natgillin/translations-raw huggingface dataset:
Dosisjustering kan også blive nødvendig, fx hvis:
Dose adjustment may also be required, for example, if
- patienten ændrer vægt,
- the patient's weight changes,
- patienten ændrer levevis,
- the patient's life-style changes,
- andre omstændigheder opstår, som øger følsomheden over for hypoglykæmi eller hyperglykæmi
- other circumstances arise that may promote an increased susceptibility to hypo- or
4. 4).
hyperglycaemia (see section 4.4).
Anvendelse til specielle patientgrupper
Use in specific patient groups
4. 4).
In patients with hepatic or renal impairment as well as in the elderly, insulin requirements may be diminished (see section 4.4).
Insulin Human Winthrop Rapid indeholder 100 IE insulin pr. ml opløsning.
Insulin Human Winthrop Rapid contains 100 IU of insulin per ml solution.
Injektionssprøjterne må ikke indeholde andre lægemidler eller rester heraf (fx spor af heparin).
The injection syringes must not contain any other medicinal product or residue (e. g. traces of heparin).
Insulinabsorptionen og den deraf følgende blodglukosesænkende virkning af en dosis kan variere mellem de forskellige injektionsfelter (fx på abdomen i forhold til låret).
Insulin absorption and hence the blood glucose lowering effect of a dose may vary from one injection area to another (e. g. the abdominal wall compared with the thigh).
Intravenøs insulinbehandling bør som hovedregel foregå på en intensivafdeling eller under lignende monitorerings - og behandlingsforhold (se "Døgndosis og tidspunkt for administration").
Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
Insulin Human Winthrop Rapid må ikke anvendes i eksterne eller implanterede insulinpumper eller i peristaltiske pumper med silikoneslanger.
Insulin Human Winthrop Rapid must not be used in external or implanted insulin pumps or in peristaltic pumps with silicone tubing.
Patienter, der er overfølsomme over for Insulin Human Winthrop Rapid, men hvor et bedre behandlingsalternativ ikke findes, må kun fortsætte behandlingen under særlig nøje kontrol og - om nødvendigt - i forbindelse med samtidig anti- allergisk behandling.
Patients hypersensitive to Insulin Human Winthrop Rapid for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.
3 Inden omstilling til Insulin Human Winthrop Rapid anbefales det at foretage en intradermal hudtest på de patienter, der er allergiske over for animalsk insulin, da disse patienter kan udvikle immunologiske krydsreaktioner.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Rapid, since they may experience immunological cross-reactions.
Hos patienter med svært nedsat leverfunktion kan insulinbehovet mindskes på grund af nedsat evne til glukoneogenese og nedsat insulinmetabolisme.
In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
I tilfælde af utilstrækkelig glukosekontrol eller ved tendens til udvikling af hyper - eller hypoglykæmi skal følgende vurderes inden en eventuel dosisjustering: hvorvidt patienten har overholdt den ordinerede behandlingsforskrift, har fulgt forskrifterne for injektionssteder, anvendt korrekt injektionsteknik, samt hvorvidt øvrige relevante faktorer er opfyldt.
In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.
Det tilrådes også til patienter med proliferativ retinopati, især hvis denne ikke er laserbehandlet (risiko for forbigående amaurose efter hypoglykæmi).
Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).
- patienter, hvor den glykæmiske kontrol er forbedret betydeligt,
- in whom glycaemic control is markedly improved,
- patienter, hvor hypoglykæmi udvikles gradvist,
- in whom hypoglycaemia develops gradually,
- ældre patienter,
- who are elderly,
- efter omstilling fra animalsk insulin til humant insulin
- after transfer from animal insulin to human insulin,
- patienter, som lider af autonom neuropati,
- in whom an autonomic neuropathy is present,
- patienter med en lang diabetes- anamnese,
- with a long history of diabetes,
- patienter, som har en psykisk lidelse,
- suffering from a psychiatric illness,
4. 5).
- receiving concurrent treatment with certain other medicinal products (see section 4.5).
Sådanne situationer kan føre til alvorlige tilfælde af hypoglykæmi, (og eventuelt bevidsthedstab) uden at patienten forudgående har erkendt hypoglykæmien.
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
Såfremt der observeres normale eller ligefrem nedsatte værdier af glykosyleret hæmoglobin observeres, skal risikoen for tilbagevendende, ikke- erkendte (især natlige) hypoglykæmiske anfald tages i betragtning.
If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.
For at mindske risikoen for hypoglykæmi er det vigtigt, at patienten overholder dosering og diæt, administrerer insulinet korrekt, og er opmærksom på symptomer på hypoglykæmi.
4 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
- skift til andet injektionsfelt,
- change in the injection area,
- forbedret insulinfølsomhed (fx pga.. fjernelse af stressfaktorer),
- improved insulin sensitivity (by, e. g., removal of stress factors),
- uvant, øget eller længerevarende fysisk aktivitet,
- unaccustomed, increased or prolonged physical activity,
- anden samtidig sygdom (fx opkastning, diarré),
- intercurrent illness (e. g. vomiting, diarrhoea),
- utilstrækkelig fødeindtagelse,
- inadequate food intake,
- oversprungne måltider,
- missed meals,
- alkoholindtagelse,
- alcohol consumption,
- visse ukompenserede endokrine lidelser (fx hypothyroidisme, hypofyseforlap - eller
- certain uncompensated endocrine disorders (e. g. in hypothyroidism and in anterior pituitary or
binyrebarkinsufficiens),
adrenocortical insufficiency),
- samtidig behandling med visse andre lægemidler.
- concomitant treatment with certain other medicinal products.
4 Interkurrente sygdomme
Intercurrent illness
Type 1- diabetikere skal fortsætte med at indtage i det mindste små mængder af kulhydrater regelmæssigt, også selv om de kun kan spise lidt eller ingen føde, kaster op etc., og de må aldrig udelade insulin helt.
Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.
En række stoffer har indflydelse på glukosemetabolismen og kan nødvendiggøre dosisjustering af human insulin.
A number of substances affect glucose metabolism and may require dose adjustment of human insulin.
Stoffer, som kan forstærke den blodsukkersænkende virkning, og som kan øge risikoen for hypoglykæmi, omfatter perorale antidiabetika, angiotensin converting enzym (ACE) - hæmmere, disopyramid, fibrater, fluoxetin, monoamin oxidase (MAO) - hæmmere, pentoxifyllin, propoxyfen, salicylater og sulfonamidantibiotika.
Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Stoffer, som kan nedsætte den blodsukkersænkende virkning, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener (f. eks orale kontraceptiver), phenthiazinderivater, somatropin, sympatomimetika (fx adrenalin, salbutamol, terbutalin) og thyreoideahormoner, proteasehæmmere samt atypisk antipsykotisk medicin (f. eks. olanzapin og clozapin).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Betablokkere, clonidin, lithiumsalte eller alkohol kan enten forstærke eller nedsætte insulins blodglukosesænkende virkning.
Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose- lowering effect of insulin.
Under behandling med sympatikolytiske lægemidler som fx betablokkere, clonidin, guanethidin og reserpin kan symptomerne på adrenerg modregulation ligeledes være reduceret eller helt mangle.
In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Der bør udvises forsigtighed ved ordinering til gravide
Caution should be exercised when prescribing to pregnant women.
Det er meget vigtigt for patienter med kendt eller gestationel diabetes at opretholde en god metabolisk kontrol under graviditeten.
5 It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy.
Der forventes ingen påvirkning på det ammende barn.
No effects on the suckling child are anticipated.
Insulin Human Winthrop Rapid kan anvendes under amning.
Insulin Human Winthrop Rapid can be used during breastfeeding.
Det kan være nødvendigt at justere insulindosis og diæt hos kvinder, der ammer.
Lactating women may require adjustments in insulin dose and diet.
Patientens koncentrations - og reaktionsevne kan nedsættes som følge af hypoglykæmi eller hyperglykæmi, eller fx på grund af nedsat syn.
The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Dette kan udgøre en risiko i situationer, hvor disse evner er af særlig betydning (fx ved bilkørsel eller ved betjening af maskiner).
This may constitute a risk in situations where these abilities are of special importance (e. g. driving a car or operating machinery).
5 Patienter bør rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Det bør i sådanne tilfælde overvejes, om bilkørsel eller betjening af maskiner er tilrådeligt.
It should be considered whether it is advisable to drive or operate machinery in these circumstances.
Hypoglykæmi, der normalt er den hyppigste uønskede virkning ved insulinbehandling, kan opstå, hvis insulindosis er for høj i forhold til insulinbehovet.
Hypoglycaemia, in general the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
I kliniske forsøg og under anvendelse efter markedsføring varierer hyppigheden mellem patientpopulation og doseringsregimer.
In clinical trials and during marketed use, the frequency varies with patient population and dose regimens.
Generelt gælder det, at jo større og hurtigere faldet i blodglukosen er, des mere udtalt er modregulationstilstanden og dens symptomer.
Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.
(< 1/ 10. 000), ikke kendt (kan ikke estimeres udfra de tilgængelige data).
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Type 1 allergiske reaktioner (hypotension, angioødem, bronkospasmer, generaliserede hudreaktioner), antistoffer mod insulin.
Uncommon: shock Not known: immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions), anti-insulin antibodies
Behandling med insulin kan føre til dannelse af antistoffer mod insulin.
Insulin administration may cause anti-insulin antibodies to form.
I sjældne tilfælde kræver forekomsten af sådanne insulinantistoffer justering af insulindosis for at korrigere for tendensen til udvikling af hyper - eller hypoglykæmi.
In rare cases, the presence of such anti-insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Stofskiftesygdomme og ernæringsbetingede sygdomme
6 Metabolism and nutrition disorders
Ødem Ikke kendt: natriumretention
Common: oedema Not known: sodium retention
Øjensygdomme
Eyes disorders
Proliferativ retinopati, diabetisk retinopati, synsforstyrrelser.
Not known: proliferative retinopathy, diabetic retinopathy, visual impairment
6 En forbedret glykæmisk kontrol over lang tid mindsker risikoen for progression af diabetisk retinopati.
Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Ikke kendt: lipodystrofi Som ved enhver anden insulinbehandling kan der opstå lipodystrofi på injektionsstedet.
As with any insulin therapy, lipodystrophy may occur at the injection site and delay local insulin absorption.
Almene lidelser og reaktioner på indgivelsesstedet.
General disorders and administration site conditions
Inflammation på injektionsstedet, hævelse på injektionsstedet, smerte på injektionsstedet, kløe på injektionsstedet, erytem på injektionsstedet
Common: injection site reactions Uncommon: injection site urticaria Not known: injection site inflammation, injection site swelling, injection site pain, injection site pruritus, injection site erythema.
Der skal muligvis foretages ændringer i dosering af lægemidlet, samt i kostplanerne og fysiske aktivitet.
Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed.
Sværere tilfælde med koma, kramper eller neurologisk svækkelse kan behandles med intramuskulær/ subkutan glucagon eller koncentreret intravenøs glukoseopløsning.
More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/ subcutaneous glucagon or concentrated intravenous glucose.
Det kan derfor være nødvendigt med vedvarende indtagelse af kulhydrater og overvågning.
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Antidiabetika.
Antidiabetic agent.
Insulin og insulin- analoger, hurtigvirkende, ATC kode:
Insulins and analogues, fast-acting, ATC Code:
Insulin
Insulin
- sænker blodglukose, fremmer anabolisme og hæmmer katabolisme,
- lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,
- øger glukosetransporten ind i cellerne, fremmer glykogendannelsen i muskler og lever, og
- increases the transport of glucose into cells as well as the formation of glycogen in the muscles
forbedrer udnyttelsen af pyruvat.
and the liver, and improves pyruvate utilisation.
- øger lipogenesen i lever og fedtvæv, og hæmmer lipolysen,
- increases lipogenesis in the liver and adipose tissue and inhibits lipolysis,
- fremmer cellernes optagelse af aminosyrer og fremmer proteinsyntese,
- promotes the uptake of amino acids into cells and promotes protein synthesis,
7 Farmakodynamiske karakteristika
Pharmacodynamic characteristics
Hos raske personer er insulins serum- halveringstid omkring 4 - 6 minutter.
In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Der ses ingen tegn på toksiske virkninger.
No evidence of toxic effects was found.
Lokale toleranceforsøg efter subkutan og intramuskulær administration på kaniner viser ingen bemærkelsesværdige fund.
Local tolerability studies following subcutaneous and intramuscular administration in rabbits gave no remarkable findings.
Farmakodynamiske undersøgelser efter subkutan administration på kaniner og hunde viser de forventede hypoglykæmiske reaktioner.
Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.
Metacresol, natriumdihydrogenphosphatdihydrat, glycerol, natriumhydroxid, saltsyre (til pH justering) vand til injektionsvæsker.
Metacresol, sodium dihydrogen phosphate dihydrate, glycerol, sodium hydroxide, hydrochloric acid (for pH adjustment), water for injections.
Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt 6. 6.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
6. 6.
Concerning mixing or incompatibility with other insulins see section 6.6.
Opbevaringstid efter første anbrud af hætteglasset:
Shelf life after first use of the vial:
Produktet kan anvendes i op til 4 uger og ikke over 25°C, væk fra direkte varme eller direkte lys.
The product may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light.
Uåbnet hætteglas:
Unopened vials:
Åbnet hætteglas:
Opened vials:
6. 3.
For storage precautions, see section 6.3.
5 ml opløsning i et hætteglas (type 1 farveløst glas med ombøjet hætte (aluminium), en prop (chlorbutylgummi (type 1)) og aftageligt låg (polypropylen).
5 ml solution in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).
Findes i pakninger med 1 eller 5 hætteglas.
Packs of 1 and 5 vials are available.
6. 6 Regler for destruktion og anden håndtering.
6.6 Special precautions for disposal and other handling
Plastbeskyttelseshætten fjernes, inden der første gang trækkes insulin op fra fra hætteglasset.
Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.
Hætteglasset må ikke rystes så kraftigt, at det kan forårsage skumdannelse.
Do not shake the vial vigorously as this may cause frothing.
Insulin Human Winthrop Rapid må kun anvendes, såfremt opløsningen er klar, farveløs, uden synlige partikler og har et vandlignende udseende.
Insulin Human Winthrop Rapid must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of a water-like consistency.
Insulin Human Winthrop Rapid må i lighed med andre insulinpræparater ikke blandes med opløsninger, der indeholder reducerende stoffer som thioler og sulfitter.
As with all insulin preparations, Insulin Human Winthrop Rapid must not be mixed with solutions containing reducing agents such as thioles and sulphites.
Opmærksomheden henledes på, at neutral, opløselig insulin præcipiterer ved pH omkring 4, 5 - 6, 5.
It must also be remembered that neutral regular insulin precipitates out at a pH of approximately 4.5 to 6.5.
Blanding af insulin
Mixing of insulins
Insulin Human Winthrop Rapid kan blandes med alle humane insuliner fra Sanofi- Aventis, men IKKE med dem der er designet til anvendelse i insulinpumper.
Insulin Human Winthrop Rapid may be mixed with all Sanofi-Aventis human insulins, but NOT with those designed specifically for use in insulin pumps.
Insulin Rapid må heller IKKE blandes med insuliner af animalsk oprindelse eller med insulinanaloger.
Insulin Human Winthrop rapid must also NOT be mixed with insulins of animal origin or with insulin analogues.
Når to forskellige insulinformer skal trækkes op i samme injektionssprøjte, tilrådes det at trække det korttidsvirkende insulin op først, så dets hætteglas ikke kontamineres med det langtidsvirkende præparat.
If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation.
Insulin i forskellige styrker (fx 100 IE pr. ml og 40 IE pr. ml) må ikke blandes.
100 IU per ml and 40 IU per ml) must not be mixed.
Insulin Human Winthrop Rapid 40 IE/ ml injektionsvæske, opløsning, i hætteglas
Insulin Human Winthrop Rapid 40 IU/ ml solution for injection in a vial
Hver ml indeholder 40 IE human insulin (svarende til1, 4 mg).
Each ml contains 40 IU insulin human (equivalent to 1.4 mg).
1 IE (International Enhed) svarer til 0, 035 mg vandfri human insulin.
One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin.
Human insulin remstilles med rekombinant DNA- teknologi i af Escherichia coli.
Human insulin is produced by recombinant DNA technology in Escherichia coli.
Omstilling til Insulin Human Winthrop Rapid
11 Transfer to Insulin Human Winthrop Rapid
11 Dosisjustering (fx reduktion) kan være nødvendig umiddelbart efter præparatomstilling.
The need to adjust (e. g. reduce) the dose may become evident immediately after transfer.
Efter omstilling fra animalsk til human insulin vil dosisreduktion især være påkrævet hos patienter, der:
Following transfer from an animal insulin to human insulin, dosage reduction may be required in particular in patients who
Insulin Human Winthrop Rapid indeholder 40 IE insulin pr. ml opløsning.
Insulin Human Winthrop Rapid contains 40 IU of insulin per ml solution.
12 Inden omstilling til Insulin Human Winthrop Rapid anbefales det at foretage en intradermal hudtest på de patienter, der er allergiske over for animalsk insulin, da disse patienter kan udvikle immunologiske krydsreaktioner.
In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insulin Human Winthrop Rapid, since they may experience immunological cross-reactions.
For at mindske risikoen for hypoglykæmi er det vigtigt, at patienten overholder dosering og diæt, administrerer insulinet korrekt, og er opmærksom på symptomer på hypoglykæmi.
13 Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Stoffer, som kan nedsætte den blodsukkersænkende virkning, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener (f. eks i orale kontraceptiver), phenthiazinderivater, somatropin, sympatomimetika (fx adrenalin, salbutamol, terbutalin) og thyreoideahormoner, proteasehæmmere samt atypisk antipsykotisk medicin (f. eks. olanzapin og clozapin).
Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e. g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e. g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e. g. olanzapine and clozapine).
Amning
14 Lactation
Der forventes ingen påvirkning af det ammende barn.
No effects on the suckling child are anticipated.
Insulin Human Winthrop Rapid kan anvendes under amning..
Insulin Human Winthrop Rapid can be used during breastfeeding.
14 Patienter bør rådes til at tage forholdsregler for at undgå hypoglykæmi i forbindelse med bilkørsel.
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.