natgillin/translations-raw huggingface dataset:
In both studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.
Glavno merilo učinkovitosti v obeh študijah je bilo število bolnikov, pri katerih je bila okužba po zdravljenju odpravljena.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sivextro's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Sivextro večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Sivextro
Druge informacije o zdravilu Sivextro
In both studies patients received 6 days of treatment with Sivextro which was compared with a 10-day treatment of linezolid.
V obeh študijah so bili bolniki šest dni zdravljeni z zdravilom Sivextro, to zdravljenje pa so primerjali z 10-dnevnim zdravljenjem z linezolidom.
A risk management plan has been developed to ensure that Sivextro is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Sivextro je bil pripravljen načrt obvladovanja tveganj.
The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone.
Zdravilna učinkovina v zdravilu Sivextro, tedizolid, je vrsta antibiotika, ki ga imenujemo oksazolidinon.
What are the risks associated with Sivextro?
Kakšna tveganja so povezana z zdravilom Sivextro?
What is Sivextro and what is it used for?
Kaj je zdravilo Sivextro in za kaj se uporablja?
What benefits of Sivextro have been shown in studies?
Kakšne koristi je zdravilo Sivextro izkazalo v študijah?
Sivextro's safety profile is comparable to that of linezolid and was considered acceptable.
Varnostni profil zdravila Sivextro je podoben varnostnemu profilu linezolida in je bil ocenjen za sprejemljivega.
Sivextro was at least as effective as linezolid at curing the infection.
Zdravilo Sivextro je bilo pri ozdravljenju okužbe vsaj tako učinkovito kot linezolid.
In light of the need for new antibiotics targeting multi-resistant bacteria, especially those available as an oral (given by mouth) formulation, the CHMP concluded that Sivextro could be a valuable alternative treatment option for bacterial infections of the skin and of skin structures.
Glede na potrebo po novih antibiotikih, ki bi bili učinkoviti proti bakterijam, odpornim na več zdravil, še zlasti takih za peroralno uporabo, je CHMP zaključil, da bi zdravilo Sivextro lahko bila dragocena alternativna možnost zdravljenja bakterijskih okužb kože in kožnih struktur.
It is not intended to provide practical advice on how to use Sivextro.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For the full list of all side effects and restrictions with Sivextro, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Sivextro glejte navodilo za uporabo.
Sivextro has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Zdravilo Sivextro je dokazano učinkovito proti bakterijam (na primer proti na meticilin odporni bakteriji Staphylococcus aureus (MRSA)), proti katerim običajni antibiotiki ne delujejo.
It contains the active substance tedizolid.
Vsebuje zdravilno učinkovino tedizolid.
Before using Sivextro, doctors should consider official guidance on the appropriate use of antibiotics.
Preden zdravnik predpiše zdravilo Sivextro, mora pretehtati njegovo uporabo glede na uradne smernice za ustrezno uporabo antibiotikov.
The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea (feeling sick), headache, diarrhoea and vomiting.
Najpogostejši neželeni učinki zdravila Sivextro (ki lahko prizadenejo od 2 do 7 oseb od 100) so slabost, glavobol, driska in bruhanje.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sivextro, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Sivextro in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1,333 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Zdravilo Sivextro so primerjali z linezolidom (drugim oksazolidinonom) v dveh glavnih študijah, v kateri je bilo vključenih skupno 1 333 bolnikov z akutnimi bakterijskimi okužbami kože in kožnih struktur, kot so celulitis, kožni abscesi in okužbe ran.
A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Seznam bakterij, proti katerim je zdravilo Sivextro učinkovito, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
For more information about treatment with Sivextro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Sivextro preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg).
Zdravilo Sivextro je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije v veno) in v obliki tablet (200 mg).
Why is Sivextro approved?
Zakaj je bilo zdravilo Sivextro odobreno?
Sivextro is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections.
Zdravilo Sivextro je antibiotik, ki se uporablja pri odraslih za zdravljenje akutnih (kratkotrajnih) bakterijskih okužb kože in kožnih struktur (podkožnega tkiva), kot so celulitis (vnetje globokega podkožnega tkiva), kožni abscesi in okužbe ran.
Sivextro can only be obtained with a prescription.
Izdaja zdravila Sivextro je le na recept.
For practical information about using Sivextro, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Sivextro naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
How does Sivextro work?
Kako zdravilo Sivextro deluje?
How is Sivextro used?
Kako se zdravilo Sivextro uporablja?
The submission of a revised protocol should take place within 10 days after the Commission Decision.
Vlogo revidiranega protokola je treba predložiti v roku 10 dni po Odločbi Komisije.
Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance
Pogoji, ki so bistveni za varno in učinkovito uporabo zdravila, vključno s farmakovigilanco
a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed.
izvedba prospektivne opazovalne študije z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
Condition of the marketing authorisations
Pogoji dovoljenja za promet z zdravilom
The way it works in this disease is not completely understood.
Njen način delovanja pri tej bolezni ni v celoti znan.
Treatment is divided into 2 phases: induction and consolidation.
Zdravljenje je razdeljeno na dve stopnji: indukcijsko in konsolidacijsko.
Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
Nadaljnje informacije o zdravilu Arzenov trioksid Accord so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment.
• bolnikih z akutno promielocitno levkemijo, katerih bolezen se ni odzvala na predhodno zdravljenje z retinoidi in zdravili za zdravljenje raka ali kadar se je bolezen po taki vrsti zdravljenja ponovila.
The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects.
Infuzija mora trajati od ene do dveh ur, če se pri bolniku pojavijo določeni neželeni učinki, pa jo bo morda treba dajati tudi dlje.
During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not.
Med konsolidacijsko stopnjo se zdravilo Arzenov trioksid Accord daje pet dni na teden, vendar sta dolžina prekinitev med cikli in trajanje zdravljenja odvisna od tega, ali so bili bolniki predhodno zdravljeni ali ne.
The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Arzenov trioksid Accord primerljivo z zdravilom Trisenox.
Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes).
Zdravilo Arzenov trioksid Accord se uporablja za zdravljenje odraslih (starejših od 18 let) z akutno promielocitno levkemijo (APL), tj. redko obliko levkemije (raka belih krvnih celic), ki jo povzroča genetska „translokacija“ (zamenjava genov med dvema kromosomoma).
Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Arzenov trioksid Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Trisenox, zato jih ni treba ponoviti za zdravilo Arzenov trioksid Accord.
During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells).
Med indukcijsko stopnjo se zdravilo Arzenov trioksid Accord daje vsak dan, dokler se ne pojavijo znaki, da zdravljenje deluje (kostni mozeg ne vsebuje več levkemičnih celic).
The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A).
Translokacija vpliva na to, kako rastejo bele krvne celice, zaradi česar ne morejo uporabljati retinojske kisline (vitamina A).
What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Arzenov trioksid Accord?
As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Arzenov trioksid Accord.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord 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 Arzenov trioksid Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Arzenov trioksid Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Trisenox.
An overview of Arsenic trioxide Accord and why it is authorised in the EU
Pregled zdravila Arzenov trioksid Accord in zakaj je odobreno v EU
For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Arzenov trioksid Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias.
Predpisovanje in izdaja zdravila Arzenov trioksid Accord je le na recept, njegovo uporabo pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi oblikami levkemije.
The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia.
Učinkovina v zdravilu Arzenov trioksid Accord, arzenov trioksid, se v zdravilih uporablja že mnogo let, tudi pri zdravljenju levkemije.
Arsenic trioxide Accord is used in:
Zdravilo Arzenov trioksid Accord se uporablja pri:
As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Arzenov trioksid Accord stalno spremljajo.
• Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid.
• bolnikih z na novo diagnosticirano akutno promielocitno levkemijo z nizkim do srednjim tveganjem, pri kateri se uporablja v kombinaciji z vse-trans-retinojsko kislino (ATRA);
There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Arzenov trioksid Accord absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
What are the benefits and risks of Arsenic trioxide Accord?
Kakšne so koristi in tveganja, povezani z zdravilom Arzenov trioksid Accord?
The recommended dose of Arsenic trioxide Accord depends on the patient's weight.
Priporočeni odmerek zdravila Arzenov trioksid Accord je odvisen od bolnikove telesne mase.
Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'.
Zdravilo Arzenov trioksid Accord vsebuje učinkovino arzenov trioksid in je „generično zdravilo“.
Other information about Arsenic trioxide Accord
Druge informacije o zdravilu Arzenov trioksid Accord
Arsenic trioxide Accord (arsenic trioxide)
Arzenov trioksid Accord (arzenov trioksid)
This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Zdravilo Arzenov trioksid Accord se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
Why is Arsenic trioxide Accord authorised in the EU?
Zakaj je bilo zdravilo Arzenov trioksid Accord odobreno v EU?
What is Arsenic trioxide Accord and what is it used for?
Kaj je zdravilo Arzenov trioksid Accord in za kaj se uporablja?
It is given as an infusion (drip) into a vein.
Zdravilo se daje z infundiranjem (kapalno infuzijo) v veno.
Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Arzenov trioksid Accord enako kot pri zdravilu Trisenox odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Arsenic trioxide Accord work?
Kako zdravilo Arzenov trioksid Accord deluje?
How has Arsenic trioxide Accord been studied?
Kako je bilo zdravilo Arzenov trioksid Accord raziskano?
How is Arsenic trioxide Accord used?
Kako se zdravilo Arzenov trioksid Accord uporablja?
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Insulatard, veljavno po vsej Evropski uniji, odobrila 7. oktobra 2002.
The full EPAR for Insulatard 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) za zdravilo Insulatard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Insulatard?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Insulatard?
Other information about Insulatard
Druge informacije o zdravilu Insulatard
It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor's recommendation.
Daje se lahko enkrat ali dvakrat dnevno skupaj s hitrodelujočim insulinom ali brez njega (v času obroka) v skladu s priporočili zdravnika.
This is a summary of the European public assessment report (EPAR) for Insulatard.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Insulatard.
The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Insulatard večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Insulatard shown during the studies?
Kakšne koristi je zdravilo Insulatard izkazalo med študijami?
A risk management plan has been developed to ensure that Insulatard is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Insulatard je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Insulatard preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients).
Zdravilo Insulatard so preučili v štirih glavnih kliničnih preskušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, 81 bolnikov), in s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, 476 bolnikov).
The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Najpogostejši neželeni učinek zdravila Insulatard (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
In most patients, Insulatard was compared with other types of human insulin or insulin analogues.
Pri večini bolnikov so zdravilo Insulatard primerjali z drugimi vrstami humanega insulina ali analogi insulina.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Insulatard in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Insulatard.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Insulatard, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached).
V študijah so merili raven glukoze v krvi na tešče ali glikoziliranega hemoglobina (HbA1c, hemoglobina v krvi, na katerega se je vezala glukoza).
Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day.
V zdravilu Insulatard je insulin zmešan z drugo snovjo, tj. protaminom, v obliki „izofan“, ki se čez dan absorbira mnogo počasneje.
What is the risk associated with Insulatard?
Kakšna tveganja so povezana z zdravilom Insulatard?
The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Zdravilna učinkovina v zdravilu Insulatard, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens.
Zdravilo Insulatard se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot pri sladkorni bolezni tipa 2, in sicer pri uporabi običajne injekcijske brizge ali enega od napolnjenih peresnikov.
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins.
Zdravilo Insulatard je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kakor pri drugih humanih insulinih.
Insulatard is used to treat diabetes.
Zdravilo Insulatard se uporablja za zdravljenje sladkorne bolezni.
Insulatard is a suspension for injection that contains the active substance human insulin.
Zdravilo Insulatard je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
Why has Insulatard been approved?
Zakaj je bilo zdravilo Insulatard odobreno?
It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen).
Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet ali FlexPen).
Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas.
Zdravilo Insulatard je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Zdravilo Insulatard se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).