natgillin/translations-raw huggingface dataset:
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). 
Ukoliko tijekom liječenja srčana frekvencija padne ispod 50 otkucaja u minuti (50/min) u mirovanju ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija, doza se mora titrirati na nižu, uključujući najnižu dozu od 2,5 mg dva puta na dan
Ivabradine Anpharm 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). 
Ivabradine Anpharm 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Patients with hypotension 
Mjere opreza pri uporabi Bolesnici s hipotenzijom
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). 
0,83, 95%CI [0.72;0.96] - p=0,0109) i smrt zbog kardiovaskularnih uzroka (omjer hazarda (HR): 0,83, 95%CI [0.71;0.97] - p=0,0166).
Ivabradine Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other. 
Ivabradine Anpharm 7,5 mg tablete su trokutaste filmom obložene tablete boje lososa s utisnutom oznakom “7.5” na jednoj strani , a na drugoj.
Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors). 
Pokazalo se da ivabradin ne utječe na metabolizam i plazmatske koncentracije drugih CYP3A4
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: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
How to store Ivabradine Anpharm 
Kako čuvati Ivabradine Anpharm
- 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 
- Kardiogeni šok - Akutni infarkt miokarda - Teška hipotenzija (< 90/50 mmHg) - Teška insuficijencija jetre - Sindrom bolesnog sinusnog čvora - Sinusatrijski blok - Nestabilno ili akutno zatajenje srca
In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012). 
(definiran kao smanjenje od najmanje 3 napadaja angine na tjedan i/ili povećanje vremena do depresije ST segmenta za 1 mm od najmanje 60 s za vrijeme testa opterećenja) tijekom 6 tjedana liječenja (omjer šansi (OR) = 1,3, 95% CI [1,0-1,7]; p=0,012).
The starting dose should not exceed one tablet of Ivabradine Anpharm 5 mg twice daily. 
Ukoliko se liječite od stabilne angine pektoris Početna doza ne smije prelaziti jednu tabletu Ivabradine Anpharm5 mg dva puta na dan.
Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine 
Uputa o lijeku: Informacije za bolesnika Ivabradine Anpharm5 mg filmom obložene tablete Ivabradine Anpharm7,5 mg filmom obložene tablete ivabradin
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. 
(50/min) u mirovanju, ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, doza se mora titrirati na slijedeću nižu u bolesnika koji primaju 7,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]). 
[0,74;1,28]) niti za ostale sekundarne ishode uključujući hospitalizaciju zbog pogoršanja zatajenja srca (omjer hazarda (HR): 0,79, 95% CI [0,56;1,10]) ili smrt zbog zatajenja srca (omjer hazarda (HR): 0,69, 95% CI [0,31;1,53]).
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). 
Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao prilagoditi dozu Ivabradina Anpharmili pratiti liječenje: - flukonazol (antifungik) - rifampicin (antibiotik) - barbiturati (za otežano spavanje ili epilepsiju) - fenitoin (za epilepsiju) - Hypericum perforatum ili Gospina trava (biljna terapija za depresiju) - lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti:
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride) 
Jedna filmom obložena tableta sadrži 7,5mg ivabradina (što odgovara 8,085 mg ivabradinklorida)
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride) 
Jedna filmom obložena tableta sadrži 5mg ivabradina (što odgovara 5,39 mg ivabradinklorida)
Ivabradine Anpharm 5 mg film-coated tablets 
Ivabradine Anpharm 5 mg filmom obložene tablete ivabradin
Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered. 
Mjerenje srčane frekvencije Budući da srčana frekvencija može značajno flukturirati tijekom vremena, mora se razmotriti provođenje serijskog mjerenja srčane frekvencije, putem EKG-a ili ambulantno 24-satno mjerenje,
- Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, 
- Ostali lijekovi koji produljuju QT-interval (npr. pimozid, ziprasidon, sertindol, meflokin,
5 How to store Ivabradine Anpharm Contents of the pack and other information 
Kako Ivabradine Anpharm izgleda i sadržaj pakiranja
What Ivabradine Anpharm looks like and contents of the pack Ivabradine Anpharm 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other. 
Ivabradine Anpharm 5 mg filmom obložene tablete Duguljasta filmom obložena tableta boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani a na drugoj.
Ivabradine Anpharm 7.5 mg film-coated tablets 
Ivabradine Anpharm 7,5 mg filmom obložene tablete ivabradin
Ivabradine Anpharm with food and drink Avoid grapefruit juice during treatment with Ivabradine Anpharm. 
Stoga je tijekom liječenja ivabradinom potrebno izbjegavati konzumiranje soka od grejpa.
The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3[ years, [3-18[ years and <40 kg and [3-18[ 
U 69,9% bolesnika koji su primali ivabradin postignuto je 20% sniženje frekvencije srca bez bradikardije naspram 12,2% bolesnika u skupini koja je primala placebo tijekom razdoblja titracije od 2 do 8 tjedana (omjer šansi: E = 17,24, 95% CI [5,91; 50,30]) Srednje doze ivabradina koje su omogućile postizanje sniženje frekvencije srca za 20% su 0,13 ± 0,04 mg/kg dva puta na dan, 0,10 ± 0,04 mg/kg dva puta na dan i 4,1 ± 2,2 mg dva puta na dan u dobnim podskupinama od [1-3[ godine, [3-18[ godina i s <40 kg, odnosno [3-18[ godina i s ≥ 40 kg.
Erythema Pruritus Urticaria 
Konstipacija Proljev
Therefore, ivabradine is contraindicated during breast-feeding (see section 4.3). 
Stoga je ivabradin kontraindiciran u žena koje doje (vidjeti dio 4.3).
Diplopia Visual impairment 
Tablični prikaz nuspojava
Stroke 
interval
NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets 
Ivabradine Anpharm 5 mg filmom obložene tablete Ivabradine Anpharm 7,5 mg filmom obložene tablete
Pharmacokinetic/pharmacodynamic (PK/PD) relationship 
Farmakokinetički/farmakodinamički odnos
D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of 
U nekim slučajevima (npr. kod starijih osoba) postoji mogućnost da Vam liječnik propiše pola doze, t.j. polovicu tablete od Ivabradina Anpharm5 mg (što odgovara količini od 2,5 mg ivabradina) ujutro, a drugu polovicu tablete od 5 mg uvečer.
For the full list of excipients, see section 6.1. 
- Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1
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 filmom obložene tablete Jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
Respiratory, 
Spazmi mišića
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, 
- ako imate niski krvni tlak; - ako imate nestabilnu anginu pektoris (težak oblik angine pektoris u kojoj se bolovi u prsima javljaju vrlo često uz napor, ali i bez napora);
Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110 
Servier Pharma d.o.o. Tel: + 386 (0)1 563 48 11
Therefore the intake of grapefruit juice should be avoided. 
Anpharmizbjegavajte konzumiranje soka od grejpa.
Servier s.r.o. 
Servier Italia S.p.A.
V.J. 
RMP-a.
Malaise, possibly related to bradycardia 
Umor, moguće povezan s bradikardijom
<Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only] 
<Alternativno, možete prijaviti putem nacionalnog sustava izvješćivanja {detalji nacionalnog sustava}.>[For MRP/DCP only]
<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/ > 
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/.
Other information> 
Ostale informacije>
<Interaction with other medicinal products and other forms of interaction:> 
<Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:>
These measures should help to protect the environment.> 
Te mjere pomažu u zaštiti okoliša.>
<Overdose (symptoms, emergency procedures, antidotes):> 
<Predoziranje (simptomi, hitni postupci, antidoti):>
<Keep the {container} tightly closed> 
<Držati {spremnik}čvrsto zatvoren>
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. 
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj etiketi ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
<For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.> 
<Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
<Do not use {name} if you notice {description of the visible signs of deterioration}.> 
<Ne primjenjujete {naziv proizvoda} ako primijetite {opis vidljivih znakova kvarenja}.>
The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable 
Riječi “Samo za primjenu na životinjama” i uvjeti ili ograničenja u pogledu opskrbe i primjene, ako je primjenjivo
<Do not <refrigerate> <or> <freeze>.> 
<Ne <hladiti> <ili> <zamrzavati>.>
The words “Keep out of the sight and reach of children” 
Riječi “Držati izvan pogleda i dosega djece”
{(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>} 
{(Izmišljeni) naziv veterinarsko-medicinskog proizvoda <jačina> farmaceutski oblik <ciljne vrste životinja>}
<Protect from direct sunlight.> 
<Zaštiti od direktnog sunčevog svjetla.>
Special precautions for the disposal of unused product or waste materials, if any 
15. Posebne mjere opreza prilikom odlaganja neupotrebljenog proizvoda ili otpadnih materijala, ako ih ima
Date on which the label was last approved 
Datum kada je uputa o VMP zadnji puta odobrena
Name of the veterinary medicinal product 
Naziv veterinarsko-medicinskog proizvoda
<Not all pack sizes may be marketed.> 
<Ne moraju sve veličine pakovanja biti u prometu.>
<Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required. 
<Pitajte vašeg <veterinara><farmaceuta> kako odlagati veterinarsko-medicinske proizvode koji vam više nisu potrebni.
<Do not store above <25°C> <30°C>.> or 
<Nemojte čuvati pri temperaturi iznad <25 (C><30 (C>>ili
Advice on correct administration 
11. Savjeti za ispravnu primjenu
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different 
Naziv i adresa nositelja odobrenja za stavljanje u promet i nositelja odobrenja za proizvodnju odgovornog za puštanje serije u promet, ako je različito
<None.> 
<Nema.>
<Store in the original <container><package>> 
<Čuvati u originalnom<spremniku><pakovanju>>
Special storage precautions 
13. Posebne mjere čuvanja
<in order to protect from <light> <and> <moisture>.> 
<radi zaštite od <svjetla> <i> <vlage>.>
<Special warnings for each target species:> 
<Posebna upozorenja <za svaku od ciljnih vrsta životinja:>
<Medicines should not be disposed of via wastewater <or household waste>.> 
<Veterinarsko-medicinski proizvodi se ne smiju odlagati u otvorene vode <ili kućni otpad.>
<This veterinary medicinal product does not require any special temperature storage conditions.> 
<Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne temperaturne uvijete čuvanja.>
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET 
OSNOVNI PODACI NA UNUTARNJEM PAKOVANJU - KOMBINIRANA ETIKETA I UPUTA O VMP
<Protect from light.> 
<Zaštiti od svjetla.>
<Special precautions to be taken by the person administering the veterinary medicinal product to animals:> 
<Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama:>
<Shelf life after <dilution> <reconstitution> according to directions: …..> 
<Rok valjanosti poslije <razrjeđenja><rekonstitucije> prema uputi: …>
<Shelf life after incorporation into meal or pelleted feed: ….> 
<Rok valjanosti poslije stavljanja u obrok ili u peletiranu hranu za životinje: …>
<This veterinary medicinal product does not require any special storage conditions.> 
<Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvijete čuvanja.>
<Store and transport frozen {temperature range}.> 
<Čuvati i prevoziti zamrznuto{temperaturni raspon
Dosage for each species, route(s) and method of administration 
Doziranje za svaku ciljnu vrstu životinja, način i put(evi) primjene
<To be supplied only on veterinary prescription.> 
<Izdaje se na veterinarski recept.>
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).> 
- vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).>
Statement of the active substance (s) and other ingredients 
Količina djelatne(ih) tvari i drugih sastojaka
<Store in a refrigerator (2°C - 8°C).> 
<Čuvati u hladnjaku (2 (C - 8 (C).>
<Incompatibilities:> 
<Inkompatibilnosti:>
<Marketing authorisation holder <and manufacturer responsible for batch release>:> 
<Nositelj odobrenja za stavljanje u promet <i proizvođač odgovoran za puštanje serije u promet>:>
<Batch> <Lot> <BN> {number} 
<Lot> <Serija> {broj}
<Store below <25°C> <30°C>.> 
<Čuvati pri temperaturi do <25 (C><30 (C>.>
<Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>> 
<upotrijebiti do…><koristiti unutar ...><odmah upotrijebiti>.>
<Store and transport refrigerated (2°C - 8°C).> 
<Čuvati i prevoziti na hladnom (2 (C - 8 (C).>
Manufacturer's batch number 
22. Broj proizvodne serije
<Shelf life after first opening the container: …..> 
<Rok valjanosti poslije prvog otvaranja pakovanja: …>
<Protect from frost.> 
<Čuvati od zamrzavanja
<Special precautions for use in animals:> 
<Posebne mjere opreza prilikom primjene na životinjama:>
Special warning(s) 
14. Posebno(a) upozorenje(a)
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)) 
- vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e))
<Pregnancy:> 
<Graviditet:>
<Manufacturer responsible for batch release:> 
<Proizvođač odgovoran za puštanje serije u promet:>
<Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.> 
<Stavljanje ljekovitih premiksa u gotovu hranu za životinje, trebalo bi razmotriti u službenim vodičima.>
<Lactation:> 
<Laktacija:>
<Pregnancy and lactation:> 
<Graviditet i laktacija:>
<Store in a freezer {temperature range}.> 
<Čuvati u zamrzivaču{temperaturni raspon}.>
- common (more than 1 but less than 10 animals in 100 animals treated) 
- česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja)
- rare (more than 1 but less than 10 animals in 10,000 animals treated) 
- rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated) 
- manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih životinja)
<The frequency of adverse reactions is defined using the following convention: 
<Učestalost nuspojava je određena sukladno sljedećim pravilima:
<Store in a dry place> 
<Čuvati na suhom mjestu.>
<Withdrawal period(s):> 
<Karencija(e):>
Marketing authorisation number(s) 
21. Broj(evi) odobrenja za stavljanje u promet
{NATURE/TYPE} 
{OSOBINE/TIP}
<Lay:> 
<Nesenje:>
Indication(s) 
12. Karencija(e)
{active substance(s)} 
{djelatna(e) tvar(i)}
Thursday 22 January 2015 
22. siječnja 2015
Frequency ‘not known': aggression 
Učestalost „nepoznata“: agresija
In addition, routine pharmacovigilance should be performed in order to better characterise the risk. 
Osim toga, treba provoditi rutinsku farmakovigilanciju kako bi se bolje okarakterizirao rizik.
Additional tests and medicines may be needed to diagnose and treat this. 
Možda će biti potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.
Adopted at the 6-9 January 2015 PRAC 
Usvojeno na sjednici PRAC-a 6. - 9. siječnja 2015.
Pharmacovigilance Risk Assessment Committee 
Povjerenstvo za ocjenu rizika na području farmakovigilancije
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. 
Također obavijestite svog liječnika ili ljekarnika ako imate konstantnu mišićnu slabost.
• in neonates up to 4 weeks of age (see section 4.4). 
• u novorođenčadi starosti do 4 tjedna (vidjeti dio 4.4).
Optimark is contraindicated 
Optimark je kontraindiciran
POLG mutation testing should be performed in accordance with current clinical practice for the diagnostic evaluation of such disorders (see section 4.3). 
Testiranje mutacije POLG-a treba provesti u skladu s aktualnom kliničkom praksom za dijagnostičku evaluaciju takvih poremećaja (vidjeti dio 4.3).
Side effects of unknown frequency: Muscle weakness that is constant. 
Nuspojave nepoznate učestalosti: Mišićna slabost koja je konstantna.
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - Immune-mediated necrotizing myopathy (IMNM) (EPITT no 18140) 
Atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin - imunološki posredovana nekrotizirajuća miopatija (IMNM) (EPITT br. 18140)
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. 
Nakon izmjene odobrenja za stavljanje lijeka u promet za ove lijekove, nositelji odobrenja za bilo koji lijek s istom djelatnom tvari trebaju predati zahtjev za odgovarajuću izmjenu.
PRAC recommendations on signals for update of the product information 
Preporuke PRAC-a vezane uz signale za ažuriranje informacija o lijeku
Footnote - cases of aggression were observed in post marketing experience Package Leaflet: 
Bilješka - slučajevi agresije uočeni su u iskustvu prikupljenom nakon stavljanja lijeka u promet Uputa o lijeku:
Paroxetine - Aggression (EPITT no 18089) 
Paroksetin - agresija (EPITT br. 18089)
What you need to know before you <take> <use> <product name> Do not <take> <use> <product name>: 
Što morate znati prije nego počnete <uzimati> <primjenjivati> <naziv lijeka> Nemojte <uzimati> <primjenjivati> <naziv lijeka>:
What you need to know before you <take> <use> <product name> Warnings and Precautions: 
Što morate znati prije nego počnete <uzimati> <primjenjivati> <naziv lijeka> Upozorenja i mjere opreza: