natgillin/translations-raw huggingface dataset:
• har tegn på overophedning: høj kropstemperatur, men kun lidt eller ingen svedproduktion, hurtig puls og åndedræt, muskelkramper og forvirring.
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.
Hver kapsel indeholder 25 mg zonisamid.
Each capsule contains 25 mg of zonisamide.
Det skal De vide, før De begynder at tage Zonisamide Mylan Sådan skal De tage Zonisamide Mylan Bivirkninger
What you need to know before you take Zonisamide Mylan 3.
Agitation
Convulsion
Zonisamide Mylan 25 mg hårde kapsler
Zonisamide Mylan 25 mg hard capsules
• 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.
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.
69-800 Saint Priest
117 Allee des Parcs 69 800 Saint Priest France
Akut myopi og sekundær glaucoma angulo clauso
Angle closure glaucoma
• Barnet må ikke tage følgende medicin: kulsyreanhydrasehæmmere (såsom topiramat og acetazolamid) og lægemidler med antikolinerg virkning (såsom clomipramin, hydroxyzin, diphenhydramin, haloperidol, imipramin og oxybutynin).
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).
Hver kapsel indeholder 50 mg zonisamid.
Each capsule contains 50 mg of zonisamide.
Ikke almindelig ≥ 1/1.000 til < 1/100 Sjælden
≥ 1/1,000 to < 1/100
Zonisamide Mylan 50 mg hårde kapsler
Zonisamide Mylan 50 mg hard capsules
Zonisamide Mylan 100 mg kapsel, hård zonisamid
Zonisamide Mylan 100 mg hard capsules zonisamide
Hver hård kapsel indeholder 100 mg zonisamid.
Each hard capsule contains 100 mg of zonisamide.
I modsat fald bør zonisamid seponeres.
In the event kidney stones are detected, zonisamide should be discontinued.
Hver hård kapsel indeholder 25 mg zonisamid.
Each hard capsule contains 25 mg zonisamide.
Hver hård kapsel indeholder 50 mg zonisamid.
Each hard capsule contains 50 mg zonisamide.
Zonisamide Mylan 25 mg kapsel, hård zonisamid
Zonisamide Mylan 25 mg hard capsules zonisamide
Zonisamide Mylan 50 mg kapsel, hård zonisamid
Zonisamide Mylan 50 mg hard capsules zonisamide
Uge 1 + 2
Week 1 Weeks 2 to 8
Uge 5 + 6
Week 1 + 2 Week 3 + 4 Week 5 + 6
Nyresten
Dizziness
Hver hårde kapsel indeholder 100 mg zonisamid
Each hard capsule contains 100 mg zonisamide.
Depression Insomni
Hepatic impairment
Perifert ødem
Heat stroke
Dosis øges med 100 mg med 2-ugers intervaller
Increase at twoweekly intervals in increments of up to 100 mg
300 - 500 mg/dag (én gang dagligt)
500 mg/day (once a day)
• unormale resultater fra leverfunktionsprøver
• Periodic safety update reports
Dette sammendrag blev sidst ajourført i marts 2017.
This summary was last updated in March 2017.
Disse undersøgelser fandt både sted i laboratorier og i typiske europæiske landbrug.
These studies were performed under laboratory as well as under typical European farming conditions.
fremover kunne reagere hurtigere mod virusset, når det udsættes for virusset.
In the future, the immune system will be able to react against the virus more quickly when it is exposed to the virus.
Den fuldstændige EPAR for Ingelvac CircoFLEX findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ingelvac CircoFLEX den 13. februar 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Ingelvac CircoFLEX on 13 February 2008.
Når et svin vaccineres, opfatter dets immunsystem proteinet som "fremmed" og reagerer ved at opbygge en aktiv immunrespons.
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.
porcint circovirus type 2-vaccine
porcine circovirus type 2 vaccine
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.
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.
Tilbageholdelsestiden for kød fra svin, der behandles med Ingelvac CircoFLEX, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
The withdrawal period for meat from pigs treated with Ingelvac CircoFLEX is ‘zero days', which means there is no mandatory waiting time.
Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Ingelvac CircoFLEX opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
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.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ingelvac CircoFLEX.
This is a summary of the European public assessment report (EPAR) for Ingelvac CircoFLEX.
Det reducerede også PCV2-niveauerne i blodet, kliniske tegn på PCV2-infektion, antallet af vraggrise og dødeligheden.
It also reduced the levels of PCV2 in the blood, clinical signs of PCV2 infection, the number of runts and death rates.
Undersøgelserne viste, at vaccination af svin med Ingelvac CircoFLEX reducerede vægttab hos smågrisene.
The trials showed that vaccination of pigs with Ingelvac CircoFLEX reduced weight loss in the piglets.
Denne aktive immunrespons medvirker til at beskytte svinet mod den sygdom, som virusset forårsager.
response will help to protect the pig against the disease caused by this virus.
Ingelvac CircoFLEX indeholder små mængder af et protein fra PCV2.
Ingelvac CircoFLEX contains small amounts of a protein from PCV2.
Derefter vil immunsystemet
This active immune
Ingelvac CircoFLEX fås som injektionsvæske, suspension, og udleveres kun efter recept.
Ingelvac CircoFLEX is available as a suspension for injection and can only be obtained with a prescription.
Ingelvac CircoFLEX er en vaccine.
Ingelvac CircoFLEX is a vaccine.
Ingelvac CircoFLEX indeholder det aktive stof porcint circovirus type 2 ORF-2-protein.
Ingelvac CircoFLEX contains the active substance porcine circovirus type 2 ORF2 protein.
Den fuldstændige liste over begrænsninger og indberettede bivirkninger ved Ingelvac CircoFLEX fremgår af indlægssedlen.
For the full list of restrictions and all side effects reported with Ingelvac CircoFLEX, see the package leaflet.
Ingelvac CircoFLEX blev anvendt i en række undersøgelser med svin af forskellige racer.
Ingelvac CircoFLEX has been studied in a number of trials involving pigs of various breeds.
Hvad er Ingelvac CircoFLEX, og hvad anvendes det til?
What is Ingelvac CircoFLEX and what is it used for?
Ingelvac CircoFLEX er en vaccine til beskyttelse af svin fra 2-ugersalderen mod porcint circovirus type 2 (PCV2).
Ingelvac CircoFLEX is a vaccine used to protect pigs from the two weeks of age against porcine circovirus type 2 (PCV2).
Det er ikke en praktisk vejledning i, hvordan Ingelvac CircoFLEX bør anvendes.
It is not intended to provide practical advice on how to use Ingelvac CircoFLEX.
Hvorfor er Ingelvac CircoFLEX blevet godkendt?
Why is Ingelvac CircoFLEX approved?
Hvilke risici er der forbundet med Ingelvac CircoFLEX?
What are the risks associated with Ingelvac CircoFLEX?
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.
For more information about treatment with Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Andre oplysninger om Ingelvac CircoFLEX
Other information about Ingelvac CircoFLEX:
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.
For practical information about using Ingelvac CircoFLEX, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Hvordan anvendes Ingelvac CircoFLEX?
How is Ingelvac CircoFLEX used?
Hvilke fordele viser undersøgelserne, at der er ved Ingelvac CircoFLEX?
What benefits of Ingelvac CircoFLEX have been shown in studies?
Hvordan virker Ingelvac CircoFLEX?
How does Ingelvac CircoFLEX work?
Eksempler på sådanne omstændigheder er:
Examples of such circumstances are:
• Du er diabetiker.
• You are diabetic.
Under visse omstændigheder kan særlige forholdsregler være nødvendige.
In certain circumstances, special precautions may be necessary.
Globalt kender man kun til nogle få familier med denne sygdom.
Only a few families with this disease are known worldwide.
Alle andre patienter bør observeres i mindst 20 minutter efter administration.
All other patients should be observed for at least 20 minutes after administration.
Hvilke omstændigheder øger risikoen for at få bivirkninger?
Which circumstances increase the risk of having side effects?
Somnolens, tremor
Somnolence, tremor
Stabilitet efter første åbning:
Stability after first opening:
Den omtrentlige procentdel af IgG-subklasser er som følger:
The approximate percentage of IgG subclasses is as follows:
Der skal fremsendes en opdateret RMP:
An updated RMP should be submitted:
Hvilken type overvågning kræves under infusionen?
What kind of monitoring is required during the infusion?
Følgende oplysninger er tiltænkt sundhedspersonale:
The following information is intended for healthcare professionals only:
• du får indgivet Privigen for første gang eller efter en lang pause i behandlingen (f.eks. flere måneder).
• you are receiving Privigen for the first time or after a long break in treatment (e.g. several months).
Halveringstiden kan variere fra patient til patient.
The half-life may vary from patient to patient.
Dato for første markedsføringstilladelse: 25, april, 2008 Dato for første fornyelse: 28, november, 2017
Date of first authorisation: 25 April 2008 Date of latest renewal: 28 November 2017
Det er en akut sygdom, der hovedsageligt rammer mindre børn.
This is an acute disease that primarily affects young children.
Interferens med serologiske test
Interference with serological testing
Behandlingseffekten skal evalueres efter hver cyklus.
The treatment effect should be evaluated after each cycle.
Der foreligger 2 forskellige behandlingsplaner:
There are two alternative treatment schedules:
Læs dette punkt grundigt.
Read this section carefully.
Ud af disse fuldførte 72 den 12 måneder lange behandling.
Of these, 72 completed the 12 months of treatment.
Hvis dette sker, må du ikke føre motorkøretøj eller betjene maskiner, før virkningerne er forsvundet.
If this happens, you should not drive or use machines until these effects have disappeared.
Din baby kan således også få indgivet de beskyttende antistoffer.
Thus, also your baby can receive the protective antibodies.
Privigen indeholder ikke saccharose, maltose eller glucose.
Privigen does not contain sucrose, maltose or glucose.
L-prolin er en fysiologisk, ikkeessentiel aminosyre.
L-proline is a physiological, nonessential amino acid.
Alle, der oplever sådanne symptomer, skal omgående transporteres til skadestuen på et hospital for at blive evalueret og behandlet
Anyone experiencing such symptoms should immediately be transported to a hospital emergency room for evaluation and treatment.
*Dosis er baseret på den dosis, som blev anvendt i de kliniske studier, der blev udført med Privigen.
*The dose is based on the dose used in the clinical studies conducted with Privigen.
I tilfælde af shock skal standardbehandling for shock gives.
In case of shock, standard medical treatment for shock should be implemented.
*Fremstillet af plasma fra humane donorer.
*Produced from the plasma of human donors.
Hvis der er utilstrækkelig behandlingseffekt efter 6 måneder, skal behandlingen seponeres.
If insufficient treatment effect is seen after 6 months, the treatment should be discontinued.
Hvis du tåler denne godt, kan din læge gradvist øge indgivelseshastigheden.
If you tolerate this well, your doctor can gradually increase the infusion rate.
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).
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).
IgG og IgG-komplekser nedbrydes i cellerne i det retikulo-endoteliale system.
IgG and IgG complexes are broken down in the cells of the reticuloendothelial system.
6.6 for instruktioner.
For instruction, see section 6.6.
Perforér altid proppen i midten i det markerede område.
Always pierce the stopper at its centre, within the marked area.
Den nødvendige behandling afhænger af arten og alvoren af den uønskede reaktion.
The treatment required depends on the nature and severity of the adverse reaction.
IgA ≤ 25 mikrogram.
IgA ≤ 25 micrograms.
Det er en yderst sjælden lidelse.
This is an extremely rare disorder.
Transmissible agenser
Transmissible agents
• 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.
• 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.
Dosisberegningen for børn og unge patienter foregår ikke anderledes, end den gør for voksne.
The dose calculation for children and young patients is not different from that for adults.
Virkningsmekanismen ved andre indikationer end substitutionsterapi er ikke fuldt belyst, men omfatter immunmodulerende virkninger.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Effekt- og sikkerhedsprofilen i PRIMA og PATH studiet hos CIDP patienter var samlet set sammenlignelig.
The efficacy and safety profile in the PRIMA and the PATH study in CIDP patients were overall comparable.
Det fremstilles normalt ud fra plasma, der er poolet fra mindst 1000 donorer.
It is usually prepared from pooled plasma from not fewer than 1,000 donors.
Samlet set viste 91 % af forsøgspersonerne (188 patienter) forbedring i mindst ét af de ovenstående kriterier i uge 13.
Overall, 91 % of subjects (188 patients) showed improvement in at least one of the criteria above by week 13.
Privigen er fremstillet af humant plasma.
Privigen is made from human plasma.
Det er meget usandsynligt, at der forekommer overdosering, da Privigen normalt indgives under lægelig overvågning.
Overdose is very unlikely to occur because Privigen is usually administered under medical supervision.
Af hensyn til din personlige sikkerhed vil behandlingen med Privigen finde sted under overvågning af din læge eller sundhedspersonalet.
For your personal safety, treatment with Privigen will take place under the supervision of your doctor or healthcare professional.
Ikke-kliniske data udviser ingen særlig risiko for mennesker på basis af farmakologiske og toksiske sikkerhedsstudier.
Non-clinical data reveal no special risk for humans based on safety pharmacology and toxicity studies.
Information om sikkerhed med hensyn til infektioner Privigen er fremstillet af humant blodplasma (det er den flydende del af blodet).
Information on safety with respect to infections Privigen is made from human blood plasma (this is the liquid part of the blood).
9 patienter responderede efter at have fået den indledende induktionsdosis i uge 4, 16 patienter responderede ved uge 10.
9 patients responded after receiving the initial induction dose by week 4, 16 patients responded by week 10.
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.
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.
I disse tilfælde vil du blive nøje overvåget under hele infusionen og i mindst 1 time bagefter.
In these cases you will be closely observed during the whole infusion and for at least 1 hour afterwards.
Privigen anvendes til behandling af voksne og børn (0-18 år) i følgende situationer:
Privigen is used for the treatment of adults and children (0-18 years) in the following situations:
Selvom der kun foreligger begrænsede data, forventes de samme interaktioner at kunne forekomme hos den pædiatriske population.
Although limited data is available, it is expected that the same interactions may occur in the paediatric population.
IVIg er ikke indiceret til patienter med selektiv IgA-mangel, hvor IgA-manglen er den eneste væsentlige abnormitet.
IVIg is not indicated in patients with selective IgA deficiency where the IgA deficiency is the only abnormality of concern.
Lignende resultater blev observeret for den ikke-dominante hånd i både PRIMA og PATH forsøgene.
For the non dominant hand similar results were observed in both PRIMA and PATH trials.
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.
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.
Substitutionsbehandling bør initieres og monitoreres under supervision af en læge, der har erfaring med behandling af immundefekter.
Replacement therapy should be commenced and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Privigen er isotonisk med en osmolalitet på cirka 320 mOsmol/kg.
Privigen is isotonic, with an approximate osmolality of 320 mOsmol/kg.
I studier, hvor doseringen var fastlagt til at afspejle de kliniske indikationer for Privigen, blev der dog ikke observeret indvirkninger på hjerneudviklingen.
However, in studies where the dosing was designed to reflect the clinical indications for Privigen, no effects on brain development were observed.
• Du har eller har tidligere haft problemer med dine nyrer eller tager lægemidler, der kan beskadige nyrerne (nefrotoksisk medicin).
• You have or had previously problems with your kidneys or take medicinal products that may harm your kidneys (nephrotoxic medicinal products).
Hvis du får indgivet Privigen, mens du ammer, findes antistofferne i dette lægemiddel også i modermælken.
If you receive Privigen while you are breast-feeding the antibodies in this medicine will also be found in the breast milk.
De to CIDP studier blev foretaget på henholdsvis 28 og 207 patienter.
The two CIDP studies were performed with 28 and 207 patients, respectively.
A) Til at forøge unormalt lave immunglobulinniveauer i blodet til normale niveauer (substitutionsterapi):
A) to increase abnormally low immunoglobulin levels in your blood to normal levels (replacement therapy):
Patienterne bør samtidig behandles med acetylsalicylsyre.
Patients should receive concomitant treatment with acetylsalicylic acid.
• Når risikostyringssystemet ændres, særligt som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Tidligere behandlede patienter blev trukket ud af IVIG indtil en bekræftet svækkelse før start på Privigen.
Previously treated patients were withdrawn from IVIG until confirmed deterioration before start of Privigen.
Selvom der kun foreligger begrænsede data, forventes det, at de samme advarsler, forholdsregler og risikofaktorer gælder for den pædiatriske population.
Although limited data is available, it is expected that the same warnings, precautions and risk factors apply to the paediatric population.
I dette studie var den gennemsnitlige halveringstid af Privigen hos PID-patienter 36,6 dage.
In this study, the median half-life of Privigen in PID patients was 36.6 days.
Svimmelhed (herunder vertigo)
Dizziness (including vertigo)
Efter administration af dette produkt bør der gå tre måneder inden vaccination med levende svækkede virusvacciner.
After administration of this medicinal product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines.
Aseptisk teknik skal strengt overholdes under fortyndingen af Privigen.
Aseptic technique must be strictly observed during the dilution of Privigen.
Efter at have fået indgivet Privigen kan virkningen af visse vaccinationer være svækket.
After receiving Privigen, the efficacy of certain vaccinations may be impaired.
Dette kan især ske, hvis du er en patient, der er i risikogruppe, hvis f.eks. du er ældre eller lider af en hjerte- eller nyresygdom.
This may happen particularly if you are a patient at risk, for example if you are elderly or if you suffer from a heart or kidney disease.
Du vil normalt blive overvåget under hele infusionen og i mindst 20 minutter herefter.
You will usually be observed during the whole infusion and for at least 20 minutes thereafter.
Lægemidlet skal have rumtemperatur (25 °C) før brug.
The product should be brought to room temperature (25°C) before use.
Patienter med hyperprolinæmi type I eller II.
Patients with hyperprolinaemia type I or II.
Ved substitutionsterapi kan der være behov for individuel dosis til den enkelte patient afhængigt af farmakokinetisk og klinisk respons.
In replacement therapy the dose may need to be individualised for each patient depending on the pharmacokinetic and clinical response.
Mulige bivirkninger kan reduceres eller endda undgås ved at indgive Privigen ved en langsom indgivelseshastighed.
Possible side effects may be reduced or even avoided by infusing Privigen at a slow infusion rate.
• Du kan være overfølsom (allergisk) over for immunglobuliner uden at vide det.
• You may be allergic (hypersensitive) to immunoglobulins without knowing it.
Der blev foretaget seks kliniske studier med Privigen, som inkluderede patienter med PID, ITP og CIDP.
Six clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP.
• hvis du lider af hyperprolinæmi type I eller II (en genetisk lidelse, der forårsger høje niveauer af aminosyren prolin i blodet).
• if you suffer from hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
B) Til at behandle visse betændelsestilstande (immunmodulation).
B) to treat certain inflammatory disorders (immunomodulation).