FrancophonIA/ELRC3.0 huggingface dataset:
English: As the absence of pain is related to the patient individual sensibility, the lowest dose of anaesthetic leading to effective anaesthesia should be used.
Danish: Da fravær af smerte er afhængig af, hvor følsom den individuelle patient er, skal den laveste dosis anæstetika, der giver effektiv bedøvelse, anvendes.
English: CYP1A2 inhibitors
Danish: CYP1A2-hæmmere
English: Sodium hydroxide (for pH-adjustment) Water for injection
Danish: Natriumhydroxid (til justering af pH-værdien) Vand til injektionsvæsker
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of mepivacaine (see section 4.8).
Danish: Der kan opstå svimmelhed (herunder vertigo, synsforstyrrelser og træthed) efter administration af mepivacain (se pkt.
English: Mepivacaine hydrochloride dose (mg)
Danish: Dosis af mepivacainhydrochlorid (mg)
English: Loss of consciousness and the onset of generalized seizures may be preceded by premonitory symptoms such as joint and muscle stiffness, or twitching.
Danish: Bevidstløshed og generaliserede anfald kan forudgås af forvarslingssymptomer såsom led- og muskelstivhed eller trækninger.
English: The clearance of mepivacaine may be reduced when associated with propranolol and it may result in higher serum concentrations of the anaesthetic.
Danish: Mepivacains clearance kan blive reduceret, når det administreres med propranolol, og det kan resultere i højere serumkoncentrationer af bedøvelsesmidlet.
English: Each ml contains 0.11 mmol of sodium (2.467 mg/ml).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver ml indeholder 0,11 mmol natrium (2,467 mg/ml).
English: Risk associated with an accidental intravascular injection Accidental intravascular injection (e.g.: inadvertent intravenous injection into the systemic circulation, inadvertent intravenous or intra-arterial injection in the head area and neck area) may be associated with severe adverse reactions, such as convulsions, followed by central nervous system or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest, due to the sudden high level of mepivacaine in the systemic circulation.
Danish: Utilsigtet intravaskulær injektion (f.eks. utilsigtet intravenøs injektion i det systemiske kredsløb, utilsigtet intravenøs eller intraarteriel injektion i hoved eller halsområdet) kan være forbundet med alvorlige bivirkninger, såsom kramper, efterfulgt af CNS- eller kardiorespiratorisk depression og koma, der ultimativt kan udvikle sig til respirationsophør, på grund af det pludseligt høje niveau af mepivacain i det systemiske kredsløb.
English: Equivalent* in cartridge numbers (1.7 ml)
Danish: Svarer i* antal cylinderampuller (1,7 ml) til
English: − restlessness, agitation;
Danish: − rastløshed, agitation
English: 4.1 Therapeutic indications {Scandonest and associated names (see Annex I) strength pharmaceutical form} is a local anaesthetic indicated for the local and loco-regional anaesthesia in dental surgery in adults, adolescents and children above 4 years of age (c.a.
Danish: 4.1 Terapeutiske indikationer {Scandonest og relaterede navne (se bilag I) styrke lægemiddelform} er et lokalanalgetikum, der er indiceret til lednings- og infiltrationsanalgesi ved tandindgreb hos voksne, unge og børn over 4 år (kropsvægt på ca. 20 kg).
English: Dysphonia (Hoarseness1)
Danish: Dysfoni (hæshed1)
English: hypoesthesia, dysesthesia, hyperesthesia, etc) of the lips, tongue and oral tissues.
Danish: paræstesi, hypoæstesi, dysæstesi, hyperæstesi, osv.) af læber, tunge og orale væv.
English: As a precautionary measure, it is preferrable to avoid the use of this product during pregnancy, unless necessary.
Danish: Som en sikkerhedsforanstaltning bør dette produkt så vidt muligt ikke anvendes til gravide.
English: The following symptoms may be signs of toxicity due to excessive doses of local anaesthetics: agitation, a sensation of numbness in the lips and tongue, prickling and tingling around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears, muscle stiffness and twitching, low blood pressure, low or irregular heart rate.
Danish: De følgende symptomer kan være tegn på toksicitet på grund af ekstremt høje doser af lokalbedøvende midler: ophidselse, følelsesløshed i læberne og tungen, stikkende og prikkende fornemmelse omkring munden, svimmelhed, synsforstyrrelser og høreforstyrrelser, summen i ørerne, muskelstivhed og muskeltrækninger, lavt blodtryk, langsomt eller uregelmæssig hjerteslag.
English: Mepivacaine has a rapid onset, a high potency of anaesthesia and a low toxicity.
Danish: Mepivacains virkning indtræder hurtigt, anæstesistyrken er høj og toksiciteten lav.
English: Dizziness (including a feeling of “spinning”, vision disorder and fatigue), loss of consciousness may occur following administration of this medicine (see section 4).
Danish: Svimmelhed (herunder en følelse af at det hele drejer rundt, synsforstyrrelse og træthed) og bevidstløshed kan forekomme efter indgivelse af dette lægemiddel (se punkt 4).
English: The cartridges are intended for single use.
Danish: Ampullerne er beregnet til engangsbrug.
English: Patients with cardiovascular disorders: - Peripheral vascular disease, - Arrhythmias particularly of ventricular origin, - Atrio-ventricular conduction disorders, - Heart failure,
Danish: - perifer vaskulær sygdom - arytmi, navnlig af ventrikulær oprindelse - atrioventrikulære ledningsforstyrrelser - hjertesvigt - hypotension
English: Sodium chloride, sodium hydroxide (for pH-adjustment),water for injection.
Danish: Natriumchlorid, natriumhydroxid (til justering af pH), vand til injektionsvæsker.
English: Mepivacaine reversibly inhibits the conduction of nerve impulses by decreasing or blocking sodium (Na+) flow during propagation of the nerve action potential.
Danish: Mepivacain fremkalder reversibel blokade af impulsledningen i nervefibre ved at hæmme indstrømningen af natriumioner (Na+) gennem nervecellemembranens natriumkanaler.
English: Not known Myocardial depression
Danish: Myokardiedepression
English: Mepivacaine should be administered with caution in patients with impaired cardiac function since they may be less able to compensate or worsen changes due to prolongation of atrio-ventricular conduction.
Danish: Mepivacain skal administreres med forsigtighed hos patienter med nedsat hjertefunktion, da de har vanskeligere ved at kompensere for ændringer, eller da det kan forværre ændringer, på grund af forlænget AV-overledning.
English: Equivalent* in cartridge numbers (2.2 ml)
Danish: Svarer i* antal cylinderampuller (2,2 ml) til
English: Mepivacaine is an amide local anaesthetic.
Danish: Mepivacain er et lokalanæstetikum af amidtypen.
English: If a rapid intravascular injection is administered, a high blood concentration of mepivacaine in the coronary arteries may lead to myocardial failure, possibly followed by cardiac arrest, before the CNS is affected.
Danish: Hvis der foretages en hurtig intravaskulær injektion, kan en høj plasmakoncentration af mepivacain i kranspulsårerne føre til myokardieinfarkt eventuelt efterfulgt af hjertestop inden centralnervesystemet påvirkes.
English: Do not throw away any medicines via wastewater or household.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Do not use this medicine after the expiry date, which is stated on the cartridge label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Elimination can be accelerated by acidifying the urine (See section 4.9).
Danish: Elimination kan accelereres ved at gøre urinen mere sur (se pkt.
English: − excessive sweating;
Danish: − overdreven svedtendens
English: Diplopia (paralysis of oculomotor muscles)
Danish: Diplopi (lammelse af de extraokulære muskler) Amaurose (blindhed)
English: The lowest dose leading to efficient anaesthesia should be used.
Danish: Den laveste dosis, der resulterer i effektiv bedøvelse, bør anvendes.
English: − ear disturbances, such as ringing in the ears, oversensitivity of hearing;
Danish: − øreforstyrrelser, såsom ringen i ørerne, lydoverfølsomhed
English: What X contains
Danish: X indeholder:
English: Confusional state, disorientation Speech disorder3 (e.g., dysarthria, logorrhea)
Danish: Forvirring, desorientering Taleforstyrrelse3 (f.eks., dysartri, logorrhea) Rastløshed/agitation3
English: Cardiovascular symptoms occur at plasma levels exceeding those inducing CNS toxicity and are therefore generally preceded by signs of CNS toxicity, unless the patient is under general anaesthesia or is heavily sedated (e.g. by a benzodiazepine or barbiturate).
Danish: CNS-toksicitetstegns indtræffer derfor generelt først med mindre patienten er under fuld narkose eller stærkt sederet (f.eks. med benzodiazepiner eller barbiturater).
English: The cartridges are for single use.
Danish: Ampullerne er til engangsbrug.
English: Not Known Ear discomfort Tinnitus
Danish: Ubehag i øret Tinnitus Hyperacusis
English: − rash, itching, swelling of the face, lips, gums, tongue and/or throat and difficulty breathing,
Danish: − udslæt, kløe, hævelse af ansigt, læber, tandkød, tunge og/eller halsen og åndedrætsbesvær,
English: Mepivacaine must be used safely and effectively under appropriate conditions: The local anaesthetic effects may be reduced when {Scandonest and associated names} is injected into an inflamed or infected area.
Danish: Den lokalbedøvende virkning kan være nedsat, hvis {Scandonest og relaterede navne} injiceres i inflammerede eller inficerede områder.
English: Caution is advised when associating the product of interest with these medications as dizziness may last longer (see section 4.7.
Danish: Det anbefales at udvise forsigtighed ved brug af dette produkt sammen med disse hæmmere, da svimmelhed kan vare længere (se pkt.
English: − impaired sense of balance (disequilibrium);
Danish: − svækket balanceevne (uligevægt)
English: − nerve injury.
Danish: − nerveskade.
English: Package leaflet: Information for the patient {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Danish: Indlægsseddel: Information til brugeren {Scandonest og relaterede navne (Se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
English: Mepivacaine is metabolized by the liver and can lead to elevated plasma levels in patients with hepatic impairment, in particular after repeated use.
Danish: Mepivacain metaboliseres i leveren og kan især efter gentagen injektion føre til forhøjede plasmaniveauer hos patienter med nedsat leverfunktion.
English: 50 x 2.2 ml cartridges
Danish: 50 x 2,2 ml ampuller
English: − dizziness (lightheadedness);
Danish: − svimmelhed (uklarhed)
English: Therefore, as a precautionary measure, it is preferable to avoid the use of mepivacaine during pregnancy, unless necessary.
Danish: Anvendelse af mepivacain bør derfor for en sikkerheds skyld undgås under graviditet og kun anvendes på tvingende indikation.
English: Dysesthesia (oral and perioral), including dysgeusia (e.g., taste metallic, taste distorted), ageusia Dizziness (light headedness) Tremor3
Danish: Hypoæstesi/følelsesløshed (oral og perioral) Dysæstesi (oral og perioral), herunder dysgeusi (f.eks. metalsmag, smagsforstyrrelse), ageusi Svimmelhed (uklarhed)
English: Sedatives (central nervous system depressants)
Danish: Sedativa (CNS-depressiva)
English: 50 x 1.7 ml cartridges
Danish: 50 x 1,7 ml ampuller
English: Discard unused solution.
Danish: Bortskaf ikke anvendt opløsning.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains 30 mg of mepivacaine hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml injektionsvæske, opløsning indeholder 30 mg mepivacainhydrochlorid.
English: Initial symptoms include agitation, a feeling of intoxication, a sensation of numbness in the lips and tongue, paraesthesia around the mouth, dizziness, visual and hearing disturbances, and buzzing in the ears.
Danish: De første symptomer omfatter agitation, følelse af at være beruset, følelsesløshed i læber og tunge, cirkumoral paræstesi, svimmelhed, syns- og høreforstyrrelser samt tinnitus.
English: NAME OF THE MEDICINAL PRODUCT {Scandonest and associated names (see Annex I) strength pharmaceutical form} [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN {Scandonest og relaterede navne (se bilag I) styrke lægemiddelform} [Se bilag I - Udfyldes nationalt]
English: Common Headache Rare
Danish: Sjælden Kvalme Opkastning
English: Visual impairment Vision blurred
Danish: Sjælden Synsforstyrrelse Sløret syn
English: − loss of consciousness, fit (convulsion), coma;
Danish: − bevidsthedstab, krampeanfald (kramper), koma
English: − swelling of the mouth, lips, tongue and gums, high saliva production;
Danish: − hævelse af munden, læberne, tungen og tandkødet, høj spytdannelse
English: Apnoea (respiratory arrest) Yawning
Danish: Apnø (åndedrætsanfald) Gaben
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN [Se bilag I - Udfyldes nationalt]
English: The drug administration to the patient should take place immediately after the opening of the cartridge.
Danish: Indgivelse af lægemiddel til patienten skal finde sted umiddelbart efter åbningen af cylinderampullen.
English: Marketing Authorisation Holder [See Annex I - To be completed nationally]
Danish: Indehaver af markedsføringstilladelsen [Se bilag I - Udfyldes nationalt]
English: Injection site pain
Danish: Smerter ved injektionsstedet
English: Very rare Hypertension Not known Vasodilatation Local/ Regional hyperaemia
Danish: Vasodilation Lokal/regional hyperæmi
English: Thus, to ensure that the needle does not penetrate a blood vessel during injection, aspiration should be performed before the local anaesthetic product is injected.
Danish: Der skal således foretages aspiration før injektion af lokalanalgetika for at sikre, at kanylen ikke penetrerer et blodkar under injektionen.
English: Patients with a hepatic disease: The lowest dose leading to efficient anaesthesia should be used.
Danish: Patienter med leversygdom: Den laveste dosis, der resulterer i effektiv bedøvelse, bør anvendes.
English: Anaphylatic / anaphylactoid reactions Angioedema (Face / tongue / lip / throat / larynx1 / periorbital oedema) Bronchospasm / asthma2
Danish: Sjælden Overfølsomhed Anafylatiske/anafylaktoide reaktioner Angioødem (ansigt/tunge/læbe/svælg/strubehoved1/periorbitalt ødem)
English: INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
Danish: <Fritaget fra krav om brailleskrift.>
English: Patients with a kidney disease: The lowest dose leading to efficient anaesthesia should be used.
Danish: Patienter med nyresygdom: Den laveste dosis, der resulterer i effektiv bedøvelse, bør anvendes.
English: Horner's syndrome), dilated pupil, the posterior displacement of the eyeball within the orbit due to changes in the volume of the orbit (called Enophthalmos), doubled vision or vision loss;
Danish: − ufrivillige øjenbevægelser, øjenproblemer såsom forsnævring af pupillen, hængende øjenlåg (som ved Horners syndrom), udvidet pupil, tilbagesynken af øjet i øjenhulen som følge af ændringer i øjenhulens volumen (også kaldet Enoftalmus), dobbeltsyn eller synstab
English: − feeling sick, vomiting, mouth or gum ulcers, swelling of tongue, lips or gums;
Danish: − kvalme, opkastning, mund- eller tandkødssår, hævelse af tungen, læberne eller tandkødet,
English: Each cartridge of 2.2 ml of solution for injection contains 66 mg of mepivacaine hydrochloride.
Danish: Hver cylinderampul på 2,2 ml injektionsvæske, opløsning indeholder 66 mg mepivacainhydrochlorid.
English: The medicine administration should take place immediately after the opening of the cartridge.
Danish: Indgivelse af lægemidlet skal finde sted umiddelbart efter åbningen af ampullen.
English: − quick or difficult breathing, drowsiness, headache, inability to think and sleepiness, which may be the signs of a high concentration of carbon dioxide in your blood (hypercapnia);
Danish: − hurtig eller svær vejrtrækning, døsighed, hovedpine, manglende evne til at tænke og søvnighed,
English: Tachypnea
Danish: Takypnø
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml for solution for injection contains 30 mg of mepivacaine hydrochloride .
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml injektionsvæske, opløsning indeholder 30 mg mepivacainhydrochlorid.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) [Se bilag I - Udfyldes nationalt]
English: Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
Danish: Hver cylinderampul på 1,7 ml injektionsvæske, opløsning indeholder 51 mg mepivacainhydrochlorid.
English: Conduction disorders (atrioventricular block)
Danish: Ledningsforstyrrelser (AV-blok) Takykardi
English: X should only be used by or under the supervision of dentists, stomatologists or other, trained clinicians by a slow local injection.
Danish: Kun tandlæger og stomatologer (specialist i mundsygdomme) er uddannede i at indgive X via langsom lokal indsprøjtning.
English: Enophthalmos
Danish: Enoftalmus
English: Gingival / oral mucosal exfoliation (sloughing) / ulceration Swelling of tongue, lip, gums Not known Stomatitis, glossitis, gingivitis Salivary hypersecretion
Danish: Gingival/oral slimhindeafstødning (Sårdannelse)/ulceration Hævelse8 af tungen, læberne, tandkødet
English: Not Known Euphoric mood Anxiety/Nervousness3
Danish: Euforisk stemning Angst/nervøsitet3
English: Ask your dentist, doctor or pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] INSTRUCTIONS ON USE
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING [Udfyldes nationalt]
English: Rash (eruption)
Danish: Sjælden Udslæt (udbrud) Erytem
English: - If you have any further questions, ask your doctor, dentist or pharmacist.
Danish: - Spørg lægen, tandlægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: Local anaesthetics should be injected with caution when there is inflammation and/or infection at the site of the injection.
Danish: Hvis der er inflammation og/eller infektion ved injektionsstedet, skal injektion af lokalanæstetika foretages med forsigtighed.
English: − changes in the color of your skin with confusion, cough, fast heart rate, rapid breathing, sweating: this might be symptoms of a deficiency of oxygen in your tissues (hypoxia);
Danish: − ændringer af hudfarve ledsaget af forvirring, hoste, hurtige hjerteslag, hurtig vejrtrækning,
English: 5 mostly in patients with underlying cardiac disease or those receiving certain drugs; 6 in predisposed patients or those with risk factors of ischemic heart disease; 7 hypoxia and hypercapnia are secondary to respiratory depression and / or to seizures and sustained muscular exertion; 8 by accidental biting or chewing of the lips or tongue while the anaesthesia persists.
Danish: 7 Hypoksi og hyperkapni er sekundære til respiratorisk depression og/eller kramper og vedvarende anspændte muskler.
English: Swelling face
Danish: Hævelse af ansigt
English: − heartbeat coordination problems (conduction disorders, atrioventricular block), abnormal slow heartbeat (bradycardia), abnormal rapid heartbeat (tachycardia), palpitations;
Danish: unormalt langsom hjerterytme (bradykardi), unormalt hurtig hjerterytme (takykardi), hjertebanken
English: − failure of the heart to contract effectively (cardiac arrest), rapid and erratic heartbeats (ventricular fibrillation), severe and crushing chest pain (angina pectoris);
Danish: svære og knusende brystsmerter (angina pectoris)
English: 1 laryngo-pharyngeal oedema may characteristically occur with hoarseness and/or dysphagia; 2 bronchospasm (bronchoconstriction) may characteristically occur with dyspnoea; 3 several adverse events, like agitation, anxiety / nervousness tremor, speech disorder may be warning signs before CNS depression.
Danish: 3 Flere bivirkninger, såsom agitation, angst/nervøs tremor, taleforstyrrelse kan være advarselstegn på
English: Local swelling Injection site swelling Not known Chest pain Fatigue, asthenia (weakness) Feeling hot
Danish: Træthed, asteni (svaghed) Varmefornemmelse
English: − fainting;
Danish: − rysten,
English: − muscle twitching;
Danish: − muskeltrækninger
English: Bradyarrhythmia
Danish: Hypertension
English: − a feeling of spinning (vertigo);
Danish: − en følelse af at det hele drejer rundt (svimmelhed)
English: Neuropathy4 :
Danish: Almindelig Hovedpine Sjælden Neuropati4 :
English: Bioavailability
Danish: Biotransformation
English: What X looks like and contents of the pack
Danish: Udseende og pakningstørrelser
English: Not known Nystagmus
Danish: Sjælden Vertigo Ikke kendt
English: Nausea
Danish: − sløvhed
English: - The active substance is mepivacaine hydrochloride 30 mg/ml; Each cartridge of 1.7 ml of solution for injection contains 51 mg of mepivacaine hydrochloride.
Danish: Hver cylinderampul med 1,7 ml injektionsvæske, opløsning indeholder 51 mg mepivacainhydrochlorid.
English: Ref. EMEA/CHMP/319054/2008
Danish: : EMEA/CHMP/319054/2008
English: All five medicines are authorised by regulatory authorities in Member States.
Danish: Alle fem lægemidler er godkendt af registreringsmyndighederne i medlemsstaterne.
English: London, 26 June 2008 Doc.
Danish: London, den 26. juni 2008 Dok.ref.
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Danish: Artikel 31 i direktiv 2001/83/EF, med senere ændringer, indbringelse af interesse for Fællesskabet.
English: • Patients or their carers who have any questions or concerns should speak to their doctor or pharmacist.
Danish: • Patienter eller plejepersonale, som har spørgsmål eller betænkeligheder, skal henvende sig til deres læge eller apoteket.
English: They have been available on the market for many years and are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Danish: De har været tilgængelige på markedet i mange år og anvendes primært til behandling af Parkinsons sygdom, enten alene eller i kombination med andre lægemidler.
English: There was not enough information available to allow the Committee to recommend a similar contraindication for lisuride.
Danish: Der forelå ikke tilstrækkelig dokumentation for, at udvalget kunne anbefale en sådan kontraindikation for lisurid.
English: • a reduction of the maximum recommended dose to 3 mg per day;
Danish: • en nedsættelse af den anbefalede maksimale dosis til 3 mg/dag
English: However, restrictions on the way these medicines are used should be introduced, to reduce the risk of fibrosis developing.
Danish: Der bør imidlertid indføres begrænsninger for anvendelsen af disse lægemidler med henblik på at nedsætte risikoen for, at der udvikles fibrose.
English: When it affects the heart valves, it can lead to problems with the flow of blood around the heart and, eventually, heart failure (an inability of the heart to pump enough blood around the body).
Danish: Når det rammer hjerteklapperne, kan det medføre problemer med kredsløbet omkring hjertet og i sidste ende hjertesvigt (når hjertet ikke kan pumpe tilstrækkeligt blod rundt i kroppen).
English: This review was carried out under an ‘Article 31' referral1.
Danish: Vurderingen blev gennemført inden for rammerne af en indbringelsesprocedure i henhold til artikel 31