FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 30 mg per 0.5 ml following reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dosis indeholder 30 mg pr. 0,5 ml efter rekonstitution.
English: The efficacy of Eperzan was evaluated in a 52 week, randomised, open-label, multicentre noninferiority study (n = 563).
Danish: Effekten af Eperzan blev vurderet i et randomiseret, ublindet, non-inferioritets-multicenterstudie (N = 563) af 52 ugers varighed.
English: Eperzan 30 mg powder and solvent for solution for injection Eperzan 50 mg powder and solvent for solution for injection
Danish: Eperzan 30 mg pulver og solvens til injektionsvæske, opløsning Eperzan 50 mg pulver og solvens til injektionsvæske, opløsning
English: On background therapy of metformin 1,500 mg daily, Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly after a minimum of 4 weeks) was compared to sitagliptin 100 mg daily, glimepiride 2 mg daily (with optional titration to 4 mg daily), or placebo.
Danish: Med metformin i en dosis på  1.500 mg dagligt som baggrundsbehandling blev Eperzan 30 mg s.c. ugentligt (med valgfri øgning til 50 mg ugentligt efter mindst 4 uger) sammenlignet med 100 mg sitagliptin dagligt, 2 mg glimepirid dagligt (med valgfri øgning til 4 mg dagligt) eller placebo.
English: Difference from placebo + pioglitazoneb (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Danish: Forskel fra placebo + pioglitazonb (95 % CI) a Intent-To-Treat-population - last observation carried forward.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose contains 50 mg per 0.5 ml following reconstitution.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dosis indeholder 50 mg pr. 0,5 ml efter rekonstitution.
English: Patients (%) Achieving HbA1c <7% Body Weight (kg)
Danish: Patienter (%), der opnåede HbA1c < 7
English: Inspect the pen for ‘1' in the number window and expiration date.
Danish: Kontroller udløbsdatoen, og at der står ‘1' i pennens nummervindue.
English: Eperzan is supplied as a pen for self injection.
Danish: Eperzan fås som en pen, hvormed du kan foretage injektionen.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 4 pens
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver og solvens til injektionsvæske, opløsning
English: Results at 52 weeks in a placebo-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to pioglitazone 30 mg daily (with optional titration to 45 mg/day) as add-on therapy in patients inadequately controlled on metformin + sulphonylurea (glimepiride 4 mg daily)
Danish: Resultater efter 52 uger i et placebokontrolleret studie, hvor Eperzan 30 mg s.c. ugentligt (med valgfri øgning til 50 mg ugentligt) blev sammenlignet med 30 mg pioglitazon dagligt (med valgfri øgning til 45 mg dagligt) som tillægsbehandling hos patienter, der ikke var tilstrækkeligt kontrolleret med metformin + sulfonylurinstof (4 mg glimepirid dagligt).
English: If the pen is jammed or leaking, throw it away and use another pen.
Danish: Kassér pennen og brug en ny pen, hvis den er blokeret eller utæt.
English: Eperzan 30 mg Weekly + Pioglitazone 30 mg daily (+/- Metformin 1,500 mg daily)
Danish: Eperzan 30 mg ugentligt +  30 mg pioglitazon dagligt (+/-  1.500 mg metformin dagligt)
English: Difference from placebo + met + glimb (95% CI)
Danish: Forskel fra placebo + met + glimb (95
English: Eperzan 30 mg/50 mg Weekly + Metformin 1,500 mg daily
Danish: Eperzan 30 mg/50 mg ugentligt +  1.500 mg metformin dagligt
English: Fasting plasma glucose
Danish: Plasmaniveauet af fasteglucose
English: Use the pen immediately after the needle is attached otherwise the solution can dry inside the needle and block it.
Danish: Pennen skal anvendes omgående, efter at nålen er påsat, da injektionsvæsken ellers kan tørre ud indeni nålen og tilstoppe den. 6.4 Særlige opbevaringsforhold
English: GlaxoSmithKline BV Tel: + 31 (0)30 6938100
Danish: GlaxoSmithKline BV Tel: + 31 (0)30 6938100 nlinfo@gsk.com
English: Patients may store the pens at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Danish: Patienter kan opbevare pennene ved stuetemperatur under 30 C i maksimalt 4 uger før brug.
English: Complete dissolution for the 30 mg pen usually occurs within 2 minutes but may take up to 5 minutes, as confirmed by visual inspection for a clear solution free of particles.
Danish: For 30 mg pennen er pulveret normalt fuldstændigt opløst inden for 2 minutter, men det kan tage op til 5 minutter.
English: The between-treatment difference in HbA1c of 0.1% (-0.04, 0.27) from baseline at 52 weeks for Eperzan and insulin glargine met the prespecified noninferiority margin (0.3%).
Danish: Ved uge 52 var behandlingsforskellen i HbA1c mellem Eperzan og insulin glargin 0,1 % (-0,04, 0,27) i forhold til baseline, og opfyldte den prædefinerede noninferioritetsmargin (0,3 %).
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 657).
Danish: Effekten af Eperzan blev vurderet i et randomiseret, dobbeltblindet multicenterstudie (N = 657) af 3 års varighed.
English: Therapeutic proteins such as albiglutide are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue; therefore, changes in hepatic function are unlikely to have any effect on the elimination of Eperzan (see section 4.2).
Danish: Terapeutiske proteiner som f.eks. albiglutid kataboliseres via vidt udbredte proteolytiske enzymer, som ikke kun findes i levervæv.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles Do not sell separately
Danish: Del af multipakning indeholdende 3 pakninger, hver pakning indeholder 4 penne og 4 nåle Må ikke sælges separat
English: Difference from placebo + metforminb, (95% CI)
Danish: Forskel fra placebo + metforminb (95 %
English: Sitagliptin 100 mg daily + Metformin 1,500 mg daily
Danish: 100 mg sitagliptin dagligt +  1.500 mg metformin dagligt
English: Results at 52 weeks in an active-controlled study comparing Eperzan 30 mg SC weekly (with optional uptitration to 50 mg weekly) to insulin glargine (titrated weekly per prescribing information) as addon therapy in patients inadequately controlled on metformin  sulfonylurea
Danish: Resultater efter 52 uger i et aktivt kontrolleret studie, hvor Eperzan 30 mg s.c. ugentligt (med valgfri øgning til 50 mg ugentligt) blev sammenlignet med insulin glargin (titreret ugentligt i henhold til doseringsvejledningen) som tillægsbehandling hos patienter, der ikke var tilstrækkeligt kontrolleret med metformin  sulfonylurinstof.
English: This can cause your needle to block, you should continue from Step 5 to Step 6 right away.
Danish: Du skal gå direkte fra trin 5 til trin 6 uden at vente.
English: Discontinuation of treatment
Danish: Kombinationsbehandling
English: Placebo + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Danish: Placebo +  1.500 mg metformin dagligt + 4 mg glimepirid dagligt
English: Change at Week 26b Difference from sitagliptinb (95% CI)
Danish: Baseline (middel) Ændring ved uge 26b Forskel fra sitagliptinb (95 % CI)
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 999).
Danish: Effekten af Eperzan blev vurderet i et randomiseret, dobbeltblindet multicenterstudie (N = 999) af 3 års varighed.
English: • irregular heartbeat
Danish: • uregelmæssig puls
English: Glimepiride 2 to 4 mg daily + Metformin 1,500 mgd aily
Danish: 2-4 mg glimepirid dagligt +  1.500 mg metformin dagligt
English: Waiting may result in a blocked or clogged needle.
Danish: Dette kan medføre, at nålen tilstoppes.
English: After you have used the pen, do not remove the needle.
Danish: Tag ikke nålen af, når du har brugt pennen.
English: A statistically significant decrease in body weight was observed for Eperzan compared to an increase in body weight for insulin glargine and the difference in weight change was statistically significant (see Table 7).
Danish: Der blev observeret et statistisk signifikant vægttab for Eperzan sammenlignet med en vægtøgning for insulin glargin.
English: The primary endpoint was change in HbA1c from baseline at 26 weeks.
Danish: Det primære endepunkt var ændringen i HbA1c i forhold til baseline efter 26 uger.
English: The primary endpoint was change in HbA1c from baseline at 52 weeks compared to placebo.
Danish: Det primære endepunkt var ændringen i HbA1c efter 52 uger i forhold til baseline sammenlignet med placebo.
English: -1.5 (-2.1, -1.0) c a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Danish: -1,5 (-2,1; -1,0)c a Intent-To-Treat-population - last observation carried forward.
English: Eperzan 30 mg powder and solvent for solution for injection albiglutide
Danish: Eperzan 30 mg pulver og solvens til injektionsvæske, opløsning albiglutid
English: -0.6 (-1.1, -0.1)c a Intent to treat population - Last Observation Carried Forward (ITT-LOCF) b Adjusted mean c P<0.05 for treatment difference
Danish: -0,6 (-1,1; -0,1)c a Intent-To-Treat-population - last observation carried forward.
English: Add-on to pioglitazone
Danish: Som tillæg til pioglitazon
English: The efficacy of Eperzan was evaluated in a 3-year, randomised, double-blind, multicentre study (n = 299).
Danish: Effekten af Eperzan blev vurderet i et randomiseret, dobbeltblindet multicenterstudie (N = 299) af 3 års varighed.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) -with blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDER ETIKET - multipakning med 12 enkeltdosispenne og 12 nåle (3 pakninger med 4 penne og 4 nåle) - med blue box
English: If you use more Eperzan than you should
Danish: Hvis du har taget for meget Eperzan
English: Pioglitazone + Metformin 1,500 mg daily + Glimepiride 4 mg daily
Danish: Pioglitazon +  1.500 mg metformin dagligt + 4 mg glimepirid dagligt
English: Pharmacotherapeutic group: Drugs used in diabetes.
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, andre blodsukkersænkende lægemidler, eksklusive insuliner.
English: Patients with hepatic insufficiency
Danish: Patienter med nedsat leverfunktion
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
Danish: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 info@glaxosmithkline.dk
English: Eperzan 50 mg powder and solvent for solution for injection albiglutide
Danish: Eperzan 50 mg pulver og solvens til injektionsvæske, opløsning albiglutid
English: Step 5 Attach needle 5a Peel tab from outer needle cap (Figure L).
Danish: 5a Træk beskyttelsespapiret af den ydre nålehætte (Figur L).
English: QUESTIONS AND ANSWERS
Danish: OFTE STILLEDE SPØRGSMÅL
English: PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING CARTON - Multipack containing 12 single-dose pens and 12 pen needles (3 packs of 4 pens and 4 needles ) - without blue box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INTERMEDIÆR EMBALLAGE ÆSKE - multipakning med 12 enkeltdosispenne og 12 nåle (3 pakninger med 4 penne og 4 nåle)uden blue box
English: Eperzan 30 mg powder and solvent for solution for injection
Danish: Eperzan 30 mg pulver og solvens til injektionsvæske, opløsning
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Danish: Pulver og solvens til injektionsvæske, opløsning.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: • Keep your pen out of the sight and reach of children For each injection, gather the following items:
Danish: For hver injektion, find de følgende ting frem:
English: Pens may be stored at room temperature, not exceeding 30C, for no more than a total of 4 weeks prior to use.
Danish: Pennene kan opbevares ved stuetemperatur under 30 C i maksimalt 4 uger før brug.
English: Eperzan 50 mg powder and solvent for solution for injection
Danish: Eperzan 50 mg pulver og solvens til injektionsvæske, opløsning
English: For shelf life of the reconstituted product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: The primary endpoint was change in HbA1c from baseline at 52 weeks.
Danish: Det primære endepunkt var ændringen i HbA1c i forhold til baseline efter 52 uger.
English: Outer Needle Cap Inner Needle Cap Needle
Danish: Indre nålehætte Nål
English: Change at Week 32b Difference from liraglutideb (95% CI)
Danish: Baseline (middel) Ændring ved uge 32b Forskel fra liraglutidb (95 % CI)
English: Difference from pioglitazone + met + glimb (95% CI)
Danish: % CI) Forskel fra pioglitazon + met + glimb
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen, sygeplejersken eller apotekspersonalet.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Component of a multipack comprising 3 packs, each containing 4 pens and 4 pen needles.
Danish: Del af multipakning indeholdende 3 pakninger, hver pakning indeholder 4 penne og 4 nåle.
English: Difference from placebob (95% CI) a Intent to treat population - last observation carried forward b Adjusted mean c P<0.05 for treatment difference
Danish: Legemsvægt (kg) Baseline (middel) Ændring ved uge 52b Forskel fra placebob (95 % CI) a Intent-To-Treat-population - last observation carried forward.
English: Remove Inner Needle Cap
Danish: Fjern den indre nålehætte
English: Difference from glimepiride + metforminb, (95% CI)
Danish: % CI) Forskel fra glimepirid + metforminb (95
English: Difference from insulin glargineb (95% CI)
Danish: Ændring ved uge 52b Forskel fra insulin glarginb (95 % CI)
English: DO NOT attach by screwing the needle on
Danish: DU MÅ IKKE skrue nålen på.
English: Albiglutide slowed gastric emptying compared with placebo for both solids and liquids when 100 mg was administered as a single dose in healthy subjects (see section 5.1).
Danish: Albiglutid medførte langsommere ventrikeltømning sammenlignet med placebo for både faste stoffer og væsker hos raske personer, når de fik en enkelt dosis på 100 mg. For faste stoffer blev halveringstiden for ventrikeltømning øget fra 1,14 t til 2,23 t (p = 0,0112).
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Multipack:12 pens (3 cartons of 4 pens/4 needles) Do not sell separately
Danish: Multipakning: 12 penne (3 æsker med 4 penne/4 nåle) Må ikke sælges separat.
English: How to take Eperzan
Danish: Sådan skal du tage Eperzan 4.
English: Tabulated summary of adverse reactions
Danish: Oversigt over bivirkninger i tabelform
English: Difference from sitagliptin + metforminb , (95% CI)
Danish: CI) Forskel fra sitagliptin + metforminb (95
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/908/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/908/004
English: Uncommon: may affect up to 1 in 100 people:
Danish: Ikke almindelige: Kan forekomme hos op til 1 ud af 100 personer: • tilstopning af tarmen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/908/001
English: The primary endpoint was change in HbA1c from baseline at 32 weeks.
Danish: Det primære endepunkt var ændringen i HbA1c ved uge 32 i forhold til baseline.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/908/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/908/003
English: However, if you take Eperzan with sulphonylurea or insulin, you may get low blood sugar (hypoglycaemia).
Danish: Du kan dog få for lavt blodsukker (hypoglykæmi), hvis du foruden Eperzan også tager sulfonylurinstof eller insulin.
English: Once weekly Eperzan pen 50 mg
Danish: Eperzan-pen 50 mg (én dosis om ugen)
English: info@glaxosmithkline.dk nlinfo@gsk.com
Danish: GlaxoSmithKline GmbH & Co.
English: Packaging Content Package size
Danish: Emballage Indhold Paknings størrelse
English: Withdrawal period
Danish: Tilbageholdelses tid
English: • The Committee considered the referral under Article 30 of Directive 2001/83/EC;
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 30 i direktiv 2001/83/EF
English: Mepivacaine was first approved in 1960 by the US Food and Drug Administration.
Danish: Mepivacain blev første gang godkendt i 1960 af de amerikanske fødevare- og lægemiddelmyndigheder.
English: The harmonisation of the quality aspects of this product is considered to be acceptable and adequately justified.
Danish: Harmoniseringen af kvalitetsaspekterne for dette produkt vurderes at være acceptabel og tilstrækkeligt berettiget.
English: This may lead to hypotension and circulatory collapse.
Danish: Dette kan medføre hypotension og cirkulatorisk kollaps.
English: In addition minor editorial changes were introduced to improve readability.
Danish: Der blev derudover foretaget mindre redaktionelle ændringer til forbedring af læsbarheden.
English: Only the most major changes have been discussed in details below.
Danish: I det følgende er kun de vigtigste ændringer beskrevet i detaljer.
English: Module 3 - Quality
Danish: Modul 3 - kvalitet
English: In section 4.9 regarding overdose, two different types are described; absolute and relative overdose.
Danish: 4.9 vedrørende overdosering er to forskellige typer beskrevet: en absolut og en relativ overdosering.
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 mængde, der skal injiceres, bør bestemmes ud fra barnets alder og vægt samt operationens omfang.
English: Other Sections
Danish: Andre punkter
English: Moreover information on managing dose-related toxicity and other acute emergencies has been included.
Danish: Desuden er der medtaget oplysninger om behandling af dosisrelateret toksicitet og andre akutte nødstilfælde.
English: In the EU, Scandonest is authorised in 22 Member States (MS) through national procedures, and in 5 MSs (Sweden, Finland, Portugal, Spain, Malta) through mutual recognition procedure (MRP).
Danish: Scandonest er godkendt i 22 lande i EU gennem nationale procedurer og i 5 medlemsstater (Sverige, Finland, Portugal, Spanien og Malta) gennem gensidige anerkendelsesprocedurer.
English: As a precautionary measure and due to lack of data in this potentially more vulnerable population, the lowest dose leading to efficient anaesthesia should be applied.
Danish: Som forholdsregel og som følge af manglende data for denne potentielt mere sårbare population bør man anvende den laveste dosis, der medfører effektiv anæstesi.
English: For the recommended doses the patient's body weight has to be taken into account.
Danish: Den anbefalede dosis afhænger af patientens legemsvægt.
English: Other ingredients include sodium chloride, sodium hydroxide and water for injection.
Danish: Øvrige indholdsstoffer omfatter natriumchlorid, natriumhydroxid og vand til injektionsvæske.
English: In the presence of high blood levels, local anaesthetics cross the blood-brain barrier.
Danish: Ved høje niveauer i blodet kan lokalanalgetika krydse blod-hjerne-barrieren.
English: Scandonest contains 30 mg/mL of mepivacaine hydrochloride.
Danish: Scandonest indeholder 30 mg/ml mepivacainhydrochlorid.
English: However, all sections of the PI have been harmonised.
Danish: Alle punkter i produktinformationen er dog blevet harmoniseret.
English: The CHMP concluded that the benefit-risk balance of Scandonest and associated names remains favourable, subject to the agreed changes to the product information.
Danish: CHMP konkluderede, at benefit/risk-forholdet for Scandonest og relaterede navne fortsat er positivt under forudsætning af, at de vedtagne ændringer af produktinformationen gennemføres.
English: The updated sections of Module 3 sections include: Active substance, Control of active substance, Specification, Finished product, Description and composition of the finished substance, Manufacture, Description of manufacturing process and process controls, Process validation and/or evaluation, Control of Excipients, Control of Finished substance, Specifications, Analytical procedures, Container Closure System and Stability.
Danish: De opdaterede afsnit i modul 3 omfatter: Aktivt stof, Kontrol af det aktive stof, Specifikation, Færdigt produkt, Beskrivelse og sammensætning af det færdige stof, Fremstilling, Beskrivelse af fremstillingsprocessen og proceskontroller, Procesvalidering og/eller -vurdering, Kontrol af hjælpestoffer, Kontrol af det færdige stof, Specifikationer, Analyseprocedurer, Beholderens lukkemekanisme og Stabilitet.
English: The wording for the method of use was harmonised to the standard terms “infiltration and perineural use” taking in consideration the requirements from the EDQM (European Directorate for the Quality of Medicines & HealthCare).
Danish: Ordlyden vedrørende anvendelsesmåden blev harmoniseret til standardtermerne "infiltration og perineural anvendelse" under hensyntagen til kravene fra EDQM (det europæiske direktorat for lægemiddelkvalitet).
English: The CHMP deemed the submitted evidence adequate to support the indication in adults and in children from 4 years of age (ca. 20 kg body weight).
Danish: CHMP vurderede, at det indsendte materiale var tilstrækkelig til at understøtte indikationen hos voksne og børn i alderen 4 år og opefter (legemsvægt på ca. 20 kg).
English: Although in dental practices, local anaesthetics administrated in therapeutic dosages do not interact with standard antiepileptic drugs, the situation for patients with uncontrolled epilepsy may be different.
Danish: Selvom lokalanalgetika administreret i terapeutiske doser itandlægepraksisser ikke interagerer med standard-antiepileptika, kan situationen være anderledes for patienter med ukontrolleret epilepsi.
English: As a result of the review of mepivacaine during a worksharing procedure in accordance to Article 45 of Regulation No 1901/2006, in 2010, the use of mepivacaine is contraindicated in children below 4 years of age (and less than 20kg of body weight).
Danish: Som følge af gennemgangen af mepivacain under arbejdsdelingsproceduren i henhold til artikel 45 i forordning nr. 1901/2006 i 2010 er anvendelsen af mepivacain kontraindiceret hos børn under 4 år (og med en legemsvægt på under 20 kg).
English: Other warnings not related with the above categories were harmonised, such as for patients with coagulation disorder and coadministration of antiplatelet/anticoagulant medicines.
Danish: Andre advarsler, der ikke er relateret til ovenstående kategorier, er blevet harmoniseret som f.eks. patienter med koagulationsforstyrrelser og samtidig administration af antitrombotiske /antikoagulerende lægemidler.
English: The finished product is presented as a solution for injection containing 30 mg/ml of mepivacaine hydrochloride as active substance.
Danish: Det færdige produkt fås som en opløsning til injektion indeholdende 30 mg/ml mepivacainhydrochlorid som aktivt stof.
English: The statement regarding the risk of possible accumulation of the product leading to toxicity in special populations (elderly and patients with renal and hepatic impairment) has been however endorsed by the CHMP.
Danish: Udsagnet vedrørende risikoen for mulig akkumulation af lægemidlet, som kan medføre toksicitet hos særlige populationer (ældre og patienter med nedsat lever- og nyrefunktion), støttes dog af CHMP.
English: Local anaesthetics as cardiovascular depressants exert a negative inotropic and chronotropic effect on the myocardium and produce peripheral vasodilation.
Danish: Lokalanalgetika som kardiovaskulære depressiva har en negativ inotropisk og kronotropisk virkning på myokardiet og medfører perifer vasodilatation.