natgillin/translations-raw huggingface dataset:
Tygacils udseende og pakningsstørrelse Tygacil leveres i et hætteglas og ligner et orange pulver eller en orange masse, før det bliver opløst.
What Tygacil looks like and contents of the pack Tygacil is supplied in a vial and looks like an orange powder or cake before it is diluted.
Disse hætteglas leveres til hospitalet i en pakke med 10 bakker.
These vials are distributed to the hospital in a ten tray pack.
Derefter skal opløsningen straks trækkes op af hætteglasset og tilsættes en 100 ml intravenøs pose eller anden passende infusionsbeholder på hospitalet.
Thereafter, the solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag or other suitable infusion container in the hospital.
Hvis det ikke er tilfældet, må opløsningen ikke bruges.
The Tygacil solution should be yellow to orange in colour after dissolving; if it is not, the solution should be discarded.
Hvis De vil have yderligere oplysninger om dette lægemiddel, skal repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
J.
Malta V. J.
De kan finde yderligere information om dette lægemiddel på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
26 Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/
SÅDAN SKAL DE BRUGE TYGACIL i denne indlægsseddel)
HOW TYGACIL IS GIVEN in this leaflet)
Derefter skal opløsningen på 5 ml straks trækkes ud af hætteglasset og tilsættes en intravenøs infusionspose på 100 ml eller en anden passende infusionsbeholder (f. eks. glasflaske).
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Ved en dosis på 100 mg skal der opløses to hætteglas i en intravenøs pose til infusion med 100 ml eller en anden passende infusionsbeholder (f. eks. glasflaske).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag for infusion or other suitable infusion container (e. g. glass bottle).
Parenteralprodukter skal efterses visuelt for partikler og misfarvning (f. eks. grøn eller sort) før administration.
Parenteral products should be inspected visually for particulate matter and discolouration (e. g. green or black) prior to administration.
25 Tygacil kan administeres intravenøst via en bestemt slange eller via et Y- site.
Tygacil may be administered intravenously through a dedicated line or through a Y-site.
Hvis den samme intravenøse slange bruges til sekventiel infusion af en række aktive stoffer, skal slangen skylles før og efter infusion af Tygacil med en injektionsopløsning, bestående af enten 9 mg/ ml (0, 9%) natriumchlorid eller 50 mg/ ml (5%) glukose.
If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of Tygacil with either sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection.
Injektionen skal foretages med en infusionsopløsning, som er forenelig med tigecyklin og alle andre lægemidler via denne fælles slange.
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line.
Forligelige intravenøse opløsninger omfatter: natriumchlorid 9 mg/ ml (0, 9%) opløsning til injektion og glucose 50 mg/ ml (5%) opløsning til injektion.
Compatible intravenous solutions include: sodium chloride 9 mg/ ml (0.9%) solution for injection and dextrose 50 mg/ ml (5%) solution for injection.
Ved administration via et Y- site er Tygacil fortyndet med natriumchlorid 0, 9% til injektion forligelig med følgende lægemidler eller fortyndingsvæsker: amikacin, dobutamin, dopamin HCl, gentamicin, haloperidol, Ringerlaktat, lidocain HCl, morfin, adrenalin, piperacillin/ tazobactam (EDTA formulering), kaliumchlorid, propofol, ranitidin HCl, theophyllin og tobramycin.
When administered through a Y-site, compatibility of Tygacil diluted in sodium chloride 0.9% for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’ s, lidocaine HCl, morphine, norepinephrine, piperacillin/ tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
Når tigecyklin er opløst og fortyndet i posen eller en anden passende infusionsbeholder (f. eks. glasflaske), bør det anvendes straks.
Once reconstituted and diluted in the bag or other suitable infusion container (e. g. glass bottle) tigecycline should be used immediately.
Medlemslandene skal sørge for følgende:
The Member States shall ensure that:
Som det er aftalt med de kompetente myndigheder i medlemslandene, skal indehaveren af markedsføringstilladelsen på nationalt plan sørge for, at alle de læger, som påtænker at ordinere Tysabri, skal forsynes med en lægepakke, der indeholder følgende:
The Marketing Authorisation Holder will implement nationally, prior to marketing, and as agreed with the competent authorities in the Member States that all physicians who intend to prescribe Tysabri are provided with a physician pack containing the following elements:
• Produktinformation • Information til lægen om Tysabri • Patientinformationskort
• Product information • Physician information about Tysabri • Patient alert card
Informationen til lægen om Tysabri skal indeholde følgende hovedelementer: • Begrænset indikation • Atypiske/ opportunistiske infektioner især PML, herunder: o Diagnosticering af PML, herunder differentiering mellem PML og MS attak o PML behandlingsalgoritme o Mulighed for andre opportunistiske infektioner • Infusionsreaktioner • Overfølsomhedsreaktioner • Antistofdannelse • Nødvendigheden af at informere patienterne om fordele og risici ved behandling med Tysabri samt nødvendigheden af at forsyne patienterne med et patientinformationskort
The physician information about Tysabri shall contain the following key elements: • Restricted indication • Atypical/ opportunistic infections in particular PML including: o Diagnosis of PML including differentiation between PML and MS relapse o PML management algorithm o Possibility of other opportunistic infections • Infusion reactions • Hypersensitivity reactions • Antibody formation • Need to inform patients about the benefits and risk of Tysabri and provide them with a patient alert card.
TYSABRI
TYSABRI
Tysabri er en koncentreret opløsning, som fortyndes til en væske, der indgives ved infusion (dråbetil - førsel i en vene).
Tysabri is a concentrate that is made up into a solution for infusion (drip into a vein).
Tysabri anvendes til behandling af voksne med multipel sklerose (MS).
Tysabri is used to treat adults with multiple sclerosis (MS).
Det anvendes til den form for multipel sklerose, der kaldes recidiverende- remitterende, hvor patienten skiftevis har sygdomsanfald (recidiv) og perioder uden symptomer (remission).
It is used in the type of MS known as ‘ relapsing-remitting’, when the patient has attacks (relapses) followed by periods with no symptoms (remissions).
Lægemidlet anvendes, når: • sygdommen er meget aktiv trods behandling med interferon beta (et andet lægemiddel, der an - vendes ved MS), eller • sygdommen er svær og hurtigt fremadskridende.
It is used when the disease is: • highly active despite treatment with a beta-interferon (another type of medicine used in MS), or; • severe and getting worse rapidly.
Behandlingen med Tysabri bør iværksættes og overvåges af en læge med erfaring i behandling af syg - domme i nervesystemet og med adgang til en særlig type scanner, som kaldes en MRI- scanner (mag - netic resonance imaging).
Treatment with Tysabri should be started and supervised by a doctor who is experienced in treating diseases of the nervous system, and who has access to a type of scanning machine called a magnetic resonance imaging (MRI) machine.
Denne maskine giver lægerne mulighed for at kontrollere ændringer i hjer - nen forbundet med multipel sklerose eller en sjælden hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML).
This machine will enable the doctor to check for changes in the brain linked to MS or the rare brain infection called progressive multifocal leukoencephalopathy (PML).
Tysabri indgives hver 4. uge ved en infusion, der varer en time.
Tysabri is given as one infusion lasting one hour every four weeks.
Da infusionen kan udløse en overføl - somhedsreaktion, skal patienten overvåges under infusionen og i en time efter infusionen.
Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Hvis be - handlingen efter 6 måneder ikke kan ses at være til klar fordel for patienten, skal lægen tage behand - lingen op til ny overvejelse.
Patients should show this card to their partner or carer, as well as to other doctors treating them, because they may notice symptoms of PML that the patient is not aware of, such as changes in mood, behaviour or speech.
Tysabri bør ikke anvendes til børn og unge.
The active substance in Tysabri, natalizumab, is a monoclonal antibody.
Patienter, der får Tysabri, skal have udleveret et særligt informationskort, som sammenfatter de vigtig - ste sikkerhedsoplysninger om lægemidlet.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Patienterne skal vise dette kort til deres partner eller plejer samt til andre læger, som behandler dem, da de kan bemærke symptomer på PML, som patienten ikke selv er klar over, såsom ændret humør, adfærd eller tale.
This is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Natalizumab, det aktive stof i Tysabri, er et monoklonalt antistof.
MS is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Natalizumab er blevet udviklet til at binde sig til en bestemt del af et ’ integrin ’ (4 1- integrinet).
By blocking the integrin, natalizumab stops the leucocytes from going from the blood into the brain.
Virkningerne af Tysabri blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Tysabri were first tested in experimental models before being studied in humans.
To undersøgelser, som begge varede 2 år, så på Tysabri til behandling af MS.
Two studies, both lasting two years, have looked at Tysabri in MS.
Den ene undersøgelse, som omfattede 942 patienter, sammenlignede Tysabri anvendt alene med placebo (virkningsløs be - handling).
One study compared Tysabri on its own (monotherapy) with placebo (a dummy treatment) in 942 patients.
I den anden undersøgelse blev virkningen af Tysabri anvendt sammen med interferon beta - 1a (et andet lægemiddel mod MS) undersøgt hos 1 171 patienter.
The second study looked at the effect of adding Tysabri to interferon beta-1a (another medicine used in MS) in 1,171 patients.
Virkningen blev hovedsagelig målt på antallet af tilbagefald og ændringerne i patienternes grad af invaliditet ved hjælp af en standardska - la (Expanded Disability Status Scale).
The main measures of effectiveness were the number of relapses, and the changes in the patients’ level of disability, measured using a standard scale (the Expanded Disability Status Scale).
Hvilken fordel viser undersøgelserne, der er ved Tysabri?
What benefit has Tysabri shown during the studies?
I undersøgelsen af behandlingen med et enkelt stof var Tysabri mere effektivt end placebo til at reducere antallet af tilbagefald.
In the monotherapy study, Tysabri was more effective than placebo in reducing the number of relapses.
Efter et år fik patienter behandlet med Tysabri ca. to tredjedele færre MS- anfald end patienter, der fik placebo.
After one year, there was a decrease of about two-thirds in the number of MS attacks in Tysabri-treated patients, in comparison with the patients who received placebo.
I løbet af en periode på 2 år blev risikoen for forværring af invaliditeten mindsket med 42% i forhold til placebo.
Tysabri was also more effective than placebo on the disabling effects of MS: over two years, the risk of disability getting worse was reduced by 42% in comparison with placebo.
I tillægsundersøgelsen med interferon beta- 1a er risikoen for, at invaliditeten bliver forværret og antal - let af tilbagefald blevet reduceret.
In the add-on study with interferon beta-1a, the risk of disability getting worse and the number of relapses were reduced.
Undersøgelsens opbygning gjorde det imidlertid ikke muligt klart at fastslå, om disse resultater udelukkende skyldtes Tysabri eller kombinationen.
However, the way the study was designed did not allow the clear identification of whether these results were due to Tysabri only, or to the combination.
Patienter, plejere og læger bør have for øje, at Tysabri kan være forbundet med infektioner, herunder PML.
Patients, carers and doctors need to be aware that Tysabri can be associated with infections, including PML.
PML har symptomer, der minder om symptomerne ved et MS- anfald, og medfører sædvanligvis svær invaliditet eller død.
PML has symptoms that are similar to those of an MS attack, and usually leads to severe disability or death.
Hvis der er mistanke om PML, skal lægerne stoppe behandlingen, indtil det er sikkert, at patienten ikke har en infektion.
If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
I undersøgelserne var de hyppigste bivirkninger af Tysabri (som ses hos mellem 1 og 10 patienter ud af 100) urinvejsbetændelse, nasopharyngitis (betændelse i hals og næse), urticaria (kløende udslæt), hovedpine, svimmelhed, opkastning, kvalme, ledsmerter, kulderystelser, feber og træthed.
In the studies, the most common side effects with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infections of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (rash), headache, dizziness, vomiting, nausea (feeling sick), arthralgia (joint pain), rigors (shaking chills), pyrexia (fever) and fatigue (tiredness).
Ca.
For the full list of all side effects reported with Tysabri, see the Package Leaflet.
6% af patienterne i undersøgelserne udviklede længerevarende antistoffer mod natalizumab.
About 6% of the patients in the studies developed long-lasting antibodies against natalizumab.
Dette forringede lægemidlets virkning.
This led to a decrease in the effectiveness of the medicine.
Tysabri må ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for natalizumab eller nogen af indholdsstofferne.
Tysabri should not be used in people who may be hypersensitive (allergic) to natalizumab or any of the other ingredients.
Det må ikke gives til patienter med PML eller som har øget risiko for infektioner, herunder patienter, hvis immunsystem er svækket, enten på grund af sygdom eller på grund af andre lægemidler de får eller tidligere har fået.
It must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune systems are weakened because of disease or other medicines they are receiving or may have received before.
Tysabri må ikke gives sammen med interferon beta eller glatirameracetat (andre lægemidler til langtidsbehandling af MS).
Tysabri must not be given with beta-interferon or glatiramer acetate (other long-term medicines for MS).
Det må heller ikke gives til patienter med kræft (bortset fra en form for hudkræft, der kaldes basalcellecarcinom) eller til perso - ner under 18 år.
It also must not be given to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma) or to people under 18 years of age.
Den fuldstændige liste over begrænsningerne for anvendelsen fremgår af indlægssed - len.
For the full list of restrictions, see the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler( CHMP) konkluderede, at virkningen af Tysabri ved MS, både på sygdomstilbagefaldene og invaliditeten, var blevet klart påvist.
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Tysabri in MS, on both relapses and disability, had been clearly shown.
På grund af sin sikkerhedspro - fil må lægemidlet dog kun anvendes hos patienter med reelt behov for det.
However, because of its safety profile, the medicine should only be used in patients who have a real need for the medicine.
Udvalget besluttede, at fordelene ved Tysabri er større end risiciene som enkelt sygdomsmodificerende behandlingsterapi ved meget aktiv recidiverende- remitterende multipel sklerose til patienter, som trods behandling med in - terferon beta, har en meget høj sygdomsaktivitet eller lider af svær og hurtigt fremadskridende multi - pel sklerose.
The Committee decided that Tysabri’ s benefits are greater than its risks as single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon, or with rapidly evolving severe relapsing remitting MS.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tysabri.
The Committee recommended that Tysabri be given marketing authorisation.
2/ 3 Hvilke forholdsregler træffes der for at garantere sikkerheden ved brug af Tysabri?
Which measures are being taken to ensure the safe use of Tysabri?
Det firma, der fremstiller Tysabri, sørger for, at alle læger, der ordinerer Tysabri, får en informations - pakke, der giver dem alle de oplysninger, der er nødvendige for at sikre korrekt brug af lægemidlet og nøje overvågning af patienterne.
The company that makes Tysabri will ensure that all doctors who prescribe Tysabri are supplied with an educational pack that gives them all the information they need to ensure that the medicine is used appropriately, and that the patients are closely monitored.
Andre oplysninger om Tysabri:
2/ 3 Other information about Tysabri:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tysabri til Elan Pharma International Ltd den 27. juni 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri to Elan Pharma International Ltd on 27 June 2006.
Den fuldstændige EPAR for Tysabri findes her.
The full EPAR for Tysabri can be found here.
EMEA’ s procedurenr
EMEA Procedure number
1 Hætteglas
1 vial
TYSABRI 300 mg koncentrat til infusionsvæske, opløsning.
TYSABRI 300 mg concentrate for solution for infusion.
Natalizumab er et rekombinant humaniseret anti- α4- integrin antistof, produceret i en murin cellelinie ved rekombinant DNA teknologi.
Natalizumab is a recombinant humanised anti-α 4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Når opløsningen er fortyndet (se sektion 6. 6), indeholder infusionsvæsken cirka 2, 6 mg/ ml natalizumab.
When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ ml of natalizumab.
Koncentrat til fortynding i opløsning til infusion.
Concentrate for solution for infusion.
TYSABRI er indiceret som en monoterapeutisk sygdomsmodificerende behandling af meget aktiv relapsing- remitting multipel sklerose (MS) hos følgende patientgrupper:
TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following patient groups:
5. 1);
• Patients with high disease activity despite treatment with a beta-interferon (see section 5.1);
5. 1).
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis (see section 5.1).
TYSABRI behandling skal initieres og overvåges af speciallæger med erfaring i diagnosticering og behandling af neurologiske tilstande på hospitaler med let adgang til MR- scanning.
TYSABRI therapy is to be initiated and supervised by specialised physicians experienced in the diagnosis and treatment of neurological conditions, in centres with timely access to MRI.
Patienter behandlet med TYSABRI skal have udleveret patientinformationskortet.
Patients treated with TYSABRI must be given the patient alert card.
6. 6) skal infusionen indgives over cirka 1 time, og patienterne skal observeres under infusionen og i 1 time, efter at infusionen er tilendebragt for tegn og symptomer på overfølsomhedsreaktioner.
After dilution (see section 6.6), the infusion is to be administered over approximately 1 hour and patients are to be observed during the infusion and for 1 hour after the completion of the infusion for signs and symptoms of hypersensitivity reactions.
Patienter kan skifte direkte fra beta interferon eller glatiramer acetat til natalizumab, forudsat at der ikke er relevante behandlingsrelaterede abnorme fund f. eks. neutropeni.
Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e. g. neutropenia.
Hvis der er
If there are signs of
2 behandlingsrelaterede abnorme fund, skal disse normaliseres, inden behandling med natalizumab påbegyndes.
2 treatment-related abnormalities these must return to normal before treatment with natalizumab is started.
Nogle patienter kan have været eksponeret for immunosuppressive lægemidler (f. eks. mitoxantron, cyclophosphamid, azathioprin).
Some patients may have been exposed to immunosuppressive medications (e. g. mitoxantrone, cyclophosphamide, azathioprine).
Disse lægemidler kan potentielt forårsage langvarig immunosuppression, selv efter at behandlingen er afbrudt.
These drugs have the potential to cause prolonged immunosuppression, even after dosing is discontinued.
Lægen skal derfor sikre sig, at sådanne patienter ikke er immunkompromitterede, inden behandling med TYSABRI påbegyndes.
Therefore the physician must confirm that such patients are not immunocompromised before starting treatment with TYSABRI.
Fortsat behandling bør overvejes nøje hos patienter, som ikke udviser tegn på terapeutisk gavn efter 6 måneders behandling.
Continued therapy must be carefully reconsidered in patients who show no evidence of therapeutic benefit beyond 6 months.
Data vedrørende sikkerheden og effekten af behandling med natalizumab ud over 2 år er ikke tilgængelige.
Data on the safety and efficacy of natalizumab beyond 2 years are not available.
Behandling ud over dette tidsrum bør kun ske efter en revurdering af mulige fordele og risici.
Continued therapy beyond this time should be considered only following a reassessment of the potential for benefit and risk.
4. 3).
TYSABRI is contraindicated in children and adolescents (see section 4.3).
Nyre - og leverinsufficiens
Renal and hepatic impairment
Der er ikke gennemført forsøg til undersøgelse af virkningerne ved nyre - eller leverinsufficiens.
Studies have not been conducted to examine the effects of renal or hepatic impairment.
Eliminationsmekanismen og resultater fra populations- farmakokinetiske undersøgelser tyder på, at dosisjustering ikke vil være nødvendig hos patienter med nyre - eller leverinsufficiens.
The mechanism for elimination and results from population pharmacokinetics suggest that dose adjustment would not be necessary in patients with renal or hepatic impairment.
Readministration
Readministration
4. 4.
The efficacy of re-administration has not been established, for safety see section 4.4.
Overfølsomhed over for natalizumab eller over for et eller flere af hjælpestofferne.
Hypersensitivity to natalizumab or to any of the excipients.
4. 4 og 4. 8).
Patients with increased risk for opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e. g. mitoxantrone or cyclophosphamide, see also sections 4.4 and 4.8).
Kombination med beta- interferoner eller glatiramer acetat.
Combination with beta-interferons or glatiramer acetate.
Dette gælder dog ikke patienter med kutant basalcelle karcinom.
Known active malignancies, except for patients with cutaneous basal cell carcinoma.