FrancophonIA/ELRC3.0 huggingface dataset:
English: Because no information is available regarding the use of CoAprovel during breast-feeding, CoAprovel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Da der ikke foreligger oplysninger om anvendelse af CoAprovel under amning, frarådes brugen af CoAprovel, og andre behandlinger med en mere veletableret sikkerhedsprofil for anvendelse under amning foretrækkes.
English: Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Danish: Yderligere information om irbesartaninteraktioner: Irbesartans farmakokinetik er i kliniske forsøg ikke blevet påvirket af hydrochlorthiazid.
English: syncope, hypotension, tachycardia, oedema
Danish: Synkope, hypotension, takykardi, ødem
English: Reproductive system and breast disorders:
Danish: Det reproduktive system og mammae:
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Danish: Forudgående behandling med store doser diuretika kan resultere i hypovolæmi og risiko for hypotension, når der påbegyndes behandling med irbesartan med eller uden thiaziddiuretika (se pkt.
English: Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Danish: Irbesartan hæmmer ikke ACE (kininase-II), et enzym som producerer angiotensin-II og også nedbryder bradykinin til inaktive metabolitter.
English: Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions.
Danish: Blandt 898 hypertensive patienter, der fik forskellige doser af irbesartan/hydrochlorthiazid (interval: 37,5 mg/6,25 mg til 300 mg/25 mg) i placebokontrollerede forsøg, oplevede 29,5% af patienterne bivirkninger.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Danish: Ved konstateret graviditet, bør behandling med AIIRAer seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes.
English: Unit dose blister packs of 56 x 1 tablet for delivery in hospitals are also available.
Danish: Der fås også enkeltdosisblisterpakninger med 56 x 1 tablet til hospitalsbrug.
English: Titanium dioxide Macrogol 3000
Danish: Titaniumdioxid (E 171) Macrogol 3000
English: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Danish: Aplastisk anæmi, knoglemarvsdepression, neutropeni/agranulocytose, hæmolytisk anæmi, leukopeni, trombocytopeni
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 56 tabletter 56 x 1 tabletter 98 tabletter
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with CoAprovel (see section 4.5).
Danish: Kaliumbesparende diuretika, kaliumtilskud eller kaliumholdige saltsubstitutioner skal derfor gives med forsigtighed sammen med CoAprovel (se pkt.
English: 14 tablets 28 tablets 30 tablets 56 tablets 56 x 1 tablets 84 tablets 90 tablets 98 tablets
Danish: 14 tabletter 28 tabletter 30 tabletter 56 tabletter 56 x 1 tabletter 84 tabletter 90 tabletter 98 tabletter
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically forcetitrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Danish: Ialt 697 patienter randomiseredes i forholdet 2:1 til irbesartan/hydrochlorothiazid 150 mg/12,5 mg eller irbesartan 150 mg, og med systematisk titrering (inden evaluering af respons på den lavere dosis) efter 1 uge til henholdsvis irbesartan/hydrochlorothiazid 300 mg/25 mg eller irbesartan 300 mg.
English: Side effects associated with hydrochlorothiazide alone Loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or build-up of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Danish: Bivirkninger forbundet med hydrochlorthiazid alene Appetitmangel; maveirritation; mavekramper; forstoppelse; gulsot (hvor huden og/eller det hvide i øjnene bliver gulfarvet); bugspytkirtelbetændelse, med stærke smerter i øvre maveregion, ofte forbundet med kvalme og opkastning; søvnproblemer; depression; sløret syn; mangel på hvide blodceller, som kan resultere i hyppige infektioner; feber; nedsat antal blodplader (blodceller, som er nødvendige for, at blodet kan størkne); nedsat antal af røde blodceller (blodmangel), som karakteriseres ved træthed, hovedpine, forpustethed ved motion, svimmelhed og bleghed; nyresygdom; lungeproblemer, inklusive lungebetændelse eller ophobning af væske i lungerne; øget følsomhed af huden for sol; årebetændelse; hudsygdom som karakteriseres ved afskalning af huden over hele kroppen; kutan lupus erythematosus, som ses i form af udslæt i ansigt, hals og hovedbund; allergiske reaktioner; svækkelse og muskelkramper; ændring i puls; nedsat blodtryk efter ændringer i kropsstilling; hævelse af spytkirtler; højt sukkerindhold i blodet; sukker i urinen; øgning i bestemte typer af fedt i blod; høj mængde urinsyre i blodet, som kan lede til urinsyregigt.
English: Due to the hydrochlorothiazide component, CoAprovel is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Danish: På grund af hydrochlorthiazid-komponenten anbefales CoAprovel ikke til patienter med alvorlig nyreinsufficiens (kreatininclearance < 30 ml/min).
English: High HCTZ use (≥50,000 mg cumulative) was associated with an adjusted OR of 1.29 (95% CI: 1.231.35) for BCC and 3.98 (95% CI: 3.68-4.31) for SCC.
Danish: Stort forbrug af hydrochlorthiazid (≥ 50.000 mg kumulativt) var forbundet med en justeret OR-værdi på 1,29 (95 %KI: 1,23-1,35) for basalcellekarcinom og på 3,98 (95 %-KI: 3,68-4,31) for pladecellekarcinom.
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Danish: Samtidig administration af thiaziddiuretika kan øge hyppigheden af overfølsomhedsreaktioner over for allupurinol;
English: CoAprovel is not indicated in patients with severe hepatic impairment.
Danish: CoAprovel er ikke indiceret til patienter med svært nedsat leverfunktion.
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Danish: Den selektive antagonisme mod angiotensin-II (AT1) receptorerne resulterer i en forhøjelse af plasma-renin- og angiotensin-IIniveauerne og i nedsat aldosteron i plasma.
English: CoAprovel is a combination of two active substances, irbesartan and hydrochlorothiazide.
Danish: CoAprovel indeholder en kombination af to aktive lægemidler, irbesartan og hydrochlorthiazid.
English: cases of hypersensitivity reactions such as angioedema, rash, urticaria
Danish: Sjældne tilfælde af overfølsomhedsreaktioner som fx angioødem, udslæt og urticaria
English: You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking CoAprovel.
Danish: Du skal også oplyse lægen om det: hvis du er på en saltfattig diæt hvis du har symptomer som voldsom tørst, mundtørhed, følelse af svaghed, sløvhed, muskelsmerter eller -kramper, kvalme, opkastning eller en voldsom hjertebanken, som kan være tegn på for kraftig effekt af hydrochlorthiazid (der er indeholdt i CoAprovel) hvis du oplever øget følsomhed af huden for sol med solskoldningssymptomer (såsom rødme, kløe, hævelse, blæredannelse), som forekommer hurtigere end normalt hvis du skal opereres eller bedøves hvis dit syn ændrer sig, eller du får smerter i et af eller begge dine øjne, mens du tager CoAprovel.
English: interstitial nephritis, renal dysfunction
Danish: Interstitiel nefritis, nyreinsufficiens
English: At the time of Commission Decision.
Danish: Kommissionens afgørelse
English: The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mm Hg.
Danish: Kombinationen af 300 mg irbesartan og 12,5 mg hydrochlorthiazid medførte en total placebo-korrigeret systolisk/diastolisk reduktion på op til 13,6/11,5 mmHg.
English: Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when CoAprovel is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Danish: Lægemidler, der påvirkes af serum-kaliumforstyrrelser: Det anbefales at måle serum-kalium periodisk, når CoAprovel administreres sammen med lægemidler, der påvirkes af serum-kaliumforstyrrelser (fx digitalis glykosider, antiarytmika).
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Danish: ACE-hæmmere og angiotensin-II-receptorblokkere bør ikke amvendes samtidig hos patienter med diabetisk nefropati.
English: NDEA Limit in ppm in API
Danish: NDMA Grænseværdi i ppm i det aktive stof
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Danish: Hvis der er givet AIIRAer under graviditetens andet trimester, anbefales ultralydskontrol af nyrefunktionen og kraniet.
English: abnormal urination
Danish: Abnorm vandladning
English: 14 - 28 - 56 - 84 - 98 tablets: Mon
Danish: 14 - 28 - 56 - 84 - 98 tabletter: Ma
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Danish: Generelt: Hos patienter, hvis vaskulære tonus og nyrefunktion hovedsageligt afhænger af reninangiotensin-aldosteronsystemets aktivitet (fx patienter med alvorlig hjerteinsufficiens eller underliggende nyresygdom, inklusive nyrearteriestenose), er behandling med angiotensinkonverterende enzymhæmmere eller angiotensin-II receptorantagonister, der påvirker dette system, blevet forbundet med akut hypotension, azotæmi, oliguri og i sjældne tilfælde akut nyresvigt (se pkt.
English: The use of CoAprovel during breast feeding is not recommended.
Danish: Anvendelse af CoAprovel i ammeperioden frarådes.
English: Medicinal products affecting potassium: the potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Danish: Lægemidler, der påvirker kalium: Den kalium-depleterende virkning af hydrochlorthiazid dæmpes af irbesartans kalium-besparende effekt.
English: In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/diastolic mean reduction of 11.1/7.2 mm Hg.
Danish: Hos patienter, der ikke var tilstrækkeligt kontrolleret med 25 mg hydrochlorthiazid alene, gav et tillæg af irbesartan en yderligere placebo-korrigeret systolisk/diastolisk gennemsnitlig reduktion på 11,1/7,2 mmHg.
English: Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy (see section 4.8).
Danish: Risikofaktorer for at udvikle akut snævervinklet glaukom kan omfatte allergi over for sulfonamider eller antibiotika i anamnesen (se pkt.
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Danish: Følgende ændringer, observeret hos rotter og makakaber, der fik en kombination af irbesartan/hydrochlorthiazid på 10/10 og 90/90 mg/kg/dag, blev også set ved anvendelse af de individuelle stoffer og/eller var sekundære til blodtryksnedsættelse (der blev ikke observeret signifikante toksikologiske interaktioner):  nyreforandringer karakteriseret ved let øgning af serum-urea og kreatinin samt hyperplasi/hypertrofi af det juxtaglomerulære apparat, hvilket er en direkte konsekvens af interaktion mellem irbesartan og renin-angiotensin-systemet;  let fald i erytrocytparametre (erytrocytter, hæmoglobin, hæmatokrit);  i et 6 måneders toksicitetsstudie med irbesartan 90 mg/kg/dag, hydrochlorthiazid 90 mg/kg/dag, og irbesartan/hydrochlorthiazid 10/10 mg/kg/dag blev der observeret misfarvning, sår og fokal nekrose af ventrikelslimhinden hos rotter.
English: Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Danish: Lægemidler mod arthritis urica: Det kan være nødvendigt at justere dosis af lægemidler mod arthritis urica, da hydrochlorthiazid kan øge niveauet af urinsyre i serum.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS): there is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).
Danish: Dobbelt hæmning af renin-angiotensin-aldosteron-systemet (RAAS): Der er evidens for, at samtidig brug af ACE-hæmmere, angiotensin-II-receptorblokkere eller aliskiren øger risikoen for hypotension, hyperkaliæmi og nedsætter nyrefunktionen (inklusive akut nyresvigt).
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Danish: Dobbelt hæmning af RAAS ved kombination af ACE-hæmmere, angiotensin-II-receptorblokkere eller aliskiren anbefales derfor ikke (se pkt.
English: 14 - 28 - 56 - 98 tablets: Mon
Danish: 14 - 28 - 56 - 98 tabletter: Ma
English: Nervous system disorders:
Danish: Nervesystemet:
English: How to take CoAprovel
Danish: Sådan skal du tage CoAprovel
English: Renal artery stenosis - Renovascular hypertension: there is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists.
Danish: Renal arteriestenose - renovaskulær hypertension: Der er øget risiko for alvorlig hypotension og nyreinsufficiens, hvis patienter med bilateral nyrearteriestenose eller stenose af arterien til den eneste fungerende nyre behandles med angiotensin-konverterende enzymhæmmere eller angiotensin-II receptor-antagonister.
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports
Danish: Tabel 1: Bivirkninger fra placebokontrollerede studier, og bivirkninger rapporteret efter markedsføring
English: Psychiatric disorders:
Danish: Psykiske forstyrrelser:
English: Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Danish: Det bør overvejesat monitorere nyrefunktionen efter samtidig behandling er initieret og periodisk derefter.
English: NDEA Limit in ng/day
Danish: Grænseværdi (ng/dag)
English: Doses higher than 300 mg irbesartan/25 mg hydrochlorothiazide once daily are not recommended.
Danish: Højere doser end 300 mg irbesartan/25 mg hydrochlorthiazid, 1 gang dagligt frarådes.
English: Therefore, the combination of lithium and CoAprovel is not recommended (see section 4.4).
Danish: Derfor frarådes kombination af lithium og CoAprovel (se pkt.
English: The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Danish: Kombinationen af disse stoffer medfører en større reduktion af blodtrykket end der opnås med hver komponent alene.
English: Immune system disorders:
Danish: Immunsystemet:
English: Side effects reported since the launch of CoAprovel Some undesirable effects have been reported since marketing of CoAprovel.
Danish: Der er indberettet bivirkninger efter markedsføring af CoAprovel.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Danish: Det er kendt, at eksponering for behandling med AIIRA under andet og tredje trimester kan inducere human føtotoksicitet (nedsat nyrefunktion, oligohydramnios, hæmning af kraniets ossifikation) og neonatal toksicitet (nyresvigt, hypotension, hyperkalæmi) (se pkt.
English: Undesirable effects where the frequency is not known are: headache, ringing in the ears, cough, taste disturbance, indigestion, pain in joints and muscles, liver function abnormal and impaired kidney function, increased level of potassium in your blood and allergic reactions such as rash, hives, swelling of the face, lips, mouth, tongue or throat.
Danish: Bivirkninger, hvor hyppigheden ikke er kendt, er: hovedpine, ringen for ørerne, hoste, smagsforstyrrelser, forstoppelse, led- og muskelsmerter, leversygdom og nedsat nyrefunktion, øget mængde af kalium i blodet og allergiske reaktioner såsom udslæt, nældefeber,opsvulmet ansigt, læber, mund, tunge og hals.
English: Respiratory, thoracic and mediastinal disorders:
Danish: Luftveje, thorax og mediastinum:
English: (It is also better to avoid CoAprovel in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: (Du bør heller ikke tage CoAprovel i begyndelsen af graviditeten - se afsnittet om graviditet) hvis du har alvorlige lever- eller nyreproblemer (spørg lægen, hvis du er i tvivl) hvis du har problemer med urinproduktionen hvis din læge har konstateret, at du har konstant forhøjet calcium eller lavt kalium i blodet hvis du har diabetes eller nedsat nyrefunktion, og du bliver behandlet med et lægemiddel, der sænker blodtrykket, som indeholder aliskiren.
English: Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Danish: Doping-test: Indholdet af hydrochlorthiazid i dette lægemiddel kan medføre et positivt fund ved en Doping-test.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of CoAprovel with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Danish: Alvorlig leverfunktionsnedsættelse, biliær cirrhose og cholestase Samtidig behandling med CoAprovel og aliskiren-holdige lægemidler er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (glomerulær filtrationshastighed (GFR) < 60 ml/min/1,73 m2 ) (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Hypromellose Titanium dioxide Macrogol 3350
Danish: Lactosemonohydrat Hypromellose Titaniumdioxid (E 171) Macrogol 3350
English: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Danish: 4.4), hyperurikæmi, glukosuri, hyperglykæmi, stigning i kolesterol og triglycerider
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Danish: På grund af voldsom diurese medfører overdosis af hydrochlorthiazid elektrolyt-depletion (hypokaliæmi, hypochloræmi, hyponatriæmi) og dehydrering.
English: When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/diastolic reductions of 15.8/10.0 mm Hg.
Danish: Ved ambulant blodtrykskontrol medførte kombinationen af 150 mg irbesartan og 12,5 mg hydrochlorthiazid, 1 gang dagligt, en vedvarende reduktion af blodtrykket over en 24 timers periode med en gennemsnitlig 24 timers placebo-korrigeret systolisk/diastolisk reduktion på 15,8/10,0 mmHg.
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Danish: Ved konstateret graviditet, bør behandling med AIIRA seponeres øjeblikkeligt, og hvis det skønnes hensigtsmæssigt bør anden behandling iværksættes (se pkt.