primerno.
Further information on Dupixent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dupixent. 
Nadaljnje informacije o zdravilu Dupixent so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/dupixentema.europa.eu/medicines/human/EPAR/dupixent.
The medicine is for long-term use and the need to continue taking the medicine should be assessed by the doctor at least yearly. 
Zdravilo je namenjeno za dolgotrajno uporabo, potrebo po nadaljevanju jemanja zdravila pa mora zdravnik oceniti vsaj enkrat na leto.
What measures are being taken to ensure the safe and effective use of Dupixent? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dupixent?
Dupixent received a marketing authorisation valid throughout the EU on 27 September 2017. 
Za zdravilo Dupixent je bilo 27. septembra 2017 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
The European Medicines Agency therefore decided that Dupixent's benefits are greater than its risks and it can be authorised in the EU. 
Evropska agencija za zdravila je zato sklenila, da so koristi zdravila Dupixent večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
As for all medicines, data on the use of Dupixent are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Dupixent stalno spremljajo.
Regarding safety, Dupixent's side effects are generally mild and manageable. 
Kar zadeva varnost, so neželeni učinki zdravila Dupixent na splošno blagi in obvladljivi.
A further study was carried out in 251 adolescents aged from 12 to less than 18 years with moderate to severe atopic dermatitis. 
Izvedena je bila dodatna študija, v kateri je sodelovalo 251 mladostnikov, starih od 12 do 18 let, z zmernim do hudim atopijskim dermatitisom.
Side effects reported with Dupixent are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Dupixent, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Dupixent have been shown in studies? 
Kakšne koristi zdravila Dupixent so se pokazale v študijah?
There have been very rare cases of serum sickness (allergy to foreign proteins) and serum sickness-like reactions. 
Zelo redki so primeri serumske bolezni (alergije na tuje beljakovine) in serumski bolezni podobne reakcije.
Other information about Dupixent 
Druge informacije o zdravilu Dupixent
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dupixent have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Dupixent upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Dupixent and why it is authorised in the EU 
Pregled zdravila Dupixent in zakaj je odobreno v EU
Why is Dupixent authorised in the EU? 
Zakaj je bilo zdravilo Dupixent odobreno v EU?
Anaphylaxis (sudden, severe allergic reaction) has been reported very rarely. 
Zelo redko je bila opažena anafilaksa (nenadna, huda alergična reakcija).
For more information about using Dupixent, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Dupixent glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Dupixent? 
Kakšna tveganja so povezana z zdravilom Dupixent?
After 12 weeks of treatment, Dupixent improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 320 ml (for 200 mg Dupixent) or 340 ml (for 300 mg Dupixent) compared with 180 ml and 210 ml for placebo. 
Po 12 tednih zdravljenja je zdravilo Dupixent izboljšalo FEV1 (največjo prostornino zraka, ki jo lahko oseba izdihne v eni sekundi) za 320 ml (ob jemanju 200-miligramskega odmerka) ali 340 ml (ob jemanju 300-miligramskega odmerka) v primerjavi s 180 ml oziroma 210 ml ob prejemanju placeba.
Dupixent is a medicine used to treat patients aged 12 years or over with moderate to severe atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry). 
Dupixent je zdravilo, ki se uporablja za zdravljenje odraslih, starih 12 let ali več, z zmernim do hudim atopijskim dermatitisom (znanim tudi kot atopijski ekcem, kar je stanje, pri katerem je koža srbeča, rdeča in suha).
In adolescents weighing less than 60 kg, the 200-mg injection is used. 
Pri mladostnikih, ki tehtajo manj kot 60 kg, se uporabi 200-miligramska injekcija.
In the first study, involving 1,902 patients, the number of severe flare-ups per year was 0.46 in patients taking 200 mg Dupixent and 0.52 in patients taking 300 mg Dupixent, compared with 0.87 or 0.97 in patients given placebo. 
V prvi študiji, ki je vključevala 1 902 bolnika, je bilo število hudih izbruhov letno 0,46 pri bolnikih, ki so jemali 200 mg zdravila Dupixent, in 0,52 pri bolnikih, ki so jemali 300 mg zdravila Dupixent, v primerjavi z 0,87 oziroma 0,97 pri bolnikih, ki so prejemali placebo.
What is Dupixent and what is it used for? 
Kaj je zdravilo Dupixent in za kaj se uporablja?
Patients with atopic dermatitis and patients with asthma produce high levels of proteins called interleukin 4 and interleukin 13 (IL-4 and IL-13), which can cause inflammation of the skin and airways leading to the symptoms of these diseases. 
Za bolnike z atopijskim dermatitisom in tiste z astmo so značilne visoke ravni beljakovin, imenovanih interlevkin 4 in interlevkin 13 (IL-4 in IL-13), ki lahko povzročita vnetje kože in dihalnih poti, kar vodi do simptomov teh bolezni.
Dupixent is also used to treat severe asthma in patients aged 12 years or over whose asthma is not properly controlled by a combination of high-dose corticosteroids taken by inhalation plus another medicine used for the prevention of asthma. 
Zdravilo Dupixent se uporablja tudi za zdravljenje hude astme pri bolnikih, starih 12 let ali več, katerih astma ni ustrezno nadzorovana s kombinacijo visokih odmerkov inhalacijskih kortikosteroidov, in drugega zdravila, ki se uporablja za preprečevanje astme.
Dupixent is available as pre-filled syringes containing 200 mg or 300 mg dupilumab in a solution for injection under the skin, usually in the thigh or belly. 
Zdravilo Dupixent je na voljo v napolnjenih injekcijskih brizgah, ki vsebujejo 200 mg ali 300 mg dupilumaba v raztopini za injiciranje pod kožo, običajno v stegno ali trebuh.
In the first study, which involved 740 patients, participants were given Dupixent or placebo, both in combination with a topical corticosteroid (a medicine for inflammation applied to the skin). 
V prvi študiji, ki je vključevala 740 bolnikov, so udeleženci prejemali zdravilo Dupixent ali placebo, oboje v kombinaciji s topikalnim kortikosteroidom (protivnetnim zdravilom, ki se nanese na kožo).
Dupixent can only be obtained with a prescription and treatment should be started by a doctor who has experience in the diagnosis and treatment of the conditions Dupixent is used to treat. 
Predpisovanje in izdaja zdravila Dupixent je le na recept, zdravljenje z njim pa lahko uvede le zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se to zdravilo uporablja.