natgillin/translations-raw huggingface dataset:
The evaluation of the data submitted as part of this procedure have allowed a better characterisation of the risk of the short term effects on SPM, myelosuppression and infections, following treatment with DRZ in children undergoing chemotherapy with anthracycline based regimens.
Ovrednotenje podatkov, predloženih v okviru tega postopka, je omogočilo boljšo opredelitev tveganja za kratkoročne učinke na pojav nove primarne malignosti, mielosupresije in okužb po zdravljenju z deksrazoksanom pri otrocih, ki se zdravijo s kemoterapijo po shemi z antraciklini.
• The Committee noted the reassuring safety data on the occurrence of secondary primary malignancies in particular acute myelogenous leukaemia and myelodysplastic syndrome in children and adolescents aged 0 to 18 years, the high risk for long term occurrence of severe cardiomyopathy when using high cumulated dose of anthracycline in children and adolescents and the medical need of high anthracycline dosing regimen for pathology such as sarcoma or acute myelogenous leukaemia relapses in children and adolescents
• odbor je upošteval spodbudne podatke o varnosti glede pojava novih primarnih malignosti, zlasti akutne mieloične levkemije in mielodisplastičnega sindroma, pri otrocih in mladostnikih, starih od 0 do 18 let, veliko tveganje za dolgoročni pojav resne kardiomiopatije ob uporabi velikih kumulativnih odmerkov antraciklina pri otrocih in mladostnikih ter zdravstveno potrebo po shemah z velikimi odmerki antraciklina pri patologijah, kot so sarkom in relapsi akutne mieloične levkemije pri otrocih in mladostnikih;
• The Committee considered the data submitted by the MAH in relation to the objections raised on the lifting of the contraindication for Cardioxane in children and adolescents receiving high cumulative doses of anthracycline.
• odbor je preučil podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom glede ugovorov v zvezi z odpravo kontraindikacije za zdravilo Cardioxane pri otrocih in mladostnikih, ki prejemajo velike kumulativne odmerke antraciklina;
The affected paediatric patients consequently treated are at high risk of acute anthracycline cardiotoxicity, as a consequence of the high doses of chemotherapy received; therefore, a treatment with a cardioprotective agent is needed in this very small number of patients.
Pri nadaljnje zdravljenih obolelih pediatričnih bolnikih obstaja visoko tveganje za akutno kardiotoksičnost antraciklina kot posledica velikih odmerkov prejete kemoterapije, zato je pri tem zelo majhnem številu bolnikov potrebno zdravljenje z zdravilom za zaščito srca.
• The Committee concluded that, in view of the above, it is justified to limit the contraindication for Cardioxane in children aged 0 to 18 years receiving low cumulative anthracycline doses (less than 300 mg/m2 of doxorubicin or equivalent)
• odbor je glede na zgoraj navedeno zaključil,, da je upravičeno omejiti kontraindikacijo za zdravilo Cardioxane pri otrocih, starih od 0 do 18 let, ki prejemajo majhne kumulativne odmerke antraciklina (manj kot 300 mg/m2 doksorubicina ali enakovrednega zdravila);
The assessment of this risk is confounded by concomitant chemotherapy treatments, small numbers of patients and the overall rarity of SPM events.
Na oceno tega tveganja vplivajo sočasno zdravljenje s kemoterapijo, majhno število bolnikov in splošna redkost novih primarnih malignosti.
Data are reassuring as regard to occurrence of SPMs in children after being exposed to DRZ, up to 12 years post treatment.
Podatki v zvezi s pojavom novih primarnih malignosti pri otrocih po izpostavitvi deksrazoksanu do 12 let po zdravljenju so spodbudni.
DRZ efficacy as a cardioprotectant has not been demonstrated in children for cumulative anthracycline doses of less than 300 mg/m2.
Pri otrocih učinkovitost deksrazoksana kot zdravila za zaščito srca pri kumulativnih odmerkih antraciklina pod 300 mg/m2 ni bila dokazana.
The CHMP noted that the MAH will reflect the ongoing observational study (Effects of Dexrazoxane Hydrochloride on Biomarkers Associated with Cardiomyopathy and Heart Failure after Cancer Treatment, NCT01790152.)
Odbor CHMP je poudaril, da bo imetnik dovoljenja za promet z zdravilom potekajočo opazovalno študijo (učinki deksrazoksanijevega klorida na biološke označevalce, povezane s kardiomiopatijo in odpovedjo srca, po zdravljenju raka, NCT01790152) vključil v svoj načrt za obvladovanje tveganj, kot bo primerno.
However, the RMS considered acceptable to alleviate the contra-indication in children and proposed limiting it to children receiving low cumulative anthracycline doses (less than 300mg/m2 of doxorubicin or equivalent).
Vendar pa je presodila, da je sprejemljivo kontraindikacijo pri otrocih omiliti, in je predlagala, da se omeji na otroke, ki prejemajo majhne kumulativne odmerke antraciklina (manj kot 300 mg/m2 doksorubicina ali enakovrednega zdravila).
However, data assessed are still insufficient to provide reassurance concerning the occurrence of long-term risk of SPM particularly solid SPMs.
Vendar ocenjeni podatki še vedno ne zadoščajo za zagotovilo glede pojavnosti dolgoročnega tveganja za nove primarne malignosti, zlasti nove primarne malignosti čvrstih organov.
Moreover, there is evidence that there is no delay to chemotherapy treatment as a result of a potential DRZ myelosuppression effect.
Obstajajo tudi dokazi, da zaradi morebitnega mielosupresivnega učinka deksrazoksana ni zakasnitve kemoterapije.
The data assessed during the Art.31 referral procedure in 2011 regarded the carcinogenic potential of dexrazoxane due its cytotoxic activity and on the occurrence of second malignant neoplasms in the paediatric population; such data justified the introduction of a contraindication of the product in children aged 0 to 18 years.
V podatkih, ocenjenih med napotitvenim postopkom v skladu s členom 31 leta 2011, so preučevali kancerogeni potencial deksrazoksana zaradi njegove citotoksične aktivnosti in pojav novih malignih neoplazem v pediatrični populaciji.
Although studies suggest there is no safe dose of anthracycline, it is known that the risk of anthracycline induced cardiotoxicity increases with higher cumulative dosing; guidelines imply that above 250 mg/m2 there is sufficient cardiac risk to provide recommendations on lifelong surveillance1.
Smernice navajajo, da pri odmerku, ki presega 250 mg/m2, obstaja zadostno tveganje za srce, da se priporoča dosmrtni nadzor1.
The infusion is given over two hours, three times daily.
Infuzija se daje dve uri, trikrat dnevno.
Treatment usually lasts between 5 and 14 days, depending on the type of infection.
Zdravljenje običajno traja od 5 do 14 dni, odvisno od vrste okužbe.
Doses may need to be reduced and/or given less often in patients with severely reduced kidney function.
Odmerke je morda treba zmanjšati in/ali jih dajati manj pogosto pri bolnikih z močno okvarjenim delovanjem ledvic.
The full EPAR for Zavicefta 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 Zavicefta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
One of the main measures of effectiveness was based on eliminating the disease-causing bacteria.
Eno glavnih meril učinkovitosti je temeljilo na izkoreninjenju bakterij, ki povzročajo bolezen.
What measures are being taken to ensure the safe and effective use of Zavicefta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zavicefta?
This is a summary of the European public assessment report (EPAR) for Zavicefta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zavicefta.
It works by interfering with the production of certain molecules that bacteria need to build their protective cell walls.
Deluje tako, da ovira tvorbo določenih molekul, ki jih bakterije potrebujejo za gradnjo svojih zaščitnih celičnih sten.
A study of Zavicefta in patients with hospital-acquired pneumonia has not yet been completed.
Študija zdravila Zavicefta pri bolnikih z bolnišnično pljučnico še ni dokončana.
Other information about Zavicefta
Druge informacije o zdravilu Zavicefta
The benefits of Zavicefta have been shown in four main studies.
Koristi zdravila Zavicefta so bile izkazane v štirih glavnih študijah.
What is Zavicefta and what is it used for?
Kaj je zdravilo Zavicefta in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zavicefta have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Zavicefta, so prav tako vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta'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 Zavicefta večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
• infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.
• okužb zaradi gramnegativnih bakterij (vrste bakterij), kadar druge oblike zdravljenja niso učinkovite.
Zavicefta is an antibiotic used in adults to treat the following infections:
Zdravilo Zavicefta je antibiotik, ki se uporablja pri odraslih za zdravljenje naslednjih okužb:
Due to the design of this study, this evidence of Zavicefta's benefits is not as strong as for the other studies; however these results support Zavicefta's activity when combined with the other studies.
Zaradi zasnove te študije ta dokaz koristi zdravila Zavicefta ni tako trden kot pri drugih študijah, vendar pa ti rezultati podpirajo učinkovitost zdravila Zavicefta v kombinaciji z drugimi študijami.
• infections of the lungs that are caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe);
• okužb dihal, pridobljenih v bolnišnici (bolnišnična pljučnica), vključno s pljučnico zaradi uporabe respiratorja (pljučnica, pridobljena zaradi respiratorja, tj. naprave, ki pomaga bolniku pri dihanju);
It is not intended to provide practical advice on how to use Zavicefta.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
For more information about treatment with Zavicefta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zavicefta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Zavicefta?
Kakšna tveganja so povezana z zdravilom Zavicefta?
However, the CHMP considered that the data already available supported Zavicefta's activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work.
Vendar pa je odbor CHMP menil, da razpoložljivi podatki podpirajo učinkovitost zdravila Zavicefta pri bolnišnični pljučnici in za zdravljenje okužb zaradi aerobnih gramnegativnih organizmov pri odraslih bolnikih, kadar druge oblike zdravljenja niso učinkovite.
In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection.
V dveh študijah so učinke kombinacije zdravila Zavicefta in metronidazola (drugega antibiotika) primerjali z učinki antibiotika meropenema pri 1 490 bolnikih z zapleteno intraabdominalno okužbo.
The company that makes Zavicefta is carrying out a study to compare the effectiveness and safety of Zavicefta with meropenem (another antibiotic) for the treatment of hospital-acquired pneumonia.
Družba, ki izdeluje zdravilo Zavicefta, izvaja študijo primerjave učinkovitosti in varnosti zdravila Zavicefta z meropenemom (drugim antibiotikom) pri zdravljenju bolnišnične pljučnice.
Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Zdravilo Zavicefta se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) zdravilni učinkovini zdravila Zavicefta ali katero koli sestavino zdravila, ter pri tistih, ki so preobčutljivi za druge cefalosporinske antibiotike ali ki so kdaj imeli hudo alergijsko reakcijo na drug betalaktamski antibiotik.
• complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
• zapletenih (težko ozdravljivih) okužb tkiv in organov v trebušnem predelu (intraabdominalnih okužb);
The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells).
Najpogostejši neželeni učinki zdravila Zavicefta (ki lahko prizadenejo več kot 5 oseb od 100) so navzeja (slabost), driska in pozitiven rezultat na Coombsovem testu (znak nastanka protiteles, ki napadejo rdeče krvničke).
Regarding Zavicefta's safety profile, side effects were those that can be expected for ceftazidime and a betalactamase inhibitor.
Kar zadeva varnostni profil zdravila Zavicefta, so neželeni učinki taki, kot jih je mogoče pričakovati pri ceftazidimu in zaviralcu betalaktamaze.
This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
S tem povzroči šibkost bakterijskih celičnih sten, ki zato pogosto propadejo, zaradi česar bakterije sčasoma odmrejo.
Why is Zavicefta approved?
Zakaj je bilo zdravilo Zavicefta odobreno?
What benefits of Zavicefta have been shown in studies?
Kakšne koristi je zdravilo Zavicefta izkazalo v študijah?
By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.
Avibaktam z zaviranjem delovanja teh encimov omogoča ceftazidimu, da učinkovito deluje proti bakterijam, ki bi sicer bile odporne.
A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime).
V tretji študiji so proučevali 332 bolnikov z zapletenimi intraabdominalnimi okužbami ali okužbami sečil zaradi gramnegativnih bakterij, ki so odporne proti ceftazidimu (ki jih ni bilo mogoče uničiti s ceftazidimom).
Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams'.
Ceftazidim je antibiotik, imenovan cefalosporin, ki spada v širšo skupino betalaktamov.
Zavicefta can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antibiotics.
Izdaja zdravila Zavicefta je le na recept, poleg tega morajo zdravniki, ki zdravilo predpisujejo, upoštevati uradne smernice za uporabo antibiotikov.
Both studies showed that Zavicefta in combination with metronidazole was at least as effective as meropenem at curing the infection.
Obe študiji sta pokazali, da je bilo zdravilo Zavicefta v kombinaciji z metronidazolom pri zdravljenju okužb vsaj tako učinkovito kot meropenem.
For practical information about using Zavicefta, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zavicefta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic's action.
Ti encimi bakterijam omogočajo, da razgrajujejo betalaktamske antibiotike, kot je ceftazidim, in posledično postanejo odporne proti njihovemu delovanju.
In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem.
V četrti študiji je bilo 1 020 bolnikov z zapletenimi okužbami sečil (vključno s pielonefritisom) zaradi gramnegativnih bakterij zdravljenih z zdravilom Zavicefta ali antibiotikom doripenemom.
Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein.
Zdravilo Zavicefta je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.
Zdravilo Zavicefta je bilo vsaj tako učinkovito kot doripenem: pri 77 % (304 od 393) bolnikov, zdravljenih z zdravilom Zavicefta, je bil opazen odziv v primerjavi z 71 % (296 od 417) bolnikov, zdravljenih z doripenemom.
Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic.
Pri samostojni uporabi zdravila Zavicefta (za zdravljenje okužb sečil) ali v kombinaciji z metronidazolom (za zdravljenje intraabdominalnih okužb) so bili rezultati podobni kot pri številnih nadomestnih antibiotikih, ki se uporabljajo za zdravljenje okužb: 91 % (140 od 154) bolnikov je bilo ozdravljenih po zdravljenju z zdravilom Zavicefta v primerjavi z 91 % (135 od 148) bolnikov, zdravljenih z najboljšim nadomestnim antibiotikom.
The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections.
Menil je, da študije zdravila Zavicefta kažejo, da je to zdravilo učinkovito pri zdravljenju zapletenih intraabdominalnih okužb in okužb sečil.
In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic.
Poleg tega so bile bakterije, ki povzročajo bolezen, izkoreninjene pri 82 % (126 od 154) bolnikov po zdravljenju z zdravilom Zavicefta v primerjavi s 63 % (94 od 148) bolnikov, zdravljenih z najboljšim nadomestnih antibiotikom.
For the full list of all side effects with Zavicefta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zavicefta, glejte navodilo za uporabo.
• complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
• zapletenih (težko ozdravljivih) okužb sečil (struktur za odvajanje urina), vključno s pielonefritisom
In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.
V drugi študiji je bilo ozdravljenih 94 % (166 od 177) bolnikov, ki so se zdravili z zdravilom Zavicefta in metronidazolom, v primerjavi s 94 % (173 od 184) bolnikov, ki so se zdravili z meropenemom.
How is Zavicefta used?
Kako se zdravilo Zavicefta uporablja?
Avibactam blocks the action of bacterial enzymes called beta-lactamases.
Avibaktam zavira delovanje bakterijskih encimov, imenovanih betalaktamaze.
In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem.
V prvi študiji je bilo v eni od skupin bolnikov ozdravljenih 92 % (376 od 410) bolnikov, ki so se zdravili z zdravilom Zavicefta in metronidazolom, v primerjavi s 93 % (385 od 416) bolnikov, ki so se zdravili z meropenemom.
The active substances in Zavicefta are ceftazidime and avibactam.
Zdravilni učinkovini v zdravilu Zavicefta sta ceftazidim in avibaktam.
How does Zavicefta work?
Kako zdravilo Zavicefta deluje?
Zavicefta contains the active substances ceftazidime and avibactam.
Zdravilo Zavicefta vsebuje zdravilni učinkovini ceftazidim in avibaktam.
International non-proprietary name (INN): abetimus
Mednarodno nelastniško ime (INN): abetimus
London, 18 October 2006 Doc.
London, 18. oktober 2006 Sklic dok.
The Company has no compassionate use programme.
Podjetje ne izvaja programa sočutne uporabe.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Dopis podjetja, v katerem obvešča agencijo EMEA o umiku svoje vloge, je na voljo tukaj.
A compassionate use programme is a programme through which doctors can request a medicine for a specific disease for one of their patients before the medicine is fully authorised.
Program sočutne uporabe je program, ki omogoča zdravnikom, da zaprosijo za zdravilo za določeno bolezen za katerega od svojih bolnikov, še preden je zdravilo v celoti odobreno.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Če sodelujete v kliničnem preizkušanju in potrebujete več informacij o svojem zdravljenju, se obrnite na zdravnika, ki vam je zdravilo predpisal.
Ref. EMEA/410799/2006
EMEA/435970/2006
The effects of Riquent were first tested in experimental models before being studied in humans.
Učinki zdravila Riquent so bili najprej raziskani v izkustvenih modelih, šele potem so bili preizkušeni na ljudeh.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for RIQUENT
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA IZDAJO DOVOLJENJA ZA PROMET za zdravilo RIQUENT
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Riquent?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih/programih sočutne uporabe zdravila Riquent?
Riquent is a solution for injection that contains 50 mg/ml of the active substance abetimus.
Zdravilo Riquent je raztopina za injiciranje, ki vsebuje 50 mg/ml zdravilne učinkovine abetimus.
Abetimus is a small piece of double-stranded DNA that has been designed to reduce circulating levels of these antibodies.
Abetimus je delček dvoverižne DNA, razvit za zmanjšanje stopnje cirkulacije teh protiteles.
The CHMP was evaluating the initial documentation provided by the Company and had not yet made any recommendations.
CHMP je takrat ocenjeval začetno dokumentacijo, ki jo je posredovalo podjetje, in še ni podal nikakršnih priporočil.
On 13 October 2006, La Jolla Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Riquent, for the treatment of lupus nephritis.
Podjetje La Jolla Limited je dne 13. oktobra 2006 obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za izdajo dovoljenja za promet z zdravilom Riquent, namenjenim za zdravljenje lupusnega nefritisa.
The company informed the CHMP that it plans to continue the ongoing clinical trials in the treatment of lupus nephritis.
Podjetje je CHMP obvestilo, da namerava nadaljevati s potekajočimi kliničnimi preizkušanji zdravljenja lupusnega nefritisa.
When Riquent is injected, the levels of these antibodies in the blood are lowered and this is expected to help reduce the patient's likelihood of experiencing a ‘flare'.
Če se vbrizga zdravilo Riquent, se raven teh protiteles v krvi zmanjša in to bi naj prispevalo k zmanjšanju verjetnosti, da bolnik doživi pojav širjenja obolenja.