FrancophonIA/ELRC3.0 huggingface dataset:
English: The following table gives the adverse reactions, reported whatever dose and treatment duration, in three clinical studies, including 435 patients treated by HEMANGIOL at 1 mg/kg/day or 3 mg/kg/day for a maximum treatment duration of 6 months.
Croatian: Tablični popis nuspojava Sljedeća tablica navodi nuspojave, prijavljene uz različite doze i trajanja liječenja, u tri klinička ispitivanja koja su uključivala 435 bolesnika liječenih HEMANGIOL-om od 1 mg/kg/dan ili 3 mg/kg/dan u maksimalnom trajanju liječenja od 6 mjeseci.
English: Improvement of haemangioma was observed at 5 weeks of treatment by propranolol in 88% of patients.
Croatian: U 88% bolesnika je nakon 5 tjedana liječenja propranololom uočeno poboljšanje hemangioma.
English: In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment should be temporarily discontinued.
Croatian: U slučaju infekcije donjih dišnih puteva povezane s dispnejom i piskanjem, liječenje mora biti privremeno obustavljeno.
English: • Propafenone has negative inotropic and beta-blocking properties that can be additive to those of propranolol.
Croatian: • Propafenon ima negativna inotropna svojstva i svojstva beta-blokatora, koja mogu imati aditivan učinak onima od propranolola.
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Croatian: ZAC d'Orgemont F-49000 Angers Francuska
English: Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure.
Croatian: Kod bolesnika s kongestivnim zatajenjem srca, simpatička stimulacija može biti životno važna komponenta koja podržava funkciju cirkulacije, a njegova inhibicija beta blokatorima može uzrokovati još teže zatajenje.
English: The medicine should not be put in the full filled bottle.
Croatian: Ne stavljajte lijek u bocu koja je već potpuno napunjena.
English: Or
Croatian: Ili
English: Second week (2 mg/kg/day)
Croatian: Drugi tjedan (2 mg/kg/dan)
English: If you forget to give HEMANGIOL to your child
Croatian: Ako ste djetetu zaboravili dati HEMANGIOL
English: • Severe peripheral arterial circulatory disturbances (Raynaud's phenomenon)
Croatian: • Teški poremećaji cirkulacije na razini perifernih arterija (Raynaudov fenomen) • Dojenčad sklona hipoglikemiji
English: • an antiangiogenic effect (decrease of vascular endothelial cells proliferation, reduction of the neovascularization and formation of vascular tubules, reduction of the secretion of Matrix
Croatian: • antiangiogenski učinak (smanjenje proliferacije vaskularnih endotelnih stanica, smanjenje neovaskularizacije i formiranje krvnih kanalića, smanjenje izlučivanja matriks metaloproteinaze 9);
English: The four major final metabolites are propranolol glucuronide, naphthyloxylactic acid and glucuronic acid, and sulfate conjugates of 4-hydroxy propranolol.
Croatian: Četiri glavna konačna metabolita su propranolol glukuronid, naftiloksioctena kiselina i glukuronska kiselina, te sulfatni konjugati 4
English: Decreased blood pressure
Croatian: Snižen krvni tlak
English: • Step 8.
Croatian: • Korak 8.
English: • Medicines for heart and blood vessels problems such as uneven heart beats, chest pain or angina,
Croatian: • lijekove za poteškoće povezane sa srcem i krvnim žilama kao što su: nepravilni otkucaji srca, bol u prsima ili angina, visoki krvni tlak, zatajenje srca,
English: • The active substance is propranolol.
Croatian: • Djelatna tvar je propranolol.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Početak liječenja
English: Halogenated Anesthetic Agents
Croatian: Halogena sredstva za anesteziju
English: Bradycardia -inducing calcium-channel blockers (diltiazem, verapamil, bepridil) Co-administration with propranolol can cause altered automaticity (excessive bradycardia, sinus arrest), sino-atrial and atrio-ventricular conduction disorders, and increased risk of ventricular arrhythmias (torsades de pointes) along with heart failure.
Croatian: Bradikardija-inducira blokatore kalcijevih kanala (diltiazem, verapamil, bepridil) Istovremena primjena s propranololom može uzrokovati promjenu automatizma (prekomjernu bradikardiju, sinusni zastoj), poremećaje sinoatrijalne i atrioventrikularne provodljivosti te povećani rizik od ventrikularnih aritmija (torsades de pointes), kao i zatajenje srca.
English: Do not use any other measuring device.
Croatian: Ne upotrebljavati nijedan drugi dozator.
English: Hyperkalaemia has been reported in the literature in few patients with large ulcerated haemangioma (see section 4.4).
Croatian: U literaturi je kod nekoliko bolesnika s velikim ulceriranim hemangiomom zabilježena hiperkalemija (vidjeti dio 4.4).
English: • has asthma or history of breathing difficulties.
Croatian: • Vaše dijete ima astmu ili je nekada imalo teškoće pri disanju.
English: • HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Croatian: • HEMANGIOL i hranu mora davati ista osoba kako bi se izbjegao rizik od hipoglikemije.
English: First week (1 mg/kg/day)
Croatian: Prvi tjedan (1 mg/kg/dan)
English: Propranolol is highly lipid-soluble and may cross the blood brain barrier and cause seizures.
Croatian: Propranolol je vrlo topljiv u lipidima i može prijeći krvno-moždanu barijeru te uzrokovati napadaje.
English: Do not use a spoon or any other dispensing device.
Croatian: Nemojte koristiti žlicu ili bilo kakav drugi dozator.
English: - Information on how to detect and manage any sign of hypoglycaemia during treatment with HEMANGIOL
Croatian: - Informaciju kako otkriti i liječiti znakove hipoglikemije za vrijeme liječenja
English: Infants with large facial infantile hemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome, with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Croatian: Kod dojenčadi s velikim hemangiomom lica prije razmatranja terapije propranololom mora se temeljito ispitati potencijalna arteriopatija povezana s PHACE sindromom, koristeći angiografiju glave i vrata magnetskom rezonancom, kao i snimanje srca, kako bi se pregledao i luk aorte.
English: Blood pressure (mmHg) 65/45
Croatian: Krvni tlak (mmHg)
English: • Give HEMANGIOL directly into your child's mouth using the oral syringe supplied with the bottle.
Croatian: • Dajte HEMANGIOL izravno u djetetova usta pomoću štrcaljke za usta priložene uz bocu.
English: The posology is expressed in propranolol base.
Croatian: Doziranje je izraženo u propranololu u obliku baze.
English: • Bronchospasm may develop particularly in patients with asthma.
Croatian: • Kod bolesnika s astmom može se razviti bronhospazam.
English: HEMANGIOL may increase potassium blood level (hyperkaliemia).
Croatian: Rizik od hiperkalijemije HEMANGIOL može povećati razinu kalija u krvi (hiperkalijemija).
English: • Bronchiolitis (inflammation of small bronchi with breathing difficulties and wheeze in the chest,
Croatian: • Bronhiolitis (upala donjih dišnih puteva s otežanim disanjem i piskanjem u prsima, popraćena kašljem i vrućicom),
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: Patients (71.3% female; 37% aged 35-90 days old and 63% aged 91-150 days old) presented a target haemangioma on the head in 70% and majority of the infantile haemangiomas were localized (89%).
Croatian: Kod bolesnika (od kojih su 71,3% bile djevojčice, 37% u dobi od 35 do 90 dana i 63% u dobi od 91 do 150 dana) u 70%
English: 120 mL solution, in a type III amber-glass bottle fitted with a low density polyethylene insert and a child resistant polypropylene screw cap, provided with a polypropylene oral syringe graduated in mg of propranolol base.
Croatian: 120 mL otopine, u smeđoj staklenoj boci tipa III, s umetkom od polietilena niske gustoće i s polipropilenskim zatvaračem s navojem sigurnim za djecu, isporučeno s polipropilenskom štrcaljkom za usta s oznakama za mg baze propranolola.
English: HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia.
Croatian: HEMANGIOL i hranu mora davati ista osoba kako bi se izbjegao rizik od hipoglikemije.
English: HEMANGIOL may be stopped at once at the end of the treatment as decided by the doctor.
Croatian: Ako djetetu prestanete davati HEMANGIOL HEMANGIOL se može odmah prestati davati nakon završetka liječenja, prema odluci liječnika.
English: HEMANGIOL (see “Other medicines and HEMANGIOL”).
Croatian: „Drugi lijekovi i HEMANGIOL“).
English: If your child is not eating, develops another illness or is vomiting, it is recommended to skip the dose.
Croatian: Ako dijete ne jede, razvije neku drugu bolest ili povraća, preporučuje se da preskočite dozu.
English: Package leaflet: Information for the user HEMANGIOL 3.75 mg/mL oral solution propranolol
Croatian: Uputa o lijeku: Informacije za korisnika HEMANGIOL 3,75 mg/ml oralna otopina propranolol
English: Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Croatian: U literaturi su zabilježeni izolirani slučajevi simptomatske bradikardije i hipotenzije.
English: In clinical trials for proliferating infantile haemangioma, the most frequently reported adverse reactions in infant treated with HEMANGIOL were sleep disorders (16.7%), aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea (16.5%), and vomiting (11.5%).
Croatian: U kliničkim ispitivanjima za proliferirajući infantilni hemangiom najčešće zabilježene nuspojave kod dojenčadi liječene HEMANGIOL-om bili su poremećaji spavanja (16,7 %), teške infekcije dišnih puteva kao što su bronhitis i bronhiolitis povezani s kašljem i vrućicom, proljev (16,5 %) i povraćanje Sveukupno gledano, nuspojave zabilježene u programu milosrdne primjene i u literaturi odnosile su se na hipoglikemiju (i povezane događaje poput hipoglikemijskog napadaja) te na teške infekcije dišnih puteva s dišnim tegobama.
English: Propranolol crosses the blood-brain barrier and the placenta, and is distributed into breast milk.
Croatian: Propranolol prolazi kroz krvno-moždanu barijeru i posteljicu, te se izlučuje u majčino mlijeko.
English: See section 2 under ‘HEMANGIOL contains sodium and propylene glycol' for further information.
Croatian: Za dodatne informacije vidjeti dio 2., „HEMANGIOL sadrži natrij i propilenglikol“.
English: Propylene glycol………………………………………………….2.60 mg.
Croatian: Pomoćna tvar s poznatim učinkom: 1 ml otopine sadrži propilenglikol………………………………………………….2,60 mg.
English: • Bradycardia below the following limits:
Croatian: • Bradikardija ispod sljedećih granica: Dob
English: Lipid lowering medicinal products
Croatian: Lijekovi za snižavanje lipida
English: For children weighing more than 5 kg the dose may be mixed with a tablespoonful of milk or fruit juice (approximately 15 mL).
Croatian: Za djecu težu od 5 kg doza se može pomiješati s jednom punom jušnom žlicom mlijeka ili voćnog soka (približno 15 ml).
English: • has circulation problems which make the toes and fingers numb and pale.
Croatian: • Vaše dijete ima probleme s cirkulacijom što uzrokuje da su mu prsti na rukama i nogama utrnuli i blijedi.
English: • It is supplied in a 120-mL amber glass bottle, with a child resistant screw-cap.
Croatian: • Isporučuje se u smeđim staklenim bocama od 120 ml, sa zatvaračem s navojem, sigurnim za djecu.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
Croatian: Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku, ljekarniku ili medicinskoj sestri.
English: In terms of reproductive development, growth and neurological development there were no propranolol-related effects or toxicologically significant findings at 40 mg/kg/day, correlating to safety margins of 1.2 in females and 2.9 in males, based on mean propranolol exposures on PND 21.
Croatian: U pogledu reproduktivnog razvoja, rasta i neurološkog razvoja nije bilo učinaka povezanih s propranololom ili toksikološki značajnih nalaza pri 40 mg/kg/dan s obzirom na granice sigurnosti od
English: Manufacturer
Croatian: Proizvođači:
English: 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Croatian: 5.1 Farmakodinamička svojstva
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi tj. zanemarive količine natrija.
English: Propranolol is metabolised in the liver and excreted by the kidneys.
Croatian: Propranolol se metabolizira u jetri, a izlučuje putem bubrega.
English: Insert tip of the oral syringe into the upright bottle and push the plunger all the way down.
Croatian: Umetnite vrh štrcaljke za usta u bocu u uspravnom položaju i gurnite klip do kraja prema dolje.
English: Risks of bronchospasm
Croatian: Rizik od bronhospazma
English: • Minor: pallor, tiredness, sweating, shaking, palpitations, anxiety, hunger, difficulty waking up.
Croatian: • Blaži: bljedilo, umor, znojenje, tresenje, osjećaj lupanja srca, tjeskoba, glad, teškoće razbuđivanja.
English: PIERRE FABRE DERMATOLOGIE 45 Place Abel Gance 92100 BOULOGNE FRANCE
Croatian: 45, place Abel GANCE 92100 BOULOGNE
English: Warnings and precautions Before your child receives HEMANGIOL, tell your doctor:
Croatian: Prije nego što Vašem djetetu počnete davati HEMANGIOL, recite svom liječniku:
English: • Step 7.
Croatian: • Korak 7.
English: • Dosing is based on your baby's weight following the scheme below: Weeks (daily dose)
Croatian: Doziranje • Doziranje se temelji na djetetovoj težini, prema rasporedu ispod:
English: Propranolol is almost completely absorbed after oral administration.
Croatian: Propranolol je nakon peroralne primjene gotovo u potpunosti apsorbiran.
English: For children weighing up to 5 kg you may mix the dose with one teaspoonful of milk (approximately 5 mL).
Croatian: Za djecu tešku do 5 kg dozu možete pomiješati s jednom punom čajnom žličicom mlijeka (oko 5 mL).
English: Treatment was administered to 456 subjects (401 Propranolol at a dose of 1 or 3 mg/kg/day for 3 or 6 months; 55 Placebo), including a titration phase over 3 weeks.
Croatian: Liječenje je primijenjeno na 456 ispitanika (na 401 propranolol u dozi od 1 ili 3 mg/kg/dan tijekom 3
English: These effects were completely reversible when treatment was discontinued.
Croatian: Ti su učinci bili u cijelosti povratni po prekidu liječenja.
English: • Low blood pressure,
Croatian: • Nizak krvni tlak,
English: • Step 6: Check for air bubbles
Croatian: • Korak 6. Provjerite ima li mjehurića zraka
English: Lidocaine toxicity (neurological and cardiac adverse events) has been reported following co-administration with propranolol.
Croatian: U istodobnoj primjeni s propranololom prijavljena je toksičnost lidokaina (neurološki i kardiološki štetni događaji).
English: It is recommended to increase the dose up to the therapeutic dose under medical supervision as follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then 3 mg/kg/day as a maintenance dose.
Croatian: 1 mg/kg/dan tijekom 1 tjedna, zatim 2 mg/kg/dan tijekom 1 tjedna, a zatim 3 mg/kg/dan kao doza održavanja.
English: • Bronchitis (inflammation of the bronchi),
Croatian: • Bronhitis (upala donjih dišnih puteva),
English: With the oral syringe in place, turn the bottle upside down.
Croatian: Nakon što štrcaljku za usta postavite na mjesto, okrenite bocu naopako.
English: Discard the syringe once the bottle is finished.
Croatian: Bacite štrcaljku u otpad kad se boca isprazni.
English: Atrioventricular blocks, intraventricular conduction delays, and congestive heart failure can occur with more severe poisoning.
Croatian: Kod slučajeva težeg trovanja mogu se pojaviti atrioventrikularni blokovi, kašnjenje intraventrikularne provodljivosti i kongestivno zatajenje srca.
English: Cardiovascular medicinal products
Croatian: Kardiovaskularni lijekovi
English: HEMANGIOL 3.75 mg/mL oral solution propranolol
Croatian: HEMANGIOL 3,75 mg/ml, oralna otopina propranolol
English: • a reduction of both VEGF and bFGF signalling pathways and subsequent angiogenesis /
Croatian: • pokretanje učinka apoptoze na kapilarnim endotelnim stanicama; • smanjenje signalnih putova VEGF-a i bFGF-a i posljedične angiogeneze/proliferacije.
English: • If you have any further questions, ask your doctor, or pharmacist or nurse.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: • Hemangiol is for oral use.
Croatian: • HEMANGIOL je namijenjen primjeni kroz usta.
English: If the child is not eating or is vomiting it is recommended to skip the dose.
Croatian: Ako dijete ne jede ili povraća, preporučuje se preskočiti dozu.
English: • is prone to low blood sugar level.
Croatian: • Vaše dijete ima sklonost niskoj razini šećera u krvi.
English: Heart rate (beats/min)
Croatian: Srčana frekvencija (otkucaji/min)
English: Constipation Abdominal pain
Croatian: Konstipacija Bol u abdomenu
English: Dose by intake Timing of intakes
Croatian: Doza po unosu Vrijeme unosa
English: HEMANGIOL 3.75 mg/mL oral solution
Croatian: HEMANGIOL 3,75 mg/ml oralna otopina
English: Neutropenia
Croatian: Agitacija
English: • Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,
Croatian: • hemangiom koji ugrožava život ili funkciju, • ulcerirani hemangiom s bolovima i/ili izostankom odgovora na jednostavne mjere njege rane,
English: HEMANGIOL should be administered directly into the child's mouth using the graduated oral syringe, calibrated in mg of propranolol base, supplied with the oral solution bottle (see instructions for use in section 3 of the patient information leaflet).
Croatian: kalibrirane u mg propranolola u obliku baze, isporučenom zajedno s bocom oralne otopine (vidjeti upute za primjenu u dijelu 3. upute o lijeku).
English: Erythema Dermatitis diaper
Croatian: Eritem Pelenski dermatitis
English: • HEMANGIOL is a clear, colourless to slightly yellow oral solution, with a fruity odour.
Croatian: Kako HEMANGIOL izgleda i sadržaj pakiranja • HEMANGIOL je bistra, bezbojna do žućkasta oralna otopina, s voćnim mirisom.
English: The effects generally totally reversed after treatment cessation.
Croatian: Učinci su nakon prestanka liječenja uglavnom bili potpuno povratni.
English: Cardiac failure:
Croatian: Zatajenje srca:
English: • Major: excessive sleeping, difficulty responding, poor feeding, decrease in body temperature,
Croatian: • Teški: prekomjerno spavanje, teško dobivanje odgovora na podražaj, loš apetit, smanjenje tjelesne temperature, konvulzije (napadaji), kratke stanke pri disanju, gubitak svijesti.
English: Remove the syringe
Croatian: Očistite štrcaljku.
English: Each ml contains 4.28 mg of propranolol hydrochloride equivalent to 3.75 mg of propranolol.
Croatian: Svaki ml sadrži 4,28 mg propranololklorida što odgovara 3,75 mg propranolola.
English: Antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc) When combined with beta-blockers, medicinal products that decrease arterial pressure can cause or increase hypotension, notably orthostatic.
Croatian: Antihipertenzivi (ACE inhibitori, antagonisti angiotenzin II-receptora, diuretici, alfa-blokatori bez obzira na indikaciju, antihipertenzivi sa središnjim djelovanjem, rezerpin, itd.)
English: Important warning signs of potential side effects such as low blood pressure, low heart rate, low blood sugar level, and bronchospasm (breathing difficulties) should be looked after following administration of HEMANGIOL.
Croatian: Nakon primjene HEMANGIOL-a potrebno je obratiti pažnju na važne znakove upozorenja mogućih nuspojava, kao što su nizak krvni tlak, usporen puls, niska razina šećera u krvi i bronhospazam (otežano disanje).
English: INSTRUCTIONS ON USE
Croatian: Upute za uporabu:
English: 3- Discard the water into your sink
Croatian: 2- Povucite klip prema gore 3- Ispraznite vodu iz štrcaljke u sudoper
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Call your doctor right away if your child has any signs such as tiredness, coldness, pallor, bluish-coloured skin, or fainting while taking HEMANGIOL.
Croatian: Ako Vaše dijete tijekom uzimanja HEMANGIOL-a ima bilo kakve znakove kao što su umor, hladnoća, bljedilo, plavkasta boja kože ili nesvjestica, odmah nazovite svog liječnika.
English: Caution should be taken into account in babies less than 4 weeks old, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
Croatian: Ovaj lijek sadrži 2,08 mg propilenglikola/kg/dan Oprez je potreban u djece mlađe od 4 tjedna, osobito ako dijete prima druge lijekove koji sadrže propilenglikol ili alkohol.
English: Bronchiolitis
Croatian: Bronhiolitis
English: Store the bottle and the oral syringe in the outer carton between each use.
Croatian: Između svake uporabe bocu i štrcaljku za usta čuvati u vanjskom pakiranju.
English: They may depress myocardial contractility and vascular compensating response when administered with propranolol.
Croatian: Kada se primjenjuju s propranololom, mogu oslabiti kontraktilnost miokarda i vaskularnu kompenzirajuću reakciju.
English: 8 MARKETING AUTHORISATION NUMBER(S)
Croatian: 8 BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp).
Croatian: Propranolol je supstrat P-glikoproteina (P-gp), koji služi za izbacivanje tvari iz crijeva.
English: How to store HEMANGIOL
Croatian: Kako čuvati HEMANGIOL
English: • If your child is not eating or is vomiting it is recommended to skip the dose.
Croatian: • Ako dijete ne jede ili povraća, preporučuje se preskočiti dozu.
English: With regard to centrally-acting antihypertensives, betablockers may exacerbate the rebound hypertension after clonidine abrupt withdrawal, and propranolol should be stopped several days before discontinuing clonidine.
Croatian: U kombinaciji s beta-blokatorima, lijekovi koji smanjuju arterijski tlak mogu uzrokovati ili povećati hipotenziju, naročito ortostatsku . S obzirom na antihipertenzive sa središnjim djelovanjem, beta blokatori mogu pogoršati povratnu hipertenziju nakon naglog povlačenja klonidina, a propranolol se mora povući nekoliko dana prije prestanka davanja klonidina.
English: Use with oral syringe graduated in mg of propranolol included in the package.
Croatian: Primjenjivati štrcaljkom za usta koja ima oznake za mg propranolola i priložena je u pakiranju.
English: Risks of hypoglycaemia
Croatian: Rizik od hipoglikemije
English: The carton contains the following items that you will need to administer the medicine: - The glass bottle containing 120 mL propranolol oral solution - The oral syringe graduated in mg provided with this medicine Remove the bottle and oral syringe from the box and remove the syringe from the plastic bag.
Croatian: - Staklena boca koja sadrži 120 ml oralne otopine propranolola - Štrcaljka za usta s oznakama u mg priložena uz ovaj lijek.
English: This is because your child can get low blood pressure if given certain anaesthetics while taking this medicine (see “Other medicines and HEMANGIOL”).
Croatian: Postupite tako jer ako se Vašem djetetu daju određeni anestetici istodobno dok uzima ovaj lijek, može se javiti nizak krvni tlak (pogledajte
English: Batch
Croatian: Dob