FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients carrying a G6PD enzyme deficiency, cases of acute haemolytic anaemia have been reported with glibenclamide.
Danish: For patienter med G6PD-enzymmangel er der indberettet tilfælde af akut hæmolytisk anæmi med glibenclamid.
English: Sulfamethoxazole with trimethoprim (Cotrimoxazole)
Danish: Sulphamethoxazol med trimethoprim (Cotrimoxazol)
English: In case of inability of food or beverage intake, the child should go to emergency department to get an insulin and glucose perfusion until vomiting stops.
Danish: Hvis barnet ikke er i stand til at indtage mad eller drikke, bør barnet bringes til en akutmodtagelse for at få en insulin- og glukoseperfusion, indtil opkastningen stopper.
English: Holding the bottle the right way up, insert the syringe firmly into the adaptor fitted to the bottle (figure 2).
Danish: Mens flasken holdes opret, sættes sprøjten godt fast i adapteren, der er monteret på flasken (figur 2).
English: During titration period patients' capillary blood-glucose concentration should continue to be monitored four times a day and at bedtime, as insulin requirements may continue to fall, or AMGLIDIA may need to be titrated.
Danish: Under titreringsperioden bør patientens kapillærblodglukose fortsat overvåges fire gange dagligt og ved sengetid, da insulinbehovet fortsat kan falde.
English: Depending on the volume to be administered orally, there are two types of oral syringes, graduated up to 1 mL or up to 5 mL.
Danish: Alt efter det volumen, der skal administreres oralt, kan der anvendes to typer orale sprøjter, der er inddelt hhv. op til 1 ml eller op til 5 ml.
English: - if your child is treated with bosentan, e.g. a medicine used to treat problems of blood circulation.
Danish: (porfyri) - hvis dit barn er i behandling med bosentan, et lægemiddel til behandling af f.eks. problemer med blodbanen.
English: EU/1/18/1279/001 (AMGLIDIA 0.6 mg/mL oral suspension with 1 mL oral syringe) EU/1/18/1279/002 (AMGLIDIA 0.6 mg/mL oral suspension with 5 mL oral syringe) EU/1/18/1279/003 (AMGLIDIA 6 mg/mL oral suspension with 1 mL oral syringe) EU/1/18/1279/004 (AMGLIDIA 6 mg/mL oral suspension with 5 mL oral syringe)
Danish: EU/1/18/1279/001 (AMGLIDIA 0,6 mg/ml oral suspension med 1 ml oral sprøjte) EU/1/18/1279/002 (AMGLIDIA 0,6 mg/ml oral suspension med 5 ml oral sprøjte) EU/1/18/1279/003 (AMGLIDIA 6 mg/ml oral suspension med 1 m oral sprøjte) EU/1/18/1279/004 (AMGLIDIA 6 mg/ml oral suspension med 5 ml oral sprøjte)
English: Barbiturates (such as phenobarbital used to treat epilepsy)
Danish: Barbiturater (såsom phenobarbital til behandling af epilepsi)
English: o For major surgery, insulin therapy should replace AMGLIDIA; o Hepatic or renal dysfunction may require a reduction in dosage; o In exceptional situations of stress (e.g. trauma, surgery, febrile infections), blood-glucose regulation may deteriorate, and a temporary change to insulin may be necessary to maintain good metabolic control.
Danish: o Ved større operationer bør AMGLIDIA oral suspension erstattes af insulinbehandling o Lever- eller nyreinsufficiens kan kræve dosisreduktion o I situationer med ekstraordinær stress (f.eks. traumer, operationer, febrile infektioner) kan reguleringen af blodglukose forringes, og midlertidigt skift til insulin kan være nødvendigt for at opretholde god metabolisk kontrol.
English: Depending on the volume calculated per administration: If the volume per administration is 1mL or below, the 1mL syringe should be prescribed; If the volume per administration is more than 1mL, the 5mL syringe should be prescribed.
Danish: Afhængigt af det beregnede volumen pr. administration: Hvis volumen pr. administration er 1 ml eller derunder, ordineres 1 ml-sprøjten Hvis volumen pr. administration er over 1 ml, ordineres 5 ml-sprøjten.
English: Barbiturates
Danish: Barbiturater
English: Reserpine
Danish: Reserpin
English: Incorrect dosage of coumarin derivatives administered
Danish: Ukorrekt dosering af administrerede kumarinderivater
English: Thyroid hormones (such as L-thyroxin) used for hormonal treatment
Danish: Thyroideahormoner (såsom L-thyroxin), der anvendes til hormonbehandling
English: If there is major vomiting, a fast-acting insulin should be used to treat the patient until vomiting stops.
Danish: Ved svær opkastning bør der anvendes et hurtigvirkende insulin til at behandle patienten, indtil opkastningen ophører.
English: In malnourished patients or those displaying a marked change in their general condition, or whose calorie intake is irregular, and in patients with impaired renal or hepatic function, treatment should be started at the lowest dose and dosage levels strictly followed, to avoid hypoglycaemic reactions (see section 4.4).
Danish: Hos underernærede patienter, patienter med markant ændret almentilstand, patienter med uregelmæssig kalorieindtagelse og patienter med nedsat nyre- eller leverfunktion bør behandlingen påbegyndes ved den laveste dosis, og doseringsniveauet skal overholdes nøje for at undgå hypoglykæmiske reaktioner (se pkt.
English: Potentiate or weaken the effect of coumarin derivatives
Danish: Potentiere eller svække virkningen af kumarinderivater
English: Liver failure reduces the metabolism of glibenclamide and therefore significantly slows down its elimination.
Danish: Leverinsufficiens nedsætter metaboliseringen af glibenclamid og forsinker således væsentligt dets eliminering.
English: At risk patients
Danish: Udsatte patienter
English: Head to head comparative pharmacokinetic data following the application of glibenclamide suspension and micronised tablets are not available.
Danish: Der foreligger ikke direkte sammenlignende farmakokinetiske data efter anvendelse af suspension og mikroniserede tabletter.
English: Increased blood sugar levels
Danish: Forhøjet blodsukker
English: Glibenclamide suspension therapy should be initiated by a physician experienced in the treatment of patients with very early onset diabetes.
Danish: Behandling med glibenclamid suspension bør initieres af en læge med erfaring i behandling af patienter med meget tidligt indsættende diabetes.
English: This medicine contains 5 mg benzoate salt in each mL oral suspension.
Danish: Dette lægemiddel indeholder 5 mg benzoatsalt pr. ml oral suspension.
English: Higher doses of AMGLIDIA can be given as needed and administered in up to four intakes per day, based on blood-glucose monitoring, as per titration recommendations given by the referring doctor.
Danish: Der kan gives højere doser af AMGLIDIA efter behov og indgives i op til fire indtagelser dagligt, baseret på overvågningen af blodsukkeret, som angivet i anbefalingerne om dosistilpasning fra den henvisende læge.
English: If blood-glucose value increases after insulin reduction, then increase AMGLIDIA by 0.2 mg/kg/day.
Danish: Hvis blodglukoseværdien stiger efter reduktion af insulin, øges AMGLIDIA med 0,2 mg/kg/dag.
English: Anabolic steroids and male sex hormones (such as testosterone enanthate) (used to treat testosterone deficiency)
Danish: Anabolske steroider og mandlige kønshormoner (såsom testosteronenanthat) (til behandling af testosteronmangel)
English: Cyclophosphamides used to treat different types of cancer
Danish: Cyclophosphamider, der anvendes til behandling af forskellige kræfttyper
English: Ifosfamide used to treat different types of cancers
Danish: Ifosfamid, der anvendes til behandling af forskellige kræfttyper
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients hydroxyethylcellulose lactic acid purified water sodium benzoate (E211) sodium citrate xanthan gum
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer hydroxyethylcellulose mælkesyre renset vand natriumbenzoat (E211) natriumcitrat xanthangummi
English: AMGLIDIA is used in newborns, infants and children to treat diabetes that occurs at birth (known as neonatal diabetes mellitus).
Danish: AMGLIDIA anvendes hos nyfødte, spædbørn og børn til behandling af sukkersyge, der opstår ved fødslen (neonatal diabetes mellitus).
English: The signs of too low blood sugar may include: - shaking, sweating, feeling very anxious or confused, fast heart beat - excessive hunger, headache
Danish: Tegn på for lavt blodsukker kan være: - rysten, svedtendens, angst eller forvirring, hurtig puls - stærk sult, hovedpine
English: Thyroid hormones
Danish: Thyroideahormoner
English: Increase ciclosporin plasma concentration
Danish: Øget plasmakoncentration af ciclosporin
English: If your child carries a G6PD enzyme deficiency, he/she may experiment an abnormal breakdown of red blood cells (acute haemolytic anaemia) after taking AMGLIDIA.
Danish: Hvis dit barn har G6PD-enzymmangel, kan dets nedbrydning af røde blodlegemer blive unormal (akut hæmolytisk anæmi), når det har fået AMGLIDIA.
English: Beta-receptor blockers (such as propranolol used to treat high blood pressure, control irregular or fast heart beats, help prevent additional heart attack)
Danish: Betablokkere (såsom propranolol, der anvendes til behandling af forhøjet blodtryk, regulering af uregelmæssig eller hurtig puls, forebyggelse af yderligere hjerteanfald)
English: Heparin used to decrease the clotting ability of the blood
Danish: Heparin, der anvendes til at nedsætte blodets størkningsevne
English: Fluoxetine used to treat depression and anxiety disorders
Danish: Fluoxetin, der anvendes til behandling af depression og angst
English: Hypoglycaemia can occur under treatment with hypoglycaemic sulphonamides.
Danish: Hypoglykæmi kan forekomme under behandling med hypoglykæmiske sulfonamider.
English: Put the syringe into the child mouth and push the plunger to slowly administer the medicine into the mouth.
Danish: Sæt sprøjten ind i barnets mund, og tryk på stemplet, så lægemidlet langsomt indgives i munden.
English: Tell your doctor if your child suffers from renal or liver disorders.
Danish: Fortæl det til lægen, hvis dit barn har en nyre- eller leversygdom.
English: A comparative study of relative bioavailability between two suspensions of glibenclamide oral suspensions (0.6 mg/mL and 6 mg/mL) and crushed glibenclamide tablets (Daonil 5 mg) showed that when glibenclamide oral suspensions were administered, peak plasma concentrations of glibenclamide are reached 0.5 hours earlier than that observed with the crushed Daonil tablet (median value after administration is 2.5 hours compared to 3 hours).
Danish: Et sammenlignende studie af den relative biotilgængelighed af to orale glibenclamid-suspensioner (0,6 mg/ml og 6 mg/ml) og knuste glibenclamid-tabletter (Daonil 5 mg) viste, at når der blev administreret glibenclamid orale suspensioner, indtrådte de maksimale plasmakoncentrationer af glibenclamid 0,5 timer tidligere end de, der blev iagttaget med den knuste Daonil-tablet (medianværdien efter administration er 2,5 time sammenholdt med 3 timer).
English: Your child's blood sugar levels may become too low (hypoglycaemia) after taking AMGLIDIA.
Danish: Dit barn kan få for lavt blodsukker (hypoglykæmi), efter at det har fået AMGLIDIA.
English: Acetazolamide
Danish: Acetazolamid
English: Calcium channel blockers (such as nifedipine used to treat high blood pressure)
Danish: Calciumkanalblokkere (såsom nifedipin, der anvendes behandling af for højt blodtryk)
English: Benzoic acid and benzoates (sodium benzoate)
Danish: Benzoesyre og benzoater (natriumbenzoat)
English: Corticosteroids (such as prednisone, prednisolone) used in various indications such as inflammation and asthma
Danish: Binyrebarkhormoner (såsom prednison, prednisolon), der anvendes ved forskellige tilstande såsom inflammation og astma
English: If there is no alternative, the decision for each patient must consider the danger of haemolysis and the potential benefit expected from the treatment.
Danish: Hvis der ikke er noget alternativ, må afgørelsen for hver patient ske ud fra hensyn til faren for hæmolyse og den potentielle fordel ved behandlingen Hvis det er nødvendigt at ordinere dette lægemiddel, bør der screenes for enhver forekomst af hæmolyse.
English: If capillary blood glucose is < 7 mmol/L, do not increase AMGLIDIA and reduce pre-meal insulin boluses by 50%.
Danish: Hvis kapillærblodglukose er <7 mmol/l, må AMGLIDIA ikke øges, og insulinbolusser før måltidet øges med 50 %.
English: In repeated dose toxicity studies with oral administration of high doses of glibenclamide, effects on pancreatic beta-cells were observed (enlargement of the islets of Langerhans with irregularly configured islets and reduction in pancreatic β-cell granulation in rats at doses of ≥ 30 mg/kg/day, beta-cell exhaustion as indicated by depletion of insulin-containing granules in rabbits at doses of > 100 mg/kg/day).
Danish: I toksicitetsstudier med gentagen dosering blev der ved oral administration af høje doser af glibenclamid iagttaget virkninger på β-cellerne i pancreas (de langerhanske øer blev større og var uregelmæssigt formet, og granuleringen af betacellerne var nedsat ved doser på ≥ 30 mg/kg/dag, udmattelse af β-cellerne sås af depletionen af insulinholdige granula hos kaniner ved doser på > 100 mg/kg/dag).
English: The bottle must be closed after each use and stored for a maximum of 30 days.
Danish: Flasken skal lukkes, hver gang den har været i brug, og må opbevares i højst 30 dage.
English: This medicine may only be used for the treatment of neonatal diabetes in newborns, infants and children.
Danish: Dette lægemiddel må kun anvendes til behandling af neonatal diabetes hos nyfødte, spædbørn og børn.
English: What you need to know before you give AMGLIDIA Do not give AMGLIDIA
Danish: Det skal du vide, før du begynder at give AMGLIDIA Giv ikke AMGLIDIA
English: If a new presentation of AMGLIDIA is prescribed by your doctor, return back your previous presentation and syringe to your pharmacist to avoid mixing up of the syringes.
Danish: Hvis din læge ordinerer en ny type pakning af AMGLIDIA, skal du indlevere din gamle pakning og sprøjte til apoteket for at undgå at blande sprøjterne.
English: Slip about the first 1 cm of the syringe into the child's mouth and place it against the inside cheek; Let the child suck.
Danish: Før ca. 1 cm af sprøjten ind i barnets mund, og anbring den mod indersiden af kinden.
English: If you forget to give AMGLIDIA
Danish: Hvis du har glemt at give AMGLIDIA
English: Nausea, vomiting, flushing, dizziness, headache, chest and abdominal discomfort, and general hangover-like symptoms among others have occurred following the concomitant use of alcohol and glibenclamide.
Danish: Der er bl.a. forekommet kvalme, opkastning, rødmen, svimmelhed, hovedpine, ubehag i brystet og maven, og generelle tømmermandslignende symptomer efter samtidig brug af alkohol og glibenclamid.
English: The median [IQR] dose of sulfonylurea fell over the follow-up with a median [IQR] dose of 0.30 mg/kg/day [0.14-0.53] mg/kg/day at one year and of 0.23 mg/kg/day [0.12-0.41 mg/kg/day] at 10 years, p=0.03).
Danish: Den mediane [IQR] dosis af sulfonylurinstof faldt i løbet af opfølgningsperioden med en median [IQR] dosis på 0,30 mg/kg/dag [0,14-0,53] mg/kg/dag efter 1 år og på 0,23 mg/kg/dag [0,120,41 mg/kg/dag] efter 10 år, p = 0,03).
English: - The other ingredients are: xanthan gum, hydroxyethylcellulose, lactic acid, purified water sodium citrate and sodium benzoate (E211) (see section 2 “AMGLIDIA contains sodium and benzoate”).
Danish: - Øvrige indholdsstoffer: xanthangummi, hydroxyethylcellulose, mælkesyre, renset vand, natriumcitrat og natriumbenzoat (E211) (se punkt 2 "AMGLIDIA indeholder natrium og benzoat").
English: Rare cases of agranulocytosis, hemolytic anemia, bone marrow aplasia and pancytopenia
Danish: Sjældne tilfælde af agranulocytose, hæmolytisk anæmi, knoglemarvsaplasi og pancytopeni.
English: The two syringes, respectively included in two different presentations for each strength, are clearly distinguishable: 1 mL oral syringe is thin and small while 5 mL syringe is thick and long.
Danish: De to sprøjter er indeholdt i to forskellige pakninger for hver styrke og er klart forskellige: Den orale sprøjte på 1 ml er tynd og lille, mens 5 ml-sprøjten er tyk og lang.
English: Gastro intestinal disorders (very common: may affect more than 1 in 10 people): - Diarrhea - Abdominal (belly) pain - Vomiting - Stomach ache (Dyspepsia)
Danish: Mave-tarm-forstyrrelser (meget almindelig: forekommer hos mere end 1 ud af 10 personer): - Diarré - Mavesmerter (abdominalsmerter) - Opkastning - Ubehag i maven (dyspepsi)
English: Turn the bottle with the syringe into its upright position.
Danish: Vend flasken med sprøjten om til opret stilling.
English: Guanethidine used to treat high blood pressure
Danish: Guanethidin, der anvendes til behandling af forhøjet blodtryk
English: Close the bottle by tightening the screw cap well on top of the adaptor.
Danish: Luk flasken ved at stramme skruelåget godt til oven på adapteren.
English: Glibenclamide therapy should be started by a doctor experienced in the treatment of patients with very early onset diabetes.
Danish: Behandling med glibenclamid bør indledes af en læge med erfaring i behandling af patienter med meget tidligt indsættende sukkersyge.
English: If you stop giving AMGLIDIA
Danish: Hvis du holder op med at give AMGLIDIA
English: AMGLIDIA should be introduced at a dose of 0.2 mg/kg/day in two administration and dose should be progressively increased each week by 0.2 mg/kg/day.
Danish: AMGLIDIA bør introduceres ved en dosis på 0,2 mg/kg/dag fordelt på to administrationer, og dosis bør gradvist øges hver uge med 0,2 mg/kg/dag.
English: Chloramphenicol (in case of oral route) is an antibiotic used to treat infections
Danish: Chloramphenicol (ad oral vej), der er et antibiotikum, der anvendes til behandling af infektioner
English: Diarrhea, nausea and vomiting
Danish: Diarré, kvalme og opkastning
English: Adrenaline (epinephrine) and other sympathomimetic agents
Danish: Adrenalin og andre sympatomimetika
English: Contents of the pack and other information What AMGLIDIA contains
Danish: Pakningsstørrelser og yderligere oplysninger AMGLIDIA indeholder:
English: Insulin used to lower blood sugar level
Danish: Insulin, der anvendes til at nedsætte blodsukkeret
English: • The Amglidia 0.6 mg/mL strength should not be used for posology higher than 0.6 mg/kg/day to limit the exposure to the sodium benzoate excipient.
Danish: • Amglidia i styrken 0,6 mg/ml bør ikke anvendes til højere dosering end 0,6 mg/kg/dag for at begrænse eksponeringen for hjælpestoffet natriumbenzoat.
English: Adverse reactions Very common
Danish: Bivirkninger Meget almindelig
English: The dose to be administered is obtained by drawing the plunger back as far as the scale marking for the dose determined for each child.
Danish: Den dosis, der skal indgives, fås ved at trække stemplet tilbage så langt, at det svarer til skalaens markering for den fastlagte dosis til barnet.
English: Oestrogens (such as 17-beta oestradiol) used for hormonal treatment
Danish: Østrogener (såsom 17-beta-østradiol), der anvendes til hormonbehandling
English: Coumarin derivatives (such as dicoumarol, acenocoumarol) used to decrease the clotting ability of the blood
Danish: Kumarinderivater (såsom dikumarol, acenokumarol), der anvendes til at nedsætte blodets størkningsevne
English: Patients with renal impairment should be monitored periodically during treatment due to the increased risk of hypoglycaemia.
Danish: Patienter med nedsat leverfunktion bør overvåges periodisk under behandlingen pga. den øgede risiko for hypoglykæmi.
English: Maximum recommended posology (expressed as mg/kg/day) where the AMGLIDIA 0.6 mg/mL strength can be used
Danish: Legemsvægt (kg) Maksimal anbefalet dosis (udtrykt som mg/kg/dag), hvor AMGLIDIA i styrken 0,6 mg/ml kan anvendes
English: Brown glass bottle (type III) with a child-resistant closure (polypropylene screw cap with polyethylene capsule inside) in a carton containing a 1 mL or 5 ml graduated oral syringe of LDPE and polypropylene depending on the presentation prescribed and an adaptor (LDPE) to be plugged on the bottle after opening for the syringe.
Danish: Flaske af brunt glas (type III) med børnesikret lukning (skruelåg af polypropylen med indvendig kapsel af polyethylen) i en æske indeholdende en 1 ml eller 5 ml inddelt oral sprøjte af LDPE og polypropylen, afhængigt af den ordinerede pakning, og en adapter (LDPE) til anbringelse af sprøjten.
English: H2-receptor antagonists used for reducing stomach acid (such as ranitidine) to relieve the symptoms of stomach and duodenal ulcers, oesophageal reflux disease and the Zollinger-Ellison syndrome
Danish: H2-receptorantagonister, der anvendes til reduktion af mavesyre (såsom ranitidin) for at lindre symptomerne på mavesår og sår i tolvfingertarmen, tilbageløb af mavesyre til spiserøret (øsofageal reflukssygdom) og Zollinger-Ellisons syndrom
English: Fluoxetine
Danish: Fluoxetin
English: Phenothiazine derivatives (such as chlorpromazine) used to treat schizophrenia and other psychoses
Danish: Fentiazinderivater (såsom chlorpromazin), der anvendes til behandling af skizofreni og andre psykoser
English: Other medicines and AMGLIDIA
Danish: Brug af anden medicin sammen med AMGLIDIA
English: To limit exposure to sodium benzoate and with respect to the mode of delivery (1 mL and 5 mL oral syringes), it is not recommended to use the AMGLIDIA 0.6 mg/mL strength for posologies higher than the ones described below:
Danish: For at begrænse eksponeringen for natriumbenzoat og af hensyn til administrationsmåden (1 ml og 5 ml orale sprøjter) frarådes det at anvende AMGLIDIA i styrken 0,6 mg/ml til doser højere end de nedenfor angivne:
English: Tetracycline antibiotics (such as doxycycline and minocycline) used to treat infections
Danish: Tetracyclin-antibiotika (såsom doxycyclin og minocyclin), der anvendes til behandling af infektioner
English: What you need to know before you give AMGLIDIA 3.
Danish: Det skal du vide, før du begynder at give AMGLIDIA 3.
English: Salicylates (such as aminosalicylic acid, para-aminosalicylic acid used for tuberculosis)
Danish: Salicylater (såsom aminosalicylsyre, paraaminosalicylsyre), der anvendes ved tuberkulose)
English: Fibrates (such as bezafibrate, fenofibrate, gemfibrozil used to lower the level of fats)
Danish: Fibrater (såsom bezafibrat, fenofibrat, gemfibrozil, der anvendes til at sænke fedtstofindholdet)
English: Please read the posology and method of administration in the SmPC attached to this prescriber's guide.
Danish: Læs om dosis og administrationsmåde i produktresuméet, der er vedhæftet denne ordinationsvejledning.
English: − in patients taking bosentan (see section 4.5)
Danish: − hos patienter, der får bosentan (se pkt.
English: Diazoxide used for low blood sugar
Danish: Diazoxid, der anvendes mod for lavt blodsukker
English: Start AMGLIDIA at a dose of 0.2 mg/kg/day, in two administration.
Danish: Start AMGLIDIA ved en dosis på 0,2 mg/kg/dag fordelt på to administrationer.
English: H2-receptor antagonists Potentiation or weakening of the bloodglucose lowering effect
Danish: H2-receptorantagonister Potentiering eller svækkelse af den blodglukosesænkende virkning
English: Both acute and chronic alcohol intake, or excessive alcohol ingestion by people who drink occasionally, may attenuate the hypoglycaemic effect of glibenclamide or dangerously potentiate it by delaying its metabolic inactivation.
Danish: Både akut og kronisk alkoholindtagelse eller overdreven alkoholindtagelse hos personer, der drikker lejlighedsvis, kan svække den hypoglykæmiske virkning af glibenclamid eller forårsage farlig potentiering af virkningen ved at forsinke stoffets metaboliske inaktivering.
English: Clonidine
Danish: Clonidin
English: As the dose is increased, it is usually possible to reduce and then stop the insulin dose.
Danish: Efterhånden som dosis øges, kan insulindosis sædvanligvis mindskes og derefter seponeres.
English: ACE inhibitors (used to treat hypertension) (such as captopril and enalapril)
Danish: ACE-hæmmere (til behandling af for højt blodtryk) (såsom captopril og enalapril)
English: If the blood-glucose level exceeds 16.5 mmol/L, the presence of ketonuria or ketonaemia must also be checked.
Danish: Ved blodglukose over 16,5 mmol/l skal der desuden kontrolleres for ketonuri eller ketonæmi.
English: Only the oral syringe included in the outer carton should be used.
Danish: Kun den orale sprøjte, der medfølger i yderkartonen, bør anvendes.