FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with severe hepatic impairment have not been studied, however, Rivastigmine Actavis capsules may be used in this patient population provided close monitoring is exercised (see section 4.4 and 5.2).
Danish: Rivastigmine Actavis kapsler kan dog bruges hos denne patientpopulation under forudsætning af nøje monitorering (se pkt.
English: Aggression, restlessness
Danish: Hallucinationer Aggression, rastløshed
English: 6-12 mg
Danish: Rivastigmin 6-12 mg N=379
English: Rivastigmine Actavis 3 mg, 4.5 mg and 6 mg hard capsules: Red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Danish: Rivastigmine Actavis 3 mg, 4,5 mg og 6 mg hårde kapsler: Rød jernoxid (E172), Titandioxid (E171), gul jernoxid (E172) og Gelatine
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules rivastigmine
Danish: Rivastigmine Actavis 1,5 mg hårde kapsler Rivastigmine Actavis 3 mg hårde kapsler Rivastigmine Actavis 4,5 mg hårde kapsler Rivastigmine Actavis 6 mg hårde kapsler rivastigmin
English: Parkinson's disease (worsening)
Danish: Parkinsons sygdom (forværring) Bradykinesi
English: Rivastigmine Actavis 1.5 mg hard capsules Rivastigmine Actavis 3 mg hard capsules Rivastigmine Actavis 4.5 mg hard capsules Rivastigmine Actavis 6 mg hard capsules
Danish: Rivastigmine Actavis 1,5 mg hårde kapsler Rivastigmine Actavis 3 mg hårde kapsler Rivastigmine Actavis 4,5 mg hårde kapsler Rivastigmine Actavis 6 mg hårde kapsler
English: The following adverse reactions, listed below in Table 1, have been accumulated in patients with Alzheimer's dementia treated with rivastigmine.
Danish: Bivirkningerne i tabel 1 er rapporteret hos patienter med Alzheimers demens, som har fået rigvastigmin.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos over 1 ud af 10 patienter)
English: Titanium dioxide (E171) Yellow iron oxide (E172) Gelatine
Danish: Titandioxid (E171) Gul jernoxid (E 172) Gelatine
English: Mean baseline ± SD 25.4 ± 9.9 27.4 ± 10.4 23.1 ± 10.4 22.5 ± 10.1 Mean change at 24 weeks 1.0 ± 9.2 ± SD
Danish: Gennemsnitlig baseline ± SD 25,4 ± 9,9 27,4 ± 10,4 23,1 ± 10,4
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 June 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Mean baseline ± SD 32.6 ± 10.4 33.7 ± 10.3 20.6 ± 7.9 20.7 ± 7.9 Mean change at 24 weeks 2.6 ± 9.4 ± SD
Danish: Gennemsnitlig baseline ± SD 32,6 ± 10,4 33,7 ± 10,3 Gennemsnitsændring ved 24 uger ± SD
English: • if you have gastrointestinal reactions such as feeling sick (nausea), being sick (vomiting) and diarrhoea.
Danish: • hvis du har gener fra mave-tarmkanalen, såsom kvalme, opkastning og diarré.
English: Capsule shell: Rivastigmine Actavis 1.5 mg hard capsules: Titanium dioxide (E171), yellow iron oxide (E172) and gelatine.
Danish: Kapsel skal: Rivastigmine Actavis 1,5 mg hårde kapsler: Titandioxid (E171), Gul jernoxid (E 172), Gelatine.
English: associated with Parkinson's disease Total patients studied Total patients with pre-defined AE(s) Tremor
Danish: Totalt antal patienter i studiet Totalt antal patienter med prædefinerede bivirkninger
English: What Rivastigmine Actavis looks like and contents of the pack - Rivastigmine Actavis 1.5 mg hard capsules, which contain off-white to slightly yellow powder, have a yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Danish: Rivastigmine Actavis udseende og pakningsstørrelser - Rivastigmine Actavis 1,5 mg hårde kapsler indeholder et råhvidt til svagt gulligt pulver, har en gul hætte og en gul skal, og er præget ”RIV 1,5mg” med rødt på skallen.
English: The ink may or may not contain potassium hydroxide
Danish: Farven kan måske indeholde kaliumhydroxid
English: Abdominal pain and dyspepsia
Danish: Abdominale smerter og dyspepsi Øget spytsekretion
English: Mean change at 24 weeks 2.1 ± 8.2 ± SD
Danish: Gennemsnitsændring ved 24 uger ± SD
English: INFORMATION IN BRAILLE Rivastigmine Actavis 1.5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Rivastigmine Actavis 1,5 mg
English: INFORMATION IN BRAILLE Rivastigmine Actavis 4.5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Rivastigmine Actavis 4,5 mg
English: Hepatobiliary disorders Not known
Danish: Lever- og galdeveje Ikke kendt
English: The ink may or may not contain potassium hydroxide.
Danish: Trykfarven kan måske indeholde kaliumhydroxid
English: N=444
Danish: Placebo N=444
English: The capsules and oral solution can also be used for the treatment of dementia in adult patients with Parkinson's disease.
Danish: Det anvendes også til behandling af demens hos voksne patienter med Parkinsons sygdom.
English: INFORMATION IN BRAILLE Rivastigmine Actavis 6 mg
Danish: INFORMATION I BRAILLE-SKRIFT Rivastigmine Actavis 6 mg
English: Rivastigmine Actavis 4.5 mg hard capsules
Danish: Rivastigmine Actavis 4,5 mg hårde kapsler
English: Rivastigmine Actavis 6 mg hard capsules
Danish: Rivastigmine Actavis 6 mg hårde kapsler
English: Rivastigmine Actavis 1.5 mg hard capsules
Danish: Rivastigmine Actavis 1,5 mg hårde kapsler
English: In view of its pharmacodynamic effects and possible additive effects, rivastigmine should not be given concomitantly with other cholinomimetic substances.
Danish: Som følge af de farmakodynamiske virkninger og mulige additive virkninger bør rivastigmin ikke gives samtidig med andre parasympatomimetika.Rivastigmin kan interferere med antikolinerge lægemidlers aktivitet (f.eks. oxybutynin, tolterodin).
English: How to take Rivastigmine Actavis
Danish: Sådan skal du bruge Rivastigmine Actavis
English: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjördur Iceland
Danish: Reykjavíkurvegur 76 - 78 IS-220 Hafnarfjördur Island
English: If you are pregnant, the benefits of using Rivastigmine Actavis must be assessed against the possible effects on your unborn child. Rivastigmine Actavis should not be used during pregnancy, unless clearly necessary.
Danish: Hvis du er gravid, skal fordelen ved at bruge Rivastigmine Actavis afvejes i forhold til de mulige bivirkninger på fosteret.
English: Rivastigmine Actavis 3 mg hard capsules
Danish: Rivastigmine Actavis 3 mg hårde kapsler
English: INFORMATION IN BRAILLE Rivastigmine Actavis 3 mg
Danish: INFORMATION I BRAILLE-SKRIFT Rivastigmine Actavis 3 mg
English: UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: - Rivastigmine Actavis 4.5 mg hard capsules, which contain off-white to slightly yellow powder, have a red cap and red body, with white imprint “RIV 4.5mg” on body.
Danish: - Rivastigmine Actavis 4,5 mg hårde kapsler indeholder et råhvidt til svagt gulligt pulver, har en rød hætte og en rød skal, og er præget ”RIV 4,5mg” med hvidt på skallen.
English: What Rivastigmine Actavis is and what it is used for What you need to know before you take Rivastigmine Actavis How to take Rivastigmine Actavis Possible side effects
Danish: Det skal du vide, før du begynder at tage Rivasigmine Actavis Sådan skal du tage Rivastigmine Actavis Bivirkninger
English: • if you have, or have ever had, difficulties in passing urine.
Danish: • hvis du har eller nogensinde har haft vandladningsbesvær.
English: N=472
Danish: Placebo N=472
English: - Rivastigmine Actavis 3 mg hard capsules, which contain off-white to slightly yellow powder, have an orange cap and orange body, with red imprint “RIV 3mg” on body.
Danish: - Rivastigmine Actavis 3 mg hårde kapsler indeholder et råhvidt til svagt gulligt pulver, har en orange hætte og en orange skal, og er præget ”RIV 3mg” med rødt på skallen.
English: Rivastigmine Actavis 6 mg hard capsules EU/1/11/693/013
Danish: Rivastigmine Actavis 6 mg hårde kapsler EU/1/11/693/013
English: - Rivastigmine Actavis 6 mg hard capsules, which contain off -white to slightly yellow powder, have an red cap and orange body, with red imprint “RIV 6mg” on body.
Danish: - Rivastigmine Actavis 6 mg hårde kapsler indeholder et råhvidt til svagt gulligt pulver, har en rød hætte og en orange skal, og er præget ”RIV 6mg” med rødt på skallen.
English: Off-white to slightly yellow powder in a hard capsule with orange cap and orange body, with red imprint “RIV 3mg” on body.
Danish: Råhvidt til svagt gulligt pulver i en hård kapsel med orange hætte og orange skal, med ”RIV 3mg” præget med rødt på skallen.
English: Each Rivastigmine Actavis 4.5 mg capsule contains 4.5 mg of rivastigmine.
Danish: Rivastigmine Actavis 4,5 mg hårde kapsler Hver kapsel indeholder rivastigminhydrogentartrat svarende til 4,5 mg rivastigmin.
English: • if you have, or have ever had impaired kidney function.
Danish: • hvis du har eller har haft nedsat nyrefunktion.
English: Contents of the pack and other information What Rivastigmine Actavis contains - The active substance is rivastigmine hydrogen tartrate.
Danish: Rivastigmine Actavis indeholder - Aktivt stof: Rivastigminhydrogentartrat - Øvrige indholdsstoffer:
English: There is no relevant use of Rivastigmine Actavis in the paediatric population in the treatment of Alzheimer's disease.
Danish: Der er ingen relevante indikationer for brug af Rivastigmine Actavis til behandling af Alzheimers sygdom hos børn og teenagere.
English: ITT - LOCF population (n=287)
Danish: ITT - LOCF population
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 4.5 mg hard capsules rivastigmine
Danish: LÆGEMIDLETS NAVN Rivastigmine Actavis 4,5 mg hårde kapsler rivastigmin
English: Off-white to slightly yellow powder in a hard capsule with red cap and red body, with white imprint “RIV 4.5mg” on body.
Danish: Råhvidt til svagt gulligt pulver i en hård kapsel med rød hætte og rødt skal, med ”RIV 4,5mg” præget med hvidt på skallen.
English: Reykjavíkurvegur 76-78 220 Hafnarfjörður Iceland
Danish: Reykjavikurvegur 76-78 220 Hafnarfjörður Island
English: Each Rivastigmine Actavis 1.5 mg capsule contains 1.5 mg of rivastigmine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Rivastigmine Actavis 1,5 mg hårde kapsler Hver kapsel indeholder rivastigminhydrogentartrat svarende til 1,5 mg rivastigmin.
English: Off-white to slightly yellow powder in a hard capsule with yellow cap and yellow body, with red imprint “RIV 1.5mg” on body.
Danish: Råhvidt til svagt gulligt pulver i en hård kapsel med gul hætte og gul skal, med ”RIV 1,5mg” præget med rødt på skallen.
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 6 mg hard capsules rivastigmine
Danish: LÆGEMIDLETS NAVN Rivastigmine Actavis 6 mg hårde kapsler rivastigmin
English: (MMSE 18-24)
Danish: Patienter med mild demens (MMSE 18-24)
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 1.5 mg hard capsules rivastigmine
Danish: LÆGEMIDLETS NAVN Rivastigmine Actavis 1,5 mg hårde kapsler rivastigmin
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 4.5 mg rivastigmine (as hydrogen tartrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 kapsel indeholder rivastigmin 4,5 mg (som rivastigminhydrogentartrat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 6 mg rivastigmine (as hydrogen tartrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 kapsel indeholder rivastigmin 6 mg (som rivastigminhydrogentartrat).
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Rivastigmine Actavis til dig personligt.
English: Rivastigmine Actavis 4.5 mg hard capsules EU/1/11/693/009
Danish: Rivastigmine Actavis 4.5 mg hårde kapsler EU/1/11/693/009
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/012
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/004
English: Gastrointestinal haemorrhage
Danish: Tandhjulsrigiditet Dystoni
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Rivastigmine Actavis, skal du henvende dig til den lokale repræsentant:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 1.5 mg rivastigmine (as hydrogen tartrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 kapsel indeholder rivastigmin 1,5 mg (som rivastigminhydrogentartrat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 capsule contains 3 mg rivastigmine (as hydrogen tartrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 kapsel indeholder rivastigmin 3 mg (som rivastigminhydrogentartrat).
English: Dementia associated with ADAS-Cog ADAS-Cog ADCS- CGIC ADCS-CGIC Parkinson's Disease
Danish: ADCS-CGIC Placebo
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Actavis 3 mg hard capsules rivastigmine
Danish: LÆGEMIDLETS NAVN Rivastigmine Actavis 3 mg hårde kapsler rivastigmin
English: Rivastigmine Actavis 3 mg hard capsules EU/1/11/693/005
Danish: Rivastigmine Actavis 3 mg hårde kapsler EU/1/11/693/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/016
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/016
English: Rivastigmine Actavis 1.5 mg hard capsules EU/1/11/693/001
Danish: Rivastigmine Actavis 1,5 mg hårde kapsler EU/1/11/693/001
English: Infections and infestations Very rare
Danish: Infektioner og parasitære sygdomme
English: • if you have, or have ever had, impaired liver function.
Danish: • hvis du har eller har haft nedsat leverfunktion.
English: Placebo
Danish: ADAS-C og Placebo
English: Capsule content:
Danish: ETIKET PÅ KAPSELBEHOLDER
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/013[ 28 blister]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/013[ 28 blister]
English: Off-white to slightly yellow powder in a hard capsule with red cap and orange body, with red imprint “RIV 6mg” on body.
Danish: Råhvidt til svagt gulligt pulver i en hård kapsel med rød hætte og rødt skal, med ”RIV 6mg” præget med rødt på skallen.
English: Hepatobiliary disorders Uncommon
Danish: Vaskulære sygdomme Almindelig Ikke almindelig
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis logo]
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/005[ 28 blister]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/005[ 28 blister]
English: Elevated liver function tests
Danish: Nedsat nyre- og leverfunktion
English: Atrioventricular block
Danish: ADAS-Cog Rivastigmin
English: difficulty in carrying out movements and muscle weakness
Danish: Gangforstyrrelse Muskelstivhed
English: Placebo of parkinsonian symptoms in patients with dementia n (%)
Danish: Placebo n (%)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/009[ 28 blister]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/009[ 28 blister]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/693/001[ 28 blister]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/11/693/001[ 28 blister]
English: Mean baseline ± SD 24.0 ± 10.3 24.5 ± 10.6 n/a n/a
Danish: 24,0 ± 10,3 24,5 ± 10,6 ikke relevant ikke relevant
English: Dementia associated with ADAS-Cog ADAS-Cog ADAS-Cog ADAS-Cog Parkinson's Disease
Danish: ADAS-Cog Placebo
English: Bradykinesia
Danish: • Svedtendens
English: Package size
Danish: Emballage Pakningsstørrelse
English: MA (EU) number (Invented) name
Danish: MF (EU) nummer
English: 1 pre-filled pen + 7 NovoTwist needles
Danish: 1 fyldt pen + 7 NovoTwist engangsnåle
English: 5 pre-filled pens
Danish: 5 fyldte penne
English: 1 pre-filled pen + 7 NovoFine needles
Danish: 1 fyldt pen + 7 NovoFine engangsnåle
English: What is Scandonest?
Danish: Hvad er Scandonest?
English: The package leaflet will be updated accordingly.
Danish: Indlægssedlen vil blive opdateret i overensstemmelse hermed.
English: Scandonest has been authorised in the EU via national procedures.
Danish: Scandonest er godkendt i EU via nationale procedurer.
English: The company that markets these medicines is Septodont.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Septodont.
English: Scandonest is given by injection.
Danish: Scandonest gives ved indsprøjtning.
English: The recommended dose of Scandonest depends on the patient's age and body weight.
Danish: Den anbefalede Scandonest-dosis afhænger af patientens alder og legemsvægt.
English: It contains the active substance mepivacaine.
Danish: Det indeholder det aktive stof mepivacain.
English: In addition, Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) has also been harmonised.
Danish: Derudover blev også modul 3 i lægemidlets dossier (som beskriver, hvordan lægemidlet fremstilles, og hvordan dets kvalitet tjekkes) harmoniseret.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2 August 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom2.
English: Scandonest is also available in the EU under the trade names Biocaine and Scandicaine.
Danish: Scandonest fås også i EU under handelsnavnene Biocaine og Scandicaine.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data, or to be redundant and already included in the current list above.
Danish: Efter gennemgangen af de tilgængelige data blev en række andre kontraindikationer, som kun gjaldt i nogle lande, anset for ikke at være tilstrækkeligt understøttet af data eller for at være redundante og allerede omfattet af den førnævnte liste.
English: Information for doctors and patients to be aligned across EU
Danish: Oplysninger til læger og patienter ensrettes i hele EU
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Danish: Den blev foretaget af EMA's udvalg for lægemidler til mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
English: In addition, it must not be used in children below 4 years of age, in patients with severe problems affecting the heart's electrical activity which are not resolved by a pace-maker, and in epileptic patients whose disease is not adequately controlled.
Danish: Det må desuden heller ikke anvendes hos børn under 4 år, hos patienter med alvorlige problemer, der påvirker hjertets elektriske aktivitet, som ikke kan afhjælpes med pacemaker, og hos epileptikere, hvis sygdom ikke er tilstrækkeligt kontrolleret.
English: In children, the recommended dose is 0.75 mg/kg.
Danish: Hos børn er den anbefalede dosis 0,75 mg pr. kg.
English: Other harmonised sections of the SmPC include sections 4.4 (special warnings and precautions for use) 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), and 4.8 (side effects).
Danish: Andre afsnit i produktresuméet blev også harmoniseret, herunder punkt 4.4 (Særlige advarsler og forsigtighedsregler vedrørende brugen), 4.5 (Interaktioner), 4.6 (Fertilitet, graviditet og amning), 4.7 (Virkning på evnen til at føre motorkøretøj og betjene maskiner) og 4.8 (Bivirkninger).
English: On 31 May 2018, the European Medicines Agency (EMA) completed a review of Scandonest and associated names and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Danish: Den 31. maj 2018 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af Scandonest og relaterede navne og anbefalede ændringer i ordinationsoplysningerne med henblik på at harmonisere den måde, som lægemidlet anvendes på i EU.
English: The review of Scandonest was initiated at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Danish: Gennemgangen af Scandonest blev indledt på anmodning fra indehaveren af markedsføringstilladelsen, Septodont, i henhold til artikel 30 i direktiv 2001/83/EF.
English: Why was Scandonest reviewed?
Danish: Hvorfor blev Scandonest gennemgået påny?
English: Use of Scandonest and associated names (mepivacaine) to be harmonised
Danish: Brugen af Scandonest og relaterede navne (mepivacain) harmoniseres
English: After considering the available data on the use of Scandonest, the Agency concluded that the SmPC should be harmonised.
Danish: Efter at have gennemgået de tilgængelige data vedrørende brugen af Scandonest konkluderede agenturet, at produktresuméet bør harmoniseres.
English: Use of Scandonest and associated names (mepivacaine) to be harmonised EMA/533239/2018
Danish: Brugen af Scandonest og relaterede navne (mepivacain) harmoniseres EMA/533239/2018
English: This has led to inconsistency across Member States in the way the medicine is produced and can be used, as seen in the differences in the prescribing information [summary of product characteristics (SmPC), labelling and package leaflet] in the countries where the medicine is marketed.
Danish: Det har medført forskelle mellem medlemsstaterne i den måde, som lægemidlet fremstilles og anvendes på, hvilket fremgår af ordinationsoplysningerne (produktresuméet, etiketteringen og indlægssedlen) i de lande, hvor lægemidlet markedsføres.
English: Scandonest is now authorised for use as local anaesthetic in dental surgery in adults, adolescents and children above 4 years of age (weighing around 20 kg).
Danish: Scandonest godkendes nu til brug som lokalbedøvelsesmiddel ved dental kirurgi hos voksne, unge og børn over 4 år (med en legemsvægt på omkring 20 kg).
English: In adults, the maximum recommended dose is 4.4 mg per kg body weight, up to a maximum total dose of 300 mg.
Danish: Hos voksne er den maksimale anbefalede dosis 4,4 mg pr. kg legemsvægt, dog højst 300 mg i alt.
English: Scandonest should no longer be used as local anaesthetic during chiropody procedures (treatment of corns, verrucae, etc.), because the data presented by the company were considered not sufficient to support this use.
Danish: Scandonest bør ikke længere bruges som lokalbedøvelsesmiddel i forbindelse med fodpleje (behandling af ligtorne, vorter osv.), da de data, som virksomheden har fremlagt, ikke anses for at være tilstrækkelige til at støtte denne anvendelse.
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 2 August 2018.
Danish: Med henblik på at gennemføre disse ændringer vedtog Europa-Kommissionen den 2. august 2018 en afgørelse, der er retligt bindende i hele EU.
English: Scandonest is a local anaesthetic, a medicine used to block sensation and pain in part of the body during medical procedures.
Danish: Scandonest er et lokalbedøvelsesmiddel, der anvendes til at blokere følelse og smerte i en del af kroppen under medicinske undersøgelser.
English: Scandonest must not be used in patients who are allergic to the active substance mepivacaine or any of the other ingredients of the medicine.
Danish: Scandonest må ikke anvendes hos patienter, der er allergiske over for det aktive stof (mepivacain) eller andre af indholdsstofferne.
English: On 25 August 2017, Septodont, the company that markets Scandonest, referred the matter to EMA in order to harmonise the marketing authorisations for Scandonest in the EU.
Danish: Septodont, som markedsfører Scandonest, indbragte den 25. august 2017 sagen for EMA med henblik på harmonisering af lægemidlets markedsføringstilladelser i EU.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 Special warnings and precautions for use.
Danish: I de tilfælde, hvor data understøttede det, er nogle af de tidligere kontraindikationer medtaget i pkt.
English: The recommended dose is 35 international units (IU) per kilogram body weight once per month.
Danish: Den anbefalede dosis er 35 internationale enheder (IE) pr. kg legemsvægt én gang om måneden.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NovoThirteen on 3 September 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for NovoThirteen den 3. september 2012.