natgillin/translations-raw huggingface dataset:
An authorised medicinal product listed in Annex IB may be considered critical by the EU Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Zdravilo, navedeno v Prilogi IB, lahko šteje za zdravilo kritičnega pomena v eni ali več državah članicah na podlagi ocene morebitnih neizpolnjenih zdravstvenih potreb ter ob upoštevanju razpoložljivosti ustreznih alternativnih zdravil v eni ali več zadevnih državah članicah in, če je primerno, narave zdravljene bolezni.
For these medicinal products considered critical by EU Member States, the marketing authorisation holders shall submit a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product within 12 months following Commission Decision.
Za ta zdravila, ki jih države članice štejejo za zdravila kritičnega pomena, imetniki dovoljenj za promet z zdravilom v 12 mesecih od sklepa Komisije predložijo študijo biološke enakovrednosti, opravljeno glede na referenčno zdravilo, odobreno v EU.
c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established (annex IA) should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
c. Dovoljenja za promet z zdravilom, za katera je bila ugotovljena biološka enakovrednost z referenčnim zdravilom, odobrenim v EU (Priloga IA), naj se ohranijo, saj je razmerje med tveganji in koristmi za ta dovoljenja za promet z zdravilom ugodno.
However, no formal request was submitted and the detailed information necessary to assess the appropriateness of a biowaiver was not made available by the MAHs/applicants.
Vendar ni bil predložen noben formalni zahtevek in imetniki dovoljenj za promet z zdravilom/predlagatelji niso dali na voljo podrobnih informacij za oceno ustreznosti izvzetja iz obveznosti izvedbe študij biološke enakovrednosti;
− Authorised medicinal products and marketing authorisation applications for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
− odobrena zdravila, za katera so bili predloženi alternativni podatki o biološki enakovrednosti ali utemeljitev, ki pa so bili za odbor CHMP nezadostni, da bi lahko ugotovili biološko enakovrednost z referenčnim zdravilom, odobrenim v EU (Priloga IB);
Therefore, for products either authorised or seeking a marketing authorisation based on data generated at Semler, bioequivalence is not established and benefit-risk balance cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded.
Za zdravila, ki so bila odobrena ali predlagana za dodelitev dovoljenja za promet na podlagi podatkov podjetja Semler, biološka enakovrednost ni dokazana in razmerja med tveganji in koristmi ni mogoče imeti za pozitivno, saj možnosti težav z zmanjšano varnostjo/prenašanjem in učinkovitostjo ni mogoče izključiti.
Alternative data were submitted to demonstrate the bioequivalence of abacavir/lamivudine-containing medicinal products to an EU reference medicinal product.
Za dokaz biološke enakovrednosti zdravil, ki vsebujejo abakavir/lamivudin, z referenčnim zdravilom, odobrenim v EU, so bili predloženi alternativni podatki.
In view of the failures of the quality management system in place at the sites, results and controls of data integrity of individual studies by MAHs cannot make the bioequivalence studies performed at Semler Research Center acceptable as basis for a marketing authorisation.
• ponovna analiza in pregledi podatkov iz posameznih študij niso pokazali nobene nepravilnosti; glede na napake vzpostavljenega sistema za upravljanje kakovosti na teh lokacijah rezultati in nadzor integritete podatkov iz posameznih študij, ki so jih opravili imetniki dovoljenj za promet z zdravilom, se študije biološke enakovrednosti, ki so bile opravljene v podjetju Semler Research Center, ne morejo šteti kot podlaga za dovoljenje za promet z zdravilom;
Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Nekatera od teh zdravil se lahko na podlagi ocene morebitnih neizpolnjenih zdravstvenih potreb in ob upoštevanju razpoložljivosti ustreznih alternativnih zdravil v eni ali več zadevnih državah članicah ter, če je primerno, narave zdravljene bolezni, štejejo za zdravila kritičnega pomena v posamezni državi članici.
• The CHMP concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
• odbor je zaključil, da so bili za dovoljenja za promet z zdravilom in vloge za pridobitev dovoljenja za promet z zdravilom iz Priloge IA predloženi alternativni podatki za dokaz biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU.
b. Marketing authorisation applications for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
b. Vloge za pridobitev dovoljenja za promet z zdravilom, za katere podatki o biološki enakovrednosti ali njena utemeljitev niso bili predloženi oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU (Priloga IB), ne izpolnjujejo meril za pridobitev dovoljenja, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi teh dovoljenj za promet z zdravilom v skladu s členom 26 Direktive 2001/83/ES ni ugodno.
Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Če v tem obdobju ena ali več držav članic zdravila ne šteje več za zdravilo kritičnega pomena, je treba uveljaviti začasen umik zadevnega dovoljenja za promet z zdravilom.
a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisations is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
a. Dovoljenja za promet z zdravilom, za katera niso bili predloženi podatki o biološki enakovrednosti ali njena utemeljitev oziroma za katera je odbor CHMP menil, da zadevni podatki ne zadostujejo za ugotovitev biološke enakovrednosti z referenčnim zdravilom, odobrenim v EU (Priloga IB), naj se začasno umaknejo, saj podatki v podporo dovoljenjem za promet niso ustrezni in razmerje med tveganji in koristmi teh dovoljenj za promet z zdravilom v skladu s členom 116 Direktive 2001/83/ES ni ugodno.
* This p value is not considered statistically significant.
* Ta vrednost p ni statistično pomembna.
The power to detect differences in these two studies was limited.
Moč za ugotavljanje razlik v teh dveh študijah je bila omejena.
You may need a lower dose.
Morda boste potrebovali manjši odmerek.
If you forget to take a dose, take it as soon as you remember.
Če ste pozabili vzeti odmerek, ga vzemite, takoj ko se spomnite.
Take your box of tablets with you.
Škatlo tablet vzemite s seboj.
The day you stop smoking should usually be between day 8 and day 14.
Dan, ko nehate kaditi, mora biti običajno med 8. in 14. dnem.
If, it is within 3-4 hours before your next dose, do not take the tablet that you have missed.
Če so do vašega naslednjega odmerka le še 3-4 ure, ne vzemite tablete, ki ste jo pozabili.
The cessation rates in this population were similar to those reported in the general population.
Stopnje prenehanja pri tej populaciji so bile podobne stopnjam, o katerih so poročali pri splošni populaciji.
The patient should set a date to stop smoking.
Bolnik si mora postaviti datum, ko bo nehal kaditi.
Località Marino del Tronto, 63100 Ascoli Piceno (AP) Italy
Località Marino del Tronto, 63100 Ascoli Piceno (AP) Italija
You start with the white tablet and then usually go to the light blue tablet.
Začnete z jemanjem belih tablet in nato običajno nadaljujete s svetlomodrimi.
Absorption is virtually complete after oral administration and systemic availability is high.
Absorpcija po peroralni uporabi je skoraj popolna in sistemska razpoložljivost je velika.
Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.
Zdravnik in farmacevt vam lahko svetujeta, ponudita podporo in vire dodatnih informacij, kar lahko pomaga zagotoviti, da bo vaš poskus opustitve kajenja uspešen.
It is important that you take CHAMPIX regularly at the same time each day.
Pomembno je, da zdravilo CHAMPIX jemljete redno, vsak dan ob istem času.
Therefore, in some cases an adjustment of the dose may be necessary.
Zato je pri nekaterih zdravilih včasih potrebna prilagoditev odmerka.
Maintenance of abstinence study
Študija vzdrževanja abstinence
Observational Studies
Opazovalne študije
If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6)
- če ste alergični na vareniklin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
All studies were retrospective cohort studies and included patients with and without a psychiatric history.
Vse študije so bile retrospektivne kohortne študije in so vključevale bolnike s psihiatrično anamnezo in brez nje.
You should write this date on the pack as a reminder.
Ta datum si kot opomnik zapišite na ovojnino.
Can't be sold separately.
Ni za posamično prodajo.
The elimination half-life of varenicline is approximately 24 hours.
Razpolovni čas izločanja vareniklina je približno 24 ur.
The tablets should be swallowed whole with water and can be taken with or without food.
Tablete morate pogoltniti cele, z vodo, in jih lahko vzamete s hrano ali brez nje.
Pharmacokinetics in special patient populations
Farmakokinetika pri posebnih populacijah bolnikov
Date of latest renewal: 29 June 2016
Datum prve odobritve: 26. september 2006 Datum zadnjega podaljšanja: 29. junij 2016
The study in patients with stable cardiovascular disease described above was included in the meta-analysis.
Zgoraj opisana študija pri bolnikih s stabilno srčnožilno boleznijo je bila vključena v meta analizo.
Before starting your course of CHAMPIX you should usually decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking.
Preden začnete uporabljati zdravilo CHAMPIX, si morate običajno določiti datum v drugem tednu zdravljenja (med 8. in 14. dnem), ko boste nehali kaditi.
Following administration of multiple oral doses to healthy volunteers, steady-state conditions were reached within 4 days.
Po uporabi več peroralnih odmerkov pri zdravih prostovoljcih je bilo stanje dinamičnega ravnovesja doseženo v 4 dneh.
These effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Te učinke so opazili samo pri izpostavljenosti, ki je močno presegala največjo izpostavljenost pri človeku, kar kaže na majhen pomen za klinično uporabo.
Varenicline distributes into tissues, including the brain.
Vareniklin se porazdeli v tkiva, vključno z možgani.
Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Depresivno razpoloženje, ki redko vključuje samomorilne misli in poskus samomora, je lahko simptom odtegnitve nikotina.
All studies used statistical methods to control for confounding factors, including preferential prescribing of varenicline to healthier patients, although there is the possibility of residual confounding.
V vseh študijah so uporabili statistične metode za nadzorovanje zavajajočih dejavnikov, vključno s prednostnim predpisovanjem vareniklina bolj zdravim bolnikom, vendar kljub temu obstaja možnost ostanka zavajanja.
*CA: Continuous Abstinence Rate
*CA: Stopnja trajne abstinence (Continuous Abstinence Rate)
The CHAMPIX safety profile in this study was consistent with that of pre-marketing studies.
Varnostni profil zdravila CHAMPIX v tej študiji je bil skladen s tistim iz študij pred začetkom trženja.
A causal relationship between these events and varenicline use has not been established.
Vzročna povezava med temi dogodki in uporabo vareniklina ni bila dokazana.
The limited data available from this single smoking cessation study are not sufficient to allow for definitive conclusions to be drawn about the safety in patients with schizophrenia or schizoaffective disorder.
Omejeni podatki iz zadevne študije prenehanja kajenja ne zadostujejo za dokončne zaključke glede varnosti pri bolnikih s shizofrenijo ali shizoafektivno motnjo.
The key efficacy results are summarised in the following table:
Ključni rezultati učinkovitosti so povzeti v naslednji preglednici:
Do not take CHAMPIX:
Ne jemljite zdravila CHAMPIX:
The individual components of the endpoint are also shown.
Prikazane so tudi posamezne komponente opazovanega dogodka.
Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
Verjetnost za uspeh terapij za prenehanje kajenja je večja pri bolnikih, ki so za prenehanje motivirani in so deležni dodatnega svetovanja in podpore.
Few patients reported these events in the other three trials (4 varenicline, 3 placebo).
Nekaj bolnikov je o teh dogodkih poročalo v drugih treh preskušanjih (4 vareniklin, 3 placebo).
CHAMPIX with food and drink
Zdravilo CHAMPIX skupaj s hrano in pijačo
As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Kajenje inducira CYP1A2, zato lahko prenehanje kajenja povzroči zvišanje koncentracije substratov CYP1A2 v plazmi.
Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Najvišja koncentracija vareniklina v plazmi se praviloma pojavi v 3 do 4 urah po peroralni uporabi.
Although it was not studied, CHAMPIX may pass into breast milk.
Kljub temu, da o tem ni bilo študij, lahko zdravilo CHAMPIX prehaja v materino mleko.
Psychiatric Adverse Events Occurring in ≥ 1% of Patients from Pooled Data from 18 Clinical Trials:
Psihiatrični neželeni učinki, ki so se pojavili pri ≥ 1 % bolnikov, na podlagi združenih podatkov iz 18 kliničnih preskušanj:
Not known o Transient loss of consciousness
Neznana prehodna izguba zavesti
There were rare reports of life-threatening angioedema requiring urgent medical attention due to respiratory compromise.
Poročali so o redkih primerih smrtno nevarnega angioedema, ki zahteva nujno medicinsko pomoč zaradi ogroženega dihanja.
See the chart below for the usual dosing instructions which you should follow from Day 1.
Za običajni režim odmerjanja glejte spodnjo preglednico, ki jo morate upoštevati od 1. dne.
Start at Day 1
Začnite na 1. dan
Safety and efficacy of CHAMPIX in combination with other smoking cessation therapies have not been studied.
Varnost in učinkovitost zdravila CHAMPIX v kombinaciji z drugimi terapijami za prenehanje kajenja nista raziskani.
Patients should be treated with CHAMPIX for 12 weeks.
Bolniki naj se z zdravilom CHAMPIX zdravijo 12 tednov.
CHAMPIX is available in the following pack presentations:
Zdravilo CHAMPIX je na voljo v naslednjih pakiranjih:
One outer carton containing:
Ena zunanja škatla, ki vsebuje:
The safety profile of varenicline was comparable to what was reported in other trials in the general population, including pulmonary safety.
Varnostni profil vareniklina je bil primerljiv s poročili iz drugih preskušanj pri splošni populaciji, vključno z varnostjo učinkov na pljuča.
Stop taking CHAMPIX and tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.
Nemudoma prenehajte jemati zdravilo CHAMPIX in obvestite zdravnika, če opazite kateregakoli od naslednjih znakov in simptomov, ki lahko kažejo na resno alergijsko reakcijo: otekanje obraza, ustnic, jezika, dlesni, grla ali telesa in/ali težave z dihanjem, piskajoče dihanje.
The P450 enzymes tested for inhibition were: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.
Glede zavrtja so testirali naslednje encime P450: 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4/5.
The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers ( 10 cigarettes per day).
Učinkovitost zdravila CHAMPIX pri opustitvi kajenja so dokazala 3 klinična preskušanja, ki so zajela kronične kadilce cigaret ( 10 cigaret na dan).
Subjects were instructed to reduce the number of cigarettes smoked by at least 50 percent by the end of the first four weeks of treatment, followed by a further 50 percent reduction from week four to week eight of treatment, with the goal of reaching complete abstinence by 12 weeks.
Preskušancem so dali navodilo, naj do konca prvih štirih tednov zdravljenja zmanjšajo število pokajenih cigaret za vsaj 50 odstotkov, nato pa še za nadaljnjih 50 odstotkov od 4. do 8. tedna zdravljenja, s ciljem doseči popolno abstinenco v 12 tednih.
In circulation, varenicline comprises 91% of drug-related material.
V krvnem obtoku obsega vareniklin 91 % z zdravilom povezanega materiala.
Examples include theophylline (a medicine to treat breathing problems), warfarin (a medicine to reduce blood clotting), and insulin (a medicine to treat diabetes).
To vključuje teofilin (zdravilo za zdravljenje težav z dihanjem), varfarin (zdravilo za zmanjševanje strjevanja krvi) in insulin (zdravilo za zdravljenje sladkorne bolezni).
Renal elimination of varenicline is primarily through glomerular filtration along with active tubular secretion via the organic cationic transporter, OCT2 (see section 4.5).
Ledvično izločanje vareniklina poteka primarno z glomerulno filtracijo ob hkratni aktivni tubulni sekreciji prek organskega kationskega transporterja, OCT2 (glejte poglavje 4.5).
There are limited clinical data on any potential interaction between alcohol and varenicline.
Kliničnih podatkov o možni interakciji med alkoholom in vareniklinom je malo.
Patients with suicidal ideation and/or behaviour* [n (%)]** Patient-years of exposure
bolniki s samomorilnimi mislimi in/ali vedenjem* [n (%)]** bolnikov-let izpostavljenosti razmerje tveganja
0.5 mg twice daily Day 8 - End of treatment: 1 mg twice daily
0,5 mg dvakrat na dan 8. dan do konca zdravljenja: 1 mg dvakrat na dan
It has been shown in clinical trials that taking all doses of your medicine at the appropriate times and for the recommended duration of treatment described above will increase your chances of stopping smoking.
V kliničnih preskušanjih so dokazali, da uporaba vseh odmerkov zdravila ob ustreznem času pri ustreznem trajanju zdravljenja, kot je opisano zgoraj, poveča možnost za opustitev kajenja.
During treatment
med zdravljenjem
See below under ‘Other medicines and CHAMPIX' for further details.
Za nadaljnje informacije glejte spodaj ''Druga zdravila in zdravilo CHAMPIX''.
CI=confidence interval; N=number of subjects randomised; n=the number of subjects who, at each visit from weeks 9 to 12 (inclusive), reported no smoking and no use of other nicotine-containing products since the last study visit/last contact (on the Nicotine Use Inventory) and at any of these visits were confirmed to have quit based on urine cotinine test.
IZ = interval zaupanja; N = število randomiziranih preskušancev; n = število preskušancev, ki so ob vsakem obisku v tednih od 9. do (vključno) 12. tedna poročali, da od zadnjega študijskega obiska/zadnjega stika (glede na vprašalnik o uporabi nikotina) niso kadili in da niso uporabljali drugih izdelkov, ki vsebujejo nikotin, ob vseh teh obiskih pa je prenehanje uporabe potrdil urinski kotininski test.
Patients were stratified by age (12-16 years of age and 17-19 years of age) and by body weight (≤55 kg and >55 kg).
Bolnike so stratificirali glede na starost (od 12 do 16 let in od 17 do 19 let) in telesno maso (≤ 55 kg in > 55 kg).
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with CHAMPIX should be made taking into account the benefit of breast-feeding to the child and the benefit of CHAMPIX therapy to the woman.
Pri odločitvi za nadaljevanje/prekinitev dojenja oz. za nadaljevanje/prekinitev zdravljenja z zdravilom CHAMPIX je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom CHAMPIX za žensko.
CHAMPIX is for oral use and the tablets should be swallowed whole with water.
Zdravilo CHAMPIX je namenjeno za peroralno uporabo, tablete pa je treba pogoltniti cele, z vodo.
The key results are summarised in the following table:
Ključni rezultati so povzeti v spodnji preglednici:
New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems.
O pojavu novih težav s srcem in ožiljem ali o poslabšanju obstoječih srčnožilnih težav so poročali predvsem pri posameznikih, ki že imajo srčnožilne težave.
CHAMPIX can be taken with or without food
Zdravilo CHAMPIX se lahko vzame s hrano ali brez nje.
The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering.
Zdravnik mora bolnika na to ustrezno opozoriti in razmisliti oziroma se pogovoriti o potrebi po postopnem zmanjševanju odmerka.
The third study assessed the benefit of an additional 12 weeks of CHAMPIX therapy on the maintenance of abstinence.
Tretja študija je ocenila koristi dodatnega 12-tedenskega zdravljenja z zdravilom CHAMPIX na vzdrževanje abstinence.
Do not use this medicine after the expiry date which is stated on the card packaging or carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zavarjenem kartonskem pakiranju ali na škatli poleg oznake ''Uporabno do''.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.
Zdravniki se morajo zavedati možnosti pojava resnih nevropsihiatričnih simptomov pri bolnikih, ki poskušajo opustiti kajenje z zdravljenjem ali brez njega.
The hazard ratio for MACE was higher in patients with cardiovascular risk factors in addition to smoking compared with that in patients without cardiovascular risk factors other than smoking.
Razmerje tveganja za MACE je bilo večje pri bolnikih, ki imajo srčnožilne dejavnike tveganja poleg kajenja, v primerjavi z bolniki, ki poleg kajenja nimajo drugih srčnožilnih dejavnikov tveganja.
Clinical signs included swelling of the face, mouth (tongue, lips, and gums), neck (throat and larynx) and extremities.
Klinični znaki vključujejo otekanje obraza, ust (jezika, ustnic in dlesni), vratu (grla in žrela) ter okončin.
CHAMPIX, (n = 248) Placebo, (n = 251) Odds ratio (CHAMPIX vs.
CHAMPIX, (n = 248) placebo, (n = 251) razmerje obetov (CHAMPIX v primerjavi s placebom)
Use with other therapies for smoking cessation
Uporaba z drugimi zdravili za prenehanje kajenja