FrancophonIA/ELRC3.0 huggingface dataset:
English: The oral administration of spinosad and milbemycin oxime combination tablets at mean cumulative monthly doses of up to 255 mg spinosad and 4.2 mg milbemycin oxime per kg body weight (up to 3.6 times the maximum recommended dose) for 6 consecutive dosing periods in young dogs was well tolerated.
Danish: Oral indgift af kombinationstabletter med spinosad og milbemycinoxim ved gennemsnitlige kumulative doser på op til 255 mg spinosad og 4,2 mg milbemycinoxim per kg legemsvægt (op til 3,6 gange den maksimale behandlingsdosis) i 6 på hinanden følgende doseringsperioder var veltoleret af unge hunde.
English: In juvenile dogs, repeated oral administration of spinosad and milbemycin oxime over six months resulted in the trough plasma concentrations of spinosad and milbemycin increasing throughout the study.
Danish: Hos unge hunde resulterede gentagen oral indgift af spinosad og milbemycinoxim over seks måneder i en stigning i de lave plasmakoncentrationer af spinosad og milbemycin i løbet af hele studiet.
English: The oral administration of spinosad and milbemycin oxime combination tablets at mean cumulative monthly doses up to 255mg spinosad and 4.2 mg milbemycin oxime per kg body weight (up to 3.6 times the recommended treatment dose) for 6 consecutive dosing periods in young dogs was well tolerated.
Danish: Oral indgift af kombinationstabletter med spinosad og milbemycinoxim ved gennemsnitlige kumulative doser på op til 255 mg spinosad og 4,2 mg milbemycinoxim per kg legemsvægt (op til 3,6 gange den anbefalede behandlingsdosis) i 6 efterfølgende doseringsperioder var veltoleret af yngre hunde.
English: After administration of the tablet monitor the dog closely.
Danish: Overvåg hunden nøje efter indgift af tabletten.
English: Trifexis 665 mg/11.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg
Danish: Trifexis 665 mg/11,1 mg spinosad 665 mg/milbemycinoxim 11,1 mg
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemycin oxime 27.0 mg
Danish: Trifexis 1620 mg/27 mg spinosad 1620 mg/milbemycinoxim 27,0 mg
English: For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: - prevention of heartworm disease (L3, L4 Dirofilaria immitis), - prevention of angiostrongylosis by reducing the level of infection with immature adult (L5)
Danish: Til behandling og forebyggelse af loppeinfestationer (Ctenocephalides felis) hos hunde, når en eller flere af følgende indikationer er påkrævet samtidigt: - forebyggelse af hjerteorm (L3, L4 Dirofilaria immitis) - forebyggelse af angiostrongylose ved at reducere infektionsniveauet med umodne voksne (L5) Angiostrongylus vasorum, - behandling af gastrointestinale nematodeinfektioner forårsaget af hageorm (L4, umodne voksne (L5) og voksne Ancylostoma caninum), spolorm (umodne voksne L5 og voksne Toxocara canis samt voksne Toxascaris leonina) og piskeorm (voksne Trichuris vulpis).
English: Trifexis 665 mg/11.1 mg tablets:
Danish: Trifexis 665 mg/11,1 mg tabletter:
English: spinosad 270 mg/milbemycin oxime 4.5 mg spinosad 425 mg/milbemycin oxime 7.1 mg spinosad 665 mg/milbemycin oxime 11.1 mg spinosad 1040 mg/milbemycin oxime 17.4 mg spinosad 1620 mg/milbemycin oxime 27 mg
Danish: spinosad 270 mg/milbemycinoxim 4,5 mg spinosad 425 mg/milbemycinoxim 7,1 mg spinosad 665 mg/milbemycinoxim 11,1 mg spinosad 1040 mg/milbemycinoxim 17,4 mg spinosad 1620 mg/milbemycinoxim 27 mg
English: 4349 and 4 dimples
Danish: 4349 og 4 fordybninger
English: Laboratory studies (in rats and rabbits) on the effect of spinosad and milbemycin oxime have neither produced any evidence of teratogenic, foetotoxic or maternotoxic effects, nor any effect on the reproductive capacity in males and females.
Danish: Laboratorieundersøgelser af effekten af spinosad og milbemycinoxim (hos rotter og kaniner) har hverken afsløret teratogene virkninger, føtal toksicitet eller maternel toksicitet.
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Danish: EU/2/13/155/001 (1 tablet, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tabletter, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tabletter, 270 mg/4,5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tabletter, 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tabletter, 425 mg/7,1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11,1 mg) EU/2/13/155/008 (1 x 3 tabletter, 665 mg/11,1 mg) EU/2/13/155/009 (1 x 6 tabletter, 665 mg/11,1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17,4 mg) EU/2/13/155/011 (1 x 3 tabletter, 1040 mg/17,4 mg) EU/2/13/155/012 (1 x 6 tabletter, 1040 mg/17,4 mg)
English: 4333 and 2 dimples
Danish: 4333 og 2 fordybninger
English: Based on the local epidemiological situation, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Danish: Veterinærlægemidlet kan indgives med en måneds mellemrum ved den anbefalede dosis gennem hele sæsonen på baggrund af de lokale epidemiske forhold.
English: Trifexis 1040 mg/17.4 mg spinosad 1040 mg/milbemycin oxime 17.4 mg
Danish: Trifexis 1040 mg/17,4 mg spinosad 1040 mg/milbemycinoxim 17,4 mg
English: In addition, in studies containing only spinosad, AUC and Cmax values were higher in fed than fasted dogs and therefore it is recommended to treat dogs with food as this maximises the opportunity for fleas to ingest lethal amounts of spinosad.
Danish: I forsøg udelukkende med spinosad var AUC- og Cmax-værdierne endvidere højere hos hunde, som havde fået mad, end hos fastende hunde.
English: Trifexis 1040 mg/17.4 mg tablets:
Danish: Trifexis 1040 mg/17,4 mg tabletter:
English: Trifexis 425 mg/7.1 mg tablets:
Danish: Trifexis 425 mg/7,1 mg tabletter:
English: 4336 and 5 dimples
Danish: 4336 og 5 fordybninger
English: Milbemycin oxime
Danish: Milbemycinoxim
English: 4346 and 3 dimples
Danish: 4346 og 3 fordybninger
English: Trifexis 425 mg/7.1 mg spinosad 425 mg/milbemycin oxime 7.1 mg
Danish: Trifexis 425 mg/7,1 mg spinosad 425 mg/milbemycinoxim 7,1 mg
English: EU/2/13/155/001 (1 tablet, 270 mg/4.5 mg) EU/2/13/155/002 (1 x 3 tablets, 270 mg/4.5 mg) EU/2/13/155/003 (1 x 6 tablets, 270 mg/4.5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7.1 mg) EU/2/13/155/005 (1 x 3 tablets, 425 mg/7.1 mg) EU/2/13/155/006 (1 x 6 tablets, 425 mg/7.1 mg)
Danish: EU/2/13/155/001 (1 tablet, 270 mg/4,5 mg) EU/2/13/155/002 (1 x 3 tabletter, 270 mg/4,5 mg) EU/2/13/155/003 (1 x 6 tabletter, 270 mg/4,5 mg) EU/2/13/155/004 (1 tablet, 425 mg/7,1 mg) EU/2/13/155/005 (1 x 3 tabletter 425 mg/7,1 mg) EU/2/13/155/006 (1 x 6 tabletter, 425 mg/7,1 mg) EU/2/13/155/007 (1 tablet, 665 mg/11,1 mg)
English: Trifexis 270 mg/4.5 mg tablets:
Danish: Trifexis 270 mg/4,5 mg tabletter:
English: The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of this product.
Danish: Den forebyggende virkning mod reinfestationer med lopper skyldes, at produktet dræber voksne lopper og reducerer ægproduktion.
English: It is recommended that lungworm prevention should be continued until at least 1 month after the last exposure to slugs and snails, but not for more than 6 consecutive months using Trifexis in any one year.
Danish: Det anbefales, at forebyggelse af lungeorm fortsættes, indtil mindst 1 måned efter den sidste eksponering for snegle, men ikke længere end 6 måneders sammenhængende brug af Trifexis i et givent år.
English: Heartworm prevention treatment should be continued monthly, with the last administration being given one month after the dog has left the region, but not for more than 6 consecutive months using Trifexis in any one year.
Danish: Behandling til forebyggelse af hjerteorm bør fortsætte en gang månedligt, med den sidste indgift en måned efter hunden har forladt området, men Trifexis må ikke bruges i mere end 6 på hinanden følgende måneder i et givent år.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Vask hænder efter brug.
English: Trifexis 270 mg/4.5 mg spinosad 270 mg/milbemycin oxime 4.5 mg
Danish: Trifexis 270 mg/4,5 mg spinosad 270 mg/milbemycinoxim 4,5 mg
English: Chewable tablets.
Danish: Tyggetabletter.
English: In pregnant and lactating dogs (bitches), the safety of this veterinary medicinal product has not been sufficiently established.
Danish: Sikkerheden af dette veterinærlægemiddel er ikke blevet tilstrækkeligt fastlagt hos drægtige eller diegivende hunde (tæver).
English: Interaction with other medicinal products and other forms of interaction: Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Danish: Interaktion med andre P-gp-substrater (f.eks. digoxin, doxorubicin) eller andre makrocykliske laktoner kan derfor forekomme.
English: It is recommended that heartworm prevention treatment should be continued at regular monthly intervals until at least 1 month after the last exposure to mosquitoes, but not for more than 6 consecutive months using Trifexis in any one year.
Danish: Det anbefales, at fortsætte den forebyggende behandling mod hjerteorm regelmæssigt med en måneds mellemrum indtil mindst 1 måned efter den sidste eksponering for myg, men Trifexis må ikke bruges i mere end 6 på hinanden følgende måneder i et givent år.
English: At doses of 30 to 60 mg spinosad and 0.5 to 1 mg milbemycin oxime per kg bodyweight, lethargy, anorexia/decreased appetite, diarrhoea, pruritus, dermatitis and reddening of the skin and pinna were commonly seen.
Danish: Det var almindeligt at se letargi, anoreksi/nedsat appetit, diarré, kløe, dermatitis samt rødmen af huden og pinna ved doser på 30 til 60 mg spinosad og 0,5 til 1 mg milbemycinoxim per kg legemsvægt.
English: Spinosad and milbemycin oxime have been shown to be substrates for P-glycoprotein (P-gp) and therefore could interact with other P-gp substrates (for example, digoxin, doxorubicin) or other macrocyclic lactones.
Danish: Spinosad og milbemycinoxim er blevet påvist at være substrater af P-glykoprotein (P-gp).
English: Based on the local epidemiological situation and the decision of the prescribing veterinarian, the veterinary medicinal product may be given at monthly intervals throughout the season at the recommended dose as outlined below.
Danish: Veterinærlægemidlet kan indgives med en måneds mellemrum ved den anbefalede dosis gennem hele sæsonen på baggrund af de lokale epidemiske forhold og i henhold til den lokale ordinerende dyrlæges beslutning.
English: PACKAGE LEAFLET FOR: Trifexis 270 mg/4.5 mg chewable tablets for dogs Trifexis 425 mg/7.1 mg chewable tablets for dogs Trifexis 665 mg/11.1 mg chewable tablets for dogs Trifexis 1040 mg/17.4 mg chewable tablets for dogs Trifexis 1620 mg/27 mg chewable tablets for dogs
Danish: INDLÆGSSEDDEL TIL: Trifexis 270 mg/4,5 mg tyggetabletter til hunde Trifexis 425 mg/7,1 mg tyggetabletter til hunde Trifexis 665 mg/11,1 mg tyggetabletter til hunde Trifexis 1040 mg/17,4 mg tyggetabletter til hunde Trifexis 1620 mg/27 mg tyggetabletter til hunde
English: Trifexis 270 mg/4.5 mg for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg for dogs (23.2 - 36.0 kg)
Danish: Trifexis 270 mg/4,5 mg til hunde (3,9- 6,0 kg) Trifexis 425 mg/7,1 mg til hunde (6,1- 9,4 kg) Trifexis 665 mg/11,1 mg til hunde (9,5- 14,7 kg) Trifexis 1040 mg/17,4 mg til hunde (14,8- 23,1 kg) Trifexis 1620 mg/27 mg til hunde (23,2- 36,0 kg)
English: The flea preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the veterinary medicinal product.
Danish: Virkningen vedvarer i op til 4 uger efter en enkelt indgift af veterinærlægemidlet.
English: Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 - 6.0 kg) Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 - 9.4 kg) Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 - 14.7 kg) Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 - 23.1 kg) Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 - 36.0 kg)
Danish: Trifexis 270 mg/4,5 mg tyggetabletter til hunde (3,9- 6,0 kg) Trifexis 425 mg/7,1 mg tyggetabletter til hunde (6,1- 9,4) kg) Trifexis 665 mg/11,1 mg tyggetabletter til hunde (9,5- 14,7 kg) Trifexis 1040 mg/17,4 mg tyggetabletter til hunde (14,8- 23,1 kg) Trifexis 1620 mg/27 mg tyggetabletter til hunde (23,2- 36,0 kg)
English: In adult dogs, after repeated oral administration of spinosad and milbemycin oxime for six consecutive months, increases in elimination half-lives were observed up to month 3.
Danish: Hos voksne hunde blev der set stigninger i elimineringshalveringstider i op til 3. måned efter gentagen oral indgift af spinosad og milbemycinoxim i seks måneder i træk.
English: EU/2/13/155/007 (1 tablet, 665 mg/11.1 mg) EU/2/13/155/008 (1 x 3 tablets, 665 mg/11.1 mg) EU/2/13/155/009 (1 x 6 tablets, 665 mg/11.1 mg) EU/2/13/155/010 (1 tablet, 1040 mg/17.4 mg) EU/2/13/155/011 (1 x 3 tablets, 1040 mg/17.4 mg) EU/2/13/155/012 (1 x 6 tablets, 1040 mg/17.4 mg) EU/2/13/155/013 (1 tablet, 1620 mg/27.0 mg) EU/2/13/155/014 (1 x 3 tablets, 1620 mg/27.0 mg) EU/2/13/155/015 (1 x 6 tablets, 1620 mg/27.0 mg)
Danish: EU/2/13/155/0011 (1 x 3 tabletter, 1040 mg/17,4 mg) EU/2/13/155/0012 (1 x 6 tabletter, 1040 mg/17,4 mg) EU/2/13/155/0013 (1 tablet, 1620 mg/27,0 mg)
English: In case of adverse reactions consult your veterinarian.
Danish: Rådfør Dem med dyrlægen, hvis der forekommer bivirkninger.
English: In another study, after repeated oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed juvenile dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached by month 7.
Danish: I et andet studie, efter gentagen oral indgift af 70 mg spinosad og 1,18 mg milbemycin oxim/kg legemsvægt til fodrede unge hunde i tolv måneder i træk, opnåedes steady state for systemisk eksponering (AUC) efter 7 måneder.
English: In another study, after repeated oral monthly administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed adult dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached in month 3.
Danish: I et andet studie, efter gentagen oral indgift af 70 mg spinosad og 1,18 mg milbemycin oxim/kg legemsvægt til fodrede voksne hunde i tolv måneder i træk opnåedes steady state for systemisk eksponering (AUC) i måned 3.
English: In another study, after repeated monthly oral administration of 70 mg spinosad and 1.18 mg milbemycin oxime/kg bodyweight to fed adult dogs for twelve consecutive months, steady state for systemic exposure (AUC) was reached in month 3.
Danish: I et andet studie, efter gentagen oral månedlig indgift af 70 mg spinosad og 1,18 mg milbemycin oxim/kg legemsvægt til fodrede voksne hunde i tolv sammenhængende måneder opnåedes steady state for systemisk eksponering (AUC) i tredje måned.
English: Angiostrongylus vasorum, - treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult (L5)
Danish: Regelmæssig månedlig behandling med produktet vil forebygge angiostrongylose ved at reducere parasitbyrden resulterende fra umodne voksne (L5).
English: • At the request of the European Medicines Agency;
Danish: • På anmodning fra Det Europæiske Lægemiddelagentur;
English: This will help you to remember to take it.
Danish: Det vil hjælpe dig til at huske at tage den.
English: - if you are 75 years old or older.
Danish: • hvis du er 75 år eller ældre.
English: This will help get the best results for your health.
Danish: Dette vil give de bedste resultater for dit helbred.
English: It is unknown whether this constitutes a class effect.
Danish: Det er ukendt, om dette er en klasseeffekt.
English: Date of first authorisation: 15 July 2016
Danish: Dato for første markedsføringstilladelse: 15. juli 2016
English: Such studies have been conducted with the individual active substances.
Danish: Sådanne studier er udført individuelt med de aktive substanser.
English: < 8.0 % ≥ 8 % to < 9.0 % ≥ 9.0 %
Danish: < 8,0 % ≥ 8 % til < 9,0 % ≥ 9,0 %
English: Then take your next dose at the usual time.
Danish: Tag derefter din næste dosis på det sædvanlige tidspunkt.
English: Your blood sugar may increase without this medicine.
Danish: Dit blodsukker kan stige uden denne medicin.
English: Some symptoms need immediate medical attention:
Danish: Nogle symptomer kræver øjeblikkelig lægehjælp:
English: Fournier's gangrene has to be treated immediately.
Danish: Fourniers gangræn skal behandles øjeblikkeligt.
English: How much to take - The recommended dose is one tablet a day.
Danish: Så meget skal du tage - Den anbefalede dosis er én tablet om dagen.
English: Talk to your doctor about the best way to control your blood sugar while you are pregnant.
Danish: Tal med lægen om den bedste måde til at kontrollere dit blodsukker, mens du er gravid.
English: Do not stop taking Qtern without talking to your doctor first.
Danish: Du må ikke stoppe med at tage Qtern uden først at tale med lægen.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Danish: LRM = Longitudinalt gentagne målinger (under anvendelse af værdier før behandling med rescue).
English: There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Danish: Der foreligger ikke tilstrækkelige data til at drage konklusioner vedrørende eksponeringen hos patienter > 70 år.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you get any of the signs above.
Danish: Lægen vil fortælle dig, hvordan du skal behandle for lavt blodsukker, og hvad du skal gøre, hvis du får nogen af ovenstående tegn.
English: Study CV181168
Danish: Studie CV181168
English: It may be taken at any time of day with or without food.
Danish: Det kan tages på et hvilket som helst tidspunkt af dagen med eller uden mad.
English: Qtern is taken orally once daily.
Danish: Qtern tages oralt én gang dagligt.
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Danish: Bivirkningerne er opstillet efter systemorganklasse (SOC) og hyppighed.
English: Monitoring of renal function is recommended as follows:
Danish: Det anbefales at monitorere nyrefunktionen på følgende måde:
English: Taking this medicine - Swallow the tablet whole with half a glass of water.
Danish: Sådan tager du medicinen - Synk tabletten hel med et halvt glas vand.
English: Tablet is to be swallowed whole.
Danish: Tabletten skal sluges hel.
English: Additional analysis did not indicate a differential effect among NYHA classes.
Danish: Yderligere analyse viste ikke nogen forskel på effekt mellem NYHA-klasser.
English: No benefit was observed for MACE or all-cause mortality.
Danish: Der blev ikke observeret nogen fordele for MACE eller totalmortalitet.
English: Do not take Qtern if any of the above apply to you.
Danish: Du må ikke tage Qtern, hvis noget af ovenstående gælder for dig.
English: EU/1/16/1108/001 14 film-coated tablets EU/1/16/1108/002 28 film-coated tablets EU/1/16/1108/003 98 film-coated tablets EU/1/16/1108/004 30 film-coated tablets
Danish: EU/1/16/1108/001 14 filmovertrukne tabletter EU/1/16/1108/002 28 filmovertrukne tabletter EU/1/16/1108/003 98 filmovertrukne tabletter EU/1/16/1108/004 30 filmovertrukne tabletter
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union references dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: However, an increased exposure due to age-related decrease in renal function can be expected.
Danish: Der kan dog forventes en øget eksponering på grund af den aldersrelaterede reduktion i nyrefunktionen.
English: Hypoglycaemia (when used with SU)
Danish: Hypoglykæmi (ved anvendelse sammen med SU)
English: - Do not take a double dose of Qtern to make up for a forgotten dose.
Danish: - Du må ikke tage en dobbeltdosis af Qtern som erstatning for den glemte dosis
English: This may occur regardless of blood glucose level.
Danish: Dette kan forekomme uanset blodsukker-niveau.
English: Your doctor may ask you to stop taking Qtern.
Danish: Lægen kan bede dig om at stoppe med at tage Qtern.
English: Use of alternative methods to monitor glycaemic control is advised.
Danish: Brug af alternative metoder til overvågning af den glykæmiske kontrol anbefales.
English: (See sections 4.2, 4.4, 4.5 and 5.1 for available data on combinations studied.)
Danish: 4.2, 4.4, 4.5 og 5.1 for tilgængelige data om undersøgte kombinationer).
English: Therefore, Qtern should not be used during pregnancy.
Danish: Derfor bør Qtern ikke anvendes under graviditet.
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Danish: Hvis du har type 2-diabetes, producerer din bugspytkirtel ikke nok insulin, eller kroppen kan ikke udnytte den insulin, som den producerer, godt nok.
English: This is a rare but serious and potentially life-threatening event that requires urgent surgical intervention and antibiotic treatment.
Danish: Dette er en sjælden, men alvorlig og potentielt livstruende hændelse, der kræver hurtig operation og antibiotisk behandling.
English: The majority of patients in this study had a baseline HbA1c of > 8 % (see table 3).
Danish: Størstedelen af patienterne i dette studie havde baseline-HbA1c > 8 % (se tabel 3).
English: The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Danish: Qterns sikkerhed og virkning hos børn og unge i alderen 0 til < 18 år er endnu ikke klarlagt.
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Danish: Stigningerne i kreatinin var generelt forbigående under fortsat behandling eller reversible efter seponering af behandlingen.
English: Your doctor will advise you of the signs and symptoms of heart failure.
Danish: Lægen vil fortælle dig om tegn og symptomer på hjertesvigt.