FrancophonIA/ELRC3.0 huggingface dataset:
English: Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs.
Danish: Clomicalm er et veterinærlægemiddel, der anvendes som en hjælp i behandlingen af hunde, som har adfærdsproblemer, når de adskilles fra deres ejere, deres hjem eller andre hunde.
English: It contains the active substance clomipramine hydrochloride.
Danish: Det indeholder det aktive stof clomipraminhydrochlorid.
English: Clomipramine is an antidepressant.
Danish: Clomicalm er et antidepressivt lægemiddel.
English: Clomicalm clomipramine hydrochloride
Danish: Clomicalm clomipraminhydrochlorid
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped.
Danish: Clomicalm kan i meget sjældne tilfælde forårsage opkastning, appetitforandringer, letargi (manglende energi) eller en forøgelse af leverenzymer, hvilket dog stabiliserer sig igen, når behandlingen ophører.
English: It is not intended to provide practical advice on how to use Clomicalm.
Danish: Det er ikke en praktisk vejledning i, hvordan Clomicalm bør anvendes.
English: What is Clomicalm and what is it used for?
Danish: Hvad er Clomicalm, og hvad anvendes det til?
English: What are the risks associated with Clomicalm?
Danish: Hvilke risici er der forbundet med Clomicalm?
English: Other information about Clomicalm:
Danish: Andre oplysninger om Clomicalm
English: Why is Clomicalm approved?
Danish: Hvorfor er Clomicalm blevet godkendt?
English: Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy.
Danish: Sådanne problemer kan omfatte ødelæggelse af ejendom, upassende defækation og urinering i hjemmet.
English: to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Danish: Feltundersøgelser udført i USA og Europa viste, at når Clomicalm blev anvendt sammen med adfærdsterapi, var det effektivt til at reducere adfærdsproblemer hos hunde, der følte ængstelse i forbindelse med adskillelse, og lægemidlet var mere effektivt end adfærdsterapi anvendt alene, set på baggrund af et bredt spektrum af adfærdsrelaterede tegn på ængstelse, herunder tegn på en tæt tilknytning til ejeren.
English: What benefits of Clomicalm have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Clomicalm?
English: For more information about treatment with Clomicalm, 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 Clomicalm, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is Clomicalm used?
Danish: Hvordan anvendes Clomicalm?
English: For practical information about using Clomicalm, 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 Clomicalm, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How does Clomicalm work?
Danish: Hvordan virker Clomicalm?
English: Route of Administration
Danish: Pakningsstø rrelse
English: These local reactions gradually reduce and disappear without need for treatment
Danish: Disse lokale reaktioner reduceres gradvist og forsvinder uden behov for behandling
English: Revaccination: 9 months after vaccination.
Danish: Revaccination: 9 måneder efter vaccination.
English: Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
Danish: Meget almindelig: Der kan opstå en forbigående temperaturstigning til lidt over 40 °C mellem to og tre dage efter vaccinationen.
English: This slight temperature increase resolves spontaneously without treatment by day 5 post-vaccination.
Danish: Denne lette temperaturstigning ophører spontant uden behandling på femte dag efter vaccinationen.
English: Duration of immunity: 9 months demonstrated by challenge
Danish: Varighed af immunitet: 9 måneder demonstreret ved ”challenge”
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inclusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRLværdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009,
English: Very common: nodules or swelling (< 2 cm) can be observed in the injection site, which may last 24 hours.
Danish: Meget almindelig: Knuder eller hævelse (<2 cm) kan observeres på injektionsstedet, hvilket kan vare i 24 timer.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP..
Danish: Må ikke bruges efter den udløbsdato, der står på etiketten efter UDL.D.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: {måneder/år} Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Laboratory studies in doe rabbits in the last third of gestation have not produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Danish: Laboratorieundersøgelser hos hunkaniner i den sidste tredjedel af drægtigheden har ikke afsløret nogen tegn på teratogene, føtotoksiske og maternotoksiske virkninger .
English: Thiomersal: ………………..0.05 mg Whitish emulsion.
Danish: Thiomersal: ………………..0,05 mg Hvidlig emulsion.
English: Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Danish: kan uforsætlig injektion af produktet medføre kraftige hævelser, der eksempelvis kan resultere i iskæmisk nekrose og endog tab af en finger.
English: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr ud af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr ud af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: HIPRA EΛΛAΣ A.E. Tηλ: (+30) 210 4978660
Danish: Tηλ: (+30) 210 4978660
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Danish: Tlf.: +34 972 430660 Fax.
English: HIPRA FRANCE Tél.
Danish: HIPRA FRANCE
English: Pregnancy
Danish: Drægtighed
English: Inactivated RHDV2, strain V-1037: ……… ≥70% cELISA40*
Danish: Inaktiveret RHDV2, stamme V-1037: ≥70% cELISA40
English: ERAVAC emulsion for injection for rabbits
Danish: ERAVAC injektionsvæske, emulsion til kaniner
English: ERAVAC Emulsion for injection for rabbits
Danish: ERAVAC Injektionsvæske, emulsion til kaniner
English: LABORATORIOS HIPRA, S.A. Tel: (34) 972 43 06 60
Danish: Tel: (34) 972 43 06 60
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Danish: Inaktiveret kanin hæmoragisk lidelse type 2 virus (RHDV2), stamme V-1037: ……≥70 % cELISA40*
English: HIPRA BENELUX NV Tel: (+32) 9 324 21 58
Danish: Tel: (+32) 9 324 21 58
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian essential oil medicines.
Danish: Patienter med åbne sår, hudproblemer, høj feber, alvorlige infektioner og alvorlige hjerte-karproblemer skal undgå bade med baldrianolie.
English: If symptoms continue during the use of the medicine, a doctor or a healthcare practitioner should be consulted.
Danish: Hvis symptomerne varer ved under brugen af lægemidlet, bør der søges råd hos en læge eller en kvalificeret sundhedsperson.
English: Valerian essential oil is the common name for the essential oil extracted from the underground parts of the plant Valeriana officinalis L.
Danish: Baldrianolie er fællesnavnet for den æteriske olie, der fremstilles af de underjordiske dele af planten Valeriana officinalis L.
English: Valerian essential oil medicines should be used only in adults and adolescents over the age of 12 years.
Danish: Lægemidler, der indeholder baldrianolie, bør kun anvendes til voksne og unge over 12 år.
English: Valerian essential oil EMA/154066/2016
Danish: Baldrianolie EMA/154066/2016
English: Any applications for the licensing of medicines containing valerian essential oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder baldrianolie, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Valerian essential oil is obtained by directing steam through the underground parts of the plant.
Danish: Baldrianolie udvindes ved at føre damp gennem de underjordiske dele af planten.
English: The HMPC noted the lack of clinical studies with valerian essential oil medicines, but took into account the well documented use of this herbal medicine.
Danish: HMPC har noteret manglen på kliniske undersøgelser med baldrianolie, men henholder sig til den veldokumenterede brug af dette plantelægemiddel.
English: Herbal medicines containing valerian essential oil are usually available in liquid forms to be taken by mouth or used as bath additives.
Danish: Plantelægemidler med baldrianolie fås normalt i flydende form til anvendelse gennem munden eller som badeadditiv.
English: Further information on the HMPC assessment of valerian essential oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder baldrianolie, herunder detaljerede oplysninger om udvalgets konklusioner, findes under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian essential oil.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder baldrianolie.
English: Valerian essential oil may also be found in combination with other herbal substances in some herbal medicines.
Danish: Baldrianolie findes desuden kombineret med andre droger i visse plantelægemidler.
English: Other information about valerian essential oil medicines
Danish: Andre oplysninger om lægemidler, der indeholder baldrianolie
English: Detailed instructions on how to take valerian essential oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger på, hvordan lægemidler med baldrianolie bør anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: Information on the use and licensing of valerian essential oil medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder baldrianolie, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC conclusions on the use of these valerian essential oil medicines for the relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Danish: HMPC's konklusioner om anvendelsen af lægemidler med baldrianolie til at lindre lettere symptomer på mental stress og gøre det lettere at falde i søvn er baseret på lægemidlernes "traditionelle anvendelse".
English: Further information on the risks associated with these valerian essential oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder baldrianolie, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian essential oil.
Danish: Dette dokument er et sammendrag af Udvalget for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af baldrianolie.
English: The HMPC concluded that, on the basis of its long-standing use, valerian essential oil can be used for relief of mild symptoms of mental stress and to aid sleep.
Danish: På grundlag af den mangeårige anvendelse har HMPC konkluderet, at baldrianolie kan anvendes til at lindre lettere symptomer på mental stress og gøre det lettere at falde i søvn.
English: This summary is not intended to provide practical advice on how to use medicines containing valerian essential oil.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder baldrianolie, skal anvendes.
English: How are valerian essential oil medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder baldrianolie, i EU?
English: What is valerian essential oil?
Danish: Hvad er baldrianolie?
English: What evidence supports the use of valerian essential oil medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af baldrianolie?
English: What are the risks associated with valerian essential oil medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder baldrianolie?
English: For more information about treatment with valerian essential oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med lægemidler, der indeholder baldrianolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: For practical information about using valerian essential oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktiske oplysninger om anvendelsen af lægemidler med baldrianolie, kan du læse indlægssedlen, der ligger i lægemiddelpakningen, eller kontakte din læge eller dit apotek.
English: Valerian essential oil
Danish: Baldrianolie
English: Side effects have been reported with valerian essential oil medicines.
Danish: Der er indberettet bivirkninger ved brug af lægemidler, der indeholder baldrianolie, herunder kvalme og mavekramper.
English: United Kingdom Medimpex UK LTD 127 Shirland road,
Danish: Medimpex UK LTD 127 Shirland road, W9 2EP London,
English: Annex I List of medicinal products and presentations
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), ADMINISTRATIONSVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Onivyde received a marketing authorisation valid throughout the EU on 14 October 2016.
Danish: Onivyde fik en markedsføringstilladelse med gyldighed i hele EU den 14. Oktober 2016.
English: The main measure of effectiveness was overall survival (how long the patients lived).
Danish: Behandlingens virkning blev hovedsagelig bedømt på den samlede overlevelse (hvor længe patienterne levede).
English: As for all medicines, data on the use of Onivyde are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Onivyde løbende overvåget.
English: Metastatic means that the cancer has spread to other parts of the body.
Danish: "Metastatisk" betyder, at kræften har spredt sig til andre dele af kroppen.
English: Other information about Onivyde
Danish: Andre oplysninger om Onivyde
English: The European Medicines Agency decided that Onivyde's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Onivyde opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.
Danish: Yderligere information om lægemidler til sjældne sygdomme kan findes her: ema.europa.eu/medicines/human/orphan-designations/eu311933.
English: For more information about using Onivyde, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Onivyde, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Onivyde?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Onivyde?
English: Side effects reported with Onivyde are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Onivyde vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What is Onivyde and what is it used for?
Danish: Hvad er Onivyde, og hvad anvendes det til?
English: An overview of Onivyde and why it is authorised in the EU
Danish: En oversigt over Onivyde, og hvorfor det er godkendt i EU
English: Further information on Onivyde can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Onivyde.
Danish: Yderligere information om Onivyde findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Onivyde.
English: Why is Onivyde authorised in the EU?
Danish: Hvorfor blev Onivyde godkendt i EU?
English: Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.
Danish: Onivyde udleveres kun efter recept, og behandlingen bør kun ordineres og gives af en læge med erfaring i brug af kræftlægemidler.
English: The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.
Danish: Liposomerne er designet til at ophobe sig i svulsten og frigive lægemidlet langsomt over tid og derved nedsætte den hastighed, hvormed irinotecan udskilles fra kroppen, så stoffet kan virke i længere tid.
English: Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Danish: Bugspytkirtelkræft er sjælden, og Onivyde blev udpeget som "lægemiddel til sjældne sygdomme" den 9. december 2011.
English: The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects.
Danish: Lægen kan justere dosen hos patienter, som får svære bivirkninger, og hos patienter med særlige genetiske karakteristika, der øger deres risiko for bivirkninger.
English: Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women.
Danish: Onivyde må ikke gives til patienter, der tidligere har haft en svær overfølsomhedsreaktion (allergisk reaktion) over for irinotecan, eller kvinder, der ammer.
English: What are the risks associated with Onivyde?
Danish: Hvilke risici er der forbundet med Onivyde?
English: The recommended dose is 70 mg per square metre of body surface given every 2 weeks together with 5-fluorouracil and leucovorin.
Danish: Den anbefalede dosis er 70 mg pr. kvadratmeter kropsoverflade, der indgives én gang hver 2. uge sammen med 5-fluorouracil og leucovorin.
English: Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination.
Danish: Patienterne fik Onivyde eller 5-fluorouracil plus leucovorin eller de tre lægemidler i kombination.
English: The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Danish: Det aktive stof i Onivyde, irinotecan, er et kræftlægemiddel, der tilhører gruppen af "topoisomerasehæmmere".
English: It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells.
Danish: Det blokerer for enzymet topoisomerase I, som cellerne skal bruge til at kopiere dna, hvilket er nødvendigt for at lave nye celler.
English: In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes'.
Danish: I Onivyde er irinotecan indkapslet i bittesmå fedtpartikler, der kaldes "liposomer".
English: In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer.
Danish: I Europa har irinotecan været godkendt i en årrække til at behandle kræft i tyktarmen og endetarmen.
English: Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.
Danish: Onivyde anvendes sammen med 5-fluorouracil og leucovorin (to andre kræftlægemidler) hos voksne, hvis kræftsygdom er blevet værre på trods af behandling baseret på kræftlægemidlet gemcitabin.
English: The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever.
Danish: De mest almindelige bivirkninger ved Onivyde (der kan forekomme hos mere end 1 ud af 5 patienter) er diarré, kvalme, opkastning, nedsat appetit, lavt antal hvide blodlegemer (neutropeni), træthed, svaghed, lavt antal røde blodlegemer (anæmi), mundbetændelse (stomatitis) og feber.