FrancophonIA/ELRC3.0 huggingface dataset:
English: This applies only to products for which the labelled posology allows the product to be taken on a daily basis for > 1 month or repeated use for more than 2 days every week.
Slovenian: To velja samo za zdravila, pri katerih odobreno odmerjanje omogoča jemanje zdravila vsak dan > 1 mesec ali jemanje več kot 2 dneva vsak teden.
English: Tell your doctor if <you/your child> have/has any known allergies.
Slovenian: Obvestite zdravnika, če imate <vi/vaš otrok> kakršno koli poznano alergijo.
English: Oral products used frequently or over a long period of time, e.g. for two weeks or longer.
Slovenian: Peroralna zdravila, ki se uporabljajo pogosto ali skozi daljše časovno obdobje, npr. dva tedna ali več.
English: Use this medicine only if recommended by a doctor.
Slovenian: Zdravilo uporabite le, če vam je tako svetoval zdravnik.
English: See Q&A document (EMA/CHMP/619104/2013) for further calculations.
Slovenian: Za nadaljnje preračune glejte dokument Q&A (EMA/CHMP/619104/2013).
English: Heparin (as an excipient)
Slovenian: Heparin (kot pomožna snov)
English: The topical route in this case refers to sites that may have access to the circulation (e.g. wounds, body cavities etc.).
Slovenian: Topikalen način uporabe se v tem primeru nanaša na mesta, kjer je možen dostop do cirkulacije (npr. rane, telesne votline, itd.).
English: May cause pain at the site of injection.
Slovenian: Lahko povzroči bolečino na mestu injiciranja.
English: Talk to your doctor or pharmacist if you need <Z> or more <dosage units> daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom če potrebujete <Z> ali več <enota odmerka> dnevno v daljšem časovnem obdobju, še posebno če so vam svetovali dieto z majhnim vnosom soli (natrija).
English: 1 mg B/day
Slovenian: 1 mg B/dan
English: Benzyl alcohol is listed as one of the 26 fragrance allergens but can also be used as an excipient.
Slovenian: Benzilalkohol je naveden kot eden od 26 alergenov dišavah, lahko pa se uporablja tudi kot pomožna snov.
English: Therefore doses higher than 500 mg/kg/day may be administered in children > 5 years old but will have to be considered case by case.
Slovenian: Zato se odmerke, večje od 500 mg/kg/dan lahko daje otrokom > 5 let, vendar je treba uporabo individualno oceniti.
English: Phenylmercuric nitrate/acetate/borate
Slovenian: Fenilživosrebrov-nitrat/ acetat/borat
English: 500 mg/kg/day Propylene glycol in this medicine can have the same effects as drinking alcohol and increase the likelihood of side effects.
Slovenian: 500 mg/kg/dan Propilenglikol v tem zdravilu ima lahko enak učinek kot pitje alkohola in poveča možnost nastanka neželenih učinkov.
English: * 1 mg B (Boron) = 5.7 mg boric acid.
Slovenian: * 1 mg B (bor) = 5,7 mg borove kisline.
English: Fragrances containing allergens*
Slovenian: Dišave, ki vsebujejo alergene*
English: The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable.
Slovenian: Količina alkohola v tem zdravilu verjetno ne bo vplivala na odrasle in mladostnike, tudi pri otrocih njegovi učinki verjetno ne bodo opazni.
English: <Z doses> reflects the lowest number of dosage units for which the threshold of 17 mmol (391 mg) of sodium is reached/ exceeded.
Slovenian: <Z odmerkov> odraža najmanjše število enot odmerka, pri katerih se doseže/preseže meja 17 mmol (391 mg) natrija.
English: 1 mmol of sodium (Na) = 23 mg Na = 58.4 mg salt (NaCl).
Slovenian: 1 mmol natrija (Na) = 23 mg Na = 58,4 mg soli (NaCl).
English: One <dosage unit> contains no more than x micrograms of gluten.
Slovenian: Ena <enota odmerka> ne vsebuje več kot x mikrogramov glutena.
English: The corresponding warning in the SmPC/PL should be added if appropriate.
Slovenian: Če je potrebno, je treba v SmPC/navodilo za uporabo dodati ustrezno opozorilo.
English: The small amount of alcohol in this medicine will not have any noticeable effects.
Slovenian: Majhna količina alkohola v zdravilu ne bo imela nobenih opaznih učinkov.
English: Latex Natural Rubber (latex)
Slovenian: Lateks Naravna guma (lateks)
English: Information relates to a threshold based on the total amount of sodium in the medicinal product.
Slovenian: Podatek se nanaša na mejo, ki temelji na celotni količini natrija v zdravilu.
English: Aspartame (E 951)
Slovenian: Aspartam (E 951)
English: If you are pregnant, talk to your doctor before taking this medicine as it contains boron which may be harmful to your baby.
Slovenian: Če ste noseči, se pred jemanjem tega zdravila posvetujte z zdravnikom, ker vsebuje bor, ki je lahko škodljiv za vašega otroka.
English: This is equivalent to y% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako y% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: <Medicinal product> contains soya oil.
Slovenian: <Zdravilo> vsebuje sojino olje.
English: Ask your doctor or pharmacist for advice if you have a liver or kidney disease.
Slovenian: Vprašajte zdravnika ali farmacevta za nasvet, če imate bolezen jeter ali ledvic.
English: In children less than 2 years, the lower glomerular function may protect against renal toxicity, but can lead to higher blood levels of cyclodextrins.
Slovenian: Manjša glomerulna filtracija pri otrocih, mlajših od 2 let, je lahko zaščita pred renalno toksičnostjo, vendar lahko vodi do višjih ravni ciklodekstrinov v krvi.
English: 5 mg/kg/day Sorbitol is a source of fructose.
Slovenian: 5 mg/kg/dan Sorbitol je vir fruktoze.
English: Bergamot oil (containing bergapten)
Slovenian: Bergamotkino olje (vsebuje bergapten)
English: A dose of (select maximum dose) of this medicine administered to (a child A years of age and weighing B kg or an adult weighing 70 kg) would result in exposure to C mg/kg of ethanol which may cause a rise in blood alcohol concentration (BAC) of about D mg/100 ml (see Appendix 1 of report EMA/CHMP/43486/2018).
Slovenian: Pri odmerku (izberite največji odmerek) tega zdravila, ki ga prejme (otrok v starosti A let in s telesno maso B kg ali odrasla oseba s telesno maso 70 kg), bo izpostavljenost etanolu C mg/kg, kar lahko povzroči dvig koncentracije alkohola v krvi na približno D mg/100 ml (glejte prilogo 1 poročila EMA/CHMP/43486/2018).
English: Wheat starch (containing gluten)
Slovenian: Pšenični škrob (vsebuje gluten)
English: Sensitivity to SLS will also vary according the type of formulation (and effects of other excipients), the concentration of SLS, contact time and patient population (children, hydration level, skin color and disease).
Slovenian: Občutljivost na natrijev lavrilsulfat se spreminja tudi glede na vrsto formulacije (in učinek drugih pomožnih snovi), koncentracijo natrijevega lavrilsulfata, čas stika s to pomožno snovjo in populacijo bolnikov (otroci, raven hidracije, barva kože in bolezni).
English: Does not apply when bergapten is shown to be absent from the oil.
Slovenian: Informacija v navodilu ni potrebna, kadar je dokazano, da olje ne vsebuje bergaptena.
English: Tell your doctor if you/your child have/has experienced any health problems after previous administration of a vaccine.
Slovenian: Povejte zdravniku, če ste vi/vaš otrok imeli po prejšnjih cepljenjih zdravstvene težave.
English: For comparison, for an adult drinking a glass of wine or 500 ml of beer, the BAC is likely to be about 50 mg/100 ml.
Slovenian: Za primerjavo: pri odraslem, ki popije en kozarec vina ali 500 ml piva, bo koncentracija alkohola v krvi približno 50 mg/100 ml.
English: Patient populations with decreased skin barrier functions such as in atopic dermatitis are more sensitive to the irritant properties of SLS.
Slovenian: Populacije bolnikov z zmanjšano funkcijo kožne pregrade, kot je pri atopičnem dermatitisu, so bolj občutljivi na dražilne lastnosti natrijevega lavrilsulfata.
English: Depending on the product and concentration of ethanol, the warning “flammable” may be necessary.
Slovenian: Odvisno od vrste zdravila in koncentracije etanola v njem bo morda potrebno opozorilo za "vnetljivo snov".
English: If you are allergic to peanut or soya, do not use this medicinal product.
Slovenian: Če ste alergični na arašide ali sojo, ne uporabljajte tega zdravila.
English: 17 mmol (391 mg) in the maximum daily dose
Slovenian: 17 mmol (391 mg) v maksimalnem dnevnem odmerku
English: Corresponding SmPC statement in Section 4.8 (Undesirable effects): “Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.”
Slovenian: Ustrezen stavek v poglavju 4.8 SmPC (Neželeni učinki): »Zelo redko so poročali o primerih kalcifikacije roženice pri nekaterih bolnikih, ki so imeli hudo poškodovano roženico in so uporabljali kapljice za oči, ki so vsebovale fosfate.«
English: Information to be included only when the medicinal product may be intended for chronic use, e.g. for two weeks or more.
Slovenian: Podatek je treba vključiti, če je zdravilo namenjeno kronični uporabi, npr. za več kot dva tedna.
English: <Benzoic acid/Benzoate salt> may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Slovenian: <Benzojska kislina/benzoat> lahko poveča tveganje za zlatenico (rumeno obarvanje kože in oči) pri novorojenčkih (do 4. tedna starosti).
English: The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Slovenian: Količina sorbitola v zdravilih za peroralno uporabo lahko vpliva na biološko uporabnost drugih zdravil za peroralno uporabo, ki se jemljejo sočasno.
English: Talk to your doctor or pharmacist if you are taking other medicines.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če jemljete druga zdravila.
English: To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
Slovenian: To morajo upoštevati bolniki, ki imajo zmanjšano funkcijo ledvic ali bolniki, ki so na dieti z nadzorovanim vnosom kalija.
English: Patients with a history of heparin-induced allergic reactions should avoid the use of heparincontaining medicines.
Slovenian: Bolniki, ki so že doživeli alergijske reakcije na heparin, se morajo izogibati zdravilom, ki ga vsebujejo.
English: Adverse events usually reverse following weaning off of propylene glycol, and in more severe cases following hemodialysis.
Slovenian: Neželeni učinki običajno izzvenijo po opustitvi propilenglikola, v hujših primerih pa šele po hemodializi.
English: Oral liquids, lozenges and chewable tablets
Slovenian: Peroralne tekočine, pastile in žvečljive tablete
English: If you have wheat allergy (different from coeliac disease) you should not take this medicine.
Slovenian: Če imate alergijo na pšenico (ki je drugačna od celiakije), ne smete jemati tega zdravila.
English: <Allergen(s)>* may cause allergic reactions.
Slovenian: <Alergen(i)>* lahko povzroči(jo) alergijske reakcije.
English: Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
Slovenian: Benzalkonijev klorid se lahko absorbira v mehke kontaktne leče in lahko spremeni barvo kontaktnih leč.
English: When a dose is given over prolonged period (e.g. by slow infusion over several hours), the rise in BAC will be less and the effects of ethanol may be reduced.
Slovenian: Če se odmerek daje daljši čas (npr. s počasno infuzijo, ki traja več ur), bo porast koncentracije v krvi manjši in učinki etanola bodo verjetno manj izraziti.
English: May cause allergic reactions (possibly delayed).
Slovenian: Lahko povzroči alergijske reakcije (lahko zapoznele).
English: May rarely cause severe hypersensitivity reactions and bronchospasm.
Slovenian: Redko lahko povzroči resne preobčutljivostne reakcije in bronhospazem.
English: Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
Slovenian: Benzalkonijev klorid lahko povzroči draženje ali otekanje znotraj nosu, še posebno, če se uporablja dlje časa.
English: The alcohol in this preparation is likely to affect children.
Slovenian: Alkohol v tem zdravilu bo verjetno vplival na otroke.
English: This medicine contains fragrance with <allergen(s)>*.
Slovenian: To zdravilo vsebuje dišave z <alergenom(i)>*.
English: In such cases the package leaflet and SmPC should include a statement such as: Because this medicine is usually given slowly over XX hours, the effects of alcohol may be reduced.
Slovenian: V tem primeru naj se v navodilo za uporabo in SmPC vključi navedba: Ker se to zdravilo običajno daje počasi, v trajanju XX ur, bodo učinki etanola verjetno manj izraziti.
English: Intravenous (IV) 30 mmol/l
Slovenian: 30 mmol/l
English: May have a mild laxative effect.
Slovenian: Lahko ima blag odvajalni učinek.
English: Soya oil Hydrogenated soya oil
Slovenian: Sojino olje Hidrogenirano sojino olje
English: Benzalkonium chloride may cause wheezing and breathing difficulties (bronchospasm), especially if you have asthma.
Slovenian: Benzalkonijev klorid lahko povzroči sopenje ali težave z dihanjem (bronhospazem), še posebno če imate astmo.
English: This is also relevant for children, where the maximum daily intake is considered to be proportional to adults and based on energy requirements.
Slovenian: To je pomembno tudi za otroke, ker se na podlagi energijskih potreb šteje, da je največji dnevi vnos sorazmeren vnosu pri odraslih.
English: Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children.
Slovenian: Na splošno pa velja, da oči pri otrocih kažejo močnejše reakcije na stimulanse kot oči pri odraslih.
English: In patients with moderate to severe renal dysfunction accumulation of cyclodextrins may occur.
Slovenian: Pri bolnikih z zmerno do hudo okvaro ledvic se lahko pojavi kopičenje ciklodekstrinov.
English: May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
Slovenian: Lahko povzroči alergijske reakcije (lahko zapoznele) in izjemoma bronhospazem.
English: 75 mg/kg per dose
Slovenian: 75 mg/kg na odmerek
English: 1 mmol per dose
Slovenian: 1 mmol na odmerek
English: The thickness of the skin varies considerably according to the body site and with age and can be an important factor in the sensitivity to sodium laurilsulfate (SLS).
Slovenian: Debelina kože na različnih delih telesa in glede na leta precej variira in je lahko pomemben faktor pri občutljivosti na natrijev lavrilsulfat.
English: Formaldehyde
Slovenian: Formaldehid
English: This medicinal product contains (thiomersal) as a preservative and it is possible that <you/your child> may experience an allergic reaction.
Slovenian: To zdravilo vsebuje (tiomersal) kot konzervans, ki lahko <pri vas/vašem otroku> povzroči alergijsko reakcijo.
English: Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.
Slovenian: Zdravila ne uporabljajte pri dojenčkih, mlajših od 4 tednov, z odprtimi ranami ali večjimi površinami razpokane ali poškodovane kože (npr. zaradi opeklin) brez posveta z zdravnikom ali farmacevtom.
English: The alcohol in this medicine may alter the effects of other medicines.
Slovenian: Alkohol v tem zdravilu lahko spremeni učinek drugih zdravil.
English: From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Slovenian: Maloštevilni razpoložljivi podatki kažejo, da razlike v profilu neželenih učinkov pri otrocih in odraslimi ni.
English: Because this medicine contains propylene glycol, do not use it on open wounds or large areas of broken or damaged skin (such as burns) without checking with your doctor or pharmacist.
Slovenian: Ker zdravilo vsebuje propilenglikol, ga ne uporabljajte na odprtih ranah ali večjih površinah razpokane ali poškodovane kože (npr. zaradi opeklin) brez posveta z zdravnikom ali farmacevtom.
English: Various adverse events, such as hyperosmolality, lactic acidosis; renal dysfunction (acute tubular necrosis), acute renal failure; cardiotoxicity (arrhythmia, hypotension); central nervous system disorders (depression, coma, seizures); respiratory depression, dyspnoea; liver dysfunction; haemolytic reaction (intravascular haemolysis) and haemoglobinuria; or multisystem organ dysfunction, have been reported with high doses or prolonged use of propylene glycol.
Slovenian: Pri uporabi velikih odmerkov ali dolgotrajni uporabi so poročali o različnih neželenih učinkih, kot na primer hiperosmolalnost, laktacidoza, ledvična disfunkcija (akutna tubularna nekroza), akutna ledvična odpoved, kardiotoksičnost (aritmija, hipotenzija), bolezni osrednjega živčnega sistema (depresija, koma, konvulzije), respiratorna depresija, dispneja, jetrna disfunkcija, hemolitična reakcija (intravaskularna hemoliza) in hemoglobinurija ali multisistemska organska disfunkcija.
English: Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Slovenian: Benzilalkohol je povezan s tveganjem za pojav hudih neželenih učinkov, vključno s težavami z dihanjem (imenovanimi »sindrom lovljenja sape«) pri majhnih otrocih.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Slovenian: Večje količine benzilalkohola se namreč lahko kopičijo v vašem telesu in povzročajo neželene učinke (imenovane »metabolična acidoza«)
English: At high doses cyclodextrins can cause reversible diarrhoea and cecal enlargement in animals.
Slovenian: Veliki odmerki ciklodekstrinov lahko povzročijo reverzibilno diarejo in povečanje slepega črevesa pri živalih.
English: Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
Slovenian: Pri bolnikih z oslabljeno ledvično in jetrno funkcijo je potreben medicinski nadzor, ker so poročali o različnih neželenih učinkih, povezanih z propilenglikolom, kot so ledvična disfunkcija (akutna tubularna nekroza), akutna ledvična odpoved in jetrna disfunkcija.
English: 15 mg/kg per dose
Slovenian: 15 mg/kg na odmerek
English: In neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).
Slovenian: Pri novorojenčkih (nedonošenih in donošenih), lahko visoke koncentracije etanola zaradi znatne absorpcije skozi nezrelo kožo (zlasti pod okluzijami) povzročijo hude lokalne reakcije in sistemsko toksičnost.
English: Sodium laurilsulfate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
Slovenian: Natrijev lavrilsulfat lahko povzroči lokalne kožne reakcije (kot je zbadajoč ali pekoč občutek) ali pa poveča kožne reakcije, nastale zaradi drugih zdravil, ki se nanašajo na isto mesto.
English: Where ethanol is present as a processing agent (for example in tablet coating) or extraction solvent and is evaporated off (under the level of ICH Q3C) there is no need to mention ethanol in patient information.
Slovenian: Če se etanol uporablja v procesu proizvodnje zdravila (na primer v filmski oblogi tablete) ali kot ekstrakcijsko topilo in med postopkom izpari (pod dovoljeno mejo v ICH Q3C), ga v informacijah za bolnika ni treba navesti.
English: Maltitol (E 965) Isomalt (E 953) (isomaltitol) Maltitol liquid (hydrogenated glucose syrup)
Slovenian: Maltitol (E 965) Izomaltitol (E 953) Tekoči maltitol
English: Do not use in children less than 2 years old unless recommended by your doctor.
Slovenian: Ne dajajte otrokom, mlajšim od 2 let, razen če vam je tako svetoval zdravnik.
English: The container of this medicinal product contains latex rubber.
Slovenian: Vsebnik tega zdravila vsebuje naravno gumo (lateks).
English: Amount of boron per age group which may impair fertility if exceeded:
Slovenian: Količina bora, ki ob prekoračitvi lahko pri navedeni starostni skupini vpliva na plodnost:
English: Lactitol (E 966)
Slovenian: Laktitol (E 966)
English: While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk.
Slovenian: Propilenglikol ni kazal škodljivega vpliva na sposobnost razmnoževanja ali na razvoj pri živalih ali ljudeh, lahko pa pride do ploda in našli so ga v materinem mleku.
English: The amount of alcohol in this medicine may alter the effects of other medicines.
Slovenian: Količina alkohola v tem zdravilu lahko spremeni učinek drugih zdravil.
English: Cyclodextrins (CDs) are excipients which can influence the properties (such as toxicity or skin penetration) of the active substance and other medicines.
Slovenian: Ciklodekstrini so pomožne snovi, ki lahko vplivajo na lastnosti učinkovine (kot je toksičnost ali prehajanje skozi kožo) in drugih zdravil.
English: <Benzoic acid/Benzoate salt> may cause local irritation.
Slovenian: <Benzojska kislina/benzoat> lahko povzroči lokalno draženje.
English: As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
Slovenian: Zaradi tega se je treba o dajanju propilenglikola nosečnicam in doječim materam odločati individualno.
English: Contains x g lactose (x/2 g glucose and x/2 g galactose) per dose.
Slovenian: Vsebuje x g laktoze (x/2 g glukoze in x/2 g galaktoze) na odmerek.
English: Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
Slovenian: Ne dajajte novorojenčkom (do 4. tedna starosti), razen če vam je tako svetoval zdravnik.
English: Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
Slovenian: Poročali so, da benzalkonijev klorid povzroča draženje oči, simptome suhega očesa, vpliva pa lahko tudi na solzni film in površino roženice.
English: To calculate the equivalent volume of beer and wine, assume the ethanol content of beer to be 5% v/v (alcohol by volume, ABV), which is equivalent to 4% w/v, and of wine to be 12.5% v/v or 10% w/v (the specific gravity of ethanol has been approximated as 0.8).
Slovenian: Pri izračunu ustreznega volumna piva ali vina se predpostavlja, da je vsebnost alkohola v pivu 5% v/v, kar ustreza 4% m/v, vsebnost v vinu pa 12,5 % v/v oz. 10 % m/v (specifična teža etanola je zaokrožena na 0,8).
English: Medicines (containing fructose) given intravenously may be life-threatening and must be contraindicated in this population unless there is an overwhelming clinical need and no alternatives are available.
Slovenian: Zdravila, ki vsebujejo fruktozo, aplicirana intravensko, so lahko življenjsko ogrožujoča in morajo biti pri tej starostni skupini kontraindicirana, razen če so klinično nujno potrebna in če na voljo ni druge alternative.
English: Co-administration with medicines containing e.g. propylene glycol or ethanol may lead to accumulation of ethanol and induce adverse effects, in particular in young children with low or immature metabolic capacity.
Slovenian: Sočasna uporaba z zdravili, ki vsebujejo npr. propilenglikol ali etanol, lahko privede do kopičenja etanola in povzroči neželene učinke, zlasti pri majhnih otrocih, pri katerih je sposobnost presnove majhna oz. še nerazvita.
English: Sodium benzoate (E 211) Potassium benzoate (E 212)
Slovenian: Natrijev benzoat (E 211) Kalijev benzoat (E 212)