FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptomatic treatment of painful osteoarthritis (see section 4.2).
Danish: Symptomatisk behandling af smertefuld osteoarthritis (se pkt.
English: The use of Nimesulide 100mg Tablets/granules may impair female fertility and is not recommended in women attempting to conceive.
Danish: Anvendelsen af Nimesulide 100 mg tabletter/granulat kan hæmme kvindens fertilitet og anbefales ikke til kvinder, som forsøge at blive gravide.
English: Severe coagulation disorders.
Danish: Alvorlige koaguleringssygdomme.
English: - are hypersensitive (allergic) to nimesulide or any of the other ingredients of TRADEMARK; - have had allergic reactions (e.g. wheezing, runny or blocked nose, hives or nettle rash) after aspirin or other non-steroidal anti-inflammatory drugs; - had a reaction to nimesulide affecting the liver in the past; - are taking other medicines that are known to affect the liver, e.g. paracetamol or any other pain killers or NSAID treatment - are taking drugs of addiction, or have developed a habit that makes you dependent on drugs or other substances - are a regular heavy drinker (alcohol), - if you have liver disease or increased liver enzymes - have a peptic ulcer (stomach or duodenal ulcer) now or had one in the past; - have had bleeding from the stomach or bowel; - have had bleeding into the brain (a stroke); - have any other problem with bleeding or any problems due to your blood not clotting; - have heart failure or a kidney disorder (poor kidney function) or any liver disorder; - are suffering from fever or flu (feeling generally achy, unwell, chills or shivering or have a temperature); - are in the last 3 months of pregnancy; - are breastfeeding.
Danish: efter at have taget aspirin eller andre non-steroide antiinflammatoriske lægemidler - hvis du tidligere har haft en reaktion mod nimesulide, der påvirkede leveren - hvis du tager anden medicin, som man ved påvirker leveren, f.eks. paracetamol eller anden smertestillende medicin eller NSAID-behandling - hvis du tager narkotika, som kan være vanedannende, eller har udviklet afhængighed af narkotika eller andre stoffer - hvis du regelmæssigt drikker meget alkohol - hvis du har en leversygdom eller øgede leverenzymer - hvis du har eller har haft mavesår (sår i maven eller på tolvfingertarmen) - hvis du har haft blødning fra mave eller tarm - hvis du har haft blødning i hjernen (hjerneblødning) - hvis du har haft andre problemer med blødninger eller andre problemer, fordi dit blod ikke kan størkne - hvis du har haft hjertesvigt eller nyresygdomme (dårlig nyrefunktion) eller leversygdom - hvis du har feber eller influenza (føler dig øm eller utilpas, har kulderystelser eller har feber) - hvis du er i de sidste 3 måneder af graviditeten - hvis du ammer
English: - Do not take other medicines that are known to affect the liver, e.g. paracetamol or any other pain killers or NSAID treatment - Avoid excess alcohol during treatment with TRADEMARK - If during nimesulide treatment you develop symptoms that suggest a liver condition, you should stop taking nimesulide and inform your doctor immediately.
Danish: - Du må ikke tage anden medicin, som man ved påvirker leveren, f.eks. paracetamol eller anden smertestillende medicin eller NSAID-behandling - Undgå for meget alkohol under behandling med TRADEMARK - Hvis du under behandlingen med nimesulide udvikler symptomer, der tyder på en leversygdom, skal du holde op med at tage nimesulide og straks informere din læge om det.
English: Rarely Nimesulide 100mg Tablets/granules has been reported to be associated with serious hepatic reactions, including very rare fatal cases (see also section 4.8).
Danish: Det er sjældent blevet indberettet, at Nimesulide 100 mg tabletter/granulat har været forbundet med alvorlige leverreaktioner, herunder meget sjældne tilfælde, der medførte døden (se også pkt.
English: Treatment of acute pain (see section 4.2).
Danish: Behandling af akutte smerter (se pkt.
English: Symptoms suggesting a liver condition include loss of appetite, nausea, vomiting, abdominal pain, persistent tiredness or dark urine.
Danish: Symptomer, der tyder på leversygdom, er nedsat appetit, kvalme, opkastning, mavesmerter, vedvarende træthed eller mørk urin.
English: Concomitant administration with known hepatotoxic drugs, and alcohol abuse must be avoided during treatment with Nimesulide 100mg tablets/granules treatment, since either may increase the risk of hepatic reactions.
Danish: Samtidig indgivelse af kendte levertoksiske lægemidler og alkoholmisbrug skal undgås under behandling med Nimesulide 100 mg tabletter/granulat, da de kan øge risikoen for leverreaktioner.
English: Children (< 12 years): Nimesulide 100mg Tablets/granules is contraindicated in these patients (see also section 4.3).
Danish: Børn (< 12 år): Nimesulide 100 mg tabletter/granulat kontraindiceres hos disse patienter (se også pkt.
English: In patients with renal or cardiac impairment, caution is required since the use of Nimesulide 100mg Tablets/granules may result in deterioration of renal function.
Danish: Hos patienter med nyre- eller hjertesvækkelse er det nødvendigt at være forsigtig, da anvendelse af Nimesulide 100 mg tabletter/granulat kan resultere i svækkelse af nyrefunktionen.
English: Use TRADEMARK for as short a period of time as possible and for not more than 15 days in any single course of treatment.
Danish: Brug TRADEMARK i så kort tid som muligt og i maks.
English: During therapy with Nimesulide 100mg Tablets/granules, patients should be advised to refrain from other analgesics.
Danish: Under behandling med Nimesulide 100 mg tabletter/granulat skal patienterne rådes til at undlade at anvende andre analgetika.
English: Elderly patients are particularly susceptible to the adverse effects of NSAIDs, including gastrointestinal haemorrhage and perforation, impaired renal, cardiac and hepatic function.
Danish: Ældre patienter er især disponeret for bivirkninger ved NSAID-midler, herunder gastrointestinal blødning og perforation og nedsat nyre-, hjerte- og leverfunktion.
English: In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Nimesulide 100mg Tablets/granules should be considered (see section 4.6).
Danish: Hos kvinder, som har vanskeligt ved at blive gravide, eller som gennemgår undersøgelser vedrørende infertilitet, skal ophør med Nimesulide 100 mg tabletter/granulat overvejes (se pkt.
English: History of hepatotoxic reactions to nimesulide
Danish: Tilfælde med levertoksiske reaktioner over for nimesulide.
English: The risk of undesirable effects may be reduced by using Nimesulide 100mg Tablets/granules for the shortest possible duration (see section 4.2)
Danish: Risikoen for bivirkninger kan reduceres ved at anvende Nimesulide 100 mg tabletter/granulat i kortest mulig tid (se pkt.
English: Severe heart failure
Danish: Alvorligt hjertesvigt.
English: Impaired renal function: on the basis of pharmacokinetics, no dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance of 30-80 ml/min), while Nimesulide 100mg Tablets/granules is contraindicated in case of severe renal impairment (creatinine clearance < 30ml/min) (see sections 4.3 and 5.2).
Danish: Nedsat nyrefunktion: På grundlag af farmakokinetikken er dosisjustering ikke nødvendig hos patienter med mild til moderat nyresvækkelse (kreatininclearance på 30-80 ml/min.
English: Additions appear in italics and underlined deletions in italics and strikethrough
Danish: Tilføjelser er vist med kursiv og understregede, sletninger med kursiv og gennemstregning
English: You should check with your doctor or pharmacist if you are unsure.
Danish: Er du i tvivl, så spørg lægen eller apoteket.
English: Hepatic impairment: the use of Nimesulide 100mg Tablets/granules is contraindicated in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion: Anvendelse af Nimesulide 100 mg tabletter/granulat kontraindiceres hos patienter med nedsat leverfunktion (se pkt.
English: - If you are taking any of the following as they may interact with TRADEMARK: - medicine to thin the blood (anti-coagulants, aspirin or other salicylates) - water tablets (diuretics) used for heart failure or blood pressure - lithium which is used to treat depression and similar conditions - methotrexate - cyclosporin make sure that your doctor or pharmacist knows that you are taking these medicines before taking TRADEMARK.
Danish: - Hvis du tager noget af følgende, kan det påvirke TRADEMARK: - blodfortyndende medicin (antikoagulantia, aspirin eller andre salicylater) - vanddrivende tabletter (diuretika), som bruges ved hjertesvigt eller blodtryksbehandling
English: - If during treatment with TRADEMARK, you develop fever and/or flu-like symptoms (feeling generally achy, unwell and chills or shivering) you should stop taking the product and inform your doctor.
Danish: - Hvis du under behandling med TRADEMARK udvikler feber og/eller influenzalignende symptomer (føler dig øm eller utilpas eller har kulderystelser), skal du holde op med at tage produktet og informere din læge om det. - Hvis du lider af hjerte- eller nyresygdom, skal du fortælle det til din læge, før du tager TRADEMARK.
English: Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
Danish: De fleste mennesker kommer sig fuldstændigt, men sygdommen er som regel alvorlig nok til at holde folk hjemme fra arbejde i ca. en måned.
English: Very rare: System Organ Class
Danish: Meget sjælden: Systemorganklasse
English: The severity and type of symptoms can vary.
Danish: Sværhedsgraden og arten af symptomer kan variere.
English: The safety profile presented below is based on data from approximately 800 subjects.
Danish: Nedennævnte sikkerhedsprofil er baseret på data fra ca. 800 personer.
English: Guidelines for boosting are based on the assumption that antibodies are required for protection.
Danish: Vejledning om boosting er baseret på antagelsen om, at antistoffer er nødvendige for beskyttelse.
English: The first dose will be given on an elected date.
Danish: Den første dosis vil blive givet på en udvalgt dato.
English: Such reactions may occur before leaving the doctor's surgery.
Danish: Disse reaktioner kan optræde, inden du forlader lægens klinik.
English: If not, you may not be fully protected against the diseases.
Danish: Hvis ikke, er du måske ikke beskyttet mod disse sygdomme.
English: The remaining two doses will be given one month, and six months after the first dose.
Danish: De resterende to doser vil blive givet en måned og seks måneder efter den første dosis.
English: Make sure you finish the complete vaccination course of three injections.
Danish: Vær sikker på, at du afslutter det fuldstændige vaccinationsprogram på tre injektioner.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En let infektion såsom forkølelse bør ikke udgøre noget problem, men rådfør dig med lægen først.
English: It causes the liver to become swollen (inflamed).
Danish: Det medfører, at leveren bliver opsvulmet (betændt).
English: After a few days the whites of eyes and skin may become yellowish (jaundice).
Danish: Efter få dage kan det hvide i øjnene samt huden blive gullig (gulsot).
English: EXPIRY DATE EXP: MM/YYYY
Danish: UDLØBSDATO EXP MM/YYYY
English: - This vaccine has been prescribed for you/ your child only.
Danish: - Lægen har ordineret denne vaccine til dig/dit barn personligt.
English: Read all of this leaflet carefully before you start/ your child starts receiving this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du/dit barn får vaccinen, da den indeholder vigtige oplysninger.
English: • you have experienced any health problems after previous administration of a vaccine.
Danish: • du har haft problemer med helbredet efter tidligere at have fået en vaccine.
English: - Booster dose
Danish: - Booster-dosis
English: The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
Danish: De hyppigst rapporterede bivirkninger efter administration af Twinrix Pædiatrisk er smerter og rødme med en frekvens pr. dosis på henholdsvis 28,5 % og 11,5 %.
English: • Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver.
Danish: • Hepatitis A: Hepatitis A er en smitsom sygdom, som kan angribe leveren.
English: Pack sizes of 1, 10 and 50 with or without needles.
Danish: Pakningsstørrelse på 1, 10 og 50 med eller uden kanyle.
English: The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose.
Danish: Standard vaccinationsprogrammet for primær vaccination med Twinrix Pædiatrisk består af tre doser, den første administreres på en udvalgt dato, den anden en måned senere og den tredie seks måneder efter den første dosis.
English: The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
Danish: En dosis på 0,5 ml (360 ELISA enheder HA/10 µg HBsAg) anbefales til spædbørn, børn og unge fra 1 år op til og inkluderende 15 år.
English: If you miss a scheduled injection, talk to your doctor and arrange another visit.
Danish: Hvis en planlagt injektion aflyses, må du tale med din læge og få en ny tid.
English: GSK Services Sp. z o.o.
Danish: Polska GSK Services Sp. z o.o.
English: However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).
Danish: Denne administrationsvej kan imidlertid medføre et suboptimalt immunresponse overfor vaccinen (se pkt.
English: Date of latest renewal: 28 August 2006
Danish: Dato for første markedsføringstilladelse: 10. februar 1997 Dato for seneste fornyelse: 28. august 2006
English: • Hepatitis B: Hepatitis B is caused by the hepatitis B virus.
Danish: • Hepatitis B: Hepatitis B forårsages af hepatitis B-virus.
English: The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage.
Danish: Hepatitis A-virus kan overføres fra person til person i mad og drikke eller ved badning i vand, som er forurenet med spildevand.
English: The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Danish: Andelen af personer, som når anti-HB ≥ 10 mIE/ml, var 98,3 % ved samtidig vaccination og 100 % ved vaccination med Twinrix alene.
English: The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Danish: Virus findes i kropsvæsker såsom blod, sæd, vaginalsekret eller spyt hos smittede personer.
English: The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
Danish: Lægen vil give Twinrix Pædiatrisk som en injektion i din øvre armmuskel eller i dit barns lårmuskel.
English: The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
Danish: Behovet for en booster-dosis med hepatitis B-vaccine hos raske individer, som har modtaget et fuldt primært vaccinationsprogram, er ikke blevet fastlagt; dog indeholder nogle officielle vaccinationsprogrammer for tiden en rekommendation af en booster-dosis af hepatitis B-vaccine, hvilket skal respekteres.
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Danish: Almindelige retningslinjer for booster-vaccination kan derfor overføres fra erfaringerne med de monovalente vacciner som beskrevet herunder.
English: For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Danish: For nogle grupper af individer eller patienter, som har øget risiko for HBV (f.eks. hæmodialyse- eller immunkompromitterede patienter) skal sikkerhedsforanstaltninger overvejes for at sikre et beskyttende antistofniveau ≥10 IE/l.
English: • you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
Danish: • du tidligere har haft en allergisk reaktion mod andre vacciner mod hepatitis A og hepatitis B.
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Danish: Det er endnu ikke fuldstændigt fastlagt, hvorvidt immunokompetente individer, som har responderet på hepatitis A vaccination, vil behøve en booster-dosis, eftersom der ved fravær af påviselige antistoffer muligvis kan opnås beskyttelse ved hjælp af immunologisk memory.
English: In two long term clinical trials, persistence of anti-HAV and anti-HBs antibodies has been demonstrated up to 10 years in children aged 12-15 years and up to 5 years in children aged 1-11
Danish: I to længerevarende kliniske studier er persistensen af anti-HAV- og anti-HB-antistoffer blevet vist i op til 10 år hos børn fra 12 til 15 år og i op til 5 år hos børn fra 1 til 11 år.
English: Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
Danish: Twinrix Pædiatrisk har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: AntiHBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected.
Danish: Den geometriske middelantistofkoncentration af anti-HB var lavere ved samtidig administration, men den kliniske betydning af denne observation kendes ikke, idet seroprotektionsraten forbliver den samme.
English: Signs of serious allergic reactions may be rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Danish: Tegn på alvorlige overfølsomhedsreaktioner kan være udslæt, der kan være kløende eller med blærer, opsvulming af øjne og ansigt, åndedræts- og synkebesvær, pludseligt blodtryksfald og bevidsthedstab.
English: Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child.
Danish: Data fra et meget begrænset antal gravide vaccinerede kvinder viser ikke nogen bivirkninger af Twinrix Pædiatrisk ved graviditet eller på helbredstilstanden for foster/nyfødt barn.
English: This disease is caused by the hepatitis A virus.
Danish: Denne sygdom forårsages af hepatitis A-virus.
English: 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLE 50 PRE-FILLED SYRINGES WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 1 PRE-FILLED SYRINGE WITH 2 NEEDLES 10 PRE-FILLED SYRINGES WITH 20 NEEDLES
Danish: 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 50 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 1 FYLDT INJEKTIONSSPRØJTE MED 1 KANYLE 10 FYLDTE INJEKTIONSSPRØJTER MED 10 KANYLER 1 FYLDT INJEKTIONSSPRØJTE MED 2 KANYLER 10 FYLDTE INJEKTIONSSPRØJTER MED 20 KANYLER
English: Very common (these may occur with more than 1 in 10 doses of the vaccine) • Pain and redness at the injection site
Danish: Meget almindelige (kan forekomme ved flere end 1 ud af 10 vaccinedoser): • Smerte og rødme ved injektionsstedet.
English: In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given.
Danish: I situationer, hvor en booster-dosis af både hepatitis A og hepatitis B ønskes, kan Twinrix Pædiatrisk gives.
English: The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe febrile illness.
Danish: Administrationen af Twinrix Pædiatrisk skal udskydes hos individer, der lider af akut svær febril sygdom.
English: • you are allergic to: - the active substances, or any of the ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for: et af de aktive stoffer eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6) neomycin.
English: These consist of nausea (feeling sick), fever and aches and pains.
Danish: De består af kvalme (sygdomsfølelse), feber og mavepine samt smerter.
English: While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Danish: Det forventes ikke, at rekombinant hepatitis B-virusoverfladeantigen medfører bivirkninger ved graviditet eller på fosteret, men det anbefales at udskyde vaccination til efter fødslen, medmindre det skønnes tvingende nødvendigt at beskytte moderen mod en hepatitis B-infektion.
English: • Drooping eyelid and sagging muscles on one side of the face (facial palsy)
Danish: • Hængende øjenlåg og muskler i den ene side af ansigtet (facialisparese)
English: Specific humoral antibodies against hepatitis B were observed in approximately 67% of the subjects after the first dose and 100% after the third dose.
Danish: Specifikke humorale antistoffer mod hepatitis B påvistes hos 67 % af de personer efter første dosis og hos 100 % efter den tredje dosis.
English: Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
Danish: Kontakt lægen eller apotekspersonalet, før du får Twinrix Pædiatrisk, hvis:
English: • Fever equal to or greater than 37.5°C
Danish: • Feber på 37,5 °C eller derover
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelse og fremstiller:
English: • you have a bleeding problem or bruise/ bruises easily.
Danish: • du har problemer med blødningstendens eller let får blå mærker.
English: Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Danish: Twinrix Pædiatrisk er en vaccine, som anvendes af spædbørn, børn og unge fra 1 år og op til og med 15 år for at beskytte mod to sygdomme: hepatitis A og hepatitis B. Vaccinen virker ved at hjælpe kroppen til selv at producere egen beskyttelse (antistoffer) mod disse sygdomme.
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Danish: I tilfælde, hvor de monovalente hepatitis A- og hepatitis B-vacciner blev administreret sammen med specifikke immunoglobuliner, sås ingen påvirkning af serokonverteringen, skønt det kan resultere i lavere antistoftiter.
English: Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Danish: Almindelig Hævelse ved administrationsstedet, andre reaktioner ved administrationsstedet (såsom blå mærker), træthed, utilpashed, feber (≥ 37,5 °C)
English: The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines.
Danish: Anti-HBs-og Anti-HAVs-antistoftitre, som påvises efter et primært vaccinationsforløb med den kombinerede vaccine, ligger inden for samme område som de, der ses efter vaccination med de monovalente vacciner.