natgillin/translations-raw huggingface dataset:
Nedsat kaliumindhold i blodet, angst, besvimelse, snurrende, prikkende og stikkende fornemmelse (paræstesi), følelse af at dreje rundt (svimmelhed), hjertebanken (takykardi), forstyrret hjerterytme, lavt blodtryk, et pludseligt fald i blodtrykket, når du rejser dig op, stakåndethed (dyspnø), diaré, mundtørhed, luftafgang fra tarmen, rygsmerter, muskeltrækninger, muskelsmerter, erektil dysfunktion (manglende evne til at få eller opretholde erektion), brystsmerter, forhøjet urinsyreindhold i blodet.
Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased blood uric acid levels.
- Medicin til behandling af diabetes (insulin eller orale lægemidler såsom metformin) - Colestyramin og colestipol, medicin til at sænke blodets fedtindhold.
- Cholestyramine and colestipol, medicines for lowering blood fat levels.
Lungebetændelse (bronkitis), provokation eller forværring af systemisk lupus erythematosus (en sygdom, hvor kroppens immunsystem angriber kroppen, hvilket forårsager ledsmerter, hududslæt og feber); ondt i halsen, bihulebetændelse, tristhed (depression), besvær med at falde i søvn (insomni), forringet syn, besvær med at trække vejret, mavesmerter, forstoppelse, oppustethed (dyspepsi), utilpashed (opkastning), mavekatar, unormal leverfunktion (japanske patienter har større sandsynlighed for at få denne bivirkning), rødme af huden, allergiske reaktioner såsom kløe eller udslæt, øget svedproduktion, nældefeber (urticaria), ledsmerter (artralgi) og smerter i arme og ben, muskelkramper, influenzalignende symptomer, smerter.
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Stort forbrug af hydrochlorthiazid (≥ 50.000 mg kumulativt) var forbundet med en justeret OR-værdi på 1,29 (95 %-KI: 1,23-1,35) for basalcellekarcinom og på 3,98 (95 %-KI: 3,68-4,31) for pladecellekarcinom.
High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.23
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Island
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland
Actelsar HCT 80 mg/12,5 mg tabletter Én tablet indeholder 80 mg telmisartan og 12,5 mg hydrochlorthiazid.
Actelsar HCT 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Actelsar HCT 80 mg/12,5 mg tabletter er hvide eller næsten hvide, 9,0 x 17,0 mm kapselformede tabletter mærket med “TH 12.5” på begge sider.
Actelsar HCT 80 mg/12.5 mg tablets are white or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides.
Somnolens Luftveje, thorax og mediastinum Ikke almindelig:
Respiratory, thoracic and mediastinal disorders Uncommon:
Knogler, led, muskler og bindevæv Ikke kendt:
Musculoskeletal, connective tissue and bone disorders Not known:
Hypokaliæmi kan ved samtidig brug af digitalisglykosider eller visse antiarytmika resultere i muskelkramper og/eller accentueret arytmi.
Hypokalaemia may result in muscle spasms and/or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Actelsar HCT 40 mg/12,5 mg tabletter
Actelsar HCT 40 mg/12.5 mg tablets
Det kan være andre vanddrivende tabletter (diuretika), afføringsmidler (f.eks. amerikansk olie), kortikosteroider (f.eks.prednison), ACTH (et hormon), amphotericin (mod svampeinfektion), carbenoxolen (til at behandle mundsår), benzylpenicillin (et antibiotikum) og salicylsyre og hermed beslægtede stoffer.
- Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, (“water tablets”), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
Reykjavíkurvegur 78, 220 Hafnarfjörður, Island
Reykjavíkurvegur 78, 220 Hafnarfjörður, Iceland
Pankreatit, gastrointestinalt ubehag
Pancreatitis, stomach discomfort
Sepsis* (ofte kaldet "blodforgiftning"), en alvorlig infektion med betændelsesreaktion i hele kroppen, hurtig hævelse af hud og slimhinder (angioødem), blærer og afskalning af det øverste lag af huden (toksisk epidermal nekrolyse).
Sepsis* (often called “blood poisoning”), is a severe infection with whole-body inflammatory response, rapid swelling of the skin and mucosa (angioedema); blistering and peeling of the top layer of skin (toxic epidermal necrolysis) these side effects are rare (may affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) but are extremely serious and patients should stop taking the medicine and see their doctor immediately.
28 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter
28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
14 tabletter 28 tabletter 30 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter
14 tablets 28 tablets 30 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Der er dog kun rapporteret om minimal eller ingen påvirkning ved den mængde thiazid (12,5 mg), som findes i Actelsar HCT.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Actelsar HCT, minimal or no effects were reported.
Der er ikke blevet udført andre prækliniske forsøg med fastdosiskombinationsproduktet 80 mg/25 mg. I tidligere prækliniske sikkerhedsforsøg med samtidig indgift af telmisartan og hydrochlorthiazid i normotensive rotter og hunde i doser, der gav en eksponering sammenlignelig med den i det kliniskterapeutiske område, fandt man ikke andre resultater end dem, der allerede var set ved indgift af de to stoffer hver for sig.
Previous preclinical safety studies performed with co-administration of telmisartan and hydrochlorothiazide in normotensive rats and dogs, in doses producing exposure comparable to that in the clinical therapeutic range, caused no additional findings not already observed with administration of either substance alone.
14 tabletter 28 tabletter 56 tabletter 84 tabletter 90 tabletter 98 tabletter
14 tablets 28 tablets 56 tablets 84 tablets 90 tablets 98 tablets
Bivirkninger med ukendt hyppighed (hyppigheden kan ikke bestemmes ud fra de kendte data) Betændelse i en spytkirtel, hud- og læbekræft (non-melanom hudkræft), lavt (eller endda manglende) indhold af røde og hvide blodlegemer, alvorlig allergisk reaktion (f.eks. overfølsomhed, anafylaktisk reaktion), appetitløshed, rastløshed, svimmelhed, sløret eller gulligt syn, synsnedsættelse og øjensmerter (mulige tegn på akut nærsynethed eller akut snævervinklet glaukom), betændelse i blodkarrene (nekrotiserende vaskulit), betændt bugspytkirtel, maveproblemer, gul i huden eller øjnene (gulsot), lupus-lignende symptomer (bivirkninger, som ligner en sygdom kaldet systemisk lupus erythematosus, hvor kroppens immunsystem angriber kroppen), hudsygdomme som f.eks. betændte blodkar i huden, øget følsomhed for sollys, udslæt, hudrødme, blærer på læber, øjne eller mund, afskalning af hud, feber (mulige tegn på erythema multiforme), svaghed, nyrebetændelse eller nedsat nyrefunktion, sukker i urinen (glykosuri), feber, forstyrrelse i elektrolytbalancen, højt indhold af kolesterol i blodet, nedsat blodvolumen, forhøjet sukkerindhold i blodet, usikkerhed med at kontrollere sukkerindholdet i blod/urin hos patienter med diabetes mellitus eller forhøjet fedtindhold i blodet.
Side effects of unknown frequency (frequency cannot be estimated from the available data) Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling , fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus,or fat in the blood.
Rygsmerter, muskelspasmer, myalgi
Back pain, muscle spasms, myalgia
Al/PVC/PVDC blister: 14, 28, 56, 84, 90 og 98 tabletter Tabletbeholder: 30, 90 og 250 tabletter
Al/PVC/PVDC blister: 14, 28, 56, 84, 90 and 98 tablets Tablet container: 30, 90 and 250 tablets
Én tablet indeholder 80 mg telmisartan og 25 mg hydrochlorthiazid.
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Lægemidler, som kan øge kaliumniveauet eller udløse hyperkaliæmi (fx ACE-hæmmere, kaliumbesparende diuretika, kaliumtilskud, saltsubstituter, der indeholder kalium, ciclosporin eller andre lægemidler, fx heparin-natrium).
ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium).
Actelsar HCT 80 mg/25 mg tabletter telmisartan/hydrochlorothiazid
Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Actelsar HCT 40 mg/12,5 mg tabletter telmisartan/hydrochlorothiazid
Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Thiazider får urinmængden til at stige, og det fører til, at blodtrykket falder.
- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure.
Den totale forekomst og mønstret for bivirkninger ved brug af telmisartan/hydrochlorothiazid 80 mg/25 mg var sammenlignelig med telmisartan/hydrochlorothiazid 80 mg/12,5 mg.
The overall incidence and pattern of adverse reactions reported with telmisartan/hydrochlorothiazide 80 mg/25 mg was comparable with telmisartan/hydrochlorothiazide 80 mg/12.5 mg. A doserelationship of adverse reaction was not established and they showed no correlation with gender, age or race of the patients.
Når Actelsar HCT anvendes sammen med lægemidler, hvis effekt påvirkes af serumkaliumforstyrrelser (såsom digitalisglykosider, antiarytmika), bør serumkalium og ekg monitoreres.
Periodic monitoring of serum potassium and ECG is recommended when Actelsar HCT is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Indlægsseddel: Information til brugeren Actelsar HCT 80 mg/25 mg tabletter telmisartan/hydrochlorothiazid
Package leaflet: Information for the user Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Indlægsseddel: Information til brugeren Actelsar HCT 40 mg/12,5 mg tabletter telmisartan/hydrochlorothiazid
Package leaflet: Information for the user Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Actelsar HCT 80 mg/12,5 mg tabletter telmisartan/hydrochlorothiazid
Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Hos patienter med nedsat nyrefunktion kan thiazid medføre azotæmi.
Thiazide diuretic associated azotaemia may occur in patients with impaired renal function.
Din læge vil anbefale en anden type medicin i stedet for Actelsar HCT.
You should consult with your doctor if you need to adjust the dose of your other medicine while taking Actelsar HCT.
Én tablet indeholder 40 mg telmisartan og 12,5 mg hydrochlorthiazid.
Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) sammenlignede virkningen af telmisartan, ramipril og kombinationen af telmisartan og ramipril på kardiovaskulære hændelser hos 25.620 patienter.
ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25,620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Mht. det prædefinerede sekundære endepunkt (reduktion af kardiovaskulær død, ikke-letalt myokardieinfarkt og ikke-letal apopleksi) - som var identisk med det primære endepunkt i HOPEstudiet (The Heart Outcomes Prevention Evaluation Study) - blev telmisartan fundet ligeværdigt med ramipril [0,99 (97,5 % CI 0,90-1,08; p (non-inferioritet) = 0,0004)].
Telmisartan was found to be similarly effective to ramipril in the pre-specified secondary endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.99 (97.5% CI 0.90-1.08), p (non-inferiority) =0.0004], the primary endpoint in the reference study HOPE (The Heart Outcomes Prevention Evaluation Study), which had investigated the effect of ramipril vs. placebo.
Indlægsseddel: Information til brugeren Actelsar HCT 80 mg/12,5 mg tabletter telmisartan/hydrochlorothiazid
Package leaflet: Information for the user Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Hvis du glemmer at tage medicinen, skal du tage den straks du kommer i tanke om det, og derefter fortsætte som du plejer.
Take it as soon as you remember, then carry on as before.
Vaskulære sygdomme
Infections and infestations
Sepsis inklusive sepsis med letalt udfald3
Sepsis including fatal outcome3 Blood and lymphatic system disorders Uncommon:
EU/1/13/817/045 EU/1/13/817/029 EU/1/13/817/046 EU/1/13/817/030 EU/1/13/817/031
EU/1/13/817/045 EU/1/13/817/029 EU/1/13/817/046 EU/1/13/817/030 EU/1/13/817/031 EU/1/13/817/032 EU/1/13/817/033
Knogler, led, muskler og bindevæv Ikke almindelig:
Musculoskeletal, connective tissue and bone disorders Uncommon:
EU/1/13/817/002 EU/1/13/817/003 EU/1/13/817/004 EU/1/13/817/005 EU/1/13/817/006 EU/1/13/817/007 EU/1/13/817/008 EU/1/13/817/009 EU/1/13/817/010 EU/1/13/817/011 EU/1/13/817/012 EU/1/13/817/013
EU/1/13/817/006 EU/1/13/817/007 EU/1/13/817/008 EU/1/13/817/009 EU/1/13/817/010 EU/1/13/817/011 EU/1/13/817/012 EU/1/13/817/013
Metabolisme og ernæring Almindelig:
Diabetes mellitus inadequate control Metabolism and nutrition disorders Common:
Samtidig behandling med angiotensin II-receptorantagonister og stoffer, der hæmmer cyklooxygenasen, kan medføre en yderligere svækkelse hos nogle patienter, der allerede har nedsat nyrefunktion (dehydrering, alder).
In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Det skal du vide, før du begynder at tage Actelsar HCT Sådan skal du tage Actelsar HCT Bivirkninger
What Actelsar HCT is and what it is used for What you need to know before you take Actelsar HCT How to take Actelsar HCT
Almene symptomer og reaktioner på administrationsstedet Ikke kendt:
Infections and infestations Not known:
Al/al blisterpakker: 14, 28, 30, 56, 84, 90 og 98 tabletter Al/PVC/PVDC blisterpakker: 14, 28, 56, 84, 90 and 98 tabletter Tabletbeholdere: 30, 90 og 250 tabletter
Al/Al blister packs: 14, 30, 28, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister packs: 14, 28, 56, 84, 90 and 98 tablets Tablet containers: 30, 90 and 250 tablets
Infektioner og parasitære sygdomme Sjælden:
Hepatobiliary disorders Rare:
AL/al blisterpakker: 14, 28, 30, 56, 84, 90 og 98 tabletter Al/PVC/PVDC blisterpakker: 28, 56, 84, 90 and 98 tabletter Tabletbeholdere: 30, 90 og 250 tabletter
Al/Al blister packs: 14, 28, 30, 56, 84, 90 and 98 tablets Al/PVC/PVDC blister packs: 28, 56, 84, 90 and 98 tablets Tablet containers: 30, 90 and 250 tablets
Hud og subkutane væv Ikke kendt:
Jaundice hepatocellular, jaundice cholestatic Skin and subcutaneous tissue disorders Not known:
Metabolisme og ernæring Ikke almindelig:
Hypersensitivity, anaphylactic reactions Metabolism and nutrition disorders Uncommon:
Hvide eller næsten hvide, 9,0 x 17,0 mm kapselformede tabletter mærket med “TH 12.5” på begge sider.
Actelsar HCT 80 mg/12.5 mg tablets White or almost white, 9.0 x 17.0 mm capsule-shaped tablets marked with “TH 12.5” on both sides.
Aflunov fik en markedsføringstilladelse med gyldighed i hele EU den 29. november 2010.
Aflunov received a marketing authorisation valid throughout the EU on 29 November 2010.
Yderligere oplysninger om Aflunov findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/aflunov.
Further information on Aflunov can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aflunov.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Aflunov?
What measures are being taken to ensure the safe and effective use of Aflunov?
Denne vaccine indeholder visse dele af H5N1-virusset.
This vaccine contains some parts of the H5N1 virus.
Aflunov fås kun på recept og bør anvendes i henhold til de officielle anbefalinger.
Aflunov can only be obtained with a prescription and should be used according to official recommendations
I tilfælde af en pandemi kan det dog være hensigtsmæssigt at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed.
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Som for alle lægemidler bliver data vedrørende brugen af Aflunov løbende overvåget.
As for all medicines, data on the use of Aflunov are continuously monitored.
Andre oplysninger om Aflunov
Other information about Aflunov
Hvorfor er Aflunov godkendt i EU?
Why is Aflunov authorised in the EU?
Hvad er Aflunov, og hvad anvendes det til?
What is Aflunov and what is it used for?
Hvis personen senere kommer i kontakt med virusset, vil disse antistoffer sammen med andre komponenter i immunsystemet være i stand til at dræbe virusset og hjælpe med at beskytte mod sygdommen.
When the person comes into contact with the virus, these antibodies, together with other components of the immune system, will be able to kill the virus and help protect against the disease.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Aflunov opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Aflunov's benefits are greater than its risks and it can be authorised for use in the EU.
I det andet studie, som omfattede 240 personer, fik deltagerne Aflunov under anvendelse af forskellige vaccinationsforløb.
In the second study involving 240 people, subjects were given Aflunov using different vaccination schedules.
En oversigt over Aflunov, og hvorfor det er godkendt i EU
An overview of Aflunov and why it is authorised in the EU
Aflunov (zoonotisk influenzavaccine [H5N1] [overfladeantigen, inaktiveret, adjuveret])
Aflunov (zoonotic influenza vaccine [H5N1] [surface antigen, inactivated, adjuvanted])
Aflunov bør ikke gives til patienter, der har haft en anafylaktisk reaktion (alvorlig allergisk reaktion) på nogen af vaccinens komponenter, herunder de komponenter i vaccinen, der indgår som sporstoffer (dvs. i meget små mængder), såsom ægge- eller kyllingeprotein, ovalbumin (et protein i æggehvide), kanamycin- og neomycinsulfat (antibiotika), bariumsulfat, formaldehyd og cetyltrimethylammoniumbromid.
Aflunov should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low) levels (egg or chicken protein, ovalbumin [a protein in egg white], kanamycin or neomycin sulphate [antibiotics], barium sulphate, formaldehyde and cetyltrimethylammonium bromide).
De indberettede bivirkninger ved Aflunov vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Aflunov are carefully evaluated and any necessary action taken to protect patients.
Studiet fastslog, at Aflunov skulle gives som to doser med mindst tre ugers mellemrum.
This study established that Aflunov should be given as two doses at least three weeks apart.
I tilfælde af en officielt anerkendt pandemi, der skyldes H5N1-stammen af influenza A, må personer, der allerede er blevet vaccineret med Aflunov (med en eller to doser), kun få én dosis mere i stedet for de to doser, der anbefales til ikke-vaccinerede personer.
In the event of an officially declared pandemic caused by the H5N1 strain of the influenza A, people who have already been vaccinated with Aflunov (with one or two doses) may be given only one more dose, instead of the two doses recommended for unvaccinated people.
Aflunov indeholder dele af influenzavira, som er blevet inaktiveret.
Aflunov contains parts of influenza (flu) viruses that have been inactivated.
I studierne så man nærmere på vaccinens evne til at udløse dannelse af antistoffer ("immunogenicitet") mod influenzavirussen.
The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against the flu virus.
I et af studierne, som omfattede 3.372 personer, fik deltagerne enten vaccine mod sæsoninfluenza efterfulgt af to doser Aflunov med tre ugers mellemrum eller placebo (en virkningsløs vaccine) efterfulgt af to doser af en adjuveret vaccine mod sæsoninfluenza med tre ugers mellemrum.
In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Aflunov three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Aflunov er en vaccinetype, som gives før eller under en influenzapandemi til at beskytte mod en ny influenzastamme.
Aflunov is a type of vaccine to be given before or during a flu pandemic to protect against a new strain of flu.
Hvilke risici er der forbundet med Aflunov?
What are the risks associated with Aflunov?
De hyppigste bivirkninger ved Aflunov (som kan forekomme hos mere end 1 ud af 10 patienter) er hovedpine, muskelsmerter (myalgi), reaktioner på injektionsstedet (hævelse, smerte, hårdhed og rødme) samt træthed.
The most common side effects with Aflunov (which may affect more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).