FrancophonIA/ELRC3.0 huggingface dataset:
English: t = 10 minutes The Pylobactell tablet is placed in the 30 ml mixing vial and water added to the marked line.
Danish: Pylobactell-tabletten anbringes i 30 ml blandeglasset, og der hældes vand på til mærket.
English: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Ireland.
Danish: Torbet Laboratories Ireland Ltd, 20 Holles Street, Dublin 2, Irland.
English: C for 20 replicate analyses of the same reference gas sample and remain within 3SD's of the mean for breath analyses.
Danish: Intern analytisk præcision skal være under +/- 0,3 ‰ d13C for 20 gentagne analyser af samme referencegasprøve og skal forblive inden for 3SD'er af gennemsnittet for UBT-analysen.
English: C-Urea breath test, for one of the following reasons:
Danish: Deres læge har anbefalet, at De får taget en 13C-urea-udåndingsprøve af en af følgende grunde:
English: Do not store the kit above 25°C.
Danish: Udstyret må ikke opbevares over 25°C.
English: HOW TO USE PYLOBACTELL
Danish: SÅDAN SKAL DE BRUGE PYLOBACTELL
English: Drink the recommended test meal.
Danish: Prøvemåltid: Drik det anbefalede prøvemåltid.
English: Povidone (E1201), Microcrystalline Cellulose (E460i), Colloidal Anhydrous Silica, Sodium Benzoate (E211).
Danish: Povidon (E1201), mikrokrystallinsk cellulose (E460i), silica, kolloid, vandfri og natriumbenzoat (E211).
English: If fasting is a problem e.g. for diabetic patients, please tell your doctor, pharmacist or nurse.
Danish: Hvis det er et problem for Dem at faste (f.eks. hvis De har sukkersyge), bør De fortælle det til Deres læge, apotekspersonalet eller sundhedspersonalet.
English: If you cannot take the recommended test meal, an alternative test meal should be taken.
Danish: Hvis De ikke kan tåle det anbefalede prøvemåltid, vil Deres læge rådgive Dem om et alternativt prøvemåltid.
English: Marketing Authorisation Holder: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland
Danish: Indehaver af markedsføringstilladelsen: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Irland
English: All foods contain a substance called carbon 13 (
Danish: Alle fødevarer indeholder et stof, der hedder kulstof-13 (13C), i forskellige mængder.
English: MEDICATION RECORD
Danish: MEDICINJOURNAL
English: Pylobactell is a breath test for determining the presence of the bacterium, Helicobacter pylori (H. pylori) in the gut (stomach and adjacent bowel) which may be the reason for your stomach (gastric) condition.
Danish: Den anvendes til at påvise tilstedeværelsen af bakterien Helicobacter pylori (H. pylori) i tarmene (maven og den tilstødende tarm).
English: • You have taken proton pump inhibitors in the last 14 days
Danish: • hvis De har taget protonpumpehæmmere (mod fordøjelsesbesvær) inden for de seneste 14 dage.
English: Alternative diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, eg.
Danish: Alternativ diagnose med invasive endoskopimetoder kan være indiceret for at undersøge forekomsten af evt. andre komplikationer, f.eks. mavesår, autoimmun gastritis og maligniteter.
English: A sachet containing one Pylobactell 100 mg soluble tablet.
Danish: En pose med én Pylobactell 100 mg opløselig tablet.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, De er i tvivl om.
English: 07 May 2008
Danish: Dato for første markedsføringstilladelse: 07 maj 1998 Dato for seneste fornyelse: 07 maj 2008
English: Analysis Request Form
Danish: Formular til rekvisition af analyse
English: If H. pylori is present and active in your stomach, these bacteria will break down the
Danish: Hvis der findes aktive H. pylori i Deres mave, vil disse bakterier nedbryde 13C-urea, og dette vil blive påvist i Deres udåndede kuldioxid.
English: ANALYSIS REQUEST FORM - Please complete in block capitals Please state clearly address for return of results:
Danish: FORMULAR TIL REKVISITION AF ANALYSE - Skriv venligst med blokbogstaver
English: These samples will be analysed to measure the normal amount of
Danish: Disse prøver vil blive analyseret for at måle den normale mængde af 13C i Deres udåndede kuldioxid.
English: Pylobactell 100mg soluble tablet C-Urea
Danish: Pylobactell 100 mg opløselig tablet 13C-urea
English: If you have eaten a heavy meal it will be necessary to fast for six hours before the test. You can drink water during the fasting period.
Danish: Hvis De har indtaget et stort måltid, er De nødt til at faste i seks timer inden prøven.
English: Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: t = 40 Collect Post-Urea samples (Red Caps - 3 times).
Danish: Opsaml post-urea-prøverne (røde hætter, 3 gange).
English: Samples logged on by :
Danish: Prøver logget ind af:
English: In the case of infection with H.pylori, orally ingested 13C-urea is metabolised by the enzyme urease which is present in H.pylori.
Danish: Farmakoterapeutisk klassifikation: Andre diagnostiske midler, ATC-kode: V04CX I tilfælde af infektion med H. pylori omsættes det oralt indtagne 13C-urea af enzymet urease, som findes i H. pylori.
English: C-urea - The other ingredients are povidone (E1201), microcrystalline cellulose (E460i), colloidal anhydrous silica and sodium benzoate (E211).
Danish: Hver tablet indeholder 100 mg 13C-urea Øvrige indholdsstoffer: Povidon (E1201), mikrokrystallinsk cellulose (E460i), silica kolloid, vandfri og natriumbenzoat (E211).
English: ADDITIONAL KIT ITEM: MIXING AND ADMINISTRATION VIAL
Danish: YDERLIGERE UDSTYR TIL SÆTTET: BLANDE- OG DRIKKEGLAS
English: • Analysis Request Form.
Danish: • 1 formular til rekvisition af analyse.
English: Batch
Danish: Check
English: One tablet contains: 100 mg
Danish: Én tablet indeholder: 100 mg 13C-urea
English: These breath samples are used to measure the natural level of
Danish: Disse prøver af udåndingsluft anvendes til at måle det naturlige niveau af 13C i udåndingsluftens kuldioxid.
English: C-urea or to any of the other ingredients of this medicine (listed in Section 6).
Danish: Brug ikke Pylobactell - hvis De er allergisk over for 13C-urea eller et af de øvrige indholdsstoffer (angivet i afsnit 6).
English: What Pylobactell is and what it is used for What you need to know before you use Pylobactell How to use Pylobactell
Danish: Det skal De vide, før De begynder at bruge Pylobactell Sådan skal De bruge Pylobactell Bivirkninger
English: Pre-test Breath Samples (3 White Capped Tubes)
Danish: Opsaml præ-urea-prøverne (hvide hætter, 3 gange).
English: Sampling instructions t = 0 minutes Note the time the patient drinks the test meal.
Danish: Nedskriv det tidspunkt, hvor patienten drikker prøvemåltidet.
English: One tablet
Danish: Én indlægsseddel
English: Date of Birth:
Danish: Modtagelsesdato:
English: 30 ml mixing and administration glass vial with cap. Two straws.
Danish: Ét 30 ml blande- og drikkeglas med hætte.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er De i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet.
English: t = 40 minutes Collect post-urea (red top) breath samples.
Danish: Opsaml post-urea-prøverne (rød hætte) af udåndingsluft.
English: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland Tel. +44 (0)1953 607856
Danish: Indehaver af markedsføringstilladelsen Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Irland Tlf.: +44 (0)1953 607856 Fax: +44 (0)1953 713649 E-mail: enquiries@torbetlaboratories.co.uk Fremstiller Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Spanien.
English: Torbet Laboratories Ireland Limited
Danish: Torbet Laboratories Ireland Limited 20 Holles Street
English: C = Negative
Danish: t = 40
English: Pylobactell, 100 mg, Soluble Tablet
Danish: LÆGEMIDLETS NAVN Pylobactell 100 mg opløselig tablet
English: 13C-urea
Danish: Klargøring af 13C-urea-opløsningen
English: C - carbon isotope ratio.
Danish: kulstofisotopforholdet.
English: Other medicines and Pylobactell
Danish: INFORMATION I BRAILLESKRIFT Pylobactell
English: M.A.
Danish: A.
English: C-urea solution in your stomach.
Danish: Dette vil hjælpe med at holde 13C-urea-prøvevæsken nede i Deres mave.
English: Three tubes of breath are to be taken, which are used to measure the presence of excess levels of
Danish: Der skal tages tre prøver af udåndingsluft, som anvendes til at måle forekomsten af for store niveauer af 13C, som findes, hvis patienten er H. pylori positiv.
English: Laboratory use only Date received:
Danish: Følgende oplysninger er kun beregnet til laboratoriebrug:
English: Analysis Request Form.
Danish: Én formular til rekvisition af analyse.
English: Date of Test:
Danish: Anvisninger for prøvetagning:
English: C-UBT) for Helicobacter pylori
Danish: Pylobactell 13C (kulstof-13) - UREA UDÅNDINGSPRØVE (13C-UBT) for Helicobacter pylori
English: Patient Reference:
Danish: Oversigt over indlægssedlen:
English: Safely discard the 30 ml mixing vial.
Danish: Kassér 30 ml blandeglasset på en forsvarlig måde.
English: Medicinal product subject to medical prescription
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel.
English: If so, please indicate when treatment ended t = 10 Patient to drink urea solution, then fill bottle to line again and drink.
Danish: Patienten skal drikke ureaopløsningen, fylde flasken til stregen igen og så drikke igen.
English: Povidone (E1201) Microcrystalline Cellulose (E460i) Colloidal Anhydrous Silica Sodium Benzoate (E211)
Danish: Cellulose, mikrokrystallinsk (E460i)
English: t = 5 minutes Collect pre-urea breath samples.
Danish: Opsaml præ-urea-prøverne af udåndingsluft.
English: Manufacturer
Danish: OPBEVARING
English: If so, please indicate type and when last taken t = 0 Note time patient drinks test meal
Danish: I så fald angiv venligst typen, og hvornår de sidst blev taget.
English: Each tablet contains 100 mg of
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver opløselige tablet indeholder 100 mg 13C-urea
English: iv.
Danish: D.
English: may lead to shock.
Danish: kan føre til chok.
English: In such cases, the western blot method is negative.
Danish: I sådanne tilfælde er Western Blot-metoden negativ.
English: Therefore, hypersensitivity reactions may occur.
Danish: Derfor kan der forekomme hypersensitivitetsreaktioner.
English: • pain in arms and/or legs (in the majority of cases reported as pain in the vaccination arm)
Danish: • smerte i arme og/eller ben (i størstedelen af tilfældene rapporteret som smerte i den vaccinerede arm)
English: Tell the doctor requesting the test that you have recently received VEPACEL.
Danish: Fortæl den læge, der ønsker testen, at du for nylig har fået VEPACEL.
English: You should tell your doctor before vaccination: - if you have a severe infection with a high temperature (over 38°C).
Danish: Før vaccinationen bør du fortælle din læge: - hvis du har en alvorlig infektion med høj temperatur (over 38 °C).
English: 4.8 Undesirable effects a) Summary of safety profile
Danish: 4.8 Bivirkninger a) Oversigt over sikkerhedsprofilen
English: See section 6.6 for administration instructions.
Danish: Se afsnit 6.6 for administration instruktioner.
English: The use of this vaccine should be in accordance with official recommendations.
Danish: Brugen af denne vaccine bør være i overensstemmelse med de officielle anbefalinger.
English: Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Danish: Læger er klar over denne risiko og har akut behandling klar til brug i sådanne tilfælde.
English: However, chemical and physical in-use stability has been demonstrated for 3 hours at room temperature.
Danish: Der er dog påvist kemisk og fysisk stabilitet i op til 3 timer ved stuetemperatur.
English: other paediatric Population
Danish: andre pædiatriske Populationer
English: When a person is given the vaccine, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease.
Danish: Når en person får indgivet vaccinen, producerer immunsystemet (kroppens naturlige forsvarssystem) sin egen beskyttelse (antistoffer) mod sygdommen.
English: Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du vaccineres, da den indeholder vigtige oplysninger.
English: OTHER Ology Bioservices Ireland Ltd Logo
Danish: ANDET Ology Bioservices Ireland Ltd logo
English: No data is available on the safety and efficacy of VEPACEL in children younger than 6 months of age.
Danish: Der findes ingen data på sikkerhed og effekt af VEPACEL hos børn yngre end 6 måneder.
English: The immunological response may be diminished if the patient is undergoing treatment with immunosuppressants.
Danish: Det immunologiske respons kan nedsættes, hvis patienten er i behandling med immunosuppressiva.
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice if you should receive VEPACEL.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, om du skal have VEPACEL.
English: VEPACEL is a vaccine for use in individuals aged 6 months and older.
Danish: VEPACEL er en vaccine, som anvendes til personer i alderen fra 6 måneder og derover.
English: In case of any particles and/or abnormal appearance, the vaccine should be discarded.
Danish: I tilfælde af partikler og/eller unormalt udseende skal vaccinen kasseres.
English: A minor infection such as a cold should not be problem, but your doctor should advise whether you could still be vaccinated with VEPACEL.
Danish: En mindre infektion som en forkølelse bør ikke være noget problem, men din læge vil vejlede dig med hensyn til, om du kan vaccineres med VEPACEL.
English: Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world.
Danish: Pandemisk influenza er en type influenza, der kommer med et par årtiers mellemrum og hurtigt spredes verden over.
English: These antigens can be considered as ‘novel' antigens and simulate a situation where the target population for vaccination is immunologically naïve.
Danish: Disse antigener kan betegnes som ”nye” antigener og simulerer en situation, hvor målpopulationen for vaccination er immunologisk naive.
English: Prompt analysis of cumulative safety information, in light of extent of exposure, will be crucial for regulatory decisions and protection of the population to be vaccinated.
Danish: Hurtig analyse af kumulerede sikkerhedsoplysninger set i lyset af omfanget af eksponering er afgørende for myndighedernes beslutning og beskyttelse af den population, der skal vaccineres.
English: Such reactions have occurred both in patients with a history of multiple allergies and in patients with no known allergy.
Danish: Sådanne reaktioner opstod både hos patienter med en forhistorie af flere allergier og patienter uden kendt allergi.
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: However, in a pandemic situation, it may be appropriate for you to have the vaccine, provided that appropriate medical treatment is immediately available in case of an allergic reaction.
Danish: Under en pandemi kan det være relevant for dig at få indgivet vaccinen under forudsætning af, at en passende medicinsk behandling er umiddelbart tilgængelig i tilfælde af en allergisk reaktion.
English: 21 Days after 2nd Dose
Danish: 21 dage efter 2. dosis
English: Your doctor or nurse will administer the vaccine in accordance with official recommendations.
Danish: Din læge eller sygeplejerske vil give vaccinen i overensstemmelse med officielle anbefalinger.
English: If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with VEPACEL, the result of the test may not be correct.
Danish: Hvis du skal have taget en blodprøve for at se efter tegn på infektion med visse vira i de første par uger efter vaccination med VEPACEL, er resultatet af denne test muligvis ikke korrekt.
English: Healthcare providers should carefully consider the potential risks and benefits for each specific patient before prescribing VEPACEL.
Danish: De potentielle risici og fordele bør nøje vurderes for hver enkelt patient, inden ordination af VEPACEL.
English: - The other ingredients are Trometamol
Danish: - Øvrige indholdsstoffer: Trometamol
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i punkt 4, hvordan du indberetter bivirkninger
English: - if you have a bleeding problem or bruise easily.
Danish: - hvis du har et problem med blødninger eller let får blå mærker.
English: It is intended to be given before the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Danish: Den skal gives før den næste influenzapandemi for at forhindre influenza, der er forårsaget af virustypen H5N1.
English: The symptoms of pandemic flu are similar to those of an ordinary flu but are usually more severe.
Danish: Symptomerne på pandemisk influenza er de samme som ved en 'almindelig' influenza, men er normalt alvorligere.
English: In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
Danish: Du skal i alle disse tilfælde FORTÆLLE DET TIL DIN LÆGE ELLER SYGEPLEJERSKE, da vaccination måske ikke anbefales eller skal udsættes.
English: NAME OF THE MEDICINAL PRODUCT VEPACEL
Danish: LÆGEMIDLETS NAVN VEPACEL
English: Immunisation shall be postponed in patients with severe febrile illness or acute infection.
Danish: Immunisering af patienter med alvorlig febril sygdom eller akut infektion skal udsættes.
English: • severe stabbing or throbbing pain along one or more nerves
Danish: • alvorlig stikkende eller dunkende smerte langs en eller flere nerver
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Danish: Antistofdannelse hos patienter med endogen eller iatrogen immunosuppression kan være utilstrækkelig.
English: Very Rare (<1/10,000)
Danish: Meget sjælden (<1/10.000)
English: PSUR submission when VEPACEL is used during an influenza pandemic:
Danish: PSUR-indsendelse, når VEPACEL bruges under en influenzapandemi:
English: One dose of 0.5 ml at an elected date.
Danish: En dosis 0,5 ml på en valgt dato.
English: Immunoglobulin is not to be given with VEPACEL unless it is necessary during a medical emergency to provide immediate protection.
Danish: Der må ikke gives immunoglobulin sammen med VEPACEL, medmindre det er nødvendigt i nødstilfælde for at give umiddelbar beskyttelse.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Danish: Disse forbigående falsk positive resultater kan skyldes et IgM-induceret respons på vaccinen.
English: Allergic reactions, in rare cases leading to shock, have been reported.
Danish: Der er rapporteret om allergiske reaktioner, der i sjældne tilfælde fører til chok.
English: In consequence, as soon as the pandemic is declared and the prepandemic vaccine is used, the MAH shall submit more frequent simplified periodic safety update reports with a format and a periodicity defined in the "CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context" (EMEA/49993/2008), and any subsequent update.
Danish: Som en konsekvens heraf skal indehaveren af markedsføringstilladelsen, så snart en pandemi er erklæret og pandemivaccinen anvendt, med hyppige mellemrum indsende en simplificeret PSUR, hvis format og frekvens er anført i ”CHMP Recommendations for the Core Risk Management Plan for Influenza Vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context” (EMEA/49993/2008 og tilhørende opdateringer.
English: As with all vaccines, VEPACEL may not fully protect all persons who are vaccinated.
Danish: Som ved alle vacciner beskytter VEPACEL ikke nødvendigvis alle personer, som er vaccineret.
English: The safety profile in immunocompromised subjects and patients with chronic disease conditions is similar to the safety profile in healthy adults and older people.
Danish: Sikkerhedsprofilen hos immunokompromitterede personer og patienter med kroniske sygdomme er den samme som sikkerhedsprofilen hos raske voksne og ældre personer.
English: Active immunisation against H5N1 subtype of influenza A virus.
Danish: Aktiv immunisering mod subtype H5N1 af influenza-A-virus.
English: 12 Month Booster
Danish: 12 måneders booster
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Danish: En 12 til 24 måneders heterolog booster er også blevet administreret i et fase 3-studie med immunokompromitterede personer og patienter med kroniske sygdomme.
English: During a pandemic situation, the frequency of submission of periodic safety update reports specified in Article 24 of Regulation (EC) No 726/2004 will not be adequate for the safety monitoring of a pandemic vaccine for which high levels of exposure are expected within a short period of time.
Danish: Under en pandemi er den frekvens for indsendelse af PSUR, som er nævnt i artikel 24 i EU's forordning nr. 726/2004, ikke tilstrækkelig til monitorering af sikkerheden af en pandemisk vaccine, hvor patienterne forventes at blive udsat for høj eksponering i løbet af kort tid.
English: The most frequently occurring side effect was injection- site pain, which was usually mild.
Danish: Den hyppigste bivirkning var smerter på injektionsstedet, og disse var som regel lette.
English: Side effects observed with flu vaccines given routinely every year In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side effects listed below have occurred.
Danish: Bivirkninger, der er iagttaget med influenzavacciner, der gives rutinemæssigt hvert år I dagene eller ugerne efter vaccination med vacciner, der gives rutinemæssigt hvert år for at forhindre influenza, er nedenstående bivirkninger forekommet: Disse bivirkninger kan forekomme med VEPACEL.
English: If you take any medicines that reduce immunity to infections or have any other type of treatment that affects the immune system (such as radiotherapy), VEPACEL can still be given but your response to the vaccine may be poor.
Danish: Hvis du tager medicin, der nedsætter immuniteten over for infektioner, eller du får en anden type behandling (som strålebehandling), der påvirker immunforsvaret, kan VEPACEL stadig gives, men din respons på vaccinen kan være ringe.
English: The vaccine contains 10 doses of 0.5 ml.
Danish: Vaccinen indeholder 10 doser på 0,5 ml.
English: This section describes the clinical experience with the H5N1 vaccine.
Danish: Dette afsnit beskriver den kliniske erfaring med H5N1-vaccinen.