natgillin/translations-raw huggingface dataset:
Reaktioner på administratio nssteda (inkl.
Application and instillation site reactionsa (incl.
Perifert ødem, asteniske tilstandea (inkl.
Oedema peripheral, asthenic conditionsa (incl.
Erytheme, hyperhidrosise, generaliseret prurituse, hudirritatione, kontaktdermatiti se, generaliseret udslæte
Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
• Til doser højere end 8 mg/24 timer (doser ordineret af Deres læge som er højere end de tilgængelige styrker ) bruges flere plastre for at opnå den endelige dosis.
• For doses higher than 8 mg/24 h (doses prescribed by your doctor above the available strengths),
Hvert plaster på 30 cm2 indeholder 13,5 mg rotigotin.
Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Hvert plaster på 15 cm2 indeholder 6,75 mg rotigotin.
Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Graviditet og amning Brug ikke Neupro, hvis De er gravid, da rotigotins effekt på graviditet og det ufødte barn ikke kendes.
This is because the effects of rotigotine on pregnancy and the unborn baby are not known.
• Restless legs-syndrom (uro i benene (RLS)) - en tilstand som karakteriseres ved ubehag i arme eller ben, trang til at bevæge sig rundt, søvnforstyrrelser og følelse af at være træt eller døsig i løbet af dagen.
• Restless Legs Syndrome (RLS) - this can be associated with discomfort in your legs or arms,
Neupro indeholder det aktive stof rotigotin.
What Neupro contains The active substance is rotigotine.
ASAT, ALAT, GGT), vægtøgninge, øget pulse, forhøjet CKd,e
AST, ALT, GGT), weight increased e, heart rate increased e, CPK increased d,e
I den anden uge anvendes Neupro 4 mg (æske mærket ”Uge 2”).
At the beginning of the second week, you should take Neupro 4 mg (package marked with “Week 2”).
Hvert plaster på 40 cm2 indeholder 18,0 mg rotigotin.
Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Immunsysteme
Immune system disorders
Forstoppelsee, mundtørhede, abdominalsmer tere, diarréc
Constipatione, dry mouthe, abdominal paine, diarrhoeac
synkope, vasogal synkope, tab af bevidsthed), dyskinesie, postural
syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
hyperseksualitet , øget libido), søvnløshed, søvnforstyrrelse r, unormale drømme, impulskontrolfo rstyrrelsera,d
hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
Nervesystemet Hovedpine Døsighed
Nervous system disorders
Palpitationere, atriefibrillatione, supraventrikulæ r takykardie
Palpitationse, atrial fibrillatione, supraventricular tachycardia e
Bevidsthedsfor styrrelser NEC a (inkl.
Disturbances in consciousness NECa (incl.
Hvert plaster på 20 cm2 indeholder 9,0 mg rotigotin.
Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Fald a) Overordnet begreb (high level term) b) Observeret i åbne studier c) Observeret efter markedsføring d) Observeret i data pool af dobbeltblinde, placebokontrollerede studier i 2011
Fall a High Level Term b Observed in open-label studies c Observed during post-marketing d
Hvert plaster på 5 cm2 indeholder 2,25 mg rotigotin.
Each patch of 5 cm2 contains 2.25 mg of rotigotine.
Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h”.
The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Neupro 1 mg/24 timer depotplaster Hvert plaster afgiver 1 mg rotigotin pr. 24 timer.
Neupro 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
ASAT, ALAT, GGT), vægtøgning, øget puls, forhøjet CKd
AST, ALT, GGT), weight increased, heart rate increased, CPK increasedd
Ydersiden er beige og påtrykt Neupro 1 mg/24 h eller Neupro 3 mg/24 h.
The outside is tan-coloured and is imprinted with Neupro 1 mg/24 h or 3 mg/24 h.
• 8 mg/24 timer:
• 8 mg/24 h:
Kontakt lægen eller apotekspersonalet, før De bruger Neupro.
Warnings and precautions Talk to your doctor or pharmacist before using Neupro.
Neupro 8 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 8 mg/24 h”.
Neupro 8 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 8 mg/24 h'.
Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 2 mg/24 h”.
The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h'.
Hvert plaster på 10 cm2 indeholder 4,5 mg rotigotin.
Each patch of 10 cm2 contains 4.5 mg of rotigotine.
Det skal De vide, før De begynder at bruge Neupro Sådan skal De bruge Neupro Bivirkninger
What Neupro is and what it is used for What you need to know before you use Neupro How to use Neupro
Neupro 1 mg/24 timer depotplaster Neupro 3 mg/24 timer depotplaster
Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Dopamindysregulationssyndromc, sanseforstyrrels ere (inkl.
Dopamine dysregulation syndromec, perception disturbancese
Ydersiden er beige og påtrykt Neupro 4 mg/24 h eller Neupro 6 mg/24 h eller Neupro 8 mg/24 h
The outside is tan-coloured and is imprinted with Neupro 4 mg/24 h, Neupro 6 mg/24 h or Neupro 8 mg/ 24 h.
• 6 mg/24 timer:
• 6 mg/24 h:
Neupro 6 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 6 mg/24 h”.
Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Neupro 8 mg/24 timer
neupro 8 mg/24 h
7 depotplastre med Neupro 6 mg/24 timer
7 transdermal patches of Neupro 6 mg/24 h
Neupro 4 mg/24 timer depotplaster Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
Neupro 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 1 mg/24 timer depotplaster EU/1/05/331/038
Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
7 depotplastre med Neupro 8 mg/24 timer
7 transdermal patches of Neupro 8 mg/24 h
Neupro 2 mg/24 timer 4 mg/24 timer 6 mg/24 timer 8 mg/24 timer
neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Neupro 6 mg/24 timer
Neupro 6 mg/24 h
Diarréc
Diarrhoeac
synkope, vasovagal synkope, tab af bevidsthed), dyskinesi, postural svimmelhed, letargi
syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsion e
Ydersiden er beige og påtrykt Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h eller 8 mg/24 h.
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Ydersiden er beige og påtrykt Neupro 2 mg/24 h.
The outside is tan-coloured and is imprinted with Neupro 2 mg/24 h.
erythem, pruritus, irritation, udslæt, dermatitis, vesikler, smerte, eksem, inflammation, hævelse, misfarvning, papler, eksfoliation, urticaria, overfølsomhed) , asteniske symptomera(ink
erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditions a
Neupro 4 mg/24 timer depotplaster Den ydre side af bagsidelaget er beige og påtrykt ”Neupro 4 mg/24 h”.
Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Neupro 6 mg/24 timer depotplaster EU/1/05/331/007
Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
7 depotplastre med Neupro 4 mg/24 timer
7 transdermal patches of Neupro 4 mg/24 h
Svimmelhede, bevidsthedsforst yrrelser NECe
Disturbances in consciousness NEC
Er De i tvivl, så spørg lægen eller apotekspersonalet.
• If you have any further questions, ask your doctor or pharmacist.
Neupro 8 mg/24 timer depotplaster EU/1/05/331/010
Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Neupro 4 mg/24 timer depotplaster EU/1/05/331/004
Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Neupro 2 mg/24 timer
Neupro 2 mg/24 h
Neupro 2 mg/24 timer Neupro 4 mg/24 timer Neupro 6 mg/24 timer Neupro 8 mg/24 timer
Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch
Neupro 3 mg/24 timer depotplaster EU/1/05/331/047
Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Hvis De har brugt for mange Neupro-plastre
How to use the Neupro patches
Neupro 8 mg/24 timer depotplaster rotigotin
Neupro 8 mg/24 h transdermal patch rotigotine
EU/1/05/331/047[7 depotplastre] EU/1/05/331/049 [28 depotplastre] EU/1/05/331/050 [30 depotplastre] EU/1/05/331/058 [14 depotplastre]
EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
Sanseforstyrrel sera
Perception disturbancesa
Det
a
Neupro 4 mg/24 timer
Neupro 4 mg/24 h
EU/1/05/331/038[7 depotplastre] EU/1/05/331/040 [28 depotplastre] EU/1/05/331/041 [30 depotplastre] EU/1/05/331/056 [14 depotplastre]
EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
Svimmelhede, bevidsthedsfors tyrrelser NECe
Dizzinesse, disturbances in consciousness NECe (incl.
EU/1/05/331/010 [7 depotplastre] EU/1/05/331/011 [28 depotplastre] EU/1/05/331/033 [30 depotplastre] EU/1/05/331/061 [14 depotplastre]
EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
• 4 mg/24 timer Hvert plaster afgiver 4 mg rotigotin pr. 24 timer.
• 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Neupro 2 mg/24 timer 4 mg/24 timer 6 mg/24 timer 8 mg/24 timer Depotplaster
Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Ascorbylpalmitat (E 304) og
sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307).
Neupro 6 mg/24 timer depotplaster rotigotin
Neupro 6 mg/24 h transdermal patch rotigotine
EU/1/05/331/004 [7 depotplastre] EU/1/05/331/005 [28 depotplastre] EU/1/05/331/021 [30 depotplastre] EU/1/05/331/059 [14 depotplastre]
EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
EU/1/05/331/007 [7 depotplastre] EU/1/05/331/008 [28 depotplastre] EU/1/05/331/027 [30 depotplastre] EU/1/05/331/060 [14 depotplastre]
EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
Neupro 4 mg/24 timer depotplaster Neupro 6 mg/24 timer depotplaster Neupro 8 mg/24 timer depotplaster
Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
EU/1/05/331/001 [7 depotplastre] EU/1/05/331/002 [28 depotplastre] EU/1/05/331/015 [30 depotplastre] EU/1/05/331/057 [14 depotplastre]
EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
For eksempel kan en daglig dosis på 10 mg nås ved at bruge ét plaster på 6 mg/24 timer og ét plaster på 4 mg/24 timer.
h may be reached by applying one patch of 6 mg/24 h and one patch of 4 mg/24 h.
Sløret syn, nedsat syn, fotopsi
Vision blurrede, visual impairmente, photopsiae
Neupro 2 mg/24 timer depotplaster rotigotin
Neupro 2 mg/24 h transdermal patch rotigotine
Neupro 4 mg/24 timer depotplaster rotigotin
Neupro 4 mg/24 h transdermal patch Rotigotine
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/036 [84 depotplastre (3 pakninger a 28)]
EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
ludomani, stereotypi/tvang shandlinger, uhæmmet madindtagelse/s piseforstyrrelseb
pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/018 [84 depotplastre (3 pakninger a 28)]
EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/053 [84 depotplastre (3 pakninger a 28)]
EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/024 [84 depotplastre (3 pakninger a 28)]
EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
I den tredje uge anvender han eller hun Neupro 6 mg/24 timer og i den fjerde uge Neupro 8 mg/24 timer.
On the first day of treatment the patient starts with Neupro 2 mg/24 h. During the second week, the patient takes Neupro 4 mg/24 h. During the third week, he or she takes Neupro 6 mg/24 h and during the fourth week Neupro 8 mg/24 h. The packages are marked with “Week 1 (2, 3 or 4)”.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/030 [84 depotplastre (3 pakninger a 28)]
EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/331/044 [84 depotplastre(3 pakninger a 28)]
EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
Det fås som lyserøde tabletter (75 mg).
It is available as pink tablets (75 mg).
Clopidogrel Teva kan gives til følgende patientgrupper:
Clopidogrel Teva can be given to the following groups of patients:
Andre oplysninger om Clopidogrel Teva:
Other information about Clopidogrel Teva:
Standarddosis af Clopidogrel Teva er én 75 mg -tablet én gang dagligt med eller uden et måltid.
The standard dose of Clopidogrel Teva is one 75 mg tablet once a day, taken with or without food.
Clopidogrel Teva clopidogrel EPAR - sammendrag for offentligheden
Clopidogrel Teva clopidogrel EPAR summary for the public
Ved akut koronarsyndrom anvendes Clopidogrel Teva sammen med aspirin, og behandlingen indledes almindeligvis med en initialdosis på fire 75 mg -tabletter.
In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Det betyder, at Clopidogrel Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
This means that Clopidogrel Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Den fuldstændige EPAR for Clopidogrel Teva findes her.
The full EPAR for Clopidogrel Teva can be found here.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Teva til Teva Pharma B.V.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
• patienter med perifer ateriesygdom (problemer med blodgennemstrømningen i arterierne)
• patients with peripheral arterial disease (problems with blood flow in the arteries);
Det kan også anvendes til patienter, der ikke har denne unormale visning på EKG'et, hvis de har ustabil angina (en alvorlig form for brystsmerter) eller myokardieinfarkt uden forekomst af Q-takker.
It can also be used in patients who do not have this abnormal reading on the ECG, if they have unstable angina (a severe type of chest pain) or ‘non-Q-wave' myocardial infarction.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Teva has been shown to have comparable quality and to be bioequivalent to Plavix.
Clopidogrel Teva anvendes til forebyggelse af aterotrombotiske hændelser hos voksne patienter (problemer forårsaget af blodpropper og åreforkalkning).
Clopidogrel Teva is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Hvilken fordel og risiko er der forbundet med Clopidogrel Teva?
What are the benefit and risk of Clopidogrel Teva?
Clopidogrel Teva er et ‘generisk lægemiddel'.
Clopidogrel Teva is a ‘generic medicine'.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Teva.
The Committee recommended that Clopidogrel Teva be given marketing authorisation.
Clopidogrel Teva kan anvendes til patienter, som har myokardieinfarkt med ”forhøjelse af ST-segmentet” (STelevation), dvs. en unormal visning på elektrokardiogrammet (EKG), når lægen vurderer, at patienterne kan have gavn af denne behandling.
Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Clopidrogel forhindrer blodpladerne i at aggregere ved at forhindre et stof, ADP, i at binde sig til en særlig receptor på overfladen af disse.
Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Behandling med Clopidogrel Teva kan påbegyndes få dage efter anfaldet og indtil 35 dage efter
Clopidogrel Teva can be started between a few days and 35 days after the attack;
Clopidogrel Teva er et lægemiddel, der indeholder det aktive stof clopidogrel.
Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Behandling med Clopidogrel Teva kan påbegyndes 7 dage efter slagtilfældet og indtil 6 måneder efter
Clopidogrel Teva can be started between seven days and six months after the stroke;
Da Clopidogrel Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
Because Clopidogrel Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Da Clopidogrel Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
Because Clopidogrel Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Det aktive stof i Clopidogrel Teva, clopidogrel, er en blodpladeaggregationshæmmer.
The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation.
Hvorfor blev Clopidogrel Teva godkendt?
Why has Clopidogrel Teva been approved?
Hvordan blev Clopidogrel Teva undersøgt?
How has Clopidogrel Teva been studied?
Hvad anvendes Clopidogrel Teva til?
What is Clopidogrel Teva used for?
Hvordan anvendes Clopidogrel Teva?
How is Clopidogrel Teva used?
Hvordan virker Clopidogrel Teva?
How does Clopidogrel Teva work?
Neutropenien varede i gennemsnit 1,6 dage ved begge lægemidler.
Neutropenia lasted on average 1.6 days with both medicines.
Yderligere information om Pelgraz findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Pelgraz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det betyder, at Pelgraz i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU.
This means that Pelgraz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pelgraz?
What measures are being taken to ensure the safe and effective use of Pelgraz?
Bivirkninger rapporteret for Pelgraz vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Pelgraz are carefully evaluated and any necessary action taken to protect patients.
Som for alle lægemidler bliver data vedrørende brug af Pelgraz løbende overvåget.
As for all medicines, data on the use of Pelgraz are continuously monitored.
Den hyppigste bivirkning ved Pelgraz (der kan forekomme hos op til 1 ud af 10 patienter) er knoglesmerter.
The most common side effect with Pelgraz (which may affect more than 1 in 10 people) is pain in the bones.
Andre oplysninger om Pelgraz
Other information about Pelgraz
For mere information om brug af Pelgraz, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Pelgraz, see the package leaflet or contact your doctor or pharmacist.
Pelgraz udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kræft eller blodforstyrrelser.
Pelgraz can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
En oversigt over Pelgraz, og hvorfor det er godkendt i EU
An overview of Pelgraz and why it is authorised in the EU
Pelgraz er et "biosimilært lægemiddel".
Pelgraz is a ‘biosimilar medicine'.
Pelgraz gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
Pelgraz is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Referencelægemidlet for Pelgraz er Neulasta.
The reference medicine for Pelgraz is Neulasta.
Hvorfor blev Pelgraz godkendt i EU?
Why is Pelgraz authorised in the EU?
Hvilke risici er der forbundet med Pelgraz?
What are the risks associated with Pelgraz?
Da Pelgraz er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke at blive gentaget for Pelgraz.
Because Pelgraz is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelgraz.
Hvad er Pelgraz, og hvad anvendes det til?
What is Pelgraz and what is it used for?
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Pelgraz har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelgraz has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Det aktive stof i Pelgraz, pegfilgrastim, består af filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
The active substance in Pelgraz, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Agenturet var derfor af den opfattelse, at fordelene ved Pelgraz opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelgraz outweighs the identified risk and it can be authorised for use in the EU.
Pelgraz er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndrom (tilstand, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
Pelgraz is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, , which can develop into leukaemia).
Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Pelgraz vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
All these data were considered sufficient to conclude that Pelgraz will behave in the same way as Neulasta in terms of effectiveness and safety in its approved uses.
Pelgraz gives specifikt for at reducere varigheden af neutropeni og forebygge såkaldt febril neutropeni, dvs. neutropeni ledsaget af feber.
It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever).
Studier har også vist, at indgivelse af Pelgraz giver samme niveau af det aktive stof i kroppen som indgivelse af Neulasta.
Studies have also shown that giving Pelgraz produces similar levels of the active substance in the body to giving Neulasta.