FrancophonIA/ELRC3.0 huggingface dataset:
English: Reduction in incidence of RV gastroenteritis through one full season post-vaccination (RotaTeq n=2,834) (% [95 % CI]) Efficacy against any severity by rotavirus genotype
Danish: Reduktion i forekomsten af gastroenteritis som følge af rotavirus gennem en hel sæson efter vaccination (RotaTeq n=2.834) % [95 % CI] Effekt mod alle sværhedsgrader af rotavirus genotype
English: RotaTeq is intended for use in infants only.
Danish: RotaTeq er alene beregnet til brug til spædbørn.
English: Efficacy against genotypes G2P[4], G3P[8], G4P[8] and G9P[8] rotavirus was based on fewer cases than for G1.
Danish: Effekten over for genotyperne G2P[4], G3P[8], G4P[8] og G9P[8] rotavirus var baseret på færre tilfælde end for G1.
English: Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty.
Danish: Indgiv dosis ved forsigtigt at trykke væsken ind i barnets mund mod indersiden af kinden, til tuben er tom.
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMER (-NUMRE)
English: Adverse Reaction/Event
Danish: Bivirkning/hændelse
English: RotaTeq may be given at the same time as your child receives other normally recommended vaccinations, such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, inactivated or oral poliomyelitis, hepatitis B, pneumococcal conjugate and meningococcus group C conjugate vaccines.
Danish: RotaTeq kan gives samtidig med, at dit barn får andre normalt anbefalede vaccinationer såsom vacciner imod difteri, stivkrampe, kighoste, Haemophilus influenzae type b, inaktiveret eller oral (som gives gennem munden) poliomyelitis-, hepatitis B- og konjugerede pneumokokvacciner og konjugerede gruppe C-meningokokvacciner.
English: In a clinical study, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Danish: I et klinisk studie blev RotaTeq givet til cirka 1.000 spædbørn, som var blevet født med en gestationsalder på 25 til 36 uger.
English: The reduction in incidence of RV gastroenteritis caused by genotypes G1-G4 during the second rotavirus season after vaccination was 88.0 % [95 % CI 49.4, 98.7] for severe disease and 62.6 % [95 % CI 44.3, 75.4] for disease of any severity.
Danish: Reduktionen i forekomsten af rotavirus-gastroenteritis forårsaget af genotype G1-G4 under anden rotavirussæson efter vaccination var 88,0 % [95 % CI 49,4; 98,7] for svær sygdom og 62,6 % [95 % CI 44,3; 75,4] for sygdom af en hvilken som helst sværhedsgrad.
English: RotaTeq oral solution
Danish: RotaTeq oral opløsning
English: Co-administration of RotaTeq with vaccines containing one or more of the following antigens at approximately 2, 4 and 6 months of age demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected: - Diphtheria-tetanus-acellular pertussis vaccine (DTaP) - Haemophilus influenzae type b vaccine (Hib) - Inactivated poliomyelitis vaccine (IPV) - Hepatitis B vaccine (HBV) - Pneumococcal conjugate vaccine (PCV)
Danish: Samtidig indgivelse af RotaTeq med andre vacciner, der indeholder et eller flere af følgende antigener, ved ca. 2, 4, og 6-måneders-alderen viste, at immunrespons og sikkerhedsprofilen for de indgivne vacciner var upåvirket: - Difteri-tetanus-acellulær pertussisvaccine (DtaP) - Haemophilus influenzae type b-vaccine (Hib) - Inaktiveret poliomyelitisvaccine (IPV) - Hepatitis B-vaccine (HBV) - Konjugeret pneumokokvaccine (PCV).
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Danish: MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
English: • Common (may affect up to 1 in 10 infants): infections of the upper respiratory system
Danish: • Almindelig (kan forekomme hos op til 1 ud af 10 spædbørn): infektioner i de øvre luftveje.
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Der skal tages højde for den potentielle risiko for apnø og behovet for respiratorisk overvågning i 4872 t. ved indgivelse af den primære vaccinationsserie hos præmature spædbørn (født ≤28.
English: RotaTeq contains sucrose.
Danish: RotaTeq indeholder saccharose.
English: RotaTeq does not protect against gastroenteritis due to other pathogens than rotavirus.
Danish: RotaTeq beskytter ikke imod gastroenteritis forårsaget af andre patogener end rotavirus.
English: These infants should receive the first dose of RotaTeq at least six weeks after birth (see sections 4.4 and 5.1).
Danish: Disse spædbørn skal have den første dosis RotaTeq mindst seks uger efter fødslen (se pkt.
English: Based on pooled data from 3 clinical trials in which 6,130 infants received RotaTeq and 5,560 received placebo, the adverse reactions listed occurred with excess incidences in RotaTeq recipients compared to placebo recipients of between 0.2 % and 2.5 %.
Danish: Baseret på de samlede data fra 3 kliniske studier, i hvilke 6.130 spædbørn fik RotaTeq, og 5.560 spædbørn fik placebo, forekom de anførte bivirkninger hos modtagerne af RotaTeq med en overhyppighed på mellem 0,2 % og 2,5 % sammenlignet med placebomodtagere.
English: In a subset of infants from 3 placebo-controlled clinical trials (n=6,130 recipients of RotaTeq and 5,560 placebo recipients), RotaTeq was evaluated for all adverse events within 42 days of vaccination with or without concomitant use of other paediatric vaccines.
Danish: I en undergruppe af spædbørn (n=6.130 modtagere af RotaTeq og 5.560 modtagere af placebo) fra 3 placebokontrollerede kliniske studier blev RotaTeq vurderet for alle uønskede hændelser indenfor 42 dage efter vaccinationen med eller uden samtidig brug af andre pædiatriske vacciner.
English: Intussusception α *
Danish: Meget sjælden Invagination α *
English: - your child was born with a malformation of the gastrointestinal system that might predispose for intussusception.
Danish: Hvis dit barn er født med misdannelser i mavetarmkanalen, som kan disponere for invagination.
English: If your child gets any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Tear open the protective bag and remove the dosing tube.
Danish: Riv beskyttelsesposen op, og tag doseringstuben ud.
English: RotaTeq Oral solution Oral use
Danish: RotaTeq Oral opløsning Oral anvendelse
English: Co-administration of RotaTeq with DTaP-IPV-HBV-Hib vaccine (Infanrix hexa) at approximately 2, 3, and 4 months of age demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected compared to separate administrations.
Danish: Samtidig indgivelse af RotaTeq med DTaP-IPV-HBV-Hib-vaccine (Infanrix hexa) ved ca. 2, 3 og 4måneders-alderen viste, at immunrespons og sikkerhedsprofil for de samtidigt indgivne vacciner var upåvirket sammenlignet med separate indgivelser.
English: Administration of RotaTeq should be postponed in infants suffering from acute severe febrile illness.
Danish: Vaccination med RotaTeq skal udsættes for spædbørn med en akut, svær sygdom med feber.
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines (or other vaccines).
Danish: Fortæl altid lægen eller på apoteket, hvis dit barn bruger anden medicin eller har gjort det for nylig.
English: The administration of RotaTeq should be postponed in subjects suffering from acute diarrhoea or vomiting.
Danish: Vaccination med RotaTeq skal udskydes for personer med akut diarré eller opkastning.
English: Method of administration Rotateq is for oral administration only.
Danish: Administration Rotateq er kun til oral indgivelse.
English: Do not use RotaTeq if:
Danish: Brug ikke RotaTeq:
English: 6 Infectious Units P1A[8] 2.3 x 10
Danish: P1A[8] 2,3 x 10
English: What you need to know before your child receives RotaTeq
Danish: Det skal du vide, før dit barn vaccineres med RotaTeq
English: Cases of gastroenteritis associated with vaccine virus have been reported post marketing in infants with severe combined immunodeficiency (SCID, see section 4.3).
Danish: Efter markedsføring er tilfælde af gastroenteritis associeret til vaccinevirus rapporteret hos børn med svær kombineret immundefekt (SCID, se pkt.
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine.
Danish: RotaTeq indeholder saccharose og bør ikke anvendes til patienter med arvelig fructoseintolerans, glucose-galactosemalabsorption eller sucrase-isomaltasemangel.
English: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561
Danish: MSD SHARP & DOHME GMBH Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de
English: RotaTeq may be given to infants who were born early provided that the pregnancy had lasted at least 25 weeks.
Danish: RotaTeq kan gives til for tidligt fødte spædbørn under forudsætning af, at graviditeten har varet mindst 25 uger.
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Sjælden
English: Hospitalization and ED visits due to all cause gastroenteritis
Danish: Hospitalsindlæggelse og skadestuebesøg pga. gastroenteritis uanset årsag
English: RotaTeq is indicated for the active immunisation of infants from the age of 6 weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
Danish: RotaTeq er indiceret til aktiv immunisering af spædbørn i alderen fra 6 uger til 32 uger til forebyggelse af rotavirus-gastroenteritis (se pkt.
English: Infants who have known or suspected immunodeficiency (see sections 4.4 and 4.8).
Danish: Spædbørn med kendt eller mistænkt immundefekt (se pkt.
English: RotaTeq IS FOR ORAL USE ONLY.
Danish: RotaTeq ER KUN TIL ORAL INDTAGELSE.
English: Waarderweg 39, 2031 BN Haarlem, P.O.
Danish: Waarderweg 39, 2031 BN Haarlem, Postboks 581, 2003 PC Haarlem
English: The active substances in RotaTeq are 5 human-bovine reassortant rotavirus strains: G1 2.2 x 10
Danish: Aktive stoffer i RotaTeq er 5 human-bovine reassortante rotavirus-stammer.
English: Keep the dosing tube in the outer carton in order to protect from light.
Danish: Opbevar doseringstuben i den ydre pakning for at beskytte mod lys.
English: Clear the fluid from the dispensing tip by holding tube vertically and tapping the twist-off cap.
Danish: Fjern væsken fra dispenserens spids ved at holde tuben lodret og banke på drejehætten.
English: During these trials, the most common circulating rotavirus genotype was G1P[8], while rotavirus genotypes G2P[4], G3P[8], G4P[8], and G9P[8] were identified less often.
Danish: Under disse studier var den hyppigst cirkulerende rotavirus-genotype G1P[8], mens rotavirus-genotyperne G2P[4], G3P[8], G4P[8] G9P[8] forekom mindre hyppigt.
English: Please read the package leaflet for disposal of medicines no longer required
Danish: Læs indlægssedlen for at få oplysninger om bortskaffelse af eventuel overskydende medicin.
English: In clinical trials, efficacy was demonstrated against gastroenteritis due to rotavirus of genotypes G1P[8], G2P[4], G3P[8], G4P[8], and G9P[8].
Danish: I kliniske studier blev der påvist effekt mod gastroenteritis forårsaget af rotavirus genotyperne G1P[8], G2P[4], G3P[8], G4P[8] og G9P[8].
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: Hvis dit barn lider af en alvorlig infektion med høj feber.Det kan være nødvendigt at udskyde vaccinationen, indtil barnet er raskt.En mindre infektion såsom en forkølelse burde ikke være noget problem, men tal først med lægen.
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France.
Danish: Indehaver af markedsføringstilladelsen: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig
English: Endpoints
Danish: Endepunkt
English: However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV-infected infants is not recommended.
Danish: Dog frarådes det at administrere RotaTeq til spædbørn med asymptomatisk HIV-infektion, idet der ikke foreligger tilstrækkelige data.
English: Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
Danish: United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com
English: Other medicines and RotaTeq:
Danish: Brug af anden medicin sammen med RotaTeq:
English: In REST, RotaTeq was administered to approximately 1,000 infants who were born at a gestational age of 25 to 36 weeks.
Danish: I REST-studiet blev RotaTeq givet til cirka 1.000 spædbørn født med en gestationsalder på 25 til 36 uger.
English: Efficacy
Danish: Effekt
English: Strain-specific - G1P[8] - G2P[4] - G3P[8] - G12P[8]
Danish: Hospitalsindlæggelse og skadestuebesøg pga. RVgastroenteritis Stammespecifik - G1P[8] - G2P[4] - G3P[8] - G12P[8]
English: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Danish: MSD VACCINS 162 avenue Jean Jaurès 69007 LYON Frankrig
English: Pharmacotherapeutic group: Vaccines, Viral Vaccine ATC code: J07BH02.
Danish: ATC-kode: J07BH02
English: RotaTeq is an oral vaccine that helps protect infants and young children against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection and may be given to infants from the age of 6 weeks to 32 weeks (see section 3).
Danish: RotaTeq er en oral vaccine (gives gennem munden), der hjælper med at beskytte spædbørn og små børn mod gastroenteritis (diarré og opkastning), der skyldes rotavirus-infektion.
English: Any severity (G1-G4)
Danish: Alle sværhedsgrader (G1-G4)
English: Address:
Danish: Adresse
English: A complete 3-dose vaccination series of RotaTeq should be administered (see section 4.2) to provide the level and duration of protection against rotavirus gastroenteritis that was observed in the clinical studies.
Danish: 4.2) for at tilvejebringe en beskyttelse imod rotavirus-gastroenteritis, der er på niveau med og har samme varighed, som der blev observeret i de kliniske studier.
English: Upper respiratory tract infection
Danish: Almindelig Infektion i de øvre luftveje
English: Hospitalization and ED visits due to RVGE
Danish: Hospitalsindlæggelse og skadestuebesøg pga. RVgastroenteritis
English: No further doses are recommended after completion of the 3-dose vaccination course (see sections 4.4 and 5.1 regarding available information on persistence of protection).
Danish: Yderligere doser efter gennemførelsen af vaccinationsforløbet på tre doser anbefales ikke (se pkt.
English: b. Tabulated summary of adverse reactions
Danish: b. Tabeloversigt over bivirkninger
English: No increased risk of Kawasaki disease was observed among infants receiving RotaTeq in a large postmarketing observational safety surveillance study (see section 5.1).
Danish: I et stort observationsstudie til overvågning af sikkerhed efter markedsføring blev der ikke observeret øget risiko for Kawasakis sygdom hos spædbørn, der fik RotaTeq (se pkt.
English: Very common Diarrhoea, vomiting
Danish: Diarré, opkastning
English: Keep this vaccine out of the sight and reach of children.
Danish: Opbevar denne vaccine utilgængeligt for børn.
English: The vaccine will be given by gently squeezing the tube and delivering the vaccine into your child's mouth.
Danish: Vaccinen vil blive givet ved at trykke forsigtigt på tuben og indgive vaccinen i barnets mund.Vaccinen kan gives uden hensyntagen til indtagelse af føde, væske eller modermælk.
English: • Rare (may affect up to 1 in 1000 infants): hives
Danish: • Sjælden (kan forekomme hos 1 ud af 1.000 spædbørn): nældefeber.
English: Outpatients due to RVGE
Danish: Hospitalsindlæggelse pga. RVgastroenteritis
English: What RotaTeq contains
Danish: RotaTeq indeholder:
English: • At the request of the European Medicines Agency
Danish: En opdateret RMP skal fremsendes • på anmodning fra Det Europæiske Lægemiddelagentur
English: Remove cap by turning it counterclockwise.
Danish: Tag hætten af ved at dreje den mod uret.
English: For subjects with a predisposition for intussusception, see section 4.3.
Danish: 4.3 vedrørende patienter, der er prædisponeret for invagination.
English: Store in a refrigerator Keep the dosing tube in the outer carton in order to protect from light.
Danish: Doseringstuben opbevares i den ydre pakning for at beskytte mod lys.
English: United States of America
Danish: USA
English: Country:
Danish: Land
English: Subjects with congenital malformation of the gastrointestinal tract that could predispose to intussusception.
Danish: Bør ikke gives til personer med medfødte misdannelser i mavetarmkanalen, da disse misdannelser kan prædisponere for invagination.
English: Intussusception
Danish: Invagination
English: Merck Sharp and Dohme BV
Danish: Merck Sharp & Dohme B.V.
English: Oral solution
Danish: Oral opløsning.
English: - If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: not less than 2.0 x 10 6 IU
Danish: mindst 2,0 x 10 6 IE
English: How to use RotaTeq.
Danish: Sådan får dit barn RotaTeq.
English: not less than 2.8 x 10 6 IU
Danish: mindst 2,8 x 10 6 IE
English: It might be necessary to postpone the vaccination until recovery.
Danish: Hvis dit barn har diarré eller kaster op.Det kan være nødvendigt at udsætte vaccinationen, indtil barnet er raskt.
English: Very common Pyrexia
Danish: Pyreksi
English: not less than 2.2 x 10 6 IU
Danish: mindst 2,2 x 10 6 IE
English: not less than 2.3 x 10 6 IU
Danish: mindst 2,3 x 10 6 IE
English: How to use RotaTeq
Danish: Sådan får dit barn RotaTeq
English: - has any disorder of the gastrointestinal system.
Danish: har en sygdom i mavetarmkanalen.
English: Previous history of intussusception.
Danish: Invagination i anamnesen.
English: Weight loss was more pronounced in women than in men.
Danish: Vægttabet var mere udtalt hos kvinder end hos mænd.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Saxenda on 23 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Saxenda den 23. marts 2003.
English: The doctor should re-assess the need of continuing treatment once a year.
Danish: Lægen bør en gang om året tage fornyet stilling til fortsættelse af behandlingen.
English: This is a summary of the European public assessment report (EPAR) for Saxenda.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Saxenda.
English: Saxenda is injected once per day, preferably at the same time every day.
Danish: Saxenda injiceres én gang dagligt, fortrinsvis på samme klokkeslæt hver dag.
English: Saxenda liraglutide
Danish: Saxenda liraglutid
English: The full EPAR and risk management plan summary for Saxenda can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Saxenda findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The starting dose is 0.6 mg per day.
Danish: Startdosis er 0,6 mg dagligt.
English: A risk management plan has been developed to ensure that Saxenda is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Saxenda anvendes så sikkert som muligt.
English: Other information about Saxenda
Danish: Andre oplysninger om Saxenda
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Saxenda's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Saxenda opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Patients in the studies were given the medicine as part of a weight loss programme involving counselling and advice on diet and exercise.
Danish: Patienterne i undersøgelserne fik lægemidlet som en del af et vægttabsprogram, der også omfattede rådgivning om diæt og motion.
English: Saxenda contains the active substance liraglutide.
Danish: Saxenda indeholder det aktive stof liraglutid.
English: What is Saxenda and what is it used for?
Danish: Hvad er Saxenda, og hvad anvendes det til?
English: The dose is then increased each week by 0.6 mg to a maximum of 3.0 mg per day.
Danish: Derefter sættes dosis hver uge op med 0,6 mg til højst 3,0 mg dagligt.
English: • who are overweight (have a BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep).
Danish: • som er overvægtige (BMI mellem 27 og 30) og har vægtrelaterede komplikationer såsom sukkersyge, abnormt højt fedtindhold i blodet, for højt blodtryk eller hyppige åndedrætsophold under søvnen (søvnapnø).
English: Saxenda is a medicine used along with diet and exercise to help manage weight in adults:
Danish: Saxenda er et lægemiddel, der sammen med diæt og motion anvendes til vægtkontrol hos voksne:
English: It is given as an injection under the skin in the thigh, upper arm or abdomen (belly).
Danish: Det gives som en indsprøjtning under huden i låret, overarmen eller maveskindet.
English: What measures are being taken to ensure the safe and effective use of Saxenda?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Saxenda?
English: The exact way that Saxenda works in weight loss is not fully understood, but it appears to act on the parts of the brain that regulate appetite, by attaching to GLP-1 receptors in brain cells and thereby increasing feelings of fullness and lowering feelings of hunger.
Danish: Man ved ikke nøjagtigt, hvordan Saxenda bevirker vægttab, men det ser ud til, at det virker på de dele af hjernen, der regulerer appetitten, ved at bindes til GLP-1-receptorerne i hjernecellerne og derved øge mæthedsfornemmelsen og nedsætte sultfornemmelsen.
English: Looking at the results of the 5 studies together, Saxenda at a daily dose of 3 mg led to a 7.5% reduction in body weight, compared with a 2.3% reduction in patients taking placebo.
Danish: Hvis man ser på resultaterne af de fem undersøgelser under ét, medførte Saxenda i en daglig dosis på 3 mg et fald af legemsvægten på 7,5 procent, sammenholdt med et fald på 2,3 procent hos de patienter, der fik placebo.
English: Why is Saxenda approved?
Danish: Hvorfor er Saxenda blevet godkendt?
English: BMI is a measurement that indicates body weight relative to height.
Danish: BMI er et mål for forholdet mellem legemsvægt og højde.
English: Treatment with Saxenda should be stopped if patients have not lost at least 5% of their initial body weight after 12 weeks of treatment with 3 mg of Saxenda per day.
Danish: Behandlingen med Saxenda bør ophøre, hvis patienten ikke har tabt mindst 5 % af sin oprindelige legemsvægt efter 12 ugers behandling med 3 mg Saxenda dagligt.
English: • who are obese (have a body-mass index - BMI - of 30 or more);
Danish: • som er svært overvægtige (legemsmasseindeks - BMI - 30 eller derover),
English: The CHMP considered that Saxenda has a modest (particularly in men) but still clinically relevant effect on weight loss.
Danish: CHMP fandt, at vægttabet med Saxenda er beskedent (navnlig hos mænd), men dog klinisk relevant.
English: It is not intended to provide practical advice on how to use Saxenda.
Danish: Det er ikke en praktisk vejledning i, hvordan Saxenda bør anvendes.
English: The most common side effects with Saxenda (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, diarrhoea and constipation.
Danish: De hyppigste bivirkninger ved Saxenda (som optræder hos mere end 1 ud af 10 personer) er kvalme, opkastning, diarré og hovedpine.