FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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,
Romanian: - dacă suferiţi de şoc cardiogen (afecţiune cardiacă tratată în spital); - dacă suferiţi de tulburări de ritm cardiac; - dacă aveţi infarct miocardic; - dacă suferiţi de hipotensiune arterială severă; - dacă suferiţi de angină instabilă (formă severă în care durerile în piept sunt foarte frecvente şi apar atât în repaus cât şi la efort);
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Romanian: CONDIȚII SAU RESTRICȚII PRIVIND UTILIZAREA SIGURĂ ȘI
English: Ivabradine Anpharm 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Romanian: Ivabradine Anpharm 7,5 mg: un comprimat filmat conţine ivabradină 7,5 mg (echivalent cu clorhidrat de ivabradină 8,085 mg).
English: Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Romanian: Prospect: Informaţii pentru pacient Ivabradine Anpharm 5 mg comprimate filmate Ivabradine Anpharm 7,5 mg comprimate filmate Ivabradină
English: How to take Ivabradine Anpharm
Romanian: Cum să luaţi Ivabradine Anpharm
English: INFORMATION IN BRAILLE Ivabradine Anpharm 5 mg
Romanian: Ivabradine Anpharm 5 mg
English: INFORMATION IN BRAILLE Ivabradine Anpharm 7.5 mg
Romanian: Ivabradine Anpharm 7,5 mg
English: Do not take Ivabradine Anpharm if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Anpharm”).
Romanian: Nu luați Ivabradine Anpharm dacă puteți rămâne gravidă și nu utilizați mijloace sigure de contracepție
English: If you forget to take Ivabradine Anpharm:
Romanian: Dacă uitaţi să luaţi Ivabradine Anpharm
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Romanian: Numele şi adresa fabricanţilor responsabili pentru eliberarea seriei
English: 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.
Romanian: În studiile clinice pivot de fază III, o serie de medicamente au fost asociate în mod curent cu ivabradina fără a se dovedi a afecta siguranţa administrării: inhibitorii enzimei de conversie a angiotensinei, antagonişti ai angiotensinei II, beta-blocante, diuretice, medicamente antialdosteronice,
English: If you stop taking Ivabradine Anpharm:
Romanian: Dacă încetaţi să luaţi Ivabradine Anpharm
English: 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).
Romanian: În subgrupul pacienţilor cu FC ≥ 75 bpm (n=4150) a fost observată o reducere mai mare în ceea ce priveşte criteriul principal final de evaluare compus, de 24% (rata de risc: 0,76; 95%IÎ [0,68; 0,85]
English: 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]).
Romanian: În subgrupul pacienţilor cu FC ≥ 75 bpm şi trataţi cu doza ţintă recomandată de beta-blocant, nu s-a observat un beneficiu semnificativ statistic în ceea ce priveşte criteriul principal final de evaluare compus (rata de risc: 0,97; 95%IÎ [0,74; 1,28]) şi alte criterii secundare finale de evaluare,
English: The concomitant use of potent CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contraindicated (see section 4.3).
Romanian: (ketoconazol, itraconazol), antibiotice macrolidice (claritromicină, eritromicină per os, josamicină, telitromicină), inhibitori de protează HIV (nelfinavir, ritonavir) şi nefazodonă (vezi pct.
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Romanian: Comprimate filmate triunghiulare, de culoarea somonului, gravate pe una dintre fețe cu ”7,5”, iar pe cealaltă cu semnul
English: The starting dose should not exceed one tablet of Ivabradine Anpharm 5 mg twice daily.
Romanian: Dacă urmați tratament pentru angină pectorală stabilă Doza de început nu trebuie să depășească un comprimat de Ivabradine Anpharm 5 mg de două ori pe zi.
English: 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).
Romanian: - rifampicină (antibiotic) - barbiturice (pentru dificultăţi de somn sau epilepsie) - fenitoină (pentru epilepsie) - Hypericum perforatum sau sunătoare (tratament pe bază de sunătoare pentru depresie) - medicamente care prelungesc intervalul QT utilizate pentru tratarea tulburărilor de ritm cardiac sau a altor afecţiuni: - chinidină, disopiramidă, ibutilidă, sotalol, amiodaronă (pentru tulburări de ritm cardiac) - bepridil (pentru angină pectorală) - unele tipuri de medicamente pentru tratarea anxietăţii, schizofreniei sau a altor psihoze (cum sunt: pimozidă, ziprasidonă, sertindol)
English: Ivabradine Anpharm should be taken during meals.
Romanian: Ivabradine Anpharm se administrează în timpul meselor.
English: Special populations
Romanian: Alte asocieri
English: (see section 5.1)
Romanian: 4.5 şi 5.2),
English: Ivabradine Anpharm 7.5 mg film-coated tablets
Romanian: Ivabradine Anpharm 7,5 mg comprimate filmate
English: Ivabradine Anpharm 5 mg film-coated tablets
Romanian: Ivabradine Anpharm 5 mg comprimate filmate
English: Sick sinus syndrome
Romanian: - Sindromul sinusului bolnav, - Bloc sino-atrial,
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Romanian: - deces de orice cauză - deces datorită IC
English: Talk to your doctor or pharmacist before taking Ivabradine Anpharm - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Romanian: - dacă aţi suferit un accident vascular cerebral recent (atac cerebral); - dacă suferiţi de hipotensiune arterială uşoară sau moderată; - dacă suferiţi de tensiune arterială necontrolată medicamentos, în special după o modificare a tratamentului dumneavoastră antihipertensiv; - dacă suferiţi de insuficienţă cardiacă severă sau de insuficienţă cardiacă cu anomalii pe ECG numită „bloc de ramură” ; - dacă suferiţi de afecţiune retiniană oculară cronică; - dacă suferiţi de afecţiuni hepatice moderate; - dacă suferiţi de afecţiuni renale severe.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Romanian: Un comprimat filmat conţine ivabradină 7,5 mg (echivalent cu clorhidrat de ivabradină 8,085 mg).
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets
Romanian: Ivabradine Anpharm 5 mg comprimate filmate Ivabradine Anpharm 7,5 mg comprimate filmate
English: Nausea
Romanian: Fertilitatea
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Romanian: Un comprimat filmat conţine ivabradină 5 mg (echivalent cu clorhidrat de ivabradină 5,390 mg).
English: Magyarország Servier Hungaria Kft. Tel.: + 36 1 238 77 99
Romanian: Laboratorios Servier S.L. Tel: +34 91 748 96 30
English: Other medicines and Ivabradine Anpharm
Romanian: Ivabradine Anpharm împreună cu alte medicamente
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Romanian: DENUMIREA COMERCIALĂ A MEDICAMENTULUI
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets ivabradine
Romanian: Ivabradine Anpharm 5 mg comprimate filmate ivabradină
English: Contraindication of concomitant use
Romanian: DECLARAREA SUBSTANŢEI(LOR) ACTIVE
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Romanian: Ivabradine Anpharm 7,5 mg comprimate filmate ivabradină
English: Do not take Ivabradine Anpharm if you are pregnant or are planning to have a baby (see “Do not take Ivabradine Anpharm”).
Romanian: Sarcina şi alăptarea Nu luaţi Ivabradine Anpharm dacă sunteţi gravidă sau intenţionaţi să rămâneţi gravidă.
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Romanian: (de exemplu: chinidină, disopiramidă, bepridil, sotalol, ibutilid, amiodaronă) - Medicamente utilizate în tratamentul altor boli decât cele cardiovasculare şi care prelungesc intervalul QT (de exemplu: pimozidă, ziprasidonă, sertindol, meflochină, halofantrină, pentamidină, cisapridă, eritromicină intravenos).
English: These measures should help to protect the environment.>
Romanian: Aceste măsuri contribuie la protecţia mediului.
English: Advice on correct administration
Romanian: Sfat pentru administrare corecta
English: Date on which the label was last approved
Romanian: Data la care eticheta a fost aprobata ultima data
English: <The frequency of adverse reactions is defined using the following convention:
Romanian: <Frecventa reactiilor adverse este definita utilizand urmatoarea conventie:
English: <Not all pack sizes may be marketed.>
Romanian: <Nu toate marimile de ambalaj pot fi comercializate.
English: <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/ >
Romanian: Informatii detaliate despre acest produs medicinal veterinar sunt disponibile pe websiteul Agentiei Europene a medicamentelor HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/
English: 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.
Romanian: Dacă observați orice reacție adversă, chiar și cele care nu sunt deja incluse în aceasta eticheta sau credeți că medicamentul nu a avut efect vă rugăm să informați medicul veterinar.
English: <Do not use {name} if you notice {description of the visible signs of deterioration}.>
Romanian: <A nu se utiliza {denumire} daca observati {descrieti semnele vizibile de deteriorare}.>
English: <Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only]
Romanian: <Alternativ, puteți raporta prin intermediul sistemului național de raportare {detalii ale sistemului național}.> [For MRP/DCP only]
English: <Overdose (symptoms, emergency procedures, antidotes):>
Romanian: <Supradozare (simptome, proceduri de urgenta, antidot):>
English: <Interaction with other medicinal products and other forms of interaction:>
Romanian: <Interactiunea cu alte produse medicinale si alte forme de interactiune:>
English: Other information>
Romanian: Alte informatii>
English: Pharmaceutical form
Romanian: Forma farmaceutica
English: The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Romanian: Cuvintele „Doar pentru tratamentul animalelor” si conditii sau restrictii privind furnizarea si utilizarea, dupa caz
English: <The expiry date refers to the last day of that month.>
Romanian: <Data de expirare se refera la ultima zi din luna>
English: <For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.>
Romanian: <Pentru informatii ulterioare despre acest produs medicinal veterinar, va rugam contactati reprezentantul local al detinatorului autorizatiei de comercializare.
English: Name of the veterinary medicinal product
Romanian: Denumirea produsului medicinal veterinar
English: Dosage for each species, route(s) and method of administration
Romanian: Dozaj pentru fiecare specie, cale (cai) si metode de administrare
English: Special precautions for the disposal of unused product or waste materials, if any
Romanian: Precautii speciale pentru eliminarea produselor neutilizate sau a deşeurilor, după caz
English: Do not use this veterinary medicinal product after the expiry date which is stated on the <label> <bottle> <...> <after {abbreviation used for expiry date}>.
Romanian: < Nu utilizati acest produs medicinal veterinar dupa data care este inscriptionata pe <eticheta> <flacon> <...> <dupa {abrevierea utilizata pentru data de expirare}>.
English: <Ask your <veterinary surgeon> <or> <pharmacist> how to dispose of medicines no longer required.
Romanian: <Solicitaţi <medicului veterinar> <sau><farmacistului> informaţii referitoare la modalitatea de eliminare a medicamentelor care nu mai sunt necesare.
English: <Consideration should be given to official guidance on the incorporation of medicated premixes in final feeds.>
Romanian: <Trebuie luate în considerare recomandările oficiale referitoare la încorporarea premixurilor medicamentate în furajele finite.
English: <Keep the {container} tightly closed>
Romanian: <A se păstra {containerul}bine închis>
English: Contraindications
Romanian: Contraindicatii
English: <Store in the original <container><package>>
Romanian: <A se păstra în <containerul> < ambalajul> original>>
English: Adverse reactions
Romanian: Reactii adverse
English: Statement of the active substance (s) and other ingredients
Romanian: Declararea substantei (substantelor) active si a altor ingrediente
English: The words “Keep out of the sight and reach of children”
Romanian: Menţiunea „A nu se lăsa la vederea si îndemâna copiilor”
English: Special storage precautions
Romanian: Precautii speciale de depozitare
English: <Special precautions to be taken by the person administering the veterinary medicinal product to animals:>
Romanian: <Precautii speciale care vor fi luate de persoana care administreaza produsul medicinal veterinar la animale:>
English: <EXP {month/year}>
Romanian: <EXP {lună/an}>
English: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
Romanian: {Denumirea (atribuită) a produsului medicinal veterinar <concentraţie> formă farmaceutică<specii tinta>}
English: <Do not <refrigerate> <or> <freeze>.>
Romanian: <A nu se <refrigera> <sau> < congela>>
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different
Romanian: Denumirea şi adresa deţinătorului autorizaţiei de comercializare şi a deţinătorului autorizaţiei de fabricare, responsabil pentru eliberarea seriilor de produs, dacă sunt diferite
English: <Protect from direct sunlight.>
Romanian: <A se proteja de lumină solara directă>
English: Marketing authorisation number(s)
Romanian: NUMĂRUL (NUMERELE) AUTORIZAŢIEI DE COMERCIALIZARE
English: <Shelf life after incorporation into meal or pelleted feed: ….>
Romanian: <Valabilitatea dupa incorporarea in hrana sau furaje peletate:...>
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET
Romanian: INFORMAŢII CARE TREBUIE ÎNSCRISE PE AMBALAJUL PRIMAR - ETICHETA SI PROSPECT COMBINAT
English: <Medicines should not be disposed of via wastewater <or household waste>.>
Romanian: <Medicamentele nu trebuie aruncate în ape reziduale sau <resturi menajere.
English: <Fertility:>
Romanian: <Fertilitate:>
English: <To be supplied only on veterinary prescription.>
Romanian: < Se eliberează numai pe bază de reţetă veterinară.
English: <Incompatibilities:>
Romanian: <Incompatibitati:>
English: <Shelf life after first opening the container: …..>
Romanian: <Valabilitatea dupa prima deschidere a containerului:...>
English: {active substance(s)}
Romanian: {substanţă activă (substanţe active)}
English: <This veterinary medicinal product does not require any special storage conditions.>
Romanian: <Acest produs medicinal veterinar nu necesita conditii de pastrare speciale>
English: <Do not store above <25°C> <30°C>.> or
Romanian: <A nu se păstra la temperatură mai mare de <25°C > <30°C >>sau
English: Expiry date
Romanian: DATA EXPIRĂRII
English: <Shelf life after <dilution> <reconstitution> according to directions: …..>
Romanian: <Valabilitatea dupa <dilutie> <reconstituire> conform recomandarilor:...>
English: <Store in a refrigerator (2°C - 8°C).>
Romanian: <A se păstra la frigider (2°C - 8°C)
English: <in order to protect from <light> <and> <moisture>.>
Romanian: <Protejare de < lumină><si> <umiditate>>
English: Indication(s)
Romanian: Indicaţie (indicaţii)
English: <Protect from light.>
Romanian: <A se proteja de lumină>
English: <Special precautions for use in animals:>
Romanian: <Precautii speciale pentru utilizare la animale>
English: - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).>
Romanian: - Foarte rare (mai putin de 1 animal din 10 000 animale tratate, inclusiv raportarile izolate).
English: <This veterinary medicinal product does not require any special temperature storage conditions.>
Romanian: <Acest produs medicinal veterinar nu necesita conditii de tempetatura speciale pentru pastrare>
English: Manufacturer's batch number
Romanian: NUMĂRUL DE FABRICAŢIE AL SERIEI DE PRODUS
English: <Store and transport refrigerated (2°C - 8°C).>
Romanian: <A se păstra şi transporta în condiţii de refrigerare (2°C - 8°C) >
English: <Manufacturer responsible for batch release:>
Romanian: <Producător responsabil pentru eliberarea seriei: >
English: <Store below <25°C> <30°C>.>
Romanian: <A se păstra la temperatură mai mică de <25°C > <30°C >>
English: <Store in a dry place>
Romanian: <A se păstra în loc uscat>
English: <Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>>
Romanian: <Dupa <desigilare> ,<deschidere> <diluare><reconstituire><se va utiliza până la …><se utilizeaza in timp de.
English: Special warning(s)
Romanian: Atenţionare (atenţionări) specială (speciale
English: <Marketing authorisation holder <and manufacturer responsible for batch release>:>
Romanian: <Deţinătorul autorizaţiei de comercializare <şi producătorul responsabil pentru eliberarea seriei:>
English: <Batch> <Lot> <BN> {number}
Romanian: <Serie> < Lot> {număr}
English: Package size
Romanian: Marimea ambalajului
English: <Store and transport frozen {temperature range}.>
Romanian: <A se păstra şi transporta în condiţii de congelare {limite de temperatura specificate}>>
English: <Withdrawal period(s):>
Romanian: <Timp(i) de aşteptare:>
English: - very common (more than 1 in 10 animals treated displaying adverse reaction(s))
Romanian: - Foarte frecvente (mai mult de 1 din 10 animale tratate care prezinta reactii adverse in timpul unui tratament)
English: <Protect from frost.>
Romanian: <A se feri de îngheţ>
English: <Store in a freezer {temperature range}.>
Romanian: <A se păstra la congelator{limite de temperatura specificate}>
English: {NATURE/TYPE}
Romanian: {NATURĂ/TIP}
English: - common (more than 1 but less than 10 animals in 100 animals treated)
Romanian: - Frecvente (mai mult de 1 dar mai putin de 10 animale din 100 animale tratate)
English: - rare (more than 1 but less than 10 animals in 10,000 animals treated)
Romanian: - Rare (mai mult de 1 dar mai putin de 10 animale din 10 000 animale tratate)
English: <Pregnancy and lactation:>
Romanian: <Gestatie si lactatie:>
English: <Lactation:>
Romanian: <Lactatie:>
English: - uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
Romanian: - Mai putin frecvente (mai mult de 1 dar mai putin de 10 animale din 1000 animale tratate)
English: <Special warnings for each target species:>
Romanian: <Precautii speciale pentru specii tinta>
English: Target species
Romanian: Speecii tinta
English: <Lay:>
Romanian: <Gestatie:>
English: <None.>
Romanian: <Fara>
English: Adopted at the 6-9 January 2015 PRAC
Romanian: Adoptate la reuniunea PRAC din 6-9 ianuarie 2015
English: Thursday 22 January 2015
Romanian: 22 ianuarie 2015
English: Pharmacovigilance Risk Assessment Committee
Romanian: Comitetul pentru evaluarea riscurilor în materie de farmacovigilență
English: PRAC recommendations on signals for update of the product information
Romanian: Recomandările PRAC privind semnalele pentru actualizarea informaţiilor referitoare la produs
English: Homeopathic products containing lithium are not affected by this PRAC recommendation.
Romanian: Produsele homeopate care conţin litiu nu sunt afectate de această recomandare a PRAC.
English: In addition, routine pharmacovigilance should be performed in order to better characterise the risk.
Romanian: În plus, trebuie întreprinse măsurile de farmacovigilenţă de rutină, pentru a caracteriza mai bine riscul.
English: Optimark is contraindicated
Romanian: Optimark este contraindicat
English: The package leaflets should be updated accordingly.
Romanian: Prospectele trebuie actualizate în consecinţă.
English: Summary of Product Characteristics (SmPC):
Romanian: Rezumatul caracteristicilor produsului (RCP):