natgillin/translations-raw huggingface dataset:
Der er ingen tilgængelige kontrollerede kliniske data om brug af Rasilamlo til patienter med unilateral eller bilateral nyrearteriestenose eller brug af Rasilamlo til patienter med stenose i en enkelt nyre. 
No controlled clinical data are available on the use of Rasilamlo in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Derfor bør drikkevarer indeholdende planteekstrakter, inklusive urteteer, ikke indtages sammen med Rasilamlo. 
Therefore, drinks containing plant extracts, including herbal teas, should not be taken together with Rasilamlo.
Måltider (med højt eller lavt fedtindhold) reducerer absorptionen af aliskiren betragteligt (se pkt. 
Meals (low or high fat content) have been shown to reduce the absorption of aliskiren substantially
Blandt de sekundære endepunkter var incidensen af hjertesvigt (del af et sammensat kombineret kardiovaskulært endepunkt) signifikant højere for amlodipin-gruppen sammenlignet med chlorthalidon-gruppen (10,2 % vs 7,7 %, RR 1,38, 95 % KI [1,25-1,52] p<0,001). 
Among secondary endpoints, the incidence of heart failure (component of a composite combined cardiovascular endpoint) was significantly higher in the amlodipine group as compared to the chlorthalidone group (10.2% vs 7.7%, RR 1.38, 95% CI [1.25-1.52] p<0.001).
Ved steady state reducerer måltider med lavt fedtindhold Cmax med 76 % og AUC0-tau med 67 % hos hypertensive patienter. 
At steady state meals with low fat content reduce Cmax by 76% and AUC 0-tau by 67% in hypertensive patients.
Generelt Ved alvorlig og vedvarende diarré bør Rasilamlo seponeres (se pkt. 
General In the event of severe and persistent diarrhoea, Rasilamlo therapy should be stopped (see section 4.8).
I kliniske interaktionsstudier påvirkede amlodipin ikke farmakokinetikken af atorvastatin, 
- In clinical interaction studies, amlodipine did not affect the pharmacokinetics of atorvastatin,
Rasilamlos sikkerhedsprofil vist herunder er baseret på kliniske studier udført med Rasilamlo og de kendte sikkerhedsprofiler for de individuelle komponenter, aliskiren og amlodipin. 
The safety profile of Rasilamlo presented below is based on clinical studies performed with Rasilamlo and the known safety profile of the individual components aliskiren and amlodipine.
Rasilamlo kombinerer to antihypertensive stoffer, som kontrollerer blodtrykket hos patienter med essentiel hypertension ved komplementære virkningsmekanismer: Aliskiren tilhører klassen kaldet direkte reninhæmmere og amlodipin tilhører klassen kaldet calciumantagonister. 
Rasilamlo combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: aliskiren belongs to the class of direct renin inhibitors and amlodipine belongs to the calcium antagonist class.
• Patienter med markant væskemangel eller patienter med natriummangel (fx patienter, der får 
• Patients with marked volume depletion or patients with salt depletion (e.g. those receiving high
Stoffer, som er undersøgt i kliniske farmakokinetiske studier med aliskiren, inkluderer acenocoumarol, atenolol, celecoxib, pioglitazon, allopurinol, isosorbid-5-mononitrat og hydrochlortiazid. 
- Compounds that have been investigated in aliskiren clinical pharmacokinetic studies include acenocoumarol, atenolol, celecoxib, pioglitazone, allopurinol, isosorbide-5-mononitrate and hydrochlorothiazide.
I et dobbeltblindet, randomiseret placebokontrolleret studie med 1.688 patienter med mildt til moderat hypertension blev behandlingen seponeret pga. en klinisk bivirkning hos 1,7 % af patienterne behandlet med Rasilamlo versus 1,5 % af patienterne, der fik 
In a double-blind, randomised placebocontrolled study in 1,688 patients with mild or moderate hypertension, discontinuation of therapy due to a clinical adverse event occurred in 1.7% of patients treated with Rasilamlo versus 1.5% of
Rasilamlo er tilgængelig i pakninger, der indeholder 14, 28, 56 eller 98 tabletter (i kalenderpakninger), 30 eller 90 tabletter (i normale blisterpakninger) og 56x1 tabletter (som 
Rasilamlo is available in packs containing 14, 28, 56 or 98 tablets (in calendar blisters), 30 or 90 tablets (in normal blisters) and 56x1 tablet (as perforated unit dose blisters).
Når Rasilamlo gives til patienter, hvis blodtryk ikke var tilstrækkeligt kontrolleret med hverken aliskiren eller amlodipin, resulterede i større blodtryksreduktion efter en uges behandling end de enkelte stoffers behandling alene, og næsten maksimal virkning opnås efter fire ugers behandling. 
When given to patients whose blood pressure was not adequately controlled by either aliskiren or amlodipine, Rasilamlo results in greater blood pressure reductions after one week of treatment than the component monotherapies and a near-maximal effect is achieved after four weeks of therapy.
Hastigheden og omfanget af absorptionen af Rasilamlo i fastende tilstand er lig dem for aliskiren og amlodipin, når det indgives som individuelle monoterapier. 
The rate and extent of absorption of Rasilamlo are similar in fasting state to those of aliskiren and amlodipine when administered as individual monotherapies.
Derfor er Rasilamlo kontraindiceret hos børn fra fødslen og op til 2 år og bør ikke anvendes til børn i alderen fra 2 år og op til 6 år. 
Therefore, Rasilamlo is contraindicated in children from birth to less than 2 years and should not be used in children aged 2 to less than 6 years.
Amlodipin har vist gavnlig klinisk effekt til patienter med kronisk stabil angina, vasospastisk angina 
Amlodipine has demonstrated beneficial clinical effects in patients with chronic stable angina, vasospastic angina and angiographically documented coronary artery disease.
Inducere af P-gp (perikon, rifampicin) kan derfor nedsætte 
Inducers of P-gp (St. John's wort, rifampicin) might therefore decrease the
Aliskiren bør, som andre præparater, der virker direkte på RAAS, ikke anvendes under 1. trimester i graviditeten og er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt. 
As for any medicine that acts directly on the RAAS, aliskiren should not be used during the first trimester of pregnancy and is contraindicated during the second and third trimesters (see section 4.3).
Der er ingen kliniske data vedrørende påvirkning af fertiliteten ved brug af Rasilamlo. 
There are no clinical data on fertility with the use of Rasilamlo.
Kombinationen med dosis 300 mg/5 mg viste også statistisk signifikant større blodtryksreduktioner end aliskiren 300 mg monoterapi. 
The combination at a dose of 300 mg/5 mg also showed statistically significantly greater blood pressure reduction than aliskiren 300 mg monotherapy.
Samtidig brug af aliskiren med ciclosporin eller itraconazol, to yderst potente P-glykoprotein(P-gp)-hæmmere, eller andre potente P-gp-hæmmere (f. eks. quinidin), er kontraindiceret (se 
The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent Pglycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is
Der er begrænset sikkerhedsinformation for Rasilamlo til patienter på 75 år og ældre. 
Safety information for Rasilamlo in patients aged 75 years and older is limited.
I kliniske undersøgelser, hvor amlodipin blev givet i kombination med betablokkere til patienter med enten hypertension eller angina, er der ikke set bivirkninger på de 
In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Indgift af aktivt kul op til 2 timer efter administration af 10 mg amlodipin har vist, at det nedsætter absorptionshastigheden af amlodipin. 
In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of
• Kvalme, manglende appetit, mørk-farvet urin eller gulfarvning af hud og øjne (tegn på 
• Nausea, loss of appetite, dark coloured urine or yellowing of skin and eyes (may be signs of
Plasma aliskiren-eksponering (AUC) hos 8 dage gamle rotter var næsten fire gange højere end hos 14 dage gamle rotter ved 100 mg/kg/dag. 
Plasma aliskiren exposure (AUC) in rats aged 8 days was nearly 4-fold higher than that in rats aged 14 days at 100 mg/kg/day.
Hæmmere af organisk anion-transporterende polypeptid (OATP) Prækliniske studier tyder på, at aliskiren kan være et substrat for organisk anion-transporterende polypetider. 
- Organic anion transporting polypeptide (OATP) inhibitors Preclinical studies indicate that aliskiren might be a substrate of organic anion transporting polypeptides.
Plasma-eksponeringen for aliskiren hos 14 dage gamle rotter var mellem 85 og 387 gange højere end hos voksne rotter på 64 dage. 
Plasma aliskiren exposure in rats aged 14 days was between 85- and 387fold higher than that in adult rats aged 64 days.
Hvis en patient får dosisbegrænsende bivirkninger af en af komponenterne alene, kan patienten skiftes til Rasilamlo, der indeholder en lavere dosis af denne komponent, for at opnå samme blodtrykssænkning. 
A patient who experiences dose limiting adverse reactions on either component alone may be switched to Rasilamlo containing a lower dose of that component to achieve similar blood pressure
BLISTER (PVC/PCTFE ELLER PA/Alu/PVC) KUN TIL KALENDERPAKNING 
BLISTERS (PVC/PCTFE OR PA/Alu/PVC) CALENDAR BLISTERS ONLY
De mest sandsynlige manifestationer for Rasilamlo vil være hypotension relateret til aliskiren og amlodipins antihypertensive virkning. 
The most likely manifestation of overdose for Rasilamlo would be hypotension, related to the antihypertensive effect of aliskiren and amlodipine.
På baggrund af de videnskabelige konklusioner for aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid er CHMP af den opfattelse, at benefit/risk-forholdet for de lægemidler, der indeholder de aktive stoffer aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid er gunstigt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen. 
On the basis of the scientific conclusions for aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing aliskiren / aliskiren, amlodipine / aliskiren, hydrochlorothiazide is favourable subject to the proposed changes to the product information.
- hvis du har nedsat nyrefunktion, vil din læge nøje overveje, om Rasilamlo er egnet til dig, og kan vælge at følge dig nøje 
- if you have impaired kidney function, your doctor will carefully consider whether Rasilamlo is suitable for you and may wish to monitor you carefully - if you suffer from liver problems (impaired liver function)
Patienterne havde mindst én ekstra risikofaktor for koronar hjertelidelse, inklusive: tidligere myokardie infarkt eller slagtilfælde (> 6 måneder før inkludering) eller dokumenteret anden aterosklerotisk kardiovaskulær sygdom (tilsammen 51,5 %), type 2 diabetes (36,1 %), høj-densitet-lipoprotein - kolesterol < 35 mg/dl eller < 0,906 mmol/l (11,6 %), venstresidig ventrikulær hypertrofi diagnosticeret ved elektrokardiogram eller ekkokardiografi (20,9 %), aktiv 
The patients had at least one additional coronary heart disease risk factor, including: previous myocardial infarction or stroke (>6 months prior to enrollment) or documentation of other atherosclerotic cardiovascular disease (overall 51.5%), type 2 diabetes (36.1%), high density lipoprotein - cholesterol <35 mg/dl or <0.906 mmol/l (11.6%), left ventricular hypertrophy diagnosed by electrocardiogram or echocardiography (20.9%), current cigarette smoking (21.9%).
Der skal derfor udvises særlig forsigtighed over for disse patienter. 
Therefore, particular caution should be exercised in these patients.
Administration af aliskiren sammen med enten metformin (↓28 %), amlodipin (↑29 %) eller cimetidin (↑19 %) resulterede i ændring af Cmax eller AUC for aliskiren på mellem 20 % og 30 %. 
- Co-administration of aliskiren with either metformin (↓28%), amlodipine (↑29%) or cimetidine (↑19%) resulted in between 20% and 30% change in Cmax or AUC of aliskiren.
Frugtjuice og drikkevarer indeholdende planteekstrakter Indtagelse af frugtjuice sammen med aliskiren resulterede i en reduktion i AUC og Cmax for aliskiren. 
- Fruit juice and drinks containing plant extracts Administration of fruit juice with aliskiren resulted in a decrease in AUC and Cmax of aliskiren.
Aliskiren er undersøgt i 1.864 patienter i alderen 65 år eller derover og i 426 patienter i alderen 75 år eller derover. 
Aliskiren has been studied in 1,864 patients aged 65 years or older, and in
Rasilamlo kan administreres sammen med andre antihypertensive lægemidler dog ikke i kombination med angiotensin-konverteringsenzym (ACE)-hæmmere eller angiotensin-II receptorblokkere (ARB) hos patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationsrate (GFR) 
Rasilamlo may be administered with other antihypertensive medicinal products with the exception of use in combination with angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) in patients with diabetes mellitus or renal impairment (glomerular filtration rate
Der er ikke udført interaktionsstudier for Rasilamlo med andre lægemidler. 
No interaction studies with other medicinal products were performed with Rasilamlo.
Der sås ingen effekt på fertiliteten hos rotter behandlet med amlodipin (hanner i 64 dage og hunner i 14 dage før parring) ved doser op til 10 mg/kg/dag (8 gange* den maksimalt anbefalede dosis til 
There was no effect on the fertility of rats treated with amlodipine (males for 64 days and females 14 days prior to mating) at doses up to 10 mg/kg/day (8 times* the maximum recommended human basis).
Amlodipins farmakokinetik er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion; der skal derfor udvises forsigtighed, hvis Rasilamlo administreres til patienter med nesat leverfunktion. 
The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment; therefore, caution should be exercised when administering Rasilamlo to patients with
Rasilamlo frarådes til patienter med stærkt nedsat 
Rasilamlo is not recommended in patients with severe renal impairment
, dyspepsi 
, dyspepsia
Væske- og natriummangel bør korrigeres før administration af Rasilamlo, ellers skal behandlingen indledes under nøje klinisk overvågning. 
The volume or salt depletion should be corrected prior to administration of Rasilamlo, or the treatment should start under close medical supervision.
I et 8-ugers studie med 754 hypertensive ældre patienter (≥ 65 år) og gamle patienter (30 % ≥ 75 år) gav aliskiren i doser på 75 mg, 150 mg og 300 mg statistisk signifikant større blodtryksreduktioner (både systolisk og diastolisk) sammenlignet med placebo. 
In a 8-week study in 754 hypertensive elderly (≥65 years) and very elderly patients (30% ≥75 years) aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Aliskirens farmakokinetik blev undersøgt hos 8 til 28 dage gamle rotter ved intravenøs indgift af aliskiren på 3 mg/kg. 
The pharmacokinetics of aliskiren was evaluated in rats aged from 8 to 28 days after intravenous administration of aliskiren 3 mg/kg.
Aorta- og mitralklapstenose, obstruktiv hypertrofisk kardiomyopati Som ved andre vasodilatorer skal der udvises særlig forsigtighed over for patienter, der lider af aortaeller mitralklapstenose eller hypertrofisk obstruktiv kardiomyopati. 
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Resultaterne fra et studie med føde, hvor der blev givet et standardmåltid med højt fedtindhold sammen med 300 mg/10 mg fast dosiskombinationstablet viste, at føde reducerede hastigheden og omfanget af aliskirens absorption i den faste kombinationstablet svarende til størrelsen af virkningen ved aliskiren monoterapi. 
The results from a food effect study using a standard high fat meal with the 300 mg/10 mg fixed combination tablet showed that food reduced the rate and extent of absorption of aliskiren in the fixed combination tablet with a similar magnitude of effect as for aliskiren monotherapy.
Rasilamlo må ikke bruges til behandling af børn fra fødslen og op til 2 år. 
Rasilamlo must not be used in children from birth to less than 2 years of age.
Der blev observeret en øget forekomst af hyperkaliæmi (20,9 % versus 17,5 %), nedsat nyrefunktion/nyresvigt (16,6 % versus 12,1 %) og hypotension (17,1 % versus 12,6 %) i aliskiren-gruppen sammenlignet med placebo-gruppen; hyppigheden var højere hos patienter med 
An increased incidence of hyperkalaemia (20.9% versus 17.5%), renal impairment/renal failure (16.6% versus 12.1%) and hypotension (17.1% versus 12.6%) was observed in the aliskiren group compared with placebo and was greater in patients with diabetes.
YDRE KARTON TIL MULTPAKNING (INKLUSIVE BLÅ BOKS) 
OUTER CARTON OF MULTIPACK (WITH BLUE BOX)
Der er ingen tilgængelige data med hensyn til mortalitet og morbiditet for aliskiren til patienter med 
No data on cardiovascular mortality and morbidity are available for aliskiren in patients with heart
Incidensen af bivirkninger var ikke forbundet med køn, alder, BMI, race eller etnicitet. 
The incidence of adverse events did not show any association with gender, age, body mass index, race or ethnicity.
Amlodipin-delen af Rasilamlo hæmmer den transmembrane indtrængning af calciumioner i hjertets og karvæggens glatte muskulatur. 
The amlodipine component of Rasilamlo inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Ved behandling med Rasilamlo i doser op til 300 mg/10 mg var den samlede incidens af bivirkninger enslydende med stoffernes monoterapi. 
Treatment with Rasilamlo at doses up to 300 mg/10 mg had an overall incidence of adverse experiences similar to the component monotherapies.
Rasilamlo er kontraindikeret under 2. og 3. trimester af graviditeten (se pkt. 
Rasilamlo is contraindicated during the second and third trimesters (see section 4.3).
, humørsvingninger (inklusive angst) 
, mood changes (including anxiety)
, misfarvning af huden hyperhidrose 
, skin decolouration hyperhidrosis
Et dobbeltblindet morbiditet-mortalitets studie kaldet ”Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial” (ALLHAT) blev gennemført for at sammenligne nye behandlinger: Amlodipin 2,5-10 mg/dag (calcium-antagonist) eller lisinopril 10-40 mg/dag (ACEhæmmer) som førstevalgsbehandling i tillæg til thiaziddiuretikummet chlorthalidon 12,5-25 mg/dag 
A randomised double-blind morbidity-mortality study called the Antihypertensive and LipidLowering treatment to prevent Heart Attack Trial (ALLHAT) was performed to compare newer therapies: amlodipine 2.5-10 mg/day (calcium channel blocker) or lisinopril 10-40 mg/day (ACEinhibitor) as first-line therapies to that of the thiazide-diuretic, chlorthalidone 12.5-25 mg/day in mild
Hæmodynamisk ustabil hjertesvigt efter akut myokardie infarkt. 
- Haemodynamically unstable heart failure after acute myocardial infarction.
Aliskiren er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller 2,00 mg/dl hos mænd og/eller estimeret GFR < 30 ml/min/1,73 m2), tidligere dialyse, nefrotisk syndrom eller renovaskulær hypertension. 
In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥150 μmol/l or 1.70 mg/dl in women and ≥177 μmol/l or 2.00 mg/dl in men and/or estimated GFR <30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Der blev observeret høj akut mortalitet (inden for timer) og svær morbiditet ved 100 og 300 mg/kg/dag (2,3 og 6,8 gange den maksimale anbefalede humane dosis (MRHD) baseret på mg/m antaget for en voksen patient på 60 kg), hvor dødsårsagen ikke kunne fastslås og skete uden tegn eller prodromale symptomer. 
High acute mortality (within hours) and severe morbidity were observed at 100 and 300 mg/kg/day (2.3- and 6.8-fold the maximum recommended basis assuming a 60 kg adult patient) with no cause of death established and occurring without signs or prodromal symptoms.
• hududslæt (dette kan også være symptomer på en overfølsomhedsreaktion eller angioødem - se 
• skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects
• hævede hænder, ankler eller fødder (perifere ødemer) 
• swelling, including swelling of hands, ankles or feet (peripheral oedema)
98 tabletter (2x49, PA/Alu/PVC blister) 98 tabletter (2x49x1, PVC/PCTFE enkeltdosisblister) 280 tabletter (20x14, PVC/PCTFE blister) 280 tabletter (20x14, PA/Alu/PVC blister) 
98 tablets (2x49, PA/Alu/PVC blisters) 98 tablets (2x49x1, PVC/PCTFE single-unit-dose blisters) 280 tablets (20x14, PVC/PCTFE blisters) 280 tablets (20x14, PA/Alu/PVC blisters)
Rotters fertilitet var upåvirket ved doser op til 250 mg/kg/dag (se pkt. 
The fertility of rats was unaffected at doses of up to aliskiren 250 mg/kg/day (see section 5.3).
Både kliniske og ikke-kliniske sikkerhedsdata for amlodipin er veletableret. 
Safety data for amlodipine are well established both clinically and non-clinically.
***Inklusive et tilfælde af 'fulminant leversvigt', der er rapporteret post-marketing, og hvor en kausal 
***Including one case of “liver failure fulminant” reported in the post-marketing experience, for which a causal relationship with aliskiren cannot be excluded.
Leverforstyrrelser a, 
Liver disorder a,
Amlodipins clearance har tendens til at være nedsat hos ældre patienter, resulterende i øget AUC og eliminationshalveringstid. 
Amlodipine clearance tends to be decreased with resulting increases in AUC and elimination half-life in elderly patients.
Calciumantagonister virker ved at hindre indtrængning af calcium ind i karvæggens vaskulære glatte muskelceller, og forhindrer derved glatte muskelcellers sammentrækning og vasokonstriktion. 
Calcium channel blockers act to prevent the influx of calcium into the vascular smooth muscle cells in the vessel wall, thereby preventing smooth muscle cell contraction and vasoconstriction.
Mutagenicitetsstudier viste ingen lægemiddelrelaterede virkninger på hverken gen- eller kromosomniveau. 
Mutagenicity studies revealed no effects related to the medicinal product at either the gene or
Som for andre lægemidler, der virker på renin-angiotensin-aldosteron-systemet, skal der udvises forsigtighed, når Rasilamlo gives til patienter, der er prædisponerede for renal dysfunktion som hypovolæmi (fx pga. blodtab, alvorlig eller vedvarende diarré, vedvarende opkastning), hjertelidelse, leverlidelse, diabetes mellitus eller nyrelidelse. 
As for other medicinal products acting on the renin-angiotensin-aldosterone system, caution should be exercised when Rasilamlo is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (e.g. due to blood loss, severe or prolonged diarrhoea, prolonged vomiting, etc.), heart disease, liver disease, diabetes mellitus or kidney disease.
Set i lyset af de tilgængelige data vedrørende aliskiren / aliskiren, amlodipin / aliskiren, hydrochlorthiazid, anser PRAC det for ønskeligt med en ændring af produktinformationen. 
Therefore, in view of available data regarding aliskiren/ aliskiren,amlodipine / aliskiren, hydrochlorothiazide, the PRAC considered that changes to the product information were warranted.
Det skal besluttes, om amning eller behandling med Rasilamlo skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Rasilamlo therapy taking into account the benefit of breast-feeding for the child and the benefit of
Dosis bør individualiseres og skal justeres i 
Dose should be individualised and adjusted according to the patient's clinical response.