FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: 500 mg/kg/døgn Propylenglycol kan, i dette lægemiddel, have samme virkninger, som at drikke alkohol og øge sandsynligheden for bivirkninger.
English: <Allergen(s)>* may cause allergic reactions.
Danish: <Allergen(er)>* kan medføre allergiske reaktioner.
English: In patients with moderate to severe renal dysfunction accumulation of cyclodextrins may occur.
Danish: Hos patienter med moderat til svær renal dysfunktion kan der opstå akkumulering af cyclodextriner.
English: Does not apply when bergapten is shown to be absent from the oil.
Danish: Dette gælder ikke, hvis det er dokumenteret, at methoxypsoralen ikke er indeholdt i olien.
English: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one Amyl cinnamal
Danish: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-on Amylcinnamal
English: Aspartame (E 951)
Danish: Aspartam (E 951)
English: High volumes should be used with caution and only if necessary, especially in subjects with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
Danish: Store mængder bør anvendes med forsigtighed og kun hvis nødvendigt, især hos personer med nedsat lever eller nedsat nyrefunktion på grund af risikoen for ophobning og toksicitet (metabolisk acidose).
English: Oral Ocular Topical
Danish: Oral Okulær Topikal
English: If you are pregnant, talk to your doctor before taking this medicine as it contains boron which may be harmful to your baby.
Danish: Hvis du er gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel, da det indeholder bor, som kan være skadeligt for dit barn.
English: The PhEur monograph does not contain a test for residual protein.
Danish: indeholder ingen prøve for restprotein.
English: Inclusion of warnings on use near an open flame, lit cigarette or some devices (e.g. hairdryers) should be considered.
Danish: Tilføjelse af advarsler vedrørende brug nær åben ild, tændte cigaretter og visse apparater (fx hårtørrere) skal overvejes.
English: <Z doses> reflects the lowest number of dosage units for which the threshold of 17 mmol (391 mg) of sodium is reached/ exceeded.
Danish: <Z doser> svarer til de laveste antal dosisenheder, hvor tærsklen 17 mmol (391 mg) natrium er opnået.
English: Purified arachis oil may contain peanut protein.
Danish: Renset jordnøddeolie kan indeholde jordnøddeprotein.
English: This medicine contains only very low levels of gluten (from wheat starch)<.
Danish: Dette lægemiddel indeholder kun spormængder af gluten (fra hvedestivelse)<.
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.
Danish: Natriumlaurilsulfat kan medføre lokale hudreaktioner (f.eks. stikkende eller brændende fornemmelse) eller øge hudreaktioner forårsaget af andre produkter, når de påføres samme område.
English: This medicine contains fragrance with <allergen(s)>*.
Danish: Dette lægemiddel indeholder duftstof med <allergen(er)>*.
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.
Danish: Mængden af alkohol i dette lægemiddel forventes ikke at påvirke voksne og unge, og dets virkning på børn forventes ikke at være nævneværdig.
English: Aspartame is hydrolysed in the gastrointestinal tract when orally ingested.
Danish: Aspartam hydrolyseres i tarmen når det indtages.
English: The amount in <dose><volume> of this medicine is equivalent to less than A ml beer or B ml wine.
Danish: Mængden i <dosis><volumen> af dette lægemiddel svarer til mindre end A ml øl eller B ml vin.
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).
Danish: Ved beregning af den tilsvarende øl- og vinmængde antages det, at øl indeholder 5% v/v (alkohol per. volumen) ethanol, svarende til 4% w/v, og at vin indeholder 12,5% v/v eller 10% w/v (ethanols massefylde er anslået til 0,8) ethanol.
English: Use this medicine only if recommended by a doctor.
Danish: Brug kun dette lægemiddel, efter aftale med lægen.
English: The small amount of alcohol in this medicine will not have any noticeable effects.
Danish: Den mindre mængde alkohol i dette lægemiddel vil ikke have nogen nævneværdig effekt.
English: Sorbic acid (E 200) and salts
Danish: Sorbinsyre (E 200) og salte
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.
Danish: Når en dosis gives over længere tid (fx ved langsom infusion over flere timer) vil stigningen i koncentrationen af ethanol i blodet være mindre og ethanols virkning kan være reduceret.
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.
Danish: Samtidig administration af lægemidler, der indeholder fx propylenglycol eller ethanol kan føre til akkumulering af ethanol og udløse bivirkninger, særligt hos yngre børn med lav eller umoden metabolisk kapacitet.
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.”
Danish: Tilsvarende i produktresuméet, punkt 4.8 (Bivirkninger): "Sjældne tilfælde af hornhindeforkalkning er blevet rapporteret i forbindelse med anvendelsen af phosphatholdige øjendråber hos nogle patienter med signifikant beskadigede hornhinder”.
English: 17 mmol (391 mg) is approximately 20% of the WHO adult recommended maximum daily dietary intake of 2 g sodium and is considered to represent ‘high' sodium.
Danish: 17 mmol (391 mg) svarer til ca. 20% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium og anses som ”højdosis” natrium.
English: This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Danish: Dette skyldes, at store mængder benzylalkohol kan ophobes i din krop og kan medføre bivirkninger (kaldet "metabolisk acidose").
English: May cause allergic reactions and reduced blood cell counts which may affect the blood clotting system.
Danish: Kan medføre allergiske reaktioner og nedsat antal blodplader i blodet, hvilket kan påvirke blodets evne til at koagulere.
English: Do not use in children less than 2 years old unless recommended by your doctor.
Danish: Må ikke anvendes til småbørn under 2 år, medmindre det anbefales af din læge.
English: 10 g per dose May cause headache, stomach upset and diarrhea.
Danish: 10 g pr. dosis Kan give hovedpine, mavebesvær og diarré.
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.
Danish: Selvom propylenglycol ikke har påvist reproduktionstoksicitet eller skadelige virkninger på dyr eller mennesker, kan det optages i fosteret og er blevet fundet i brystmælken.
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.
Danish: Gælder kun for lægemidler, hvor doseringen tillader at lægemidlet anvendes dagligt i mere end 1 måned eller hvor lægemidlet indtages mere end 2 dage om ugen.
English: Adverse events usually reverse following weaning off of propylene glycol, and in more severe cases following hemodialysis.
Danish: Bivirkninger forsvinder normalt efter seponering af propylenglycol og i alvorligere tilfælde efter hæmodialyse.
English: 09/10/2017 Oral, parenteral (other than IV)
Danish: 09/10/2017 Oral, parenteral (andet end IV)
English: The amount of alcohol in this medicine can affect your ability to drive or use machines.
Danish: Mængden af alkohol i dette lægemiddel kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: <Medicinal product> contains soya oil.
Danish: <Navn> indeholder sojaolie.
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.
Danish: Generelt reagerer øjnene hos børn stærkere over for en given stimulans end øjnene hos voksne.
English: Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Danish: Benzylalkohol er forbundet med risiko for alvorlige bivirkninger inklusive åndedrætsbesvær (kaldet ”gasping syndrome”) hos små børn.
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.
Danish: I tilfælde hvor ethanol er et proceshjælpestof (fx ved coatning af tabletter) eller et ekstraktionsmiddel og er fordampet (under ICH Q3c´s grænse) er det ikke nødvendigt at nævne ethanol i indlægssedlen.
English: May have a mild laxative effect.
Danish: Kan have en mild afførende virkning.
English: Maltitol (E 965) Isomalt (E 953) (isomaltitol) Maltitol liquid (hydrogenated glucose syrup)
Danish: Maltitol (E 965) Isomalt (E 953) Flydende maltitol (hydrogeneret glucosesirup)
English: Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
Danish: Benzalkoniumchlorid kan medføre irritation eller hævelse i næsen, især under langvarig anvendelse.
English: 17 mmol (391 mg) in the maximum daily dose
Danish: 17 mmol (391 mg) i den maximale daglige dosis
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.
Danish: Brug ikke dette lægemiddel til babyer under 4 uger med åbne sår eller store områder med beskadiget hud (som ved forbrændinger) uden at tale med din læge eller apotekspersonalet.
English: 5 mg/kg/day Sorbitol is a source of fructose.
Danish: 5 mg/kg/døgn Sorbitol er en kilde til fructose.
English: When benzyl alcohol is used as an excipient (in addition to a fragrance or not), the label of this excipient applies.
Danish: Når benzylalkohol anvendes som hjælpestof (ud over som duft), gælder mærkning for dette hjælpestof.
English: The additive effect of concomitantly administered products containing fructose (or sorbitol) and dietary intake of fructose (or sorbitol) should be taken into account.
Danish: Den additive virkning af samtidigt administrerede produkter indeholdende fructose (eller sorbitol) og diætindtagelse af fructose (eller sorbitol) bør tages i betragtning.
English: Hydroxymethylpentyl-cyclohexenecarboxaldehyde Isoeugenol
Danish: Hydroxymethylpentyl-cyclohexen carboxaldehyd Isoeugenol
English: The topical route in this case refers to sites that may have access to the circulation (e.g. wounds, body cavities etc.).
Danish: Topikal administration refererer her til områder, der har forbindelse med blodcirkulationen (f.eks. sår og legemshulheder etc.).
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.
Danish: Monitorering er påkrævet hos patienter med nedsat nyreeller leverfunktion, fordi der er rapporteret adskillige bivirkninger, der skyldes propylenglycol, såsom renal dysfunktion (akut tubulær nekrose), akut nyresvigt og nedsat nyreleverfunktion.
English: Talk to your doctor or pharmacist if you are taking other medicines.
Danish: Kontakt lægen eller apotekspersonalet, hvis du tager andre lægemidler.
English: If you have wheat allergy (different from coeliac disease) you should not take this medicine.
Danish: Hvis du har hvedeallergi (ikke det samme som cøliaki) bør du ikke bruge/tage dette lægemiddel.
English: Fragrances containing allergens*
Danish: Duftstoffer indeholdende allergener*
English: The alcohol in this preparation is likely to affect children.
Danish: Alkoholen i dette lægemiddel vil sandsynligvis påvirke børn.
English: Less than 1 mmol per dose
Danish: Mindre end 1 mmol pr. dosis
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.
Danish: Fordi dette lægemiddel indeholder propylenglycol, må du ikke bruge det på åbne sår eller store områder med beskadiget hud (som ved forbrændinger) uden at tale med din læge eller apotekspersonalet.
English: Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye).
Danish: Benzalkoniumchlorid kan også give øjenirritation, især hvis du har tørre øjne eller problemer med hornhinderne (det klare lag forrest i øjet).
English: Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
Danish: Rapporteringer har vist, at benzalkoniumchlorid kan medføre øjenirritation, symptomer på tørre øjne og det kan påvirke tårefilmen og hornhindeoverfladen.
English: Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Danish: Patienter med hereditær fructoseintolerans (HFI) bør ikke tage/få dette lægemiddel.
English: Betadex (E 459) γ-cyclodextrin Sulfobutyl-ether-βcyclodextrin (SBE-β-CD) Hydroxypropyl betadex Randomly methylated βcyclodextrin (RM-β-CD)
Danish: Betadex (E 459) γ-cyclodextrin Sulfobutyl-ether-βcyclodextrin (SBE-β-CD) Hydroxypropyl betadex Tilfældigt methyleret βcyclodextrin (RM-β-CD)
English: Wheat starch (containing gluten)
Danish: Hvedestivelse (indeholder gluten)
English: Benzalkonium chloride may irritate the skin.
Danish: Benzalkoniumchlorid kan irritere huden.
English: 15 mg/kg per dose
Danish: 15 mg/kg pr. dosis
English: 140 mg/kg/day Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Danish: 140 mg/kg/døgn Sorbitol kan medføre gastrointestinalt ubehag og en mild afførende virkning.
English: <Benzoic acid/Benzoate salt> may cause local irritation.
Danish: <Benzoesyre/benzoat> kan medføre lokal irritation.
English: The container of this medicinal product contains latex rubber.
Danish: Denne lægemiddelbeholder indeholder naturgummi/latex.
English: Chlorocresol
Danish: Chlorcresol
English: Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Phenylalanin kan være skadeligt, hvis du har phenylketonuri (PKU, Føllings sygdom), en sjælden genetisk lidelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
English: 75 mg/kg per dose
Danish: 75 mg/kg pr. dosis
English: 200 mg/kg/day Cyclodextrins may cause digestive problems such as diarrhoea.
Danish: 200 mg/kg/døgn Cyclodextriner kan medføre fordøjelsesproblemer som diarré.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.
Danish: Hvis du (eller dit barn) har arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, må du (eller dit barn) ikke få dette lægemiddel.
English: Contains x g lactose (x/2 g glucose and x/2 g galactose) per dose.
Danish: Indeholder x g lactose (svarer til x/2 g glucose og x/2 g galactose) pr. dosis.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Danish: Den additive virkning af samtidigt administrerede produkter indeholdende sorbitol (eller fructose) og indtagelse af sorbitol (eller fructose) i kosten bør tages i betragtning.
English: Ask your doctor or pharmacist for advice if you have a liver or kidney disease.
Danish: Spørg din læge eller apotekspersonalet til råds, hvis du har en lever- eller nyresygdom.
English: 1 mg/kg/day 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.
Danish: 1 mg/kg/døgn Hvis din baby er yngre end 4 uger, skal du tale med din læge eller apotekspersonalet, før du giver barnet dette lægemiddel, især hvis barnet får andre lægemidler, der indeholder propylenglycol eller alkohol.
English: Proposed wording for SmPC: “This medicinal product contains x mg sodium per <dosage unit>, equivalent to y% of the WHO recommended maximum daily intake of 2 g sodium for an adult.”
Danish: Produktresumé, forslag: “Dette lægemiddel indeholder x mg natrium pr. <dosisenhed>, svarende til y% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.”
English: 1 mmol (23 mg) per dose
Danish: 1 mmol (23 mg) pr. dosis
English: Intravenous administration of benzyl alcohol has been associated with serious adverse events and death in neonates (“gasping syndrome”).
Danish: Intravenøs indgift af benzylalkohol er blevet forbundet med alvorlige bivirkninger og død hos nyfødte ("gasping syndrome").
English: Phenylmercuric nitrate/acetate/borate
Danish: Thiomersal, Phenylmercurinitrat/ acetat/borat
English: It is regarded as ‘gluten-free'*> and is very unlikely to cause problems if you have coeliac disease.
Danish: Det betragtes som »glutenfrit«*> og anses derfor for sikkert for patienter med cøliaki.
English: May have a laxative effect.
Danish: Kan have en afførende virkning.
English: Benzyl alcohol may cause mild local irritation.
Danish: Benzylalkohol kan forårsage mild lokal irritation
English: If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
Danish: Hvis du har alvorlige skader på det forreste, klare lag i øjet (hornhinden), kan phosphater i meget sjældne tilfælde forårsage, at der dannes uklare pletter på hornhinden.
English: 22/11/2019 Cutaneous
Danish: 22/11/2019 Kutan
English: May cause stomach upset and diarrhea.
Danish: Kan give mavebesvær og diarré.
English: Calorific value 2.3 kcal/g <maltitol><isomalt>.
Danish: Energi: 10 kJ (2,3 kcal) pr. g <maltitol><isomalt>.
English: Ask your doctor or pharmacist for advice if you are pregnant or breast‑feeding.
Danish: Spørg din læge eller apotekspersonalet til råds, hvis du er gravid eller ammer.
English: Dimethyl sulphoxide
Danish: Dimethylsulfoxid
English: Benzyl salicylate
Danish: Benzylsalicylat
English: Hexyl cinnamaldehyde
Danish: Hexylcinnamaldehyd
English: You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
Danish: Tal med lægen inden du får dette lægemiddel, hvis du (eller dit barn) har HFI, eller hvis dit barn ikke længere kan tage sød mad eller drikke, fordi barnet føler sig sygt, kaster op eller får ubehagelige virkninger som oppustethed, mavekramper eller diarré.
English: Oral liquids, lozenges and chewable tablets
Danish: Oral væske, sugetabletter og tyggetabletter
English: For parenterals with variable (e.g. weight-based) dosing sodium content may be expressed in mg per vial.
Danish: For parenterale lægemidler med variabelt indhold (f.eks. vægtbaseret) kan natriumindholdet angives som mg pr. hætteglas.
English: 09/10/2017 All
Danish: 09/10/2017 Alle
English: Bergamot oil (containing bergapten)
Danish: Bergamotteolie (indeholder methoxypsoralen (bergapten))
English: 50 mg/kg/day If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.
Danish: 50 mg/kg/døgn Hvis dit barn er under 5 år, skal du tale med din læge eller apotekspersonalet, før du giver barnet dette lægemiddel, især hvis barnet får andre lægemidler, der indeholder propylenglycol eller alkohol.
English: Information relates to a threshold based on the total amount of sodium in the medicinal product.
Danish: Denne information gælder som tærskelværdi for det totale indhold af Na+ i lægemidlet.
English: Less than 1 mmol (23 mg) per dose
Danish: Mindre end 1 mmol (23 mg) pr. dosis
English: The alcohol in this medicine may alter the effects of other medicines.
Danish: Alkoholen i dette lægemiddel kan påvirke andre lægemidlers virkning.
English: Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
Danish: Samtidig administration med substrater til alkoholdehydrogenase, såsom ethanol, kan fremkalde alvorlige bivirkninger hos børn under 5 år.
English: It is especially relevant to products used in children or in patients on a low sodium diet, to provide information to prescribers and reassurance to parents or patients concerning the low level of sodium in the product.
Danish: For lægemidler, der anvendes til børn eller patienter, som skal have diæt med lavt natriumindhold, er det særlig vigtigt at sikre, at behandlende læger og forældre er informeret om lægemidlets lave indhold af Na+.
English: Benzoic acid (E 210) and benzoates e.g.:
Danish: Benzoesyre (E 210) og benzoater f.eks.:
English: Information to be included only when the medicinal product may be intended for chronic use, e.g. for two weeks or more.
Danish: Denne advarsel skal kun anføres, hvis lægemidlet skal anvendes i længere tid, f.eks. 14 dage eller længere.
English: May rarely cause severe hypersensitivity reactions and bronchospasm.
Danish: Kan i sjældne tilfælde medføre overfølsomhedsreaktioner og vejrtrækningsbesvær.
English: Contains x g of a mixture of fructose and glucose per dose.
Danish: Indeholder x g af en blanding af fructose og glucose pr. dosis.
English: The amount of alcohol in this medicine may alter the effects of other medicines.
Danish: Mængden af alkohol i dette lægemiddel kan påvirke andre lægemidlers virkning.
English: May cause allergic reactions (possibly delayed), and exceptionally, bronchospasm.
Danish: Kan give allergiske reaktioner (kan optræde efter behandlingen) og i sjældne tilfælde åndedrætsbesvær.
English: Cyclodextrins e.g.:
Danish: Cyclodextriner f.eks.
English: May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Danish: Kan give lokalt hududslæt (f.eks. kontakteksem) og irritation af øjne og slimhinder.
English: Sodium benzoate (E 211) Potassium benzoate (E 212)
Danish: Natriumbenzoat (E 211) Kaliumbenzoat (E 212)
English: 5 mg/kg/day If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Danish: 5 mg/kg/døgn Hvis din læge har fortalt dig, at du (eller dit barn) har intolerance over for nogle sukkerarter eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge før du (eller dit barn) tager eller får dette lægemiddel.
English: If you have a kidney disease, talk to your doctor before you receive this medicine.
Danish: Hvis du har en nyresygdom, skal du tale med din læge inden du får dette lægemiddel.