natgillin/translations-raw huggingface dataset:
If different people are involved, good communication is essential in order to ensure the safety of the child.
Če to počnejo različne osebe, je nujna dobra komunikacija, da se zagotovi varnost otroka.
Less than 1% of a dose is excreted as unchanged drug in the urine.
Manj kot 1 % odmerka se z urinom izloči v nespremenjenem stanju.
Do not mix the medicine with a full bottle of milk or juice.
Ne vlivajte zdravila v polno stekleničko mleka ali soka.
• Tell your doctor before giving this medicine.
• Pred dajanjem zdravila to povejte zdravniku.
• Bradycardia below the following limits:
• Bradikardija pod naslednjimi mejami:
• If your child has problems with his/her liver or kidneys.
• če ima vaš otrok težave z jetri ali ledvicami.
• Step 5: Remove the dose
• 5. korak: Odvzemanje odmerka
• The medicine is to be given during or straight after a feed.
• Zdravilo je treba dati med obrokom ali takoj po njem.
• Cold extremities,
• hladne okončine,
Although some data were equivocal, based on the overall available in vitro and in vivo data, it can be concluded that propranolol is devoid of genotoxic potential.
Čeprav so bili nekateri podatki nezanesljivi, lahko na podlagi vseh razpoložljivih podatkih in vitro in in vivo zaključimo, da propranolol nima genotoksičnega potenciala.
• If your child has ever had an allergic reaction whatever its origin (e.g. medicine or alimentary substance etc.).
• če je imel otrok že kakšno alergijsko reakcijo ne glede na izvor (npr. zdravilo ali živilo ipd.).
Concomitant use may reduce the reflex sympathetic response involved when excessive distal vasodilatation.
Sočasna uporaba lahko zmanjša refleksni simpatični odgovor pri pretirani distalni vazodilataciji.
In this case, the need of stopping breast-feeding should be discussed.
V tem primeru se je treba pogovoriti o prenehanju dojenja.
After the titration phase, the dose will be readjusted by the physician according to the changes in the child's weight.
Po fazi titracije bo zdravnik prilagajal odmerek v skladu s spremembami telesne mase otroka.
However, it undergoes an extensive first-pass metabolism by the liver and on average only about 25% of propranolol reaches the systemic circulation.
Vseeno pa je v veliki meri podvržen presnovi prvega prehoda v jetrih in v povprečju le približno 25 % propranolola doseže sistemski krvni obtok.
Excipients with known effect:
Pomožne snovi z znanimi učinki:
Do not use any soap or alcohol based product to clean.
Za čiščenje ne uporabljajte izdelkov na osnovi mila ali alkohola.
Initiation of treatment
Začetek zdravljenja
It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
Zdravilo je indicirano pri dojenčkih, starih od 5 tednov do 5 mesecev (glejte poglavje 4.2).
Concommitant use not recommended
Sočasna uporaba ni priporočljiva
Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5.
Doječe matere: glejte poglavje 4.4 in poglavje 4.5.
EXP After first opening, the medicine should be used within 2 months.
EXP Po prvem odprtju je treba zdravilo porabiti v roku 2 mesecev.
In this case, inform the caregiver, and increase monitoring of blood glucose levels, particularly at the start of treatment.
V tem primeru obvestite negovalno osebje in povečajte pogostnost spremljanja ravni glukoze v krvi, zlasti na začetku zdravljenja.
Clinical monitoring of the child condition, and dose readjustment, need to be performed at least monthly.
Klinično spremljanje otrokovega stanja in prilagajanje odmerka je treba izvajati vsaj enkrat na mesec.
The pharmacokinetic evaluation was performed at steady-state, after 1 or 3 months of treatment.
Ocena farmakokinetike je bila izvedena v stanju dinamičnega ravnovesja po 1 ali 3 mesecih zdravljenja.
After first opening, the medicine should be used within 2 months.
Po prvem odprtju je treba zdravilo uporabiti v roku 2 mesecev.
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.
Cilj tega izobraževalnega paketa je povečanje zavedanja o morebitnih tveganjih hipotenzije, bradikardije in bronhospazma po jemanju zdravila HEMANGIOL in zagotavljanje smernic o spremljanju/obravnavanju tega tveganja.
• Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,
• ulceriran hemangiom, ki ga spremlja bolečina in/ali pomanjkanje odzivnosti na enostavne ukrepe pri oskrbi rane,
Do not put the syringe through a sterilizer or dishwasher.
Ne vstavljajte brizge v sterilizator ali pomivalni stroj.
Now you can slowly squirt HEMANGIOL from the syringe directly into your baby's mouth.
Zdaj lahko počasi brizgate zdravilo HEMANGIOL iz brizge neposredno v dojenčkova usta.
These effects were completely reversible when treatment was discontinued.
Ti učinki so bili popolnoma reverzibilni po prekinitvi zdravljenja.
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.
Uspešnost zdravljenja je bila določena kot dokončno ali skoraj dokončno izginotje ciljnega hemangioma, ki je bil ocenjen s slepo centralizirano, neodvisno oceno na osnovi fotografij v 24. tednu, zdravljenje pa ni bilo predčasno prekinjeno.
• Disease of the sinus node (including sinoatrial block)
• Bolezen sinusnega vozla (vključno s sinoatrijskim blokom)
• Step 6: Check for air bubbles
• 6. korak: Preverjanje zračnih mehurčkov
• 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)
• Prezgodaj rojeni dojenčki, ki še niso dosegli popravljene starosti 5 tednov (popravljena starost se izračuna tako, da odštejemo število tednov prezgodnjega rojstva od dejanske starosti)
If your child should undergo a general anaesthesia
Če mora otrok prejeti splošno anestezijo
• infants breastfed by mothers taking any other medicinal products, notably those mentioned below.
• dojeni dojenčki, katerih matere jemljejo kakršna koli druga zdravila, predvsem spodaj omenjena.
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.
Med fazo titracije mora vsako povečanje odmerka izvesti in nadzorovati zdravnik pri enakih pogojih kot pri dajanju začetnega odmerka.
This is why your child will be kept under close clinical and heart rate monitoring for 2 hours after the first dose or after a dose increase.
Zaradi tega bodo pri vašem otroku izvajali klinični nadzor in pozorno spremljali srčni utrip 2 uri po prvem odmerku in po povečanju odmerka.
The potential effects of propranolol on the development of juvenile rats were evaluated following daily oral administration from post-natal Day 4 (PND 4) to PND 21 at dose-levels of 0, 10, 20 or 40 mg/kg/day.
Potencialni učinki propranolola na razvoj juvenilnih podgan so bili ocenjeni po dnevnem peroralnem dajanju od 4. postnatalnega dneva (PND 4) do PND 21 v odmerkih 0, 10, 20 ali 40 mg/kg/dan.
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.
Propranolol se je hitro absorbiral, največja koncentracija v plazmi se je običajno pojavila 2 uri po jemanju z ustrezajočo povprečno vrednostjo približno 79 ng/ml, ne glede na starost dojenčka.
10 DATE OF REVISION OF THE TEXT
Datum zadnjega podaljšanja: 10 DATUM ZADNJE REVIZIJE BESEDILA
• Breastfed infants, if the mother is treated with medicinal products contraindicated with propranolol
• Dojeni dojenčki, če je bila mati zdravljena z zdravili, ki so kontraindicirana s propranololom
Do not remove the syringe adapter from the neck of the bottle.
Ne odstranjujte nastavka za brizgo z vratu steklenice.
Do not lie the child down immediately after the administration.
Takoj po dajanju otroka ne polagajte v ležeči položaj.
The 4-hydroxy-propranolol metabolite was quantified, its plasma exposure accounting for less than 7% of the parent drug exposure.
Metabolit 4-hidroksi propranolol je bil količinsko opredeljen, njegova izpostavljenost v plazmi pa je bila manj kot 7 % izpostavljenosti matičnega zdravila.
These hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma.
Te hipoglikemične epizode, povezane z jemanjem propranolola, se lahko izjemoma pojavijo v obliki konvulzij in/ali kome.
Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Sočasno zdravljenje s sistemskimi kortikosteroidi lahko poveča tveganje hipoglikemije (glejte poglavje 4.5).
The plasma half-life of propranolol ranges from 3 to 6 hours.
Razpolovna doba propranolola v plazmi je od 3 do 6 ur.
Locate this number on the oral syringe.
Najdite to številko na peroralni brizgi.
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%).
Bolniki (71,3 % deklic; 37 % starih od 35 do 90 dni in 63 % starih od 91 do 150 dni) so imeli v 70 % ciljni hemangiom na glavi, večina infantilnih hemangiomov pa je bila lokalizirana (89 %).
0-3 months
0-3 mesece
3-6 months
3-6 mesecev
Propylene glycol………………………………………………….2.60 mg.
1 ml raztopine vsebuje propilenglikol………………………………………………….2,60 mg
Glucagon then catecholamines should be considered if the patient does not respond appropriately to intravenous fluid.
Treba je razmisliti o glukagonu in nato o kateholaminih, če se bolnik ne odziva ustrezno na intravensko tekočino.
If you see air bubbles in the syringe, hold the syringe upright, push the plunger upwards just far enough to completely push out any large air bubbles and then readjust to the dose prescribed by your doctor.
Če v brizgi vidite zračne mehurčke, držite brizgo pokonci, potisnite bat navzgor toliko, da v celoti odstranite vse večje zračne mehurčke in popravite odmerek, ki ga je predpisal zdravnik.
• Urticaria (allergic reaction of the skin), alopecia (loss of hair),
• koprivnica (alergijska reakcija kože), alopecija (izguba las),
Never change the dose you are giving to your child yourself.
Nikoli sami ne računajte ali spreminjajte odmerka, ki ga dajete otroku.
• Low blood pressure below the following limits:
• Nizek krvni tlak pod naslednjimi mejami:
For ethical reasons related to the use of placebo, the demonstration of the efficacy was not established in patients with high-risk haemangioma.
Iz etičnih razlogov, povezanih z uporabo placeba, dokazov učinkovitosti niso ugotavljali pri bolnikih s hemangiomom z visoko stopnjo tveganja.
The mixing should be used within 2 hours.
Mešanico je potrebno porabiti v roku 2 ur.
• has a slow heart rate for his/her age.
• počasen srčni utrip za svojo starost.
To avoid risks of hypoglycaemia, your child must be fed regularly during treatment.
Da bi preprečili tveganje za hipoglikemijo, morate otroka med zdravljenjem redno hraniti.
HEMANGIOL (see “Other medicines and HEMANGIOL”).
HEMANGIOL (glejte »Druga zdravila in zdravilo HEMANGIOL«).
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.
Po prvem odmerku in vsakem povečanju odmerka je treba izvajati klinični nadzor, vključno z nadzorom krvnega tlaka in srčnega utripa vsaj vsako uro najmanj 2 uri.
Cardiovascular events reported during clinical studies were asymptomatic.
Kardiovaskularni dogodki, o katerih so poročali med kliničnimi študijami, so bili asimptomatski.
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.