natgillin/translations-raw huggingface dataset:
• diarré, opkastning, mavesmerter, en følelse af at være oppustet, mavebesvær, forstoppelse, vægttab • hovedpine, svimmelhed, unormal smagsfornemmelse, søvnighed, problemer med at sove, unormal følelse i kroppen som prikken og stikken • udslæt, kløe, muskeltrækninger, rygsmerter, følelse af svaghed, hoste • forhøjede værdier, som bruges til bestemmelse af leverfunktionen.
• diarrhoea, being sick (vomiting), stomach ache, feeling bloated, indigestion, constipation, weight loss • headache, dizziness, abnormal sense of taste, sleepiness, problems sleeping, abnormal sensations in the body such as pins and needles • rash, itching, muscle spasms, back pain, feeling weak, cough • increased levels of substances that measure the function of the liver and pancreas.
Dette kan ses i blodprøveresulater og kan være tegn på nedsat funktion eller skade på disse organer.
These can be seen in the results of blood tests and can be a sign of reduced function or damage of these organs.
Kontakt lægen, hvis De får symptomer som nedsat appetit, kvalme/ opkastning og/ eller gulfarvning af huden og det hvide i øjnene.
If you experience symptoms, such as loss of appetite, feeling sick/ being sick and/ or yellowing of skin or eyes, you should inform your doctor.
Ikke almindelige bivirkninger (det forekommer hos færre end 1 ud af 100 patienter) omfatter:
Uncommon side effects (likely to occur in fewer than 1 in 100 patients) include:
• nedsættelse i antallet af hvide og røde blodlegemer, hævede lymfekirtler, hjerteanfald, nedsat blodgennemstrømning i hjertet • betændelse i bugspytkirtlen, blødning fra endetarmen, leverproblemer, muskelømhed og smerter • besvimelse, epilepsi, krampeanfald, ude af stand til at bevæge musklerne i ansigtet, prikkende og brændende fornemmelse i hænder og fødder, manglende reflekser, hallucinationer • nyresvigt, dannelse af mere urin end normalt • lungebetændelse, vejrtrækningsbesvær såsom kortåndethed.
• reduction in number of white and red blood cells, enlarged lymph glands, heart attack, reduced blood flow to the heart • inflammation of the pancreas, rectal bleeding, liver disease, muscle aches and pains • fainting, epilepsy, fits, inability to move the muscles in the face, tingling or burning sensation in the hands or feet, loss of reflexes, hallucination • kidney failure, producing more urine than normal • pneumonia, breathing difficulties such as shortness of breath.
Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
OPBEVARING
HOW TO STORE CELSENTRI
• Brug ikke CELSENTRI efter den udløbsdato, der står på kartonen, blister eller etiketten på beholderen.
• Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label.
• Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
60 • This medicine does not require any special storage conditions.
CELSENTRI indeholder:
What CELSENTRI contains
Tabletkerne: cellulose, mikrokrystallinsk; calciumhydrogenphosphat, vandfrit; natriumstivelsesglycolat, magnesiumstearat
Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate
Filmovertræk: polyvinylalkohol; titandioxid (E171); macrogol 3350; talcum; sojalecithin; indigocarmin (E132).
Film-coat: poly (vinyl alcohol), titanium dioxide, macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).
Udseende og pakningstørrelser
What CELSENTRI looks like and contents of the pack
CELSENTRI filmovertrukne tabletter er blå med ” Pfizer ” på den ene side og ” MVC 150 ” eller ” MVC300 ” på den anden side.
CELSENTRI film-coated tablets are blue coloured with “ Pfizer” on one side and “ MVC 150” or “ MVC 300” on the other.
CELSENTRI 150 mg og 300 mg filmovertrukne tabletter findes i beholdere med 180 tabletter eller i blisterpakning med 30, 60, 90 filmovertrukne tabletter og multipakning med 180 (2 pakninger med 90) filmovertrukne tabletter.
CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film-coated tablets.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Storbritannien.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
Gödecke GmbH (a pharma plant of Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Tyskland.
Gödecke GmbH (a pharma plant of Pfizer GmbH), Mooswaldallee 1, 79090 Freiburg, Germany.
Hvis De vil have yderligere oplysninger om CELSENTRI, skal De henvende Dem til den lokale repræsentant:
61 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
65 Deutschland Pfizer Pharma GmbH Tel: +49 30 550055 51000
Deutschland Pfizer Pharma GmbH Tel: +49 (0)30 550055 51000
Ireland Pfizer Healthcare Ireland Tel: +1800 633 363
1 800 633 363
Latvija Pfizer Luxembourg SARL Filiāle Latvijā Tel: + 371 670 35 775 Lietuva Pfizer Luxembourg SARL, filialas Lietuvoje Tel: +3705 2514000
Latvija Pfizer Luxembourg SARL Filiā le Latvijā Tel: + 371 670 35 775
De kan finde yderligere information om CELSENTRI på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/.
Celvapan er en vaccine, der gives som injektion.
Celvapan is a vaccine that is given by injection.
Celvapan indeholder influenzastammen A/ VietNam/ 1203/ 2004 (H5N1).
Celvapan contains a flu strain called A/ VietNam/ 1203/ 2004 (H5N1).
Celvapan er en vaccine til forebyggelse af influenzapandemi.
Celvapan is a vaccine to prevent ‘ pandemic’ flu.
Det er en vaccine, der kun må bruges, når Verdenssundhedsorganisationen eller Den Europæiske Union officielt har erklæret, at der er udbrudt en pandemi.
It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
En influenzapandemi kan bryde ud, når der opstår en ny type (stamme) af en influenzavirus, der let smitter fra menneske til menneske, fordi mennesker ikke er immune over for den.
A flu pandemic happens when a new type (strain) of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it.
Celvapan vil da blive udleveret i henhold til officielle anbefalinger.
Celvapan would be given according to official recommendations.
Celvapan er blevet undersøgt hos voksne, herunder også ældre over 60 år.
Celvapan has been studied in adults, including the elderly (above 60 years of age).
Celvapan gives ved injektion i skuldermusklen i to doser med mindst tre ugers mellemrum.
Celvapan is given by injection into the shoulder muscle in two doses, at least three weeks apart.
Celvapan er en "modelvaccine".
Celvapan is a ‘ mock-up’ vaccine.
En modelvaccine er en særlig vaccinetype, der medvirker til at kontrollere en pandemi.
This is a special type of vaccine that is designed to help with the management of a pandemic.
Vaccinen kan derfor ikke fremstilles på forhånd.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
I stedet kan virksomhederne fremstille en vaccine med en influenzavirusstamme, der specifikt udvælges, fordi ingen personer har været udsat for smitte med den, og ingen er immune over for den.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Virksomhederne kan afprøve vaccinen på mennesker for at se, hvordan de reagerer på den.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
Derved kan det forudsiges, hvordan mennesker vil reagere på en vaccine med den influenzastamme, der er årsag til en pandemi.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Vacciner fungerer ved at lære kroppens naturlige forsvar (immunsystemet), hvordan det forsvarer sig mod en sygdom.
Celvapan contains a virus called H5N1 that has been inactivated (killed) so that it does not cause any disease.
Celvapan indeholder en virus kaldet H5N1, som er blevet inaktiveret (dræbt), så den ikke længere forårsager sygdom.
If a pandemic starts, the virus strain in Celvapan will be replaced by the strain causing the pandemic before the vaccine can be used.
Hvis pandemien bryder ud, skal virusstammen i Celvapan erstattes af den stamme, der er årsag til pandemien, før vaccinen kan bruges.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘ foreign’ and makes antibodies against it.
De vira, der anvendes i Celvapan, dyrkes i pattedyrceller i modsætning til andre influenzavacciner, der dyrkes i hønseæg.
The viruses used in Celvapan are grown in mammal cells (‘ vero cells’), unlike those in some other flu vaccines, which are grown in hen ’ s eggs.
Virkningerne af Celvapan blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Celvapan were first tested in experimental models before being studied in humans.
Hovedundersøgelsen med Celvapan omfattede 561 frivillige, hvoraf 281 var over 60 år.
The main study of Celvapan included 561 healthy volunteers, 281 of whom were over the age of 60 years.
Undersøgelsen så nærmere på Celvapans evne til at udløse dannelse af antistoffer (den immunogene virkning), når det blev givet i doser på 7, 5 mikrogram.
The study looked at the ability of two 7.5-microgram doses of Celvapan, given 21 days apart, to trigger the production of antibodies (‘ immunogenicity’). The main measures of effectiveness were the levels of antibodies against the flu virus in the blood before vaccination, on the day of the second injection (day 21), and 21 days after the second vaccination (day 42).
Ifølge de kriterier, der er fastlagt af Udvalget for Humanmedicinske Lægemidler (CHMP), skal en modelvaccine frembringe en beskyttende mængde antistoffer hos mindst 70% af de vaccinerede, for at den anses for egnet.
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
I undersøgelsen udløste Celvapan en antistofrespons, der opfylder disse kriterier.
The study showed that Celvapan produced an antibody response that met these criteria.
21 dage efter den anden injektion havde 72% af de voksne under 60 år (192 ud af 265) og 74% af dem over 60 år (200 ud af 270) dannet nok antistoffer til at være beskyttet mod H5N1.
At 21 days after the second injection, 72% of the adults below 60 years of age (192 out of 265) and 74% of those above 60 years of age (200 out of 270) had levels of antibodies that would protect them against H5N1.
De mest almindelige bivirkninger ved Celvapan (der ses hos mere end 1 ud af hver 10 vaccinerede) er smerter på injektionsstedet.
The most common side effect with Celvapan (seen in more than 1 people vaccinated in 10) is pain at the site of the injection.
Den fuldstændige liste over alle de indberettede bivirkninger ved Celvapan fremgår af indlægssedlen.
For the full list of all side effects reported with Celvapan, see the Package Leaflet.
Celvapan må ikke gives til personer, der har haft en anafylaktisk reaktion (svær overfølsomhedsreaktion) over for en af vaccinens komponenter eller over for et af de sporstoffer, den indeholder (meget lavt), f. eks. formaldehyd, benzonase eller sukrose.
Celvapan should not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
I tilfælde af en pandemi kan det dog være hensigtsmæssigt alligevel at vaccinere sådanne patienter, forudsat at der er genoplivningsudstyr til rådighed.
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
CHMP fandt, at den gavnlige virkning af Celvapan er større end risiciene ved forebyggelse af influenza ved en officielt erklæret pandemisk situation.
The CHMP decided that Celvapan’ s benefits are greater than its risks for the prophylaxis of influenza in an officially declared pandemic situation.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Celvapan.
The Committee recommended that Celvapan be given marketing authorisation.
Celvapan er blevet godkendt under ” særlige omstændigheder ”.
Celvapan has been authorised under ‘ Exceptional Circumstances’.
Det betyder, at det ikke har været muligt at indhente fyldestgørende oplysninger om vaccinen til brug mod en fremtidig pandemi, da man ikke kender den influenzavirusstamme, der eventuelt vil forårsage en sådan pandemi.
This means that because the strain of flu virus that may cause a pandemic is not known, it has not been possible to obtain full information about the future pandemic vaccine.
Det Europæiske Lægemiddelagentur (EMEA) vil hvert år gennemgå alle nye oplysninger, der måtte blive til rådighed, og vil ajourføre dette sammendrag, når der bliver behov for det.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Hvilke oplysninger afventes der stadig for Celvapan?
What information is still awaited for Celvapan?
Hvis der udsendes en erklæring om udbrud af en pandemi, skal virksomheden, der fremstiller Celvapan, tilsætte den pågældende influenzastamme til vaccinen.
If a pandemic is declared, the company that makes Celvapan will include the flu strain responsible in the vaccine.
Virksomheden skal da indsamle oplysninger om sikkerheden og virkningen af den endelige vaccine til brug mod pandemien, og skal indsende oplysningerne til CHMP til vurdering.
It will then collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Celvapan?
Which measures are being taken to ensure the safe use of Celvapan?
Hvis Celvapan bliver taget i brug under en pandemi, skal den virksomhed, der fremstiller vaccinen, indsamle oplysninger om vaccinens sikkerhed, mens den bruges.
If Celvapan is used during a pandemic, the company that makes it will collect information on the safety of the vaccine while it is being used.
Oplysningerne skal omfatte vaccinens bivirkninger og sikkerheden hos ældre, gravide, meget syge patienter og personer med svækket immunforsvar.
This will include information on its side effects and its safety in the elderly, pregnant women, patients with severe conditions, and people who have problems with their immune systems.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Celvapan til Baxter AG den 04. marts 2009.
The European Commission granted a marketing authorisation valid throughout the EU for Celvapan to Baxter AG on 04 March 2009.
2/ 3 Den fuldstændige EPAR for Celvapan findes her.
The full EPAR for Celvapan can be found here.
Dette sammendrag blev sidst ajourført i 03- 2009.
This summary was last updated in 03-2009.
7. 5 microgram / 0. 5 ml
7.5 microgram/ 0.5 ml
CELVAPAN injektionsvæske, suspension Pandemisk influenzavaccine (hele virion, vero- celleafledt, inaktiveret)
CELVAPAN suspension for injection Pandemic influenza vaccine (whole virion, Vero cell derived, inactivated)
Influenzavaccine, hele virion, inaktiveret, indeholder antigen af pandemisk stamme *:
Whole virion influenza vaccine, inactivated containing antigen of pandemic strain*:
0, 5 ml dosis
A/ Vietnam/ 1203/ 2004 (H5N1) per 0.5 ml dose
7, 5 mikrogram **
7.5 micrograms**
* dyrket i vero- celler (kontinuerlig cellelinje fra pattedyr) ** udtrykt i mikrogram hæmagglutinin
* propagated in Vero cells (continuous cell line of ** expressed in micrograms haemagglutinin.
Denne vaccine opfylder WHO’ s anbefalinger og EU’ s anbefalinger for en pandemi.
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
6. 5.
See section 6.5 for the number of doses per vial.
CELVAPAN er blevet evalueret hos voksne fra 18- 59 år og ældre over 60 år.
CELVAPAN has been evaluated in adults 18-59 years of age and in elderly 60 years of age and above.
Et vaccinationsprogram består af to doser á 0, 5 ml indgivet intramuskulært.
Adults: first dose of 0.5 ml at an elected date.
Efter første vaccinering, skal anden dosis gives efter et interval på mindst 3 uger.
A second dose of vaccine should be given after an interval of at least 3 weeks.
Der foreligger ingen data om dosis og tidsinterval for CELVAPAN- vaccinering for personer under 18 år og for personer med komorbiditet (f. eks. personer med immunosuppression).
There is no data on CELVAPAN vaccination dose and schedule for subjects under 18 years old and for subjects with co-morbidities (e. g. immunosuppressed subjects).
I en pandemisk situation skal anvendelse af vaccinen i disse populationer følge de nationale anbefalinger.
In a pandemic situation administration of the vaccine in those populations shall follow national recommendations.
5. 1.
For further information, see section 5.1.
Vaccinationen skal gives som intramuskulær injektion i delta- musklen.
Immunization should be carried out by intramuscular injection into the deltoid muscle.
Tidligere anafylaktisk reaktion (dvs. livstruende) over for et af vaccinens indholdstoffer eller spor heraf (f. eks. formaldehyd, benzonase, saccharose).
History of an anaphylactic (i. e. life-threatening) reaction to any of the constituents or trace residues (e. g. formaldehyde, benzonase, sucrose) of this vaccine.
4. 4.
See section 4.4.
Der skal udvises forsigtighed, når vaccinen gives til personer med kendt overfølsomhed (ud over anafylaktisk reaktion) over for det aktive stof, over for et af hjælpestofferne og over for sporstofferne, f. eks. formaldehyd, benzonase eller saccharose.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e. g. formaldehyde, benzonase, or sucrose.
CELVAPAN må under ingen omstændigheder indgives intravaskulært.
CELVAPAN should under no circumstances be administered intravascularly.
Der foreligger ingen data om subkutan brug af CELVAPAN.
There are no data with CELVAPAN using the subcutaneous route.
5. 1).
A protective response may not be induced in all vaccinees (see section 5.1).
4. 5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interactions with other medicinal products and other forms of interaction
CELVAPAN må ikke gives samtidig med andre vacciner.
CELVAPAN should not be given at the same time as other vaccines.
Immunoglobulin må ikke gives sammen med CELVAPAN.
Immunoglobulin is not to be given with CELVAPAN.
Hvis dette er nødvendigt for at give omgående beskyttelse, kan CELVAPAN gives samtidig med normal eller specifik immunoglobulin.
If it is necessary to provide immediate protection, CELVAPAN may be given at the same time as normal or specific immunoglobulin.
CELVAPAN og immunoglobulin bør injiceres i hver sin ekstremitet.
Injections of CELVAPAN and immunoglobulin should be made into separate limbs.
Efter influenzavaccination er der set falske positive resultater i serologitests med ELISA- metoden i forbindelse med antistoffer mod HIV1, hepatitis C og især HTLV1.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed.
Western Blot- teknik kan i sådanne tilfælde konfirmere, at der er tale om falsk- positive resultater.
The Western Blot technique disproves the results.
De forbigående falsk positive resultater kan skyldes IgM- respons mod vaccinen.
The transient false positive reactions could be due to the IgM response by the vaccine.
4. 6 Graviditet og amning
3 4.6 Pregnancy and lactation
Data fra anvendelse af interpandemiske trivalente vacciner ved graviditet har ikke vist tegn på vaccine- relaterede bivirkninger.
Data from vaccinations with interpandemic trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine.
Derfor anbefales brugen af pandemisk influenzavaccine til gravide kvinder, uanset hvilket stadium af graviditeten de befinder sig i.
Therefore, for pregnant women, administration of the pandemic influenza vaccine is recommended, irrespective of their stage of pregnancy.
Vaccinen CELVAPAN kan bruges under amning.
The vaccine CELVAPAN may be used during lactation.
3 4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
4.7 Effects on ability to drive and use machines
4. 8, såsom svimmelhed og vertigo kan påvirke evnen til at føre motorkøretøj eller betjene maskiner.
Some undesirable effects mentioned under section 4.8 such as dizziness and vertigo may affect the ability to drive or use machines.
5. 1.) udført på 606 personer (326 mellem 18 og 59 år og 280 på 60 år og derover) blev følgende bivirkninger af undersøgeren anset for at have en mulig sammenhæng med vaccinationen.
In clinical trials with the mock-up vaccine (see section 5.1) in 606 subjects (326 between 18 and 59 years old, and 280 aged 60 and above), the following adverse reactions were assessed as at least possibly related by the investigator.
Den mest almindelige bivirkning var smerte på injektionsstedet, og denne var som regel mild.
The most frequently occurring adverse reaction was injection site pain, which was usually mild.
Bivirkningerne er angivet efter nedenstående frekvenser.
Adverse reactions are listed according to the following frequency.
De alvorligste bivirkninger er anført først.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Meget almindelig (≥1/ 10) Almindelig (≥1/ 100 til < 1/ 10) Ikke almindelig (≥1/ 1. 000 til < 1/ 100) Sjælden (≥1/ 10. 000 til < 1/ 1000) Meget sjælden (< 1/ 10. 000) Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
Not known (cannot be estimated from the available data)
Infektioner og parasitære sygdomme U
Infections and infestations U
Nasofaryngitis
Common: nasopharyngitis
Blod - og lymfesystem U
Blood and the lymphatic system disorders U
Lymfadenopati
Uncommon: lymphadenopathy
Psykiske forstyrrelser U
Psychiatric disorders U
Søvnløshed, rastløshed
Uncommon: insomnia, restlessness
Nervesystemet U
Nervous system disorders U
Somnolens, dysæstesi
Common: headache, dizziness Uncommon: somnolence, dysaesthesia,
Øjne U
Eye disorders U
Conjunctivitis
Uncommon: conjunctivitis
Øre og labyrint U
Ear and labyrinth disorders U
Svimmelhed Ikke almindelig:
Common: vertigo Uncommon: sudden hearing loss
Vaskulære sygdomme U
Vascular disorders U
Hypotension
Uncommon: hypotension
Luftveje, thorax og mediastinum U
Respiratory, thoracic and mediastinal disorders U
Dyspnø, hoste, rhinorré, stoppet næse
4 Common: pharyngolaryngeal pain Uncommon: dyspnoea, cough, rhinorrhoea, nasal congestion
Mave- tarm- kanalen U
Gastrointestinal disorders U
Symptomer i mave- tarmkanalen (som kvalme, opkastning, diarré og smerter i den øvre del af abdomen)
Uncommon: gastro-intestinal symptoms (such as nausea, vomiting, diarrhoea and upper abdominal pain)
Udslæt, pruritus
Skin and subcutaneous tissue disorders Common: hyperhidrosis Uncommon: rash, pruritus
Artralgi, myalgi
Musculoskeletal and connective tissue disorders Common: arthralgia, myalgia
Irritation ved injektionsstedet
General disorders and administration site conditions Very common: injection site pain Common: pyrexia, chills, fatigue, malaise, induration, erythema, swelling and haemorrhage at the injection site Uncommon: injection site irritation