FrancophonIA/ELRC3.0 huggingface dataset:
English: Approximately 19% of the population had eGFR ≥45 to <60 mL/min/1.73 m2, 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2 and 15%
Danish: Ca. 19 % af populationen havde eGFR ≥ 45 til < 60 ml/min/1,73 m2, 28 % af populationen havde eGFR ≥ 30 til < 45 ml/min/1,73 m 2, og 15 % havde eGFR < 30 ml/min/1,73 m
English: Clinically meaningful interactions would not be expected with other sulphonylureas (e.g., glipizide, tolbutamide, and glimepiride) which, like glibenclamide, are primarily eliminated by CYP2C9.
Danish: Der forventes ikke klinisk betydningsfulde interaktioner med andre sulfonylurinstoffer (f.eks. glipizid, tolbutamid og glimepirid), der som glibenclamid primært elimineres af CYP2C9.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger på fertiliteten (se pkt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med linagliptin skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: INFORMATION IN BRAILLE Trajenta 5 mg
Danish: INFORMATION I BRAILLESKRIFT Trajenta 5 mg
English: Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide).
Danish: Linagliptin hæmmer enzymet DPP-4 (dipeptidylpeptidase 4, EC 3.4.14.5), et enzym, der er involveret i inaktiveringen af inkretinhormonerne GLP-1 og GIP (glucagon-lignende peptid-1, glucoseafhængigt insulintropt polypeptid).
English: At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20% were unbound in plasma.
Danish: Ved høje koncentrationer, hvor DPP-4 er fuldt mættet, var 70-80 % af linagliptin bundet til andre plasmaproteiner end DPP-4, og 30-20 % var ubundet.
English: Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
Danish: Din læge kan ordinere Trajenta sammen med andre diabeteslægemidler.
English: • when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
Danish: • når metformin ikke er hensigtsmæssig pga. intolerans eller kontraindiceret pga. nedsat nyrefunktion som kombinationsterapi
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger på reproduktionstoksicitet (se pkt.
English: Macrogol (6000) Iron oxide red (E172)
Danish: Macrogol (6000) Jernoxid, rød (E172)
English: The recommended dose of Trajenta is one 5 mg tablet once a day.
Danish: Den anbefalede dosis af Trajenta er 5 mg som 1 tablet én gang dagligt.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Danish: • Svære og vedvarende smerter i maven, som kan stråle ud til ryggen, samt kvalme og opkastning,
English: Linagliptin has no or negligible influence on the ability to drive and use machines.
Danish: Linagliptin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If bullous pemphigoid is suspected, Trajenta should be discontinued.
Danish: Hvis der er mistanke om bulløs pemfigoid, skal Trajenta seponeres.
English: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy
Danish: Trajenta er indiceret til behandling af voksne patienter med type 2-diabetes mellitus som tillæg til diæt og motion for at forbedre den glykæmiske kontrol: som monoterapi
English: Co-administration with other potent inducers of P-glycoprotein and CYP3A4, such as carbamazepine, phenobarbital and phenytoin has not been studied.
Danish: Samtidig administration af andre potente P-glykoprotein- og CYP3A4induktorer, såsom carbamazepin, phenobarbital og phenytoin, er ikke undersøgt.
English: What Trajenta contains - The active substance is linagliptin
Danish: Trajenta indeholder: - Aktivt stof: Linagliptin
English: The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
Danish: Koncentrationen af ubundet linagliptin, der normalt er mindre end 1 % ved terapeutisk dosis, blev forøget 4-5 gange efter samtidig administration med ritanovir.
English: rare
Danish: sjælden
English: Patients treated with linagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glimepiride (-1.39 vs +1.29 kg).
Danish: Patienter behandlet med linagliptin havde en signifikant gennemsnitlig reduktion i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtstigning hos patienter, der fik glimepirid (-1,39 vs +1,29 kg).
English: After oral administration of a 5 mg dose to healthy volunteers or patients, linagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1.5 hours post-dose.
Danish: Efter oral administration af en 5 mg dosis til enten raske frivillige eller patienter absorberes linagliptin hurtigt og maksimal plasmakoncentration (median Tmax) blev opnået 1,5 time efter indtagelsen.
English: The placebo-controlled studies included studies where linagliptin was given as
Danish: I de placebokontrollerede studier blev linagliptin givet som:
English: Oral anti-diabetics are used to treat high blood sugar levels.
Danish: Orale antidiabetika bruges til at behandle for højt blodsukker, idet det medvirker til at sænke indholdet af sukker i blodet.
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Danish: Farmakoterapeutisk klassifikation: Antidiabetika, dipeptidylpeptidase-4 (DPP-4)-hæmmere, ATCkode: A10BH05
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15% but no influence on AUC 0-72h was observed.
Danish: Samtidig indtagelse af et måltid med højt fedtindhold og linagliptin forlængede tiden til at opnå Cmax med 2 timer og sænkede Cmax med 15 %, men der blev ikke observeret nogen påvirkning af AUC0-72t.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Trajenta if you:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Trajenta, hvis du:
English: Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Danish: Der forventes derfor ikke klinisk relevante interaktioner med andre P-glykoprotein/CYP3A4-hæmmere.
English: • Trajenta is available in perforated aluminium/aluminium unit dose blisters.
Danish: • Trajenta fås i perforerede enkeltdosisblistere i aluminium/aluminium.
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Danish: Dosisreduktion af sulfonylurinstof eller insulin kan overvejes (se pkt.
English: In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy volunteers.
Danish: Desuden fandt man i fase I-studier, at linagliptins farmakokinetiske karakteristika var ens hos japanske, kinesiske og kaukasiske raske frivillige.
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/l to 75-89% at ≥30 nmol/l, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Danish: Plasmaproteinbindingen af linagliptin var koncentrationsafhængig og faldt fra ca. 99 % ved 1 nmol/l til 75-89 % ved ≥ 30 nmol/l, hvilket afspejler, at bindingen til DPP-4 blev mættet med stigende koncentrationer af linagliptin.
English: When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4)
Danish: Når linagliptin anvendes i kombination med et sulfonylurinstof eller med insulin, kan en lavere dosis sulfonylurinstof eller insulin overvejes for at reducere risikoen for hypoglykæmi (se pkt.
English: Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
Danish: Pankreatitis blev rapporteret hyppigere hos patienter randomiseret til linagliptin (7 tilfælde ud af 6.580 linagliptin-behandlede patienter mod 2 tilfælde ud af 4.383 placebobehandlede).
English: Therefore, caution is advised when linagliptin is used in combination with a sulphonylurea and/or insulin.
Danish: Derfor bør der udvises forsigtighed, når linagliptin bruges i kombination med et sulfonylurinstof og/eller insulin.
English: Pregelatinised starch (maize) Maize starch
Danish: Pregelatineret stivelse (majs) Majsstivelse
English: Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Danish: Tabel 3 Større kardiovaskulære bivirkninger (MACE) og mortalitet pr. behandlingsgruppe i CAROLINA-studiet
English: As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1,110 litres, indicating that linagliptin extensively distributes to the tissues.
Danish: Som et resultat af vævsbindingen var det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 5 mg linagliptin hos raske frivillige ca. 1.110 liter, hvilket antyder, at linagliptin har en udtalt vævsfordeling.
English: In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
Danish: Hos patienter med moderat nedsat nyrefunktion sås en moderat øget eksponeringen på ca. 1,7 gange sammenlignet med kontrolgruppen.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was higher than placebo, due to an increase in asymptomatic hypoglycaemic events.
Danish: Incidensen af hypoglykæmi hos patienter behandlet med linagliptin var højere end for placebo på grund af en øget incidens af asymptomatiske hypoglykæmiske hændelser.
English: Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours), that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Danish: Plasmakoncentrationen af linagliptin aftog tre-fasisk med en lang terminal halveringstid (længere end 100 timer), der overvejende var relateret til linagliptins mættede, tætte binding til DPP-4, uden at bidrage til lægemiddelakkumuleringen.
English: After once daily dosing of 5 mg linagliptin, steady-state plasma concentrations are reached by the third dose.
Danish: Efter administration af 5 mg linagliptin én gang dagligt opnåedes steady state-plasmakoncentrationerne efter tredje dosis.
English: No dosage adjustment is necessary based on BMI.
Danish: Dosisjustering er ikke nødvendig på baggrund af BMI.
English: Simvastatin: multiple daily doses of linagliptin had a minimal effect on the steady-state pharmacokinetics of simvastatin, a sensitive CYP3A4 substrate, in healthy volunteers.
Danish: Simvastatin: Daglige doser af linagliptin havde hos raske frivillige en minimal indvirkning på steady state-farmakokinetikken af simvastatin, et sensitivt CYP3A4-substrat.
English: Driving and using machines Trajenta has no or negligible influence on the ability to drive and use machines.
Danish: Trajenta har ingen eller kun ubetydelig indvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: 8 mm diameter round, light red film-coated tablet debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Danish: Rund, lyserød, filmovertrukket 8 mm tablet præget med D5 på den ene side og firmalogo på den anden.
English: The observed difference in HbA1c over placebo was0.72% after 52 weeks.
Danish: Den observerede forskel i HbA1c i forhold til placebo var -0,72 % efter 52 uger.
English: Other medicines and Trajenta
Danish: Brug af anden medicin sammen med Trajenta
English: Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Danish: For daglige supraterapeutiske doser på 10 mg linagliptin og 40 mg simvastatin i 6 dage, var simvastatins plasma-AUC øget med 34 % og plasma-Cmax var øget med 10 %.
English: Linagliptin is a P-glycoprotein substrate, and inhibits P-glycoprotein mediated transport of digoxin with low potency.
Danish: Linagliptin er substrat for P-glykoprotein og hæmmer P-glykoproteinmedieret transport af digoxin med lav potens.
English: - monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add on to metformin and empagliflozin - add-on to insulin with or without metformin
Danish: - monoterapi i op til 4 uger - monoterapi i ≥ 12 uger - kombinationsbehandling med metformin - kombinationsbehandling med metformin + sulfonylurinstof - kombinationsbehandling med metformin og empagliflozin - kombinationsbehandling med insulin, med eller uden metformin
English: However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.
Danish: Det kan være hensigtsmæssigt at teste blodsukkeret hyppigere for at minimere risikoen for for lavt blodsukker, især når Trajenta kombineres med sulfonylurinstof og/eller insulin.
English: In rats effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1,500 times human exposure.
Danish: I rotter blev der set påvirkning af kønsorganerne, thyroidea og lymfoide organer ved en eksponering på mere end 1.500 gange den humane eksponering.
English: Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
Danish: Trajenta kan bruges sammen med anden diabetesmedicin, f.eks. metformin, sulfonylurinstof (f.eks. glimepirid eller glipizid), empagliflozin eller insulin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu og på Lægemiddelstyrelsens hjemmeside http://www.laegemiddelstyrelsen.dk
English: What you need to know before you take Trajenta Do not take Trajenta - if you are allergic to linagliptin or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Trajenta - hvis du er allergisk over for linagliptin eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of linagliptin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 5 mg linagliptin.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Danish: Den observerede incidens af hypoglykæmi hos linagliptin-behandlede patienter svarede til incidensen i placebo-gruppen (22,2 % linagliptin; 21,2 % placebo).
English: Table 1 Adverse reactions reported in patients who received linagliptin 5 mg daily as monotherapy or as add-on therapies in clinical trial and from post-marketing experience
Danish: Tabel 1 Bivirkninger rapporteret hos patienter i behandling med linagliptin 5 mg dagligt som monoterapi eller i kombinationsbehandling i kliniske studier og fra postmarketing erfaring.
English: when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Danish: 4.4, 4.5 og 5.1 for de tilgængelige oplysninger om forskellige kombinationer).
English: Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Danish: Nogle patienter fik udslæt (hyppighed ikke almindelig), nældefeber (urticaria; hyppigheden er sjælden (kan forekomme hos op til 1 ud af 1.000 personer)) samt hævelse af ansigt, læber, tunge og svælg, hvilket kan forårsage problemer med at trække vejret eller synke (angioødem; hyppighed sjælden).
English: 8 phase III randomised controlled trials involving 5,239 patients with type 2 diabetes, of which 3,319 were treated with linagliptin were conducted to evaluate efficacy and safety.
Danish: Med henblik på at evaluere effekt og sikkerhed er der gennemført 8 randomiserede, kontrollerede fase III-studier med 5.239 type 2-diabetespatienter, hvoraf 3.319 blev behandlet med linagliptin.
English: In clinical trials of linagliptin as part of combination therapy with medicinal products not known to cause hypoglycaemia (metformin), rates of hypoglycaemia reported with linagliptin were similar to rates in patients taking placebo.
Danish: I kliniske studier, hvor linagliptin blev givet i kombination med lægemidler, der ikke er kendt for at medføre hypoglykæmi (metformin), rapporteredes hypoglykæmirater for linagliptin, der var sammenlignelige med raterne for patienter, der fik placebo.
English: Some patients have experienced allergic reactions (hypersensitivity; frequency uncommon, may affect up to 1 in 100 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes, which may be serious, including wheezing and shortness of breath (bronchial hyperreactivity; frequency not known, frequency cannot be estimated from the available data).
Danish: Nogle patienter har haft overfølsomhedsreaktioner (hyppigheden er ikke almindelig (kan forekomme hos op til 1 ud af 100 personer), når Trajenta tages alene eller i kombination med andre lægemidler til behandling af sukkersyge, herunder hvæsende vejrtrækning og åndenød (bronkial hyperreaktivitet; hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data)).
English: Oral contraceptives: co-administration with 5 mg linagliptin did not alter the steady-state pharmacokinetics of levonorgestrel or ethinylestradiol.
Danish: Orale kontraceptiva: Samtidig administration af 5 mg linagliptin ændrede ikke steady statefarmakokinetikken af levonorgestrel eller ethinylestradiol.
English: Linagliptin as add-on to metformin therapy
Danish: Linagliptin som tillæg til metformin
English: Due to the impact of the background therapy on adverse reactions (e.g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin).
Danish: Forekomsten af bivirkninger (f.eks. hypoglykæmi) er afhængig af baggrundsbehandlingen, og bivirkninger er derfor analyseret for de enkelte behandlingsregimer (monoterapi, tillægsbehandling til metformin, til metformin plus sulfonylurinstof og til insulin).
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure.
Danish: Lever, nyrer og mave-tarm-kanalen var de primære målorganer for toksisk påvirkning i mus og rotter ved gentagne doser af linagliptin på mere end 300 gange den humane eksponering.
English: The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 tablets.
Danish: Pakningsstørrelserne er 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 og 120 x 1 tabletter.
English: Linagliptin alone showed a comparable incidence of hypoglycaemia to placebo.
Danish: Linagliptin alene har sammenlignelig forekomst af hypoglykæmi som placebo.
English: Sulphonylureas: the steady-state pharmacokinetics of 5 mg linagliptin was not changed by concomitant administration of a single 1.75 mg dose glibenclamide (glyburide).
Danish: Sulfonylurinstoffer: Steady state-farmakokinetikken for linagliptin 5 mg blev ikke påvirket af samtidig administration af en enkelt dosis af 1,75 mg glibenclamid (glyburid).
English: Linagliptin as add-on to insulin therapy
Danish: Linagliptin som tillæg til insulinbehandling
English: • Trajenta 5 mg tablets are 8 mm diameter round, light red film-coated tablets debossed with
Danish: • Trajenta 5 mg er runde, lyserøde, filmovertrukne tabletter på 8 mm, præget med henholdsvis
English: The most frequently reported adverse reaction was “hypoglycaemia” observed under the triple combination, linagliptin plus metformin plus sulphonylurea 14.8% versus 7.6% in placebo.
Danish: Den hyppigst rapporterede bivirkning observeret under trestof-kombinationsbehandlingen linagliptin plus metformin plus sulfonylurinstof var hypoglykæmi med 14,8 % mod 7,6 % for placebo.
English: Some patients have experienced inflammation of the pancreas (pancreatitis; frequency rare, may affect up to 1 in 1000 people) while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes.
Danish: Betændelse i bugspytkirtlen (pankreatitis) er set hos nogle patienter (hyppighed sjælden, kan forekomme hos op til 1 ud af 1.000 personer), når Trajenta tages alene eller i kombination med andre lægemidler til behandling af sukkersyge.
English: Warfarin: multiple daily doses of 5 mg linagliptin did not alter the pharmacokinetics of S(-) or R(+) warfarin, a CYP2C9 substrate, administered in a single dose.
Danish: Warfarin: Gentagne daglige doser af 5 mg linagliptin og en enkelt dosis af S(-)- eller R(+)-warfarin, et CYP2C9-substrat, ændrede ikke farmakokinetikken af warfarin.
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucureşti Tel: +40 21 302 28 00
Danish: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +40 21 302 28 00
English: Number of patients Primary CV composite (Cardiovascular death, non-fatal MI, non-fatal stroke)
Danish: Antal patienter Primært sammensat kardiovaskulært (kardiovaskulær mortalitet, ikke dødeligt MI, ikkedødelig apopleksi) Mortalitet uanset årsag
English: Each film-coated tablet (tablet) contains 5 mg of linagliptin
Danish: Hver filmovertrukket tablet (tablet) indeholder 5 mg linagliptin
English: Therefore, linagliptin is not an inhibitor of P-glycoprotein-mediated transport in vivo.
Danish: Linagliptin er derfor ikke en in vivo-inhibitor af P-glykoproteinmedieret transport.
English: Effects of other medicinal products on linagliptin Clinical data described below suggest that the risk for clinically meaningful interactions by coadministered medicinal products is low.
Danish: De nedenfor beskrevne kliniske data tyder på, at risikoen for klinisk betydningsfulde interaktioner med samtidigt administrerede lægemidler er lav.
English: The NOAEL for maternal-, embryo-fetal-, and offspring toxicity in rats was 49 times human exposure.
Danish: NOAEL for toksicitet i moderdyret, embryoføtal toksicitet og toksicitet i afkommet hos rotter var 49 gange den humane eksponering.
English: The NOAEL for fertility, early embryonic development and teratogenicity in rats was set at >900 times the human exposure.
Danish: NOAEL (niveauet uden observeret negativ effekt) for fertilitet, tidlig fosterudvikling og teratogenicitet i rotter blev sat til > 900 gange den humane eksponering.