natgillin/translations-raw huggingface dataset:
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summary of Product Characteristics in the Annex III.
Seznam zadevnih imen proizvodov je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II,
A Marketing Authorisation for Rigevidon was granted to Medimpex France SA by Denmark on 10
Danska je 10. marca 2003 družbi Medimpex France SA za Rigevidon podelila dovoljenje za promet z zdravilom.
International Non-Proprietary Name (INN): levonorgestrel and ethinylestradiol
MNENJE V ZVEZI Z NAPOTITVIJO IZ ČLENA 29(2) Rigevidon Mednarodno nelastniško ime (INN): levonorgestrel in etinilestradiol
Outcome of a procedure under Article 13(2) of Regulation (EC) 1234/2008
Izid postopka v skladu s členom 13(2) Uredbe (ES) 1234/2008
The Committee looked at the study presented by the company to support its application.
Odbor je pregledal študijo, ki jo je družba predložila v podporo vlogi.
The company that markets these medicines is Mundipharma GmbH.
Ta zdravila trži farmacevtska družba Mundipharma GmbH.
However, the Member States were unable to reach agreement on whether to accept this new indication and on 2 May 2014, Germany referred the matter to the CHMP for arbitration.
Vendar države članice niso uspele doseči soglasja glede odobritve te nove indikacije, zato je Nemčija 2. maja 2014 zadevo napotila v arbitražo odboru CHMP.
The European Commission issued an EU-wide legally binding decision to implement this change on 22 December 2014.
Evropska komisija je 22. decembra 2014 izdala pravno zavezujoči sklep o izvajanju navedene spremembe, ki velja za celotno EU.
On 23 October 2014, the European Medicines Agency completed an arbitration procedure for Oxynal, Targin and associated names.
Evropska agencija za zdravila je 23. oktobra 2014 končala postopek arbitraže za zdravila Oxynal, Targin in povezana imena.
Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Sindrom nemirnih nog je motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju udov, s katerim poskuša preprečiti neudobne, boleče ali čudne občutke v telesu, navadno ponoči.
Oxynal, Targin and associated names are marketed in all EU Member States except Croatia, Greece, Lithuania and Malta.
Zdravila Oxynal, Targin in povezana imena se tržijo v vseh državah članicah EU, razen na Hrvaškem, v Grčiji, Litvi in na Malti.
Regarding the safety, the CHMP concluded that overall the risk of tolerance and misuse is considered low and that the proposed measures to reduce this risk are appropriate.
Glede varnosti je odbor CHMP menil, da je splošno tveganje za toleranco in zlorabo majhno ter da so predlagani ukrepi za zmanjšanje tega tveganja ustrezni.
Oxynal and Targin have been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by Germany.
Zdravili Oxynal in Targin sta v EU odobreni s postopkom medsebojnega priznavanja na podlagi prvotnega dovoljenja, ki ga je odobrila Nemčija.
The company wanted the authorisation for the additional use in restless legs syndrome to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom (the ‘concerned Member States').
Družba je želela, da se dovoljenje za dodatno uporabo pri sindromu nemirnih nog prizna v naslednjih državah članicah: v Avstriji, Belgiji, Bolgariji, na Cipru, v Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, na Madžarskem, Irskem, v Italiji, Latviji, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu („zadevne države članice“).
Why was Oxynal and Targin reviewed?
Zakaj sta bili zdravili Oxynal in Targin pregledani?
Oxynal and Targin are medicines used to treat severe pain that can only be managed with opioids.
Oxynal in Targin sta zdravili, ki se uporabljata za zdravljenje hude bolečine, ki jo je mogoče obvladati samo z opioidi.
Based on the evaluation of the available data and the scientific discussion within the Committee, the CHMP agreed that the study had convincingly shown that Oxynal and Targin are beneficial in the treatment of symptoms of severe to very severe restless legs syndrome when standard therapy has failed.
Na podlagi ocene razpoložljivih podatkov in interne znanstvene razprave se je odbor CHMP strinjal, da je študija prepričljivo pokazala, da sta zdravili Oxynal in Targin koristni pri zdravljenju simptomov hudega do zelo hudega sindroma nemirnih nog, kadar je standardna terapija neuspešna.
In particular, there were concerns that the use of Oxynal and Targin could lead to tolerance and misuse and that this was not adequately studied in the clinical trial and the proposed measures to reduce the risk of tolerance and misuse were not considered sufficient.
Predvsem so bili prisotni pomisleki, da bi lahko uporaba zdravil Oxynal in Targin povzročila toleranco in zlorabo, da tega niso zadostno proučevali v kliničnem preskušanju ter da predlagani ukrepi za zmanjšanje tveganja za toleranco in zlorabo niso zadostni.
In November 2012, the company for Oxynal and Targin applied for an additional use in Germany: treatment of symptoms of severe to very severe restless legs syndrome when treatment with other medicines called dopaminergics has failed.
Novembra 2012 je družba za zdravili Oxynal in Targin v Nemčiji predložila vlogo za dodatno uporabo: zdravljenje simptomov hudega do zelo hudega sindroma nemirnih nog, kadar zdravljenje z drugimi zdravili, imenovanimi dopaminergiki, ni uspešno.
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for these medicines to include a new use in the treatment of restless legs syndrome.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji so pozvali, naj presodi o spremembi dovoljenja za promet s temi zdravili, s katero bi k dovoljenju vključili novo uporabo zdravil, in sicer za zdravljenje sindroma nemirnih nog.
The Committee concluded that the benefits of Oxynal, Targin and associated names outweigh their risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Hungary, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
Odbor je zaključil, da so koristi zdravil Oxynal, Targin in povezanih imen pri novi uporabi večje od z njimi povezanih tveganj in da se sprememba dovoljenja za promet z zdravili lahko odobri v Nemčiji in naslednjih državah članicah: v Avstriji, Belgiji, Bolgariji, na Cipru, v Češki republiki, na Danskem, v Estoniji, na Finskem, v Franciji, na Madžarskem, Irskem, v Italiji, Latviji, Luksemburgu, na Nizozemskem, Norveškem, Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu.
Questions and answers on Oxynal, Targin and associated names (oxycodone hydrochloride / naloxone hydrochloride)
Vprašanja in odgovori o zdravilih Oxynal, Targin in povezanih imenih (oksikodonijev klorid/naloksonijev klorid)
The CHMP therefore concluded that the benefits of Oxynal and Targin for restless legs syndrome outweigh their risks and recommended that the change to the marketing authorisation be granted in Germany and the concerned Member States.
Odbor CHMP je zato zaključil, da so koristi zdravil Oxynal in Targin pri sindromu nemirnih nog večje od z njima povezanih tveganj in priporočil, da se odobri sprememba dovoljenja za promet z zdraviloma v Nemčiji in zadevnih državah članicah.
What are Oxynal and Targin?
Kaj sta zdravili Oxynal in Targin?
Oxynal and Targin contain two active substances: oxycodone hydrochloride, an opioid painkiller, and naloxone hydrochloride, an opioid antagonist, which is added to counteract opioid-induced constipation by blocking the action of oxycodone at opioid receptors found locally in the gut.
Zdravili Oxynal in Targin vsebujeta dve zdravilni učinkovini: oksikodonijev klorid, opioidni analgetik, in naloksonijev klorid, opioidni antagonist, ki se dodaja za lajšanje zaprtosti, ki jo povzročajo opioidi, tako da zavira delovanje oksikodona na opioidnih receptorjih v črevesju.
The grounds for the referral were concerns from the Netherlands that the data on Oxynal and Targin submitted in the application were not sufficient to demonstrate a positive benefit-risk balance in restless legs syndrome.
Razlogi za napotitveni postopek so bili pomisleki Nizozemske, da podatki o zdravilih Oxynal in Targin, predloženi v vlogi, niso zadostni za dokazovanje pozitivnega razmerja med tveganji in koristmi pri sindromu nemirnih nog.
Overall summary of the scientific evaluation of Novosis Goserelin 3,6 mg Implantat and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Novosis Goserelin 3,6 mg Implantat in z njim povezanih imen (glejte Dodatek I)
• The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novosis Goserelin and associated names as listed in Annex I.
• Odbor je upošteval napotitveni postopek, sprožen v skladu s členom 36 Direktive 2001/83/ES, za zdravilo Novosis Goserelin in povezana imena, kot določa Priloga I.
The average accumulation factor is about 1.7.
Povprečni akumulacijski faktor je okrog 1,7.
Based on this data, the tolerability would be expected to be similar between those two groups.
Na podlagi teh podatkov se pričakuje, da bo toleranca v teh dveh skupinah podobna.
Sessions 4.5, 5.1, and 5.2 have been updated in order to guarantee the safety of the medicine.
Poglavja 4.5, 5.1 in 5.2 so bila posodobljena z namenom zagotoviti varnost zdravila.
The main areas for harmonisation were as follows.
Glavna področja usklajevanja so navedena v nadaljevanju.
• sudden loss of consciousness
• nenadna izguba zavesti
This combination apparently increases the risk for adverse events and is therefore not recommended.
Kaže, da ta kombinacija povečuje tveganje za neželene učinke, zato ni priporočena.
• swollen face, tongue or throat
• oteklina obraza, jezika ali grla
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• to treat high blood pressure.
• Za zdravljenje visokega krvnega tlaka.
• the use of Diovan in children and adolescents is not recommended (below the age of 18 years).
• uporaba zdravila Diovan pri otrocih in mladostnikih (starih manj kot 18 let) ni priporočena,
The issue has been solved
S tem je bila zadeva rešena.
The CHMP considered that there is little support for the triple combination use so far.
CHMP je menil, da je imela uporaba trojne kombinacije doslej majhno podporo.
Some symptoms need immediate medical attention: You may experience symptoms of angioedema, such as
Nekateri simptomi zahtevajo takojšnjo zdravstveno oskrbo: Pojavijo se lahko simptomi angioedema, kot so
This indication was approved in all Member States and the CHMP adopted the following wording:
Ta indikacija je bila potrjena v vseh državah članicah, zato je CHMP sprejel naslednje besedilo:
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Diovan affects you.
Preden začnete voziti, uporabljati orodje, upravljati stroje ali izvajati druge dejavnosti, ki zahtevajo zbranost, morate zagotovo vedeti, kako zdravilo Diovan deluje na vas.
It is caused when the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body.
Do tega pride takrat, ko srčna črpalka ne more črpati dovolj krvi, da bi s krvjo oskrbela celotno telo.
In addition the VALIANT study demonstrated that mortality was not increased in patients receiving the triple combination.
Poleg tega je študija VALIANT pokazala, da se umrljivost pri bolnikih, ki so prejemali trojno kombinacijo, ni povečala.
Considering the non inferiority in clinical outcome of valsartan compared to current standard treatment, an ACEI, the CHMP adopted the following harmonised wording for this indication:
Upoštevajoč neinferiornost kliničnih rezultatov za valsartan v primerjavi s trenutnim standardnim zdravljenjem, ACEI, je CHMP sprejel naslednje usklajeno besedilo za to indikacijo:
The mean treatment duration was two years.
Zdravljenje je trajalo povprečno dve leti.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DIOVAN AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA DIOVAN IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
- povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
• if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section).
• če ste noseči več kot 3 mesece (tudi v zgodnji nosečnosti raje ne jemljite zdravila Diovan) - glejte poglavje nosečnost.
• low blood pressure with symptoms such as dizziness
• nizek krvni pritisk s simptomi kot je omotičnost
Valsartan also demonstrated beneficial effects on signs and symptoms of HF.
Valsartan je pokazal tudi koristne učinke na znake in simptome srčnega popuščanja.
The first area of disagreement is about the use of triple combination (Valsartan + ACEI+ BB) in chronic HF.
Prvo področje nestrinjanja se nanaša na uporabo trojne kombinacije (Valsartan + ACEI + BB) pri kroničnem srčnem popuščanju.
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Neželeni učinki se pojavljajo s pogostnostjo, ki je opredeljena spodaj: zelo pogosti: prizadenejo več kot 1 od 10 uporabnikov pogosti: prizadenejo 1 do 10 od 100 uporabnikov občasni: prizadenejo 1 do 10 od 1.000 uporabnikov redki: prizadenejo 1 do 10 od 10.000 uporabnikov zelo redki: prizadenejo manj kot 1 od 10.000 uporabnikov neznana: pogostnosti ni mogoče oceniti iz razpoložljivih podatkov
• other medicines that lower blood pressure, especially water pills (diuretics).
• druga zdravila za znižanje krvnega tlaka, posebno tablete za odvajanje vode (diuretike),
If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dosage reduction.
Če pride do simptomatske hipotenzije ali ledvične disfunkcije, je treba razmisliti o zmanjšanju odmerka.
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However, no safety issue can be predicted because valsartan would not have specific safety issues associated with renal failure in general.
Vendar pa ni predviden noben zadržek glede varnosti, saj za valsartan ne obstajajo nobeni posebni zadržki glede njegove varnosti v povezavi z odpovedjo ledvic na splošno.
If you forget to take Diovan Do not take a double dose to make up for a forgotten dose.
Če ste pozabili vzeti zdravilo Diovan Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Bolnikom, pri katerih krvni tlak ni ustrezno urejen, je mogoče odmerek zvečati na 160 mg in na največ 320 mg.
However, the CHMP, requested to summarize all indications in one table, according to the `Guideline of SPC`.
CHMP pa je zahteval, da se naredi povzetek vseh indikacij v eni tabeli v skladu s „Smernicami za pripravo povzetka glavnih značilnosti zdravila“.
Valsartan does not undergo extensive biotransformation and 70% of the available dose is excreted.
Pri valsartanu ne pride do obsežne biotransformacije, zato se 70 % razpoložljivega odmerka izloči.
The proposed harmonized text for this section is acceptable by the majority of CHMP members in regard to this indication; therefore the following wording was adopted:
Predlagano besedilo za uskladitev tega poglavja in glede te indikacije je bilo sprejemljivo za večino članov CHMP, zato je bilo sprejeto naslednje besedilo:
Valsartan is not known to bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Ni znano, da bi valsartan vezal ali zaviral druge receptorje hormonov ali ionske kanalčke, ki so pomembni za kardiovaskularn o regulacijo.
• if you have severe heart disease other than heart failure or heart attack.
• če imate hudo bolezen srca, razen srčnega popuščanja in srčnega napada,
The following sentence has been added to Section 5.2: “Diovan has not been studied in patients with severe hepatic dysfunction”.
V poglavju 5.2 je bil dodan naslednji stavek: „Zdravilo Diovan ni bilo raziskano pri bolnikih s hudo disfunkcijo jeter“.
In CHMP's opinion the wording “not recommended” should be used until there is more solid supportive benefit/risk-profile evidence to triple combination.
Po mnenju CHMP se mora uporabljati izraz „ni priporočljiva“, dokler se ne zberejo trdnejši dokazi, ki bi podprli razmerje med koristmi in tveganji trojne kombinacije.
4.5 - Interaction with other medicinal products and other forms of interaction
4.5 - Medsebojno delovanje z drugimi zdravili in druge vrste interakcij
The safety profile seen in controlled-clinical studies in patients with post-myocardial infarction and/or heart failure varies from the overall safety profile seen in hypertensive patients.
Varnostni profil iz kontroliranih kliničnih študij pri bolnikih po miokardnem infarktu in/ali srčnim popuščanjem se razlikuje od splošnega profila varnosti pri hipertenzivnih bolnikih.
There was disagreement on whether the use of Diovan should be contraindicated in patients with renal failure.
Do nesporazuma je prišlo glede tega, ali mora biti uporaba zdravila Diovan kontraindicirana pri bolnikih z odpovedjo ledvic.
• to treat people after a recent heart attack (myocardial infarction).
• Za zdravljenje ljudi po nedavnem srčnem infarktu (miokardni infarkt).
Adverse reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000) very rare (< 1/10,000), including isolated reports.
V razvrstitvah pogostnosti so neželeni učinki navedeni po pogostnosti, najbolj pogosti najprej, in sicer po naslednjem dogovoru: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (<1/10.000), vključno s posamičnimi poročili.
High blood pressure: The usual dose is 80 mg daily.
Visok krvni tlak: Običajni odmerek je 80 mg na dan.
Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000 fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Valsartan nima delnega agonističnega učinka na receptorje AT1 in ima veliko (približno 20.000-kratno) večjo afiniteto za receptorje AT1 kot za receptorj AT
The primary endpoint was time to all-cause mortality.
Primarni cilj opazovanja je bil čas do smrti (umrljivost iz vseh vzrokov).
Hard gelatine capsules
Hard gelatine capsules peroralna
For example, side effects such as dizziness, and decreased kidney function, were seen less frequently in patients treated with high blood pressure than in patients treated for heart failure or after a recent heart attack.
Tako so na primer neželeni učinki kot sta omotičnost ali zmanjšano delovanje ledvic manj pogosta pri bolnikih, ki se zdravijo zaradi visokega krvnega pritiska, kot pri bolnikih, ki se zdravijo zaradi srčnega popuščanja ali po nedavnem srčnem infarktu.
-Second and third trimester of pregnancy (see sections 4.4 and 4.6).
-Drugo in tretje trimesečje nosečnosti (glejte poglavji 4.4 in 4.6)
The CHMP was also of the opinion that the 320 milligram dose provides a modest, statistically significant additional reduction in MSDBP and MSSBP compared to 160mg and a similarly modest increase in the rate of blood pressure control.
CHMP je tudi menil, da odmerek 320 mg v primerjavi z odmerkom 160 mg nudi skromno statistično pomembno dodatno znižanje krvnih tlakov MSDBP in MSSBP ter podobno skromno povečanje stopnje nadzora krvnega tlaka.
Irrespective of treatment, mortality was lower in the group of patients treated with a beta blocker, suggesting that the known beta blocker benefit in this population was maintained in this trial.
Ne glede na vrsto zdravljenja je bila umrljivost manjša v skupini bolnikov, ki so se zdravili z antagonistom adrenergičnih receptorjev beta, kar kaže, da so se znane koristi antagonistov adrenergičnih receptorjev beta v tej skupini bolnikov v tej študiji ohranile.
In Heart failure patients:
Pri bolnikih s srčnim popuščanjem:
4.8 - Undesirable effect
4.8 - Neželeni učinki
• if you are allergic (hypersensitive) to valsartan or any of the other ingredients of Diovan .
• če ste alergični (preobčutljivi) na valsartan ali katerokoli sestavino zdravila Diovan,
(diuretics).
(NSAIDs).
The CHMP considered it acceptable to remove this contraindication, as the primary route of elimination of valsartan is via biliary route and renal clearance accounts for less than 30% of plasma clearance.
CHMP je menil, da se lahko ta kontraindikacija odstrani, saj je primaren način izločanja valsartana po biliarni poti, ledvični očistek pa predstavlja manj kot 30 % očistka plazme.
Regarding the indication in recent myocardial infarction the CHMP noted that this indication was limited to patients intolerants to ACE inhibitors in some Member States.
Glede indikacije, ki se nanaša na nedavni miokardni infarkt, je CHMP opazil, da je v nekaterih državah članicah ta indikacija omejena samo na bolnike, ki ne prenašajo zaviralcev ACE.
The average time to peak concentration and elimination half-life of valsartan in heart failure patients are similar to that observed in healthy volunteers.
Povprečni čas do najvišje koncentracije in razpolovni čas izločanja valsartana pri bolnikih s srčnim popuščanjem sta podobna kot pri zdravih prostovoljcih.
The mean daily dose of Diovan in Val-HeFT was 254 mg.
Povprečni odmerek zdravila Diovan na dan v študiji Val-HeFT je bil 254 mg.
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• če se zdravite po srčnem napadu ali zaradi srčnega popuščanja, bo morda zdravnik preveril delovanje vaših ledvic,
The safety and tolerability of valsartan in patients with severe renal failure (creatinine clearance of <10 ml/min) was not evaluated in any clinical study.
Varnost in toleranca za valsartan pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 10 ml/min) nista bili ovrednoteni v nobeni klinični študiji.
Therefore in the situation of potential use of the triple combination the text within the SPC has been adjusted to indicate that caution (rather than “not recommended”) is appropriate
Zato je bilo za primere morebitne uporabe trojne kombinacije besedilo v povzetku glavnih značilnosti zdravila prilagojeno, in sicer tako, da se navede, da je potrebna previdnost (namesto navedbe „ni priporočljiva“).
Other side effects include:
Drugi možni neželeni učinki vključujejo:
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
Pri klinično stabilnih bolnikih je mogoče zdravljenje začeti že 12 ur po miokardnem infarktu.
“Treatment of essential hypertension”
„Zdravljenje esencialne hipertenzije.“