natgillin/translations-raw huggingface dataset:
The main measure of effectiveness was the change in the patients' nerve damage, as measured using a standard scale called ‘mNIS+7', with scores ranging from 0 to 304 (a higher score indicates more severe nerve damage).
Glavno merilo učinkovitosti je bila sprememba poškodbe živcev pri bolnikih, izmerjena s standardno lestvico, imenovano „mNIS+7“, pri čemer je rezultat v razponu od 0 do 304 (višji rezultat pomeni hujšo poškodbo živcev).
The active substance in Onpattro, patisiran, is a ‘small interfering RNA' (siRNA), a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Učinkovina zdravila Onpattro, patisiran, je „majhna interferenčna RNK“, tj. zelo kratek košček umetnega genetskega materiala, ki je bil zasnovan tako, da se pritrdi na genetski material celice, odgovorne za tvorbo transtiretina, in ga zavira.
hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Dedna transtiretinska amiloidoza je redka bolezen, zato je bilo zdravilo Onpattro 15. aprila 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
To reduce the risk of infusion-related reactions, patients should be given corticosteroid medicines, paracetamol and medicines known as H1 and H2 blockers before receiving Onpattro.
Preden bolniki prejmejo zdravilo Onpattro, morajo za zmanjšanje tveganja za reakcije, povezane z infuzijo, prejeti kortikosteroide, paracetamol in zdravila, znana kot zaviralci H1 in H2.
For the full list of side effects and restrictions with Onpattro, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Onpattro glejte navodilo za uporabo.
This compares with an increase on average by 28 points with placebo (from around 75 to around 101 points), indicating that nerve damage got worse in these patients.
Pri placebu je prišlo do zvišanja rezultata za približno 28 točk (s približno 75 točk na približno 101 točko), kar kaže, da se je poškodba živcev pri teh bolnikih poslabšala.
In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Pri bolnikih z dedno transtiretinsko amiloidozo je beljakovina transtiretin v krvnem obtoku okvarjena in se hitro razgradi.
In one main study involving 225 hATTR amyloidosis patients with stage 1 or 2 nerve damage, Onpattro was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
V eni glavni študiji, ki je vključevala 225 bolnikov z dedno transtiretinsko amiloidozo s 1. ali 2. stopnjo poškodbe živcev, so dokazali, da je zdravilo Onpattro pri upočasnitvi poškodbe živcev, ki jo povzroča bolezen, učinkovitejše od placeba (zdravila brez učinkovine).
Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Zdravilo Onpattro se uporablja za zdravljenje poškodbe živcev, ki jo povzroča dedna transtiretinska amiloidoza, tj. bolezen, pri kateri se beljakovine, imenovane amiloidi, kopičijo v tkivih po telesu, tudi okoli živcev.
How is Onpattro used?
Kako se zdravilo Onpattro uporablja?
How does Onpattro work?
Kako zdravilo Onpattro deluje?
Onpattro was shown to be effective at slowing down nerve damage in hATTR amyloidosis patients with stage 1 or stage 2 nerve damage; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Zdravilo Onpattro se je izkazalo za učinkovito pri zdravljenju 1. ali 2. stopnje poškodbe živcev pri bolnikih z dedno transtiretinsko amiloidozo; razpoložljivi podatki ne zadoščajo za izpeljavo predpostavke o koristih zdravila pri bolnikih s 3. stopnjo poškodbe (ki so na invalidskem vozičku).
− If you are older than 70 years
− če ste starejši od 70 let
This is one of the most common causes of heart disease.
To je eden najpogostejših razlogov za bolezni srca.
− If you regularly drink a large amount of alcohol
− če redno uživate večje količine alkohola
Common: allergic reactions.
Pogosto: alergijske reakcije.
The following side effects are important and will require immediate action if you experience them:
Naslednji neželeni učinki so pomembni in v primeru, da jih izkusite, bo potrebno takojšnje ukrepanje:
Indeed, many of the patients were at low risk, particularly the females in ASCOT-LLA.
Seveda je v resnici imelo veliko bolnikov majhno tveganje, zlasti ženske v raziskavi ASCOT-LLA.
Increases and decreases in blood sugar levels have also been seen (If you have diabetes you should continue careful monitoring of your blood sugar levels).
Opazili so tudi upadanje in naraščanje ravni sladkorja v krvi (Če imate diabetes, morate še naprej skrbno spremljati raven sladkorja v krvi).
The CHMP recommended the granting of the type II variation to extend the indication.
CHMP priporoča odobritev variacije tipa II, da se razširi indikacija.
At the December plenary meeting, the CHMP adopted a LoQ centred on the following points:
Na decembrskem plenarnem zasedanju je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel seznam vprašanj (LoQ), ki se osredotoča na naslednje točke:
- The posology in Section 4.2 has been revised as follows:
- Odmerjanje v poglavju 4.2 je bilo popravljeno na naslednji način:
Finally, there has been much discussion regarding the wording of the indication that best reflects the results of the of the assessed trials.
Na koncu je bilo veliko razpravljanja o besedilu indikacije, ki najbolje odraža rezultate pregledanih preskušanj.
He/she will decide on the further steps needed.
Ta bo odločil o nadaljnjem ravnanju.
OTHER SPECIAL WARNING(S), IF NECESSARY Sealed for your protection.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Zalepljeno za vašo varnost.
Cholesterol is a naturally occurring substance in the body necessary for normal growth.
Holesterol je snov, ki je normalno prisotna v telesu in je potrebna za normalno rast.
• no untoward safety findings related to the extension of the indication have been identified.
• Ni bilo opaženih nobenih neželenih varnostnih ugotovitev v zvezi z razširitvijo indikacije,
Atorvastatin was not carcinogenic in rats.
Atorvastatin za podgane ni bil karcinogen.
• the CHMP considered the referral made under article 6.12 of Commission Regulation (EC) No 1084/2003, for atorvastatin (Sortis and associated names - see Annex I),
• je CHMP upošteval napotitev, podano po členu 6.12 Uredbe Komisije (ES) št. 1084/2003 za atorvastatin (zdravilo Sortis in povezana imena - glejte Dodatek I),
In a compassionate-use study of 64 patients there were 46 patients for whom confirmed LDL receptor information was available.
V raziskavi sočutne uporabe pri 64 bolnikih so bili za 46 bolnikov na voljo podatki o potrjenih receptorjih LDL.
The safety profile of atorvastatin in the MIRACL study was consistent with what is described in Section 4.8.
Varnostni profil atorvastatina je bil v študiji MIRACL skladen z navedbami v poglavju 4.8.
In order to get the same absolute efficacy of atorvastatin in both sexes, it is therefore necessary to treat women who have the same absolute risk as men, i.e. women with more additional risk factors, such as higher age, menopause, etc.
Da bi dobili enako absolutno učinkovitost atorvastatina pri obeh spolih, je treba zdraviti ženske, ki imajo enako absolutno tveganje kot moški, tj. ženske z več dodatnimi dejavniki tveganja, kot so višja starost, menopavza itd.
Dosage in patients with renal insufficiency
Odmerjanje pri bolnikih z ledvično insuficienco
Sortis and associated names contain atorvastatin, a well-known HMG-CoA reductase inhibitor (statin), registered in the EU since 1996 through Mutual Recognition Procedure and national procedures.
Sortis in povezana imena vsebujejo atorvastatin, splošno znani zaviralec reduktaze HMG-CoA (statin), ki je v EU registriran od leta 1996 po postopku medsebojnega priznavanja in nacionalnih postopkih.
- Section 5.1 has been updated to include the results of the ASCOT-LLA and CARDS trials as follows:
- Poglavje 5.1 je bilo posodobljeno z vključitvijo rezultatov preskušanj ASCOT-LLA in CARDS z naslednjim besedilom:
Overall conclusion on benefit/risk
Skupni zaključek o razmerju med koristmi in tveganji
• the CHMP, as a consequence, considered the benefit/risk balance for the above-mentioned extension of indication to be favourable,
• zato je CHMP mnenja, da je razmerje med koristmi in tveganji za zgoraj omenjeno razširitev indikacije ugodno.
Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
Pri bolnikih, starejših od 70 let, sta učinkovitost in varnost zdravila v priporočenih odmerkih podobna kot pri splošni populaciji.
Moreover, the Applicant has provided an adequate and objective justification against a restriction to exclude women from the proposed indication given the current knowledge regarding the beneficial effects of statin treatment overall and also in women, including trial results, guidelines and international recommendations.
Poleg tega je vlagatelj predložil zadostno in objektivno utemeljitev proti omejitvi, ki izključuje ženske iz predlagane indikacije, na podlagi trenutnega znanja o koristnih učinkih statinov na splošno in istočasno tudi pri ženskah, vključno z rezultati preskušanj, smernicami in mednarodnimi priporočili.
Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of {PRODUCT}.
Na dan ne spijte več kot en ali dva majhna kozarca grenivkinega soka, saj lahko le-ta v velikih količinah spremeni učinek {(Lastniško) ime}.
The CHMP agrees that there is no reason to believe that higher doses would have a lower effect than the 10mg dose in the approved indication, independently of individual target cholesterol levels, and the potentially different safety profile of higher dosages.
CHMP se strinja, da ni razlogov za mnenje, da bi imeli večji odmerki manjši učinek za odobreno indikacijo kot 10 mg odmerek, neodvisno od ciljnih ravni holesterola in potencialno drugačnega varnostnega profila večjih odmerkov.
Total coronary events
Skupno število koronarnih dogodkov
It is accepted that raised cholesterol levels increase the risk of heart disease.
Znano je, da zvišana raven holesterola povečuje tveganje za bolezni srca.
An overview of the approved indications for atorvastatin based on the ASCOT-LLA and CARDS studies across the EU.
Pregled odobrenih indikacij za atorvastatin, ki temeljijo na preskušanjih ASCOT-LLA in CARDS po vsej EU.
Liver function tests should be performed and serum CPK levels should be monitored.
Narediti je treba laboratorijske preiskave jetrne funkcije in nadzorovati raven CPK v serumu.
This wording was based on the results of 2 randomised controlled trials performed with atorvastatin 10 mg for the primary prevention of cardiovascular disease (CVD).
Besedilo je temeljilo na rezultatih 2 randomiziranih kontroliranih preskušanj, ki sta bili opravljeni z atorvastatinom 10 mg za primarno preprečevanje srčno-žilne bolezni (CVD).
The physician should bear in mind that the decision to treat women should be based not only on clinical treatment guidelines but also on the determination of the absolute CV risk taking into account gender, age, smoking, blood pressure, cholesterol, etc (e.g. using Score and Framingham).
Zdravnik mora upoštevati, da mora odločitev o zdravljenju žensk temeljiti ne le na smernicah za klinično zdravljenje, ampak tudi na določevanju absolutnega tveganja za srčno-žilno bolezen, pri čemer je treba upoštevati spol, starost, kadilstvo, krvni tlak, holesterol itd. (npr. z uporabo lestvic Score in Framingham).
In the atorvastatin group (n=253), there was no progression of atherosclerosis.
V skupini z atorvastatinom (n=253) ateroskleroza ni napredovala.
Mortality and morbidity studies with atorvastatin have not yet completed.
Raziskave obolevnosti in umrljivosti z atorvastatinom še niso končane.
You should always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because they might interact.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli drugo zdravilo, tudi če ste ga dobili brez recepta, saj lahko pride do medsebojnih učinkov.
− if you are pregnant, trying to become pregnant or breast-feeding
− če ste noseči, skušate zanositi ali dojite
Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujte z zdravnikom ali s farmacevtom, preden vzamete katerokoli zdravilo.
4.7 Effects on ability to drive and use machines {PRODUCT NAME} has negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji {(Lastniško) ime} ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Absolute Risk Reduction p-value
absolutno zmanjšanje tveganja vrednost p
The other secondary endpoints did not reach statistical significance on their own (overall: Placebo: 22.2%, Atorvastatin: 22.4%).
Ostali sekundarni opazovani dogodki sami niso bili statistično pomembni (skupno: placebo 22,2%, atorvastatin 22,4%).
− if you are a woman able to have children and not using reliable contraception
− če ste ženska v rodni dobi in ne uporabljate zanesljive kontracepcijske zaščite
Pharmacotherapeutic group: HMG-CoA-reductase inhibitors, ATC code: C10AA05
Farmakoterapevtska skupina: zaviralci HMG CoA reduktaze, oznaka ATC: C10AA05
Other factors that will increase the risk of heart disease include high blood pressure, diabetes, increased weight, lack of exercise, smoking, or a family history of heart disease.
Ostali dejavniki, ki povečujejo tveganje za bolezni srca, so visok krvni pritisk, diabetes, povečana telesna masa, pomanjkanje gibanja, kajenje ali prisotnost bolezni srca v družini.
Regarding the interaction observed between atorvastatin and amlodipine, the body of data assessed indicates that this interaction is of questionable clinical relevance, if it exists at all, and does not warrant regulatory action dictating the prescription of the product.
V zvezi z interakcijo, opaženo med atorvastatinom in amlodipinom, zbrani pregledani podatki kažejo, da ima ta interakcija vprašljiv klinični pomen, če le-ta sploh obstaja, in ne more biti podlaga za regulatorne ukrepe, ki bi vplivali na predpisovanje zdravila.
Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.
Kreatin fosfokinaze (CPK) ne smemo meriti po naporni telesni dejavnosti ali v prisotnosti drugih verjetnih vzrokov za zvišanje CPK, kajti v takšnem primeru je tolmačenje vrednosti težavno.
The Applicant has presented arguments for the view that the results for women in ASCOT-LLA based on subgroup analyses are most likely chance findings and are not considered scientifically robust enough to form the basis for regulatory actions.
Vlagatelj je predstavil argumente za stališče, da so rezultati za ženske v raziskavi ASCOT-LLA, pridobljeni v analizi podskupin, najverjetneje posledica naključja in ne štejejo za dovolj znanstveno trdne dokaze, da bi postali osnova za regulatorne ukrepe.
− Protease inhibitors used in the treatment of HIV
− zaviralci proteaze HIV, ki se uporabljajo proti virusu HIV
However, if there is too much cholesterol in your blood it can be deposited on the walls of the blood vessels, which may eventually become blocked.
Če pa je holesterola v vaši krvi preveč, lahko pride do njegovega odlaganja na stene žil, ki se zato sčasoma lahko zamašijo.
This is a very rare reaction, which can be serious if it occurs.
To je zelo redek neželen učinek, ki pa je lahko nevaren.
It may harm them, even if their symptoms are the same as yours.
Drugim lahko to zdravilo celo škoduje, tudi če imajo znake bolezni, ki so podobni vašim.
{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
{(Lastniško) ime} je treba previdno uporabljati pri bolnikih, ki uživajo veliko alkohola in/ali imajo anamnezo o bolezni jeter.
Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Vsebuje eno ali več sestavin, ki zavirajo CYP3A4, in lahko zveča plazemsko koncentracijo zdravil, ki se presnavljajo s CYP3A4.
Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Izkušnje z uporabo pri otrocih so omejene na maloštevilne bolnike (stare od 4 do 17 let) s hudimi dislipedamijami, npr. s homozigotno familiarno hiperholesterolemijo.
There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
Izsledki raziskav na živalih kažejo, da lahko zaviralci HMG CoA reduktaze vplivajo na razvoj zarodka oz. ploda.
Therefore, the CHMP favours restricting the indication to patients who have a high risk for a first cardiovascular event, thus forcing the prescriber to perform an individual risk assessment rather than following an algorithm for decision on treatment.
Zato CHMP podpira omejitev indikacije na bolnike, ki imajo veliko tveganje za prvi srčno-žilni dogodek, s čimer se zdravnika, ki zdravilo predpisuje, prisili k individualnemu vrednotenju tveganja in ne k predpisovanju zdravila v skladu z običajnim algoritmom za izbiro zdravljenja.
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption should not take this medicine.
Bolniki z redkimi dednimi težavami, kot so galaktozna intoleranca, Lappovo pomanjkanje laktaze ali glukozno-galaktozna malabsorpcija, ne smejo jemati tega zdravila.
Therefore, the benefit and the risk of concurrent treatment should be carefully weighed (see section 4.4).
Zato je treba natančno pretehtati koristi in tveganja sočasnega zdravljenja (glejte poglavje 4.4).
− Occasionally, patients have developed muscle wasting or inflammation, and very rarely this has progressed to become a serious, potentially life-threatening condition (called ‘rhabdomyolysis').
− Občasno je pri bolnikih prišlo do propadanja mišic ali vnetja, in zelo redko je le-to vodilo v hudo, potencialno življensko nevarno stanje (imenovano rabdomioliza).
The safety of atorvastatin in pregnancy and lactation has not yet been proven.
Varnost atorvastatina med nosečnostjo in dojenjem ni dokazana.
In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
V kliničnih raziskavah, v katerih so {(Lastniško) ime} uporabljali hkrati z antihipertenzivi ali antidiabetiki, niso ugotovili klinično pomembnih interakcij.
It is not known whether this medicinal product or its metabolites are excreted in human milk.
Ni znano, ali se to zdravilo ali njegovi presnovki pri ljudeh človeku izločajo v materinem mleku.
− Medicines used to alter the way your immune system works, e.g. ciclosporin
− zdravila, ki spremenijo delovanje vašega imunskega sistema, npr. ciklosporin
− If symptoms resolve and CPK levels return to normal, then re-introduction of atorvastatin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring.
- Če simptomi minejo in se CPK normalizira, pretehtamo možnost ponovne uvedbe atorvastatina ali uvedbe kakšnega drugega statina v najmanjšem odmerku in ob natančnem nadzoru.
− If you have kidney problems
− če imate težave z ledvicami
Uncommon: impotence.
Občasno: impotenca.
− if you have or have ever had a disease which affects the liver
− če imate ali ste kdaj imeli kakšno bolezen jeter
− If you have had repeated or unexplained muscle aches or pains, a personnal history or family history of muscle problems
− če ste imeli ponavljajoče se in nepojasnjene bolečine v mišicah ter osebno ali družinsko zgodovino težav z mišicami
Hospital packs containing 200 (10 x 20) or 500 film-coated tablets.
Bolnišnična pakiranja z 200 (10 x 20) ali 500 filmsko obloženimi tabletami.
The possible interaction with other substrates of this isozyme is unknown but should be considered for other medicinal products with a narrow therapeutic index, for example, antiarrhythmic agents Class III including amiodarone.
Morebitne interakcije z drugimi substrati tega izoencima niso znane, vendar jih je treba upoštevati pri drugih zdravilih z nizkim terapevtskim indeksom, npr. pri antiaritmikih iz skupine III, vključno z amiodaronom.
Atorvastatin was administered at doses up to 80 mg/day.
Atorvastatin je bil uporabljen v odmerkih do 80 mg/dan.
At its meeting of 20-23 March 2006, the CHMP considered the data on efficacy presented by the MAHs and concluded that it had been shown that atorvastatin, as an adjunct to correction of other risk factors, was effective in the prevention of CV events in patients estimated to have a high risk for a first CV event.
CHMP je na svoji seji 20.-23. marca 2006 upošteval podatke o učinkovitosti, ki so jih predložili imetniki dovoljenja za promet z zdravilom, in je bil mnenja, da podatki dokazujejo učinkovitost atorvastatina kot dopolnila h korekciji drugih dejavnikov tveganja za preprečevanje srčno-žilnih dogodkov pri bolnikih z velikim ocenjenim tveganjem za prvi srčno-žilni dogodek.
Not all included patients were estimated to have a high risk for a first cardiovascular event.
Niso ocenili, da pri vseh vključenih bolnikih obstaja visoko tveganje za prvi kardiovaskularni dogodek
Mean plasma elimination half-life of atorvastatin in humans is approximately 14 hours.
Povprečni eliminacijski razpolovni čas atorvastatina pri ljudeh je približno 14 ur.
The main issue discussed by the CHMP has been the results of the ASCOT-LLA trial, most importantly the lack of established benefit and adverse mortality trends in the female subgroup and, secondly, the impact of the observed interaction between the antihypertensive amlodipine and atorvastatin on the main trial outcomes for certain subgroups.
Glavna tema razprave CHMP so bili rezultati preskušanja ASCOT-LLA, zlasti pomanjkanje dokazov o koristnih učinkih in neželeni trendi smrtnosti pri ženskah, na drugem mestu pa vpliv opažene interakcije med antihipertenzivno učinkovino amlodipin in atorvastatinom na glavne kazalce izida v določnih podskupinah.
A point of minor discussion was the applicability of the trial results to other strengths of atorvastatin.
Manjša razprava se je vrtela okrog sprejemljivosti rezultatov preskušanja za druge jakosti atorvastatina.
This may possibly lead to increased plasma levels of atorvastatin (see section 4.4).
To bi lahko povzročilo zvišano koncentracijo atorvastatina v plazmi (glejte tudi poglavje 4.4).
The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMG-CoA reductase inhibitory activity is approximately 30%.
Absolutna biološka uporabnost atorvastatina je približno 12%, sistemska uporabnost zaviralnega delovanja na HMG CoA reduktazo pa približno 30%.
Clarithromycin increased the Cmax and AUC of atorvastatin by 56% and 80% respectively.
Klaritromicin je povečal Cmax atorvastatina za 56% in njegovo AUC za 80%.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS PRESENTED BY THE EMEA
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNITEV POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, PREDSTAVLJENI S STRANI EVROPSKE AGENCIJE ZA ZDRAVILA
When compared to pravastatin the effects of atorvastatin were statistically significant (p=0.02).
Učinki atorvastatina so bili v primerjavi z učinki pravastatina statistično pomembni (p=0,02).