natgillin/translations-raw huggingface dataset:
I DTC-studiet (se produktresuméet for Lenvima) udviklede 5,0 % af patienterne nyresvigt, og 1,9 % udviklede nedsat nyrefunktion (3,1 % af patienterne havde grad ≥ 3 nyresvigt eller nedsat nyrefunktion). 
In the DTC study (see Lenvima SmPC), 5.0% of patients developed renal failure and 1.9% developed renal impairment, (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment).
I DTC-studiet (se produktresuméet for Lenvima) blev diarré rapporteret hos 67,4 % af patienterne i lenvatinib-gruppen (9,2 % var grad ≥ 3) og hos 16,8 % i placebogruppen (ingen var grad ≥ 3). 
In the DTC study (see Lenvima SmPC), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3).
Kardial dysfunktion (< 1 %) og nedsat venstre ventrikel uddrivningsfraktion er blevet rapporteret hos patienter i behandling med lenvatinib (se pkt. 
Cardiac failure (<1%) and decreased left ventricular ejection fraction have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Patienter med RCC og diabetes ved baseline havde en højere forekomst af grad 3 eller 4 hypertension, hypertriglyceridæmi og akut nyresvigt. 
In RCC, patients with baseline diabetes had a higher incidence of Grade 3 or 4 hypertension, hypertriglyceridemia and acute renal failure.
Reaktioner af sværhedsgrad 3 eller 4 forekom hos 5,0 % af patienterne i lenvatinib-gruppen. 
Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinib-treated vs 0 placebo-treated patients.
Mediantiden til start i lenvatinibgruppen var 16 dage. 
The median time to onset in lenvatinib-treated patients was 16 days.
• oppustethed eller luft i tarmen 
• feeling bloated or having gas in the bowel
Hazard ratio (95 % CI)b lenvatinib + everolimus vs everolimus 
Median PFS in months (95% CI) Hazard Ratio (95% CI)b lenvatinib + everolimus vs everolimus
Mediantiden til første start i lenvatinibgruppen var 11,1 uger. 
The median time to first onset in lenvatinib-treated patients was 11.1 weeks.
En MSKCC- (Memorial Sloan Kettering Cancer Center) risiko for dårlig prognose blev observeret hos 39 % af patienterne i lenvatinib plus everolimus-armen, hos 44 % i lenvatinib-armen og hos 38 % i everolimus-armen. 
Memorial Sloan Kettering Cancer Centre (MSKCC) poor risk was observed in 39% of patients in the lenvatinib plus everolimus arm, 44% in the lenvatinib arm and 38% in the everolimus arm. International mRCC Database Consortium (IMDC) poor risk was observed in 20% of patients in the lenvatinib plus everolimus arm, 23% in the lenvatinib arm, and 24% in the everolimus arm.
Hæmning af suppression af thyreoideastimulerende hormon/thyreoideadysfunktion Der er blevet rapporteret hypotyreoidisme hos patienter i behandling med lenvatinib (se pkt. 
Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
I DTC-studiet (se produktresuméet for Lenvima) blev arteriel tromboemboli rapporteret hos 5,4 % af patienterne i lenvatinib-gruppen og hos 2,3 % i placebogruppen. 
In the DTC study (see Lenvima SmPC), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
I DTC-studiet (se produktresuméet for Lenvima) blev blødning rapporteret hos 34,9 % (1,9 % var grad ≥ 3) af patienterne i lenvatinib-gruppen versus 18,3 % (3,1 % var grad ≥ 3) i placebogruppen. 
In the DTC study (see Lenvima SmPC), haemorrhage was reported in 34.9% (1.9% were Grade ≥ 3) of lenvatinib-treated patients versus 18.3% (3.1% were Grade ≥ 3) of placebo-treated patients.
5.1) blev hypertension rapporteret hos 41,9 % af patienterne i lenvatinib plus everolimus-gruppen (forekomsten af grad 3 eller grad 4 hypertension var 12,9 %) og hos 10,0 % i everolimus-gruppen (forekomsten af grad 3 eller grad 4 hypertension var 2,0 %). 
In the RCC study (see section 5.1), hypertension was reported in 41.9% of patients in the lenvatinib plus everolimus-treated group (the incidence of Grade 3 or Grade 4 hypertension was 12.9%) and 10.0% of patients in the everolimus-treated group (the incidence of Grade 3 or Grade 4 hypertension was 2.0%).
5.1) medførte bivirkninger dosisreduktion hos 67,7 % af patienterne og seponering hos 18 (29,0 %). 
In the RCC study (see section 5.1), adverse reactions led to dose reductions in 67.7% of patients and 18 (29.0%) patients discontinued the treatment.
Elektrolytforstyrrelser, såsom hypokaliæmi, hypokalcæmi eller hypomagnesiæmi, øger risikoen for QT-forlængelse. 
Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore electrolyte abnormalities should be monitored and corrected in all patients before starting treatment.
I DTC-studiet (se produktresuméet for Lenvima) blev proteinuri rapporteret hos 33,7 % af patienterne i lenvatinib-gruppen og hos 3,1 % i placebogruppen. 
In the DTC study (see Lenvima SmPC), proteinuria was reported in 33.7% of lenvatinib-treated patients and 3.1% of patients in the placebo-treated group.
Kolecystitis 
Cholecystitis
Kisplyx 10 mg hårde kapsler 
Kisplyx 10 mg hard capsules
I DTC-studiet (se produktresuméet for Lenvima) blev der rapporteret nedsat uddrivningsfraktion/hjertesvigt hos 6,5 % af patienterne (1,5 % var grad ≥ 3) i lenvatinib-gruppen og hos 2,3 % i placebogruppen (ingen var grad ≥ 3). 
In the DTC study (see Lenvima SmPC), decreased ejection fraction/cardiac failure was reported in 6.5% of patients (1.5% were Grade ≥ 3) in the lenvatinib treated group, and 2.3% in the placebo group (none were Grade ≥ 3).
Hos patienter med symptomer på PRES kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt. 
In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Kisplyx 4 mg hårde kapsler Kisplyx 10 mg hårde kapsler lenvatinib 
Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules lenvatinib
Kisplyx 4 mg hårde kapsler 
Kisplyx 4 mg hard capsules
Mediantiden til første symptomer på hypokalcæmi var 28,3 uger (alle grader) og 45,9 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen. 
The median time to onset of hypocalcaemia was 28.3 weeks (any grade) and 45.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Lenvatinib hæmmer eksogen thyreoideasuppression (se pkt. 
Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
I tilfælde af gastrointestinal perforation eller fisteldannelse kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt. 
In the case of a gastrointestinal perforation or fistula, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
De fleste reaktioner fortog sig efter understøttende behandling uden doseringsafbrydelse eller dosisreduktion, hvilket forekom hos hhv. 1,5 % og 1,1 % af patienterne. 
Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Kisplyx 10 mg hårde kapsler: - Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat). 
Kisplyx 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Der er begrænsede data for patienter med nedsat leverfunktion og RCC. 
There are limited data on patients with hepatic impairment in RCC.
Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat). 
Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Nyrer og urinveje 
nausea and vomiting
Blodtryksniveau 
Blood pressure (BP) level
Kisplyx 10 mg 
INFORMATION IN BRAILLE Kisplyx 10 mg
Kisplyx 4 mg hårde kapsler: - Hver hård kapsel indeholder 4 mg lenvatinib (som mesilat). 
Kisplyx 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Forhøjet basisk fosfatase i blodet Unormal leverfunktion Forhøjet gammaglutamyltransferasek 
Blood alkaline phosphatase increased Hepatic function abnormal Gamma-glutamyltransferase increasedk Blood bilirubin increased‡
Behandling af bivirkninger kan kræve doseringsafbrydelse, dosisjustering eller seponering af kombinationsbehandlingen (se pkt. 
Management of adverse reactions may require dose interruption, adjustment, or discontinuation of the combination therapy (see section 4.4).
Diarré er blevet hyppigt rapporteret hos patienter i behandling med lenvatinib og opstår normalt tidligt i behandlingsforløbet (se pkt. 
Diarrhoea has been reported frequently in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Træthed Asteni Perifert ødem 
Fatigue Asthenia Oedema peripheral
Mediantiden til fremkomst af nedsat uddrivningsfraktion eller hjertesvigt var 15,7 uger (alle grader) og 32,8 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen. 
The median time to onset of decreased ejection fraction and cardiac failure was 15.7 weeks (any grade) and 32.8 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
I tilfælde af hepatotoksicitet kan doseringsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt. 
In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
LÆGEMIDLETS NAVN Kisplyx 4 mg hårde kapsler lenvatinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 4 mg lenvatinib (som mesilat). 
NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg lenvatinib (as mesilate).
Tabel 1 Bivirkninger, hvor justering af lenvatinibdosis er nødvendig Bivirkning 
Adverse reactions requiring dose modification of lenvatinib
For at undgå forværring bør lenvatinibbehandling ikke påbegyndes hos patienter med fistel, og lenvatinib bør seponeres permanent hos patienter med øsofageal eller trakeobronkial involvering og ved enhver grad 4 fistel (se pkt. 
Lenvatinib should not be started in patients with fistulae to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Blod og lymfesystem Trombocytopenia 
Blood and lymphatic disorders
Mediantiden til start var 4,9 uger (alle grader) og 6,9 uger (grad ≥3) i lenvatinib plus everolimus-gruppen. 
The median time to onset was 4.9 weeks (any grade) and 6.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
5.1) blev der rapporteret forlængelse af QTc-intervallet på over 60 ms hos 11 % af patienterne i lenvatinib plus everolimus-gruppen. 
In the RCC study (see section 5.1), QTc interval increases greater than 60 ms were reported in 11% of patients in the lenvatinib plus everolimus-treated group.
Mediantiden til forekomst var 4,1 uger (alle grader) og 8,1 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen. 
The median time to onset was 4.1 weeks (any grade) and 8.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
5.1) udviklede 8,1 % af patienterne i lenvatinib plus everolimus-gruppen nyresvigt, og 3,2 % udviklede nedsat nyrefunktion (9,7 % af patienterne havde grad 3 nyresvigt eller nedsat nyrefunktion). 
In the RCC study (see section 5.1), 8.1% of patients in the lenvatinib plus everolimus treated group developed renal failure and 3.2% developed renal impairment, (9.7% of patients had a Grade 3 event of renal failure or impairment).
• smerter i led eller muskler 
• joint or muscle pain
5.1) forekom hypotyreoidisme hos 24 % af patienterne i lenvatinib plus everolimus-gruppen og hos 2 % i everolimus-gruppen. 
In the RCC study (see section 5.1), hypothyroidism occurred in 24% of patients in the lenvatinib plus everolimus-treated group and 2% of patients in the everolimus-treated group.
Mediantiden til første symptom var 10,2 uger (alle grader) og 7,6 uger (grad ≥ 3) i lenvatinib plus everolimusgruppen. 
The median time to first onset of was 10.2 weeks (any grade) and 7.6 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
• Hvis du har alvorlige problemer med leveren eller nyrerne, er den anbefalede dosis Kisplyx 10 mg én gang dagligt (en 10 mg kapsel) sammen med en 5 mg tablet everolimus én gang dagligt. 
• If you have severe liver or kidney problems the recommended dose of Kisplyx is 10 mg once a day
• Kisplyx 10 mg hård kapsel: gul underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 10 mg” på underdelen. 
• Kisplyx 10 mg hard capsule: yellow body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
LÆGEMIDLETS NAVN Kisplyx10 mg hårde kapsler lenvatinib ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 10 mg lenvatinib (som mesilat). 
NAME OF THE MEDICINAL PRODUCT Kisplyx 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesyilate).
I DTC-studiet (se produktresuméet for Lenvima) blev hypokalcæmi rapporteret hos 12,6 % af patienterne i lenvatinib-gruppen og hos 0 % i placebogruppen. 
In the DTC study (see Lenvima SmPC), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
• Kisplyx 4 mg hård kapsel: gullig-rød underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 4 mg” på underdelen. 
• Kisplyx 4 mg hard capsule: yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Nedsat nyrefunktion 
Nongastrointestinal fistulak
Vægttab 
Malaise
Derfor anbefales lenvatinib ikke til disse patienter. 
Patients with end-stage renal disease were not studied, therefore the use of lenvatinib in these patients is not recommended.
Mediantiden til start af proteinuri var 6,1 uger (alle grader) og 20,1 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen. 
The median time to onset of proteinuria was 6.1 weeks (any grade) and 20.1 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Mediantiden til start af leverrelaterede reaktioner var 6,7 uger (alle grader) og 14,2 uger (grad ≥ 3) i lenvatinib plus everolimus-gruppen. 
The median time to onset of liver events was 6.7 weeks (any grade) and 14.2 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Hjertesvigt QT-forlængelse i ekg Nedsat uddrivningsfraktion 
Cardiac failure Electrocardiogram QT prolonged Ejection fraction decreased
Én 10 mg kapsel plus to 4 mg kapsler 
14 mg orally once daily One 10 mg capsule plus one 4 mg capsule
Kardial dysfunktion (se pkt. 
Cardiac dysfunction (see section 4.4)
Palmoplantar erytrodysæstesisynd rom Erytem i håndfladen Udslæt Alopeci 
Palmar-plantar erythrodysaesthesia syndrome Palmar erythema Rash Alopecia
5.1) blev blødning rapporteret hos 38,7 % (8,1 % var grad ≥ 3) af patienterne i lenvatinib plus everolimus-gruppen. 
In the RCC study (see section 5.1), haemorrhage was reported in 38.7% (8.1% were Grade ≥ 3) of patients in the lenvatinib plus everolimus-treated group.
4.4 Hæmning af suppression af thyreoideastimulerende hormon/thyreoideadysfunktion) 
Blood thyroid stimulating hormone increased (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction) (see section 4.4)
Optimal behandling af kvalme, opkastning og diarré bør påbegyndes før enhver behandlingsafbrydelse eller reduktion af lenvatinibdosis. 
Optimal medical management (i.e. treatment or therapy) for nausea, vomiting, and diarrhoea should be initiated prior to any lenvatinib therapy interruption or dose reduction; however, gastrointestinal toxicity should be actively treated in order to reduce the risk of development of renal impairment or renal failure (see section 4.4 Renal failure and impairment).
5.1) blev hypokalcæmi rapporteret hos 8,1 % af patienterne i lenvatinib plus everolimus-gruppen (3,2 % var grad ≥ 3) og hos 4,0 % i everolimus-gruppen (ingen var grad ≥ 3). 
In the RCC study (see section 5.1), hypocalcaemia was reported in 8.1% of patients in the lenvatinib plus everolimus-treated group (3.2% were Grade ≥ 3) and 4.0% of patients in the everolimus-treated group (none were Grade ≥ 3).
Der er blevet rapporteret proteinuri hos patienter i behandling med lenvatinib, hvilket sædvanligvis opstod tidligt i behandlingsforløbet (se pkt. 
Proteinuria has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer) 
Very common (may affect more than 1 in 10 people) • high or low blood pressure
Udseende og pakningsstørrelser 
What Kisplyx looks like and contents of the pack
Det skal du vide, før du begynder at tage Kisplyx Sådan skal du tage Kisplyx Bivirkninger 
What Kisplyx is and what it is used for What you need to know before you take Kisplyx How to take Kisplyx
Trombocytopeni omfatter trombocytopeni og nedsat antal trombocytter. 
The following terms have been combined: a: Thrombocytopenia includes thrombocytopenia and decreased platelet count.
5.1) blev proteinuri rapporteret hos 30,6 % af patienterne i lenvatinib plus everolimus-gruppen (8,1 % var grad ≥ 3) og hos 14,0 % i everolimus-gruppen (2,0 % var grad ≥ 3). 
In the RCC study (see section 5.1), proteinuria was reported in 30.6% of patients in the lenvatinib plus everolimus-treated group (8.1% were Grade ≥ 3) and 14.0% of patients in the everolimus-treated group (2.0% were Grade ≥3).
5.1) blev diarré rapporteret hos 80,6 % i lenvatinib plus everolimus-gruppen (21,0 % var grad ≥ 3) og hos 34,0 % i everolimus-gruppen (2,0 % var grad ≥ 3). 
In the RCC study (see section 5.1), diarrhoea was reported in 80.6% of patients in the lenvatinib plus everolimus-treated group (21.0% were Grade ≥ 3) and in 34.0% of patients in the everolimus-treated group (2.0% were Grade ≥ 3).
En gul underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og”LENV 10 mg” på underdelen. 
A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
5.1) blev der rapporteret nedsat uddrivningsfraktion/hjertesvigt hos 4,8 % af patienterne i lenvatinib plus everolimus-gruppen (3,2 % var grad ≥ 3) og hos 4,0 % i everolimusgruppen (2,0 % var grad ≥ 3). 
In the RCC study (see section 5.1), decreased ejection fraction/cardiac failure was reported in 4.8% of patients (3.2% were Grade ≥ 3) in the lenvatinib plus everolimus treated group, and 4.0% in the everolimus group (2.0% were Grade ≥ 3).
Ved observation af forhøjet blodtryk skal patienter, som tidligere var normotensive, starte med monoterapi med et antihypertensivum. 
For previously normotensive subjects, monotherapy with one of the classes of antihypertensive should be started when elevated BP is observed.
Der er blevet rapporteret om hypertension, der sædvanligvis opstod tidligt i behandlingsforløbet, hos patienter i behandling med lenvatinib (se pkt. 
Hypertension has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
I tilfælde af blødning kan behandlingsafbrydelse, dosisjustering eller seponering være nødvendig (se pkt. 
In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 2).
En gullig-rød underdel og en gullig-rød hætte, ca. 14,3 mm lang med ”Є” præget med sort blæk på hætten og ”LENV 4 mg” på underdelen. 
A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Justering af startdosis er ikke nødvendig på basis af alder. Der foreligger kun begrænsede data for patienter ≥ 75 år (se også pkt. 
Limited data are available on use in patients aged ≥75 years (see also section 4.8, Other special populations).
Forhøjet kreatinin i blodet Forhøjet urinstof i blodet 
Renal failure j, †, ‡ Renal impairment‡ Blood creatinine increased Blood urea increased
Hypokaliæmi Appetitløshed 
Hypokalaemia Decreased appetite Weight decreased
5.1) blev der rapporteret arteriel tromboemboli hos 1,6 % af patienterne i lenvatinib plus everolimus-gruppen. 
In the RCC study (see section 5.1), 1.6% of patients in the lenvatinib plus everolimus-treated group reported arterial thromboembolic events.
5.1) blev perforeret blindtarmsbetændelse (af grad 3) rapporteret hos 1,6 % af patienterne i lenvatinib plus everolimus-gruppen. 
In the RCC study (see section 5.1), 1.6% of cases of perforated appendicitis (of Grade 3) occurred in the lenvatinib plus everolimus-treated group; there were no reports in the lenvatinib or everolimus groups.
Initialdosis af lenvatinib skal justeres hos patienter med svært nedsat leverfunktion (se pkt. 
If patients have severe hepatic impairment, the initial dose of lenvatinib should be adjusted (see sections 4.2 and 5.2).
Gastrointestinal perforation eller fisteldannelse 
Gastrointestinal disorders
I RCC-studiet (se pkt. 
Breast-feeding (see section 4.6).
Hvad sikkerheden angår, bemærkede agenturet, at sikkerhedsprofilen var acceptabel. 
With regard to safety, the Agency noted an acceptable safety profile.
Praluent fik en markedsføringstilladelse med gyldighed i hele EU den 23. september 2015. 
Praluent received a marketing authorisation valid throughout the EU on 23 September 2015.
Hvis den ønskede virkning ikke er opnået efter 4-8 ugers behandling, kan lægen øge eller nedsætte dosissen. 
If the desired response is not achieved after 4 to 8 weeks of treatment, the doctor can increase or decrease the dose.
Yderligere information om Praluent findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Praluent. 
Further information on Praluent can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Praluent.
Som for alle lægemidler bliver data vedrørende brugen af Praluent løbende overvåget. 
As for all medicines, data on the use of Praluent are continuously monitored.
Nogle patienter skal have fedtfattig kost. 
Some patients are required to be on a low fat diet.
Andre oplysninger om Praluent 
Other information about Praluent
Den sædvanlige startdosis er 75 mg hver anden uge, men patienter, der har behov for større nedsættelse af blodets fedtindhold, kan begynde med 150 mg hver anden uge eller 300 mg hver fjerde uge. 
The usual starting dose is 75 mg every two weeks, but patients requiring bigger reductions of blood fat levels may start with 150 mg every two weeks or 300 mg every 4 weeks.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Praluent? 
What measures are being taken to ensure the safe and effective use of Praluent?
Patienten selv eller dennes omsorgsgiver kan injicere lægemidlet efter at være blevet instrueret heri af en sundhedsperson. 
Patients or their carers can inject the medicine once they have been trained by a healthcare professional.
Hvad er Praluent, og hvad anvendes det til? 
What is Praluent and what is it used for?
De indberettede bivirkninger ved Praluent vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Praluent are carefully evaluated and any necessary action taken to protect patients.
Hvorfor er Praluent godkendt i EU? 
Why is Praluent authorised in the EU?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Praluent opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
The European Medicines Agency decided that Praluent's benefits are greater than its risks and it can be authorised for use in the EU.
Det indeholder det aktive stof alirocumab. 
It contains the active substance alirocumab.