FrancophonIA/ELRC3.0 huggingface dataset:
English: This product is specifically developed for cats and should not be used in any other animal species.
Danish: Dette lægemiddel er specielt udviklet til katte og bør ikke anvendes til andre dyrearter.
English: ProMeris should not be used in cats less than 8 weeks old since it has not been sufficiently studied in these animals.
Danish: ProMeris bør ikke anvendes til katte, som er under 8 uger gamle, da midlet ikke er blevet tilstrækkeligt undersøgt hos disse dyr.
English: There may be a change in appearance of the fur (oily appearance and clumping or spiking of hair) at the application site.
Danish: Der kan forekomme en ændring i pelsens udseende (olieagtigt udseende og hårklumper eller piggeagtigt hår) på påføringsstedet.
English: Data were provided on the pharmaceutical quality, the safety of the product in cats and the safety in humans (people in contact with the product) and the environment.
Danish: Der blev fremlagt oplysninger om den farmaceutiske kvalitet, sikkerheden ved lægemidlet til katte og sikkerheden for mennesker (personer, som kommer i kontakt med lægemidlet) og for miljøet.
English: It is given to cats with a pre-filled spot-on pipette, a small plastic container which is already filled with the correct amount of ProMeris needed to treat one cat (ProMeris is available in 2 different sizes for various cat weights).
Danish: Det gives til katte ved hjælp af en fyldt spot-on pipette, en lille plasticbeholder, som allerede er fyldt med den rette mængde ProMeris, der er nødvendig for at behandle en kat (ProMeris findes i 2 forskellige størrelser til katte af forskellig vægt).
English: Cats from various breeds (mainly European shorthair), age groups and weight that were infested with fleas were either treated with ProMeris or with other products authorised in the EU for this indication.
Danish: Katte af forskellige racer (hovedsagelig europæisk korthåret race), alders- og vægtgrupper, som var inficeret med lopper, blev enten behandlet med ProMeris eller med andre lægemidler, som er godkendt i EU til denne indikation.
English: When administering ProMeris, the user should not smoke, eat or drink.
Danish: Den, der påfører ProMeris, må ikke ryge, spise eller drikke, mens lægemidlet håndteres.
English: ProMeris is an “ectoparasiticide”, this means that it will kill parasites that live on the skin or in the fur of animals, such as fleas and ticks.
Danish: ProMeris er et ”ektoparasitdræbende” middel, hvilket betyder, at det dræber parasitter, der lever på dyrs hud eller i dyrs pels, som f.eks. lopper og flåter.
English: The effectiveness was measured looking at the number of fleas on the cat at various times up to 2 months after application.
Danish: Virkningen blev målt ud fra antallet af lopper på katten på forskellige tidspunkter i op til 2 måneder efter påføringen af præparatet.
English: ProMeris is a clear yellow to amber solution that contains metaflumizone as active substance.
Danish: ProMeris er en klar gul til ravgul opløsning, der indeholder metaflumizon som aktivt stof.
English: As other products of this group, ProMeris should not be used in sick animals or cats that have just recovered from illness.
Danish: ProMeris bør som andre lægemidler i denne gruppe ikke anvendes til syge dyr eller til katte, som lige er blevet raske.
English: The active substance of ProMeris, metaflumizone, interferes with the neural activity of the fleas and consequently leads to the death of these parasites.
Danish: Det aktive stof i ProMeris, metaflumizon, påvirker loppernes nerveaktivitet og fører følgelig til, at disse parasitter dør.
English: It can also be used as part of a treatment strategy for the control of Flea Allergy Dermatitis, an allergic reaction of cats to flea bites.
Danish: Det kan også indgå i behandlinger til kontrol af loppeallergidermatitis, som er en allergisk reaktion, katte kan få på loppebid.
English: The effectiveness of metaflumizone against flea infestations in cats was investigated in laboratory studies and in a field trial.
Danish: Metaflumizons virkning mod loppeangreb hos katte blev undersøgt i både laboratorieundersøgelser og feltundersøgelser.
English: Once applied, it remains active for up to 6 weeks.
Danish: Lægemidlets virkning efter påføringen varer ved i op til 6 uger.
English: What is the risk associated with ProMeris?
Danish: Hvilken risiko er der forbundet med ProMeris?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProMeris exceed the risks for the treatment and prevention of flea infestations in cats.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved ProMeris opvejer risiciene ved behandling og forebyggelse af loppeangreb hos katte.
English: ProMeris is used to treat and to prevent flea infestations in cats.
Danish: ProMeris anvendes til behandling og forebyggelse af loppeangreb hos katte.
English: The content of the pipette is squeezed onto the skin after parting the fur between the shoulder blades of the cat.
Danish: Pelsen mellem kattens skulderblade holdes ud til siderne, og pipettens indhold påføres huden.
English: If a cat licks the application area, the cat might salivate considerably for a short period.
Danish: Hvis katten kommer til at slikke på påføringsstedet, kan det give anledning til kortvarig, kraftig spytafsondring.
English: How has ProMeris been studied?
Danish: Hvordan blev ProMeris undersøgt?
English: Why has ProMeris been approved?
Danish: Hvorfor blev ProMeris godkendt?
English: What is ProMeris used for?
Danish: Hvad anvendes ProMeris til?
English: What is ProMeris?
Danish: Hvad er ProMeris?
English: The results of the field trial showed that ProMeris is effective in the treatment and prevention of flea infestations in cats.
Danish: Resultaterne af feltundersøgelserne viste, at ProMeris er effektivt til behandling og forebyggelse af loppeangreb hos katte.
English: What benefit has ProMeris shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved ProMeris?
English: How does ProMeris work?
Danish: Hvordan virker ProMeris?
English: Other pharmaceutical forms/strengths may be more appropriate for this population.
Danish: Andre lægemiddelformer og -styrker kan være mere velegnede til denne population.
English: This medicinal product is authorised in the Member States of the EEA under the following names: {As currently approved}.
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Udfyldes nationalt]
English: These amendments to the SPC, labelling and package leaflet are valid at the time of the Commission Decision.
Danish: Disse ændringer til produktresumé og indlægsseddel er gældende fra Kommissionens beslutning.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E) OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: • Restart the cycle of PSUR submission for Sortis and associated names as follows: o Six-monthly PSURs until two full years of experience with the paediatric indication in the EU has been gained o Yearly PSURs for the following two years o Thereafter submission at 3-yearly intervals The PSURs should focus on the use in the paediatric population.
Danish: • Indsendelse af PSUR genstartes for Zarator (og tilhørende navne) som følger: o Halvårlig PSUR, indtil der er opnået to års erfaring med den pædiatriske indikation i EU o Årlige PSUR i de efterfølgende 2 år o Derefter PSUR hvert 3. år Disse PSUR bør fokusere på brug hos den pædiatriske population.
English: A total of 39 children and adolescents, 6 to 17 years of age, were enrolled.
Danish: Der Deltog i alt 39 børn og unge i alderen 6-17 år.
English: 4.5 Interaction with other medicinal products and other forms of interaction {As currently approved}.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: ANNEX II AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: BILAG II ÆNDRINGER TIL PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: QUALITATIVE AND QUANTITATIVE COMPOSITION {As currently approved}.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: Atorvastatina Parke-Davis
Danish: Atorvastatina ParkeDavis
English: 4.7 Effects on ability to drive and use machines {As currently approved}.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
English: {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Danish: Zarator er indiceret som supplement til diæt ved forhøjet total-cholesterol, LDL-cholesterol, apolipoprotein B og forhøjede triglycerider hos patienter voksne, unge samt børn over 10 år med primær hyperkolesterolæmi inklusive familiær hyperkolesterolæmi (heterozygot variant) eller kombineret hyperlipidæmi (svarende til type IIa og IIb i Fredericksons klassifikation), hvor diæt og andre ikke farmakologiske foranstaltninger er utilstrækkelige.
English: The dosage of atorvastatin (once daily) was 10 mg for the first 4 weeks and up-titrated to 20 mg if the LDL-C level was >3.36 mmol/l.
Danish: Atorvastatin-dosis var 10 mg 1 gang dagligt i de første 4 uger og derefter titreret til 20 mg, hvis LDL-cholesterol var > 3,36 mmol/l.
English: HOW TO STORE {PRODUCT NAME} {As currently approved}.
Danish: {Navn og adresse} <{tlf}> <{fax}> <{email}>
English: 4.9 Overdose {As currently approved}.
Danish: 4.9 Overdosering [Udfyldes nationalt]
English: 6.2 Incompatibilities {As currently approved}.
Danish: 6.2 Uforligeligheder [Udfyldes nationalt]
English: The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Danish: Ved behandling af børn og unge skal der tages højde for de ovenfor nævnte interaktioner for voksne og for advarslerne i pkt.
English: Atorvastatin significantly decreased plasma levels of total-C, LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Danish: Atorvastatin sænkede signifikant totalcholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger (dobbeltblindede fase).
English: In an openlabel, 8-week study, Tanner Stage 1 (N=15) and Tanner Stage ≥2 (N=24) paediatric patients (ages 6-17 years) with heterozygous familial hypercholesterolemia and baseline LDL-C ≥4 mmol/L were treated with 5 or 10 mg of chewable or 10 or 20 mg of film-coated atorvastatin tablets once daily, respectively.
Danish: I et 8-ugers, open-label klinisk forsøg blev børn i alderen 6-17 år og i Tanner-stadie 1 (n=15) eller Tanner-stadie ≥ 2 (n=24) med heterozygot familiær hyperkolesterolæmi og baseline LDL-C ≥ 4 mmol/l behandlet med hhv. 5 mg eller 10 mg tyggetabletter eller 10 mg eller 20 mg filmovertrukne tabletter 1 gang dagligt.
English: 4.4 Special warnings and precautions for use {As currently approved}.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: 6.4 Special precautions for storage {As currently approved}.
Danish: 6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
English: 4.6 Pregnancy and lactation {As currently approved}.
Danish: 4.6 Fertilitet, graviditet og amning
English: LDL-C, triglycerides, and apolipoprotein B during the 26 week double-blind phase.
Danish: Atorvastatin sænkede signifikant total-cholesterol, LDL-cholesterol, triglycerider og apolipoprotein B i de første 26 uger (dobbelt-blindede fase).
English: Consistent decreases in LDL-C and TC were observed over the range of atorvastatin and o-hydroxyatorvastatin exposures.
Danish: Tilsvarende hermed sås fald i LDL-cholesterol og total-cholesterol i forhold til atorvastatin- og ohydroxyatorvastatin-niveauer.
English: 6.6 Special precautions for disposal {As currently approved}.
Danish: 6.6 Regler for destruktion <og anden håndtering> [Udfyldes nationalt]
English: 4.3 Contraindications {As currently approved}.
Danish: 4.3 Kontraindikationer
English: 6.5 Nature and contents of container {As currently approved}.
Danish: 6.5 Emballagetype og pakningsstørrelser <og specielt udstyr til anvendelse, administration eller implantation> [Udfyldes nationalt]
English: Marketing Authorisation Holder and Manufacturer {Name and address} <{tel}> <{fax}> <{e-mail}> [See Annex I - To be completed nationally]
Danish: Indehaveren af markedsføringstilladelsen og fremstiller [Udfyldes nationalt]
English: − Paediatric: Pharmacokinetic data in the paediatric population are not available.
Danish: Særlige patientgrupper: -[Udfyldes nationalt] - Børn: Der findes ikke farmakokinetiske data hos børn.
English: BEFORE YOU TAKE {PRODUCT NAME} {As currently approved}.
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE ZARATOR [Udfyldes nationalt]
English: {PRODUCT NAME} 80 mg film-coated tablets Atorvastatin calcium [See Annex I - To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN <MM/ÅÅÅÅ> <[Udfyldes nationalt]>
English: 1.3∙108 to 9.0∙108 CFU*/dose.
Danish: -1 Levende, ikke-patogene Escherichia coli O8:K87: 1,3∙108 til 9,0∙108 CFU/dosis
English: * colony forming units
Danish: * kolonidannende enheder
English: EU (MA) Number Invented name
Danish: EU-nummer (Markedsføringstilladelse)
English: Date of latest renewal: 28 April 2017.
Danish: Dato for seneste fornyelse: 28 april 2017.
English: The response rate in these patients was about 52%.
Danish: Responsraten hos disse patienter var cirka 52 %.
English: Risk reduction of suffering from multiple events**
Danish: Reduktion i risiko for multiple hændelser**
English: NA Not applicable
Danish: NA Ikke relevant (Not Applicable)
English: Median time to normocalcaemia was 4 days.
Danish: Mediantid til normokalcæmi var 4 dage.
English: In particular there was no clear evidence of efficacy on incidence of fracture or on pain.
Danish: Der sås i særdeleshed ikke noget klart bevis for virkning på forekomsten af fraktur eller på smerte.
English: Any unused solution should be discarded.
Danish: Al ubrugt opløsning bør bortskaffes.
English: The package leaflet is updated accordingly.
Danish: Indlægssedlen er tilsvarende opdateret.
English: The contributive role of zoledronic acid therapy in these cases could not be excluded.
Danish: Den bidragende rolle af zoledronsyre behandling kunne i disse tilfælde ikke udelukkes.
English: The occurrence of osteonecrosis is multifactorial and is associated with various risk factors.
Danish: Forekomsten af osteonekrose er multifaktoriel og er sammenkædet med forskellige risikofaktorer.
English: - to reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour.
Danish: - at nedsætte mængden af calcium i blodet hos voksne patienter, hvor det er for højt som følge af tilstedeværelsen af en tumor.
English: • The total time between dilution, storage in the refrigerator and end of administration must not exceed 96 hours.
Danish: • Den totale tidsperiode mellem fortynding, opbevaring i køleskab og afslutning af administration må ikke overskride 96 timer.
English: Baseline creatinine clearance (ml/min)
Danish: Baseline kreatininclearance (ml/min)
English: The solution must be allowed to reach 20°C to 23.5°C before administration.
Danish: Opløsningen skal have tid til at nå til 20 °C - 23,5 °C før administration.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 August 2012.
Danish: Dato for første markedsføringstilladelse: 03 august 2012.
English: As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
Danish: Da der kun eksisterer begrænsede kliniske data for patienter med svært nedsat leverfunktion, kan der ikke gives nogen specifikke anbefalinger for denne patientgruppe.
English: The treatment effects were less pronounced in patients with blastic lesions.
Danish: Behandlingens virkning var mindre udtalt hos patienter med blastiske læsioner.
English: These transverse or short oblique fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare.
Danish: Disse transverse eller korte skrå frakturer kan forekomme hvor som helst på femur, fra lige under trochanter minor til lige over det suprakondylære svaj.
English: - A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).
Danish: - En nyresygdom, der hedder Fanconis syndrom (vil normalt blive fastslået af din læge med nogle bestemte urinprøver).
English: Tell your doctor if you are or think that you may be pregnant.
Danish: Fortæl lægen, hvis du er gravid eller har mistanke om, at du er det.
English: Age, body weight, gender and creatinine clearance appear to have no effect on zoledronic acid systemic exposure.
Danish: Alder, vægt, køn og kreatininclearance synes ikke at have nogen virkning på systemisk eksponering over for zoledronsyre.
English: There are no adequate data on the use of zoledronic acid in pregnant women.
Danish: Der er ingen tilstrækkelige data fra anvendelse af zoledronsyre til gravide kvinder.
English: Many of these patients were also receiving chemotherapy and corticosteroids and had signs of local infection including osteomyelitis.
Danish: Mange af disse patienter fik også kemoterapi og kortikosteroider og viste tegn på lokal infektion inklusive osteomyelitis.
English: Pamidronate 90 mg
Danish: Pamidronat 90 mg
English: • Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Danish: • Bisfosfonatets potens (øget risiko ved højpotente stoffer), administrationsvej (øget risiko ved parenteral administration) og kumuleret dosis af bisfosfonat.
English: • The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
Danish: • Den totale tidsperiode mellem fortynding, opbevaring i køleskab og afslutning af administration må ikke overskride 24 timer.
English: Zoledronic acid medac can be given to people aged 65 years and over.
Danish: Zoledronsyre medac kan gives til patienter i alderen 65 år og derover.
English: Estimated treatment effects on BMD were similar, but the trial design was not sufficiently robust to establish non-inferior efficacy for zoledronic acid.
Danish: De estimerede behandlingsvirkninger på BMD var ens, men studiedesignet var ikke robust nok til at etablere en non-inferiør virkning for zoledronsyre.
English: Although no teratogenicity or foetotoxicity was observed in the rabbit, maternal toxicity was found.
Danish: Selvom der ikke blev observeret teratogenicitet eller føtal toksicitet hos kaniner, blev der observeret maternal toksicitet.
English: CLcr is calculated from serum creatinine using the Cockcroft-Gault formula.
Danish: CLcr beregnes ud fra serum-kreatinin ved brug af Cockeroft-Gault-formlen.
English: - Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Danish: - Alvorlige allergiske reaktioner: åndenød, hævelse hovedsageligt i ansigt og hals.
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which
Danish: - hvis du er allergisk over for zoledronsyre, et andet bisfosfonat (den gruppe af stoffer, som
English: Over the first 24 hours, 39 ± 16% of the administered dose is recovered in the urine, while the remainder is principally bound to bone tissue.
Danish: I løbet af de første 24 timer genfindes 39±16 % af den administrerede dosis i urinen, hvorimod den resterende mængde primært er bundet til knoglevævet.
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Danish: Der har været meget sjældne tilfælde af døsighed og søvnighed ved brug af zoledronsyre.
English: If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Danish: Hvis hypokalcæmi, hypofosfatæmi eller hypomagnesæmi forekommer, kan supplerende behandling være nødvendigt i kort tid.
English: If you are given more Zoledronic acid medac than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Danish: Hvis du har fået for meget Zoledronsyre medac Hvis du har fået højere doser end dem, der er anbefalet, skal du nøje overvåges af din læge.
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Danish: Forekomsten af SRE (hændelser/person-år) var 0,628 for zoledronsyre og 1,096 for placebo.
English: Thus these results precluded determining a definitive effect of zoledronic acid on fertility in humans.
Danish: Disse resultater forhindrede bestemmelsen af zoledronsyres definitive virkning på fertiliteten hos mennesker.
English: After dilution of the concentrate the prepared solution should be clear, colourless and free of visible particles.
Danish: Efter fortynding af koncentratet skal den fremstillede opløsning være klar, farveløs og uden synlige partikler.
English: While being treated with Zoledronic acid medac, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Danish: Mens du er i behandling med Zoledronsyre medac, skal du opretholde god mundhygiejne (herunder regelmæssig tandbørstning) og få rutinemæssige tandeftersyn.
English: Dystocia was observed at the lowest dose (0.01 mg/kg bodyweight) tested in the rat.
Danish: Dystoci blev observeret ved den laveste dosis (0,01 mg/kg kropsvægt), der blev testet hos rotter.
English: These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a completed femoral fracture.
Danish: Disse frakturer forekommer efter minimalt eller intet traume, og nogle patienter får lår- eller lyskesmerter, ofte med tilhørende scanningskarakteristika af stressfrakturer, uger til måneder før den komplette femurfraktur viser sig.
English: Mutagenicity and carcinogenic potential
Danish: Mutagenicitet og karcinogenicitet
English: The interpatient variability in pharmacokinetic parameters for zoledronic acid was high, as seen with other bisphosphonates.
Danish: Interindividuel variabilitet med hensyn til farmakokinetiske parametre for zoledronsyre var høj, som det er set med andre bisfosfonater.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid medac.
Danish: Alle patienter bør opfordres til at opretholde god oral hygiejne, få rutinemæssige tandeftersyn og straks rapportere alle orale symptomer, såsom tandmobilitet, smerter eller hævelse, eller ikke helende sår eller udsivning i løbet af behandlingen med Zoledronsyre medac.
English: If a lower dose of Zoledronic acid medac is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Danish: Hvis der kræves en nedsat dosis af Zoledronsyre medac, skal der først udtages en passende volumen som angivet nedenfor og derefter fortynde yderligere med 100 ml infusionsopløsning.
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Danish: Andre lægemidler, der indeholder zoledronsyre som aktivt stof, er tilgængelige for osteoporoseindikationer og behandling af Pagets knoglesygdom.