FrancophonIA/ELRC3.0 huggingface dataset:
English: Every increase in dose or any dose adjustment to your baby's weight must be done by your doctor.
Croatian: Svako povećanje doze ili bilo kakvu drugu prilagodbu doze prema težini djeteta mora učiniti
English: HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy:
Croatian: HEMANGIOL je indiciran za liječenje proliferirajućeg infantilnog hemangioma koji zahtijeva sistemsku terapiju:
English: 1 NAME OF THE MEDICINAL PRODUCT
Croatian: 1 NAZIV LIJEKA
English: These hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma.
Croatian: Te hipoglikemijske epizode povezane s uzimanjem propranolola mogu se iznimno prezentirati u obliku napadaja i/ili kome.
English: • Medicines to treat anxiety and depression as well as more serious mental health problems, and epilepsy,
Croatian: • lijekove za liječenje tjeskobe i depresije, kao i ozbiljnije psihičke probleme, i za epilepsiju, • lijekove za liječenje tuberkuloze,
English: Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5.
Croatian: Majke koje doje: vidjeti dio 4.4 i dio 4.5.
English: Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia.
Croatian: Poremećaji spavanja odgovarali su nesanici, lošoj kvaliteti sna i hipersomniji.
English: A close clinical surveillance of any impaired tolerance of propranolol is requested.
Croatian: Potreban je poman klinički nadzor bilo kakve oslabljene tolerancije propranolola.
English: Do not shake the bottle before use.
Croatian: Nemojte tresti bocu prije uporabe.
English: In the absence of specific studies in children, the drug interactions with propranolol are those known in adults.
Croatian: U nedostatku posebnih ispitivanja u djece, interakcija lijekova s propranololom svodi se na one poznate kod odraslih.
English: If you have given to your child more HEMANGIOL than you should, please consult your doctor immediately.
Croatian: Ako ste djetetu dali više HEMANGIOL-a nego što ste trebali, molimo odmah se obratite svom liječniku.
English: 3-6 months
Croatian: 3-6 mjeseci
English: This educational pack is aimed at increasing awareness about the potential risk of hypotension, bradycardia, and bronchospasm, after taking HEMANGIOL, and providing guidance on how to monitor/manage that risk.
Croatian: Taj edukacijski paket ima za cilj povećati svjesnost o mogućem riziku od hipotenzije, bradikardije i bronhospazma nakon uzimanja HEMANGIOL-a, te omogućiti smjernice za nadzor/upravljanje tim rizikom.
English: • Disease of the sinus node (including sinoatrial block)
Croatian: • Bolest sinusnog čvora (uključujući sinoatrijalni blok)
English: PHACE syndrome
Croatian: PHACE sindrom
English: Beta stimulating agents may be used to counteract the beta-blockade.
Croatian: Beta stimulirajući agensi mogu se koristiti za suzbijanje beta-blokada.
English: An allergic reaction can include a rash, itching or shortness of breath.
Croatian: Alergijska reakcija može uključivati osip, svrbež ili nedostatak zraka.
English: After the first intake and each dose increase, a clinical monitoring, including blood pressure and heart rate must be performed at least hourly for at least 2 hours.
Croatian: Nakon prvog unosa i svakog povećanja doze, svakih sat vremena mora se provoditi klinički nadzor, uključujući krvni tlak i frekvenciju otkucaja srca tijekom najmanje narednih 2 sata.
English: If you are breastfeeding your child, and if you are taking medicines that must not be used with HEMANGIOL (see ‘‘If you are breastfeeding your child'' and “Other medicines and HEMANGIOL”) do not give this medicine to your child.
Croatian: Ako dojite svoje dijete i istodobno uzimate lijekove koji se ne smiju uzimati s HEMANGIOL-om (pogledajte „Ako dojite dijete“ i „Drugi lijekovi i HEMANGIOL“), nemojte davati ovaj lijek svom djetetu.
English: The administration of beta2 agonists and inhaled corticosteroids is possible.
Croatian: Moguća je primjena beta-2 agonista i inhalacijskih kortikosteroida.
English: Keep the bottle in the outer carton in order to protect from light.
Croatian: Čuvajte bocu u vanjskom pakiranju radi zaštite od svjetlosti.
English: • If your child has diabetes: in this case, your child's blood sugar level should be measured more frequently.
Croatian: • Ako Vaše dijete ima dijabetes: u tom slučaju, razina šećera u krvi vašeg djeteta mora se učestalije mjeriti.
English: • Sleep disorders (insomnia, poor quality of sleep and difficulties to wake-up),
Croatian: • Poremećaji spavanja (nesanica, loša kvaliteta sna i poteškoće buđenja),
English: The plasma half-life of propranolol ranges from 3 to 6 hours.
Croatian: Poluvijek propranolola u plazmi ima raspon od 3 do 6 sati.
English: After first opening, the medicine should be used within 2 months.
Croatian: Nakon prvog otvaranja lijek se mora upotrijebiti unutar 2 mjeseca.
English: When treatment was re-initiated, a satisfactory response was observed in a large majority of patients.
Croatian: Kada se liječenje ponovno započelo, kod velike većine bolesnika zabilježeni su zadovoljavajući odgovori na liječenje.
English: Then, your doctor will regularly examine your child during treatment.
Croatian: Osim toga, za vrijeme trajanja liječenja liječnik će redovito pregledavati Vaše dijete.
English: Wipe the outside dry.
Croatian: Osušite izvana brisanjem.
English: Propranolol was rapidly absorbed, the maximum plasma concentration generally occurring 2 hours after administration with a corresponding mean value around 79 ng/mL whatever the infant age.
Croatian: Propranolol je bio brzo apsorbiran, maksimalna koncentracija u plazmi obično se javljala 2 sata nakon primjene uz odgovarajuću srednju vrijednost oko 79 ng/ml bez obzira na dob dojenčeta.
English: It is also aimed to instruct caregivers to correctly feed the children during treatment in order to avoid the risk of hypoglycaemia.
Croatian: Cilj je i podučiti pružatelje skrbi o pravilnoj prehrani djece tijekom liječenja kako bi izbjegli rizik od hipoglikemije.
English: If different people are involved, good communication is essential in order to ensure the safety of your child.
Croatian: Ako su u davanje lijeka uključene različite osobe, bitna je dobra komunikacija kako bi se osigurala sigurnost Vašeg djeteta.
English: Isoproterenol and aminophylline may be used for bronchospasm.
Croatian: Izoproterenol i aminofilin se mogu koristiti za bronhospazam.
English: The toxicity of beta-blockers is an extension of their therapeutic effects:
Croatian: Toksičnost beta-blokatora posljedica je njihovih terapeutskih učinaka:
English: It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger.
Croatian: On prikriva adrenergičke upozoravajuće znakove hipoglikemije, osobito tahikardiju, drhtanje, anksioznost i glad.
English: • Reduction of the number of white blood cells.
Croatian: • Smanjen broj bijelih krvnih stanica.
English: Cardiovascular events reported during clinical studies were asymptomatic.
Croatian: Kardiovaskularni događaji prijavljeni za vrijeme kliničkih ispitivanja bili su asimptomatski.
English: Treatment success was defined as a complete or nearly complete resolution of the target haemangioma, which was evaluated by blinded centralized independent assessments made on photographs at Week 24, in the absence of premature treatment discontinuation.
Croatian: Uspjeh liječenja definiran je kao potpuno ili gotovo potpuno iščezavanje ciljnog hemangioma, što je procijenjeno putem slijepe središnje nezavisne procjene, izvršene na temelju fotografija u 24. tjednu, u odsutnosti prijevremenog prekida liječenja.
English: • Medicines used to lower lipids in the blood,
Croatian: • lijekove za snižavanje lipida u krvi,
English: • Information on the conditions for which HEMANGIOL should not be given
Croatian: • Informaciju o slučajevima u kojima se HEMANGIOL ne smije davati
English: • Cold extremities,
Croatian: • Hladni udovi,
English: In particular, in case you are breastfeeding, tell your doctor or pharmacist if you are or if your child is taking:
Croatian: Naročito, ako dojite, obavijestite svog liječnika ili ljekarnika u slučaju da Vi ili Vaše dijete uzimate:
English: One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation.
Croatian: Jedan slučaj drugostupanjskog atrioventrikularnog srčanog bloka kod bolesnika s podležećim poremećajem provođenja doveo je do definitivnog prekida liječenja.
English: • Feed your child regularly to avoid prolonged fast.
Croatian: • Dijete hranite redovito kako biste izbjegli produljena razdoblja gladovanja.
English: Rinse the empty syringe after each use into a glass of clean water: 1- Take a glass of clean water
Croatian: Isperite praznu štrcaljku nakon svake uporabe u čaši čiste vode:
English: • Hypoglycemia may develop and manifestations of hypoglycemia (tremor, tachycardia) may be masked by other clinical effects of beta-blocker toxicity.
Croatian: • Može se razviti hipoglikemija, a manifestacije hipoglikemije (tremor, tahikardija) mogu biti prikrivene drugim kliničkim učincima toksičnosti beta-blokatora.
English: In healthy subjects, no difference was observed between CYP2D6 extensive metabolizers and poor metabolizers with respect to oral clearance or elimination half-life.
Croatian: Kod zdravih osoba nije bilo razlike između snažnih CYP2D6 metabolizatora i slabih metabolizatora u odnosu na oralni klirens ili poluvijek eliminacije.
English: The patient should be placed on a cardiac monitor, monitor vital signs, mental status and blood glucose.
Croatian: Bolesnika se mora postaviti na srčani monitor te se moraju pratiti njegovi vitalni znakovi, mentalno stanje i razina glukoze u krvi.
English: During the titration phase, each dose increase must be managed and monitored by a physician in the same conditions as the administration of the initial dose.
Croatian: Tijekom faze titracije, svako povećanje doze mora određivati i nadzirati liječnik u istim uvjetima kao i pri primjeni početne doze.
English: In dietary administration studies in which mice and rats were treated with propranolol hydrochloride for up to 18 months at doses of up to 150 mg/kg/day, there was no evidence of drug-related tumorigenesis.
Croatian: U studijama upravljanja prehranom u kojima su miševi i štakori liječeni propranololkloridom u dozama do 150 mg/kg/dan u trajanju do 18 mjeseci nije bilo dokaza o tumorigenezi povezanoj s lijekom.
English: Other medicines and HEMANGIOL
Croatian: Drugi lijekovi i HEMANGIOL
English: In case of suspected cardiac abnormality, a specialist advice must be sought before treatment initiation to determine any subjacent contra-indication.
Croatian: U slučaju sumnje na srčane abnormalnosti, prije početka liječenja mora se zatražiti savjet specijalista kako bi se utvrdilo postoje li bilo kakve skrivene kontraindikacije.
English: • Premature infants, for whom the corrected age of 5 weeks has not been reached (the corrected age being calculated by subtracting the number of weeks of prematurity from the actual age)
Croatian: • Prijevremeno rođena dojenčad, koja nisu dosegla korigiranu dob od 5 tjedana (korigirana dob se izračunava oduzimanjem broja tjedana od prijevremenog rođenja od stvarne dobi)
English: Potential mechanisms of action of propranolol in proliferating infantile haemangioma described in the literature could include various mechanisms all in close relationship:
Croatian: Potencijalni mehanizmi djelovanja propranolola u proliferirajućem infantilnom hemangiomu opisani u literaturi mogu uključivati različite usko povezane mehanizme:
English: All beta-blocking agents can mask certain symptoms of hypoglycaemia: palpitations and tachycardia.
Croatian: Svi beta-blokatori mogu prikriti neke simptome hipoglikemije: palpitacije i tahikardiju.
English: • Decreased appetite,
Croatian: • Smanjen apetit,
English: If your child has any signs of hypoglycaemia while taking HEMANGIOL, give if possible oral liquid containing sugar and, if symptoms persist, call your doctor right away or go directly to hospital.
Croatian: Ako Vaše dijete ima bilo kakve znakove hipoglikemije dok uzima HEMANGIOL, ako je moguće dajte mu da popije tekućinu koja sadrži šećer, a ako simptomi i dalje traju odmah nazovite svog liječnika ili otiđite izravno u bolnicu.
English: Box of 1 bottle.
Croatian: Kutija sadrži 1 bocu.
English: The main effects reported after repeated administration of propranolol in adult and juvenile rats were a transient decrease in body weight and body weight gain associated with a transient decrease in organ weight.
Croatian: Glavni učinci zabilježeni nakon ponovljene primjene propranolola kod odraslih i mladih štakora bili su prolazno smanjenje tjelesne težine i povećanje tjelesne težine povezano s prolaznim smanjenjem težine organa.
English: 1 bottle of 120 mL and 1 oral syringe.
Croatian: 1 boca od 120 ml i 1 štrcaljka za usta.
English: • If your child has problems with his/her liver or kidneys.
Croatian: • Ako Vaše dijete ima problema s jetrom ili bubrezima.
English: • Erythema (skin redness),
Croatian: • Eritem (crvenilo kože),
English: Insert the syringe into your baby's mouth and place it against the inside of the cheek.
Croatian: Umetnite štrcaljku u djetetova usta i postavite je uz unutarnju stranu obraza.
English: In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism.
Croatian: In vitro ispitivanja pokazuju da su CYP2D6 (aromatična hidroksilacija), CYP1A2 (lančana oksidacija) i u manjoj mjeri CYP2C19 uključeni u metabolizam propranolola.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet.
English: Very limited safety data of propranolol in PHACE syndrome patients are available.
Croatian: Dostupna je vrlo ograničena količina podataka o sigurnosti propranolola kod bolesnika s PHACE
English: Evidence of the efficacy of propranolol in patients with highrisk haemangioma is available both in literature and in a specific compassionate use program performed with Hemangiol.
Croatian: Dokaz o učinkovitosti propranolola kod bolesnika s visoko rizičnim hemangiomom dostupan je u literaturi i u određenom programu milosrdne primjene provedenog s Hemangiolom.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: This medicine can mask the warning signs of hypoglycaemia (also known as low blood sugar level), especially if the baby is fasting, vomiting or in case of overdose.
Croatian: Ovaj lijek može prikriti upozoravajuće znakove hipoglikemije (također poznate kao niske razine šećera u krvi), osobito ako dijete nije uzimalo hranu, povraća ili u slučaju predoziranja.
English: Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia.
Croatian: Propranolol sprječava odgovor endogenih kateholamina da korigiraju hipoglikemiju.
English: • Moreover, if you are breastfeeding your child, it is important to tell your doctor, pharmacist or nurse which medicines you are yourself taking, as they may pass into your breast-milk and interfere with the treatment of your child.
Croatian: • Štoviše, ako dojite dijete, važno je da obavijestite svog liječnika, ljekarnika ili medicinsku sestru o svim lijekovima koje Vi uzimate, jer oni mogu prijeći u majčino mlijeko i ometati liječenje
English: Before opening: 3 years.
Croatian: 6.3 Rok valjanosti Prije otvaranja: 3 godine.
English: • Medicines used for anaesthesia.
Croatian: • lijekove koji se koriste za anesteziju.
English: • Breastfed infants, if the mother is treated with medicinal products contraindicated with propranolol
Croatian: • Dojenčad na majčinom mlijeku, ako se majka liječi lijekovima kontraindiciranima s propranololom
English: Enzyme inducers
Croatian: Enzimski induktori
English: It is necessary to alert the anaesthetist to the fact that the patient is being treated with beta-blockers.
Croatian: Neophodno je upozoriti anesteziologa na činjenicu da se bolesnik liječi beta-blokatorima.
English: This also applies when children are breastfed by mothers treated with corticosteroids in case of high dosage or prolonged treatment (see section 4.4 concerning hypoglycaemia).
Croatian: To vrijedi i za slučajeve djece dojene od strane majki liječenih kortikosteroidima, u slučaju visokog doziranja ili produljenog liječenja (vidjeti dio 4.4, Hipoglikemija).
English: In animals, after an acute dosing, propranolol is considered as a moderately toxic drug with an oral LD50 of about 600 mg/kg.
Croatian: Kod životinja, nakon akutnog doziranja, propranolol se smatra umjereno toksičnim lijekom s oralnim LD50 od oko 600 mg/kg.
English: PIERRE FABRE MEDICAMENT PRODUCTION Site PROGIPHARM, Rue du Lycée 45500 GIEN
Croatian: PIERRE FABRE MEDICAMENT PRODUCTION Site PROGIPHARM, Rue du Lycée
English: If your child:
Croatian: Vašem djetetu
English: Pack size: carton containing 1 bottle and 1 oral syringe.
Croatian: Veličina pakiranja: pakiranje sadrži 1 bocu i 1 štrcaljku za usta.
English: A monitoring of electrolyte should be performed in these patients.
Croatian: Kod tih bolesnika mora se provoditi praćenje elektrolita.
English: In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought.
Croatian: U slučaju simptomatske bradikardije ili bradikardije ispod 80 otkucaja u minuti, mora se odmah zatražiti savjet specijalista.
English: • has a slow heart rate for his/her age.
Croatian: • Vaše dijete ima usporen puls za svoju dob.
English: A haemangioma is a collection of extra blood vessels that have formed a lump in or under the skin.
Croatian: Hemangiom je nakupina viška krvnih žila koje oblikuju kvržicu unutar ili ispod kože.
English: The treatment of your child has been initiated by a physician who has expertise in the diagnosis, treatment and management of infantile haemangioma.
Croatian: Liječenje Vašeg djeteta započinje liječnik koji ima iskustvo u dijagnosticiranju, liječenju i praćenju dojenačkih hemangioma.
English: Clear, colourless to slightly yellow oral solution, with a fruity odour.
Croatian: Bistra, bezbojna do blago žuta oralna otopina, s voćnim mirisom.
English: • Asthma or history of bronchospasm
Croatian: • Astma ili anamneza bronhospazma
English: • Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension.
Croatian: • Srčani simptomi blagog do umjerenog trovanja su smanjeni broj otkucaja srca i hipotenzija.
English: In case of severe and/or symptomatic bradycardia or hypotension occurring at any time during treatment, treatment must be discontinued and a specialist advice should be sought.
Croatian: U slučaju teške i/ili simptomatske bradikardije ili hipotenzije do koje je došlo u bilo kojem trenutku tijekom liječenja, liječenje se mora prekinuti, te potražiti savjet specijalista.
English: In case the child spits up a dose or does not take all of the medicinal product no other dose should be given before the next scheduled dose.
Croatian: U slučaju da dijete ispljune dozu ili ne uzme cijeli lijek, ne treba mu davati drugu dozu prije sljedeće planirane doze.
English: Similar results were obtained following intra-testicular administration of propranolol and using in vitro models.
Croatian: Slični rezultati dobiveni su nakon intra testikularne primjene propranolola i pomoću in vitro modela.
English: • lack of partial agonist activity (or intrinsic sympathomimetic activity).
Croatian: • antiaritmički učinak, • nepostojanje djelomične aktivnosti agonista (ili intrinzične simpatomimetičke aktivnosti).
English: • If your child has psoriasis (a skin condition that produces red, dry plaques of thickened skin), as this medicine may worsen the symptoms of this condition.
Croatian: • Ako Vaše dijete ima psorijazu (stanje kože kod kojeg dolazi do nastanka crvenih, suhih promjena zadebljane kože), jer ovaj lijek može pogoršati simptome tog stanja.
English: The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes.
Croatian: Terapijska doza je 3 mg/kg/dan, koja se treba primijeniti u 2 odvojene doze od 1,5 mg/kg, jednu ujutro, a jednu u kasno poslijepodne, s vremenskim razmakom od najmanje 9 sati između dva unosa.
English: HEMANGIOL contains sodium and propylene glycol
Croatian: HEMANGIOL sadrži natrij i propilenglikol
English: Although some reversible effects on male and female fertilities were reported in adult rats receiving high doses of propranolol in the literature, the study performed in juvenile animals did not show any effect on fertility (see section 5.3).
Croatian: Iako su u literaturi zabilježeni neki reverzibilni učinci na plodnost mužjaka i ženki kod odraslih štakora koji su primali visoke doze propranolola, ispitivanje provedeno na mladim životinjama nije pokazalo nikakav učinak na plodnost (vidjeti dio 5.3).
English: Do not use this medicine after the expiry date which is stated on the outer carton and bottle label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i naljepnici na boci.
English: Locate this number on the oral syringe.
Croatian: Pronađite taj broj na štrcaljki za usta.
English: • at least 9 hours interval between two intakes
Croatian: • vremenski razmak između dva unosa mora biti najmanje 9 sati
English: Sleep disorder
Croatian: Poremećaj spavanja
English: • Diarrhoea and vomiting.
Croatian: • Proljev i povraćanje.
English: None of cases was of severe intensity and led to treatment discontinuation.
Croatian: Niti jedan od slučajeva nije bio toliko snažnog intenziteta da bi doveo do prekida liječenja.
English: Intravenous fluids for hypotension and atropine for bradycardia should be given.
Croatian: Bolesniku se moraju davati intravenska tekućina za hipotenziju i atropin za bradikardiju.
English: Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease.
Croatian: Proljev je bio često zabilježen te nije uvijek bio povezan sa zaraznim bolestima probavnog sustava.
English: Co-administration of cholestyramine or colestipol with propranolol resulted in up to 50% decrease in propranolol concentrations.
Croatian: Istodobna primjena kolestiramina ili kolestipola s propranololom rezultirala je smanjenjem koncentracije propranolola do 50%.
English: Treatment with HEMANGIOL should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available.
Croatian: Liječenje HEMANGIOL-om trebaju započeti liječnici koji imaju iskustvo u dijagnostici, liječenju i vođenju infantilnog hemangioma, u kontroliranom kliničkom okruženju u kojem stoje na raspolaganju odgovarajuće mogućnosti za zbrinjavanje nuspojava, uključujući i one koje zahtijevaju hitne mjere.
English: • Cardiogenic shock
Croatian: • Kardiogeni šok
English: However, several reports of hypoglycaemia with related hypoglycaemic seizure were reported during the compassionate use program and in literature, especially in case of fasting period during intercurrent illness (see section
Croatian: Međutim, nekoliko izvješća hipoglikemije s povezanim hipoglikemijskim napadajima zabilježeni su tijekom programa milosrdne primjene i u literaturi, naročito u slučaju razdoblja posta tijekom interkurentne bolesti (vidjeti dio 4.4).