FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor, but do not stop taking Airexar Spiromax unless the doctor tells you to stop.
Danish: men hold ikke op med at bruge Airexar Spiromax, medmindre lægen fortæller dig, at du skal stoppe.
English: Airexar Spiromax is not likely to affect your ability to drive or use machines.
Danish: Det er ikke sandsynligt, at Airexar Spiromax vil påvirke din evne til at føre motorkøretøj eller betjene
English: Rarely, Airexar Spiromax may cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses.
Danish: I sjældne tilfælde kan Airexar Spiromax ved høje terapeutiske doser forårsage hjertearytmi, f.eks. supraventrikulær takykardi, ekstrasystoler og atrieflimmer, og en let, forbigående reduktion i serumkalium.
English: Low dose ICS ( ≤500 micrograms BDP or
Danish: Lavdosis ICS (≤500 mikrogram BDP dagligt
English: When it is appropriate to titrate down to a lower strength not available for Airexar Spiromax, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is
Danish: Når det er hensigtsmæssigt at titrere ned til en lavere styrke, der ikke findes for Airexar Spiromax, er det nødvendigt at ændre til en fastdosiskombination af salmeterol og fluticasonpropionat, der indeholder en lavere dosis inhaleret kortikosteroid.
English: • Low blood pressure and seizures (fits)
Danish: • lavt blodtryk og krampeanfald
English: Airexar Spiromax 50 micrograms/500 micrograms inhalation powder salmeterol/fluticasone propionate
Danish: Airexar Spiromax 50 mikrogram/500 mikrogram inhalationspulver salmeterol/fluticasonpropionat
English: Airexar Spiromax should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.
Danish: Airexar Spiromax skal omgående seponeres og patienten vurderes med iværksættelse af alternativ
English: - if you are allergic (hypersensitive) to salmeterol, fluticasone propionate or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Airexar Spiromax: - hvis du er allergisk (overfølsom) over for salmeterol, fluticasonpropionat eller et af de øvrige indholdsstoffer i Airexar Spiromax (angivet i punkt 6).
English: The studies described were carried out with a previously authorised product available in three different strengths; the studies were not carried out with
Danish: Studierne blev udført med et tidligere godkendt præparat, tilgængeligt i tre forskellige styrker; studierne blev ikke udført med Airexar Spiromax.
English: Serious asthma-related adverse events and exacerbations may occur during treatment with Airexar Spiromax.
Danish: Der kan opstå alvorlige astmarelaterede bivirkninger og eksacerbationer under behandling med Airexar Spiromax.
English: Patients may notice a taste when using Airexar Spiromax due to the lactose excipient.
Danish: Patienterne registrerer muligvis en smag, når de bruger Airexar Spiromax.
English: If you feel more wheezy, your chest feels tight more often or you need to use more of your fast-acting ‘reliever' medicine, your chest condition may be getting worse and you could become seriously ill. You should continue to take Airexar Spiromax but do not increase the number of puffs you take.
Danish: Hvis din vejrtrækning bliver mere hvæsende, hvis du oftere får en trykkende fornemmelse for brystet, eller hvis du hyppigere har behov for hurtigtvirkende anfaldsmedicin, kan det være, at din sygdom er blevet værre, og du kan evt. blive alvorligt syg.
English: Airexar Spiromax should only be used to treat severe asthma in adults aged 18 years and older and
Danish: Airexar Spiromax må kun anvendes til at behandle svær astma hos voksne i alderen 18 år og derover
English: Symptomatic candidiasis of the mouth and throat can be treated with topical anti-fungal therapy whilst still continuing with Airexar Spiromax.
Danish: Symptomatisk candidiasis i mund og svælg kan behandles med topikal svampebehandling, mens behandlingen med Airexar Spiromax fortsættes.
English: In the subset of steroid naive asthmatics the time to an individual well controlled week was 16 days in the salmeterol/fluticasone propionate treatment compared with 23 days following treatment with ICS.
Danish: der ikke tidligere havde fået steroid, gik der 16 dage, før der blev opnået en individuel velkontrolleret uge i salmeterol/fluticasonpropionat-gruppen sammenlignet med 23 dage i ICS-gruppen.
English: What you need to know before you use Airexar Spiromax
Danish: Det skal du vide, før du begynder at bruge Airexar Spiromax
English: An updated RMP should be submitted:
Danish: En opdateret RMP skal fremsendes: • på anmodning fra Det Europæiske Lægemiddelagentur
English: Airexar Spiromax is not recommended for use in children and adolescents aged less than 18 years.
Danish: Airexar Spiromax anbefales ikke til børn og unge under 18 år.
English: Airexar Spiromax may not be suitable to be taken with some other medicines.
Danish: I nogle tilfælde er det ikke hensigtsmæssigt at tage Airexar Spiromax sammen med andre former for medicin.
English: Airexar Spiromax is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age.
Danish: Airexar Spiromax er ikke indiceret til børn på 12 år eller yngre eller til unge i alderen 13 til 17 år.
English: Airexar Spiromax helps to stop breathlessness and wheeziness coming on.
Danish: Airexar Spiromax hjælper med at forhindre, at du får åndenød og hvæsende vejrtrækning.
English: Airexar Spiromax is not recommended for use in either children aged 12 years of age and younger or in adolescents aged 13 to 17 years.
Danish: Airexar Spiromax bør hverken anvendes til børn på 12 år eller yngre eller til unge i alderen 13 til 17 år.
English: The safety and efficacy of Airexar Spiromax in children and adolescents aged less than 18 years of age has not been established.
Danish: Airexar Spiromax' sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: Airexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:
Danish: Airexar Spiromax er indiceret til regelmæssig behandling af patienter med svær astma, hvor anvendelse af et kombinationspræparat (inhaleret kortikosteroid og langtidsvirkende β2-agonist) er hensigtsmæssig: - patienter, hvis astma ikke i tilstrækkelig grad kontrolleres med et kortikosteroidkombinationspræparat af en lavere styrke
English: If a patient with severe COPD has experienced pneumonia, treatment with Airexar Spiromax should
Danish: Hvis en patient med svær KOL har fået pneumoni, skal behandlingen med Airexar Spiromax revurderes.
English: Airexar Spiromax is not indicated for use in children and adolescents under the age of 18 years (see Section 4.2).
Danish: Airexar Spiromax er ikke indiceret til børn og unge under 18 år (se pkt.
English: Airexar Spiromax is only appropriate for use in the treatment of patients with severe asthma.
Danish: Airexar Spiromax er kun hensigtsmæssig til behandling af patienter med svær astma.
English: forceful inhalation) was over 60 L/min, a flow rate at which both devices studied are known to deliver comparable amounts of drug to the lungs.
Danish: Den gennemsnitlige PIFR, der blev opnået af patienter med astma eller KOL med optimal træning (dvs. kraftig inhalation), var over 60 l/min, en flowhastighed, hvor det er kendt, at begge de undersøgte inhalationsdevices vil levere sammenlignelige mængder lægemiddel til lungerne.
English: • Bruising and fractures.
Danish: • opkastning og diarré
English: Airexar Spiromax is for the treatment of patients with severe asthma only.
Danish: Airexar Spiromax er kun til behandling af patienter med svær astma.
English: Treatment with Airexar Spiromax should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Danish: På grund af risikoen for eksacerbationer bør behandling med Airexar Spiromax ikke stoppes pludseligt hos patienter med astma.
English: Tell your doctor if you are taking the following medicines, before starting to use Airexar Spiromax:
Danish: Fortæl altid lægen, før du begynder at bruge Airexar Spiromax, hvis du tager et af følgende lægemidler:
English: There are no data available from clinical trials on overdose with Airexar Spiromax, however data on overdose with both active substances are given below:
Danish: Der foreligger ingen data fra kliniske studier om overdosering af Airexar Spiromax.
English: It is very important that you take your Airexar Spiromax every day as directed.
Danish: Hvis du holder op med at bruge Airexar Spiromax Det er meget vigtigt, at du hver dag bruger din Airexar Spiromax efter anvisningerne.
English: If you stop using Airexar Spiromax
Danish: Sådan skal du bruge Airexar Spiromax
English: Headache
Danish: Sinuitis
English: Reporting of suspected adverse reactions
Danish: Kutane overfølsomhedsreaktioner
English: Airexar Spiromax is indicated in adults 18 years of age and older only.
Danish: Airexar Spiromax er kun indiceret til voksne i alderen 18 år og derover.
English: What Airexar Spiromax looks like and contents of the pack Airexar Spiromax is an inhalation powder.
Danish: Airexar Spiromax er et inhalationspulver.
English: Mogilska 80 Str. 31-546 Kraków, Poland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Mogilska 80 Str. 31-546 Kraków, Polen
English: You must use Airexar Spiromax every day as directed by your doctor.
Danish: Du skal bruge Airexar Spiromax hver dag efter lægens anvisning for at sikre, at din astma eller KOL
English: Do not stop or suddenly reduce your dose of Airexar Spiromax.
Danish: Fortsæt med at tage lægemidlet, indtil lægen fortæller dig, at du skal holde op. Du må ikke holde op eller pludseligt nedsætte din dosis af Airexar Spiromax.
English: Nervous system disorders
Danish: Hæshed/dysfoni
English: Oral infections
Danish: Immunsystemet
English: Tremor
Danish: Svælgirritation
English: Each 0.5 ml dose contains:
Danish: 1 dosis (0,5 ml) indeholder:
English: *Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium)
Danish: Konjugeret til CRM197 bærerproteinet og adsorberet på aluminiumphosphat (0,125 mg aluminium).
English: 1 multidose container (4 doses)
Danish: 1flerdosisbeholder (4 doser)
English: 1 pre-filled syringe
Danish: 1 fyldte injektionssprøjte
English: 1 pre-filled syringe with separate needle
Danish: 1 fyldte injektionssprøjte med separat kanyle
English: pneumococcal conjugate serotype 6B* 4.4 µg pneumococcal conjugate serotype 9V* 2.2 µg pneumococcal conjugate serotype 18C* 2.2 µg
Danish: Pneumokok polysaccharid serotype 18C
English: • Sensitivity to sunlight.
Danish: • Følsomhed overfor sollys.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede studier gravide kvinder.
English: Date of latest renewal: 19 August 2014
Danish: Dato for seneste fornyelse: 19 August 2014
English: Drink it straightaway.
Danish: Drik den med det samme.
English: If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller til råds, før du bruger dette lægemiddel.
English: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Danish: City Tower, Hvezdova 1716/2b, 140 78 Prag 4 Tjekkiet
English: • Unusual movements (dyskinesias).
Danish: • Unormale bevægelser (dyskinesi)
English: In cases where dose increments of 2.5 mg are considered necessary, Olanzapine Glenmark tablets should be used.
Danish: I tilfælde, hvor dosisstigninger på 2,5 mg er nødvendige, bør Olanzapine Glenmark tabletter anvendes.
English: • Absence or decrease in menstrual periods.
Danish: • Manglende menstruation eller længere intervaller mellem menstruationerne.
English: Potential for olanzapine to affect other medicinal products
Danish: Olanzapins potentielle indvirken på andre lægemidler
English: • Moderate to severe manic episodes,a condition with symptoms of excitement or euphoria
Danish: • Moderate til svære maniske episoder, en tilstand med symptomer som begejstring og eufori.
English: Olanzapine Glenmark Europe belongs to a group of medicines called antipsychotics.
Danish: Olanzapine Glenmark Europe tilhører en gruppe af lægemidler, der kaldes antipsykotika.
English: 20 mg/day.
Danish: 20 mg:
English: In patients with Parkinson's disease Olanzapine Glenmark Europe may worsen the symptoms
Danish: Hos patienter med Parkinsons sygdom kan Olanzapine Glenmark Europe forværre symptomerne.
English: mmol/l) were observed commonly.
Danish: 5.17 mmol/l) blev observeret almindeligt.
English: • Changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes.
Danish: • Ændringer i mængderne af visse blodceller, cirkulerende fedtstoffer i blodet samt forbigående forhøjede leverenzymer tidligt i behandlingen
English: Aluminium/aluminium blisters in cartons of 28, 56, 70 tablets per carton.
Danish: Aluminium/aluminium blisterkort i kartoner a 28, 56 eller 70 tabletter pr. karton.
English: If you take more Olanzapine Glenmark Europe than you should Patients who have taken more Olanzapine Glenmark Europe than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Danish: Hvis du har taget for meget Olanzapine Glenmark Europe Patienter, som har taget mere Olanzapine Glenmark Europe end de burde, har oplevet følgende symptomer: Hurtig hjerterytme, ophidselse/aggression, problemer med at tale, usædvanlige bevægelser (især af ansigt eller tunge) eller nedsat bevidsthedsniveau (døsighed).
English: Olanzapine Glenmark Europe orodispersible tablets should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed.
Danish: Olanzapine Glenmark Europe orodispergible tabletter bør placeres i munden, hvor den hurtigt vil dispergere i spyttet, så den let kan synkes.
English: • Carbamazepine (an anti-epileptic and mood stabiliser), fluvoxamine (an antidepresant) or ciprofloxacin (an antibiotic) - it may be necessary to change your Olanzapine Glenmark Europe dose.
Danish: • Carbamazepin (mod epilepsi og stemningsforstyrrelser), fluvoxamin (mod depression) eller ciprofloxacin (mod infektion), da det kan blive nødvendigt at ændre din Olanzapine Glenmark Europe-dosis
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Danish: Derfor forventes ingen særlig interaktion, hvilket bekræftes af in vivo studier, hvor der ikke blev fundet inhibition af metaboliseringen af følgende aktive substanser: tricykliske antidepressiva (hovedsageligt CYP2D6), warfarin (CYP2C9), theophyllin (CYP1A2) eller diazepam (CYP3A4 og 2C 19).
English: The following symptoms may occur in newborn babies, of mothers that have used Olanzapine Glenmark Europe in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget Olanzapine Glenmark Europe I sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: Children and adolescents Olanzapine Glenmark Europe is not for patients who are under 18 years.
Danish: Olanzapine Glenmark Europe er ikke til patienter under 18 år.
English: Olanzapine may antagonise the effects of direct and indirect dopamine agonists.
Danish: Olanzapin kan antagonisere effekten af direkte og indirekte dopamin agonister.
English: Olanzapine Glenmark Europe has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment.
Danish: Det er vist, at Olanzapine Glenmark Europe forebygger tilbagefald af disse symptomer ved bipolar lidelse (maniodepressiv sygdom) hos patienter, hvis maniske episode har reageret på olanzapinbehandling.
English: - High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Glenmark Europe.
Danish: • Højt sukker- og fedtindhold (triglycerider og kolesterol) i blodet er set hos patienter, som tager Olanzapine Glenmark Europe.
English: 16 Elevated plasma prolactin levels were reported in 47.4 % of adolescent patients.
Danish: 16 Forhøje plasmaprolaktin blev rapporteret hos 47,4 % af de unge patienter.
English: - Very rarely, medicines of this type cause a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness.
Danish: • Yderst sjældent forårsager denne slags medicin en kombination af feber, hurtigere vejrtrækning, svedtendens, muskelstivhed og døsighed/søvnighed.
English: If you stop taking Olanzapine Glenmark Europe Do not stop taking your tablets just because you feel better.
Danish: Hvis du holder op med at tage Olanzapine Glenmark Europe Du må ikke holde op med at tage tabletterne, fordi du har fået det bedre.
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Danish: Meget almindelig: Øget vægt13, forhøjede triglyceridniveauer14 , øget appetit..
English: If this happens after you have been given Olanzapine Glenmark Europe, tell your doctor.
Danish: Hvis dette forekommer, når du har taget Olanzapine Glenmark Europe, skal du fortælle det til lægen.
English: • Water retention leading to swelling of the hands, ankles or feet.
Danish: • Væskeophobning som medfører hævede hænder, arme eller fødder
English: You should take your Olanzapine Glenmark Europe orodispersible tablets once a day following the advice of your doctor.
Danish: Du bør tage Olanzapine Glenmark Europe orodispergible tabletter én gang dagligt efter din læges anvisning.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use in patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Danish: Demensrelaterede psykoser og/eller adfærdsforstyrrelser Olanzapin bør ikke anvendes patienter med demensrelateret psykose og/eller adfærdsforstyrrelse på grund af øget mortalitet og risiko for cerebrovaskulære hændelser.
English: In addition, a Single Photon Emission Computed Tomography (SPECT) imaging study in schizophrenic patients revealed that olanzapine-responsive patients had lower striatal D2 occupancy than some other antipsychotic and risperidone-responsive patients, while being comparable to clozapine-responsive patients.
Danish: Desuden afslørede et Single Photon Emission Computed Tomography (SPECT) studie af skizofrene patienter, at olanzapin-responderende patienter havde en lavere striatal D2-binding end visse andre antipsykotika- og risperidon-responderende patienter, hvorimod det var sammenligneligt med clozapin-responderende patienter.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Danish: Den gennemsnitlige dosis, som barnet blev udsat for (mg/kg), blev ved steady state bestemt til at være 1,8% af moderens olanzapindosis (mg/kg).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studie af virkninger på evnen til at føre motorkøretøj eller betjene maskiner.
English: However, the incidence of death was higher in olanzapine-treated than in placebo-treated patients independent of these risk factors.
Danish: Forekomsten af dødsfald var dog højere hos olanzapinbehandlede patienter end hos patienter, behandlet med placebo, uafhængig af disse risikofaktorer.
English: It is important that you carry on taking Olanzapine Glenmark Europe for as long as your doctor tells you.
Danish: Det er vigtigt, du fortsætter med at tage Olanzapine Glenmark Europe, så længe lægen beder dig om det.
English: 6.4 Special precautions for storage Store below 30C.
Danish: 9.SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved temperaturer under 30ºC
English: If you suddenly stop taking Olanzapine Glenmark Europe, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur.
Danish: Hvis du pludseligt holder op med at tage Olanzapine Glenmark Europe, kan der forekomme symptomer som svedtendens, søvnbesvær, rysten, angst, kvalme og opkastning.
English: Olanzapine Glenmark Europe contains the active substance olanzapine.
Danish: Olanzapine Glenmark Europe indeholder det aktive stof olanzapine.
English: • Slow heart rate.
Danish: • Langsom hjertefrekvens.
English: - Weight gain has been seen in patients taking Olanzapine Glenmark Europe.
Danish: • Vægtøgning er set hos patienter, som tager Olanzapine Glenmark Europe.
English: 2 Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were greater in patients without evidence of lipid dysregulation at baseline.
Danish: 2Gennemsnitlig forøgelse i fastende lipidtal (total kolesterol, LDL kolesterol og triglycerider) var højere hos patienter uden tegn på lipiddysregulering ved baseline.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS Aluminium blisterpakninger 1.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 03 December 2009
Danish: Dato for første tilladelse: 03 December 2009
English: Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg and 20 mg are available in aluminium foil blisters of 28, 56, and 70 orodispersible tablets
Danish: Olanzapine Glenmark Europe 5 mg, 10 mg, 15 mg og 20 mg findes i aluminium-blisterpakninger med 28, 56 og 70 orodispergible tabletter.
English: Olanzapine Glenmark Europe orodispersible tablet contains aspartame, which is a source of phenylalanine.
Danish: Olanzapine Glenmark Europe orodispergible tabletter indeholder aspartam, der er en phenylalaninkilde.
English: Do not take Olanzapine Glenmark Europe - if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for olanzapin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: • Fever
Danish: • feber;
English: There is a risk of feeling drowsy when you are given Olanzapine Glenmark Europe.
Danish: Der er risiko for døsighed, når du får Olanzapine Glenmark Europe.
English: METHOD AND ROUTE(S) OF ADMINISTRATION The tablet should be dissolved in the mouth or in a drink.
Danish: Tabletten bør opløses i munden eller i en drikkevare.
English: Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine Glenmark Europe 20 mg orodispersible tablets
Danish: Olanzapine Glenmark Europe 5 mg orodispergible tabletter Olanzapine Glenmark Europe 10 mg orodispergible tabletter Olanzapine Glenmark Europe 15 mg orodispergible tabletter Olanzapine Glenmark Europe 20 mg orodispergible tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver orodispergible tablet indeholder 5 mg olanzapin.