FrancophonIA/ELRC3.0 huggingface dataset:
English: Exalief 600 mg tablets are packed in HDPE bottles with polypropylene child resistant closure, placed into cardboard boxes, containing 90 tablets.
Danish: Exalief 600 mg tabletter fås i HDPE-flasker med børnesikret lukning af polypropylen i æsker med 90 tabletter.
English: As clinical data are limited in patients with mild to moderate hepatic impairment and pharmacokinetic and clinical data are missing in patients with severe hepatic impairment, Exalief should be used with caution in patients with mild to moderate hepatic impairment and is not recommended in patients with severe hepatic impairment.
Danish: Der foreligger begrænsede kliniske data fra patienter med let til moderat nedsat leverfunktion, og der mangler kliniske data fra patienter med alvorligt nedsat leverfunktion.
English: Therefore, an alternative, effective and safe method of contraception should be used during treatment and up to the end of the current menstrual cycle after treatment has been stopped.
Danish: Derfor bør anden sikker kontraception anvendes under behandling med eslicarbazepinacetat og frem til afslutningen på den aktuelle menstruationscyklus efter endt behandling.
English: The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Danish: Delekærven er der, for at tabletten kan deles, så den er nemmere at sluge, ikke for at kunne dosere to halve tabletter.
English: • Feeling sick or vomiting
Danish: • Kvalme eller opkastning
English: • Having falls
Danish: • Fald
English: • you have kidney problems.
Danish: • hvis De har dårlige nyrer.
English: White oblong tablets, engraved ‘ESL 800'on one side and scored on the other side.
Danish: Hvide, aflange tabletter med 'ESL 800' præget på den ene side og delekærv på den anden side.
English: Eslicarbazepine acetate metabolites are eliminated from the systemic circulation primarily by renal excretion.
Danish: Eslicarbazepinacetats metabolitter udskilles primært fra det systemiske kredsløb via nyrerne.
English: If you are not sure if the medicines you are taking could have this effect, discuss
Danish: Tal med lægen om dette, hvis De er usikker på, om den medicin, De får, kan have denne virkning.
English: White oblong tablets, engraved ‘ESL 600'on one side and scored on the other side.
Danish: Hvide, aflange tabletter med 'ESL 600' præget på den ene side og delekærv på den anden side.
English: White circular biconvex tablets, engraved ‘ESL 400'on one side and scored on the other side.
Danish: Hvide, runde, bikonvekse tabletter med 'ESL 400' præget på den ene side og delekærv på den anden side.
English: • Nosebleed
Danish: • Klodsethed
English: Eslicarbazepine acetate
Danish: Hjerte sinusbradykardi
English: • Shaking
Danish: • Rysten
English: Dysphonia, epistaxis, chest pain
Danish: Myalgi, rygsmerter, nakkesmerter
English: If at any time you have these thoughts, when taking Exalief, contact your doctor immediately.
Danish: Kontakt straks Deres læge, hvis De på noget tidspunkt får den slags tanker.
English: Each tablet contains 800 mg of eslicarbazepine acetate.
Danish: Hver tablet indeholder 800 mg eslicarbazepinacetat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg of eslicarbazepine acetate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 800 mg eslicarbazepinacetat.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: De kan finde yderligere information om Exalief på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Patients with renal impairment
Danish: Patienter med dårlige nyrer
English: • Feeling unsteady or having a sensation of spinning or floating
Danish: • Usikker på benene eller en følelse af, at det hele drejer rundt
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg of eslicarbazepine acetate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 600 mg eslicarbazepinacetat.
English: Each tablet contains 600 mg of eslicarbazepine acetate.
Danish: Hver tablet indeholder 600 mg eslicarbazepinacetat.
English: Each tablet contains 400 mg of eslicarbazepine acetate.
Danish: Hver tablet indeholder 400 mg eslicarbazepinacetat.
English: HOW TO TAKE EXALIEF
Danish: SÅDAN SKAL DE TAGE EXALIEF
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg of eslicarbazepine acetate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 400 mg eslicarbazepinacetat.
English: Eslicarbazepine acetate adversely interacts with oral contraceptives.
Danish: Interaktion ved samtidig behandling med eslicarbazepinacetat og orale kontraceptionsmidler nedsætter den kontraceptionelle sikkerhed.
English: The scoreline is only to facilitate breaking the tablet into two for ease of swallowing, and it does not divide the tablet into two equal doses.
Danish: Delekærven deler ikke tabletten i to lige store doser.
English: The influence of Exalief on primary generalised seizures has not been studied.
Danish: Exaliefs påvirkning af primært generaliserede anfald er ikke undersøgt, og det frarådes derfor at anvende lægemidlet til denne patientpopulation.
English: Exalief is not recommended in patients with severe renal disease.
Danish: Patienter med alvorlig leversygdom bør ikke tage Exalief.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 800 mg of eslicarbazepine acetate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 800 mg eslicarbazepinacetat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 600 mg of eslicarbazepine acetate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 600 mg eslicarbazepinacetat.
English: This leaflet was last approved in MMM/YYYY
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ }
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg of eslicarbazepine acetate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 400 mg eslicarbazepinacetat.
English: Liver disorder
Danish: Nedsat nyrefunktion
English: The pharmacokinetics of eslicarbazepine has not been evaluated in patients with severe hepatic impairment (see section 4.4 and 5.2) and use in these patients is therefore not recommended.
Danish: Eslicarbazepins farmakokinetik er ikke undersøgt hos patienter med alvorligt nedsat leverfunktion (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/520/001-006
Danish: EU/1/09/520/001-006
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Box of 7, 14 or 28 tablets
Danish: Æske med 7, 14 eller 28 tabletter
English: What Exalief looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Injury, poisoning
Danish: Traumer, forgiftninger og behandlingskompli kationer
English: Common Uncommon
Danish: Ikke almindelige
English: If you do, you are at risk of having more seizures.
Danish: De må ikke afbryde behandlingen pludseligt, da det medfører en risiko for, at De vil få flere anfald.
English: <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: After the Commission Decision the Member State Competent Authorities will update the product information as required
Danish: Efter Kommissionens beslutning vil myndighederne i de enkelte medlemslande opdaterer produktinformationen efter behov.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E) OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Magnesium stearate Hydroxypropyl cellulose Amylum pregelificatum Mannitol (E421) Aspartame (E951) Sucralose (E955) Grape flavour
Danish: Magnesiumstearat Hydroxypropylcellulose Pregelatineret stivelse Mannitol (E421) Aspartam (E951) Sucralose (E955) Vindruesmag
English: Cohort B included 24 children, 10 to 17 years of age and at Tanner Stage ≥2.
Danish: Kohorte B omfattede 24 børn i alderen 10-17 år i Tanner-stadie ≥ 2.
English: Pediatric use should only be carried out by specialists.
Danish: Børn bør kun behandles af specialister.
English: Paediatric use
Danish: Pædiatrisk brug
English: Common: Abdominal pain
Danish: Mave-tarm-kanalen Almindelig: Abdominalsmerter
English: Important information about some of the ingredients of {PRODUCT NAME} If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Zarator Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt dem, at De ikke tåler visse sukkerarter.
English: This medicine is available as 5 mg, 10 mg, 20 mg and 40 mg chewable tablets and 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.
Danish: Zarator findes som tyggetabletter på 5 mg, 10 mg, 20 mg og 40 mg, samt som filmovertrukkne tabletter på 10 mg, 20 mg, 40 mg og 80 mg.
English: Developmental safety in the paediatric population has not been established (see section 4.8).
Danish: Udviklingsmæssig sikkerhed i den pædiatriske population er ikke blevet undersøgt (se pkt.
English: The blisters consist of a forming foil made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl /acryl heat-seal coating.
Danish: Blisteren består af en folie af polyamid/aluminiumsfolie/polyvinylchlorid samt en aluminiumsfolie/vinyl/acryl varmeforseglet bagside.
English: The mean achieved LDL-C value was 3.38 mmol/l (range: 1.81-6.26 mmol/l) in the atorvastatin group compared to 5.91 mmol/l (range: 3.93-9.96 mmol/l) in the placebo group during the 26-week double-blind phase.
Danish: Gennemsnitlig LDL-cholesterol på 3,38 mmol/l (1,81-6,26 mmol/l) i atorvastatingruppen sammenlignet med 5,91 mmol/l (3,93-9,96 mmol/l) i placebogruppen blev nået i løbet af de første 26 uger (dobbelt-blindede fase).
English: An 8-week, open-label study to evaluate pharmacokinetics, pharmacodynamics, and safety and tolerability of atorvastatin was conducted in children and adolescents with genetically confirmed heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L.
Danish: Et 8-ugers, open-label klinisk forsøg til evaluering af farmakokinetik, farmakodynamik samt sikkerhed og tolerabilitet af atorvastatin blev udført med børn og unge med genetisk bekræftet heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l.
English: Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Danish: Atorvastatin sænkede signifikant total-cholesterol, LDLcholesterol, triglycerider og apolipoprotein B i de første 26 uger (dobbelt-blindede fase).
English: Calcium carbonate Microcrystalline cellulose Croscarmellose sodium Polysorbate 80
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Polysorbat 80
English: − Paediatric: Pharmacokinetic data in the paediatric population are not available.
Danish: -[Udfyldes nationalt] - Børn: Der findes ikke farmakokinetiske data hos børn.
English: The active substance of {PRODUCT NAME} is atorvastatin.
Danish: Zarator indeholder: Aktivt stof: atorvastatin.
English: Blister packs containing 30 chewable tablets.
Danish: Blisterpakning med 30 tyggetabletter.
English: Polysorbate 80
Danish: Croscarmellosenatrium Polysorbat 80
English: Each {PRODUCT NAME} 10 mg chewable tablet contains 1.25 mg aspartame.
Danish: 1 Zarator 10 mg tyggetablet indeholder 1,25 mg aspartam.
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Zarator til Dem personligt.
English: Common: Alanine aminotransferase increased, blood creatine phosphokinase increased Based on the data available, frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Danish: Ud fra de tilgængelige data forventes frekvens, type og alvorlighed af bivirkningerne hos børn og unge at være de samme som hos voksne.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN <[Udfyldes nationalt]> <[Se bilag I - Udfyldes nationalt]> [For referral procedures] {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
Danish: I et 8-ugers, open-label klinisk forsøg blev børn i alderen 6-17 år og i Tanner-stadie 1 (n=15) eller Tanner-stadie ≥ 2 (n=24) med heterozygot familiær hyperkolesterolæmi og baseline LDL-cholesterol ≥ 4 mmol/l behandlet med hhv. 5 mg eller 10 mg tyggetabletter eller 10 mg eller 20 mg filmovertrukne tabletter 1 gang dagligt.
English: Pottery Road, Dun Laoghaire, Co Dublin Ireland
Danish: Pfizer Irland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland
English: {PRODUCT NAME} are available in blister packs containing 30 chewable tablets.
Danish: Pakningsstørrelser Zarator findes i en blisterpakning, der indeholder 30 tyggetabletter.
English: They are marked with 40 on one side and Pfizer on the other side.
Danish: De er præget med ”40” på den ene side og ”Pfizer” på den anden side.
English: In a double-blind, placebo controlled study followed by an open-label phase, 187 boys and postmenarchal girls 10-17 years of age (mean age 14.1 years) with heterozygous familial hypercholesterolaemia (FH) or severe hypercholesterolaemia were randomised to atorvastatin (n=140) or placebo (n=47) for 26 weeks and then all received atorvastatin for 26 weeks..
Danish: I et dobbelt-blindet, placebokontrolleret klinisk forsøg efterfulgt af en periode med open-label blev 187 drenge og piger (der havde fået første menstruation) i alderen 10-17 år (gennemsnit 14,1 år) med heterozygot familiær hyperkolesterolæmi eller svær hyperkolesterolæmi randomiseret til enten atorvastatin (n=140) eller placebo (n=47) i 26 uger, hvorefter alle fik atorvastatin i 26 uger.
English: POSSIBLE SIDE EFFECTS
Danish: 4.8 Bivirkninger
English: They are marked with 20 on one side and Pfizer on the other side.
Danish: De er præget med ”20” på den ene side og ”Pfizer” på den anden side.
English: They are marked with 10 on one side and Pfizer on the other side.
Danish: De er præget med ”10” på den ene side og ”Pfizer” på den anden side.
English: Each {PRODUCT NAME} 20 mg chewable tablet contains 2.5 mg aspartame.
Danish: 1 Zarator 20 mg tyggetablet indeholder 2,5 mg aspartam.
English: Each {PRODUCT NAME} 40 mg chewable tablet contains 5 mg aspartame.
Danish: 1 Zarator 40 mg tyggetablet indeholder 5 mg aspartam.
English: Common: Headache
Danish: Nervesystemet Almindelig: Hovedpine
English: Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
Danish: Tilsvarende hermed sås fald i LDL-cholesterol og total-cholesterol i forhold til efter atorvastatin- og o-hydroxyatorvastatin-niveauer.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER [Udfyldes nationalt]
English: White to off-white, round chewable tablets with pink to purple specks, debossed "40" on one side and "Pfizer" on the other measuring 10.3 mm in diameter.
Danish: Hvide til råhvide, runde tyggetabletter med lyserøde til violette prikker, præget med ”40” på den ene side og ”Pfizer” på den anden side.
English: White to off-white, round chewable tablets with pink to purple specks debossed "20" on one side and "Pfizer" on the other measuring 8.7 mm in diameter.
Danish: Hvide til råhvide, runde tyggetabletter med lyserøde til violette prikker, præget med ”20” på den ene side og ”Pfizer” på den anden side.
English: White to off-white, round chewable tablets with pink to purple specks, debossed "10" on one side and “Pfizer” on the other measuring 7.1 mm in diameter.
Danish: Hvide til råhvide, runde tyggetabletter med lyserøde til violette prikker, præget med ”10” på den ene side og ”Pfizer” på den anden side.
English: Each tablet contains 40 mg of atorvastatin as atorvastatin calcium trihydrate.
Danish: 1 tablet indeholder 40 mg atorvastatin som atorvastatincalciumtrihydrat.
English: Each tablet contains 20 mg of atorvastatin as atorvastatin calcium trihydrate.
Danish: 1 tablet indeholder 20 mg atorvastatin som atorvastatincalciumtrihydrat.
English: Each tablet contains 10 mg of atorvastatin as atorvastatin calcium trihydrate.
Danish: 1 tablet indeholder 10 mg atorvastatin som atorvastatincalciumtrihydrat.
English: INFORMATION IN BRAILLE {PRODUCT NAME} 20 mg chewable tablets
Danish: INFORMATION I BRAILLE-SKRIFT Zarator 20 mg tyggetabletter
English: INFORMATION IN BRAILLE {PRODUCT NAME} 10 mg chewable tablets
Danish: INFORMATION I BRAILLE-SKRIFT Zarator 10 mg tyggetabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 20 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 tyggetablet indeholder 20 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 10 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 tyggetablet indeholder 10 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 20 mg chewable tablets Atorvastatin
Danish: LÆGEMIDLETS NAVN Zarator 20 mg tyggetabletter Atorvastatin
English: INFORMATION IN BRAILLE {PRODUCT NAME} 40 mg chewable tablets
Danish: INFORMATION I BRAILLE-SKRIFT Zarator 40 mg tyggetabletter
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 40 mg chewable tablets Atorvastatin
Danish: LÆGEMIDLETS NAVN Zarator 40 mg tyggetabletter Atorvastatin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains 40 mg atorvastatin (as atorvastatin calcium (trihydrate)).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 tyggetablet indeholder 40 mg atorvastatin (som atorvastatincalciumtrihydrat).
English: NAME OF THE MEDICINAL PRODUCT {PRODUCT NAME} 10 mg chewable tablets Atorvastatin
Danish: LÆGEMIDLETS NAVN Zarator 10 mg tyggetabletter Atorvastatin
English: In this leaflet:
Danish: Anvendes før:
English: What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 10 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
Danish: Zarator 10 mg tyggetabletter er runde og hvide til råhvide med lyserøde til violette prikker.
English: Calcium carbonate
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Calciumcarbonat
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 40 mg atorvastatin (as calcium salt trihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tyggetablet indeholder 40 mg atorvastatin (som atorvastatincalciumtrihydrat)
English: What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 40 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
Danish: Zarator 40 mg tyggetabletter er runde og hvide til råhvide med lyserøde til violette prikker.
English: What {PRODUCT NAME} looks like and contents of the pack {PRODUCT NAME} 20 mg chewable tablets are white to off-white with pink to purple specks with a round shape.
Danish: Zarator 20 mg tyggetabletter er runde og hvide til råhvide med lyserøde til violette prikker.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 20 mg atorvastatin (as calcium salt trihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tyggetablet indeholder 20 mg atorvastatin (som atorvastatincalciumtrihydrat) LISTE OVER HJÆLPESTOFFER Indeholder aspartam.
English: MARKETING AUTHORISATION HOLDER [To be completed nationally] [See Annex I - To be completed nationally] {Name and address}
Danish: <[Se bilag I - Udfyldes nationalt]> [For referral procedures]
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 chewable tablet contains 10 mg atorvastatin (as calcium salt trihydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 tyggetablet indeholder 10 mg atorvastatin (som atorvastatincalciumtrihydrat) LISTE OVER HJÆLPESTOFFER Indeholder aspartam.
English: 4.9 Overdose {To be completed nationally}.
Danish: 4.9 Overdosering
English: − {To be completed nationally}.
Danish: - [Udfyldes nationalt]
English: {PRODUCT NAME} 20 mg chewable tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <[Udfyldes nationalt]>
English: by washing your hands.
Danish: ved at vaske hænder.
English: I'm not sure my pen worked correctly.
Danish: Jeg er ikke sikker på, at min pen virkede korrekt.
English: Read both sides for full instructions
Danish: Læs alle instruktionerne på begge sider
English: The median study follow-up time was 5.4 years.
Danish: Medianen for studieopfølgningen var 5,4 år.
English: If you drop it on a hard surface, do not use it.
Danish: Hvis du taber den på en hård overflade, må du ikke bruge den.
English: Make sure the pen is locked.
Danish: Sørg for at pennen er låst.
English: Check to see if you have received your dose.
Danish: Kontrollér den for at se, om du har fået din dosis.
English: BEFORE YOU GET STARTED Remove
Danish: INDEN DU STARTER Tag ud
English: Exenatide+
Danish: Exenatid+
English: Change in FBG
Danish: Ændring i FBG
English: Meta-analysis of phase II and III studies
Danish: Meta-analyse af fase II og III-studier
English: You may give them an infection or get an infection from them.
Danish: Du kan give dem en infektion eller få en infektion af dem.
English: This is not necessary, but it may help you keep the pen steady and firm against your skin.
Danish: Det er ikke nødvendigt, men det kan gøre det lettere at holde pennen roligt og godt fast mod huden.
English: These effects were sustained to the end of the study (104 weeks).
Danish: Disse virkninger blev fastholdt til studiets afslutning (104 uger).
English: These side effects are usually not severe.
Danish: Disse bivirkninger er som regel ikke alvorlige.
English: • in addition to other medicinal products for the treatment of diabetes.
Danish: • i tillæg med andre lægemidler til behandling af diabetes.
English: Air bubbles are normal.
Danish: Det er normalt med luftbobler.
English: the label to make sure you have the correct medicine and it has not expired.
Danish: etiketten for at sikre, at det er den korrekte medicin, og at den ikke er udløbet.
English: There were 3,114 (31.5 %) patients with established CV disease.
Danish: Der var 3.114 (31,5 %) patienter med etableret CV-sygdom.
English: Week 1 Week 2
Danish: Uge 1 Uge 2
English: Week 1 Week 2 Week 3 Week 4
Danish: Uge 1 Uge 2 Uge 3 Uge 4
English: If you want to do so, you can use the same area of your body each week.
Danish: Hvis du vil, kan du bruge samme kropsdel hver uge.
English: Please keep this in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Danish: Det skal du huske på i alle situationer, hvor du kan udsætte dig selv og andre for fare (f.eks. bilkørsel og betjening af maskiner).
English: There was no difference in diastolic blood pressure (DBP).
Danish: Der var ingen forskel i det diastoliske blodtryk (DBP).
English: Each MACE component contributed to the reduction of MACE, as shown in Figure 2.
Danish: Hver MACEkomponent bidrog til reduktionen af MACE, som vist i figur 2.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Danish: I tilfælde af overdosering skal der iværksættes passende understøttende behandling i overensstemmelse med patientens kliniske tegn og symptomer.
English: Did I get my complete injection?
Danish: Har jeg fået hele min injektion?