natgillin/translations-raw huggingface dataset:
Produktet er mere sensitivt (93, 9% mod 80, 6%), men mindre specifikt (51, 6% mod 72, 9%) til diagnose af osteomyelitis hos patienter med diabetisk fodsår end hos patienter med osteomyelitis i rørknogler.
However, there is an equivalent diagnostic accuracy between these two presentations
Der er imidlertid en ækvivalent diagnostisk præcision for disse to former (77, 5% mod 75, 8% henholdsvis).
75.8%, respectively).
En vurdering af LeukoScans potentielle kliniske betydning viste, at LeukoScan kunne ændre den kliniske behandling i 50, 2% eller forbedre det kliniske resultat i 43, 4% af de 175 evaluerbare patienter med mulig osteomyelitis.
An evaluation of potential clinical impact of LeukoScan demonstrated that LeukoScan could change clinical management in 50.2% or improve clinical outcome in 43.4% of the 175 evaluable patients with suspected osteomyelitis.
Hos 49, 7% af disse patienter formodedes LeukoScan at give kliniske fordele, der ikke kunne opnås med andre tilgængelige diagnostiske undersøgelsesmetoder med det potentiale, at diagnosen
In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients.
Disse fordele var også ledsaget af en væsentlig reduktion (85,. 4%) i antallet af patienter, som ville have behov for andre diagnostiske undersøgelser.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging procedures.
Eftersom LeukoScan krydsreagerer med CEA, skal der gøres opmærksom på, at det kan reagere med CEA- producerende tumorer.
Since LeukoScan cross-reacts with CEA, it should be borne in mind that it may interact with CEA producing tumours.
5. 2 Farmokokinetiske egenskaber
5.2 Pharmacokinetic properties
En time efter infusion var blod niveauet 34% af startniveauet, 17% ved fire timer og 7% ved 24 timer.
At one hour after infusion, the blood level was 34% of baseline, 17% at four hours and 7% of baseline at 24 hours.
1, 5 timer, udskillelse sker hovedsageligt gennem nyrerne med 41% af radioaktiviteten udskilt i urin indenfor de første 24 timer efter administration.
The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration.
Der er kun udført meget begrænsede prækliniske studier med enten mærket eller umærket stof.
Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent.
6. 1 Hhjælpestoffer
6.1 List of excipients
Stannoklorid, dihydrat Iseddikesyre (spor) Natriumkaliumtartrat, tetrahydrat Sakkarose
Stannous Chloride, Dihydrate Acetic Acid, Glacial (Trace) Sodium Potassium Tartrate, Tetrahydrate Sucrose
Natriumklorid Saltsyre (spor) Natriumacetat, trihydrat Nitrogen
Sodium Chloride Hydrochloric Acid (Trace) Sodium Acetate, Trihydrate Nitrogen
6. 6 eller 12.
This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6 or 12.
48 måneder.
Kit - 48 months.
4 timer.
Reconstituted and radiolabelled material - 4 hours.
Kit:
Kit - Store in a refrigerator (2ºC - 8ºC).
Skal opbevares i køleskab (2- 8°C).
Do not freeze.
Et hætteglas indeholdende 0, 31 mg frysetørret LeukoScan monoklonalt antistoffragment.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Type I hætteglasset er lukket med en grå butylgummiprop med et grønt flip- off segl.
The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Et hætteglas pr. karton.
Pack size: one vial per carton container.
7 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
LeukoScan er en steril, frysetørret formulering, som indeholder 0, 31 mg sulesomab per hætteglas samt 0, 22 mg stannoklorid, dihydrat, 3, 2 mg natriumkaliumtartrat, tetrahydrat, 7, 4 mg natriumacetat, trihydrat, 5, 5 mg natriumklorid, iseddikesyre (Spor), saltsyre (Spor), 37, 8 mg sakkarose, nitrogen (vacuum).
LeukoScan is a sterile, lyophilised formulation, containing 0.31 mg of sulesomab per vial and includes 0.22 mg stannous chloride dihydrate, 3.2 mg potassium sodium tartrate tetrahydrate, 7.4 mg sodium acetate trihydrate, 5.5 mg sodium chloride, glacial acetic acid (trace), hydrochloric acid (trace), 37.8 mg sucrose, nitrogen (vacuum).
Billedbehandlingskomponenten technetium- 99m LeukoScan [technetium- 99m sulesomab] fremstilles ved rekonstituering af indholdet i LeukoScan- hætteglasset med 0, 5 ml natriumkloridinjerktionsvæske efterfulgt af tilsætning af 1100 MBq natriumperteknetat [99mTc] i 1 ml natriumkloridinjektionsvæske.
The imaging agent, technetium-99m LeukoScan [technetium-99m sulesomab] is formed by reconstitution of the contents of the LeukoScan vial with 0.5 mL sodium chloride for injection followed by the addition of 1100 MBq of sodium pertechnetate [99mTc] in 1 mL of Sodium Chloride for Injection.
Den færdige opløsning har en pH på 4, 5- 5, 5 og må kun bruges til intravenøs anvendelse.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only.
Volumen af eluatet justeres til 1, 0 ml med 0, 9% natriumkloridopløsning.
Using saline injection, bring the final volume of eluate solution to 1.0 ml.
Opløs det frysetørrede pulver i 0, 50 ml 0, 9% natriumklorid injektionsvæske i det blybeskyttede LeukoScan 3- ml hætteglas.
For reconstitution of lyophilised powder, with a sterile disposable syringe add 0.50 ml of saline injection into the shielded LeukoScan 3-ml vial.
Det totale volumen i hætteglasset er 1, 5 ml.
Total volume in vial equals 1.5 ml.
På baggrund af den i dosiskalibratoren målte aktivitet udtages en tilstrækkelig mængde til at give den ønskede aktivitet (750- 1100MBq 99mTc, se afsnittet om Dosering og indgivelse).
Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1100 MBq of 99mTc, see Dosage and Administration).
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
14. februar 1997
14 February 1997
Dato for sidste fornyelse af tilladelsen:
Date of lastest renewal:
Dato for godkendelse af sidste variation eller overførsel af markedsføringstilladelse:
MM/ YYYY
For dette lægemiddel er den effektive dosisækvivalent fra en administreret aktivitet på 750 MBq typisk 7, 7 mSv for en person på 70 kg.
For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual.
Technicium [99mTc] henfalder under udsendelse af gammastråling med en energi på 140 keV og en halveringstid på 6 timer til technicium [99Tc], der kan betragtes som værende quasi- stabil.
9 Technetium [99mTc] disintegrates with the emission of gamma radiation with an energy of 140 keV and a half life of 6 hours to technetium [99Tc] which can be regarded as quasi stable.
Den estimerede absorberede stråledosis til en gennemsnitlig voksen patient (70 kg) fra en intravenøs indgivelse af LeukoScan, der er mærket med 750 MBq technicium- 99 m er givet i Tabel 1.
The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous administration of LeukoScan labeled with 750 MBq of technetium-99m are provided in Table 1.
9 Tabel 1.
Table 1
Oversigt over normal organdosimetri for en gennemsnitlig voksen patient (70 kg) fra en intravenøs dosis af LeukoScan, der er mærket med 750 MBq technetium- 99 m (Dosisoverslag fra 13 patienter, 26 indgivelser)
Summary of Normal Organ Dosimetry to an Average Adult Patient (70 kg) from an Intravenous Dose of LeukoScan Labelled with 750 MBq of Technetium-99m [Dose Estimate from 13 Subjects 26 Administrations]
LeukoScan [99mTc]
LeukoScan [99mTc]
Organ
Organ
dosis mGy/ MBq
Average Dose µGy/ MBq
Nyrer Urinblærevæg Milt Hjertevæg Lunger Lever Knogleoverflader Binyrer Rød knoglemarv Bugspytkirtel Skjoldbruskkirtel Galdeblærevæg Livmoder Ovarier Tyndtarm Mave Øvre tyktarmsvæg Nedre tyktarmsvæg Brissel Total legemsmasse Muskler Testikler Bryster Hjerne Hud
Kidneys Urinary Bladder Wall Spleen Heart Wall Lungs Liver Bone Surfaces Adrenals Red Marrow Pancreas Thyroid Gall Bladder Wall Uterus Ovaries Small Intestine Stomach
44, 9 21, 5 15, 7 11, 8 10, 0 9, 0 8, 0 7, 2 7, 1 6, 8 6, 7 6, 2 5, 9 4, 9 4, 8 4, 8 4, 7 4, 7 4, 5 4, 2 3, 5 3, 0 2, 8 2, 4 2, 1
Upper Large Intestinal Wall Lower Large Intestinal Wall Thymus Total Body Muscle Testes Breasts Brain Skin
Effektiv dosisækvivalent * Effektiv dosis *
Effective Dose Equivalent* Effective Dose*
10, 3 8, 0
10.3 8.0
Effektiv dosisækvivalent og effektiv dosis er opgivet i enheden μSv/ MBq
Effective Dose Equivalent and Effective Dose are in units of µSv/ MBq.
LeukoScan opløses i 0, 5 ml isotonisk natriumklorid injektionsvæske.
10 LeukoScan is reconstituted with 0.5 ml isotonic sodium chloride injection.
1, 2 ml).
The recommended adult dose is 0.25 mg of Fab′ fragment labelled with 900 ± 200 MBq of technetium 99m Tc pertechnetate (approximately 1.2 ml).
Efter mærkning af antistoffragmentet og fortynding af 10 μl prøven med 1, 5 ml 0, 9% natriumkloridopløsning, skal den radiokemiske renhed omgående bestemmes ved hjælp af hurtig tyndtlagskromatografi (Instant thin Layer Chromatography) på 1 x 9 cm glasfiberstrimler, der er
After radiolabelling the antibody and diluting a 10 µl sample with 1.5 ml saline, immediately determine the radiochemical purity by Instant Thin Layer Chromatography on silica gel impregnated glass fiber strips, 1 × 9 cm using acetone as the solvent.
10 imprægneret med silica- gel, idet man bruger acetone som udviklingsvæske.
When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube.
Aktivitet i den øverste halvdel af strimlen x 100 Total aktivitet
% Free Technetium = Activity in top half of strip × 100 Total Activity.
FREMSTILLER( E) AF DET (DE) BIOLOGISK AKTIVE STOF( FER) OG > FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER/ FREMSTILLERE AF DET (DE) BIOLOGISK AKTIVE STOF( FER) OG FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
300 American Road Morris Plains, New Jersey 07950 USA
300 American Road Morris Plains, New Jersey 07950, USA
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Tyskland
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany
15 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGEOGPÅ DEN INDRE EMBALLAGE
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
LeukoScan 0, 31 mg Pulver til injektionsvæske, opløsning sulesomab
LeukoScan 0.31 mg, powder for solution for injection sulesomab
Hvert hætteglas indeholder 0, 31 mg sulesomab.
One vial contains 0.31 mg sulesomab
Pulver til injektionsvæske, opløsning 0, 31 mg sulesomab
0.31 mg sulesomab Powder for solution for injection
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ( E)
METHOD AND ROUTe(S) OF ADMINISTRATION
16 EXP MM/ ÅÅÅÅ
16 EXP MM/ YYYY
Opbevares i køleskab (2- 8 °C).
Store in a refrigerator (2ºC-8ºC).
Immunomedics GmbH Otto- Röhm- Straße 69 D- 64293 Darmstadt Tyskland Telephone: +49- 6151 - 66 715 66 Fax: +49- 6151- 66 715 77 e- mail: europe@ immunomedics. com
Immunomedics GmbH Otto-Röhm-Straße 69 D-64293 Darmstadt Germany Telephone: +49-6151- 66 715 66 Fax: +49-6151-66 715 77
Batch #
Batch #
LÆGEMIDLETS NAVN, STYRKE OG/ ELLER ADMINISTRATIONSVEJ( E)
NAME OF MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
LeukoScan 0, 31 mg Pulver til injektionsvæske, opløsning 0, 31 mg frysetørret stannoklorid og stabiliseringsmidler.
LeukoScan 0.31 mg, powder for solution for injection 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
ANVENDELSESMÅDE
For Intravenouse Use.
EXP MM/ ÅÅÅÅ
EXP 48 Months
Indeholder 0, 31 mg frysetørret stannoklorid og stabiliseringsmidler.
Contains 0.31 mg lyophilised sulesomab, stannous chloride and stabilizers.
Hydratiseres igen med sterilt ikke- pyrogent 99mTc natriumperteknetat.
Rehydrate with sterile, non-pyrogenic 99mTc Na pertechnetate.
LeukoScan (0, 31 pulver til injektionsvæske, opløsning) (sulesomab)
INFORMATION FOR THE USER LeukoScan (0.31 powder for solution for injection) (sulesomab)
Lad derfor være med at give LeukoScan til andre.
You may need to read it again. • It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions.
Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har. • Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
This leaflet only applies to LeukoScan. • If you have any further questions, please ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
LeukoScans virkning og hvad du skal bruge det til 2.
What LeukoScan is used for 2.
Det skal du vide, før du begynder brug af LeukoScan 3.
Before you use LeukoScan 3.
Sådan skal du bruge LeukoScan 4.
How to use LeukoScan 4.
Sådan opbevarer du LeukoScan 6.
How to store LeukoScan 6.
Et antistof er et naturligt stof, som produceres i din krop og som binder sig til fremmede substanser, for at fjerne/ nedbryde dem i kroppen.
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body.
Når det bindes til den radioaktive techniciumisotop og indsprøjtes, finder det en unormal ophobning af hvide blodlegemer og binder sig til dem.
One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras.
Brug ikke LeukoScan 0, 31 mg, pulver til injektionsvæske, opløsning,
You should not use LeukoScan 0.31 mg, sulesomab, powder for solution for injection
Du skal underrette din læge.
• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor.
• Hvis den fremstillede opløsning af LeukoScan forekommer misfarvet eller indeholder partikler, må den ikke anvendes.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be used.
Der er ikke udført studier vedrørende føde- og drikkevarers indflydelse på effekten.
No studies effects of food/ drink have been performed.
• Hvis du ammer skal du ophøre med amning af dit barn i mindst 24 timer efter, at du har fået LeukoScan.
• If you are breast feeding, you should stop breast feeding your baby for at least 24 hours after you have been given LeukoScan.
• Radiofarmaka må kun anvendes af kvalificeret personale med behørig statsanerkendelse angående brug og behandling af radionukleider.
• Radiopharmaceutical agents should be used only by qualified personnel with appropriate government authorisation for the use and manipulation of radionuclides.
Dets modtagelse, opbevaring, anvendelse, flytning og fjernelse er underlagt regler og/ eller respektive licenser fra statslige og lokale myndigheder.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/ or appropriate licenses of local competent official organisations.
• Radiofarmaka skal præpareres af brugeren på en måde, således at kravene angående strålingssikkerhed og lægemidlets kvalitet overholdes.
21 • Radiopharmaceuticals should be prepared by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements.
21 Trafik - og arbejdssikkerhed
Driving and using machines
Kontakt lægen, før De/ du tager denne medicin, hvis lægen har fortalt Dem/ dig, at De/ du ikke tåler visse sukkerarter.
If you have been told that you have an intolerance to some sugars, inform your doctor before you are given this medicine.
Du vil få en enkelt dosis på 0, 25 mg af LeukoScan.
You will receive a single dose of 0.25 mg of LeukoScan.
Indgivelsesmåde
Method and/ or route(s) of administration
Din læge vil fremstille LeukoScan og den radioaktive techniciumisotop i et volumen på 1, 5 ml.
Your doctor will prepare the LeukoScan and the radioactive isotope technetium in a volume of 1.5 ml.
LeukoScan vil blive mærket med 740- 1110 MBq technicium.
0.25 mg of LeukoScan will be labelled with 740-1110 MBq of technetium.
24 timer.
This dose of radioactivity is safe and will be gone from the body in about 24 hours.
22 Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
SÅDAN OPBEVARER DU LEUKOSCAN
HOW TO STORE LEUKOSCAN
Opbevaringsperiode
Expiry date and storage conditions
Skal opbevares i køleskab (2- 8°C).
Store in a refrigerator (2°C-8°C).
LeukoScan indeholder:
What LeukoScan contains
Aktivt stof: sulesomab Hvert 3 ml hætteglas indeholder 0, 31 mg sulesomab (IMMU- MN3- murinus Fab 'SH antigranulocyt monoklonale antistoffragmenter)
The active substance is sulesomab Each 3 ml vial contains 0.31 mg sulesomab (IMMU-MN3 murine Fab′ -SH antigranulocyte monoclonal antibody fragments).
Et hætteglas, der indeholder 0, 31 mg frysetørret LeukoScan monoklonalt antistoffragment.
One vial prepared so as to contain 0.31 mg lyophilised LeukoScan monoclonal antibody fragment.
Pakningsstørrelse:
The Type I glass vial is closed with a grey butyl rubber stopper with a green flip-off seal.
Indehaveren af markedsføringstilladelsen og fremstiller
Pack size: one vial per carton container.
Levemir er en klar, farveløs væske til injektion.
Levemir is a clear colourless solution for injection.
Levemir leveres i et cylinderampul (Penfill) eller i en fyldt pen (FlexPen og InnoLet).
It is available in a cartridge (PenFill) or in a prefilled pen (FlexPen and InnoLet).
Levemir indeholder det aktive stof insulin detemir.
Levemir contains the active ingredient insulin detemir.
Levemir anvendes til patienter (voksne og børn over 6 år) med sukkersyge.
Levemir is used to treat patients (adults and children over the age of 6) who have diabetes.
Levemir indgives ved injektion subkutant (under huden) i bugvæggen (maven), lårene eller i overarmene.
Levemir is administered subcutaneously (under the skin) by injection in the abdominal wall (tummy), the thigh, or the upper arm.
Levemir er langtidsvirkende insulin.
Levemir is a long-acting insulin.
Det kan anvendes på følgende måder: • en gang dagligt som et supplement til orale midler mod sukkersyge.
It can be used in the following ways: • once a day as an add-on to oral anti-diabetes medicines.
Doseringen skal tilpasses den enkelte patients blodsukkerniveau • i kombination med injektion af korttids - eller hurtigvirkende insulin i forbindelse med måltider.
The dose should be adjusted according to the individual patients ’ blood glucose levels, • in combination with injections at mealtimes of a short- or rapid-acting insulin.
Det gives én eller to gange dagligt, afhængigt af patientens behov.
It should be given once or twice a day depending on patients’ needs.
Patientens blodsukker skal kontrolleres regelmæssigt for at fastsætte den effektive minimumsdosis.
The patient ’ s blood glucose should be regularly tested to find the lowest effective dose.
Diabetes er en sygdom, hvor kroppen ikke producerer tilstrækkeligt insulin til at regulere blodsukkeret.
Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar.
Det aktive indholdsstof i Levemir, insulin detemir, produceres via en metode, der er kendt som ‘ DNA- teknologi ’.
Levemir is a replacement insulin which is very similar to the insulin made by the pancreas. The active ingredient of Levemir, insulin detemir, is produced by a method known as ‘ recombinant DNA technology’.
Det fremstilles af en gærcelle, som har modtaget et gen (DNA), der sætter den i stand til at producere insulin detemir.
It is made by a yeast that has received a gene (DNA), which makes it able to produce insulin detemir.
Denne forskel bevirker, at det optages langsommere af kroppen og er længere om at nå sit mål i kroppen.
Insulin detemir is very slightly different from human insulin, and the change means that it is absorbed more slowly by the body, and takes longer to reach its target in the body.
Dette medfører, at Levemir virker i lang tid.
This means that Levemir has a long duration of action.
Levemir blev undersøgt hos 1575 patienter med type 1- diabetes, hvor bugspytkirtlen ikke kan producere insulin, og hos 2 400 patienter med type 2- diabetes, hvor kroppen ikke kan udnytte insulinet effektivt.
Levemir has been studied in 1,575 patients with type 1 diabetes, when the pancreas cannot produce insulin, and over 2,400 patients with type 2 diabetes, when the body is unable to use insulin effectively.
Levemir blev sammenlignet med humant insulin NPH (mellemvirkende insulin) eller insulin glargin (langtidsvirkende insulin).
The studies compared Levemir to human insulin NPH (an intermediate-acting insulin) or to insulin glargine (a long-acting insulin).
Lægemidlerne blev givet en eller to gange dagligt som injektion.
Injections of fast-acting insulin were also used at mealtimes.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
In four of the six studies in type 2 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Desuden blev der givet injektioner af hurtigtvirkende insulin i forbindelse med måltiderne.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged diabetes, patients also received one or two oral anti-diabetes medicines.
I alle undersøgelser målte man niveauerne for glykosyleret hæmoglobin (HbA1c), der indicerer, hvor godt blodsukkeret reguleres.
All studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
I undersøgelserne viste det sig, at Levemir regulerer HbA1c på samme måde som insulin NPH med en mindre grad af risiko for et lavt blodsukkerniveau om natten og ingen vægtforøgelse i forbindelse hermed.
The studies showed that Levemir controls HbA1c in a similar manner to insulin NPH, with less risk of low blood glucose level during the night and no associated weight gain.
Levemir i kombination med orale midler mod sukkersyge regulerer HbA1c på samme måde som insulin glargin.
In combination with oral anti- diabetes medicines, Levemir also controlled HbA1c in a similar manner to insulin glargine.
De hyppigste bivirkninger ved Levemir (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er hypoglykæmi (lavt blodsukker) og reaktioner på injektionsstedet (rødme, hævelse, kløe).
The most common side effects when taking Levemir (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose) and injection site reactions (redness, swelling, itching).
Almindelige bivirkninger hos patienter, der også tager orale midler mod sukkersyge, er tegn på allergi.
In patients also taking oral anti-diabetes medicines, a common side effect is signs of allergy.
Den fuldstændige liste over alle indberettede bivirkninger ved Levemir fremgår af indlægssedlen.
For the full list of all side effects reported with Levemir, see the Package Leaflet.
Levemir må ikke anvendes af personer, der kan være overfølsomme over for insulin detemir eller nogen af indholdsstofferne.
Levemir should not be used in people who may be hypersensitive to insulin detemir or any of the other ingredients.