FrancophonIA/ELRC3.0 huggingface dataset:
English: • Set the dose to the missing amount you recorded in the treatment diary OR the number still displayed in the Dose Feedback Window on your previous pen, and inject.
Danish: • Indtil dosis til den manglende mængde, som du registrerede i behandlingsdagbogen ELLER
English: • Hold the Pergoveris pre-filled pen with the needle pointing upward.
Danish: • Hold Pergoveris fyldt pen med kanylen pegende opad.
English: • Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate and water for injections.
Danish: • Saccharose, argininmonohydrochlorid, poloxamer 188, methionin, phenol, dinatriumphosphatdihydrat, natriumdihydrogenphosphatmonohydrat og vand til injektionsvæsker.
English: Powder: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, sucrose, sodium hydroxide (for pH adjustment) and concentrated phosphoric acid (for pH adjustment).
Danish: Pulver: Dinatriumphosphatdihydrat, natriumdihydrogenphosphatmonohydrat, methionin, polysorbat 20, saccharose, natriumhydroxid (til justering af pH) og koncentreret phosphorsyre (til justering af pH).
English: Pack of 1 Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen and 5 injection needles.
Danish: Pakning med 1 Pergoveris (300 IE + 150 IE)/0,48 ml fyldt pen og 5 kanyler.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment)
Danish: Dinatriumphosphatdihydrat Natriumdihydrogenphosphatmonohydrat Phosphorsyre, koncentreret (til pH justering) Natriumhydroxid (til pH justering)
English: How to use Pergoveris
Danish: Sådan skal du bruge Pergoveris
English: • Pergoveris (900 IU + 450 IU)/1.44 mL is supplied in packs of 1 multidose pre-filled pen and
Danish: • Pergoveris (900 IE + 450 IE)/1,44 ml leveres i pakninger med 1 fyldt multidosispen og
English: • Contains 450 IU follitropin alfa and 225 IU lutropin alfa.
Danish: • Indeholder 0,72 ml Pergoveris-opløsning • Indeholder 450 IE follitropin alfa og 225 IE lutropin alfa.
English: EXP Once opened, the medicinal product may be stored for a maximum of 28 days at 25°C.
Danish: EXP Efter åbning kan lægemidlet opbevares i maks.
English: INFORMATION IN BRAILLE pergoveris (450 iu + 225 iu)/0.72 ml pen 17.
Danish: INFORMATION I BRAILLESKRIFT pergoveris (450 ie + 225 ie)/0,72 ml pen
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Phosphoric acid, concentrated (for pH adjustment) Water for injections
Danish: Dinatriumphosphatdihydrat Natriumdihydrogenphosphatmonohydrat Natriumhydroxid (til justering af pH) Phosphorsyre, koncentreret (til justering af pH) Vand til injektionsvæsker
English: Pergoveris is not indicated during breast-feeding.
Danish: Pergoveris er ikke indiceret til ammende kvinder.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 450 IU r-hFSH-225 IU r-hLH/0.72 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 450 IE r-hFSH-225 IE r-hLH/0,72 ml
English: 10/06 19:00 450IU + 225 IU 150IU/ 75IU 150
Danish: 450IE+ 225 IE 150IE/ 75 IE 150
English: • One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa and 75 IU (equivalent to 3 micrograms) of lutropin alfa.
Danish: • Et hætteglas indeholder 150 IE (ækvivalent til 11 mikrogram) follitropin alfa og 75 IE (ækvivalent til 3 mikrogram) lutropin alfa.
English: Solvent: 3 mL vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap. 1 vial of solvent contains 1 mL of water for injections.
Danish: Solvens: 3 ml hætteglas (type I glas) med en Teflon-belagt gummiprop beskyttet med aluminiumsringe og “flip-off”-låg.
English: Excipients: sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide and concentrated phosphoric acid (for pH adjustment), and water for injections.
Danish: Hjælpestoffer: saccharose, argininmonohydrochlorid, poloxamer 188, methionin, phenol, dinatriumphosphatdihydrat, natriumdihydrogenphosphatmonohydrat, natriumhydroxid og koncentreret phosphorsyre (til justering af pH) og vand til injektionsvæsker.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris 150 IU/75 IU powder and solvent for solution for injection
Danish: LÆGEMIDLETS NAVN Pergoveris 150 IE/75 IE, pulver og solvens til injektionsvæske, opløsning
English: Storing the Pergoveris pre-filled pen.
Danish: Opbevaring af Pergoveris fyldt pen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 IU r-hFSH/75 IU r-hLH
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 150 IE r-hFSH / 75 IE r-hLH
English: Contents
Danish: Ovarietorsion
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 IU r-hFSH-150 IU r-hLH/0.48 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 300 IE r-hFSH-150 IE r-hLH/0,48 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (300 IU + 150 IU)/0.48 mL injection Follitropin alfa/Lutropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pergoveris (300 IE + 150 IE)/0,48 ml injektion Follitropin alfa/Lutropin alfa
English: Pack of 1 Pergoveris (450 IU + 225 IU)/0.72 mL pre-filled pen and 7 injection needles.
Danish: Pakning med 1 Pergoveris (450 IE + 225 IE)/0,72 ml fyldt pen og 7 kanyler.
English: Each Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen contains 1.44 mL of solution for injection and can deliver six doses of Pergoveris 150 IU/75 IU.
Danish: Hver Pergoveris (900 IE + 450 IE)/1,44 ml fyldt pen indeholder 1,44 ml injektionsvæske, opløsning, og kan levere seks doser Pergoveris 150 IE/75 IE.
English: Once opened, the pre-filled pen may be stored for a maximum of 28 days outside of the refrigerator (at 25°C).
Danish: 28 dage uden at være på køl (ved 25 °C).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa* (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa* (r-hLH).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Et hætteglas indeholder 150 IE (svarer til 11 mikrogram) follitropin alfa* (r-hFSH) og 75 IE (svarer til 3 mikrogram) lutropin alfa* (r-hLH).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (450 IU + 225 IU)/0.72 mL injection Follitropin alfa/Lutropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pergoveris (450 IE + 225 IE)/0,72 ml injektion Follitropin alfa/Lutropin alfa
English: If you use more Pergoveris than you should
Danish: Hvis du har brugt for meget Pergoveris
English: Pack of 1 Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen and 14 injection needles.
Danish: Pakning med 1 Pergoveris (900 IE + 450 IE)/1,44 ml fyldt pen og 14 kanyler.
English: Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Danish: Pergoveris (300 IE + 150 IE)/0,48 ml injektionsvæske, opløsning i fyldt pen Follitropin alfa/Lutropin alfa
English: Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Danish: Pergoveris (450 IE + 225 IE)/0,72 ml injektionsvæske, opløsning i fyldt pen Follitropin alfa/Lutropin alfa
English: • The numbers in the Dose Feedback Window present the number of International Units, or IUs,
Danish: • Tallene på skærmen med dosisfeedback viser antallet af internationale enheder eller IE'er, og viser dosis af follitropin alfa.
English: Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Danish: Pergoveris (900 IE + 450 IE)/1,44 ml injektionsvæske, opløsning i fyldt pen Follitropin alfa/Lutropin alfa
English: Fig.7
Danish: Figur 7
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (900 IU + 450 IU)/1.44 mL injection Follitropin alfa/Lutropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pergoveris (900 IE + 450 IE)/1,44 ml injektion Follitropin alfa/Lutropin alfa
English: • Contains 900 IU follitropin alfa and 450 IU lutropin alfa.
Danish: • Indeholder 1,44 ml Pergoveris-opløsning • Indeholder 900 IE follitropin alfa og 450 IE lutropin alfa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PERGOVERIS (450 IE + 225 IE)/0,72 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN, ETIKET PÅ PEN
English: Each Pergoveris (450 IU + 225 IU)/0.72 mL pre-filled pen contains 0.72 mL of solution for injection and can deliver three doses of Pergoveris 150 IU/75 IU.
Danish: Hver Pergoveris (450 IE + 225 IE)/0,72 ml fyldt pen indeholder 0,72 ml injektionsvæske, opløsning, og kan levere tre doser Pergoveris 150 IE/75 IE.
English: Each Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen contains 0.48 mL of solution for injection and can deliver two doses of Pergoveris 150 IU/75 IU.
Danish: Hver Pergoveris (300 IE + 150 IE)/0,48 ml fyldt pen indeholder 0,48 ml injektionsvæske, opløsning, og kan levere to doser Pergoveris 150 IE/75 IE.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PERGOVERIS (300 IE + 150 IE)/0,48 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN, ETIKET PÅ PEN
English: • abdominal or pelvic pain
Danish: • mavekramper eller oppustethed
English: Fig.2
Danish: Figur 2
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN, PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER PERGOVERIS (900 IE + 450 IE)/1,44 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN, ETIKET PÅ PEN
English: • Turn the vial upside down, gently draw the solution back into the syringe.
Danish: • Vend hætteglasset på hovedet og træk forsigtigt opløsningen tilbage i sprøjten.
English: Pergoveris pre-filled pen treatment diary
Danish: Dagbog over behandling med Pergoveris fyldt pen
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldte flerdosispen indeholder 450 IE (svarer til 33 mikrogram) follitropin alfa* (r-hFSH) og 225 IE (svarer til 9 mikrogram) lutropin alfa* (r-hLH) i 0,72 ml opløsning.
English: 2 Hold the pen with the needle pointing upward.
Danish: Hold pennen med kanylen pegende opad.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) Each pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa (r-hLH) in 0.48 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 300 IE (svarer til 22 mikrogram) follitropin alfa (r-hFSH) og 150 IE (svarer til 6 mikrogram) lutropin alfa (r-hLH) i 0,48 ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldte flerdosispen indeholder 900 IE (svarer til 66 mikrogram) follitropin alfa* (r-hFSH) og 450 IE (svarer til 18 mikrogram) lutropin alfa* (r-hLH) i 1,44 ml opløsning.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Pergoveris (300 IE + 150 IE)/0,48 ml injektionsvæske, opløsning i fyldt pen
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 150 IE (ækvivalent til 11 mikrogram) follitropin alfa (r-hFSH) og 75 IE (ækvivalent til 3 mikrogram) lutropin alfa (r-hLH)
English: Amount Set to Inject
Danish: Volumen indstillet til at injicere
English: • Look closely at the tip of the needle for tiny drop(s) of fluid.
Danish: • Inspicer kanylespidsen nøje for bittesmå dråber væske.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris 150 IU/75 IU powder for solution for injection Follitropin alfa/Lutropin alfa
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pergoveris 150 IE/75 IE pulver til injektionsvæske, opløsning Follitropin alfa/Lutropin alfa s.c.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Pergoveris (450 IE + 225 IE)/0,72 ml injektionsvæske, opløsning i fyldt pen
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Pergoveris (900 IE + 450 IE)/1,44 ml injektionsvæske, opløsning i fyldt pen
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PERGOVERIS (450 IE + 225 IE)/0,72 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PERGOVERIS (900 IE + 450 IE)/1,44 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PERGOVERIS (300 IE + 150 IE)/0,48 ML INJEKTIONSVÆSKE, OPLØSNING I FYLDT PEN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldte flerdosispen indeholder 300 IE (svarer til 22 mikrogram) follitropin alfa* (r-hFSH) og 150 IE (svarer til 6 mikrogram) lutropin alfa* (r-hLH) i 0,48 ml opløsning.
English: • feeling sick or vomiting
Danish: • mavesmerter eller bækkensmerter
English: Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Danish: Den terminale halveringstid er en anelse forlænget.
English: Getting the syringe ready for injection
Danish: Forbered injektionssprøjten
English: Window will turn back to 0.
Danish: • Dosisnummeret vist på skærmen med dosisfeedback vil dreje tilbage til 0.
English: Each pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa (r-hLH) in 0.72 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 450 IE (svarer til 33 mikrogram) follitropin alfa (r-hFSH) og 225 IE (svarer til 9 mikrogram) lutropin alfa (r-hLH) i 0,72 ml.
English: Solvent Batch
Danish: Solvens Lot
English: Each pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa (r-hLH) in 1.44 mL.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver fyldt pen indeholder 900 IE (svarer til 66 mikrogram) follitropin alfa (r-hFSH) og 450 IE (svarer til 18 mikrogram) lutropin alfa (r-hLH) i 1,44 ml.
English: Units) of follitropin alfa and 450 IU of lutropin alfa in 1.44 mL and can deliver six doses of Pergoveris 150 IU/75 IU.
Danish: • Hver fyldt pen med Pergoveris (900 IE + 450 IE)/1,44 ml indeholder 900 IE (internationale enheder) follitropin alfa og 450 IE lutropin alfa i 1,44 ml, og den kan levere seks doser Pergoveris 150 IE/75 IE.
English: 12/06 19:00 450IU + 225 IU
Danish: Nr. 3 12/06 19:00
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/005
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/396/005
English: Units) of follitropin alfa and 225 IU of lutropin alfa in 0.72 mL and can deliver three doses of Pergoveris 150 IU/75 IU.
Danish: • Hver fyldt pen med Pergoveris (450 IE + 225 IE)/0,72 ml indeholder 450 IE (internationale enheder) follitropin alfa og 225 IE lutropin alfa i 0,72 ml, og den kan levere tre doser Pergoveris 150 IE/75 IE.
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/004
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/396/004
English: Units) of follitropin alfa and 150 IU of lutropin alfa in 0.48 mL and can deliver two doses of Pergoveris 150 IU/75 IU.
Danish: • Hver fyldt pen med Pergoveris (300 IE + 150 IE)/0,48 ml indeholder 300 IE (internationale enheder) follitropin alfa og 150 IE lutropin alfa i 0,48 ml, og den kan levere to doser Pergoveris 150 IE/75 IE.
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/001
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/396/001
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/006
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/396/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/396/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/396/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/396/004
English: Caution: Do not attach the needle too tightly; the needle could be difficult to remove after the injection.
Danish: Det kan være svært at fjerne kanylen efter injektionen.
English: What is in this leaflet
Danish: Dette er beskrevet under pkt.
English: Immune system disorders
Danish: Nervesystemet
English: They might ask you to stop using this medicine (see in section 4. under “Most serious side effects”).
Danish: 4 under “Bivirkninger”).
English: Testing during and after the transition period
Danish: Undersøgelser under og efter overgangsperioden
English: • If there is a need for further recalls or other measures, national authorities will inform you of what action to take.
Danish: • Hvis der er behov for yderligere tilbagekaldelser eller andre foranstaltninger, vil de nationale myndigheder informere dig om, hvad der skal gøres.
English: An assessment report with further details about the review has been published on EMA's website.
Danish: En vurderingsrapport med yderligere oplysninger om gennemgangen er offentliggjort på EMA's websted.
English: You can also contact your national medicines authority.
Danish: Du kan også kontakte de danske lægemiddelmyndigheder.
English: The estimates have been extrapolated from animal studies and are very low compared with the lifetime risk of cancer in the EU (1 in 2).
Danish: Estimaterne er ekstrapoleret fra dyrestudier og er meget lave sammenholdt med livstidsrisikoen for kræft i EU (1 ud af 2).
English: 2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1)
Danish: 2 Vejledning fra International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH): M7(R1)
English: Investigation continuing
Danish: Undersøgelserne fortsætter
English: The review estimated the highest possible cancer risk with these impurities.
Danish: Gennemgangen skønnede den højest mulige kræftrisiko med disse urenheder.
English: Active substance (max daily dose)
Danish: Aktivt stof (maksimal daglig dosis)
English: The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af valsartan-lægemidler blev indledt den 5. juli 2018 på anmodning fra EuropaKommissionen i henhold til artikel 31 i direktiv 2001/83/EC.
English: Following tests, some medicines have been recalled from pharmacies and are no longer used in the EU.
Danish: Efter en række undersøgelser er nogle lægemidler blevet tilbagekaldt fra apoteker og anvendes ikke længere i EU.
English: Authorities in the EU will also consider the lessons that can be learned from this review to improve the way impurities in medicines are identified and handled.
Danish: Myndighederne i EU vil også bruge erfaringen fra denne gennemgang til at forbedre den måde, som urenheder i lægemidler opdages og håndteres på.
English: • You should not stop taking any sartan medicines without speaking to your doctor.
Danish: • Du bør ikke holde op med at tage et sartanlægemiddel, før du har talt med lægen.
English: EMA's recommendations for NDMA and NDEA were sent to the European Commission, which issued a legally binding decisions.
Danish: EMA's anbefalinger vedrørende NDMA og NDEA blev sendt til Europa-Kommissionen, der traf juridisk bindende afgørelser.
English: Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review.
Danish: Andre lægemidler af samme klasse, der ikke har denne ring, som f.eks. azilsartan, eprosartan og telmisartan, var ikke omfattet af gennemgangen.
English: After this period, companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU.
Danish: Efter denne periode skal virksomhederne dokumentere, at deres sartanprodukter ikke har målbare niveauer af urenhederne, før de kan bruges i EU.
English: These medicines are used to treat patients with hypertension (high blood pressure) and those with certain heart or kidney diseases.
Danish: Disse lægemidler anvendes til at behandle patienter med forhøjet blodtryk (hypertension) og patienter med visse hjerte- eller nyresygdomme.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Danish: Gennemgangen blev foretaget af EMA's udvalg for humanmedicinske lægemidler (CHMP), der har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets udtalelse.
English: • Manufacturers must now review their manufacturing processes to avoid the presence of nitrosamines.
Danish: • Fremstillerne skal nu gennemgå deres fremstillingsprocesser for at undgå tilstedeværelsen af nitrosaminer.
English: • If you have any questions about your medicine or any medicine you have taken in the past, speak to your doctor or pharmacist.
Danish: • Hvis du har spørgsmål om et lægemiddel, som du aktuelt tager, eller som du tidligere har taget, kan du tale med lægen eller apotekspersonalet.
English: NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.1
Danish: NDEA i disse lægemidler kan medføre 8 ekstra tilfælde pr. 100.000 patienter, der tager medicinen ved den højeste dosis dagligt i 4 år.1
English: • Nitrosamines are potent carcinogens in animals and probable carcinogens in humans.
Danish: • Nitrosaminer er potente karcinogener hos dyr og sandsynlige karcinogener hos mennesker.
English: Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products.
Danish: Virksomhederne skal nu træffe foranstaltninger for at undgå tilstedeværelsen af urenhederne og gennemføre grundige undersøgelser af deres produkter.
English: • EMA is now taking further action to prevent these impurities from being present in future batches of sartan medicines.
Danish: • EMA iværksætter nu yderligere handlinger for at forhindre, at disse urenheder forekommer i fremtidige batcher af sartanlægemidler.
English: A similar step - involving diethylamine (DEA) - is linked to the presence of NDEA.
Danish: Et lignende trin - der involverer diethylamin (DEA) - er forbundet med tilstedeværelsen af NDEA.