natgillin/translations-raw huggingface dataset:
The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
povezani z bradikardijo, kot so omotica, utrujenost ali hipotenzija.
NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets
Ivabradine Anpharm 5 mg filmsko obložene tablete Ivabradine Anpharm 7,5 mg filmsko obložene tablete
josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
- nestabilno ali akutno srčno popuščanje - odvisnost od srčnega spodbujevalnika (srčna frekvenca, ki jo narekuje izključno srčni spodbujevalnik) - nestabilna angina pektoris - atrioventrikularni blok 3. stopnje - kombinacija z močnimi zaviralci citokroma P450 3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2) - kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema citokroma P450 3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5)
Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Navodilo za uporabo Ivabradine Anpharm 5 mg filmsko obložene tablete Ivabradine Anpharm 7,5 mg filmsko obložene tablete ivabradin
After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
utripov na minuto, ali zmanjšate na 2,5 mg dvakrat na dan (eno polovico 5-mg tablete dvakrat na dan), če je srčna frekvenca med mirovanjem vztrajno pod 50 utripov na minuto ali se pojavijo simptomi,
Therefore, ivabradine is contraindicated during pregnancy (see section 4.3).
Morebitno tveganje pri ljudeh ni znano, zato je ivabradin kontraindiciran med nosečnostjo (glejte poglavje 4.3).
and 45%), ivabradine did not have any deleterious influence on LVEF.
ivabradin ni imel nobenih škodljivih učinkov na iztisni delež levega prekata.
Erythema Pruritus Urticaria
- hudo jetrno popuščanje
Excipient with known effect: 63.91 mg lactose monohydrate Ivabradine Anpharm 7.5 mg film-coated tablets One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Ivabradine Anpharm 7,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Ivabradine Anpharm 7,5 mg filmsko obložene tablete Trikotna, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
Excipients
Otroci
In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine 10 mg o.d. at the trough of drug activity (12 hours after oral intake) while an additional efficacy was shown at peak (3-4 hours after oral intake).
10 mg enkrat na dan ni pokazal dodatne učinkovitosti v času najmanjšega učinka (12 ur po peroralnem jemanju), medtem ko so v času največjega učinka (3 do 4 ure po peroralnem jemanju)
A sustained reduction of heart rate was demonstrated in patients treated with ivabradine for at least one year (n = 713).
Pri bolnikih, ki so ivabradin jemali najmanj 1 leto, so dokazali vztrajno znižanje srčne frekvence
Special populations
Posebne skupine bolnikov Starejši
Ivabradine is indicated : - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
- ali v kombinaciji z antagonisti adrenergičnih receptorjev beta pri bolnikih, ki ob optimalnem odmerku antagonistov adrenergičnih receptorjev beta nimajo urejene bolezni.
Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face.
Ivabradine Anpharm 5 mg filmsko obložene tablete Podolgovata, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.
These measures should help to protect the environment.>
Ti ukrepi pomagajo varovati okolje.>
<Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/ >
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) ( HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/).
Other information>
Druge informacije>
If you notice any side effects, even those not already listed in this label or you think that the medicine has not worked, please inform your veterinary surgeon.
Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tej stični ovojniniali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
<Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only]
<Poročate lahko tudi preko nacionalnega sistema za poročanje {podatki nacionalnega sistema}.> [For MRP/DCP only]
<Interaction with other medicinal products and other forms of interaction:>
<Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:>
The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Besedilo “samo za živali” in pogoji ali omejitve glede oskrbe in uporabe, če je smiselno
<Overdose (symptoms, emergency procedures, antidotes):>
<Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):>
<The frequency of adverse reactions is defined using the following convention:
<Pogostost neželenih učinkov je določena po naslednjem dogovoru:
<Batch> <Lot> <BN> {number}
<Serija> <Lot> <BN> {številka}
<Do not use {name} if you notice {description of the visible signs of deterioration}.>
<Ne uporabite {ime zdravila}, če opazite {opis vidnih znakov kvarjenja}.>
Special storage precautions
Posebna navodila za shranjevanje
Special precautions for the disposal of unused product or waste materials, if any
Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
<Keep the {container} tightly closed>
Hranite {vsebinik} tesno zaprt.>
{(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
{(Izmišljeno) ime zdravila <jakost> farmacevtska oblika <ciljne živalske vrste>}
<Medicines should not be disposed of via wastewater <or household waste>.>
<Ne odvrzite zdravila v odpadno vodo ali <med gospodinjske odpadke>.>
Name of the veterinary medicinal product
Ime zdravila za uporabo v veterinarski medicini
<For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.>
<Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.>
<Protect from direct sunlight.>
<Zaščitite pred neposredno sončno svetlobo.>
Manufacturer's batch number
Proizvajalčeva številka serije
<Special warnings for each target species:>
<Posebna opozorila za vsako ciljno živalsko vrsto:>
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different
Ime in naslov imetnika dovoljenja za promet z zdravilom ter proizvajaleca zdravilaodgovoren za sproščanje serij, če sta si različna
<Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>>
<Načeto> <odprto> <razredčeno> <rekonstituirano>zdravilo uporabite do…> <uporabite v…> <uporabite takoj>.>
<Special precautions for use in animals:>
<Posebni previdnostni ukrepi za uporabo pri živalih:>
<Shelf life after incorporation into meal or pelleted feed: ….>
<Rok uporabnosti po vključitvi v obrok ali peletirano hrano: ….>
<None.>
<Jih ni.>
Advice on correct administration
Nasvet o pravilni uporabi zdravila
Do not use this veterinary medicinal product after the expiry date which is stated on the <label> <bottle> <...> <after {abbreviation used for expiry date}>.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na <ovojnini > <steklenici> <...> po {kratica, ki se uporablja za datum izteka roka uporabnosti}.> <Rok uporabnosti zdravila se nanaša na zadnji dan v navedenem mesecu.>
<in order to protect from <light> <and> <moisture>.>
<da se zaščiti pred <svetlobo><in> <vlago>.>
<Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.>
<Upoštevati je treba uradna priporočila o dodajanju zdravilnih predmešanic v krmo.>
Dosage for each species, route(s) and method of administration
Odmerki za posamezne živalske vrste ter pot(i) in način uporabe zdravila
Date on which the label was last approved
Datum zadnje odobritve stične ovojnine
<Do not store above <25°C> <30°C>.> or
<Ne shranjujte pri temperaturi nad <25 (C> <30 (C>.>
Marketing authorisation number(s)
Številka(e) dovoljenj(a) za promet
<Do not <refrigerate> <or> <freeze>.>
<Ne <shranjujte v hladilniku> <.> <ali> <zamrzujte>.>
<Shelf life after first opening the container: …..>
<Rok uporabnosti po prvem odpiranju vsebnika: ….>
<Store in a refrigerator (2°C - 8°C).>
<Shranjujte v hladilniku (2 (C - 8 (C).>
<This veterinary medicinal product does not require any special temperature storage conditions.>
<Za shranjevanje zdravila ni posebnih temperaturnih omejitev.>
<Store below <25°C> <30°C>.>
<Shranjujte pri temperaturi pod <25 (C> <30 (C>.>
<Protect from frost.>
<Zaščitite pred zamrznitvijo.>
<Manufacturer responsible for batch release:>
<Proizvajalec odgovoren za sproščanje serij:>
<Store and transport frozen {temperature range}.>
<Shranjujte in prevažajte zamrznjeno {temperaturni interval}.>
<Special precautions to be taken by the person administering the veterinary medicinal product to animals:>
<Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo:>
<Shelf life after <dilution> <reconstitution> according to directions: …..>
<Rok uporabnosti po <razredčenju> <ali> <rekonstituciji> v skladu z navodili: ….>
<Protect from light.>
<Zaščitite pred svetlobo.>
<Not all pack sizes may be marketed.>
<Ni nujno, da so v prometu vsa navedena pakiranja.>
<Marketing authorisation holder <and manufacturer responsible for batch release>:>
<Imetnik dovoljenja za promet z zdravilom <in proizvajalec odgovoren za sproščanje serij>:>
<Store and transport refrigerated (2°C - 8°C).>
<Shranjujte in prevažajte v hladilniku (2 (C - 8 (C)>.>
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
- zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).>
Special warning(s)
Posebno(a) opozorilo(a)
<This veterinary medicinal product does not require any special storage conditions.>
<Za shranjevanje zdravila niso potrebna posebna navodila.>
<Store in the original <container><package>>
<Shranjujte v originalni(em) <vsebniku> <ovojnini>.>
<Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required.
<Glede odstranjevanja zdravil, ki jih ne uporabljate več, se posvetujte z <veterinarjem> <ali> <farmacevtom>.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
PODATKI KI MORAJO BITI NAVEDENE NA ZUNANJI OZ. STIČNI OVOJNINI - ZDRUŽENA STIČNA OVOJNINA IN NAVODILO ZA UPORABO
{active substance(s)}
{učinkovina(e)}
<Store in a dry place>
<Shranjujte na suhem mestu.>
<Store in a freezer {temperature range}.>
<Shranjujte v zamrzovalniku {temperaturni interval}.>
The words “Keep out of the sight and reach of children”
Besedilo “zdravilo shranjujte nedosegljivo otrokom”
- common (more than 1 but less than 10 animals in 100 animals treated)
- pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali)
<Pregnancy and lactation:>
<Brejost in laktacija:>
<Lay:>
<Brejost:>
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali)
Thursday 22 January 2015
22. januar 2015
Pharmacovigilance Risk Assessment Committee
Odbor za oceno tveganja na področju farmakovigilance
Adopted at the 6-9 January 2015 PRAC
Sprejeto na seji odbora PRAC 6.-9. januarja 2015
In addition, routine pharmacovigilance should be performed in order to better characterise the risk.
Poleg tega je treba izvajati rutinske farmakovigilančne dejavnosti, da bi bolje opredelili tveganje.
Additional tests and medicines may be needed to diagnose and treat this.
Za diagnozo in zdravljenje bodo morda potrebni dodatne preiskave in zdravila.
PRAC recommendations on signals for update of the product information
Priporočila odbora PRAC o signalih za posodobitev informacij o zdravilu
Also tell your doctor or pharmacist if you have a muscle weakness that is constant.
Svojemu zdravniku ali farmacevtu prav tako povejte, če se vam pojavi stalna oslabelost mišic.
Frequency ‘not known': aggression
Neznana pogostnost: agresivnost
• in neonates up to 4 weeks of age (see section 4.4).
• pri novorojenčkih, starih do štiri tedne (glejte poglavje 4.4).
POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3).
Opraviti je treba testiranje za mutacije gena POLG v skladu s trenutno klinično prakso za diagnostično oceno takšnih motenj (glejte poglavje 4.3).
Side effects of unknown frequency: Muscle weakness that is constant.
Neželeni učinki neznane pogostnosti: stalna oslabelost mišic.
Section 4.4 - Special warnings and precautions for use:
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi:
The package leaflets should be updated accordingly.
Ustrezno je treba posodobiti tudi navodila za uporabo.
Valproate and related substances - Mitochondrial toxicity (EPITT no 17956)
Valproat in sorodne učinkovine - mitohondrijska toksičnost (EPITT no 17956)
Paroxetine - Aggression (EPITT no 18089)
Paroksetin - agresivnost (EPITT no 18089)
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140)
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - imunsko posredovana nekrotizirajoča miopatija (IMNM) (EPITT no 18140)
• in patients in the perioperative liver transplantation period and
• pri bolnikih v perioperativnem obdobju presaditve jeter in
Optimark is contraindicated
Zdravilo Optimark je kontraindicirano
What you need to know before you <take> <use> <product name> Do not <take> <use> <product name>:
Kaj morate vedeti, preden <boste vzeli> <boste uporabili> <ime zdravila> Ne <jemljite> <uporabljajte> <ime zdravila>:
Section 4.8 - Undesirable effects:
Poglavje 4.8 - Neželeni učinki:
What you need to know before you <take> <use> <product name> Warnings and Precautions:
Kaj morate vedeti, preden <boste vzeli> <boste uporabili> <ime zdravila> Opozorila in previdnostni ukrepi:
Footnote - cases of aggression were observed in post marketing experience Package Leaflet:
Opomba - V okviru izkušenj v obdobju trženja so bili zabeleženi primeri agresivnosti.
Homeopathic products containing lithium are not affected by this PRAC recommendation.
To priporočilo odbora PRAC ne velja za homeopatske izdelke, ki vsebujejo litij.
Following the variation of the marketing authorisation for these products, the MAHs for any product with the same active substance should submit a respective variation application.
Po spremembi dovoljenja za promet za ta zdravila morajo imetniki dovoljenja za promet s katerim koli zdravilom z isto zdravilno učinkovino predložiti zadevno vlogo za spremembo.
Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408)
Gadodiamid; gadopentetna kislina; gadoversetamidnefrogena sistemska fibroza pri bolnikih z akutno poškodbo ledvic (EPITT no 408)
In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations.
Na podlagi podatkov, ki so jih predložili imetniki dovoljenja za promet, in nasvetov delovne skupine za farmakogenomiko je odbor PRAC zaključil, da so na voljo zadostni dokazi v podporo vzročni povezavi med valproatom in poslabšanjem osnovnih mitohondrijskih bolezni, vključno s tveganjem za hepatotoksičnost, do katere prihaja predvsem pri bolnikih z mutacijami POLG (polimeraza gama).
Section 2:
Poglavje 2:
POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
Na motnje, povezane z genom POLG, je treba posumiti pri bolnikih s pozitivno družinsko anamnezo ali značilnimi simptomi za motnjo, povezano s POLG, kamor med drugim spadajo nepojasnjena encefalopatija, neodzivna epilepsija (fokalna, mioklonična), epileptični status pri pregledu, zaostanki v razvoju, psihomotorično nazadovanje, aksonalna senzorično-motorična nevropatija, miopatija, cerebralna ataksija, oftalmoplegija ali komplicirana migrena z okcipitalno avro.
In light of the data available, the PRAC has agreed that the evidence is sufficient to conclude that longterm use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas.
Na podlagi razpoložljivih podatkov se je odbor PRAC strinjal, da so na voljo zadostni dokazi za zaključek, da dolgotrajna uporaba litija lahko povzroči mikrociste, onkocitome in karcinome Bellinijevih vodov.
Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene.
Valproat lahko izzove ali poslabša klinične znake osnovnih mitohondrijskih bolezni, ki jih povzročajo mutacije mitohondrijske DNK in jedrnega gena POLG.
SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration
Spremembe povzetka glavnih značilnosti za zdravilo Optimark (gadoversetamid) 4.2 Odmerjanje in način uporabe
Optimark is contraindicated in these patients (see section 4.3).
Zdravilo Optimark je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment.
Klinična znaka IMNM sta trdovratna oslabelost proksimalnih mišic in povišana vrednost serumske kreatin kinaze, ki kljub ukinitvi zdravljenja s statini ne izzvenita.
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Pred apliciranjem zdravila Optimark je treba pri vseh bolnikih z laboratorijskimi preiskavami ugotoviti morebitno ledvično disfunkcijo.
Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Pri bolnikih, pri katerih so opravili presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini pogostost akutne ledvične odpovedi visoka.
<invented name> is contraindicated in these patients (see section 4.3).
Kontrastno sredstvo <izmišljeno ime> je pri teh bolnikih kontraindicirano (glejte poglavje 4.3).
Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet:
Neznana pogostnost: imunsko posredovana nekrotizirajoča miopatija (glejte poglavje 4.4.)
• in patients who have had liver transplantation or
• pri bolnikih, pri katerih so opravili presaditev jeter, ali
Possible side effects:
Možni neželeni učinki:
If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions
Če imate genetsko motnjo, ki povzroča mitohondrijsko bolezen(npr. sindrom Alpers-Huttenlocher).
Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Pri bolnikih, pri katerih so opravili ali opravljajo presaditev jeter, je tveganje še zlasti veliko, saj je v tej skupini incidenca akutne ledvične odpovedi visoka.
Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4).
Valproat je kontraindiciran pri bolnikih z ugotovljenimi mitohondrijskimi motnjami, ki jih povzročajo mutacije jedrnega gena, ki kodira mitohondrijski encim polimerazo γ (POLG), npr. sindromom AlpersHuttenlocher, in pri otrocih, starih manj kot dve leti, pri katerih sumijo na motnjo, povezano s POLG (glejte poglavje 4.4).
SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid)
Spremembe povzetka glavnih značilnosti za zdravili Omniscan (gadodiamid) in Magnevist (gadopentetna kislina)
Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Pred uporabo kontrastnega sredstva <izmišljeno ime> je treba pri vseh bolnikih na podlagi laboratorijskih preiskav oceniti delovanje ledvic.
Musculoskeletal disorders:
Bolezni mišično-skeletnega sistema in vezivnega tkiva:
Lithium - Solid renal tumours (EPITT no 18090)
Litij - čvrsti ledvični tumorji (EPITT no 18090)
Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).
Ledvični tumorji: Pri bolnikih s hudo okvaro ledvic, ki so jemali litij več kot 10 let, lahko obstaja povečano tveganje za razvoj benignega ali malignega tumorja ledvic (mikrocist, onkocitomov ali karcinomov Bellinijevih vodov).
Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined):
Po preučitvi razpoložljivih dokazov v literaturi se je odbor PRAC strinjal, da morajo imetniki dovoljenja za promet z zdravili, ki vsebujejo atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin ali lovastatin v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo podčrtano):
Patients with known or suspected mitochondrial disease
Bolniki z ugotovljeno mitohondrijsko boleznijo ali sumom nanjo
Package leaflet:
Bolezni sečil: