FrancophonIA/ELRC3.0 huggingface dataset:
English: Instanyl 100 micrograms nasal spray, solution in single-dose container EU/1/09/531/014-017
Norwegian Bokmål: Instanyl 100 mikrogram nesespray, oppløsning i endosebeholder EU/1/09/531/014-017
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 July 2009
Norwegian Bokmål: DATO FOR FØRSTE MARKEDSFØRINGSTILLATELSE / SISTE FORNYELSE
English: Instanyl 200 micrograms/dose nasal spray, solution EU/1/09/531/007-009
Norwegian Bokmål: Instanyl 200 mikrogram/dose nesespray, oppløsning EU/1/09/531/007-009
English: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Norwegian Bokmål: 1 ml inneholder fentanylsitrat tilsvarende 1000 mikrogram fentanyl.
English: Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/022-025
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning EU/1/09/531/022-025
English: Always place the nasal spray in the child-resistant box after use.
Norwegian Bokmål: Legg alltid nesesprayen i esken med barnesikring etter bruk.
English: You should wait for 4 hours before treating the next episode of breakthrough pain.
Norwegian Bokmål: Du bør vente i 4 timer før du bruker nesesprayen mot gjennombruddssmerter igjen.
English: 1 dose of 100 microlitres equals 200 micrograms fentanyl.
Norwegian Bokmål: 1 spray á 100 mikroliter tilsvarer 200 mikrogram fentanyl.
English: 50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Norwegian Bokmål: 50 mikrogram/dose: 1 ml inneholder fentanylsitrat tilsvarende 500 mikrogram fentanyl.
English: 100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Norwegian Bokmål: 100 mikrogram/dose: 1 ml inneholder fentanylsitrat tilsvarende 1000 mikrogram fentanyl.
English: Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/001-003
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning EU/1/09/531/001-003
English: • For the multi-dose nasal spray: information about the dose counting scheme.
Norwegian Bokmål: • Informasjon om dosetellingsskjemaet for multidose nesespray.
English: Instanyl 50 micrograms nasal spray, solution in single-dose container EU/1/09/531/010-013
Norwegian Bokmål: Instanyl 50 mikrogram nesespray, oppløsning i endosebeholder EU/1/09/531/010-013
English: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Norwegian Bokmål: 1 ml inneholder fentanylsitrat tilsvarende 2000 mikrogram fentanyl.
English: 200 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms fentanyl.
Norwegian Bokmål: 200 mikrogram: 1 dose (100 mikroliter) inneholder fentanylsitrat tilsvarende 200 mikrogram fentanyl.
English: 200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Norwegian Bokmål: 200 mikrogram/dose: 1 ml inneholder fentanylsitrat tilsvarende 2000 mikrogram fentanyl.
English: Instanyl 50 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 50 micrograms fentanyl.
Norwegian Bokmål: Instanyl 50 mikrogram nesespray, oppløsning i endosebeholder Hver nesespraybeholder inneholder én dose (100 mikroliter) fentanylsitrat tilsvarende 50 mikrogram fentanyl.
English: 3.2 ml containing 6.40 mg fentanyl ensuring the delivery of 20 doses of 200 micrograms 4.3 ml containing 8.60 mg fentanyl ensuring the delivery of 30 doses of 200 micrograms 5.3 ml containing 10.60 mg fentanyl ensuring the delivery of 40 doses of 200 micrograms
Norwegian Bokmål: 4,3 ml inneholdende 8,60 mg fentanyl som sikrer levering av 30 doser på 200 mikrogram.
English: 50 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms fentanyl.
Norwegian Bokmål: 50 mikrogram: 1 dose (100 mikroliter) inneholder fentanylsitrat tilsvarende 50 mikrogram fentanyl.
English: Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/026-029
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning EU/1/09/531/026-029
English: Instanyl 200 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 200 micrograms fentanyl.
Norwegian Bokmål: Instanyl 200 mikrogram nesespray, oppløsning i endosebeholder Hver nesespraybeholder inneholder én dose (100 mikroliter) fentanylsitrat tilsvarende 200 mikrogram fentanyl.
English: What Instanyl looks like and contents of the pack Instanyl is a nasal spray, solution.
Norwegian Bokmål: Hvordan Instanyl ser ut og innholdet i pakningen
English: The labelling of the three Instanyl strengths is differentiated by colour: 50 micrograms/dose labelling is orange.
Norwegian Bokmål: Instanylstyrkene er atskilt med forskjellige farger: 50 mikrogram/dose er orange 100 mikrogram/dose er lilla 200 mikrogram/dose er grønnblå
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray, solution in single-dose container Fentanyl
Norwegian Bokmål: Instanyl 50 mikrogram nesespray, oppløsning i endosebeholder fentanyl
English: 1 dose of 100 microlitres equals 50 micrograms fentanyl.
Norwegian Bokmål: 1 spray á 100 mikroliter tilsvarer 50 mikrogram fentanyl.
English: 1 dose of 100 microlitres equals 100 micrograms fentanyl.
Norwegian Bokmål: 1 spray á 100 mikroliter tilsvarer 100 mikrogram fentanyl.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray, solution in single-dose container Fentanyl
Norwegian Bokmål: Instanyl 200 mikrogram nesespray, oppløsning i endosebeholder Fentanyl
English: 1 dose (100 microlitres) contains 200 micrograms fentanyl.
Norwegian Bokmål: 1 dose (100 mikroliter) inneholder 200 mikrogram fentanyl.
English: Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/004-006
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning EU/1/09/531/004-006
English: 100 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms fentanyl.
Norwegian Bokmål: 100 mikrogram: 1 dose (100 mikroliter) inneholder fentanylsitrat tilsvarende 100 mikrogram fentanyl.
English: Your single-dose container is now empty
Norwegian Bokmål: • Endosebeholderen er nå tom.
English: What Instanyl looks like and contents of the pack Instanyl DoseGuard is a nasal spray, solution.
Norwegian Bokmål: Instanyl DoseGuard er en nesespray, oppløsning.
English: Suomi/Finland Takeda Oy
Norwegian Bokmål: Takeda Oy
English: 1 dose (100 microlitres) contains 50 micrograms fentanyl.
Norwegian Bokmål: 1 dose (100 mikroliter) inneholder 50 mikrogram fentanyl.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda Pharma A/S
Norwegian Bokmål: Takeda Pharma A/S
English: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms (mcg) fentanyl
Norwegian Bokmål: 1 dose (100 mikroliter) inneholder fentanylsitrat tilsvarende 200 mikrogram fentanyl
English: Instanyl 50 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning 1 ml inneholder fentanylsitrat tilsvarende 500 mikrogram fentanyl.
English: Preparing the Instanyl nasal spray
Norwegian Bokmål: Klargjøring av Instanyl nesespray
English: Instanyl 100 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 100 micrograms fentanyl.
Norwegian Bokmål: Instanyl 100 mikrogram nesespray, oppløsning i endosebeholder Hver nesespraybeholder inneholder én dose (100 mikroliter) fentanylsitrat tilsvarende 100 mikrogram fentanyl.
English: 1.8 ml containing 0.90 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 2.9 ml containing 1.45 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 5.0 ml containing 2.50 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms
Norwegian Bokmål: 2,9 ml inneholdende 1,45 mg fentanyl som sikrer levering av 20 doser på 50 mikrogram.
English: 1 dose (100 microlitres) contains 100 micrograms fentanyl.
Norwegian Bokmål: 1 dose (100 mikroliter) inneholder 100 mikrogram fentanyl.
English: Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution fentanyl
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning Instanyl 100 mikrogram/dose nesespray, oppløsning Instanyl 200 mikrogram/dose nesespray, oppløsning
English: During the priming process product will be expelled.
Norwegian Bokmål: Under klargjøringen vil det avgis legemiddel.
English: Instanyl 200 micrograms/dose nasal spray, solution.
Norwegian Bokmål: Instanyl 200 mikrogram/dose nesespray, oppløsning DoseGuard
English: NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray, solution in single-dose container Fentanyl
Norwegian Bokmål: Instanyl 100 mikrogram nesespray, oppløsning i endosebeholder fentanyl
English: Instanyl 50 micrograms/dose nasal spray, solution.
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning
English: NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray Fentanyl
Norwegian Bokmål: Instanyl 100 mikrogram nesespray Fentanyl
English: NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray Fentanyl
Norwegian Bokmål: Instanyl 200 mikrogram nesespray fentanyl
English: 1.8 ml containing 1.80 mg fentanyl ensuring the delivery of 10 doses of 100 micrograms 2.9 ml containing 2.90 mg fentanyl ensuring the delivery of 20 doses of 100 micrograms 5.0 ml containing 5.00 mg fentanyl ensuring the delivery of 40 doses of 100 micrograms
Norwegian Bokmål: 1,8 ml inneholdende 0,90 mg fentanyl som sikrer levering av 10 doser på 50 mikrogram.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray Fentanyl
Norwegian Bokmål: Instanyl 50 mikrogram nesespray fentanyl
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Instanyl 100 micrograms/dose nasal spray, solution Instanyl 200 micrograms/dose nasal spray, solution
Norwegian Bokmål: Pakningsvedlegg: Informasjon til brukeren Instanyl 50 mikrogram/dose nesespray, oppløsning Instanyl 100 mikrogram/dose nesespray, oppløsning Instanyl 200 mikrogram/dose nesespray, oppløsning fentanyl
English: 1 puff (100 microlitres) contains 200 micrograms fentanyl.
Norwegian Bokmål: 1 spray (100 mikroliter) inneholder 200 mikrogram fentanyl.
English: Instanyl 50 micrograms/dose nasal spray, solution
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning DoseGuard
English: Flushing, hot flush
Norwegian Bokmål: Rødme, hetetokter
English: LIST OF EXCIPIENTS Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, purified water
Norwegian Bokmål: Inneholder også: natriumdihydrogenfosfatdihydrat, dinatriumfosfatdihydrat, renset vann.
English: Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning 1 ml inneholder fentanylsitrat tilsvarende 1000 mikrogram fentanyl.
English: Name and address of the manufacturers responsible for batch release for single-dose nasal spray
Norwegian Bokmål: Navn og adresse til tilvirker ansvarlig for batch release av endose nesespray
English: Vascular disorders
Norwegian Bokmål: Seponeringssymptomer
English: Instanyl 100 micrograms/dose nasal spray, solution.
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning
English: 1 puff (100 microlitres) contains 50 micrograms fentanyl.
Norwegian Bokmål: 1 spray (100 mikroliter) inneholder 50 mikrogram fentanyl.
English: Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Norwegian Bokmål: Instanyl 200 mikrogram/dose nesespray, oppløsning 1 ml inneholder fentanylsitrat tilsvarende 2000 mikrogram fentanyl.
English: Instanyl 100 micrograms/dose nasal spray, solution
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning DoseGuard
English: Any unused single-dose containers should be returned systematically and suitably in the child-resistant blister and discarded according to local requirements or returned to the pharmacy.
Norwegian Bokmål: Ubrukte endosebeholdere skal systematisk destrueres i overensstemmelse med lokale krav eller returneres til apoteket i den barnesikre blisterpakningen.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms/dose nasal spray, solution Fentanyl
Norwegian Bokmål: Instanyl 100 mikrogram/dose nesespray, oppløsning fentanyl
English: 1 puff (100 microlitres) contains 100 micrograms fentanyl.
Norwegian Bokmål: 1 spray (100 mikroliter) inneholder 100 mikrogram fentanyl.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Fentanyl
Norwegian Bokmål: Instanyl 50 mikrogram/dose nesespray, oppløsning fentanyl
English: Motion sickness
Norwegian Bokmål: Bivirkningstabell
English: Any used or unused nasal spray should be returned systematically and suitably in the child-resistant outer box and discarded according to local requirements or returned to the pharmacy.
Norwegian Bokmål: Brukte eller ubrukte nesesprayer skal systematisk destrueres i overensstemmelse med lokale krav eller returneres til apoteket i den barnesikre esken.
English: NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms/dose nasal spray, solution Fentanyl
Norwegian Bokmål: Instanyl 200 mikrogram/dose nesespray, oppløsning fentanyl
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / SINGLE-DOSE NASAL SPRAY
Norwegian Bokmål: MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ SMÅ INDRE EMBALLASJER
English: Hallucination, drug dependence (addiction), drug abuse
Norwegian Bokmål: Hallusinasjon Legemiddelavhengighet Legemiddelmisbruk
English: Fentanyl
Norwegian Bokmål: Amming
English: PHARMACEUTICAL PARTICULARS
Norwegian Bokmål: Vedlikeholdsbehandling
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INTERMEDIATE CHILD-RESISTANT BLISTER PACK (Single dose)
Norwegian Bokmål: MINSTEKRAV TIL OPPLYSNINGER SOM SKAL ANGIS PÅ GJENNOMTRYKKSPAKNINGER (BLISTER)
English: Very rare, not known*
Norwegian Bokmål: Svært sjeldne, ikke kjent
English: * Information related to clopidogrel with frequency “not known”
Norwegian Bokmål: * informasjon relatert til klopidogrel med frekvens «ikke kjent».
English: In addition, clinical tolerance was good in
Norwegian Bokmål: Dessuten var den kliniske toleransen god hos alle pasientene.
English: Clopidogrel ratiopharm with food and drink Clopidogrel ratiopharm may be taken with or without food.
Norwegian Bokmål: Inntak av Clopidogrel ratiopharm sammen med mat og drikke Clopidogrel ratiopharm kan tas med eller uten mat.
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Norwegian Bokmål: Innehaver av markedsføringstillatelsen skal imidlertid sende inn periodiske sikkerhetsoppdateringsrapporter for dette legemidlet hvis det blir inkludert i EURD-listen (European Union Reference Date list) som gjort rede for i Artikkel 107c(7) av direktiv 2001/83/EF og publisert på nettstedet til Det europeiske legemiddelkontor (The European
English: In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute
Norwegian Bokmål: På grunn av manglende data kan klopidogrel ikke anbefales i løpet av de første 7 dager etter akutt
English: Since the CAPRIE trial was not powered to evaluate efficacy of individual subgroups, it is not clear whether the differences in relative risk reduction across qualifying conditions are real, or a result of
Norwegian Bokmål: Ettersom CAPRIE ikke var planlagt for å evaluere effekten i individuelle subgrupper, er det ikke klart om forskjellen i relativ risikoreduksjon i forhold til underliggende årsak er reell eller et resultat av
English: The other ingredients are (see section 2 ‘Clopidogrel ratiopharm contains hydrogenated castor oil'):
Norwegian Bokmål: Andre innholdsstoffer er (se avsnitt 2 «Clopidogrel ratiopharm inneholder hydrogenert ricinusolje»):
English: What Clopidogrel ratiopharm is and what it is used for
Norwegian Bokmål: Hva Clopidogrel ratiopharm er og hva det brukes mot
English: Absorption is at least 50%, based on urinary
Norwegian Bokmål: Minst 50 % absorberes, basert på urinutskillelse av klopidogrels
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Norwegian Bokmål: Innehaver av markedsføringstillatelsen må sikre at et system for pharmacovigilance, som presentert i modul 1.8.1 i søknaden om markedsføringstillatelse, er opprettet og fungerende, før og mens
English: None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Norwegian Bokmål: Ingen av disse analysene hadde tilstrekkelig størrelse for å kunne oppdage forskjellig utfall for ”poor
English: The binding is non-saturable in vitro over a wide concentration
Norwegian Bokmål: Bindingen er ikke-mettet in vitro innenfor et bredt
English: EU/1/09/554/001 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/09/554/002 - Cartons of 28 film-coated tablets in all aluminium blisters EU/1/09/554/003 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/09/554/004 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/09/554/005 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/09/554/006 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/09/554/007 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/09/554/008 - Cartons of 7 film-coated tablets in all aluminium blisters
Norwegian Bokmål: EU/1/09/554/001 - Kartonger á 14 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/002 - Kartonger á 28 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/003 - Kartonger á 30 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/004 - Kartonger á 50x1 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/005 - Kartonger á 84 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/006 - Kartonger á 90 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/007 - Kartonger á 100 filmdrasjerte tabletter i aluminiumsblister EU/1/09/554/008 - Kartonger á 7 filmdrasjerte tabletter i aluminiumsblister
English: Do not use Clopidogrel ratiopharm if you notice any visible sign of damage of blister or film-coated
Norwegian Bokmål: Bruk ikke Clopidogrel ratiopharm hvis du ser synlige tegn på forringelse på blisterpakningen eller de
English: The incidence of severe cases was similar for clopidogrel and ASA.
Norwegian Bokmål: Forekomsten av alvorlige tilfeller var lik for klopidogrel og for ASA.
English: Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
Norwegian Bokmål: Publiserte forekomster for ”poor” CYP2C19metaboliserende genotyper er ca. 2 % for kaukasiere, 4 % for svarte og 14 % for kinesere.
English: TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
Norwegian Bokmål: TTP er en potensielt dødelig tilstand og krever rask behandling inkludert
English: In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the
Norwegian Bokmål: I en relativ biotilgjengelighetsstudie hos voksne ga klopidogrelløsningen lignende omfang og litt høyere absorpsjonsrate av den sirkulerende (inaktive) hovedmetabolitten sammenlignet med den godkjente
English: They are supplied in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 tablets in aluminium blisters.
Norwegian Bokmål: De leveres i pappkartonger med 7, 14, 28, 30, 50, 84, 90 og 100 tabletter i aluminiumsblister.
English: Other side effects reported with Clopidogrel ratiopharm are: -Common side effects (may affect up to 1 in 10 people):
Norwegian Bokmål: De andre bivirkningene som er rapportert med Clopidogrel ratiopharm er: - vanlige bivirkninger (kan oppstå hos opptil 1 av 10 personer):
English: At the time of granting the marketing authorisation, the submission of periodic safety update reports is not required for this medicinal product.
Norwegian Bokmål: Periodiske sikkerhetsoppdateringsrapporter (PSUR) Ved tidspunkt for utstedelse av markedsføringstillatelsen er det ikke nødvendig å sende inn periodiske sikkerhetsoppdateringsrapporter for dette legemidlet.
English: Platelet aggregation induced by agonists other than ADP is also inhibited by blocking the amplification of
Norwegian Bokmål: Blodplateaggregasjon indusert av andre agonister enn ADP hemmes også ved å hindre forsterkningen
English: Tests are available to determine a patient's CYP2C19 genotype.
Norwegian Bokmål: Tester for å identifisere en pasients CYP2C19 genotype finnes.
English: Patients should be told that it might take longer than usual to stop bleeding when they take clopidogrel, and that they should report any unusual bleeding (site or duration) to their physician.
Norwegian Bokmål: Pasientene bør informeres om at det kan ta lenger tid enn normalt for å stoppe en blødning når man bruker klopidogrel, og at de skal informere sin lege om enhver uvanlig blødning (lokalisasjon og
English: What Clopidogrel ratiopharm looks like and contents of the pack Clopidogrel ratiopharm 75 mg film-coated tablets are white to off-white, marbled, round and biconvex.
Norwegian Bokmål: Hvordan Clopidogrel ratiopharm ser ut og innholdet i pakningen Clopidogrel ratiopharm 75 mg filmdrasjerte tabletter er hvite til elfenbenshvite, marmorerte, runde og bikonvekse.
English: The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimisation activities have been identified.
Norwegian Bokmål: Søknaden er basert på et referanselegemiddel hvor ingen sikkerhetsbekymringer vedrørende ytterligere
English: If you become pregnant while taking Clopidogrel ratiopharm, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Norwegian Bokmål: Hvis du blir gravid mens du bruker Clopidogrel ratiopharm, ta umiddelbart kontakt med legen din, siden det ikke er anbefalt å ta klopidogrel når du er gravid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Norwegian Bokmål: OPPLYSNINGER SOM SKAL ANGIS PÅ DEN YTRE EMBALLASJE YTTERKARTONGESKE
English: The CYP2C19*2 and CYP2C19*3 alleles account for the majority of reduced function alleles in Caucasian (85%) and Asian (99%) poor metabolisers.
Norwegian Bokmål: CYP2C19*2 og CYP2C19*3 allelene står for majoriteten av alleler med redusert funksjon blant kaukasiske (85 %) og asiatiske (99%) ”poor metabolisers”.
English: It is unknown whether clopidogrel is excreted in human breast milk.
Norwegian Bokmål: Det er ukjent om klopidogrel blir skilt ut i morsmelk hos mennesker.
English: You should take Clopidogrel ratiopharm for as long as your doctor continues to prescribe it.
Norwegian Bokmål: Du skal ta Clopidogrel ratiopharm så lenge legen din skriver det ut til deg.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Norwegian Bokmål: D. VILKÅR ELLER RESTRIKSJONER VEDRØRENDE SIKKER OG EFFEKTIV BRUK
English: Clopidogrel should not be used in children because of efficacy concerns (see section 5.1).
Norwegian Bokmål: Klopidogrel bør ikke brukes hos barn pga. usikker effekt (se pkt.
English: What you need to know before you take Clopidogrel ratiopharm
Norwegian Bokmål: Hva du må vite før du bruker Clopidogrel ratiopharm