FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any further questions on the use of Spedra, ask your doctor or pharmacist.
Danish: Spørg lægen eller på apoteket, hvis der er mere, du vil vide om brugen af Spedra.
English: Although specific interactions have not been studied, other CYP3A4 inhibitors, including grapefruit juice would likely increase avanafil exposure.
Danish: Andre CYP3A4-hæmmere, herunder grapefrugtjuice, må forventes at øge eksponeringen for avanafil, skønt der ikke er udført specifikke interaktionsundersøgelser.
English: Consequently, the maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours for patients taking concomitant moderate CYP3A4 inhibitors (see section 4.2).
Danish: Ved samtidig administration af moderate CYP3A4-hæmmere er den maksimale anbefalede dosis af avanafil derfor 100 mg, og denne dosis bør højst tages én gang for hver 48 timer (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets
Danish: LÆGEMIDLETS NAVN Spedra 50 mg tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of avanafil.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 200 mg avanafil.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of avanafil.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 100 mg avanafil.
English: • premature ejaculation
Danish: • for tidlig sædafgang (præmatur ejakulation)
English: Package leaflet: Information for the patient Spedra 200 mg tablets avanafil
Danish: Indlægsseddel: Information til patienten Spedra 200 mg tabletter avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets
Danish: LÆGEMIDLETS NAVN Spedra 200 mg tabletter
English: Package leaflet: Information for the patient Spedra 50 mg tablets avanafil
Danish: Indlægsseddel: Information til patienten Spedra 50 mg tabletter avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets
Danish: LÆGEMIDLETS NAVN Spedra 100 mg tabletter
English: respectively and 5/24 subjects experienced blood pressure values or decreases from baseline that were of potential clinical significance following avanafil dosing (see section 4.4).
Danish: og 3,1 mmHg, og efter dosering med avanafil fik 5/24 personer værdier eller fald i forhold til baseline af potentiel klinisk betydning (se pkt.
English: Spedra is a pale yellow oval tablet, marked “50”on one side.
Danish: Spedra er en gullig, oval tablet præget med “50” på den ene side.
English: Package leaflet: Information for the patient Spedra 100 mg tablets avanafil
Danish: Indlægsseddel: Information til patienten Spedra 100 mg tabletter avanafil
English: Spedra is a pale yellow oval tablet, marked “100” on one side.
Danish: Spedra er en gullig, oval tablet præget med “100” på den ene side.
English: Alpha-blockers
Danish: Alfablokkere
English: Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy (NAION) have been reported in connection with the intake of other PDE5 inhibitors.
Danish: I forbindelse med andre PDE5-hæmmere er indberettet synsdefekter og ikke-arteritisk anterior iskæmisk opticusneuropati (NAION).
English: Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
Danish: For andre PDE5-hæmmere er der indberettet nogle få tilfælde af priapisme i undersøgelser efter markedsføring og kliniske undersøgelser.
English: Spedra is a pale yellow oval tablet, marked “200” on one side.
Danish: Spedra er en gullig, oval tablet præget med “200” på den ene side.
English: Fumaric acid
Danish: Rygsmerter Muskelstivhed
English: Hydroxypropylcellulose
Danish: Hydroxypropylcellulose Hydroxypropylcellulose lavsubstitueret Calciumcarbonat
English: If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors') the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.
Danish: Hvis du får lægemidler, der er moderate CYP3A4-hæmmere, såsom erythromycin, amprenavir, aprepitant, diltiazem, fluconazol, fosamprenavir eller verapamil, bør du nøjes med 100 mg Spedra, og der skal gå mindst 48 timer mellem hver dosis.
English: Medicinal products reducing systemic blood pressure As a vasodilator, avanafil may reduce systemic blood pressure.
Danish: Lægemidler, der sænker det systemiske blodtryk
English: • indigestion, feeling or being sick to your stomach
Danish: • fordøjelsesbesvær, kvalme eller opkastning
English: EU/1/13/841/002 8 tablets
Danish: EU/1/13/841/001-003
English: Pale yellow oval tablets, debossed with “50” on one side.
Danish: Gullige, ovale tabletter præget med “50” på den ene side.
English: 6.6 Special precautions for disposal
Danish: 6.6 Særlige regler for bortskaffelse Ingen særlige forholdsregler.
English: Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see sections 4.3, 4.4 and 4.5).
Danish: Samtidig administration af avanafil og potente CYP3A4-hæmmere (herunder ketoconazol, ritonavir, atazanavir, clarithromycin, indinavir, itraconazol, nefazodon, nelfinavir, saquinavir og telithromycin) er kontraindiceret(se pkt.
English: The tablets are provided in perforated unit dose blister packs containing 2x1, 4x1, 8x1, or 12x1 tablets.
Danish: Tabletterne leveres i perforeret enkeltdosisblister med 2x1, 4x1, 8x1 eller 12x1 tabletter.
English: These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors.
Danish: Der er beskrevet tidsmæssig sammenhæng mellem indtagelse af PDE5-hæmmere og sådanne hændelser, der kan være ledsaget af tinnitus og svimmelhed.
English: Problems with your sight or hearing
Danish: Pludseligt større eller mindre høretab
English: • stomach ache or heartburn
Danish: • mavesmerter eller halsbrand
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 2x1, 4x1, 8x1 and 12x1 tablets.
Danish: Perforeret enkeltdosisblister af PVC/PCTFE/aluminium i karton med 2x1, 4x1, 8x1 og 12x1 tabletter.
English: Pale yellow oval tablets, debossed with “200” on one side.
Danish: Gullige, ovale tabletter præget med “200” på den ene side.
English: Pale yellow oval tablets, debossed with “100” on one side.
Danish: Gullige, ovale tabletter præget med “100” på den ene side.
English: The tablets are provided in perforated unit dose blister packs containing 4x1, 8x1, or 12x1 tablets.
Danish: Tabletterne leveres i perforeret enkeltdosisblister med 4x1, 8x1 eller 12x1 tabletter.
English: Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.
Danish: Brug af Spedra sammen med drikkevarer og alkohol Du skal lade være med at drikke grapefrugtjuice 24 timer før, du tager Spedra, da det kan øge koncentrationen af lægemidlet.
English: Visual problems
Danish: Synsforstyrrelser
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.
Danish: Perforetet enkeltdosisblister af PVC/PCTFE/aluminium i karton med 4x1, 8x1 og 12x1 tabletter.
English: Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see sections 4.2, 4.4 and 4.5).
Danish: - samtidig anvendelse af potente CYP3A4-hæmmere (herunder ketoconazol, ritonavir, atazanavir, clarithromycin, indinavir, itraconazol, nefazodon, nelfinavir, saquinavir og telithromycin) (se pkt.
English: • blurred vision.
Danish: • sløret syn
English: Avanafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 4.5), and as such potentiates the hypotensive effect of nitrates (see section 4.3).
Danish: 4.5) og potentierer således den hypotensive virkning af nitrater (se pkt.
English: • penile disorder
Danish: • penislidelse
English: Body temperature increased
Danish: Øvre luftvejskongestion Epistakse
English: • feeling out of breath when you exert yourself
Danish: • stakåndethed ved fysisk anstrengelse
English: What Spedra is and what it is used for What you need to know before you take Spedra How to take Spedra
Danish: Det skal du vide, før du begynder at tage Spedra Sådan skal du tage Spedra Bivirkninger
English: Haematuria, haematospermia and penile haemorrhage has been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
Danish: For andre PDE5-hæmmere er der er indberettet nogle få tilfælde af hæmaturi, hæmatospermi og blødning fra penis i undersøgelser efter markedsføring og kliniske forsøg.
English: • rash
Danish: • rødmen
English: Pharmaprim AB Sími: +46 8355933
Danish: Pharmaprim AB Simi: +468355933
English: • dry mouth
Danish: • muskeltrækninger
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets avanafil
Danish: Spedra 200 mg tabletter Avanafil
English: Gout
Danish: BLISTER
English: Gastritis
Danish: Hedeture
English: Consequently, co-administration of avanafil with potent CYP3A4 inhibitors is contraindicated (see sections 4.2, 4.3 and 4.4).
Danish: Ved brug af potente CYP3A4-hæmmere er samtidig administration af avanafil derfor kontraindiceret (se pkt.
English: • stuffy or runny nose
Danish: • tilstoppet eller løbende næse
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets avanafil
Danish: Spedra 50 mg tabletter Avanafil
English: Patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: - tab af syn på et øje som følge af ikke-arteritisk anterior iskæmisk opticusneuropati (NAION),
English: Vision blurred
Danish: INFORMATION I BRAILLESKRIFT
English: What Spedra looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets avanafil
Danish: Spedra 100 mg tabletter Avanafil
English: The company that applied for authorisation is Merial.
Danish: Virksomheden, der ansøgte om tilladelse, er Merial.
English: What was Longrange expected to be used for?
Danish: Hvad forventedes Longrange anvendt til?
English: Although the company proposed measures to reduce the environmental risk, the CVMP did not consider them to be sufficient.
Danish: Selvom virksomheden foreslog foranstaltninger til at minimere risikoen for miljøet, fandt CVMP ikke, at de var tilstrækkelige.
English: What is Longrange?
Danish: Hvad er Longrange?
English: After considering the grounds for this request, the CVMP re-examined the opinion and confirmed the refusal of the marketing authorisation on 11 October 2018.
Danish: Efter en drøftelse af begrundelserne for denne anmodning revurderede CVMP den oprindelige udtalelse og bekræftede afslaget på ansøgningen om markedsføringstilladelse den 11. oktober 2018.
English: The animals were monitored for 4 months and the main measure of effectiveness was the percentage of animals that were cured of worms over 4 months.
Danish: Dyrene blev fulgt i 4 måneder, og det primære mål for virkningen var procentdelen af dyr, der blev helbredt for orm i løbet af de 4 måneder.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Longrange, intended for the treatment and prevention of parasitic infections in cattle.
Danish: Den 21. juni 2018 vedtog Udvalget for Lægemidler til Dyr (CVMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Longrange, der er beregnet til behandling og forebyggelse af parasitære infektioner hos kvæg.
English: 12 December 2018 EMA/778491/2018 EMEA/H/V/004291
Danish: EMA/15594/2019 EMEA/H/V/004291
English: Prolonged-release means that the solution releases eprinomectin slowly over an extended time period - four months in the case of Longrange.
Danish: "Depot" betyder, at opløsningen frigiver eprinomectin langsomt over en længere periode (fire måneder i Longranges tilfælde).
English: Longrange is a veterinary medicine that contains the active substance eprinomectin.
Danish: Longrange er et lægemiddel til dyr, der indeholder det aktive stof eprinomectin.
English: This leads to an increase in the amount of chloride ions that enter the cells, resulting in paralysis and death of the parasite.
Danish: Det medfører en stigning i mængden af chlorid-ioner, der trænger ind i cellerne, hvilket resulterer i, at parasitten paralyseres og dør.
English: The company presented data from a main field study of 156 young cattle with natural roundworm and/or lungworm infections that were treated with Longrange.
Danish: Virksomheden fremlagde data fra et hovedfeltstudie af 156 unge kvæg inficeret med naturlige rundorm og/eller lungeorm, som blev behandlet med Longrange.
English: Therefore, the CVMP was of the opinion that the benefits of Longrange did not outweigh its risks and recommended that it be refused marketing authorisation.
Danish: CVMP var derfor af den opfattelse, at fordelene ved Longrange ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: The CVMP was concerned mainly about the possible effects of Longrange on the environment, specifically its effects on organisms in cattle dung.
Danish: CVMP var primært betænkelig ved Longranges mulige indvirkning på miljøet, især dets indvirkning på organismer i kvæggødning.
English: Refusal of the marketing authorisation for Longrange (eprinomectin)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Longrange (eprinomectin)
English: The active substance in Longrange, eprinomectin, is a well-known antiparasitic substance that works by attaching to tiny pores on the surface of parasitic nerve or muscle cells called glutamate-gated chloride ion channels.
Danish: Det aktive stof i Longrange, eprinomectin, er et velkendt antiparasitært stof, der virker ved at binde sig til små porer på overfladen af parasitære nerve- eller muskelceller, der hedder glutamat-gatede chlorid-ionkanaler.
English: It was also expected to prevent reinfections with gut roundworms and lungworm for 100 to 120 days.
Danish: Lægemidlet forventedes også at kunne forebygge re-infektioner med rundorm i tarmene og lungeorm i 100-120 dage.
English: It was to be available as a prolonged-release solution for injection under the skin in cattle.
Danish: Det var hensigten, at det skulle markedsføres som depotinjektionsvæske til indsprøjtning under huden hos kvæg.
English: Longrange was expected to be used to treat infections with the following parasites: gut roundworms, lungworm, warbles, mange mites, lice and horn flies.
Danish: Longrange forventedes anvendt til at behandle infektioner med følgende parasitter: rundorm i tarmene, lungeorm, bremselarver, skabsmider, lus og stikfluer.
English: The company also presented data on the effectiveness of Longrange against ectoparasites - those parasites such as lice and warble flies that live on the outside of the animal's body.
Danish: Virksomheden fremlagde også data for virkningen af Longrange mod ektoparasitter, der er de parasitter, f.eks. lus og bremsefluer, der lever uden på dyrets krop.
English: Refusal of the marketing authorisation for Longrange (eprinomectin) EMA/778491/2018
Danish: Afslag på ansøgningen om markedsføringstilladelse for Longrange (eprinomectin) EMA/15594/2019
English: How does Longrange work?
Danish: Hvordan virker Longrange?
English: This summary was last updated on: 04-2013.
Danish: Dette sammendrag blev sidst ajourført den: 04-2013.
English: These effects disappeared after a few weeks and did not require any further treatment.
Danish: Disse bivirkninger forsvinder efter nogle få uger og kræver ingen yderligere behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Naxcel on 19 May 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Naxcel den 19. maj 2005.
English: If you want more information regarding the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CVMP's anbefalinger, kan du læse den videnskabelige drøftelse (også en del af denne EPAR).
English: Other information about Naxcel:
Danish: Øvrige oplysninger om Naxcel:
English: Swelling of the face, lips or eyes, or any difficulty breathing are more serious symptoms and require urgent medical attention.
Danish: Hævelse i ansigtet, på læberne eller i øjnene eller enhver form for vejrtrækningsbesvær er mere alvorlige symptomer og kræver øjeblikkelig lægehjælp.
English: Naxcel should be handled with care and all of the recommended precautions be taken to avoid exposure to the product.
Danish: Naxcel skal håndteres med forsigtighed, og alle de anbefalede forholdsregler skal træffes for at undgå eksponering for produktet.
English: This document is a summary of the European Public Assessment report for Naxcel.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport Naxcel (EPAR).
English: In pigs, the withdrawal period in meat and offal is 71 days.
Danish: Hos svin er tilbageholdelsestiden for kød og indvolde 71 dage.
English: In cattle, the withdrawal period in meat and offal is nine days, and in milk it is zero days.
Danish: Hos kvæg er tilbageholdelsestiden for kød og indvolde ni dage, og for mælk er tilbageholdelsestiden nul dage.
English: The Committee therefore recommended that Naxcel should be given a marketing authorisation.
Danish: Udvalget anbefalede derfor udstedelse af markedsføringstilladelse for Naxcel.
English: It should also not be used in animals which may be hypersensitive to any of the ingredients.
Danish: Det må ikke anvendes til dyr, der kan være overfølsomme over for nogen af indholdsstofferne.
English: If any symptoms occur after accidental exposure to Naxcel, for example a skin rash, then the advice of a doctor should be sought immediately.
Danish: Hvis der opstår symptomer efter utilsigtet eksponering for Naxcel som for eksempel hududslæt, skal der straks søges læge.
English: Like other antibiotics, ceftiofur is only effective against certain types of bacteria.
Danish: Ligesom andre antibiotika er ceftiofur kun effektivt mod bestemte bakterietyper.
English: What is the risk associated with Naxcel?
Danish: Hvilken risiko er der forbundet med Naxcel?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Naxcel were greater than any risks when used as recommended.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at Naxcels gavnlige virkninger er større end de mulige risici, når anvisningen følges.
English: Naxcel is used to treat pigs and cattle that have an infection caused by certain groups of bacteria.
Danish: Naxcel anvendes til behandling af svin og kvæg, som har en infektion, der er forårsaget af bestemte bakteriegrupper.
English: Ceftiofur (like other cephalosporins or penicillins) may cause allergic reaction in humans or in animals, which may occasionally be serious.
Danish: Ceftiofur kan (ligesom andre cephalosporiner eller penicillintyper) fremkalde allergiske reaktioner hos mennesker eller dyr, som af og til kan være alvorlige.
English: Why has Naxcel been approved?
Danish: Hvorfor blev Naxcel godkendt?
English: Data from laboratory studies with different bacteria showed that ceftiofur is effective against bacteria involved in causing the pig and cattle diseases listed above.
Danish: Data fra laboratorieundersøgelser med forskellige bakterier har vist, at ceftiofur er effektivt mod de bakterier, der er involveret i fremkaldelse af ovennævnte sygdomme hos svin og kvæg.
English: What is Naxcel?
Danish: Hvad er Naxcel?
English: The most common side effects noted during the studies were local swelling and other mild reactions at the injection site (skin discoloration or small cysts).
Danish: De mest almindelige bivirkninger, der blev registreret i undersøgelserne, er lokal hævelse og andre milde reaktioner (misfarvning af huden, små cyster) ved injektionsstedet.
English: In cattle, Naxcel was given under the skin at the base of the ear.
Danish: Hos kvæg blev Naxcel indgivet under huden ved øreroden.
English: All these cephalosporin antibiotics, including ceftiofur, kill bacteria by disrupting the building of the bacterial cell walls.
Danish: Alle disse cephalosporin-antibiotika, heriblandt ceftiofur, dræber bakterier ved at hæmme bakteriens cellevægssyntese.
English: In pigs, these infections can be respiratory tract infections such as lung infections, infections of the joints and infections affecting the general health of the pigs such as septicaemia (blood infection).
Danish: Hos svin kan disse infektioner være luftvejsinfektioner, såsom lungeinfektioner, infektioner i led, og infektioner, der påvirker svinenes generelle sundhedstilstand såsom septicaemia (blodforgiftning).
English: It should, therefore, not be used in animals that have previously shown an allergy to any cephalosporin or penicillin-type antibiotics.
Danish: Det må derfor ikke anvendes til svin, som vides at være allergiske over for nogen form for cephalosporin eller antibiotika af penicillintypen.
English: The efficacy of the treatment with Naxcel was compared with the results seen in another group of cattle that were treated with ceftiofur hydrochloride.
Danish: Virkningen af behandlingen med Naxcel blev i denne undersøgelse sammenlignet med resultaterne i en anden gruppe af kalve, som blev behandlet med ceftiofurhydrochlorid.
English: However, these withdrawal periods in cattle are only valid when Naxcel has been injected under the skin in nonedible tissue at the recommended location (the base of the ear).
Danish: Disse tilbageholdelsestider for kvæg er imidlertid kun gyldige, når Naxcel er blevet indgivet i ikke-spiseligt væv på det anviste sted (øreroden).
English: Naxcel should therefore not be handled by anyone who is hypersensitive (allergic) to these antibiotics, or by anyone who has been advised not to work with them.
Danish: Naxcel må derfor ikke håndteres af personer, der er overfølsomme (allergiske) over for sådanne antibiotika, eller af personer, som er blevet frarådet at arbejde med disse antibiotika.
English: Cephalosporin and penicillin antibiotics can cause allergies in humans, and sometimes these allergies can be very serious.
Danish: Antibiotika baseret på cephalosporin eller penicillin kan fremkalde allergi hos mennesker, og disse allergier kan i nogle tilfælde være alvorlige.
English: In all studies, Naxcel was at least as effective as the comparator antibiotic.
Danish: I alle undersøgelserne var Naxcel lige så effektivt til behandling af infektionen som det antibiotikum, det blev sammenlignet med.
English: Naxcel is an antibiotic suspension that contains ceftiofur (as crystalline free acid) as the active substance.
Danish: Naxcel er en antibiotisk væske til suspension, der indeholder ceftiofur (krystallinsk fri syre svarende til ceftiofur) som aktivt stof.
English: It is available as a suspension for injection into the muscle of the neck (for pigs) or under the skin at the base of the ear (for cattle).
Danish: Det fås som en væske til injektion i en muskel i halsen (på svin) eller som en væske til injektion under huden ved øreroden (på kvæg).
English: The active substance in Naxcel is ceftiofur, which belongs to a class of antibiotics called “third generation cephalosporins”.
Danish: Det aktive stof i Naxcel er ceftiofur, som tilhører gruppen af antibiotika kaldet "3.generationscephalosporiner".