FrancophonIA/ELRC3.0 huggingface dataset:
English: Stop treatment and contact your doctor immediately if after giving HEMANGIOL to your child you observe the following symptoms suggestive of a bronchospasm (temporary restriction of the bronchial tubes that leads to difficulty breathing): cough, quick or difficult breathing or wheezing, associated or not with a bluish-coloured skin.
Croatian: Prekinite liječenje i odmah se obratite svom liječniku ako nakon što date djetetu HEMANGIOL primijetite sljedeće simptome koji upućuju na bronhospazam (privremeno sužavanje dišnih puteva koje dovodi do otežanog disanja): kašalj, brzo ili otežano disanje ili piskanje pri disanju, uz moguće prisutnu plavkastu boju kože.
English: 1 What HEMANGIOL is and what it is used for What HEMANGIOL is
Croatian: Što je HEMANGIOL i za što se koristi Što je HEMANGIOL
English: If you give to your child more HEMANGIOL than you should
Croatian: Ako ste djetetu dali više HEMANGIOL-a nego što ste trebali
English: • If your child spits up a dose or if you are uncertain whether he/she got all of the medicine, do not give another dose, just wait until the next scheduled dose.
Croatian: • Ako Vaše dijete ispljune dozu ili ako niste sigurni je li ono popilo sav lijek, nemojte mu davati drugu dozu, već pričekajte do sljedeće planirane doze.
English: - Instructions on when to discontinue the administration of HEMANGIOL
Croatian: - Upute kada prekinuti primjenu HEMANGIOL-a
English: Peak plasma concentrations occur about 1 to 4 hours after an oral dose.
Croatian: Do prve vršne koncentracije u plazmi dolazi oko 1 do 4 sata nakon peroralne primjene.
English: The MAH shall provide an educational pack for the proposed indication, targeting all caregivers who are expected to prepare and administer HEMANGIOL to children.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet osigurat će edukacijski paket za predloženu indikaciju svim pružateljima skrbi za koje se očekuje da će pripremati i primjenjivati HEMANGIOL djeci.
English: It can aggravate hypoglycaemia in children, especially in case of fasting, vomiting or overdose.
Croatian: Može pogoršati hipoglikemiju kod djece, naročito u slučaju neuzimanja hrane, povraćanja ili predoziranja.
English: In case of large ulcerated haemangioma,, your child's blood potassium level should be measured.
Croatian: U slučaju velikog ulceriranog hemangioma, mora se izmjeriti razina kalija u krvi Vašeg djeteta.
English: Patients with infantile haemangioma may be at increased risk if they have received or are concomitantly receiving treatment with corticosteroids because adrenal suppression may result in loss of the counterregulatory cortisol response and increase the risk of hypoglycaemia.
Croatian: Bolesnici s infantilnim hemangiomom mogu biti pod povećanim rizikom ako su primili liječenje ili su istodobno podvrgnuti liječenju s kortikosteroidima, jer adrenalna supresija može rezultirati gubitkom proturegulatorne reakcije na kortizol i povećati rizik od hipoglikemije.
English: In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Croatian: U slučaju akutnih bronho-pulmonalnih abnormalnosti, početak liječenja mora se odgoditi.
English: • Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),
Croatian: • Konvulzije (napadaji) povezane s hipoglikemijom (neuobičajeno niska razina šećera u krvi),
English: Once corrected by the body weight, primary pharmacokinetic parameters for propranolol (such as plasma clearance) determined in infants were similar to those reported in the literature for adults.
Croatian: primarni farmakokinetički parametri za propranolol (poput klirensa plazme) utvrđeni kod dojenčadi bili su slični onima zabilježenima za odrasle u literaturi.
English: • Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with β-blockers such as propranolol.
Croatian: • Amiodaron je antiaritmičko sredstvo s negativnim kronotropnim svojstvima koja mogu biti aditiv onima s β-blokatorima, kao što je propranolol.
English: • has a heart problem (such as disorders of the heart rhythm and heart failure.
Croatian: • Vaše dijete ima srčanih poteškoća (kao što su poremećaji srčanog ritma i zatajenje srca).
English: An analysis of the medical history and a full clinical examination must be performed including heart rate, cardiac and pulmonary auscultation.
Croatian: Mora se provesti analiza povijesti bolesti i puni klinički pregled, uključujući frekvenciju otkucaja srca, te auskultaciju srca i pluća.
English: Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities.
Croatian: Zbog svog farmakološkog djelovanja, propranolol može uzrokovati ili pogoršati bradikardiju ili abnormalnosti krvnog tlaka.
English: In children with cardiac failure, the treatment should be managed by the cardiologist.
Croatian: Kod djece sa zatajenjem srca liječenje treba biti pod nadzorom kardiologa.
English: Read all of this leaflet carefully before your child starts receiving this medicine because it contains important information.
Croatian: Vaše dijete počne uzimati ovaj lijek jer sadrži važne podatke.
English: • infants given any other medicinal products, notably those mentioned below.
Croatian: • dojenčad kojima se daje bilo koji drugi lijek, posebice oni koji su navedeni u nastavku.
English: • Tell your doctor before giving this medicine.
Croatian: Ako dojite dijete • Recite to svom liječniku prije davanja ovog lijeka.
English: If necessary, the medicinal product may be diluted in a small quantity of baby-milk or age-adapted apple and/or orange fruit juice.
Croatian: Ako je potrebno, lijek se može razrijediti u maloj količini mlijeka za bebe ili voćnog soka od jabuke i/ili naranče prilagođenog dobi djeteta.
English: If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment.
Croatian: Ako se pojave klinički znakovi hipoglikemije, potrebno je dati djetetu da pije otopinu slatke tekućine te privremeno zaustaviti liječenje.
English: • a local haemodynamic effect (vasoconstriction which is a classical consequence of beta adrenergic blockade and a decrease of infantile haemangioma lesion perfusion);
Croatian: • lokalni hemodinamski učinak (vazokonstrikciju koja je klasična posljedica beta-adrenergičke blokade i smanjene perfuzije infantilnog hemangioma);
English: • is born prematurely and he/she has not reached the corrected age of 5 weeks (the corrected age being the age a premature baby would be if he/she had been born on their due date).
Croatian: • je Vaše dijete rođeno prerano te ako nije doseglo korigiranu dob od 5 tjedana (korigirana dob je dob koju bi prerano rođeno dijete imalo da je rođeno na dan termina).
English: Use of propranolol alongside hypoglycaemic therapy in diabetic patients should be with caution since it may prolong the hypoglycaemic response to insulin.
Croatian: Uporaba propranolola uz hipoglikemijsku terapiju kod bolesnika s dijabetesom mora se obavljati oprezno budući da to može produljiti hipoglikemijski odgovor na inzulin.
English: Hemangiol is started in infants aged 5 weeks to 5 months, when: - the localisation and/or extend of the lesions are life- or function threatening (might impair vital organs or senses such as vision or hearing); - the haemangioma is ulcerated (i.e. with sore on the skin which fails to heal) and painful, and/or does not respond to simple wound care measures; - there is a risk of permanent scars or disfigurement.
Croatian: Hemangiol se započinje primjenjivati kod dojenčadi u dobi od 5 tjedana do 5 mjeseci, kada: - smještaj i/ili proširenost lezija ugrožava život ili funkciju (može oštetiti vitalne organe ili osjetila kao što su vid ili sluh); - hemangiom je ulceriran (s ranama na koži koje ne zacjeljuju) i bolan i/ili ne odgovara na jednostavne mjere njege rane;
English: • The metabolism of intravenous lidocaine is inhibited by co-administration of propranolol, resulting in a 25% increase in lidocaine concentrations.
Croatian: • Metabolizam intravenskog lidokaina inhibiran je istodobnom primjenom propranolola, što rezultira povećanjem koncentracije lidokaina od 25%.
English: Dermatitis psoriasiform
Croatian: Psorijaziformni dermatitis
English: Propranolol passes through breast milk, mothers being treated with propranolol who breastfeed their infant should inform their health care professional.
Croatian: Propranolol se izlučuje u majčino mlijeko, stoga majke koje se liječe propranololom a istovremeno doje djecu o tome moraju obavijestiti svog zdravstvenog radnika.
English: In adult male rats, repeated administration of propranolol at high dose levels (≥7.5 mg/kg) induced histopathological lesions of the testes, epididymis, and seminal vesicles, decrease in sperm motility, sperm cell concentration, plasma testosterone levels and significant increase in sperm head and tail abnormalities.
Croatian: Kod odraslih mužjaka štakora, ponovljena primjena propranolola u visokim dozama (≥ 7,5 mg/kg) izazvala je histopatološke lezije testisa, epididimisa i sjemenih mjehurića, smanjenje pokretljivosti spermija, koncentracije spermija, razine testosterona u plazmi i značajan porast abnormalnosti u glavi i repu spermija.
English: • Somnolence,
Croatian: • Pospanost,
English: Blood sugar decreases observed during clinical studies were asymptomatic.
Croatian: Zabilježeno smanjenje šećera u krvi tijekom kliničkih ispitivanja bilo je asimptomatsko.
English: Mortality with unknown although unlikely relationship to treatment was observed at 40 mg/kg/day, leading to a NOAEL of 20 mg/kg/day for juvenile toxicity.
Croatian: Smrtnost, čija povezanosti s liječenjem nije poznata iako nije vjerojatna, uočena je u dozi od 40 mg/kg/dan, što dovodi do NOAEL razine od 20 mg/kg/dan za toksičnost u mladih životinja.
English: Here is how to open it: push down the plastic cap while turning the cap counter-clockwise (to the left).
Croatian: Otvara se na sljedeći način: pritisnite plastični zatvarač prema dolje dok ga istovremeno okrećete u smjeru suprotnom od kazaljke sata (ulijevo).
English: During this pharmacokinetic study including infants with function-threatening haemangioma, haemangioma in certain anatomic locations that often leave permanent scars or deformity, large facial haemangioma, smaller haemangioma in exposed areas, severe ulcerated haemangioma, pedunculated haemangioma, efficacy was also studied as a secondary evaluation criteria.
Croatian: Tijekom ovog farmakokinetičkog ispitivanja, koje je uključivalo dojenčad s hemangiomima opasnim po funkcije, hemangiomima na određenim anatomskim mjestima koja često ostavljaju trajne ožiljke ili deformaciju, velikim hemangiomima lica, manjim hemangiomima na izloženim područjima, teškim ulceriranim hemangiomima i pedunkuliranim hemangiomima, kao sekundarni kriterij vrednovanja ispitivana je i učinkovitost.
English: Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol.
Croatian: Vezano uz infekcije donjih dišnih puteva poput bronhitisa ili bronhiolitisa, kod bolesnika liječenih HEMANGIOL-om uočeno je pogoršanje simptoma (uključujući bronhospazam) zbog bronhokonstriktivnog učinka propranolola.
English: However, studies suggest that P-gp is not dose-limiting for intestinal absorption of propranolol in the usual therapeutic dose range.
Croatian: Međutim, ispitivanja pokazuju da u uobičajenim rasponima terapijskih doza, P-gp nije ograničavajuć po pitanju doze za crijevnu apsorpciju propranolola.
English: • If your child has a PHACE syndrome (a condition combining haemangioma and vascular abnormalities including cerebral blood vessels), as this medicine may increase the risk of cerebral stroke.
Croatian: • Ako Vaše dijete ima PHACE sindrom (stanje kod kojeg udruženo postoji hemangiom i vaskularne abnormalnosti uključujući krvne žile mozga), jer ovaj lijek može povećati opasnost od moždanog udara.
English: In the context of the 4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration.
Croatian: kontekstu 4-satnog kardiovaskularnog praćenja, nakon primjene lijeka tijekom dana titracije uočeno je smanjenje broja otkucaja srca (oko 7 o/m) i sistoličkog krvnog tlaka (manje od 3 mmHg).
English: Replace the plastic cap on the bottle by turning it clock-wise (to the right).
Croatian: Vratite plastični zatvarač na bocu okrećući ga u smjeru kazaljke sata (udesno).
English: In adult female rats, propranolol given into the uterus or by intravaginal administration is a powerful anti-implantation agent at dose ≥4 mg per animal, the effects being reversible.
Croatian: Kod ženki odraslih štakora, propranolol primijenjen u maternicu ili intravaginalno je snažno antiimplantacijsko sredstvo u dozi ≥ 4 mg po životinji, pri čemu su učinci povratni.
English: Hyperkaliemia cases have been reported in patients with large ulcerated hemangioma.
Croatian: Slučajevi hiperkalemije zabilježeni su kod bolesnika s velikim ulceriranim hemangiomom.
English: Mean apparent oral clearance was 2.71 L/h/kg in infants aged 65- 120 days and 3.27 L/h/kg in infant aged 181- 240 days.
Croatian: Srednja vrijednost vidljivog oralnog klirensa bila je 2,71 l/h/kg kod dojenčadi u dobi od 65 do 120 dana i 3,27 l/h/kg kod dojenčadi u dobi od 181 do 240 dana.
English: • The dose should always be measured using the oral syringe supplied with the bottle.
Croatian: • Doza se uvijek mora mjeriti pomoću štrcaljke za usta koja dolazi priložena uz bocu.
English: • If necessary, you may mix the medicine with a small quantity of baby-milk or age-adapted apple and/or orange fruit juice and give it to your child in a baby bottle.
Croatian: Ako je potrebno, lijek možete pomiješati s malom količinom mlijeka za bebe ili voćnog soka od jabuke i/ili naranče prilagođenog dobi djeteta te ga dajte djetetu u dječjoj bočici.
English: • Bradycardia (abnormally low heart rate),
Croatian: • Bradikardija (neuobičajeno usporen puls),
English: Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate.
Croatian: Glikozidi digitalisa Glikozidi digitalisa i beta-blokatori usporavaju atrioventrikularnu provodljivost i smanjuju otkucaje srca.
English: In the event of isolated bronchospasm, treatment must be permanently discontinued.
Croatian: U slučaju izoliranog bronhospazma, liječenje se mora trajno prekinuti.
English: • The metabolism of propranolol is reduced by co-administration of quinidine, leading to a twothree-fold increased blood concentration and greater degrees of clinical beta-blockade.
Croatian: • Metabolizam propranolola je smanjen kod istodobne primjene kinidina, što dovodi do dva do tri puta povišene koncentracije u krvi i većih stupnjeva kliničkih beta-blokada.
English: Propranolol is metabolized through three primary routes: aromatic hydroxylation (mainly 4hydroxylation), N-dealkylation followed by further side-chain oxidation, and direct glucuronidation.
Croatian: Propranolol se metabolizira kroz tri osnovna puta: aromatičnom hidroksilacijom (uglavnom 4hidroksilacija), N-dealkilacijom praćenom daljnjom oksidacijom bočnih lanaca, i izravnom glukuronidacijom.
English: The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day.
Croatian: Pojava proljeva čini se ovisna o dozi između 1 i 3 mg/kg/dan.
English: • Medicines to treat pain and inflammation,
Croatian: • lijekove protiv bolova i upale,
English: Medicinal products inducing orthostatic hypotension Medicinal products that induce postural hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen…) may add their effects to that of beta-blockers.
Croatian: Lijekovi koji izazivaju posturalnu hipotenziju (derivati nitrata, inhibitori fosfodiesteraze tipa 5, triciklički antidepresivi, antipsihotici, dopaminergički agonisti, levodopa, amifostin, baklofen...) mogu pojačati učinke beta-blokatora.
English: • has very low blood pressure.
Croatian: • Vaše dijete ima vrlo nizak krvni tlak.
English: Clinical efficacy and safety in the paediatric population The efficacy of propranolol in infants (aged 5 weeks to 5 months at treatment initiation) with proliferating infantile haemangioma requiring systemic therapy has been demonstrated in a pivotal randomised, controlled, multicentre, multidose, adaptive phase II/III study aimed to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind).
Croatian: Djelotvornost propranolola kod dojenčadi (u dobi od 5 tjedana do 5 mjeseci na početku liječenja) s proliferirajućim infantilnim hemangiomom koji zahtijeva sistemsku terapiju dokazana je u ključnom randomiziranom, kontroliranom, multicentričnom, višedoznom, adaptivnom ispitivanju faze II/III, čiji je cilj bio usporediti četiri režima propranolola (1 ili 3 mg/kg/dan tijekom 3 ili 6 mjeseci) s placebom (dvostruko slijepo).
English: - For bradycardia and hypotension: fatigue, coldness, pallor, bluish-coloured skin, and fainting.
Croatian: Za bradikardiju i hipotenziju: umor, hladnoća, bljedilo, plavkasta boja kože i nesvjestica.
English: • has a high blood pressure caused by a tumour on the adrenal gland.
Croatian: • Vaše dijete ima visok krvni tlak uzrokovan tumorom u nadbubrežnoj žlijezdi.
English: • Haemangioma with a risk of permanent scars or disfigurement.
Croatian: • hemangiom s opasnošću od trajnih ožiljaka ili izobličavanja.
English: In children with diabetes, blood glucose monitoring should be more frequent and followed by the endocrinologist.
Croatian: Kod djece s dijabetesom praćenje glukoze u krvi mora biti učestalije i pod nadzorom endokrinologa.
English: Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Croatian: Istodobno liječenje sistemskim kortikosteroidima može povećati rizik od hipoglikemije (vidjeti dio
English: HEMANGIOL is to be given during or right after a feed to avoid the risk of hypoglycaemia.
Croatian: HEMANGIOL treba dati tijekom ili neposredno nakon hranjenja kako bi se izbjegao rizik od hipoglikemije.
English: • Prinzmetal's angina
Croatian: • Prinzmetalova angina
English: Propranolol is a beta-blocker that is characterised by three pharmacological properties:
Croatian: Propranolol je beta-blokator kojeg karakteriziraju tri farmakološka svojstva:
English: Turn bottle upright and remove the entire syringe from the bottle.
Croatian: Izvucite štrcaljku Okrenite bocu uspravno i izvucite cijelu štrcaljku iz boce.
English: • Urticaria (allergic reaction of the skin), alopecia (loss of hair),
Croatian: • Urtikarija (alergijska reakcija na koži), alopecija (gubitak kose), • Smanjena razina šećera u krvi,
English: - For hypoglycaemia: minor symptoms like pallor, tiredness, sweating, shakiness, palpitations, anxiety, hunger, difficulty waking up; major symptoms like excessive sleeping, difficulty to get a response, poor feeding, temperature decrease, convulsions (fits), brief pauses in breathing, loss of consciousness
Croatian: Za hipoglikemiju: manji simptomi poput bljedila, umora, znojenja, drhtavice, palpitacija, anksioznosti, gladi, teškoće buđenja; veći simptomi poput prekomjernog spavanja, teškog dobivanja odgovora, lošeg apetita, smanjenja temperature, konvulzija (napadaja), kratkih stanki pri disanju, gubitka svijesti.
English: The readministration of propranolol may be considered when the child has fully recovered; in case of reoccurrence, treatment should be permanently discontinued.
Croatian: Kada se dijete u potpunosti oporavi, može se ponovno razmotriti dati propranolol, a u slučaju da se simptomi vrate liječenje se mora trajno prekinuti.
English: Do not lie the child down immediately after the administration.
Croatian: Nemojte dijete polegnuti odmah nakon što ste mu dali lijek.
English: In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to worsening of the reaction and resistance to its treatment with adrenaline at normal doses.
Croatian: Kod bolesnika za koje je vjerojatno da će doživjeti tešku anafilaktičku reakciju, bez obzira na podrijetlo, posebice s jodnim kontrastnim sredstvima, liječenje beta-blokatorom može dovesti do pogoršanja reakcije i njene otpornosti na liječenje adrenalinom u normalnim dozama.
English: • The other ingredients are hydroxyethylcellulose, sodium saccharin, strawberry flavour (contains propylene glycol), vanilla flavour (contains propylene glycol), citric acid monohydrate, purified water.
Croatian: • Drugi sastojci su hidroksietilceluloza, saharinnatrij, aroma jagode (sadrži propilenglikol), aroma vanilije (sadrži propilenglikol), citratna kiselina hidrat, pročišćena voda.
English: For ethical reasons related to the use of placebo, the demonstration of the efficacy was not established in patients with high-risk haemangioma.
Croatian: Zbog etičkih razloga vezanih uz korištenje placeba, kod bolesnika s visoko rizičnim hemangiomom prikaz učinkovitosti nije određen.
English: • infants breastfed by mothers taking any other medicinal products, notably those mentioned below.
Croatian: • dojenčad koje doje majke koje uzimaju bilo koji drugi lijek, posebice jedan od onih koji su navedeni u nastavku.
English: The pharmacokinetics of repeated administrations of HEMANGIOL at 3 mg/kg/day given in 2 intakes has been investigated in 19 infants aged 35 to 150 days at the beginning of treatment.
Croatian: Pedijatrijska populacija Farmakokinetika ponovljenih primjena HEMANGIOL-a u dozi od 3 mg/kg/dan davana kroz 2 unosa ispitivana je u 19-ero dojenčadi u dobi od 35 do 150 dana na početku liječenja.
English: The mixing may be done with one teaspoonful (approximately 5 mL) of milk for children weighing up to 5 kg, or with a tablespoonful (approximately 15 mL) of milk or fruit juice for children weighing more than 5 kg, delivered in a baby's bottle.
Croatian: Za miješanje se može koristiti jedna puna čajna žličica (oko 5 ml) mlijeka za djecu tešku do 5 kg ili jedna puna jušna žlica (oko 15 ml) mlijeka ili voćnog soka za djecu težu od 5 kg, dano putem dječje bočice.
English: HEMANGIOL can decrease blood pressure (hypotension) and heart rate (bradycardia).
Croatian: HEMANGIOL može sniziti krvni tlak (hipotenzija) i usporiti puls (bradikardija).
English: Tell the your doctor that he/she is taking HEMANGIOL.
Croatian: Recite svom liječniku da Vaše dijete uzima HEMANGIOL.
English: • Low blood pressure below the following limits:
Croatian: • Nizak krvni tlak, ispod sljedećih granica: Dob
English: The active ingredient is propranolol.
Croatian: Djelatni sastojak je propranolol.
English: • Medicines for diabetes,
Croatian: • lijekove za dijabetes,
English: • Phaeochromocytoma
Croatian: • Feokromocitom
English: Do not remove the syringe adapter from the neck of the bottle.
Croatian: Nemojte uklanjati nastavak za štrcaljku s grla boce.
English: In the absence of data in children, propranolol is not recommended in case of renal or hepatic impairment (see section 4.2).
Croatian: U nedostatku podataka u djece, propranolol se ne preporučuje kod djece s oštećenjem jetre ili bubrega (vidjeti dio 4.2).
English: In children who are at risk of anaphylaxis, the benefit risk of the medicinal product should be evaluated.
Croatian: Kod djece koja su izložena riziku od anafilaksije treba procijeniti omjer koristi i rizika lijeka.
English: Do not dismantle the syringe.
Croatian: Nemojte rastavljati štrcaljku.
English: This medicine contains 2.08 mg of propylene glycol/kg/day.
Croatian: Ovaj lijek sadrži 2,08 mg propilenglikola/kg/dan.
English: Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar pojedinog organskog sustava, nuspojave su prikazane redoslijedom od ozbiljnih prema manje ozbiljnima.