FrancophonIA/ELRC3.0 huggingface dataset:
English: Dogs (kg) Pipette cap colour mg of selamectin dispensed
Danish: Hunde (kg) Tubelågets farve mg selamectin appliceret
English: Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestations in the litter up to seven weeks of age.
Danish: På grund af reduktion af loppebestanden vil månedlig behandling af drægtige og diegivende dyr støtte forbyggelse mod loppeangreb hos hvalpekuld til de er 7 uger.
English: Special precautions for use in animals:
Danish: Særlige advarsler for hver dyreart:
English: If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats.
Danish: Hvis dyret optager produktet ved slikning, kan der i en kort periode ses en forøget spytsekretion hos katte.
English: The veterinary medicinal product is ovicidal for 3 weeks after administration.
Danish: Dette produkt dræber æg 3 uger efter behandling.
English: Flea treatment and prevention (cats and dogs)
Danish: Behandling og forebyggelse af loppeinfestationer (katte og hunde)
English: Avoid contact between the product and your fingers.
Danish: Undgå at få Stronghold på fingrene.
English: Treatment of ear mites (Otodectes cynotis).
Danish: Behandling mod øremider (0todectes cynotis) Kat:
English: Holding the pipette upright, firmly depress the cap to puncture the applicator seal, then remove the cap
Danish: Hold pipetten lodret og pres hætten nedad for at punktere applikatorens segl.
English: The systemic persistence of selamectin in plasma and the lack of extensive metabolism provide effective concentrations of selamectin for the duration of the inter-dosing interval (30 days).
Danish: Terapeutiske plasmakoncen-trationer i perioden mellem 2 behandlinger (30 dage) sikres ved at plasmakoncentrationen af selamectin opretholdes og ved en langsom metabolisme.
English: However, shampooing or soaking the animal 2 or more hours after treatment will not reduce the efficacy of the product.
Danish: Dyret kan vaskes med sæbe eller pelsen kan gennemblødes to timer efter behandlingen, uden at effekten af produktet forringes.
English: Apply the tip of the Stronghold pipette directly to the skin without massaging.
Danish: Uden at massere tømmes pipetten helt på stedet ved at presse tuben sammen.
English: Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin
Danish: Stronghold 30 mg spot-on opløsning til hunde 2,6 - 5,0 kg Stronghold 60 mg spot-on opløsning til hunde 5,1 - 10,0 kg Stronghold 120 mg spot-on opløsning til hunde 10,1 - 20,0 kg Stronghold 240 mg spot-on opløsning til hunde 20,1 - 40,0 kg Stronghold 360 mg spot-on opløsning til hunde 40,1 - 60,0 kg selamectin
English: Part the hair at the base of your animal's neck in front of the shoulder blades to expose a small area of skin
Danish: For at få et frit hudområde skilles hårene i nakken foran skulderbladene.
English: Each single-dose (pipette) delivers: Stronghold 15 mg for cats and dogs
Danish: Katte og hunde, der vejer 2,5 kg eller mindre (Stronghold 15 mg Spot-on opløsning til katte og hunde ≤ 2,5 kg)
English: This stops flea reproduction and may aid in the control of existing environmental flea infestations in areas to which the animal has access.
Danish: Dette stopper udvikling af nye lopper og støtter konmtrol med loppeangrenb i dyrets omgivelser.
English: Stronghold 15 mg spot-on for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on for dogs 2.6-5.0 kg Stronghold 45 mg spot-on for cats 2.6-7.5 kg Stronghold 60 mg spot-on for cats 7.6-10.0 kg Stronghold 60 mg spot-on for dogs 5.1-10.0 kg Stronghold 120 mg spot-on for dogs 10.1-20.0 kg Stronghold 240 mg spot-on for dogs 20.1-40.0 kg Stronghold 360 mg spot-on for dogs 40.1-60.0 kg selamectin
Danish: Stronghold 15 mg spot-on opløsning til katte og hunde ≤ 2,5 kg Stronghold 30 mg spot-on opløsning til hunde 2,6 - 5,0 kg Stronghold 45 mg spot-on opløsning til katte 2,6 - 7,5 kg Stronghold 60 mg spot-on opløsning til katte 7,6 - 10,0 kg Stronghold 60 mg spot-on opløsning til hunde 5,1 - 10,0 kg Stronghold 120 mg spot-on opløsning til hunde 10,1 - 20,0 kg Stronghold 240 mg spot-on opløsning til hunde 20,1 - 40,0 kg Stronghold 360 mg spot-on opløsning til hunde 40,1 - 60,0 kg selamectin
English: Marketing authorisation holder and manufacturer responsible for batch release: Zoetis Belgium SA
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: Treatment of ear mites (dogs)
Danish: Behandling af øremider (hunde)
English: 6% w/v solution selamectin 15 mg
Danish: 6% w/v opløsning 12% w/v opløsning
English: Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg Stronghold 30 mg spot-on solution for dogs 2.6-5.0 kg Stronghold 45 mg spot-on solution for cats 2.6-7.5 kg Stronghold 60 mg spot-on solution for cats 7.6-10.0 kg Stronghold 60 mg spot-on solution for dogs 5.1-10.0 kg Stronghold 120 mg spot-on solution for dogs 10.1-20.0 kg Stronghold 240 mg spot-on solution for dogs 20.1-40.0 kg Stronghold 360 mg spot-on solution for dogs 40.1-60.0 kg
Danish: Stronghold 15 mg spot-on opløsning til katte og hunde ≤ 2,5 kg Stronghold 30 mg spot-on opløsning til hunde 2,6 - 5,0 kg Stronghold 45 mg spot-on opløsning til katte 2,6 - 7,5 kg Stronghold 60 mg spot-on opløsning til katte 7,6 - 10,0 kg Stronghold 60 mg spot-on opløsning til hunde 5,1 - 10,0 kg Stronghold 120 mg spot-on opløsning til hunde 10,1 - 20,0 kg Stronghold 240 mg spot-on opløsning til hunde 20,1 - 40,0 kg Stronghold 360 mg spot-on opløsning til hunde 40,1 - 60,0 kg
English: 12% w/v solution selamectin 240 mg
Danish: Pipetter med grøn hætte indeholder 2,0 ml 12% w/v opløsning og afgiver 240 mg selamectin.
English: 12% w/v solution selamectin 120 mg
Danish: Pipetter med rød hætte indeholder 1,0 ml 12% w/v opløsning og afgiver 120 mg selamectin.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zostavax on 19 May 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zostavax den 19. maj 2006.
English: Most of these side effects were mild.
Danish: De fleste af disse bivirkninger var milde.
English: The study was a double-blind trial, which means that neither the doctor nor the patient knew what treatment the patient was receiving.
Danish: Undersøgelsen var dobbeltblind, hvilket betyder, at hverken lægen eller patienten vidste, hvilken behandling patienten fik.
English: The patients were followed for 2 to 4.5 years after vaccination.
Danish: Patienterne blev fulgt i 2 til 4,5 år efter vaccinationen.
English: In patients who have bleeding problems, the vaccine should be given under the skin.
Danish: Hos patienter med blødningsproblemer bør vaccinen gives under huden.
English: The full EPAR for Zostavax is available on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Zostavax findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Zostavax.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zostavax.
English: It must also not be used in patients with active untreated tuberculosis or in pregnant women.
Danish: Lægemidlet må heller ikke anvendes til patienter med aktiv, ubehandlet tuberkulose eller til gravide.
English: A risk management plan has been developed to ensure that Zostavax is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zostavax anvendes så sikkert som muligt.
English: Zostavax shingles (herpes zoster) vaccine (live)
Danish: Zostavax helvedesild (herpes zoster) vaccine (levende)
English: Other information about Zostavax
Danish: Andre oplysninger om Zostavax
English: What measures are being taken to ensure the safe and effective use of Zostavax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zostavax?
English: The effect was seen both in patients aged between 50 and 59 years and in those aged 60 years and older.
Danish: Virkningen blev iagttaget både hos patienter i alderen mellem 50 og 59 år og hos patienter i alderen 60 og derover.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zostavax.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Zostavax skal anvendes.
English: The CHMP decided that Zostavax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Zostavax opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: The risk of developing shingles increases with age and seems to be linked to a decline in immunity (protection) against varicella-zoster virus.
Danish: Risikoen for at udvikle helvedesild øges med alderen og synes at være forbundet med en nedsættelse af immuniteten (beskyttelsen) mod varicella zoster-virus.
English: The main measure of effectiveness was based on the number of people who developed shingles and post-herpetic pain.
Danish: Det primære mål for effekt var antallet af personer, som udviklede helvedesild og postherpetiske smerter.
English: For more information about treatment with Zostavax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zostavax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In studies, the most common side effects with Zostavax are reactions at the site of the injection (redness, pain, swelling, itching, warmth and bruising), headache and pain in the arm or leg.
Danish: I undersøgelsen var de hyppigste bivirkninger ved Zostavax reaktioner på injektionsstedet (rødme, smerte, hævelse, kløe, brændende fornemmelse og blå mærker), hovedpine og smerter i arme eller ben.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zostavax, 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 Zostavax, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Zostavax was more effective than placebo in preventing shingles.
Danish: Zostavax var mere effektivt end placebo til forebyggelse af helvedesild.
English: The vaccine must not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, acquired immune deficiency syndrome (AIDS), or because they are taking medicines that affect the immune system.
Danish: Vaccinen må ikke anvendes til personer, som har problemer med deres immunsystem, enten fordi de har haft sygdomme såsom leukæmi, lymfom, aids, eller fordi de tager lægemidler, der indvirker på deres immunsystem.
English: Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo.
Danish: Der var færre personer, som udviklede helvedesild efter vaccinationen med Zostavax end med placebo: 315 af de 19 254 patienter, som fik Zostavax, fik helvedesild i løbet af undersøgelsen sammenlignet med 642 af de 19 247, der fik placebo.
English: Two further studies looked at Zostavax in over 1,000 patients aged 50 years or older, of whom 389 were between 50 and 59 years of age.
Danish: I to yderligere undersøgelser så man nærmere på Zostavax hos godt 1 000 patienter i alderen 50 år eller derover, hvoraf 389 var mellem 50 og 59 år.
English: Zostavax is given as a single dose injected under the skin or into the muscle, preferably around the shoulder.
Danish: Zostavax gives som en enkelt injektion under huden eller i musklen, fortrinsvis i skulderregionen.
English: Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.
Danish: Zostavax var også mere effektivt end placebo til forebyggelse af postherpetisk neuralgi: 27 af Zostavax-patienterne fik postherpetisk neuralgi sammenlignet med 80 i placebogruppen.
English: The studies looked at the ability of the vaccine to stimulate the production of antibodies against varicella-zoster virus in the blood, four weeks after injection.
Danish: I undersøgelserne så man på vaccinens evne til at stimulere produktionen af antistoffer mod varicella zoster-virus i blodet fire uger efter injektionen.
English: The main study of Zostavax compared the vaccine with placebo (a dummy) vaccine in around 39,000 patients aged between 59 and 99 years.
Danish: I hovedundersøgelsen af Zostavax blev vaccinen sammenlignet med placebo (en uvirksom behandling) hos ca. 39 000 patienter i alderen 59 til 99 år.
English: Zostavax is a vaccine that was shown to ‘boost' this immunity, protecting against shingles and the pain associated with it.
Danish: Zostavax er en vaccine, der har vist sig at "booste" denne specifikke immunitet, hvorved den giver beskyttelse mod helvedesild og de smerter, der er forbundet hermed.
English: What is the risk associated with Zostavax?
Danish: Hvilken risiko er der forbundet med Zostavax?
English: Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Danish: Herpes zoster eller helvedesild er en sygdom forårsaget af varicella zoster-virus, den samme virus, som forårsager skoldkopper.
English: The additional two studies showed that patients vaccinated with Zostavax had blood levels of antibodies against varicella-zoster virus that were about two to three times higher four weeks after vaccination.
Danish: De to yderligere undersøgelser viste, at patienter vaccineret med Zostavax, havde antistofmængder i blodet mod varicella zoster-virus, som var ca. to til tre gange højere fire uger efter vaccinationen.
English: Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).
Danish: Zostavax anvendes til vaccination af personer på 50 år eller derover til forebyggelse af herpes zoster (også kaldet zoster eller helvedesild) og de langvarige nervesmerter, som kan efterfølge sygdommen (postherpetisk neuralgi).
English: The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain (post-herpetic neuralgia) in the area where the rash was.
Danish: Det tager sædvanligvis flere uger, før virusset forsvinder, og det kan efterfølges af svære langvarige smerter (postherpetisk neuralgi) i det område, hvor udslættet var.
English: Why has Zostavax been approved?
Danish: Hvorfor blev Zostavax godkendt?
English: Zostavax must not be used in people who are hypersensitive (allergic) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine such as neomycin (an antibiotic).
Danish: Zostavax må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nogle af de komponenter eller sporstoffer, vaccinen indeholder (i meget små mængder), f.eks. neomycin (et antibiotika).
English: What is Zostavax?
Danish: Hvad er Zostavax?
English: Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection.
Danish: Zostavax er en vaccine, der fås som pulver og solvens til fremstilling af en injektionsvæske, opløsning.
English: For the full list of all side effects reported with Zostavax, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Zostavax fremgår af indlægssedlen.
English: Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful,
Danish: Virusset kan undertiden efter mange år og af endnu ukendte årsager blive aktivt igen, og patienten udvikler helvedesild, et smertefuldt blæredannende udslæt, som regel på den ene side af kroppen.
English: How has Zostavax been studied?
Danish: Hvordan blev Zostavax undersøgt?
English: What is Zostavax used for?
Danish: Hvad anvendes Zostavax til?
English: The active substance is the attenuated (weakened) varicella-zoster virus.
Danish: Det aktive stof er svækket varicella zoster-virus.
English: How is Zostavax used?
Danish: Hvordan anvendes Zostavax?
English: What benefit has Zostavax shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zostavax?
English: Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant' (inactive) state.
Danish: Når man har haft skoldkopper, forbliver varicella zostervirusset i nervesystemet i en "dvale"-lignende (inaktiv) tilstand.
English: How does Zostavax work?
Danish: Hvordan virker Zostavax?
English: 23 August 2012
Danish: Den 23. august 2012
English: What is Zinnat?
Danish: Hvad er Zinnat?
English: The European Commission issued a decision on 23 August 2012.
Danish: Europa-Kommissionen traf en afgørelse den 23. august 2012.
English: Zinnat is marketed in all EU Member States, as well as Iceland.
Danish: Zinnat markedsføres i alle EU's medlemsstater samt Island.
English: Zinnat is authorised in the EU via national procedures.
Danish: Zinnat blev godkendt i EU via nationale procedurer.
English: Zinnat should be used twice a day at different doses depending on the condition it is used to treat.
Danish: Zinnat bør anvendes to gange dagligt i forskellige doseringer, afhængigt af hvilken sygdom, der behandles.
English: Why was Zinnat reviewed?
Danish: Hvorfor blev Zinnat vurderet igen?
English: • Treatment of early Lyme disease.
Danish: • Behandling af tidlige stadier af Lyme-sygdom.
English: It is also available under other trade names: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
Danish: Det leveres også under andre handelsnavne, nemlig Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos og Zoref.
English: The CHMP also harmonised other sections of the SmPC including sections 4.3 (contra-indications) and 4.4 (special warnings and precautions for use).
Danish: CHMP harmoniserede desuden andre afsnit af produktresuméet, herunder afsnit 4.3 (kontraindikationer) og 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen).
English: The CHMP concluded that Zinnat should be used in adults and children from three months of age for the following conditions:
Danish: CHMP konkluderede, at Zinnat bør anvendes til voksne og børn fra alderen tre måneder til følgende indikationer:
English: On 24 May 2012, the European Medicines Agency completed a review of Zinnat.
Danish: Den 24. maj 2012 afsluttede Det Europæiske Lægemiddelagentur (EMA) en gennemgang af Zinnat.
English: On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinnat in the EU.
Danish: Den 20. april 2010 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Zinnat i EU.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinnat in adults and children and in patients with reduced kidney and liver function.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Zinnat hos voksne og børn og hos patienter med nedsat nyre- eller leverfunktion.
English: The active substance, cefuroxime axetil, belongs to the group ‘cephalosporins'.
Danish: Det aktive stof, cefuroximaxetil, tilhører cefalosporin-gruppen.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the different EU countries.
Danish: Dette har ført til afvigelser mellem medlemsstaterne med hensyn til den måde, lægemidlet kan anvendes på, således som det fremgår af forskellene mellem produktresuméer, etikettering og indlægssedler i de forskellige EU-lande.
English: Questions and answers on Zinnat and associated names (cefuroxime axetil, 125, 250 and 500 mg tablets and 125, 250 and 500 mg granules for oral suspension) EMA/CHMP/339191/2012
Danish: Spørgsmål og svar vedrørende Zinnat og relaterede navne (cefuroximaxetil, tabletter 125, 250 og 500 mg, og granulat til oral suspension 125, 250 og 500 mg) EMA/CHMP/339191/2012
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinnat in the European Union (EU).
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Zinnat i Den Europæiske Union (EU).
English: Questions and answers on Zinnat and associated names (cefuroxime axetil, 125, 250 and 500 mg tablets and 125, 250 and 500 mg granules for oral suspension)
Danish: Spørgsmål og svar vedrørende Zinnat og relaterede navne (cefuroximaxetil, tabletter 125, 250 og 500 mg, og granulat til oral suspension 125, 250 og 500 mg)
English: Zinnat is an antibiotic used to treat certain infections caused by bacteria, including respiratory tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).
Danish: Zinnat er et antibiotikum, der anvendes til behandling af visse bakterielle infektioner, herunder luftvejsinfektioner såsom tonsillitis og faryngitis (infektioner i halsen), urinvejsinfektioner, hudinfektioner, bløddelsinfektioner (infektioner i hudens underliggende væv) samt Lyme-sygdom (en bakteriel infektion, der overføres til mennesker af smittede flåter).
English: The CHMP agreed that Zinnat should no longer be used to treat community acquired pneumonia (infection of the lungs acquired outside the hospital) and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae) because not enough clinical data are available to support these indications.
Danish: CHMP fandt, at Zinnat ikke længere burde anvendes til behandling af lungebetændelse erhvervet uden for sygehus og gonoré (en seksuelt overført sygdom forårsaget af bakterien Neisseria gonorrhoeae), da der ikke findes tilstrækkelige kliniske data til støtte for disse indikationer.
English: The CHMP also decided that Zinnat should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
Danish: CHMP besluttede desuden, at Zinnat ikke længere burde anvendes til sekvensbehandling (dvs. skift fra injektioner til oral behandling), fordi overgang til den orale behandling medførte en betydeligt lavere eksponering for det aktive stof.
English: • Uncomplicated skin and soft tissue infections.
Danish: • Ukomplicerede hud- og bløddelsinfektioner
English: • Pyelonephritis (kidney infection).
Danish: • Pyelonefritis (nyreinfektion)
English: • Acute otitis media (infection of the middle ear).
Danish: • Akut otitis media (mellemørebetændelse)