natgillin/translations-raw huggingface dataset:
4.2, 4.4 og 5.2); - akutte tilstande med potentiale til at ændre nyrefunktionen såsom: dehydrering, svær infektion, shock; akut eller kronisk sygdom som kan forårsage vævshypoksi såsom: hjerte- eller respirationssvigt, nyligt overstået myokardieinfarkt, shock; nedsat leverfunktion (se pkt.
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - diabetic ketoacidosis, diabetic pre-coma; - moderate and severe renal impairment (creatinine clearance < 60 ml/min; eGFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
Vitamin B12mangelh,§
Diabetic ketoacidosisk Lactic acidosis Vitamin B12 deficiencyh,
Polyvinylalkohol (E1203) Macrogol 3350 (E1520(iii)) Talcum (E553b) Titandioxid (E171) Gul jernoxid (E172) Rød jernoxid (E172)
− film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
Rygsmerter*
Fungal infection**
Symptomerne omfatter kvalme eller opkastning, mavesmerter, muskelkramper, udtalt træthed eller vejrtrækningsbesvær.
Signs include feeling or being very sick, vomiting, stomach ache, muscular cramps, severe tiredness, or difficulty breathing.
Resultater fra et 24-ugers placebokontrolleret studie med dapagliflozin som tillægsbehandling til metformin og et sulfonylurinstof Tillægskombination Sulfonylurinstof + metformin1
Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placeboc
Baseline (mean) Change from baselinec Difference from placeboc
EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tabletter (multipakning)
EU/1/13/900/006 Xigduo 5 mg/850 mg 196 (2 x 98) tablets (multipack)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 850 mg metforminhydrochlorid.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tabletter (multipakning)
EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
Baseline (gennemsnit) Ændring fra baselinec Forskel fra placeboc
Baseline (mean) Change from Baselinec Difference from Placeboc
”sulfonylurinstof”.
• Lactic acidosis.
4.3, 4.4, 4.8, 5.1 og 5.2).
• Prior to initiation of treatment and at least yearly thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
LÆGEMIDLETS NAVN Xigduo 5 mg/850 mg tabletter dapagliflozin/metformin HCl
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
LÆGEMIDLETS NAVN Xigduo 5 mg/1000 mg tabletter dapagliflozin/metformin HCl
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Brug af anden medicin sammen med Xigduo
How to store Xigduo
EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (enkeltdosis)
EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose)
Øget urinstof i blodet** Vægttab**
Blood urea increased**
EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (enkeltdosis)
EU/1/13/900/005 Xigduo 5 mg/850 mg 60 x 1 tablet (unit dose)
EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tabletter
EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets
Urinvejsinfektio n*, b, d
Nocturia** Renal impairment**,b
LÆGEMIDLETS NAVN Xigduo 5 mg/850 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/850 mg film-coated tablets dapagliflozin/metformin hydrochloride
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin og 1000 mg metforminhydrochlorid.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
LÆGEMIDLETS NAVN Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
NAME OF THE MEDICINAL PRODUCT Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
MARKETING AUTHORISATION HOLDER AstraZeneca AB
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tabletter
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets
EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tabletter
EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets
Xigduo 5 mg/850 mg filmovertrukne tabletter Xigduo 5 mg/1000 mg filmovertrukne tabletter dapagliflozin/metforminhydrochlorid
Package leaflet: Information for the patient Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tabletter
EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets
EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tabletter
EU/1/13/900/004 Xigduo 5 mg/850 mg 60 tablets
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tabletter
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets
EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tabletter
EU/1/13/900/002 Xigduo 5 mg/850 mg 28 tablets
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tabletter
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN AstraZeneca AB
NAME OF THE MARKETING AUTHORISATION HOLDER AstraZeneca AB
Metformin Absorption
Add-on combination
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E) / INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Særnavn/ Navn
Invented name/ Name
Indgivelsesvej Indhold (Koncentration)
Content (concentratio n)
Lægemiddelform
Strength Pharmaceutic al form
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Azilect den 21. februar 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005.
Undersøgelserne varede henholdsvis 26 og 18 uger.
The studies lasted 26 and 18 weeks, respectively.
Azilect rasagilin
Azilect rasagiline
Det fås som tabletter (1 mg).
It is available as tablets (1 mg).
Den fuldstændige EPAR for Azilect findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Azilect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Azilect.
This is a summary of the European public assessment report (EPAR) for Azilect.
Andre oplysninger om Azilect
Other information about Azilect
Den anbefalede dosis Azilect er én tablet én gang dagligt.
The standard dose of Azilect is one tablet once a day.
Azilect var mere effektivt end placebo i alle undersøgelserne.
Azilect was more effective than placebo in all of the studies.
Azilect er et lægemiddel, der indeholder det aktive stof rasagilin.
Azilect is a medicine that contains the active substance rasagiline.
Azilect anvendes til behandling af Parkinsons sygdom.
Azilect is used to treat Parkinson's disease.
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 Azilect skal anvendes.
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 Azilect.
Azilect udleveres kun efter recept.
Azilect can only be obtained with a prescription.
Azilect blev undersøgt i tre hovedundersøgelser, som omfattede i alt 1 563 patienter med Parkinsons sygdom.
Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease.
Et fald i UPDRS-scoren betyder en forbedring af symptomerne, mens en stigning betyder en forværring.
A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Neurotransmittere er kemiske stoffer, som nervecellerne anvender til deres indbyrdes kommunikation.
Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells.
Hvis du ønsker yderligere oplysninger om behandling med Azilect, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Azilect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Den hyppigste bivirkning ved Azilect (som optræder hos flere end 1 ud af 10 patienter) er hovedpine.
The most common side effect with Azilect (seen in more than 1 patient in 10) is headache.
Azilect bør ikke anvendes hos patienter med svær leversygdom.
Azilect must not be used in patients who have severe problems with their liver.
De to andre undersøgelser omfattede i alt 1 159 patienter med sygdommen i senere stadium, hvor Azilect blev givet som tillægsbehandling til den eksisterende behandling, herunder levodopa.
The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa.
Det primære effektmål var ændringen i symptomerne over 26 uger vurderet på en standardskala (UPDRS, Unified Parkinson's Disease Rating Scale).
The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS).
CHMP besluttede, at fordelene ved Azilect opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Azilect.
The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det blev sammenlignet med placebo eller entacapon (et andet lægemiddel, der anvendes ved Parkinsons sygdom).
It was compared with placebo or entacapone (another medicine for Parkinson's disease).
Azilect kan anvendes enten alene eller som en tillægsbehandling til levodopa (et andet lægemiddel, der anvendes ved Parkinsons sygdom) hos patienter, der har "fluktuationer" mod slutningen af perioden mellem levodopa-doserne.
Azilect can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Hvilken risiko er der forbundet med Azilect?
What is the risk associated with Azilect?
Det aktive stof i Azilect, rasagilin, er en "monoaminoxidase-B-hæmmer".
The active substance in Azilect, rasagiline, is a ‘monoamine oxidase-B inhibitor'.
I den undersøgelse, hvor Azilect anvendtes alene, gav 1 mg én gang dagligt i løbet af undersøgelsens 26 ugers varighed et gennemsnitligt fald i UPDRS-scoren på 0,13 points fra startværdien på 24,69.
In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
Det primære effektmål var den tid, patienterne var i "off-tilstand" i løbet af dagen, således som registreret i patientdagbøgerne.
The main measure of effectiveness was the time spent in the ‘off' state during the day, as recorded in patients' diaries.
Efter ophør af behandlingen med Azilect skal der gå mindst 14 dage før påbegyndelse af behandling med en anden monoaminoxidasehæmmer eller petidin.
There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Det må heller ikke anvendes sammen med petidin (et smertestillende middel).
It must also not be used with pethidine (a painkiller).
Den fuldstændige liste over alle de indberettede bivirkninger ved Azilect fremgår af indlægssedlen.
For the full list of all side effects reported with Azilect, see the package leaflet.
I den første undersøgelse blev virkningerne af to forskellige doser af Azilect anvendt alene sammenlignet med virkningerne af placebo (en virkningsløs behandling) hos 404 patienter med sygdommen i et tidligt stadium.
In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease.
I begge undersøgelser tilbragte de patienter, der fik Azilect som tillægsbehandling, ca. en time mindre i "off-tilstand" end dem, der fik placebo.
In both studies, patients adding Azilect spent an average of around one hour less in the ‘off' state than those adding placebo.
Ved at øge dopaminindholdet i de dele af hjernen, der styrer bevægelser og ko-ordinering, bedrer Azilect symptomerne på Parkinsons sygdom såsom stivhed og langsomme bevægelser.
By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Til sammenligning fik patienterne på placebo en stigning på 4,07 points fra en startværdi på 24,54.
This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Hvorfor blev Azilect godkendt?
Why has Azilect been approved?
En tilsvarende mindskelse af tiden i "off-tilstand" sås hos de patienter, der fik entacapon.
A similar decrease in time spent in the ‘off' state was seen in patients taking entacapone.
Fluktuationer er forbundet med den aftagende virkning af levodopa, der for patienten medfører pludselige skift mellem "on-perioder", hvor patienten kan bevæge sig, og "offperioder", hvor patienten er immobil.
Fluctuations are linked to a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Hvad er Azilect?
What is Azilect?
Azilect må ikke anvendes sammen med andre monoaminoxidasehæmmere, herunder ikkereceptpligtige lægemidler og drogetilberedninger såsom perikum.
Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort.
Som tillægsbehandling til levodopa var 1 mg Azilect bedre end placebo til at forkorte tiden i "offtilstand”.
When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off' state more than placebo did.
Hvordan blev Azilect undersøgt?
How has Azilect been studied?
Hvilken fordel viser undersøgelserne, at der er ved Azilect?
What benefit has Azilect shown during the studies?
Hvad anvendes Azilect til?
What is Azilect used for?
Hvordan anvendes Azilect?
How is Azilect used?
Hvordan virker Azilect?
How does Azilect work?
VeraSeal fik en markedsføringstilladelse med gyldighed i hele EU den 10. november 2017.
VeraSeal received a marketing authorisation valid throughout the EU on 10 November 2017.
Andre oplysninger om VeraSeal
Other information about VeraSeal
Yderligere information om VeraSeal findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/veraseal
Further information on VeraSeal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/veraseal
Som for alle lægemidler bliver data vedrørende brugen af VeraSeal løbende overvåget.
As for all medicines, data on the use of VeraSeal are continuously monitored.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved VeraSeal opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that VeraSeal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvad er VeraSeal, og hvad anvendes det til?
What is VeraSeal and what is it used for?
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af VeraSeal?
What measures are being taken to ensure the safe and effective use of VeraSeal?
En oversigt over VeraSeal, og hvorfor det er godkendt i EU
An overview of VeraSeal and why it is authorised in the EU
Selvom patienterne kan udvikle antistoffer mod lægemidlet og dermed nedsætte dets effektivitet, er dette ikke set i studierne.
Although patients could develop antibodies against the medicine, which might reduce its effectiveness, this has not been seen in the studies.
VeraSeal anvendes, når de gængse operationsteknikker ikke er tilstrækkelige.
VeraSeal is used when standard surgery techniques do not work well enough.
Hvorfor er VeraSeal godkendt i EU?
Why is VeraSeal authorised in the EU?
VeraSeal kan i sjældne tilfælde forårsage en allergisk reaktion, som kan være alvorlig, navnlig ved gentagen anvendelse.
Rarely, VeraSeal may cause an allergic reaction which can be severe especially when the medicine is used repeatedly.
De indberettede bivirkninger ved VeraSeal vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with VeraSeal are carefully evaluated and any necessary action taken to protect patients.
Den mængde VeraSeal, der skal anvendes, afhænger af en række faktorer, herunder operationstype, sårstørrelse og antal påføringer.
The amount of VeraSeal to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
VeraSeal fås som to fyldte sprøjter i en sprøjteholder, hvor den ene indeholder en opløsning af humant fibrinogen (80 mg/ml), og den anden indeholder en opløsning af humant trombin (500 internationale enheder/ml).
It is available as two prefilled syringes in a syringe holder, one containing a solution of human fibrinogen (80 mg/ml), and the other containing a solution of human thrombin (500 international units/ml).
VeraSeal (humant fibrinogen/humant trombin) EMA/687019/2019
VeraSeal (human fibrinogen / human thrombin) EMA/687019/2019
De aktive stoffer i VeraSeal, fibrinogen og trombin, er stoffer, der findes i humant plasma (blodvæske), og som indgår i den normale blodstørkningsproces.
The active substances in VeraSeal, fibrinogen and thrombin, are substances present in human plasma (the liquid part of the blood), which are involved in the normal blood clotting process.
De hyppigste bivirkninger ved VeraSeal (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, kløe og indgrebsrelaterede smerter (smerter fra operationen).
The most common side effects with VeraSeal (which may affect up to 1 in 10 people) are nausea (feeling sick), pruritus (itchiness) and procedural pain (pain from the surgery).
Som ved alle lægemidler, der udvindes af blod, kan der ske overførsel af infektioner via VeraSeal, men det er fremstillet ved brug af filtrering og en proces til inaktivering af virusser, så risikoen er minimal.
As for all medicines obtained from blood, infections could be transmitted with the medicine; however, the medicine is manufactured using filtration and a process to inactivate viruses that minimise this risk.
VeraSeal (humant fibrinogen/humant trombin)
VeraSeal (human fibrinogen / human thrombin)
Hvilke risici er der forbundet med VeraSeal?
What are the risks associated with VeraSeal?
Det indeholder de aktive stoffer humant fibrinogen og humant trombin.
It contains the active substances human fibrinogen and human thrombin.
I sjældne tilfælde har patienter udviklet antistoffer mod proteinerne i VeraSeal, hvilket kan påvirke blodets størkningsproces.
In rare cases, patients have developed antibodies to the proteins in VeraSeal, which could interfere with blood clotting.
Tre hovedstudier med deltagelse af 614 patienter har vist, at VeraSeal er effektivt til at standse blødning inden for 4 minutter efter påføring i forbindelse med kirurgi.
Three main studies in 614 patients found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.
De observerede bivirkninger var som forventet i betragtning af operationens omfang eller patientens tilstand.
The observed side effects were as expected with major surgeries or the patient's condition.
Inden brug fastgøres sprøjterne til en medleveret anordning, der sørger for, at sprøjternes indhold blandes, mens det dryppes eller sprayes på såret.
Before use, the syringes are attached to a device supplied with the medicine that allows their contents to mix as they are dripped or sprayed on the wound.
Det er påvist, at VeraSeal er effektivt til at standse blødning i forbindelse med operative indgreb; VeraSeal forventes således at kunne reducere patientens blodtab, reducere tiden på operationsstuen og eventuelt afkorte hospitalsopholdet.
VeraSeal has been shown to effectively stop bleeding during surgery, which can be expected to reduce blood loss, reduce time in the operating theatre and possibly shorten hospital stays.
Den fuldstændige liste over bivirkninger og begrænsninger ved VeraSeal fremgår af indlægssedlen.
For the full list of all side effects and restrictions with VeraSeal, see the package leaflet.
VeraSeal må kun anvendes af en specialkirurg med erfaring i brug af vævsklæber.
VeraSeal should only be used by an experienced surgeon who has been trained in its use.
Når de to aktive stoffer blandes, sørger trombinet for, at fibrinogenet spaltes til fibrin (trådstof).
When the two active substances are mixed, thrombin cuts fibrinogen up into fibrin.
VeraSeal må ikke anvendes intravaskulært (inde i blodkar) eller til behandling af kraftig pulsåreblødning.
VeraSeal must not be used intravascularly (inside blood vessels) or to treat heavy bleeding of the arteries.
Hvordan anvendes VeraSeal?
How is VeraSeal used?
Hvilke fordele viser studierne, at der er ved VeraSeal?
What benefits of VeraSeal have been shown in studies?
Fibrinet klæber derefter sammen til en fibrinklump, som medvirker til sårets heling ved at forhindre blødning.
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
VeraSeal er en vævsklæber (en slags lim), der anvendes til standsning af blødning under operative indgreb eller til understøttelse af sting ved kirurgi i blodkar.
VeraSeal is a sealant (glue) used to stop bleeding during surgery or to support stitches during surgery on blood vessels.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af VeraSeal.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of VeraSeal have been included in the summary of product characteristics and the package leaflet.
I et andet studie i forbindelse med organkirurgi var VeraSeal lige så effektivt som et andet produkt, Surgicel: Hos 93 % af patienterne blev blødningen standset inden for 4 minutter efter påføring af VeraSeal (103 ud af 111), mens blødningen blev standset hos 81 % af patienterne ved anvendelse af Surgicel (91 ud af 113).
In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).