FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Chanhold is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Chanhold er et generisk lægemiddel, anses dets fordele og risici for at være de samme som for referencelægemidlet.
English: This is because the composition of Chanhold is comparable to the reference medicine and when applied to the skin, the active substance in both products is expected to be absorbed in the same way.
Danish: Det skyldes, at sammensætningen af Chanhold er sammenlignelig med referencelægemidlets, og når det påføres huden, forventes det, at det aktive stof i begge produkter optages på samme måde.
English: Why is Chanhold authorised in the EU?
Danish: Hvorfor blev Chanhold godkendt i EU?
English: The precautions are the same as for the reference medicine since Chanhold is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Chanhold er et generisk lægemiddel.
English: What is Chanhold and what is it used for?
Danish: Hvad er Chanhold, og hvad anvendes det til?
English: Therefore, the Agency's view was that, as for Stronghold, the benefit of Chanhold outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene ved Chanhold opvejer de identificerede risici som for Stronghold, og at det kan godkendes til anvendelse i EU.
English: Chanhold contains the active substance selamectin and is a ‘generic medicine'.
Danish: Chanhold indeholder det aktive stof selamectin og er et "generisk lægemiddel".
English: For more information about using Chanhold, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Chanhold, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Chanhold contains selamectin, which is an antiparasitic medicine that belongs to the ‘avermectin' class.
Danish: Chanhold indeholder selamectin, som er et lægemiddel mod parasitter, der tilhører klassen "avermectin".
English: Safety information has been included in the summary of product characteristics and the package leaflet for Chanhold, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Chanhold, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Chanhold is an antiparasitic medicine used to treat and prevent infestations with parasites that live on the skin or in the fur of cats and dogs, such as fleas and mites, as well as treating worm parasites that live inside the body.
Danish: Chanhold er et lægemiddel mod parasitter, der anvendes til behandling og forebyggelse af angreb fra parasitter, der lever på huden eller i pelsen på katte og hunde, såsom lopper og mider, samt til behandling af ormeparasitter, der lever i kroppen.
English: How has Chanhold been studied?
Danish: Hvordan er Chanhold blevet undersøgt?
English: How does Chanhold work?
Danish: Hvordan virker Chanhold?
English: It can also be used as part of a treatment for flea allergy dermatitis (skin inflammation), to prevent heartworm disease in cats and dogs, to treat ear mites in cats and dogs, to treat adult intestinal roundworms and intestinal hookworms in cats, to treat adult intestinal roundworms in dogs, to treat biting lice infestations in cats and dogs, to treat sarcoptic mange (scabies) in dogs.
Danish: til forebyggelse af hjerteorm hos katte og hunde til behandling af øremider hos katte og hunde til behandling af voksne spolorme og hageorme i tarmene hos katte til behandling af voksne spolorme hos hunde til behandling af angreb med bidende lus hos katte og hunde til behandling af sarcoptesskab hos hunde.
English: How is Chanhold used?
Danish: Hvordan anvendes Chanhold?
English: ATCvet code: QI06AH08.
Danish: ATCvet-kode: QI06AH08.
English: Date of first authorisation: 23/02/2005 Date of last renewal: 15/01/2010
Danish: Dato for første markedsføringstilladelse: 23/02/2005 Dato for seneste fornyelse af markedsføringstilladelse: 15/01/2010
English: 69800 SAINT-PRIEST FRANCE
Danish: 69800 SAINT-PRIEST FRANKRIG
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Danish: I yderst sjældne tilfælde kan hypersensitivitetsreaktion forekomme, der kan kræve passende symptomatisk behandling.
English: Name and address of the manufacturers of the biological active substances
Danish: Navn og adresse på fremstillere af de biologisk aktive stoffer
English: Primary vaccination course: - first injection: from 8 weeks of age, - second injection: 3 to 4 weeks later.
Danish: Basisvaccination: - første injektion fra 8-ugersalderen, - anden injektion: 3-4 uger senere.
English: The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Danish: Produktet reducerer udskillelsen af felin calicivirus ved indtræden af immunitet og i et år efter vaccination.
English: 1 cell culture infective dose 50%.
Danish: 1 cellekultur infektiøs dosis 50%.
English: Use immediately after reconstitution.
Danish: Anvendes umiddelbart efter opløsning.
English: Special precautions for use in animals: Use in healthy animals only.
Danish: Særlige forholdsregler til brug hos dyr: Vacciner kun raske dyr.
English: Laboratory of Lyon Porte des Alpes Rue de l'aviation
Danish: Laboratoires Porte des Alpes Rue de l'Aviation
English: EU/2/04/051/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/051/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
Danish: EU/2/04/051/001 Lyofilisat (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/2/04/051/002 Lyofilisat (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs.
Danish: Aktiv immunisering af katte, der er 8 uger eller ældre: - mod felin viral rhinotracheitis for at reducere kliniske tegn, - mod calicivirus infektion for at reducere kliniske tegn.
English: Casein hydrolysate Collagen hydrolysate Dipotassium phosphate Potassium dihydrogen phosphate Potassium hydroxide Sodium chloride
Danish: Casein hydrolysat Kollagen hydrolysat Dikaliumphosphat Kaliumdihydrogenphosphat Kaliumhydroxid
English: In normal conditions of use, transient apathy and anorexia may occasionally occur, as well as hyperthermia (lasting usually for 1 or 2 days).
Danish: Under normale omstændigheder kan der af og til forekomme apati og anoreksi samt hypertermi (der sædvanligvis varer 1 til 2 dage).
English: Water for injection ...................................................................................................................... q.s.
Danish: Vand til injektion ........................................................................................................................ q.s 1 ml.
English: No effect other than those already mentioned in section 4.6 “Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
Danish: Der er ikke iagttaget andre symptomer end de, der er nævnt under punkt 4.6 ”Bivirkninger”, bortset fra hypertermi, der i sjældne tilfælde kan vare op til 5 dage.
English: Manufacturing authorisation holder responsible for batch release: MERIAL
Danish: Fremstiller ansvarlig for batchfrigivelse: MERIAL
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered 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: Revaccination: - the first revaccination must be carried out one year after the primary vaccination course, - subsequent revaccinations must be carried out at intervals of up to three years for the rhinotracheitis and calicivirosis components.
Danish: Revaccination: - den første revaccination skal foretages et år efter basisvaccinationen, - efterfølgende revaccinationer skal foretages med intervaller på op til tre år for rhinotracheitis og calicivirus komponenterne.
English: Water for injections ..................................................................................................................... q.s.
Danish: Vand til injektion ....................................................................................................................... q.s.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Lyophilisate (10x1 dose) + solvent (10x1 ml) Lyophilisate (50x1 dose) + solvent (50x1 ml)
Danish: Lyofilisat (10x1 dosis) + 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 of 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: Per dose of 1 ml: Lyophilisate:
Danish: 1 dosis (1 ml) indeholder: Lyofilisat:
English: Purevax RC solvent
Danish: Purevax RC solvens.
English: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50 FCV (431 and G1 strains) ............................................................................................... ≥ 2.0 ELISA U.
Danish: FHV (F2 stamme) ............................................................................................................... ≥ 104,9 CCID50 FCV (431 og G1 stammer) ............................................................................................ ≥ 2,0 ELISA U.
English: Inject by subcutaneous route one dose (1 ml) of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Danish: Injicer subkutant en dosis (1 ml) af vaccinen efter opløsning af den frysetørrede pille i solvens, i henhold til følgende vaccinationsprogram:
English: A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Danish: Der kan forekomme lokal reaktion (let smerte ved berøring, kløe eller let hævelse), der vil forsvinde inden for højst 1 til 2 uger.
English: Vaccine against feline viral rhinotracheitis and feline calicivirosis.
Danish: Vaccine mod felin viral rhinotracheitis og felin calicivirus.
English: Where high levels of maternal antibodies against rhinotracheitis or calicivirosis components are expected to be present (e.g. in kittens of 9-12 weeks of age borne 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 eller calicivirus 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: PACKAGE LEAFLET FOR:
Danish: INDLÆGSSEDDEL TIL:
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis and calicivirosis components.
Danish: Varigheden af immunitet efter sidste revaccination er 3 år for rhinotracheitis og calicivirus komponenterne.
English: Shelf life after reconstitution according to directions: use immediately.
Danish: Opbevaringstid efter rekonstituering: anvendes straks.
English: Stimulates active immunity against feline rhinotracheitis herpesvirus and feline calicivirus.
Danish: Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus og felin calicivirus.
English: Do not use in pregnant animals.
Danish: Må ikke anvendes til drægtige dyr.
English: Incompatibilities: Do not mix with Merial adjuvanted vaccine against rabies.
Danish: Uforligeligheder: Må ikke blandes med Merials vaccine med adjuvans mod rabies.
English: EXP (mm/yyyy) Once reconstituted use immediately.
Danish: EXP {MM/ÅÅÅÅ} Anvendes straks efter rekonstituering.
English: Do not mix with Merial adjuvanted vaccine against rabies.
Danish: Må ikke blandes med Merials vaccine med adjuvans mod rabies.
English: Per dose of 1 ml:
Danish: 1 dosis (1 ml) indeholder:
English: No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Danish: Efter administration af flere doser er der ikke iagttaget andre symptomer end de, der er nævnt under ”Bivirkninger”, bortset fra forhøjet temperatur, der i sjældne tilfælde kan vare op til 5 dage.
English: The use is not recommended during lactation.
Danish: Anvendelse er ikke anbefalet under diegivning.
English: Disodium hydrogen orthophosphate Monopotassium phosphate anhydrous
Danish: Dinatriumhydrogenorthophosphat Monokaliumphosphat, vandfrit
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske med solvens.
English: Gentamicin, at most ....................................................................................................................... 16.5 µg
Danish: Gentamycin max............................................................................................................................ 16,5 µg
English: Gentamicin, at most ....................................................................................................................... 16.5 µg Solvent:
Danish: Gentamycin max........................................................................................................................... 16,5 µg Solvens:
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens .................................. ≥ 2.0 ELISA U.
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ...................................... ≥ 2,0 ELISA U.
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.
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme) .......................................... ≥ 104,9 CCID501 Dræbte feline calicivirusantigener (FCV 431 og G1 stammer) ....................................... ≥ 2,0 ELISA U.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate bottle
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske med lyofilisat.
English: Use in healthy animals only.
Danish: Vacciner kun raske dyr.
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis and calicivirus components.
Danish: Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis og calicivirus.
English: Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent.
Danish: Æske indeholdende 50 flasker med 1 dosis lyofilisat og 50 flasker med 1 ml solvens.
English: Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent.
Danish: Æske indeholdende 10 flasker med 1 dosis lyofilisat og 10 flasker med 1 ml solvens.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Pack containing 10 bottles of lyophilisate and 10 bottles of solvent Pack containing 50 bottles of lyophilisate and 50 bottles of solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 10 flasker lyofilisat og 10 flasker solvens
English: Purevax RC lyophilisate and solvent for suspension for injection.
Danish: Purevax RC Lyofilisat og solvens til injektionsvæske, suspension.
English: Lyophilisate:
Danish: Hjælpestoffer:
English: Purevax RC lyophilisate and solvent for suspension for injection
Danish: Purevax RC, lyofilisat og solvens til injektionsvæske, suspension.
English: Excipient:
Danish: Lyofilisat:
English: Date of first authorisation: 14 May 2014
Danish: Dato for første markedsføringstilladelse: 14. maj 2014
English: If you do, your medicine may not work properly.
Danish: Hvis du gør det, vil din medicin muligvis ikke virke rigtigt.
English: Comparison based on historic controls.
Danish: Sammenligning baseret på historiske kontroller.
English: * see section below for further details.
Danish: * Se nedenstående afsnit for yderligere oplysninger.
English: Very common: may affect more than 1 in 10 people:
Danish: Meget almindelig: Kan ramme flere end 1 ud af 10 personer:
English: Alone or in combination with other substitutions (includes mixtures).
Danish: Alene eller i kombination med andre substitutioner (herunder blandinger).
English: Summary of study design
Danish: Resumé af studiedesign
English: * Ketoconazole: pending further ATC classification.
Danish: * Ketoconazol: Afventer yderligere ATC-klassificering.
English: Other double or triple mutations were observed with lower frequencies.
Danish: Andre dobbelt- eller tripelmutationer blev observeret med lavere frekvenser.
English: 6 cells/ml).
Danish: 6 celler/ml).
English: Patients with these combinations are also included in other rows describing the individual substitutions.
Danish: Patienter med disse kombinationer er også inkluderet i andre rækker med beskrivelse af de individuelle substitutioner.
English: - This medicine may pose a risk to the environment.
Danish: - Dette lægemiddel kan udgøre en risiko for miljøet.
English: Following a single oral administration of 200 mg
Danish: Efter en enkelt oral administration af 200 mg
English: Less than 1% of the administered dose was recovered in urine.
Danish: Mindre end 1% af den administrerede dosis blev påvist i urin.
English: - Always take OLYSIO with food.
Danish: - Tag altid OLYSIO sammen med mad.
English: - Try to take OLYSIO at the same time each day.
Danish: - Forsøg at tage OLYSIO på samme tidspunkt hver dag.
English: OLYSIO must not be used in children and adolescents (under 18 years of age) because it has not been studied in this age group.
Danish: OLYSIO må ikke anvendes til børn og unge (under 18 år), da det ikke er blevet undersøgt hos denne aldersgruppe.
English: This is because OLYSIO and other medicines may interact with each other.
Danish: Det skyldes, at OLYSIO og andre lægemidler kan påvirke hinanden.
English: Ribavirin can affect your unborn baby.
Danish: Ribavirin kan påvirke det ufødte barn.
English: Do not drive or use machines if you feel faint or have problems with your vision.
Danish: Du må ikke køre motorkøretøj eller arbejde med maskiner, hvis du føler dig svimmel eller har problemer med dit syn.
English: The expiry date refers to the last day of that month.
Danish: EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: X represents multiple amino acids.
Danish: X repræsenterer flere aminosyrer.
English: Maximum plasma concentrations (Cmax) are typically achieved between 4 to
Danish: De maksimale plasmakoncentrationer (Cmax) opnås typisk mellem 4 og
English: If the capsule shell has been broken or opened, some medicine may be lost and you should take a new capsule.
Danish: Hvis kapselskallen har været brudt eller åbnet, kan noget af medicinen være tabt, og du skal så tage en ny kapsel.
English: Your doctor will test your blood before you start your treatment and regularly during your treatment.
Danish: Din læge vil tage nogle blodprøver, inden du starter på din behandling og derefter regelmæssigt under behandlingen.
English: Two patients had emerging single substitution I170T.
Danish: To patienter havde en opstået enkelt substitution I170T.
English: A course of OLYSIO lasts for either 12 or 24 weeks but you may need to take the other medicines for longer, according to your doctor's instructions.
Danish: En behandling med OLYSIO varer enten 12 eller 24 uger; men det kan være nødvendigt for dig at tage andre lægemidler i længere tid i henhold til din læges anvisninger.
English: Steady-state was reached after 7 days of once daily dosing.
Danish: Steady state blev nået efter 7 dage med dosering én gang dagligt.
English: Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in
Danish: Patienter, der konstateres at have stor risiko for bradyarytmi, bør monitoreres kontinuerligt i 48 timer under
English: Renal clearance plays an insignificant role in its elimination.
Danish: Renal clearance spiller en ubetydelig rolle for elimination.
English: The type of food is not important.
Danish: Typen af mad har ingen betydning for
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin.
Danish: Der er påvist signifikante teratogene og/eller embryoletale virkninger hos alle dyrearter, der blev eksponeret for ribavirin.
English: Cross-resistance is not expected between direct-acting antiviral agents with different mechanisms of action.
Danish: Der forventes ingen krydsresistens mellem direkte virkende antivirale midler med forskellige virkningsmekanismer.
English: There are no adequate and well-controlled studies with simeprevir in pregnant women.
Danish: Der findes ingen tilstrækkelige og velkontrollerede studier af anvendelse af simeprevir til gravide kvinder.
English: 24 weeks N = 31
Danish: 24 uger N = 31
English: Less than 10% Less than 10% Less than 10%
Danish: Under 10%
English: Although causality is difficult to establish due to background advanced liver disease, a potential risk cannot be excluded.
Danish: Selvom det er svært at fastlægge kausaliteten på grund af den underliggende, fremskredne leversygdom, kan en potentiel risiko ikke udelukkes.
English: Ribavirin may cause birth defects and/or death of the exposed foetus.
Danish: Ribavirin kan forårsage fødselsdefekter og/eller dødsfald hos det eksponerede foster.
English: Pregnancy and contraception
Danish: Graviditet og kontraception
English: Do not take OLYSIO if you are allergic to simeprevir or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke OLYSIO hvis du er allergisk over for simeprevir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: These blood tests help your doctor to - check if the treatment is working for you
Danish: Disse blodprøver tages, så din læge bedre kan - kontrollere, om behandlingen virker på dig
English: If you are pregnant, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.