FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Corbilta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levodopa/Carbidopa/Entacapone Sandoz, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Corbilta, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Levodopa/Carbidopa/Entacapone Sandoz, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: This is a summary of the European public assessment report (EPAR) for Corbilta.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levodopa/Carbidopa/Entacapone Sandoz.
English: What measures are being taken to ensure the safe and effective use of Corbilta?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Levodopa/Carbidopa/Entacapone Sandoz?
English: For practical information about using Corbilta, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Levodopa/Carbidopa/Entacapone Sandoz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Corbilta and on how the dose is adjusted during treatment.
Danish: Fuldstændige anvisninger for, hvordan patienten skal skifte til Levodopa/Carbidopa/Entacapone Sandoz, og hvordan dosis skal tilpasses under behandlingen, findes i produktresuméet, der ligeledes er en del af denne EPAR.
English: This overview was last updated in June 2019.
Danish: Denne oversigt blev sidst ajourført i juni 2019.
English: Advocate received a marketing authorisation valid throughout the EU on 2 April 2003.
Danish: Advocate modtog en markedsføringstilladelse med gyldighed i hele EU den 2. april 2003.
English: Other information about Advocate
Danish: Andre oplysninger om Advocate
English: Further information on Advocate can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/advocate.
Danish: Yderligere information om Advocate findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/advocate.
English: Advocate should not be used for any other animal species.
Danish: Advocate bør ikke anvendes til andre dyrearter.
English: The European Medicines Agency decided that Advocate's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Advocate opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: It is very important that the cat products should only be used for cats, and the dog products for dogs.
Danish: Det er meget vigtigt, at produkter til katte kun anvendes til katte, og produkter til hunde kun til hunde.
English: Dogs and cats weighing less than 1 kg and ferrets weighing less than 0.8 kg should only be treated after special consideration by the veterinarian.
Danish: Hunde og katte under 1 kg og fritter under 0,8 kg bør kun behandles efter en særskilt vurdering foretaget af dyrlægen.
English: Vomiting has also occurred rarely.
Danish: Også opkastning er i sjældne tilfælde forekommet.
English: Although no side effects have been confirmed in ferrets, similar side effects could occur rarely.
Danish: Der er ikke påvist bivirkninger hos fritter, men lignende bivirkninger ville i sjældne tilfælde kunne forekomme.
English: It contains two active substances, imidacloprid and moxidectin.
Danish: Det indeholder to aktive stoffer, imidacloprid og moxidectin.
English: An overview of Advocate and why it is authorised in the EU
Danish: Oversigt over Advocate, og hvorfor det er godkendt i EU
English: What is Advocate and what is it used for?
Danish: Hvad er Advocate, og hvad anvendes det til?
English: Why is Advocate authorised in the EU?
Danish: Hvorfor er Advocate godkendt i EU?
English: Advocate should not be used in kittens under 9 weeks of age or in puppies under 7 weeks of age.
Danish: Advocate bør ikke anvendes til killinger under ni uger eller til hvalpe under syv uger.
English: The content of a full pipette is applied onto the animal's skin, after parting the fur.
Danish: Indholdet af en fyldt pipette påføres dyrets hud, efter at pelsen er delt.
English: The effectiveness of the product was measured by the number of live parasites or egg counts in the faeces at various times after treatment.
Danish: Produktets effektivitet blev målt på antallet af levende parasitter eller æg i fæces på forskellige tidspunkter efter behandlingen.
English: What are the risks associated with Advocate?
Danish: Hvilke risici er der forbundet med Advocate?
English: When administering Advocate, the user should not smoke, eat or drink, and should wash their hands thoroughly after use.
Danish: Brugeren bør under påføringen af Advocate ikke ryge eller indtage mad og drikke og bør efter brug vaske hænderne grundigt.
English: Only the product called “Advocate spot-on solution for small cats and ferrets” should be used for ferrets.
Danish: Kun produktet "Advocate spot-on-opløsning til små katte og fritter" bør anvendes til fritter.
English: People with a known sensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution.
Danish: Personer med kendt overfølsomhed over for benzylalkohol, imidacloprid eller moxidectin bør udvise forsigtighed ved anvendelsen af lægemidlet.
English: Field studies involving heartworm in dogs were conducted both in the USA and Europe.
Danish: Feltstudier af hjerteorm hos hunde blev udført både i USA og i Europa.
English: In both cats and dogs, the most common side effects are local reactions at the site of application, such as temporary itchiness, and on rare occasions, greasy fur and redness of the skin.
Danish: Hos både katte og hunde er de hyppigste bivirkninger lokale reaktioner på påføringsstedet, f.eks. forbigående kløe og i sjældne tilfælde fedtet pels og rødme af huden.
English: Advocate should not be used in dogs classified as Class 4 for heartworm disease.
Danish: Advocate bør ikke anvendes hos hunde, der er angrebet af hjerteorm på klasse 4-niveau.
English: Advocate is a medicine used on cats, ferrets and dogs suffering from, or at risk from, mixed parasitic infections (caused by several different types of parasites):
Danish: Advocate er et lægemiddel, der anvendes hos katte, fritter og hunde, der er smittede eller udsatte for smitte med parasitære blandingsinfektioner (dvs. infektioner forårsaget af flere forskellige typer af parasitter):
English: The effectiveness of Advocate against the specified parasites was investigated in laboratory studies in cats, ferrets and dogs.
Danish: Effektiviteten af Advocate mod de specificerede parasitter blev undersøgt i laboratorieforsøg med katte, fritter og hunde.
English: Subsequently, the efficacy was confirmed in several field studies in cats and dogs, conducted in different European geographical locations.
Danish: Derefter blev virkningsgraden bekræftet i en række feltforsøg med katte og hunde på forskellige lokaliteter i Europa.
English: The results of the laboratory and field trials in cats, ferrets and dogs showed that Advocate is effective, when used as detailed in the package leaflet (see “What is Advocate and what is it used for?” above, or for more details see the package leaflet).
Danish: Resultaterne af laboratorie- og feltforsøgene med katte, fritter og hunde viste, at Advocate er effektivt, når det anvendes som foreskrevet i indlægssedlen (se afsnittet "Hvad er Advocate, og hvad anvendes det til?"
English: If a cat or dog licks the application area, it might salivate for a short period and might show signs such as a lack of muscular coordination, shaking, abnormal breathing and/or vomiting.
Danish: Hvis katten eller hunden slikker på påføringsstedet, kan dyret kortvarigt få stærk spytudskillelse efterfulgt af symptomer som manglende muskelkoordination, rysten, unormal vejrtrækning og/eller opkastning.
English: How is Advocate used?
Danish: Hvordan anvendes Advocate?
English: Cats, ferrets and dogs from various breeds, age groups and weights were treated.
Danish: Katte, fritter og hunde inddelt efter race, aldersgruppe og vægt blev behandlet.
English: Skin contact with the pipette contents should be avoided and animals should not be stroked or groomed until the application site is dry.
Danish: Som forholdsregel bør brugeren undgå hudkontakt med indholdet af pipetten og undgå at ae eller børste dyret, før påføringsstedet er tørt.
English: Imidacloprid interferes with certain specific receptors (nicotinergic acetylcholine receptors) in the nervous systems of lice and fleas, which results in their subsequent paralysis and death.
Danish: Imidacloprid indvirker på visse specifikke receptorer (nikotinerge acetylkolinreceptorer) i nervesystemet hos lus og lopper, så de lammes og dør.
English: What benefits of Advocate have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Advocate?
English: • for the treatment of skin diseases in dogs caused by parasitic mites (sarcoptic mange and demodicosis);
Danish: • til behandling af hudsygdomme hos hunde forårsaget af mider (sarcoptesskab og demodicose)
English: Advocate is available as a spot-on solution in pre-filled pipettes (small plastic droppers), and comes in different strengths and pack sizes, depending on whether it is for use on cats, ferrets, or dogs, and on the size of the animal being treated.
Danish: Advocate findes som spot-on-opløsning i fyldte pipetter (små dråbetællere af plastic) og i forskellige styrker og pakningsstørrelser alt efter, om det er til katte, fritter eller hunde, og afhængigt af det behandlede dyrs størrelse.
English: Moxidectin causes paralysis and death of parasites by interfering with the way signals are passed between nerve cells (neurotransmission) in the parasites' nervous system.
Danish: Moxidectin indvirker på udvekslingen af signaler mellem nerveceller (neurotransmission) i nervesystemet hos parasitter, så de lammes og dør.
English: Advocate comes in different strengths and different pipette sizes depending on whether it is for use on cats, ferrets or dogs.
Danish: Advocate leveres i forskellige styrker og pipettestørrelser alt efter, om det er til katte, fritter eller hunde.
English: • as part of treatment strategies for flea allergy dermatitis (an allergic reaction to flea bites) in cats and dogs;
Danish: • som led i behandlingen af loppeforårsaget dermatitis (en allergisk reaktion på loppebid) hos katte og hunde
English: • for the prevention of heartworm disease (infection with Dirofilaria immitis) in cats, ferrets and dogs;
Danish: • til forebyggelse af hjerteorm (infektion med Dirofilaria immitis) hos katte, fritter og hunde
English: • for the prevention of spirocercosis (a worm infection affecting the gullet) in dogs;
Danish: • til forebyggelse af spirocercose (en ormeinfektion, der påvirker spiserøret) hos hunde
English: The solvent in Advocate may stain or damage certain materials including leather, fabrics, plastics and finished surfaces, so contact between the product and such surfaces should be avoided.
Danish: Opløsningsvæsken i Advocate kan give pletter på materialer som læder, tekstiler og plastic og på behandlede overflader.
English: • for the prevention and treatment of skin worm (infection with Dirofilaria repens) in dogs;
Danish: • til forebyggelse og behandling af kutan dirofilariose (infektion med Dirofilaria repens) hos hunde
English: • for the treatment of infections with certain gastrointestinal roundworms, hookworms and whipworms in cats and dogs.
Danish: • til behandling af infektioner med visse rundorm, hageorm og piskeorm i mavetarmsystemet hos katte og hunde.
English: How does Advocate work?
Danish: Hvordan virker Advocate?
English: • for the treatment and prevention of flea infestations in cats, ferrets and dogs;
Danish: • til behandling og forebyggelse af loppeangreb hos katte, fritter og hunde
English: The dose and frequency of application depend on why Advocate is being used and whether it is used in cats, ferrets or dogs; the package leaflet includes detailed information on dosage and duration of treatment.
Danish: Dosen og hyppigheden afhænger af, hvorfor Advocate anvendes, og om det anvendes hos katte, fritter eller hunde.
English: • for the prevention and treatment of lungworm in cats and dogs;
Danish: • til forebyggelse og behandling af lungeorm hos katte og hunde
English: • for the treatment of ear mite infestations in cats and dogs;
Danish: • til behandling af angreb af øjenparasitter hos katte og hunde
English: • for the treatment of biting lice infestations in dogs;
Danish: • til behandling af angreb af næsemider hos hunde
English: • for the treatment of notoedric mange in cats;
Danish: • til behandling af angreb af fnatmider hos katte
English: NN: {number} [national reimbursement number or other national number identifying the medicinal Product]
Danish: NN: {nummer} [nationalt refusionsnummer eller andet nationalt nummer, der identificerer lægemidlet]
English: Aluminium/aluminium blisters (PA/PA/Al/PVC/Al).
Danish: Aluminium/aluminium blister (PA/PA/Al/PVC/Al).
English: See also information under the heading “Do not take Kinzalmono”.
Danish: Se også information under overskriften ”Tag ikke Kinzalmono”
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 December 1998
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 16. december 1998 Dato for seneste fornyelse: 16. december 2008
English: Some people feel dizzy or tired when taking Kinzalmono.
Danish: Nogle vil føle sig svimle eller blive trætte, når de tager Kinzalmono.
English: One blister contains 7 tablets.
Danish: En blister indeholder 7 tabletter.
English: You can take Kinzalmono with or without food.
Danish: Kinzalmono kan både tages med mad og uden.
English: (It is also better to avoid Kinzalmono in early pregnancy - see pregnancy section.)
Danish: (Du skal desuden helst undgå at bruge Kinzalmono tidligt i graviditeten - se afsnittet om Graviditet)
English: Do not take Kinzalmono
Danish: Tag ikke Kinzalmono
English: Volume and/or sodium depletion should be corrected prior to administration of Kinzalmono.
Danish: Volumen- og/eller natriumdepletering bør korrigeres før behandling med Kinzalmono.
English: Hypotension 2, orthostatic hypotension
Danish: Hypotension 2, ortostatisk hypotension
English: Remove your Kinzalmono tablet from the blister only directly prior to intake.
Danish: Tag først din Kinzalmono-tablet ud af blisteren lige før indtagelse.
English: If you have the impression that the effect of Kinzalmono is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du tror, at virkningen af Kinzalmono er for stærk eller svag, så sig det til lægen eller på apoteket.
English: It is important that you take Kinzalmono every day until your doctor tells you otherwise.
Danish: Du skal fortsætte med at tage Kinzalmono hver dag, så længe lægen ikke har givet dig besked på andet.
English: If you forget to take Kinzalmono
Danish: Hvis du har glemt at tage Kinzalmono
English: Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000)
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til <1/1.000); meget sjælden (< 1/10.000).
English: Talk to your doctor before taking Kinzalmono:
Danish: Kontakt lægen, før du tager Kinzalmono:
English: Talk to your doctor before taking Kinzalmono if you are suffering or have ever suffered from any of the following conditions or illnesses:
Danish: Kontakt lægen, før du tager Kinzalmono, hvis du har eller har haft nogen af nedenstående sygdomme eller tilstande:
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for telmisartan eller et af de øvrige indholdsstoffer i Kinzalmono (angivet i punkt 6).
English: Kinzalmono contains sorbitol.
Danish: Kinzalmono indeholder sorbitol.
English: The safety and efficacy of Kinzalmono in children and adolescents aged below 18 years have not been established.
Danish: Kinzalmonos sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: When Kinzalmono is used in patients with impaired renal function, periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Når Kinzalmono anvendes til patienter med nedsat nyrefunktion, anbefales periodisk kontrol af serumniveauerne for kalium og kreatinin.
English: Kinzalmono is used to treat essential hypertension (high blood pressure) in adults.
Danish: Kinzalmono bruges til behandling af essentiel hypertension (forhøjet blodtryk) hos voksne.
English: Such conditions should be corrected before the administration of Kinzalmono.
Danish: Sådanne tilstande bør korrigeres før behandling med Kinzalmono.
English: Your doctor will normally advise you to stop taking Kinzalmono before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Kinzalmono.
Danish: Normalt vil din læge anbefale dig at stoppe med at tage Kinzalmono, før du bliver gravid eller så snart du ved, du er gravid.
English: Possible side effects of Kinzalmono
Danish: Bivirkninger ved Kinzalmono
English: Kinzalmono blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.
Danish: Kinzalmono blokerer angiotensin II´s virkning, så blodkarrene afslappes og blodtrykket falder.
English: Telmisartan tablets are for once-daily oral administration and should be taken with liquid with or without food.
Danish: Telmisartan-tabletter administreres oralt én gang daglig med væske, med eller uden mad.
English: Kinzalmono may be less effective in lowering the blood pressure in black patients.
Danish: Kinzalmono kan have en mindre blodtrykssænkende virkning hos sorte patienter.
English: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Danish: Ud fra de farmakologiske egenskaber må det forventes, at den hypotensive virkning af alle antihypertensiva inklusive telmisartan vil forstærkes af følgende lægemidler: Baclofen, amifostin.
English: If any of the above applies to you, tell your doctor or pharmacist before taking Kinzalmono.
Danish: Hvis du har nogen af ovenstående tilstande, så fortæl det til lægen eller på apoteket før du tager Kinzalmono.
English: The concomitant use of Kinzalmono with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5, and 5.1).
Danish: Samtidig brug af Kinzalmono og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: If you are intolerant to some sugars, consult your doctor before taking Kinzalmono.
Danish: Hvis du ikke tåler visse sukkerarter, bør du kontakte lægen, før du tager Kinzalmono.
English: When driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy such as Kinzalmono.
Danish: Når der føres motorkøretøj eller betjenes maskiner bør man være opmærksom på, at der ved antihypertensiv behandling, som for eksempel med Kinzalmono, lejlighedsvis kan forekomme svimmelhed eller døsighed.
English: What Kinzalmono contains
Danish: Kinzalmono indeholder:
English: There is no experience regarding the administration of Kinzalmono in patients with recent kidney transplantation.
Danish: Der er ingen erfaring med anvendelse af Kinzalmono til patienter, der kort tid forinden har fået foretaget en nyretransplantation.
English: What you need to know before you take Kinzalmono
Danish: Det skal du vide, før du begynder at tage Kinzalmono
English: 14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
Danish: 14 tabletter 28 tabletter 56 tabletter 98 tabletter 28 x 1 tablet
English: Kinzalmono may increase the blood pressure lowering effect of other medicines used to treat high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Danish: Kinzalmono kan øge den blodtrykssænkende virkning, både af anden blodtrykssænkende medicin og af medicin, der potentielt kan sænke blodtrykket (f.eks. baclofen eller amifostin).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Kinzalmono 20 mg tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Kinzalmono 20 mg tabletter
English: As with other medicinal products acting on the renin-angiotensin-aldosterone-system, telmisartan may provoke hyperkalaemia (see section 4.4).
Danish: Som for andre lægemidler, der påvirker renin-angiotensin-aldosteronsystemet, kan telmisartan fremprovokere hyperkaliæmi (se pkt.
English: However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Kinzalmono may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Kinzalmono.
Danish: Nogle patienter får anbefalet en lavere dosis på 20 mg eller en højere dosis på 80 mg. Kinzalmono kan også ordineres i kombination med diuretika (vanddrivende medicin) såsom hydrochlorthiazid, der har vist sig at øge den blodtryksnedsættende virkning af Kinzalmono.
English: Kinzalmono is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Din læge vil vælge en anden behandling til dig, hvis du ønsker at amme, specielt hvis dit barn er nyfødt eller er født for tidlig.
English: Kinzalmono is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Danish: Det frarådes at anvende Kinzalmono tidligt i graviditeten, og det må ikke tages senere end 3 måneder henne i graviditeten, da det kan forårsage alvorlige fosterskader.
English: If you take more Kinzalmono than you should If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Danish: Hvis du har taget for meget Kinzalmono Hvis du har taget for mange tabletter, så kontakt lægen, skadestuen eller apoteket.
English: There are no adequate data from the use of Kinzalmono in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af telmisartan til gravide kvinder.
English: For reduction of cardiovascular events, the usual dose of Kinzalmono is one 80 mg tablet once a day.
Danish: Til nedsættelse af risikoen for hjerte-kar-hændelser er den sædvanlige dosis Kinzalmono 80 mg én gang daglig.
English: In case of surgery or anaesthesia, you should tell your doctor that you are taking Kinzalmono.
Danish: Hvis du skal opereres eller have anden form for bedøvelse, så fortæl lægen, at du tager Kinzalmono.
English: Kinzalmono 40 mg and 80 mg tablets 4 years
Danish: Kinzalmono 40 mg og 80 mg tabletter 4 år.