FrancophonIA/ELRC3.0 huggingface dataset:
English: No data were provided concerning the efficacy against ectoparasites.
Danish: Der er ikke indhentet data vedrørende virkningen mod ektoparasitter.
English: 12mg/g Horses Oral use.
Danish: 12 mg/g Heste
English: Thus the proposal from the MAH, although scientifically justified, remains practically very questionable.
Danish: Selvom det er videnskabeligt begrundet, forbliver forslaget fra indehaveren af markedsføringstilladelsen derfor meget tvivlsomt.
English: Efficacy could be claimed if effectiveness against each parasite declared on the labelling was at 90% or above based on calculation of geometric means and there was a statistically significant difference in parasite numbers between control and treated horses.
Danish: I forbindelse med undersøgelser til kontrol af dosis ‘anbefales mindst to kontrollerede, eller i påkommende tilfælde, kritiske dosisbekræftende undersøgelser' Virkningsfuldhed kan hævdes, hvis virkningen mod hver parasit, der er angivet på etiketteringen, var på 90% eller mere på baggrund af en beregning af geometriske midler, og der var en statistisk signifikant forskel i antal parasitter mellem kontrol og behandlede heste.
English: It is known that there is a potential resistance build up to ivermectin in Parascaris equorum, however the highest number of P. equorum may be found in grazing horses 3-18 months old.
Danish: Det højeste antal P. equorum kan dog findes i 3-18 måneder gamle heste på græs.
English: Recommended dose
Danish: Anbefalet anvendelse
English: During the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/CVMP/016/00-corrFINAL), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Danish: Under henvisningsproceduren blev det fastlagt, at den indsendte bioækvivalensundersøgelse ikke var tilstrækkelig til at påvise bioækvivalens (endelig definition i den gældende vejledning EMEA/CVMP/016/00-corr-FINAL).
English: Strength Animal species
Danish: Særnavn Lægemiddelform Styrke DyrearterIndgivelsesvej og -hyppighed
English: This overview was last updated in 06-2019.
Danish: Denne oversigt blev sidst ajourført i 06-2019.
English: ‘Complicated' means that the infection is difficult to treat;
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle
English: Studies in children
Danish: Studier hos børn
English: Studies in adults
Danish: Studier hos voksne
English: It is used to treat adults and children (including newborn babies) who have:
Danish: Det anvendes til behandling af voksne og børn (inklusive nyfødte spædbørn) med:
English: Zinforo received a marketing authorisation valid throughout the EU on 23 August 2012.
Danish: Zinforo fik en markedsføringstilladelse med gyldighed i hele EU den 23. august 2012.
English: Further information on Zinforo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zinforo
Danish: Yderligere information om Zinforo findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/zinforo
English: However, as there were uncertainties about the effects of Zinforo in patients with certain very severe infections these effects will be investigated in further studies.
Danish: Da der var usikkerhed med hensyn til virkningen af Zinforo hos patienter med visse, meget svære infektioner, vil disse virkninger imidlertid blive undersøgt i yderligere studier.
English: Zinforo is given by infusion (drip) into a vein usually over 5 to 60 minutes.
Danish: Zinforo indgives ved infusion (drop) i en vene sædvanligvis over 5 til 60 minutter.
English: As for all medicines, data on the use of Zinforo are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Zinforo løbende overvåget.
English: Zinforo is an antibiotic.
Danish: Zinforo er et antibiotikum.
English: What measures are being taken to ensure the safe and effective use of Zinforo?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zinforo?
English: Other information about Zinforo
Danish: Andre oplysninger om Zinforo
English: In children and adolescents weighing less than 33 kilograms, the dose depends on the patient's weight.
Danish: Hos børn og unge, der vejer under 33 kg, afhænger dosis af patientens vægt.
English: For some serious skin infections, the recommended dose is 600 mg every 8 hours, with each infusion lasting 120 minutes.
Danish: Ved visse alvorlige hudinfektioner er den anbefalede dosis 600 mg hver 8. time, hvor hver infusion varer 120 minutter.
English: • complicated infections of the skin and soft tissue (tissue below the skin).
Danish: • komplicerede infektioner i hud og bløddele (væv under huden).
English: Side effects reported with Zinforo are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Zinforo vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: In adults and adolescents from 12 years of age weighing at least 33 kg, the usual dose is 600 mg every 12 hours.
Danish: Hos voksne og unge fra 12-årsalderen, som vejer mindst 33 kg, er den sædvanlige dosis 600 mg hver 12. time.
English: An overview of Zinforo and why it is authorised in the EU
Danish: En oversigt over Zinforo, og hvorfor det er godkendt i EU
English: Patients with complicated skin and soft tissue infections should be treated for 5 to 14 days and patients who have community-acquired pneumonia should be treated for 5 to 7 days.
Danish: Patienter med komplicerede infektioner i hud og bløddele bør behandles i 5-14 dage, og patienter med samfundserhvervet lungebetændelse bør behandles i 5-7 dage.
English: For more information about using Zinforo, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Zinforo, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The Agency decided that Zinforo's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede, at fordelene ved Zinforo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Zinforo (ceftaroline fosamil)
Danish: Zinforo (ceftarolinfosamil)
English: Prescribers should consider official guidance on the appropriate use of antibiotics.
Danish: Når lægen ordinerer lægemidlet, bør det ske i overensstemmelse med de officielle retningslinjer for hensigtsmæssig brug af antibiotika.
English: The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick) and pruritus (itching).
Danish: De hyppigste bivirkninger ved Zinforo (som optræder hos mere end 3 % af patienterne) er diarré, hovedpine, kvalme og kløe.
English: Why is Zinforo authorised in the EU?
Danish: Hvorfor er Zinforo godkendt i EU?
English: This weakens the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Danish: Dette svækker bakteriernes cellevæg, som derved bliver tilbøjelig til at briste, så bakterierne til sidst dør.
English: What are the risks associated with Zinforo?
Danish: Hvilke risici er der forbundet med Zinforo?
English: It interferes with the production of complex molecules called peptidoglycans, which are essential components of bacterial cell walls.
Danish: Det griber ind i produktionen af de sammensatte molekyler "peptidoglycaner", som er vigtige bestanddele i bakteriernes cellevæg.
English: The European Medicines Agency concluded that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and its side effects in both adults and children were manageable.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at Zinforo var effektivt til behandling af komplicerede infektioner i hud og bløddele og samfundserhvervet lungebetændelse, og at bivirkningerne hos både voksne og børn var håndterbare.
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Danish: • lungebetændelse, der er samfundserhvervet (erhvervet uden for hospitalet).
English: What is Zinforo and what is it used for?
Danish: Hvad er Zinforo, og hvad anvendes det til?
English: The Agency also noted that in laboratory studies Zinforo had shown activity against certain bacteria, such as MRSA, against which other beta-lactam antibiotics do not work.
Danish: Agenturet bemærkede også, at Zinforo i laboratoriestudier havde udvist aktivitet over for visse bakterier, såsom MRSA, som andre betalaktamantibiotika ikke virker mod.
English: In laboratory studies Zinforo was active against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (meticillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
Danish: I laboratoriestudier virkede Zinforo mod visse bakterier, som andre antibiotika i betalaktam-klassen ikke virker mod (meticillinresistent Staphylococcus aureus (MRSA) og ikkepenicillinfølsom Streptococcus pneumoniae (PNSP)).
English: It does so by blocking enzymes, called penicillin-binding protein transpeptidases, that are involved in the last steps of bacterial cell wall production.
Danish: Dette sker ved, at stoffet blokerer nogle enzymer, der kaldes penicillinbindende protein-transpeptidaser, som medvirker i de afsluttende trin i opbygningen af bakteriernes cellevæg.
English: Zinforo was as effective as other antibiotics in curing skin and soft tissue infections and pneumonia in adults.
Danish: Zinforo var lige så effektivt som andre antibiotika til at helbrede infektioner i hud og bløddele samt lungebetændelse hos voksne.
English: Zinforo must not be used in people who are hypersensitive (allergic) to ceftaroline fosamil or any of the other ingredients.
Danish: Zinforo må ikke anvendes hos personer, der er overfølsomme (allergiske) over for ceftarolinfosamil eller andre af indholdsstofferne.
English: Zinforo contains the active substance ceftaroline fosamil.
Danish: Zinforo indeholder det aktive stof ceftarolinfosamil.
English: For the full list of side effects of Zinforo, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Zinforo fremgår af indlægssedlen.
English: The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group ‘beta-lactams'.
Danish: Det aktive stof i Zinforo, ceftarolinfosamil, er et antibiotikum af cefalosporintypen, der tilhører gruppen "betalaktamer".
English: Zinforo must also not be used in patients who are hypersensitive to other antibiotics belonging to the cephalosporin class and in patients who are severely allergic to other betalactam antibiotics.
Danish: Zinforo må heller ikke anvendes hos patienter, der er overfølsomme over for andre antibiotika af cefalosporintypen, eller hos patienter med svær allergi over for andre betalaktamantibiotika.
English: How is Zinforo used?
Danish: Hvordan anvendes Zinforo?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinforo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zinforo.
English: Among those with complicated community-acquired pneumonia, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
Danish: Blandt dem med kompliceret samfundserhvervet lungebetændelse blev 90 % af de patienter, der fik Zinforo, helbredt sammenlignet med 100 % af dem, der fik kombinationen af ceftriaxon og vancomycin.
English: What benefits of Zinforo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Zinforo?
English: In a children's study of complicated skin and soft tissue infection, 94% of the children receiving Zinforo were cured (101 out of 107), compared with 87% of those receiving vancomycin or cefazolin, with or without aztreonam (45 out of 52).
Danish: I et studie af komplicerede infektioner i hud og bløddele hos børn blev 94 % af de børn, der fik Zinforo, helbredt (101 ud af 107) sammenholdt med 87 % af dem, der fik vancomycin eller cefazolin, med eller uden aztreonam (45 ud af 52).
English: In another study, 81% of patients receiving Zinforo were cured (235 out of 289) compared with 76% of the patients receiving ceftriaxone (206 out of 273).
Danish: I et andet studie blev 81 % af de patienter, der fik Zinforo, helbredt (235 ud af 289) sammenholdt med 76 % af de patienter, der fik ceftriaxon (206 ud af 273).
English: For community-acquired pneumonia, one study showed that 84% of the patients receiving Zinforo were cured (244 out of 291), compared with 78% of the patients receiving ceftriaxone (233 out of 300).
Danish: Ved samfundserhvervet lungebetændelse viste et studie, at 84 % af de patienter, der fik Zinforo, blev helbredt (244 ud af 291), sammenholdt med 78 % af de patienter, der fik ceftriaxon (233 ud af 300).
English: Among children with community-acquired pneumonia that required hospital stay, 88% of those on Zinforo were cured (94 out of 107), compared with 89% of those receiving ceftriaxone.
Danish: Blandt børn med samfundserhvervet lungebetændelse, som krævede indlæggelse, blev 88 % af de patienter, der fik Zinforo, helbredt (94 ud af 107) sammenholdt med 89 % af de patienter, der fik ceftriaxon.
English: In a second study, 85% of patients receiving Zinforo were cured (291 out of 342) compared with 86% of the patients receiving the combination of vancomycin and aztreonam (289 out of 338).
Danish: I et andet studie blev 85 % af de patienter, der fik Zinforo, helbredt (291 ud af 342) sammenholdt med 86 % af de patienter, der fik kombinationen af vancomycin og aztreonam (289 ud af 338).
English: In a study of patients with complicated skin and soft tissue infection, 87% of the patients receiving Zinforo were cured (304 out of 351), compared with 86% of the patients receiving the combination of vancomycin and aztreonam (297 out of 347).
Danish: I et studie, som omfattede patienter med komplicerede infektioner i hud og bløddele, blev 87 % af de patienter, der fik Zinforo, helbredt (304 ud af 351) sammenholdt med 86 % af de patienter, der fik kombinationen af vancomycin og aztreonam (297 ud af 347).
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer Særnavn
English: The significance for man is unknown.
Danish: Betydningen for mennesker kendes ikke.
English: In this latter case, appropriate other measures should be taken.
Danish: I sidstnævnte tilfælde skal de nødvendige foranstaltninger træffes.
English: Dose proportionality was not observed.
Danish: Der blev ikke observeret nogen dosisproportionalitet.
English: Results are emerged from a meta-analysis of both trials.
Danish: Resultaterne er taget fra en meta-analyse af begge studier.
English: 4.8 Undesirable effects a) General Description:
Danish: 4.8 Bivirkninger a) Generel beskrivelse:
English: Continue treatment for four weeks.
Danish: Fortsæt behandlingen i 4 uger.
English: There was no evidence for systemic reactions.
Danish: Der var ingen evidens for systemiske reaktioner.
English: Date of first authorisation: 18/09/1998 Date of last renewal: 03/09/2008
Danish: Dato for første markedsføringstilladelse: 18/09/1998 Dato for seneste fornyelse: 03/09/2008
English: - The active substance is imiquimod.
Danish: - Det aktive stof er imiquimod.
English: 56% of the patients have been free of hypopigmentation; hyperpigmentation has not been reported.
Danish: 56% af patienterne var fri for hypopigmentering; hyperpigmentering blev ikke rapporteret.
English: Treatment should be initiated and monitored by a physician.
Danish: Behandlingen skal indledes og følges af en læge.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Der bør udvises forsigtighed ved ordinering til gravide kvinder.
English: In some individuals a lowering of blood counts was noted.
Danish: Hos enkelte personer har man konstateret en reducering i antallet af blodlegemer.
English: All patients were followed-up until withdrawal or up to 3 years after randomisation.
Danish: Der blev fulgt op på alle patienter indtil seponering eller op til 3 år efter randomisering.
English: The frequency of side effects is classified as follows:
Danish: Hyppigheden af bivirkninger er inddelt efter følgende:
English: 4-8 AK lesions were treated.
Danish: 4-8 AK-læsioner blev behandlet.
English: Wear protective clothing and wide brimmed hats when outdoors.
Danish: Bær beskyttende tøj og hat med bred skygge, når De er udendørs.
English: Follow-up information suggests that these skin colour changes may be permanent in some patients.
Danish: Opfølgende oplysninger antyder, at disse ændringer i hudfarven kan være permanente hos visse patienter.
English: • Do not use more cream than your doctor has advised.
Danish: o Brug ikke mere creme, end Deres læge har ordineret.
English: The extent of percutaneous absorption did not change significantly between the first and last doses of this study.
Danish: Omfanget af den perkutane absorption blev ikke ændret markant mellem de første og sidste doser i dette forsøg.
English: Alternative forms of contraception should be considered.
Danish: Alternative svangerskabsforebyggende metoder bør overvejes.
English: Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Danish: Studier med dyr indikerer ikke nogen direkte eller indirekte skadelig effekt under graviditet.
English: Imiquimod has no direct antiviral activity.
Danish: Imiquimod udviser ingen direkte antiviral aktivitet.
English: Local dermal irritation, especially at higher doses, was observed in both species.
Danish: Der blev observeret lokal dermal irritation, især ved større doser, hos begge arter.
English: Benzyl alcohol may cause allergic reactions and mild local irritation.
Danish: Benzylalkohol kan forårsage allergiske reaktioner og mild lokal irritation.
English: He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment).
Danish: Han/hun vil måske råde Dem til at standse behandlingen med Aldara creme i et par dage (dvs. en kort pause i behandlingen).
English: Information applicable to all indications:
Danish: Information gældende for alle indikationer:
English: This includes studies with immunosuppressive drugs.
Danish: Dette omfatter undersøgelser med immunhæmmende lægemidler.
English: A small number of patients have experienced hair loss at the treatment site or surrounding area.
Danish: Et lille antal patienter har oplevet hårtab på behandlingsstedet eller i det omkringliggende område.
English: Some patients have experienced changes in skin colour in the area where Aldara cream was applied.
Danish: Nogle patienter har oplevet forandringer i hudfarven i det område, hvor Aldara creme blev påført.
English: The maximum recommended dose is one sachet.
Danish: Maksimal rekommenderet dosis er et brev.
English: Some are skin coloured, others are greyish, pink, red or brown.
Danish: Nogle er hudfarvede, andre er grålige, rosa, røde eller brune.
English: These results were statistically significant (p<0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
Danish: Disse resultater var statistisk signifikante (p<0,001) ved sammenligning med vehikelgruppen, henholdsvis 3% (6/179) og 2% (3/179).
English: Inflammation c) Frequently occurring adverse events:
Danish: Inflammation c) Hyppigt forekommende bivirkninger:
English: Do not apply the cream on Saturday and Sunday.
Danish: Påfør ingen creme lørdag og søndag.
English: Remember, Aldara cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
Danish: Vær opmærksom på, at Aldara creme ikke beskytter mod overførsel af HIV eller andre seksuelt overførte sygdomme.
English: However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation.
Danish: I nogle tilfælde har disse reaktioner dog været alvorlige og dermed nødvendiggjort behandling og/eller forårsaget invaliditet.
English: These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Danish: Disse reduktioner anses ikke for at være klinisk signifikante hos patienter med normale hæmatologiske reserver.
English: See 4.2 and 4.4 for information on rest periods.
Danish: 4.2 og 4.4 for information om pause i behandlingen)
English: In younger patients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
Danish: Hos yngre patienter i alderen 2-5 år var absorptionen, baseret på Cmax værdier, større i forhold til voksne.
English: • Tell your doctor if you have problems with your immune system.
Danish: o Giv Deres læge besked, hvis De har problemer med Deres immunsystem.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: Den trykte indlægsseddel I produktet skal angive navn og adresse på den ansvarlige producent vedrørende frigivelsen af den pågælende batch.
English: White to slightly yellow cream.
Danish: Hvid til let gullig creme.
English: Frequencies are defined as Very common (1/10), Common (1/100 to <1/10) and Uncommon (1/1,000 to <1/100).
Danish: Hyppigheden defineres som Meget almindelig (≥1/10), Almindelig (>1/100 til <1/10), Ikke almindelig (>1/1.000 til, <1/100).
English: If left untreated, basal cell carcinoma can disfigure, especially on the face - therefore early recognition and treatment are important.
Danish: Hvis basalcellekræft ikke behandles, kan det skæmme, især i ansigtet - og derfor er tidlig opdagelse og behandling vigtig.
English: Do not use Aldara cream for more than 16 weeks in the treatment of each episode of warts.
Danish: Brug ikke Aldara creme i mere end 16 uger til behandling af hver episode af vorter.
English: Because of the way Aldara works, there is a possibility that the cream may worsen existing inflammation in the treatment area.
Danish: På grund af den måde, Aldara virker på, er der mulighed for, at cremen kan forværre en eventuel eksisterende betændelse i behandlingsområdet.
English: This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body.
Danish: Dette er en almindelig,form for hudkræft, som vokser langsomt , og hvor sandsynligheden for at det spreder sig til andre dele af kroppen er meget lille.
English: Imiquimod cream is indicated for the topical treatment of:
Danish: Imiquimod-creme er indikeret til topikal behandling af:
English: This medicine has no or negligible influence on the ability to drive and use machines.
Danish: Dette lægemiddel har ingen eller ubetydelig indflydelse på evnen til at betjene maskiner eller føre motorkøretøjer.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for Aldara i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: If you think this applies to you talk to your doctor.
Danish: Hvis de mener, at dette er tilfældet for Dem, bør De tale med Deres læge.
English: Uterovaginal prolapse
Danish: Uterovaginal prolaps
English: This medicine contains 5 mg benzyl alcohol in each sachet.
Danish: Dette lægemiddel indeholder 5 mg benzylalkohol i hvert brev.
English: There are no medicines known to be incompatible with Aldara cream.
Danish: Ingen lægemidler vides at være uforligelige med Aldara creme.