natgillin/translations-raw huggingface dataset:
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 kakor je bila spremenjena, napotitev na podlagi potencialnega resnega tveganja za javno zdravje.
Dr Michal Pirożynski (Poland)
dr. Michal Pirożynski (Poljska)
The review was carried out under an ‘Article 29' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom iz „člena 29“.
The grounds for the referral were a disagreement among Member States on the use of the medicine in adolescents and children (over 6 years of age).
Razlog za napotitev je bilo nesoglasje med državami članicami glede uporabe zdravila pri mladostnikih in otrocih (starejših od 6 let).
19 February 2009
19. februar 2009
Dr Barbara Van Zwieten-Boot (the Netherlands)
dr. Barbara Van Zwieten-Boot (Nizozemska)
The German authorities recommended that the medicine should not be authorised for use in children, as no studies had been carried out in this age group.
Nemški pristojni organ je priporočil, da se uporaba zdravila pri otrocih ne odobri, ker za to starostno skupino niso bile izvedene nobene študije.
Questions and answers on the referral for Budesonide Sandoz nasal suspension with 32 or 64 microgram per spray
Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Budesonide Sandoz nosna suspenzija z 32 ali 64 mikrogrami na vpih
However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 4 August 2008.
Ker pa omenjene države članice niso dosegle soglasja, je nemški regulatorni organ dne 4. avgusta 2008 zadevo napotil na CHMP v arbitražo.
The CHMP also recommended that the product information for the medicine in Germany be amended.
CHMP je priporočil tudi, da se informacije o tem zdravilu v Nemčiji dopolnijo.
This is a procedure when one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom).
To je postopek, pri katerem ena država članica („referenčna država članica“, v tem primeru Nemčija) oceni zdravilo glede tega, ali se zanj lahko odobri dovoljenje za promet, ki bo veljavno v tej državi in drugih državah članicah („zadevnih državah članicah“, v tem primeru v Češki republiki, na Danskem, v Franciji, na Nizozemskem, Norveškem, Švedskem in v Združenem kraljestvu).
The active substance, budesonide, is a corticosteroid, which is a type of substance that helps to reduce inflammation.
Zdravilna učinkovina budesonid je kortikosteroid, tj. vrsta snovi, ki pomaga ublažiti vnetje.
It is used to treat and prevent the symptoms of seasonal allergic rhinitis (allergy to pollen, also known as hayfever) and perennial allergic rhinitis (when the allergy is due to other triggers, such as house dust or animals).
Uporablja se za zdravljenje in preprečevanje simptomov sezonskega alergijskega rinitisa (alergije na cvetni prah, poznane tudi pod imenom seneni nahod) in celoletnega alergijskega rinitisa (pri katerem alergijo sprožijo drugi dejavniki, kot so denimo hišni prah ali živali).
It can also be used to treat nasal polyps (growths in the lining of the nose).
Lahko se uporablja tudi za zdravljenje nosnih polipov (izrastkov v nosni sluznici).
Based on evaluation of the currently available data, including the studies carried out to compare the way Budesonide Sandoz is handled by the body to that of Rhinocort, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Budesonide Sandoz outweigh its risks, and that therefore the marketing authorisation for Budesonide Sandoz should be granted in all concerned Member States for patients aged from 6 years.
Na podlagi ocene trenutno razpoložljivih podatkov, vključno s študijami, ki so primerjale zdravilo Budesonide Sandoz in zdravilo Rhinocort glede tega, kako ju telo presnavlja, in znanstvene razprave v Odboru, je CHMP zaključil, da koristi zdravila Budesonide Sandoz odtehtajo z njim povezana tveganja in da se zato dovoljenje za promet za uporabo zdravila Budesonide Sandoz pri bolnikih, starejših od 6 let, lahko odobri v vseh zadevnih državah članicah.
However, another Member State, the Netherlands, recommended that the medicine should also be authorised for use in children, as the medicine on which it is based, Rhinocort, can be used in this population.
Druga država članica, Nizozemska, pa je priporočila, da se uporaba zdravila pri otrocih odobri, saj se zdravilo Rhinocort, na katerem temelji zdravilo Budesonide Sandoz, lahko uporablja v tej populaciji.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Budesonide Sandoz outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the European Union, the Czech Republic, Denmark, France, the Netherlands, Norway, Sweden and the United Kingdom.
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da koristi zdravila Budesonide Sandoz odtehtajo z njim povezana tveganja in da se dovoljenje za promet z zdravilom lahko odobri v Nemčiji in naslednjih državah članicah Evropske unije: Češki republiki, na Danskem, v Franciji, na Nizozemskem, Norveškem, Švedskem in v Združenem kraljestvu.
Sandoz Pharmaceuticals GmbH submitted Budesonide Sandoz to the German medicines regulatory agency for a decentralised procedure.
Družba Sandoz Pharmaceuticals GmbH je predložila zdravilo Budesonide Sandoz nemškemu regulatornemu organu za zdravila v presojo po decentraliziranem postopku.
Budesonide Sandoz is almost identical to another medicine authorised in the European Union, Rhinocort.
Zdravilo Budesonide Sandoz je skoraj popolnoma enako drugemu zdravilu, ki je že odobreno v Evropski uniji, in sicer zdravilu Rhinocort.
London, 3 June 2009
London, 3. junija 2009 Sklic dok.
Referral start date:
Datum izdaje mnenja:
Why was Budesonide Sandoz reviewed?
Zakaj je bilo zdravilo Budesonide Sandoz pregledano?
The only difference is that it contains very small amounts of ascorbic acid (an antioxidant).
Edina razlika med njima je, da zdravilo Budesonide Sandoz vsebuje majhne količine askorbinske kisline (antioksidant).
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Budesonide Sandoz.
Evropska agencija za zdravila (EMEA) je po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Budesonide Sandoz zaključila arbitražni postopek.
What is Budesonide Sandoz?
Kaj je zdravilo Budesonide Sandoz?
Co-Rapporteur:
Soporočevaec:
Budesonide Sandoz is an anti-inflammatory medicine.
Zdravilo Budesonide Sandoz je protivnetno zdravilo.
Company responses provided on: 24 December 2008 Opinion date:
Odgovori družbe poslani dne:
This summary was last updated in 06-2011.
Povzetek je bil nazadnje posodobljen 06-2011.
The European Commission granted a marketing authorisation valid throughout the European Union for Kentera on 15 June 2004.
Evropska komisija je dovoljenje za promet z zdravilom Kentera, veljavno po vsej Evropski uniji, odobrila dne 15. junija 2004.
The full EPAR for Kentera 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 Kentera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For the transdermal patches, one patch is used twice a week (every three to four days).
Pri transdermalnih obližih se uporabi en obliž dvakrat na teden (na vsake tri do štiri dni).
It blocks some receptors in the body called muscarinic M1 and M3 receptors.
Zavira nekatere receptorje v telesu, imenovane muskarinski receptorji M1 in M3.
Kentera was more effective than placebo.
Zdravilo Kentera je bilo učinkovitejše od placeba.
This helps Kentera to prevent unwanted urination.
Na ta način zdravilo Kentera pomaga preprečiti neželeno uhajanje urina.
EPAR summary for the public oxybutynin
Povzetek EPAR za javnost oksibutinin
The main measure of effectiveness was the number of incontinence episodes over either three or seven days.
Glavno merilo učinkovitosti je bilo število inkontinenčnih epizod v obdobju treh ali sedmih dni.
This is a summary of the European public assessment report (EPAR) for Kentera.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kentera.
Oxybutynin has been available as a tablet for the treatment of overactive bladder since the 1970s.
Oksibutinin je kot tableta za zdravljenje čezmerno aktivnega sečnega mehurja na voljo od sedemdesetih let 20. stoletja.
For more information about treatment with Kentera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Kenetra preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
The main measure of effectiveness was the change in the number of daily incontinence episodes after 12 weeks of treatment.
Glavno merilo učinkovitosti je bila sprememba števila dnevnih inkotinenčnih epizod po 12 tednih zdravljenja.
What benefit has Kentera shown during the studies?
Kakšne koristi je zdravilo Kentera izkazalo med študijami?
Kentera patches were as effective as tolterodine, with both treatments decreasing the number of episodes by about three per day.
Obliži Kentera so bili tako učinkoviti kot tolterodin, pri obeh zdravljenjih se je število epizod zmanjšalo za približno tri na dan.
For the gel, the recommended daily dose is 4 mg of oxybutynin once a day, which corresponds to one gram of gel delivered using a metering pump or to the content of one sachet.
Priporočeni dnevni odmerek gela je 4 mg oksibutinina enkrat dnevno, kar ustreza enemu gramu gela, ki se odmeri s pomočjo črpalke za odmerjanje, ali vsebini ene vrečke.
In the other, they were compared with tolterodine capsules (another medicine used to treat urge incontinence) in 361 patients.
V drugi študiji so zdravilo primerjali s kapsulami tolterodina (drugim zdravilom za zdravljenje urgentne incontinence) pri 361 bolnikih.
Other information about Kentera
Druge informacije o zdravilu Kentera:
The Committee therefore decided that the benefits of Kentera gel also outweighed its risks and recommended the approval of the new formulation.
Zato je CHMP odločil, da so tudi koristi gela Kentera večje od z njim povezanih tveganj in priporočil odobritev nove formulacije.
Kentera should not be used in people who may be hypersensitive (allergic) to oxybutynin or any of the other ingredients.
Zdravila Kentera ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) oksibutinin ali katero koli drugo sestavino zdravila.
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 Kentera.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Kentera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
A new application site should be chosen for each new patch so that the same area of skin is not used more than once within a week.
Za vsak nov obliž je treba izbrati novo mesto nanosa, tako da ga ne namestimo na isti predel kože več kot enkrat tedensko.
The most commonly reported side effect with Kentera gel is dry mouth (seen in between 1 and 10 patients in 100).
Najpogostejši neželeni učinek zdravila Kentera so suha usta (opažen pri 1 do 10 bolnikov od 100).
The Committee recommended that the Kentera patch be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Kentera odobri dovoljenje za promet.
Kentera gel was compared with placebo in one main study in 789 patients with overactive bladders.
Gel Kentera so primerjali s placebom v eni glavni študiji s 789 bolniki s čezmerno aktivnim mehurjem.
In the study on the gel, after 12 weeks the average number of daily incontinence episodes, which was initially at 5.4, was reduced by 2.7 episodes per day in patients receiving Kentera gel compared with a drop on average of 2 episodes per day in patients receiving placebo.
V študiji gela se je povprečno število dnevnih inkontinenčnih epizod po 12 tednih zmanjšalo s prvotnih 5,4 za 2,7 epizod na dan pri bolnikih, ki so prejemali gel Kentera, v primerjavi z zmanjšanjem za povprečno 2 epizodi na dan pri bolnikih, ki so prejemali placebo.
The active substance in Kentera, oxybutynin, is an anticholinergic medicine.
Zdravilna učinkovina zdravila Kentera, oksibutinin, je antiholinergično zdravilo.
What is the risk associated with Kentera?
Kakšna tveganja so povezana z zdravilom Kentera?
Kentera is used to treat urge incontinence (sudden lack of control over urination), increased urinary frequency (need to urinate frequently) and urgency (sudden urge to pass urine) in adults with an overactive bladder (when the bladder muscles contract suddenly).
Zdravilo Kentera se uporablja za zdravljenje urgentne inkontinence (nenadne izgube nadzora nad uriniranjem), povečane pogostosti mokrenja (potrebe po pogostem uriniranju) in urgence (nenadne močne nuje po mokrenju) pri odraslih s čezmerno aktivnim sečnim mehurjem (za katerega je značilno nenadno krčenje mišic sečnega mehurja).
It must not be used in patients with urinary retention (difficulty in passing urine), severe gastro-intestinal conditions (problems with the stomach and gut), uncontrolled narrow-angle glaucoma (increased eye pressure even with treatment) or myasthenia gravis (a disease of the nerves and muscles causing muscle weakness), or in patients at risk of these conditions.
Ne sme se uporabljati pri bolnikih z zastajanjem urina (težavami pri odvajanju urina), z resnimi želodčno-črevesnimi motnjami (težave s prebavili), neobvladanim glavkomom z zaprtim zakotjem (povišanim tlakom v očesu kljub zdravljenju), miastenijo gravis (boleznijo živčevja, ki povzroča šibkost mišic), ali pri bolnikih, pri katerih obstaja tveganje za te bolezni.
Kentera transdermal patches were studied in a total of 881 patients, mostly elderly women, with overactive bladders in two main studies.
Učinki transdermalnih obližev Kentera so bili raziskani v dveh glavnih študijah pri skupno 881 bolnikih, večinoma starejših ženskah s čezmerno aktivnim sečnim mehurjem.
After 12 weeks, the average number of incontinence episodes per week had decreased by 19 (about three per day) with Kentera patches, compared with a decrease of 15 episodes with placebo.
Po 12 tednih se je povprečno število inkontinenčnih epizod na teden ob uporabi obližev Kentera zmanjšalo za 19 (ali za približno 3 na dan), v primerjavi z zmanjšanjem za 15 epizod pri nanosu placeba.
It is available as a transdermal patch (a patch that delivers a medicine across the skin) and as a gel in a sachet or a metering pump.
Na voljo je v obliki transdermalnega obliža (obliža, ki dovaja zdravilo skozi kožo) in gela v vrečki ali gela za črpalko za odmerjanje.
Kentera is a medicine that contains the active substance oxybutynin.
Kentera je zdravilo, ki vsebuje zdravilno učinkovino oksibutinin.
The gel is applied to dry, intact skin on the abdomen, upper arm, shoulders or thighs.
nepoškodovano kožo trebuha, nadlakti, rame ali stegna.
In the bladder, this causes the muscles that push urine out of the bladder to relax.
Ta povzroča, da se mišice, ki iztiskajo urin iz sečnega mehurja, sprostijo.
The CHMP had first evaluated Kentera transdermal patches and concluded that their effectiveness was similar to that of the oxybutynin tablets already on the market and that the benefits outweighed the risks.
Odbor za zdravila za uporabo v humani medicini (CHMP) je najprej ocenil transdermalne obliže Kentera in sklenil, da je njihova učinkovitost primerljiva s tabletami oksibutinina, ki so že v prometu, in da koristi zdravila odtehtajo z njim povezana tveganja.
During its assessment of the application for Kentera gel, the CHMP concluded that its effectiveness was similar to that of the previously approved patches.
Med oceno nanosa gela Kentera je CHMP sklenil, da je njegova učinkovitost podobna učinkovitosti obližev, ki so bili že odobreni.
For the full list of all side effects reported with Kentera, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kentera, glejte navodilo za uporabo.
Why has Kentera been approved?
Zakaj je bilo zdravilo Kentera odobreno?
The most common side effects with Kentera patches (seen in more than 1 patient in 10) are application site reactions (including itching around the site of patch application).
Najpogostejši neželeni učinki obližev Kentera (opaženi pri več kot 1 od 10 bolnikov) so reakcije na mestu nanosa (vključno s srbenjem okrog mesta nanosa obliža).
In one study, they were compared with placebo (a dummy treatment) in 520 patients.
V prvi študiji so učinke zdravila primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 520 bolnikih.
This leads to an increase in the amount of urine that the bladder can hold, and to changes in the way the bladder muscles contract as the bladder fills up.
Zaradi tega se poveča zmogljivost sečnega mehurja in spremeni način krčenja mišic sečnega mehurja med njegovim polnjenjem.
What is Kentera used for?
Za kaj se zdravilo Kentera uporablja?
The patch should be applied to dry, intact skin on the abdomen (tummy), hip, or buttock immediately after it is removed from the protective sachet.
Obliž se namesti na suho, nepoškodovano kožo trebuha, boka ali zadnjice takoj, ko ga vzamemo iz ovojne vrečke.
Different application sites should be chosen, so that the same area of skin is not used on consecutive days.
Mesto nanosa je treba dnevno spreminjati, tako da se gel ne nanaša zaporedoma na isti predel kože.
How has Kentera been studied?
Kako je bilo zdravilo Kentera raziskano?
How is Kentera used?
Kako se zdravilo Kentera uporablja?
What is Kentera?
Kaj je zdravilo Kentera?
How does Kentera work?
Kako zdravilo Kentera deluje?
All active substances are authorised at the level of the Member States.
Vse zdravilne učinkovine so odobrene na ravni držav članic.
- Restriction of the maximum dose to 3 mg/day.
- Omejitev največjega odmerka na 3 mg/dan.
This has been subject to previous reviews leading to risk minimisation measures at national level.
To je bil predmet starejših pregledov, ki so privedli do ukrepov za zmanjšanje tveganja na državni ravni.
- The conditions of the marketing authorisations are set out in Annex IV.
- Pogoji dovoljenj za promet z zdravili so navedeni v Dodatku IV.
The stimulation of the 5-HT2B receptor agonists is considered the most plausible mechanism that induces cardiac valvulopathy, although other mechanisms may be involved.
Stimulacija agonistov receptorja 5-HT2B se smatra za najbolj verjeten mehanizem, ki sproži srčno valvulopatijo, čeprav so morda vpleteni tudi drugi mehanizmi.
The majority of reported fibrotic events were not completely reversible although symptomatic improvement occurs for various reasons and indeed occasionally fibrosis may regress.
Pri večini fibroznih dogodkov, o katerih se je poročalo, le-teh ni bilo mogoče popolnoma pozdraviti, čeprav je zaradi različnih razlogov prišlo do simptomatskih izboljšav, občasno celo do regresije fibroze.
- Strengthening of the contra-indications, warnings and precautions for use, outlining the necessity for patients to be monitored for signs of fibrosis with echocardiography before and during long-term treatment.
- Okrepitev kontraindikacij, opozoril in previdnostnih ukrepov pri uporabi, z opisom potrebe po opazovanju bolnikov glede prisotnosti znakov fibroze z ehokardiografijo pred in med dolgotrajnim zdravljenjem.
The mechanism of fibrotic reaction induced by ergot alkaloids has not been completely clarified yet.
Mehanizmi fibroznih reakcij, ki jih sprožijo alkaloidi rženega rožička, še niso povsem pojasnjeni.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CABERGOLINE AND PERGOLIDE AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA KABERGOLINA IN PERGOLIDA TER Z NJIMA POVEZANIH IMEN (GLEJTE DODATEK I)
Whether this mechanism also applies to the non-cardiac fibrotic events is unclear.
Ni jasno, ali ta mehanizem velja tudi za dogodke fibroze, ki niso povezani s srcem.
However, most trials did not include echocardiographic monitoring, thus preventing a reliable estimation of incidence rates.
Vendar pa pri večini preskušanj niso uporabili ehokardiografskega opazovanja, kar onemogoča zanesljivo oceno deležev pojavnosti.
Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
V štirih glavnih opazovalnih študijah so opazovali tveganje pojava srčne valvulopatije pri bolnikih, ki so jih zaradi Parkinsonove bolezni zdravili z agonisti dopamina (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
- In view of the available data, the Committee concluded that the risk of fibrosis, including cardiac valvulopathy, is well established for cabergoline and pergolide, and is higher at doses exceeding 3mg/day.
- Glede na razpoložljive podatke je Odbor odločil, da je tveganje fibroze, vključno s srčno valvulopatijo, dobro ugotovljeno za kabergolin in pergolid ter da je večje pri odmerkih, večjih od 3 mg/dan.
On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Dne 21. junija 2007 je Združeno kraljestvo skladno z 31. členom Direktive 2001/83/ES, kakor je bila spremenjena, zaprosilo CHMP, naj opravi pregled tveganja fibroze in srčne valvulopatije, povezanih z uporabo vseh iz rženega rožička pridobljenih agonistov dopamina, ter poda mnenje o tem, ali naj ostanejo dovoljenja za promet z vsemi zdravili te skupine še dalje veljavna, oziroma se spremenijo, začasno ukinejo ali umaknejo.
They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Uporabljajo se tudi za zdravljenje stanj, med katerimi sta hiperprolaktinemija in prolaktinom, ter preprečevanje laktacije in migrene.
- The CHMP considered the referral made under Article 31 of Directive 2001/83/EC, as amended, for medicinal products containing bromocriptine, cabergoline dihydroergocryptine, lisuride and pergolide,
- CHMP je obravnaval napotitev, ki je bila sprožena v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, za zdravila, ki vsebujejo bromokriptin, kabergolin, dihidroergokriptin, lizurid in pergolid.
The CHMP also recommended that marketing authorisation holders provide a detailed protocol (e.g. drug utilisation studies or survey done by record linkage) for the long term follow-up on the adherence to and effectiveness of the changes to the product information.
CHMP je prav tako priporočil, da imetniki dovoljenj za promet z zdravilom priskrbijo podroben protokol (npr. študije uporabe zdravila ali oceno na podlagi povezovanja zapiskov) za dolgotrajno sledenje upoštevanja in učinkovitosti dopolnjenih informacij o zdravilu.
Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Iz rženega rožička pridobljeni agonisti dopamina se v glavnem uporabljajo za zdravljenje Parkinsonove bolezni bodisi kot samostojna zdravila ali v kombinaciji z drugimi zdravili.