natgillin/translations-raw huggingface dataset:
The dose was adapted depending on the therapeutic response with maximum doses of 0.2 mg/kg bid, 0.3 mg/kg bid and 15 mg bid respectively.
Doza se prilagodila ovisno o terapijskom odgovoru s maksimalnim dozama do 0,2 mg/kg dva puta na dan, 0,3 mg/kg dva puta na dan i 15 mg dva puta na dan, ovisno o starosnoj podskupini.
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.
Nakon tri do četiri tjedna liječenja, ukoliko su u bolesnika još uvijek prisutni simptomi, ukoliko se početna doza dobro podnosi i ako srčana frekvencija u mirovanju ostaje iznad 60 otkucaja u minuti, doza se može povećati na slijedeću višu dozu u bolesnika koji uzimaju 2,5 mg dva puta na dan ili 5
The concomitant use of ivabradine with these medicinal products is contraindicated (see section 4.3).
Kontraindicirana je istovremena primjena ivabradina s tim lijekovima (vidjeti dio 4.4).
Treatment of chronic heart failure Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Ivabradin je indiciran u kroničnom zatajenju srca stupnja II do IV NYHA klasifikacije sa sistoličkom disfunkcijom, u bolesnika u sinusnom ritmu sa srčanom frekvencijom ≥ 75 otkucaja u minuti u kombinaciji sa standardnom terapijom uključujući terapiju s beta-blokatorom ili kada je primjena beta-blokatora kontraindicirana ili se ne podnosi (vidjeti dio 5.1).
The starting dose was 0.02 mg/kg bid in age-subset [6-12[months, 0.05 mg/kg bid in [1-3[ years and
Početna doza bila je 0,02 mg/kg dva puta na dan u starosnoj podskupini [6-12[ mjeseci, 0,05 mg/kg dva puta na dan u starosnim podskupinama [1-3[ godine i [3-18[ godina s <40 kg te 2,5 mg dva puta na dan u starosnoj podskupini [3-18[ godina s ≥ 40 kg.
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm.
Simptomatsko liječenje kronične stabilne angine pektoris Ivabradin je indiciran za simptomatsko liječenje kronične stabilne angine pektoris u odraslih bolesnika s koronarnom arterijskom bolesti s normalnim sinusnim ritmom i sa srčanom frekvencijom ≥ 70 otkucaja u minuti.
How does Ivabradine Anpharm work?
Kako djeluje Ivabradine Anpharm?
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).
U randomiziranom, placebom kontroliranom ispitivanju na 725 bolesnika pokazalo se da ivabradin nema dodatne djelotvornosti povrh aktivnosti amlodipina od 10 mg jednom dnevno pri najnižoj koncentraciji lijeka (12 sati nakon uzimanja peroralno), dok je u vršnoj koncentraciji uočena dodatna djelotvornost (3-4 sata nakon uzimanja peroralno).
QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Lijekovi koji produljuju QT-interval - Kardiovaskularni lijekovi koji produljuju QT-interval (npr. kinidin, disopiramid, bepridil, sotalol,
Do not take Ivabradine Anpharm if you are breast-feeding (see “Do not take Ivabradine Anpharm”).
Ne uzimajte Ivabradine Anpharmako dojite (vidjeti “Nemojte uzimati Ivabradine Anpharm”).
INFORMATION IN BRAILLE Ivabradine Anpharm 7.5 mg
16. PODACI NA BRAILLEOVOM PISMU Ivabradine Anpharm 7,5 mg
INFORMATION IN BRAILLE Ivabradine Anpharm 5 mg
16. PODACI NA BRAILLEOVOM PISMU Ivabradine Anpharm 5 mg
If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist (see section 4.2).
Ukoliko se, tijekom liječenja, srčana frekvencija u mirovanju neprestano uspori na manje od 50/min, ili ako bolesnik osjeti simptome koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija, doza se mora smanjiti ili se liječenje mora prekinuti ukoliko frekvencija u mirovanju ostane manje od 50/min ili perzistiraju simptomi bradikardije (vidjeti dio 4.2).
Annopol 6B 03-236 Warszawa Poland
Annopol 6B 03-236 Varšava Poljska
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.
- ako bolujete od poremećaja srčanog ritma (kao nepravilni rad srca, osjećaj lupanja srca, pojačan bol u prsima) ili fibrilacije atrija (vrsta nepravilnog rada srca) ili abnormalnosti u elektrokardiogramu (EKG) koje se nazivaju “sindrom dugog QT intervala”, - ako imate simptome kao što je umor, omaglica ili nedostatka zraka (to bi moglo značiti da Vam srce radi presporo), - ako imate simptome fibrilacije atrija (puls u mirovanju neuobičajeno visok (iznad 110 otkucaja u minuti) ili nepravilan, bez jasnog razloga, što otežava njegovo mjerenje), - ako ste nedavno imali moždani udar, - ako imate blago ili umjereno niski krvni tlak, - ako bolujete od visokog krvnog tlaka koji nije dobro kontroliran, osobito nakon promjene u terapiji
In a 97-patient randomised placebo-controlled study, the data collected during specific ophthalmologic investigations, aiming at documenting the function of the cone and rod systems and the ascending visual pathway (i.e. electroretinogram, static and kinetic visual fields, colour vision, visual acuity), in patients treated with ivabradine for chronic stable angina pectoris over 3 years, did not show any retinal toxicity.
U randomiziranom, placebom kontroliranom ispitivanju na 97 bolesnika, podaci prikupljeni tijekom specifičnih oftalmoloških pretraga, s ciljem utvrđivanja funkcije sustava ćunjića i štapića te ascendentnog vidnog puta (npr. elektroretinogram, statička i kinetička perimetrija, opažanje boja,
Ivabradine Anpharm contains lactose
Ivabradine Anpharmsadrži laktozu
Cardiac arrhythmias
Srčani poremećaji
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).
KVALITATIVNI I KVANTITATIVNI SASTAV Ivabradine Anpharm 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 5mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Annopol 6B 03-236 Warszawa - Poland
Annopol 6B 03-236 Varšava - Poljska
However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.
DC-kardioverzija se može učiniti 24 sata nakon posljednje doze ivabradina.
How to take Ivabradine Anpharm
Kako uzimati Ivabradine Anpharm
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava; navedenog u Dodatku V.
Ivabradine is metabolised by CYP3A4 only and it is a very weak inhibitor of this cytochrome.
Citokrom P450 3A4 (CYP3A4) Ivabradin se metabolizira jedino citokromom CYP3A4 i vrlo je slab inhibitor toga citokroma.
If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily).
Ukoliko tijekom liječenja srčana frekvencija padne ispod 50 otkucaja u minuti (50/min) u mirovanju ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, kao što su omaglica, umor ili hipotenzija, doza se mora titrirati na nižu, uključujući najnižu dozu od 2,5 mg dva puta na dan
Ivabradine Anpharm 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Ivabradine Anpharm 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (što odgovara 5,390 mg ivabradinklorida).
Patients with hypotension
Mjere opreza pri uporabi Bolesnici s hipotenzijom
In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] - p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] - p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] - p=0.0166).
0,83, 95%CI [0.72;0.96] - p=0,0109) i smrt zbog kardiovaskularnih uzroka (omjer hazarda (HR): 0,83, 95%CI [0.71;0.97] - p=0,0166).
Ivabradine Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and on the other.
Ivabradine Anpharm 7,5 mg tablete su trokutaste filmom obložene tablete boje lososa s utisnutom oznakom “7.5” na jednoj strani , a na drugoj.
Ivabradine was shown not to influence the metabolism and plasma concentrations of other CYP3A4 substrates (mild, moderate and strong inhibitors).
Pokazalo se da ivabradin ne utječe na metabolizam i plazmatske koncentracije drugih CYP3A4
Ivabradine Anpharm 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Ivabradine Anpharm 7,5 mg: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
How to store Ivabradine Anpharm
Kako čuvati Ivabradine Anpharm
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Resting heart rate below 70 beats per minute prior to treatment - Cardiogenic shock - Acute myocardial infarction - Severe hypotension (< 90/50 mmHg) - Severe hepatic insufficiency - Sick sinus syndrome - Sino-atrial block - Unstable or acute heart failure - Pacemaker dependent (heart rate imposed exclusively by the pacemaker) - Unstable angina - AV-block of 3rd degree - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals
- Kardiogeni šok - Akutni infarkt miokarda - Teška hipotenzija (< 90/50 mmHg) - Teška insuficijencija jetre - Sindrom bolesnog sinusnog čvora - Sinusatrijski blok - Nestabilno ili akutno zatajenje srca
In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012).
(definiran kao smanjenje od najmanje 3 napadaja angine na tjedan i/ili povećanje vremena do depresije ST segmenta za 1 mm od najmanje 60 s za vrijeme testa opterećenja) tijekom 6 tjedana liječenja (omjer šansi (OR) = 1,3, 95% CI [1,0-1,7]; p=0,012).
The starting dose should not exceed one tablet of Ivabradine Anpharm 5 mg twice daily.
Ukoliko se liječite od stabilne angine pektoris Početna doza ne smije prelaziti jednu tabletu Ivabradine Anpharm5 mg dva puta na dan.
Package leaflet: information for the patient Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets ivabradine
Uputa o lijeku: Informacije za bolesnika Ivabradine Anpharm5 mg filmom obložene tablete Ivabradine Anpharm7,5 mg filmom obložene tablete ivabradin
If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily.
(50/min) u mirovanju, ili u bolesnika nastupe simptomi koji su povezani s bradikardijom, doza se mora titrirati na slijedeću nižu u bolesnika koji primaju 7,5 mg dva puta dnevno ili 5 mg dva puta dnevno.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
[0,74;1,28]) niti za ostale sekundarne ishode uključujući hospitalizaciju zbog pogoršanja zatajenja srca (omjer hazarda (HR): 0,79, 95% CI [0,56;1,10]) ili smrt zbog zatajenja srca (omjer hazarda (HR): 0,69, 95% CI [0,31;1,53]).
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine Anpharm or monitoring should be required: - fluconazole (an antifungal medicine) - rifampicin (an antibiotic) - barbiturates (for difficult sleeping or epilepsy) - phenytoin (for epilepsy) - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole) - anti-malarial medicines (such as mefloquine or halofantrine) - intravenous erythromycin (an antibiotic) - pentamidine (an antiparasitic medicine) - cisapride (against the gastro-oesophageal reflux) - Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao prilagoditi dozu Ivabradina Anpharmili pratiti liječenje: - flukonazol (antifungik) - rifampicin (antibiotik) - barbiturati (za otežano spavanje ili epilepsiju) - fenitoin (za epilepsiju) - Hypericum perforatum ili Gospina trava (biljna terapija za depresiju) - lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti:
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride)
Jedna filmom obložena tableta sadrži 7,5mg ivabradina (što odgovara 8,085 mg ivabradinklorida)
STATEMENT OF ACTIVE SUBSTANCE(S) One film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine as hydrochloride)
Jedna filmom obložena tableta sadrži 5mg ivabradina (što odgovara 5,39 mg ivabradinklorida)
Ivabradine Anpharm 5 mg film-coated tablets
Ivabradine Anpharm 5 mg filmom obložene tablete ivabradin
Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered.
Mjerenje srčane frekvencije Budući da srčana frekvencija može značajno flukturirati tijekom vremena, mora se razmotriti provođenje serijskog mjerenja srčane frekvencije, putem EKG-a ili ambulantno 24-satno mjerenje,
- Non cardiovascular QT prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole,
- Ostali lijekovi koji produljuju QT-interval (npr. pimozid, ziprasidon, sertindol, meflokin,
5 How to store Ivabradine Anpharm Contents of the pack and other information
Kako Ivabradine Anpharm izgleda i sadržaj pakiranja
What Ivabradine Anpharm looks like and contents of the pack Ivabradine Anpharm 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and on the other.
Ivabradine Anpharm 5 mg filmom obložene tablete Duguljasta filmom obložena tableta boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom “5” na jednoj strani a na drugoj.
Ivabradine Anpharm 7.5 mg film-coated tablets
Ivabradine Anpharm 7,5 mg filmom obložene tablete ivabradin
Ivabradine Anpharm with food and drink Avoid grapefruit juice during treatment with Ivabradine Anpharm.
Stoga je tijekom liječenja ivabradinom potrebno izbjegavati konzumiranje soka od grejpa.
The mean ivabradine doses allowing to achieve a 20% HRR were 0.13 ± 0.04 mg/kg bid, 0.10 ± 0.04 mg/kg bid and 4.1 ± 2.2 mg bid in the age subsets [1-3[ years, [3-18[ years and <40 kg and [3-18[
U 69,9% bolesnika koji su primali ivabradin postignuto je 20% sniženje frekvencije srca bez bradikardije naspram 12,2% bolesnika u skupini koja je primala placebo tijekom razdoblja titracije od 2 do 8 tjedana (omjer šansi: E = 17,24, 95% CI [5,91; 50,30]) Srednje doze ivabradina koje su omogućile postizanje sniženje frekvencije srca za 20% su 0,13 ± 0,04 mg/kg dva puta na dan, 0,10 ± 0,04 mg/kg dva puta na dan i 4,1 ± 2,2 mg dva puta na dan u dobnim podskupinama od [1-3[ godine, [3-18[ godina i s <40 kg, odnosno [3-18[ godina i s ≥ 40 kg.
Erythema Pruritus Urticaria
Konstipacija Proljev
Therefore, ivabradine is contraindicated during breast-feeding (see section 4.3).
Stoga je ivabradin kontraindiciran u žena koje doje (vidjeti dio 4.3).
Diplopia Visual impairment
Tablični prikaz nuspojava
Stroke
interval
NAME OF THE MEDICINAL PRODUCT Ivabradine Anpharm 5 mg film-coated tablets Ivabradine Anpharm 7.5 mg film-coated tablets
Ivabradine Anpharm 5 mg filmom obložene tablete Ivabradine Anpharm 7,5 mg filmom obložene tablete
Pharmacokinetic/pharmacodynamic (PK/PD) relationship
Farmakokinetički/farmakodinamički odnos
D CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of
U nekim slučajevima (npr. kod starijih osoba) postoji mogućnost da Vam liječnik propiše pola doze, t.j. polovicu tablete od Ivabradina Anpharm5 mg (što odgovara količini od 2,5 mg ivabradina) ujutro, a drugu polovicu tablete od 5 mg uvečer.
For the full list of excipients, see section 6.1.
- Preosjetljivost na djelatnu tvar ili na neku od pomoćnih tvari navedenih u dijelu 6.1
Excipient with known effect: 63.91 mg lactose monohydrate Ivabradine Anpharm 7.5 mg film-coated tablets One film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
Ivabradine Anpharm 7,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 7,5 mg ivabradina (što odgovara 8,085 mg ivabradinklorida).
Respiratory,
Spazmi mišića
- if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
- ako imate niski krvni tlak; - ako imate nestabilnu anginu pektoris (težak oblik angine pektoris u kojoj se bolovi u prsima javljaju vrlo često uz napor, ali i bez napora);
Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Servier Pharma d.o.o. Tel: + 386 (0)1 563 48 11
Therefore the intake of grapefruit juice should be avoided.
Anpharmizbjegavajte konzumiranje soka od grejpa.
Servier s.r.o.
Servier Italia S.p.A.
V.J.
RMP-a.
Malaise, possibly related to bradycardia
Umor, moguće povezan s bradikardijom
<Alternatively you can report via your national reporting system {national system details}.>[For MRP/DCP only]
<Alternativno, možete prijaviti putem nacionalnog sustava izvješćivanja {detalji nacionalnog sustava}.>[For MRP/DCP only]
<Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/ >
Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove HYPERLINK "http://www.ema.europa.eu/" http://www.ema.europa.eu/.
Other information>
Ostale informacije>
<Interaction with other medicinal products and other forms of interaction:>
<Interakcije s drugim medicinskim proizvodima i drugi oblici interakcija:>
These measures should help to protect the environment.>
Te mjere pomažu u zaštiti okoliša.>
<Overdose (symptoms, emergency procedures, antidotes):>
<Predoziranje (simptomi, hitni postupci, antidoti):>
<Keep the {container} tightly closed>
<Držati {spremnik}čvrsto zatvoren>
If you notice any side effects, even those not already listed in this label or you think that the medicine has not worked, please inform your veterinary surgeon.
Ako zamijetite bilo koju nuspojavu, čak i one koje nisu navedene u ovoj etiketi ili mislite da veterinarsko-medicinski proizvod ne djeluje, molimo obavijestite svog veterinara.
<For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.>
<Za bilo koju informaciju o ovom veterinarsko-medicinskom proizvodu molimo kontaktirajte lokalnog predstavnika nositelja odobrenja za stavljanje u promet.
<Do not use {name} if you notice {description of the visible signs of deterioration}.>
<Ne primjenjujete {naziv proizvoda} ako primijetite {opis vidljivih znakova kvarenja}.>
The words “For animal treatment only” and conditions or restrictions regarding supply and use, if applicable
Riječi “Samo za primjenu na životinjama” i uvjeti ili ograničenja u pogledu opskrbe i primjene, ako je primjenjivo
<Do not <refrigerate> <or> <freeze>.>
<Ne <hladiti> <ili> <zamrzavati>.>
The words “Keep out of the sight and reach of children”
Riječi “Držati izvan pogleda i dosega djece”
{(Invented) name of veterinary medicinal product <strength> pharmaceutical form <target species>}
{(Izmišljeni) naziv veterinarsko-medicinskog proizvoda <jačina> farmaceutski oblik <ciljne vrste životinja>}
<Protect from direct sunlight.>
<Zaštiti od direktnog sunčevog svjetla.>
Special precautions for the disposal of unused product or waste materials, if any
15. Posebne mjere opreza prilikom odlaganja neupotrebljenog proizvoda ili otpadnih materijala, ako ih ima
Date on which the label was last approved
Datum kada je uputa o VMP zadnji puta odobrena
Name of the veterinary medicinal product
Naziv veterinarsko-medicinskog proizvoda
<Not all pack sizes may be marketed.>
<Ne moraju sve veličine pakovanja biti u prometu.>