FrancophonIA/ELRC3.0 huggingface dataset:
English: Cilostazol-containing medicinal products (see Annex I) 50 mg tablets Cilostazol-containing medicinal products (see Annex I) 100 mg tablets Cilostazol [See Annex I - To be completed nationally]
Danish: Lægemiddel indeholdende cilostazol (se Bilag I) 50 mg tabletter Lægemiddel indeholdende cilostazol (se Bilag I) 100 mg tabletter [Se Bilag I - Udfyldes nationalt]
English: Take special care with <Cilostazol-containing medicinal product> Before taking <Cilostazol-containing medicinal product> make sure your doctor knows: if you have a severe heart problem or any problems with your heart beat.
Danish: Brug af anden medicin sammen med lægemiddel indeholdende cilastazol Før du begynder at tage lægemiddel indeholdende cilastozal, skal du fortælle din læge eller apotekspersonalet det, hvis du tager anden medicin eller har gjort det for nylig.
English: HOW TO TAKE <CILOSTAZOL-CONTAINING MEDICINAL PRODUCT>
Danish: Lægemidlet indeholdende cilostazol indeholder
English: Chest pain, asthenia
Danish: Brystsmerter, asteni
English: Oedema (peripheral, face), anorexia
Danish: Ødem (perifert, ansigt), anoreksi Ikke almindelige Hyperglykæmi, diabetes mellitus
English: Lactation
Danish: PRODUKTRESUMÉ
English: Based on these data, the recommended dose of cilostazol is 50 mg bid in the presence of erythromycin and similar agents (e.g., clarithromycin).
Danish: ved tilstedeværelse af erythromycin og tilsvarende midler (fx clarithromycin).
English: What <Cilostazol-containing medicinal product> is and what it is used for Before you take <Cilostazol-containing medicinal product> How to take <Cilostazol-containing medicinal product> Possible side effects
Danish: Det skal du vide, før du begynder at tage lægemidlet indeholdende cilostazol Sådan skal du tage lægemidlet indeholdende cilostazol Bivirkninger
English: Co-administration of ketoconazole (an inhibitor of CYP3A4 with cilostazol resulted in a 117% increase in the AUC of cilostazol, accompanied by a 15% decrease in the AUC of the dehydro metabolite and a 87% increase in the AUC of the 4`-trans-hydroxy metabolite.
Danish: Samtidig administration af ketoconazol (CYP3A4-hæmmer) og cilostazol medførte en 117 % forøgelse af AUC for cilostazol ledsaget af et 15 % fald i AUC for dehydro-metabolitten og en 87 % forøgelse af AUC for 4`-transhydroxy-metabolitten Baseret på AUC øges den samlede farmakologiske aktivitet for cilostazol alene med 35 % ved administration sammen med ketoconazol.
English: If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital immediately.
Danish: Kontakt straks lægen eller det lokale hospital hvis du har taget flere tabletter end den ordinerede dosis.
English: BEFORE YOU TAKE <CILOSTAZOL-CONTAINING MEDICINAL PRODUCT>
Danish: Det skal du vide, før du begynder at tage lægemidlet indeholdende cilostazol
English: <Cilostazol-containing medicinal product> 50 mg <Cilostazol-containing medicinal product> 100 mg [To be completed nationally]
Danish: < Läkemedel som innehåller cilostazol > 100 mg tabletter Forenede Kongerige < Cilostazol-containing medicinal product > 100 mg tablets
English: Gastrointestinal disorders
Danish: Hæmmere af trombocytaggregation
English: {Not applicable}
Danish: • utilpashed
English: Manufacturer [To be completed nationally]
Danish: LISTE OVER HJÆLPESTOFFER [Udfyldes nationalt]
English: Dyspnoea, pneumonia, cough
Danish: Ikke almindelige Dyspnø, pneumoni, hoste Ukendte
English: Renal failure, renal impairment
Danish: Nyreinsufficiens, nyresvækkelse
English: Ecchymosis
Danish: Cmaks.
English: NAME OF THE MEDICINAL PRODUCT Cilostazol-containing medicinal products (see Annex I) 50 mg tablets Cilostazol-containing medicinal products (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Cilostazol
Danish: Lægemiddel indeholdende Cilostazol (se Bilag 1) 50 mg tabletter Lægemiddel indeholdende Cilostazol (se Bilag 1) 100 mg tabletter
English: Gastritis
Danish: • hoste
English: This summary was last updated in March 2016.
Danish: Dette sammendrag blev sidst ajourført i marts 2016.
English: EMA/93770/2007 EMEA/V/C/000097
Danish: EMA/93770/2007 EMA/V/C/000097
English: These signs disappear without further treatment.
Danish: Disse bivirkninger forsvinder uden yderligere behandling.
English: The European Commission granted a marketing authorisation valid throughout the EU for Profender on 27 July 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Profender den 27. juli 2005.
English: Profender emodepside / praziquantel
Danish: Profender emodepsid / praziquantel
English: The full EPAR for Profender can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Profender findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Profender.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Profender.
English: No side effects have been reported in dogs.
Danish: Der er ikke observeret bivirkninger hos hunde.
English: Mild and short-lived signs relating to the nervous system such as ataxia (inability to co-ordinate muscle movements) or tremor (shaking) may occur in very rare cases.
Danish: Milde og kortvarige indvirkninger på nervesystemet, såsom ataksi (manglende evne til at koordinere muskelbevægelser) eller rysten (tremor) kan forekomme i meget sjældne tilfælde.
English: The two active substances in Profender interact with different parts of the parasites systems.
Danish: De to aktive stoffer i Profender interagerer med forskellige dele af parasitsystemerne.
English: Profender should not be allowed to enter surface water, as it may be harmful for aquatic organisms.
Danish: Profender må ikke hældes ud i overfladevand, da det kan være skadeligt for vandorganismer.
English: Other information about Profender:
Danish: Andre oplysninger om Profender:
English: Profender should not be used in young animals (cats under 8 weeks of age or weighing less than 0.5 kg, or puppies under 12 weeks of age or weighing less than 1 kg).
Danish: Profender må ikke anvendes til unge dyr (killinger under 8 uger eller som vejer mindre end 0,5 kg, eller hundehvalpe under 12 uger eller som vejer mindre end 1 kg).
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Profender's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Profender opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Over 90% of cats and 99% of dogs had no roundworm or tapeworm infection after treatment with Profender.
Danish: Over 90 % af kattene og 99 % af hundene havde ingen rundorms- eller bændelormsinfektion efter behandlingen med Profender.
English: The correct number of tablets or half tablets to use is calculated based on the dog's weight.
Danish: Det rette antal hele eller halve tabletter, der skal bruges, beregnes ud fra hundens vægt.
English: Users should also wash their hands after giving Profender as tablets to a dog.
Danish: Brugerne bør også vaske hænder efter at have givet hunden Profender-tabletter.
English: It is not intended to provide practical use on how to use Profender.
Danish: Det er ikke en praktisk vejledning i, hvordan Profender bør anvendes.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom med flere doser, som kun må anvendes til veterinærkirurgi, hvor dyrlægen selv afmåler den nøjagtige mængde Profender til hver enkelt kat inden anvendelsen.
English: The laboratory study showed Profender to reduce the worm count in the lungs by more than 99%.
Danish: Laboratorieundersøgelser viste, at Profender reducerede antallet af orme i lungerne med mere end 99 %.
English: The person giving the dose should not smoke, eat or drink, and should wash their hands thoroughly after use.
Danish: Brugeren bør under påføringen af Profender ikke ryge eller indtage mad og drikke og bør efter brug vaske hænderne grundigt.
English: What is Profender and what is it used for?
Danish: Hvad er Profender, og hvad anvendes det til?
English: The results from the laboratory studies and from the field studies, in both cats and dogs, showed that Profender was as effective as the comparator medicine.
Danish: Resultaterne af laboratorieundersøgelserne og feltundersøgelserne hos både katte og hunde viste, at Profender er lige så effektivt som sammenligningspræparatet.
English: Why is Profender approved?
Danish: Hvorfor blev Profender godkendt?
English: These effects are thought to occur as a result of the cat licking the application site straight after treatment.
Danish: Det menes, at disse bivirkninger skyldes, at katten slikker sig på påføringsstedet lige efter behandling.
English: Profender is a medicine used to treat cats and dogs that have, or are at risk of catching, “mixed” (caused by more than one parasite) parasitic infections.
Danish: Profender anvendes til behandling af katte og hunde, som har eller er udsatte for at få parasitære blandingsinfektioner (dvs. med mere end én parasit).
English: The effectiveness was measured by looking at the number of worm eggs or parts of tapeworms passed out in the animal's faeces after treatment.
Danish: Virkningen blev målt ud fra antallet af ormeæg eller dele af bændelorme, som blev udskilt med dyrets afføring efter behandlingen.
English: Emodepside interferes with certain specific receptors in the nervous systems of roundworms, which results in their subsequent paralysis and death.
Danish: Emodepsid interagerer med visse, specifikke receptorer i rundormenes nervesystem, hvorved de lammes og dør.
English: What are the risks associated with Profender?
Danish: Hvilke risici er der forbundet med Profender?
English: In cats, in very rare cases, the cat might salivate or vomit after treatment.
Danish: Hos katte kan der i meget sjældne tilfælde forekomme savlen eller opkastning efter behandlingen.
English: If accidental exposure occurs, the eyes should be rinsed with water or the skin washed with soap and water.
Danish: Hvis lægemidlet ved et uheld kommer i kontakt med hud eller øjne, skylles øjnene straks med vand, og huden vaskes med vand og sæbe.
English: Profender is given as a single treatment for roundworms and tapeworms.
Danish: Profender gives som én enkelt behandling mod rundorme og bændelorme.
English: The effectiveness of each of the products against the specified roundworms and tapeworms was investigated in both laboratory studies and in large field studies (one for the spot-on for cats and another for the tablets for dogs) carried out at several different places across Europe.
Danish: De enkelte lægemidlers virkning på de pågældende rundorme og bændelorme blev undersøgt i såvel laboratorieundersøgelser som i store feltundersøgelser (én for spot-on-præparatet til katte og én for tabletterne til hunde) forskellige steder i Europa.
English: In each of the field studies, animals of various breeds, age groups and different weights that were naturally infected with roundworms or tapeworms in their guts, were treated either with Profender or another approved worming medicine (selamectin in cats, and milbemycin oxime and praziquantel in dogs).
Danish: I hver feltundersøgelse blev dyr af forskellig race, alder og med forskellig vægt, som var naturligt inficeret med parasitiske gastrointestinale rundorme eller bændelorme, behandlet enten med Profender eller et andet lægemiddel, som er godkendt til behandling mod orme (selamectin til katte og milbemycinoxim og praziquantel til hunde).
English: Cats are treated using the Profender spot-on solution range.
Danish: Katte behandles med en af Profender spot-on opløsningerne.
English: For lungworms two treatments are needed two weeks apart.
Danish: Lungeorme behandles med to behandlinger med mindst to ugers mellemrum.
English: For lungworms in cats a laboratory study together with a field study showed Profender to reduce the number of larvae passed in the animal's faeces by more than 99%.
Danish: Vedrørende lungeorme hos katte viste en laboratorieundersøgelse og en feltundersøgelse, at Profender reducerer antallet af larver i dyrenes ekskrementer med mere end 99%.
English: When giving Profender spot-on solution, skin contact with the pipette contents should be avoided and animals should not be stroked, groomed or allow to groom each other, until the application site is dry.
Danish: Når Profender gives som spot-on opløsning, bør brugeren undgå kontakt med indholdet af pipetten og undgå at stryge eller strigle dyret eller at dyret stryger sig op ad brugeren, før påføringsstedet er tørt.
English: Profender works for infections caused by certain types of roundworms, tapeworms, as well as lungworms in cats.
Danish: Profender virker mod infektioner forårsaget af visse typer rundorme, bændelorme og lungeorme hos katte.
English: Praziquantel damages the skin-like outer layer of tapeworms, leading to their paralysis and death.
Danish: Praziquantel beskadiger bændelormenes ydre hudlignende lag, hvorved de lammes og dør.
English: Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose bottle for use only in a veterinary surgery, where the vet will measure the exact volume of Profender needed for each cat before application.
Danish: Profender-opløsningen fås som spot-on pipetter, der allerede er fyldt med den rette mængde Profender til behandling af én kat (der findes pipetter i tre størrelser til forskellige vægtgrupper) og som en flaske med flere doser, som kun må anvendes til veterinærkirurgi, hvor dyrlægen selv afmåler den nøjagtige mængde Profender til hver enkelt kat inden anvendelsen.
English: What is Profender?
Danish: Hvad er Profender?
English: Profender is available as a solution for use on cats, and as modified release tablets for dogs.
Danish: Profender findes som en opløsning til katte, og som tabletter med modificeret udløsning til hunde.
English: Profender solution is packed as spot-on pipettes, which are already filled with the correct amount of Profender needed to treat one cat (3 sizes of pipette for different cat weights) and as a multidose
Danish: Profender-opløsningen fås som spot-on pipetter, der allerede er fyldt med den rette mængde Profender til behandling af én kat (der findes pipetter i tre størrelser til forskellige vægtgrupper) og som en flaske
English: Dogs are treated using Profender modified-release tablets, which are given by mouth when the dog is fasting.
Danish: Hunde behandles med Profender-tabletterne med modificeret udløsning, som gives oralt under faste.
English: As with other products of this type, Profender should be used on sick or ill cats or dogs only after a risk-benefit assessment by the vet. Profender should not be used for any other animal species.
Danish: Ligesom med andre lægemidler af denne type må Profender først anvendes til syge katte eller hunde, når dyrlægen har foretaget en risk/benefit-vurdering.
English: In very rare cases there might also be some temporary itchiness, inflammation or hair loss at the place where the product has been applied to the cat's skin.
Danish: I meget sjældne tilfælde kan der også forekomme forbigående kløe, betændelse og hårtab på påføringsstedet.
English: The solvent in Profender spot-on solution may stain certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Danish: Opløsningsvæsken i Profender kan give pletter på materialer som læder, tekstiler og plast og på behandlede overflader.
English: Profender tablets are available in three different strengths to cover a range of dog weights (small, medium or large dogs).
Danish: Profender-tabletterne findes i tre styrker til henholdsvis små, mellemstore og store hunde.
English: What benefits of Profender have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Profender?
English: Profender is an antiparasitic medicine that contains two active substances, emodepside and praziquantel.
Danish: Det indeholder de to aktive stoffer emodepsid og praziquantel.
English: For more information about treatment with Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Profender, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Profender, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Profender, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is Profender used?
Danish: Hvordan anvendes Profender?
English: How does Profender work?
Danish: Hvordan virker Profender?
English: The appropriate quantity of Profender (either the contents of one full pipette or the volume measured by the vet) is applied onto the cat's skin, after parting the fur on the back of its neck at the base of its head.
Danish: Kattens nakkepels ved den nedre del af kraniet holdes ud til siderne, og den rette mængde Profender (enten hele pipettens indhold eller den mængde, som afmåles af dyrlægen) påføres kattens hud.
English: Profender can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: The frequency of these types of events is not known (cannot be estimated from available data).
Danish: Hyppigheden af disse bivirkninger er ikke kendt (kan ikke vurderes ud fra tilgængelige data).
English: TACHOSIL (Human fibrinogen, human thrombin)Intestinal obstruction (EPITT no 18373)
Danish: TACHOSIL (humant fibrinogen, humant thrombin)Tarmobstruktion (EPITT nr. 18373)
English: Adopted at the 30 November - 3 December 2015 PRAC
Danish: Vedtaget den 30. november-3.
English: BEFORE YOU TAKE X
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE X
English: Ovarian cancer is rare - much rarer than breast cancer.
Danish: Kræft i æggestokkene (ovariecancer) er sjælden ses sjældent - langt sjældnere end brystkræft.
English: To avoid TachoSil from being pulled loose it may be held in place at one end, e.g. with a pair of forceps.
Danish: For at undgå at TachoSil trækkes løs, kan det holdes på plads i den ene ende med et par tænger eller lignende.
English: Frequency ‘unknown': Intestinal obstruction (in abdominal surgeries) General disorders and administration site conditions: Frequency ‘unknown': Adhesions
Danish: Hyppighed ikke kendt: Tarmobstruktion (ved abdominalkirurgi) Almene symptomer og reaktioner på administrationsstedet: Hyppighed ikke kendt: Adhæsion
English: What you need to know before TachoSil is used Warnings and precautions
Danish: Det skal du vide, før du begynder at bruge TachoSil Advarsler og forsigtighedsregler
English: Hormone replacement therapy (HRT) medicinal products, which are not pharmaceutical forms for vaginal use, containing oestrogens or combined oestrogens-progestagens (tibolone containing products also concerned); DUAVIVE (bazedoxifene, oestrogens conjugated) - Increased risk of ovarian cancer (EPITT no 18258)
Danish: Lægemidler til hormonsubstitutionsbehandling (HRTpræparater), der ikke er til vaginal brug, og som indeholder østrogen eller kombineret østrogen og gestagen (gælder også for tibolonholdige præparater); DUAVIVE (bazedoxifen, konjugerede østrogener) - Øget risiko for ovariecancer (EPITT nr. 18258)
English: The effect of DUAVIVE on the risk of ovarian cancer is unknown.
Danish: Virkningen af DUAVIVE på risikoen for ovariecancer er ukendt.
English: Instructions for Use
Danish: Brugsanvisning
English: For DUAVIVE product
Danish: For DUAVIVE
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Danish: Da kollagen har stor affinitet til blod, kan TachoSil også hænge fast i instrumenter, eller handsker eller tilstødende væv, der er dækket af blod.
English: For tibolone containing products
Danish: For tibolonholdige præparater
English: To prevent the development of tissue adhesions at undesired sites, ensure tissue areas outside the desired application area are adequately cleansed before administration of TachoSil (see section 6.6).
Danish: For at hindre vævsadhæsion uønskede steder skal det tilstødende væv omkring applikationsområdet rengøres omhyggeligt, inden TachoSil appliceres (se pkt.
English: Events of adhesions to gastrointestinal tissues leading to gastrointestinal obstruction have been reported with use in abdominal surgery carried out in proximity to the bowel.
Danish: Der er rapporteret om adhæsion til gastrointestinalt væv og deraf følgende tarmobstruktion ved brug i forbindelse med abdominalkirurgi tæt på tarmen.
English: After pressing TachoSil to the wound, the glove or the pad must be removed carefully.
Danish: Når TachoSil er trykket mod såret, fjernes handskerne eller gazekompresset forsigtigt.
English: A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Danish: Der er rapporteret om en lidt højere risiko for kræft i æggestokkene for kvinder, som tager HRT i mindst 5-10 år.
English: Pressure is applied with moistened gloves or a moist pad.
Danish: Der trykkes med fugtede handsker eller et fugtet gazekompres.
English: Scar tissues can cause surfaces in your bowel to stick together, which can lead to blockage of the bowel.
Danish: Arvæv kan få ydersiderne af dine tarme til at klæbe sammen, og det kan medføre blokering af tarmene.
English: BEFORE YOU TAKE DUVAVIVE
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DUAVIVE
English: After abdominal surgery and if TachoSil sticks to nearby tissues, it is possible that scar tissues can develop in the operated area.
Danish: Hvis du er blevet opereret i maveregionen, og TachoSil klæber fast til tilstødende væv, kan det ske, at der dannes arvæv i det opererede område.
English: In the Million Women Study, it was shown that the relative risk for ovarian cancer with use of tibolone was similar to the risk associated with use of other types of HRT.
Danish: Million Women-studiet viste, at den relative risiko for ovariecancer ved brug af tibolon svarede til den risiko, der er forbundet med brug af andre typer HRT.
English: SmPC
Danish: Ovariecancer
English: Your surgeon will make sure to clean the operating area when applying TachoSil to reduce this risk.
Danish: For at mindske denne risiko vil kirurgen rengøre operationsområdet omhyggeligt, inden TachoSil påføres.
English: This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application.
Danish: For at undgå dette bør instrumenter, handsker og tilstødende væv rengøres, inden TachoSil appliceres.
English: Other adverse reactions have been reported in association with oestrogen and oestrogenprogestogen treatment:
Danish: 4.8: Bivirkninger Der er rapporteret om andre bivirkninger ved østrogen- og østrogen-gestagen-behandling:
English: Scar tissues may develop in some patients after surgery and use of TachoSil.
Danish: Hos nogle patienter kan der dannes arvæv efter brug af TachoSil i forbindelse med en operation.
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions.
Danish: Det er vigtigt at være opmærksom på, at adhæsion kan forekomme, hvis tilstødende væv ikke rengøres omhyggeligt.
English: For oestrogen only and combined oestrogen-progestagen HRT products
Danish: For HRT-præparater med østrogen alene og med kombineret østrogen og gestagen