FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommended therapeutic dose:
Danish: Anbefalet terapeutisk dosis:
English: The higher risk of bleeding is more associated with the procedure, rather than with the medicine.
Danish: Den højere risiko for blødning er snarere forbundet med indgrebet end med lægemidlet.
English: The injection rate shall be very slow (1 ml/min).
Danish: Injektionshastigheden skal være meget langsom (1 ml/min).
English: This property could be beneficial when the use of vasoconstrictor is contraindicated.
Danish: Denne egenskab kan være nyttig, når anvendelsen af en vasokonstriktor er kontraindiceret.
English: Children should be given doses commensurate with age and weight.
Danish: Børn bør gives doser, der svarer til deres alder og vægt.
English: However, considering the lack of data for mepivacaine, a risk to the newborns/infants cannot be excluded.
Danish: I betragtning af de manglende data for mepivacain kan det dog ikke udelukkes, at der er en risiko for nyfødte/spædbørn.
English: Elderly patients: Dosages should be reduced in elderly patients (due to lack of clinical data).
Danish: Ældre patienter: Dosis bør reduceres hos ældre patienter (på grund af manglende kliniske data).
English: The bioavailability is 100% at the action site.
Danish: Biotilgængelighed Biotilgængeligheden er 100 % på virkningsstedet.
English: One or more of the following side effects may occur following administration of X.
Danish: Der kan opstå en eller flere af følgende bivirkninger efter indgivelse af X.
English: Concomitant use of sedatives to reduce patient anxiety:
Danish: Samtidig brug af sedativa til nedsættelse af patientens angst:
English: Possible side effects (frequency cannot be estimated from the available data):
Danish: Mulige bivirkninger (hyppigheden kan ikke estimeres ud fra forhåndenværende data):
English: In case of relative overdose, patients generally present symptoms within 1-3 minutes.
Danish: I tilfælde af relativ overdosering ses der generelt symptomer inden for 1-3 minutter.
English: Unused solution must be discarded.
Danish: Ikke anvendte opløsning skal bortskaffes.
English: They may also result from hypersensitivity, idiosyncrasy, or diminished tolerance by patient.
Danish: De kan også skyldes overfølsomhed, idiosynkrasi eller nedsat tolerans hos patienten.
English: They will determine the appropriate dose taking into account the procedure, your age, your weight and your general health.
Danish: De bestemmer den passende dosis under hensyntagen til indgrebet, din alder, din vægt og dit generelle helbred.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet.
English: Epileptic patients:
Danish: Epileptiske patienter:
English: X is a local anaesthetic, which numbs a particular region to prevent or minimize pain.
Danish: X er et lokalbedøvelsesmiddel, som bedøver et bestemt område for at forhindre eller minimere smerte.
English: CNS toxicity occurs gradually, with symptoms and reactions of progressively increasing severity.
Danish: CNS toksicitet forekommer gradvist med symptomer og reaktioner med gradvist stigende sværhedsgrad.
English: Metabolites are excreted in the urine with less than 10% of unchanged mepivacaine.
Danish: Udskillelse af metabolitter sker i urinen med mindre end 10 % af uforandret mepivacain.
English: − low blood pressure;
Danish: − lavt blodtryk
English: The total dose of administered mepivacaine should not exceed the maximum recommended dose.
Danish: Den samlede dosis af administreret mepivacain må ikke overstige den maksimale anbefalede dosis.
English: This is equivalent to 1.23 % of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,23 % af det anbefalede maksimale daglige indtag af natrium til en voksen.
English: The cartridges should under no circumstance be dipped into any solution whatsoever.
Danish: Ampullerne må under ingen omstændigheder dyppes i nogen som helst opløsning.
English: − abnormal sensation in and around the mouth (hypoesthesia);
Danish: − unormal følelse i og omkring munden (hypoæstesi)
English: Caution should be taken in all patients with porphyria, as this medicinal product may trigger porphyria.
Danish: Der skal udvises forsigtighed hos alle patienter med porfyri, da dette lægemiddel kan udløse porfyri.
English: In severe cases, respiratory arrest may occur.
Danish: Respirationsstop kan forekomme i alvorlige tilfælde.
English: This medicine does not require any special storage condition.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaring.
English: Types of overdose
Danish: Typer af overdosering
English: Cimetidine reduces the clearance of mepivacaine.
Danish: Cimetidin reducerer clearance af mepivacain.
English: Clearance of amides is dependent on hepatic blood flow.
Danish: Clearance af amider afhænger af den hepatiske blodgennemstrømning.
English: Patients with porphyria {Scandonest and associated names} should only be used to patients with acute porphyria when no safer alternative is available.
Danish: Patienter med porfyri: {Scandonest og relaterede navne} må kun anvendes til patienter med akut porfyri, når der ikke findes et mere sikkert alternativ.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, dentist or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, tandlæge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
English: Should cardiac arrest occur, a successful outcome may require prolonged resuscitative efforts.
Danish: Hvis der forekommer hjertestop, kan det være nødvendigt med en længerevarende, genoplivende indsats for at opnå et succesfuldt resultat.
English: When a dental peripheral nerve block is performed, mepivacaine effect occurs rapidly (generally within 3 to 5 minutes).
Danish: Ved anlæggelse af en dental perifer nerveblokade indtræder mepivacains virkning hurtigt (normalt inden for 3 til 5 minutter).
English: Manifestation of these effects during injection of the product is a warning signal and the injection should be stopped immediately.
Danish: Tegn på disse virkninger under injektion af produktet er et advarselssignal og injektionen skal omgående afbrydes.
English: The maximum plasma level of mepivacaine is achieved approximately after 30-60 minutes.
Danish: Mepivacains maksimale plasmakoncentration opnås efter ca. 30-60 minutter.
English: Mepivacaine must be used with caution in:
Danish: Mepivacain skal anvendes med forsigtighed til:
English: Risk associated with intraneural injection
Danish: Risiko forbundet med intraneural injektion
English: SN: {number}
Danish: PC: {nummer} SN: {nummer} NN: {nummer}
English: This medicine is a clear and colourless solution.
Danish: Dette lægemiddel er en klar og farveløs opløsning.
English: − confusion, disorientation;
Danish: − forvirring, desorientering
English: − altered voice (hoarseness);
Danish: − ændret stemme (hæshed)
English: Seizures may last from a few seconds to several minutes and rapidly lead to hypoxia and hypercapnia, as a result of increased muscular activity and insufficient ventilation.
Danish: Anfald kan vare fra få sekunder til flere minutter og hurtigt føre til hypoxi og hyperkapni på grund af den øgede muskelaktivitet og utilstrækkelig ventilation.
English: The patient's state of consciousness should be monitored after each local anaesthetic injection.
Danish: Patientens bevidsthedsstatus skal overvåges efter hver injektion af lokalanæstetika.
English: * Rounded to the nearest half-cartridge
Danish: * Afrundet til nærmeste halve cylinderampul
English: Whereas in case of absolute overdose, signs of toxicity, depending on the injection site, appear about 20-30 minutes after the injection.
Danish: Hvorimod der i tilfælde af absolut overdosering forekommer tegn på toksicitet ca. 20-30 minutter efter injektionen afhængigt af injektionsstedet.
English: X contains sodium
Danish: X indeholder natrium
English: Do not use X: - If you are allergic to mepivacaine or any of the other ingredients of this medicine (listed in section 6); - if you are allergic to other local anaesthetics of the same group (e.g. lidocaine, bupivacaine); - If you suffer from:
Danish: Brug ikke X: - hvis du er allergisk over for mepivacain eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6) - hvis du er allergisk overfor andre lokalbedøvelsesmidler af samme gruppe (fx lidokain, bupivacain) - Hvis du lider af:
English: If any of these situations applies to you, tell your dentist.
Danish: Hvis nogen af disse situationer gælder for dig, skal du tale med din tandlæge.
English: − speech disturbances, excessive talkativeness;
Danish: − taleforstyrrelser, overdreven taletrang
English: The rate of injection should not exceed 1 ml of solution per minute.
Danish: Injektionshastigheden må ikke overstige 1 ml opløsning pr. minut.
English: This medicine may have a minor influence on the ability to drive and use machines.
Danish: Dette lægemiddel kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: These data originated in post-marketing reports, mostly following nerve blocks in mandible, involving various branches of the trigeminal nerve;
Danish: Disse data stammer fra rapporter efter markedsføring hovedsagelig efter nerveblokade i kæben, der involverede forskellige grene af nervus trigeminus.
English: These plasmatic concentrations are well below the threshold of CNS and CVS toxicity, respectively 10 to 25 fold lower.
Danish: Disse plasmakoncentrationer ligger langt under grænsen for CNS- og CVS-toksicitet, henholdsvis 10 til 25 gange lavere.
English: Undesirable toxic effects may appear at plasma concentrations upper than 5 mg/l, and convulsions could appear with 10 mg/l or higher.
Danish: Uønskede toksiske virkninger kan forekomme ved plasmakoncentrationer på over 5 mg/l, og kramper kan forekomme ved 10 mg/l eller højere.
English: The ratio of the average plasma levels following one and two cartridges were approximately 50%, evidencing a dose proportionality at these dose levels.
Danish: Ratioen for de gennemsnitlige plasmaniveauer efter en og to ampuller var ca. 50 %, dvs. at der dosisproportionalitet ved disse dosisniveauer.
English: Contains sodium, see package leaflet for further information.
Danish: Indeholder natrium, se indlægssedlen for yderligere information.
English: Higher concentrations are found in highly perfused tissues such as liver, lungs, heart and brain.
Danish: Der findes højere koncentrationer i højt perfunderede væv, såsom lever, lunger, hjertet og hjernen.
English: Caution should be used in case of acidosis such as worsened of renal insufficiency or poorly control of type 1 diabetes mellitus.
Danish: Der skal udvises forsigtighed i tilfælde af acidose, såsom forværring af nyreinsufficiens eller dårlig kontrolleret type 1 diabetes mellitus.
English: Elimination can be accelerated by acidifying the urine.
Danish: Elimination kan accelereres ved forsuring af urinen.
English: Dialysis is not effective in treating an overdose of Mepivacaine.
Danish: Dialyse er ikke en effektiv behandling af en overdosering med mepivacain.
English: What you need to know before you use X
Danish: Det skal du vide, før du begynder at bruge X
English: If signs of acute systemic toxicity appear, injection of the local anaesthetic should be stopped immediately.
Danish: Hvis der opstår tegn på akut systemisk toksicitet, skal injektionen af lokalanæstetikum straks stoppes.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført iAppendix V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are of vital importance.
Danish: Optimal iltning og ventilation og kredsløbsunderstøttende behandling samt behandling af acidose er yderst vigtigt.
English: Caution should be exercised when mepivacaine is administered concomitantly with propranolol.
Danish: Der bør udvises forsigtighed, når mepivacain administreres samtidigt med propranolol.
English: H2 antihistaminics (cimetidine)
Danish: H2-antihistamerner (cimetidin)
English: In vitro and in vivo testing carried out on mepivacaine hydrochloride did not reveal any genotoxic effect of this product.
Danish: In vitro og in vivo test på mepivacainhydrochlorid viste ingen genotoksisk virkning af dette produkt.
English: Balance disorder (disequilibrium) Somnolence
Danish: Balanceforstyrrelse (uligevægt) Somnolens
English: − widening of blood vessels (vasodilatation);
Danish: − udvidelse af blodårerne (vasodilatation)
English: Concomitant use of the other medicinal products may require thorough monitoring (see section 4.5).
Danish: Samtidig anvendelse af andre lægemidler kan kræve nøje monitorering (se pkt.
English: The frequencies classification follows the convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000) and Very rare (<1/10,000).
Danish: < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (<
English: The medicinal product should only be used by or under the supervision of dentists, stomatologists or other clinicians sufficiently trained and familiar with diagnosis and treatment of systemic toxicity.
Danish: Lægemidlet må kun anvendes af eller under tilsyn af tandlæger, stomatologer eller andre klinikere, som er tilstrækkeligt uddannet og har kendskab til diagnosticering og behandling af systemisk toksicitet.
English: Not known Hypoxia7 (including cerebral) Hypercapnia7
Danish: Hypoxi7 (herunder cerebral) Hyperkapni7
English: No nursing mothers were included in the clinical studies with {Scandonest and associated names}.
Danish: Der indgik ikke ammende mødre i de kliniske studier med {Scandonest og relaterede navne}.
English: In case a reinjection is required, patient should be monitored, to identify any sign of relative overdose.
Danish: Hvis gentagen injektion er påkrævet, skal patienten overvåges for at identificere tegn på relativ overdosis.
English: If you experience any of these, administration should immediately be stopped and emergency medical assistance should be summoned.
Danish: Hvis du oplever nogen af disse, skal indsprøjtningen straks standses, og der skal opsøges lægehjælp.
English: This medicine is given as an injection in the oral cavity.
Danish: Dette lægemiddel gives som en indsprøjtning i mundhulen.
English: However, the absence of blood in the syringe does not guarantee that intravascular injection has been avoided.
Danish: Fravær af blod i sprøjten kan imidlertid ikke fuldstændig udelukke intravaskulær injektion.
English: The duration of the local anaesthetic is unrelated to the half-life as its action is terminated when the drug is removed from the receptor.
Danish: Varigheden af bedøvelsesmidlet er ikke forbundet med halveringstiden, eftersom virkningen ophører, når lægemidlet fjernes fra receptoren.
English: Overdose of local anaesthetics may be absolute, resulting from the injection of excessive doses, or relative, resulting from the injection of a normally non-toxic dose under particular circumstances.
Danish: Overdosering på grund af lokalanæstetika kan være absolut, som følge af injektion af ekstremt høje doser, eller relativ, som følge af injektion af en normal ikke-toksisk dosis under særlige omstændigheder.
English: − breathing difficulties such as shortness of breath, abnormally slow or very rapid breathing;
Danish: − vejrtrækningsproblemer såsom stakåndethed, unormalt langsom eller meget hurtig vejrtrækning
English: The quantity to be injected should be determined by the age and weight of the child and the magnitude of the operation.
Danish: Den injicerede mængde skal baseres på barnets alder og vægt samt indgrebets kompleksitet.
English: X with food
Danish: Brug af X sammen med mad
English: Over 50% of a dose is excreted as metabolites into the bile but these probably undergo entero-hepatic circulation as only small amounts appear in the faeces.
Danish: Over 50 % af en dosis udskilles som metabolitter i galden, men disse gennemgår sandsynligvis enterohepatisk cirkulation, eftersom kun små mængder forekommer i fæces.
English: Acidosis exacerbates the toxic effects of local anaesthetics.
Danish: Acidose forværrer de toksiske virkninger af lokalanæstetika.
English: Presyncope, syncope;
Danish: Præsynkope, synkope;
English: • Heart disorders due to the abnormality of the electronic impulse triggering the heart beat (severe conduction disturbances);
Danish: • hjertesygdomme som følge af en abnormitet i den elektroniske impuls, der udløser hjerteslag (alvorlige ledningsforstyrrelser)
English: Box containing 50 cartridges.
Danish: Æske med 50 ampuller.
English: Deep CNS depression:
Danish: Dyb CNS-depression:
English: Clinical studies were not performed in pregnant women and no cases of pregnant women injected with mepivacaine 30 mg/ml were reported in the literature.
Danish: Der er ikke udført kliniske forsøg hos gravide, og litteraturen indeholder ingen tilfælde af gravide kvinder, som er blevet injiceret med mepivacain 30 mg/ml.
English: Mepivacaine binds to plasmatic proteins up to around 75% and can cross placental barrier by simple diffusion.
Danish: Mepivacain har en plasmaproteinbinding på op til omkring 75 % og kan passere placentabarrieren ved simpel diffusion.
English: These include inadvertent intravascular injection or abnormal rapid absorption into the systemic circulation, or delayed metabolism and elimination of the product.
Danish: Disse omfatter utilsigtet intravaskulær injektion eller unormal hurtig absorption i det systemiske kredsløb eller forsinket metabolisering og elimination af produktet.
English: Frequency “not known”: “not known (cannot be estimated from the available data)”.
Danish: 1/10.000) og "ikke kendt" (kan ikke estimeres ud fra forhåndenværende data).
English: The availability of appropriate resuscitation equipment and medication and adequately trained staff is recommended before induction of regional anaesthesia with local anaesthetics to enable prompt treatment of any respiratory and cardiovascular emergencies.
Danish: Tilgængeligheden af passende genoplivningsudstyr og medicin samt tilstrækkeligt uddannet personale anbefales inden injektion af lokalanæstetika for at muliggøre hurtig behandling af alle respiratoriske og kardiovaskulære nødsituationer.
English: Skin and subcutaneous tissue Rare
Danish: Hud og subkutane væv
English: For more extensive procedures one or more cartridges may be required, without exceeding the maximum recommended dose.
Danish: Ved mere komplekse indgreb kan der anvendes en eller flere cylinderampuller uden dog at overskride den maksimale anbefalede dosis.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Mepivacaine is metabolised primarily by CYP1A2 enzyme.
Danish: Mepivacain metaboliseres primært af CYP1A2-enzymet.
English: Mepivacaine distribution covers all body tissues.
Danish: Fordelingen af mepivacain dækker alle kropsvæv.
English: Respiratory depression Bradypnoea
Danish: Sjælden Respirationsdepression Bradypnø
English: Delay in proper management of dose-related toxicity, under ventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death.
Danish: Forsinkelse af korrekt behandling af dosisrelateret toksicitet, ventilation uanset årsag og/eller ændret følsomhed kan føre til udvikling af acidose, hjertestop og muligvis død.
English: The plasma half-life is prolonged if the patient is suffering from liver and renal insufficiency.
Danish: Plasmahalveringstiden forlænges, hvis patienten lider af lever- og nyreinsufficiens.
English: General toxicity studies (Single dose toxicity, Repeat-dose toxicity) were performed with mepivacaine demonstrating a good safety margin.
Danish: Generelle toksicitetsstudier (enkelt- eller gentagen dosis) udført med mepivacain viste en god sikkerhedsmargen.
English: Pharmacotherapeutic group: Nervous System/Anaesthetics/Local anaesthetics/Amides/Mepivacaine ATC code: N01 BB 03
Danish: Farmakoterapeutisk klassifikation: Nervesystem/anæstetika/lokalanæstetika/amider/mepivacain ATC-kode: N01 BB 03
English: Patients who are being treated with antiarrhythmic drugs may encounter an accumulation of side effects after the use of mepivacaine due the similarity of structures (such as Class I drug i.e. lidocaine).
Danish: Hos patienter, som behandles med antiarytmika, kan der ske akkumulering af bivirkninger efter anvendelse af mepivacain på grund af den strukturelle lighed (såsom et klasse I-lægemiddel, dvs. lidocain).
English: In order to avoid intraneural injection and to prevent nerve injuries in connection with nerve blockades, the needle should always be slightly withdrawn if electric shock sensation is felt by the patient during injection or if the injection is particularly painful.
Danish: For at undgå intraneural injektion og forhindre nervelæsioner i forbindelse med nerveblokader skal kanylen altid trækkes lidt tilbage, hvis patienten oplever en følelse af elektrisk stød under injektion, eller hvis injektionen er særdeles smertefuld.
English: If cardiovascular depression occurs (hypotension, bradycardia), appropriate treatment with intravenous fluids, vasopressor, and/or inotropic agents should be considered.
Danish: Hvis der forekommer kardiovaskulær depression (hypotension, bradykardi), skal passende behandling med intravenøse væsker, vasopressor og/eller inotrope stoffer overvejes.
English: Tachyarrhythmia (including ventricular extrasystoles and ventricular fibrillation)5
Danish: Takyarytmi (herunder ventrikulære ekstrasystoler og ventrikelflimren)5
English: Precautions to be taken before administering the medicinal product The medicinal product should not be used if cloudy and discoloured.
Danish: Sikkerhedsforanstaltninger, der skal tages, inden administration af lægemidlet Lægemidlet må ikke anvendes, hvis det er uklart og misfarvet.
English: Hypoxaemia and metabolic acidosis may potentiate the cardiovascular toxicity.
Danish: Hypoxæmi og metabolisk acidose kan forstærke den kardiovaskulære toksicitet.
English: Tabulated list of adverse reactions The reported adverse effects come from spontaneous reporting and literature.
Danish: De indberettede bivirkninger stammer fra spontane indberetninger og litteraturen.
English: Very rare side effects (may affect up to 1 in 10,000 people): − high blood pressure.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer): − højt blodtryk.
English: CNS symptoms (convulsions, CNS depression) must promptly be treated with appropriate airway/respiratory support and the administration of anticonvulsant drugs.
Danish: CNS-symptomer (kramper, CNS-depression) skal straks behandles med passende luftvejs/respiratorisk støtte og administration af et krampestillende middel.
English: Hyperhidrosis (sweating or perspiration)
Danish: Hyperhidrose (sved eller transpiration)
English: So, patients should not leave the dental office until they recover their abilities (generally within 30 minutes) following the dental procedure.
Danish: Patienter bør derfor ikke forlade tandlægens klinik, før de har genvundet deres evner (normalt inden for 30 minutter) efter indgrebet.
English: wheezing/asthma, hives (urticaria): these might be symptoms of hypersensitivity reactions (allergic or allergy-like reactions);
Danish: hvæsende vejrtrækning/astma, nældefeber (urticaria): disse kan være symptomer på overfølsomhedsreaktioner (allergiske eller allergilignende reaktioner)
English: − increase of blood flow (hyperaemia);
Danish: − forøgelse af blodgennemstrømning (hyperæmi)