natgillin/translations-raw huggingface dataset:
Common side-effects which may affect more than 1 person in 100 are listed below: 
Spodaj so našteti pogosti neželeni učinki, ki se lahko pojavijo pri več kot 1 od 100 oseb:
Take special care with [Neurontin and associated names] 
Bodite posebno pozorni pri jemanju zdravila [Neurontin in povezana imena]
dyspnoea, bronchitis, pharyngitis, cough, rhinitis Gastrointestinal disorders Common: 
dispneja, bronhitis, faringitis, kašelj, rinitis
hypertension, vasodilatation Respiratory, thoracic and mediastinal disorders Common: 
Bolezni dihal, prsnega koša in mediastinalnega prostora Pogosti:
Each 300 mg hard capsule contains 300 mg of gabapentin. 
Ena 300 mg trda kapsula vsebuje 300 mg gabapentina.
Each 400 mg hard capsule contains 400 mg of gabapentin. 
Ena 400 mg trda kapsula vsebuje 400 mg gabapentina.
Each 600 mg film-coated tablet contains 600 mg of gabapentin. 
Ena 600 mg filmsko obložena tableta vsebuje 600 mg gabapentina.
400 mg Capsules, hard 
400 mg Trde kapsule
Neurontin and associated names 100 mg hard capsule 
Neurontin in povezana imena 100 mg trde kapsule
Peripheral Neuropathic Pain: 
Periferne nevropatske bolečine:
Your doctor may prescribe a different dosing schedule and/or dose if you have problems with your kidneys. 
Če imate težave z ledvicami, vam bo zdravnik morda predpisal drugačen program jemanja in/ali odmerek zdravila.
Neurontin and associated names 300 mg hard capsule 
Neurontin in povezana imena 300 mg trde kapsule
These doses are approximately 1/4 to 8 times the daily human dose of 3600 mg on a mg/m2 basis. 
Na podlagi mg/m2 so ti odmerki približno 1/4- do 8-krat tolikšni kot dnevni odmerek 3600 mg pri človeku.
• Adverse events following the abrupt discontinuation of gabapentin (anxiety, difficulty sleeping, feeling sick, pain, sweating), chest pain 
• neželeni učinki po nenadni prekinitvi zdravljenja z gabapentinom (tesnobnost, težave s spanjem,
Neurontin and associated names 100 mg hard capsules Neurontin and associated names 300 mg hard capsules Neurontin and associated names 400 mg hard capsules Neurontin and associated names 600 mg film-coated tablets Neurontin and associated names 800 mg film-coated tablets [See Annex I - To be completed nationally] Gabapentin 
Neurontin in povezana imena 100 mg trde kapsule Neurontin in povezana imena 300 mg trde kapsule Neurontin in povezana imena 400 mg trde kapsule Neurontin in povezana imena 600 mg filmsko obložene tablete Neurontin in povezana imena 800 mg filmsko obložene tablete [Glejte Dodatek I - Izpolni država članica] Gabapentin
Each 100 mg hard capsule contains 13 mg lactose (as monohydrate). 
Ena 100 mg trda kapsula vsebuje 13 mg laktoze v obliki monohidrata.
Neurontin and associated names 400 mg hard capsule 
Neurontin in povezana imena 400 mg trde kapsule
Finally, in children, aggressive behaviour and hyperkinesias were reported commonly. 
Ravno tako pri otrocih pogosto opažajo napadalno vedenje in hiperkinezije.
Each 400 mg hard capsule contains 54 mg lactose (as monohydrate). 
Ena 400 mg trda kapsula vsebuje 54 mg laktoze v obliki monohidrata.
Dosages up to 50 mg/kg/day have been well tolerated in a longterm clinical study. 
V dolgotrajni klinični študiji so bolniki dobro prenašali odmerke do 50 mg/kg/dan.
Somnolence, peripheral oedema and asthenia may be more frequent in the elderly. 
Somnolenco, periferni edem in astenijo so pogosteje opazili pri starostnikih.
Neurontin and associated names 100 mg hard capsule Neurontin and associated names 300 mg hard capsule Neurontin and associated names 400 mg hard capsule Neurontin and associated names 600 mg film-coated tablet Neurontin and associated names 800 mg film-coated tablet Gabapentin [See Annex I - To be completed nationally] 
Neurontin in povezana imena 100 mg trde kapsule Neurontin in povezana imena 300 mg trde kapsule Neurontin in povezana imena 400 mg trde kapsule Neurontin in povezana imena 600 mg filmsko obložene tablete Neurontin in povezana imena 800 mg filmsko obložene tablete Gabapentin [Glejte Dodatek I - Izpolni država članica]
Dosage adjustment is recommended in patients with compromised renal function as described in Table 2 and/or those undergoing haemodialysis. 
Pri bolnikih z okvarjenim delovanjem ledvic in/ali na hemodializi je priporočljivo prilagoditi odmerek, kot prikazuje tabela 2.
Gabapentin is indicated as monotherapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above. 
Gabapentin je indiciran kot monoterapija za zdravljenje parcialnih epileptičnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in mladostnikih, starih 12 let in več.
Each 300 mg hard capsule contains 41 mg lactose (as monohydrate). 
Ena 300 mg trda kapsula vsebuje 41 mg laktoze v obliki monohidrata.
300 mg Capsules, hard 
300 mg Trde kapsule
The therapeutic indication of gabapentin as adjunctive epilepsy therapy in the treatment of partial seizures with and without secondary generalization in adults and adolescents aged 12 years and above is well established. 
Dobro uveljavljena terapevtska indikacija za gabapentin je dodatno zdravljenje epilepsije pri zdravljenju parcialnih napadov s sekundarno generalizacijo ali brez nje pri odraslih in otrocih, starih 12 let ali več.
Grounds for amendments of the Summaries of Products Characteristics, labelling and Package leaflet 
Podlaga za dopolnilo Povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
Peripheral neuropathic pain 
Periferne nevropatske bolečine
• Joint pain, muscle pain, back pain, twitching 
• bolečine v sklepih, bolečine v mišicah, bolečine v hrbtu, trzanje
These doses are approximately 1 to 5 times the human dose of 3600 mg on a mg/m2 basis. 
Na podlagi mg/m2 so ti odmerki približno 1- do 5-krat tolikšni kot odmerek 3600 mg pri človeku.
Neurontin 800 mg Film-coated tablets 
Neurontin 800 mg Filmsko obložene tablete Peroralna uporaba
Therapy may be initiated by titrating the dose as described in Table 1 or by administering 300 mg three times a day (TID) on Day 1. 
Zdravljenje je mogoče začeti s titriranjem odmerka, kot prikazuje tabela 1, ali z uporabo 300 mg trikrat na dan 1. dan. Potem je mogoče odmerek glede na bolnikov odziv in prenašanje povečevati po 300 mg/dan na 2 do 3 dni do največjega odmerka 3600 mg/dan.
• Convulsions, jerky movements, difficulty with speaking, loss of memory, tremor, difficulty sleeping, headache, sensitive skin, decreased sensation, difficulty with coordination, unusual eye movement, increased, decreased or absent reflexes 
glavobol, občutljivost kože, slabše zaznavanje dotika, težave s koordinacijo, nenavadno premikanje očesnih zrkel, okrepljeni, oslabljeni ali odsotni refleksi
[Neurontin and associated names] may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking [Neurontin and associated names]. 
Če morate opraviti pregled urina, zdravniku ali v bolnišnici povejte, da jemljete zdravilo [Neurontin in povezana imena].
Neurontin 600 mg Film-coated tablets 
Neurontin 600 mg Filmsko obložene tablete Peroralna uporaba
− The other ingredients in [Neurontin and associated names] tablets are: 
− Pomožne snovi v tabletah [Neurontin in povezana imena] so: [Izpolni država članica]
No adverse effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately five times the maximum daily human dose on a mg/m2 of body surface area basis). 
Pri podganah v odmerkih do 2000 mg/kg (kar je glede na razmerje mg/m2 telesne površine približno petkratnik največjega dnevnega odmerka pri človeku) niso zabeležili nobenih neželenih učinkov na plodnost ali reprodukcijo.
What [Neurontin and associated names] looks like and contents of the pack 
Izgled zdravila [Neurontin in povezana imena] in vsebina pakiranja Trda kapsula
800 mg Film-coated tablets 
800 mg Filmsko obložene tablete
600 mg Film-coated tablets 
600 mg Filmsko obložene tablete
− Keep this leaflet. 
PRETISNI OMOT
Mean %CV Mean %CV Mean %CV 
800 mg (n = 14) povprečje % KV povprečje % KV povprečje % KV
PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities 
6.4 Posebna navodila za shranjevanje [Izpolni država članica]
Acute, life-threatening toxicity has not been observed with gabapentin overdoses of up to 49 g. Symptoms of the overdoses included dizziness, double vision, slurred speech, drowsiness, lethargy and mild diarrhoea. 
Med simptomi prevelikega odmerjanja so bili omotica, dvojen vid, nerazločno govorjenje, zaspanost, letargija in blaga driska.
STATEMENT OF ACTIVE SUBSTANCE(S) Each 100 mg hard capsule contains 100 mg of gabapentin. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena 100 mg trda kapsula vsebuje 100 mg gabapentina.
An oral lethal dose of gabapentin was not identified in mice and rats given doses as high as 8000 mg/kg. 
Pri miših in podganah, ki so dobile velike odmerke do 8000 mg/kg, niso ugotovili peroralnega smrtnega odmerka.
anorexia, increased appetite Psychiatric disorders Common: 
anoreksija, povečan apetit
Always take [Neurontin and associated names] exactly as your doctor has told you. 
Pri jemanju zdravila [Neurontin in povezana imena] natančno upoštevajte zdravnikova navodila.
leucopenia 
levkopenija
General disorders and administration site conditions Very Common: fatigue, fever Common: 
Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy, therefore it is important that monotherapy is practised whenever possible. 
Tveganje za prirojene malformacije je lahko med zdravljenjem z več antiepileptičnimi zdravili večje kot med monoterapijo.
Pneumonia, respiratory infection, urinary tract infection, infection, otitis media Blood and the lymphatic system disorders Common: 
pljučnica, okužba dihal, okužba sečil, okužba, otitis media
What [Neurontin and associated names] contains 
Kaj vsebuje zdravilo [Neurontin in povezana imena]
• Inflammation of the pancreas 
• vnetje trebušne slinavke
Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency. 
Da bi bolniki z ledvično insuficienco lahko upoštevali priporočeno odmerjanje, naj uporabljajo 100 mg kapsule gabapentin.
HOW TO STORE [NEURONTIN AND ASSOCIATED NAMES] Keep out of the reach and sight of children. 
SHRANJEVANJE ZDRAVILA [NEURONTIN IN POVEZANA IMENA] Zdravilo shranjujte nedosegljivo otrokom!
Marketing Authorisation Holder and Manufacturer 
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Izpolni država članica]
• Vomiting (being sick), nausea (feeling sick), problems with teeth, inflamed gums, diarrhoea, 
• bruhanje, navzea (slabost s siljenjem na bruhanje), težave z zobmi, vnetje dlesni, driska, bolečine v želodcu, prebavne težave, zaprtje, suhost ust ali grla, vetrovi
No special requirements. 
Ni bilo odkritih pomembnih zadržkov, ki se nanašajo na kakovost.
Neurontin 
NP
International non-proprietary name (INN): spiramycin 
Mednarodno nelastniško ime (INN): spiramicin
The final opinion was converted into a Decision by the European Commission on 11 December 2014. 
Končno mnenje je bilo 11. decembra 2014 spremenjeno v sklep Evropske komisije.
Oral explanations were given on 9 September 2014. 
Ustna pojasnila so bila podana 9. septembra 2014.
Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014. 
Predlagatelji in imetniki dovoljenja za promet z zdravili so pisna pojasnila predložili 10. decembra 2012, 14. oktobra 2013, 1. aprila 2014 in 10. junija 2014.
The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur. 
Odbor je imenoval Cornelio Ibrahim za poročevalko in Bruna Urbaina za soporočevalca.
The referral started on 13 September 2012. 
Napotitveni postopek se je začel 13. septembra 2012.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III. 
Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodila za uporabo v Prilogi III.
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. 
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.
Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml. 
Zdravilo Captalin raztopina za injiciranje vsebuje 31,25 g spiramicina na 100 ml, kar ustreza 1 000 000 i.e. spiramicina na ml.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
Opinion following an Article 350F referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof EMA/745255/2014 
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
Opinion following an Article 351 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof 
za zdravilo Suanovil 20 in povezana imena, zdravilo Captalin in povezana imena ter njuna generična zdravila
--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. 
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.
Horses Intramuscular use vial (glass) 1 ml 
Suspenzija za injiciranje Konji intramuskularno Viala (steklo) 1 ml
EU (MA) Number Invented name 
EU Številka
Target Species 
Izmišljeno ime Jakost Farmacvtska oblika Ciljna živalska vrsta
This means that Fyzoclad was intended to be highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da naj bi bilo zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je v EU že odobreno.
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. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi spremembe v svoji strategiji.
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. 
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.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations. 
Ker je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
The company informed the CHMP that there are no ongoing clinical trials with Fyzoclad. 
Družba je odbor CHMP obvestila, da trenutno ne potekajo nobena klinična preskušanja z zdravilom Fyzoclad.
Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab)
The application was withdrawn while the CHMP was still evaluating the initial documentation provided by the company. 
Vlogo so umaknili, ko je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases. 
Adalimumab z vezavo na TNF zavre njegovo delovanje ter tako zmanjša vnetje in druge simptome bolezni.
It was to be available as a solution for injection. 
Na voljo naj bi bilo v obliki raztopine za injiciranje.
Withdrawal of the marketing authorisation application for Fyzoclad (adalimumab) EMA/866697/2018 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Fyzoclad (adalimumab) EMA/10639/2019
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. 
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.
Fyzoclad acts on the immune system and was to be used to treat the following inflammatory conditions: 
Zdravilo Fyzoclad deluje na imunski sistem in naj bi se uporabljalo za zdravljenje naslednjih vnetnih bolezni:
Fyzoclad is a medicine that contains the active substance adalimumab. 
Fyzoclad je zdravilo, ki vsebuje učinkovino adalimumab.
13 December 2018 
13. december 2018 EMA/10639/2019
Fyzoclad was expected to work in the same way as the reference medicine, Humira. 
Zdravilo Fyzoclad naj bi delovalo na enak način kot referenčno zdravilo Humira.
Fyzoclad was developed as a ‘biosimilar' medicine. 
Zdravilo Fyzoclad je bilo razvito kot „podobno biološko zdravilo“.
• uveitis (inflammation of the layer beneath the white of the eyeball) and paediatric uveitis. 
• uveitisa (vnetja sloja pod beločnico očesa) in pediatričnega uveitisa.
What was Fyzoclad expected to be used for? 
Za kaj naj bi se zdravilo Fyzoclad uporabljalo?
The reference medicine for Fyzoclad is Humira. 
Referenčno zdravilo za zdravilo Fyzoclad je zdravilo Humira.
The company presented laboratory studies comparing Fyzoclad to its reference medicine Humira in terms of structure, purity and biological activity. 
Družba je predložila laboratorijske študije, v katerih so zgradbo, čistost in biološko delovanje zdravila Fyzoclad primerjali z referenčnim zdravilom Humira.
• psoriasis and paediatric plaque psoriasis (both are diseases causing red, scaly patches on the skin). 
• psoriaze in pediatrične psoriaze v plakih (bolezni, ki povzročata nastajanje rdečih, luskastih zaplat na koži);
How does Fyzoclad work? 
Kako zdravilo Fyzoclad deluje?
In addition, a study in patients with rheumatoid arthritis compared Fyzoclad with Humira. 
Poleg tega so zdravili Fyzoclad in Humira primerjali tudi v študiji pri bolnikih z revmatoidnim artritisom.
• axial spondyloarthritis (inflammation of the spine causing back pain); 
• aksialnega spondiloartritisa (vnetja hrbtenice, ki povzroča bolečine v hrbtu);
What is Fyzoclad? 
Kaj je zdravilo Fyzoclad?
• juvenile idiopathic arthritis (disease causing inflammation in the joints); 
• juvenilnega idiopatskega artritisa (bolezni, ki povzroča vnetje sklepov);
been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF). 
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.
• psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints); 
• psoriatičnega artritisa (bolezni, ki povzroča nastajanje rdečih in luskastih lis na koži in vnetje sklepov);
Children Procoralan is not intended for use in children and adolescents younger than 18 years. 
Otroci Procoralan ni namenjen za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
In this way Procoralan helps to control and reduce the number of angina attacks. 
Na ta način Procoralan pripomore k nadzoru in zmanjševanju anginoznih napadov.
If you forget to take a dose of Procoralan, take the next dose at the usual time. 
Če ste pozabili vzeti odmerek zdravila Procoralan, vzemite naslednji odmerek ob običajnem času.
92284 Suresnes cedex - France 
92284 Suresnes cedex- Francija
If you are pregnant and have taken Procoralan, talk to your doctor. 
Če ste noseči in ste jemali zdravilo Procoralan, se posvetujte z zdravnikom.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan. 
Koledar, ki je natisnjen na pretisnem omotu s tabletami, vam pomaga, da si zapomnite, kdaj ste nazadnje vzeli tableto zdravila Procoralan.
Procoralan mainly works by reducing the heart rate by a few beats per minute. 
Procoralan deluje predvsem tako, da znižuje srčno frekvenco za nekaj utripov na minuto.
The safety and efficacy of ivabradine in children aged below 18 years have not yet been established. 
Pediatrična populacija Varnost in učinkovitost ivabradina pri otrocih, mlajših od 18 let, še nista bili dokazani.
What Procoralan is and what it is used for What you need to know before you take Procoralan How to take Procoralan 
Kaj je zdravilo Procoralan in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Procoralan Kako jemati zdravilo Procoralan
If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist. 
Če menite, da je učinek zdravila Procoralan premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
Procoralan should be taken during meals. 
Zdravilo Procoralan morate jemati med obrokom.
If any of the above applies to you, talk straight away to your doctor before or while taking Procoralan. 
Če karkoli od naštetega velja za vas, se takoj pogovorite z zdravnikom pred jemanjem zdravila Procoralan ali med njim.