FrancophonIA/ELRC3.0 huggingface dataset:
English: - in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.
Danish: - hos patienter, der ikke er tilstrækkeligt velkontrollerede med inhaleret kortikosteroid og inhaleret korttidsvirkende β2-agonister ved behov.
English: Close the mouthpiece cover.
Danish: Luk låget på mundstykket.
English: Not applicable.
Danish: Ingen særlige forholdsregler.
English: To treat your asthma your doctor will prescribe two asthma inhalers: Budesonide/Formoterol Teva Pharma B.V. together with a separate ‘reliever inhaler' such as salbutamol.
Danish: Til behandling af din astma vil din læge ordinere to astma-inhalatorer: Budesonid/Formoterol Teva Pharma B.V.
English: Hyperglycaemia
Danish: Hypokaliæmi Meget sjælden Hyperglykæmi
English: Rare side effects: may affect up to 1 in 1,000 people
Danish: Sjældne bivirkninger: kan påvirke op til 1 ud af 1.000 personer
English: Potentially serious hypokalaemia may result from high doses of β2 adrenoceptor agonists.
Danish: Høje doser af β2-agonister kan give anledning til potentielt alvorlig hypokaliæmi.
English: • Mild sore throat, coughing and a hoarse voice.
Danish: • Let ømhed i halsen, hoste og hæshed.
English: Budesonide/Formoterol Teva Pharma B.V. contains lactose Lactose is a type of sugar found in milk.
Danish: indeholder lactose Lactose er en slags sukker, der findes i mælk.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan påvirke op til 1 ud af 100 personer
English: Cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles
Danish: Hjertearytmier, f.eks. atrieflimren, supraventrikulær takykardi, ekstrasystoler Meget sjælden Angina pectoris, forlænget QTc-interval
English: The inhaler is white with a semi-transparent wine red mouthpiece cover.
Danish: Inhalatoren er hvid med et halvgennemsigtigt vinrødt låg til mundstykket.
English: Keep the mouthpiece cover closed after removal of the foil wrapping.
Danish: Hold mundstykkets låg lukket efter, inhalatoren er taget ud af folien.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking Budesonide/Formoterol Teva Pharma B.V. - do NOT use this medicine unless your doctor tells you to.
Danish: • Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager Budesonid/Formoterol Teva Pharma B.V.
English: The effects include: - changes in bone mineral density (thinning of the bones) - cataract (clouding of the lens in the eye) - glaucoma (increased pressure in the eye) - a slowing of the rate of growth of children and adolescents - an effect on the adrenal gland (a small gland next to the kidney)
Danish: grå stær (uklarhed i øjets linse) grøn stær (glaukom − øget tryk i øjet) forsinkelse af væksten hos børn og unge påvirkning af binyrerne (2 små kirtler, der sidder ved nyrerne).
English: • Uneven heartbeat.
Danish: • Uregelmæssig hjerterytme (puls).
English: 1 inhalation (actuation), twice a day.
Danish: 1 inhalation 2 gange dagligt.
English: Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled shortacting β2 adrenoreceptor agonists.
Danish: er ikke en passende behandling til voksne patienter, som blot lider af mild astma, som ikke kontrolleres tilstrækkeligt med inhalationssteroid samt korttidsvirkende β2-agonist efter behov.
English: The use of Budesonide/Formoterol Teva Pharma B.V. follows three simple steps: open, breathe and close which are outlined below.
Danish: følger tre enkle trin: åbning, indånding og lukning, som beskrevet nedenfor.
English: Each delivered (inhaled) dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet (inhaleret) dosis indeholder 320 mikrogram budesonid og 9 mikrogram formoterolfumaratdihydrat.
English: You are allergic to budesonide, formoterol fumarate dihydrate, or the other ingredient in this medicine (listed in section 6).
Danish: Hvis du er allergisk over for budesonid, formoterolfumaratdihydrat eller det øvrige indholdsstof i Budesonid/Formoterol Teva Pharma B.V.
English: If you stop using Budesonide/Formoterol Teva Pharma B.V.
Danish: Hvis du holder op med at bruge Budesonid/Formoterol Teva Pharma B.V.
English: Each delivered (inhaled) dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet (inhaleret) dosis indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: Budesonide/Formoterol Teva Pharma B.V. 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate
Danish: 320 mikrogram/9 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: • Muscle cramps.
Danish: • Muskelkramper.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 320 mikrogram budesonid og 9 mikrogram formoterolfumaratdihydrat.
English: What you need to know before you use Budesonide/Formoterol Teva Pharma B.V.
Danish: Det skal du vide, før du begynder at bruge Budesonid/Formoterol Teva Pharma B.V.
English: If you forget to use Budesonide/Formoterol Teva Pharma B.V.
Danish: Hvis du har glemt at bruge Budesonid/Formoterol Teva Pharma B.V.
English: For a fixed-dose combination therapy of budesonide and formoterol fumarate dihydrate or the concomitant treatment with formoterol and budesonide, no clinical data on exposed pregnancies are available.
Danish: Der foreligger ingen kliniske data for behandling med fastdosiskombination af budesonid og formoterolfumaratdihydrat eller tilsvarende behandling med formoterol og budesonid under graviditet.
English: What Budesonide/Formoterol Teva Pharma B.V. contains - The active substances are budesonide and formoterol fumarate dihydrate.
Danish: indeholder: - Aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate.
Danish: Dette svarer til en afmålt dosis på 200 mikrogram budesonid og 6 mikrogram formoterolfumaratdihydrat.
English: This is equivalent to a metered dose of 400 micrograms budesonide and 12 micrograms of formoterol fumarate dihydrate.
Danish: Dette svarer til en afmålt dosis på 400 mikrogram budesonid og 12 mikrogram formoterolfumaratdihydrat.
English: Side panel: Each delivered dose contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate.
Danish: Kartonside: Hver afgivet dosis indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms /4.5 micrograms inhalation powder budesonide / formoterol fumarate dihydrate
Danish: 160 mikrogram/4,5 mikrogram inhalationspulver budesonid/formoterolfumaratdihydrat
English: Side panel: Each delivered dose contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Danish: Kartonside: Hver afgivet dosis indeholder 320 mikrogram budesonid og 9 mikrogram formoterolfumaratdihydrat.
English: Teva Pharmaceuticals Europe B.V. Swensweg 5
Danish: Teva Pharmaceuticals Europe B.V.
English: Budesonide/Formoterol Teva Pharma B.V. contains two different active substances: budesonide and formoterol fumarate dihydrate.
Danish: indeholder to aktive stoffer: budesonid og formoterolfumaratdihydrat.
English: Budesonide/Formoterol Teva Pharma B.V. is not indicated in children and adolescents under the age of 18 years (see section 4.2).
Danish: er ikke indiceret hos børn og unge under 18 år (se pkt.
English: Front panel: This delivered dose is equivalent to a metered dose of 400 micrograms of budesonide and 12 micrograms of formoterol fumarate dihydrate.
Danish: Karton-forside: Den afgivne dosis svarer til en afmålt dosis på 400 mikrogram budesonid og 12 mikrogram formoterolfumaratdihydrat.
English: Lactose contains small amounts of milk protein which may cause allergic reactions.If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.
Danish: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: White inhaler with a semi-transparent wine red mouthpiece cover.
Danish: Hvid inhalator med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: Front panel: This delivered dose is equivalent to a metered dose of 200 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate.
Danish: Karton-forside: Den afgivne dosis svarer til en afmålt dosis på 200 mikrogram budesonid og 6 mikrogram formoterolfumaratdihydrat.
English: Immune system disorders Rare
Danish: Meget sjælden Smagsforstyrrelser
English: Taste disturbances
Danish: søvnforstyrrelser
English: Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht The Netherlands
Danish: Computerweg 10, 3542 DR Utrecht Holland
English: Budesonide/Formoterol Teva Pharma B.V. 160 micrograms/4.5 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Danish: 160 mikrogram/4,5 mikrogram inhalationspulver (budesonid/formoterolfumaratdihydrat)
English: Tachycardia
Danish: Dosering
English: In pharmacokinetic studies with and without a charcoal blockage, Budesonide/Formoterol Teva Pharma B.V. was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Danish: evalueret ved at sammenligne det med et andet godkendt inhalationspræparat med fastdosiskombination, der indeholdt de samme aktive indholdsstoffer, budesonid og formoterol.
English: Budesonide/Formoterol Teva Pharma B.V.320 micrograms/9 micrograms, inhalation powder (budesonide/formoterol fumarate dihydrate)
Danish: 320 mikrogram/9 mikrogram inhalationspulver (budesonid/formoterolfumaratdihydrat)
English: Manufacturer
Danish: Administration
English: See section 4.
Danish: Se punkt.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 120 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: inhalator indeholder 120 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: Each Budesonide/Formoterol Teva Pharma B.V. inhaler contains 60 inhalations and has a white body with a semi-transparent wine red mouthpiece cover.
Danish: inhalator indeholder 60 inhalationer og har en hvid hoveddel med et halvgennemsigtigt, vinrødt låg til mundstykket.
English: If Budesonide/Formoterol Teva Pharma B.V. therapy has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
Danish: på grund af overdosering med lægemidlets formoterol-komponent, skal det overvejes at give passende behandling med inhaleret kortikosteroid.
English: Use the product within 6 months of removing from foil wrapping.
Danish: EXP Skal anvendes senest 6 måneder efter, inhalatoren er taget ud af folien.
English: If the patient experiences paradoxical bronchopasm Budesonide/Formoterol Teva Pharma B.V. should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
Danish: Hvis patienten oplever paradoks bronkospasme, skal Budesonid/Formoterol Teva Pharma B.V.
English: inhalations when it is full.
Danish: Indikatoren starter med 60 inhalationer, når den er fuld.
English: If you are doing exercise and you get asthma symptoms, use your separate ‘reliever inhaler' to relieve these symptoms.
Danish: Hvis du dyrker motion, og du får astmasymptomer, skal du bruge din separate inhalator med anfaldsmedicin for at lindre symptomerne Du må ikke bruge Budesonid/Formoterol Teva Pharma B.V.
English: Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) contains 320 micrograms of budesonide and 9 micrograms of formoterol fumarate dihydrate.
Danish: Hver afgivet dosis (den dosis, som forlader mundstykket på Spiromax) indeholder 160 mikrogram budesonid og 4,5 mikrogram formoterolfumaratdihydrat.
English: How to use Budesonide/Formoterol Teva Pharma B.V.
Danish: Brugen af Budesonid/Formoterol Teva Pharma B.V.
English: If any of the following happen to you, stop using Budesonide/Formoterol Teva Pharma B.V. and talk to your doctor immediately:
Danish: Hvis noget af følgende sker for dig, skal du holde op med at bruge Budesonid/Formoterol Teva Pharma B.V.
English: If either of these symptoms occur, stop using Budesonide/Formoterol Teva Pharma B.V. straightaway and use your ‘reliever inhaler'.
Danish: Hvis et af disse symptomer forekommer, skal du straks holde op med at bruge Budesonid/Formoterol Teva Pharma B.V.
English: Nausea
Danish: Amning
English: Preparing your new Budesonide/Formoterol Teva Pharma B.V.
Danish: Doseringen af Budesonid/Formoterol Teva Pharma B.V.
English: Budesonide/Formoterol Teva Pharma B.V. is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Danish: er ikke indiceret til brug hos børn under 12 år eller unge mellem 13 og 17 år.
English: LIST OF EXCIPIENTS
Danish: BILAG I PRODUKTRESUMÉ
English: How to store Budesonide/Formoterol Teva Pharma B.V.
Danish: Brug af Budesonid/Formoterol Teva Pharma B.V.
English: Patients should not be initiated on Budesonide/Formoterol Teva Pharma B.V. during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Danish: under en eksacerbation eller ved signifikant eller akut forværring af astma.
English: Budesonide/Formoterol Teva Pharma B.V. pharmacokinetic profile
Danish: Budesonid/Formoterol Teva Pharma B.V..
English: INFORMATION IN BRAILLE Budesonide/Formoterol Teva Pharma B.V. 160 mcg/4.5 mcg
Danish: INFORMATION I BRAILLESKRIFT Budesonid/Formoterol Teva Pharma B.V.
English: • It is important to use Budesonide/Formoterol Teva Pharma B.V. every day, even if you have no asthma symptoms at the time.
Danish: hver dag, også selvom du ikke har nogen astmasymptomer på det pågældende tidspunkt.
English: Dizziness
Danish: Hjerte
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Budesonide/Formoterol Teva Pharma B.V. 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Budesonid/Formoterol Teva Pharma B.V.
English: • Use Budesonide/Formoterol Teva Pharma B.V. every day.
Danish: • Brug Budesonid/Formoterol Teva Pharma B.V.
English: Packaging Content (concentration)
Danish: Indgivelsesvej Emballage Indhold (koncentration)
English: Pharmaceutical Form
Danish: Lægemiddelform
English: Lyophilisate and solvent for suspension for injection
Danish: Tørstof og solvens til injektionsvæske, suspension
English: Withdrawal period
Danish: Tilbagehol delsestid
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per
Danish: Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme): mindst 4,9 log 10 CCID50 pr. dosis
English: Strength
Danish: Katte
English: Package size
Danish: Paknings størrelse
English: EU/2/04/049/002 Purevax log 10 EID50 per dose
Danish: EU/2/04/049/002 Purevax
English: Target species
Danish: Særnavn Styrke
English: 1ml (solvent)
Danish: EUnummer
English: 50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
Danish: Chlamydophila felis (905 stamme): mindst 3,0 log 10
English: 1 falcon tube with 1, 2 or 3 vials + 1 syringe + 18G intravenous catheter + 2
Danish: 1 falconglas med 1, 2 eller 3 hætteglas + 1 sprøjte + 18G intravenøs kateter + 2 Vicryl 6.0
English: l t o r
Danish: t r
English: EU/1/09/563/001
Danish: EU/1/09/563/001 ChondroCelect 10000 celler/µl Cellesuspension til implantation
English: Vial (glass/alu)
Danish: Hætteglas (glas/alu) 1 ml
English: Route of Administration
Danish: Lægemiddelform Indgivelsesvej
English: The treatment will be repeated every two weeks.
Danish: Behandlingen gentages hver anden uge.
English: Based on Normal approximation
Danish: Baseret på normal approksimation.
English: The following side effects may occur:
Danish: Følgende bivirkninger kan forekomme:
English: It must be protected from light, and it must not be frozen.
Danish: Den skal beskyttes mod lys og må ikke nedfryses.
English: Overall survival is illustrated in Figure 1.
Danish: Samlet overlevelse er illustreret i figur 1.
English: It is important that you are aware of what these side effects may be.
Danish: Det er vigtigt, at du er klar over, hvilke bivirkninger der kan opstå.
English: Patients received treatment until disease progression or unacceptable toxicity.
Danish: Patienterne fik behandling indtil sygdomsprogression eller uacceptabel toksicitet.
English: All dose modifications should be based on the worst preceding toxicity.
Danish: Alle dosisændringer bør baseres på den værste tidligere toksicitet.
English: Total SN-38
Danish: TotalSN-38
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis det ikke anvendes omgående, er opbevaringstid og -forhold efter fortynding brugerens ansvar.
English: Fisher's exact test
Danish: Fishers eksakte test.
English: This prevents the cancer cells from multiplying and growing, and they eventually die.
Danish: Dermed forhindres kræftcellerne i at formere sig og vokse, og de ender med at dø.
English: Results are shown in Table 4.
Danish: Resultaterne er vist i tabel 4.
English: They may differ from the general information contained in this leaflet.
Danish: De kan være forskellige fra de generelle oplysninger i denne indlægsseddel.
English: Cox model analysis
Danish: Cox-modelanalyse.
English: The primary outcome measure was Overall Survival (OS).
Danish: Det primære effektmål var samlet overlevelse (OS).
English: Do not interchange.
Danish: Må ikke udskiftes indbyrdes.
English: Blood tests and medical examinations
Danish: Blodprøver og lægeundersøgelser
English: Figure 1: Overall survival
Danish: Figur 1: Samlet overlevelse
English: Patients should be monitored for signs of infections.
Danish: Patienterne bør kontrolleres for tegn på infektion.
English: Precautions to be taken before handling or administering the medicinal product
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra en mikrobiologisk synsvinkel bør præparatet anvendes omgående.
English: Asian population
Danish: Asiatisk population
English: Median is the Kaplan-Meier estimate of the median survival time
Danish: Median er Kaplan-Meier-estimatet for den mediane overlevelsestid.
English: Patients should be aware of the risk of neutropenia and the significance of fever.
Danish: Patienterne skal være opmærksomme på risikoen for neutropeni og betydningen af feber.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1130/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1130/001
English: Genotoxic and carcinogenic potential
Danish: Genotoksisk og karcinogent potentiale
English: SD= standard deviation
Danish: SD = standardafvigelse.
English: You should avoid driving, using machines or performing other tasks that need full attention if you feel sleepy, dizzy and exhausted.
Danish: Du må ikke føre motorkøretøj, betjene maskiner eller udføre andre opgaver, som kræver din fulde opmærksomhed, hvis du føler dig søvnig, svimmel eller udmattet.
English: For patients who start treatment with 50 mg/m
Danish: For patienter, som starter behandlingen med 50 mg/m
English: Contact your doctor immediately to give you a suitable treatment.
Danish: Kontakt straks lægen, så du kan få den nødvendige behandling.
English: Grade 3 or 4 (despite antiemetic therapy)
Danish: Grad 3 eller 4 (trods antiemetisk behandling)
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter "EXP".
English: Unstratified log-rank test
Danish: Ustratificeret log-rank-test.
English: METHOD AND ROUTE OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ Udelukkende til engangsbrug.
English: Loperamide should not be used for more than 48 consecutive hours due to risk of paralytic ileus.
Danish: Loperamid bør ikke anvendes i mere end 48 timer i træk på grund af risikoen for paralytisk ileus.
English: The appropriate starting dose for patients taking these anticonvulsants or other strong inducers has not been defined.
Danish: En passende startdosis til patienter, som tager disse antikonvulsiva eller andre potente induktorer, er ikke fastlagt.
English: 5-FU dose modification as in Table 1
Danish: 5-FU-dosisændring som i tabel 1
English: Irinotecan is a derivative of camptothecin.
Danish: Irinotecan er et derivat af camptothecin.
English: Your doctor will decide upon the doses you will receive.
Danish: Lægen afgør, hvilken dosis du skal have.
English: Additional outcome measures included Progression Free Survival (PFS) and Objective Response Rate (ORR).
Danish: Yderligere effektmål var progressionsfri overlevelse (PFS) og objektiv responsrate (ORR).
English: Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.
Danish: Dræbte eller inaktiverede vacciner kan indgives, men responset kan være nedsat.
English: Your doctor may give you a medicine which contains loperamide to begin treatment at home but it must not be used for longer than 48 consecutive hours.
Danish: Lægen vil muligvis sørge for, at du har et lægemiddel, som indeholder loperamid, så du kan påbegynde behandlingen hjemme, men det må ikke anvendes i mere end 48 timer i træk.
English: Immunosuppressive effects and vaccines
Danish: Immunsupprimerende effekter og vacciner
English: Grade 3 or 4
Danish: Grad 3 eller 4
English: However, in other studies with irinotecan they have been shown to be devoid of any mutagenic potential in the Ames test.
Danish: I andre studier med irinotecan blev det dog påvist, at det ikke havde mutagent potentiale i Ames' test.
English: • From a microbiological point of view, the product should be used as soon as possible after dilution.
Danish: • Ud fra en mikrobiologisk synsvinkel bør præparatet anvendes hurtigst muligt efter fortynding.
English: Frequencies categories used for adverse reactions are: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000)**.
Danish: De anvendte hyppighedskategorier for bivirkningerne er: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) og sjælden (≥ 1/10.000 til < 1/1.000)**.
English: Loperamide should be given until patient is without diarrhoea for at least 12 hours.
Danish: Loperamid bør gives, indtil patienten ikke har haft diarré i mindst 12 timer.
English: During treatment patients should observe caution when driving or using machines.
Danish: Under behandlingen bør patienterne udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
English: • The active substance is irinotecan.
Danish: • Aktivt stof: irinotecan.
English: Marketing Authorisation Holder Les Laboratoires Servier 50, rue Carnot
Danish: Indehaver af markedsføringstilladelsen Les Laboratoires Servier 50, rue Carnot
English: Very common: Alopecia
Danish: Meget almindelig: Alopeci
English: MedDRA* system organ class
Danish: MedDRA-systemorganklasse*
English: Your doctor may need to adjust the dose or stop treatment.
Danish: Lægen vil muligvis justere din dosis eller standse behandlingen.