FrancophonIA/ELRC3.0 huggingface dataset:
English: Jentadueto must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Danish: Behandling med metformin skal afbrydes forud for eller på tidspunktet for en billeddiagnostisk procedure og først genoptages efter mindst 48 timer, forudsat at nyrefunktionen er blevet vurderet og fundet stabil, se pkt.
English: Hepatic impairment
Danish: Hepatitis §
English: Linagliptin provided significant improvements in HbA1c (-0.64% change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,64 % sammenlignet med placebo efter 24 uger) i forhold til et gennemsnitligt HbA1c ved baseline på 7,8 %.
English: The incidence of hypoglycaemia was similar across treatment groups (placebo 1.4%, linagliptin 5 mg 0%, metformin 2.1%, and linagliptin 2.5 mg plus metformin twice daily 1.4%).
Danish: 1,4 %, linagliptin 5 mg 0 %, metformin 2,1 % og linagliptin 2,5 mg plus metformin 2 gange dagligt
English: If a dose is missed, it should be taken as soon as the patient remembers.
Danish: En glemt dosis bør tages, så snart patienten bliver opmærksom på dette - dog ikke som en dobbelt dosis.
English: Jentadueto 2.5 mg/1,000 mg are oval, biconvex light pink film-coated tablets (tablets).
Danish: Jentadueto 2,5 mg/1.000 mg er ovale, bikonvekse lyserøde filmovertrukne tabletter.
English: Oval, biconvex, light orange, film-coated tablet of 19.2 mm x 9.4 mm debossed with "D2/850" on one side and the company logo on the other.
Danish: Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Oval, bikonveks, lysorange, filmovertrukket tablet på 19,2 mm x 9,4 mm, præget med Boehringer Ingelheim logo på den ene side og ”D2/850” på den anden.
English: Discontinuation of therapy due to adverse events was comparable in patients who received placebo and metformin to patients treated with linagliptin and metformin (3.8% and 2.9%).
Danish: Andelen af patienter, der seponerede behandlingen som følge af bivirkninger i placebo + metformingruppen, var sammenlignelig med andelen i linagliptin + metformingruppen (henholdsvis 3,8 % og 2,9 %).
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Danish: Behandling med metformin skal afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi og må tidligst genoptages 48 timer efter kirurgi eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet vurderet og fundet stabil.
English: In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
Danish: Dette giver in vivo-evidens for lav tilbøjelighed til interaktioner med substrater af CYP3A4, CYP2C9, CYP2C8, P-glykoprotein og organisk kationisk transport (OCT).
English: Linagliptin provided significant improvements in HbA1c (-0.62% change compared to placebo), from a mean baseline HbA1c of 8.14%.
Danish: Linagliptin medførte signifikant reduktion i HbA1c, (ændring på -0,62 % vs placebo) i forhold til en gennemsnitlig baseline-HbA1c på 8,14 %.
English: Refer to Summary of Product Characteristics for metformin for additional information Adverse reaction observed in combination of Jentadueto with sulphonylurea Adverse reaction observed in combination of Jentadueto with insulin
Danish: Bivirkning observeret ved kombination af Jentadueto og sulfonylurinstof Bivirkning observeret ved kombination af Jentadueto og insulin
English: Due to the concentration dependent binding of linagliptin to DPPIV, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner, while unbound AUC increases in a roughly dose-proportional manner.
Danish: Linagliptins total-plasma-AUC steg ikke dosisproportionalt, mens stigningen i AUC for ubundet linagliptin stort set var dosisproportional.
English: Blister Store in the original package in order to protect from moisture.
Danish: Blister Opbevares i den originale blister for at beskytte mod fugt.
English: Linagliptin as add-on to metformin therapy
Danish: Linagliptin som supplement til metformin
English: Tel: +34 91 663 50 00
Danish: Lilly S.A. Tel: +34 91 663 50 00
English: Propylene glycol
Danish: Propylenglycol
English: Boehringer Ingelheim International GmbH Binger Strasse 173
Danish: Indehaver af markedsføringstilladelsen Boehringer Ingelheim International GmbH Binger Strasse 173
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1,000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter
English: Race had no obvious effect on the plasma concentrations of linagliptin based on a composite analysis of available pharmacokinetic data, including patients of Caucasian, Hispanic, African, and Asian origin.
Danish: Baseret på en sammensat analyse af tilgængelige farmakokinetiske data, herunder patienter af kaukasisk, latinamerikansk, afrikansk og asiatisk oprindelse fandtes, at etnisk oprindelse ikke havde tydelig indvirkning på plasmakoncentrationerne af linagliptin.
English: Linagliptin added to metformin provided significant improvements in HbA1c, (-0.64% change compared to placebo), from a mean baseline HbA1c of 8%.
Danish: Linagliptin i kombination med metformin medførte signifikant reduktion i HbA1c (ændring på -0,64 % sammenlignet med placebo) i forhold til et gennemsnitligt baseline-HbA1c på 8 %.
English: - if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
Danish: Alvorlige infektioner kan medføre nyreproblemer, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler') - hvis du har mistet en masse vand fra kroppen (dehydrering), f.eks. på grund af langvarig eller svær diarré eller hvis du har kastet op flere gange efter hinanden.
English: Baseline (mean) Change from baseline (adjusted mean)
Danish: Baseline (gennemsnit) Ændring i forhold til baseline (justeret gennemsnit) Afvigelse fra placebo (justeret gennemsnit) (95 % CI)
English: Linagliptin also showed significant improvements in fasting plasma glucose (FPG) by -21.1 mg/dl and 2-hour postprandial glucose (PPG) by -67.1 mg/dl compared to placebo, as well as a greater portion of patients achieving a target HbA1c of < 7.0% (28.3% on linagliptin versus 11.4% on placebo).
Danish: Linagliptin viste sig desuden at medføre signifikant reduktion i faste-plasma-glucose (FPG) på -21,1 mg/dl og 2-timers post-prandialt-glucose (PPG) på -67,1 mg/dl sammenlignet med placebo.
English: - if you are treated for acute heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties.
Danish: Dehydrering kan medføre nyreproblemer, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler') - hvis du er behandlet for akut hjertesvigt eller for nylig har haft et hjerteanfald, har alvorlige kredsløbsproblemer (f.eks. shock) eller vejrtrækningsbesvær.
English: Hepatobiliary disorders Liver function disorders uncommon
Danish: Lever og galdeveje Leverfunktionsforstyrrelse ikke almindelig
English: No other additive toxicity caused by the combination of linagliptin and metformin was observed at AUC exposure levels up to 2 and 23 times human exposure, respectively.
Danish: Den eneste observerede interaktion mellem linagliptin og metformin var, at kropsvægten ikke steg i samme grad. Ved AUC-eksponeringsniveauer op til henholdsvis 2 og 23 gange human eksponering, blev der ikke observeret anden additiv toksicitet forårsaget af kombinationen af linagliptin og metformin.
English: Linagliptin as add on to a combination of metformin and empagliflozin therapy In patients inadequately controlled with metformin and empagliflozin (10 mg (n=247) or 25 mg (n=217)), 24-weeks treatment with add-on therapy of linagliptin 5 mg provided adjusted mean HbA1c reductions from baseline by -0.53% (significant difference to add-on placebo -0.32% (95% CI -0.52, -0.13) and -0.58% (significant difference to add-on placebo -0.47% (95% CI -0.66; -0.28), respectively.
Danish: Linagliptin som supplement til metformin plus empagliflozin Hos patienter, der ikke var tilstrækkeligt reguleret med metformin og empagliflozin (10 mg (n = 247) eller 25 mg (n = 217)), medførte 24 ugers behandling med linagliptin 5 mg som supplement, justerede gennemsnitlige fald i HbA1c i forhold til baseline på hhv. -0,53 % (signifikant forskel ift.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - INDERPAKNING UDEN BLUE BOX - 2,5 MG/850 MG FILMOVERTRUKNE TABLETTER
English: Jentadueto 2.5 mg/850 mg film-coated tablets Film coating
Danish: Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Filmovertræk
English: GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels.
Danish: Når blodglucosekoncentrationen er normal eller forhøjet, bevirker GLP-1 og GIP en øget insulinsyntese og frigørelse af insulin fra bugspytkirtlens betaceller.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/850 mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE AF MULTIPAKNING - PAKKET I TRANSPARENT FOLIE - MED BLUE BOX - 2,5 mg/850 mg FILMOVERTRUKNE TABLETTER
English: - if you drink alcohol to excess, either every day or only from time to time (see section 'Jentadueto with alcohol').
Danish: Det kan betyde, at du ikke får nok ilt ud i vævene, hvorved du risikerer at få laktatacidose (se 'Advarsler og forsigtighedsregler') - hvis du har en leversygdom - hvis du drikker meget alkohol, enten hver dag eller kun nogle gange (se 'Jentadueto sammen med alkohol').
English: Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
Danish: Jentadueto 2,5 mg/850 mg er ovale, bikonvekse lysorange filmovertrukne tabletter.
English: One main metabolite with a relative exposure of 13.3% of linagliptin at steady-state was detected which was found to be pharmacologically inactive, and thus does not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Danish: En hovedmetabolit med en relativ eksponering på 13,3 % af linagliptin-dosis ved steady state blev påvist.
English: Bullous pemphigoid has been observed in patients taking linagliptin.
Danish: Der er blevet observeret bulløs pemfigoid hos patienter, der tog linagliptin.
English: What Jentadueto is and what it is used for What you need to know before you take Jentadueto How to take Jentadueto
Danish: Det skal du vide, før du begynder at tage Jentadueto Sådan skal du tage Jentadueto Bivirkninger
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets Film coating
Danish: Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter Filmovertræk
English: Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
Danish: Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - INDERPAKNING UDEN BLUE BOX - 2,5 mg/1.000 mg FILMOVERTRUKNE TABLETTER
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/032 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/033 (180 (2 x 90 x 1) filmovertrukne tabletter ) EU/1/12/780/034 (200 (2 x 100 x 1) filmovertrukne tabletter )
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg tablets Linagliptin/metformin HCl
Danish: LÆGEMIDLETS NAVN Jentadueto 2,5 mg/1.000 mg tabletter linagliptin/metformin HCl
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg tablets Linagliptin/metformin HCl
Danish: LÆGEMIDLETS NAVN Jentadueto 2,5 mg/850 mg tabletter linagliptin/metformin HCl
English: Secondary renal composite (renal death, ESRD, 40% sustained decrease in eGFR)
Danish: Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikke-dødeligt MI, ikke-dødelig apopleksi) Sekundært sammensat renalt (nyredød, ESRD, 40 % vedvarende reduktion i eGFR) Mortalitet uanset årsag
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/029 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/030 (180 (2 x 90 x 1) filmovertrukne tabletter ) EU/1/12/780/031 (200 (2 x 100 x 1) filmovertrukne tabletter )
English: Jentadueto 2.5 mg/850 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Danish: Jentadueto 2,5 mg/850 mg filmovertrukne tabletter Hver tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid.
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Danish: Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter Hver tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid
English: The efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 12 weeks duration.
Danish: Et 12-ugers dobbeltblindet placebokontrolleret studie undersøgte effekt og sikkerhed af linagliptin 2,5 mg 2 gange dagligt vs 5 mg én gang dagligt i kombination med metformin hos patienter i metformin-monoterapi med utilstrækkelig glykæmisk kontrol.
English: Gender
Danish: Etnisk oprindelse
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid
English: Iodinated contrast agents
Danish: Iodholdige kontrastmidler
English: Jentadueto in order to avoid low blood sugar (hypoglycaemia).
Danish: så fald vil lægen måske nedsætte dosis af insulin eller sulfonylurinstof for at undgå lavt blodsukker (hypoglykæmi).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - WRAPPED IN TRANSPARENT FOILINCLUDING THE BLUE BOX - 2.5 mg/1,000 mg FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL YDRE EMBALLAGE AF MULTIPAKNING PAKKET I TRANSPARENT FOLIE - MED BLUE BOX - 2,5 mg/1.000 mg FILMOVERTRUKNE TABLETTER
English: Twice Daily Metformin HCl 500 mg
Danish: Linagliptin 2,5 mg to gange dagligt + metformin HCl 500 mg to gange dagligt
English: Keep taking Jentadueto until your doctor tells you to stop.
Danish: Du må ikke holde op med at tage Jentadueto uden at tale med lægen først.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/026 14 film-coated tablets EU/1/12/780/027 60 film-coated tablets EU/1/12/780/028 180 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/026 14 filmovertrukne tabletter EU/1/12/780/027 60 filmovertrukne tabletter EU/1/12/780/028 180 filmovertrukne tabletter
English: If you take more Jentadueto than you should
Danish: Hvis du har taget for meget Jentadueto
English: However, taking Jentadueto in combination with medicines called sulphonylureas or with insulin can cause too low blood sugar level (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Danish: Jentadueto kan dog sammen med sulfonylurinstof eller insulin medføre for lavt blodsukker (hypoglykæmi).
English: Bottle Keep the bottle tightly closed in order to protect from moisture.
Danish: Beholder Hold beholderen tæt tillukket for at beskytte mod fugt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/012 14 film-coated tablets EU/1/12/780/013 60 film-coated tablets EU/1/12/780/014 180 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/780/012 14 filmovertrukne tabletter EU/1/12/780/013 60 filmovertrukne tabletter EU/1/12/780/014 180 filmovertrukne tabletter
English: Co-administration of metformin with
Danish: Samtidig administration af metformin og
English: Gender had no clinically relevant effect on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde køn ikke nogen klinisk relevant indvirkning på linagliptins farmakokinetik.
English: Bottle: Keep the bottle tightly closed in order to protect from moisture.
Danish: Beholder: Beholderen holdes lukket for at beskytte mod fugt.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/1,000 mg film-coated tablets Linagliptin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
English: - Each Jentadueto 2.5 mg/850 mg film-coated tablet contains 2.5 mg of linagliptin and 850 mg of metformin hydrochloride.
Danish: Hver Jentadueto 2,5 mg/850 mg filmovertrukket tablet indeholder 2,5 mg linagliptin og 850 mg metforminhydrochlorid.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Linagliptin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Jentadueto 2,5 mg/850 mg filmovertrukne tabletter linagliptin/metforminhydrochlorid
English: Dose reduction may be considered in relation to declining renal function.
Danish: Den maksimale daglige dosis er 3.000 mg Dosisreduktion kan overvejes i forbindelse med tiltagende nedsættelse af nyrefunktionen.
English: Lactic acidosis very rare
Danish: Lactatacidose meget sjælden
English: - Each Jentadueto 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg of linagliptin and 1,000 mg of metformin hydrochloride.
Danish: Hver Jentadueto 2,5 mg/1.000 mg filmovertrukket tablet indeholder 2,5 mg linagliptin og 1.000 mg metforminhydrochlorid.
English: They have "D2/1000" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Danish: De er præget med henholdsvis Boehringer Ingelheims logo og D2/1000.
English: If any of the above apply to you, talk to your doctor for further instructions.
Danish: Kontakt lægen for at få yderligere vejledning, hvis noget af ovennævnte gælder for dig.
English: If you are overweight, continue your energy-restricted diet as instructed.
Danish: Hvis du er overvægtig, skal du fortsætte med din energibegrænsede diæt, som du er blevet instrueret i. Det er ikke sandsynligt, at Jentadueto medfører unormalt lavt blodsukker (hypoglykæmi).
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Danish: opkastning mavesmerter muskelkramper almen utilpashed med udpræget træthed vejrtrækningsbesvær nedsat kropstemperatur og langsommere puls
English: Bullous pemphigoid rare #
Danish: Bulløs pemfigoid sjælden
English: Age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Danish: Baseret på en farmakokinetisk populationsanalyse af fase I- og fase II-data, havde alder ikke nogen klinisk relevant indflydelse på linagliptins farmakokinetik.
English: - if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or sulphonylurea when you take either of them together with
Danish: - hvis du tager insulin eller et sulfonylurinstof (anden diabetesmedicin) sammen med Jentadueto.
English: They have "D2/850" debossed on one side and the Boehringer Ingelheim logo debossed on the other.
Danish: De er præget med henholdsvis Boehringer Ingelheims logo og D2/850.
English: Jentadueto 2.5 mg/1,000 mg film-coated tablets EU/1/12/780/015 (10 x 1 film-coated tablets) EU/1/12/780/016 (14 x 1 film-coated tablets) EU/1/12/780/017 (28 x 1 film-coated tablets) EU/1/12/780/018 (30 x 1 film-coated tablets) EU/1/12/780/019 (56 x 1 film-coated tablets) EU/1/12/780/020 (60 x 1 film-coated tablets) EU/1/12/780/021 (84 x 1 film-coated tablets) EU/1/12/780/022 (90 x 1 film-coated tablets) EU/1/12/780/023 (98 x 1 film-coated tablets) EU/1/12/780/024 (100 x 1 film-coated tablets) EU/1/12/780/025 (120 x 1 film-coated tablets) EU/1/12/780/026 (14 film-coated tablets, bottle) EU/1/12/780/027 (60 film-coated tablets, bottle) EU/1/12/780/028 (180 film-coated tablets, bottle) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Danish: Jentadueto 2,5 mg/1.000 mg filmovertrukne tabletter EU/1/12/780/015 (10 x 1 filmovertrukne tabletter) EU/1/12/780/016 (14 x 1 filmovertrukne tabletter) EU/1/12/780/017 (28 x 1 filmovertrukne tabletter) EU/1/12/780/018 (30 x 1 filmovertrukne tabletter) EU/1/12/780/019 (56 x 1 filmovertrukne tabletter) EU/1/12/780/020 (60 x 1 filmovertrukne tabletter) EU/1/12/780/021 (84 x 1 filmovertrukne tabletter) EU/1/12/780/022 (90 x 1 filmovertrukne tabletter) EU/1/12/780/023 (98 x 1 filmovertrukne tabletter) EU/1/12/780/024 (100 x 1 filmovertrukne tabletter) EU/1/12/780/025 (120 x 1 filmovertrukne tabletter) EU/1/12/780/026 (14 filmovertrukne tabletter, beholder) EU/1/12/780/027 (60 filmovertrukne tabletter, beholder) EU/1/12/780/028 (180 filmovertrukne tabletter, beholder) EU/1/12/780/032 (120 (2 x 60 x 1) filmovertrukne tabletter) EU/1/12/780/033 (180 (2 x 90 x 1) filmovertrukne tabletter) EU/1/12/780/034 (200 ( 2 x 100 x 1) filmovertrukne tabletter)
English: EU/1/12/780/001 10 x 1 film-coated tablets EU/1/12/780/002 14 x 1 film-coated tablets EU/1/12/780/003 28 x 1 film-coated tablets EU/1/12/780/004 30 x 1 film-coated tablets EU/1/12/780/005 56 x 1 film-coated tablets EU/1/12/780/006 60 x 1 film-coated tablets EU/1/12/780/007 84 x 1 film-coated tablets EU/1/12/780/008 90 x 1 film-coated tablets EU/1/12/780/009 98 x 1 film-coated tablets EU/1/12/780/010 100 x 1 film-coated tablets EU/1/12/780/011 120 x 1 film-coated tablets
Danish: EU/1/12/780/001 10 x 1 filmovertrukne tabletter EU/1/12/780/002 14 x 1 filmovertrukne tabletter EU/1/12/780/003 28 x 1 filmovertrukne tabletter EU/1/12/780/004 30 x 1 filmovertrukne tabletter EU/1/12/780/005 56 x 1 filmovertrukne tabletter EU/1/12/780/006 60 x 1 filmovertrukne tabletter EU/1/12/780/007 84 x 1 filmovertrukne tabletter EU/1/12/780/008 90 x 1 filmovertrukne tabletter EU/1/12/780/009 98 x 1 filmovertrukne tabletter EU/1/12/780/010 100 x 1 filmovertrukne tabletter EU/1/12/780/011 120 x 1 filmovertrukne tabletter