natgillin/translations-raw huggingface dataset:
Similar effects have been seen in patients on placebo.
Podobni učinki so bili opaženi pri bolnikih, ki so prejemali placebo.
This is a summary of the European public assessment report (EPAR) for Zinplava.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zinplava.
A new episode of diarrhoea was defined as 3 or more loose stools in 24 or fewer hours.
Nova epizoda driske je bila opredeljena kot tri- ali večkratna pojavitev redkega blata v 24 urah ali manj.
It is given as a single infusion lasting around 1 hour.
Zdravilo se daje enkrat dnevno v obliki enojne infuzije, ki traja približno eno uro.
What benefits of Zinplava have been shown in studies?
Kakšne koristi je zdravilo Zinplava izkazalo v študijah?
Bezlotoxumab is a monoclonal
Bezlotoksumab je monoklonsko
What is Zinplava and what is it used for?
Kaj je zdravilo Zinplava in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinplava have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zinplava upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It is not intended to provide practical advice on how to use Zinplava.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
antibody (a type of protein) that has been designed to attach to these toxins, blocking their action, thereby preventing further damage and diarrhoea from occurring.
protitelo (vrsta beljakovine), zasnovano tako, da se veže na te toksine in zavre njihovo delovanje, s tem pa prepreči nadaljnje poškodbe in drisko.
After an initial infection, some dormant forms of the bacteria (spores) may persist in the body and eventually produce further toxins, causing the symptoms to return.
Po začetni okužbi lahko v telesu ostanejo nekatere mirujoče oblike bakterije (spore), ki sčasoma spet proizvedejo toksine, zato se simptomi znova pojavijo.
Other information about Zinplava
Druge informacije o zdravilu Zinplava
The most common side effects with Zinplava (seen in more than 4 in 100 patients) are nausea (feeling sick), diarrhoea, fever and headache.
Najpogostejši neželeni učinki zdravila Zinplava (opaženi pri več kot 4 bolnikih od 100) so navzeja (slabost), driska, povišana telesna temperatura in glavobol.
For more information about treatment with Zinplava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zinplava preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The effect was mainly seen in patients at higher risk of C. difficile infection coming back (such as older patients or those with a weakened immune system).
Učinek je bil v glavnem opažen pri bolnikih z višjim tveganjem za ponovitev okužbe z bakterijo C. difficile (kot so starejši bolniki ali bolniki z oslabljenim imunskim sistemom).
What are the risks associated with Zinplava?
Kakšna tveganja so povezana z zdravilom Zinplava?
Why is Zinplava approved?
Zakaj je bilo zdravilo Zinplava odobreno?
Zinplava has been shown to be effective at preventing recurrence of C. difficile infection, particularly in patients at high risk of the infection coming back (which occurs in about 15 to 35% of cases and is particularly difficult to treat).
Dokazano je bilo, da je zdravilo Zinplava učinkovito pri preprečevanju ponovitve okužbe z bakterijo C. difficile, še posebej pri bolnikih z visokim tveganjem za ponovitev okužbe (do česar pride v približno 15-35 % primerov in kar se še posebej težko zdravi).
In the second study, figures were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo.
V drugi študiji je bilo v skupini, ki je prejemala zdravilo Zinplava, takih bolnikov 16 % (62 od 395), v skupini, ki je prejemala placebo, pa 26 % (97 od 378).
For practical information about using Zinplava, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zinplava naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Zinplava is a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea.
Zdravilo Zinplava se uporablja pri odraslih, pri katerih so prisotne okužbe zaradi bakterije, imenovane Clostridium difficile, ki povzroča hudo drisko.
In the first study, 17% of patients given Zinplava (67 out of 386) had a new episode of diarrhoea in the 12 weeks after treatment compared with 28% of patients given placebo (109 out of 395).
V prvi študiji je 17 % (67 od 386) bolnikov, zdravljenih z zdravilom Zinplava, v 12 tednih po zdravljenju doživelo novo epizodo driske, pri bolnikih, ki so prejemali placebo, pa je bilo takih bolnikov 28 % (109 od 395).
For the full list of all side effects and restrictions with Zinplava, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Zinplava glejte navodilo za uporabo.
Zinplava is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Zdravilo Zinplava je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
It is used to prevent future episodes of diarrhoea in patients who are taking antibiotics to treat their C. difficile infection and who are at high risk of the infection coming back.
Uporablja se za preprečevanje ponovnih epizod driske pri bolnikih, ki za zdravljenje okužbe z bakterijo C. difficile jemljejo antibiotike in pri katerih obstaja visoko tveganje ponovitve okužbe.
Zinplava is generally well tolerated with side effects similar to those observed in patients on placebo.
Bolniki v splošnem dobro prenašajo zdravilo Zinplava, katerega neželeni učinki so podobni tistim, opaženim pri bolnikih, ki so prejemali placebo.
C. difficile bacteria produce toxins that damage the lining of the gut causing diarrhoea which may be severe.
Bakterija C. difficile izdeluje toksine, ki lahko poškodujejo sluznico prebavil; to povzroča drisko, ki je lahko huda.
How does Zinplava work?
Kako zdravilo Zinplava deluje?
How is Zinplava used?
Kako se zdravilo Zinplava uporablja?
Zinplava given during antibiotic treatment was shown to be more effective than placebo (a dummy treatment) at preventing a new episode of diarrhoea caused by C. difficile infection in 2 main studies involving a total of 2,655 patients.
V dveh glavnih študijah, ki sta vključevali skupaj 2 655 bolnikov, je bilo dokazano, da je zdravilo Zinplava, dano med zdravljenjem z antibiotiki, pri preprečevanju nove epizode driske, ki jo povzroča okužba z bakterijo C. difficile, učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
Intrinsa has been authorised since July 2006.
Zdravilo Intrinsa je odobreno od julija 2006.
The full European Public Assessment Report for Intrinsa 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 Intrinsa je na voljo na spletni strani agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The application was withdrawn after ‘day 90'.
Družba je vlogo umaknila po „90.
The main measure of effectiveness was based on how frequently the women had ‘satisfying sexual episodes'.
Glavno merilo učinkovitosti je bila pogostnost „zadovoljivih spolnih odnosov“ pri ženskah.
This means that the CHMP had evaluated the documentation provided by the company and formulated two lists of questions.
To pomeni, da je CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval dva seznama vprašanj.
What is happening with Intrinsa for its existing indication?
Kaj se dogaja z zdravilom Intrinsa za obstoječe indikacije?
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“ (vsi dokumenti).
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice tega umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
These women will also be receiving treatment with an oestrogen (a female sex hormone).
Te ženske se zdravijo tudi z estrogenom (ženski spolni hormon).
The amount of testosterone in the blood is reduced after the menopause.
Količina testosterona v krvi se po menopavzi zniža.
The CHMP noted that there was insufficient long-term data on the safety of the medicine in this larger group of patients and was therefore of the opinion that the medicine's benefits in these women did not outweigh its risks.
CHMP je menil, da ni zadostnih podatkov o dolgoročni varnosti zdravila pri tej večji skupini bolnic, in izrazil mnenje, da koristi zdravila pri teh ženskah ne odtehtajo njegovih tveganj.
The company presented results of four studies in a total of 2,245 women with HSDD.
Družba je predstavila rezultate štirih študij, v katerih je sodelovalo 2 245 žensk z motnjo hipoaktivne spolne želje.
The active substance in Intrinsa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Zdravilna učinkovina v zdravilu Intrinsa, testosteron, je naravni spolni hormon, ki ga proizvajajo moški in v manjši meri tudi ženske.
The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Obliž v 24 urah sprosti 300 mikrogramov zdravilne učinkovine testosteron.
On 22 September 2010, Warner Chilcott Pharmaceuticals UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Intrinsa, to extend treatment to all postmenopausal women with hypoactive sexual desire disorder.
Družba Warner Chilcott Pharmaceuticals UK Limited je dne 22. septembra 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za spremembo dovoljenja za promet z zdravilom Intrinsa, namenjenim daljšemu zdravljenju žensk po menopavzi z motnjo hipoaktivne spolne želje.
The company informed the CHMP that there are no consequences for patients currently in clinical trials or compassionate use programmes with Intrinsa.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnice, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Intrinsa.
They were given either Intrinsa or placebo (a dummy treatment).
Dajali so jim zdravilo Intrinsa ali placebo (zdravilo brez zdravilne učinkovine).
Intrinsa is a transdermal patch (a patch that delivers a medicine across the skin).
Zdravilo Intrinsa je transdermalni obliž (obliž, ki dovaja zdravilo skozi kožo).
It is already used to treat women with hypoactive sexual desire disorder (HSDD, a lack of sexual thoughts and sexual desire) who have had their womb and both ovaries surgically removed.
Uporablja se za zdravljenje žensk z motnjo hipoaktivne spolne želje (HSDD, pomanjkanje spolnih misli in spolnega poželenja), ki so jim kirurško odstranili maternico in oba jajčnika.
Low testosterone levels have been linked to low sexual desire and to reduced sexual thoughts and arousal.
Nizke ravni testosterona so povezane z majhnim spolnim poželenjem ter
Based on the review of the data and the company's response to the CHMP's lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Intrinsa could not have been approved for use in all postmenopausal women who have HSDD.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je zastavil CHMP, je Odbor v času umika vloge izrazil določene zadržke in začasno menil, da zdravila Intrinsa ni mogoče odobriti za zdravljenje vseh žensk po menopavzi z motnjo hipoaktivne spolne želje.
In postmenopausal women, Intrinsa was expected to release testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before the menopause.
Pri ženskah po menopavzi naj bi zdravilo Intrinsa sproščalo testosteron skozi kožo v krni obtok in tako zagotavljalo takšno raven testosterona, kot je bila prisotna pred menopavzo.
What is Intrinsa?
Kaj je zdravilo Intrinsa?
This was to incude all women who have been through the menopause and not only those who are ‘surgically postmenopausal' as result of having had their womb or ovaries removed.
To naj bi vključevalo vse ženske po menopavzi in ne le tistih, ki so v menopavzi zaradi kirurške odstranitve maternice ali jajčnikov.
What was Intrinsa expected to be used for?
Za kaj naj bi se zdravilo Intrinsa uporabljalo?
Some of the women had their womb and both ovaries surgically removed while others were postmenopausal women who had not had their womb or ovaries removed.
Nekaterim sodelujočim ženskam so kirurško odstranili maternico in oba jajčnika, druge ženske pa so bile po menopavzi, vendar jim maternice ali jajčnikov niso odstranili.
How is Intrinsa expected to work?
Kako naj bi zdravilo Intrinsa delovalo?
Intrinsa is expected to work in the same way as it does in women who have had their womb and both ovaries surgically removed.
Zdravilo Intrinsa naj bi delovalo na enak način kot pri ženskah, pri katerih so kirurško odstranili maternico in oba jajčnika.
Intrinsa was expected to be used to treat HSDD in postmenopausal women with or without hormone treatment.
Zdravilo Intrinsa naj bi se uporabljalo za zdravljenje motnje hipoaktivne spolne želje pri ženskah po menopavzi, ki se ali se ne zdravijo s hormonsko terapijo.
There are no consequences on the use of Intrinsa in the treatment of HSDD in women who have had their womb and both ovaries removed.
Za zdravljenje žensk z motnjo hipoaktivne spolne želje, ki so jim odstranili maternico in oba jajčnika, glede uporabe zdravila Intrinsa ni posledic.
The company wanted the authorisation to be granted in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia and Spain (the concerned Member States).
Družba je želela, da se dovoljenje odobri v Avstriji, Belgiji, Bolgariji, Češki republiki, na Danskem, v Estoniji, Franciji, Nemčiji, Italiji, Latviji, Litvi, Luksemburgu, na Norveškem, Poljskem, Portugalskem, Slovaškem, v Sloveniji in Španiji (zadevne države članice).
1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
1 Člen 29 Direktive 2001/83/ES, kot je bila spremenjena, o napotitvi na podlagi možnega resnega tveganja za javno zdravje.
Ref. EMEA/CHMP/191900/2009 EMEA/H/A-29/1096
: EMEA/189590/2009 EMEA/H/A-29/1096
As a result the cells cannot multiply.
Celice se posledično ne morejo več deliti.
The CHMP assessed the available data in order to establish whether the two indications can be supported.
Odbor CHMP je ovrednotil razpoložljive podatke, da bi ugotovil, ali je mogoče zadevni indikaciji podpreti.
The review was carried out under an ‘Article 29' referral1 procedure.
Pregled se je opravil v okviru napotitvenega postopka v skladu s členom 291.
Germany considered that the submitted data was insufficient for granting a marketing authorisation for the proposed indications.
Nemčija je menila, da predloženi podatki niso bili zadostni za odobritev dovoljenja za promet z zdravilom za predlagane indikacije.
Why was Bleomycin reviewed?
Zakaj je bilo zdravilo Bleomycin pregledano?
On 3 November 2008, the Netherlands medicines regulatory agency, the Medicines Evaluation Board, referred the matter to the CHMP.
Nizozemska regulatorna agencija za zdravila, Odbor za vrednotenje zdravil, je 3. novembra 2008 zadevo napotila na CHMP.
The RMS and the other positive CMSs were in favour of retaining these indications.
Referenčna država članica in druge pozitivne zadevne države članice so naklonjene ohranitvi teh indikacij.
The grounds for the referral were that Germany was not in a position to accept some of the anti-cancer indications because they were not recognised as acceptable for bleomycin in the country.
Razlogi za napotitev so bili, ker Nemčija ni mogla sprejeti nekaterih indikacij proti raku, saj jih ne priznava kot sprejemljive za bleomicin.
What is Bleomycin?
Kaj je zdravilo Bleomycin?
Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/Vial, from Pharmachemie BV
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Bleomycin, prašek za raztopino za injiciranje, 15 e/vialo, družbe Pharmachemie BV
Bleomycin is an anti-cancer medicine used to treat certain forms of cancer of the head or the neck, cervix (the neck of the womb) and external sexual organs; certain forms of lymphoma (cancer of the lymphatic system) such as Hodgkin's disease; and to treat cancer of the testicles.
Bleomycin je zdravilo proti raku, ki se uporablja za zdravljenje določenih oblik raka glave ali vratu, cerviksa (materničnega vratu) in zunanjih spolovil, nekaterih oblik limfoma (raka limfnega sistema), kot je Hodgkinova bolezen, ter raka testisov.
The indications ‘head and neck carcinoma' and ‘epidermoid carcinoma of external genitalia such as penile carcinoma, or cervix' had been deleted from the authorised indications for all bleomycin-containing products in Germany because the balance of benefit/risk for bleomycin in these indications was considered negative.
Indikaciji „karcinom glave in vratu“ ter „epidermoidni karcinom zunanjih spolovil, kot je karcinom penisa ali cerviksa“, sta bili v Nemčiji izbrisani iz odobrenih indikacij za vsa zdravila, ki vsebujejo bleomicin, ker se je menilo, da je razmerje med koristmi in tveganji za bleomicin pri teh indikacijah negativno.
Bleomycin is almost always used in combination with anti-cancer drugs or in combination with radiation.
Zdravilo Bleomycin se skoraj vedno uporablja v kombinaciji z zdravili proti raku ali z obsevanjem.
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Bleomycin injection, from Pharmachemie BV.
Evropska agencija za zdravila (EMEA) je končala napotitveni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Bleomycin, injekcija, družbe Pharmachemie BV.
Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
Družba Pharmachemie BV je vlogo za pridobitev dovoljenja za promet z zdravilom Bleomycin, prašek za raztopino za injiciranje, 15 e/vialo, predložila po decentraliziranem postopku dne 10. julija 2007, pri tem pa je Nizozemska prevzela vlogo referenčne države članice.
Based on evaluation of the currently available data, including published literature and current treatment guidelines, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and therefore the marketing authorisation for Bleomycin should be granted in all concerned member states.
Na podlagi vrednotenja trenutno razpoložljivih podatkov, vključno z objavljeno literaturo in trenutno veljavnimi smernicami za zdravljenje, ter znanstvene razprave znotraj CHMP je ta zaključil, da koristi zdravila Bleomycin, injekcija, družbe Pharmachemie BV odtehtajo njegova tveganja ter da je zato treba dovoljenje za promet z zdravilom Bleomycin odobriti v vseh zadevnih državah članicah.
Bleomycin can also be used by injection directly inside the chest cavity to treat fluid accumulation in the lungs as a result of cancer.
Zdravilo Bleomycin se lahko injicira neposredno v prsno votlino za zdravljenje pojava tekočine, ki se v pljučih nabira kot posledica raka.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and the marketing authorisation can be granted in the Member States of the European Union and the European Economic Area.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMEA je zaključil, da koristi zdravila Bleomycin, injekcija, družbe Pharmachemie BV odtehtajo njegova tveganja in da se dovoljenje za promet z zdravilom lahko odobri v državah članicah Evropske unije in Evropskega gospodarskega prostora.
Referral start date:
Datum začetka postopka napotitve: 20. november 2008 Datum izdaje mnenja:
Bleomycin inserts itself within the strands of DNA, the genetic material of cells, making the strands break.
Zdravilo Bleomycin se vrine v verige DNK, tj. genetsko gradivo celice, ki se začne zaradi zdravila trgati.
Because consensus could not be reached, the procedure was
Postopek je bil napoten na odbor CHMP, ker ni bilo mogoče doseči soglasja.
Bleomycin is a cytostatic substance; this means that it stops the growth of cells.
Zdravilo Bleomycin je citostatična spojina.
40 IU/ml Solution for injection
raztopina za injiciranje raztopina za injiciranje
EMEA/436209/2008
EMEA/436209/2008-SL
• The benefit/risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age.
• Razmerje med koristmi in tveganji se je pokazalo kot pozitivno, kljub temu pa je v povzetku glavnih značilnosti zdravila za uporabo pri mladih živalih potrebno navesti, da zdravilo ni namenjeno uporabi pri komaj skotenih ali zelo mladih teletih, starih manj kot dva tedna, ter pri pujskih, starih manj kot štiri tedne.
The CVMP Opinion was adopted on 16 July 2008 and the subsequent Commission Decision adopted on 26 September 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto 16.07.2008 odločba Komisije pa 26.09.2008.
OPINION FOLLOWING AN ARTICLE 35 REFERRAL FOR SODIUM SALICYLATE
ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 35 ZA ZDRAVILO NATRIJEV SALICILAT
--1Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
--1 živ oslabljen bovini respiratorni sincicijski virus (BRSV), sev Lym-56 104,7-6,5 CCID50* * 50-% infektivni odmerek v celični kulturi
Immediate packaging
Način uporabe Pakiranje za takojšnjo uporabo
Package size Withdraw al period
Velikost pakiranja
Intravenous use vial (glass)
4,5 mg/ml koncentrat za raztopino za infundiranje intravenska uporaba viala (steklena)
(Invented) name Strength Pharmaceutical Form Route of Administration
Številka EU (Izmišljeno) ime Jakost
hours before taking the other.
3 ure, preden vzamete drugo.
Date of first authorisation: 16 September 1998 Date of latest renewal: 3 September 2008
Datum prve odobritve: 16. september 1998 Datum zadnjega podaljšanja: 3. september 2008
After taking one of them, wait at least 2 to 3
Po zaužitju enega od teh zdravil počakajte vsaj 2 do
Comtess and iron supplements at the same time.
Comtess in dodatkov železa istočasno.
• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).
• prenajedanje (uživanje velikih količin hrane v kratkem času) ali kompulzivno prenajedanje (uživanje večjih količin hrane kot običajno oziroma več, kot je potrebno za potešitev lakote).
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive;
• spremenjeno ali povečano zanimanje za spolnost in zaskrbljujoče spolno vedenje, na primer povečano spolno slo;