FrancophonIA/ELRC3.0 huggingface dataset:
English: Reassortant influenza virus* (live attenuated) of the following strain**:
Danish: Reassortant influenzavirus* (levende svækket) af følgende stamme **:
English: * propagated in fertilised hens' eggs from healthy chicken flocks.
Danish: * formeret i befrugtede hønseæg fra sunde hønsehold.
English: ** produced in VERO cells by reverse genetic technology.
Danish: ** produceret i VERO-celler ved revers genteknologi.
English: Nasal spray, suspension
Danish: Næsespray, suspension
English: 10 sprayers
Danish: 10 sprays
English: Nasal use sprayer (glass) in trays
Danish: Nasal anvendelse spray (glas) i bakker
English: EU/1/16/1089/001 Pandemic influenza vaccine H5N1 AstraZeneca
Danish: Pandemisk influenza- vaccine H5N1
English: Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage Indhold (Koncentration)
English: EMA Number
Danish: EMA's procedurenr
English: Inductos was authorised centrally in the EU in September 2002.
Danish: Inductos blev godkendt centralt i EU i september 2002.
English: Inductos to be suspended in the EU
Danish: Inductos suspenderes i EU
English: The review of Inductos was initiated on 23 July 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Inductos blev påbegyndt den 23. juli 2015 på anmodning af Europa-Kommissionen i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: • Patients who have any questions or concerns should speak to their healthcare professional.
Danish: • Patienter, der har spørgsmål eller betænkeligheder, bør kontakte lægen eller apotekspersonalet.
English: • There are alternative treatments available in the EU.
Danish: • Der er ingen andre tilsvarende behandlinger til rådighed i EU.
English: It was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Danish: Den blev foretaget af Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
English: Inductos to be suspended in the EU EMA/683814/2015
Danish: Inductos suspenderes i EU EMA/683814/2015
English: The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Danish: Inspektørerne bemærkede, at fremstilleren, der er hjemmehørende i USA, ikke traf tilstrækkelige foranstaltninger til at forhindre partikelforurening af svampene.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 20/11/2015.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som vedtog en endelig retligt bindende beslutning med gyldighed i alle EU-medlemsstater den 20/11/2015.
English: • Problems have been identified with the way the absorbable sponge in Inductos is manufactured.
Danish: • Der er konstateret problemer med den måde, den resorberbare svamp i Inductos fremstilles på.
English: The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og vedtog en retligt bindende beslutning.
English: The new bone tissue grows into the sponge, which is gradually degraded by the body.
Danish: Det nye knoglevæv vokser ind i svampen, som efterhånden nedbrydes af kroppen.
English: Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process.
Danish: Skønt der ikke er tegn på risiko for patienter i forbindelse med resultaterne, fandt EMA's Udvalg for Lægemidler til Mennesker (CHMP), at kvaliteten af Inductos ikke kan sikres med den nuværende fremstillingsproces.
English: The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.
Danish: CHMP konkluderede derfor, at Inductos bør suspenderes, indtil problemerne med fremstillingen er løst på tilfredsstillende vis.
English: The active substance is dibotermin alfa, a protein that acts on the bone structure and helps with the formation of new bone tissue.
Danish: Det aktive stof er dibotermin alfa, som er et protein, der virker på knoglestrukturen og medvirker til dannelsen af nyt knoglevæv.
English: EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements.
Danish: EMA begyndte sin gennemgang af Inductos, efter at de nederlandske og spanske myndigheder havde foretaget en inspektion, hvor det blev konstateret, at fremstillingsstedet for den resorberbare svamp ikke var i overensstemmelse med kravene til fremstilling.
English: On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures.
Danish: Den 22. oktober 2015 anbefalede Det Europæiske Lægemiddelagentur (EMA) suspendering af Inductos, der anvendes til at fremkalde vækst af nyt knoglevæv hos patienter med lidelser i rygsøjlens disci og med brækket ben.
English: Suspension will remain until manufacturing issues are resolved
Danish: Suspenderingen vil være i kraft indtil problemerne med fremstillingen er løst
English: Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
Danish: Inductos vil forblive suspenderet, indtil problemerne med fremstillingsstedet for en af komponenterne i Inductos (en resorberbar svamp) er løst.
English: • Although there is no indication of risk to patients, Inductos has been suspended and will no longer be available in the EU until issues with the manufacturing site for the absorbable sponge are solved.
Danish: • Selv om der ikke er tegn på risiko for patienterne, er markedsføringen af Inductos blevet stillet i bero, og lægemidlet vil ikke være på markedet i EU, før problemerne med fremstillingsstedet for den resorberbare svamp er løst.
English: Inductos is available as a kit for implant containing a powder, solvent and absorbable collagen sponge (or matrix).
Danish: Inductos er et implantationssæt, der indeholder et pulver, en opløsningsvæske og en resorberbar kollagensvamp (eller matrix).
English: It is used during surgery in patients with damaged spinal discs or leg (tibia) fractures.
Danish: Det anvendes under operation af patienter med beskadigede bruskskiver (disci) i rygsøjlen eller brud på skinnebenet.
English: In this study the majority of patients had a vital capacity less than 60%.
Danish: I denne undersøgelse havde flertallet af patienterne en vitalkapacitetsratio på mindre end 60%.
English: date of first authorisation: 10 June 1996 date of last renewal: 10 June 2006
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 10. juni 1996 Dato for seneste fornyelse: 10. juni 2006
English: About 90% of the dose is absorbed and the absolute bioavailability is 60 ± 18%.
Danish: Omkring 90% absorberes og den absolutte biotilgængelighed er 60 ± 18%.
English: Each package contains 56 tablets.
Danish: Hver pakning indeholder 56 tabletter.
English: The tablets should be taken by mouth, every 12 hours, at the same time of the day each day (e.g. in the morning and evening).
Danish: Du skal indtage tabletterne oralt hver 12. time, på samme tidspunkt af dagen hver dag (for eksempel om morgenen og om aftenen).
English: No malformations were seen in animal reproductive studies.
Danish: Der blev ikke observeret misdannelser i dyre-reproduktionsstudierne.
English: Glucuronides accounted for more than 85% of the metabolites in the urine.
Danish: Glucoroniderne udgør mere end 85% af metabolitterne i urinen.
English: Undesirable effects ranked under headings of frequency are listed below, using the following convention: very common (1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Følgende benævnelser anvendes: Meget almindelige (≥1/10), almindelige (≥1/100 til til <1/10), ikke almindelige (≥1/1.000 til <1/100), sjældne (≥1/10.000 til <1/1.000), meget sjældne (<1/10.000) og ikke kendte (kan ikke estimeres ud fra forhåndenværende data).
English: The overall urinary excretion accounts for about 90% of the dose.
Danish: Den samlede udskillelse i urinen udgør ca. 90% af dosis.
English: If you are less than 18 years of age, the use of RILUTEK is not recommended because there is no information available in this population.
Danish: Hvis du er under 18 år, anbefales det ikke, at du tager Rilutek, da der ikke er nogen information tilgængelig for denne patientgruppe.
English: RILUTEK stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Danish: Rilutek forhindrer frigivelsen af glutamat og dette kan hjælpe med at forebygge, at nerveceller bliver ødelagt.
English: Riluzole is about 97% protein bound and it binds mainly to serum albumin and to lipoproteins.
Danish: Riluzol er ca. 97% proteinbundet og bindes hovedsageligt til serumalbumin og lipoproteiner.
English: The rate and extent of absorption is reduced when riluzole is administered with high-fat meals (decrease in Cmax of 44%, decrease in AUC of 17%).
Danish: Hastigheden og graden af absorption reduceres, når riluzol gives med fedtholdige måltider (fald i Cmax på 44%, fald af AUC på 17%).
English: Therefore, RILUTEK should not be used in patients with any other form of motor neurone disease.
Danish: Derfor bør RILUTEK ikke bruges til patienter med andre former af motor-neuronsygdomme.
English: Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Danish: Få mere information hos din læge om ALS, og hvorfor du får denne medicin
English: Patients should be warned about the potential for dizziness or vertigo, and advised not to drive or operate machinery if these symptoms occur.
Danish: Patienter bør advares om muligheden for at blive svimle eller omtågede, og de bør opfordres til ikke at køre bil eller betjene maskiner, hvis disse symptomer opstår.
English: Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX02.
Danish: Terapeutisk klassifikation: Centralnervesystemet, øvrige lægemidler, ATC kode: N07XX02
English: Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population.
Danish: Med udgangspunkt i de farmakokinetiske undersøgelser, er der ingen særlige anvisninger for brug af RILUTEK i denne patientgruppe.
English: RILUTEK is available in a pack of 56 tablets to be taken orally.
Danish: Rilutek fås i en pakning af 56 tabletter til oral anvendelse.
English: RILUTEK has not been shown to be effective in the late stages of ALS.
Danish: RILUTEK er ikke vist at være effektiv i behandlingen af de sene stadier af ALS.
English: Tell your doctor immediately if you experience any fever (increase in temperature) because RILUTEK may cause a decrease in the number of white blood cells.
Danish: Kontakt straks din læge - Hvis du får nogen form for feber (forhøjet temperatur), da Rilutek kan medføre nedsættelse af antallet af hvide blodlegemer.
English: Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases.
Danish: Behandling med RILUTEK bør kun iværksættes af speciallæger med erfaring i behandling af motorneuronsygdomme.
English: What RILUTEK contains
Danish: Rilutek indeholder
English: IMPORTANT
Danish: VIGTIGT
English: There is no evidence that RILUTEK exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Danish: Der er intet bevis for, at RILUTEK udviser terapeutisk effekt på den motoriske funktion, på lungefunktion, facikulationer, muskelstyrke og motoriske symptomer.
English: RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Danish: RILUTEK anbefales ikke til pædiatriske patienter, pga. manglende data vedrørende riluzols sikkerhed og virkning ved neurodegenerative sygdomme hos børn og unge.
English: Sanofi Mature IP 54 rue La Boétie 75008 Paris France
Danish: Sanofi Mature IP 54 rue La Boétie 75008 Paris Frankrig
English: The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Danish: Tabletten er kapselformet, hvid og mærket ”RPR 202” på den ene side.
English: What you need to know before you take RILUTEK
Danish: Det skal du vide, før du begynder at tage Rilutek
English: if you experience cough or difficulties in breathing, as this may be a sign of lung disease (called interstitial lung disease).
Danish: - Hvis du får hoste eller besvær med at trække vejret, da dette kan være tegn på en lungesygdom (som hedder interstitiel lungesygdom).
English: Method of administration Oral use
Danish: Administration Oral anvendelse
English: The active substance in RILUTEK is riluzole which acts on the nervous system.
Danish: Hvad Riluteker Det aktive indholdsstof i Riluteker riluzol, som virker på nervesystemet.
English: Clinical trials have demonstrated that RILUTEK extends survival for patients with ALS (see section 5.1).
Danish: Kliniske undersøgelser har vist, at RILUTEK forlænger overlevelsen for patienter med ALS (se pkt.
English: You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Danish: Du kan køre bil og anvende værktøj og maskiner, når du tager Rilutek, medmindre du føler dig svimmel eller omtåget.
English: Other medicines and RILUTEK Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Rilutek Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Film-coated tablet
Danish: Filmovertrukken tablet.
English: If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Danish: Hvis der opstår respiratoriske symptomer som tør hoste og/eller dyspnø, bør der tages et røgtenbillede af brystkassen, og ved tegn på eventuelle interstitielle lungesygdomme (f.eks. bilaterale diffuse lungeinfiltrater) bør behandling med riluzol seponeres øjeblikkeligt.
English: Each tablet contains 50 mg of riluzole and is engraved with “RPR 202” on one side.
Danish: Hver tablet indeholder 50 mg riluzol og har ”RPR 202” præget på den ene side af tabletten.
English: RILUTEK is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Danish: RILUTEK anvendes for at forlænge livet eller tiden indtil mekanisk ventilation hos patienter med amyotrofisk lateral sclerose (ALS).
English: France sanofi-aventis France
Danish: Sanofi-aventis France
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Hvis du har glemt at tage Rilutek Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Sanofi Winthrop Industrie 56, Route de Choisy au Bac 60205 Compiègne France
Danish: Sanofi Winthrop Industrie 56, Route de Choisy au Bac, 60205 Compiègne Frankrig
English: Very common side effects (may affect more than 1 in 10 people) of RILUTEK are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) af Riluteker: - Træthed - Kvalme - Forføjet niveau af nogle enzymer (aminotransferaser) i blodet.
English: Marketing Authorisation Holder Sanofi Mature IP
Danish: Indehaver af markedsføringstilladelsen Sanofi Mature IP
English: RILUTEK is used in patients with amyotrophic lateral sclerosis (ALS).
Danish: Hvad Rilutekanvendes til Rilutekanvendes til patienter med amyotrofisk lateral sclerose (ALS).
English: In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Danish: I et dobbelt-blindt placebo kontrolleret studie, der var designet til at undersøge effekt og sikkerhed hos japanske patienter, blev 204 patienter randomiseret til enten 100 mg riluzol/dag (50 mg 2 gange daglig) eller placebo.
English: Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Danish: Sanofi-aventis Norge AS Tlf: +47 67 10 71 00
English: Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Danish: Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
English: You MUST NOT take RILUTEK if you are or think you may be pregnant, or if you are breast-feeding.
Danish: Graviditet, amning og frugtbarhed Du må ikke tage Rilutek, hvis du er gravid eller ammer, eller har mistanke om, at du er gravid.
English: RILUTEK is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Danish: RILUTEK kan ikke anbefales til patienter med nedsat nyrefunktion, da der ikke er foretaget undersøgelser med gentagne doseringer hos denne patientgruppe (se pkt.
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Danish: Sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
English: Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
Danish: Sanofi-aventis Estonia OÜ Tel: +372 627 34 88
English: If you take too many tablets, contact your doctor or the nearest hospital emergency department immediately.
Danish: Hvis du har taget for mange Rilutek Hvis du har taget for mange tabletter, skal du straks kontakte læge eller skadestue.
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00
Danish: Sanofi-aventis AEBE Τηλ: +30 210 900 16 00
English: Latvija sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
Danish: Sanofi-aventis Latvia SIA Tel: +371 67 33 24 51
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi Mature IP
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Sanofi Mature IP
English: España sanofi-aventis, S.A. Tel: +34 93 485 94 00
Danish: Sanofi-aventis, S.A. Tel: +34 93 485 94 00
English: if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking RILUTEK to make sure that this does not occur.
Danish: - Hvis du får nogen af følgende symptomer: Gulfarvning af huden eller det hvide i øjnene (gulsot), kløe over hele kroppen, du føler dig syg, eller kaster op, da dette kan være tegn på leverbetændelse (hepatitis).
English: Renal impairment Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Danish: Nedsat nyrefunktion Der ikke udført undersøgelser med gentagne doseringer hos patienter med nedsat nyrefunktion (se pkt.
English: Core:
Danish: Overtræk:
English: Uncommon side effects (may affect up to 1 in 100 people) of RILUTEK are:
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) af Riluteker: Svimmelhed
English: If you think you may be pregnant, or if you intend to breast-feed, ask your doctor for advice before taking RILUTEK.
Danish: Hvis du har mistanke om, du er gravid, eller hvis du overvejer at amme, skal du diskutere det med din læge.
English: Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Danish: theophyllin, amitriptylin, og quinoloner) kan potentielt nedsætte riluzols eliminations-hastighed, hvorimod stoffer, der fremmer CYP1A2 (f.eks. cigaretrygning, grillmad, rifampicin og omeprazol) kan øge eliminationshastigheden af riluzol.
English: RILUTEK is contraindicated in pregnancy (see sections 4.3 and 5.3).
Danish: RILUTEK er kontraindiceret under graviditeten (se pkt.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs indlægssedlen inden brug.
English: How to take RILUTEK
Danish: Sådan skal du tage Rilutek
English: RILUTEK 50 mg film-coated tablets Riluzole
Danish: Rilutek 50 mg, filmovertrukne tabletter Riluzol
English: Oral use SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children.
Danish: SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
English: Hrvatska sanofi-aventis Croatia d.o.o.
Danish: Sanofi-aventis Croatia d.o.o.
English: NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole
Danish: LÆGEMIDLETS NAVN RILUTEK 50 mg filmovertrukne tabletter riluzol
English: Do not take RILUTEK if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases), if you are pregnant or breast-feeding.
Danish: Tag ikke Rilutek - hvis du er allergisk over for riluzol eller et af de øvrige indholdsstoffer i Rilutek (angivet i punkt 6).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON NAME OF THE MEDICINAL PRODUCT RILUTEK 50 mg film-coated tablets riluzole STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 50 mg of riluzole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En filmovertrukken tablet indeholder 50 mg riluzol
English: RILUTEK is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Danish: RILUTEK er kontraindiceret til ammende kvinder (se pkt.
English: Slovenija sanofi-aventis d.o.o.
Danish: Sanofi-aventis d.o.o.
English: What RILUTEK is and what it is used for What you need to know before you take RILUTEK How to take RILUTEK
Danish: Det skal du vide, før du begynder at tage Rilutek Sådan skal du tage Rilutek Bivirkninger
English: Polska sanofi-aventis Sp. z o.o.
Danish: Sanofi-aventis Sp. Z o.o.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF 11.
English: Common side effects (may affect up to 1 in 10 people) of RILUTEK are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) af Riluteker: - Blodmangel - Allergiske reaktioner - Betændelse i bugspytkirtlen (pancreatitis).
English: Safety and efficacy of RILUTEK has only been studied in ALS.
Danish: Sikkerhed og effekt af RILUTEK ved andre motor-neuronsygdomme end ALS er ikke undersøgt.
English: Impaired hepatic function
Danish: Mave-tarm-kanalen Kvalme
English: Sanofi S.p.A. Tel: 800 536389
Danish: Tel: 800 536389