FrancophonIA/ELRC3.0 huggingface dataset:
English: If accidental eye exposure occurs, flush the eyes immediately with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Herefter søges straks lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: • Treatment of adult roundworms (Toxocara cati)
Danish: • Behandling mod voksne rundorme (Toxocara cati)
English: A single dose of the veterinary medicinal product should be administered.
Danish: Der gives én behandling med veterinærlægemidlet.
English: Chanhold 240 mg for dogs
Danish: Chanhold 240 mg til hunde
English: The product is ovicidal for 3 weeks after administration.
Danish: Produktet dræber æg 3 uger efter behandling.
English: Product mg of selamectin dispensed
Danish: Produkt mg appliceret
English: Flea treatment and prevention (cats and dogs)
Danish: Behandling og forebyggelse af lopper (katte og hunde)
English: Chanhold 60 mg for cats
Danish: Chanhold 60 mg til katte
English: Chanhold 120 mg for dogs
Danish: Chanhold 120 mg til hunde
English: • Treatment of adult intestinal roundworms (Toxocara canis).
Danish: • Behandling mod voksne stadier af intestinale rundorme (Toxocara canis).
English: When replacing another heartworm preventive product in a heartworm disease prevention programme, the first dose of the veterinary medicinal product must be given within a month of the last dose of the former medication.
Danish: Hvis behandling med Chanhold erstatter en behandling med et andet præparat, skal første dosis af veterinærlægemidlet appliceres senest en måned efter den sidste behandling med det andet præparat.
English: ≤ 2.5 1 pipette of Chanhold 15 mg for cats and dogs ≤ 2.5 kg
Danish: 1 pipette af Chanhold 15 mg til katte og hunde ≤ 2,5 kg
English: This is as a result of the adulticidal, larvicidal and ovicidal properties of the product.
Danish: Dette er et resultat af produktets dræbende virkning på voksne lopper, larver og æg.
English: Prevention of heartworm disease (cats and dogs)
Danish: Forebyggelse mod hjerteorm (katte og hunde)
English: The systemic persistence of selamectin in plasma and the lack of extensive metabolism provide effective concentrations of selamectin for the duration of the inter-dosing interval (30 days).
Danish: Terapeutiske plasmakoncentrationer i perioden mellem 2 behandlinger (30 dage) sikres ved at plasmakoncentrationen af selamectin opretholdes og ved en langsom metabolisme.
English: Activity has also been demonstrated against heartworm larvae.
Danish: Selamectin er også påvist effektivt til at dræbe hjerteormens larver.
English: EU/2/19/236/003 EU/2/19/236/004 EU/2/19/236/005 EU/2/19/236/006
Danish: EU/2/19/236/005 EU/2/19/236/006
English: 12% w/v solution Selamectin 120 mg
Danish: 12% w/v opløsning Selamectin 120 mg
English: 12% w/v solution Selamectin 240 mg
Danish: 12% w/v opløsning Selamectin 240 mg
English: Do not apply when the hair coat is wet.
Danish: Man må kun behandle, når pelsen er tør.
English: Chanhold 60 mg for dogs
Danish: Chanhold 60 mg til hunde
English: The product can be used in breeding, pregnant and lactating cats and dogs.
Danish: Drægtige og diegivende hunde og katte samt avlshunde og avlskatte kan behandles med produktet.
English: 6% w/v solution Selamectin 45 mg
Danish: 6% w/v opløsning Selamectin 45 mg
English: However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
Danish: Dyret kan vaskes med sæbe eller pelsen kan gennemblødes mindst to timer efter behandlingen, uden at effekten af produktet forringes.
English: 12% w/v solution Selamectin 360 mg
Danish: 12% w/v opløsning Selamectin 360 mg
English: Treatment of biting lice (cats and dogs)
Danish: Behandling mod bidende lus (katte og hunde)
English: Treatment of hookworm infections (cats)
Danish: Behandling mod øremider (katte)
English: Containers and residual contents should be disposed of along with collected domestic refuse to avoid contamination of any water courses.
Danish: For at undgå forurening af fiskevand og andre vandkilder, skal medicinbeholdere og medicinrester bortskaffes som almindeligt husholdningsaffald.
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
Danish: På grund af reduktion af loppebestanden vil månedlig behandling af drægtige og diegivende dyr støtte forbyggelse mod loppeangreb hos kuld til de er 7 uger.
English: 12% w/v solution Selamectin 30 mg
Danish: 12% w/v opløsning Selamectin 30 mg
English: 6% w/v solution Selamectin 60 mg
Danish: 6% w/v opløsning Selamectin 60 mg
English: 10.1-20.0 1 pipette of Chanhold 120 mg for dogs 10.120.0 kg
Danish: Hunde som vejer mellem 10,1 kg og 20,0 kg (Chanhold 120 mg Spot-on opløsning til hunde 10,120,0 kg)
English: Fertility: Can be used in breeding cats and dogs.
Danish: Fertilitet: Kan bruges til avlskatte og alvshunde.
English: Dogs weighing 10.1-20.0 kg.
Danish: Hunde som vejer 10,1- 20,0 kg.
English: Dogs weighing 40.1-60.0 kg.
Danish: Hunde som vejer 40,1 - 60,0 kg.
English: Treatment of ear mites (dogs)
Danish: Behandling mod øremider (hunde)
English: Dogs weighing 2.6-5.0 kg.
Danish: Hunde som vejer 2,6 - 5,0 kg.
English: Chanhold 15 mg for cats and dogs
Danish: Chanhold 15 mg til hunde
English: Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Danish: Chanhold 30 mg Spot-on opløsning til hunde 2,6 - 5,0 kg Chanhold 60 mg Spot-on opløsning til hunde 5,1 - 10,0 kg Chanhold 120 mg Spot-on opløsning til hunde 10,1 - 20,0 kg Chanhold 240 mg Spot-on opløsning til hunde 20,1 - 40,0 kg Chanhold 360 mg Spot-on opløsning til hunde 40,1 - 60,0 kg selamectin
English: Other precautions:
Danish: Hjælpestoffer:
English: 12% w/v solution Selamectin 60 mg
Danish: 12% w/v opløsning Selamectin 60 mg
English: If significant licking occurs, a brief period of hypersalivation may rarely be observed in cats.
Danish: Kortvarige perioder med forøget salivation kan i sjældne tilfælde ses hos katte, der i længere tid har slikket på applikationsstedet.
English: Following absorption from the skin selamectin distributes systemically and is slowly eliminated from plasma as manifested in detectable plasma concentrations in dogs and cats 30 days after administration of a single topical dose at 6 mg/kg.
Danish: Efter en enkel kutan applikation af 6 mg selamectin pr. kg legemsvægt vil der stadig være målbare plasmakoncentrationer hos hunde og katte i ca. 30 dage.
English: Cats weighing 2.6-7.5 kg. Cats weighing 7.6-10.0 kg.
Danish: Katte som vejer 2,6 - 7,5 kg.
English: 20.1-40.0 1 pipette of Chanhold 240 mg for dogs 20.1-40.0 kg
Danish: Hunde som vejer mellem 20,1 kg og 40,0 kg (Chanhold 240 mg Spot-on opløsning til hunde 20,140,0 kg)
English: Dogs weighing 5.1-10.0 kg.
Danish: Hunde som vejer 5,1 - 10,0 kg.
English: Cats and dogs weighing 2.5 kg or less (Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg) Dogs weighing 2.6 kg-5.0 kg (Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg) Cats weighing 2.6 kg-7.5 kg (Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg) Cats weighing 7.6 kg-10.0 kg (Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg) Dogs weighing 5.1 kg-10.0 kg (Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg) Dogs weighing 10.1 kg-20.0 kg (Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg) Dogs weighing 20.1 kg-40.0kg (Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg) Dogs weighing 40.1 kg-60.0 kg (Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg)
Danish: Hunde som vejer mellem 2,6 kg og 5,0 kg (Chanhold 30 mg Spot-on opløsning til hunde 2,6 - 5,0 kg) Katte som vejer mellem 2,6 kg og 7,5 kg (Chanhold 45 mg Spot-on opløsning til katte 2,6 - 7,5 kg) Katte som vejer mellem 7,6 kg og 10,0 kg (Chanhold 60 mg Spot-on opløsning til katte 7,6 - 10,0 kg) Hunde som vejer mellem 5,1 kg og 10,0 kg (Chanhold 60 mg Spot-on opløsning til hunde 5,1 - 10,0 kg)
English: Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg
Danish: Chanhold 15 mg Spot-on opløsning til katte og hunde ≤ 2,5 kg Chanhold 30 mg Spot-on opløsning til hunde 2,6 - 5,0 kg Chanhold 45 mg Spot-on opløsning til katte 2,6 - 7,5 kg Chanhold 60 mg Spot-on opløsning til katte 7,6 - 10,0 kg Chanhold 60 mg Spot-on opløsning til hunde 5,1 - 10,0 kg Chanhold 120 mg Spot-on opløsning til hunde 10,1 - 20,0 kg Chanhold 240 mg Spot-on opløsning til hunde 20,1 - 40,0 kg Chanhold 360 mg Spot-on opløsning til hunde 40,1 - 60,0 kg
English: Chanhold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Chanhold 30 mg spot-on solution for dogs 2.6-5.0 kg Chanhold 45 mg spot-on solution for cats 2.6-7.5 kg Chanhold 60 mg spot-on solution for cats 7.6-10.0 kg Chanhold 60 mg spot-on solution for dogs 5.1-10.0 kg Chanhold 120 mg spot-on solution for dogs 10.1-20.0 kg Chanhold 240 mg spot-on solution for dogs 20.1-40.0 kg Chanhold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Danish: Chanhold 15 mg Spot-on opløsning til katte og hunde ≤ 2,5 kg Chanhold 30 mg Spot-on opløsning til hunde 2,6 - 5,0 kg Chanhold 45 mg Spot-on opløsning til katte 2,6 - 7,5 kg Chanhold 60 mg Spot-on opløsning til katte 7,6 - 10,0 kg Chanhold 60 mg Spot-on opløsning til hunde 5,1 - 10,0 kg Chanhold 120 mg Spot-on opløsning til hunde 10,1 - 20,0 kg Chanhold 240 mg Spot-on opløsning til hunde 20,1 - 40,0 kg Chanhold 360 mg Spot-on opløsning til hunde 40,1 - 60,0 kg selamectin
English: 40.1-60.0 1 pipette of Chanhold 360 mg for dogs 40.1-60.0 kg
Danish: Hunde som vejer mellem 40,1 kg og 60,0 kg (Chanhold 360 mg Spot-on opløsning til hunde 40,160,0 kg)
English: Cats (kg)
Danish: Katte (kg) Produkte mg appliceret
English: Treatment of roundworm infections (cats and dogs)
Danish: Behandling mod spolorm (katte og hunde)
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age.
Danish: Månedlige behandlinger af drægtige og diegivende dyr vil reducere antallet af lopper og dermed hjælpe med til forebyggelse af loppeangeb hos kuldet op til 7 ugers alderen.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Special forholdsregler til brug hos dyr: Produktet må kun påføres huden.
English: Chanelle Pharmaceuticals Manufacturing Ltd, Loughrea,
Danish: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Irland
English: ADVERSE REACTIONS
Danish: Indgivelsesmåde
English: The recommended starting dose of Pioglitazone Teva Pharma is 15 or 30 mg once a day.
Danish: Den anbefalede startdosis af Pioglitazone Teva Pharma er 15 eller 30 mg en gang dagligt.
English: The full EPAR for Pioglitazone Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Pioglitazone Teva Pharma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pioglitazone Teva Pharma on 26 March 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pioglitazone Teva Pharma den 26. marts 2012.
English: The active substance in Pioglitazone Teva Pharma, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Pioglitazone Teva Pharma, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv producerer.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Pioglitazone Teva Pharma.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Pioglitazone Teva Pharma skal anvendes.
English: Treatment with Pioglitazone Teva Pharma should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Danish: Behandlingen med Pioglitazone Teva Pharma skal tages op til fornyet vurdering efter tre til seks måneder og afbrydes hos patienter, der ikke har tilstrækkelig gavn af behandlingen.
English: For more information about treatment with Pioglitazone Teva Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pioglitazone Teva Pharma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Pioglitazone Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Danish: Det betyder, at Pioglitazone Teva Pharma er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Actos.
English: Pioglitazone Teva Pharma is used to treat type 2 diabetes in adults (aged 18 years or over), particularly those who are overweight.
Danish: Pioglitazone Teva Pharma anvendes til behandling af type 2-diabetes hos voksne (på 18 år og derover), især overvægtige.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Pharma has been shown to have comparable quality and to be bioequivalent to Actos.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pioglitazone Teva Pharma er af sammenlignelig kvalitet og er bioækvivalent med Actos.
English: Pioglitazone Teva Pharma can also be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Danish: Pioglitazone Teva Pharma kan også anvendes sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin.
English: This is a summary of the European public assessment report (EPAR) for Pioglitazone Teva Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pioglitazone Teva Pharma.
English: Pioglitazone Teva Pharma is a medicine that contains the active substance pioglitazone.
Danish: Pioglitazone Teva Pharma er et lægemiddel, der indeholder det aktive stof pioglitazon.
English: Pioglitazone Teva Pharma should not be used in patients on dialysis (a blood clearance technique used in people with kidney disease).
Danish: Pioglitazone Teva Pharma bør ikke anvendes til patienter i dialyse (en blodrensningsteknik, der anvendes hos personer med nyresygdom).
English: Other information about Pioglitazone Teva Pharma
Danish: Andre oplysninger om Pioglitazone Teva Pharma
English: Because Pioglitazone Teva Pharma is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Danish: Da Pioglitazone Teva Pharma er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos.
English: Pioglitazone Teva Pharma is a ‘generic medicine'.
Danish: Pioglitazone Teva Pharma er et ‘generisk lægemiddel'.
English: Because Pioglitazone Teva Pharma is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pioglitazone Teva Pharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Pioglitazone Teva Pharma is used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Danish: Pioglitazone Teva Pharma anvendes som enebehandling til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet.
English: What are the benefits and risks of Pioglitazone Teva Pharma?
Danish: Hvilken fordel og risiko er der forbundet med Pioglitazone Teva Pharma?
English: Why has Pioglitazone Teva Pharma been approved?
Danish: Hvorfor er Pioglitazone Teva Pharma blevet godkendt?
English: The Committee recommended that Pioglitazone Teva Pharma be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Pioglitazone Teva Pharma.
English: How has Pioglitazone Teva Pharma been studied?
Danish: Hvordan er Pioglitazone Teva Pharma blevet undersøgt?
English: What is Pioglitazone Teva Pharma?
Danish: Hvad er Pioglitazone Teva Pharma?
English: What is Pioglitazone Teva Pharma used for?
Danish: Hvad anvendes Pioglitazone Teva Pharma til?
English: How is Pioglitazone Teva Pharma used?
Danish: Hvordan anvendes Pioglitazone Teva Pharma?
English: The medicine is currently marketed in the following Member States of the EU: Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Malta, Netherlands, Poland, Portugal, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Danish: Lægemidlet markedsføres på nuværende tidspunkt i EU-medlemsstaterne Østrig, Belgien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Letland, Luxembourg, Malta, Nederlandene, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige samt i Island og Norge.
English: The company that markets these medicines is Astra Zeneca.
Danish: Den virksomhed, der markedsfører disse lægemidler, er Astra Zeneca.
English: The European Commission issued an EU-wide legally binding decision on 28 November 2014.
Danish: Europa-Kommissionen vedtog den 28. november 2014 en afgørelse, der er retligt bindende i hele EU.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom28 November 2014
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: What is EMLA cream?
Danish: Hvad er EMLA creme?
English: EMLA cream has been nationally authorised in EU Member States since 1984.
Danish: EMLA creme har været godkendt nationalt i EU's medlemsstater siden 1984.
English: The CHMP also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions for use), 4.6 (fertility, pregnancy and lactation) and 4.8 (side effects).
Danish: CHMP harmoniserede derudover andre punkter i produktresuméet, herunder 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (fertilitet, graviditet og amning) og 4.8 (bivirkninger).
English: EMLA cream is authorised in the EU via national procedures.
Danish: EMLA creme blev godkendt i EU via nationale procedurer.
English: It is used as a local anaesthetic to prevent pain during medical or superficial surgical procedures.
Danish: Den anvendes som lokalbedøvende middel til at forebygge smerter ved medicinske eller overfladiske kirurgiske indgreb.
English: Why was EMLA cream reviewed?
Danish: Hvorfor blev EMLA creme vurderet igen?
English: On 25 September 2014, the European Medicines Agency completed a review of EMLA cream.
Danish: Den 25. september 2014 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af EMLA creme.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses and the duration of application of EMLA cream before different medical or surgical procedures in children, adolescents or adults.
Danish: Efter harmonisering af indikationerne harmoniserede CHMP også anbefalingerne for dosis og varighed af påføringen af EMLA creme før forskellige medicinske eller kirurgiske indgreb hos børn, unge og voksne.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in differences in the SmPCs (Summary of Product Characteristics), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har ført til afvigelser mellem medlemsstaterne i den måde, lægemidlet kan anvendes på, hvilket fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de lande, hvor lægemidlet markedsføres.
English: In addition, information has been included to explain that studies did not show that EMLA cream is effective at providing adequate pain relief for circumcision (surgical removal of the foreskin).
Danish: Desuden er der indsat oplysninger med forklaring af, at undersøgelserne ikke viste, at EMLA creme er effektivt til at give tilstrækkelig smertelindring ved omskæring (kirurgisk fjernelse af forhuden).
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that EMLA cream can be used for the following:
Danish: Efter gennemgang af de foreliggende oplysninger, der dokumenterer lægemidlets anvendelse, fandt CHMP, at EMLA creme kan anvendes til følgende:
English: EMLA cream is a topical (skin) cream that contains the active substances lidocaine and prilocaine.
Danish: EMLA creme er en creme til anvendelse på huden og indeholder de aktive stoffer lidocain og prilocain.
English: In view of this, on 11 October 2013 the German medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for EMLA cream in the EU.
Danish: På denne baggrund indbragte den tyske lægemiddelstyrelse den 11. oktober 2013 sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for EMLA creme i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for EMLA cream in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for EMLA creme i Den Europæiske Union (EU).
English: The CHMP agreed that hypersensitivity (allergy) to lidocaine and/or prilocaine or similar local anaesthetics or to any other ingredients in EMLA cream should be the only contraindication.
Danish: CHMP fandt, at den eneste kontraindikation bør være overfølsomhed (allergi) over for lidocain og/eller prilocain eller tilsvarende lokalbedøvende midler eller et eller flere af de øvrige indholdsstoffer i EMLA creme.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: CHMP fandt på baggrund af de forelagte oplysninger og den videnskabelige drøftelse i udvalget det nødvendigt at harmonisere produktresuméer, etikettering og indlægssedler i EU.
English: • topical anaesthesia of the skin in adults and children;
Danish: • lokalbedøvelse (overfladeanalgesi) af huden hos voksne og børn
English: • topical anaesthesia of leg ulcers in adults only.
Danish: • lokalbedøvelse (overfladeanalgesi) af bensår udelukkende hos voksne.
English: • topical anaesthesia of the genital mucosa in adults and adolescents;
Danish: • lokalbedøvelse (overfladeanalgesi) af slimhinden på kønsdelene hos voksne og unge
English: This summary was last updated on 18/02/2011.
Danish: Dette sammendrag blev sidst ajourført den 18/02/2011.
English: Dogs can be treated for up to six months.
Danish: Hunde kan behandles i op til seks måneder.
English: The owner also noted pain-related observations.
Danish: Ejeren foretog ligeledes smerterelaterede observationer.