natgillin/translations-raw huggingface dataset:
Ivabradine Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other. 
Tablete zdravila Ivabradine Anpharm 7,5 mg so lososove barve, trikotne in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
In pivotal phase III clinical trials the following medicinal products were routinely combined with ivabradine with no evidence of safety concerns: angiotensin converting enzyme inhibitors, angiotensin II antagonists, beta-blockers, diuretics, anti-aldosterone agents, short and long acting nitrates, HMG CoA reductase inhibitors, fibrates, proton pump inhibitors, oral antidiabetics, aspirin and other antiplatelet medicinal products. 
antagonisti adrenergičnih receptorjev beta, diuretiki, antagonisti aldosterona, kratko in dolgodelujoči nitrati, zaviralci hidroksimetilglutaril koencim A (HMG CoA) reduktaze, fibrati, zaviralci protonske črpalke, peroralni antidiabetiki, aspirin ter druga antitrombocitna zdravila.
(5 mg b.i.d, if age ≥ 75 years) and titration up to 10 mg b.i.d). 
starih ≥ 75 let) in povečanje odmerka do 10 mg dvakrat na dan).
Ivabradine Anpharm contains lactose 
Zdravilo Ivabradine Anpharm vsebuje laktozo.
Ivabradine Anpharm 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). 
Ivabradine Anpharm 5 mg: ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
Ivabradine Anpharm 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride). 
Ivabradine Anpharm 7,5 mg: ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
Marketing Authorisation Holder and Manufacturer: 
Imetnik dovoljenja za promet z zdravilom in izdelovalec
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals 
- preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - srčna frekvenca med mirovanjem pod 70 utripov na minuto pred zdravljenjem - kardiogeni šok - akutni miokardni infarkt - huda hipotenzija (< 90/50 mm Hg)
Stable angina is a heart disease which happens when the heart does not receive enough oxygen. 
O stabilni angini pektoris (običajno imenovani “angina pektoris”): Stabilna angina pektoris je bolezen srca, ki nastaja, ko srce ne dobiva dovolj kisika.
Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1). 
Dodatne učinkovitosti ivabradina v kombinaciji z dihidropiridinskimi kalcijevimi antagonisti niso zasledili
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine Anpharm or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure). 
določene vrste zdravil proti tesnobnosti, shizofreniji ali drugim psihozam (kot so pimozid, ziprazidon, sertindol) zdravila proti malariji (na primer meflokin ali halofantrin) eritromicin v žilo (antibiotik) pentamidin (zdravilo proti parazitom) cisaprid (proti gastroezofagealnemu refluksu) - nekatere vrste diuretikov, ki lahko povzročijo zmanjšanje vrednosti kalija v krvi, kot so furosemid, hidroklorotiazid, indapamid (ki se uporabljajo za zdravljenje edema, visokega krvnega tlaka).
Annopol 6B - 03-236 Warszawa - Poland and 
Annopol 6B - 03-236 Varszawa - Poljska in
The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ml (CV=29%). 
Porazdelitev Ivabradin se veže na beljakovine v plazmi v približno 70 % in volumen porazdelitve v stanju dinamičnega ravnovesja pri bolnikih znaša blizu 100 l. Največja koncentracija v plazmi po kroničnem jemanju priporočenega odmerka 5 mg dvakrat na dan je 22 ng/ml (koeficient variacije = 29 %).
Other medicines and Ivabradine Anpharm 
Shranjevanje zdravila Ivabradine Anpharm
In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] - p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] - p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] - p=0.0166). 
[0,68; 0,85] - p<0,0001) in drugih sekundarnih končnih izidov, vključno z umrljivostjo zaradi različnih vzrokov (razmerje tveganja: 0,83, 95 % interval zaupanja [0,72; 0,96] - p=0,0109) in srčno-žilno umrljivostjo (razmerje tveganja: 0,83, 95 % interval zaupanja [0,71; 0,97] - p=0,0166).
A therapeutic scheme higher than the approved posology was used (starting dose 7.5 mg b.i.d. 
V študiji so uporabili shemo zdravljenja z odmerkom, ki je bil večji od odobrenega odmerjanja (začetni odmerek 7,5 mg dvakrat na dan (5 mg dvakrat na dan pri bolnikih,
Pharmacokinetic/pharmacodynamic (PK/PD) relationship 
PK/PD
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja občasni*
The difference in heart rate between ivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and 8.3 bpm at 24 months. 
utripov na minuto v 28 dneh, 9,1 utripov na minuto v 12 mesecih in 8,3 utripov na minuto v 24 mesecih.
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride) 
Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
Other concomitant use 
peroralna uporaba
It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring. 
Simptomatsko zdravljenje kronične stabilne angine pektoris Priporočljivo je, da se o uvedbi zdravljenja oz. povečanju odmerka odločate v skladu z razpoložljivimi zaporednimi meritvami srčne frekvence, EKG oz. 24-urnim ambulantnim spremljanjem.
Ivabradine Anpharm 5 mg film-coated tablets 
Ivabradine Anpharm 5 mg filmsko obložene tablete ivabradin
Ivabradine Anpharm 7.5 mg film-coated tablets 
Ivabradine Anpharm 7,5 mg filmsko obložene tablete ivabradin
mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). 
kinidin, dizopiramid, ibutilid, sotalol, amjodaron (proti motnjam srčnega ritma)
QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine Anpharm 5 mg film-coated tablets One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). 
Ivabradine Anpharm 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained. 
utripov na minuto, je potrebno ohraniti odmerek 5 mg dvakrat na dan.
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: