natgillin/translations-raw huggingface dataset:
Spørg lægen, apotekspersonalet eller sygeplejersken, før du tager Qtrilmet, hvis du er i tvivl.
If you are not sure, talk to your doctor, pharmacist or nurse before taking Qtrilmet.
Dette lægemiddel er kontraindiceret til patienter med GFR < 30 ml/min (se pkt.
This medicinal product is contraindicated in patients with GFR < 30 mL/min (see sections 4.3, 4.4, 4.8 and 5.2).
- når patienten allerede er i behandling med metformin og saxagliptin og dapagliflozin.
when already being treated with metformin and saxagliptin and dapagliflozin.
Et 52 ugers randomiseret, dobbeltblindet, aktivt kontrolleret, parallelgruppestudie med en blindet 104 ugers forlængelse sammenlignede én gang dagligt saxagliptin 5 mg og dapagliflozin 10 mg plus metformin med glimepirid (et sulfonylurinstof) optitreret 1-6 mg plus placebo med metformin hos T2DM-patienter med utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7,5 % og ≤ 10,5 %) alene på metformin.
A 52-week randomised, double-blind, active-controlled, parallel-group study with a blinded 104-week extension compared once daily saxagliptin 5 mg and dapagliflozin 10 mg plus metformin to glimepiride (a sulphonylurea) up-titrated 1-6 mg plus placebo with metformin in T2DM patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 10.5%) on metformin alone.
Behandling med saxagliptin 5 mg og dapagliflozin 10 mg i sammenligning med glimepirid hos patienter, som ikke er tilstrækkeligt kontrolleret på metformin
Therapy with saxagliptin 5 mg and dapagliflozin 10 mg in comparison to glimepiride in patients inadequately controlled on metformin
Et 24 ugers randomiseret, dobbeltblindet placebokontrolleret studie med en 28 ugers forlængelse sammenlignede den sekventielle tilføjelse af 10 mg dapagliflozin til 5 mg saxagliptin og metformin med placebo til 5 mg saxagliptin (DPP-4 hæmmer) og metformin hos patienter med type 2-diabetes mellitus og utilstrækkelig glykæmisk kontrol (HbA1c ≥ 7 % og ≤ 10,5 %).
A 24-week randomised, double-blind, placebo-controlled study with a 28-week extension compared the sequential addition of 10 mg dapagliflozin to 5 mg saxagliptin and metformin to the addition of placebo to 5 mg saxagliptin (DPP-4 inhibitor) and metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10.5%).
Obstipation mundtørhed pankreatitis
Constipation dry mouth pancreatitis
Dette lægemiddel bør ikke anvendes til patienter med moderat til svært nedsat nyrefunktion (patienter med GFR < 60 ml/min (se pkt.
This medicinal product should not be used in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min (see sections 4.4, 4.8, 5.1 and 5.2).
De samme anbefalinger for monitorering af nyrefunktionen hos ældre patienter gør sig også gældende for alle andre patienter (se pkt.
The same recommendations for monitoring of renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Volumendepl etering
Volume depletion thirst
4.5), eller som er volumendepleterede, f.eks. på grund af akut sygdom (såsom akut gastrointestinal sygdom med kvalme, opkastning eller diarré).
This medicinal product is not recommended for use in patients at risk of volume depletion (e.g. receiving loop diuretics) (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as acute gastrointestinal illness with nausea, vomiting or diarrhoea).
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter er beige, bikonvekse, 11 x 21 mm ovale tabletter, præget med 3005 på den ene side.
What Qtrilmet looks like and contents of the pack Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets are beige, biconvex, 11 x 21 mm oval tablet, with 3005 debossed on one side.
Derfor anbefales det at monitorere for hudlidelser, f.eks. blærer, ulcerationer eller udslæt, i forbindelse med de normale kontroller af diabetespatienter.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration, or rash, is recommended.
Dysuri polyuri
Dysuria polyuria
- træthed - svære ledsmerter (artralgi) - mavepine og fordøjelsesbesvær (dyspepsi) - opkastning, betændelse i maven (mavekatar) - betændelse i mave eller tarme, der normalt skyldes en infektion (gastroenteritis) - hovedpine, muskelsmerter (myalgi) - ændringer i blodprøver (ændringer i mængden af kolesterol eller fedt i dit blod, stigninger i mængden af røde blodlegemer i dit blod eller nedsat udskillelse af kreatinin fra nyrerne) - udslæt - smagsændringer - hævelse af hænder, ankler eller fødder (perifert ødem)
changes in blood tests (changes in the amount of cholesterol or fats in your blood, increases in the amount of red blood cells in your blood or decreases in creatinine renal clearance) rash changes in taste swelling of the hands, ankles or feet (peripheral oedema)
Dapagliflozin 10 mg i tillæg til saxagliptin
Dapagliflozin 10 mg added to saxagliptin 5 mg + metformin
Nyrefunktionen skal bestemmes: - inden behandlingsstart med dette lægemiddel og regelmæssigt derefter (se pkt.
Renal function should be assessed: prior to initiation of this medicinal product and regularly thereafter (see sections 4.2, 4.8, 5.1 and prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter (see section 4.5);
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets
Qtrilmet kan forårsage en meget sjælden, men meget alvorlig bivirkning, der kaldes laktatacidose.
Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Qtrilmet may cause a very rare, but very serious side effect called lactic acidosis.
Forhøjet blodkreatinin forhøjet urinstof i blodet vægttab Bivirkninger rapporteret for dapagliflozin.
Blood creatinine increased blood urea increased weight decreased
Den samlede forekomst af hypoglykæmi i to 52ugers undersøgelser, der sammenlignede kombinationsbehandling med glimepirid (SU), var: For den første undersøgelse 4,2 % for kombinationsbehandling versus 27,9 % for glimepirid plus metformin versus 2,9 % for dapagliflozin plus metformin; for den anden undersøgelse 18,5 % for kombinationsbehandling versus 43,1 % for glimepirid plus metformin.
st study, 4.2% for the combination therapy versus 27.9% for glimepiride plus metformin versus 2.9% for dapagliflozin plus metformin; for the 2
- hvis du har haft en alvorlig allergisk reaktion over for nogle andre lægemidler, som du har taget for at kontrollere dit blodsukker, nemlig: o "gliptiner" (eller DPP-4-hæmmere) - såsom alogliptin, linagliptin og sitagliptin eller o "glifloziner" (eller SGLT2-hæmmere) - såsom canagliflozin og empagliflozin.
Do not take Qtrilmet: if you are allergic to metformin, saxagliptin, dapagliflozin, or any of the other ingredients of this medicine (listed in section 6); if you have had a serious allergic reaction to some other medicines used to control your blood sugar, namely: o ‘gliptins' (or DPP-4 inhibitors) - like alogliptin, linagliptin and sitagliptin or, o ‘gliflozins' (or SGLT2 inhibitors) - like canagliflozin and empagliflozin; if you have uncontrolled diabetes, with: o severe hyperglycaemia (very high blood glucose), o nausea, vomiting, diarrhoea, rapid weight loss, o lactic acidosis (see “Risk of lactic acidosis” below),
- hvis du har alvorligt nedsat nyrefunktion.
if you have reduced kidney function or liver problems;
Andelen af patienter, der opnåede HbA1c <7,0 % ved uge 24 i tillægsbehandling med dapagliflozin 10 mg til saxagliptin 5 mg plus metformin var højere i dapagliflozin 10 mg og saxagliptin 5 mg plus metformin-gruppen 38,0 % (95 % CI [ 30,9, 45,1]) sammenlignet med placebo plus saxagliptin 5 mg plus metformin-gruppen 12,4 % (95 % CI [7,0, 17,9]).
Proportion of patients achieving HbA1c < 7% in study MB102129 and study CV181168 The proportion of patients achieving HbA1c < 7.0% at week 24 in the add-on therapy with dapagliflozin 10 mg to saxagliptin 5 mg plus metformin trial was higher in the dapagliflozin 10 mg and saxagliptin 5 mg plus metformin group 38.0% (95% CI [30.9, 45.1]) compared to the placebo plus saxagliptin 5 mg plus metformin group 12.4% (95% CI [7.0, 17.9]).
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter metforminhydrochlorid/saxagliptin/dapagliflozin
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
EU/1/19/1401/015 14 depottabletter EU/1/19/1401/016 28 depottabletter EU/1/19/1401/017 56 depottabletter EU/1/19/1401/018 60 depottabletter EU/1/19/1401/019 196 depottabletter EU/1/19/1401/020 14 depottabletter (kalenderblister) EU/1/19/1401/021 28 depottabletter (kalenderblister) EU/1/19/1401/022 56 depottabletter (kalenderblister) EU/1/19/1401/023 196 depottabletter (kalenderblister)
EU/1/19/1401/015 14 modified-release tablets EU/1/19/1401/016 28 modified-release tablets EU/1/19/1401/017 56 modified-release tablets EU/1/19/1401/018 60 modified-release tablets EU/1/19/1401/019 196 modified-release tablets EU/1/19/1401/020 14 modified-release tablets (calendar blister) EU/1/19/1401/021 28 modified-release tablets (calendar blister) EU/1/19/1401/022 56 modified-release tablets (calendar blister) EU/1/19/1401/023 196 modified-release tablets (calendar blister)
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter:
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets:
- hvis du nogensinde har haft diabetisk koma.
if you have “type 1 diabetes”.
EU/1/19/1401/001 14 depottabletter EU/1/19/1401/002 28 depottabletter EU/1/19/1401/003 56 depottabletter EU/1/19/1401/004 60 depottabletter EU/1/19/1401/005 196 depottabletter EU/1/19/1401/006 14 depottabletter (kalenderblister) EU/1/19/1401/007 28 depottabletter (kalenderblister) EU/1/19/1401/008 56 depottabletter (kalenderblister) EU/1/19/1401/009 196 depottabletter (kalenderblister)
EU/1/19/1401/001 14 modified-release tablets EU/1/19/1401/002 28 modified-release tablets EU/1/19/1401/003 56 modified-release tablets EU/1/19/1401/004 60 modified-release tablets EU/1/19/1401/005 196 modified-release tablets EU/1/19/1401/006 14 modified-release tablets (calendar blister) EU/1/19/1401/007 28 modified-release tablets (calendar blister) EU/1/19/1401/008 56 modified-release tablets (calendar blister) EU/1/19/1401/009 196 modified-release tablets (calendar blister)
Faldet i systolisk blodtryk ved uge 52 i saxagliptin 5 mg og dapagliflozin 10 mg plus metformin-gruppen (-2,6 mmHg 95 % CI [-4,4, -0,8]) var større end i glimepirid plus metformin-gruppen (1,0 mmHg 95 % Cl [-0,9, 2.9]).
In the study comparing concomitant therapy of saxagliptin and dapagliflozin with glimepiride in patients inadequately controlled on metformin alone, the decrease in systolic blood pressure at week 52 in the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin group (-2.6 mmHg 95% CI [-4.4, -0.8]) was greater than in the glimepiride plus metformin group (1.0 mmHg 95% CI [-0.9, 2.9]).
Placebo + dapagliflozin 10 mg + metformin (N=162)
Placebo + dapagliflozin 10 mg + metformin
Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter:
Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets:
EU/1/19/1401/024 14 depottabletter EU/1/19/1401/025 28 depottabletter EU/1/19/1401/026 56 depottabletter EU/1/19/1401/027 60 depottabletter EU/1/19/1401/028 196 depottabletter
EU/1/19/1401/024 14 modified-release tablets EU/1/19/1401/025 28 modified-release tablets EU/1/19/1401/026 56 modified-release tablets EU/1/19/1401/027 60 modified-release tablets EU/1/19/1401/028 196 modified-release tablets
Hver tablet indeholder 1.000 mg metforminhydrochlorid, saxagliptinhydrochlorid svarende til 2,5 mg saxagliptin og dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin.
Each tablet contains 1,000 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Det skal du vide, før du begynder at tage Qtrilmet Sådan skal du tage Qtrilmet Bivirkninger
What Qtrilmet is and what it is used for What you need to know before you take Qtrilmet How to take Qtrilmet
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets
Tal med lægen, før du tager Qtrilmet, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).
If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtrilmet.
EU/1/19/1401/010 14 depottabletter EU/1/19/1401/011 28 depottabletter EU/1/19/1401/012 56 depottabletter EU/1/19/1401/013 60 depottabletter EU/1/19/1401/014 196 depottabletter
EU/1/19/1401/010 14 modified-release tablets EU/1/19/1401/011 28 modified-release tablets EU/1/19/1401/012 56 modified-release tablets EU/1/19/1401/013 60 modified-release tablets EU/1/19/1401/014 196 modified-release tablets
Qtrilmet 850 mg/2,5 mg/5 mg tabletter metformin HCl/saxagliptin/dapagliflozin
Qtrilmet 850 mg/2.5 mg/5 mg tablets metformin HCl/saxagliptin/dapagliflozin
Hver tablet indeholder 850 mg metforminhydrochlorid, saxagliptinhydrochlorid svarende til 2,5 mg saxagliptin og dapagliflozinpropandiolmonohydrat svarende til 5 mg dapagliflozin.
Each tablet contains 850 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Qtrilmet skal straks seponeres hos patienter med mistænkt eller diagnosticeret DKA.
In patients where DKA is suspected or diagnosed, treatment with Qtrilmet should be discontinued immediately.
- OCT2-hæmmere (såsom cimetidin, dolutegravir, ranolazin, trimethoprim, vandetanib, isavuconazol) kan reducere den renale udskillelse af metformin og dermed medføre en stigning i metforminkoncentrationen i plasma.
Co-administration of metformin with: inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin; inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin; inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration; inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter
Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets
4.2, 4.4 og 5.2) - akutte tilstande med potentiale til at ændre nyrefunktionen såsom: o dehydrering o svær infektion o shock - akut eller kronisk sygdom, som kan forårsage vævshypoksi såsom: o hjerte- eller respirationssvigt o nyligt overstået myokardieinfarkt o shock - nedsat leverfunktion (se pkt.
Qtrilmet is contraindicated in patients with: hypersensitivity to the active substances or to any of the excipients listed in section 6.1, history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP-4) inhibitor or to any sodium-glucose co-transporter 2 (SGLT2) inhibitor (see sections 4.4, 4.8 and 6.1); any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) (see sections 4.4 and 4.8); diabetic pre-coma (see section 4.4); severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); acute conditions with the potential to alter renal function such as: o dehydration, o severe infection, o shock; acute or chronic disease which may cause tissue hypoxia such as: o cardiac or respiratory failure, o recent myocardial infarction, o shock; hepatic impairment (see sections 4.2 and 5.2); acute alcohol intoxication, alcoholism (see section 4.5).
A Ikke Almindelig almindelig
Common A Uncommon B Rare Very rare Not known
Depottabletter
Modified-release tablets
- hvis du har alvorlige ledsmerter - hvis du tager pioglitazon for at nedsætte dit blodsukker, kan Qtrilmet måske ikke anbefales til dig - hvis du tager nogen af følgende lægemidler: glucokortikoider, beta-2-agonister, vanddrivende lægemidler (diuretika), carbamazepin, dexamethason, phenobarbital, phenytoin og rifampicin, da de kan nedsætte virkningen af Qtrilmet (se "Brug af anden medicin sammen med Qtrilmet") - hvis du er 75 år eller ældre - hvis blodprøver viser, at mængden af røde blodlegemer i dit blod er for høj.
if you take any of the following medicines: glucocorticoids, beta-2 agonists, diuretics, carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin as they may reduce the effect of Qtrilmet (see “Other medicines and Qtrilmet”);
- Dehydrering, (tab af for meget væske fra kroppen), ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Tegn på dehydration: o meget tør eller klæbrig mund, udpræget tørst o udpræget søvnighed eller træthedsfølelse o meget lille eller ingen vandladning (urin) o hurtig hjerterytme.
Signs of dehydration: o very dry or sticky mouth, feeling very thirsty, o feeling very sleepy or tired, o passing little or no water (urine), o fast heartbeat.
Qtrilmet 1.000 mg/2,5 mg/5 mg tabletter metformin HCl/saxagliptin/dapagliflozin
Qtrilmet 1,000 mg/2.5 mg/5 mg tablets metformin HCl/saxagliptin/dapagliflozin
Ikke kendt administration sstedet
General disorders and administratio n site conditions
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter og Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter fås i blisterpakninger.
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets and Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets are available in blister.
Tal med lægen, apotekspersonalet eller sygeplejersken, før du tager Qtrilmet, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking Qtrilmet.
Qtrilmet 850 mg/2,5 mg/5 mg depottabletter metforminhydrochlorid/saxagliptin/dapagliflozin
Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
Svampeinfekt ion
Headache dizziness
Qtrilmet 1.000 mg/2,5 mg/5 mg depottabletter metforminhydrochlorid/saxagliptin/dapagliflozin
Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
Nykturi nedsat nyrefunktion
Kidney function
Hvis du har taget for meget Qtrilmet
If you take more Qtrilmet than you should
Symptomer på laktatacidose inkluderer: o opkastning o mavesmerter (abdominalsmerter) o muskelkramper o generel følelse af utilpashed med udtalt træthed o vejrtrækningsbesvær o nedsat kropstemperatur og langsom hjerterytme Hvis dette sker for dig, skal du omgående stoppe med at tage Qtrilmet og kontakte lægen eller nærmeste skadestue, da laktatacidose kan føre til koma.
Symptoms of lactic acidosis include: o vomiting, o stomach ache (abdominal pain), o muscle cramps, o general feeling of not being well with severe tiredness, o difficulty in breathing, o reduced body temperature and slower heartbeat.
Tors.
RHD).
Symptomerne omfatter mavesmerter, hurtig og dyb vejrtrækning, søvnighed, eller din ånde kan få en usædvanlig frugtagtig lugt.
Symptoms include stomach pain, fast and deep breathing,
- hvis du har type 1-diabetes, må Qtrilmet ikke bruges til behandling af denne sygdom - hvis du har eller har haft en sygdom i bugspytkirtlen - hvis du har nedsat nyrefunktion eller leverproblemer - hvis din krops evne til at bekæmpe infektioner (immunitet) er nedsat, såsom ved en sygdom som aids, eller hvis du tager medicin efter en organtransplantation - hvis du har eller tidligere har haft en alvorlig allergisk reaktion, eller hvis lægen har fortalt dig, at du måske har haft én - hvis du har eller har haft en alvorlig hjertesygdom
sleepiness, or your breath developing an unusual fruity smell; if you have ever had a diabetic coma; if you have severely reduced kidney function; if you have a severe infection; if you have lost a lot of water from your body (dehydration) - due to long-lasting or severe diarrhoea, or if you have vomited several times in a row (see “Warnings and precautions” below); if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing; if you have problems with your liver; if you drink large amounts of alcohol, either every day or only from time to time (please see section “Qtrilmet with alcohol”).
Efter markedsføring af saxagliptin og dapagliflozin blev udslæt rapporteret som bivirkning.
Rash was reported during the postmarketing use of saxagliptin and dapagliflozin.
Forskel i HbA1c-effekt Justeret gennemsnit (95 % CI)
Difference in HbA1c effect
• stigende behandlingsvarighed (behandling >24 måneder)
• the increasing duration of treatment (treated > 24 months),
Balancen mellem følsomhed og specificitet i dette interval skal omhyggeligt overvejes.
The balance between sensitivity and specificity in this range needs to be carefully considered.
Der er behov for at overveje, om regulatoriske tiltag er nødvendige som følge af de nye oplysninger.
There is a need to consider whether regulatory action is necessary in light of the new elements.
De patienter, der overlever, har ofte alvorlig morbiditet forbundet med alvorlig og permanent invalidering.
Patients who survive often have serious morbidity associated with serious and permanent disability.
10 tilfælde blev rapporteret i USA, mens hovedparten af de asymptomatiske tilfælde blev registreret i EU og resten af verden (83 %, 52/62).
While 10 cases have been reported in the US, most of the asymptomatic cases were reported from EU/ROW (83%, 52/62).
Europa-Kommissionen bad agenturet om en udtalelse om, hvorvidt et regulatorisk tiltag vedrørende produktets markedsføringstilladelse er nødvendigt.
The EC requested the Agency to give its opinion on whether a regulatory action with regard to the marketing authorisation for this product is necessary.
I lyset af ovenstående startede Europa-Kommissionen d. 29. april 2015 en procedure i henhold til artikel 20 i forordning (EF) nr. 726/2004 og bad agenturet om at vurdere ovenstående oplysninger og deres mulige indvirkning på benefit/risk-forholdet for Tysabri.
In view of the above, on 29 April 2015 the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004, and asked the Agency to assess the above elements and their potential impact on the benefit-risk balance of Tysabri.
Følsomheden varierer meget lidt mellem indeksværdien 0,9 og 1,5, men specificiteten forbedres ved 1,5.
Sensitivity differs very little between the index of 0.9 and 1.5 but there is improved specificity with 1.5.
Tidlig diagnosticering af PML synes at være forbundet med bedre udfald.
Early diagnosis of PML appears to be associated with improved outcomes.
Ordlyden af et brev til sundhedspersonerne er vedtaget sammen med en kommunikationsplan.
The wording of a Direct Healthcare Professional Communication has been adopted, together with a communication plan.
Den aktuelle evidens tyder på, at risikoen stiger med stigende antistof-indeks, men der er ikke nogen klar cut off-værdi.
Current evidence suggests that risk increases with increasing antibody index but there is no clear cut off value.
Pr. maj 2015 har 142 958 patienter verden over fået natalizumab, og eksponeringen udgør i alt 432 814 patientår.
As of May 2015, 142,958 patients had received natalizumab worldwide with 432,814 patient-years of exposure.
Da anmodningen bunder i en gennemgang af data fra lægemiddelovervågningsaktiviteter, skal udtalelsen vedtages af Udvalget for Lægemidler til Mennesker (CHMP) på grundlag af en anbefaling fra Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
As the request results from the evaluation of data resulting from pharmacovigilance activities, the opinion should be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC).
Patienter, der har alle tre risikofaktorer, har en signifikant højere risiko for PML.
Patients who have all three risk factors for PML have a significantly higher risk of PML.