natgillin/translations-raw huggingface dataset:
Du får hele posens mængde infunderet intravenøst med en konstant hastighed i løbet af 1 time ved hjælp af en standard infusionspumpe.
The entire volume of the bag will be infused intravenously into you at a constant rate over a period of 1 hour by use of a standard infusion pump.
VISTIDEs kemiske stabilitet i saltvandsopløsning er blevet vist i glasflasker, infusionsposer af enten polyvinylchlorid (PVC) eller ethylen/ propylencopolymer og i PVC- baserede i. v. - administrationssæt.
22 The chemical stability of VISTIDE mixed in saline solution has been demonstrated in glass bottles, in infusion bags composed of either polyvinyl chloride (PVC) composition or ethylene/ propylene copolymer, and in PVC based vented I. V. administration sets.
Andre typer infusionssæt og infusionsposer er ikke undersøgt.
Other types of I. V. set tubing and infusion bags have not been studied.
22 VISTIDEs forligelighed med Ringer- opløsning, Ringer- laktat eller bakteriostatiske infusionsvæsker er ikke blevet undersøgt.
Compatibility of VISTIDE with Ringer’ s Solution, Lactated Ringer’ s Solution or bacteriostatic infusion fluids has not been evaluated.
Mikrobiologisk set skal VISTIDE bruges lige efter opblanding.
From a microbiological point of view, the product must be used immediately.
Der er set kemisk og fysisk stabilitet op til 24 timer i køleskab (2- 8oC), hvis tilberedningen er foretaget aseptisk.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 – 8 ºC when dilution is performed under controlled and validated aseptic conditions.
VISTIDE skal administreres af professionelt plejepersonale med erfaring i behandling af AIDS - patienter.
VISTIDE should be administered by health care professionals adequately experienced in the care of AIDS patients.
Passende forholdsregler inklusive brug af korrekt sikkerhedsudstyr anbefales ved præparation, administration og bortskaffelse af VISTIDE.
Adequate precautions including the use of appropriate safety equipment are recommended for the preparation, administration and disposal of VISTIDE.
Præparationen af VISTIDE rekonstitueret opløsning bør ske i LAF- bænk.
The preparation of VISTIDE diluted solution should be done in a laminar flow biological safety cabinet.
Personale, der præparerer opløsningen skal bære operationshandsker, sikkerhedsbriller og en lukket operationskittel med tætsluttende manchetter.
Personnel preparing the solution should wear surgical gloves, safety glasses and a closed front surgical-type gown with knit cuffs.
Hvis VISTIDE kommer i kontakt med huden, vaskes og skylles grundigt med vand.
If VISTIDE contacts the skin, wash membranes and flush thoroughly with water.
Hvorfor gives lægemidlet probenecid sammen med VISTIDE?
Why is the medication probenecid given with VISTIDE?
Probenecidtabletter gives for at reducere risikoen for nyreskader.
Probenecid tablets are given to minimise the potential for kidney damage.
Du skal gennemgå en kur med probenecidtabletter, der indgives oralt med hver VISTIDE- dosis.
You must receive a course of probenecid tablets administered orally with each VISTIDE dose.
Du skal have to gram 3 timer før hver VISTIDE- dosis og ét gram, 2 timer og igen 8 timer efter afslutningen af VISTIDE- infusionen på 1 time (dvs. i alt 4 gram).
Two grams must be administered 3 hours prior to the VISTIDE dose and one gram administered at 2 hours and again at 8 hours after completion of the 1 hour VISTIDE infusion (for a total of 4 grams).
Probenecid tages kun den samme dag, som du får VISTIDE.
Probenecid is only taken on the same day that VISTIDE is administered.
Se afsnit 6 Yderligere oplysninger, vedrørende information om levering af probenecid.
See section 6 for further information on obtaining probenecid.
Hvorfor gives der saltvandsopløsning sammen med VISTIDE?
Why is normal saline solution given with VISTIDE?
Der gives saltvandsopløsning for at nedsætte risikoen for nyreskader.
Normal saline is given to minimise the potential for kidney damage.
Du bør i alt få 1 liter 0, 9% saltvandsopløsning intravenøst i forbindelse med hver VISTIDE- infusion.
You should receive a total of one litre of 0.9% (normal) saline solution intravenously with each infusion of VISTIDE.
Saltvandsopløsningen skal infunderes i løbet af 1 time, umiddelbart før VISTIDE- infusionen.
The saline solution should be infused over a 1 hour period immediately before the VISTIDE infusion.
Denne anden liter saltvandsopløsning skal infunderes i løbet af 1 til 3 timer, og infusionen påbegyndes enten samtidig med VISTIDE - infusionen, eller umiddelbart efter infusionen er afsluttet.
If administered, the second litre of saline should be initiated either at the start of the VISTIDE infusion or immediately afterwards, and infused over a 1 to 3 hour period.
Din læge kan også bede dig drikke rigelig væske.
Your doctor may also instruct you to drink plenty of fluids.
Spørg lægen eller apoteket, hvis der er noget, du er i tvivl om eller føler dig usikker på
If you have any further questions on the use of this product, ask your doctor or pharmacist.
VISTIDE kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, VISTIDE can cause side effects, although not everybody gets them.
Bivirkningerne i dette afsnit angives med en vurdering af hyppigheden for, hvor ofte de kan forekomme.
The side effects in this section are given with an estimation of the frequency with which they may occur.
Til dette formål er følgende hyppighedskategorier og klasser blevet brugt:
For this purpose, the following frequency categories and denominations have been used:
Bivirkninger som kan forekomme hos mere end 1 ud af 10 patienter.
Very common: side effects which may occur in more than 1 in 10 patients.
Bivirkninger som kan forekomme hos 1 til 10 ud af 100 patienter.
Common: side effects which may occur in 1 to 10 out of 100 patients.
Bivirkninger som kan forekomme hos 1 til 10 ud af 1000 patienter.
Uncommon: side effects which may occur in 1 to 10 out of 1000 patients.
Bivirkninger som kan forekomme hos 1 til 10 ud af 10 000 patienter.
23 Rare: side effects which may occur in 1 to 10 out of 10 000 patients.
Bivirkninger som kan forekomme hos mindre end 1 ud af 10 000 patienter.
Very rare: side effects which may occur in less than 1 out of 10 000 patients.
Den almindeligste bivirkning, der er set med VISTIDE, er nyreskader.
The most common side effect observed with VISTIDE has been damage to the kidneys.
Meget almindelige bivirkninger er: nedsat antal hvide blodlegemer, hovedpine, kvalme, opkast, protein i urinen, stigning i serumkreatinin (et mål for nyrefunktionen), hårtab, udslæt, mathed/ træthed og feber.
Very common side effects are: low white blood cell counts, headache, nausea, vomiting, protein in the urine, increase in blood creatinine (a measure of kidney function), hair loss, rash, weakness/ fatigue and fever.
23 Almindelige bivirkninger er: betændelse i øjet, nedsat tryk i øjet, stakåndethed, vejrtrækningsproblemer og kulderystelser.
Common side effects are: inflammation of the eye, reduced pressure in the eyes, difficult or laboured breathing, shortness of breath and chills.
Andre bivirkninger rapporteret efter markedsføring omfatter nyresvigt, betændelse i bugspytkirtlen og nedsat hørelse.
Additional reactions reported from post marketing experience include kidney failure, inflammation of the pancreas and hearing impairment.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
De nævnte bivirkninger forsvinder normalt, når behandlingen med VISTIDE indstilles.
These side effects usually disappear when treatment with VISTIDE is stopped.
Hvad er probecenids mulige bivirkninger?
What are the possible side effects of taking probenecid?
Meget almindelige bivirkninger, der muligvis er forbundet med probenecid er kvalme, opkast, udslæt og feber.
Very common side effects possibly related to probenecid are nausea, vomiting, rash and fever.
Almindelige bivirkninger, der muligvis er forbundet med probenecid er hovedpine, svaghed/ træthed, kulderystelser og allergiske reaktioner.
Common side effects possibly related to probenecid include headache, weakness/ fatigue, chills and allergic reactions.
Du kan nedsætte risikoen for kvalme og/ eller opkastning forbundet med behandling med probenecid, hvis du spiser inden hver dosis af probenecid.
To decrease the potential for nausea and/ or vomiting associated with taking probenecid, you should eat food prior to each dose of probenecid.
Din læge kan muligvis anbefale dig, at tage anden medicin f. eks. midler mod opkastning, midler mod allergiske reaktioner og/ eller paracetamol for at nedsætte bivirkninger af probenecid.
Your Doctor might instruct you to take other medications such as antiemetics, antihistamines and/ or paracetamol to decrease the side effects of probenecid.
Probenecid kan også give andre bivirkninger, f. eks. nedsat appetit, ømme gummer, rødmen, hårtab, svimmelhed, nedsat antal røde blodlegemer samt øget tendens til vandladning.
Probenecid may also cause other side effects including loss of appetite, sore gums, flushing, hair loss, dizziness, reduced red blood cell count and increased frequency to urinate.
Din læge bør derfor rådføre sig med de seneste produktoplysninger for probenecid angående oplysninger om sikkerhed, inden probenecid foreskrives i behandlingen.
Therefore before being given probenecid your doctor should consult the current prescribing information for further information regarding the safety of that product.
Sådan opbevarer du VISTIDE
How to store VISTIDE
Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use after the expiry date stated on the label.
VISTIDE indeholder
What VISTIDE contains
Det aktive stof i VISTIDE 75 mg/ ml er cidofovir.
The active substance of VISTIDE 75 mg/ ml is cidofovir.
Hvert hætteglas indeholder 375 mg/ 5 ml vandfrit cidofovir.
Each vial contains 375 mg/ 5ml cidofovir anhydrous
De øvrige indholdsstoffer er Natriumhydroxid Saltsyre Vand til injektionsvæsker
The other ingredients are Sodium Hydroxide Hydrochloric Acid Water for injection
Udseende og pakningstørrelse
What VISTIDE looks like and contents of the pack
Efter opløsning i vand til injektionsvæsker er koncentrationen 75 mg/ ml.
VISTIDE is supplied as a sterile concentrate for solution for infusion in clear, glass vials containing 375 mg of the active ingredient, anhydrous cidofovir, in 5 ml formulated in Water for Injection at a concentration of 75 mg/ ml.
Opløsningen er pH- justeret med natriumhydroxid (og saltsyre om nødvendigt) og indeholder ikke konserveringsmidler.
The formulation is pH-adjusted with sodium hydroxide (and Hydrochloric Acid if needed) and contains no preservatives.
Indehaveren af markedsføringstilladelsen Gilead Sciences International Limited Cambridge CB21 6GT Storbritannien
Marketing Authorisation Holder Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom
Fremstiller Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
The Manufacturer Authorisation Holder responsible for batch release in the European Economic Area Gilead Sciences Limited IDA Business & Technology Park Carrigtohill Co.
Hvis du vil have yderligere oplysninger om VISTIDE, skal du henvende dig til den lokale repræsentant.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
VISTIDE skal gives sammen med probenecid.
Vistide must be given with probenecid.
Sådan skal du bruge VISTIDE, Hvorfor gives lægemidlet sammen med probenecid).
If you have not been provided probenecid, please contact your pharmacist or the local representative of the Marketing Authorisation Holder of Vistide for information (see also section 3 How to use VISTIDE, Why is the medication given with probenecid).
25 Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890- 0
25 Deutschland Gilead Sciences GmbH Tel: + 49 (0) 89 899890-0
Denne indlægsseddel blev senest godkendt
This leaflet was last approved on {MM/ YYYY}
Visudyne er et lægemiddel, der indeholder det aktive stof verteporfin.
Visudyne is a medicine containing the active substance verteporfin.
Det leveres i hætteglas som et pulver, der benyttes til at fremstille en opløsning, der gives som infusion.
It is available as a powder in a vial, to be made into a solution for infusion.
Visudyne anvendes til behandling af subfoveal koroidal neovaskularisering.
Visudyne is used for the treatment of patients who have subfoveal choroidal neovascularisation.
Derved forstås abnorm karvækst under den gule plet, der er den centrale del af nethinden (øjets bageste, lysfølsomme overflade).
This is the abnormal growth of blood vessels under the macula, the central part of the retina (the light- sensitive membrane at the back of the eye).
Når disse kar bløder eller afgiver væske, medfører det synstab.
When these blood vessels bleed or leak fluid, it causes a loss of vision.
Visudyne anvendes til behandling af to sygdomme, hvor dette sker: dels den våde form af aldersbetinget maculadegeneration (AMD), dels patologisk nærsynethed, en sjælden type nærsynethed, hvor øjeæblet bliver ved med at vokse og bliver for langt.
Visudyne is used for two diseases where this occur, the wet form of age-related macular degeneration (AMD) and pathological myopia, a rare type of short-sightedness where the eyeball continues to grow, becoming longer than it should be.
Lægemidlet udleveres kun efter recept.
In wet AMD, Visudyne is used when the neovascularisation is ‘ predominantly classic’ (when the blood vessels affected are well defined on an eye scan), The medicine can only be obtained with a prescription.
Behandlingen med Visudyne finder sted i to trin:
Visudyne should be used only by ophthalmologists (eye specialists) who have experience in the management of patients with AMD or pathological myopia.
Først får patienten Visudyne som intravenøs infusion (dråbetilførsel i en vene).
Treatment with Visudyne is a two-step process.
Der anvendes en dosis på 6 mg pr. kvadratmeter legemsoverflade, som gives i løbet af 10 minutter.
First, the patient receives Visudyne as an intravenous infusion (drip in to a vein) at a dose of 6 mg per square metre of body surface area over 10 minutes.
Her bliver Visudyne aktiveret ved belysning af øjet med laserlys.
The second step, 15 minutes after the start of the infusion, is the activation of Visudyne in the eye using the light generated by a laser beam.
Det anvendes ved "fotodynamisk behandling", hvor et fotosensibiliserende middel aktiveres med lys (sædvanligvis laserlys).
It is used in ‘ photodynamic therapy’, a method of treatment that uses light (generally from a laser) to activate a photosensitising agent.
Når der lyses ind i øjet med laserlys, aktiveres verteporfin og bliver cytotoksisk (celledræbende).
When the laser light is shone into the eye, verteporfin is activated and becomes cytotoxic (able to kill cells).
Dette medvirker til at lukke de abnorme blodkar, der er årsag til AMD.
This helps to close the abnormal blood vessels that cause AMD.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan blev Visudyne undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Visudyne been studied?
Visudyne blev her sammenlignet med placebo (virkningsløs behandling).
Visudyne has been studied in two studies lasting two years and involving 609 AMD patients with classic subfoveal lesions, where it was compared with placebo (a dummy treatment).
Af de patienter, der gennemførte undersøgelserne, blev 476 behandlet længere, indtil fem år.
Among the patients who completed the studies, 476 were treated for longer, up to 5 years.
Visudyne blev desuden undersøgt i to år hos 120 patienter med subfoveal koroidal neovaskularisering forårsaget af patologisk nærsynethed.
Visudyne has also been studied for two years in 120 patients with subfoveal choroidal neovascularisation caused by pathologic myopia.
Heraf fortsatte 67 med behandlingen i op til fem år.
Of these, 67 continued treatment for up to 5 years.
I alle undersøgelserne blev virkningen af Visudyne sammenlignet med placebo (virkningsløs behandling).
All of the studies compared the effectiveness of Visudyne with that of placebo.
Behandlingens virkning blev hovedsagelig bedømt på den andel af patienterne, hos hvem behandlingen virkede efter ét år (dvs. den del af patienterne, hvis syn var forringet med mindre end tre linjer (15 bogstaver) på synstavlen).
The measure of effectiveness was the percentage of responders after 1 year (the proportion of patients who lost fewer than 3 lines [15 letters] on a sight chart).
Visudyne blev desuden sammenlignet med placebo ved "okkult" subfoveal koroidal neovaskularisering (dvs. de abnorme blodkar trådte ikke tydeligt frem ved scanningen) i en undersøgelse, der varede to år og omfattede 339 patienter.
Visudyne has also been compared with placebo in ‘ occult’ subfoveal choroidal neovascularisation (when the blood vessels affected are not well defined on the scan), in a 2-year study of 339 patients.
I de to undersøgelser med klassisk subfoveal koroidal neovaskularisering var Visudyne mere effektivt end placebo.
In the two studies of classic subfoveal choroidal neovascularisation, Visudyne was more effective than placebo.
Efter 12 måneder virkede behandlingen hos 61% af de patienter, der blev behandlet med Visudyne, mod 46% hos de patienter, der blev behandlet med placebo.
After 12 months, the proportion of patients responding to the treatment was 61% for Visudyne-treated patients compared with 46% for placebo-treated patients.
Den gavnlige virkning holdt sig i indtil fem år.
The benefit was maintained for up to 5 years.
Den gavnlige virkning holdt sig i indtil fem år.
For patients with neovascularisation caused by pathologic myopia, after 12 months, 86% of the Visudyne-treated patients had a loss of less than 15 letters compared with 67% of the placebo-treated patients.
Mens den første undersøgelse ved okkult sygdom viste nogen virkning, kunne dette ikke bekræftes i den anden undersøgelse.
The benefit was maintained for up to 5 years.
Det har altså ikke kunnet påvises, at der er en fordel ved at bruge Visudyne til okkult subfoveal koroidal neovaskularisering.
While the first study in occult disease showed some effectiveness, this was not confirmed by the second study, and the benefit of Visudyne in occult subfoveal choroidal neovascularisation has not been established.
De hyppigste bivirkninger (som ses hos mellem 1 og 10 ud af hver 100 patienter) er synsforstyrrelser i form af sløret, diset, tåget syn, lysglimt, nedsat syn, grå eller mørke omrids, sorte pletter, reaktioner på indsprøjtningsstedet (smerte, hævelse og irritation) samt smerter, f. eks. rygsmerter, i forbindelse med infusionen, kvalme, lysoverfølsomhed (skoldning på huden ved lyspåvirkning), træthed og forhøjet kolesteroltal.
The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are abnormal vision (blurry, hazy, fuzzy vision, flashes of light, decreased vision, grey or dark haloes, and black spots), reactions at the injection site (pain, swelling and inflammation), and infusion-related pain such as back pain, nausea (feeling sick), photosensitivity reactions (sunburn on skin areas exposed to light), asthenia (weakness) and hypercholesteraemia (high blood cholesterol).
Den fuldstændige liste over de indberettede bivirkninger for Visudyne fremgår af indlægssedlen.
For the full list of side effects reported with Visudyne, see the Package Leaflet.
Visudyne bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for verteporfin eller andre af indholdsstofferne, patienter med porfyri (manglende evne til at nedbryde stoffer, der kaldes porfyriner), eller patienter med svær leversygdom.
Visudyne should not be used in people who may be hypersensitive (allergic) to verteporfin or any of the other ingredients, in patients with porphyria (an inability to break down chemicals called porphyrins) or in patients with severe liver disease.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Visudyne opvejer risiciene til behandling subfoveal koroidal neovaskularisering som følge af ekssudativ aldersrelateret maculadegeneration, når forandringerne overvejende er af klassisk art eller skyldes patologisk nærsynethed.
The Committee for Medicinal products for Human Use (CHMP) decided that Visudyne’ s benefits are greater than its risks for the treatment of patients with subfoveal choroidal neovascularisation due to exudative age-related macular degeneration, when the lesions are predominantly classic, or due to pathological myopia.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Visudyne.
The Committee recommended that Visudyne be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Visudyne til Novartis Europharm Limited den 27. juli 2000.
The European Commission granted a marketing authorisation valid throughout the European Union, for Visudyne to Novartis Europharm Limited on 27 July 2000.
Den fuldstændige EPAR for Visudyne findes her.
The full EPAR for Visudyne is available here.
Hætteglas (glas)
Glass vial
1 x 10 ml Hætteglas
1 x 10 ml vial
7, 5 ml rekonstitueret opløsning indeholder 15 mg verteporfin.
7.5 ml of reconstituted solution contains 15 mg of verteporfin.
Visudyne er beregnet til behandling af
Visudyne is indicated for the treatment of
- patienter med exudativ (våd) aldersrelateret makuladegeneration (AMD) med fortrinsvis
- patients with exudative (wet) age-related macular degeneration (AMD) with predominantly
klassisk subfoveal choroidal neovaskularisation (CNV), eller
classic subfoveal choroidal neovascularisation (CNV) or
- patienter med subfoveal choroidal neovaskularisation sekundært til patologisk myopi.
- patients with subfoveal choroidal neovascularisation secondary to pathological myopia.
Visudyne bør kun anvendes af øjenlæger, som har erfaring med behandling af patienter med aldersrelateret makuladegeneration eller patologisk myopi.
Visudyne should be used only by ophthalmologists experienced in the management of patients with age-related macular degeneration or with pathological myopia.
Photodynamisk terapi med Visudyne (PDT) er en to- trinsprocedure.
Visudyne photodynamic therapy (PDT) is a two-step process:
6. 6).
The first step is a 10-minute intravenous infusion of Visudyne at a dose of 6 mg/ m2 body surface area, diluted in 30 ml infusion solution (see section 6.6).
Andet trin er aktivering af Visudyne med lys 15 minutter efter infusionens start.
The second step is the light activation of Visudyne at 15 minutes after the start of the infusion.
Det ikke- termiske røde lys (som har en bølgelængde på 689 nm ± 3 nm) afgives fra en diode laser via fiberoptik og en spaltelampe med brug af en passende kontaktlinse.
For this, a diode laser generating non-thermal red light (wavelength 689 nm ± 3 nm) is used via a slit lamp mounted fibre optic device and a suitable contact lens.
Det tager 83 sekunder at af give den anbefalede dosis på 50 J/ cm2 med den anbefalede intensitet på 600 mW/ cm2.
At the recommended light intensity of 600 mW/ cm2, it takes 83 seconds to deliver the required light dose of 50 J/ cm2.
Den største diameter af den choroidale neovaskulære læsion bestemmes ved hjælp af fluorescein - angiografi og fotografering af fundus.
The greatest linear dimension of the choroidal neovascular lesion is estimated using fluorescein angiography and fundus photography.
Det anbefales at benytte et funduskamera med en forstørrelse af størrelsesordenen 2, 4 – 2, 6 gange.
Fundus cameras with a magnification within the range of 2.4 - 2.6X are recommended.