FrancophonIA/ELRC3.0 huggingface dataset:
English: Arthralgia Back pain Muscle rigidity Muscular weakness Musculoskeletal pain Myalgia Pain in extremity
Danish: Artralgi Rygsmerte Muskelstivhed Muskelsvaghed Muskuloskeletale smerter Myalgi Ekstremitetssmerter
English: Erythema Pruritus Rash Hyperhidrosis Sweating
Danish: Erytem Kløe Udslæt Hyperhidrose Hedeture
English: Therefore, dosing should be adjusted according to their renal hepatic status (see section 4.2 and 4.4).
Danish: Dosis bør derfor justeres i henhold til patientens nyre-leverstatus (se pkt.
English: Wakix 18 mg tablet Each tablet contains 20 mg of pitolisant hydrochloride, equivalent to 17.8 mg of pitolisant.
Danish: Wakix 18 mg tablet Hver tablet indeholder 20 mg pitolisant-hydrochlorid, svarende til 17,8 mg pitolisant.
English: Musculoskeletal and connective tissue disorders
Danish: Nakkesmerter Muskuloskeletale brystsmerter
English: What is in this leaflet?
Danish: Se i pkt.
English: Wakix 4.5 mg tablet Each tablet contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant
Danish: Wakix 4,5 mg tablet Hver tablet indeholder 5 mg pitolisant-hydrochlorid, svarende til 4,45 mg pitolisant.
English: The study design was similar to study Harmony I except that the maximum dose for pitolisant reached by 75% of patients was 18 mg once a day instead of 36 mg in Harmony I. As an important unbalance led to comparison of results with or without cluster grouping of sites, the most conservative approach showed non-significant ESS score decrease with pitolisant compared to placebo (pitolisant-placebo=-1.94 with p=0.065).
Danish: Da en vigtig ubalance førte til sammenligning af resultater med eller uden klyngegruppering af udgangsobjekter, viste den mest konservative tilgang et ikke-signifikant fald i ESS-score med pitolisant sammenlignet med placebo (pitolisant-placebo = -1,94; p=0,065).
English: Each film-coated tablet of Wakix 18 mg contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Danish: Hver filmovertrukket Wakix tablet 18 mg indeholder 20 mg pitolisant-hydrochlorid, svarende til 17,8 mg pitolisant.
English: Rare side effects (may affect up to 1 in 1000 people): - Loss of appetite, increased appetite - Abnormal behaviour, confusional state, depressed mood, excitability, feelings of emotional and mental discomfort, feeling of seeing or hearing things that are not really there when you sleep - Loss of consciousness, tension headache, , trouble of the memory, poor sleep quality - Abdominal discomfort, difficulty or pain in swallowing, flatulence, inflammation of the digestive tract - Infection of the skin, abnormally high sensitivity to sunlight - Neck pain, chest pain - Spontaneous abortion - Pain, night sweats, sense of oppression
Danish: hallucinationer (følelse af at se eller høre ting, som ikke er der) under søvn - Tab af bevidsthed, spændingshovedpine, problemer med hukommelsen, dårlig søvnkvalitet - Ubehag i maven, synkebesvær eller smerter, når du synker, luft fra tarmen, betændelseslignende tilstand (inflammation) i fordøjelseskanalen - Infektion i huden, unormalt høj følsomhed for sollys - Nakkesmerter, brystsmerter
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets
Danish: Wakix 4,5 mg filmovertrukne tabletter Wakix 18 mg filmovertrukne tabletter
English: Wakix 4.5 mg film-coated tablets Wakix 18 mg film-coated tablets Pitolisant
Danish: Wakix 4,5 mg filmovertrukne tabletter Wakix 18 mg filmovertrukne tabletter Pitolisant
English: Each film-coated tablet of Wakix 4.5 mg contains 5 mg of pitolisant hydrochloride, equivalent to 4.45 mg of pitolisant.
Danish: Hver filmovertrukket Wakix tablet 4,5 mg indeholder 5 mg pitolisanthydrochlorid, svarende til 4,45 mg pitolisant.
English: Wakix 18 mg film-coated tablet Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Danish: Wakix 18 mg filmovertrukken tablet Hver tablet indeholder 20 mg pitolisanthydrochlorid, svarende til 17,8 mg pitolisant.
English: Wakix 4.5 mg film-coated tablet Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
Danish: Wakix 4,5 mg filmovertrukken tablet Hver tablet indeholder 5 mg pitolisanthydrochlorid, svarende til 4,45 mg pitolisant.
English: 30 film-coated tablets.
Danish: 90 filmovertrukne tabletter.
English: White, round, biconvex film-coated tablet, 7.5 mm diameter marked with “20” on one side.
Danish: Wakix 18 mg filmovertrukken tablet Hvid, rund, bikonveks filmovertrukken tablet, diameter 7,5 mm, mærket med "20" på den ene side.
English: White, round, biconvex film-coated tablet, 3.7 mm diameter, marked with “5” on one side.
Danish: Wakix 4,5 mg filmovertrukken tablet Hvid, rund, bikonveks filmovertrukken tablet, diameter 3,7 mm, mærket med "5" på den ene side.
English: With St John's Wort (Hypericum Perforatum), due to its strong CYP3A4 inducing effect, caution should be exercised when taken concurrently with pitolisant.
Danish: Der bør udvises forsigtighed ved samtidig indtagelse af pitolisant og perikon, da perikon er en potent CYP3A4-induktor.
English: Nutrition disorders
Danish: Ernæring
English: Posology
Danish: Øjenlidelse
English: - Headaches, feeling of “spinning” (vertigo), loss of balance, trembling - Feeling sick, vomiting, indigestion - Tiredness (fatigue)
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): - Søvnbesvær, angst, irritabilitet, nedtrykthed, søvnproblemer - Hovedpine, følelse af at snurre rundt (vertigo), balanceforstyrrelser, rysten - Kvalme, opkastning, fordøjelsesbesvær - Træthed (afkræftelse)
English: It is available as white round tablets (10 and 20 mg).
Danish: Det fås som hvide, runde tabletter (10 og 20 mg).
English: The applicant presented data on experimental models from the scientific literature.
Danish: Ansøgeren fremlagde data om forsøgsmodeller fra faglitteraturen.
English: The full EPAR for Leflunomide ratiopharm can be searched for on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Leflunomide ratiopharm findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Leflunomide ratiopharm on 29 November 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Leflunomide ratiopharm den 29. november 2010.
English: This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Leflunomide ratiopharm.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Leflunomide ratiopharm.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Leflunomide ratiopharm.
English: This means that Leflunomide ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Arava.
Danish: Det betyder, at Leflunomide ratiopharm er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Arava.
English: Leflunomide ratiopharm treatment starts with a ‘loading dose' of 100 mg once a day for three days, followed by a maintenance dose.
Danish: Behandlingen med Leflunomide ratiopharm indledes med en ‘initialdosis' på 100 mg en gang dagligt i tre dage efterfulgt af en vedligeholdelsesdosis.
English: For more information about treatment with Leflunomide ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Leflunomide ratiopharm, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The recommended maintenance dose is 10 to 20 mg once a day in patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis.
Danish: Den anbefalede dosis er 10 til 20 mg en gang dagligt hos patienter med rheumatoid arthritis og 20 mg en gang dagligt hos patienter med arthritis psoriatica.
English: Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience in the treatment of rheumatoid arthritis and psoriatic arthritis.
Danish: Behandlingen med Leflunomide ratiopharm skal indledes og overvåges af en specialist, som har erfaring i behandling af rheumatoid arthritis og arthritis psoriatica.
English: The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been shown to have comparable quality and to be bioequivalent to Arava.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Leflunomide ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Arava.
English: Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints).
Danish: Leflunomide ratiopharm anvendes til behandling af voksne med aktiv rheumatoid arthritis (en sygdom i immunsystemet, der fremkalder inflammation i leddene) eller arthritis psoriatica (en sygdom, der giver røde skællende pletter på huden og betændelse i leddene).
English: The doctor should carry out blood tests to check the patient's liver, white blood cell counts and platelet counts before prescribing Leflunomide ratiopharm, and regularly during treatment.
Danish: Lægen skal tage blodprøver for at kontrollere patientens lever, leukocyttal og trombocyttal, inden der ordineres Leflunomide ratiopharm, og regelmæssigt under behandlingen.
English: Leflunomide ratiopharm is a ‘generic medicine'.
Danish: Leflunomide ratiopharm er et ‘generisk lægemiddel'.
English: The Committee recommended that Leflunomide ratiopharm be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Leflunomide ratiopharm.
English: Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Danish: Da Leflunomide ratiopharm er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Leflunomide ratiopharm is a medicine that contains the active substance leflunomide.
Danish: Leflunomide ratiopharm er et lægemiddel, der indeholder det aktive stof leflunomid.
English: The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant.
Danish: Det aktive stof i Leflunomide ratiopharm, leflunomid, er et immundæmpende stof.
English: Other information about Leflunomide ratiopharm
Danish: Andre oplysninger om Leflunomide ratiopharm
English: Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Arava.
Danish: Da Leflunomide ratiopharm er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Arava.
English: What are the benefits and risks of Leflunomide ratiopharm?
Danish: Hvilken fordel og risiko er der forbundet med Leflunomide ratiopharm?
English: Leflunomide ratiopharm leflunomide
Danish: Leflunomide ratiopharm leflunomid
English: Why has Leflunomide ratiopharm been approved?
Danish: Hvorfor blev Leflunomide ratiopharm godkendt?
English: How has Leflunomide ratiopharm been studied?
Danish: Hvordan blev Leflunomide ratiopharm undersøgt?
English: What is Leflunomide ratiopharm used for?
Danish: Hvad anvendes Leflunomide ratiopharm til?
English: What is Leflunomide ratiopharm?
Danish: Hvad er Leflunomide ratiopharm?
English: How is Leflunomide ratiopharm used?
Danish: Hvordan anvendes Leflunomide ratiopharm?
English: How does Leflunomide ratiopharm work?
Danish: Hvordan virker Leflunomide ratiopharm?
English: The name of the medicine was changed to Adcirca on 21 October 2009.
Danish: Lægemidlets navn blev ændret til Adcirca den 21. oktober 2009.
English: Other information about Adcirca
Danish: Andre oplysninger om Adcirca
English: The European Commission granted a marketing authorisation valid throughout the EU for Tadalafil Lilly on 1 October 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tadalafil Lilly den 1. oktober 2008.
English: The full EPAR for Adcirca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Adcirca findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Adcirca.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adcirca.
English: It is available as tablets (20 mg).
Danish: Det leveres som tabletter (20 mg).
English: This authorisation was based on the authorisation granted to Cialis in 2002 (‘informed consent').
Danish: Markedsføringstilladelsen var baseret på den tilladelse, som blev udstedt for Cialis i 2002 ("informeret samtykke").
English: Before treatment, the patients could walk an average of 343 metres in six minutes.
Danish: Inden behandlingen kunne patienterne i gennemsnit gå 343 m på 6 minutter.
English: Adcirca treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Danish: Behandling med Adcirca bør kun indledes og overvåges af en læge med erfaring i behandling af PAH.
English: A risk management plan has been developed to ensure that Adcirca is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Adcirca anvendes så sikkert som muligt.
English: Adcirca is used in patients with class II or III disease.
Danish: Adcirca anvendes hos patienter med sygdom i klasse II eller III.
English: Adcirca was more effective than placebo at improving exercise capacity.
Danish: Adcirca var mere effektivt end placebo til at forbedre den fysiske kapacitet.
English: Previously known as Tadalafil Lilly.
Danish: Tidligere kaldet Tadalafil Lilly.
English: tadalafil
Danish: Adcirca tadalafil
English: What is Adcirca?
Danish: Hvad er Adcirca?
English: What measures are being taken to ensure the safe and effective use of Adcirca?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adcirca?
English: Adcirca is taken as two tablets (40 mg) once a day, with or without food.
Danish: Adcirca tages som to tabletter (40 mg) en gang dagligt med eller uden et måltid.
English: Adcirca is a medicine that contains the active substance tadalafil.
Danish: Adcirca er et lægemiddel, der indeholder det aktive stof tadalafil.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom necessary depending on the patient's response.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Adcirca has been shown to be effective in PAH with no identified cause and in PAH caused by collagen vascular disease.
Danish: Adcirca har vist sig effektivt ved PAH uden identificeret årsag og ved PAH forårsaget af kollagen vaskulær sygdom.
English: The ‘class' reflects the seriousness of the disease: ‘class II' involves slight limitation of physical activity and ‘class III' involves marked limitation of physical activity.
Danish: Klassen angiver sygdommens sværhedsgrad, hvor "klasse II" omfatter lettere begrænsning af fysisk aktivitet, og "klasse III" omfatter markant begrænsning af fysisk aktivitet.
English: What is the risk associated with Adcirca?
Danish: Hvilken risiko er der forbundet med Adcirca?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adcirca.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Adcirca skal anvendes.
English: For more information about treatment with Adcirca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Adcirca, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Danish: Adcirca anvendes til behandling af voksne med pulmonal arteriel hypertension (PAH) med henblik på at forbedre deres fysiske kapacitet (evne til at udføre fysisk aktivitet).
English: Patients with mild or moderate kidney or liver problems should start with a lower dose, but this can be increased if
Danish: Patienter med milde til moderate nyre- eller leverproblemer bør starte med en lavere dosis, men denne kan om nødvendigt øges, afhængigt af patientens respons.
English: The CHMP decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Adcirca opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Adcirca.
English: Adcirca is not recommended for patients with severe kidney or liver problems.
Danish: Adcirca anbefales ikke til patienter med svære nyre- eller leverproblemer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Adcirca, 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 Adcirca, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Four doses of Adcirca (2.5, 10, 20 and 40 mg once a day) have been compared with placebo (a dummy treatment) in one main study involving 406 patients with PAH, most of whom had class II or class III disease that was of unknown cause or caused by collagen vascular disease.
Danish: Fire doser af Adcirca (2,5 mg, 10 mg, 20 mg og 40 mg en gang dagligt) er blevet sammenlignet med placebo (en virkningsløs behandling) i en hovedundersøgelse, der omfattede 406 patienter med PAH, hvoraf de fleste havde klasse II- eller klasse III-sygdom, som var af ukendt årsag eller forårsaget af kollagen vaskulær sygdom.
English: The active substance in Adcirca, tadalafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Danish: Det aktive stof i Adcirca, tadalafil, tilhører en gruppe af lægemidler kaldet "phosphodiesterase type 5 (PDE5)-hæmmere", hvilket betyder, at det blokerer PDE5-enzymet.
English: The main measure of effectiveness was the change in exercise capacity (the ability to carry out physical activity) measured by the distance the patients could walk in six minutes after 16 weeks of treatment.
Danish: Virkningen blev hovedsagelig bedømt på ændringerne i evnen til at udføre fysisk aktivitet målt på den afstand, patienterne kunne gå på 6 minutter efter 16 ugers behandling.
English: Adcirca must not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the last three months, or who have severe hypotension (low blood pressure).
Danish: Adcirca må ikke anvendes til patienter, som har haft et akut myokardieinfarkt (pludseligt hjerteanfald) inden for de seneste tre måneder, eller som har svær hypotension (lavt blodtryk).
English: For the full list of all side effects and restrictions with Adcirca, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Adcirca fremgår af indlægssedlen.
English: Adcirca must not be taken with nitrates (a group of medicines used to treat angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (another medicine to treat pulmonary hypertension).
Danish: Adcirca må ikke tages sammen med nitrater (en gruppe af lægemidler der anvendes til behandling af angina) eller lægemidler i klassen "guanylatcyklase-stimulatorer", såsom riociguat (et andet lægemiddel til behandling af pulmonal hypertension).
English: The most common side effects with Adcirca (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), nasopharyngitis (inflammation of the nose and throat) including a blocked or runny nose and blocked sinuses, nausea (feeling sick), dyspepsia (heartburn) including stomach ache, myalgia (muscle pain), back pain and pain in the extremities (arms, hands, legs and feet).
Danish: De hyppigste bivirkninger ved Adcirca (som optræder hos mere end 1 ud af 10 patienter) er hovedpine, rødme, nasopharyngitis (betændelse i næse og hals), herunder stoppet eller løbende næse og stoppede bihuler, kvalme, dyspepsi (halsbrand), herunder mavesmerter, muskelsmerter, rygsmerter og smerter i ekstremiteterne (arme, hænder, ben og fødder).
English: When the enzyme is blocked, a substance called ‘cyclic guanosine monophosphate' (cGMP) cannot be broken down and remains in the vessels where it causes the relaxation and widening of the blood vessels.
Danish: Når enzymet blokeres, kan der ikke nedbrydes et stof kaldet "cyklisk guanosin monophosphat" (cGMP), som bliver i karrene, hvor det får blodkarrene til at slappe af og udvide sig.
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Danish: Trykket reducerer den iltmængde, der kan komme ind i blodet i lungerne, og gør derved fysisk aktivitet sværere.
English: After 16 weeks, this distance had increased by 26 metres more in the patients taking 40 mg Adcirca than in the patients taking placebo.
Danish: Hos de patienter, der fik 40 mg Adcirca, var denne distance efter 16 uger forlænget med 26 m mere end hos de patienter, der fik placebo.
English: Why has Adcirca been approved?
Danish: Hvorfor blev Adcirca godkendt?
English: It must not be used in patients who have ever had loss of vision because of a problem called nonarteritic anterior ischaemic optic neuropathy (NAION) that affects the blood flow to the nerve in the eye.
Danish: Det må heller ikke anvendes hos patienter, som på noget tidspunkt har haft synstab forårsaget af et problem kaldet non-arteritis anterior iskæmisk opticusneuropati (NAION), der påvirker blodtilførslen til nerven i øjet.
English: What benefit has Adcirca shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Adcirca?
English: What is Adcirca used for?
Danish: Hvad anvendes Adcirca til?
English: In patients with PAH, Adcirca widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.
Danish: Hos patienter med PAH udvider Adcirca blodkarrene i lungerne, hvilket får blodtrykket til at falde og lindrer symptomerne.
English: How has Adcirca been studied?
Danish: Hvordan blev Adcirca undersøgt?
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs.
Danish: Det giver forhøjet blodtryk i de kar, der fører blodet fra hjertet til lungerne.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Danish: PAH er en invaliderende sygdom, hvor der er en svær forsnævring af blodkarrene i lungerne.
English: How is Adcirca used?
Danish: Hvordan anvendes Adcirca?
English: How does Adcirca work?
Danish: Hvordan virker Adcirca?