FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not pull off the needle cap until you are ready to inject.
Danish: Lad være med at fjerne kanylehætten, før du er klar til at indsprøjte Kevzara.
English: kevzara 150 mg syringe
Danish: kevzara 150 mg sprøjte
English: Do not remove the cap until you are ready to inject.
Danish: Lad være med at fjerne hætten, før du er klar til at indsprøjte Kevzara.
English: Platelet count Treatment with Kevzara was associated with a reduction in platelet counts in clinical studies.
Danish: Trombocyttal I kliniske studier er behandling med Kevzara blevet associeret med fald i antallet af trombocytter.
English: Kevzara 150 mg solution for injection in pre-filled pen Kevzara 200 mg solution for injection in pre-filled pen
Danish: Kevzara 150 mg injektionsvæske, opløsning i fyldt pen Kevzara 200 mg injektionsvæske, opløsning i fyldt pen
English: • Use your thumb and first (index) finger to pinch a fold of skin at the injection site.
Danish: • Klem huden omkring injektionsstedet sammen med tommel- og pegefingeren.
English: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange cap.
Danish: Fyldt pen 200 mg: Fyldt pen til engangsbrug med et gult kanylebeskyttelseshylster og en mørk orange hætte.
English: Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people):
Danish: Fortæl det til lægen, apotekspersonalet eller sundhedspersonalet, hvis du får en eller flere af følgende bivirkninger:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED PEN
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - PAKNING MED 1 FYLDT PEN
English: EU/1/17/1196/008 6 pre-filled pens (3 packs of 2)
Danish: EU/1/17/1196/008 6 fyldte penne (3 pakninger med hver 2)
English: Solution for injection 2 pre-filled syringes.
Danish: injektionsvæske, opløsning 2 fyldte injektionssprøjter.
English: Kevzara 200 mg + MTX N = 399
Danish: Kevzar a 200 mg + MTX N = 399
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 2 PRE-FILLED SYRINGES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON - PAKNING MED 2 FYLDTE INJEKTIONSSPRØJTER
English: solution for injection 2 pre-filled pens
Danish: injektionsvæske, opløsning 2 fyldte penne
English: If you miss a dose of Kevzara
Danish: Hvis du har brugt for meget Kevzara
English: How Kevzara works
Danish: Sådan virker Kevzara
English: EU/1/17/1196/006 6 pre-filled pens (3 packs of 2)
Danish: EU/1/17/1196/006 6 fyldte penne (3 pakninger med hver 2)
English: solution for injection 2 pre-filled pens.
Danish: injektionsvæske, opløsning 2 fyldte penne.
English: MTX exposure is not expected to be changed by sarilumab coadministration; however, no clinical data was collected.
Danish: MTXeksponering forventes ikke at blive påvirket af samtidig administration af sarilumab.
English: Kevzara 200 mg q2w* + MTX (N = 399)
Danish: KEVZARA 200 mg + MTX (N=399)
English: solution for injection 2 pre-filled syringes
Danish: injektionsvæske, opløsning 2 fyldte injektionssprøjter
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on neutrophil counts were consistent with those seen in the placebo-controlled population (see section 4.4).
Danish: I langtidssikkerhedspopulationen med Kevzara + DMARDs og populationen med Kevzara som monoterapi svarede de observerede neutrofiltal til de neutrofiltal, der blev observeret i den placebokontrollerede population (se pkt.
English: Each pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Danish: Hver fyldt pen indeholder 200 mg sarilumab i 1,14 ml opløsning (175 mg/ml).
English: EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2)
Danish: EU/1/17/1196/004 6 fyldte injektionssprøjter (3 pakninger med hver 2)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 2 PRE-FILLED PENS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON - PAKNING MED 2 FYLDTE PENNE
English: ALT
Danish: Hætte
English: Liver Enzyme Abnormalities Lab Value
Danish: Leverenzymanormaliteter Laboratorieværdi
English: Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled syringe
Danish: Kevzara 150 mg injektionsvæske, opløsning i fyldt injektionssprøjte Kevzara 200 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON - PAKNING MED 1 FYLDT injektionssprøjte
English: Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Danish: Hver fyldt pen indeholder 150 mg sarilumab i 1,14 ml opløsning (131,6 mg/ml).
English: Posology
Danish: Vindue
English: solution for injection 1 pre-filled syringe
Danish: injektionsvæske, opløsning 1 fyldt injektionssprøjte
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on platelet counts were consistent with those seen in the placebo-controlled population.
Danish: I langtidssikkerhedspopulationen med Kevzara + DMARDs og i populationen med Kevzara som monoterapi var trombocyttallene de samme som i den placebokontrollerede population.
English: Kevzara 150 mg q2w* + MTX (N = 400)
Danish: KEVZARA 150 mg + MTX (N=400)
English: EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2)
Danish: EU/1/17/1196/002 6 fyldte injektionssprøjter (3 pakninger med hver 2)
English: Do not dispose of your used puncture-resistant container in your household waste unless your local guidelines permit this.
Danish: Læg ikke den brugte sprøjte i dit husholdningsaffald eller din skraldespand.
English: Do not touch the needle.
Danish: Røre ved kanylen.
English: Learning how to use the pre-filled syringe
Danish: Sådan skal du bruge den fyldte injektionssprøjte
English: AST
Danish: ASAT
English: Do not remove the needle cap until just before you are ready to inject.
Danish: Fjerne kanylehætten, indtil lige inden du skal foretage indsprøjtningen.
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations in lipid parameters were consistent with those seen in the placebo-controlled population.
Danish: De observerede lipidparametre i langtidssikkerhedspopulationen med Kevzara + DMARDs og populationen med Kevzara monoterapi svarede til lipidparametrene i den placebokontrollerede population.
English: Each single-dose pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Danish: Hver enkeltdosis fyldt pen indeholder 200 mg sarilumab i 1,14 ml opløsning (175 mg/ml).
English: Each single-dose pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Danish: Hver enkeltdosis fyldt pen indeholder 150 mg sarilumab i 1,14 ml opløsning (131,6 mg/ml).
English: Rensselaer
Danish: Kevzara
English: Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Danish: Hver enkeltdosis fyldt injektionssprøjte indeholder 200 mg sarilumab i 1,14 ml opløsning (175 mg/ml).
English: Do
Danish: min
English: Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Danish: Hver enkeltdosis fyldt injektionssprøjte indeholder 150 mg sarilumab i 1,14 ml opløsning (131,6 mg/ml).
English: Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Danish: Hver fyldt injektionssprøjte indeholder 200 mg sarilumab i 1,14 ml opløsning (175 mg/ml).
English: Kevzara 200 mg q2w (N=184)
Danish: 200 mg hver 2. uge (N=184)
English: Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Danish: Hver fyldt injektionssprøjte indeholder 150 mg sarilumab i 1,14 ml opløsning (131,6 mg/ml).
English: KEVZARA 200 mg solution for injection in pre-filled syringe sarilumab
Danish: KEVZARA 200 mg injektionsvæske, opløsning i fyldt injektionssprøjte sarilumab
English: Do not remove the cap until just before you are ready to inject.
Danish: Fjerne hætten, indtil lige inden du skal foretage indsprøjtningen.
English: Тел.
Danish: Kanyle
English: Kevzara 200 mg solution for injection in a pre-filled syringe sarilumab
Danish: Kevzara 200 mg injektionsvæske, opløsning i fyldt injektionssprøjte sarilumab
English: Placebo
Danish: Trombocyttal
English: KEVZARA 200 mg q2w* + MTX (N = 399)
Danish: Kevzara 200 mg hver 2. uge + MTX (N = 399)
English: Kevzara 200 mg solution for injection in a pre-filled pen sarilumab
Danish: Kevzara 200 mg injektionsvæske, opløsning i fyldt pen sarilumab
English: • Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag.
Danish: • Når sprøjten er taget ud af køleskabet eller køleboksen/køletasken, skal den anvendes inden for 14 dage.
English: • 1 pre-filled syringe
Danish: • 1 fyldt injektionssprøjte
English: Consider the risks and benefits of treatment prior to initiating Kevzara in patients who have:
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Kevzara, hvis du tager noget af følgende medicin:
English: The opinion was converted into a Decision by the European Commission on 14 July 2014.
Danish: Udtalelsen blev konverteret til en afgørelse truffet af Europa-Kommissionen den 14. juli 2014.
English: 14 July 2014
Danish: Den 14. juli 2014
English: on 10 February 2014.
Danish: den 10. februar 2014.
English: The presentations for dogs have been nationally authorised in the Czech Republic since December 2011, and the presentation for cats has also been nationally authorised in the Czech Republic since May 2012.
Danish: Styrkerne til hunde har været nationalt godkendt i Tjekkiet siden december 2011, og styrken til katte har været nationalt godkendt i Tjekkiet siden maj 2012.
English: were involved ( Austria, Belgium, Denmark, Greece, Ireland, Italy, the Netherlands, Spain, the Slovak Republic and the United Kingdom).
Danish: anerkendelsesprocedure var Tjekkiet, og der var ti berørte medlemsstater (Østrig, Belgien, Danmark, Grækenland, Irland, Italien, Nederlandene, Spanien, Slovakiet og Det Forenede Kongerige).
English: notified the Agency of their intention to request a re-examination of the CVMP opinion of 11 December 2013.
Danish: agenturet om, at virksomheden havde til hensigt at anmode om fornyet overvejelse af CVMP's udtalelse af 11. december 2013.
English: International non-proprietary name (INN): fipronil
Danish: Internationalt fællesnavn (INN): fipronil
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De videnskabelige konklusioner findes i bilag II, og betingelserne for ophævelse af suspenderingen af markedsføringstilladelserne findes i bilag III.
English: The mutual recognition procedures, CZ/V/0116/001/MR concerning the presentation for cats and CZ/V/0116/002-005/MR concerning the four presentations for dogs, started on 25 October 2012.
Danish: De gensidige anerkendelsesprocedurer (CZ/V/0116/001/MR for styrken til katte og CZ/V/0116/002-005/MR for de fire styrker til hunde) blev indledt den 25. oktober 2012.
English: Written explanations were provided by the marketing authorisation holder on 10 September 2013 and 21 October 2013.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 10. september 2013 og den 21. oktober 2013.
English: Oral explanations were given on 10 December
Danish: Mundtlige redegørelser blev afgivet den 10. december 2013.
English: Fiprex is available in five different presentations, one for cats and four for different sizes of dogs.
Danish: Fiprex leveres i fem forskellige styrker, nemlig en til katte, og fire til hunde af forskellig størrelse.
English: The re-examination procedure started on 11 February 2014.
Danish: Proceduren for fornyet overvejelse blev indledt den 11. februar 2014.
English: The CVMP therefore adopted by majority a negative opinion recommending the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations for the aforementioned veterinary medicinal products.
Danish: CHMP vedtog derfor ved flertalsafgørelse en negativ udtalelse, der anbefalede afslag på ansøgningen om udstedelse af markedsføringstilladelse og suspendering af markedsføringstilladelserne for ovennævnte veterinærlægemidler.
English: On 20 December 2013, Vet-Agro Trading Sp. z o.o.
Danish: Den 20. december 2013 underrettede Vet-Agro Trading Sp. z o.o.
English: During its meeting of 14-16 January 2014 the CVMP appointed R. Breathnach as rapporteur and B. Zemann as the co-rapporteur for the re-examination procedure.
Danish: På sit møde den 14.-16. januar 2014 udnævnte CVMP R. Breathnach og B. Zemann som henholdsvis rapportør og medrapportør vedrørende proceduren for fornyet overvejelse.
English: for up to 28 days after administration, for the control of Flea Allergy Dermatitis, as well as for treatment and prevention of tick (Ixodes spp., Rhipicephalus sanguineus and Dermacentor reticulatus) infestations between 7 and 21 days after administration.
Danish: i op til 28 dage efter administration, til kontrol af loppebetinget allergisk dermatitis og til behandling og forebyggelse af angreb af flåter (Ixodes spp., Rhipicephalus sanguineus og Dermacentor reticulatus) mellem 7 og 21 dage efter administration.
English: The detailed grounds for the re-examination request were submitted by Vet-Agro Trading Sp. z o.o.
Danish: Den detaljerede begrundelse for anmodningen om fornyet overvejelse blev indgivet af Vet-Agro Trading Sp. z o.o.
English: Day 60 of the CMDv referral procedure was on 18 April 2013.
Danish: Dag 60 af indbringelsesproceduren for CMD(v) var den 18. april 2013.
English: On 29 April 2013, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 29. april 2013 underrettede referencemedlemsstaten (Tjekkiet) Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed, og indbragte sagen for CVMP i medfør af artikel 33, stk. 4, i direktiv 2001/82/EF.
English: Fiprex is a veterinary medicinal product presented as a spot-on formulation containing fipronil as an active substance (pharmacotherapeutic group: ectoparasiticides for topical use).
Danish: Fiprex er et veterinærlægemiddel, der dispenseres som en spot-on-formulering, som indeholder fipronil som det aktive stof (farmakoterapeutisk gruppe: ektoparasiticider til topisk anvendelse).
English: The referral procedure started on 15 May 2013.
Danish: Indbringelsesproceduren blev indledt den 15. maj 2013.
English: Later in 2012 the marketing authorisation holder, Vet-Agro Trading Sp. z o.o., submitted applications for mutual recognition of the marketing authorisation granted by the Czech Republic for the aforementioned five presentations of Fiprex.
Danish: Senere i 2012 indgav indehaveren af markedsføringstilladelsen, Vet-Agro Trading Sp. z o.o., ansøgninger om gensidig anerkendelse af markedsføringstilladelsen udstedt af Tjekkiet for ovennævnte fem styrker af Fiprex.
English: The legal basis of the applications was also Article 13a of Directive 2001/82/EC.
Danish: Det retlige grundlag for ansøgningerne var ligeledes artikel 13, litra a), i direktiv 2001/82/EF.
English: The Committee appointed D. Murphy as rapporteur and J. Bureš as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis D. Murphy og J. Bureš.
English: Based on the evaluation of the available data, the CVMP concluded that Fiprex does not pose a risk in terms of target animal safety.
Danish: Efter vurdering af de foreliggende data konkluderede CVMP, at Fiprex ikke udgjorde en sikkerhedsmæssig risiko for måldyrearten.
English: Potential serious risks to animal health were identified during the mutual recognition procedure by Ireland regarding the efficacy and target animal safety of the products.
Danish: Under den gensidige anerkendelsesprocedure påpegede Irland potentielle alvorlige risici vedrørende virkningen og sikkerheden hos de dyrearter, som lægemidlet er beregnet til.
English: Regarding efficacy, the CVMP concluded that the data provided for Fiprex could not adequately justify the proposed duration of efficacy and consequently it is not possible to establish a positive benefit-risk balance for the product.
Danish: Vedrørende virkningen konkluderede CVMP, at de forelagte data for Fiprex ikke gav tilstrækkelig begrundelse for den ansøgte virkningsvarighed, og at benefit/riskforholdet for lægemidlet derfor ikke kunne anses for at være positivt.
English: On 9 April 2014, the CVMP adopted by majority a final opinion confirming the recommendation included in its opinion of 11 December 2013, that the granting of the marketing authorisations should be refused and the existing marketing authorisations should be suspended for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spot-on solution for dogs.
Danish: Den 9. april 2014 vedtog CVMP ved en flertalsafgørelse en endelig udtalelse, der bekræftede anbefalingen i udvalgets udtalelse af 11. december 2013 om, at der bør gives afslag på ansøgning om markedsføringstilladelse, og de eksisterende markedsføringstilladelser suspenderes for Fiprex CAT, spot-on, opløsning, 52,5 mg, til katte; Fiprex S spot-on, opløsning, 75 mg, til hunde; Fiprex M, spoton, opløsning, 150 mg, til hunde; Fiprex L, spot-on, opløsning, 300 mg, til hunde og Fiprex XL, spoton, opløsning, 412,5 mg, til hunde.
English: On day 90 of the mutual recognition procedure these issues remained unsolved and therefore a referral procedure under Article 33(1) of Directive 2001/82/EC to the veterinary coordination group for the mutual recognition and decentralised procedures (CMDv) was started on 18 February 2013.
Danish: På dag 90 af den gensidige anerkendelsesprocedure var disse spørgsmål fortsat uafklaret, hvorfor sagen den 18. februar 2013 blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til dyr (CMD(v)) i medfør af artikel 33, stk. 1, i direktiv 2001/82/EF.
English: The legal basis of the marketing authorisations granted by the Czech Republic was Article 13a of Directive 2001/82/EC i.e. citing well-established use.
Danish: Det retlige grundlag for markedsføringstilladelserne udstedt af Tjekkiet var artikel 13, litra a), i direktiv 2001/82/EF, med henvisning til almindelig anvendelse.
English: infestations for up to 28 days, as well as for the control of Flea Allergy Dermatitis.
Danish: i 1-28 dage samt til kontrol af loppebetinget allergisk dermatitis.
English: 52.5 mg spot-on solution for cats; Fiprex S 75 mg spoton solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs, Fiprex XL 412.5 mg spot-on solution for dogs
Danish: Udtalelse efter en sag indbragt i henhold til artikel 33, stk. 4,1 for Fiprex CAT, spot-on, opløsning, 52,5 mg, til katte; Fiprex S, spot-on, opløsning, 75 mg, til hunde; Fiprex M, spot-on, opløsning, 150 mg, til hunde; Fiprex L, spot-on, opløsning, 300 mg, til hunde og Fiprex XL, spoton, opløsning, 412,5 mg, til hunde
English: Fiprex for dogs is indicated for the treatment and prevention of flea infestations (Ctenocephalides spp.)
Danish: Fiprex til hunde er indiceret til behandling og forebyggelse af angreb af lopper (Ctenocephalides spp.)
English: Fiprex for cats is indicated for the treatment and prevention of flea (Ctenocephalides spp.)
Danish: Fiprex til katte er indiceret til behandling og forebyggelse af angreb af lopper (Ctenocephalides spp.)
English: The reference Member State for the mutual recognition procedure was the Czech Republic and ten concerned Member States
Danish: Referencemedlemsstaten for den gensidige
English: This will give your body a chance to recover.
Danish: Dette giver din krop mulighed for at komme sig.
English: After day 28, the next cycle will begin.
Danish: Efter dag 28 starter den næste cyklus.
English: Date of first authorization: 13 July 2011 Date of latest renewal: 21 April 2016
Danish: Dato for første markedsføringstilladelse : 13 juli 2011 Dato for seneste fornyelse: 21. april 2016
English: You may also need other treatments.
Danish: Du får muligvis også brug for andre behandlinger.
English: There may be up to 6 treatment periods (cycles).
Danish: Der kan være op til 6 behandlingsperioder (cyklusser).
English: The marking on the capsule is different for each strength (see table below).
Danish: Mærket på kapslen er forskelligt for hver styrke (se tabellen nedenfor).
English: You should make sure you fully understand and remember the following: - the number of capsules you need to take every dosing day.
Danish: Du skal sørge for at forstå og huske følgende fuldstændigt: - det antal kapsler, du skal tage på hver doseringsdag.
English: Tell your doctor if you notice any of these symptoms.
Danish: Fortæl din læge, hvis du bemærker nogen af disse symptomer.
English: Each one lasts 28 days.
Danish: Hver periode varer 28 dage.
English: Tell your doctor immediately if this occurs.
Danish: Fortæl det øjeblikkeligt til din læge, hvis det opstår.
English: Once the radiotherapy is completed, you will have no treatment for 4 weeks.
Danish: Når strålebehandlingen er overstået, får du ingen behandling i 4 uger.
English: Capsules should not be opened.
Danish: Kapsler må ikke åbnes.
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Danish: I dette tilfælde ordinerer din læge også medicin, som hjælper dig med at undgå denne type lungebetændelse (PCP).
English: Making a mistake in how you take this medicine may have serious health consequences.
Danish: Hvis du tager dette lægemiddel forkert, kan det have alvorlige sundhedsmæssige konsekvenser.
English: Your doctor may decide to reduce the dose, interrupt, stop or change your treatment.
Danish: Din læge kan evt. beslutte at reducere dosis, afbryde, standse eller ændre din behandling.
English: Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Danish: Kontrollér dosis med lægen, hver gang du starter en ny cyklus, da den kan være forskellig fra sidste cyklus.
English: Depending on the prescribed dose, you may have to take more than one capsule at the same time.
Danish: Afhængigt af den ordinerede dosis skal du muligvis tage mere end én kapsel på samme tid.
English: The following side effects may occur, and may require medical attention.
Danish: Følgende bivirkninger kan forekomme og kan kræve medicinsk behandling.
English: The reduction in blood cell counts is usually short-lived.
Danish: Reduktionen af antallet af blodlegemer er normalt kortvarig.
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Fortæl apotekeren, hvis du bemærker ændringer i kapslernes udseende.
English: Dosage and duration of treatment
Danish: Dosering og varighed af behandling
English: Your doctor will work out your exact dose.
Danish: Din læge vil fastlægge din nøjagtige dosis.
English: Take the missed dose as soon as possible during the same day.
Danish: Tag den glemte dosis så hurtigt som muligt samme dag.
English: This is because you must not be treated with Temozolomide SUN during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at De ikke må tage Temozolomide SUN under graviditet, medmindre det er klart angivet af Deres læge.
English: Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis, medmindre lægen beder dig om det.