natgillin/translations-raw huggingface dataset:
The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 mg/kg. 
Priporočen začetni odmerek je 1 mg/kg/dan, ki je razdeljen na dva ločena odmerka po 0,5 mg/kg.
Every increase in dose or any dose adjustment to your baby's weight must be done by your doctor. 
Vsako povečanje ali prilagoditev odmerka na dojenčkovo telesno maso mora izvesti zdravnik.
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. 
Če vašega otroka dojite in če jemljete zdravila, ki se ne smejo uporabljati sočasno z zdravilom HEMANGIOL (glejte »Če otroka dojite« in »Druga zdravila in zdravilo HEMANGIOL«), mu ne dajajte tega zdravila.
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. 
V primeru hude in/ali simptomatične bradikardije ali hipotenzije, ki se pojavi kadar koli med zdravljenjem, je treba zdravljenje prekiniti in pridobiti nasvet strokovnjaka.
Prior to initiating propranolol therapy, screening for risks associated with propranolol use must be performed. 
Pred začetkom zdravljenja s propranololom je treba izvesti presejalne teste glede tveganj, povezanih z uporabo propranolola.
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. 
Glavni učinki, o katerih so poročali po ponavljajočem dajanju propranolola pri odraslih in juvenilnih podganah, so bili prehodno zmanjšanje telesne teže in pridobitev telesne teže, povezane s prehodnim zmanjšanjem teže organov.
The MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational pack. 
Imetnik dovoljenja za promet z zdravilom mora pred distribucijo izobraževalnega paketa uskladiti vsebino in obliko izobraževalnega materiala in komunikacijskega načrta s pristojnim nacionalnim organom.
The patient should be placed on a cardiac monitor, monitor vital signs, mental status and blood glucose. 
Bolnika morate priključiti na srčni monitor, nadzorovati življenjske znake, duševno stanje in glukozo v krvi.
What HEMANGIOL is and what it is used for 2. 
Kaj je zdravilo HEMANGIOL in za kaj ga uporabljamo 2.
Intravenous fluids for hypotension and atropine for bradycardia should be given. 
Treba je dajati intravenske tekočine za hipotenzijo in atropin za bradikardijo.
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. 
Zdravljenih je bilo 456 oseb (401 s propranololom v odmerku 1 ali 3 mg/kg/dan 3 ali 6 mesecev; 55 s placebom), vključno s 3-tedensko fazo titracije.
This medicine is used to treat a disease called haemangioma. 
Zdravilo se uporablja za zdravljenje bolezni, imenovane hemangiom.
Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease. 
O driski so poročali pogosto, vendar ni bila vedno povezana z infekcijsko boleznijo prebavil.
In children who are at risk of anaphylaxis, the benefit risk of the medicinal product should be evaluated. 
Pri otrocih, pri katerih obstaja tveganje anafilakse, je treba oceniti tveganje koristi zdravila.
None of cases was of severe intensity and led to treatment discontinuation. 
Noben primer ni bil resne narave in ni privedel do prekinitve zdravljenja.
• Do not give this medicine to your child if you are taking medicines that must not be used with 
• Zdravila ne dajajte otroku, če jemljete zdravila, ki se ne smejo uporabljati sočasno z zdravilom
Approximately 90% of circulating propranolol is bound to plasma proteins (albumin and alpha1 acid glycoprotein). 
Približno 90 % propranolola v obtoku je vezanega na beljakovine v plazmi (albumin in alfa1 kisli glikoprotein).
An allergic reaction can include a rash, itching or shortness of breath. 
Alergijska reakcija lahko vključuje izpuščaje, srbenje ali težave z dihanjem.
Within each system organ class, adverse reactions are presented in order of decreasing seriousness. 
Znotraj vsakega organskega sistema so neželeni učinki navedeni padajoče glede na resnost.
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. 
Dokazi o učinkovitosti propranolola pri bolnikih s hemangiomom z visoko stopnjo tveganja so na voljo v literaturi in v specifičnem programu sočutne uporabe, izvedenim z zdravilom HEMANGIOL.
Potential mechanisms of action of propranolol in proliferating infantile haemangioma described in the literature could include various mechanisms all in close relationship: 
Potencialni mehanizem delovanja propranolola pri hitro rastočem infnatilnem hemangiomu, opisanem v literaturi, lahko vključuje različne mehanizme, ki so tesno povezani:
If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol. 
Če je vaš dojenček mlajši od 4 tednov se, preden mu date to zdravilo, posvetujte z zdravnikom ali farmacevtom, še posebej, če dojenček prejema druga zdravila, ki vsebujejo propilenglikol ali alkohol.
6 Contents of the pack and other information What HEMANGIOL contains 
6 Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo HEMANGIOL
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. 
Po korekciji zaradi telesne teže so bili primarni farmakokinetični parametri propranolola (kot je plazemski očistek), ugotovljeni pri dojenčkih, podobni tistim, ki so navedeni v literaturi za odrasle.
Keep the bottle in the outer carton in order to protect from light. 
Steklenico shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Agitation Nightmares Irritability 
Nočne more Razdražljivost
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients 
6 FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
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. 
Pri študijah z dodajanjem v prehrano, kjer so mišim in podganam dajali propranololijev klorid do 18 mesecev v odmerkih do 150 mg/kg/dan, ni bilo dokazov za tumorogenezo, povezano z zdravilom.
Before opening: 3 years. 
6.3 Rok uporabnosti Pred odprtjem: 3 leta.
• Step 10: Clean the syringe. 
• 10. korak: Očistite brizgo.
Read all of this leaflet carefully before your child starts receiving this medicine because it contains important information. 
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
In children with diabetes, blood glucose monitoring should be more frequent and followed by the endocrinologist. 
Pri otrocih z diabetesom je treba povečati pogostost nadzora glukoze v krvi, pri čemer mora stanje spremljati endokrinolog.
Peak plasma concentrations occur about 1 to 4 hours after an oral dose. 
Najvišje koncentracije v plazmi se pojavijo približno od 1 do 4 ur po peroralnem odmerku.
• Medicines to treat anxiety and depression as well as more serious mental health problems, and epilepsy, 
• zdravila za zdravljenje tesnobnosti in depresije ter resnejše težave z duševnim zdravjem in epilepsijo • zdravila za zdravljenje tuberkuloze,
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. 
Med 4-urnim kardiovaskularnim spremljanjem v dnevih titracije so opazili zmanjšanje srčnega utripa (približno 7 utripov na minuto) in sistoličnega krvnega tlaka (manj kot 3 mmHg) po dajanju zdravila.
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). 
To velja tudi, če otroke dojijo matere, ki so zdravljene s kortikosteroidi v visokih odmerkih ali dlje časa (v zvezi s hipoglikemijo glejte poglavje 4.4).
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1
Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia. 
Propranolol preprečuje odziv endogenih kateholaminov za odpravo hipoglikemije.
In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought. 
V primeru simptomatične bradikardije ali bradikardije s srčnim utripom pod 80 utripov na minuto je treba takoj pridobiti nasvet strokovnjaka.
There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in infants and children aged above 5 months. 
Na voljo ni podatkov o klinični učinkovitosti in varnosti v kliničnih študijah, izpeljanih z zdravilom HEMANGIOL, da bi ga priporočili za zdravljenje dojenčkov in otrok, starejših od 5 mesecev.
• 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). 
• prezgodaj rojen in njegova starost še ni dosegla popravljene starosti 5 tednov (popravljena starost je tista, kolikor bi bil star dojenček, če bi bil rojen na predviden datum poroda).
For any information about this medicine, please contact the Marketing Authorisation Holder. 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na imetnika dovoljenja za promet z zdravilom.
A close clinical surveillance of any impaired tolerance of propranolol is requested. 
Potrebno je natančno klinično spremljanje vsakršne motene tolerance na propranolol.
In the absence of specific studies in children, the drug interactions with propranolol are those known in adults. 
Zaradi pomanjkanja specifičnih študij pri otrocih so medsebojna delovanja zdravil s propranololom znana le pri odraslih.
If necessary, the medicinal product may be diluted in a small quantity of baby-milk or age-adapted apple and/or orange fruit juice. 
Če je treba, zdravilo lahko razredčite z majhno količino mleka ali starostno prilagojenega jabolčnega in/ali pomarančnega sadnega soka.
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). 
Čeprav so poročali o nekaterih reverzibilnih učinkih na plodnost samcev in samic pri odraslih podganah, ki so prejemale velike odmerke propranolola, raziskava, izvedena na juvenilnih živalih, ni pokazala nobenih učinkov na plodnost (glejte poglavje 5.3).
In healthy subjects, no difference was observed between CYP2D6 extensive metabolizers and poor metabolizers with respect to oral clearance or elimination half-life. 
Pri zdravih osebah ni bilo opaziti razlik med dobrimi in slabimi metabolizatorji CYP2D6 glede na peroralni očistek ali razpolovno dobo izločanja.
• Haemangioma with a risk of permanent scars or disfigurement. 
• hemangiom s tveganjem trajnih brazgotin ali izmaličenja.
• Information on the conditions for which HEMANGIOL should not be given 
• podatke o stanjih, pri katerih se zdravilo HEMANGIOL ne sme uporabljati
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. 
Glede okužb spodnjih dihal, kot sta bronhitis ali bronhiolitis, so opazili poslabšanje simptomov (vključno z bronhospazmom) pri bolnikih, zdravljenih z zdravilom HEMANGIOL zaradi bronhokonstriktivnega učinka propranolola.
In children with cardiac failure, the treatment should be managed by the cardiologist. 
Pri otrocih s srčnim popuščanjem mora zdravljenje voditi kardiolog.
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). 
Klinična učinkovitost in varnost pri pediatrični populaciji Učinkovitost propranolola pri dojenčkih (starosti od 5 tednov do 5 mesecev na začetku zdravljenja) z močno povečanim infantilnim hemangiomom, ki zahteva sistematično zdravljenje, je bila dokazana v osrednji randomizirani, nadzorovani, multicentrični študiji faze II/III z več odmerki z možnim prilagajanjem, katere cilj je bil primerjava štirih režimov propranolola (1 ali 3 mg/kg/dan 3 ali 6 mesecev) in placeba (dvojno slepa).
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. 
Farmakokinetika ponavljajoče uporabe zdravila HEMANGIOL v odmerku 3 mg/kg/dan v dveh vnosih je bila raziskana pri 19 dojenčkih v starosti od 35 do 150 dni na začetku zdravljenja.
What you need to know before your child receives HEMANGIOL 3. 
Kaj morate vedeti, preden vaš otrok prejme zdravilo HEMANGIOL 3.
Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. 
Sočasno dajanje s katerim koli substratom za alkohol-dehidrogenazo, kot je etanol, lahko pri novorojenčkih vodi do resnih neželenih učinkov.
When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure. 
Ko je bolnik načrtovan za operacijo, je treba zdravljenje z antagonisti adrenergičnih receptorjev beta prekiniti vsaj 48 ur pred posegom.
In the absence of clinical efficacy and safety data, HEMANGIOL should not be used in infants aged below 5 weeks. 
Zaradi pomanjkanja podatkov o klinični učinkovitosti in varnosti zdravila HEMANGIOL ni dovoljeno uporabljati pri dojenčkih, mlajših od 5 tednov.
In case of suspected cardiac abnormality, a specialist advice must be sought before treatment initiation to determine any subjacent contra-indication. 
V primeru suma na srčne nepravilnosti je treba pred začetkom zdravljenja pridobiti nasvet strokovnjaka, da se ugotovijo morebitne spodnje kontraindikacije.
In animals, after an acute dosing, propranolol is considered as a moderately toxic drug with an oral LD50 of about 600 mg/kg. 
Pri živalih se po akutnem odmerku propranolol šteje za zmerno toksično zdravilo s peroralno LD50 približno 600 mg/kg.
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. 
Zdravilo lahko zakrije opozorilne znake hipoglikemije (znana tudi kot nizka raven sladkorja v krvi), zlasti če dojenček ne je, če bruha ali v primeru prevelikega odmerka.
• 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. 
• Po potrebi lahko zdravilo razredčite z majhno količino mleka ali starosti prilagojenega jabolčnega in/ali pomarančnega sadnega soka in ga dajte otroku prek otroške stekleničke.
HEMANGIOL should be administered for a 6-month period. 
Zdravilo HEMANGIOL je treba dajati 6 mesecev.
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. 
Če ima otrok med jemanjem zdravila HEMANGIOL kakršne koli znake hipoglikemije, mu dajte, če je mogoče, peroralno tekočino, ki vsebuje sladkor, in če simptomi ne izginejo, takoj pokličite zdravnika ali pojdite v bolnišnico.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožnega tkiva
The name of your medicine is HEMANGIOL. 
Vaše zdravilo se imenuje HEMANGIOL.
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. 
Med to farmakokinetično študijo, ki je vključevala dojenčke s hemangiomom, ki je ogrožal telesne funkcije, hemangiomom na določenih anatomskih lokacijah, ki pogosto pustijo trajne brazgotine ali deformacije, z velikim hemangiomom na obrazu, manjšim hemangiomom na izpostavljenih območjih, s hudim ulceriranim hemangiomom, pedunkularnim hemangiomom, je bila prav tako raziskana učinkovitost kot sekundarni kriterij ocenjevanja.
• Sleep disorders (insomnia, poor quality of sleep and difficulties to wake-up), 
• motnje spanja (nespečnost, slaba kakovost spanja in težave pri prebujanju),
• Medicines to treat pain and inflammation, 
• zdravila za lajšanje bolečin in vnetja,
- Information on how to detect and manage any sign of hypoglycaemia during treatment with HEMANGIOL 
- podatki o tem, kako odkriti in ravnati v primeru katerih koli znakov hipoglikemije med zdravljenjem z zdravilom HEMANGIOL,
Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia. 
Motnje spanja so bile nespečnost, slaba kakovost spanja in hipersomnija.
In vitro studies indicated that CYP2D6 (aromatic hydroxylation), CYP1A2 (chain oxidation) and to a less extent CYP2C19 were involved in propranolol metabolism. 
Študije in vitro so pokazale, da so bili v presnovo propranolola vključeni CYP2D6 (aromatična hidroksilacija), CYP1A2 (oksidacija verige) in v manjšem obsegu CYP2C19.
HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: 
je indicirano za zdravljenje hitro rastočega infantilnega hemangioma, ki zahteva sistematično zdravljenje:
However, in the study conducted in juvenile animals treated all over the development period corresponding to infancy, childhood and adolescence, no effect on male and female fertilities was observed (See section 4.6). 
Vseeno pa pri raziskavi, izvedeni na juvenilnih živalih skozi celotno razvojno obdobje, ki pri ljudeh ustreza obdobju od dojenčka prek otroka do adolescence, ni bilo opaženih učinkov na plodnost samcev in samic (glejte poglavje 4.6).
• Erythema (skin redness), 
• eritem (rdečica kože),
The medicine should not be put in the full filled bottle. 
Zdravila se ne sme vlivati v polno dojenčkovo stekleničko.
It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger. 
Zakrije adrenergične opozorilne znake hipoglikemije, zlasti tahikardijo, tresenje, tesnobnost in lakoto.
Similar results were obtained following intra-testicular administration of propranolol and using in vitro models. 
Podobni rezultati so bili pridobljeni po dajanju propranolola v moda in uporabi modelov in vitro.
• the absence of cardioselective beta-1 beta-blocking activity, 
• odsotnost kardioselektivne beta-1 aktivnosti antagonistov adrenergičnih receptorjev beta,
Here is how to open it: push down the plastic cap while turning the cap counter-clockwise (to the left). 
Tako jo odprete: potisnite plastični pokrovček navzdol, medtem pa ga obrnite v nasprotni smeri urnega kazalca (v levo).
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. 
Pri dojenčkih, starih do 4 tedne, je potrebna pazljivost, še posebej, če dojenček prejema druga zdravila, ki vsebujejo propilenglikol ali alkohol.
An analysis of the medical history and a full clinical examination must be performed including heart rate, cardiac and pulmonary auscultation. 
Treba je izvesti analizo zdravstvene anamneze in celoten kliničen pregled, vključno z avskultacijo srčnega utripa, srca in pljuč.
• An oral polypropylene syringe graduated in mg of propranolol, is provided with each bottle. 
• Peroralna polipropilenska brizga, umerjena v mg propranolola je priložena vsaki steklenici.
• Cardiac symptoms of mild to moderate poisoning are decreased heart rate and hypotension. 
• Srčna simptoma blage do zmerne zastrupitve sta zmanjšan srčni utrip in hipotenzija.
The toxicity of beta-blockers is an extension of their therapeutic effects: 
Toksičnost antagonistov adrenergičnih receptorjev beta je razširitev njihovih zdravilnih učinkov:
Very limited safety data of propranolol in PHACE syndrome patients are available. 
Sindrom PHACE Na voljo so zelo omejeni podatki o varnosti propranolola pri bolnikih s sindromom PHACE.
1 NAME OF THE MEDICINAL PRODUCT 
1 IME ZDRAVILA
The MAH shall provide an educational pack for the proposed indication, targeting all caregivers who are expected to prepare and administer HEMANGIOL to children. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti izobraževalni paket za predlagano indikacijo, ciljna skupina pa so vsi negovalci, od katerih se pričakuje priprava in dajanje zdravila HEMANGIOL otrokom.
Do not shake the bottle before use. 
Ne tresite steklenice pred uporabo.
One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation. 
V enem primeru je atrioventrikularni blok druge stopnje pri bolniku z motnjo prevajanja privedel do dokončne prekinitve zdravljenja.
The administration of beta2 agonists and inhaled corticosteroids is possible. 
Mogoče je dajanje beta2 agonistov in inhalacijskih kortikosteroidov.
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. 
V primeru, da otrok izpljune odmerek ali ne vzame celotnega odmerka zdravila, mu ne dajajte drugega odmerka pred naslednjim načrtovanim odmerkom.
• 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. 
• Če otrok izpljune odmerek oz. niste prepričani, ali je prejel celotno zdravilo, mu ne dajte drugega odmerka, ampak počakajte na naslednji načrtovani odmerek.
Propranolol is a substrate for the intestinal efflux transporter, P-glycoprotein (P-gp). 
Propranolol je substrat intestinalnega efluksnega transporterja P-glikoproteina (P-gp).
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni »brez natrija«.
Age (35-90 days / 91150 days), gender and haemangioma location (head / body) subgroups did not identify differences in response to propranolol. 
Pri podskupinah po starosti (od 35 do 90 dni/od 91 do 150 dni), spolu in lokaciji hemangioma (glava/telo) ni bilo odkritih razlik v odzivu na propranolol.
In case of large ulcerated haemangioma,, your child's blood potassium level should be measured. 
V primeru velikega ulceriranega hemangioma, je treba otroku meriti raven kalija v krvi.
Please refer to section 2 of this leaflet. 
Glejte poglavje 2 tega navodila za uporabo.
Use of propranolol alongside hypoglycaemic therapy in diabetic patients should be with caution since it may prolong the hypoglycaemic response to insulin. 
Pri uporabi propranolola skupaj s hipoglikemičnim zdravljenjem pri sladkornih bolnikih je potrebna previdnost, saj lahko podaljša hipoglikemični odziv na inzulin.