natgillin/translations-raw huggingface dataset:
NeuroBloc (botulinum toxin type B) EMA/356522/2018
NeuroBloc (botulinski toksin vrste B) EMA/356522/2018
Other information about NeuroBloc
Druge informacije o zdravilu NeuroBloc
What measures are being taken to ensure the safe and effective use of NeuroBloc?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NeuroBloc?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NeuroBloc 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 NeuroBloc upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
NeuroBloc received a marketing authorisation valid throughout the EU on 22 January 2001.
Za zdravilo NeuroBloc je bilo 22. januarja 2001 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of NeuroBloc are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila NeuroBloc stalno spremljajo.
NeuroBloc was more effective than placebo (a dummy treatment) at improving symptoms of cervical dystonia in four studies involving a total of 392 adults.
Zdravilo NeuroBloc je bilo učinkovitejše od placeba (zdravila brez učinkovine) pri izboljševanju simptomov cervikalne distonije v štirih študijah, ki so vključevale skupaj 392 odraslih.
Side effects reported with NeuroBloc are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu NeuroBloc, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
NeuroBloc must not be used in patients with other neuromuscular (nerve and muscle) disorders.
Zdravilo NeuroBloc se ne sme uporabljati pri bolnikih z drugimi nevromuskularnimi boleznimi (boleznimi živcev in mišic).
For more information about using NeuroBloc, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila NeuroBloc glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Neurobloc have been shown in studies?
Kakšne koristi zdravila NeuroBloc so se pokazale v študijah?
Why is NeuroBloc authorised in the EU?
Zakaj je bilo zdravilo NeuroBloc odobreno v EU?
NeuroBloc is available as a solution for injection (5,000 units [U] per millilitre) and it can only be obtained with a prescription.
Zdravilo NeuroBloc je na voljo v obliki raztopine za injiciranje (5 000 enot [E] na mililiter), njegovo predpisovanje in izdaja pa je le na recept.
The toxin reduces the release of acetylcholine from the nerve endings.
Toksin zmanjša sproščanje acetilholina iz živčnih končičev.
When injected directly into a muscle it reduces the release of acetylcholine and muscle contraction in the affected neck or shoulder muscles, thereby relieving the patient's symptoms.
Če je injiciran neposredno v mišico, zmanjša sproščanje acetilholina in krčenje prizadetih mišic v vratu ali ramenih, kar pomaga ublažiti bolnikove simptome.
Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.
Cervikalna distonija, imenovana tudi tortikolis, je bolezen, pri kateri se mišice vratu krčijo, kar povzroča nenormalno premikanje in zvijanje vratu ter nenavaden položaj glave.
An overview of NeuroBloc and why it is authorised in the EU
Pregled zdravila NeuroBloc in zakaj je odobreno v EU
In NeuroBloc, the toxin is used as a muscle relaxant.
V zdravilu NeuroBloc je toksin uporabljen kot mišični relaksant.
NeuroBloc is a medicine used to treat cervical dystonia in adults.
NeuroBloc je zdravilo, ki se uporablja za zdravljenje cervikalne distonije pri odraslih.
The most common side effects with NeuroBloc (which may affect more than 1 in 10 people) are dry mouth, headache (in patients new to treatment with botulinum toxins), dysphagia (difficulty swallowing) and pain at the site of the injection.
Najpogostejši neželeni učinki zdravila NeuroBloc (opaženi pri več kot 1 od 10 bolnikov) so suha usta, glavobol (pri bolnikih, ki zdravljenje z botulinskimi toksini šele začenjajo), disfagija (težave s požiranjem) in bolečina na mestu injiciranja.
What is NeuroBloc and what is it used for?
Kaj je zdravilo NeuroBloc in za kaj se uporablja?
What are the risks associated with NeuroBloc?
Kakšna tveganja so povezana z zdravilom NeuroBloc?
The effect of an injection of NeuroBloc gradually wears off over time.
Učinek injekcije zdravila NeuroBloc sčasoma izzveni.
NeuroBloc treatment starts with 10,000 U, divided into equal doses and injected directly into the two to four muscles in the neck and shoulders that are most affected.
Začetni odmerek zdravila NeuroBloc je 10 000 enot in ga je treba razdeliti v enake odmerke, ki se vbrizgajo neposredno v dve do štiri najbolj prizadete mišice vratu in ramen.
The active substance in NeuroBloc, botulinum toxin type B, is a well-known toxic substance produced by the bacterium Clostridium botulinum.
Učinkovina v zdravilu NeuroBloc, botulinski toksin vrste B, je dobro znana strupena snov, ki jo tvori bakterija Clostridium botulinum.
Acetylcholine is needed to transfer electrical impulses from the nerves to the muscles in order for the muscles to contract.
Acetilholin je potreben za prenos električnih impulzov iz živcev v mišice, da se te krčijo.
NeuroBloc (botulinum toxin type B)
NeuroBloc (botulinski toksin vrste B)
The toxin is the cause of a type of food poisoning called botulism, where patients suffer from muscle weakness and paralysis.
Ta toksin povzroča botulizem, vrsto zastrupitve s hrano, pri kateri se pri bolnikih pojavita šibkost mišičja in paraliza.
For the full list of side effects reported with NeuroBloc, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NeuroBloc, glejte navodilo za uporabo.
It is only used in hospitals, by a doctor who has experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Zdravilo NeuroBloc lakko uporablja le v bolnišnici, daje pa ga lahko le zdravnik, ki ima izkušnje z zdravljenjem cervikalne distonije in uporabo botulinskih toksinov.
The medicine improved the TWSTRS score of the non-responders to type A botulinum toxin as well as the score of the responders.
Zdravilo je izboljšalo rezultate tako pri bolnikih, ki se niso odzvali na botulinski toksin vrste A, kot pri tistih, ki so se nanj odzvali.
How does NeuroBloc work?
Kako zdravilo NeuroBloc deluje?
Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
V tri študije so bili vključeni bolniki, ki so se prenehali odzivati na botulinski toksin vrste A (druga vrsta botulinskega toksina, ki se prav tako lahko uporablja za zdravljenje cervikalne distonije), v četrto študijo pa so bili vključeni le bolniki, ki so se odzivali na toksin vrste A. Učinkovitost so merili z opazovanjem sprememb simptomov (resnost, bolečina in nezmožnost) po štirih tednih, ki so jih zabeležili z uporabo lestvice za oceno spazmičnega tortikolisa Toronto Western (Toronto Western Spasmodic Torticollis Rating Scale - TWSTRS).
NeuroBloc contains the active substance botulinum toxin type B.
Zdravilo NeuroBloc vsebuje učinkovino botulinski toksin vrste B.
How is NeuroBloc used?
Kako se zdravilo NeuroBloc uporablja?
London, 26 April 2007 Doc.
London, 26. aprila 2007 Sklic dok.
‘Primary' means that there is no known reason for the insensitivity.
„Primarno“ pomeni, da za neobčutljivost ni znanih razlogov;
In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
V študiji je 27 otrok (starih od 3 do 15 let) prejemalo zdravilo IPLEX do največ enega leta.
International non-proprietary name (INN): mecasermin rinfabate
Mednarodno nelastniško ime (INN): mekasermin rinfabat
The main measure of effectiveness was based on the speed of growth during the study, compared to that in the year before the study began.
Glavno merilo učinkovitosti je temeljilo na primerjavi hitrosti rasti med študijo in hitrosti v letu pred začetkom študije.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Če ste vključeni v klinično preizkušanje ali program sočutne uporabe in potrebujete več podatkov o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
Patients had also not been treated for long enough to show that the medicine's effect continues when used for longer than one year.
Zdravljenje bolnikov poleg tega ni trajalo dovolj dolgo, da bi lahko dokazalo učinkovanje zdravila tudi pri uporabi, daljši od enega leta.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA DOVOLJENJE ZA PROMET za zdravilo IPLEX
Its effectiveness has been studied in one clinical trial, which is still ongoing.
Učinkovitost zdravila se preučuje v enem kliničnem preizkušanju, ki še vedno poteka.
Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Ko CHMP izda mnenje, potrebuje Evropska komisija še približno dva meseca, da izda dovoljenje.
Because the number of patients with these diseases is low, they are considered ‘rare', and mecasermin rinfabate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 June 2006.
Ker je število bolnikov s temi boleznimi majhno, bolezen velja za redko, zato je bil mekasermin rinfabat 20. junija 2006 opredeljen kot zdravilo sirota (zdravilo za redke bolezni).
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila IPLEX?
• they have primary insensitivity to the hormone, so that injected growth hormone has no effect.
• so primarno neobčutljivi na hormon, tako da vbrizgan hormon nima nikakršnih učinkov.
The effects of IPLEX were first tested in experimental models before being studied in humans.
Učinki zdravila IPLEX so bili najprej preizkušeni s pomočjo izkustvenih modelov, nato pa so jih raziskali pri ljudeh.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ko podjetje predloži odgovore na vprašanja, jih CHMP pregleda, pred izdajo mnenja pa lahko na 180. dan zaprosi podjetje še za odgovore na dodatna vprašanja.
In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
IGF-I v zdravilu IPLEX je vezano na IGFBP-3, ker se s tem posnema način, po katerem se IGF-1 prenaša po telesu.
IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because:
Zdravilo IPLEX naj bi se uporabljalo pri otrocih majhne postave, katerih telesa imajo težave z rastnim hormonom, ker:
Ref. EMEA/111199/2007
EMEA/231332/2007
Mecasermin rinfabate is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Mekasermin rinfabat se izdeluje z metodo, ki se imenuje „tehnologija rekombinantne DNA“: tvori ga celica, ki je prejela gen (DNA), zaradi katerega lahko tvori mekasermin rinfabat.
They also had major concerns regarding the way in which the medicine's effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Glavni zadržki CHMP so se nanašali tudi na način ocenjevanja učinkovitosti zdravila, zlasti glede tipov bolnikov, ki so jih vključili v klinično preizkušanje.
This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Zaradi tega lahko IGF-I po telesu kroži pri večji koncentraciji in dlje časa kakor nevezani IGF-I.
The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Podjetje je CHMP obvestilo, da umik vloge ne bo imel vpliva na potekajočo klinično študijo varnosti in učinkovitosti zdravila IPLEX pri zdravljenju sindroma neobčutljivosti na rastni hormon.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Zato je bil v času umika CHMP mnenja, da koristi zdravila IPLEX niso bile zadostno dokazane in niso večje od znanih tveganj.
IPLEX is a solution for injection containing 60 mg/ml mecasermin rinfabate as the active substance.
Zdravilo IPLEX je raztopina za injiciranje, ki kot zdravilno učinkovino vsebuje 60 mg/ml mekasermin rinfabata.
In the body, natural growth hormone promotes growth in children by stimulating the body to produce IGF-I. IGF-I then stimulates the bones to grow.
Naravni rastni hormon pospešuje telesno rast otrok, tako da telo spodbuja k tvorjenju IGF-I, ta pa nadalje spodbuja rast kosti.
• they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
• niso sposobni proizvajati rastnega hormona in so v preteklosti prejemali rastni hormon, a so proti njemu razvili protitelesa, posebne beljakovine, ki vbrizganemu hormonu preprečujejo, da bi imel kakršne koli učinke.
What is IPLEX?
Kaj je zdravilo IPLEX?
On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Dne 26. marca 2007 je podjetje Insmed Europe Ltd uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom IPLEX, ki je namenjeno zdravljenju bolnikov s primarno neobčutljivostjo na rastni hormon in bolnikov z delecijo gena rastnega hormona, ki so razvili protitelesa za nevtralizacijo rastnega hormona.
The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Mekasermin rinfabat, ki je zdravilna učinkovina zdravila IPLEX, je dvojna beljakovina, sestavljena iz dveh beljakovin, ki ju telo proizvaja v normalnih pogojih: insulinu podobnega rastnega faktorja (IGFI) in insulinu podobnega veznega proteina 3 (IGFBP-3).
Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Na podlagi pregleda podatkov, ki so bili na razpolago v času umika vloge, je imel CHMP nekaj zadržkov in je izdal začasno mnenje, da zdravila IPLEX ni mogoče odobriti za zdravljenje bolnikov s primarno neobčutljivostjo na rastni hormon in bolnikov z delecijo gena rastnega hormona, ki so razvili protitelesa za nevtralizacijo rastnega hormona.
The CHMP had major concerns regarding the way the medicine is manufactured, and they were unsure that the medicine that would have been marketed would have been comparable to the one used in the clinical trial.
Glavni zadržki CHMP so se nanašali na način proizvodnje zdravila, saj CHMP ni bil prepričan, da bo za tržišče proizvedeno zdravilo primerljivo tistemu, ki se uporablja v kliničnem preizkušanju.
IPLEX provides IGF-I directly, as part of the binary protein, and this allows bone growth while bypassing the need for growth hormone itself.
Zdravilo IPLEX telo oskrbuje neposredno z IGF-I, ki je del dvojne beljakovine, in s tem omogoča rast kosti brez potrebe po samem rastnem hormonu.
What was IPLEX expected to be used for?
Za kaj naj bi se zdravilo IPLEX uporabljalo?
How is IPLEX expected to work?
Kako naj bi zdravilo IPLEX delovalo?
The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Podjetje še ni odgovorilo na ta vprašanja.
The application was at day 120 when the company withdrew.
Podjetje je umaknilo vlogo na 120. dan. CHMP je pripravil seznam vprašanj, na katere naj bi podjetje odgovorilo.
The divergent positions are appended to this opinion.
Razhajajoča se stališča so priložena temu mnenju.
On 15 July 2011, Germany triggered a referral under Article 31 of Directive 2001/83/EC.
Nemčija je 15. julija 2011 sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES.
This effect is well demonstrated in several animal models.
Učinek je bil dokazan na različnih živalskih modelih.
Tolperisone-containing products are currently approved in the following EU countries: Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
Zdravila, ki vsebujejo tolperizon, so trenutno odobrena v naslednjih državah EU: v Bolgariji, na Cipru, v Češki republiki, Nemčiji, na Madžarskem, v Latviji, Litvi, na Poljskem, v Romuniji ter v Slovaški republiki.
The precise mechanism of action is not fully known.
Natančen mehanizem njegovega delovanja ni povsem znan.
Therefore, in accordance with Article 32(4)(d) of Directive 2001/83/EC, the CHMP recommended:
CHMP je torej v skladu s členom 32(4)(d) Direktive 2001/83/ES priporočil:
There are a few studies where a parenteral formulation was used.
Obstaja nekaj študij, v katerih je bila uporabljena parenteralna oblika.
The CHMP also consulted its Neurology Scientific Advisory Group (SAG).
CHMP se je posvetoval tudi s svojo znanstveno svetovalno skupino za nevrologijo (SAG).
It is well known that the safety profile of a product may vary depending on the formulation.
Splošno znano je, da je varnostni profil zdravila lahko različen glede na formulacijo.
In addition, all patients started by receiving doses above the approved dose.
Poleg tega so vsi bolniki na začetku prejemali odmerke, višje od odobrenih.
Tolperisone exerts its action at 3 levels:
Tolperizon deluje na 3 ravneh:
The following indications have been approved in at least one Member State (specific wording of the indication may vary from product to product):
Najmanj ena od držav članic je potrdila indikacije, naštete v nadaljevanju (besedilo indikacije se lahko od zdravila do zdravila razlikuje):
In contrast, the prematurely terminated Avigen study AV650-018 (2007) failed to demonstrate any effect in the multiple sclerosis population.
Po drugi strani predčasno zaključena študija AV650-018 podjetja Avigen (2007) ni pokazala nobenih učinkov pri populaciji bolnikov z multiplo sklerozo.
This indication is mainly supported by the Stamenova (2005) study, which is of acceptable quality.
Ta indikacija pretežno temelji na študiji, ki jo je izvedla Stamenova (2005), in je sicer sprejemljive kakovosti.
The CHMP was therefore requested to give its opinion on whether the marketing authorisations for medicinal products containing tolperisone, and associated names should be maintained, varied, suspended or withdrawn.
Zato je bil CHMP zaprošen za mnenje, ali naj se dovoljenja za promet z zdravili, ki vsebujejo tolperizon, in povezanimi imeni ohranijo, spremenijo, začasno umaknejo ali prekličejo.
The CHMP therefore carried out a new assessment of the available efficacy data in the concerned indication.
CHMP je torej opravil novo oceno razpoložljivih podatkov o učinkovitosti pri zadevni indikaciji.
The conditions affecting the marketing authorisations are set out in Annex IV.
Pogoji za dovoljenja za promet z zdravilom so določeni v Prilogi IV.
In particular, the CHMP re-assessed 4 pooled analyses (Alken-2005, Farkas-2011, Varga2011a and Varga-2011b) of randomised clinical trials (Pratzel 1995, Struck 2002 and Struck 2004) and requested the Biostatistics Working Party (BSWP) to give its view on the pooled analyses data.
Zlasti je znova ocenil štiri združene analize (Alken 2005, Farkas 2011, Varga 2011a in Varga 2011b) randomiziranih kliničnih preskušanj (Pratzel 1995, Struck 2002 in Struck 2004) ter zaprosil delovno skupino za biostatistiko (BSWP), naj poda svoje mnenje o podatkih združenih analiz.
Overall summary of the scientific evaluation of tolperisone-containing products (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo tolperizon (glejte Prilogo I)
It is therefore considered that efficacy in these indications has not been demonstrated.
Zato velja, da učinkovitost zdravila v zvezi s temi indikacijami ni dokazana.
The data available on this indication comes from two observational studies (1986 and 1989) with a total of 166 patients, where 450 mg tolperisone were given daily for a few weeks.
Podatke, na voljo v zvezi s to indikacijo, sta zagotovili dve opazovalni študiji (1986 in 1989), ki sta skupaj zajeli 166 bolnikov, ki so nekaj tednov dnevno prejemali 450 mg tolperizona.
Overall, the SAG considered that the analyses has not been performed appropriately and that the provided data did not allow an assessment of how the various population and treatment characteristics were taken into account for the analyses.
Na splošno je menila, da analize niso bile ustrezno izvedene in da na podlagi predloženih podatkov ni mogoče oceniti, kako so bile pri analizah upoštevane značilnosti različnih populacij in zdravljenja.
Tolperisone is a centrally acting muscle relaxant first synthesized in 1956, and used in clinical practice since the 1960's.
Tolperizon je mišični relaksant, ki deluje na osrednje živčevje in je bil prvič sintetiziran leta 1956, v klinični praksi pa so ga začeli uporabljati v 60. letih prejšnjega stoletja.
Annex II Scientific conclusions and grounds for Variation to the terms of the Marketing Authorisations (oral formulations) and Revocation of the Marketing Authorisations (parenteral formulations)
Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom (peroralne oblike) ter preklic dovoljenj za promet z zdravilom (parenteralne oblike)
Hypotheses include structural similarity to the local anaesthetic lidocaine, so the risk for cross-reactions needs to be consistently described in the product information.
Ena izmed hipotez je, da obstaja strukturna podobnost z lokalnim anestetikom lidokainom, zato mora biti tveganje za navzkrižne reakcije dosledno opisano v informacijah o zdravilu.
The interim analysis results indicated that it failed to achieve statistical significance in any evaluated efficacy endpoint.
Vmesni rezultati analiz so pokazali, da učinki niso dosegli statistične značilnosti v nobenem od zaključenih opazovanih dogodkov učinkovitosti.
It is also noted that the reporting rates in Germany appear to be significantly higher than those calculated through the MAH's database.
Ugotovljeno je bilo tudi, da je stopnja pogostosti poročanja v Nemčiji verjetno znatno višja, kot kažejo izračuni na podlagi podatkovne baze imetnika dovoljenja za promet z zdravilom.
It was noted that information in the Summary of Product Characteristics regarding interactions, effects on ability to drive and use machines and effect of food on pharmacokinetic parameters was not reflecting the latest available data.
Ugotovljeno je bilo, da informacije v povzetku glavnih značilnosti zdravila o medsebojnem delovanju zdravil, vplivu na sposobnost vožnje in upravljanje s stroji ter vplivu hrane na farmakokinetične parametre ne odražajo najnovejših razpoložljivih podatkov.