FrancophonIA/ELRC3.0 huggingface dataset:
English: - ≥10% fall from baseline in SpO2 at any point of the assessment; - FEV1 fall from baseline is ≥20% at 240 mg cumulative dose; - FEV1 has fallen 20-<50% (from baseline) at the end of the assessment and does not return to
Danish: En patient defineres som hyperreaktiv overfor inhaleret mannitol og må ikke blive ordineret den terapeutiske dosisplan, hvis de oplever noget af det følgende under den indledende vurdering af dosis: - ≥10 % fald i SpO2 i forhold til baseline på noget tidspunkt i vurderingen - Fald i FEV1 er ≥20 % i forhold til baseline ved 240 mg kumulativ dosis - FEV1 er faldet med 20-<50 % (i forhold til baseline) ved vurderingens afslutning og vender ikke tilbage til <20 % inden for 15 minutter - FEV1 er faldet med ≥50 % (i forhold til baseline) ved vurderingens afslutning
English: Each of the capsules is loaded into the device separately.
Danish: Kapslerne indføres særskilt i inhalatoren.
English: The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Danish: Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol er hæmoptyse.
English: Carcinogenicity studies have not been carried out with inhaled mannitol.
Danish: Der er ikke udført karcinogenicitets studie med mannitol til inhalation.
English: The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Danish: Hos rhDNase-brugerne i studie 301 var den relative ændring i forventet FEV1 % i forhold til baseline over 26 ugers behandling 2,83 (95 % CI -0,62, 6,27).
English: Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol.
Danish: Der er ikke udført reproduktions- og udviklingstoksicitets studie med mannitol til inhalation.
English: Bronchitol is for inhalation use, using the inhaler provided in the pack.
Danish: Bronchitol er til inhalation med den inhalator, som medfølger i pakningen.
English: Hyperresponsive patients should not be prescribed the therapeutic dose regimen of Bronchitol (see section 4.3).The usual precautions regarding bronchial hyperresponsiveness monitoring apply (see section 4.2).
Danish: Hyperreaktive patienter bør ikke ordineres den terapeutiske dosisplan med Bronchitol (se afsnit 4.3).
English: Inhaler device
Danish: Inhalator
English: Do not remove capsules from blister until immediately before use.
Danish: Kapslerne må først tages ud af blisterpakningen umiddelbart før brug.
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment is bronchospasm (see section 4.4).
Danish: Den vigtigste bivirkning i forbindelse med anvendelse af Bronchitol under vurdering af initialdosis er bronkospasme (se pkt.
English: How to use Bronchitol
Danish: Sådan skal du bruge Bronchitol
English: The initiation dose assessment described in section 4.2 should be repeated if uncertainty exists.
Danish: I tvivlstilfælde gentages vurderingen af initialdosis som beskrevet i pkt.
English: While it is drying, use your other inhaler.
Danish: Brug den anden inhalator, mens den tørrer.
English: The safety and efficacy of Bronchitol in children and adolescents aged less than 18 years has not been established (see section 4.2).
Danish: Pædiatrisk population Sikkerhed og virkning af Bronchitol hos børn og unge under 18 år endnu ikke klarlagt (se pkt.
English: Bronchitol 40 mg inhalation powder, hard capsules
Danish: Bronchitol 40 mg inhalationspulver, hårde kapsler
English: Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Danish: Hoste var en almindelig bivirkning, som blev rapporteret i de kliniske studie af Bronchitol (se pkt.
English: Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
Danish: Ikke almindelig Produktiv hoste, irritation i halsen, astma, bronkospasme, fald i forceret eksspiratorisk volumen, rinoré, dyspnø, dysfoni, hyperventilation, obstruktion af luftvejene,
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4).
Danish: Den hyppigst observerede bivirkning i forbindelse med anvendelse af Bronchitol er hoste (se pkt.
English: Take off the cap - Using both hands, hold the inhaler upright and take off the cap.
Danish: Tag hætten af - Hold inhalatoren lodret med begge hænder, og tag hætten af.
English: Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol.If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
Danish: Patienter skal overvåges for bronkial hyperreaktivitet overfor inhaleret mannitol under deres indledende vurdering af dosis før de påbegynder den terapeutiske dosisplan med Bronchitol.
English: The contents of the capsules are inhaled via the inhaler device with one or two breaths.
Danish: Kapslernes indhold inhaleres via inhalatoren to gange dagligt med en til to inhalationer.
English: Refer to package leaflet for inhaler device instructions.
Danish: Læs indlægssedlen for oplysninger om anvendelse af inhalator.
English: Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Danish: Bronchitol 40 mg, inhalationspulver, hårde kapsler mannitol
English: Bronchitol 40 mg, inhalation powder, hard capsules Mannitol
Danish: Bronchitol 40 mg, inhalationspulver, hårde kapsler Mannitol
English: Condition aggravated, Chest discomfort Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia pain, Malaise, Chest pain
Danish: Ikke almindelig Pyreksi, træthed, influenzalignende sygdom, broksmerter, utilpashed, brystsmerter
English: Study DPM-CF-303 was all adult patients.
Danish: Der indgik kun voksne patienter i studie DPM-CF303.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Bronchitol Fortæl altid lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: Post-tussive vomiting, Vomiting Uncommon Nausea, Diarrhoea, Eructation, Flatulence, Gastrooesophageal reflux disease, Glossodynia, Retching, Stomatitis, Abdominal pain upper, Aphthous Stomatitis, Odynophagia
Danish: Posttussiv opkastning, opkastning Ikke almindelig Kvalme, diarré, opstød, flatulens, gastroøsofageal reflukssygdom, glossodyni, kløgning, stomatitis, smerter i øvre abdomen, aftøs stomatitis, odynofagi Hud og subkutane væv Ikke almindelig Akne, koldsved, pruritus, udslæt, kløende udslæt Knogler, led, muskler og bindevæv
English: In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
Danish: I studie DPM-CF-303 (N=423) var den forventede baseline FEV1-procent 63,17 (SD: 15,15) og 62,98 (SD: 13,65).
English: Animal reproduction studies have not been carried out with inhaled mannitol.
Danish: Der er ikke udført reproduktionsStudie med mannitol til inhalation.
English: What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol
Danish: Det skal du vide, før du begynder at bruge Bronchitol Sådan skal du bruge Bronchitol Bivirkninger
English: Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection
Danish: Ikke almindelig Bærer af bakteriel sygdom, bronkitis, bronkopneumoni, lungeinfektion, oral candidiasis, faryngitis, stafylokokinfektion, infektion i øvre luftveje Metabolisme og ernæring Ikke almindelig Nedsat appetit, CF-relateret diabetes, dehydrering Psykiske forstyrrelser
English: Uncommon Bronchitis, Bronchopneumonia, Dysphonia, Hyperventilation, Sputum Discoloured, Throat irritation, Pharyngitis, Upper respiratory tract infection, Bronchospasm, Dyspnoea, Chest pain
Danish: Almindelig Hoste, tilstand forværret, hæmoptyse, orofaryngeale smerter, brystubehag, hvæsende vejrtrækning, astma, produktiv hoste Ikke almindelig Bronkitis, bronkopneumoni, dysfoni, hyperventilation, misfarvet sputum, irritation i halsen, faryngitis, infektion i øvre luftveje, bronkospasme, dyspnø, brystsmerter
English: Cough, Haemoptysis,
Danish: Luftveje, thorax og mediastinum
English: If you use more Bronchitol than you should
Danish: Hvis du har brugt for meget Bronchitol
English: Refer to enclosed leaflet for inhaler device instructions.
Danish: Læs den medfølgende indlægsseddel for oplysninger om anvendelse af inhalator.
English: Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 6: Patients FEV1 is measured 15 minutes post initiation dose.
Danish: Trin 6: Patientens FEV1 måles 15 minutter efter initialdosis
English: Renal or hepatic impairment
Danish: Almindelig Hovedpine Ikke almindelig Svimmelhed
English: Proceed immediately to next step.
Danish: Fortsæt øjeblikkeligt til næste trin.
English: Do not re-freeze under any circumstances.
Danish: Må under ingen omstændigheder fryses igen.
English: Apply the usual aseptic precautions to all administration procedures.
Danish: Anvend sædvanlige aseptiske forholdsregler ved alle administrationsprocedurer.
English: It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Danish: Den bør anvendes umiddelbart efter tilberedningen (al den opløste vaccine skal bruges inden for en time).
English: Repeat the rinsing operation once or twice.
Danish: Gentag denne oprensningsproces en eller to gange.
English: ATCvet code QI01AD15
Danish: ATCvet kode QI01AD15
English: A single vaccination is sufficient to provide protection during the risk period.
Danish: En enkelt vaccination er tilstrækkelig til at yde beskyttelse i hele risikoperioden.
English: The device should be proven to safely and effectively deliver the appropriate dose.
Danish: Apparatet skal være godkendt til sikkert og effektivt at give den korrekte dosis.
English: Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Danish: Dato for første markedsføringstilladelse: 09/08/2002 Dato for seneste fornyelse: 06/07/2012
English: Use immediately after preparation.
Danish: Skal anvendes umiddelbart efter tilberedning.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv nr. 2001/82/EØF, med senere ændringer, kan en medlemsstat forbyde fremstilling, indførsel, besiddelse, salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
English: Day-old chickens and 18 days embryonated eggs.
Danish: Daggamle kyllinger og 18-dages embryonerede æg.
English: Do not use after the expiry date stated on the ampoule.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på ampullen.
English: For active immunisation of chickens:
Danish: Til aktiv immunisering af kyllinger:
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Danish: Imidlertid bør der tages forholdsregler for at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner.
English: This diluent may be used with the following products: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
Danish: Denne opløsning kan anvendes sammen med følgende produkter: Vaxxitek HVT+IBD (EU/2/02/032/001-002)
English: The onset of protection is from 2 weeks and the protection extends to 9 weeks.
Danish: Beskyttelse indtræder efter 2 uger og varer op til 9 uger.
English: Vaccinate only healthy birds.
Danish: Vacciner kun raske fugle.
English: Use sterile and antiseptic-free and/or disinfectant-free equipment for injections purposes.
Danish: Anvend sterilt og antiseptisk - og/eller desinfektionsfrit udstyr til injektion.
English: The onset of protection is from 4 days.
Danish: Beskyttelse indtræder efter 4 dage.
English: 1000 doses 2000 doses
Danish: 1000 doser 2000 doser
English: The instructions for use of this device should be strictly followed.
Danish: Man bør nøje følge apparatets brugsvejledning.
English: ADVICE ON CORRECT ADMINISTRATION Frozen vaccines:
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Frossen vaccine:
English: the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret.
English: Each dose of vaccine contains:
Danish: En vaccinedosis indeholder:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanser), som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: • Remove from the liquid nitrogen container only those ampoules which are to be used immediately.
Danish: • Fjern kun de ampuller fra den flydende kvælstofbeholder, der umiddelbart skal bruges.
English: Safety and reversion to virulence trials have shown that the strain is safe for turkeys.
Danish: Undersøgelser for sikkerhed og reversion til virulens har vist, at stammen er sikker for kalkuner.
English: The vaccine strain is a recombinant Herpesvirus of turkeys (HVT) expressing the protective antigen (VP2) of the Infectious Bursal Disease Virus (IBDV) strain Faragher 52/70.
Danish: Vaccinestammen er et rekombinant herpesvirus fra kalkuner (HVT), der udviser beskyttende antigen (VP2) over for stammen Faragher 52/70 fra infektiøs bursal sygdom virus (IBDV).
English: For in ovo administration, an automated egg injection machine can be used.
Danish: Til in ovo - administration kan man anvende en automatisk injektionsmaskine beregnet til æg.
English: Ampoule carriers are stored in canister, and in liquid nitrogen containers.
Danish: Ampulbeholderne opbevares i tromler og i flydende kvælstofbeholdere.
English: the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: 1 bottle of 200 ml
Danish: 1 flaske à 200 ml
English: Merial Laboratoire Lyon Gerland, 254 rue Marcel Merieux 69007 Lyon
Danish: Merial Laboratoire Lyon Gerland 254 rue Marcel Mérieux 69007 Lyon
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Danish: Laboratoire Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Frankrig
English: For in ovo route:
Danish: Til in ovo administration:
English: • Once the ampoule is opened, draw up the contents into a 5 ml sterile syringe.
Danish: • Når ampullen er åbnet, trækkes indholdet op i en 5 ml steril sprøjte.
English: The active substance being a principle of biological origin intended to active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans, som principielt er af biologisk oprindelse, hvis formål er at producere aktiv immunitet, falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009, når det anvendes som i dette veterinære lægemiddel.
English: The vaccine must be administered by subcutaneous route or by in ovo route.
Danish: Vaccinen skal gives subkutant eller ved in ovo-administration.
English: • To prevent mortality and to reduce clinical signs and lesions of Infectious Bursal disease.
Danish: • For at forebygge dødelighed samt reducere kliniske symptomer og læsioner forårsaget af infektiøs bursal sygdom.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {AMPOULE 1000 and 2000 doses}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER AMPUL 1000 og 2000 doser
English: Casein hydrolysate Phenol red 1% solution Salts
Danish: Opløsning saccharose caseinhydrolysat fenolrødt 1 % opløsning salte
English: Do not mix with any other veterinary medicinal product except those mentioned in the above paragraph and the diluent supplied for use with the product.
Danish: Må ikke blandes med lægemidler til dyr undtaget de nævnte i afsnittet ovenfor samt det opløsningsmiddel, der leveres til brug med dette produkt.
English: Store the vaccine in liquid nitrogen.
Danish: Opbevar vaccinen i flydende kvælstof.
English: • Thaw rapidly the contents of the ampoules by agitation in water at 25°C-30°C.
Danish: • Optø hurtigt ampullernes indhold ved at ryste dem i vand på 25 °C - 30 °C.
English: Do not re-use opened containers of diluted vaccine.
Danish: Åbne beholdere med opløst vaccine må ikke bruges igen.
English: The vaccine induces an active immunity and a serological response against Infectious Bursal Disease and Marek's Disease in chickens.
Danish: Vaccinen inducerer aktiv immunitet og et serologisk respons over for infektiøs bursal sygdom og Marek's sygdom hos kyllinger.
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Merial attenuated vaccines against Newcastle disease and Infectious bronchitis.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan gives samme dag som, men ikke blandet med Merials svækkede vacciner mod Newcastle sygdom og infektiøs bronkitis.
English: For subcutaneous route:
Danish: Til subkutan administration:
English: This is why the vaccine suspension should only be prepared as and when required.
Danish: Derfor bør vaccinesuspensionen kun tilberedes, når det er påkrævet.
English: Live recombinant vaccine against Infectious Bursal Disease and Marek's Disease.
Danish: Levende rekombinant vaccine mod infektiøs bursal sygdom og Marek's sygdom.
English: • Transfer the suspension into the diluent (Do not use if cloudy).
Danish: • Suspensionen overføres til opløsningsmidlet (Må ikke bruges, hvis det er uklart.)
English: • Rinse the ampoule with these 2 ml and then transfer the rinsing liquid into the diluent.
Danish: • Rens ampullen med disse 2 ml og overfør derefter dette indhold til opløsningsmidlet.
English: - (polypropylene) bottle of 200ml of diluent.
Danish: - (Polypropylen)flaske med 200 ml opløsningsmiddel.
English: • Transfer the suspension into the diluent.
Danish: • Suspensionen overføres til opløsningsmidlet.
English: • To reduce mortality, clinical signs and lesions of Marek's disease.
Danish: • For at nedsætte dødelighed, kliniske symptomer og læsioner forårsaget af Marek's sygdom.
English: • The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Danish: • For at være klar til brug opblandes den opløste vaccine, tilberedt som beskrevet, ved rolig omrystning.
English: Name and address of the manufacturers of the biological active substance(s)
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof
English: Suspension and solvent for suspension for injection
Danish: Suspension og solvens til injektionsvæske, suspension
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER
English: Live vHVT013-69 recombinant virus, at least ....................................................... 3.6 to 5.0 log10 PFU* Excipients .................................................................................................................................... qs 1 dose Diluent:
Danish: Levende vHVT013-69 rekombinant virus, min. ..................................................... 3,6 - 5,0 log10 PFU* Hjælpestoffer: ........................................................................................................................... q.s.
English: • As soon as they are thawed, open ampoules holding them at arm's length in order to prevent any risk of injury should an ampoule break.
Danish: • Så snart ampullerne er optøet, skal de åbnes ved at holde dem bort fra kroppen i en arms længde for at forebygge risiko for skade, hvis en ampul skulle gå i stykker.
English: Live vHVT013-69 recombinant virus, at least ......................................................... 3.6 to 5.0 log10 PFU Excipient ...................................................................................................................................... qs 1 dose Diluent:
Danish: Levende vHVT013-69 rekombinant virus, min. ....................................................... 3,6 - 5,0 log10 PFU Hjælpestoffer ............................................................................................................................ q.s.
English: Subcutaneous or in ovo route.
Danish: Subkutan eller in ovo administration.
English: Dimethyl sulfoxide Dilution medium
Danish: Suspension: dimethylsulfoxid fortyndingsmiddel
English: In ovo route: one single injection of 0.05 ml per egg at 18 days of embryonation.
Danish: In ovo administration: En injektion på 0,05 ml pr. æg på 18.dag efter embryonering.
English: Read the package leaflet supplied with the vaccine vial.
Danish: Se indlægssedlen i vaccinepakningen.
English: SC or in ovo route
Danish: s.c. eller in ovo
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial attenuated vaccines against Marek's disease Rispens strain.
Danish: Der foreligger oplysninger om sikkerhed og virkning, som viser, at vaccinen kan blandes med Merials svækkede vacciner mod Marek's sygdom Rispens stamme.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG C. ANGIVELSE AF MRL-VÆRDIER
English: Shelf life of the diluent in polypropylene bottles: 12 months at a temperature below 30°C.
Danish: Opbevaringstid for opløsningsmidlet i polypropylen flasker: 12 måneder ved en temperatur under 30 °C.
English: Shelf life of the reconstituted vaccine: up to 2 hours at a temperature below 25°C.
Danish: Opbevaringstid for den opløste vaccine: op til 2 timer ved en temperatur under 25 °C.