FrancophonIA/ELRC3.0 huggingface dataset:
English: Articaine, a local amide anaesthetic, reversibly blocks nerve conduction through a well-known mechanism commonly observed with other local amide anaesthetics.
Danish: Articain er et lokalanæstetikum af amidtypen, der blokerer nerveledningen reversibelt gennem en velkendt mekanisme, der er almindeligt observeret med andre lokalanæstetika af amidtypen.
English: Elevated product plasma levels may occur in elderly patients in particular after repeated use.
Danish: Der kan forekomme forhøjede produktplasmaniveauer hos ældre patienter, især efter gentagen brug.
English: Patients with plasma cholinesterase deficiency
Danish: Patienter med mangel på plasmakolinesterase
English: Clinical efficacy and safety: {(Invented) name and associated names (see Annex I)} has an onset of 1.51.8 min for infiltration and 1.4-3.6 min for nerve block.
Danish: Klinisk virkning og sikkerhed: {Særnavn og relaterede navne (se bilag I)} virkning indtræder efter 1,5-1,8 min ved infiltration og 1,43,6 min ved nerveblokade.
English: Neuralgia (neuropathic pain) Hypoesthesia / numbness (oral and perioral) 4
Danish: Neuropati: neuralgi (neuropatisk smerte) hypoæstesi/følelsesløshed (oral og perioral)4
English: • inflammation of the tongue and mouth
Danish: • betændelse i tungen og munden
English: Adverse reactions following administration of articaine / adrenaline are similar to those observed with other local amide anaesthetics / vasoconstrictors.
Danish: Bivirkninger efter administration af articain/adrenalin svarer til de bivirkninger, der observeres med andre lokale amidanæstetika/vasokonstriktorer.
English: • heart and blood pressure medicines (such as guanadrel, guanethidine, propranolol, nadolol,)
Danish: • hjerte- og blodtryksmedicin (såsom guanadrel, guanethidin, propranolol, nadolol)
English: Maximum dose of articaine hydrochloride (mg)
Danish: Maksimal dosis articainhydrochlorid (mg)
English: • nervousness, anxiety
Danish: • nervøsitet, angst
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
Danish: ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: oxymetazoline), used to raise the blood pressure: if used within the past 24 hours, the planned dental treatment has to be postponed.
Danish: oxymetazolin), der bruges til at hæve blodtrykket: Hvis det er taget inden for de seneste 24 timer,
English: Visual impairment (temporary blindness)4
Danish: Synsnedsættelse (midlertidig blindhed)4
English: At the discretion of the dentist, more cartridges may be required for more extensive procedures without exceeding the maximum recommended dose.
Danish: Efter tandlægens skøn kan det være påkrævet med flere cylinderampuller til mere omfattende procedurer uden at den maksimale anbefalede dosis overskrides.
English: • wheezing (bronchospasm), asthma
Danish: • hvæsende vejrtrækning (bronkospasme), astma
English: Paresthesia can be defined as spontaneous abnormal usually non-painful sensation (e.g., burning, pricking, tingling or itching) well beyond the expected duration of anesthesia.
Danish: Paræstesi kan defineres som spontan sædvanligvis ikke-smertefuld føleforstyrrelse (fx. brændende, prikkende, snurrende eller kløende fornemmelse) lang tid ud over anæstesiens forventede varighed.
English: This may be associated with severe adverse reactions, such as convulsions, followed by central nervous and cardiorespiratory depression and coma, progressing to respiratory and circulatory arrest.
Danish: Dette kan være forbundet med alvorlige bivirkninger, såsom kramper, efterfulgt af CNS- og kardiorespiratorisk depression og koma, der udvikler sig til respirations- og kredsløbsstop.
English: No adverse effects on fertility are anticipated at doses used for a dental procedure.
Danish: Der forventes ingen skadelige virkninger på frugtbarhed ved doser, der anvendes ved tandlægebehandling.
English: Not known Erythema Hyperhidrosis
Danish: Erytem Hyperhidrose
English: A reduced amount of adrenaline in dental anaesthesia should be given to patients on COMT inhibitors.
Danish: Der bør gives en reduceret mængde adrenalin ved dentalbedøvelse til patienter, der får COMThæmmere.
English: If there is any risk of an allergic reaction, choose a different medicine for anesthesia (see section 4.3).
Danish: Hvis der er risiko for en allergisk reaktion, skal der vælges et andet lægemiddel til anæstesi (se pkt.
English: Reduced doses of this medicinal product should be used due to sensitization of the heart to the arrhythmogenic effects of catecholamines: risk of severe ventricular arrhythmia.
Danish: Der bør anvendes reducerede doser af dette lægemiddel på grund af hjertets sensibilisering over for de arytmogene virkninger af katekolaminer: risiko for alvorlig ventrikularytmi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Cardboard carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske
English: Dose of adrenaline (mg)
Danish: Adrenalin dosis (mg)
English: Contradictory findings were raised from in-vitro and in-vivo genotoxicity studies with adrenaline.
Danish: Der er modstridende resultater fra in vitro og in vivo genotoksicitetsstudier med adrenalin.
English: If you get any side effects, talk to your dentist, doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din tandlæge, læge eller apoteket.
English: <[To be completed nationally]>
Danish: <[Udfyldes nationalt]>
English: • rash, itching, swelling of the throat and difficulty breathing: this might be symptoms of an allergic
Danish: • udslæt, kløe, hævelse i halsen og vejrtrækningsbesvær: dette kan være symptomer på en overfølsomhedsreaktion.
English: Uncommon Burning sensation Rare
Danish: Ikke almindelig Brændende fornemmelse Sjælden
English: • a disease called Myasthenia Gravis causing weakness in the muscles;
Danish: • hvis du lider af en sygdom kaldet myasthenia gravis, der forårsager muskelsvækkelse
English: Absorption: In three published clinical studies describing the pharmacokinetic profile of the combination articaine hydrochloride 40 mg/ml with adrenaline 10 or 5 micrograms/ml, Tmax values were between 10 and 12 minutes, with Cmax values ranging from 400 to 2100 ng/ml.
Danish: Absorption: I tre offentliggjorte kliniske studier, der beskriver den farmakokinetiske profil af kombinationen articainhydrochlorid 40 mg/ml med adrenalin 10 eller 5 mikrogram/ml, var Tmaxværdier mellem 10 og 12 minutter, med Cmax værdier i området fra 400 til 2100 ng/ml.
English: • medicines used to treat irregular heartbeats (for example digitalis, quinidine);
Danish: • lægemidler til behandling af uregelmæssig hjerterytme (f.eks. digitalis, quinidin)
English: Very rare cases of prolonged or irreversible nerve injury and gustatory loss have been reported after mandibular block analgesia.
Danish: Der er indberettet meget sjældne tilfælde af længerevarende eller irreversibel nervelæsion og gustatoriske tab efter mandibular blokade med analgetika.
English: What you need to know before you are given X / Y 3.
Danish: Det skal du vide, før du begynder at bruge X/Y 3.
English: {(Invented) name and associated names (see Annex I)} contains 0.804 mg sodium per 1 ml of solution i.e. 1.44 mg/1.7 ml.
Danish: {Særnavn og relaterede navne (se bilag I)} indeholder 0,804 mg natrium pr. 1 ml opløsning, dvs. 1,44 mg/1,7 ml.
English: • feeling hot or feeling cold
Danish: • varme- eller kuldefornemmelse
English: Postganglionic adrenergic blocking agents (e.g., guanadrel, guanethidine, and rauwolfia alkaloids): Reduced doses of this medicinal product should be used under strict medical supervision with careful aspiration due to possible increase response to adrenergic vasoconstrictors: risk of hypertension and other cardiovascular effects.
Danish: Postganglionære adrenerge blokkere (fx guanadrel, guanethidin og rauwolfiaalkaloider): Der bør anvendes reducerede doser af dette lægemiddel under nøje medicinsk overvågning med omhyggelig aspiration på grund af mulig øgning i respons over for adrenerge vasokonstriktorer: risiko for hypertension og andre kardiovaskulære effekter.
English: Drugs causing arrhythmias (e.g., antiarrhythmics like digitalis, quinidine): Dose of administration of this medicinal product should be reduced due to the increased risk of arrhythmia when both adrenaline and digital glucosides are administered concomitantly to patients.
Danish: Præpatater, der forårsager arytmier (fx antiarytmika som digitalis, quinidin): Dette lægemiddels administrationsdosis bør reduceres på grund af den øgede risiko for arytmi, når både adrenalin og digitalisglycosider administreres samtidigt til patienter.
English: Tell your dentist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til din tandlæge, hvis du tager anden medicin eller har gjort det for nylig.
English: Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
Danish: Lokalanæstetika bør injiceres med forsigtighed, når der er inflammation og/eller infektion på injektionsstedet.
English: • muscle twitch, involuntary muscle contraction
Danish: • muskelspjæt, ufrivillig sammentrækning af muskel
English: This medicinal product should be used cautiously due to the presence of hepatic disease although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
Danish: Dette lægemiddel bør anvendes med forsigtighed ved tilstedeværelsen af leversygdom, selvom 90 % af articain først inaktiveres af uspecifikke plasmaesteraser i væv og blod.
English: • Porphyria which causes either neurological complications or skin problems;
Danish: • hvis du lider af en tilstand, der kaldes porfyri, som enten forårsager neurologiske komplikationer eller hudproblemer
English: • COMT-inhibitors to treat Parkinson's disease (such as entacapone or tolcapone);
Danish: • COMT-hæmmere til behandling af Parkinsons sygdom (såsom entacapon eller tolcapon)
English: • lacking of a natural chemical substance called cholinesterase in your blood (plasma cholinesterase deficiency);
Danish: • hvis du mangler et naturligt kemisk stof kaldet kolinesterase i dit blod
English: X / Y contains sodium and sodium metabisulfite.
Danish: X/Y indeholder natrium (salt) og natriummetabisulfit.
English: If the concurrent use of these agents cannot be avoided, the dose and rate of administration of this product should be reduced, and the product should be used under strict medical supervision due to possible potentiation of the effects of adrenaline leading to the risk of hypertensive crisis.”
Danish: Hvis samtidig brug af disse lægemidler ikke kan undgås, bør dosis og administrationshastighed reduceres for dette produkt, og produktet skal anvendes under streng medicinsk overvågning på grund af mulig potensering af adrenalinens virkninger, hvilket kan medføre risiko for hypertensive kriser.
English: • have or have had any heart problem
Danish: • hvis du lider af eller har lidt af nogen form for hjertesygdom
English: Total volume (ml) and equivalent in number of cartridges (1.7 ml)
Danish: Samlet volumen (ml) og tilsvarende antal cylinderampuller (1,7 ml)
English: • inflammation or infection in the area to be injected.
Danish: • hvis du har betændelse eller infektion i det område, hvor indsprøjtningen skal foretages.
English: Non-selective beta-adrenergic blockers (e.g., propranolol, nadolol):
Danish: Non-selektive beta-adrenerge blokkere (fx propranolol, nadolol):
English: Swelling of tongue, lip, gums Uncommon Stomatitis, glossitis Nausea, vomiting, diarrhoea
Danish: Hævelse af tunge, læber, tandkød Ikke almindelig Stomatitis, glossitis Kvalme, opkastning, diarré
English: COMT inhibitors (Catechol-O-methyl transferase inhibitors) (e.g., entacapone, tolcapone): Arrhythmias, increased heart rate and blood pressure variations may occur.
Danish: COMT-hæmmere (catechol-O-methyltransferasehæmmere) (fx entacapon, tolcapon): Arytmier, forhøjet hjertefrekvens og blodtryksvariationer kan forekomme.
English: What you need to know before you are given X / Y Do not use X / Y if you suffer from any of the following conditions:
Danish: Det skal du vide, før du begynder at bruge X/Y Brug ikke X/Y:
English: The safety of {(Invented) name and associated names (see Annex I)} in children aged 4 years and below has not been established.
Danish: Sikkerheden af {Særnavn og relaterede navne (se bilag I)} hos børn i alderen 4 år og yngre er ikke blevet fastslået.
English: Adrenaline impairs the flow of blood in the gums, potentially causing local tissue necrosis.
Danish: Adrenalin hæmmer blodgennemstrømningen i tandkødet, hvilket kan forårsage lokal vævsnekrose.
English: • involuntary eye movement
Danish: • ufrivillige øjenbevægelser
English: What X / Y contains - The active substances are articaine hydrochloride and adrenaline tartrate.
Danish: X/Y indeholder: - Aktive stoffer: articainhydrochlorid og adrenalintartrat.
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of {(Invented) name and associated names (see Annex I)} (see Section 4.8 of SmPC).
Danish: Der kan forekomme svimmelhed (herunder vertigo, synsforstyrrelser og træthed) efter administration af {Særnavn og relaterede navne (se bilag I)} (se pkt.
English: In case of required reinjection, patient should be strictly monitored, to identity any sign of relative overdose.
Danish: Ved behov for gentagen injektion skal patienten nøje overvåges for at identificere tegn på relativ overdosering.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label (cartridge)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket (cylinderampul)
English: Adults and adolescents (12 to 18 years of age)
Danish: Voksne og unge (12-18 år)
English: The availability of appropriate resuscitation equipment and medication should be ensured before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Danish: Der skal sikres adgang til passende genoplivningsudstyr og lægemidler før induktion af regional anæstesi med lokalanæstetika for at muliggøre hurtig behandling af eventuelle respiratoriske og kardiovaskulære nødsituationer.
English: Do not use this medicine if you notice that the solution is cloudy or discoloured.
Danish: Brug ikke lægemiddel, hvis du bemærker, at opløsningen er uklar eller misfarvet.
English: The availability of resuscitation equipment and medication should be ensured before administration of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Danish: Tilgængeligheden af genoplivningsudstyr og medicin bør sikres før administration af regionalanæstesi med lokalanæstetika for at muliggøre hurtig behandling af eventuelle respiratoriske og kardiovaskulære nødsituationer.
English: In attendance of these signs, patients should be requested to hyperventilate and surveillance should be instituted (see Section 4.9 of SmPC).
Danish: Ved observation af disse tegn skal patienten anmodes om at hyperventilere og der bør iværksættes overvågning (se pkt.
English: Allergic1, anaphylactic / anaphylactoid reactions
Danish: Allergiske reaktioner1, anafylaktiske/anafylaktoide reaktioner
English: Infiltration and perineural use in oral cavity.
Danish: Infiltration og perineural anvendelse i mundhulen.
English: {(Invented) name and associated names (see Annex I)} is indicated in adults, adolescents and children above 4 years of age (or from 20 kg (44 lbs) of body weight).
Danish: {Særnavn og relaterede navne (se bilag I)} er indiceret til voksne, unge og børn over 4 år (eller fra 20 kg).
English: It is packed in single use glass cartridges sealed at the base by a mobile rubber plunger and at the top by a rubber seal kept in place by an aluminium cap.
Danish: Det er pakket i glascylinderampuller til engangsbrug, der er forseglet i bunden med et bevægeligt gummistempel og øverst med en gummiforsegling, der holdes på plads af en aluminiumshætte.
English: If sedatives are employed to reduce patient's apprehension, reduced doses of anaesthetics should be used since local anaesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect (see section 4.2).
Danish: Hvis der anvendes sedativer til at reducere patientens angst, skal der anvendes nedsatte doser af anæstetika, da lokalanæstetika, såsom sedativer, er CNS-depressiva, hvilket i kombination kan have en additiv effekt (se pkt.
English: Not known Dysphonia (Hoarseness)1
Danish: Dysfoni (hæshed)1
English: • drooping of the eyelid, and constriction of the pupil (Horner's syndrome)
Danish: • hængende øjenlåg og forsnævring af pupillen (Horners syndrom)
English: In adults and adolescents, the maximum articaine dose is 7 mg/kg with an absolute maximum articaine dose of 500 mg.
Danish: Den maksimale dosis articain til voksne og unge er 7 mg/kg med en absolut maksimal dosis articain på 500 mg.
English: Children (4 to 11 years of age)
Danish: Børn (4-11 år)
English: ● Adults and adolescents (12 to 18 years of age)
Danish: • Voksne og unge (12-18 år)
English: ● Children (4 to 11 years of age)
Danish: • Børn (4-11 år)
English: • acute heart failure (acute heart weakness, e.g. unexpected chest pain while resting or after myocardial infraction (e.g. heart attack));
Danish: • hvis du lider af akut hjertesvigt (akut hjertesvaghed, f.eks. uventede brystsmerter under hvile eller efter myokardieinfarkt (f.eks. hjerteanfald))
English: Elevated product plasma levels may occur in patients with cholinesterase deficiency or under acetylcholinesterase inhibitors treatment since the product is inactivated at 90% by plasmatic esterases.
Danish: Forhøjede produktplasmaniveauer kan forekomme hos patienter med mangel på kolinesterase eller som er under behandling med acetylcholinesterasehæmmere, da 90% af produktet inaktiversaf plasmaesteraser, se pkt.
English: paralysis and paresis) Horner's syndrome (eyelid ptosis, enophthalmos, miosis).
Danish: Horners syndrom (øjenlågsptose, enoftalmus, miose).
English: Paresthesia3 (persistent hypoesthesia and gustatory loss) after mandibular or inferior alveolar nerve blocks
Danish: Meget sjælden Paræstesi3 (vedvarende hypoæstesi og gustatorisk tab) efter mandibular nerveblokade eller efter blokade af nervus alveolaris inferior
English: • Hypersensitivity to articaine (or any local anaesthetic agent of the amide type), to adrenaline or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for articain (eller ethvert andet lokalanæstesimiddel af amidtypen), adrenalin eller over for et eller flere af hjælpestofferne anført i pkt.
English: 7 MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt]
English: MAO inhibitors (both A-selective (e.g. moclobemide) and non-selective (e.g. phenelzine, tranylcypromine, linezolide) :
Danish: MAO-hæmmere (både A-selektive (fx moclobemid) og ikke-selektive (fx phenelzin, tranylcypromin, linezolid):
English: Other side effects not listed above may also occur in some patients.
Danish: Hos nogle patienter kan der kan også forekomme andre bivirkninger, som ikke er nævnt ovenfor.
English: • Patients with cardiovascular diseases (e.g. heart failure, coronary heart disease, history of myocardial infarction, cardiac arrhythmia, hypertension)
Danish: - Patienter med kardiovaskulære sygdomme (for eksempel hjertesvigt, koronar hjertesygdom, myokardieinfarkt i anamnesen, hjertearytmi, hypertension)
English: 50 x 1.7 ml cartridges 50 x 1.7 ml cartridges, selfaspirating 4 (50 x 1.7 ml) cartridges 8 (50 x 1.7 ml) cartridges
Danish: 50 x 1,7 ml cylinderampuller 50 x 1,7 ml cylinderampuller, selvaspirerende 4 (50 x 1,7 ml) cylinderampuller 8 (50 x 1,7 ml) cylinderampuller
English: These actions lead the anaesthetic action.
Danish: Disse virkninger fører til den anæstetiske virkning.
English: The maximum safe dose of local anaesthetic may be reduced in sedated patients due to an additive effect on central nervous system depression.
Danish: Den maksimale sikre dosis af lokalanæstetikum kan reduceres til sederede patienter grundet en additiv virkning af centralnervesystemesdepression.
English: • swollen face, tongue or pharynx, difficulty to swallow, hives or difficulties to breath (angioedema)
Danish: • hævet ansigt, tunge eller svælg, synkebesvær, nældefeber eller åndedrætsbesvær (angioødem)
English: • ringing of the ears, over-sensitivity of hearing
Danish: • ringen for ørerne, lydoverfølsomhed
English: • allergy to other local anaesthetics;
Danish: • hvis du er allergisk overfor andre lokalbedøvende midler
English: Due to the lack of clinical data, particular precaution should be used in order to administer the lowest dose leading to effective anaesthesia in elderly patients and in patients with renal disorders.
Danish: På grund af manglende kliniske data skal der udvises særlig omhu for at indgive den laveste dosis, der fører til effektiv anæstesi hos ældre patienter samt hos patienter med nyresygdomme.
English: Particular precaution should be used in order to administer the lowest dose leading to efficient anaesthesia in patients with hepatic impairment, in particular after repeated use, although 90% of articaine is first inactivated by unspecific plasma esterases in the tissue and blood.
Danish: Der skal udvises særlig omhu for at indgive den laveste dosis, der fører til effektiv anæstesi hos patienter med nedsat leverfunktion, især efter gentagen brug, selvom 90 % af articain først inaktiveres af uspecifikke plasmaesteraser i væv og blod.
English: Patients with myasthenia gravis treated by acetylcholinesterase inhibitors: The lowest dose leading to effective anaesthesia should be used.
Danish: Patienter med myasthenia gravis, der behandles med acetylcholinesterasehæmmere: Der bør anvendes den laveste dosis, der resulterer i effektiv anæstesi.
English: Not known Conduction disorders (atrioventricular block)
Danish: Ledningsforstyrrelser (atrioventrikulært blok)
English: • medicines used for migraine attacks (such as methysergide or ergotamine);
Danish: • lægemidler mod migræneanfald (f.eks. methysergid eller ergotamin)
English: nortriptyline, maprotiline and protriptyline);
Danish: imipramin, nortriptylin, maprotilin og protriptylin)
English: Other medicines and X / Y
Danish: Brug af anden medicin sammen med X/Y
English: In children aged 4 years (or from 20 kg (44 lbs) of body weight) and above, the maximum dose of articaine is 7 mg/kg only with an absolute maximum dose of 385 mg articaine for a healthy child of 55 kg body weight.
Danish: Hos børn i alderen 4 år (eller fra 20 kg) og derover er den maksimale dosis 7 mg/kg med en absolut maksimal dosis articain på 385 mg til et raskt barn på 55 kg.
English: 10 DATE OF REVISION OF THE TEXT [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: Ptosis
Danish: Ptose
English: The anaesthetic duration of articaine 40 mg/mL with adrenaline 1: 200 000 is of 45 to 60 minutes for pulpal anaesthesia and 120 to 300 minutes for soft tissue anaesthesia.
Danish: Anæstetisk varighed af articain 40 mg/ml med adrenalin 1: 200 000 er på 45 til 60 minutter for pulpal anæstesi og 120 til 300 minutter for anæstesi i blødvæv.