FrancophonIA/ELRC3.0 huggingface dataset:
English: Never place a Hirobriz Breezhaler capsule directly into the mouthpiece of the Hirobriz Breezhaler inhaler.
Danish: Læg aldrig en Hirobriz Breezhaler-kapsel direkte i mundstykket på Hirobriz Breezhalerinhalatoren.
English: Only use the Hirobriz Breezhaler inhaler contained in this pack.
Danish: Brug kun den Hirobriz Breezhaler-inhalator, som er vedlagt denne pakning.
English: Only use the capsules with the inhaler provided in this pack (Hirobriz Breezhaler inhaler).
Danish: Brug kun kapslerne sammen med den vedlagte inhalator (Hirobriz Breezhaler-inhalator).
English: The Hirobriz Breezhaler inhaler enables you to inhale the medicine contained in a capsule.
Danish: Hirobriz Breezhaler-inhalatoren skal du bruge til at inhalere medicinen i kapslen.
English: How much Hirobriz Breezhaler to use
Danish: Så meget Hirobriz Breezhaler skal du tage
English: Never blow into the mouthpiece of the Hirobriz Breezhaler inhaler.
Danish: Pust aldrig ned i mundstykket på Hirobriz Breezhaler-inhalatoren.
English: Each capsule contains 24.6 mg lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver kapsel indeholder 24,6 mg lactose.
English: Do not store the capsules in the Hirobriz Breezhaler inhaler.
Danish: Kapslerne må ikke opbevares i Hirobriz Breezhaler-inhalatoren.
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Danish: Hirobriz Breezhaler 150 mikrogram inhalationspulver i kapsler Hirobriz Breezhaler 300 mikrogram inhalationspulver i kapsler indacaterol
English: Never take the Hirobriz Breezhaler inhaler apart.
Danish: Skil aldrig Hirobriz Breezhaler-inhalatoren ad.
English: COPD is a long-term disease and you should use Hirobriz Breezhaler every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Så længe skal du fortsætte med Hirobriz Breezhaler-behandling Fortsæt med Hirobriz Breezhaler-behandlingen, så længe din læge siger, at du skal gøre det. KOL er en langtidssygdom, og du skal bruge Hirobriz Breezhaler hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: Hirobriz Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and should not be used in asthma due to the absence of long-term outcome data in asthma.
Danish: Hirobriz Breezhaler er en langtidsvirkende beta2-adrenerg agonist, som kun er beregnet til KOL.
English: What Hirobriz Breezhaler is and what it is used for What you need to know before you use Hirobriz Breezhaler How to use Hirobriz Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at tage Hirobriz Breezhaler Sådan skal du tage Hirobriz Breezhaler Bivirkninger
English: How to use Hirobriz Breezhaler
Danish: Sådan skal du tage Hirobriz Breezhaler
English: Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Danish: Hirobriz Breezhaler 300 mikrog inhalationspulver i kapsler indacaterol
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Danish: Hirobriz Breezhaler 150 mikrog inhalationspulver i kapsler indacaterol
English: Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules
Danish: Hirobriz Breezhaler 150 mikrogram inhalationspulver i kapsler
English: Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules
Danish: Hirobriz Breezhaler 300 mikrogram inhalationspulver i kapsler
English: 700 micrograms
Danish: 700 mikrogram
English: Intravitreal implant in applicator Intravitreal use pouch (foil) 1 pouch with applicator system
Danish: Intravitrealt implantat i applikator
English: This summary was last updated on 14 June 2012.
Danish: Dette sammendrag blev sidst ajourført i 14/06/2012.
English: It may also reduce the use of antimicrobials in pig production units.
Danish: Det mindsker muligvis også anvendelsen af antimikrobielle stoffer i svineproducerende brug.
English: The company has presented data from both laboratory and field studies on the effectiveness of the vaccine against the two bacteria.
Danish: Virksomheden har fremlagt data fra såvel laboratorie- som feltundersøgelser af vaccinens effektivitet mod de to bakterier.
English: Reduced activity and lack of appetite on the day of vaccination commonly occurs.
Danish: Der forekommer ofte nedsat aktivitet og appetitløshed på vaccinationsdagen.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Danish: Vacciner virker ved at ‘lære' immunsystemet (kroppens naturlige forsvar), hvordan det skal beskytte sig mod en sygdom.
English: Sows that have been vaccinated according to this scheme before need a single revaccination two to four weeks before the expected farrowing date.
Danish: Søer, som tidligere er blevet vaccineret i overensstemmelse med dette system, har kun behov for en enkelt revaccination to til fire uger inden den forventede faringsdato.
English: E. Coli and C. perfringens vaccine
Danish: E. Coli og C. perfringens vaccine
English: An increase in body temperature of up to 2°C may be observed on the day of vaccination.
Danish: Der kan ses en stigning i kropstemperaturen på op til 2°C på vaccinationsdagen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Porcilis ColiClos on 14 June 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Porcilis ColiClos den 14/06/2012.
English: A sometimes painful and hard swelling up to 10 cm in diameter may be observed at the injection site for up to 25 days.
Danish: Der kan også iagttages en smertefuld og hård hævelse på 10 cm i diameter på injektionsstedet i op til 25 dage.
English: The benefit/risk balance can be found in the scientific discussion module of this EPAR.
Danish: Benefit/riskforholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Danish: Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum eller æg eller mælk kan anvendes til menneskeligt konsum.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the physician.
Danish: I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The first injection is given to sows or gilts, six or eight weeks before the expected farrowing (giving birth) date and a second injection is given four weeks later.
Danish: Den første injektion gives til søer eller gylte seks eller otte uger inden den forventede faringsdato, og den anden injektion gives fire uger efter.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Porcilis ColiClos exceed the risks and recommended that Porcilis ColiClos be given a marketing authorisation.
Danish: Udvalget for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Porcilis ColiClos opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Porcilis ColiClos.
English: To demonstrate protection against E.coli infection, studies were also presented with Porcilis Porcoli Diluvac Forte, a vaccine authorised within the EU with the same E. coli components as Porcilis ColiClos.
Danish: For at påvise beskyttelse mod E.coli-infektion blev der også fremlagt resultater af undersøgelser med Porcilis Porcoli Diluvac Forte, en vaccine, som er godkendt i EU med de samme E. coli-komponenter som Porcilis ColiClos.
English: The withdrawal period for Porcilis ColiClos is zero days for pig meat.
Danish: Tilsbageholdelsestiden for Porcilis ColiClos er nul dage for svinekød
English: Porcilis ColiClos is given by injection into a muscle in the neck area behind the ear.
Danish: Porcilis ColiClos gives som en injektion i en muskel i nakkeregionen bag øret.
English: Porcilis ColiClos is a vaccine.
Danish: Porcilis ColiClos er en vaccine.
English: When Porcilis ColiClos is given to sows or gilts, the pig's immune system recognises the inactivated bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Porcilis ColiClos gives til søer eller gylte, genkender svinets immunsystem de inaktiverede bakterier som ‘fremmede' og danner antistoffer mod dem.
English: Porcilis ColiClos contains an adjuvant to enhance the immune response.
Danish: Porcilis ColiClos indeholder et adjuvans til at forstærke immunresponsen.
English: Porcilis ColiClos contains parts of the bacteria E. coli and C. perfringens that have been inactivated so that they cannot cause disease.
Danish: Porcilis ColiClos indeholder dele af bakterierne E. coli og C. Perfringens, som er blevet inaktiveret, så de ikke er sygdomsfremkaldende.
English: It contains parts of the Escherichia coli (E. coli) bacterium called fimbrial adhesins F4ab, F4ac, F5 and F6 and LT toxoid (weakened toxin), as well as toxoid of the Clostridium perfringens (C. perfringens) bacterium type C.
Danish: Den indeholder dele af Escherichia coli- (E. coli) bakterien kaldet fimbrial adhesins F4ab, F4ac, F5 og F6 og LT toksoid (svækket toksin) i tillæg til toksoid af Clostridium perfringens (C. perfringens) bakterie type C.
English: These antibodies are transferred from the mother to the piglets through the colostrum (first milk), and they help the piglets to fight E. coli or C. perfringens infection if they become exposed after birth.
Danish: Disse antistoffer overføres fra moderdyret til pattegrisene via råmælken (colostrum), og de hjælper pattegrisene med at bekæmpe E. coli- eller C. perfringensinfektion, hvis de udsættes herfor efter fødslen.
English: Porcilis ColiClos is given to sows (female pigs that have already given birth to piglets) or gilts (female pigs that have not yet given birth to piglets) to provide their offspring with protection against infections caused by E. coli strains that express the components F4ab, F4ac, F5 or F6, and by C. perfringens type C. The vaccine is used to reduce death and clinical signs of infections caused by these bacteria during the first days of life.
Danish: Porcilis ColiClos gives til søer (hunsvin, som allerede har født pattegrise) eller gylte (hunsvin, som endnu ikke har født pattegrise) for at give deres afkom beskyttelse mod infektioner forårsaget af E. Coli-stammer, som aktiverer komponenterne F4ab, F4ac, F5 eller F6, og af C. perfringens type C. Vaccinen anvendes til at reducere antallet af dødsfald og kliniske symptomer på infektioner forårsaget af disse bakterier i de første levedage.
English: Porcilis ColiClos is a vaccine that is available as a suspension for injection.
Danish: Porcilis ColiClos er en vaccine, der fås som en suspension til injektion.
English: Porcilis ColiClos has been shown to reduce death and the clinical signs of E. coli or C. perfringens infections such as neonatal piglet diarrhoea and necrotic enterotoxaemia (a severe infection of the intestines).
Danish: Det er blevet påvist, at Porcilis ColiClos reducerer antallet af dødfald og kliniske symptomer på E. Colieller C. Perfringens-infektioner såsom neonatal diarre hos pattegrise og nekrotisk enterotoksæmi (en svær tarminfektion).
English: Other information about Porcilis ColiClos:
Danish: Andre oplysninger om Porcilis Porcoli
English: What is the risk associated with Porcilis ColiClos?
Danish: Hvilken risiko er der forbundet med Porcilis ColiClos?
English: Why has Porcilis ColiClos been approved?
Danish: Hvorfor blev Porcilis ColiClos godkendt?
English: How has Porcilis ColiClos been studied?
Danish: Hvordan blev Porcilis ColiClos undersøgt?
English: What is Porcilis ColiClos?
Danish: Hvad er Porcilis ColiClos?
English: What benefit has Porcilis ColiClos shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Porcilis ColiClos?
English: What is Porcilis ColiClos used for?
Danish: Hvad anvendes Porcilis ColiClos til?
English: How does Porcilis ColiClos work?
Danish: Hvordan virker Porcilis ColiClos?
English: Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse
English: 1 PRAC recommendations issued on 11 February 2016
Danish: 1 PRAC-anbefalinger vedtaget den 11. februar 2016
English: Treatment may be restarted once the patient's condition has stabilised.
Danish: Behandlingen kan genstartes, når patientens tilstand er stabiliseret.
English: Healthcare professionals should be aware of possible atypical cases
Danish: Sundhedspersoner skal være opmærksomme på mulige atypiske tilfælde
English: You may need emergency treatment and your diabetes medicine may need to be changed.
Danish: Du kan have behov for nødbehandling, og det kan være nødvendigt at ændre din diabetesbehandling.
English: The review of SGLT2 inhibitors was initiated at the request of European Commission in June 2015, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af SGLT2-hæmmere blev indledt på anmodning fra Europa-Kommissionen i juni 2015 i henhold til artikel 20 i forordning (EF) nr. 726/2004.
English: The CHMP opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Danish: CHMP's udtalelse blev derefter overgivet til Europa-Kommissionen, som vedtog en juridisk bindende beslutning, der er gyldig i hele EU.
English: An atypical presentation of diabetic ketoacidosis can delay diagnosis and treatment.
Danish: En atypisk præsentation af diabetisk ketoacidose kan forsinke diagnosen og behandlingen.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016 (Invokana, Jardiance) and 28/04/2016 (Forxiga, XigDuo, Synjardy, Vokanamet).
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som traf en endelig juridisk bindende beslutning med gyldighed i alle EU-medlemsstater den 25/04/2016 (for Invokana, Jardiance) og 28/04/2016 (for Forxiga, XigDuo, Synjardy, Vokanamet).
English: EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: EMA's anbefalinger er baseret på en indledende gennemgang, som Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC) har foretaget.
English: The benefits of these medicines continue to outweigh the risks in the treatment of type 2 diabetes.
Danish: Fordelene ved disse lægemidler opvejer fortsat risiciene ved behandling af type 2-diabetes.
English: • Diabetic ketoacidosis is a serious complication of diabetes.
Danish: • Diabetisk ketoacidose er en alvorlig komplikation af diabetes.
English: • Inform patients of the signs and symptoms of diabetic ketoacidosis and advise them to seek medical advice immediately if they develop such signs and symptoms.
Danish: • Patienterne skal informeres om tegn og symptomer på diabetisk ketoacidose, og de skal rådes til straks at søge lægehjælp, hvis de oplever sådanne tegn eller symptomer.
English: Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels.
Danish: Diabetisk ketoacidose er en alvorlig komplikation til diabetes forårsaget af for lavt insulinniveau.
English: On 25 February 2016, the European Medicines Agency (EMA) confirmed recommendations1 to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors (a class of type 2 diabetes medicines).
Danish: Den 25. februar 2016 bekræftede det Europæiske Lægemiddelagentur (EMA) anbefalinger1 om at minimere risikoen for diabetisk ketoacidose hos patienter, der tager SGLT2-hæmmere (et lægemiddel til behandling af type 2-diabetes).
English: The following SGLT2 inhibitors are authorised in the EU: Ebymect (dapagliflozin/metformin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin / metformin), Vokanamet (canagliflozin / metformin) and Xigduo (dapagliflozin / metformin).
Danish: Følgende SGLT2-hæmmere er godkendt i EU: Ebymect (dapagliflozin/metformin), Edistrid (dapagliflozin), Forxiga (dapagliflozin), Invokana (canagliflozin), Jardiance (empagliflozin), Synjardy (empagliflozin/metformin), Vokanamet (canagliflozin/metformin) and Xigduo (dapagliflozin/metaforik).
English: Following a review of the cases, EMA recommended updating the product information of SGLT2 inhibitors to list diabetic ketoacidosis as a rare adverse reaction (affecting up to 1 in 1,000 patients).
Danish: Efter en gennemgang af tilfældene anbefaler EMA at opdatere produktinformationen for SGLT2hæmmere med angivelse af diabetisk ketoacidose som en sjælden bivirkning (der forekommer hos op til 1 ud af 1.000 patienter).
English: By blocking the action of SGLT2, these medicines cause more glucose to be removed through the urine, thereby reducing the levels of glucose in the blood.
Danish: Ved at blokere virkningen af SGLT2 bevirker disse lægemidler, at der udskilles mere glukose gennem urinen, så glukoseindholdet i blodet falder.
English: • If you have any of the symptoms above while taking an SGLT2 inhibitor, contact a doctor or the nearest hospital straightaway even if your sugar level is not particularly high.
Danish: • Hvis du oplever et eller flere af ovenstående symptomer, mens du tager SGLT2-hæmmere, skal du straks søge læge eller tage til det nærmeste hospital, også selvom dit blodsukkerniveau ikke er særligt højt.
English: • SGLT2 inhibitors in the EU are available under the following trade names: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet and Xigduo.
Danish: • SGLT2-hæmmere sælges i EU under følgende handelsnavne: Ebymect, Edistride, Forxiga, Invokana, Jardiance, Synjardy, Vokanamet og Xigduo.
English: If diabetic ketoacidosis is suspected or confirmed, treatment with SGLT2 inhibitors should be stopped immediately and should not be re-started unless another cause for the ketoacidosis is identified and resolved.
Danish: Hvis der er mistanke om diabetisk ketoacidose, eller hvis tilstanden bekræftes, skal behandlingen med SGLT2-hæmmere straks afbrydes, og den må ikke startes igen, medmindre en anden årsag til ketoacidosen identificeres og fortager sig.
English: • Exercise caution in patients with risk factors for ketoacidosis and inform patients of these factors.
Danish: • Der skal udvises forsigtighed ved behandling af patienter med risikofaktorer for ketoacidose, og patienterne skal informeres om disse faktorer.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted the Agency's final opinion.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som bekræftede anbefalingerne og vedtog agenturets endelige udtalelse.
English: Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.
Danish: Sundhedspersoner skal derfor overveje muligheden for ketoacidose hos patienter i behandling med SGLT2-hæmmere, som har symptomer, der er konsistente med tilstanden, selv om blodsukkerniveauet ikke er højt.
English: Healthcare professionals should exercise caution with SGLT2 inhibitors in patients with risk factors for ketoacidosis and inform patients of these factors.
Danish: Sundhedspersoner skal udvise forsigtighed ved behandling med SGLT2-hæmmere hos patienter med risikofaktorer for ketoacidose og informere patienterne om disse faktorer.
English: Finally, EMA reminded healthcare professionals that SGLT2 inhibitors are not authorised for type 1 diabetes, noting that cases of ketoacidosis have also occurred during off-label use and clinical trials in type 1 diabetes.
Danish: Endelig minder EMA sundhedspersoner om, at SGLT2-hæmmere ikke er godkendt til behandling af type 1-diabetes, og bemærker, at der er set tilfælde af ketoacidose ved brug i ikke-godkendte indikationer og i kliniske studier af type 1-diabetes.
English: • Always consider the possibility of diabetic ketoacidosis in patients taking SGLT2 inhibitors who have non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Danish: • Man skal altid overveje muligheden for diabetisk ketoacidose hos patienter i behandling med SGLT2-hæmmere, der har ikke-specifikke symptomer såsom kvalme, opkastning, anoreksi, mavesmerter, voldsom tørst, vejrtrækningsbesvær, konfusion, usædvanlig træthed eller søvnighed.
English: They block a protein in the kidneys called SGLT2, which absorbs glucose back from the urine into the bloodstream as the blood is filtered in the kidneys.
Danish: De blokerer et protein i nyrerne, der hedder SGLT2 (sodium-glucose co-transporter-2), og som transporterer glukose fra urinen tilbage til blodbanen, når blodet filtreres i nyrerne.
English: A number of these cases were atypical with patients having only moderately raised blood sugar levels and some of them occurred during offlabel use and clinical trials in patients with type 1 diabetes.
Danish: En række af disse tilfælde var atypiske, idet patienterne kun havde moderat forhøjede blodsukkerniveauer, og nogle af tilfældene sås i forbindelse med ikke-godkendte indikationer og i kliniske studier hos patienter med type 1diabetes.
English: In addition, EMA recommended temporarily stopping SGLT2 inhibitors in patients who are undergoing major surgery or are in hospital due to serious illness.
Danish: EMA anbefaler desuden et midlertidigt stop for SGLT2-inhibitor-behandling hos patienter, der skal gennemgå en større operation, eller som er indlagt på hospital på grund af alvorlig sygdom.
English: • Stop treatment with SGLT2 inhibitors immediately if diabetic ketoacidosis is suspected or confirmed, and do not re-start treatment unless another clear precipitating factor for the condition is identified and resolved.
Danish: • Stands øjeblikkeligt behandlingen med SGLT2-hæmmere, hvis der er mistanke om diabetisk ketoacidose, eller hvis tilstanden bekræftes, og start ikke behandlingen igen, medmindre en anden tydelig, medvirkende faktor identificeres og fortager sig.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected.
Danish: Der er set sjældne tilfælde af denne tilstand, herunder livstruende tilfælde, hos patienter, der tager SGLT2hæmmere til behandling af type 2-diabetes; en række af disse tilfælde har været atypiske, idet patienterne ikke har haft så højt blodsukkerniveau som forventet.
English: • Stop treatment with SGLT2 inhibitors temporarily in patients undergoing major surgical procedures or hospitalised due to acute serious medical illnesses.
Danish: • Stop midlertidigt behandlingen med SGLT2-hæmmere hos patienter, der skal gennemgå en større operation, eller som indlægges på hospital på grund af akut alvorlig medicinsk sygdom.
English: These include low reserve of insulin-secreting cells, a sudden reduction in insulin dose, an increased requirement for insulin (due to illness, surgery or alcohol abuse) and conditions that restrict food intake or can lead to severe dehydration.
Danish: Risikofaktorerne omfatter en lav reserve af insulinudskillende celler, pludseligt reduceret insulindosis, øget insulinbehov (på grund af sygdom, operation eller alkoholmisbrug) eller tilstande, der kan begrænse indtagelsen af føde eller medføre svær dehydrering.