FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Slovenian: Na podlagi ovrednotenja trenutno razpoložljivih podatkov je odbor CVMP menil, da splošno razmerje med koristmi in tveganji za ta zdravila ostaja pozitivno, če se upoštevajo spremembe v informacijah o zdravilu.
English: Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.
Slovenian: Zdravilo Captalin raztopina za injiciranje vsebuje 31,25 g spiramicina na 100 ml, kar ustreza 1 000 000 i.e. spiramicina na ml.
English: The CVMP was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.
Slovenian: Odbor CVMP so prosili, naj na podlagi razpoložljivih podatkov poda mnenje o indikacijah, režimih odmerjanja in karencah za govedo in prašiče, da bi zagotovili učinkovito zdravljenje in zmanjšali tveganje za razvoj odpornosti mikrobov proti spiramicinu ter da bi za zadevna zdravila uskladili karence za govedo in prašiče.
English: The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.
Slovenian: Zdravilo za uporabo v veterinarski medicini Suanovil 20 raztopina za injiciranje in njegovo generično zdravilo Spirovet sta raztopini za injiciranje, ki vsebujeta 20 g spiramicina na 100 ml, kar ustreza 600.000 i.e. spiramicina na ml.
English: Therefore, on 9 September 2014 the Committee adopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Slovenian: Zato je 9. septembra 2014 sprejel pozitivno mnenje z večino glasov ter priporočil spremembo dovoljenj za promet z zdravilom Suanovil 20 in povezanimi imeni, zdravilom Captalin in povezanimi imeni ter njunimi generičnimi zdravili.
English: On 12 September 2012, Gemany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Suanovil 20 and associated names, Captalin and associated names and generic products thereof.
Slovenian: Nemčija je 12. septembra 2012 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za zdravilo Suanovil 20 in povezana imena, zdravilo Captalin in povezana imena ter njuna generična zdravila.
English: Opinion following an Article 350F referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof EMA/745255/2014
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 350F za zdravilo Suanovil 20 in povezana imena, zdravilo Captalin in povezana imena ter njuna generična zdravila stran 2/2
English: Opinion following an Article 351 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof
Slovenian: za zdravilo Suanovil 20 in povezana imena, zdravilo Captalin in povezana imena ter njuna generična zdravila
English: --1 Influenza A/eq/Ohio/03 [H3N8] recombinant canarypox virus (vCP2242) ≥ 5.3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] recombinant canarypox virus (vCP3011) ≥ 5.3 log10 FAID50*/ml Clostridium tetani toxoid: ≥ 30 IU**/ml * vCP content checked by global FAID50 (fluorescent assay infectious dose 50%) and qPCR ratio between vCP.
Slovenian: 1 Influenza A/eq/Ohio/03 [H3N8] rekombinantni Canarypox virus (vCP2242) ≥ 5,3 log10 FAID50*/ml Influenza A/eq/Richmond/1/07 [H3N8] rekombinantni Canarypox virus (vCP3011) ≥ 5,3 log10 FAID50*/ml Clostridium tetani toksoid ≥ 30 IU**/ml * vCP vsebnost določena s celokupnim FAID50 (fluorescenčni test infektivnega odmerka 50 %) in qPCR razmerjem med vCP.
English: Horses Intramuscular use vial (glass) 1 ml
Slovenian: Suspenzija za injiciranje Konji intramuskularno Viala (steklo) 1 ml
English: EU (MA) Number Invented name
Slovenian: EU Številka
English: Target Species
Slovenian: Izmišljeno ime Jakost Farmacvtska oblika Ciljna živalska vrsta
English: This means that Fyzoclad was intended to be highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da naj bi bilo zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je v EU že odobreno.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal was due to a change in the company's strategy.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi spremembe v svoji strategiji.
English: On 5 December 2018, Pfizer Europe MA EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Fyzoclad, for the treatment of a number of inflammatory diseases.
Slovenian: Družba Pfizer Europe MA EEIG je 5. decembra 2018 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Fyzoclad, namenjenim zdravljenju več vnetnih bolezni.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Slovenian: Ker je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
English: The company informed the CHMP that there are no ongoing clinical trials with Fyzoclad.
Slovenian: Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja z zdravilom Fyzoclad.
English: Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab)
English: The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company.
Slovenian: Vlogo so umaknili, ko je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Slovenian: Adalimumab z vezavo na TNF zavre njegovo delovanje ter tako zmanjša vnetje in druge simptome bolezni.
English: It was to be available as a solution for injection.
Slovenian: Na voljo naj bi bilo v obliki raztopine za injiciranje.
English: Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab) EMA/866697/2018
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab) EMA/10639/2019
English: This substance is involved in causing inflammation associated with the diseases that adalimumab is intended to treat and is found at high levels in patients with these diseases.
Slovenian: Ta snov sodeluje pri povzročanju vnetja, povezanega z boleznimi, ki naj bi jih adalimumab zdravil, in je pri bolnikih s temi boleznimi prisotna v večjih količinah.
English: Fyzoclad acts on the immune system and was to be used to treat the following inflammatory conditions:
Slovenian: Zdravilo Fyzoclad deluje na imunski sistem in naj bi se uporabljalo za zdravljenje naslednjih vnetnih bolezni:
English: Fyzoclad is a medicine that contains the active substance adalimumab.
Slovenian: Fyzoclad je zdravilo, ki vsebuje učinkovino adalimumab.
English: 13 December 2018
Slovenian: 13. december 2018 EMA/10639/2019
English: Fyzoclad was expected to work in the same way as the reference medicine, Humira.
Slovenian: Zdravilo Fyzoclad naj bi delovalo na enak način kot referenčno zdravilo Humira.
English: Fyzoclad was developed as a ‘biosimilar' medicine.
Slovenian: Zdravilo Fyzoclad je bilo razvito kot „podobno biološko zdravilo“.
English: • uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis.
Slovenian: • uveitisa (vnetja sloja pod beločnico očesa) in pediatričnega uveitisa.
English: What was Fyzoclad expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Fyzoclad uporabljalo?
English: The reference medicine for Fyzoclad is Humira.
Slovenian: Referenčno zdravilo za zdravilo Fyzoclad je zdravilo Humira.
English: The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity.
Slovenian: Družba je predložila laboratorijske študije, v katerih so zgradbo, čistost in biološko delovanje zdravila Fyzoclad primerjali z referenčnim zdravilom Humira.
English: • psoriasis and paediatric plaque psoriasis (both are diseases causing red, scaly patches on the skin).
Slovenian: • psoriaze in pediatrične psoriaze v plakih (bolezni, ki povzročata nastajanje rdečih, luskastih zaplat na koži);
English: How does Fyzoclad work?
Slovenian: Kako zdravilo Fyzoclad deluje?
English: In addition, a study in patients with rheumatoid arthritis compared Fyzoclad with Humira.
Slovenian: Poleg tega so zdravili Fyzoclad in Humira primerjali tudi v študiji pri bolnikih z revmatoidnim artritisom.
English: • axial spondyloarthritis (inflammation of the spine causing back pain);
Slovenian: • aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu);
English: What is Fyzoclad?
Slovenian: Kaj je zdravilo Fyzoclad?
English: • juvenile idiopathic arthritis (disease causing inflammation in the joints);
Slovenian: • juvenilnega idiopatskega artritisa (bolezni, ki povzroča vnetje sklepov);
English: been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Slovenian: Učinkovina zdravila Fyzoclad, adalimumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da v telesu prepozna snov, imenovano tumorje nekrotizirajoči faktor (TNF), in se veže nanjo.
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Slovenian: • psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih lis na koži in vnetje sklepov);
English: Children Procoralan is not intended for use in children and adolescents younger than 18 years.
Slovenian: Otroci Procoralan ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: In this way Procoralan helps to control and reduce the number of angina attacks.
Slovenian: Na ta način Procoralan pripomore k nadzoru in zmanjševanju anginoznih napadov.
English: If you forget to take a dose of Procoralan, take the next dose at the usual time.
Slovenian: Če ste pozabili vzeti odmerek zdravila Procoralan, vzemite naslednji odmerek ob običajnem času.
English: 92284 Suresnes cedex - France
Slovenian: 92284 Suresnes cedex- Francija
English: If you are pregnant and have taken Procoralan, talk to your doctor.
Slovenian: Če ste noseči in ste jemali zdravilo Procoralan, se posvetujte z zdravnikom.
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
Slovenian: Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Procoralan.
English: Procoralan mainly works by reducing the heart rate by a few beats per minute.
Slovenian: Procoralan deluje predvsem tako, da znižuje srčno frekvenco za nekaj utripov na minuto.
English: The safety and efficacy of ivabradine in children aged below 18 years have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost ivabradina pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: What Procoralan is and what it is used for What you need to know before you take Procoralan How to take Procoralan
Slovenian: Kaj je zdravilo Procoralan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Procoralan Kako jemati zdravilo Procoralan
English: If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila Procoralan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Procoralan should be taken during meals.
Slovenian: Zdravilo Procoralan morate jemati med obrokom.
English: If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan.
Slovenian: Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila Procoralan ali med njim.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Procoralan in one or more subsets of the paediatric population in the treatment of chronic heart failure (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Procoralan za eno ali več podskupin pediatrične populacije za zdravljenje kroničnega srčnega popuščanja (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Other medicines and Procoralan
Slovenian: Druga zdravila in zdravilo Procoralan
English: Procoralan may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”).
Slovenian: Procoralan lahko povzroča začasne vidne pojave svetlikanja (prehodno povečanje svetlosti v vidnem polju, glejte “Možni neželeni učinki”).
English: Elevated creatinine in blood ECG prolonged QT interval
Slovenian: Preiskave občasni povečanje kreatinina v krvi podaljšanje intervala QT na EKG
English: How does Procoralan work?
Slovenian: Kako deluje zdravilo Procoralan?
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation:
Slovenian: Ivabradin ne vpliva na znotrajsrčno prevajanje, kontraktilnost (ni negativnega inotropnega učinka) ali repolarizacijo prekatov:
English: Do not take Procoralan - if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Procoralan Ne jemljite zdravila Procoralan če ste alergični na ivabradin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Slovenian: Nekaterim bolnikom (na primer, če ste starejši) lahko zdravnik predpiše polovični odmerek, se pravi eno polovico 5 mg tablete (kar ustreza 2,5 mg ivabradina) zjutraj in eno polovico 5 mg tablete zvečer.
English: Procoralan contains lactose
Slovenian: Zdravilo Procoralan vsebuje laktozo.
English: The starting dose should not exceed one tablet of Procoralan 5 mg twice daily.
Slovenian: Začetni odmerek ne sme presegati ene tablete zdravila Procoralan 5 mg dvakrat na dan.
English: Do not take Procoralan if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Procoralan”).
Slovenian: Če ste ženska v rodni dobi ne smete jemati zdravila Procoralan, razen če uporabljate zanesljive kontracepcijske metode (glejte “Ne jemljite zdravila Procoralan”).
English: Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters : high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Slovenian: Palpitacije in dodatni srčni utripi, občutek slabosti (navzea), zaprtje, driska, bolečina v trebuhu, občutek vrtoglavosti (vertigo), oteženo dihanje (dispneja), mišični krči, spremembe laboratorijskih parametrov: visoke vrednosti sečne kisline v krvi, preveliko število eozinofilcev (vrsta belih krvnih celic) in povečanje kreatinina v krvi (razgradni produkt mišic), kožni izpuščaj, angioedem (kot je otečen obraz, jezik ali grlo, težave pri dihanju ali požiranju), nizek krvni tlak, omedlevica, občutek utrujenosti, občutek šibkosti, nepravilnosti v zapisu EKG srca, dvojni vid, okvara vida.
English: Luxembourg/Luxemburg S.A. Servier Benelux N.V.
Slovenian: S.A. Servier Benelux N.V.
English: The usual recommended starting dose is one tablet of Procoralan 5 mg twice daily increasing if necessary to one tablet of Procoralan 7.5 mg twice daily.
Slovenian: Običajen priporočljiv začetni odmerek je ena tableta zdravila Procoralan 5 mg dvakrat na dan, kar lahko povečate na eno tableto zdravila Procoralan 7,5 mg dvakrat na dan, če je potrebno.
English: If you forget to take Procoralan:
Slovenian: Če ste pozabili vzeti zdravilo Procoralan
English: INFORMATION IN BRAILLE PROCORALAN 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI PROCORALAN 5 mg
English: Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”).
Slovenian: Ne jemljite zdravila Procoralan, če dojite (glejte “Ne jemljite zdravila Procoralan”).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/001-007
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/316/001-007
English: * Frequency calculated from clinical trials for adverse events detected from spontaneous report
Slovenian: *Pogostnost neželenih učinkov iz spontanega poročanja je izračunana na podlagi podatkov iz kliničnih študij Opis izbranih neželenih učinkov
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/316/008-014
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/316/008-014
English: INFORMATION IN BRAILLE PROCORALAN 7.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI PROCORALAN 7,5 mg
English: Procoralan with food and drink Avoid grapefruit juice during treatment with Procoralan.
Slovenian: Med zdravljenjem z zdravilom Procoralan se izogibajte uživanju grenivkinega soka.
English: How to take Procoralan
Slovenian: Kako jemati zdravilo Procoralan
English: 5 How to store Procoralan Contents of the pack and other information
Slovenian: Shranjevanje zdravila Procoralan Vsebina pakiranja in dodatne informacije
English: As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
Slovenian: Če ste prenehali jemati zdravilo Procoralan Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
English: A large dose of Procoralan could make you feel breathless or tired because your heart slows down too much.
Slovenian: Če ste vzeli večji odmerek zdravila Procoralan, kot bi smeli Velik odmerek zdravila Procoralan bi lahko povzročil zasoplost ali utrujenost, ker preveč upočasni srce.
English: Very Rare
Slovenian: Zelo redki:
English: The European Medicines Agency has waived the obligation to submit the results of studies with Procoralan in all subsets of the paediatric population in the treatment of angina pectoris.
Slovenian: Procoralan za vse podskupine pediatrične populacije za zdravljenje angine pektoris.
English: D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA • Načrt za obvladovanje tveganja (RMP)
English: Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Slovenian: Tablete zdravila Procoralan 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.
English: What Procoralan contains - The active substance is ivabradine (as hydrochloride).
Slovenian: - Zdravilna učinkovina je ivabradin (v obliki klorida).
English: Servier Italia S.p.A. Tel: +39 (06) 669081
Slovenian: Tel: +39 (06) 669081
English: NAME OF THE MEDICINAL PRODUCT Procoralan 5 mg film-coated tablets
Slovenian: IME ZDRAVILA Procoralan 5 mg filmsko obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Procoralan 7.5 mg film-coated tablets
Slovenian: IME ZDRAVILA Procoralan 7,5 mg filmsko obložene tablete
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 heart beat 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,
Slovenian: če imate kardiogeni šok (bolezen srca, ki zahteva zdravljenje v bolnišnici); če imate motnje srčnega ritma; če imate miokardni infarkt; če imate zelo nizek krvni tlak; če imate nestabilno angino pektoris (hudo obliko, pri kateri se bolečine v prsih pojavljajo zelo pogosto, med naporom ali brez njega);
English: Do not take Procoralan if you are pregnant or are planning to have a baby (see “Do not take Procoralan”).
Slovenian: Nosečnost in dojenje Ne jemljite zdravila Procoralan, če ste noseči ali če načrtujete nosečnost (glejte “Ne jemljite zdravila
English: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (≥1/10); common (≥1/100 to, <1/10); uncommon (≥1/1,000 to, <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do
English: Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Slovenian: Procoralan 7,5 mg: ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
English: SIA Servier Latvia Tel: + 371 6750 2039
Slovenian: Tel: + 371 6750 2039
English: Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Slovenian: Procoralan 5 mg: ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
English: What Procoralan looks like and contents of the pack Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Slovenian: Tablete zdravila Procoralan 5 mg so lososove barve, podolgovate in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.