FrancophonIA/ELRC3.0 huggingface dataset:
English: How to take {Paracetamol/Ibuprofen 500 mg/150mg film coated tablets}{Novogesic 500 mg/150 mg film coated tablets}
Danish: Sådan skal du tage {Paracetamol/Ibuprofen 500 mg/150 mg filmovertrukne tabletter}{Novogesic 500 mg/150 mg filmovertrukne tabletter}
English: This medicine is for short term use and is not recommended for use beyond 3 days.
Danish: Lægemidlet er til kortvarig brug og anbefales ikke til brug i mere end 3 dage.
English: For short term use only (not more than 3 days).
Danish: Kun til kortvarig brug (ikke mere end 3 dage).
English: [The wording below should be inserted in this section] - You should not take this product for longer than 3 days.
Danish: [Nedenstående ordlyd skal indsættes i dette afsnit] - Du må ikke tage produktet i mere end 3 dage.
English: Section 6.1 List of excipients [The following phrase is amended]
Danish: Afsnit 6.1 Hjælpestoffer [Følgende sætning er ændret]
English: For oral administration and short term use only (not more than 3 days).
Danish: Kun til oral administration og kortvarig brug (højst 3 dage).
English: [The phrase below should be amended as follows]
Danish: [Følgende ordlyd skal ændres som følger]
English: [The phrase below should be inserted] This medicine is for short term use and is not recommended for use beyond 3 days.
Danish: [Nedenstående sætning skal indsættes] Lægemidlet er til kortvarig brug og anbefales ikke til brug i mere end 3 dage.
English: Hepatic Impairment
Danish: Nedsat nyrefunktion
English: Adults: [The wording below should be inserted in this section] Do not take for more than 3 days.
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN Voksne: [Nedenstående ordlyd skal indsættes i dette afsnit] Må ikke tages i mere end 3 dage.
English: [The following wording should be amended as follows] For oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) [Følgende ordlyd skal ændres som følger] Til oral anvendelse.
English: C. Package Leaflet
Danish: C. Indlægsseddel
English: Ibuprofen [The following phrase is deleted]
Danish: Afsnit 5.3 Prækliniske sikkerhedsdata Ibuprofen [Følgende sætning er slettet]
English: Do not take if you: [The wording below should be inserted in this section]
Danish: Må ikke tages, hvis du: [Nedenstående ordlyd skal indsættes i dette afsnit]
English: This means that it has yet not been possible to obtain complete information about the product.
Danish: Det skyldes, at det endnu ikke har været muligt at skaffe fuldstændige oplysninger om lægemidlet.
English: This summary was last updated in May 2007.
Danish: Dette sammendrag blev sidst ajourført i 05/2007.
English: The vaccine contains a mineral oil.
Danish: Vaccinen indeholder en mineralsk olie.
English: The vaccine will only be used as part of an approved national disease control programme.
Danish: Vaccinen må kun anvendes som led i et godkendt nationalt sygdomsbekæmpelsesprogram.
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Danish: Hvor lang tid skal der gå, før dyret kan slagtes og kødet kan anvendes til menneskeligt forbrug (tilbageholdelsestid)?
English: Due to the current epidemiological situation of avian influenza and the consequent threat to both human and animal health, the Committee recommended the granting of a Marketing Authorisation.
Danish: På grund af den aktuelle epidemiologiske situation med hensyn til fugleinfluenza og den heraf følgende trussel mod menneskers og dyrs sundhed anbefalede udvalget udstedelse af markedsføringstilladelse.
English: This is because control of avian influenza is the responsibility of national veterinary authorities in consultation with the European Commission.
Danish: Dette skyldes, at bekæmpelse af fugleinfluenza hører under de nationale veterinærmyndigheder i samråd med Europa-Kommissionen.
English: The European Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur (EMEA) vil gennemgå alle nye oplysninger, der foreligger i henhold til den fastlagte tidsplan, og ajourfører om nødvendigt dette sammendrag.
English: If you need more information about how this product may be used, you should consult your national veterinary authority.
Danish: Hvis du ønsker yderligere oplysninger om, hvordan dette lægemiddel må anvendes, kan du henvende dig til den nationale veterinærmyndighed.
English: The person who injects the vaccine should be careful to avoid accidental self injection.
Danish: Den, der giver vaccinen, skal være påpasselig med at undgå utilsigtet indsprøjtning i sig selv.
English: This differentiation is important for disease surveillance and control.
Danish: Muligheden for at skelne på denne måde er vigtig for overvågning og bekæmpelse af sygdommen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Nobilis Influenza H7N1 to Intervet International BV on 14/05/2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobilis Influenza H7N1 til Intervet International BV den 14/05/2007.
English: In common with many adjuvanted vaccines swelling may occur at the vaccination site which may last for about 14 days.
Danish: I lighed med mange andre vacciner med adjuvans (forstærkende hjælpestof) kan vaccinen på vaccinationsstedet forårsage hævelse, som kan vare i ca. 14 dage.
English: • The results of the safety studies indicated that the product is safe for chickens and ducks.
Danish: • Resultaterne af sikkerhedsundersøgelserne viser, at lægemidlet er sikkert for kyllinger og ænder.
English: The vaccine was assessed in the context of an emergency situation which means that further studies with Nobilis H7N1 are still ongoing and will be assessed.
Danish: Vaccinen er blevet vurderet i forbindelse med en nødsituation, hvilket betyder, at der stadig pågår yderligere undersøgelser af Nobilis H7N1, som vil blive vurderet.
English: The vaccine is injected intramuscularly (into a muscle) or subcutaneously (under the skin).
Danish: Vaccinen kan enten gives intramuskulært (ved indsprøjtning i en muskel) eller subkutant (ved indsprøjtning under huden).
English: The Committee for Medicinal Products for Veterinary use concluded that the vaccine has been shown to be effective in reducing clinical disease in poultry and could be a useful tool in controlling an outbreak of avian influenza infection.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at vaccinen viser sig effektiv til reducering af klinisk sygdom hos fjerkræ, og at den kan være et nyttigt redskab til bekæmpelse af udbrud af fugleinfluenza.
English: • The vaccine is able to induce antibodies in a wide range of birds.
Danish: • Vaccinen er i stand til at frembringe antistoffer i et bredt udsnit af fuglearter.
English: When it is given to chickens and ducks, the birds' immune system (their natural defence mechanism) makes antibodies (a special type of protein) to fight the disease.
Danish: Når vaccinen gives til kyllinger og ænder, vil fuglens immunsystem (dens naturlige forsvar) danne antistoffer (en særlig type proteiner) for at bekæmpe sygdommen.
English: Nobilis Influenza H7N1 is a vaccine containing an inactivated avian influenza virus H7N1 (inactivated means that the virus has been killed so that it can no longer cause the disease).
Danish: Nobilis Influenza H7N1 er en vaccine, der indeholder en inaktiveret fugleinfluenzavirus H7N1 (inaktiveret vil sige, at virussen er dræbt, så den ikke længere kan forårsage sygdommen).
English: The vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated birds.
Danish: Vaccinen indeholder ikke stoffer, der forventes at udgøre en risiko for mennesker, der indtager de vaccinerede fugle.
English: When compared, the subcutaneous and intramuscular routes were shown to produce the same responses.
Danish: Det blev påvist, at subkutan og intramuskulær indgivelse giver samme virkning.
English: In the future, if the birds are exposed to the avian flu virus, the immune system will be able to make those antibodies quicker and this will help them fight the disease.
Danish: Hvis fuglene senere udsættes for fugleinfluenzavirus, vil deres immunsystem hurtigere kunne producere sådanne antistoffer, der gør dem i stand til at bekæmpe sygdommen.
English: • If the circulating avian influenza field virus has a different N component to the N1 included in the vaccine, it may be possible to differentiate between vaccinated from infected birds by using a diagnostic test to detect Neuraminidase antibodies.
Danish: • Hvis N-komponenten i den fugleinfluenzavirus, der er i omløb, er forskellig fra den N1, der indgår i vaccinen, kan vaccinerede og smittede fugle muligvis skelnes fra hinanden ved en diagnostisk test til påvisning af neuraminidase-antistoffer.
English: This means that vaccinated birds make antibodies against these two antigens.
Danish: Det betyder, at fugle, der er vaccineret med vaccinen, danner antistoffer mod disse to antigener.
English: The virus used for the vaccine carries the H7 (haemagglutinin 7) and N1 (neuramidase 1) antigens.
Danish: Den virus, der anvendes til denne vaccine, bærer antigenerne H7 (hæmagglutinin 7) og N1 (neuraminidase 1).
English: Nobilis Influenza H7N1 is a vaccine used in chickens and ducks to protect against avian influenza.
Danish: Nobilis Influenza H7N1 er en vaccine, der anvendes til at beskytte kyllinger og ænder mod fugleinfluenza.
English: Nobilis Influenza H7N1 has been authorised under “Exceptional Circumstances”.
Danish: Nobilis Influenza H7N1 er godkendt på "særlige vilkår".
English: The company also performed a laboratory study in chickens with a vaccine similar to Nobilis Influenza H7N1.
Danish: Firmaet udførte desuden laboratorieundersøgelser hos kyllinger med en vaccine, der har stor lighed med Nobilis Influenza H7N1.
English: Vaccinated birds can be differentiated identified from infected birds by a diagnostic test for antibodies against the N1 component.
Danish: Vaccinerede fugle kan skelnes fra smittede fugle ved, at de har dannet antistoffer mod N1-komponenten.
English: The company carried out laboratory studies using Nobilis Influenza H7N1 in chickens and ducks.
Danish: Firmaet udførte laboratorieundersøgelser med Nobilis Influenza H7N1 hos kyllinger og ænder.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NOBILIS INFLUENZA H7N1
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) NOBILIS INFLUENZA H7N1 EPAR - sammendrag for offentligheden
English: Nobilis Influenza H7N1 is a vaccine.
Danish: Nobilis Influenza H7N1 er en vaccine.
English: • The vaccine has been shown reduce virus shedding in infected ducks.
Danish: • Det er påvist, at vaccinen nedsætter virusudskillelsen fra smittede ænder.
English: This strain has been chosen because it protects birds against virulent H7 field strains (cross-protection), while allowing differentiation of vaccinated from infected birds.
Danish: Den pågældende virusstamme er valgt, fordi den beskytter fuglene mod de sygdomsfremkaldende H7-feltstammer (krydsbeskyttelse).
English: • The vaccine has been shown to reduce clinical signs and mortality and reduce virus shedding in infected chickens.
Danish: • Det er påvist, at vaccinen mindsker kliniske symptomer og dødsfald og nedsætter virusudskillelsen fra smittede kyllinger.
English: Other information about Nobilis Influenza H7N1:
Danish: Andre oplysninger om Nobilis Influenza H7N1:
English: This vaccine has some of the same ingredients but a different antigen (virus) to Nobilis Influenza H7N1.
Danish: Denne vaccine indeholder nogle af de samme indholdsstoffer som Nobilis Influenza H7N1, men indeholder et andet antigen (virus).
English: The vaccine reduces the signs of flu in chickens and the excretion (shedding) and transmission (spreading) of the virus by the infected chickens and ducks.
Danish: Vaccinen mindsker symptomerne på influenza hos kyllinger og nedsætter kyllingers og ænders virusudskillelse og -overførsel.
English: What is the risk associated with Nobilis Influenza H7N1?
Danish: Hvilken risiko er der forbundet med Nobilis Influenza H7N1?
English: Why has Nobilis Influenza H7N1 been approved?
Danish: Hvorfor blev Nobilis Influenza H7N1 godkendt?
English: What is Nobilis Influenza H7N1?
Danish: Hvad er Nobilis Influenza H7N1?
English: How has Nobilis Influenza H7N1 been studied?
Danish: Hvordan blev Nobilis Influenza H7N1 undersøgt?
English: How does Nobilis Influenza H7N1 work?
Danish: Hvordan virker Nobilis Influenza H7N1?
English: What is Nobilis Influenza H7N1 used for?
Danish: Hvad anvendes Nobilis Influenza H7N1 til?
English: What benefit has Nobilis Influenza H7N1 shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Nobilis Influenza H7N1?
English: MA (EU) number (Invented) name
Danish: MF (EU)-nummer.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, indgivelsesvej, ansøger i medlemsstaterne
English: Pharmaceutical form Route of administration
Danish: Lægemiddelform Indgivelsesvej
English: Belgium Teva Pharma B.V. Computerweg 10
Danish: Rumænien Teva Pharma B.V.
English: Tel.: +800 66838470
Danish: Tlf: +800 66838470
English: The frequency of these ADRs is not known.
Danish: Hyppigheden af disse ADR'er er ikke kendt.
English: Date of first authorisation: 16 July 2001 Date of last renewal: 16 July 2006
Danish: Dato for første markedsføringstilladelse: 16. juli 2001 Dato for seneste fornyelse: 16. juli 2006
English: APC has also been shown to have profibrinolytic effects.
Danish: APC har også vist sig at have profibrinolytiske virkninger.
English: Each pack also contains:
Danish: Hver pakning indeholder desuden:
English: If such a reaction occurs, your doctor will decide on the most appropriate treatment.
Danish: Hvis en sådan reaktion forekommer, vil Deres læge træffe beslutning om den mest passende behandling.
English: In case of shock, the current medical standards for shock treatment are to be observed.
Danish: I tilfælde af shock skal de gældende medicinske standarder for shock behandling følges.
English: However, this has not been observed in the clinical studies to date.
Danish: Dette har imidlertid indtil videre ikke været iagttaget ved kliniske forsøg.
English: The following ADRs have been reported in the post-marketing experience:
Danish: Følgende ADR'er er blevet rapporteret i forbindelse med erfaring postmarketing:
English: Immediate discontinuation of product use is advised.
Danish: Omgående afbrydelse af anvendelsen af produktet anbefales.
English: Do not stop using CEPROTIN without consulting your doctor.
Danish: Hold ikke op med at anvende CEPROTIN uden at konsultere Deres læge.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs hele denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: CEPROTIN with food and drink
Danish: Brug af CEPROTIN sammen med mad og drikke
English: The reports suggest that CEPROTIN is well tolerated in children and small infants.
Danish: Rapporterne tyder på, at CEPROTIN tåles godt hos børn og små børn.
English: In total 6375 administrations of CEPROTIN have been given.
Danish: CEPROTIN er blevet indgivet i alt 6.375 gange.
English: The individual half-lives varied from 4.4 to 15.8 hours using a compartmental model and from 4.9 to 14.7 using the non-compartmental method.
Danish: De individuelle halveringstider varierede fra 4,4 til 15,8 timer ved anvendelse af kompartment model og fra 4,9 til 14,7 timer ved anvendelse af ikke-kompartment metode.
English: It is recommended that you adhere to the dose level and frequency of administration as recommended by your doctor.
Danish: Det anbefales, at De overholder doseringsniveauet og hyppigheden for indgivelse som anbefalet af Deres læge.
English: In case you administered more CEPROTIN than recommended, please inform your doctor as soon as possible.
Danish: I tilfælde af, at De indgiver mere CEPROTIN end anbefalet, oplys venligst Deres læge derom så hurtigt som muligt.
English: A protein C activity of 100 % should be achieved initially and the activity should be maintained above 25 % for the duration of the treatment.
Danish: En protein C aktivitet på 100 % bør opnås initialt, og aktiviteten bør bibeholdes i over 25 % af behandlingens varighed.
English: The wide variation in individual responses implies that the effects of CEPROTIN on coagulation parameters should be checked regularly.
Danish: Den store variation i individuelle svar indebærer, at effekten af CEPROTIN på koagulationsparametrene bør kontrolleres regelmæssigt.
English: • surgery or invasive therapy is imminent
Danish: • kirurgi eller invasiv terapi er umiddelbart forestående
English: If you have APC resistance which is a thromboembolic risk factor present in up to 5 % of the population in Europe your doctor may need to adjust your treatment accordingly.
Danish: Hvis De har APC resistens, som er en thromboembolisk risikofaktor til stede hos op til 5% af Europas befolkning, kan Deres læge have behov for at justere Deres behandling i forhold til dette.
English: Therefore, the benefit of using CEPROTIN during pregnancy or lactation must be judged against the risk for the mother and baby, and should be used only if clearly needed.
Danish: Derfor skal fordelen ved anvendelse af CEPROTIN under graviditet eller amning vurderes over for risikoen for mor og barn og bør kun anvendes, hvis det er klart nødvendigt.
English: No symptoms of overdose with CEPROTIN have been reported.
Danish: Ingen symptomer for overdosering med CEPROTIN har været rapporteret.
English: Patients with HIT should avoid the use of heparin containing drugs in the future.
Danish: Patienter med HIT bør i fremtiden undgå anvendelsen af lægemidler indeholdende heparin.
English: See section 4.4 for information on parvovirus B19 infection.
Danish: 4.4 for oplysninger om parvovirus B19-infektion.
English: In the context of clinical experience several bleeding episodes have been observed.
Danish: I sammenhæng med klinisk erfaring har der været observeret adskillige blødningsepisoder.
English: Patients should be advised to immediately contact their physician if these symptoms occur (see section 4.4).
Danish: Patienter bør rådgives om at kontakte deres læge omgående, hvis disse symptomer forekommer (se pkt.
English: Dosage will vary depending on your condition and your body weight.
Danish: Dosering vil variere afhængig af Deres tilstand og Deres kropsvægt.
English: CIOMS frequency categories: Very Common (>=10%); Common (>=1%<10%),Uncommon (>=0.1% - <1%), Rare (>=0.01% - <0.1%), Very Rare (<0.01%).
Danish: Sjælden CIOMS hyppighedskategorier: Meget almindelig (>=10 %), almindelig (>=1 % - <10 %), ikke almindelig (>=0,1 % - <1%), sjælden (>=0.01% - <0.1%), meget sjælden (<0,01 %).
English: If these symptoms occur, they should inform the physician.
Danish: Hvis disse symptomer forekommer, bør de informere lægen.
English: Furthermore no information on excretion of protein C in the milk is available.
Danish: Endvidere findes der ingen information om udskillelse af protein C i mælk.
English: Pharmacotherapeutic group: group antithrombotic; ATC Code: B01AD12
Danish: Farmakoterapeutisk klassifikation: Klasse Antitrombotisk; ATC Kode: B01AD12
English: Repeated toxicity studies were not conducted because prior experience with coagulation preparations had shown them to be of limited value.
Danish: Gentagne toksicitetsstudier blev ikke udført, fordi tidligere erfaring med koagulations lægemidler har vist, at de er af begrænset værdi.
English: However, several small retrospective and prospective studies investigating other clinical application areas have been published in this population.
Danish: Imidlertid er der publiceret adskillige små retrospektive og prospektive studier, hvor andre kliniske anvendelsesområder er undersøgt.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medecin give bivirkninger, men ikke alle får bivirkninger.
English: After reconstitution the solution has a pH of between 6.7 and 7.3 and an osmolality of not lower than 240 mosmol/kg.
Danish: Efter opløsning har væsken en pH mellem 6,7 og 7,3 og en osmolalitet på ikke lavere end 240 mosmol/kg.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle forligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: No experience in the treatment of patients with renal and/or hepatic impairment is available and therefore it is recommended that such patients be monitored more closely.
Danish: Der findes ingen erfaring med behandling af patienter med nyre og/eller leversvækkelse, og derfor anbefales det, at sådanne patienter overvåges mere nøje.
English: As the tendency for thrombus formation decreases, the frequency may be reduced.
Danish: Efterhånden som tendensen til trombosedannelse falder, kan hyppigheden for indgivelse nedsættes.
English: However, it cannot be completely ruled out that the administration of CEPROTIN further contributed to these bleeding events.
Danish: Imidlertid kan det ikke fuldstændig afgøres, om indgivelse af CEPROTIN er yderligere medvirkende til disse blødningshændelser.
English: The patients differed significantly in age, body weight and plasma volume.
Danish: Patienterne varierede signifikant i alder, legemsvægt og plasmavolumen.
English: Your doctor will decide if CEPROTIN may be used during pregnancy and lactation.
Danish: Lægen vil derefter afgøre, hvorvidt CEPROTIN kan anvendes under graviditet og amning.
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2C til 8C).
English: Subsequently, in the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors.
Danish: Derefter i den initiale fase af behandlingen hæmmes aktiviteten af protein C hurtigere end aktiviteten af prokoagulationsfaktorer.
English: No interactions with other medicinal products are currently known.
Danish: I øjeblikket er der ikke kendskab til nogen interaktioner med andre lægemidler.
English: Talk to your doctor or pharmacist before using CEPROTIN.
Danish: Kontakt lægen eller apoteketspersonalet, før De bruger CEPROTIN.
English: Heparin induced allergic reactions, which can be associated with a rapid decrease of the number of thrombocytes, may be observed (heparin induced thrombocytopenia [HIT]).
Danish: Heparin inducerede allergiske reaktioner, som kan være forbundet med et hurtigt fald i antallet af thrombocytter, kan måske observeres (heparin induceret thrombocytopeni [HIT]).
English: Your physician will take several blood drawings over time to determine how long protein C is remaining in your body.
Danish: Deres læge vil tage adskillige blodprøver med jævne mellemrum for at bestemme, hvor lang tid protein C forbliver i Deres krop.
English: The individual incremental recovery ranged from 0.50 to 1.76 [(IU/dL)/(IU/kg)].
Danish: Den individuelle gradvist stigende genfinding var i intervallet fra 0,50 til 1,76 (IE/dl)/(IE/kg).
English: Each pack also contains one transfer needle and one filter needle.
Danish: Hver pakning indeholder også en overføringskanyle og en filterkanyle.
English: 500 IU and 1000 IU: CEPROTIN powder comes in vials of neutral glass of either hydrolytic type I (500 IU) or hydrolytic type II (1000 IU).
Danish: 500 IE og 1000 IE: CEPROTIN pulver leveres i hætteglas af neutralt glas af enten hydrolytisk type I (500 IE) eller hydrolytisk type II (1000 IE).
English: If HIT is suspected, the number of thrombocytes should be determined immediately and if necessary therapy with CEPROTIN should be stopped.
Danish: Hvis der er mistanke om HIT, bør antallet af thrombocytter omgående bestemmes, og hvis det er nødvendigt, bør behandlingen med CEPROTIN stoppes.