natgillin/translations-raw huggingface dataset:
De skal undgå at indtage store mængder alkohol, mens De er i behandling med Efficib, da det kan øge risikoen for laktacidose (se punktet ”Advarsler og forsigtighedsregler”). 
Avoid excessive alcohol intake while taking Efficib since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Ændring i klinisk status hos patienter med tidligere velbehandlet type 2-diabetes En patient med type 2-diabetes, der tidligere var velbehandlet på Efficib, og som udvikler unormale laboratorieværdier eller klinisk sygdom (især vagt eller uklart defineret sygdom) bør vurderes hurtigt med henblik på tegn på ketoacidose eller laktacidose. 
Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Efficib who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Stop med at tage Efficib og kontakt omgående læge eller nærmeste hospital, hvis De får et eller flere af nedenstående symptomer på laktacidose, da denne tilstand kan føre til koma. 
Stop taking Efficib and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Sitagliptin forbedrede totalt set den glykæmiske kontrol, når det blev givet som monoterapi eller som kombinationbehandling. 
Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment.
De skal eventuelt have kontrolleret Deres blodsukker eller Deres nyrefunktion hyppigere, eller lægen kan ændre Deres dosis af Efficib. 
You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Efficib.
Efficib er kontraindiceret hos patienter med GFR < 30 ml/min, og behandlingen skal afbrydes midlertidigt ved tilstedeværelse af tilstande, der påvirker nyrefunktionen (se pkt. 
Efficib is contraindicated in patients with GFR < 30 mL/min and should be temporarily discontinued during conditions with the potential to alter renal function (see section 4.3).
Efficib indeholder to slags medicin, sitagliptin og metformin. 
Efficib contains two different medicines called sitagliptin and metformin.
• Sitagliptin tilhører en klasse af medicin, som kaldes DPP-4-hæmmere (dipeptylpeptidase-4 
• sitagliptin belongs to a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors)
Desuden bør patienter advares om risikoen for hypoglykæmi, når Efficib anvendes sammen med et sulfonylurinstof eller sammen med insulin. 
In addition, patients should be alerted to the risk of hypoglycaemia when Efficib is used in combination with a sulphonylurea or with insulin.
Det vil være nødvendigt at stoppe med Efficib på tidspunktet for røntgenundersøgelsen og i 2 dage eller mere som foreskrevet af lægen, afhængigt af hvordan Deres nyrer fungerer. 
You will need to stop taking Efficib at the time of the X-ray and for 2 or more days after as directed by your doctor,
Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apotekspersonalet, før De tager Efficib. 
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Efficib.
Efficib påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Efficib has no or negligible influence on the ability to drive and use machines.
Brug af anden medicin sammen med Efficib 
Other medicines and Efficib
De kan finde yderligere oplysninger om Efficib på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicine is available on the website of the European Medicines Agency web site: http://www.ema.europa.eu.
En bioækvivalensundersøgelse med raske forsøgspersoner viste, at Efficib (sitagliptin/metforminhydrochlorid) kombinationstabletter er bioækvivalente med samtidig administration af sitagliptinphosphat og metforminhydrochlorid som individuelle tabletter. 
A bioequivalence study in healthy subjects demonstrated that the Efficib (sitagliptin/metformin hydrochloride) combination tablets are bioequivalent to co-administration of sitagliptin phosphate and metformin hydrochloride as individual tablets.
Efficib må derfor ikke anvendes til kvinder, der ammer (se pkt. 
Efficib must therefore not be used in women who are breast-feeding (see section 4.3).
Patienter, der får Efficib sammen med et sulfonylurinstof eller sammen med insulin, har øget risiko for at få hypoglykæmi. 
Patients receiving Efficib in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Efficib indeholder: 
What Efficib contains
Når Efficib anvendes sammen med et sulfonylurinstof, kan en lavere dosis af sulfonylurinstoffet være nødvendig for at reducere risikoen for hypoglykæmi (se pkt. 
When Efficib is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Sådan skal De tage Efficib 
How to take Efficib
Efficib er en kombination af to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer til forbedring af glykæmisk kontrol hos patienter med type 2-diabetes: Sitagliptinphosphat, en dipeptidylpeptidase-4-hæmmer (DPP-4), og metforminhydrochlorid, der tilhører biguanidklassen. 
Efficib combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Når Efficib anvendes sammen med insulin, kan det være nødvendigt at nedsætte insulindosis for at reducere risikoen for hypoglykæmi (se pkt. 
When Efficib is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Der er ikke udført behandlingsmæssige kliniske undersøgelser med Efficib-tabletter, men Efficibs bioækvivalens er blevet påvist, når det gives sammen med sitagliptin og metformin (se pkt. 
There have been no therapeutic clinical trials conducted with Efficib tablets however bioequivalence of Efficib with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Er De i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før De tager Efficib. 
If you are not sure, talk to your doctor, pharmacist or nurse before taking Efficib.
Efficib er også indiceret som tillægsbehandling til insulin (dvs. tripel kombinationsbehandling) som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, når stabil dosering af insulin og metformin alene ikke giver tilstrækkelig glykæmisk kontrol. 
Efficib is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Brug ikke Efficib efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. 
The expiry date refers to the last day of the month.
Efficib er indiceret som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin alene eller hos de patienter, som allerede er i behandling med kombinationen af sitagliptin og metformin. 
Efficib is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Nedsat leverfunktion Efficib må ikke anvendes til patienter med nedsat leverfunktion (se pkt. 
Hepatic impairment Efficib must not be used in patients with hepatic impairment (see section 5.2).
Efficib er indiceret som tripel kombinationsbehandling sammen med en peroxisom proliferatoraktiveret receptor-gamma (PPAR)-agonist (dvs. et glitazon) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og en PPAR-agonist. 
Efficib is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Til de forskellige metformindoser findes Efficib i styrker på 50 mg sitagliptin og 850 mg metforminhydrochlorid eller 1.000 mg metforminhydrochlorid. 
For the different doses on metformin, Efficib is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Behandlingen med Efficib skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil (se pkt. 
Efficib should 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 4.3 and
Kontakt lægen, apoteket eller sundhedspersonalet, før De tager Efficib: - Hvis De har eller har haft en sygdom i bugspytkirtlen (f.eks. pankreatitis). 
Talk to your doctor or pharmacist before taking Efficib: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Behandling med Efficib 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. 
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.
obstipation (almindelig med sulfonylurinstoffer), perifert ødem (almindelig med pioglitazon) og hovedpine og mundtørhed (ikke almindelig med insulin). 
These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin).
Efficib 50 mg/850 mg filmovertrukne tabletter. 
Efficib 50 mg/850 mg film-coated tablets
Efficib 50 mg/1.000 mg filmovertrukne tabletter. 
Efficib 50 mg/1,000 mg film-coated tablets
Undersøgelse af sitagliptin i kombination med metformin og insulin En 24-ugers placebokontrolleret undersøgelse blev designet til at evaluere effekt og sikkerhed af sitagliptin (100 mg en gang dagligt) som supplement til insulin (ved stabil dosis i mindst 10 uger) med eller uden metformin (mindst 1.500 mg). 
Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Efficib er indiceret som supplement til diæt og motion i kombination med et sulfonylurinstof (dvs. tripel kombinationsbehandling) hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og sulfonylurinstof. 
Efficib is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
EU/1/08/457/008 14 filmovertrukne tabletter EU/1/08/457/009 28 filmovertrukne tabletter EU/1/08/457/010 56 filmovertrukne tabletter EU/1/08/457/021 60 filmovertrukne tabletter EU/1/08/457/011 112 filmovertrukne tabletter EU/1/08/457/012 168 filmovertrukne tabletter EU/1/08/457/022 180 filmovertrukne tabletter EU/1/08/457/013 196 filmovertrukne tabletter EU/1/08/457/014 50 x 1 filmovertrukne tabletter EU/1/08/457/016 196 (2 x 98) filmovertrukne tabletter EU/1/08/457/018 168 (2 x 84) filmovertrukne tabletter 
EU/1/08/457/008 14 film-coated tablets EU/1/08/457/009 28 film-coated tablets EU/1/08/457/010 56 film-coated tablets EU/1/08/457/021 60 film-coated tablets EU/1/08/457/011 112 film-coated tablets EU/1/08/457/012 168 film-coated tablets EU/1/08/457/022 180 film-coated tablets EU/1/08/457/013 196 film-coated tablets EU/1/08/457/014 50 x 1 film-coated tablets EU/1/08/457/016 196 (2 x 98) film-coated tablets EU/1/08/457/018 168 (2 x 84) film-coated tablets
Metformin virker via tre mekanismer: - ved reduktion af hepatisk glucoseproduktion gennem hæmning af glukoneogenese og glycogenolyse. 
Metformin may act via three mechanisms: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
EU/1/08/457/001 14 filmovertrukne tabletter EU/1/08/457/002 28 filmovertrukne tabletter EU/1/08/457/003 56 filmovertrukne tabletter EU/1/08/457/019 60 filmovertrukne tabletter EU/1/08/457/004 112 filmovertrukne tabletter EU/1/08/457/005 168 filmovertrukne tabletter EU/1/08/457/020 180 filmovertrukne tabletter EU/1/08/457/006 196 filmovertrukne tabletter EU/1/08/457/007 50 x 1 filmovertrukne tabletter EU/1/08/457/015 196 (2 x 98) filmovertrukne tabletter EU/1/08/457/017 168 (2 x 84) filmovertrukne tabletter 
EU/1/08/457/001 14 film-coated tablets EU/1/08/457/002 28 film-coated tablets EU/1/08/457/003 56 film-coated tablets EU/1/08/457/019 60 film-coated tablets EU/1/08/457/004 112 film-coated tablets EU/1/08/457/005 168 film-coated tablets EU/1/08/457/020 180 film-coated tablets EU/1/08/457/006 196 film-coated tablets EU/1/08/457/007 50 x 1 film-coated tablets EU/1/08/457/015 196 (2 x 98) film-coated tablets EU/1/08/457/017 168 (2 x 84) film-coated tablets
Det skal De vide, før De begynder at tage Efficib Sådan skal De tage Efficib Bivirkninger 
What Efficib is and what it is used for What you need to know before you take Efficib How to take Efficib
- Lægen har ordineret Efficib til Dem personligt. 
- This medicine has been prescribed for you only.
- Hvis De tager anden diabetesmedicin, sulfonylurinstof eller insulin, sammen med Efficib, da De så kan opleve lavt blodsukker (hypoglykæmi). 
This is sometimes called insulin-dependent diabetes - if you have or have had an allergic reaction to sitagliptin, metformin, or Efficib (see section 4) - if you are taking a sulphonylurea or insulin, diabetes medicines, together with Efficib, as you may experience low blood sugar levels (hypoglycaemia).
Hos patienter, der tog ikke-forblandet insulin (middellangtidsvirkende/langtidsvirkende), var den gennemsnitlige daglige dosis 44,3 E/dag.Data fra 73% af de patienter, som tog metformin, fremgår af tabel 2. 
In patients taking non-pre-mixed (intermediate/long-acting) insulin, the mean daily dose was 44.3 U/day.
Efficib 50 mg/1.000 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid 
Efficib 50 mg/1,000 mg film-coated tablets sitagliptin/metformin hydrochloride
Efficib 50 mg/850 mg filmovertrukne tabletter sitagliptin/metforminhydrochlorid 
Efficib 50 mg/850 mg film-coated tablets sitagliptin/metformin hydrochloride
- Hvis De har dårligt kontrolleret diabetes, der eksempelvis er ledsaget af alvorlig hyperglykæmi (højt blodsukker), kvalme, opkastning, diarré, hurtigt vægttab, laktacidose (se ”Risiko for laktacidose” nedenfor) eller ketoacidose. 
Do not take Efficib: - if you are allergic to sitagliptin or metformin or any of the other ingredients of this medicine (listed in section 6) - if you have severely reduced kidney function - if you have uncontrolled diabetes, with e.g. severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Efficib 50 mg/1000 mg tabletter sitagliptin/metforminhydrochlorid 
Efficib 50 mg/1,000 mg tablets sitagliptin/metformin HCl
Udseende og pakningsstørrelser 
What Efficib looks like and contents of the pack
Efficib 50 mg/850 mg tabletter sitagliptin/metforminhydrochlorid 
Efficib 50 mg/850 mg tablets sitagliptin/metformin HCl
Hvis De har taget for meget Efficib 
If you take more Efficib than you should
Sådanne afgørelser bør i stedet træffes i det enkelte tilfælde efter en vurdering af resultaterne og deres potentielle betydning. 
Such decisions should instead be taken on a case by case basis, following an evaluation of the findings and their potential impact.
Samlet resumé af den videnskabelige vurdering af Tibocina og relaterede navne (se bilag I) 
Overall summary of the scientific evaluation of Tibocina and associated names (see Annex I)
Der blev udført en enkelt bioækvivalensundersøgelse til støtte for begge ansøgninger. 
A single bioequivalence study was conducted to support both applications.
Tibolon er et syntetisk steroidt hormon, der navnlig virker agonistisk på østrogenreceptorer. 
Tibolone is a synthetic steroid hormone drug which acts as an agonist, mainly on oestrogen receptors.
Der blev indgivet to ansøgninger under den decentrale procedure for de generiske produkter Tibolona Aristo og Tibocina, der begge er 2,5 mg tabletter med indikationen “symptomer på østrogenmangel hos kvinder, tidligst et år efter menopausen”. 
Two applications under the decentralised procedure were submitted for the generic products Tibolona Aristo and Tibocina, both 2.5 mg tablets with the indication “treatment of oestrogen deficiency symptoms in women, more than one year after the menopause”.
Disse resultater blev klassificeret som kritiske, og en af de berørte medlemsstater fandt det derfor umuligt at drage konklusioner om pålideligheden af bioækvivalensundersøgelsen. 
These findings were classified as critical and one of the concerned member states therefore considered it impossible to conclude on the reliability of the bioequivalence study.
Der blev indledt en indbringelse i medfør af artikel 29, stk. 4, af direktiv 2001/83/EF, og CHMP blev anmodet om at fremsætte en udtalelse om, hvorvidt de ansøgte produkter Tibolona Aristo og Tibocina kan anses for bioækvivalente med referenceproduktet. 
A referral under Article 29(4) of Directive 2001/83/EC was triggered and the CHMP was requested to give its opinion on whether the proposed products Tibolona Aristo and Tibocina can be considered bioequivalent to the reference product.
• CHMP gennemgik de foreliggende data, herunder rapportørernes vurderingsrapporter og ansøgerens redegørelser, der var forelagt under proceduren i CMDh, 
• the CHMP reviewed the available data, including the Rapporteurs' assessment reports and the explanations submitted by the Applicant during the CMDh procedure
Efter gennemgang af de foreliggende data fandt CHMP, at der var tilstrækkelig supplerende dokumentation for, at prøverne fra undersøgelsen ikke blev udsat for risici under undersøgelsen, og at de blev opbevaret under tilfredsstillende temperaturbetingelser. 
Having reviewed the available data, the CHMP considered that there was sufficient additional evidence indicating that the study samples were not put at risks during the study and that these were maintained under adequate temperature conditions.
Ved vurderingen af ansøgningernes dokumentation viste en GCP-inspektion (GCP = god klinisk praksis) af det kliniske forsøgssted, at der savnedes dokumentation for overførselsdato og -tidspunkt og identifikation af farmakogenetiske prøver fra den tørisboks, der blev anvendt til lynfrysning, til den fryser, der blev anvendt på forsøgsstedet, indtil prøverne blev overført til det bioanalytiske center. 
During the assessment of the application dossiers, a Good Clinical Practice (GCP) inspection of the clinical site identified a lack of evidence documenting the transfer date and time and the identification of pharmacokinetic samples from the dry ice box used for flash freezing to the freezer used at this site until the samples were transferred to the bioanalytical site.
CHMP vedgik, at resultaterne anses for en kritisk mangel, men fandt ikke, at resultater af en GCPinspektion, der klassificeres som kritiske, automatisk bør afkræfte resultaterne af en bioækvivalensundersøgelse. 
The CHMP acknowledged that the findings are considered as a critical deficiency, however it did not consider that GCP inspection findings classified as critical should automatically invalidate the results of a bioequivalence study.
Den udførte undersøgelse viste desuden bioækvivalens, idet de iagttagne koncentrationer af lægemidlet var sammenlignelige med eller oversteg dem, der er beskrevet i i litteraturen, og CHMP fandt, at resultaterne tyder på, at der ikke har været tale om nævneværdig nedbrydning af lægemidlet. 
In addition, the bioequivalence study conducted demonstrated bioequivalence, with observed drug concentrations being comparable or superior to those reported in the literature and the CHMP considered that these results suggest that no significant degree of drug degradation occurred.
CHMP gennemgik derfor den foreliggende supplerende kliniske dokumentation, herunder den vurdering, der blev foretaget under proceduren i CMDh (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer (human)) og den dokumentation, der var forelagt af ansøgeren. 
The CHMP therefore reviewed the additional clinical evidence available, including the assessment carried out during the CMDh procedure and the evidence submitted by the Applicant.
CHMP konkluderede derfor, at den samlede dokumentation - uanset de fundne fravigelser af GCPkravene - bekræfter pålideligheden af resultaterne af bioækvivalensundersøgelsen og godtgør bioækvivalensen af de ansøgte produkter med referenceproduktet. 
The CHMP therefore concluded that while deviations from GCP requirements were identified, the totality of the available evidence confirms that the results of the bioequivalence study are reliable and demonstrates the bioequivalence of the proposed products and the reference product.
Produktresuméet, etiketteringen og indlægssedlen hertil forbliver uændrede og svarer til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen, som anført i bilag III for Tibocina og relaterede navne (se bilag I). 
• the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibocina and associated names (see Annex I).
Virkninger på human reproduktion kan ikke udelukkes. 
Effects on human reproduction cannot be excluded.
Alle symptomer forsvandt helt i løbet af nogle få timer. 
All symptoms resolved completely within a few hours.
• Allergiske reaktioner, der i sjældne tilfælde kan være alvorlige 
• Allergic reactions which can, rarely, be serious
Omhyggelig monitorering. 
Careful monitoring.
Ved langvarig behandling (over 6 måneder): 
In case of long term treatment (more than 6 months):
Aktivt kul kan gives, hvis det anses for hensigtsmæssigt. 
Activated charcoal may be given if considered appropriate.
Responsraterne lå på mellem 43-80 % afhængigt af studierne og responskriterierne. 
Response rates varied between 43 and 80% depending on the studies and the criteria to define a response.
Forbedring af de kliniske symptomer blev bemærket hos de fleste patienter efter initiering af behandling. 
Improvement of clinical symptoms was noted in most patients after initiation of treatment.
Cmax og AUC øges mere end proportionalt med dosis. 
Cmax and AUC increase more than proportionally with dose.
Forventet virkning på lægemiddelniveauer 
Expected effect on drug levels