FrancophonIA/ELRC3.0 huggingface dataset:
English: Unscrew the cap on the bottle by pushing down hard on the cap while turning the cap to the left (counter clockwise).
Danish: Skru låget af flasken ved at presse låget hårdt ned og drej samtidigt til venstre (mod uret).
English: Serious liver events (including hepatitis, jaundice and liver failure)
Danish: Alvorlige leverpåvirkninger (herunder hepatitis, icterus og leverinsufficiens)
English: United Kingdom Pfizer Ltd Ramsgate Road Sandwich
Danish: Storbritannien Pfizer Ltd Ramsgate Road Sandwich
English: Respiratory, Thoracic, and Mediastinal Disorders Yawning* Bronchospasm* , Dyspnoea, Epistaxis
Danish: Luftveje, thorax og mediastinum Gaben* Bronkospasmer*, dyspnø, epistaxis
English: Age 6-12 years: Initially 25 mg once daily.
Danish: 6-12 år: Initialt gives 25 mg 1 gang dagligt.
English: The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced.
Danish: Risikoen for at få disse abstinenssymptomer afhænger af, hvor længe De er blevet behandlet, og hvor hurtigt dosis bliver nedsat.
English: • Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemid (to treat depression) and selegiline (to treat Parkinson's disease) and the antibiotic linezolid.
Danish: • Medicin mod depression (MAO-hæmmere, f.eks. moclobemid) og medicin mod Parkinsons sygdom (selegilin) og linozid (et antibiotikum).
English: • If you are having electro-convulsive therapy (ECT).
Danish: • De får eller har fået elektrochok (ECT).
English: Palpitations* Tachycardia Myocardial Infarction,
Danish: Palpitationer* Takykardi* Myokardieinfarkt, bradykardi, hjerteforstyrrelser
English: Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder: For panic disorder, social anxiety disorder and post traumatic stress disorder, treatment should be started at (1.25 ml) 25 mg/day, and increased to (2.5 ml) 50 mg/day after one week.
Danish: Panikangst, socialangst og posttraumatisk belastningsreaktion: Startdosis er (1,25 ml)25 mg 1 gang dagligt.
English: The use of sertraline in patients with hepatic disease should be approached with caution.
Danish: Anvendelse af sertralin til patienter med leversygdom bør foregå med forsigtighed.
English: Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartrate, shaking, agitation, dizziness and in rare cases unconsciousness.
Danish: Symptomer på overdosering kan være døsighed, kvalme og opkastning, hurtig puls, rysten, uro, svimmelhed og i sjældne tilfælde bevidstløshed.
English: Abnormal Bleeding (such as epistaxis, gastrointestinal bleeding or haematuria)
Danish: Abnorm blødning (f.eks. epistaxis, gastrointestinal blødning eller hæmaturi)
English: Adolescents aged 13 to 17: the recommended starting dose is (2.5 ml) 50 mg daily.
Danish: Unge i alderen 13-17 år: Den anbefalede startdosis er (2,5 ml)50 mg 1 gang dagligt.
English: No data is available for children under 6 years of age (see also section 4.4)
Danish: Der er ingen tilgængelige data for behandling af børn under 6 år (se pkt.
English: Patients randomized to sertraline showed significantly greater improvement than those randomised to placebo on the Children's Yale-Brown Obsessive Compulsive Scale CY-BOCS (p =0.005) the NIMH Global Obsessive Compulsive Scale (p=0.019), and the CGI Improvement (p =0.002) scales.
Danish: Efter Children's Yale-Brown Obsessive Compulsive Scale CY-BOCS (p=0,005), the NIMH Global Obessive Compulsive Scale (p=0,0019) og the CGI Improvement (p=0,002) viste de patienter, der blev randomiseret til sertralin en større forbedring end dem, der blev randomiseret til placebo.
English: If you stop taking Zoloft:
Danish: Hvis De holder op med at tage Zoloft
English: Sertraline should not be used in patients with severe hepatic impairment (see section 4.2).
Danish: Sertralin bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
English: Arthralgia, Muscle Cramps
Danish: Arthralgi, muskelkramper
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Patients were gradual uptitrated to a 200 mg daily dose within 32 days, either with 25 mg starting dose and increment steps, or with 50 mg starting dose or increments.
Danish: De fik enten en startdosis på 25 mg og derpå trinvis stigning i dosis, eller en startdosis på 50 mg og trinvis stigning i dosis.
English: Since the bioavailability of sertraline capsules is increased in the presence of food, it is recommended that sertraline capsules be administered with meals.
Danish: Det anbefales, at sertralin kapsler indtages sammen med føde, da biotilgængeligheden af sertralin kapsler stiger, når der er føde tilstede.
English: Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Danish: Intensitet og frekvens kan falde ved fortsat behandling for nogle af de bivirkninger, der er anført i tabel 1, og det vil som regel ikke føre til seponering af behandlingen.
English: Section 4.1 - Indications: Social Anxiety Disorder
Danish: Afsnit 4.1 - Indikationer: socialangst
English: After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline.
Danish: Hvis De afbryder behandlingen med MAO-hæmmer, skal der gå mindst 2 uger, før De må starte i behandling med sertralin.
English: The following symptoms may occur in the neonate after maternal sertraline use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping.
Danish: Følgende symptomer kan opstå hos nyfødte efter maternel brug af sertralin i et senere trin af graviditeten: respirationsbesvær, cyanose, apnø, krampeanfald, ustabil temperatur, vanskelighed ved fødeindtagelse, opkastning, hypoglykæmi, hypertoni, hypotoni, hyperrefleksi, rysten, sitren, irritabilitet, sløvhed, konstant grædende, døsighed og svært ved at sove.
English: Concentrate for Oral solution
Danish: Koncentrat til oral opløsning
English: Dermatitis, Dermatitis Bullous, Rash Follicular, Hair Texture Abnormal, Skin Odour Abnormal
Danish: Dermatitis, bulløs dermatitis, follikulært udslæt, abnorm hårstruktur, abnorm hudlugt
English: It is therefore advised that when sertraline treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).
Danish: Det anbefales derfor, når sertralinbehandling ikke længere er påkrævet, at seponere medicinen gradvist ved nedtrapning af dosis (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoloft and associated names (see Annex I) 20 mg/ml concentrate for oral solution [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Zoloft og tilhørende navne (se bilag I) 20 mg/ml koncentrat til oral opløsning [Se bilag I - Udfyldes nationalt]
English: Children aged 6 to 12: the recommended starting dose is (1.25 ml) 25 mg daily.
Danish: Børn i alderen 6-12 år: Den anbefalede startdosis er (1,25 ml)25 mg 1 gang dagligt.
English: Nocturia, Urinary Retention*, Polyuria, Pollakiura, Micturition disorder
Danish: Nokturi, urinretention*, polyuri, pollakisura, vandladningsproblemer
English: Therefore, sertraline concentrate for oral solution should not be used in combination with disulfiram or within 14 days of discontinuing treatment with disulfiram (see sections 4.3 and 4.4).
Danish: Sertralin koncentrat til oral opløsning bør derfor ikke anvendes samtidigt med disulfiram eller inden for 14 dage efter behandling med disulfiram er seponeret (se pkt.
English: Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible (non-selective) MAOI.
Danish: Sertralinbehandling må ikke initieres inden for 14 dage efter seponering af en irreversibel (ikke-selektiv) MAO-hæmmer.
English: It is therefore advised that sertraline should be gradually tapered when discontinuing treatment over a period of several weeks or months, according to the patient's needs (see section 4.2).
Danish: Det anbefales derfor at seponere behandlingen gradvist ved nedtrapning af dosis over en periode på flere uger eller måneder alt efter patientens behov (se "Symptomer ved seponering af sertralin" i pkt.
English: However, the generally lower body weights of children compared to those of adults should be taken into consideration when increasing the dose from 50 mg.
Danish: 50 mg bør der dog tages højde for, at børns kropsvægt generelt er lavere end voksnes.
English: If you forget to take Zoloft:
Danish: Hvis De har glemt at tage Zoloft
English: Sertraline concentrate for oral solution must be diluted before use (see section 6.6).
Danish: Sertralin koncentrat til oral opløsning skal altid fortyndes inden brug (se pkt.
English: The dosage may be increased to 50 mg once daily after one week.
Danish: Dosis kan øges til 50 mg 1 gang dagligt efter 1 uge.
English: • If you are taking another medicine called Pimozide (an antipsychotic medicine).
Danish: • hvis De er i behandling med medicin mod sindslidelser (anden medicin kaldet Pimozid).
English: If adverse experience occurred in depression, OCD, panic disorder, PTSD and social anxiety disorder, body term reclassified by depression studies body term.
Danish: Hvis bivirkningerne optrådte i forsøgene med depression, OCD, panikangst, PTSD og socialangst er terminologien genklassificeret til den terminologi, der blev anvendt for depressionsforsøgene.
English: Measuring the dose:
Danish: Oversigt over indlægssedlen:
English: • If you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs (such as linezolid).
Danish: • hvis De er i behandling med eller har fået en anden medicin mod depression (MAO-hæmmere f.eks. selegilin, moclobemid) eller MAO-hæmmer-lignende medicin (f.eks. linezolid).
English: If you suddenly stop taking this medicine you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Danish: Hvis De stopper behandlingen pludseligt, kan De få en række særdeles ubehagelige symptomer som f.eks. svimmelhed, følelsesløshed, søvnforstyrrelser, blive urolig eller angst, få hovedpine, kvalme, kaste op og ryste.
English: Concomitant intake of pimozide is contraindicated (see section 4.5).
Danish: Samtidig brug hos patienter, der tager pimozid er kontraindiceret (se pkt.
English: Furthermore, if any of the symptoms listed above appear or worsen when a patient under 18 is taking Zoloft, you should inform your doctor.
Danish: De bør underrette Deres læge, hvis nogle af de ovennævnte symptomer opstår eller forværres, når patienter under 18 år indtager Zoloft.
English: Sertraline concentrate for oral solution is contraindicated with the use of disulfiram due to the alcohol content of the oral concentrate (see sections 4.4 and 4.5).
Danish: Sertralin koncentrat til oral opløsning er kontraindiceret ved samtidig behandling med disulfiram på grund af alkoholindholdet i koncentratet (se pkt.
English: In controlled studies in normal volunteers, sertraline did not cause sedation and did not interfere with psychomotor performance.
Danish: I kontrollerede forsøg med raske forsøgspersoner, havde sertralin ingen sederende virkning og påvirkede ikke den psykomotoriske adfærd.
English: The number of male and female patients in the pooled general population trials was 184 and 430, respectively and hence the results in females are more robust and males were associated with other baseline variables (more substance abuse, longer duration, source of trauma etc) which are correlated with decreased effect.”
Danish: Resultaterne for kvinderne er derfor mere pålidelige, mens resultaterne for mændene var forbundet med andre baseline-variabler (hyppigere stofmisbrug, længere varighed, kilde til traume etc.), som er korreleret med en mindsket effekt."
English: Vasodilation Procedure
Danish: Induceret vasodilation
English: The daily dose may be increased in (2.5 ml) 50 mg increments and at intervals of at least one week over a period of weeks.
Danish: Den daglige dosis må øges med (2,5 ml)50 mg ad gangen i intervaller på mindst 1 uge og over en periode på et par uger.
English: Use in children and adolescents under 18 years of age Sertraline should not be used in the treatment of children and adolescents under the age of 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old.
Danish: Sertralin bør ikke anvendes til behandling af børn og unge under 18 år, undtagen børn og unge i alderen 6-17 år med obsessiv-kompulsiv sygdom.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Danish: - formålet med indbringelsen af sagen var at harmonisere produktresuméerne, etiketteringen og indlægssedlen
English: Oedema Peripheral
Danish: Perifert ødem
English: Zoloft concentrate for oral solution may be taken with or without food.
Danish: Zoloft koncentrat til oral opløsning kan tages med eller uden mad.
English: Sertraline should be discontinued in any patient who develops seizures.
Danish: Sertralin bør seponeres hos patienter, der udvikler kramper.
English: Increased pimozide levels of approximately 35% have been demonstrated in a study of a single low dose pimozide (2 mg).
Danish: I et klinisk forsøg har samtidig indtagelse af sertralin og en lav enkeltdosis pimozid (2 mg) vist stigning i pimozidkoncentrationen på ca. 35 %.
English: Nausea (24%), Dry Mouth
Danish: Svimmelhed (11%), døsighed hovedpine
English: • Products containing the amino acid tryptophan.
Danish: • Visse proteindrikke mod nedsat appetit eller kosttilskud, som indeholder aminosyren tryptophan.
English: • Medicines to treat migraines (e.g. sumatriptan).
Danish: • Medicin mod migræne (f.eks. sumatriptan).
English: • Medicines to treat severe pain (e.g. tramadol).
Danish: • Medicin mod stærke smerter (f.eks. tramadol).
English: Zoloft must only be used to treat children and adolescents suffering from OCD aged 6-17 years old.
Danish: Zoloft må kun bruges til behandling af børn og unge med tvangstanker og tvangshandlinger i alderen 6-17 år.
English: Ethanol ingestion will result in an adverse reaction with disulfiram as long as serum levels of disulfiram persist, or the activity of acetaldehyde dehydrogenase is diminished.
Danish: Så længe serumniveauet af disulfiram vedvarer, eller aktiviteten af acetaldehyddehydrogenase er formindsket, vil ethanolindtagelse resultere i en bivirkning.
English: • Liver disease; your doctor may decide that you should have a lower dose of Zoloft.
Danish: Deres læge vil måske beslutte, at De skal have en lavere dosis.
English: The clinical programme for the indication social anxiety disorder consisted of two short term double blind, randomized, placebo controlled clinical trials and two long term efficacy and safety studies.
Danish: Det kliniske program for indikationen socialangst bestod af to kortvarige, dobbeltblindede, randomiserede, placebokontrollerede kliniske undersøgelser samt to langvarige effekt- og sikkerhedsundersøgelser.
English: Contractions Involuntary*, Coordination Abnormal, Hyperkinesia, Amnesia, Hypoaesthesia* , Speech Disorder, Dizziness Postural, Migraine*
Danish: Kramper*, ufrivillige muskelsammentrækninger*, abnorm koordination, abnorm hyperkinesi, amnesi, hypæstesi*, taleforstyrrelser, ortostatisk svimmelhed, migræne*
English: Skin and Subcutaneous Tissue Disorders Rash*,
Danish: Hud og subkutant væv Udslæt*, hyperhidrose
English: When stopping treatment with Sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, depending on the patient's needs.
Danish: Afhængig af patientens behov, tilrådes det at nedsætte dosis langsomt over en periode på adskillige uger eller måneder, når sertralinbehandlingen skal stoppes.
English: Generally these symptoms are mild to moderate; however, in some patients they may be severe in intensity.
Danish: Hos de fleste patienter er disse symptomer milde til moderate, men hos nogle patienter kan de være svære.
English: Paediatric patients with OCD
Danish: Pædiatriske OCD-patienter
English: Abdominal Pain* Vomiting*, Constipation* Dyspepsia, Flatulence
Danish: Abdominalsmer -ter* opkastning*, obstipation* dyspepsi, flatulens
English: Zoloft should only be used to treat children and adolescents aged 6-17 years old, suffering from obsessive compulsive disorder.
Danish: Zoloft må kun anvendes til at behandle børn og unge i alderen 617 år, som lider af tvangstanker eller tvangshandlinger.
English: Pharmacotherapeutic group: Selective serotonin reuptake inhibitors (SSRI), ATC code: N06 AB06 Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals.
Danish: Sertralin er en potent, specifik neuronal serotonin (5-HT)-genoptagshæmmer in vitro, hvilket resulterer i en potentiering af effekten af 5-HT i dyr.
English: • Social anxiety disorder (in adults).
Danish: • Socialangst (hos voksne).
English: It also contains glycerol which at high doses can cause headache, abdominal pain and diarrhea.
Danish: Glycerol kan i høje doser give hovedpine, mavebesvær og diarré.
English: OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
Danish: De kan have symptomer, som f.eks. kan være konstante tvangstanker (vedvarende ideer) og tvangshandlinger (gentager ritualer).
English: Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI.
Danish: Sertralin må ikke anvendes inden for 14 dage efter seponering af en irreversibel MAOhæmmer.
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: - commitments “to undertake a long-term safety study looking at aspects of growth, sexual maturation, cognitive and emotional development to support the paediatric OCD indication in paediatric patients aged 6-17 years old.
Danish: - forpligtelser "til at foretage en langsigtet undersøgelse af sikkerhed, der fokuserer på aspekter af vækst, seksuel modning samt kognitiv og følelsesmæssig udvikling som dokumentation for indikationen for OCD hos pædiatriske patienter på 6-17 år.
English: Withdrawal symptoms seen on discontinuation of sertraline treatment Discontinuation of sertraline (particularly when abrupt) commonly leads to withdrawal symptoms.
Danish: Seponering af sertralin (især brat seponering) medfører ofte seponeringssymptomer.
English: In general, the harmonised wording proposed by the MAH was accepted by the CHMP.
Danish: CHMP accepterede generelt den harmoniserede formulering, som indehaveren af markedsføringstilladelsen havde foreslået.
English: The antibiotic linezolid is a weak reversible and non-selective MAOI and should not be given to patients treated with sertraline (see section 4.3).
Danish: Reversibel, ikke-selektiv MAO-hæmmer (linezolid) Linezolid, der er et antibiotikum, er en svag reversibel og ikke-selektiv MAO-hæmmer, der ikke bør anvendes samtidig med sertralin (se pkt.
English: Obsessive Compulsive Disorder:
Danish: Depression og tvangstanker/tvangshandlinger:
English: Glycaemic control should be carefully monitored in patients receiving sertraline and the dosage of insulin and/or concomitant oral hypoglycaemic medicinal products may be needed to be adjusted.
Danish: Det kan være nødvendigt at justere dosis af insulin og/eller oral hypoglykæmisk dosering.
English: Section 4.1 - Indications: Obsessive Compulsive Disorder (In paediatric patients)
Danish: Afsnit 4.1 - Indikationer: obsessiv-kompulsiv tilstand (hos børn)
English: Obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.
Danish: Obsessiv-kompulsiv sygdom (OCD) hos voksne og hos børn og unge i alderen 6-17 år.
English: Choreoathetosis, Dyskinesia, Hyperaesthesia, Sensory Disturbance
Danish: Koma*, koreoatose, dyskinesi, hyperæstesi, sensorisk forstyrrelse
English: • If you develop yellow skin and eyes which may mean liver damage.
Danish: • Hvis De udvikler gulfarvning af hud og det hvide i øjnene.
English: As the capsule contains the excipient lactose (see section 6.1), patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: 6.1) og bør derfor ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: 6.6 Special precautions for disposal and other handling No special requirements
Danish: 6.6 Regler for destruktion og anden håndtering
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl så spørg lægen eller på apoteket.
English: Sertraline concentrate for oral solution can be administered with or without food.
Danish: Sertralin koncentrat til oral opløsning kan tages med eller uden føde.
English: Sertraline concentrate for oral solution contains 12% ethanol (see sections 4.3 and 4.5), glycerol and butylhydroxytoluene.
Danish: 4.3 og 4.5), glycerol og butylhydroxytoluen.
English: Oliguria, Urinary Incontinence*, Urinary Hesitation
Danish: Oliguri, urininkontinens*, forsinket påbegyndelse af vandladning
English: If you have a manic episode, contact your doctor immediately.
Danish: Kontakt straks lægen, hvis De får en manisk episode.
English: The daily dose then may be increased in (2.5 ml) 50 mg increments over a period of weeks.
Danish: Den daglige dosis må derefter øges med (2,5 ml)50 mg ad gangen over en periode på et par uger.
English: Use of sertraline during pregnancy has been reported to cause symptoms, compatible with withdrawal reactions, in some neonates, whose mothers had been on sertraline.
Danish: Der er rapporteret om symptomer svarende til seponeringssymptomer hos nogle nyfødte, hvis mødre har anvendt sertralin under graviditeten.
English: Kent CT13 9NJ United Kingdom
Danish: Kent CT13 9NJ Storbritannien
English: Kent CT13 9 NJ United Kingdom
Danish: Kent CT13 9 NJ Storbritannien
English: Zoloft and associated names (see Annex I) 25 mg hard capsules Zoloft and associated names (see Annex I) 50 mg hard capsules Zoloft and associated names (see Annex I) 100 mg hard capsules
Danish: Zoloft og tilhørende navne (Se bilag I) 25 mg hårde kapsler Zoloft og tilhørende navne (Se bilag I) 50 mg hårde kapsler Zoloft og tilhørende navne (Se bilag I) 100 mg hårde kapsler
English: Vision Abnormal
Danish: Unormalt syn
English: NAME OF THE MEDICINAL PRODUCT Zoloft and associated names (see Annex I) 25 mg film coated tablets Zoloft and associated names (see Annex I) 50 mg film coated tablets Zoloft and associated names (see Annex I) 100 mg film coated tablets Zoloft and associated names (see Annex I) 25 mg hard capsules Zoloft and associated names (see Annex I) 50 mg hard capsules Zoloft and associated names (see Annex I) 100 mg hard capsules Zoloft and associated names (see Annex I) 20 mg/ml concentrate for oral solution [See Annex I - To be completed nationally]
Danish: Zoloft og tilhørende navne (se bilag I) 25 mg filmovertrukne tabletter Zoloft og tilhørende navne (Se bilag I) 50 mg filmovertrukne tabletter Zoloft og tilhørende navne (Se bilag I) 100 mg filmovertrukne tabletter Zoloft og tilhørende navne (Se bilag I) 25 mg hårde kapsler Zoloft og tilhørende navne (Se bilag I) 50 mg hårde kapsler Zoloft og tilhørende navne (Se bilag I) 100 mg hårde kapsler Zoloft og tilhørende navne (Se bilag I) 20 mg/ml koncentrat til oral opløsning [Se bilag I - Udfyldes nationalt]