natgillin/translations-raw huggingface dataset:
Trafik - og arbejdssikkerhed Virkningen på evnen til at køre bil eller betjene maskiner er ikke undersøgt.
Driving and using machines The effects on the ability to drive and to use machines have not been studied.
Vigtig information om nogle af de øvrige indholdsstoffer i Aldurazyme Dette lægemiddel indeholder 1, 29 mmol natrium pr. hætteglas.
Important information about some of the ingredients of Aldurazyme This medicinal product contains 1.29 mmol sodium per vial.
SÅDAN SKAL DE BRUGE ALDURAZYME
HOW TO USE ALDURAZYME
Instruktioner vedrørende anvendelsen – opløsning og indgivelse Koncentratet til opløsning til infusion skal fortyndes før indgivelse og er beregnet til intravenøs brug (se oplysningerne til sundhedspersonalet).
Instruction for use - dilution and administration The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals).
Dosering Den anbefalede dosering for Aldurazyme er 100 E/ kg kropsvægt, der indgives én gang om ugen som intravenøs infusion.
Dosage The recommended dosage regimen of Aldurazyme is 100 U/ kg body weight given once every week as an intravenous infusion.
Den indledende infusionshastighed på 2 E/ kg/ t kan gradvist øges for hver 15 minutter, hvis det tåles, til maksimalt 43 E/ kg/ t.
The initial infusion rate of 2 U/ kg/ h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/ kg/ h.
Hvis De er gået glip af en Aldurazyme- infusion, bedes De kontakte Deres læge.
If you forget to use Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor.
Der er ikke rapporteret tilfælde af overdosering.
If you use more Aldurazyme than you should No case of overdose of Aldurazyme has been reported.
Aldurazyme kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Aldurazyme can cause side effects, although not everybody gets them.
Bivirkningeme blev hovedsagligt observeret, mens patienterne fik medicinen eller kort tid derefter (infusionsrelaterede reaktioner).
Side effects were mainly seen while patients were being given the medicine or shortly after (infusion- associated reactions).
Hvis De oplever en sådan reaktion, skal De straks fortælle det til Deres læge.
If you experience any reaction like this, please tell your doctor immediately.
Størstedelen af disse reaktioner var milde eller moderate i styrke.
The majority of these reactions were mild or moderate in intensity.
Nogle få patienter, som havde tidligere tilfælde af alvorlige angreb på øvre luftveje og lunger, som var MPI I- relateret, oplevede dog alvorlige reaktioner, herunder bronchospasme, åndedrætsstop og hævelse i ansigtet.
However, a few patients who had a prior history of severe MPS I related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and swelling of the face.
21 Følgende bivirkninger blev indberettet i kliniske forsøg:
In clinical trials the following side effects were reported:
Meget almindelige (opstår for mere end 1 ud af 10 patienter) • hovedpine • kvalme • mavesmerter • udslæt • ledsygdom, ledsmerter, rygsmerter, smerter i arme eller ben • rødmen • feber • kulderystelser • hurtig hjerterytme • forhøjet blodtryk • mindre ilt i blodet • reaktion på infusionsstedet
20 Very common (occurring in more than 1 in 10 patients) • headache • nausea • abdominal pain • rash • joint disease, joint pain, back pain, pain in arms or legs • flushing • fever • chills • increased heart rate • increased blood pressure • less oxygen in the blood • reaction at the infusion site
Almindelige (opstår for mere end 1 ud af 100 patienter og for mindre end 1 ud af 10 patienter) • forhøjet legemstemperatur • prikken • svimmelhed • hoste • åndedrætsbesvær, som kan være ekstrem • opkastning • diaré • hævelse i ansigt eller hals • nældefeber • kløe • hårtab • koldsved, kraftig svedtendens • muskelsmerter • lavt blodtryk • bleghed • kolde hænder eller fødder • følelse af varme, følelse af kulde • træthed • influenzalignende sygdom • allergisk reaktion • hvileløshed
Common (occurring in more than 1 in 100 patients and less than 1 in 10 patients) • increased body temperature • tingling • dizziness • cough • difficulty in breathing which may be extreme • vomiting • diarrhoea • swelling of the face or neck • hives • itching • hair loss • cold sweat, heavy sweating • muscle pain • low blood pressure • paleness • cold hands or feet • feeling hot, feeling cold • fatigue • influenza like illness • allergic reaction • restlessness
SÅDAN OPBEVARER DE ALDURAZYME
HOW TO STORE ALDURAZYME
Brug ikke Aldurazyme efter den udløbsdato, der står på pakningen efter bogstaverne EXP.
Do not use Aldurazyme after the expiry date which is stated on the label after the letters EXP.
22 6.
21 6.
Aldurazyme indeholder:
What Aldurazyme contains
- Aktivt stof: laronidase.
- The active substance is laronidase.
1 ml af opløsningen i hætteglasset indeholder 100 U laronidase. Hvert
One ml of the solution in the vial contains 100 U of
hætteglas på 5 ml indeholder 500 U laronidase.
Each vial of 5 ml contains 500 U of laronidase.
dibasisk heptahydrat, polysobat 80, vand til injektion
Sodium chloride, Sodium phosphate monobasic monohydrate, Sodium phosphate dibasic heptahydrate, Polysorbate 80, Water for injections
Aldurazymes udseende og pakningsstørrelse Aldurazyme leveres som et koncentrat til opløsning til infusion.
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
1, 10 og 25 hætteglas pr. karton.
1, 10 and 25 vials per carton.
Indehaver af markedsføringstilladelsen Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD, Naarden, Holland.
Marketing Authorisation Holder Genzyme Europe B. V., Gooimeer 10, NL-1411 DD, Naarden, The Netherlands.
Fremstilleren Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Storbritannien.
Manufacturer Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom.
23 Hvis De vil have yderligere oplysninger om Aldurazyme, skal De henvende Dem til den lokale repræsentant:
22 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Aldurazyme er godkendt under ” særlige omstændigheder ”.
This medicine has been authorised under “ exceptional circumstances”.
Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for Aldurazyme, fordi det drejer sig om en sjælden sygdom.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Det europæiske Lægemiddelagentur (EMEA) vurderer hvert år ny information vedrørende Aldurazyme, og denne indlægsseddel vil om nødvendigt blive opdateret.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
De kan finde yderligere information om Aldurazyme på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
23 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
24 ------------------------------------------------------------------------------------------------------------------------------
If not used immediately, in-use storage should not be longer than 24 hours at 2°C - 8°C provided that dilution has taken place under controlled and validated aseptic conditions.
Følgende oplysninger er kun tiltænkt læger og sundhedspersonale:
Aldurazyme should not be mixed with other medicinal products in the same infusion.
Hvert hætteglas med Aldurazyme er kun beregnet til engangsbrug.
Preparation of the Aldurazyme Infusion (Use Aseptic Technique) Determine the number of vials to be diluted based on the individual patient's weight.
Koncentratet til opløsning til infusion skal fortyndes med 9 mg/ ml (0, 9%) natriumkloridopløsning til infusion med aseptisk teknik.
Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚ C).
Det anbefales, at den fortyndede Aldurazyme- opløsning indgives til patienterne med et infusionssæt, der er udstyret med et 0, 2 µm in- line- filter.
Before dilution, visually inspect each vial for particulate matter and discoloration.
Af hensyn til den mikrobiologiske sikkerhed skal produktet anvendes med det samme.
The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles.
Hvis det ikke anvendes med det samme, må det ikke opbevares mere end 24 timer ved 2°C - 8°C, forudsat at fortyndingen er sket under kontrollerede og validerede aseptiske betingelser.
Do not use vials exhibiting particles or discoloration.
Aldurazyme bør ikke blandes med andre lægemidler i samme infusion.
Determine the total volume of infusion based on the individual patient's weight, either 100 ml (if bodyweight is less or equal than 20 kg) or 250 ml (if bodyweight is more than 20 kg) of 0.9% sodium chloride intravenous solution.
Klargøring af Aldurazyme- infusionen (brug aseptisk teknik) • Beregn det antal hætteglas, der skal fortyndes, på basis af den enkelte patients vægt.
Withdraw and discard a volume of sodium chloride 9 mg/ ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
Tag det nødvendige antal hætteglas ud af køleskabet ca.
Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
20 minutter før, så de kan opnå stuetemperatur (under 30°C). • Før fortynding efterses hvert hætteglas for fremmedlegemer og misfarvning.
Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ ml (0.9%) solution for infusion.
Den klare til let opaliserede og farveløse til lysegule opløsning skal være fri for synlige partikler.
Prior to use visually inspect the solution for particulate matter.
Hvad er Alimta?
What is Alimta?
Alimta er et pulver, der blandes til en infusionsvæske (opløsning), der gives ved dråbetilførsel i en vene.
Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Alimta anvendes til behandling af to kræfttyper: • lungehindekræft, der sædvanligvis skyldes udsættelse for asbest.
Alimta is used to treat two types of cancer: • pleural mesothelioma (cancer of the lining of the lungs that is usually caused by exposure to asbestos).
Alimta anvendes her sammen med cisplatin (en anden kræftmedicin), når kræften ikke kan fjernes ved operation, og når kræften har bredt sig eller let kan brede sig fra det oprindelige sygdomssted til andre dele af kroppen, hos patienter, der ikke tidligere har fået kemoterapi (lægemidler mod kræft), • fremskreden eller metastatisk ” ikke- småcellet ” lungekræft, som ikke påvirker pladecellerne.
Alimta is used together with cisplatin (another anticancer medicine) when the cancer is ‘ unresectable’ (cannot be removed by surgery alone) and ‘ malignant’ (has spread, or is likely to spread easily, to other parts of the body), in patients who have not received chemotherapy (medicines for cancer) before. • advanced or metastatic ‘ non-small cell’ lung cancer that is not affecting the ‘ squamous’ cells.
Alimta anvendes i kombination med cisplatin til patienter, der ikke er behandlet tidligere, og alene til patienter, der tidligere har fået en anden type kemoterapi.
Alimta is used in combination with cisplatin in patients who have not been treated before, and on its own in patients who have received another type of chemotherapy in the past.
Alimta bør kun gives under opsyn af en læge med tilstrækkeligt kendskab til brug af kemoterapi.
Alimta should only be given under the supervision of a doctor who is qualified in the use of anti-cancer chemotherapy.
Den anbefalede dosis af Alimta er 500 mg pr. kvadratmeter legemsoverflade (beregnet efter patientens højde og vægt).
The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient ’ s height and weight).
Det gives hver tredje uge ved en intravenøs infusion, der varer 10 minutter.
It is given once every three weeks as an intravenous infusion lasting 10 minutes.
For at mindske bivirkningerne bør patienten under behandlingen med Alimta have et kortikosteroid, folinsyre (et vitamin) og indsprøjtninger med vitamin B12.
To reduce side effects, patients should take a corticosteroid and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Når Alimta gives sammen med cisplatin, bør der desuden før og efter cisplatindosen gives medicin mod kvalme og opkastninger samt væsketilskud for at forhindre udtørring.
When Alimta is given with cisplatin, an ‘ anti-emetic’ medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Hvis patienten får unormale blodtal, eller der opstår visse andre bivirkninger, bør behandlingen udsættes eller standses eller dosen nedsættes.
Treatment should be delayed or discontinued, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Alimta anbefales ikke til patienter med moderat eller svær nyresygdom.
Alimta is not recommended for use in patients with moderate or severe kidney problems.
Yderligere oplysninger fremgår af produktresuméet, der ligeledes er en del af EPAR.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Det hører til gruppen af stofskiftehæmmere.
The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘ anti-metabolites’.
I kroppen omdannes 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In the body, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged pemetrexed til en aktiv form, der blokerer de enzymer, der medvirker ved dannelsen af nukleotider, som er byggestenene i dna og rna, cellernes genetiske materiale.
Reproduction is authorised provided the source is acknowledged. pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘ nucleotides’ (the building blocks of DNA and RNA, the genetic material of cells).
Dannelsen af dna og rna bremses derved af den aktive form af pemetrexed, så cellerne forhindres i at dele sig.
As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing.
Derfor findes den aktive form af lægemidlet i højere koncentration og i længere tid i kræftceller end i normale celler.
The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Det får derfor kræftcellerne til at dele sig langsommere, hvorimod det kun har ringe virkning på normale celler.
This results in the division of cancer cells being reduced, while normal cells are only slightly affected.
Til behandling af lungehindekræft blev Alimta anvendt i én hovedundersøgelse hos 456 patienter, der ikke tidligere havde fået kemoterapi mod sygdommen.
For the treatment of malignant pleural mesothelioma, Alimta has been studied in one main study in 456 patients who had not received chemotherapy for their disease before.
Virkningerne Alimta, anvendt i kombination med cisplatin, blev sammenholdt med virkningerne af cisplatin alene.
The effects of Alimta in combination with cisplatin were compared with those of cisplatin alone.
Patienterne havde lokalt fremskreden eller metastatisk sygdom og havde tidligere havde fået kemoterapi.
For the treatment of non-small cell lung cancer, the effects of Alimta were compared with those of docetaxel (another anticancer medicine) in one study involving 571 patients with locally advanced or metastatic disease who had received chemotherapy in the past.
Alimta blev også sammenlignet med gemcitabin (et andet lægemiddel mod kræft), begge i kombination med cisplatin, i en undersøgelse med deltagelse af 1 725 patienter, som ikke tidligere havde fået kemoterapi mod lungekræft.
Alimta was also compared with gemcitabine (another anticancer medicine), both in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy for lung cancer in the past.
I alle tre undersøgelser blev behandlingens virkning hovedsagelig bedømt på, hvor længe patienterne overlevede.
In all three studies, the main measure of effectiveness was how long the patients survived.
Alimta øgede overlevelsestiden hos patienter med lungehindekræft.
Alimta increased the survival time of patients with malignant pleural mesothelioma.
De patienter, der fik Alimta og cisplatin, overlevede i gennemsnit i 12, 1 måneder, sammenholdt med 9, 3 måneder for dem, der kun fik cisplatin.
Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
I behandlingen af patienter med ikke- småcellet lungekræft var Alimta ligeså effektivt som sammenligningspræparaterne.
In the treatment of patients with non-small cell lung cancer, Alimta was as effective as the comparators.
Hos patienter, der tidligere havde fået kemoterapi, var den gennemsnitlige overlevelsestid for patienter, der fik Alimta, 8, 3 måneder, sammenlignet med 7, 9 måneder for dem, der fik docetaxel.
In patients who had received chemotherapy in the past, the average survival time was 8.3 months with Alimta, compared with 7.9 months with docetaxel.
Hos patienter, der ikke tidligere havde fået kemoterapi, var den gennemsnitlige overlevelsestid 10, 3 måneder i begge grupper.
In patients who had not received chemotherapy in the past, the average survival time was 10.3 months in both groups.
I begge undersøgelser havde patienter, hvis kræft ikke påvirkede pladecellerne, imidlertid en længere overlevelsestid, hvis de fik Alimta, end hvis de fik et sammenligningspræparat.
However, in both studies, patients whose cancer was not affecting squamous cells had longer survival times if they received Alimta than if they received the comparator.
Patienter, hvis kræft påvirkede pladecellerne, havde derimod en kortere overlevelsestid, hvis de fik Alimta.
In contrast, patients whose cancer was affecting squamous cells had had shorter survival times if they received Alimta.
De almindeligste bivirkninger af Alimta (der ses hos flere end 1 ud af 10 patienter) er nedsat mængde af neutrofiler eller granulocytter og af leukocytter (typer af hvide blodlegemer), nedsat hæmoglobin (det protein i de røde blodlegemer, der transporterer ilt rundt i kroppen) diarré, opkastning, mund - eller svælgbetændelse, kvalme, appetitløshed, træthed og udslæt eller skællende hud.
The most common side effects with Alimta (seen in more than 1 patient in 10) are decreased levels of neutrophils or granulocytes and of leucocytes (types of white blood cell), decreased levels of haemoglobin (the protein found in red blood cells that carries oxygen around the body), diarrhoea, vomiting, stomatitis or pharyngitis (inflammation of the lining of the mouth or throat), nausea (feeling sick), anorexia (loss of appetite), fatigue (tiredness), and rash or desquamation (shedding of the upper layers of the skin).
Den fuldstændige liste over de indberettede bivirkninger for Alimta fremgår af indlægssedlen.
For the full list of all side effects reported with Alimta, see the Package Leaflet.
Alimta bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for pemetrexed eller andre af indholdsstofferne.
Alimta should not be used in people who may be hypersensitive (allergic) to pemetrexed or any of the other ingredients.
Det bør ikke anvendes hos patienter, der ammer, og bør ikke gives samtidig med vaccination mod gul feber.
It should not be used during breast feeding or at the same time as the vaccine for yellow fever.
Dette bør både mandlige og kvindelige patienter gøres opmærksomme på.
Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Alimta opvejer risiciene i kombination med cisplatin til behandling af kemoterapi- naive patienter med inoperabel lungehindekræft og i kombination med cisplatin til førstevalgsbehandling og som monoterapi ved andetvalgsbehandling af patienter med lokalt fremskreden eller metastatisk, ikke- småcellet længekræft uden dominerende pladecellehistologi.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Alimta’ s benefits are greater than its risks in combination with cisplatin for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma, and in combination with cisplatin for the first line treatment and as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Alimta.
The Committee recommended that Alimta be given marketing authorisation.
Andre oplysninger om Alimta:
Other information about Alimta:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Alimta til Eli Lilly Nederland B. V. den 20. september 2004.
The European Commission granted a marketing authorisation valid throughout the European Union for Alimta to Eli Lilly Nederland B. V. on 20 September 2004.
2/ 3 Den fuldstændige EPAR for Alimta findes her.
The full EPAR for Alimta can be found here.
EU- nummer EU/ 1/ 04/ 290/ 001 EU/ 1/ 04/ 290/ 002
EU Number EU/ 1/ 04/ 290/ 001 EU/ 1/ 04/ 290/ 002
Særnavn Alimta Alimta
Invented name Alimta Alimta
Styrke 500 mg 100 mg
Strength 500 mg 100 mg
Lægemiddelform Pulver til koncentrat til infusionsvæske, opløsning Pulver til koncentrat til infusionsvæske, opløsning
Pharmaceutical Form Powder for concentrate for solution for infusion Powder for concentrate for solution for infusion
Indgivelsesvej Intravenøs anvendelse Intravenøs anvendelse
Route of Administration Intravenous use Intravenous use
Emballage Hætteglas (glas) Hætteglas (glas)
Packaging vial (glass) vial (glass)
Pakningsstørrelse 1 hætteglas 1 hætteglas
Package size 1 vial 1 vial
Hvert hætteglas skal rekonstitueres med 4, 2 ml natriumchlorid 9 mg/ ml (0, 9%) injektionsvæske, som resulterer i en opløsning på 25 mg/ ml.
Each vial must be reconstituted with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection resulting in 25 mg/ ml of solution.
6. 6).
The appropriate volume of required dose is removed from the vial and further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection (see section 6.6.).
Hvidt til lysegult eller grøngult frysetørret pulver.
A white to either light yellow or green-yellow lyophilised powder.
Malignt pleura mesotheliom ALIMTA er indiceret til behandling af patienter med inoperabelt malignt pleura mesotheliom i kombination med cisplatin, som ikke tidligere har været i kemoterapi.
ALIMTA in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
5. 1).
ALIMTA in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
5. 1).
ALIMTA is indicated as monotherapy for the second line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
6. 6.
The ALIMTA solution must be prepared according to the instructions provided in section 6.6.
ALIMTA i kombination med cisplatin:
ALIMTA in combination with cisplatin:
Den anbefalede dosis af ALIMTA er 500 mg/ m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21- dages- cyklus.
The recommended dose of ALIMTA is 500 mg/ m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.