FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX IV CONDITION OF THE MARKETING AUTHORISATIONS
Danish: BILAG IV BETINGELSE FOR MARKEDSFØRINGSTILLADELSEN
English: This can result in serious vision loss and even blindness.
Danish: Dette kan resultere i svært synstab og endda blindhed.
English: Further information on Rhokiinsa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rhokiinsa
Danish: Yderligere information om Rhokiinsa findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/rhokiinsa.
English: The safety of Rhokiinsa will be further investigated in a study.
Danish: Sikkerheden ved Rhokiinsa vil blive undersøgt nærmere i et studie.
English: As for all medicines, data on the use of Rhokiinsa are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Rhokiinsa løbende overvåget.
English: However, side effects on the eye were more frequent than those of timolol, and this may lead people to stop treatment.
Danish: Der var dog mere hyppigt bivirkninger i øjet end med timolol, og dette kan få folk til at stoppe behandlingen.
English: Other information about Rhokiinsa
Danish: Andre oplysninger om Rhokiinsa
English: What measures are being taken to ensure the safe and effective use of Rhokiinsa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rhokiinsa?
English: For more information about using Rhokiinsa, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Rhokiinsa, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: An overview of Rhokiinsa and why it is authorised in the EU
Danish: En oversigt over Rhokiinsa, og hvorfor det er godkendt i EU
English: The European Medicines Agency therefore decided that Rhokiinsa's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Rhokiinsa opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Rhokiinsa are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Rhokiinsa vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Rhokiinsa is only available on prescription and should be started by an eye specialist.
Danish: Rhokiinsa fås kun på recept, og behandlingen bør indledes af en øjenspecialist.
English: In patients with moderately high eye pressure (up to 25 mmHg), Rhokiinsa was as effective as timolol (another medicine), lowering the pressure by around 3.9 mmHg to 4.7 mmHg, compared with reductions of 3.8 mmHg to 5.2 mmHg for patients using timolol.
Danish: Hos patienter med et moderat øjentryk (op til 25 mmHg) var Rhokiinsa lige så effektivt som timolol (et andet lægemiddel), idet det sænkede trykket med ca. 3,9 mmHg til 4,7 mmHg sammenholdt med en fald på 3,8 mmHg til 5,2 mmHg for patienter, der brugte timolol.
English: Why is Rhokiinsa authorised in the EU?
Danish: Hvorfor er Rhokiinsa godkendt i EU?
English: This means that it blocks the activity of an enzyme called Rho kinase, which has a role in controlling drainage of fluid from the eye.
Danish: Det betyder, at det blokerer aktiviteten af et enzym kaldet Rho-kinase, der er med til at kontrollere dræningen af væske fra øjet.
English: It is available as an eye-drop solution (200 microgram/ml) and the dose is one drop in the affected eye once a day, in the evening.
Danish: Det fås som øjendråber, opløsning (200 mikrogram/ml), og dosis er én dråbe i det pågældende øje hver aften.
English: Rhokiinsa contains the active substance netarsudil.
Danish: Rhokiinsa indeholder det aktive stof netarsudil.
English: However, when these results were combined with results from other studies, decreases in eye pressure with Rhokiinsa were larger than those seen in the main study only.
Danish: Når disse resultater blev kombineret med resultater fra andre studier, var faldet i øjentrykket med Rhokiinsa imidlertid større end i hovedstudiet.
English: The effect of Rhokiinsa was less pronounced in patients whose eye pressure was more than 30 mmHg, but these results were considered less important because Rhokiinsa is not expected to be used on its own in this group.
Danish: Virkningen af Rhokiinsa var mindre udtalt hos patienter, hvis øjentryk var højere end 30 mmHg, men disse resultater blev anset for mindre vigtige, fordi Rhokiinsa ikke forventes at blive anvendt alene i denne gruppe.
English: What is Rhokiinsa and what is it used for?
Danish: Hvad er Rhokiinsa, og hvad anvendes det til?
English: Rhokiinsa, which has a different mode of action from previously authorised treatments, provides another treatment option for patients with open-angle glaucoma and ocular hypertension.
Danish: Rhokiinsa, der har en anden virkemåde end tidligere godkendte behandlinger, giver en anden behandlingsmulighed for patienter med åbenvinklet glaukom og okulær hypertension.
English: Other common side effects (which may affect up to 2 in 10 people) are: cornea verticillata (deposits in the cornea, the transparent layer in front of the eye that covers the pupil and iris), eye pain, conjunctival haemorrhage (bleeding in the surface layer of the eye), erythema (reddening) at the site where the medicine was applied and the eyelid, corneal staining, blurred vision and increased lacrimation (watery eyes).
Danish: Andre hyppige bivirkninger (som kan forekomme hos op til 2 ud af 10 personer) er cornea vertiillata (aflejringer i hornhinden, det gennemsigtige lag forrest i øjet, som dækker pupillen og regnbuehinden), øjensmerter, konjunktival blødning (blødning i øjets overfladelag), erytem (rødme) på øjenlåget og det sted, hvor lægemidlet blev anvendt, farvning af hornhinden, sløret syn og øget tåredannelse (øjne, der løber i vand).
English: The most common side effect with Rhokiinsa (which may affect around 5 in 10 people) is conjunctival hyperaemia (increased blood supply to the eye, leading to redness).
Danish: Den hyppigste bivirkning ved Rhokiinsa (som kan forekomme hos ca. 5 ud af 10 personer) er konjunktival hyperæmi (øget blodforsyning til øjet, der fører til rødme).
English: The active substance in Rhokiinsa, netarsudil, is a Rho kinase inhibitor.
Danish: Det aktive stof i Rhokiinsa, netarsudil, er en Rho-kinasehæmmer.
English: In terms of safety, the side effects of Rhokiinsa are considered manageable and were more likely to be confined to the eye.
Danish: For så vidt angår sikkerheden, anses bivirkningerne af Rhokiinsa for at være håndterbare, og de er mere tilbøjelige til at være begrænset til øjet.
English: Rhokiinsa showed good effects across a range of eye pressures.
Danish: Rhokiinsa viste sit at have en god virkning på en række forskellige øjentryk.
English: Rhokiinsa is an eye-drop solution that is used to reduce pressure inside the eye in adults who have open-angle glaucoma (a disease where the pressure in the eye rises because fluid cannot drain out of the eye) or ocular hypertension (when the pressure in the eye is higher than normal).
Danish: Rhokiinsa er en øjendråbeopløsning, der anvendes til at reducere trykket i øjet hos voksne med åbenvinklet glaukom (en sygdom, hvor trykket i øjet stiger, fordi væsken ikke kan løbe ud af øjet) eller okulær hypertension (når trykket i øjet er højere end normalt).
English: What are the risks associated with Rhokiinsa?
Danish: Hvilke risici er der forbundet med Rhokiinsa?
English: A main study of 708 patients with open-angle glaucoma or ocular hypertension showed that Rhokiinsa is effective at lowering eye pressure.
Danish: Et hovedstudie, der omfattede 708 patienter med åbenvinklet glaukom eller okulær hypertension, viste, at Rhokiinsa er effektivt til at sænke øjentryk.
English: When pressure in the eye is raised, it can cause damage to the retina (the light-sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Danish: Et forhøjet tryk i øjet kan beskadige nethinden (den lysfølsomme membran bagerst i øjet) og synsnerven, der sender signaler fra øjet til hjernen.
English: For the full list of side effects and restrictions with Rhokiinsa, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Rhokiinsa fremgår af indlægssedlen.
English: In patients whose eye pressure was higher than 25 mmHg, Rhokiinsa was less effective than timolol.
Danish: Hos patienter med et øjentryk på over 25 mmHg var Rhokiinsa mindre effektivt end timolol.
English: How is Rhokiinsa used?
Danish: Hvordan anvendes Rhokiinsa?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rhokiinsa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rhokiinsa.
English: When it blocks this enzyme, Rhokiinsa increases the flow of fluid out of the eyeball, thereby lowering pressure inside the eye. Rhokiinsa is also thought to lower eye pressure by reducing pressure in the veins around the eyes.
Danish: Når Rhokiinsa blokerer dette enzym, øger det væskestrømmen ud af øjeæblet og sænker dermed trykket i øjet.
English: What benefits of Rhokiinsa have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Rhokiinsa?
English: How does Rhokiinsa work?
Danish: Hvordan virker Rhokiinsa?
English: 1 bottle; 2 sachets
Danish: 1 flaske, 2 pakker
English: 1 bottle; 1 sachet
Danish: 1 flaske, 1 pakke
English: ATCvet code: QI06AJ03.
Danish: ATCvet-kode: QI06AJ03.
English: Date of first authorisation: 23/02/2005 Date of last renewal: 14/01/2010
Danish: Dato for første markedsføringstilladelse: 23/02/2005 Dato for seneste fornyelse af markedsføringstilladelsen: 14/01/2010
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals ) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: EU/2/04/050/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/050/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Danish: EU/2/04/050/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/050/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
English: Lyophilisate (10xdose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Danish: Lyofilisat (10xdosis) + solvens (10x1 ml) Lyofilisat (50x1 dosis) + solvens (50x1 ml)
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium or plastic cap.
Danish: Type I glasflaske indeholdende 1 dosis af lyofilisat og type I glasflaske indeholdende 1 ml solvens, begge lukket med en butyl elastomer prop og forseglet med en aluminiums- eller plastkapsel.
English: Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Danish: − anden injektion: 3-4 uger senere.
English: 2 egg infective dose 50%
Danish: 2 æg infektiøs dosis 50%.
English: If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Danish: Hvis selv-injektion opstår ved et uheld, bør der øjeblikkeligt søges læge og lægen informeres om, at selv-injektion med en levende chlamydia vaccine er sket.
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis, panleucopenia or Chlamydophila components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Danish: Ved mistanke om tilstedeværelse af høje værdier af maternelle antistoffer over for rhinotracheitis, calicivirus, panleukopeni eller Chlamydophila komponenterne (fx hos 9-12 uger gamle killinger født af hunkatte, der var vaccineret før drægtighed og/eller ved kendskab til eller mistanke om, at moderdyret har været udsat for de pågældende patogener), bør basisvaccination udsættes til killingerne er 12 uger gamle.
English: 1 cell culture infective dose 50%
Danish: 1 cellekultur infektiøs dosis 50%.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Danish: Der foreligger oplysninger om sikkerhed og virkning, der viser, at denne vaccine kan blandes og gives med Merials vaccine uden adjuvans mod felin leukæmi og/eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies.
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the Chlamydophila felis component.
Danish: Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis, calicivirus og panleukopeni komponenterne og 1 år for Chlamydophila felis komponenten.
English: Gentamicin, at most .......................................................................................................................... 28 µg Solvent:
Danish: Gentamycin max.............................................................................................................................. 28 µg Solvens:
English: Incompatibilities : Do not mix with Merial adjuvanted vaccine against rabies.
Danish: Uforligeligheder: Må ikke blandes med Merials vaccine med adjuvans mod rabies.
English: Purevax RCPCh solvent
Danish: Purevax RCPCh solvens.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the chlamydiosis component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Danish: − efterfølgende revaccinationer skal foretages: hvert år for chlamydiose komponenten og med intervaller på op til tre år for rhinotracheitis, calicivirus og panleukopeni komponenterne.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ....................................... ≥ 2,0 ELISA U. Svækket Chlamydophila felis (905 stamme) ....................................................................... ≥ 103,0 EID502 Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Danish: 1 dosis (1 ml) indeholder: FHV (F2 stamme) ............................................................................................................... ≥ 104,9 CCID50
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated Chlamydophila felis (905 strain) ...................................................................... ≥ 103.0 EID502 Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ...................................... ≥ 2,0 ELISA U. Svækket Chlamydophila felis (905 stamme) ....................................................................... ≥ 103,0 EID502 Svækket felin panleukopeni virus (PLI IV) ...................................................................... ≥ 103,5 CCID501
English: Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus, Chlamydophila felis and feline panleucopenia virus.
Danish: Vaccine mod felin viral rhinotracheitis, felin calicivirus, chlamydiose og felin panleukopeni Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calicivirus, Chlamydophila felis og felin panleukopeni virus.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus, Chlamydophila felis and panleucopenia components.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus, Chlamydophila felis og panleukopeni.
English: Pregnancy and lactation:
Danish: Revaccination:
English: Purevax RCPCh Lyophilisate and solvent for suspension for injection.
Danish: Purevax RCPCh Lyofilisat og solvens til injektionsvæske, suspension.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Danish: Dinatriumhydrogenorthophosphat
English: Purevax RCPCh lyophilisate and solvent for suspension for injection
Danish: Purevax RCPCh lyofilisat og solvens til injektionsvæske, suspension.
English: Gentamicin, at most .......................................................................................................................... 28 µg
Danish: Gentamycin max............................................................................................................................... 28 µg
English: PACKAGE LEAFLET FOR: Purevax RCPCh lyophilisate and solvent for suspension for injection
Danish: Purevax RCPCh, lyofilisat og solvens til injektionsvæske, suspension.
English: However, the same EFSA document also states that:
Danish: EFSA-dokumentet anfører dog også følgende:
English: Therefore this indication was removed.
Danish: Derfor er denne indikation blevet fjernet.
English: ATCvet code: QA07AA92.
Danish: ATCvet-kode: QA07AA92.
English: A disease shall be included on the list if it has been assessed in accordance with Article 7.
Danish: En sygdom skal medtages på listen, hvis den er blevet vurderet i overensstemmelse med artikel 7.
English: Member State EU/EEA
Danish: Medlemssta t EU/EEA
English: This is stated in the Regulation (EC) No 2160/20039 and based on the EFSA Opinion (2004)11.
Danish: Dette er nævnt i forordning (EF) nr. 2160/20039 og baseret på EFSA's udtalelse (2004)11.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 g indeholder:
English: 100% w/w
Danish: 100% v/v
English: in poultry has little justification.
Danish: hos fjerkræ generelt ikke megen berettigelse.
English: Drinking systems should be clean and free of rust to avoid reduction of activity.
Danish: Drikkesystemer bør være rengjorte og rustfrie for at undgå nedsat aktivitet.
English: Those measures may cover, for example, prohibitions and restrictions on the use of veterinary medicinal products.
Danish: Disse foranstaltninger kan f.eks. omfatte forbud mod og begrænsninger af anvendelse af veterinærlægemidler.
English: The weight of the animals should be determined as accurately as possible to avoid underdose.
Danish: Dyrets vægt skal bestemmes så præcist som muligt for at undgå underdosering.
English: Additionally, the shelf life has been reduced to 18 months.
Danish: Derudover er opbevaringstiden blevet reduceret til 18 måneder.
English: No accelerated data have been provided during the referral procedure.
Danish: Der er ikke fremlagt accelererede data under indbringelsesproceduren.
English: MANUFACTURER'S BATCH NUMBER Lot:
Danish: FREMSTILLERENS BATCHNUMMER Lot:
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Danish: Der skal tages hensyn til den officielle, nationale og regionale antibiotikapolitik, når veterinærlægemidlet anvendes.
English: Average daily water intake (l/animal)
Danish: Gennemsnitligt dagligt vandindtag (l/dyr)
English: Additionally, in some Member States a measuring device was authorised for the administration of Girolan.
Danish: Derudover var det i nogle medlemsstater tilladt at anvende en måleanordning ved administration af Girolan.
English: This lack of storage precautions for the product is based on historical data, and was already approved in the individual Member States prior to the referral.
Danish: Dette fravær af forholdsregler vedrørende opbevaring af produktet er baseret på historiske data og var allerede godkendt i de enkelte medlemsstater inden indbringelsen.
English: All calves were subjected to a full clinical examination daily for at least the first week of each trial.
Danish: Alle kalvene gennemgik dagligt en fuld klinisk vurdering i mindst den første uge af hver undersøgelse.
English: Mortality was the principal criteria for efficacy.
Danish: Reduceret dødelighed var det primære effektkriterium.
English: The harmonisation of withdrawal periods was based on the better conducted and most reliable studies.
Danish: Harmoniseringen af tilbageholdelsestiderne var baseret på de undersøgelser, der var udført bedst og mest pålideligt.
English: Medicated water should be the only source of drinking.
Danish: Det medicinerede vand bør være den eneste tilgængelige vandkilde.
English: and Campylobacter spp.
Danish: og Campylobacter spp.
English: Furthermore, the European Commission shall adopt delegated acts concerning amendments to the list referred.
Danish: Europa-Kommissionen skal desuden vedtage delegerede retsakter vedrørende ændringer i den omtalte liste.
English: This evaluation focuses on issues with regard to the harmonisation that may change the benefit-risk balance.
Danish: Vurderingen fokuserer på de punkter vedrørende harmoniseringen, som kan ændre benefit/risk-forholdet.
English: Do not exceed the recommended dose.
Danish: Den anbefale dosis må ikke overskrides.
English: Furthermore, in this sense, the European Commission shall adopt delegated acts in accordance with Article 264 concerning amendments to the list referred.
Danish: I den forbindelse skal Europa-Kommissionen desuden vedtage delegerede retsakter i henhold til artikel 264 vedrørende ændringer i den omtalte liste.
English: • The restriction of the indications to those that are adequately substantiated by efficacy data;
Danish: • Indikationerne begrænses til de indikationer, der er tilstrækkeligt underbygget af effektdata.
English: Dose/response was clearly observed for the mortality rate.
Danish: Dosis/respons-forholdet blev observeret specifikt, hvad angår dødelighed.