FrancophonIA/ELRC3.0 huggingface dataset:
English: • On the other hand, the switching from nimesulide to other Non-Steroidal Anti-inflamatory drugs may lead to an increase of gastrointestinal toxicity occurrences.
Danish: • På den anden side kan en overgang fra nimesulide til andre non-steroide antiinflammatoriske midler føre til en stigning i antallet af gastrointestinale tilfælde af toksicitet.
English: It was furthermore noted that alternative products also present some risks, namely of gastrointestinal bleeding.
Danish: Det blev ligeledes bemærket, at der også er en vis risiko i tilknytning til alternative lægemidler, herunder gastrointestinal blødning.
English: • Nimesulide presents a risk of hepatotoxicity, including risk of fulminant hepatic failure.
Danish: • Nimesulide medfører en risiko for hepatotoksicitet, herunder en risiko for fulminant leversvigt.
English: The restriction of the indication in the summary of the product characteristics should ensure that this prescription practice is followed in all Member States where the product is authorised.
Danish: Ved at begrænse indikationerne i produktresuméet kan det sikres, at denne receptpraksis følges i alle medlemsstater, hvor lægemidlet er tilladt.
English: The opinion adopted by the Committee for Medicinal Products for Human Use on 20 September 2007 recommended the maintenance of the national marketing authorisations for nimesulide-containing medicinal products with the introduction of several risk minimisation measures (limitation of the maximum duration of treatment, safety warnings in the product information, additional safety studies).
Danish: I sin udtalelse af 20. september 2007 anbefaler Udvalget for Humanmedicinske Lægemidler at opretholde de nationale markedsføringstilladelser for lægemidler indeholdende nimesulide, under forudsætning af at der samtidig indføres en række foranstaltninger til risikominimering (begrænsning af behandlingens maksimale varighed, sikkerhedsadvarsler i produktinformationen, supplerende sikkerhedsundersøgelser).
English: It also appeared from the discussions that certain Member States were applying at national level measures not reflected in the harmonised product information and intended to further reduce the risks associated with nimesulide.
Danish: Det fremgik også af drøftelserne, at medlemsstaterne på nationalt niveau anvender foranstaltninger, som ikke fremgår af den harmoniserede produktinformation, og som har til formål at begrænse de risici, der er forbundet med nimesulide.
English: In view of this situation, the Commission chairman decided not to submit the draft decision to a vote by the Standing Committee during the meeting but to refer the matter to the CHMP for further examination of any new reports of suspected hepatotoxicity related to nimesulide and identification and consideration of existing national measures, such as guidelines or recommendations, in relation to the use of nimesulide with a view to recommending necessary risk minimisation measures.
Danish: Formanden fra Kommissionen besluttede på mødet og på grundlag af disse forhold ikke at fremlægge udkastet til beslutning til afstemning i Det Stående Udvalg og at indbringe sagen for CHMP med henblik på yderligere undersøgelse af eventuelle nye rapporter om formodet hepatotoksicitet i tilknytning til nimesulide samt identifikation og vurdering af eksisterende nationale foranstaltninger, f.eks. retningslinjer eller anbefalinger, med hensyn til anvendelsen af nimesulide med henblik på en anbefaling af de nødvendige risikominimeringsforanstaltninger.
English: However, in view of the severity of the adverse events, these measures should in the Commission's perspective be further intensified by (1) limiting the prescription of nimesulide to second line treatment and by (2) introducing a clear obligation upon the marketing authorisation holder to inform healthcare professionals of the safety risks associated with this product.
Danish: Disse bivirkningers alvor taget i betragtning, bør disse foranstaltninger efter Kommissionens opfattelse yderligere styrkes ved 1) at begrænse ordineringen af nimesulide til andenlinjebehandling og 2) at indføre en klar forpligtelse for indehaveren af markedsføringstilladelsen til at informere fagfolk inden for sundhedssektoren om de sundhedsrisici, der er forbundet med dette lægemiddel.
English: • There are divergent views within the CHMP on the assessment of whether this risk may be addressed through risk minimisation measures allowing maintenance of the products on the market or whether the risk is such that the authorisation should be revoked.
Danish: • Der er inden for CHMP forskellige meninger om, hvorvidt problemerne i forbindelse med denne risiko kan løses gennem risikominimeringsforanstaltninger, der gør det muligt at opretholde lægemidlerne på markedet, eller om risikoen er af en sådan art, at tilladelsen bør inddrages.
English: Therefore, an increase in gastrointestinal toxicity events may occur if nimesulide ceases to be available.
Danish: Det kan derfor medføre en stigning i antallet af gastrointestinale tilfælde af toksicitet, hvis nimesulide ikke længere er til rådighed.
English: By letter dated 26 June 2008, the Chairman of the CHMP has informed the Commission that following the assessment of the new additional reports and consideration of other risk minimisation measures, the assessment report was updated with the new factual information and a CHMP opinion containing the same recommendations as the September opinion was put to a vote in the CHMP.
Danish: Ved skrivelse af 26. juni 2008 informerede formanden for CHMP Kommissionen om, at evalueringsrapporten på grundlag af evalueringen af de nye supplerende rapporter og i betragtning af de øvrige risikominimeringsforanstaltninger var blevet ajourført med de seneste faktuelle oplysninger, og at en udtalelse fra CHMP indeholdende de samme anbefalinger som udtalelsen fra september var lagt ud til afstemning i CHMP.
English: A significant number of members of the Committee expressed however a divergent opinion, sustaining that the benefit/risk profile of these products should be considered negative and that the marketing authorisations should rather be revoked.
Danish: Et betydeligt antal af udvalgets medlemmer havde dog en anden opfattelse, idet de gjorde gældende, at disse lægemidler måtte anses for at have et negativt risk/benefit-forhold, og at markedsføringstilladelserne derfor snarere burde inddrages.
English: These additional measures should contribute to minimising the risks associated with the use of nimesulide whilst awaiting the results of the Article 31 referral.
Danish: Disse supplerende foranstaltninger burde bidrage til at begrænse de risici, der er forbundet med anvendelsen af nimesulide, indtil resultaterne af undersøgelsen i henhold til artikel 31 foreligger.
English: Upon recommendation from the CHMP, given that an assessment of the gastrointestinal toxicity of nimesulide was outside the scope of the review procedure under Article 107, the Commission will initiate a referral under Article 31 of Directive 2001/83/EC, under which a full risk-benefit assessment will be undertaken.
Danish: Kommissionen vil efter anbefaling fra CHMP og under henvisning til, at en vurdering af den gastrointestinale toksicitetsprofil for nimesulide lå uden for rammerne af kontrolproceduren i artikel 107, indlede en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF, således at der kan blive foretaget en fuldstændig risk/benefit-vurdering.
English: It also appeared that a fundamental disagreement persisted among Member States competent authorities on whether risk minimisation measures were capable of addressing the risk of hepatotoxicity of the product.
Danish: Det viste sig også, at der var en grundlægende uenighed mellem medlemsstaternes kompetente myndigheder om, hvorvidt foranstaltninger til risikominimering er tilstrækkelige i forhold til den risiko for hepatotoxiticitet, der er forbundet med lægemidlet.
English: The risk minimisation measures proposed by the CHMP shall also be introduced as it is uncontested that the maintenance of the product in the market has to be accompanied by measures aiming at lowering the possibility of adverse events.
Danish: De risikominimeringsforanstaltninger, der foreslås af CHMP, bør ligeledes indføres, da der ikke er nogen tvivl om, at opretholdelsen af disse lægemidler på markedet bør ledsages af passende foranstaltninger med henblik på at begrænse muligheden for bivirkninger.
English: This approach is strengthened by the fact that a full risk-benefit assessment is to be conducted in the framework an Article 31 procedure, where the risks of nimesulide will be weighted vis-à-vis the gastrointestinal risks of other products.
Danish: Denne løsning understøttes ligeledes af det forhold, at der inden for rammerne af indbringelsesproceduren i artikel 31 vil blive foretaget en fuldstændig risk/benefit-vurdering, hvor risiciene ved nimesulide vil blive holdt op imod de gastrointestinale risici ved andre lægemidler.
English: The restriction of the indication to second line treatment is intended to ensure that nimesulide is not used as a routine pain killer where other treatment options which present a reduced hepatotoxic risk are available.
Danish: Formålet med kun at ordinere lægemidlet som andenlinjebehandling er at sikre, at nimesulide ikke anvendes rutinemæssigt som smertestillende middel, hvis der findes andre behandlingsformer med en lavere hepatotoksicitet.
English: This is a summary of the European public assessment report (EPAR) for Tolucombi.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tolucombi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tolucombi on 13 March 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tolucombi den 13. marts 2013.
English: The full EPAR for Tolucombi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tolucombi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tolucombi is a ‘generic medicine'.
Danish: Tolucombi er et ‘generisk lægemiddel'.
English: A risk management plan has been developed to ensure that Tolucombi is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Tolucombi anvendes så sikkert som muligt.
English: The Committee recommended that Tolucombi be approved for use in the EU.
Danish: Udvalget anbefalede, at Tolucombi godkendes til anvendelse i EU.
English: This means that Tolucombi is similar to a ‘reference medicine' already authorised in the European Union (EU) called MicardisPlus.
Danish: Det betyder, at Tolucombi er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder MicardisPlus.
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to Tolucombi.
Danish: Tabletterne med 80/25 mg anvendes til patienter, hvis blodtryk ikke kan kontrolleres med 80/12,5 mg-tabletterne, eller som er blevet stabiliseret ved hjælp af de to aktive stoffer indtaget separat, inden de skiftede til Tolucombi.
English: Tolucombi telmisartan / hydrochlorothiazide
Danish: Telmisartan/hydrochlorothiazid
English: Other information about Tolucombi
Danish: Andre oplysninger om Tolucombi
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tolucombi, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Tolucombi, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tolucombi has been shown to have comparable quality and to be bioequivalent to MicardisPlus.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Tolucombi er af sammenlignelig kvalitet og er bioækvivalent med MicardisPlus.
English: Tolucombi is available as tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide) to be taken by mouth once a day with liquid.
Danish: Tolucombi fås som tabletter (40 mg eller 80 mg telmisartan og 12,5 mg hydrochlorothiazid, 80 mg telmisartan og 25 mg hydrochlorothiazid), som indtages gennem munden en gang dagligt med væske.
English: For more information about treatment with Tolucombi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tolucombi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Tolucombi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tolucombi?
English: What are the benefits and risks of Tolucombi?
Danish: Hvilke fordele og risici er der forbundet med Tolucombi?
English: Because Tolucombi is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, MicardisPlus.
Danish: Da Tolucombi er et generisk lægemiddel, har patientundersøgelserne været begrænset til test for at fastslå, at det er bioækvivalent med referencelægemidlet MicardisPlus.
English: It is not intended to provide practical advice on how to use Tolucombi.
Danish: Det er ikke en praktisk vejledning i, hvordan Tolucombi bør anvendes.
English: What is Tolucombi and what is it used for?
Danish: Hvad er Tolucombi, og hvad anvendes det til?
English: Because Tolucombi is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Tolucombi er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Tolucombi contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Tolucombi indeholder to aktive stoffer, telmisartan og hydrochlorothiazid.
English: Tolucombi is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Danish: Tolucombi er et lægemiddel, som indeholder de to aktive stoffer telmisartan og hydrochlorothiazid.
English: For practical information about using Tolucombi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tolucombi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The dose of Tolucombi to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Danish: Patienter, som fik 40 mg telmisartan, skal tage 40/12,5 mg-tabletterne, og patienter, der fik 80 mg telmisartan, skal tage 80/12,5 mg-tabletterne.
English: Why is Tolucombi approved?
Danish: Hvorfor blev Tolucombi godkendt?
English: How has Tolucombi been studied?
Danish: Hvordan blev Tolucombi undersøgt?
English: How is Tolucombi used?
Danish: Hvordan anvendes Tolucombi?
English: How does Tolucombi work?
Danish: Hvordan virker Tolucombi?
English: Date of latest renewal: 19 July 2013.
Danish: Dato for seneste fornyelse: 19. juli 2013
English: Date of first authorisation: 15 September 2008.
Danish: Dato for første markedsføringstilladelse: 15. september 2008.
English: International retrospective study (2006)
Danish: International retrospektivt studie (2006)
English: 08409 Vilnius Lithuania
Danish: 08409 Vilnius
English: Do not warm Tevagrastim in any other way (for example, do not warm it in a microwave or in hot water).
Danish: De må ikke opvarme Tevagrastim på anden vis (for eksempel hverken ved at lægge den i mikroovnen eller i varmt vand).
English: Administer the dose as per standard protocol.
Danish: Administrer dosis i henhold til standardprotokollen.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Danish: En specifik studie af denne interaktion er ikke udført, men der foreligger ingen dokumentation, der viser, at en sådan interaktion skulle være skadelig.
English: It is unknown whether filgrastim/metabolites are excreted in human milk.
Danish: Det er ukendt, om filgrastim/dets metabolitter udskilles i human mælk.
English: Your doctor may want to monitor you closely , see section 4 of the package leaflet.
Danish: Deres læge vil måske overvåge Deres tilstand nøje, se punkt 4 i indlægssedlen.
English: Nevertheless, a risk of promotion of a malignant myeloid clone can not be excluded.
Danish: Risikoen for dannelsen af en malign myeloid klon kan dog ikke udelukkes.
English: 4.8 Undesirable effects a.Summary of the safety profile
Danish: 4.8 Bivirkninger a. Oversigt over sikkerhedsprofil
English: Name and address of the manufacturer of the biological active substance UAB Teva Baltics
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof UAB Teva Baltics
English: Timing of leukapheresis: 1 or 2 leukapheresis on days 5 and 6 are often sufficient.
Danish: Tidsplan for leukaferese: Ofte vil 1-2 leukafereser på dag 5 og 6 være tilstrækkeligt.
English: There were no relevant differences between Tevagrastim and the reference product with regard to duration of severe neutropenia and incidence of febrile neutropenia.
Danish: Der sås ingen relevante forskelle mellem Tevagrastim og referenceproduktet, hvad angår varighed af svær neutropeni og incidens af febril neutropeni.
English: The recommendation of a minimum yield of ≥ 2.0 x 106 CD34+ cells/kg is based on published experience resulting in adequate haematologic reconstitution.
Danish: Anbefalingen af en minimumshøst på ≥ 2,0 x 106 CD34+ celler/kg er baseret på publicerede erfaringer, der har medført en adækvat hæmatologisk rekonstitution.
English: Take your Tevagrastim pre-filled syringe out of the refrigerator.
Danish: Tag medicinsprøjten med Tevagrastim ud af køleskabet.
English: How long will I have to take Tevagrastim?
Danish: Hvor længe skal jeg tage Tevagrastim?
English: If you develop or are likely to develop cancers of the blood, you should not use Tevagrastim, unless instructed by your doctor.
Danish: Hvis De får eller med sandsynlighed kan udvikle blodkræft, må De ikke bruge Tevagrastim, medmindre lægen siger det.
English: How is Tevagrastim given and much should I take?
Danish: Hvordan gives Tevagrastim, og hvor meget skal jeg have?
English: Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
Danish: Tevagrastim er indiceret til mobilisering af perifere blodstamceller (PBPC).
English: Tevagrastim is a biosimilar medicinal product.
Danish: Tevagrastim er et biosimilært lægemiddel.
English: The needle safety guard will rapidly move to cover the needle (see picture 7).
Danish: Kanylebeskytteren flytter sig hurtigt, så kanylen dækkes (se figur 7).
English: Disinfect the injection site by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 5).
Danish: Desinficer indsprøjtningsstedet med en spritserviet, og tag godt fat i huden mellem tommel- og pegefinger uden at klemme til (se figur 5).
English: Tevagrastim is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection).
Danish: Tevagrastim gives normalt som en daglig indsprøjtning i vævet lige under huden (kaldes en subkutan injektion).
English: - if you are allergic to filgrastim or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for filgrastim eller et af de øvrige indholdsstoffer i Tevagrastim (angivet i punkt 6).
English: Tell your doctor or pharmacist if you are using have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: Before you inject Tevagrastim you must do the following:
Danish: Før injektion af Tevagrastim skal De foretage følgende:
English: > 2.0 x 109/L).
Danish: (ANC > 2,0 x 109/l).
English: Check again to make sure the correct dose of Tevagrastim is in the syringe.
Danish: Tjek en ekstra gang for at sikre, at medicinsprøjten indeholder den korrekte dosis Tevagrastim.
English: When diluted in glucose 50 mg/mL (5 %) solution for infusion, Tevagrastim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
Danish: Ved fortynding med 50 mg/ml (5 %) glucose infusionsvæske er Tevagrastim kompatibelt med glas og flere plastmaterialer inklusive PVC, polyolefin (et copolymer af polypropylen og polyethylen) og polypropylen.
English: Reversal of neutropenia or maintaining normal neutrophil counts:Filgrastim should be given by subcutaneous injection.
Danish: Reversering af neutropeni eller opretholdelse af normale neutrofiltal: Filgrastim skal gives som subkutan injektion.
English: If you become pregnant during Tevagrastim treatment, please inform your doctor.
Danish: Hvis De bliver gravid under behandling med Tevagrastim, skal De fortælle det til lægen.
English: In cancer patients, the pharmacokinetic profile of Tevagrastim and the reference product was comparable after single and repeated subcutaneous administration.
Danish: Hos cancerpatienter var den farmakokinetiske profil af Tevagrastim og referenceproduktet sammenlignelige efter en enkelt og gentagne subkutane doser.
English: This section contains information on how to give yourself an injection of Tevagrastim.
Danish: Dette afsnit indeholder oplysninger om, hvordan De kan give Dem selv indsprøjtninger med Tevagrastim.
English: The efficacy and safety of Tevagrastim has been assessed in randomised, controlled phase III studies in breast cancer, lung cancer and Non-Hodgkin-Lymphoma.
Danish: Tevagrastims sikkerhed og virkning er undersøgt i randomiserede, kontrollerede fase III-studier hos patienter med brystcancer, lungecancer og non-Hodgkin-lymfom.
English: You will need to take Tevagrastim until your white blood cell count is normal.
Danish: De skal tage Tevagrastim, indtil Deres antal af hvide blodlegemer er normalt.
English: Randomised, single-blind, single dose, crossover studies in 196 healthy volunteers showed that the pharmacokinetic profile of Tevagrastim was comparable to that of the reference product after subcutaneous and intravenous administration.
Danish: Randomiserede, enkeltblinde, crossover-studier med enkeltdosis, der omfattede 196 raske forsøgspersoner, viste, at Tevagrastims farmakokinetiske profil var sammenlignelig med profilen af referenceproduktet efter subkutan og intravenøs administration.
English: (300 μg)/day is recommended.
Danish: (300 μg)/døgn.
English: Do not release the pressure on the plunger!
Danish: Slip ikke trykket på stemplet!
English: Tevagrastim is a white blood cell growth factor (granulocyte colony stimulating factor) and belong to a group of medicines called cytokines.
Danish: Tevagrastim er en vækstfaktor (granulocyt-kolonistimulerende faktor) for hvide blodlegemer og tilhører en gruppe af lægemidler, som kaldes cytokiner.