FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintenance dose (IU/hour) = [(100 - patient's pre-treatment AT activity level in %) /10.22] x Body
Slovenian: Vzdrževalni odmerek (i.e./uro) = [(100 - raven aktivnosti antitrombina pri bolniku pred zdravljenjem v %) /10,22] x telesna mase v kilogramih
English: The doctor will treat you, as appropriate, if you have any particular side effects.
Slovenian: Če imate kakršnekoli posebne neželene učinke, vas bo zdravnik ustrezno zdravil.
English: Haemorrhage
Slovenian: Odmerjanje
English: • nausea
Slovenian: Plodnost
English: • dizziness
Slovenian: • omotica,
English: Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti krvavitev na mestu venepunkcije občasni občutek vročice eritem na mestu infundiranja bolečina na mestu infundiranja izpuščaj na mestu infundiranja modrica na mestu venepunkcije
English: associated with cough and fever),
Slovenian: povezan s kašljem in z vročino),
English: These signs may be:
Slovenian: Ti znaki so lahko:
English: • one in late afternoon
Slovenian: • en pozno popoldan
English: Appropriate monitoring of the child is required until symptoms disappear.
Slovenian: Potreben je ustrezen nadzor otroka, dokler simptomi ne izginejo.
English: • one in the morning
Slovenian: • en zjutraj
English: 4- Repeat this cleaning process 3 times.
Slovenian: 4- 3-krat ponovite ta postopek čiščenja.
English: Therefore the need for treatment should be carefully weighed up.
Slovenian: Zato je treba potrebo po zdravljenju skrbno pretehtati.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Slovenian: 2 KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: Based on a retrospective study, a minority of patients (12%) required a re-initiation of systemic treatment.
Slovenian: Na osnovi retrospektivne študije je manjšina bolnikov (12 %) potrebovala ponovno sistematično zdravljenje.
English: Your doctor will advise you on whether you need to stop breastfeeding or not.
Slovenian: Zdravnik vam bo svetoval, ali morate prekiniti dojenje ali ne.
English: Continue the treatment at the usual frequency: one dose in the morning and one in the late afternoon.
Slovenian: Nadaljujte z zdravljenjem z običajno pogostostjo: en odmerek zjutraj in drugega pozno popoldan.
English: 11.4% of patients needed to be re-treated after treatment discontinuation.
Slovenian: 11,4 % bolnikov je potrebovalo vnovično zdravljenje po prekinitvi zdravljenja.
English: Other Central Nervous System disorders were principally observed during the early periods of treatment.
Slovenian: Druge motnje osrednjega živčnega sistema so bile načeloma opažene v zgodnjih obdobjih zdravljenja.
English: AV block
Slovenian: AV blok
English: When treatment was re-initiated, a satisfactory response was observed in a large majority of patients.
Slovenian: Po ponovni vzpostavitvi zdravljenja je bil opažen zadovoljiv odziv pri veliki večini bolnikov.
English: After first opening: 2 months.
Slovenian: Po prvem odprtju: 2 meseca.
English: Haemangioma can be superficial or deep.
Slovenian: Hemangiom je lahko površinski ali globok.
English: Due to the clinical trial database size rare and very rare categories are not represented.
Slovenian: Zaradi velikosti zbirke podatkov kliničnega preskušanja kategoriji redki in zelo redki nista zastopani.
English: Date of first authorisation: 23 April 2014 Date of latest renewal:
Slovenian: Datum prve odobritve: 23. april 2014
English: Automatism and conduction disorders are expected because of the suppression of sympathetic compensative mechanisms.
Slovenian: Avtomatizem in prevodne motnje se pričakujejo zaradi supresije simpatičnih kompenzatornih mehanizmov.
English: Concomitant use can increase the risk of bradycardia.
Slovenian: Sočasna uporaba lahko poveča tveganje bradikardije.
English: • lack of partial agonist activity (or intrinsic sympathomimetic activity).
Slovenian: • pomanjkanje delne agonistične aktivnosti (ali intrinzične simpatomimetične aktivnosti).
English: Discontinuation of treatment does not require a progressive decrease in the dose.
Slovenian: Prekinitev zdravljenja ne zahteva postopnega nižanja odmerka.
English: Rinse the empty syringe after each use into a glass of clean water: 1- Take a glass of clean water
Slovenian: Po vsaki uporabi izperite prazno brizgo v kozarcu čiste vode: 1- Vzemite kozarec s čisto vodo
English: Be careful, do not push the plunger in during this step.
Slovenian: Bodite previdni, da pri tem ne potisnete bata v brizgo.
English: Biotransformation and elimination:
Slovenian: Biotransformacija in izločanje:
English: Store the bottle and the syringe together in the carton until next use in a safe place where your child can't see or reach it.
Slovenian: Steklenico in brizgo skupaj shranite do naslednje uporabe v škatlo in na varno mesto, kjer je otrok ne more videti ali doseči.
English: • Purified water
Slovenian: • prečiščena voda
English: Then, your doctor will regularly examine your child during treatment.
Slovenian: Nato bo zdravnik med zdravljenjem redno pregledoval vašega otroka.
English: Always give this medicine to your child exactly as your doctor or pharmacist has told you.
Slovenian: Zdravilo vedno dajajte otroku natančno tako, kot vam je povedal zdravnik ali farmacevt.
English: Please check with your doctor if you are not sure.
Slovenian: Posvetujte se z zdravnikom, če niste prepričani.
English: • The need to monitor and to contact the healthcare professionals if the following signs and symptoms occur after treatment:
Slovenian: • Potreba po spremljanju in obveščanju zdravnika, če po zdravljenju pride do naslednjih znakov in simptomov:
English: The educational materials for caregivers treating children with HEMANGIOL should include the following key safety elements:
Slovenian: Izobraževalni material za negovalce, ki zdravijo otroke z zdravilom HEMANGIOL, mora vključevati naslednje ključne varnostne elemente:
English: Absorption and distribution:
Slovenian: Absorpcija in porazdelitev:
English: Use the mixture within 2 hours of preparation.
Slovenian: Mešanico porabite v 2 urah po pripravi.
English: • Second- or third-degree atrioventricular blocks
Slovenian: • Atrioventrikularni blok druge ali tretje stopnje
English: If different people are involved, good communication is essential in order to ensure the safety of your child.
Slovenian: Če je vključenih več ljudi, je dobra komunikacija bistvenega pomena, da se zagotovi varnost vašega otroka.
English: Specialised advice should be sought.
Slovenian: Treba je pridobiti nasvet strokovnjaka.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data)
Slovenian: Pogostnost naslednjih neželenih učinkov ni znana (iz razpoložljivih podatkov je ni mogoče oceniti)
English: Box of 1 bottle.
Slovenian: Škatla z eno steklenico.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neželenih učinkih po izdaji dovoljenja za promet z zdravili je pomembno.
English: These effects rarely led to definitive treatment discontinuation (see section 4.4).
Slovenian: Ti učinki so redko privedli do dokončne prekinitve zdravljenja (glejte poglavje 4.4).
English: The educational pack must be available for distribution prior to the launch of the new indication (treatment of proliferating infantile haemangioma) in the Member State.
Slovenian: Izobraževalni paket mora biti na voljo za distribucijo pred uvedbo nove indikacije (zdravljenje hitro rastočega infantilnega hemangioma) v državi članici.
English: The volume of distribution of propranolol is approximately 4 L/kg.
Slovenian: Volumen porazdelitve propranolola je približno 4 l/kg.
English: This is because HEMANGIOL can change the way other medicines work, and some medicines can have an effect on the way HEMANGIOL works.
Slovenian: To pa zaradi tega, ker lahko zdravilo HEMANGIOL spremeni način učinkovanja drugih zdravil, nekatera zdravila pa lahko učinkujejo na delovanje zdravila HEMANGIOL.
English: 3 PHARMACEUTICAL FORM
Slovenian: 3 FARMACEVTSKA OBLIKA
English: • Feed your child regularly to avoid prolonged fast.
Slovenian: • Redno hranite otroka, da preprečite predolg post.
English: • Heart failure not controlled by treatment
Slovenian: • Srčno popuščanje, ki ni nadzorovano z zdravljenjem
English: Support and treatment:
Slovenian: Podpora in zdravljenje:
English: • Reduction of the number of white blood cells.
Slovenian: • zmanjšanje števila belih krvnih celic.
English: Pull the plunger of the syringe up to the number of mg you need.
Slovenian: Povlecite bat brizge do številke v mg, ki jih potrebujete.
English: - Advice on how to feed children during treatment
Slovenian: - nasvetom glede hranjenja otrok med zdravljenjem,
English: • at least 9 hours interval between two intakes
Slovenian: • med obema vnosoma mora miniti vsaj 9 ur
English: • If your child has diabetes: in this case, your child's blood sugar level should be measured more frequently.
Slovenian: • če ima otrok sladkorno bolezen: v tem primeru je treba otroku pogosteje meriti raven sladkorja v krvi.
English: • is allergic to propranolol or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • alergičen na propranolol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Bronchospasm may develop particularly in patients with asthma.
Slovenian: • Zlasti pri bolnikih z astmo se lahko razvije bronhospazem.
English: Both agents may induce hypotension and/or heart failure in patients whose cardiac function is partially controlled because of additive inotropic effects.
Slovenian: Oba agensa lahko povzročita hipotenzijo in/ali srčno popuščanje pri bolnikih, pri katerih je srčna funkcija delno pod nadzorom zaradi aditivnih inotropnih učinkov.
English: The percentage contributions of these routes to total metabolism are 42%, 41% and 17%, respectively, but with considerable variability between individuals.
Slovenian: Deleži teh poti glede na skupno presnovo so 42, 41 oz. 17 %, vendar z veliko variabilnostjo med posamezniki.
English: • Agitation, nightmares, irritability,
Slovenian: • agitacija, nočne more, razdražljivost,
English: 6-12 months
Slovenian: 6-12 mesecev
English: • Somnolence,
Slovenian: • zaspanost,
English: It is sometimes called ‘strawberry mark' because the surface of a haemangioma looks a bit like a strawberry.
Slovenian: Včasih ga imenujemo »jagodno znamenje«, saj površina hemangioma spominja na jagodo.
English: It is also aimed to instruct caregivers to correctly feed the children during treatment in order to avoid the risk of hypoglycaemia.
Slovenian: Njegov cilj je tudi poučiti negovalce, da bodo pravilno hranili otroke med zdravljenjem, da preprečijo tveganje hipoglikemije.
English: This combination must only be administered under close clinical and ECG monitoring, particularly at the start of the treatment.
Slovenian: To kombinacijo je dovoljeno dajati le z natančnim kliničnim in EKG-nadzorom, zlasti ob začetku zdravljenja.
English: Do not use this medicine after the expiry date which is stated on the outer carton and bottle label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na steklenici.
English: • an antiarrhythmic effect,
Slovenian: • antiaritmični učinek,
English: In the minority of patients showing a relapse of symptoms after treatment discontinuation, treatment may be re-initiated under the same conditions with a satisfactory response.
Slovenian: Pri manjšem številu bolnikov, ki kažejo na ponovitev simptomov po prekinitvi zdravljenja, lahko zdravljenje ponovno uvedemo pod enakimi pogoji z zadovoljivim odzivom.
English: Improvement of haemangioma was observed at 5 weeks of treatment by propranolol in 88% of patients.
Slovenian: Izboljšanje hemangioma je bilo pri 5 tednih zdravljenja s propranololom opaženo pri 88 % bolnikov.
English: Do not use any other measuring device.
Slovenian: Ne uporabljajte drugih merilnih naprav.
English: • Tell your doctor, pharmacist or nurse if you are giving, have recently given or might give any other medicines to your child.
Slovenian: • Obvestite zdravnika ali farmacevta, če dajete, ste pred kratkim dajali ali pa boste morda začeli dajati otroku kakršna koli druga zdravila.
English: A monitoring of electrolyte should be performed in these patients.
Slovenian: Pri teh bolnikih je treba nadzorovati elektrolite.
English: However, studies suggest that P-gp is not dose-limiting for intestinal absorption of propranolol in the usual therapeutic dose range.
Slovenian: Raziskave namigujejo, da P-gp ne omejuje odmerka za intestinalno absorpcijo propranolola v običajnem območju terapevtskih odmerkov.
English: HEMANGIOL might need to be discontinued at least 48h before the anaesthesia.
Slovenian: Zdravilo HEMANGIOL bo morda potrebno prenehati dajati vsaj 48 h pred anestezijo.
English: If different people are involved, good communication is essential in order to ensure the safety of the child.
Slovenian: Če to počnejo različne osebe, je nujna dobra komunikacija, da se zagotovi varnost otroka.
English: Less than 1% of a dose is excreted as unchanged drug in the urine.
Slovenian: Manj kot 1 % odmerka se z urinom izloči v nespremenjenem stanju.
English: Do not mix the medicine with a full bottle of milk or juice.
Slovenian: Ne vlivajte zdravila v polno stekleničko mleka ali soka.
English: • Tell your doctor before giving this medicine.
Slovenian: • Pred dajanjem zdravila to povejte zdravniku.
English: • Bradycardia below the following limits:
Slovenian: • Bradikardija pod naslednjimi mejami:
English: • If your child has problems with his/her liver or kidneys.
Slovenian: • če ima vaš otrok težave z jetri ali ledvicami.
English: • Step 5: Remove the dose
Slovenian: • 5. korak: Odvzemanje odmerka
English: • The medicine is to be given during or straight after a feed.
Slovenian: • Zdravilo je treba dati med obrokom ali takoj po njem.
English: • Cold extremities,
Slovenian: • hladne okončine,
English: 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.
Slovenian: Čeprav so bili nekateri podatki nezanesljivi, lahko na podlagi vseh razpoložljivih podatkih in vitro in in vivo zaključimo, da propranolol nima genotoksičnega potenciala.
English: • If your child has ever had an allergic reaction whatever its origin (e.g. medicine or alimentary substance etc.).
Slovenian: • če je imel otrok že kakšno alergijsko reakcijo ne glede na izvor (npr. zdravilo ali živilo ipd.).
English: Concomitant use may reduce the reflex sympathetic response involved when excessive distal vasodilatation.
Slovenian: Sočasna uporaba lahko zmanjša refleksni simpatični odgovor pri pretirani distalni vazodilataciji.
English: In this case, the need of stopping breast-feeding should be discussed.
Slovenian: V tem primeru se je treba pogovoriti o prenehanju dojenja.
English: After the titration phase, the dose will be readjusted by the physician according to the changes in the child's weight.
Slovenian: Po fazi titracije bo zdravnik prilagajal odmerek v skladu s spremembami telesne mase otroka.
English: However, it undergoes an extensive first-pass metabolism by the liver and on average only about 25% of propranolol reaches the systemic circulation.
Slovenian: Vseeno pa je v veliki meri podvržen presnovi prvega prehoda v jetrih in v povprečju le približno 25 % propranolola doseže sistemski krvni obtok.
English: Excipients with known effect:
Slovenian: Pomožne snovi z znanimi učinki:
English: Do not use any soap or alcohol based product to clean.
Slovenian: Za čiščenje ne uporabljajte izdelkov na osnovi mila ali alkohola.
English: Initiation of treatment
Slovenian: Začetek zdravljenja
English: It is to be initiated in infants aged 5 weeks to 5 months (see section 4.2).
Slovenian: Zdravilo je indicirano pri dojenčkih, starih od 5 tednov do 5 mesecev (glejte poglavje 4.2).
English: Concommitant use not recommended
Slovenian: Sočasna uporaba ni priporočljiva
English: Breast-feeding Breastfeeding mothers: see section 4.4 and section 4.5.
Slovenian: Doječe matere: glejte poglavje 4.4 in poglavje 4.5.
English: EXP After first opening, the medicine should be used within 2 months.
Slovenian: EXP Po prvem odprtju je treba zdravilo porabiti v roku 2 mesecev.
English: In this case, inform the caregiver, and increase monitoring of blood glucose levels, particularly at the start of treatment.
Slovenian: V tem primeru obvestite negovalno osebje in povečajte pogostnost spremljanja ravni glukoze v krvi, zlasti na začetku zdravljenja.
English: Clinical monitoring of the child condition, and dose readjustment, need to be performed at least monthly.
Slovenian: Klinično spremljanje otrokovega stanja in prilagajanje odmerka je treba izvajati vsaj enkrat na mesec.
English: The pharmacokinetic evaluation was performed at steady-state, after 1 or 3 months of treatment.
Slovenian: Ocena farmakokinetike je bila izvedena v stanju dinamičnega ravnovesja po 1 ali 3 mesecih zdravljenja.
English: After first opening, the medicine should be used within 2 months.
Slovenian: Po prvem odprtju je treba zdravilo uporabiti v roku 2 mesecev.
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.
Slovenian: 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.
English: • Ulcerated haemangioma with pain and/or lack of response to simple wound care measures,
Slovenian: • ulceriran hemangiom, ki ga spremlja bolečina in/ali pomanjkanje odzivnosti na enostavne ukrepe pri oskrbi rane,
English: Do not put the syringe through a sterilizer or dishwasher.
Slovenian: Ne vstavljajte brizge v sterilizator ali pomivalni stroj.
English: Now you can slowly squirt HEMANGIOL from the syringe directly into your baby's mouth.
Slovenian: Zdaj lahko počasi brizgate zdravilo HEMANGIOL iz brizge neposredno v dojenčkova usta.
English: These effects were completely reversible when treatment was discontinued.
Slovenian: Ti učinki so bili popolnoma reverzibilni po prekinitvi zdravljenja.
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.
Slovenian: 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.
English: • Disease of the sinus node (including sinoatrial block)
Slovenian: • Bolezen sinusnega vozla (vključno s sinoatrijskim blokom)
English: • Step 6: Check for air bubbles
Slovenian: • 6. korak: Preverjanje zračnih mehurčkov
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)
Slovenian: • 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)
English: If your child should undergo a general anaesthesia
Slovenian: Če mora otrok prejeti splošno anestezijo
English: • infants breastfed by mothers taking any other medicinal products, notably those mentioned below.
Slovenian: • dojeni dojenčki, katerih matere jemljejo kakršna koli druga zdravila, predvsem spodaj omenjena.
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.
Slovenian: Med fazo titracije mora vsako povečanje odmerka izvesti in nadzorovati zdravnik pri enakih pogojih kot pri dajanju začetnega odmerka.
English: 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.
Slovenian: Zaradi tega bodo pri vašem otroku izvajali klinični nadzor in pozorno spremljali srčni utrip 2 uri po prvem odmerku in po povečanju odmerka.
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: 10 DATE OF REVISION OF THE TEXT
Slovenian: Datum zadnjega podaljšanja: 10 DATUM ZADNJE REVIZIJE BESEDILA
English: • Breastfed infants, if the mother is treated with medicinal products contraindicated with propranolol
Slovenian: • Dojeni dojenčki, če je bila mati zdravljena z zdravili, ki so kontraindicirana s propranololom
English: Do not remove the syringe adapter from the neck of the bottle.
Slovenian: Ne odstranjujte nastavka za brizgo z vratu steklenice.
English: Do not lie the child down immediately after the administration.
Slovenian: Takoj po dajanju otroka ne polagajte v ležeči položaj.
English: The 4-hydroxy-propranolol metabolite was quantified, its plasma exposure accounting for less than 7% of the parent drug exposure.
Slovenian: Metabolit 4-hidroksi propranolol je bil količinsko opredeljen, njegova izpostavljenost v plazmi pa je bila manj kot 7 % izpostavljenosti matičnega zdravila.
English: These hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma.
Slovenian: Te hipoglikemične epizode, povezane z jemanjem propranolola, se lahko izjemoma pojavijo v obliki konvulzij in/ali kome.
English: Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Slovenian: Sočasno zdravljenje s sistemskimi kortikosteroidi lahko poveča tveganje hipoglikemije (glejte poglavje 4.5).
English: The plasma half-life of propranolol ranges from 3 to 6 hours.
Slovenian: Razpolovna doba propranolola v plazmi je od 3 do 6 ur.
English: Locate this number on the oral syringe.
Slovenian: Najdite to številko na peroralni brizgi.
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%).
Slovenian: 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 %).
English: 0-3 months
Slovenian: 0-3 mesece
English: 3-6 months
Slovenian: 3-6 mesecev
English: Propylene glycol………………………………………………….2.60 mg.
Slovenian: 1 ml raztopine vsebuje propilenglikol………………………………………………….2,60 mg
English: Glucagon then catecholamines should be considered if the patient does not respond appropriately to intravenous fluid.
Slovenian: Treba je razmisliti o glukagonu in nato o kateholaminih, če se bolnik ne odziva ustrezno na intravensko tekočino.
English: 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.
Slovenian: 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.