FrancophonIA/ELRC3.0 huggingface dataset:
English: These symptoms are usually of transitory nature.
Danish: Disse symptomer er sædvanligvis
English: Pack sizes: 1 and 5 vials x 10 ml and a multipack with 5 x (1 x 10 ml) vials.
Danish: Pakningsstørrelser: 1 og 5 x 10 ml og en multipakning med 5 x (1 x 10 ml) hætteglas.
English: See the advice in 4 What to do in an emergency.
Danish: Se vejledning under 4 Forholdsregler i nødsituationer.
English: Frequencies of adverse drug reactions from clinical trials that are considered related to fast-acting ≥1/1,000 to human insulin (Actrapid) are listed below.
Danish: Frekvensen af bivirkninger fra de kliniske forsøg, som kan betragtes at være relateret til hurtigtvirkende humaninsulin (Actrapid), er angivet nedenfor.
English: If it does not disappear, see your doctor.
Danish: Kontakt Deres læge, hvis det ikke forsvinder.
English: A hypo means your blood sugar level is too low.
Danish: Hypoglykæmi betyder, at Deres blodsukker bliver for lavt.
English: Renal or hepatic impairment may reduce insulin requirement.
Danish: Nedsat nyre- eller leverfunktion kan reducere insulinbehovet.
English: Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, angioneurotic oedema, difficulties in breathing, palpitation, reduction in blood pressure and fainting/loss of consciousness.
Danish: Symptomer på almen hypersensibilitet kan indbefatte hududslæt, kløe, svedtendens, gastrointestinalt ubehag, angioneurotisk ødem, åndedrætsbesvær, hjertebanken, blodtryksfald og besvimelse/tab af bevidsthed.
English: Injection site reactions (redness, swelling, itching, pain and haematoma at the injection site) may occur during treatment with insulin.
Danish: Reaktioner på injektionsstedet (rødmen, hævelser, kløe, smerte og hæmatom på injektionsstedet) kan forekomme ved insulinbehandling.
English: Refraction anomalies may occur upon initiation of insulin therapy.
Danish: Refraktionsanormalier kan forekomme ved initiering af insulinterapi.
English: Keep the needle under your skin for at least 6 seconds to make sure that the full dose has been delivered.
Danish: Efter injektionen skal nålen forblive under huden i mindst 6 sekunder for at sikre, at hele dosis er injiceret.
English: However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.
Danish: Imidlertid kan en intensivering af insulinbehandlingen med en akut forbedring af blodglucosekontrollen være forbundet med en temporær forværring af den diabetiske retinopati.
English: The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Danish: Advarselssignalerne på hypoglykæmi kan komme pludseligt og kan omfatte: Koldsved, kold bleg hud, hovedpine, hurtig hjertebanken, kvalme, usædvanlig stor sultfornemmelse, midlertidige synsforstyrrelser, døsighed, unormal træthed og svaghed, nervøsitet eller rysten, indre uro, forvirring
English: 1 ml contains 100 IU of insulin human.
Danish: 1 ml indeholder 100 IE insulin (human).
English: On rare occasions, injection site reactions may require discontinuation of Velosulin.
Danish: I sjældne tilfælde kan reaktioner på injektionsstedet nødvendiggøre ophør af
English: As for other insulin products, in general, hypoglycaemia is the most frequently occurring undesirable effect.
Danish: Hypoglykæmi er, som ved andre insulintyper, den oftest forekommende bivirkning.
English: Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Danish: Blodglucosekontrol forbedret gennem lang tid nedsætter risikoen for forværring af diabetisk retinopati.
English: Continuous subcutaneous insulin infusion (CSII) in external insulin infusion pumps is usually administered in the abdominal wall.
Danish: Kontinuert subkutan insulininfusion (CSII) i eksterne infusionspumpesystemer administreres normalt i maven.
English: In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal.
Danish: Hos type 1-diabetikere fører ubehandlede hyperglykæmiske tilfælde i sidste instans til diabetisk
English: If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor.
Danish: Hvis De får hypoglykæmi, som fører til bevidstløshed, eller hvis De har haft gentagne tilfælde af hypoglykæmi, skal De tale med Deres læge.
English: Oral hypoglycaemic agents (OHA), monoamine oxidase inhibitors (MAOI), non-selective betablocking agents, angiotensin converting enzyme (ACE) inhibitors, salicylates, alcohol, anabolic steroids or sulphonamides.
Danish: Orale hypoglykæmiske lægemidler (OHA), monoaminooxidasehæmmere (MAOI), ikke-selektive betablokkere, ACE-hæmmere, salicylater, alkohol, anaboliske steroider og sulfonamider.
English: 1 ml solution contains 100 IU (3.5 mg) of insulin human (rDNA).
Danish: 1 ml opløsning indeholder 100 IE (3,5 mg) human insulin (rDNA).
English: Use only catheters where the material in contact with the insulin is made of polyethylene or polypropylene.
Danish: Der bør kun bruges katetre af polyethylen eller polypropylen, når materialet er i kontakt med insulin.
English: Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.
Danish: Kontakt Deres læge efter en glucagoninjektion for at finde årsagen til den svære hypoglykæmi og for at undgå, at De får det igen.
English: If you drive or use tools or machines: watch out for signs of a hypo.
Danish: Hvis De kører eller arbejder med værktøj eller maskiner: Vær opmærksom på symptomer på hypoglykæmi (lavt blodsukker).
English: The vials may be used with insulin syringes with a corresponding unit scale.
Danish: Hætteglassene kan anvendes med insulininjektionssprøjter med en tilsvarende enhedsskala.
English: Keep the vials in the original package.
Danish: Opbevar hætteglassene i den originale yderpakning.
English: See also warning in 2 Before you use Velosulin.
Danish: Se også advarslen i 2 Det skal De vide før
English: Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; betasympathomimetics; growth hormone; danazol; octreotide or lanreotide.
Danish: Deres insulinbehov kan ændre sig, hvis De også tager: Orale antidiabetika, monoaminooxidasehæmmere (MAOI), betablokkere, ACE-hæmmere, acetylsalicylsyre, anaboliske steroider, sulfonamider, orale kontraceptiva, thiazider, glukokortikoider, skjoldbruskkirtelhormon, beta-sympatomimetika, væksthormon, danazol, octreotid eller lanreotid.
English: PARTICULARS TO APPEAR ON THE PACKAGING OUTER WRAPPER LABLE ON MULTIPACKS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ PAKNINGEN DEN YDRE INDPAKNINGSETIKET PÅ MULTIPAKNINGEN
English: Due to the lack of long-acting insulin, patients receiving continuous subcutaneous insulin infusion via an insulin pump are at risk of fast development of ketoacidosis in case of prolonged interruption of continuous subcutaneous insulin infusion.
Danish: Da patienter, som modtager CSII via insulinpumpe, ikke får langtidsvirkende insulin, er de i risiko for hurtigt at udvikle ketoacidose ved længerevarende afbrydelse af CSII.
English: Adjustment of dosage may also be necessary if patients change physical activity or their usual diet.
Danish: Justering af dosis kan også blive nødvendig, hvis patienter ændrer den fysiske aktivitet eller deres Dosisjustering kan også blive nødvendig, hvis patienter skifter fra et insulinpræparat til et andet (se pkt.
English: If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse.
Danish: Hvis De lider af diabetisk retinopati kan dette forværres, hvis Deres blodsukkerniveauer forbedres meget hurtigt.
English: Velosulin should never be mixed with any other insulin when used in a pump.
Danish: Velosulin må ikke blandes med andre insulintyper, når det anvendes i en pumpe.
English: Pharmacotherapeutic group: insulins and analogues for injection, fast-acting, insulin (human).
Danish: Farmakoterapeutisk klassifikation: Insuliner og analoger til injektion, hurtigtvirkende, insulin (human) ATC-kode: A10A B01.
English: The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms.
Danish: De bedste steder til injektion er maveskindet, bagerst på hoften, foran på låret og overarmen.
English: zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: zinkchlorid, glycerol, metacresol, dinatriumphosphatdihydrat, natriumhydroxid, saltsyre og vand til
English: To get the benefit of insulin infusion, and to detect possible malfunction of the pump, the patient should measure his blood glucose level regularly.
Danish: For at udnytte insulininfusionen optimalt og opdage eventuelle pumpefejl bør patienten måle
English: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement (see sections 4.8 and 4.9).
Danish: Hypoglykæmi kan opstå, hvis insulindosis er for høj i forhold til insulinbehovet (se pkt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG
English: When you start taking insulin, water retention may cause swelling around your ankles and other joints.
Danish: Når De påbegynder insulinbehandling, kan væskeophobning forårsage hævede ankler og andre led.
English: If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol: watch for signs of a hypo and never drink alcohol on an empty
Danish: Hvis De har problemer med nyrer, lever, binyrer, hypofyse eller skjoldbruskkirtel Hvis De drikker alkohol: Vær opmærksom på symptomer på hypoglykæmi (lavt blodsukker),
English: However, hypoglycaemia may develop over sequential stages:
Danish: Imidlertid kan hypoglykæmi udvikle
English: Your insulin will work more quickly if you inject it around the waist.
Danish: De vil få hurtigere virkning, hvis insulinet injiceres i maveskindet.
English: Before use: store in a refrigerator (2°C - 8°C).
Danish: Opbevares i køleskab (2°C - 8°C)
English: Patients administering Velosulin by CSII must have injection syringes and alternative insulin readily available in case of emergency or pump interruption or failure, in order that insulin can be administered by subcutaneous injection.
Danish: Patienter, som får Velosulin ved CSII, bør altid have injektionssprøjter og andet insulin umiddelbart tilgængeligt, således at subkutan injektion kan udføres i tilfælde af nødsituationer, pumpeafbrydelse
English: In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications.
Danish: Forbedret glykæmisk kontrol hos patienter med diabetes mellitus giver en senere indsættelse af sendiabeteskomplikationer.
English: Velosulin is administered subcutaneously in the abdominal wall.
Danish: Velosulin administreres subkutant i maven.
English: Swollen joints.
Danish: Hævede led.
English: When administered by CSII no other medicinal products or other insulin products should be mixed in the reservoir of the infusion pump with Velosulin.
Danish: Når Velosulin administreres ved CSII, må den aldrig blandes med andre lægemidler eller andre insuliner i insulinpumpens beholder.
English: Check the label to make sure it is the right type of insulin Disinfect the rubber membrane with a medicinal swab.
Danish: Kontrollér på etiketten, at det er den rigtige insulintype
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Velosulin til Dem personligt.
English: Draw the right dose of insulin into the syringe Pull the needle out of the vial
Danish: Vend hætteglasset og sprøjten med bunden i vejret Træk den korrekte mængde insulin ind i sprøjten Træk nålen ud af hætteglasset
English: They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.
Danish: De omfatter: Hyppig vandladning, tørst, appetitløshed, kvalme, opkastning, døsighed eller træthed, rød tør hud, mundtørhed og frugtlugtende (acetonelugtende) ånde.
English: Concerning compatibility with insulin infusion pumps, reservoirs, catheters and needles, see section
Danish: Forligelighed med insulininfusionspumper, beholdere, katetre og nåle er anført under 6.6.
English: Before using Velosulin
Danish: Hvis Velosulin anvendes alene
English: Oedema may occur upon initiation of insulin therapy.
Danish: Ødemer kan forekomme ved initiering af insulinbehandling.
English: The amount or timing of insulin, food or exercise may need to be adjusted.
Danish: Tidspunktet for eller mængden af insulin, kost
English: Medicinal products added to the insulin solution may cause degradation of the insulin, e.g. if the medicinal products contain thiols or sulphites.
Danish: Lægemidler, som tilsættes insulinopløsningen, kan medføre nedbrydning af insulinet, f.eks. hvis
English: Octreotide/lanreotide may both decrease and increase insulin requirement.
Danish: Betablokkere kan maskere symptomerne på hypoglykæmi og forsinke genetablering af normal tilstand Octreotid/lanreotid kan både reducere og forøge insulinbehovet.
English: To mix Velosulin with long acting insulin
Danish: Hvis Velosulin skal blandes med et langtidsvirkende insulin
English: Upon regaining consciousness, administration of oral carbohydrate is recommended for the
Danish: Efter at patienten har genvundet bevidstheden, anbefales det at give kulhydrater oralt for at forhindre tilbagefald.
English: If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Danish: Hvis De oplever nogle af ovennævnte signaler, spis straks sukker eller et sukkerholdigt produkt
English: HOW TO USE VELOSULIN
Danish: SÅDAN OPBEVARER DE VELOSULIN
English: One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Danish: 1 hætteglas indeholder 10 ml svarende til 1000 IE En international enhed (IE) svarer til 0,035 mg vandfrit human insulin.
English: The vial may be kept at room temperature (not above 25°C) for 6 weeks after first opening.
Danish: Når hætteglasset er taget i brug, kan det opbevares ved stuetemperatur (ikke over 25°C) i op til 6 uger.
English: - If you have any further questions, ask your doctor, diabetes nurse or your pharmacist.
Danish: - Spørg lægen, diabetessygeplejersken eller på apoteket, hvis der er mere De vil vide.
English: Continuous subcutaneous infusion eliminates some of the variations/fluctuations inherent to injection therapy.
Danish: Kontinuert subkutan injektion fjerner nogle af de variationer/svingninger, som er en følge af Den relativt hurtige absorption af opløselig insulin sikrer konstant tilførsel af insulin til blodet fra det
English: Solution for injection or infusion in a vial.
Danish: Injektionsvæske / infusionsvæske, opløsning i et hætteglas.
English: If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar).
Danish: Se en beskrivelse af symptomer på allergi Hvis De føler en begyndende hypoglykæmi (for lavt blodsukker).
English: Velosulin vials are for use with insulin syringes with the corresponding unit scale.
Danish: Hætteglassene med Velosulin skal anvendes med insulininjektionssprøjter med tilsvarende
English: What Velosulin looks like and contents of the pack The solution for injection or infusion comes as a clear, colourless, aqueous solution.
Danish: Injektionsvæske, suspension leveres som en klar, farveløs og vandig opløsning.
English: Most reactions are transitory and disappear during continued treatment.
Danish: Disse reaktioner er sædvanligvis forbigående og vil normalt
English: - The other ingredients are zinc chloride, glycerol, metacresol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid and water for injections.
Danish: 1 hætteglas indeholder 10 ml svarende til 1000 IE. - Øvrige indholdsstoffer: zinkchlorid, glycerol, metacresol, dinatriumphosphatdihydrat, natriumhydroxid, saltsyre, og vand til injektionssvæsker.
English: When filling a new syringe, no large air bubbles should be left in either the syringe or the catheter.
Danish: Når en ny sprøjte fyldes, må der ikke efterlades store luftbobler i sprøjten eller kateteret, Patienten bør omhyggeligt følge lægens instruktioner om basal infusionshastighed og bolusdoser, som
English: MARKETING AUTHORISATION HOLDER
Danish: Indehaveren af markedsføringstilladelsen og fremstiller
English: Velosulin should never be mixed with any other insulin products when used in a pump.
Danish: Når Velosulin anvendes i pumpe, må den aldrig blandes med andre insulinprodukter.
English: They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath.
Danish: De indbefatter tørst, hyppig vandladning, kvalme, opkastning, døsighed, rødme og tørhed af huden,
English: After first use as infusion, the insulin solution may be stored in the pump reservoir for six days at up to 37°C (close to the body).
Danish: Efter ibrugtagning til infusion kan insulinopløsningen opbevares i pumpebeholderen i 6 dage ved op
English: Always vary the sites you inject, to avoid lumps (see 5 Possible side effects).
Danish: For at undgå hudfortykkelse bør De vælge et nyt injektionssted inden for samme område til hver injektion (se 5 Bivirkninger ).
English: If they do not disappear, see your doctor.
Danish: Kontakt Deres læge, hvis symptomerne ikke forsvinder.
English: When you first start your treatment, it may disturb your vision, but the reaction usually disappears.
Danish: Når De påbegynder insulinbehandling, kan De opleve synsforstyrrelser, men det
English: Velosulin should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: please tell your doctor, diabetes nurse or your pharmacist.
Danish: - Tal med lægen, diabetessygeplejersken eller apoteket, hvis en bivirkning bliver værre, eller De
English: NAME OF THE MEDICINAL PRODUCT Velosulin 100 IU/ml solution for injection or infusion in a vial.
Danish: LÆGEMIDLETS NAVN Velosulin 100 IE/ml.injektionsvæske / infusionsvæske, opløsning i et hætteglas.
English: Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on.
Danish: De må aldrig køre eller arbejde med maskiner, hvis De kan mærke symptomer på en begyndende hypoglykæmi.
English: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones and beta-sympathomimetics, growth hormone and danazol.
Danish: Følgende lægemidler kan forøge behovet for insulin: Orale kontraceptiva, thiazider, glukokortikoider, thyreoideahormoner og betasympatomimetika,
English: After first use as infusion: the insulin solution may be stored in the pump reservoir at up to 37°C (close to the body).
Danish: Efter ibrugtagning til infusion kan insulinopløsningen opbevares i pumpebeholderen ved temperaturer
English: Velosulin 100 IU/ml solution for injection in a vial Insulin human (rDNA)
Danish: Velosulin hætteglas 100 IE/ml injektionsvæske, opløsning i et hætteglas Insulin human (rDNA)
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Danish: Dette gælder også medicin, som ikke er købt på recept.
English: NAME OF THE MEDICINAL PRODUCT Velosulin 100 IU/ml solution for injection or infusion in a vial Insulin human (rDNA)
Danish: Velosulin 100 IE/ml injektionsvæske/infusionsvæske, opløsning i et hætteglas Insulin, human (rDNA)
English: 1407 Sofia, Bulgaria Teл.
Danish: 1407 Sofia, Bulgarien Teл.
English: [Only Carton for bottle:] PC: {number} SN: {number} NN: {number}
Danish: Kun ydre karton til flaske: PC: {nummer} SN: {nummer} NN: {nummer}
English: EXP Use within 3 months after first opening.
Danish: EXP Anvendes senest 3 måneder efter første åbning.
English: There are a further 154 cumulative spontaneous reports of eye movement disorder, of which 22 were serious.
Danish: Der var yderligere 154 kumulative spontane indberetninger af øjenbevægelses-forstyrrelser, hvoraf 22 var alvorlige.
English: Use within 3 months after first opening of the bottle.
Danish: Anvendes senest 3 måneder efter første åbning af flasken.
English: Consequently, the frequency of these adverse events is qualified as "not known"
Danish: Hyppigheden af sådanne bivirkninger er derfor angivet som “ikke kendt”.
English: OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE
Danish: YDRE KARTON TIL FLASKE OG ETIKET TIL FLASKE
English: If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Danish: Hvis du ikke kan få fat i lægen, skal du tage til det nærmeste skadestue og medbringe medicinpakningen.
English: Str. Livezeni nr. 7A Târgu Mureş 540472 Romania
Danish: Str. Livezeni nr. 7A Târgu Mureş 540472 Rumænien
English: - binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
Danish: - uhæmmet madindtagelse (spise store mængder mad i en kort periode) eller overdreven madindtagelse (spise mere mad end sædvanligt og mere end nødvendigt for at dække sulten),
English: Schizophrenia in adolescents aged 15 years and older
Danish: Skizofreni hos unge i alderen 15 år og ældre
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 August 2015
Danish: Dato for første markedsføringstilladelse: 20. august 2015
English: People with this condition may also feel depressed, guilty, anxious or tense.
Danish: Mennesker, der har disse symptomer, kan også føle sig deprimerede, have skyldfølelse, være angste og anspændte.
English: Try to take Aripiprazole Sandoz at the same time each day.
Danish: Forsøg at tage Aripiprazole Sandoz på samme tidspunkt hver dag.
English: Prolactin levels were evaluated in all trials of all doses of aripiprazole (n=28,242).
Danish: Prolaktin-niveauerne blev vurderet i alle studier og ved alle doser af aripiprazol (n = 28.242).
English: In a sub-analysis of the adolescent patients between the ages of 15 to 17 years, representing 74% of the total enrolled population, maintenance of effect was observed over the 26-week open-label extension trial.
Danish: I en delanalyse af de unge patienter mellem 15 og 17 år, som repræsenterede 74 % af den totale inkluderede population, blev effekten bibeholdt i det 26-uger åbne, forlængelsesforsøg.
English: Pharmacotherapeutic group: Psycholeptics, other antipsychotics, ATC code: N05AX12
Danish: Farmakoterapeutisk klassifikation: psykoleptika, andre antipsykotika, ATC-kode: N05AX12
English: Aripiprazole Sandoz with food, drink and alcohol This medicine can be taken regardless of meals.
Danish: Brug af Aripiprazole Sandoz sammen med mad, drikke og alkohol Dette lægemiddel kan tages uafhængigt af måltider.
English: It is likely that healthcare professionals would be able to diagnose oculogyric crisis as dystonia and therefore attribute this symptom to aripiprazole, however it is unlikely that patients would be able to link the eye movements to any of the side effects listed in the PIL.
Danish: Det er sandsynligt, at sundhedspersoner vil kunne diagnosticere okulogyr krise som dystoni og derfor forbinde dette symptom med aripiprazol, men det er imidlertid usandsynligt, at patienter ville være i stand til at forbinde øjenbevægelserne med nogen af de anførte bivirkninger i indlægssedlen.