FrancophonIA/ELRC3.0 huggingface dataset:
English: A small number of people being treated with anti epileptics such as Zonisamide Mylan have had thoughts of harming or killing themselves- have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems - get a sudden pain in your back or stomach, have pain on urinating (passing water) or notice blood in your urine, as this may be a sign of kidney stones - develop visual problems such as eye pain or blurred vision while taken zonisamide.
Danish: • De pludselig får smerter i ryggen eller maven, har smerter ved vandladning (når De tisser) eller bemærker blod i urinen, da dette kan være tegn på nyresten.
English: A white opaque body and a white opaque cap, marked ‘Z 50' in red containing white/almost white powder.
Danish: En gennemsigtig lys overdel og en lys underdel markeret med 'Z 50' i rød skrift, fyldt med lyst/næsten hvidt pulver.
English: Increase at weekly intervals in increments of 100 mg
Danish: Dosis øges med 100 mg med ugentlige intervaller
English: A white opaque body and a white opaque cap, marked ‘Z 100' in black containing white/almost white powder.
Danish: En gennemsigtig lys overdel og en lys underdel markeret med 'Z 100' i sort skrift, fyldt med lyst/næsten hvidt pulver.
English: 100 mg/day (once a day)
Danish: 100 mg/dag (én gang dagligt)
English: Zonisamide Mylan 100 mg hard capsules
Danish: Zonisamide Mylan 100 mg hårde kapsler
English: Zonisamide Mylan 25 mg and 100 mg hard capsules
Danish: Zonisamide Mylan 25 mg og 100 mg, hård kapsel
English: Amnesia
Danish: Amning
English: Each capsule contains 100 mg of zonisamide.
Danish: Hver kapsel indeholder 100 mg zonisamid.
English: A white opaque body and a white opaque cap, marked ‘Z 25' in black containing white/almost white powder.
Danish: En lys, gennemsigtig underdel og en lys overdel, markeret med 'Z 25' i sort skrift, fyldt med lyst/næsten hvidt pulver.
English: When you take Zonisamide Mylan with other antiepileptic medicines: - The starting dose is 50 mg daily taken in two equal doses of 25 mg. - This may be increased by up to 100 mg at intervals of one to two weeks.
Danish: • Startdosis er 50 mg dagligt indtaget i to lige store doser på 25 mg.
English: Contact your doctor immediately if you: - have difficulty breathing, a swollen face, lips or tongue, or a severe skin rash as these symptoms may indicate that you are having a severe allergic reaction - have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion - have thoughts of harming or killing yourself.
Danish: • har tegn på overophedning: høj kropstemperatur, men kun lidt eller ingen svedproduktion, hurtig puls og åndedræt, muskelkramper og forvirring.
English: Each capsule contains 25 mg of zonisamide.
Danish: Hver kapsel indeholder 25 mg zonisamid.
English: What you need to know before you take Zonisamide Mylan 3.
Danish: Det skal De vide, før De begynder at tage Zonisamide Mylan Sådan skal De tage Zonisamide Mylan Bivirkninger
English: Convulsion
Danish: Agitation
English: Zonisamide Mylan 25 mg hard capsules
Danish: Zonisamide Mylan 25 mg hårde kapsler
English: Contact your doctor as soon as possible if you: - have an unexplained skin rash, as this could develop into a more severe skin rash or skin peeling - feel unusually tired or feverish, have a sore throat, swollen glands, or find that you bruise more easily, as this may mean you have a blood disorder - have signs of increased acid level in the blood- headaches, drowsiness, shortness of breath and loss of appetite.
Danish: • De føler Dem usædvanlig træt eller feberagtig, får ondt i halsen, hævede kirtler eller bemærker, at De let får blå mærker, da dette kan betyde, at De har en blodsygdom.
English: 117 Allee des Parcs 69 800 Saint Priest France
Danish: 69-800 Saint Priest
English: Angle closure glaucoma
Danish: Akut myopi og sekundær glaucoma angulo clauso
English: When your child is taking Zonisamide Mylan: keep your child cool especially in hot weather your child must avoid heavy exercise especially when the weather is hot give your child plenty of cold water to drink your child must not take these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Danish: • Barnet må ikke tage følgende medicin: kulsyreanhydrasehæmmere (såsom topiramat og acetazolamid) og lægemidler med antikolinerg virkning (såsom clomipramin, hydroxyzin, diphenhydramin, haloperidol, imipramin og oxybutynin).
English: Each capsule contains 50 mg of zonisamide.
Danish: Hver kapsel indeholder 50 mg zonisamid.
English: ≥ 1/1,000 to < 1/100
Danish: Ikke almindelig ≥ 1/1.000 til < 1/100 Sjælden
English: Zonisamide Mylan 50 mg hard capsules
Danish: Zonisamide Mylan 50 mg hårde kapsler
English: Zonisamide Mylan 100 mg hard capsules zonisamide
Danish: Zonisamide Mylan 100 mg kapsel, hård zonisamid
English: Each hard capsule contains 100 mg of zonisamide.
Danish: Hver hård kapsel indeholder 100 mg zonisamid.
English: In the event kidney stones are detected, zonisamide should be discontinued.
Danish: I modsat fald bør zonisamid seponeres.
English: Each hard capsule contains 25 mg zonisamide.
Danish: Hver hård kapsel indeholder 25 mg zonisamid.
English: Each hard capsule contains 50 mg zonisamide.
Danish: Hver hård kapsel indeholder 50 mg zonisamid.
English: INFORMATION IN BRAILLE Zonisamide Mylan 25 mg
Danish: Zonisamide Mylan 25 mg
English: Zonisamide Mylan 25 mg hard capsules zonisamide
Danish: Zonisamide Mylan 25 mg kapsel, hård zonisamid
English: Zonisamide Mylan 50 mg hard capsules zonisamide
Danish: Zonisamide Mylan 50 mg kapsel, hård zonisamid
English: Week 1 Weeks 2 to 8
Danish: Uge 1 + 2
English: Week 1 + 2 Week 3 + 4 Week 5 + 6
Danish: Uge 5 + 6
English: Dizziness
Danish: Nyresten
English: Each hard capsule contains 100 mg zonisamide.
Danish: Hver hårde kapsel indeholder 100 mg zonisamid
English: Hepatic impairment
Danish: Depression Insomni
English: Heat stroke
Danish: Perifert ødem
English: Increase at twoweekly intervals in increments of up to 100 mg
Danish: Dosis øges med 100 mg med 2-ugers intervaller
English: 500 mg/day (once a day)
Danish: 300 - 500 mg/dag (én gang dagligt)
English: • Periodic safety update reports
Danish: • unormale resultater fra leverfunktionsprøver
English: This summary was last updated in March 2017.
Danish: Dette sammendrag blev sidst ajourført i marts 2017.
English: These studies were performed under laboratory as well as under typical European farming conditions.
Danish: Disse undersøgelser fandt både sted i laboratorier og i typiske europæiske landbrug.
English: In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Danish: fremover kunne reagere hurtigere mod virusset, når det udsættes for virusset.
English: The full EPAR for Ingelvac CircoFLEX can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ingelvac CircoFLEX findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ingelvac CircoFLEX den 13. februar 2008.
English: When a pig is given the vaccine, the pig's immune system recognises the protein as ‘foreign' and reacts by building up an active immune response.
Danish: Når et svin vaccineres, opfatter dets immunsystem proteinet som "fremmed" og reagerer ved at opbygge en aktiv immunrespons.
English: porcine circovirus type 2 vaccine
Danish: porcint circovirus type 2-vaccine
English: The most common side effect with Ingelvac CircoFLEX (which may affect more than 1 in 10 animals) is a mild and short lived increase in body temperature on the day of vaccination.
Danish: Den hyppigste bivirkning ved Ingelvac CircoFLEX (som kan optræde hos mere end 1 ud af 10 dyr) er en let, kortvarig stigning i kropstemperaturen på vaccinationsdagen.
English: The withdrawal period for meat from pigs treated with Ingelvac CircoFLEX is ‘zero days', which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød fra svin, der behandles med Ingelvac CircoFLEX, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Ingelvac CircoFLEX's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Ingelvac CircoFLEX opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ingelvac CircoFLEX.
English: It also reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, the number of runts and death rates.
Danish: Det reducerede også PCV2-niveauerne i blodet, kliniske tegn på PCV2-infektion, antallet af vraggrise og dødeligheden.
English: The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets.
Danish: Undersøgelserne viste, at vaccination af svin med Ingelvac CircoFLEX reducerede vægttab hos smågrisene.
English: response will help to protect the pig against the disease caused by this virus.
Danish: Denne aktive immunrespons medvirker til at beskytte svinet mod den sygdom, som virusset forårsager.
English: Ingelvac CircoFLEX contains small amounts of a protein from PCV2.
Danish: Ingelvac CircoFLEX indeholder små mængder af et protein fra PCV2.
English: This active immune
Danish: Derefter vil immunsystemet
English: Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription.
Danish: Ingelvac CircoFLEX fås som injektionsvæske, suspension, og udleveres kun efter recept.
English: Ingelvac CircoFLEX is a vaccine.
Danish: Ingelvac CircoFLEX er en vaccine.
English: Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
Danish: Ingelvac CircoFLEX indeholder det aktive stof porcint circovirus type 2 ORF-2-protein.
English: For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Ingelvac CircoFLEX fremgår af indlægssedlen.
English: Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds.
Danish: Ingelvac CircoFLEX blev anvendt i en række undersøgelser med svin af forskellige racer.
English: What is Ingelvac CircoFLEX and what is it used for?
Danish: Hvad er Ingelvac CircoFLEX, og hvad anvendes det til?
English: Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2).
Danish: Ingelvac CircoFLEX er en vaccine til beskyttelse af svin fra 2-ugersalderen mod porcint circovirus type 2 (PCV2).
English: It is not intended to provide practical advice on how to use Ingelvac CircoFLEX.
Danish: Det er ikke en praktisk vejledning i, hvordan Ingelvac CircoFLEX bør anvendes.
English: Why is Ingelvac CircoFLEX approved?
Danish: Hvorfor er Ingelvac CircoFLEX blevet godkendt?
English: What are the risks associated with Ingelvac CircoFLEX?
Danish: Hvilke risici er der forbundet med Ingelvac CircoFLEX?
English: For more information about treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Ingelvac CircoFLEX, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Other information about Ingelvac CircoFLEX:
Danish: Andre oplysninger om Ingelvac CircoFLEX
English: For practical information about using Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Ingelvac CircoFLEX, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: How is Ingelvac CircoFLEX used?
Danish: Hvordan anvendes Ingelvac CircoFLEX?
English: What benefits of Ingelvac CircoFLEX have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ingelvac CircoFLEX?
English: How does Ingelvac CircoFLEX work?
Danish: Hvordan virker Ingelvac CircoFLEX?
English: Examples of such circumstances are:
Danish: Eksempler på sådanne omstændigheder er:
English: • You are diabetic.
Danish: • Du er diabetiker.
English: In certain circumstances, special precautions may be necessary.
Danish: Under visse omstændigheder kan særlige forholdsregler være nødvendige.
English: Only a few families with this disease are known worldwide.
Danish: Globalt kender man kun til nogle få familier med denne sygdom.
English: All other patients should be observed for at least 20 minutes after administration.
Danish: Alle andre patienter bør observeres i mindst 20 minutter efter administration.
English: Which circumstances increase the risk of having side effects?
Danish: Hvilke omstændigheder øger risikoen for at få bivirkninger?
English: Somnolence, tremor
Danish: Somnolens, tremor
English: Stability after first opening:
Danish: Stabilitet efter første åbning:
English: The approximate percentage of IgG subclasses is as follows:
Danish: Den omtrentlige procentdel af IgG-subklasser er som følger:
English: An updated RMP should be submitted:
Danish: Der skal fremsendes en opdateret RMP:
English: What kind of monitoring is required during the infusion?
Danish: Hvilken type overvågning kræves under infusionen?
English: The following information is intended for healthcare professionals only:
Danish: Følgende oplysninger er tiltænkt sundhedspersonale:
English: • you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
Danish: • du får indgivet Privigen for første gang eller efter en lang pause i behandlingen (f.eks. flere måneder).
English: The half-life may vary from patient to patient.
Danish: Halveringstiden kan variere fra patient til patient.
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 28 November 2017
Danish: Dato for første markedsføringstilladelse: 25, april, 2008 Dato for første fornyelse: 28, november, 2017
English: This is an acute disease that primarily affects young children.
Danish: Det er en akut sygdom, der hovedsageligt rammer mindre børn.
English: Interference with serological testing
Danish: Interferens med serologiske test
English: The treatment effect should be evaluated after each cycle.
Danish: Behandlingseffekten skal evalueres efter hver cyklus.
English: There are two alternative treatment schedules:
Danish: Der foreligger 2 forskellige behandlingsplaner:
English: Read this section carefully.
Danish: Læs dette punkt grundigt.
English: Of these, 72 completed the 12 months of treatment.
Danish: Ud af disse fuldførte 72 den 12 måneder lange behandling.
English: If this happens, you should not drive or use machines until these effects have disappeared.
Danish: Hvis dette sker, må du ikke føre motorkøretøj eller betjene maskiner, før virkningerne er forsvundet.
English: Thus, also your baby can receive the protective antibodies.
Danish: Din baby kan således også få indgivet de beskyttende antistoffer.
English: Privigen does not contain sucrose, maltose or glucose.
Danish: Privigen indeholder ikke saccharose, maltose eller glucose.
English: L-proline is a physiological, nonessential amino acid.
Danish: L-prolin er en fysiologisk, ikkeessentiel aminosyre.
English: Anyone experiencing such symptoms should immediately be transported to a hospital emergency room for evaluation and treatment.
Danish: Alle, der oplever sådanne symptomer, skal omgående transporteres til skadestuen på et hospital for at blive evalueret og behandlet
English: *The dose is based on the dose used in the clinical studies conducted with Privigen.
Danish: *Dosis er baseret på den dosis, som blev anvendt i de kliniske studier, der blev udført med Privigen.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock skal standardbehandling for shock gives.
English: *Produced from the plasma of human donors.
Danish: *Fremstillet af plasma fra humane donorer.
English: If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Danish: Hvis der er utilstrækkelig behandlingseffekt efter 6 måneder, skal behandlingen seponeres.
English: If you tolerate this well, your doctor can gradually increase the infusion rate.
Danish: Hvis du tåler denne godt, kan din læge gradvist øge indgivelseshastigheden.
English: Frequencies were evaluated according to the following conventions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).
Danish: Hyppigheden var evalueret i henhold til følgende konvention: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100), Sjælden (≥1/10.000 til <1/1.000), Meget sjælden (<1/10.000).
English: IgG and IgG complexes are broken down in the cells of the reticuloendothelial system.
Danish: IgG og IgG-komplekser nedbrydes i cellerne i det retikulo-endoteliale system.
English: For instruction, see section 6.6.
Danish: 6.6 for instruktioner.
English: Always pierce the stopper at its centre, within the marked area.
Danish: Perforér altid proppen i midten i det markerede område.
English: The treatment required depends on the nature and severity of the adverse reaction.
Danish: Den nødvendige behandling afhænger af arten og alvoren af den uønskede reaktion.
English: IgA ≤ 25 micrograms.
Danish: IgA ≤ 25 mikrogram.
English: This is an extremely rare disorder.
Danish: Det er en yderst sjælden lidelse.
English: Transmissible agents
Danish: Transmissible agenser
English: • You receive this medicine in high doses either on 1 day or over several days and you have a blood group A, B or AB and/or you have an underlying inflammatory condition.
Danish: • Du får dette lægemiddel i høje doser enten på dag 1 eller over flere dage, og du har en blodtype A, B eller AB, og/eller du har en underliggende inflammatorisk tilstand.
English: The dose calculation for children and young patients is not different from that for adults.
Danish: Dosisberegningen for børn og unge patienter foregår ikke anderledes, end den gør for voksne.
English: The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Danish: Virkningsmekanismen ved andre indikationer end substitutionsterapi er ikke fuldt belyst, men omfatter immunmodulerende virkninger.
English: The efficacy and safety profile in the PRIMA and the PATH study in CIDP patients were overall comparable.
Danish: Effekt- og sikkerhedsprofilen i PRIMA og PATH studiet hos CIDP patienter var samlet set sammenlignelig.
English: It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Danish: Det fremstilles normalt ud fra plasma, der er poolet fra mindst 1000 donorer.
English: Overall, 91 % of subjects (188 patients) showed improvement in at least one of the criteria above by week 13.
Danish: Samlet set viste 91 % af forsøgspersonerne (188 patienter) forbedring i mindst ét af de ovenstående kriterier i uge 13.
English: Privigen is made from human plasma.
Danish: Privigen er fremstillet af humant plasma.
English: Overdose is very unlikely to occur because Privigen is usually administered under medical supervision.
Danish: Det er meget usandsynligt, at der forekommer overdosering, da Privigen normalt indgives under lægelig overvågning.
English: For your personal safety, treatment with Privigen will take place under the supervision of your doctor or healthcare professional.
Danish: Af hensyn til din personlige sikkerhed vil behandlingen med Privigen finde sted under overvågning af din læge eller sundhedspersonalet.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Danish: Ikke-kliniske data udviser ingen særlig risiko for mennesker på basis af farmakologiske og toksiske sikkerhedsstudier.
English: Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
Danish: Information om sikkerhed med hensyn til infektioner Privigen er fremstillet af humant blodplasma (det er den flydende del af blodet).
English: 9 patients responded after receiving the initial induction dose by week 4, 16 patients responded by week 10.
Danish: 9 patienter responderede efter at have fået den indledende induktionsdosis i uge 4, 16 patienter responderede ved uge 10.
English: If, in spite of this, you receive more Privigen than you should, your blood may become too thick (hyperviscous) which might increase the risk of developing blood clots.
Danish: Hvis du, på trods af dette, får indgivet mere Privigen, end du skulle, bliver dit blod for tykt (hyperviskøst), hvilket kan forøge risikoen for at udvikle blodpropper.
English: In these cases you will be closely observed during the whole infusion and for at least 1 hour afterwards.
Danish: I disse tilfælde vil du blive nøje overvåget under hele infusionen og i mindst 1 time bagefter.
English: Privigen is used for the treatment of adults and children (0-18 years) in the following situations:
Danish: Privigen anvendes til behandling af voksne og børn (0-18 år) i følgende situationer:
English: Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
Danish: Selvom der kun foreligger begrænsede data, forventes de samme interaktioner at kunne forekomme hos den pædiatriske population.
English: IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Danish: IVIg er ikke indiceret til patienter med selektiv IgA-mangel, hvor IgA-manglen er den eneste væsentlige abnormitet.
English: For the non dominant hand similar results were observed in both PRIMA and PATH trials.
Danish: Lignende resultater blev observeret for den ikke-dominante hånd i både PRIMA og PATH forsøgene.
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Danish: Det fordeler sig relativt hurtigt mellem plasma og ekstravaskulær væske, og efter ca. 3-5 dage opnås der ligevægt mellem det intra- og ekstravaskulære rum.
English: Replacement therapy should be commenced and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Danish: Substitutionsbehandling bør initieres og monitoreres under supervision af en læge, der har erfaring med behandling af immundefekter.
English: Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
Danish: Privigen er isotonisk med en osmolalitet på cirka 320 mOsmol/kg.
English: However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed.
Danish: I studier, hvor doseringen var fastlagt til at afspejle de kliniske indikationer for Privigen, blev der dog ikke observeret indvirkninger på hjerneudviklingen.
English: • You have or had previously problems with your kidneys or take medicinal products that may harm your kidneys (nephrotoxic medicinal products).
Danish: • Du har eller har tidligere haft problemer med dine nyrer eller tager lægemidler, der kan beskadige nyrerne (nefrotoksisk medicin).