natgillin/translations-raw huggingface dataset:
- Lægen har ordineret Ristaben til Dem personligt.
- This medicine has been prescribed for you only.
Myalgi
Posology
6.1 (se pkt.
For the full list of excipients, see section 6.1.
I to 24-ugers undersøgelser gav sitagliptin 100 mg en gang dagligt som supplerende behandling, den ene i kombination med metformin og den anden med pioglitazon, en signifikant glykæmisk forbedring, sammenlignet med placebo.
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
Ristaben 25 mg filmovertrukne tabletter sitagliptin
Ristaben 25 mg film-coated tablets Sitagliptin
Ristaben 50 mg filmovertrukne tabletter
Ristaben 50 mg film-coated tablets
Akut nyresvigt
Hepatic impairment
Børn Der er ikke udført undersøgelser med anvendelse af Ristaben til børn.
Paediatric No studies with Ristaben have been performed in paediatric patients.
Ristaben 100 mg filmovertrukne tabletter sitagliptin
Ristaben 100 mg film-coated tablets Sitagliptin
Population; alle behandlede patienter (analyse med henblik på behandling) Gennemsnit ved mindste kvadraters metode justeret for status for tidligere antihyperglykæmisk behandling og baseline-værdi.
Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Ristaben 50 mg filmovertrukne tabletter sitagliptin
Ristaben 50 mg film-coated tablets Sitagliptin
Knogler, led, muskler og bindevæv Artralgi
Musculoskeletal and connective tissue disorders arthralgia
Hver filmovertrukken tablet (tablet) indeholder sitagliptin phosphatmonohydrat, der svarer til 100 mg sitagliptin.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Hver filmovertrukken tablet (tablet) indeholder sitagliptin phosphatmonohydrat, der svarer til 25 mg sitagliptin.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Hver tablet indeholder sitagliptin phosphatmonohydrat svarende til 100 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate equivalent to 100 mg of sitagliptin.
Hver tablet indeholder sitagliptin phosphatmonohydrat svarende til 25 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate equivalent to 25 mg of sitagliptin.
Hver filmovertrukken tablet (tablet) indeholder sitagliptin phosphatmonohydrat, der svarer til 50 mg sitagliptin.
Each film-coated tablet (tablet) contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Hver tablet indeholder sitagliptin phosphatmonohydrat svarende til 50 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate equivalent to 50 mg of sitagliptin.
Bulløs pemfigoid
Common dizziness
Hver tablet indeholder sitagliptin-phosphatmonohydrat, svarende til 100 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Hver tablet indeholder sitagliptin-phosphatmonohydrat, svarende til 25 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Hver tablet indeholder sitagliptin-phosphatmonohydrat, svarende til 50 mg sitagliptin.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Kutan vaskulitis
Bullous pemphigoid
Dette kan være tegn på en allergisk reaktion.
These may be the signs of an allergic reaction.
Der er ikke indsendt et risikostyringsprogram.
Risk Management Plan was not submitted.
Ingen nye sikkerhedsricisi blev konstateret under denne langtidsopfølgning.
No new safety concerns were noted during this long-term follow-up.
Den kliniske relevans af denne interaktion er uvis.
The clinical relevance of this interaction is uncertain.
Neutropeni, inklusive svær neutropeni
Neutropenia, including severe neutropenia
Ansøgningen er baseret på et referencelægemiddel, for hvilket der ikke er identificeret nogen sikkerhedsanliggender, der kræver yderligere risikominimeringsaktiviteter.
The application is based on a reference medicinal product for which no safety concerns requiring additional risk minimization activities have been identified.
Dette kan ske på grund af et sjældent fald i visse blodlegemer.
These may be due to rare decrease of some blood cells.
I øvrigt kan Deres læge eventuelt finde ændringer i resultaterne af Deres blod- eller urinprøver.
In addition, your doctor may identify changes in your blood or urine test results.
Imidlertid er clopidogrel og ASA administreret samtidig i op til et år (se pkt.
However, clopidogrel and ASA have been administered together for up to one year (see
Disse resultater indikerer, at clopidogrel kan administreres sammen med pantoprazol.
These results indicate that clopidogrel can be administered with pantoprazole.
Brug af Clopidogrel Qualimed sammen med mad og drikke Clopidogrel Qualimed kan tages sammen med eller uden mad.
Taking Clopidogrel Qualimed with food and drink Clopidogrel Qualimed may be taken with or without food.
Følgelig kan en direkte virkning (let toksicitet) eller en indirekte virkning (mindre velsmagende) ikke udelukkes.
Consequently, a direct effect (slight toxicity), or an indirect effect (low palatability) cannot be
De må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
Do not take a double dose to make up for a forgotten tablet dose.
Ingen af disse analyser var tilstrækkeligt store til at kunne detektere forskelle i outcome hos personer med ringepoor metabolisme.
None of these analyses were adequately sized to detect differences in outcome in poor metabolisers.
Den mest almindelige bivirkning er blødning.
The most common side effect is bleeding.
Esomeprazol forventes at give en lignende interaktion med clopidogrel
Esomeprazole is expected to give a similar interaction with clopidogrel.
Clopidogrel er blevet evalueret sikkerhedsmæssigt hos mere end 42.000 patienter, der har deltaget i kliniske studier, inklusive over 9.000 patienter, der blev behandlet i mindst 1 år.
Clopidogrel has been evaluated for safety in more than 42,000 patients, who have participated in clinical studies, including over 9,000 patients treated for 1 year or more.
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse KRKA, d.d., Novo mesto
Name and address of the manufacturer(s) responsible for batch release KRKA, d.d., Novo mesto
• bør De fortælle Deres læge, hvis De skal have foretaget en planlagt operation (herunder tandoperation).
• You should tell your doctor if a surgery (including dental) is planned.
En patient med status som poor metabolisers vil besidde to ikke-funktionelle alleller, som beskrevet ovenfor.
A patient with poor metaboliser status will possess two loss-of-function alleles as defined above.
Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet som er beskrevet i markedsføringstilladelsen (Modul 1.8.1), er på plads og fungerer før og mens produktet markedsføres.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Dato for første tilladelse: September 21, 2009
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 September 2009
En analyse med total mortalitet som sekundært endpoint viste ingen signifikant forskel mellem clopidogrel (5,8 %) og ASA (6,0 %).
Analysis of total mortality as a secondary endpoint did not show any significant difference between clopidogrel (5.8%) and ASA (6.0%).
Den kliniske tolerance var endvidere god hos alle patienter.
In addition, clinical tolerance was good in
• hvis De er overfølsom (allergisk) over for clopidogrel eller et af de øvrige indholdsstoffer i
• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel
Imidlertid er det på grund af manglen på interaktionsstudier med andre NSAID'er ikke umiddelbart klart, om der er øget risiko for gastrointestinal blødning med alle NSAID'er.
However, due to the lack of interaction studies with other NSAIDs it is presently unclear whether there is an increased risk of gastrointestinal bleeding with all NSAIDs.
Bivirkninger der opstod enten under de kliniske studier eller der spontant blev indberettet er beskrevet i tabellen nedenfor.
Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented in the table below.
Clopidogrel Qualimed er ikke beregnet til anvendelse hos børn og unge.
Clopidogrel Qualimed is not intended for use in children or adolescents.
Visse typer medicin kan påvirke brugen af Clopidogrel Qualimed eller omvendt.
Some other medicines may influence the use of Clopidogrel Qualimed or vice versa.
De må ikke amme, når De tager denne medicin.
You should not breastfeed while taking this medicine.
Blødning er den mest almindeligt rapporterede bivirkning fra både kliniske studier, såvel som fra post-marketing erfaring, hvor den mestendels blev rapporteret i løbet af behandlingens første måned.
Bleeding is the most common reaction reported both in clinical studies as well as in post-marketing experience where it was mostly reported during the first month of treatment.
Cmax opnås efter ca. 30-60 minutter aefter administration.
Cmax occurs approximately 30 to 60 minutes after
Halveringstiden for elimination af den cirkulerende (inaktive) hovedmetabolit var 8 timer efter en enkelt og efter gentagen administration.
The elimination halflife of the main circulating (inactive) metabolite was 8 hours after single and repeated administration.
Hyppighed defineres i henhold til følgende konvention: almindelig (>1/100 til <1/10); ikke almindelig (>1/1.000 til <1/100); sjælden (>1/10.000 til <1/1.000); meget sjælden
Their frequency is defined using the following conventions: common (≥1/100 to <1/10); uncommon (≥1/1,000 to < 1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Kan indtages med ogeller uden mad.
It may be given with or without food.
I delgruppen med myokardieinfarkt fik de fleste patienter ASA i de første dage efter det akutte myokardieinfarkt.
In the myocardial infarction subgroup, most of the patients received ASA for the first few days following the acute myocardial infarction.
• Aktiv patologisk blødning såsom ulcus pepticum eller intrakraniel blødning.
• Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Ca. 88% af patienterne fik samtidig ASA (interval 1 til 23 mg/kg/dag).
Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Dyreforsøg viser ikke direkte eller indirekte skadelige virkninger for graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Læs denne indlægsseddel grundigt inden De begynder at tage medicinen.
Read all of this leaflet carefully before you start taking this medicine.
Distribution Clopidogrel og den cirkulerende (inaktive) hovedmetabolit binder reversibelt in vitro til humane plasmaproteiner (henholdsvis 98 % og 94 %).
Clopidogrel and the main circulating (inactive) metabolite bind reversibly in vitro to human plasma proteins (98% and 94% respectively).
Den gennemsnitlige tid fra anlæggelse af palliativ shunt til første administration af forsøgslægemidlet var 20 dage.
The mean time between shunt palliation and first administration of study medicinal product was 20 days.
Clopidogrel Qualimed kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Clopidogrel Qualimed can cause side effects, although not everybody gets them.
Patienterne skal kontrolleres omhyggeligt for tegn på blødninger, herunder okkulte blødninger, især i behandlingens første uger og/eller efter invasive hjerteindgreb eller -kirurgi.
Patients should be followed carefully for any signs of bleeding including occult bleeding, especially during the first weeks of treatment and/or after invasive cardiac procedures or surgery.
TTP er en potentielt letal tilstand, der kræver øjeblikkelig behandling, der omfatter plasmaferese.
TTP is a potentially fatal condition requiring prompt treatment including plasmapheresis.
• hvis De har risiko for blødning som f.eks:
• if you have a risk of bleeding such as
• BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Dette var ensartet blandt undergrupperne af patienter, defineret ved baseline karakteristika og typen af fibrinolytika eller heparinbehandling.
This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
I ikke-kliniske forsøg på rotter og bavianer var de hyppigst forekommende virkninger leverforandringer.
During non clinical studies in rat and baboon, the most frequently observed effects were liver changes.
• hvis De lider af en alvorlig leversygdom
• if you suffer from severe liver disease;
Indflydelsen af CYP2C19-genotype på det kliniske udfald hos patienter i behandling med clopidogrel, er ikke blevet evalueret i prospektive, randomiserede, kontrollerede studier.
The influence of CYP2C19 genotype on clinical outcomes in patients treated with clopidogrel has not been evaluated in prospective, randomised, controlled trials.
Dette var associeret med en reduktion i den gennemsnitlige trombocythæmning på henholdsvis 15 % og 11 %.
This was associated with a reduction of the mean inhibition of platelet aggregation by 15% and 11%, respectively.
Spørg Deres læge eller apoteket til råds, før De tager nogen form for medicin.
Ask your doctor or pharmacist for advice before taking any medicine.
Endvidere tydede en analyse af aldersbaserede delgrupper på, at fordelen ved clopidogrel hos patienter over 75 år var mindre end hos patienter ≤75 år.
In addition, a subgroup analysis by age suggested that the benefit of clopidogrel in patients over 75 years was less than that observed in patients ≤75 years.
• hvis de har haft en blodprop i en blodåre (arterie) i hjernen (iskæmisk apopleksi), inden for de seneste 7 dage
• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days
Hallucinationer, konfusion
Hallucinations, confusion Taste disturbances
Dette skyldes måden Deres medicin virker på, da den forebygger blodets evne til at danne blodpropper.
This is linked to the way your medicine works as it prevents the ability of blood clots to form.
Den sædvanlige dosis er én tablet Clopidogrel Qualimed à 75 mg dagligt, som tages gennem munden sammen med eller uden mad, og på samme tid hver dag.
The usual dose is one 75 mg tablet of Clopidogrel Qualimed per day to be taken orally with or without food, and at the same time each day.
Andre lægemidler: Der er gennemført en række andre kliniske studier med clopidogrel og anden samtidig medicinering for at undersøge muligheden for farmakodynamisk og farmakokinetisk interaktion.
Other medicinal products: A number of other clinical studies have been conducted with clopidogrel and other concomitant medicinal products to investigate the potential for pharmacodynamic and pharmacokinetic interactions.
In vitro bliver denne metaboliseringsvej medieret af CYP3A4, CYP2C19, CYP1A2 og CYP2B6.
In vitro, this metabolic pathway is mediated by CYP3A4, CYP2C19, CYP1A2 and CYP2B6.
Hos poor metabolisers var eksponeringen nedsat med 63-71 %, sammenlignet med personer med extensive metabolisme.
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
De skal tage Clopidogrel Qualimed, så længe som Deres læge fortsætter med at ordinere det.
You should take Clopidogrel Qualimed for as long as your doctor continues to prescribe it.
7 filmovertrukne tabletter - kalenderblisterpakning : EU/1/09/559/012 14 filmovertrukne tabletter - kalenderblisterpakning : EU/1/09/559/013 28 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/014 56 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559015 84 filmovertrukne tabletter - kalenderblisterpakning: EU/1/09/559/016
7 film-coated tablets - calendar blister: EU/1/09/559/012 14 film-coated tablets - calendar blister: EU/1/09/559/013 28 film-coated tablets - calendar blister: EU/1/09/559/014 56 film-coated tablets - calendar blister: EU/1/09/559/015 84 film-coated tablets - calendar blister: EU/1/09/559/016
Blødning var den hyppigst rapporterede bivirkning både i clopidogrel- og placebogruppen; der var imidletid ingen signifikant forskel i blødningsfrekvensen mellem de to grupper.
Bleeding was the most frequently reported adverse reaction in both clopidogrel and placebo groups; however, there was no significant difference in the bleeding rate between groups.
Der er ikke etableret et relevant dosisregime for denne patientpopulation i kliniske outcome-studier.
An appropriate dose regimen for this patient population has not been established in clinical outcome trials.
I et studie af den relative biotilgængelighed hos voksne absorberedes opløsningen af clopidogrel i et lignende omfang og med en lidt højere absorptionsrate af den cirkulerende (inaktive) hovedmetabolit sammenlignet med den godkendte tablet.
In a relative bioavailability study in adults, the constituted solution of clopidogrel showed a similar extent and slightly higher rate of absorption of the main circulating (inactive) metabolite compared to the authorised tablet.
Overdosering efter administration af clopidogrel kan føre til forlænget blødningstid og efterfølgende blødningskomplikationer.
Overdose following clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications.
På grund af manglende data kan clopidogrel ikke anbefales i de første 7 dage efter et akut iskæmisk slagtilfælde.
In view of the lack of data, clopidogrel cannot be recommended during the first 7 days after acute
Når personer med poor metabolisme fik 600 mg/150 mg regimet, var eksponeringen for den aktive metabolit større end ved 300 mg/75 regimet.
When poor metabolisers received the 600 mg/150 mg regimen, active metabolite exposure was greater than with the 300 mg/75 mg regimen.
Patienterne blev randomiseret til clopidogrel 75 mg/dag eller ASA 325 mg/dag og blev kontrolleret i 1-3 år.
Patients were randomised to clopidogrel 75 mg/day or ASA 325 mg/day, and were followed for 1 to 3 years.
Opbevares i den originale pakning for at beskytte mod fugt og lys.
Store in the original package in order to protect from moisture and light.
Hvis De holder op med at tage Clopidogrel Qualimed De må ikke stoppe behandlingen medmindre Deres læge fortæller Dem, at De skal gøre det..
If you stop taking Clopidogrel Qualimed: Do not stop the treatment unless your doctor tells you so.
For patienter, der skal have foretaget elektiv kirurgi, og hvor en midlertidig antitrombotisk virkning ikke er ønskelig, bør clopidogrel seponeres 7 dage før indgrebet.
If a patient is to undergo elective surgery and antiplatelet effect is temporarily not desirable, clopidogrel should be discontinued 7 days prior to surgery.
Når diegivende rotter fik clopidogrel, opstod der en mindre forsinkelse i ungernes udvikling.
When given to lactating rats, clopidogrel caused a slight delay in the development of the offspring.
Glomerulonefritis, øget blodkreatinin
Glomerulonephritis, blood creatinine increased
Nyligt myokardieinfarkt (MI), nylig apopleski eller påvist perifer arteriel lidelse
Recent myocardial infarction (MI), recent stroke or established peripheral arterial disease
Andre alleler, der associeres med manglende eller nedsat metabolisme er mindre hyppige og, inkluderer CYP2C19*4, *5, *6, *7 og *8.
Other alleles associated with absent or reduced metabolism are less frequent and include CYP2C19*4, *5, *6, *7, and *8.
Den planlagte PSUR-indsendelse for Clopidogrel Qualimed filmovertrukne tabletter bør følge den planlagte PSUR-indsendelse for referencelægemidlet.
The PSUR submission schedule for Clopidogrel Qualimed film coated tablets should follow PSURs submission schedule for the reference medicinal product.
I den forlængede sikkerhedsopfølgning af studiet fik 26 patienter, der stadig havde shunten indopereret, da de fyldte 1 år, clopidogrel til de var op til 18 måneder gamle.
In the long-term safety follow-up of this study, 26 patients with the shunt still in place at one year of age received clopidogrel up to 18 months of age.
Bindingen er umættet in vitro over et bredt koncentrationsområde.
The binding is non-saturable in vitro over a wide concentration
Efter enkelt og gentagne orale doser på 75 mg/dag bliver clopidogrel hurtigt absorberet.
After single and repeated oral doses of 75 mg per day, clopidogrel is rapidly absorbed.
Den publicerede forekomst af poor metaboliser-genotyper er ca. 2 % for kaukasiske personer, 4 % for negroide og 14 % for kinesiske.
Published frequencies for the poor CYP2C19 metaboliser genotypes are approximately 2% for Caucasians, 4% for Blacks and 14% for Chinese.
For pakninger med 7, 14, 28, 56 stk. og 84 stk. tabletter kan De kontrollere på hvilken dag De sidst tog en Clopidogrel Qualimed tablet ved at se på kalenderen, der er trykt på blisterpakningen.
For the 7, 14, 28, 56, 84 tablets (calendar blister) pack sizes, you can check the day on which you last took a tablet of Clopidogrel Qualimed by referring to the calendar printed on the blister.
Ud over ovenstående oplysninger om specifik lægemiddelinteraktion er der ikke udført interaktionsstudier med clopidogrel og visse lægemidler, som almindeligvis gives til patienter med aterotrombotiske sygdomme.
Apart from the specific medicinal product interaction information described above, interaction studies with clopidogrel and some medicinal products commonly administered in patients with atherothrombotic disease have not been performed.
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale yderpakning for at beskytte mod fugt og lys.
SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture and light.
Der var ikke tegn på karcinogen virkning, når clopidogrel blev administreret i 78 uger til mus og 104 uger til rotter og givet i doser op til 77 mg/kg/dag (hvilket udgør mindst 25 gange eksponeringen hos mennesker, der får den kliniske dosis på 75 mg/dag).
There was no evidence of carcinogenic effect when clopidogrel was administered for 78 weeks to mice and 104 weeks to rats when given at doses up to 77 mg/kg per day (representing at least 25 times the exposure seen in humans receiving the clinical dose of 75 mg/day).
Da den aktive metabolit dannes af CYP450-enzymer, hvoraf nogle er polymorfe eller genstand for hæmning af andre lægemidler, vil ikke alle patienter opnå passende trombocytaggregation.
Because the active metabolite is formed by CYP450 enzymes, some of which are polymorphic or subject to inhibition by medicinal products, not all patients will have adequate platelet inhibition.
Hvis De får langvarige blødninger, mens De tager Clopidogrel Qualimed Hvis De skærer Dem eller kommer til skade, kan det tage lidt længere end normalt, før blødningen stopper.
If you experience prolonged bleeding when taking Clopidogrel Qualimed If you cut or injure yourself, it may take longer than usual for bleeding to stop.
Trombocytaggregation og kapillærblødningstid vendte gradvist tilbage til baselineværdierne, almindeligvis inden for 5 dage efter behandlingens ophør.
Platelet aggregation and bleeding time gradually returned to baseline values, generally within 5 days after treatment was discontinued.
Hos patienter, som fortsatte med behandlingen indtil 5 dage før bypassoperationen, var forekomsten 9,6 % for clopidogrel plus ASA og 6,3% for placebo plus ASA.
In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6% for clopidogrel plus ASA, and 6.3% for placebo plus ASA.