natgillin/translations-raw huggingface dataset:
Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: For at forhindre at børn får adgang til veterinærlægemidlet, skal der kun tages én tablet ud af blisteret ad gangen. 
Special precautions to be taken by the person administering the veterinary medicinal product to animals: To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Indehaver af markedsføringstilladelsen: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein TYSKLAND 
Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
EU/2/19/240/012 EU/2/19/240/013 EU/2/19/240/014 EU/2/19/240/015 EU/2/19/240/016 
EU/2/19/240/015 EU/2/19/240/016
Præparatet kan indgå som led i behandlingen af loppebetinget allergisk dermatitis (FAD). 
The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Behandlingsinterval: 
Treatment schedule:
En tyggetablet indeholder: Afoxolaner MERIAL 
Each chewable tablet contains: Afoxolaner MERIAL
1 æske indeholdende ét blister à 1, 3 eller 6 tyggetabletter eller 15 blistre à 1 tyggetablet. 
One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr For at forhindre at børn får adgang til veterinærlægemidlet, skal der kun tages én tablet ud af blisteret ad gangen. 
Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Metabolitter og modersubstans elimineres fra kroppen via urin og galde, heraf hovedparten via galden. 
The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Drægtighed og diegivning: 
Pregnancy and lactation:
Povidon (E1201) Macrogol 400 
Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
Behandling af loppe- og flåtinfestation: 
Treatment of flea and tick infestations:
Behandling af skab (forårsaget af Sarcoptes scabiei var. canis) 
Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Behandling af flåtangreb hos hund (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus). 
Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Hund 2-4 kg Hund >4-10 kg Hund >10-25 kg Hund >25-50 kg 
Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Behandling af demodecose (forårsaget af Demodex canis). 
Treatment of demodicosis (caused by Demodex canis).
Behandling af demodecose (forårsaget af Demodex canis): 
Treatment of demodicosis (caused by Demodex canis):
I meget sjældne tilfælde er der rapporteret om lette gastrointestinale forstyrrelser (opkastning, diarré), pruritus, letargi, anoreksi og neurologiske symptomer (kramper, ataksi og muskelrysten). 
Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Afoxolaner MERIAL virker over for voksne lopper samt over for flere flåtarter så som Dermacentor reticulatus og D. variabilis, Ixodes ricinus og I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, og Haemaphysalis longicornis. 
Afoxolaner MERIAL is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, and Haemaphysalis longicornis.
Afoxolaner virker over for voksne lopper samt over for flere flåtarter så som Dermacentor reticulatus og D. variabilis, Ixodes ricinus og I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, og Haemaphysalis longicornis. 
Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Marmoreret rød til rødbrun, rund (tablet til hund 2-4 kg) eller rektangulær (tablet til hund >4-10 kg, tablet til hund >10-25 kg og tablet til hund >25-50 kg). 
Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
4 Chemin du Calquet 31000 Toulouse 
31000 Toulouse
Majsstivelse 
Maize starch
Tyggetabletter til hund 2-4 kg Tyggetabletter til hund >4-10 kg Tyggetabletter til hund >10-25 kg Tyggetabletter til hund >25-50 kg Alle hjælpestoffer er anført under pkt. 
chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjældne (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)> 
• rare (more than 1 but less than 10 animals in 10,000 animals treated)
Soyaprotein 
Chewable tablets
Afoxolaner MERIAL 11 mg hund 2-4 kg Afoxolaner MERIAL 28 mg hund >4-10 kg Afoxolaner MERIAL 68 mg hund >10-25 kg Afoxolaner MERIAL 136 mg hund >25-50 kg afoxolaner. 
Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Tyggetablet. 
Chewable tablets.
INDLÆGSSEDDEL: Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg 
PACKAGE LEAFLET: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg afoxolaner 
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg afoxolaner
Afoxolaner MERIAL 11 mg tyggetabletter til hund 2-4 kg Afoxolaner MERIAL 28 mg tyggetabletter til hund >4-10 kg Afoxolaner MERIAL 68 mg tyggetabletter til hund >10-25 kg Afoxolaner MERIAL 136 mg tyggetabletter til hund >25-50 kg 
Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
EMA/H/C/produkt nr. 
EMEA/H/C/product number
Den virksomhed, der har indgivet ansøgningen, er Celgene Europe Ltd. 
The company that applied for authorisation is Celgene Europe Ltd.
Hvad er Istodax? 
What is Istodax?
Det kunne derfor ikke konkluderes, at lægemidlets fordele overstiger risiciene, og CHMP bekræftede sin indledende negative udtalelse. 
Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Den 15. november 2012 EMA/725439/2012 
EMA/725439/2012
Navnlig kunne udvalget ikke drage konklusioner om lægemidlets kliniske fordel. 
In particular, the Committee could not conclude on the clinical benefit of the medicine.
Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen. 
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Virkningerne af Istodax blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Istodax were first tested in experimental models before being studied in humans.
Istodax er et lægemiddel, der indeholder det aktive stof romidepsin. 
Istodax is a medicine that contains the active substance romidepsin.
Behandlingens virkning blev hovedsagelig målt på den andel af patienterne, der udviste fuldstændig respons på behandlingen. 
The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
I undersøgelsen blev Istodax ikke sammenlignet med nogen anden behandling. 
In the study, Istodax was not compared with any other treatment.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Istodax findes på EMA's websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin) EMA/725439/2012 
Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Da lægemidlet ikke var sammenlignet med nogen anden behandling, kunne det ikke fastslås, om de iagttagne virkninger skyldtes lægemidlet eller sygdommens egenskaber hos patienterne i hovedundersøgelsen. 
As it was not compared with any other treatment, it was not possible to establish whether the observed effects were due to the medicine or due to the disease characteristics of patients in the main study.
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 15. november 2012 afslaget på ansøgningen om markedsføringstilladelse. 
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Hvad forventedes Istodax anvendt til? 
What was Istodax expected to be used for?
CHMP konstaterede desuden, at virksomheden ved en fejl havde undladt at fremlægge et tilfredsstillende certifikat for god fremstillingspraksis for fremstillingsstedet for lægemidlet, hvilket kræves ifølge loven. 
The CHMP also noted that, due to an oversight, the company failed to provide an adequate certificate of Good Manufacturing Practice for the site where the medicine is manufactured, which is legally required.
Da Istodax ikke blev sammenlignet med nogen anden behandling, kunne udvalget imidlertid ikke drage konklusioner om lægemidlets kliniske fordel i form af samlet overlevelse (hvor længe patienterne levede) eller progressionsfri overlevelse (hvor længe patienterne levede uden forværring af sygdommen). 
However, the fact that Istodax was not compared with any other treatment did not allow the Committee to conclude on the clinical benefit of the medicine in terms of overall survival (how long the patients lived) or progression-free survival (how long the patients lived without their disease getting worse).
Afslag på ansøgningen om markedsføringstilladelse for Istodax (romidepsin) 
Refusal of the marketing authorisation for Istodax (romidepsin)
Perifert T-cellelymfom er kræft, der udgår fra hvide blodlegemer af typen T-celler, som er en del af immunsystemet. 
Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Efter den fornyede overvejelse i november 2012 bortfaldt CHMP's betænkeligheder vedrørende certifikatet for god fremstillingspraksis, men de øvrige betænkeligheder bestod. 
In November 2012, following the re-examination, the CHMP removed its concern over the certificate of Good Manufacturing Practice, but retained its other concerns.
Den 19. juli 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Istodax, som er bestemt til behandling af perifert T-cellelymfom. 
On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Virksomheden fremlagde resultaterne af én hovedundersøgelse med Istodax, hvori der deltog 131 patienter med perifert T-cellelymfom, som tidligere var blevet behandlet. 
The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Hvordan forventes Istodax at virke? 
How is Istodax expected to work?
I juli 2012 konstaterede CHMP, at hovedundersøgelsen viste, at Istodax havde virkning på sygdommen, målt som patienternes respons på behandlingen. 
In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der aktuelt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Istodax. 
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Istodax.
Den 28. oktober 2005 blev Istodax udpeget som “lægemiddel til sjældne sygdomme” til behandling af perifert T-cellelymfom (nodalt, andet ekstranodalt og leukæmisk/dissemineret). 
Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Istodax forventedes anvendt til behandling af voksne med perifert T-cellelymfom ved manglende behandlingsvirkning eller tilbagefald af sygdommen efter mindst to forudgående behandlinger. 
Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Det vides ikke nøjagtigt, hvordan romidepsin virker ved perifert T-cellelymfom, men romidepsin forventes at bremse kræftcellernes vækst og deling ved sin indvirkning på de gener, der regulerer cellernes formering og død. 
The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Det aktive stof i Istodax, romidepsin, virker ved at blokere enzymer af typen histonedeacetylaser, som slår generne “fra” eller “til” i cellerne. 
The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Det leveres som et pulver, der efter opløsning i den medfølgende væske indgives ved infusion (med drop i en vene). 
It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
I begge studier var der ingen tilfælde af resistens over for behandling efter 48 uger. 
In both studies there were no cases of resistance to treatment after 48 weeks.
Som for alle lægemidler bliver data vedrørende brug af Dovato løbende overvåget. 
As for all medicines, data on the use of Dovato are continuously monitored.
Andre oplysninger om Dovato 
Other information about Dovato
Begge aktive stoffer er allerede godkendt i Den Europæiske Union som separate tabletter:dolutegravir i 2014 og lamivudin i 1996. 
Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Den anbefalede dosis er én tablet én gang dagligt. 
The patient should take one tablet once a day.
Dovato er et lægemiddel til behandling af infektion med humant immundefektvirus type 1 (hiv-1) hos voksne og unge over 12 år, der vejer mindst 40 kg. 
Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Dovato? 
What measures are being taken to ensure the safe and effective use of Dovato?
For mere information om brug af Dovato, se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Dovato, see the package leaflet or contact your doctor or pharmacist.
Dovato (dolutegravir / lamivudin) 
Dovato (dolutegravir / lamivudine)
En oversigt over Dovato, og hvorfor det er godkendt i EU 
An overview of Dovato and why it is authorised in the EU
De indberettede bivirkninger ved Dovato vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Dovato fås som tabletter, der indeholder 50 mg dolutegravir og 300 mg lamivudin. 
Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Tredobbelt kombinationsbehandling anvendes til hiv-behandling for at mindske risikoen for, at virussen bliver resistent over for behandling. 
Triple combination therapy is used for HIV treatment to reduce the chance of the virus becoming resistant to treatment.
Hvorfor er Dovato godkendt i EU? 
Why is Dovato authorised in the EU?
De hyppigste alvorlige bivirkninger (som kan forekomme hos op til 1 ud af 100 personer) er allergiske reaktioner, herunder udslæt og alvorlige leverproblemer. 
The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Dovato helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids. 
Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
I disse studier var der hos 91 % af de patienter med hiv-1, som fik Dovato-kombinationen, ikke længere målelige koncentrationer af hiv (under 50 kopier pr. ml) efter 48 uge sammenlignet med 93 % af dem, der tog den tredobbelte kombination. 
In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Hvad er Dovato, og hvad anvendes det til? 
What is Dovato and what is it used for?
Dovato (dolutegravir / lamivudin) EMA/276259/2019 
Dovato (dolutegravir / lamivudine) EMA/276259/2019
Hvilke risici er der forbundet med Dovato? 
What are the risks associated with Dovato?
De hyppigste bivirkninger ved Dovato (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine, diarré, kvalme og søvnbesvær. 
The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Dovato fås kun på recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion. 
Dovato can only be obtained with a prescription and should be prescribed by a doctor who is experienced in managing HIV infection.
De to aktive stoffer i Dovato, dolutegravir og lamivudin, blokerer de enzymer, som virussen bruger til at fremstille nye eksemplarer af sig selv. 
The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
I to hovedstudier var Dovato-kombinationen lige så effektiv som en tredobbelt kombination hos patienter med hiv-1, og der var ingen tegn på udvikling af resistens hos disse patienter. 
In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Dolutegravir blokerer et enzym kaldet integrase (og kaldes en integrasehæmmer), mens lamivudin forhindrer revers transkriptase (og kaldes en nukleotid revers transkriptase-hæmmer eller NRTI). 
Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Dette lægemiddel indeholder de aktive stoffer dolutegravir og lamivudin og anvendes til behandling af infektioner, der ikke er resistente over for lægemidler i samme klasse som dolutegravir eller lamivudin. 
This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
To hovedstudier, hvori der indgik 1.433 patienter, har vist, at kombinationen af de to aktive stoffer i Dovato er lige så effektiv til at reducere mængden af hiv i blodet som en tredobbelt kombinationsbehandling (dolutegravir, tenofovir og emtricitabin). 
Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Yderligere information om Dovato findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/dovato 
Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Hvilke fordele viser studierne, at der er ved Dovato? 
What benefits of Dovato have been shown in studies?
Hvordan anvendes Dovato? 
How is Dovato used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Dovato. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dovato have been included in the summary of product characteristics and the package leaflet.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Dovato opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
Furthermore, both active substances are available in a single tablet and are acceptably safe.The European Medicines Agency therefore decided that Dovato's benefits are greater than its risks and that it can be authorised for use in the EU.
Hvordan virker Dovato? 
How does Dovato work?
3 (3x1) inhalatorer (360(3x120) pust) (multipakning) 
3 (3x1) inhalers (360(3x120) actuations) (multipack)
1 inhalator (120 pust) 
1 inhaler (120 actuations)
EU-nummer 
Pack size
(Særnavn) Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse EU/1/16/1152/001 Roteas 
Strength Pharmaceutical Form
• Ikke kendt (kan ikke estimeres ud fra forhåndenværende data) 
• Not known (frequency cannot be estimated from the available data)
Der var en signifikant og gavnlig effekt på livskvaliteten (målt på PD-QUALIF skalaen). 
There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
597 678 01 Blansko Tjekkiet 
597 678 01 Blansko Czech Republic
Hyppigheden af mulige bivirkninger er anført nedenfor i henhold til følgende konvention: 
The frequency of possible side effects listed below is defined using the following convention:
Tag den næste dosis på det tidspunkt, hvor De normalt ville gøre det. 
Take the next dose normally, when it is time to take it.
Lægen kan være nødt til at ændre Deres dosis eller stoppe behandlingen. 
Your doctor may need to adjust or stop your dose.