FrancophonIA/ELRC3.0 huggingface dataset:
English: The Reference Member State for this MRP was Ireland with Austria, Belgium, Denmark, Germany, Greece, Finland, Iceland, Italy, Luxembourg, Norway, Portugal, Spain, and Sweden as Concerned Member States.
Danish: Referencemedlemsstaten under den gensidige anerkendelsesprocedure er Irland med Østrig, Belgien, Danmark, Tyskland, Grækenland, Island, Italien, Luxembourg, Norge, Portugal, Spanien og Sverige som berørte medlemsstater.
English: Supplementary information was provided by the Marketing Authorisation Holder on 11 November 2002 and further written explanations on 5 February 2003.
Danish: Indehaveren af markedsføringstilladelsen fremsendte yderligere oplysninger den 11. november 2002 og fremsendte yderligere skriftlige redegørelser den 5. februar 2003.
English: The scientific conclusions and the grounds for the amendment of the Summary of Product Characteristics are set out in Annex II.
Danish: De faglige konklusioner og begrundelserne for ændringen af produktresuméet fremgår af bilag II.
English: Primary hyperhydrosis is a chronic idiopathic disorder of excessive and uncontrolled sweating.
Danish: Primær hyperhydrosis er en kronisk idiopatisk sygdom med kraftig og ukontrollerbar sveden.
English: In June 2002, the Marketing Authorisation Holder, Allergan Pharmaceuticals (Ireland) Ltd applied for a new indication through Mutual Recognition Procedure (MRP), for Botox for the treatment of axillary hyperhidrosis.
Danish: I juni 2002 ansøgte Allergan Pharmaceuticals (Irland) Ltd, indehaveren af markedsføringstilladelsen, om en ny indikation under proceduren for gensidig anerkendelse af markedsføringstilladelserne for Botox vedrørende behandling af aksillær hyperhidrosis.
English: On September 3rd 2002 a referral for arbitration according to article 29 of Directive 2001/83/EC was triggered by Germany and Italy regarding the major objections on the clinical safety and efficacy of this new indication for the medicinal product Botox.
Danish: Den 3. september 2002 blev der i henhold til artikel 29 i direktiv 2001/83/EF indbragt en sag med henblik på voldgift af Tyskland og Italien, som berørte væsentlige indsigelser vedrørende virkning og klinisk sikkerhed af lægemidlet Botox til den nye indikation.
English: Botox was first licensed in the European Union in 1994 for neuromuscular disorders via intramuscular route.
Danish: Botox blev godkendt første gang i Den Europæiske Union i 1994 til intramuskulær behandling af neuromuskulære lidelser.
English: The CPMP, having considered the points of disagreement and the responses provided by the Marketing Authorisation Holder, was of the opinion that the objections raised by Germany and Italy should not prevent the granting of a Marketing Authorisation for the new indication “persistent severe primary hyperhidrosis of the axillae, which interferes with the activities of daily living and is resistant to topical treatment” subject to certain essential conditions for the safe and effective use of the medicinal product.
Danish: Efter at CPMP har behandlet de punkter, hvorom der er uenighed, og de svar, der er afgivet af indehaveren af markedsføringstilladelsen, er CPMP af den opfattelse, at de af Tyskland og Italien rejste indsigelser ikke bør forhindre udstedelse af en markedsføringstilladelse for den nye indikation, forudsat at en række vigtige betingelser til sikring af en sikker og effektiv anvendelse af lægemidlet er opfyldt.
English: The mechanism of action of Botox in hyperhidrosis is thought to be the inhibition of cholinergically-induced excessive sweating by blockage of autonomic sympathetic nerve fibres innervating sweat glands.
Danish: Virkemåden for Botox ved hyperhidrosis anses for at være hæmning af kolinergt induceret heftig sveden ved at blokere de autonome sympatiske nervefibre, som innerverer svedkirtlerne.
English: Botox [Clostridium botulinum toxin type A neurotoxin complex] inhibits the release of acetylcholine at the presynaptic membrane on cholinergic neurons.
Danish: Botox [Clostridium botulinum toksin type A neurotoksinkompleks] hæmmer frigivelse af acetylkolin ved præsynaptisk membran på kolinerge neuroner.
English: COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) SUMMARY INFORMATION ON REFERRAL OPINION FOLLOWING ARBITRATION PURSUANT TO ARTICLE 29 OF COUNCIL DIRECTIVE 2001/83/EC FOR
Danish: UDVALGET FOR FARMACEUTISKE SPECIALITETER (CPMP) SAMMENFATTENDE OPLYSNINGER OM UDTALELSEN OM DEN INDBRAGTE SAG EFTER VOLDGIFTEN I HENHOLD TIL ARTIKEL 29 I DIREKTIV 2001/83/EF BOTOX Aktivt stof: Clostridium botulinum type A neurotoksinkompleks
English: Further information).
Danish: Yderligere oplysninger).
English: In addition, an updated RMP should be submitted:
Danish: Desuden skal der fremsendes en opdateret RMP:
English: Risk Management plan (RMP)
Danish: Risikostyringsprogram (RPM)
English: Please consult the Product Information of:
Danish: Se venligst produktinformationen for:
English: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italy
Danish: Loc. Bellaria - 53018 Rosia - Sovicille (SI) Italien
English: Influenza vaccine, ATC Code: J07BB02
Danish: Influenzavaccine, ATC-kode: J07BB02
English: Adverse reactions reported are listed according to the following frequency: Very common (1/10),
Danish: De rapporterede bivirkninger er opstillet efter følgende hyppighed: Meget almindelig (1/10),
English: Tell your doctor if you have any known allergies.
Danish: Fortæl det til lægen, hvis du har nogen kendte allergier.
English: None of the ingredient in the vaccine can cause flu.
Danish: Ingen af ingredienserne i vaccinen kan give influenza.
English: Immunisation should be postponed in patients with severe febrile illness or acute infection.
Danish: Immunisering bør udskydes hos patienter med alvorlig febril sygdom eller akut infektion.
English: In such cases, you should be aware that the side effects may be more intense.
Danish: I sådanne tilfælde skal du være klar over, at bivirkningerne kan være mere intense.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Lægerne er opmærksomme på denne mulighed og har nødbehandling til rådighed i disse tilfælde.
English: Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
Danish: Co-administration blev ikke associeret med højere forekomster af lokale eller systemiske reaktioner sammenlignet med administration af Focetria alene.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: A clinical study was conducted with the same vaccine in children.
Danish: Der blev udført et klinisk studie hos børn med den samme vaccine.
English: • if you have a severe infection with a high temperature (over 38°C).
Danish: - hvis du har en alvorlig infektion og feber (temperatur over 38 °C).
English: In such cases, the Western Blot method is negative.
Danish: I disse tilfælde vil Western Blot-teknikken give et negativt resultat.
English: Induration was a common reaction in toddlers but was less common in infants.
Danish: Induration var en almindelig reaktion hos børn, men mindre almindelig hos spædbørn.
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Danish: CHMP er enig i PRAC's videnskabelige konklusioner.
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
Danish: • Når der modtages nye oplysninger, der kan have indflydelse på den gældende sikkerhedsspecifikation, lægemiddelovervågningsplan eller på risikominimeringsaktiviteter
English: There were fewer reactions after the second vaccination compared with the first.
Danish: Der var færre bivirkninger efter den anden vaccination end efter den første.
English: • Official batch release In accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: The common reactions usually disappear within 1-2 days without treatment.
Danish: De almindelige reaktioner forsvinder som regel inden for 1-2 dage uden behandling.
English: The immune response to the seasonal antigens was satisfactory.
Danish: Immunresponset over for sæsonbetingede antigener var tilfredsstillende.
English: Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters.
Danish: Der findes sikkerhedsdata for gravide kvinder, som er blevet eksponeret for Focetria, især under andet og tredje trimester.
English: The vaccine contains an ‘adjuvant' (MF59C.1) to stimulate a better response.
Danish: Vaccinen indeholder et ‘adjuvans' (MF59C.1), der skal stimulere en bedre reaktion.
English: Pharmacotherapeutic group: Vaccines.
Danish: Farmakoterapeutisk klassifikation: Vacciner.
English: This is a multidose container.
Danish: Dette er en flerdosisbeholder.
English: It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines.
Danish: Det er almindeligt accepteret, at adjuvanseffekten, som medfører øget immunogenicitet, er forbundet med en let forøget hyppighed af lokale reaktioner (især lette smerter) sammenlignet med konventionelle, ikke-adjuverede influenzavacciner.
English: The vaccine will be injected into a muscle (usually in the upper arm).
Danish: Vaccinen vil blive sprøjtet ind i en muskel (normalt i overarmen).
English: These side effects usually disappear within 1-2 days without treatment.
Danish: Disse bivirkninger forsvinder normalt i løbet af 1-2 dage uden behandling.
English: These side effects may occur with Focetria.
Danish: Disse bivirkninger kan opstå i forbindelse med Focetria.
English: Packs of 1 and 10.
Danish: Pakninger med 1 og 10.
English: The PSUR cycle for the medicinal product should follow a half-yearly cycle until otherwise agreed by the CHMP
Danish: Lægemidlets PSUR-cyklus skal følge en halvårlig cyklus, indtil andet aftales med CHMP.
English: Focetria should be used in accordance with Official Guidance.
Danish: Focetria bør anvendes i overensstemmelse med officielle retningslinjer.
English: Taking into account the PRAC Assessment Report on the PSUR for Focetria, the scientific conclusions of PRAC are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'erne for Focetria er PRAC nået frem til følgende videnskabelige konklusioner:
English: In addition, the side effects listed below have occurred in the days or weeks after vaccination with adjuvanted and non-adjuvanted vaccines given routinely every year to prevent flu.
Danish: Herudover er bivirkningerne i listen nedenfor er opstået i dagene eller ugerne efter vaccinationen med adjuverede og ikke-adjuverede vacciner, som gives rutinemæssigt en gang om året for at forebygge influenza.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Danish: • Senest 60 dage efter en vigtig milepæl er nået (lægemiddelovervågning eller risikominimering)
English: Systemic
Danish: Systemisk
English: These transitory false positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk-positive reaktioner kan skyldes produktion af IgM som respons på vaccinen.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som med alle injicerbare vacciner skal relevant medicinsk behandling samt mulighed for overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter indgift af vaccinen.
English: Fever ≥ 40° C
Danish: Feber ≥ 40° C
English: In the clinical studies with the vaccine, most side effects were mild in nature and short term.
Danish: I de kliniske studier med vaccinen var de fleste bivirkninger milde og kortvarige.
English: Adjuvant MF59C.1 containing: squalene
Danish: Adjuvans MF59C.1, som indeholder: squalen
English: 9.75 milligrams polysorbate 80
Danish: 9,75 milligram polysorbat 80
English: Vasculitis with transient renal involvement and exudative erythema multiforme.
Danish: Vasculitis med forbigående nyrepåvirkning og ekssudativ erythema multiforme.
English: Therefore, in view of available data regarding the use of Focetria during pregnancy, the PRAC considered that changes to the product information were warranted.
Danish: I lyset af de tilgængelige data vedrørende anvendelse af Focetria under graviditet vurderede PRAC derfor, at ændringerne i produktresumeet var berettigede.
English: Side effects from clinical studies in children
Danish: Bivirkninger under kliniske studier med børn
English: Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines.
Danish: De fleste reaktioner var milde, kortvarige og kvalitativt på samme niveau som dem, der blev induceret af konventionelle sæson-influenzavacciner.
English: Health care providers need to assess the benefits and potential risks of administering Focetria vaccine to pregnant women, taking into consideration official recommendations.
Danish: Sundhedspersonalet skal afveje fordelene i forhold til de potentielle risici ved at administrere Focetria vaccine til gravide kvinder under hensyntagen til de officielle anbefalinger.
English: 21 days after 2nd dose (day 43)
Danish: 21 dage efter 2. dosis (dag 43)
English: Safety data after the first and second dose in children and adolescents suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation.
Danish: Sikkerhedsdata efter første og anden dosis i børn og unge indikerer en tilsvarende sikkerhedsprofil som rapporteret for H5N1 mock-up vaccine-formuleringen.
English: Italy.
Danish: Italien.
English: • if you are having a blood test to look for evidence of infection with certain viruses.
Danish: - hvis du skal have taget en blodprøve for at afgøre, om du har bestemte virusinfektioner.
English: • The minimal data elements to be transmitted in individual case safety reports in order to facilitate the evaluation and the identification of the vaccine administered to each subject, including the invented name, the vaccine manufacturer and the batch number.
Danish: • De dataelementer, der som minimum skal oplyses i individuelle sikkerhedsindberetninger for at muliggøre evaluering og identificering af den specifikke vaccine, der er anvendt til hver enkelt person, herunder produktnavn, producenten af vaccinen og batchnummeret.
English: Focetria contains
Danish: Focetria indeholder
English: A minor infection such as a cold should not be a problem, but your doctor or nurse should advise whether you could still be vaccinated with Focetria,
Danish: En mindre infektion, såsom en forkølelse, er normalt ikke nogen hindring, men din læge eller sygeplejerske afgør, om du alligevel kan vaccineres med Focetria.
English: The side effects listed below have occurred in the days or weeks after vaccination with Focetria.
Danish: Bivirkningerne i listen nedenfor er opstået i dagene eller ugerne efter vaccinationen med Focetria.
English: Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy.
Danish: Spontant rapporterede bivirkninger efter markedsføringen, et interventionsstudie og store observationsstudier indikerer ikke direkte eller indirekte skadelige påvirkninger hos gravide, der eksponeres for Focetria.
English: Children aged less than 6 months of age: Vaccination is currently not recommended in this age group.
Danish: Børn under 6 måneder: Det anbefales ikke at vaccinere denne aldersgruppe
English: Instructions for administration of the vaccine:
Danish: Instruktioner i indgivelse af vaccinen:
English: • Safety and immunogenicity data obtained after administration of a one or two doses of Focetria
Danish: • Sikkerheds- og immunogenicitetsdata indhentet efter administration af en eller to doser Focetria
English: Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C (36° and 46° F).
Danish: Mellem hver brug returneres multidosishætteglas til anbefalede opbevaringsbetingelser mellem 2 og 8° C (36° og 46° F).
English: The side effects listed below have occurred with Focetria in clinical studies in adults, including the elderly:
Danish: Bivirkningerne nedenfor er opstået under kliniske studier med Focetria hos voksne, inklusive ældre:
English: Vaccination is not currently recommended in this age group.
Danish: Det anbefales ikke at vaccinere denne aldersgruppe.
English: • Studies in adults and elderly
Danish: • Studier hos voksne og ældre
English: Store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2° C - 8° C).
English: Immunogenicity data obtained at three weeks after one dose of Focetria H1N1v suggest that a single dose may be sufficient.
Danish: Immunogenicitetsdata, indhentet tre uger efter en dosis Focetria H1N1v, indikerer, at en enkelt dosis kan være tilstrækkeligt.
English: Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion.
Danish: Det er vigtigt at være særlig opmærksom på personer, der lider af epilepsi, og lægen skal informere personerne (eller forældrene) om risikoen for at opleve kramper (se pkt.
English: Dispose of in accordance with local requirements
Danish: Bortskaffes i henhold til lokale krav.
English: Like all medicines, Focetria can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Rare: Transient thrombocytopenia.
Danish: Sjælden: Forbigående trombocytopeni.
English: Citric acid,
Danish: Citronsyre,
English: Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Danish: Data fra vaccinationer med sæsonbestemte inaktiverede trivalente vacciner hos gravide kvinder indikerer heller ikke, at negative resultater hos føtus eller moder skyldtes vaccinen.
English: The side-effects are generally similar to those related to the seasonal flu vaccine.
Danish: Bivirkningerne ligner generelt dem, der også opstår i forbindelse med vaccinen mod sæsonbetinget influenza.
English: Data are available that suggest that multidose vials could be used up to a maximum of 72 hours after first withdrawal, although such pro-longed storage periods should not be the preferred option.
Danish: Data antyder, at multidosishætteglas kan anvendes op til maksimalt 72 timer efter første udtrækning, men en sådan forlænget opbevaring bør ikke udgøre en foretrukket måde.
English: It should be noted that the adverse reactions may be intensified.
Danish: Det bør bemærkes, at bivirkningerne i så fald kan forstærkes.
English: This medicinal contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per 0.5 ml dose, i.e. essentially sodium- and potassium free.
Danish: Dette lægemiddel indeholder mindre en 1 mmol natrium (23 mg) og mindre end 1 mmol kalium (39 mg) per 0,5 ml dosis, hvilket betyder, at det i princippet er natrium- og kaliumfrit.
English: • The MAH shall agree with Member States to measures facilitating the identification and traceability of the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients and health care professionals to report adverse reactions.
Danish: • Indehaveren af markedsføringstilladelsen skal sammen med medlemslandene indgå aftale om tiltag, der vil gøre det lettere at identificere og spore A/H1N1-vaccinen, som administreres til den enkelte patient, for derved at reducere medicineringsfejl og hjælpe patienter og sundhedspersonale med at indberette bivirkninger.
English: Nervous system disorders Very common: headache Rare: convulsions
Danish: Nervesystemet Meget almindelig: hovedpine Sjælden: konvulsioner
English: 1.175 milligrams sorbitan trioleate
Danish: 1,175 milligram sorbitantrioleat
English: - The active substance is:
Danish: - Aktivt stof:
English: Children aged less than 6 months:
Danish: Børn under 6 måneder:
English: You or your child will receive one dose of 0.5 ml vaccine.
Danish: Du eller dit barn vil modtage én dosis på 0,5 ml vaccine.
English: 10 x 10 doses of 0.5 ml vaccine (5 ml)
Danish: 10 x 10-doser på 0,5 ml vaccine (5 ml)
English: Very common reactions reported in 233 infants and toddlers 6 to 35 months of age:
Danish: Meget almindelige reaktioner hos 233 spædbørn og børn mellem 6 og 35 måneder:
English: The physician should inform you about the possibility to experience convulsion, in particular if you have had previous history of epilepsy.
Danish: Lægen bør oplyse dig om, at der kan være en risiko for, at du får kramper, særlig hvis du tidligere har haft krampeanfaldi.
English: - Via Fiorentina, 1 - Siena, Italy.
Danish: - Via Fiorentina, 1 - Siena, Italien.
English: * propagated in eggs ** expressed in microgram haemagglutinin.
Danish: * dyrket i æg ** udtrykt i mikrogram hæmagglutinin
English: Record date and time of the first dose withdrawal on the vial label.
Danish: Registrér dato og klokkeslet for første udtagning af dosis på mærkaten.
English: The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects.
Danish: Doseringsanbefalingerne er baseret på sikkerheds- og immunogenicitetsdata fra kliniske studier med raske forsøgspersoner.
English: Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
Danish: Der er indberettet tilfælde af kramper med og uden feber hos personer, der var blevet vaccineret med Focetria.
English: Based on the findings of an observational study conducted in >2000 pregnant women, reflecting the use of Focetria in pregnant women, influenza A (H1N1) vaccination with Focetria does not seem to be associated with an increased risk of adverse pregnancy outcomes, especially in the second or third trimesters of pregnancy.
Danish: Baseret på resultaterne fra et observationsstudie med deltagelse af >2.000 gravide, som afspejler brug af Focetria hos gravide kvinder, er influenza A (H1N1) vaccination med Focetria, især i andet og tredje trimester af graviditeten, tilsyneladende ikke forbundet med øget risiko for negative graviditetsresultater.
English: Elderly: A dose (0.5 ml) of the vaccine and a second dose of 0.5 ml at least three weeks later.
Danish: Ældre: Én dosis (0,5 ml) af vaccinen og endnu en dosis på 0,5 ml efter mindst tre uger.
English: Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Danish: Det overlades til sundhedspersonalet at vurdere fordelene og de potentielle risici ved administration af vaccinen til personer, der lider af trombocytopeni eller anden blødningslidelse, der kontraindikerer intramuskulær injektion, medmindre den potentielle fordel opvejer risikoen for blødninger.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE