FrancophonIA/ELRC3.0 huggingface dataset:
English: Ivabradine does not influence intracardiac conduction, contractility (no negative inotropic effect) or ventricular repolarisation: - in clinical electrophysiology studies, ivabradine had no effect on atrioventricular or intraventricular conduction times or corrected QT intervals; - in patients with left ventricular dysfunction (left ventricular ejection fraction (LVEF) between 30
Slovenian: - v kliničnih elektrofizioloških študijah ivabradin ni vplival na čase atrioventrikularnega ali intraventrikularnega prevajanja ali na interval QT s popravkom; - pri bolnikih z disfunkcijo levega prekata (iztisnim deležem levega prekata med 30 in 45 %)
English: Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided (see section 4.5).
Slovenian: Uporabi ivabradina se moramo izogibati pri bolnikih, ki imajo prirojeni sindrom podaljšanega intervala QT ali jemljejo zdravila, ki ga podaljšujejo (glejte poglavje 4.5).
English: How does Ivabradine Anpharm work?
Slovenian: Kako deluje zdravilo Ivabradine Anpharm?
English: Ivabradine influences retinal function.
Slovenian: Funkcija vida Ivabradin vpliva na delovanje mrežnice.
English: After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting heart rate remains above 60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
Slovenian: Po treh do štirih tednih zdravljenja, če bolnik še vedno doživlja simptome, vendar dobro prenaša začetni odmerek, in če srčna frekvenca v mirovanju ostaja nad 60 utripov na minuto, lahko odmerek povečate na naslednji večji odmerek pri bolnikih, ki se zdravijo z 2,5 mg odmerkom dvakrat na dan oz. 5 mg odmerkom dvakrat na dan. Vzdrževalni odmerek ne sme presegati 7,5 mg dvakrat na dan.
English: 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).
Slovenian: V randomizirani, s placebom nadzorovani študiji pri 1.277 bolnikih je ivabradin kot dodatek amlodipinu 5 mg enkrat na dan ali nifedipinu GITS (gastrointestinalni terapevtski sistem) 30 mg enkrat na dan v času najmanjšega učinka (12 ur po peroralnem jemanju) med 6-tedenskim zdravljenjem (razmerje obetov = 1,3; 95% interval zaupanja [1,0-1,7]; p = 0,012) dokazal statistično značilno dodatno učinkovitost pri odzivu na zdravljenje (definiranem kot zmanjšanje za najmanj
English: These studies have shown embryotoxic and teratogenic effects (see section 5.3).
Slovenian: Te študije so pokazale embriotoksične in teratogene učinke
English: Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Ivabradine Anpharm.
Slovenian: Če dojite ali nameravate dojiti se posvetujte z zdravnikom, ker morate z dojenjem prekiniti, če jemljete zdravilo Ivabradine Anpharm.
English: 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.
Slovenian: Izgled zdravila Ivabradine Anpharm in vsebina pakiranja Tablete zdravila Ivabradine Anpharm 5 mg so lososove barve, podolgovate in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.
English: Warnings and precautions
Slovenian: Previdnostni ukrepi
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 Ivabradine Anpharm Ker je zdravljenje angine pektoris ali kroničnega srčnega popuščanja običajno doživljenjsko, se pred prenehanjem jemanja tega zdravila posvetujte z zdravnikom.
English: Concomitant use not recommended
Slovenian: Farmakodinamična medsebojna delovanja Sočasno jemanje ni priporočljivo
English: The concomitant use of cardiovascular and non cardiovascular QT prolonging medicinal products with ivabradine should be avoided since QT prolongation may be exacerbated by heart rate reduction.
Slovenian: meflokin, halofantrin, pentamidin, cisaprid, eritromicin intravensko) Sočasni uporabi srčno-žilnih in nesrčno-žilnih zdravil, ki podaljšujejo interval QT, se morate ob ivabradinu izogibati, saj se podaljšanje intervala QT lahko poslabša z zniževanjem srčne frekvence.
English: Annopol 6B 03-236 Warszawa Poland
Slovenian: Annopol 6B 03-236 Varszawa Poljska
English: itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris); - if you are a woman able to have children and not using reliable contraception; - if you are pregnant or trying to become pregnant; - if you are breast-feeding.
Slovenian: makrolidne antibiotike (na primer josamicin, klaritromicin, telitromicin ali eritromicin peroralno), zdravila proti okužbam z virusom HIV (na primer nelfinavir, ritonavir) ali nefazodon (zdravilo proti depresiji) ali diltiazem, verapamil (uporabljata se za zniževanje krvnega tlaka oz. zdravljenje angine pektoris);
English: There was a significant improvement in NYHA class at last recorded value, 887 (28%) of patients on ivabradine improved versus 776 (24%) of patients on placebo (p=0.001).
Slovenian: zdravljenih z ivabradinom, se je stanje izboljšalo v primerjavi z izboljšanjem pri 776 (24 %) bolnikih, ki so prejemali placebo (p=0,001).
English: Do not take Ivabradine Anpharm if you are breast-feeding (see “Do not take Ivabradine Anpharm”).
Slovenian: Ne jemljite zdravila Ivabradine Anpharm, če dojite (glejte “Ne jemljite zdravila Ivabradine
English: How to take Ivabradine Anpharm
Slovenian: Kako jemati zdravilo Ivabradine Anpharm
English: Annopol 6B 03-236 Warszawa - Poland
Slovenian: Annopol 6B 03-236 Varszawa - Poljska
English: Ivabradine Anpharm 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 Ivabradine Anpharm 7,5 mg so lososove barve, trikotne in filmsko obložene, z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
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.
Slovenian: antagonisti adrenergičnih receptorjev beta, diuretiki, antagonisti aldosterona, kratko in dolgodelujoči nitrati, zaviralci hidroksimetilglutaril koencim A (HMG CoA) reduktaze, fibrati, zaviralci protonske črpalke, peroralni antidiabetiki, aspirin ter druga antitrombocitna zdravila.
English: (5 mg b.i.d, if age ≥ 75 years) and titration up to 10 mg b.i.d).
Slovenian: starih ≥ 75 let) in povečanje odmerka do 10 mg dvakrat na dan).
English: Ivabradine Anpharm contains lactose
Slovenian: Zdravilo Ivabradine Anpharm vsebuje laktozo.
English: Ivabradine Anpharm 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Slovenian: Ivabradine Anpharm 5 mg: ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
English: Ivabradine Anpharm 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Slovenian: Ivabradine Anpharm 7,5 mg: ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
English: Marketing Authorisation Holder and Manufacturer:
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec
English: - 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
Slovenian: - preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - srčna frekvenca med mirovanjem pod 70 utripov na minuto pred zdravljenjem - kardiogeni šok - akutni miokardni infarkt - huda hipotenzija (< 90/50 mm Hg)
English: Stable angina is a heart disease which happens when the heart does not receive enough oxygen.
Slovenian: O stabilni angini pektoris (običajno imenovani “angina pektoris”): Stabilna angina pektoris je bolezen srca, ki nastaja, ko srce ne dobiva dovolj kisika.
English: Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established (see section 5.1).
Slovenian: Dodatne učinkovitosti ivabradina v kombinaciji z dihidropiridinskimi kalcijevimi antagonisti niso zasledili
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).
Slovenian: določene vrste zdravil proti tesnobnosti, shizofreniji ali drugim psihozam (kot so pimozid, ziprazidon, sertindol) zdravila proti malariji (na primer meflokin ali halofantrin) eritromicin v žilo (antibiotik) pentamidin (zdravilo proti parazitom) cisaprid (proti gastroezofagealnemu refluksu) - nekatere vrste diuretikov, ki lahko povzročijo zmanjšanje vrednosti kalija v krvi, kot so furosemid, hidroklorotiazid, indapamid (ki se uporabljajo za zdravljenje edema, visokega krvnega tlaka).
English: Annopol 6B - 03-236 Warszawa - Poland and
Slovenian: Annopol 6B - 03-236 Varszawa - Poljska in
English: The maximum plasma concentration following chronic administration at the recommended dose of 5 mg twice daily is 22 ng/ml (CV=29%).
Slovenian: Porazdelitev Ivabradin se veže na beljakovine v plazmi v približno 70 % in volumen porazdelitve v stanju dinamičnega ravnovesja pri bolnikih znaša blizu 100 l. Največja koncentracija v plazmi po kroničnem jemanju priporočenega odmerka 5 mg dvakrat na dan je 22 ng/ml (koeficient variacije = 29 %).
English: Other medicines and Ivabradine Anpharm
Slovenian: Shranjevanje zdravila 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).
Slovenian: [0,68; 0,85] - p<0,0001) in drugih sekundarnih končnih izidov, vključno z umrljivostjo zaradi različnih vzrokov (razmerje tveganja: 0,83, 95 % interval zaupanja [0,72; 0,96] - p=0,0109) in srčno-žilno umrljivostjo (razmerje tveganja: 0,83, 95 % interval zaupanja [0,71; 0,97] - p=0,0166).
English: A therapeutic scheme higher than the approved posology was used (starting dose 7.5 mg b.i.d.
Slovenian: V študiji so uporabili shemo zdravljenja z odmerkom, ki je bil večji od odobrenega odmerjanja (začetni odmerek 7,5 mg dvakrat na dan (5 mg dvakrat na dan pri bolnikih,
English: Pharmacokinetic/pharmacodynamic (PK/PD) relationship
Slovenian: PK/PD
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni*
English: The difference in heart rate between ivabradine and placebo arms was 10.8 bpm at 28 days, 9.1 bpm at 12 months and 8.3 bpm at 24 months.
Slovenian: utripov na minuto v 28 dneh, 9,1 utripov na minuto v 12 mesecih in 8,3 utripov na minuto v 24 mesecih.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Slovenian: Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
English: Other concomitant use
Slovenian: peroralna uporaba
English: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
Slovenian: Simptomatsko zdravljenje kronične stabilne angine pektoris Priporočljivo je, da se o uvedbi zdravljenja oz. povečanju odmerka odločate v skladu z razpoložljivimi zaporednimi meritvami srčne frekvence, EKG oz. 24-urnim ambulantnim spremljanjem.
English: Ivabradine Anpharm 5 mg film-coated tablets
Slovenian: Ivabradine Anpharm 5 mg filmsko obložene tablete ivabradin
English: Ivabradine Anpharm 7.5 mg film-coated tablets
Slovenian: Ivabradine Anpharm 7,5 mg filmsko obložene tablete ivabradin
English: mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin).
Slovenian: kinidin, dizopiramid, ibutilid, sotalol, amjodaron (proti motnjam srčnega ritma)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Ivabradine Anpharm 5 mg film-coated tablets One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Slovenian: Ivabradine Anpharm 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg ivabradina (kar ustreza 5,390 mg ivabradinijevega klorida).
English: If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
Slovenian: utripov na minuto, je potrebno ohraniti odmerek 5 mg dvakrat na dan.
English: The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.
Slovenian: povezani z bradikardijo, kot so omotica, utrujenost ali hipotenzija.
English: NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets
Slovenian: Ivabradine Anpharm 5 mg filmsko obložene tablete Ivabradine Anpharm 7,5 mg filmsko obložene tablete
English: josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2) - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5) - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures (see section 4.6)
Slovenian: - nestabilno ali akutno srčno popuščanje - odvisnost od srčnega spodbujevalnika (srčna frekvenca, ki jo narekuje izključno srčni spodbujevalnik) - nestabilna angina pektoris - atrioventrikularni blok 3. stopnje - kombinacija z močnimi zaviralci citokroma P450 3A4, kot so azolski antimikotiki (ketokonazol, itrakonazol), makrolidni antibiotiki (klaritromicin, eritromicin peroralno, josamicin, telitromicin), zaviralci proteaze virusa HIV (nelfinavir, ritonavir) in nefazodon (glejte poglavji 4.5 in 5.2) - kombinacija z verapamilom ali diltiazemom, zmernima zaviralcema citokroma P450 3A4, ki imata lastnosti zniževanja srčne frekvence (glejte poglavje 4.5)
English: Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Slovenian: Navodilo za uporabo Ivabradine Anpharm 5 mg filmsko obložene tablete Ivabradine Anpharm 7,5 mg filmsko obložene tablete ivabradin
English: After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension.
Slovenian: utripov na minuto, ali zmanjšate na 2,5 mg dvakrat na dan (eno polovico 5-mg tablete dvakrat na dan), če je srčna frekvenca med mirovanjem vztrajno pod 50 utripov na minuto ali se pojavijo simptomi,
English: Therefore, ivabradine is contraindicated during pregnancy (see section 4.3).
Slovenian: Morebitno tveganje pri ljudeh ni znano, zato je ivabradin kontraindiciran med nosečnostjo (glejte poglavje 4.3).
English: and 45%), ivabradine did not have any deleterious influence on LVEF.
Slovenian: ivabradin ni imel nobenih škodljivih učinkov na iztisni delež levega prekata.
English: Erythema Pruritus Urticaria
Slovenian: - hudo jetrno popuščanje
English: 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).
Slovenian: Ivabradine Anpharm 7,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7,5 mg ivabradina (kar ustreza 8,085 mg ivabradinijevega klorida).
English: Salmon-coloured, triangular, film-coated tablet engraved with “7.5” on one face and on the other face.
Slovenian: Ivabradine Anpharm 7,5 mg filmsko obložene tablete Trikotna, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “7.5” na eni ter na drugi strani.
English: Excipients
Slovenian: Otroci
English: In a 725-patients randomised placebo-controlled study, ivabradine did not show additional efficacy on top of amlodipine 10 mg o.d. at the trough of drug activity (12 hours after oral intake) while an additional efficacy was shown at peak (3-4 hours after oral intake).
Slovenian: 10 mg enkrat na dan ni pokazal dodatne učinkovitosti v času najmanjšega učinka (12 ur po peroralnem jemanju), medtem ko so v času največjega učinka (3 do 4 ure po peroralnem jemanju)
English: A sustained reduction of heart rate was demonstrated in patients treated with ivabradine for at least one year (n = 713).
Slovenian: Pri bolnikih, ki so ivabradin jemali najmanj 1 leto, so dokazali vztrajno znižanje srčne frekvence
English: Special populations
Slovenian: Posebne skupine bolnikov Starejši
English: Ivabradine is indicated : - in adults unable to tolerate or with a contraindication to the use of beta-blockers - or in combination with beta-blockers in patients inadequately controlled with an optimal beta blocker dose.
Slovenian: - ali v kombinaciji z antagonisti adrenergičnih receptorjev beta pri bolnikih, ki ob optimalnem odmerku antagonistov adrenergičnih receptorjev beta nimajo urejene bolezni.
English: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with “5” on one face and on the other face.
Slovenian: Ivabradine Anpharm 5 mg filmsko obložene tablete Podolgovata, filmsko obložena tableta lososove barve z zarezo na obeh straneh in vrezano oznako “5” na eni ter na drugi strani.
English: These measures should help to protect the environment.>
Slovenian: Ti ukrepi pomagajo varovati okolje.>
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/ >
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) ( HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/).
English: Other information>
Slovenian: Druge informacije>
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.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso navedeni v tej stični ovojniniali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: <Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only]
Slovenian: <Poročate lahko tudi preko nacionalnega sistema za poročanje {podatki nacionalnega sistema}.> [For MRP/DCP only]
English: <Interaction with other medicinal products and other forms of interaction:>
Slovenian: <Medsebojno delovanje z drugimi zdravili in druge oblike interakcij:>
English: The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Slovenian: Besedilo “samo za živali” in pogoji ali omejitve glede oskrbe in uporabe, če je smiselno
English: <Overdose (symptoms, emergency procedures, antidotes):>
Slovenian: <Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):>
English: <The frequency of adverse reactions is defined using the following convention:
Slovenian: <Pogostost neželenih učinkov je določena po naslednjem dogovoru:
English: <Batch> <Lot> <BN> {number}
Slovenian: <Serija> <Lot> <BN> {številka}
English: <Do not use {name} if you notice {description of the visible signs of deterioration}.>
Slovenian: <Ne uporabite {ime zdravila}, če opazite {opis vidnih znakov kvarjenja}.>
English: Special storage precautions
Slovenian: Posebna navodila za shranjevanje
English: Special precautions for the disposal of unused product or waste materials, if any
Slovenian: Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
English: <Keep the {container} tightly closed>
Slovenian: Hranite {vsebinik} tesno zaprt.>
English: {(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
Slovenian: {(Izmišljeno) ime zdravila <jakost> farmacevtska oblika <ciljne živalske vrste>}
English: <Medicines should not be disposed of via wastewater <or household waste>.>
Slovenian: <Ne odvrzite zdravila v odpadno vodo ali <med gospodinjske odpadke>.>
English: Name of the veterinary medicinal product
Slovenian: Ime zdravila za uporabo v veterinarski medicini
English: <For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.>
Slovenian: <Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom.>
English: <Protect from direct sunlight.>
Slovenian: <Zaščitite pred neposredno sončno svetlobo.>
English: Manufacturer's batch number
Slovenian: Proizvajalčeva številka serije
English: <Special warnings for each target species:>
Slovenian: <Posebna opozorila za vsako ciljno živalsko vrsto:>
English: Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release , if different
Slovenian: Ime in naslov imetnika dovoljenja za promet z zdravilom ter proizvajaleca zdravilaodgovoren za sproščanje serij, če sta si različna
English: Indication(s)
Slovenian: Indikacija(e)
English: <Once <broached> <opened> <diluted> <reconstituted> <use by…> <use within…><use immediately.>>
Slovenian: <Načeto> <odprto> <razredčeno> <rekonstituirano>zdravilo uporabite do…> <uporabite v…> <uporabite takoj>.>