FrancophonIA/ELRC3.0 huggingface dataset:
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Afhængigt af brystkræftens art og stadium kan det også anvendes sammen med andre kræftlægemidler (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) hos patienter, der endnu ikke har fået nogen behandling for deres kræftsygdom, eller hos hvem andre behandlinger ikke har virket
English: The dose of Docetaxel Zentiva may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.
Danish: Hvis patienten oplever visse bivirkninger, kan det være nødvendigt at nedsætte dosis af Docetaxel Zentiva eller afbryde eller standse behandlingen.
English: How is Docetaxel Zentiva used?
Danish: Hvordan anvendes Docetaxel Zentiva?
English: How does Docetaxel Zentiva work?
Danish: Hvordan virker Docetaxel Zentiva?
English: What benefits of Docetaxel Zentiva have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Docetaxel Zentiva?
English: 12 February 2013
Danish: Den 12. februar 2013
English: Meloxicam is a Non-Steroidal Anti-Inflammatory Drug.
Danish: Meloxicam er et ikke-steroidt antiinflammatorisk lægemiddel.
English: The final opinion was converted into a Decision by the European Commission on 12 February 2013.
Danish: Den endelige udtalelse blev den 12. februar 2013 omarbejdet til en beslutning af EuropaKommissionen.
English: International non-proprietary name (INN): meloxicam
Danish: Internationalt fællesnavn (INN): meloxicam
English: The decentralised procedure (NL/V/0164/003/DC) started on 17 June 2011.
Danish: Den decentrale procedure (NL/V/0164/003/DC) blev indledt den 17. juni 2011.
English: The Committee appointed Ms H. Jukes as rapporteur and Mr G. J. Schefferlie as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget henholdsvis fru H. Jukes og hr. G. J. Schefferlie.
English: The referral procedure started on 11 July 2012.
Danish: Indbringelsesproceduren blev indledt den 11. juli 2012.
English: The application was submitted to the Netherlands as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom as concerned Member States.
Danish: Ansøgningen blev indgivet med Nederlandene som referencemedlemsstat og med Belgien, Danmark, Det Forenede Kongerige, Frankrig, Irland, Italien, Polen, Spanien, Tjekkiet, Tyskland, Ungarn og Østrig som berørte medlemsstater.
English: Written explanations were provided by the applicant on 11 September 2012.
Danish: Ansøgeren indsendte skriftlige redegørelser den 11. september 2012.
English: Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Danish: Dag 60 af proceduren i CMD(v) var den 29. juni 2012, og da de berørte medlemsstater ikke var i stand til at nå til enighed vedrørende produktet, blev proceduren indbragt for CVMP.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States, Ireland and the United Kingdom, regarding the bioequivalence for the target species pigs.
Danish: Under den decentrale procedure påpegede to berørte medlemsstater, Det Forenede Kongerige og Irland, potentielle alvorlige risici vedrørende bioækvivalensen i måldyrearten svin.
English: On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Danish: På dag 210 var disse spørgsmål fortsat uafklarede, hvorfor sagen den 2. maj 2012 i medfør af artikel 33, stk. 1, i direktiv 2001/82/EF blev indbragt for koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - veterinær (CMD(v)).
English: Based on the evaluation of the currently available data, the CVMP considered that the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Danish: Efter at have vurderet de foreliggende data fandt CVMP, at ansøgningens oplysninger for måldyrearten svin ikke opfyldte bestemmelserne i artikel 13 i direktiv 2001/82/EF og således ikke opfyldte godkendelseskriterierne hvad angår sikkerhed og virkning hos måldyrearten svin.
English: On 29 June 2012 the reference Member State, the Netherlands, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Danish: Den 29. juni 2012 underrettede referencemedlemsstaten, Nederlandene, Det Europæiske Lægemiddelagentur om, at CMD(v) ikke havde været i stand til at nå til enighed vedrørende produktet, og indbragte sagen for CVMP i medfør af artikel 33, stk. 4, i direktiv 2001/82/EF.
English: The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
Danish: Det aktive stof indgår i veterinærlægemidler, som i EU, dels via den centrale procedure, dels nationalt, er godkendt til anvendelse hos kvæg, svin, heste, hunde og katte.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics, labelling and package leaflet in the Annex III.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Therefore, the Committee adopted a negative opinion on 8 November 2012 recommending the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Danish: Den 8. november 2012 afgav udvalget derfor en negativ udtalelse og anbefalede afslag på ansøgningen om udstedelse af markedsføringstilladelse for Melosolute, injektionsvæske, opløsning, 40 mg/ml, til måldyrearten svin.
English: This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004).
Danish: Ansøgningen er en "hybrid"-ansøgning i henhold til artikel 13, stk. 3, i direktiv 2001/82/EF, som ændret, idet ansøgningen henviser til et referenceprodukt, Metacam, injektionsvæske, opløsning, 20 mg/ml, til kvæg, svin og heste (EU/2/97/004).
English: Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam as active ingredient.
Danish: Melosolute, injektionsvæske, opløsning, 40 mg/ml, til kvæg, svin og heste, indeholder meloxicam som aktivt indholdsstof.
English: The applicant, CP-Pharma Handelsgesellschaft mbH, submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses.
Danish: Ansøgeren, CP-Pharma Handelsgesellschaft mbH, har via den decentrale procedure indgivet en ansøgning for Melosolute, injektionsvæske, opløsning, 40 mg/ml, til kvæg, svin og heste.
English: Opinion following an Article 33(4)
Danish: 1 Artikel 33, stk. 4, i direktiv 2001/82/EF
English: Opinion following an Article 33(4)0F referral for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses
Danish: Udtalelse efter en indbringelse i henhold til artikel 33, stk. 1, for Melosolute, injektionsvæske, opløsning, 40 mg/ml, til kvæg, svin og heste
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 30 i direktiv 2001/83/EF
English: Pieter de Graeff (The Netherlands)
Danish: Pieter de Graeff (Nederlandene)
English: The European Commission issued a decision on 16 September 2010.
Danish: Europa-Kommissionen traf en afgørelse den 16. september 2010.
English: Alar Irs (Estonia)
Danish: Alar Irs (Estland)
English: Atacand Plus is authorised in the EU via national procedures.
Danish: Atacand Plus er godkendt i EU efter nationale procedurer.
English: Atacand Plus should be taken at a dose of one tablet once a day.
Danish: Atacand Plus bør tages i en dosis på én tablet én gang om dagen.
English: Why was Atacand Plus reviewed?
Danish: Hvorfor blev Atacand Plus vurderet igen?
English: The companies that market these medicines are AstraZeneca and Takeda.
Danish: Disse lægemidler markedsføres af virksomhederne AstraZeneca og Takeda.
English: It is used to treat essential hypertension (high blood pressure).
Danish: Det anvendes til at behandle essentiel hypertension (højt blodtryk).
English: This means that the doctor should try different tablet strengths until the strength that adequately controls the patient's blood pressure is found.
Danish: Det betyder, at lægen bør prøve forskellige tabletstyrker, indtil den styrke, der kontrollerer patientens blodtryk tilstrækkeligt, er blevet fundet.
English: What is Atacand Plus?
Danish: Hvad er Atacand Plus?
English: On 27 October 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand Plus in the EU.
Danish: Den 27. oktober 2009 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Atacand Plus i EU.
English: Atacand Plus is also available in the EU under other trade names: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus and Ratacand Plus.
Danish: Atacand Plus markedsføres ligeledes i EU under andre særnavne: Atacand Plus Forte, Atacand Plus Mite, Atacand Zid, Blopresid, Blopress, Blopress Comp, Blopress Forte, Blopress Plus, CoKenzen, Hytacand, Parapres Comp, Parapres Comp Forte, Parapres Plus og Ratacand Plus.
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Danish: Hydrochlorthiazid er et diuretikum, som er en anden type behandling af hypertension.
English: The European Medicines Agency has completed a review of Atacand Plus and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Atacand Plus og relaterede navne.
English: Dose titration is recommended.
Danish: Dosistitrering anbefales.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Danish: Kombinationen af de to aktive stoffer har en additiv effekt, eftersom det sænker blodtrykket mere end de enkelte lægemidler alene.
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing blood pressure.
Danish: Det virker ved at øge urinproduktionen, reducere mængden af væske i blodet og sænke blodtrykket.
English: The Committee also harmonised other sections of the SmPC including sections on special warnings, interactions with other medicines and pregnancy and lactation.
Danish: Udvalget harmoniserede ligeledes andre punkter i produktresuméet, herunder punkterne om særlige advarsler, interaktion med andre lægemidler samt fertilitet, graviditet og amning.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe kidney or liver problems, cholestasis (problems with the elimination of bile), gout (a painful inflammation of the joints) and hypokalaemia (low blood potassium levels) or hypercalcaemia (high blood calcium levels).
Danish: Det må heller ikke gives til kvinder i anden eller tredje trimester af graviditen eller til patienter med svære levereller nyreproblemer, kolestase (problemer med udskillelse af galde), urinsyregigt (en smertefuld betændelse i leddene) og hypokaliæmi (lavt kaliumniveau i blodet) eller hypercalcæmi (højt calcium niveau i blodet).
English: The CHMP recommended that Atacand Plus be used to treat essential hypertension in adults whose blood pressure is not optimally controlled by candesartan cilexetil or hydrochlorothiazide alone.
Danish: CHMP anbefalede, at Atacand Plus blev anvendt til behandling af essentiel hypertension hos voksne, hvis blodtryk ikke kontrolleres optimalt ved hjælp af candesartan cilexetil eller hydrochlorthiazid alene.
English: Atacand Plus is a medicine that contains two active substances candesartan cilexetil and hydrochlorothiazide.
Danish: Atacand Plus er et lægemiddel, der indeholder de to aktive stoffer candesartan cilexetil og hydrochlorthiazid.
English: Candesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Candesartan er en "angiotensin II-receptorantagonist", hvilket betyder, at det blokerer virkningen af et hormon i kroppen, der kaldes angiotensin II.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Danish: På grundlag af de fremlagte oplysninger og den videnskabelige drøftelse i udvalget var CHMP af den opfattelse, at produktresuméet, etiketteringen og indlægssedlen skulle harmoniseres inden for EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand Plus in the European Union (EU).
Danish: EMA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at der er behov for at harmonisere ordinationsoplysningerne for Atacand Plus i Den Europæiske Union (EU).
English: By blocking the receptors to which angiotensin II normally attaches, candesartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to fall.
Danish: Ved at blokere de receptorer, som angiotensin II normalt binder sig til, forhindrer candesartan cilexetil virkningen af hormonet, således at blodkarrene kan udvide sig, og blodtrykket falder.
English: Atacand Plus must not be used in patients who are hypersensitive (allergic) to the active substances, any of the other ingredients or to substances derived from sulfonamide.
Danish: Atacand Plus må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for det aktive stof, over for et eller flere af hjælpestofferne eller over for sulfonamid-afledte stoffer.
English: Atacand Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Atacand Plus skulle harmoniseres.
English: Company responses provided on: 25 February 2010 Opinion date:
Danish: Dato for virksomhedens svar:
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen henviser til den sidste dag i den pågældende måned.
English: Ropinirole is rapidly distributed and has a relatively high apparent volume of distribution.
Danish: Ropinirol fordeles hurtigt og har et forholdsvist højt tilsyneladende distributionsvolumen.
English: The fraction bound to plasma proteins in dogs is low (37%).
Danish: Fraktionen bundet til plasmaproteiner hos hunde er lav (37 %).
English: The volume of one drop is approximately 27 µl.
Danish: Volumen af én dråbe er ca. 27 µl.
English: Extended vomiting (for more than 60 minutes) which should be evaluated by the responsible veterinarian as it might need appropriate treatment.
Danish: Langvarig opkastning (i mere end 60 minutter), som bør vurderes af den ansvarlige dyrlæge, da der kan være behov for en passende behandling.
English: pH 3.8-4.5 and osmolality 300-400 mOsm/kg.
Danish: pH 3,8-4,5 og osmolalitet 300-400 mOsm/kg.
English: See the detailed instructions for administration at the end of this leaflet.
Danish: Se de detaljerede anvisninger om indgivelse i slutningen af denne indlægsseddel.
English: Inform your veterinarian if your dog is given other medicines.
Danish: Informer din dyrlæge, hvis din hund får anden medicin.
English: The portion recovered as unchanged ropinirole in the urine is below 3% within the first 24 hours.
Danish: Den del, der genfindes som uforandret ropinirol i urinen er under 3 % inden for de første 24 timer.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13/04/2018
Danish: Dato for første markedsføringstilladelse: 13/04/2018
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml opløsning indeholder:
English: REPEATED DOSE:
Danish: GENTAGET DOSIS:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label or carton after “EXP”.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten eller æsken efter "EXP".
English: Three dogs (3%) did not vomit at all despite an additional dose.
Danish: Tre hunde (3 %) kastede slet ikke op trods en yderligere dosis.
English: It is not recommended to administer further doses to these dogs.
Danish: Det anbefales ikke at give disse hunde flere doser.
English: The systemic bioavailability of the drug by this ocular route of administration is 23%.
Danish: Lægemidlets systemiske biotilgængelighed via denne okulære indgivelsesvej er 23 %.
English: Based on the clinical trial results, most dogs are expected to respond to a single dose of the veterinary medicinal product; however, a small proportion of dogs will require a second dose to induce vomiting.
Danish: Baseret på de kliniske forsøgsresultater forventes de fleste hunde at reagere på en enkelt dosis af veterinærlægemidlet; dog vil nogle få hunde have brug for endnu en dosis for at fremkalde opkastning.
English: This veterinary medicinal product can cause eye irritation.
Danish: Dette veterinærlægemiddel kan forårsage øjenirritation.
English: People with known hypersensitivity to ropinirole should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt overfølsomhed over for ropinirol bør undgå kontakt med veterinærlægemidlet.
English: It is recommended to record the time of first administration.
Danish: Det anbefales, at notere tidspunktet for den første indgivelse.
English: Increased mean heart rate was observed one hour after treatment with all three doses (1X, 3X, 5X) and went back to normal levels after 6 hours.
Danish: En stigning i gennemsnitlig hjertefrekvens blev observeret en time efter behandlingen med alle tre doser (1X, 3X, 5X) og vendte tilbage til normale niveauer efter 6 timer.
English: Each eye drop contains 810 µg of ropinirole.
Danish: Hver øjendråbe indeholder 810 µg ropinirol.
English: Pharmacotherapeutic group: Dopaminergic agents, dopamine agonists ATC vet code: QN04BC04
Danish: Farmakoterapeutisk gruppe: Dopaminerge midler, dopaminagonister ATC vet-kode: QN04BC04
English: This veterinary medicinal product may cause the following adverse reactions:
Danish: Dette veterinærlægemiddel kan forårsage følgende bivirkninger:
English: The pouch/pouches are then packed in a cardboard box together with the same number of package leaflets (intended for the animal owners) as the number of single-dose containers in the outer package.
Danish: Posen/poserne er derefter pakket i en papæske sammen med det samme antal indlægssedler (beregnet til dyreejerne) som antallet af enkeltdosisbeholdere i den ydre emballage.
English: In case of accidental eye or skin contact, rinse immediately the affected area with plenty of fresh water.
Danish: Hvis der ved et uheld opstår kontakt med øjne eller hud, skylles det berørte område omgående med rigelige mængder frisk vand.
English: An additional dose was administered after 20 minutes to 13% of the dogs because of lack of efficacy.
Danish: En yderligere dosis blev indgivet efter 20 minutter til 13 % af hundene på grund af manglende effekt.
English: Symptoms of overdose consist of the same signs seen as adverse reactions.
Danish: Symptomer på overdosis består af de samme symptomer, der ses som bivirkninger.
English: Sodium hydroxide (to adjust pH) Hydrochloric acid (to adjust pH) Water for injections
Danish: Natriumhydroxid (for at justere pH) Saltsyre (for at justere pH) Vand til injektionsvæsker
English: Biotransformation occurs by dealkylation, hydroxylation and subsequent conjugation with glucuronic acid or oxidation to carboxylic acid.
Danish: Biotransformation sker ved dealkylering, hydroxylering og efterfølgende konjugation med glucuronsyre eller oxidation til carboxylsyre.
English: Administer the product with caution.
Danish: Anvend produktet med forsigtighed.
English: Very slightly yellow to yellow clear solution.
Danish: Meget let gul til gul, klar opløsning.
English: In dogs, the volume of distribution (Vz) is 5.6 l/kg after intravenous administration.
Danish: Hos hunde er distributionsvoluminet (Vz) 5,6 l/kg efter intravenøs indgivelse.
English: Vomiting starts before the Cmax in plasma is reached; at 4-6 minutes in a pharmacokinetic study in dogs.
Danish: Opkastning starter, før Cmax i plasma er nået; efter 4-6 minutter i et farmakokinetisk forsøg med hunde.
English: 1 x 0.6 ml single-dose container 2 x 0.6 ml single-dose containers 3 x 0.6 ml single-dose containers 4 x 0.6 ml single-dose containers 5 x 0.6 ml single-dose containers 6 x 0.6 ml single-dose containers 8 x 0.6 ml single-dose containers 10 x 0.6 ml single-dose containers
Danish: 1 x 0,6 ml enkeltdosisbeholder 2 x 0,6 ml enkeltdosisbeholdere 3 x 0,6 ml enkeltdosisbeholdere 4 x 0,6 ml enkeltdosisbeholdere 5 x 0,6 ml enkeltdosisbeholdere 6 x 0,6 ml enkeltdosisbeholdere 8 x 0,6 ml enkeltdosisbeholdere 10 x 0,6 ml enkeltdosisbeholdere
English: This veterinary medicinal product may cause a transient increase in heart rate up to 2 hours after administration.
Danish: Dette veterinærlægemiddel kan forårsage en kortvarig stigning i hjertefrekvensen op til to timer efter indgivelse.
English: About 40% of radioactive ropinirole is excreted in the urine within 24 hours after intravenous administration to dogs.
Danish: Ca. 40 % af radioaktivt ropinirol udskilles i urinen inden for 24 timer efter intravenøs indgivelse til hunde.
English: Pack sizes: 1, 2, 3, 4, 5, 6, 8 and 10 single-dose containers.
Danish: Pakningsstørrelser: 1, 2, 3, 4, 5, 6, 8 og 10 enkeltdosisbeholdere.
English: STORING THE OPENED CONTAINER:
Danish: OPBEVARING AF DEN ÅBNEDE BEHOLDER:
English: Clevor is administered as eye drops into one or both of the dog's eyes at a dose of 1-8 eye drops, depending on the dog's bodyweight.
Danish: Clevor indgives som øjendråber i et eller begge af hundens øjne i en dosis på 1-8 øjendråber afhængigt af hundens kropsvægt.
English: OPENING THE CONTAINER:
Danish: ÅBNING AF BEHOLDEREN:
English: Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Danish: Opbevaringstiden for veterinærlægemidlet i salgspakning: 30 måneder.
English: The additional dose should be the same as the initial dose.
Danish: Den anden dosis skal være den samme som den indledende dosis.
English: The time between the first to the last vomit was 0-108 minutes (0 if the dog vomited only once) with a mean duration of 23 minutes and a median duration of 16 minutes.
Danish: Tiden mellem den første og den sidste opkastning var 0-108 minutter (0, hvis hunden kun kastede op én gang) med en gennemsnitlig varighed på 23 minutter og en median varighed på 16 minutter.
English: Keep the dog´s head steady in a slightly upright position.
Danish: Hold hundens hoved fast i en let opretstående position.
English: These doses have been tested in dogs weighing between 1.8 kg and 100 kg (0.15-2.21 m2 body surface area).
Danish: Disse doser er blevet testet til hunde, der vejer mellem 1,8 kg og 100 kg (0,15-2,21 m2 legemsoverflade).