natgillin/translations-raw huggingface dataset:
- Kontakte din læge eller apotek, hvis De har yderligere spørgsmål.
- If you have any further questions, ask your doctor or pharmacist.
nævnt i denne indlægsseddel, bør De fortælle det til din læge eller apotek.
please tell your doctor or pharmacist.
Hvad Trazec er, og hvad det anvendes til 2.
What Trazec is and what it is used for 2.
Hvad De skal gøre, før De begynder at anvende Trazec 3.
Before you take Trazec 3.
Hvordan De anvender Trazec 4.
How to take Trazec 4.
Hvilke mulige bivirkninger Trazec har 5.
Possible side effects 5.
Hvordan De opbevarer Trazec 6.
How to store Trazec 6.
Trazec fungerer ved at stimulere bugspytkirtlen, så den producerer insulin hurtigere, og det bidrager til at kontrollere blodsukkeret efter måltiderne.
This helps to keep the blood sugar controlled after meals.
Du bør ikke anvende Trazec
Do not take Trazec
- hvis du er allergisk (overfølsom) over for nateglinid eller et af de øvrige indholdsstoffer i
- if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Trazec.
37 Vær særlig forsigtig med at anvende Trazec Diabetikere får af og til symptomer på lavt blodsukker (også kaldet hypoglykæmi).
37 Take special care with Trazec People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia).
4, ” Hvilke mulige bivirkninger Trazec har ” – skal du spise eller drikke noget, der indeholder sukker.
If you get any of these symptoms – feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, “ Possible side effects” – eat or drink something containing sugar.
Dette kan medføre stigning eller fald i blodsukkerniveauet.
The amount of Trazec that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
3 ” Hvordan De anvender Trazec ”).
Food, drink and exercise Take Trazec before meals (see section 3, “ How to take Trazec”).
38 Alkohol kan forstyrre blodsukkerkontrollen, så det anbefales, at du taler med din læge om alkoholindtagelse under behandlingen med Trazec.
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Trazec.
Trazec og børn og unge Trazec anbefales ikke til børn og unge (under 18 år), fordi virkningerne i denne aldersgruppe ikke er undersøgt.
38 Trazec and children and adolescents Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Graviditet og amning Anvend ikke Trazec, hvis du er gravid eller planlægger at blive gravid.
Pregnancy and breast-feeding Do not take Trazec if you are pregnant or planning to become pregnant.
HVORDAN DE ANVENDER TRAZEC
HOW TO TAKE TRAZEC
Hvornår skal Trazec tages Trazec skal tages før de 3 hovedmåltider, normalt:
When to take Trazec Take Trazec before the three main meals, usually:
Hvor meget skal der tages Følg lægens vejledning, når du tager Trazec.
How much to take Take Trazec as your doctor told you to.
39 Hvor længe skal Trazec tages Trazec skal tages dagligt, indtil lægen giver dig besked om at standse behandlingen.
How long to take Trazec Take Trazec daily until your doctor tells you to stop.
Hvis De tager mere Trazec, end De bør Søg straks læge, hvis du kommer til at tage for mange tabletter.
If you take more Trazec than you should If you have accidentally taken too many tablets, talk to a doctor straight away.
4, ” Hvilke mulige bivirkninger Trazec har ” – skal du spise eller drikke noget, der indeholder sukker.
If you experience symptoms of low blood sugar – if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, “ Possible side effects” – eat or drink something containing sugar.
Hvis De glemmer at tage Trazec Hvis du glemmer at tage en tablet, skal du blot tage den næste før det næste måltid.
If you forget to take Trazec If you forget to take a tablet simply take the next one before your next meal.
HVILKE MULIGE BIVIRKNINGER TRAZEC HAR
POSSIBLE SIDE EFFECTS
En meget sjælden bivirkning er hududslæt med blistre som rammer læber, øjne, mund sommetider med hovedpine, feber og/ eller diarré.
A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/ or diarrhoea.
40 Medicinen må ikke tilføres spildevand eller husholdningsaffald.
40 6.
Hvad Trazec indeholder
What Trazec contains
- Det aktive stof er nateglinid.
- The active substance is nateglinide.
- Andre indholsstoffer er laktosemonohydrat; cellulose, mikrokrystallinsk; povidon;
- The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone;
croscarmellosenatrium; magnesium stearat og silica, kolloid vandfri.
croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
- Tabletovertrækker indeholder hypromellose; titandioxid (E171); talkum; macrogol og rød (60
- The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60
og 180 mg tabletter) eller gul (120 mg jernoxid (E172).
and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
Produktets udseende og pakningsstørrelse Trazec 60 mg filovertrukne tabletter er lyserøde, runde tabletter med ” NVR ” indprintet på én side og ” TS ” på den anden.
What Trazec looks like and contents of the pack Trazec 60 mg film-coated tablets are pink, round tablets with “ NVR” marked on one side and “ TS” on the other.
Trazec 120 mg filovertrukne tabletter er gule, ovale tabletter med ” NVR ” indprintet på én side og ” TSL ” på den anden.
Trazec 120 mg film-coated tablets are yellow, ovaloid tablets with “ NVR” marked on one side and “ TSL” on the other.
Trazec 180 mg filovertrukne tabletter er røde, ovale tabletter med ” NVR ” indprintet på én side og ” TSX ” på den anden.
Trazec 180 mg film-coated tablets are red, ovaloid tablets with “ NVR” marked on one side and “ TSX” on the other.
Tredaptive er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3- vitamin) og laropiprant.
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Tredaptive anvendes som supplement til diæt og motion hos patienter med dyslipidæmi (unormalt højt fedtindhold i blodet), især "kombineret blandet dyslipidæmi" og "primær hyperkolesterolæmi".
Tredaptive is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
I Tredaptive- tabletter er der laropiprant i et af lagene, mens det andet lag indeholder nikotinsyre.
In Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Den første undersøgelse, der omfattede i alt 1 613 patienter, sammenlignede virkningen af Tredaptive med virkningen af nikotinsyre alene eller med placebo (uvirksom behandling) med hensyn til sænkning af indholdet af LDL- kolesterol.
The first study compared the effectiveness of Tredaptive with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
Tredaptive var effektivt til at sænke blodets indhold af LDL- kolesterol.
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
I den første undersøgelse blev indholdet af LDL- kolesterol reduceret med 19% hos patienter, der fik Tredaptive, sammenlignet med 1% hos dem, der fik placebo.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Den anden undersøgelse viste, at indholdet af LDL- kolesterol blev yderligere sænket, når Tredaptive blev givet sammen med simvastatin (48% reduktion) sammenlignet med Tredaptive alene (17% reduktion) eller simvastatin alene (37% reduktion).
The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tredaptive er større end risiciene ved behandling af dyslipidæmi, især hos patienter med kombineret blandet dyslipidæmi og patienter med primær hyperkolesterolæmi.
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Den 3. juli 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
2/ 3 Den fuldstændige EPAR for Tredaptive findes her.
The full EPAR for Tredaptive can be found here.
Tredaptive 1. 000 mg/ 20 mg tabletter med modificeret udløsning.
Tredaptive 1000 mg/ 20 mg modified-release tablets.
Kapselformet, hvid/ off- white tablet mærket med "552" på den ene side.
Capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Tredaptive er indiceret til behandling af dyslipidæmi, især hos patienter med kombineret dyslipidæmi (karakteriseret ved forhøjede koncentrationer af LDL- kolesterol og triglycerider samt lavt HDL - kolesterol) og hos patienter med primær hyperkolesterolæmi (heterozygot familiær og non- familiær).
Tredaptive is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Tredaptive bør anvendes sammen med HMG- CoA reduktasehæmmere (statiner), når den kolesterolsænkende effekt af monoterapi med HMG- CoA- reduktasehæmmere er utilstrækkelig.
Tredaptive should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Tredaptive kan anvendes som monoterapi hos patienter, hvor HMG- CoA- reduktasehæmmere anses for at være utilstrækkelige eller ikke tåles.
It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated.
Diæt og anden ikke- farmakologisk behandling (f. eks. motion, vægtreduktion) bør fortsætte under behandlingen med Tredaptive.
Diet and other non-pharmacological treatments (e. g. exercise, weight reduction) should be continued during therapy with Tredaptive.
Hvis patienten har undladt at tage Tredaptive i 7 eller flere på hinanden følgende dage, kan behandlingen genoptages med 1. 000 mg/ 20 mg i en uge, før dosis øges til vedligeholdelsesdosis på 2. 000 mg/ 40 mg.
If Tredaptive is missed for 7 or more consecutive days, therapy should be resumed at the 1000 mg/ 20 mg dose for 1 week, before advancing to the maintenance dose of 2000 mg/ 40 mg.
Patienter, som skifter fra 2. 000 mg eller mere af et nicotinsyredepotpræparat, kan starte behandling med Tredaptive med en dosis på 2. 000 mg/ 40 mg.
2 Those patients switching from 2000 mg or more of prolonged-release nicotinic acid can initiate Tredaptive at the 2000 mg/ 40 mg dose.
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Tredaptive, bør starte behandling med 1. 000 mg/ 20 mg og overgå til en vedligeholdelsesdosis på 2. 000 mg/ 40 mg efter fire uger.
For patients switching from immediate-release nicotinic acid to Tredaptive, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
Pædiatriske patienter Tredaptive bør ikke anvendes til pædiatriske patienter p. g. a. manglende dokumentation for sikkerhed og virkning.
Therefore, treatment is not recommended in this age group.
Patienter med lever - eller nyreinsufficiens Anvendelse af Tredaptive er ikke undersøgt hos patienter med lever - eller nyreinsufficiens.
Use in patients with hepatic or renal insufficiency Use of Tredaptive in patients with hepatic or renal insufficiency has not been studied.
Samtidig behandling Acetylsalicylsyre giver ikke yderligere reduktion af flushing, ud over den der opnås ved Tredaptive.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Tredaptive.
4. 5).
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Leverpåvirkning Skift fra nicotinsyre med umiddelbar udløsning (krystallinsk) til Tredaptive er ikke undersøgt.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Tredaptive has not been studied.
Patienter, der skifter fra nicotinsyre med umiddelbar udløsning til Tredaptive, bør derfor starte med 1. 000 mg/ 20 mg.
Therefore, patients switching from immediate-release nicotinic acid to Tredaptive should be initiated at the 1000 mg/ 20 mg dose.
Tredaptive bør anvendes med forsigtighed hos patienter, som indtager væsentlige mængder alkohol og/ eller har leversygdom i anamnesen.
Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Læger, som overvejer kombinationsbehandling med statiner og Tredaptive, bør nøje overveje de mulige fordele i forhold til risikoen og bør monitorere patienterne nøje med henblik på tegn og symptomer på muskelsmerte, - ømhed eller - svaghed, især i de første måneder af behandlingen, og når doseringen af et af lægemidlerne øges.
Physicians contemplating combined therapy with statins and Tredaptive should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
Hvis muskelsmerter, - svaghed eller - kramper opstår, mens patienten er i behandling med Tredaptive sammen med et statin, skal CK- koncentrationerne måles.
If muscle pain, weakness or cramps occur while a patient is receiving Tredaptive with a statin, their CK levels should be measured.
Nyreinsufficiens Da nicotinsyre og dets metabolitter udskilles via nyrerne, bør Tredaptive anvendes med forsigtighed hos patienter med nyreinsufficiens.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive should be used with caution in patients with renal dysfunction.
Akut koronarsyndrom Som med andre nicotinsyrepræparater bør der udvises forsigtighed, når Tredaptive anvendes til patienter med ustabil angina eller patienter i den akutte fase af myokardieinfarkt, især når disse patienter også får vasoaktive lægemidler, såsom nitrater, calciumkanalblokkere eller adrenerge blokkere.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Tredaptive is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
4. 8).
Haematologic effects As with other nicotinic acid medicinal products, Tredaptive (2000 mg/ 40 mg) was associated with small reductions in platelet count (see section 4.8).
4. 8).
Effect on uric acid As with other nicotinic acid medicinal products, Tredaptive (2000 mg/ 40 mg) was associated with small increases in uric acid levels (see section 4.8).
Hypofosfatæmi Som med andre nicotinsyrepræparater er Tredaptive blevet forbundet med små fald i fosfor.
Hypophosphatemia As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
4 Tredaptive indeholder lactose.
Excipient Tredaptive contains lactose.
Samtidig indtagelse af alkohol eller varme drikke kan forstærke flushing- effekten og bør derfor undgås omkring tidspunktet for indtagelse af Tredaptive.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Tredaptive.
4. 4).
The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
Da samtidig administration af galdesyrebindende lægemidler kan reducere biotilgængeligheden af sure lægemidler, såsom nicotinsyre, anbefales det, at Tredaptive administreres > 1 time før eller > 4 timer efter administration af et galdesyrebindende lægemiddel.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Vitaminer eller andre ernæringstilskud med (≥ 50 mg / dag) nicotinsyre (eller nicotinamid) er ikke blevet undersøgt sammen med Tredaptive.
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive.
Forsigtighed bør udvises, når Tredaptive administreres sammen med lægemidler, der overvejende metaboliseres af UGT2B4 eller UGT2B7, f. eks. zidovudin.
Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Tredaptive Der foreligger ingen data for kombineret anvendelse af nicotinsyre og laropiprant til gravide.
Pregnancy Tredaptive There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Tredaptive Der er ikke udført undersøgelser med Tredaptive hos diegivende dyr.
Lactation Tredaptive No studies in lactating animals have been conducted with Tredaptive.
Beslutning om, hvorvidt amningen eller behandlingen skal fortsætte/ ophøre, bør tages i forhold til den gavnlige virkning af amning for barnet og den gavnlige virkning af Tredaptive for kvinden.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Tredaptive to the woman.
4. 8 Bivirkninger I kliniske undersøgelser har mere end 2. 500 patienter fået Tredaptive alene eller sammen med en HMG- CoA- reduktasehæmmer.
4.8 Undesirable effects In clinical trials, over 2500 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
6 Flushing er den mest almindelige bivirkning ved Tredaptive.
Flushing Flushing is the most common adverse reaction of Tredaptive.
I fire aktive eller placebo- kontrollerede kliniske undersøgelser (n=2. 548) blev der af investigator rapporteret om flushing som enten en mulig, sandsynlig eller klart behandlingsrelateret bivirkning hos 12, 3% af de patienter, der fik Tredaptive.
In a pool of four active- or placebo-controlled clinical trials (N=2548), flushing was reported by the investigator as a possibly, probably, or definitely treatment-related adverse reaction in 12.3% of patients taking Tredaptive.
I disse undersøgelser var procentdelen af patienter, der fik Tredaptive, nicotinsyre (depotformuleringer, poolede) eller placebo/ simvastatin (poolet), og som stoppede behandlingen på grund af flushing - relaterede symptomer (rødme, varme, kløe og prikken i huden) henholdsvis 7, 2%, 16, 6% og 0, 4%.
In these studies, the percentage of patients taking Tredaptive, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/ simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2%, 16.6%, and 0.4%, respectively.
Seponering på grund af andre specifikke bivirkninger var sjælden (< 1%) blandt de patienter, der tog Tredaptive.
Discontinuations due to other specific adverse reactions among patients taking Tredaptive were infrequent (< 1%).
Samlede bivirkninger ved Tredaptive Nedenfor ses de kliniske bivirkninger, der ud over flushing er rapporteret af investigatorerne som muligvis, sandsynligvis eller klart relateret til Tredaptive hos ≥ 1% af de patienter, der blev behandlet med Tredaptive alene (n=947) eller sammen med et statin (n=1. 601) samt kliniske relevante bivirkninger (< 1%) i op til et år.
7 Overall adverse reactions with Tredaptive In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Tredaptive in ≥ 1% of patients treated with Tredaptive alone (n=947) or co-administered with statin (n=1601) and clinically meaningful adverse reactions (< 1%), for up to one year are listed below.
Bivirkning Stigninger i ALAT og/ eller ASAT (konsekutivt, ≥3 x ULN), fasteglucose, urinsyre (se nedenfor).
Adverse reaction elevations in ALT and/ or AST (consecutive, ≥ 3 X ULN), fasting glucose, uric acid (see below)
Stigninger i CK (≥10 x ULN), totalt bilirubin, fald i fosfor og antal blodplader (se nedenfor).
elevations in CK (≥ 10 X ULN), total bilirubin, reductions in phosphorus and platelet counts (see below)
I kontrollerede kliniske undersøgelser var incidensen af klinisk relevante stigninger i serumtransaminaser (ALAT og/ eller ASAT ≥ 3 x ULN (øvre normalgrænse) konsekutivt) 1, 0% for patienter, der blev behandlet med Tredaptive med eller uden et statin.
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/ or AST ≥ 3 X ULN, consecutive) was 1.0% for patients treated with Tredaptive with or without a statin.
4. 4).
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Tredaptive with or without a statin (see section 4.4).
7 Som med andre nicotinsyrepræparater er der i kontrollerede kliniske undersøgelser med Tredaptive (2. 000 mg/ 40 mg) rapporteret om stigninger i fasteglucose (en gennemsnitlig stigning på ca.
As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/ dL), and uric acid (mean change from baseline of +14.7%), and reductions in platelet counts (a mean change from baseline of -14.0%) were reported in
4. 4).
8 controlled clinical studies with Tredaptive (2000 mg/ 40 mg) (see section 4.4).
Nicotinsyrerelaterede bivirkninger Følgende nicotinsyrerelaterede bivirkninger er set i kliniske undersøgelser eller efter markedsføring med andre nicotinsyrepræparater i ukendt frekvens eller i kliniske undersøgelser med Tredaptive (eller nicotinsyrekomponenten af Tredaptive) hos < 1% af de behandlede patienter:
Nicotinic acid-related adverse reactions The following nicotinic acid-related adverse reactions have been seen in clinical trials or post-marketing experience with other nicotinic acid medicinal products at unknown frequency or in clinical trials with Tredaptive (or the nicotinic acid component of Tredaptive) in < 1% of the patients treated:
Tredaptive I tilfælde af overdosering er det hensigtsmæssigt at anvende de sædvanlige symptomatiske og understøttende forholdsregler.
Tredaptive In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Der er rapporteret om tilfælde af overdosering; den højeste dosis, der var taget, var 5. 000 mg/ 100 mg.
Cases of overdose have been reported; the maximum dose of Tredaptive taken was 5000 mg/ 100 mg.
8 Tredaptive indeholder nicotinsyre, som i terapeutiske doser er et lipidmodificerende stof, og laropiprant, der er en potent, selektiv prostaglandin D2- antagonist (PGD2) receptorsubtype 1 (DP1).
Tredaptive contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).