FrancophonIA/ELRC3.0 huggingface dataset:
English: Apotex Europe B.V. Darwinweg 20 2333 CR LEIDEN The Netherlands
Danish: Darwinweg 20 2333 CR LEIDEN The Netherlands
English: Sanofi-Aventis Bulgaria EOOD
Danish: Bulgarien Sanofi-Aventis Bulgaria EOOD
English: Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Danish: Tyskland Aristo Pharma GmbH Wallenroder Str. 8-10
English: Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM The Netherlands
Danish: Swensweg 5 2031 GA HAARLEM The Netherlands
English: Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
Danish: Tyskland ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19
English: Valproic acid Ácido Valpróico Generis
Danish: Valproinsyre Ácido Valpróico Generis
English: Lithuania Sandoz d.d.
Danish: Litauen Sandoz d.d.
English: EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Danish: Frankrig EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
English: Germany betapharm Arzneimittel GmbH
Danish: Tyskland betapharm Arzneimittel GmbH
English: 500-1000 mg Modified-release granules
Danish: 500-1000 mg Granulat med modificeret udløsning
English: Germany Neuraxpharm Arzneimittel GmbH
Danish: Tyskland Neuraxpharm Arzneimittel GmbH
English: Sanofi-Aventis zrt.
Danish: Ungarn Sanofi-Aventis zrt.
English: Modified-release capsule, hard
Danish: Kapsel med modificeret udløsning, hård
English: Germany Winthrop Arzneimittel GmbH
Danish: Tyskland Winthrop Arzneimittel GmbH
English: Germany G.L.
Danish: Tyskland G.L.
English: Germany TAD Pharma GmbH Heinz-Lohmann-Str. 5
Danish: Tyskland TAD Pharma GmbH Heinz-Lohmann-Str. 5
English: Film-coated tablet Oral Use
Danish: Tablet, overtrukket Oral anvendelse
English: Valproic acid VALPROATE SODIUM SANDOZ 500MG
Danish: Valproinsyre VALPROATE SODIUM SANDOZ 500MG
English: Romania Sanofi-Aventis France 1-13 Boulevard Romain Rolland
Danish: Rumænien Sanofi-Aventis France 1-13 Boulevard Romain Rolland
English: Oral solution
Danish: Oral opløsning Oral anvendelse
English: LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf 91140 Villebon Sur Yvette France
Danish: Frankrig LABORATOIRES ALTER 3, avenue de la Baltique, ZI de Courtaboeuf
English: Lithuania G.L.
Danish: Litauen G.L.
English: G.E.S.
Danish: Spanien G.E.S.
English: Valproic acid ORFIRIL SAFT
Danish: Valproinsyre ORFIRIL SAFT
English: Valproic acid DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
Danish: Valproinsyre DEPAKINE 100 mg/ml por és oldószer oldatos injekcióhoz
English: Dunajska cesta 151 1000 Ljubljana Slovenia
Danish: Dunajska cesta 151
English: Valpromide Depamide 300 mg comprimidos gastrorresistentes
Danish: Valpromid Depamide 300 mg comprimidos gastrorresistentes
English: Germany TEVA GmbH Graf-Arco-Str. 3
Danish: Tyskland TEVA GmbH Graf-Arco-Str. 3
English: Valproic acid Depakine 400 mg/4 ml
Danish: Valproinsyre Depakine 400 mg/4 ml
English: Valproic acid Orfiril Long
Danish: Valproinsyre Orfiril Long
English: Valproic acid Valproat "Sandoz"
Danish: Valproinsyre Valproat "Sandoz"
English: Valproic acid Diplexil
Danish: Valproinsyre Diplexil
English: Valproic acid Convulex 50 mg/ml - Sirup für Kinder
Danish: Valproinsyre Convulex 50 mg/ml - Sirup für Kinder
English: Valproic acid CONVULEX 100 mg/ml oldatos injekció
Danish: Valproinsyre CONVULEX 100 mg/ml oldatos injekció
English: Germany AbZ-Pharma GmbH Graf-Arco-Str. 3
Danish: Tyskland AbZ-Pharma GmbH Graf-Arco-Str. 3
English: Valproic acid CONVULEX 50 mg/ml szirup gyermekeknek
Danish: Valproinsyre CONVULEX 50 mg/ml szirup gyermekeknek
English: Valpromide DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
Danish: Valpromid DEPAMIDE 300 mg, comprimé pelliculé gastro-résistant
English: Powder for injection Intravenous use
Danish: Pulver til injektionsvæske
English: Sanofi-Aventis Croatia d.o.o.
Danish: Kroatien Sanofi-Aventis Croatia d.o.o.
English: Valproic acid Convulex 100 mg/mlInjektionslösung
Danish: Valproinsyre Convulex 100 mg/mlInjektionslösung
English: Valproic acid Depakine Chronosphere
Danish: Valproinsyre Depakine Chronosphere
English: Valproic acid Orfiril Retard
Danish: Valproinsyre Orfiril Retard
English: Modified-release granules
Danish: Granulat med modificeret udløsning
English: Convulex 300 mg/ml - Lösung zum Einnehmen
Danish: Convulex 300 mg/mlLösung zum Einnehmen
English: Valproic acid Depakine Chrono 500
Danish: Valproinsyre Depakine Chrono 500
English: Valproic acid DEPAKINE 50 mg/ml szirup 50 mg/ml
Danish: Valproinsyre DEPAKINE 50 mg/ml szirup 50 mg/ml
English: Valproic acid Diplexil 1000
Danish: Valproinsyre Diplexil 1000
English: Valproic acid ORFIRIL 600
Danish: Valproinsyre ORFIRIL 600
English: Valpromide Depamide
Danish: Valpromid Depamide
English: Valproic acid ORFIRIL 150
Danish: Valproinsyre ORFIRIL 150
English: Valproic acid Diplexil 150
Danish: Valproinsyre Diplexil 150
English: Valproic acid Delepsine
Danish: Valproinsyre Delepsine
English: Oral drops, solution Oral Use
Danish: Depotkapsel, hard Oral anvendelse
English: Valproic acid Convulex 300 mg - Kapseln 300 mg
Danish: Valproinsyre Convulex 300 mg - Kapseln 300 mg
English: Valproic acid Depakine chrono 300 mg tablete s podaljšanim sproščanjem
Danish: Valproinsyre Depakine chrono 300 mg tablete s podaljšanim sproščanjem
English: Valproic acid ORFIRIL 300
Danish: Valproinsyre ORFIRIL 300
English: Sandoz d.d.
Danish: Estland Sandoz d.d.
English: Valproic acid Absenor 300 mg tablety s predĺženým uvoľňovaním
Danish: Valproinsyre Absenor 300 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Convulex 150
Danish: Valproinsyre Convulex 150
English: Valproic acid Convulex 500 mg - Kapseln 500 mg
Danish: Valproinsyre Convulex 500 mg - Kapseln 500 mg
English: Valproic acid Deprakine Retard
Danish: Valproinsyre Deprakine Retard
English: Valproic acid Absenor 500 mg tablety s predĺženým uvoľňovaním
Danish: Valproinsyre Absenor 500 mg tablety s predĺženým uvoľňovaním
English: Valproic acid Depakine chrono 500 mg tablete s podaljšanim sproščanjem
Danish: Valproinsyre Depakine chrono 500 mg tablete s podaljšanim sproščanjem
English: Germany Ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Tyskland Ratiopharm GmbH Graf-Arco-Strasse 3
English: Belgium Eurogenerics N.V. Heizel Esplanade b22
Danish: Heizel Esplanade b22
English: Valproic acid Convulex 150 mg - Kapseln 150 mg
Danish: Valproinsyre Convulex 150 mg - Kapseln 150 mg
English: DEPAKINE CHRONO (SPHERE) 1000 mg/sachet Coated granules in sachet
Danish: DEPAKINE CHRONO (SPHERE) 1000 mg/brev Overtrukket granulat, brev
English: Valproic acid CONVULEX RETARD 500MG 500 mg
Danish: Valproinsyre CONVULEX RETARD 500MG 500 mg
English: Valproic acid CONVULEX RETARD 300MG 300 mg
Danish: Valproinsyre CONVULEX RETARD 300MG 300 mg
English: Valproic acid DEPAKINE CHRONO 300 MG 300 mg
Danish: Valproinsyre DEPAKINE CHRONO 300 MG 300 mg
English: Valproic acid ORFIRIL LONG 1000 MG 1000 mg
Danish: Valproinsyre ORFIRIL LONG 1000 MG 1000 mg
English: Valproic acid Convulex Capsules 150mg 150 mg
Danish: Valproinsyre Convulex Capsules 150mg 150 mg
English: Lithuania Orion Corporation Orionintie 1 A
Danish: Litauen Orion Corporation Orionintie 1 A
English: Valproic acid Depakine Chrono 300
Danish: Valproinsyre Depakine Chrono 300
English: Valproic acid CONVULEX 300 MG/ML
Danish: Valproinsyre CONVULEX 300 MG/ML
English: Valproic acid Diplexil 300
Danish: Valproinsyre Diplexil 300
English: Germany Orion Corporation Orionintie 1 A
Danish: Tyskland Orion Corporation Orionintie 1 A
English: Valproic acid CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
Danish: Valproinsyre CONVULEX 300 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Diplexil 500
Danish: Valproinsyre Diplexil 500
English: DEPAKINE CHRONO (SPHERE) 750 mg/sachet
Danish: DEPAKINE CHRONO (SPHERE) 750 mg/brev
English: Valproic acid Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
Danish: Valproinsyre Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada
English: DEPAKINE CHRONO (SPHERE) 250 mg/sachet
Danish: DEPAKINE CHRONO (SPHERE) 250 mg/brev
English: 500 mg/sachet
Danish: 500 mg/brev
English: Valproid acid, Sodium valproate
Danish: Valproinsyre, Natriumvalpr oat
English: Valproic acid Convulex 150 mg gastroresistant capsules, soft
Danish: Valproinsyre Convulex 150 mg gastroresistant capsules, soft
English: Valproic acid Convulex Capsules 300mg 500 mg
Danish: Valproinsyre Convulex Capsules 300mg 500 mg
English: Valproic acid CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
Danish: Valproinsyre CONVULEX 150 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
Danish: Valproinsyre Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada
English: Denmark Orion Corporation Orionintie 1 A
Danish: Danmark Orion Corporation Orionintie 1 A
English: Valproic acid Delepsine Retard
Danish: Valproinsyre Delepsine Retard
English: Valproic acid Convulex Capsules 500mg 300 mg
Danish: Valproinsyre Convulex Capsules 500mg 300 mg
English: Valproic acid CONVULEX
Danish: Valproinsyre CONVULEX
English: Valproic acid CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
Danish: Valproinsyre CONVULEX 500 mg gyomornedv-ellenálló lágy kapszula
English: Valproic acid DEPAKINE CHRONO 500 MG 500 mg
Danish: Valproinsyre DEPAKINE CHRONO 500 MG 500 mg
English: Valproic acid Convulex 150 mg kapsuly
Danish: Valproinsyre Convulex 150 mg kapsuly
English: Valproic acid Convulex 300
Danish: Valproinsyre Convulex 300
English: Valproic acid Convulex 300 mg kapsuly
Danish: Valproinsyre Convulex 300 mg kapsuly
English: Valproic acid Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
Danish: Valproinsyre Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada
English: DEPAKINE CHRONO (SPHERE) 100 mg/sachet
Danish: DEPAKINE CHRONO (SPHERE) 100 mg/brev
English: Valproic acid Convulex 500
Danish: Valproinsyre Convulex 500
English: Powder and solvent for solution for injection/infusion
Danish: Pulver og solvens til injektionsvæske, opløsning/infusions væske, opløsning
English: Valproic acid Convulex 300 mg gastroresistant capsules, soft
Danish: Valproinsyre Convulex 300 mg gastroresistant capsules, soft
English: Valproic acid Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
Danish: Valproinsyre Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada
English: Valproic acid ORFIRIL
Danish: Valproinsyre Orfiril
English: Valproic acid Orfiril
Danish: Valproinsyre ORFIRIL
English: Valproic acid CONVULEX 150 MG
Danish: Valproinsyre CONVULEX 150 MG
English: Valproic acid ORFIRIL LONG 150 MG
Danish: Valproinsyre ORFIRIL LONG 150 MG
English: Valproic acid Propymal Enteric 150 mg, maagsapresistente capsules
Danish: Valproinsyre Propymal Enteric 150 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 600 mg, maagsapresistente capsules
Danish: Valproinsyre Propymal Enteric 600 mg, maagsapresistente capsules
English: Valproic acid Propymal Enteric 450 mg, maagsapresistente capsules
Danish: Valproinsyre Propymal Enteric 450 mg, maagsapresistente capsules
English: Valproic acid Convulex 500 mg gastroresistant capsules, soft
Danish: Valproinsyre Convulex 500 mg gastroresistant capsules, soft
English: Valproic acid Deprakine
Danish: Valproinsyre Deprakine
English: Valproic acid ORFIRIL LONG 300 MG
Danish: Valproinsyre ORFIRIL LONG 300 MG
English: Valproic acid Convulex 500 mg kapsuly
Danish: Valproinsyre Convulex 500 mg kapsuly
English: Valproic acid ORFIRIL LONG 500 MG
Danish: Valproinsyre ORFIRIL LONG 500 MG
English: 400 mg /vial
Danish: 400 mg /hætteglas
English: Sanofi-Aventis d.o.o.
Danish: Slovenien Sanofi-Aventis d.o.o.
English: Valproic acid Propymal Enteric 300 mg, maagsapresistente capsules
Danish: Valproinsyre Propymal Enteric 300 mg, maagsapresistente capsules
English: DEPAKINE CHRONO (SPHERE) 500 mg/sachet
Danish: DEPAKINE CHRONO (SPHERE) 500 mg/brev
English: 103, Alexander Stamboliiski Blvd 1303 Sofia
Danish: 1303 Sofia
English: Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Danish: Danmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Germany Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Danish: Tyskland Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Romania Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Danish: Rumænien Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: MICROPAKINE L.P. 750 mg, granulés à libération prolongée en sachet-dose
Danish: 750 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid CONVULEX 300 MG
Danish: Valproinsyre CONVULEX 300 MG
English: Valproic acid CONVULEX 500 MG
Danish: Valproinsyre CONVULEX 500 MG
English: MICROPAKINE L.P. 1000 mg, granulés à libération prolongée en sachet-dose
Danish: 1000 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 250 mg, granulés à libération prolongée en sachet-dose
Danish: 250 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 500 mg, granulés à libération prolongée en sachet-dose
Danish: 500 mg, granulés à libération prolongée en sachet-dose
English: MICROPAKINE L.P. 100 mg, granulés à libération prolongée en sachet-dose
Danish: 100 mg, granulés à libération prolongée en sachet-dose
English: Valproic acid DEPAKINE
Danish: Valproinsyre DEPAKINE
English: Solution for injection/concentra te for solution for infusion
Danish: Injektionvæske, opløsning/ Koncentrat til infusionsvæske, opløsning
English: Solution for injection/infusion
Danish: Injektionsvæske, opløsning/ Infusionsvæske, opløsning
English: Depakine Crono 300 mg comprimidos recubiertos
Danish: Depakine Crono 300 mg comprimidos de liberación prolongada
English: Depakine Crono 500 mg comprimidos recubiertos
Danish: Depakine Crono 500 mg comprimidos de liberación prolongada
English: Iceland Desitin Arzneimittel Gmbh Weg beim Jaeger 214
Danish: Estland Desitin Arzneimittel Gmbh Weg beim Jaeger 214
English: Biogaran
Danish: Depotgranulat
English: Gastro-resistant film-coated tablet
Danish: Tablet, filmovertrukket
English: The marketing authorisations for chlormadinone containing combined hormonal contraceptives are subject to the conditions set out in Annex IV.
Danish: Markedsføringstilladelserne for kombinerede hormonale kontraceptiva indeholdende chlormadinon underkastes de betingelser, der fremgår af bilag IV.
English: The amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are set out in Annex III.
Danish: Ændringerne af de pågældende punkter i produktresuméet og indlægssedlen fremgår af bilag III.
English: The CHMP, having considered the PRAC recommendation dated 10 October 2013 pursuant to Article 107k(3) of Directive 2001/83/EC, is of the opinion that the marketing authorisations for combined hormonal contraceptives containing chlormadinone, desogestrel, dienogest, drospirenone, etonogestrel, gestodene, norgestimate should be varied.
Danish: Efter gennemgang af PRAC's anbefaling af 10. oktober 2013 i medfør af artikel 107k, litra 3), i direktiv 2001/83/EF er CHMP af den opfattelse, at markedsføringstilladelserne bør ændres for kombinerede hormonale kontraceptiva indeholdende chlormadinon, desogestrel, dienogest, drospirenon, etonogestrel, gestoden og norgestimat.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the marketing authorisations, and detailed explanation for the differences from the PRAC recommendation
Danish: Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne samt detaljeret redegørelse for afvigelserne fra anbefalingen fra PRAC (Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering)
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation measures.
Danish: konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for lægemidlerne omhandlet i bilag I til indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen samt supplerende risikominimeringsforanstaltninger.
English: Having considered all the above, the PRAC concluded that the benefit-risk balance of the medicinal products identified in Annex I in the indication of contraception remains favourable, subject to the inclusion of the restrictions, warnings and other changes to the product information agreed.
Danish: Efter at have taget alt det ovenstående i betragtning konkluderede PRAC, at benefit/risk-forholdet fortsat er positivt for de i bilag I omhandlede lægemidler til indikationen antikonception under forudsætning af de vedtagne kontraindikationer, advarsler og andre ændringer i produktinformationen.
English: Strength Pharmaceutical Form Route of Administration Packaging Package size EU/1/10/654/001 Leflunomide ratiopharm 10 mg Film-coated tablet
Danish: Styrke Lægemiddelform Indgivelsesvej
English: Date of first authorisation: 21 March 2007 Date of latest renewal: 23 February 2012
Danish: Dato for første markedsføringstilladelse: 21. marts 2007 Dato for seneste fornyelse: 23. februar 2012
English: It is important to stay on the diet and exercise recommended by your doctor while taking Januvia.
Danish: Det er vigtigt at forblive på den diæt og motion, som lægen anbefaler, mens De tager Januvia.
English: STOP taking Januvia and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Januvia og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger:
English: Due to lack of human data, Januvia should not be used during pregnancy.
Danish: På grund af mangel på humane data bør Januvia ikke anvendes under graviditet.
English: Method of administration Januvia can be taken with or without food.
Danish: Administration Januvia kan tages med eller uden mad.
English: - an allergic reaction to Januvia (see section 4).
Danish: - Allergisk reaktion over for Januvia (se punkt 4).
English: Common: flu
Danish: Almindelig: Influenza.
English: Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Januvia bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: The level of digoxin in your blood may need to be checked if taking with Januvia.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Januvia.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter.
Danish: Da der er dosisjustering på baggrund af nyrefunktionen, anbefales det at vurdere nyrefunktionen før initiering af Januvia og med mellemrum derefter.
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Danish: Fortsæt med at tage Januvia, så længe Deres læge ordinerer det, så De fortsat kan få hjælp til at kontrollere Deres blodsukker.
English: If you have kidney problems, your doctor may prescribe lower doses(such as 25mg or 50mg).
Danish: Hvis De har nyreproblemer, kan Deres læge ordinere en lavere dosis (såsom 25 mg eller 50 mg).
English: Your doctor may ask you to stop Januvia.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Januvia.
English: If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
Danish: Hvis en dosis Januvia glemmes, bør den tages, så snart patienten kommer i tanke om det.
English: Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Danish: Eftersom samtidig administration af et fedtrigt måltid sammen med sitagliptin ikke havde nogen effekt på farmakokinetikken, kan Januvia administreres med eller uden mad.
English: When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Januvia administered concomitantly.
Danish: Ved anvendelse sammen med metformin og/eller en PPAR-agonist bør dosis af metformin og/eller PPAR-agonisten opretholdes, og Januvia administreres samtidigt.
English: If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Januvia should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Januvia og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Januvia ikke genoptages.
English: Do not take Januvia - if you are allergic to sitagliptin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Januvia: - hvis De er allergisk over for sitagliptin eller et af de øvrige indholdsstoffer i lægemidlet
English: It is not known if this medicine passes into breast milk.
Danish: Det vides ikke, om lægemidlet går over i mælken.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Januvia (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får Januvia (se punkt 4).
English: In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with a sulphonylurea or with insulin.
Danish: Desuden bør patienterne være opmærksomme på risikoen for hypoglykæmi, når Januvia anvendes sammen med et sulfonylurinstof eller sammen med insulin.
English: No dose adjustment for Januvia is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Danish: Dosisjustering af Januvia er ikke nødvendig hos patienter med let eller moderat leverinsufficiens (Child-Pugh score ≤9).
English: If you forget to take Januvia
Danish: Hvis De har glemt at tage Januvia
English: Januvia is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.
Danish: Januvia er også indiceret som tillægsbehandling til insulin (med eller uden metformin), når diæt og motion plus stabil dosering af insulin ikke giver tilstrækkelig glykæmisk kontrol.
English: If you stop taking Januvia
Danish: Hvis De holder op med at tage Januvia
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Danish: I en klinisk undersøgelse havde sitagliptin en lille effekt på digoxinkoncentrationerne i plasma, som tyder på, at sitagliptin kan være en svag hæmmer af p-glykoprotein.
English: There was also a significant difference between groups with respect to change from baseline body weight (sitagliptin -0.6 kg; glipizide +1.2 kg).
Danish: Der var også signifikant forskel mellem grupperne med hensyn til ændring i kropsvægt ved baseline (sitagliptin0,6 kg; glipizid +1,2 kg).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Januvia in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om fremlæggelse af resultaterne af studier med Januvia hos alle undergrupper af den pædiatriske population ved type 2-diabetes mellitus (se pkt.
English: Januvia has no or negligible influence on the ability to drive and use machines.
Danish: Januvia påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Januvia should not be used during breast-feeding.
Danish: Januvia bør ikke anvendes under amning.
English: If a hypersensitivity reaction is suspected, Januvia should be discontinued.
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, skal Januvia seponeres.