FrancophonIA/ELRC3.0 huggingface dataset:
English: Prevenar 13 suspension for injection Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Danish: Prevenar 13 injektionsvæske, suspension Konjugeret pneumokok polysaccharidvaccine (13-valent, adsorberet)
English: Additional serotypes covered by Prevenar 13
Danish: Yderligere serotyper, som Prevenar 13 beskytter imod
English: Adults 50-59 years not previously vaccinated with 23-valent pneumococcal polysaccharide vaccine
Danish: Voksne 50-59 år, som ikke tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine Voksne 60-64 år, som ikke tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine
English: Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197.
Danish: Prevenar 13 vaccinationsplan for spædbørn og børn, som tidligere blev vaccineret med Prevenar (7valent) (Streptococcus pneumoniae-serotyperne 4, 6B, 9V, 14, 18C, 19F og 23F)
English: For the most recent epidemiological information in your country you should consult with the relevant national organisation.
Danish: Ret henvendelse til Statens Serum Institut for at få de seneste, epidemiologiske oplysninger.
English: If you have any further questions on the use of Prevenar 13, ask your doctor, pharmacist, or nurse.
Danish: Hvis De vil have yderligere oplysninger om Prevenar 13, skal De henvende Dem til den lokale repræsentant:
English: EU/1/09/590/007 - pack of 1 vial EU/1/09/590/008 - pack of 5 vials EU/1/09/590/009 - pack of 10 vials EU/1/09/590/010 - pack of 25 vials EU/1/09/590/011 - pack of 50 vials
Danish: EU/1/09/590/007 - pakning med 1 hætteglas EU/1/09/590/008 - pakning med 5 hætteglas EU/1/09/590/009 - pakning med 10 hætteglas EU/1/09/590/010 - pakning med 25 hætteglas EU/1/09/590/011 - pakning med 50 hætteglas
English: Nervous system disorders: Uncommon:
Danish: Nervesystemet: Ikke almindelig:
English: In a head-to-head, comparative trial conducted in adults aged 60-64 years, subjects received a single dose of either Prevenar 13 or 23-valent pneumococcal polysaccharide vaccine.
Danish: Voksne, der ikke tidligere er vaccineret med 23-valent pneumokok polysaccharidvaccine I et head-to-head sammenligningsforsøg, foretaget blandt voksne i alderen 60-64 år, fik forsøgspersoner en enkeltdosis af enten Prevenar 13 eller 23-valent pneumokok polysaccharidvaccine.
English: Studies in unvaccinated children (12 -23 months) with Prevenar (7-valent) demonstrated that 2 doses were required to achieve serum IgG concentrations for 6B and 23F similar to those induced by a 3-dose infant series.
Danish: viste, at 2 doser er nødvendigt for at opnå serum-IgG-koncentrationer for 6B og 23F, der er sammenlignelige med de serumkoncentrationer, der opnås med en 3-dosis børneserie.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to diphtheria toxoid.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Pneumococcal polysaccharide serotype 1
Danish: Pneumokok polysaccharid serotype 1
English: Prevenar 13 suspension for injection in single dose vial Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Danish: Prevenar 13 injektionsvæske, suspension, i enkeltdosis-hætteglas Konjugeret pneumokok polysaccharidvaccine (13-valent, adsorberet)
English: The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown.
Danish: Immunresponset for serotype 3 efter boosterdosen var ikke øget over de niveauer, som sås efter børnevaccinationsserierne.
English: Pneumococcal polysaccharide serotype 14
Danish: Pneumokok polysaccharid serotype 14
English: Prevenar 13 suspension for injection in multidose container Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
Danish: Prevenar 13 injektionsvæske, suspension, i flerdosisbeholder Konjugeret pneumokok polysaccharidvaccine (13-valent, adsorberet)
English: For children 1 to 5 years of age previously vaccinated with Prevenar, your doctor or nurse will recommend how many injections of Prevenar 13 are required.
Danish: Lægen eller sygeplejersken vil afgøre, hvor mange indsprøjtninger med Prevenar 13, der er nødvendige til børn fra 1 til 5 år, som tidligere er vaccineret med Prevenar.
English: Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:
Danish: Ikke almindelige bivirkninger (disse kan forekomme ved op til 1 ud af 100 vaccinationer):
English: Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:
Danish: Almindelige bivirkninger (forekommer ved op til 1 ud af 10 doser af vaccinen):
English: 18 to 381
Danish: 18C 1.939
English: Prevenar 13 suspension for injection in single dose vial IM
Danish: Prevenar 13 injektionsvæske, suspension, i enkeltdosis-hætteglas i.m.
English: Pneumococcal polysaccharide serotype 5
Danish: Pneumokok polysaccharid serotype 5
English: Pneumococcal polysaccharide serotype 3
Danish: Pneumokok polysaccharid serotype 3
English: Headaches
Danish: Udslæt
English: Pneumococcal polysaccharide serotype 4
Danish: Pneumokok polysaccharid serotype 4
English: Immune responses in preterm and term infants were compared using the proportion of subjects achieving a pneumococcal polysaccharide IgG binding antibody concentration ≥0.35 μg/mL 1 month after the infant series, the approach used for immunogenicity comparisons of Prevenar 13 to Prevenar based on WHO guidelines.
Danish: Immunreaktionen hos for tidligt fødte spædbørn og spædbørn født til terminen blev sammenlignet ved brug af den andel af forsøgspersoner, som opnåede en polysaccharid-pneumokok-IgG-bindende antistofkoncentration på ≥ 0,35 μg/ml 1 måned efter spædbørnsserien.
English: interfering with arm movement (severe pain or tenderness at vaccination-site for those 18-39 years of age and severe limitation of arm movements for those 18 to 39 years of age)
Danish: • Kulderystelser, træthed, smerter, rødme, opsvulmet hård infiltration eller ømhed på vaccinationsstedet, som påvirker armens bevægelighed (svær smerte eller ømhed på vaccinationsstedet hos voksne i alderen 18-39 år og svær begrænsning i armens bevægelighed hos voksne i alderen 18-39 år)
English: Suspension for injection
Danish: Fyldte injektionssprøjter
English: Prevenar 13 non-inferiority (lower bound of the 95% CI for the difference in percentage of responders at 0.35 µg/ml between groups was >-10%) was demonstrated for all 7 common serotypes, except for serotype 6B in study 006 and serotypes 6B and 9V in study 004, which missed by a small margin.
Danish: Undtagelsen er serotype 6B i studie 006 og serotype 6B og 9V i studie 004, hvor noninferioritet med en lille margin ikke blev opnået.
English: • Decreased appetite; headaches; diarrhoea; vomiting (for those 18 to 49 years of age) • Chills; tiredness; rash; pain, redness, swelling hardness or tenderness at the vaccination-site,
Danish: • Nedsat appetit, hovedpine, diarré, opkastning (hos voksne i alderen 18-49 år)
English: However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown (see section 5.1).
Danish: Den kliniske relevans af denne observation med hensyn til den beskyttende virkning kendes ikke (se pkt.
English: 5 to 45
Danish: A 85
English: 9V
Danish: 19F
English: Multidose containers:
Danish: Oversigt over indlægssedlen:
English: This is a summary of the European public assessment report (EPAR) for Humalog.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Humalog.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Humalog on 30 April 1996.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Humalog den 30. april 1996.
English: The full EPAR for Humalog can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Humalog findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Humalog Mix is a mixture of these two formulations.
Danish: Humalog Mix er en blanding af disse to former.
English: A risk management plan has been developed to ensure that Humalog is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Humalog anvendes så sikkert som muligt.
English: Humalog and Humalog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Danish: Humalog og Humalog Mix gives normalt umiddelbart inden et måltid, men kan gives umiddelbart efter et måltid, hvis det er nødvendigt.
English: Other information about Humalog
Danish: Andre oplysninger om Humalog
English: What measures are being taken to ensure the safe and effective use of Humalog?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Humalog?
English: Studies also looked at the use of Humalog in 542 patients aged between two and 19 years, and the use of Humalog in combination with sulphonylureas.
Danish: I undersøgelserne så man også nærmere på anvendelsen af Humalog hos 542 patienter mellem to og 19 år og på anvendelsen af Humalog i kombination med sulfonylurinstoffer.
English: For more information about treatment with Humalog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Humalog, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • Humalog Basal: insulin lispro protamine suspension;
Danish: • Humalog Basal: insulin lispro protamin-suspension
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Humalog.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Humalog skal anvendes.
English: Humalog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Danish: Humalog blev oprindelig undersøgt i otte kliniske undersøgelser, der omfattede 2 951 patienter med type 1-diabetes (hvor kroppen ikke kan producere insulin) eller type 2-diabetes (hvor kroppen ikke kan udnytte insulinet effektivt).
English: Humalog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Danish: Det kan være nødvendigt at justere dosis af Humalog, når det gives sammen med andre lægemidler, der kan indvirke på blodglukoseniveauet.
English: • Humalog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Danish: • Humalog: insulin lispro-opløsning, der fås i en standardstyrke eller en højere styrke (100 eller 200 enheder/ml)
English: What is the risk associated with Humalog?
Danish: Hvilken risiko er der forbundet med Humalog?
English: The Committee recommended that Humalog be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Humalog.
English: In addition, the company that makes Humalog has provided information to patients and healthcare professionals to remind them that there are two strengths of Humalog and to advise them on how to use them safely to avoid medication errors.
Danish: Derudover har den virksomhed, der fremstiller Humalog, indsendt oplysninger til patienter og sundspersonale med påmindelse om, at der findes to styrker af Humalog, og med rådgivning om, hvordan disse anvendes sikkert, så medicineringsfejl undgås.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Humalog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Humalog er større end risiciene ved behandling af patienter med diabetes mellitus, som har behov for insulin til opretholdelse af normal glukosehomøostase og til initial stabilisering af diabetes mellitus.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Humalog, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Humalog, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The active substance in Humalog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Danish: Det aktive stof i Humalog, insulin lispro, fremstilles via en metode, der er kendt som "rekombinant dna-teknologi": Det fremstilles af bakterier, der har fået indsat et gen (DNA), som sætter dem i stand til at producere insulin lispro.
English: Humalog may cause hypoglycaemia (low blood glucose levels) and must not be given to patients whose blood glucose is already low.
Danish: Humalog kan medføre hypoglykæmi (for lavt blodglukoseniveau) og må ikke gives til patienter, hvis blodglukoseniveau i forvejen er lavt.
English: Humalog Mix, Humalog Basal and Humalog 200 units/ml should never be given into a vein.
Danish: Humalog Mix, Humalog Basal og Humalog, 200 enheder/ml, må aldrig gives i en vene.
English: For the full list of all side effects and restrictions with Humalog, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Humalog fremgår af indlægssedlen.
English: Humalog is a replacement insulin which is very similar to the insulin made by the body.
Danish: Humalog er en insulinerstatning, der næsten er identisk med det insulin, der produceres af kroppen.
English: Why has Humalog been approved?
Danish: Hvorfor blev Humalog godkendt?
English: Humalog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Danish: Humalog, 100 enheder/ml, kan også gives ved kontinuerlig infusion ved hjælp af en insulinpumpe eller i en vene.
English: Humalog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Danish: Humalog kan anvendes sammen med en længerevirkende insulin eller med sulfonylurinstoffer (en gruppe diabeteslægemidler, som indtages gennem munden).
English: Insulin lispro is available as Humalog in the soluble form, which acts more or less immediately after injection, and as Humalog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Danish: Insulin lispro fås som Humalog i en opløselig form, som mere eller mindre virker umiddelbart efter injektion, og som Humalog Basal i form af en »protaminsuspension«, der optages langsommere og derfor virker længere.
English: Humalog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Danish: Humalog, 200 enheder/ml, må kun gives ved injektion under huden ved hjælp af den KwikPen-anordning, det leveres i.
English: The effectiveness of Humalog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Danish: Virkningen af Humalog blev sammenlignet med virkningen af Humulin R (et opløseligt rekombinant DNA-fremstillet humant insulin), når det blev føjet til langtidsvirkende insuliner givet en eller to gange dagligt.
English: Humalog, Humalog Basal and Humalog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy).
Danish: Humalog, Humalog Basal og Humalog Mix kan gives ved injektion under huden i overarmen, låret, ballerne eller abdomen (maven).
English: The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog Basal), and combinations of both in various proportions (Humalog Mix):
Danish: Humalogserien omfatter hurtigtvirkende insulinopløsninger (Humalog), længerevirkende insulinsuspensioner (Humalog Basal) og kombinationer af disse to i forskellige blandingsforhold (Humalog Mix):
English: Humalog is used to treat patients who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.
Danish: Humalog anvendes til behandling af patienter med diabetes, der har brug for insulin til at regulere deres blodglukose, herunder patienter, hvis diabetes netop er diagnosticeret.
English: What is Humalog?
Danish: Hvad er Humalog?
English: Humalog is a range of solutions and suspensions for injection that contain the active substance insulin lispro and are supplied in vials, cartridges and prefilled pens (Humalog KwikPen).
Danish: Humalog er en serie opløsninger og suspensioner til injektion, som indeholder det aktive stof insulin lispro, og som leveres i hætteglas, cylinderampuller og fyldte penne (Humalog KwikPen).
English: Humalog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.
Danish: Virkningen af Humalog svarede til virkningen af Humulin R med hensyn til reguleringen af diabetes, der blev målt i HbA1c og fastende glukosemængder.
English: What is Humalog used for?
Danish: Hvad anvendes Humalog til?
English: What benefit has Humalog shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Humalog?
English: How has Humalog been studied?
Danish: Hvordan blev Humalog undersøgt?
English: How is Humalog used?
Danish: Hvordan anvendes Humalog?
English: How does Humalog work?
Danish: Hvordan virker Humalog?
English: It is used in children and adolescents from 4 to 18 years of age.
Danish: Lægemidlet anvendes til børn og unge i alderen 4-18 år.
English: Other information about Verkazia
Danish: Andre oplysninger om Verkazia
English: Verkazia ciclosporin
Danish: Ciclosporin
English: This is a summary of the European public assessment report (EPAR) for Verkazia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Verkazia.
English: Verkazia must not be used in patients with active or suspected infections in or around the eye.
Danish: Verkazia må ikke anvendes hos patienter med aktive eller formodede infektioner i og omkring øjet
English: What is Verkazia and what is it used for?
Danish: Hvad er Verkazia, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Verkazia?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Verkazia?
English: It is not intended to provide practical advice on how to use Verkazia.
Danish: Det er ikke en praktisk vejledning i, hvordan Verkazia bør anvendes.
English: Because the number of patients with vernal keratoconjunctivitis is low, the disease is considered ‘rare', and Verkazia was designated an ‘orphan medicine' (a medicine used in rare diseases) on 6 April 2006.
Danish: Da antallet af patienter med vernal keratoconjunctivitis er lavt, betragtes sygdommen som "sjælden", og Verkazia blev udpeget som "lægemiddel til sjældne sygdomme" den 6. april 2006.
English: In a main study involving 169 children and adolescents with severe VKC, 55% of patients treated with Verkazia achieved CFS improvements of 50% or more, without the need of other medications, after 4 months, compared with around 28% of patients receiving a dummy treatment.
Danish: I en hovedundersøgelse af 169 børn og unge med svær VKC opnåede 55 % af de patienter, der fik Verkazia, forbedringer på CFS-skalaen på mindst 50 % efter 4 måneder og uden behov for andre lægemidler sammenholdt med ca. 28 % af de patienter, der fik placebo.
English: The most common side effects with Verkazia are eye pain and itching, which may affect around 1 in 10 people.
Danish: De hyppigste bivirkninger ved Verkazia er øjensmerter og øjenkløe, der kan forekomme hos ca. 1 ud af 10 personer.
English: The European Medicines Agency therefore decided that Verkazia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Verkazia opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: If symptoms persist after the end of the season, Verkazia can continue to be used at the recommended dose until symptoms are under control and at a reduced dose (1 drop twice a day) thereafter.
Danish: Hvis symptomerne fortsætter ud over sæsonen, kan Verkazia fortsat anvendes i den anbefalede dosis, indtil symptomerne er under kontrol, hvorefter dosen nedsættes til 1 dråbe to gange dagligt.
English: What are the risks associated with Verkazia?
Danish: Hvilke risici er der forbundet med Verkazia?
English: Verkazia has been shown to be effective at improving the condition of the cornea and reducing the symptoms of the disease.
Danish: Det er påvist, at Verkazia er effektivt til at forbedre hornhindens tilstand og reducere symptomerne på sygdommen.
English: Verkazia contains the active substance ciclosporin.
Danish: Det indeholder det aktive stof ciclosporin.
English: The active substance in Verkazia, ciclosporin, blocks cells of the immune system (the body's natural defences) that are involved in the processes that cause the allergic reaction and inflammation in patients with VKC.
Danish: Det aktive stof i Verkazia, ciclosporin, blokerer for de celler i immunsystemet (kroppens naturlige forsvarssystem), der indgår i de processer, som forårsager allergiske reaktioner og betændelsestilstande hos patienter med VKC.
English: The recommended dose is 1 drop 4 times a day in each affected eye, during VKC season.
Danish: Den anbefalede dosis er 1 dråbe 4 gange dagligt i hvert øje, så længe VKC-sæsonen varer.
English: The full EPAR for Verkazia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Verkazia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Verkazia approved?
Danish: Hvorfor er Verkazia godkendt?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Verkazia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Verkazia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Verkazia is available as eye drops.
Danish: Verkazia fås som øjendråber.
English: For more information about treatment with Verkazia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Verkazia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Applying it directly to the eye reduces eye inflammation but limits its effects elsewhere in the body.
Danish: Da lægemidlet anvendes direkte i øjet, reduceres betændelsestilstanden, mens der ikke er nogen virkning andre steder i kroppen.