FrancophonIA/ELRC3.0 huggingface dataset:
English: The median OS for the overall population (N = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95% CI= 0.65-0.95, p = 0.01192).
Danish: Den mediane samlede overlevelse (OS) for den totale population (N = 663) var 13,4 måneder for pemetrexed-armen og 10,6 måneder for placeboarmen, hazard ratio = 0,79 (95 % CI = 0,65- 0,95; p
English: What Pemetrexed Hospira looks like and contents of the pack Pemetrexed Hospira is a powder for concentrate for solution for infusion in a glass vial.
Danish: Pemetrexed Hospira er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas.
English: Common Neuropathysensory
Danish: Sensorisk neuropati
English: Neutrophils/Granulocyt es decreased
Danish: Nedsat neutrofil-/ granulocyttal
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Danish: Forkortelser: ALAT = alaninaminotransferase; ASAT = aspartataminotransferase; CTCAE =
English: Pemetrexed + Cisplatin
Danish: Superioritet p-værdi pemetrexed + cisplatin gemcitabin + cisplatin
English: Patients received maintenance
Danish: Fuldt tilskud Patienter
English: Pemetrexed Hospira in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Danish: Pemetrexed Hospira er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: Stomatitis/Pharyngitis 23.2 Nausea
Danish: Stomatitis/ pharyngitis
English: Pemetrexed Hospira as single agent
Danish: Pemetrexed Hospira givet alene
English: ***Integrated adverse reactions table combines the results of the JMEN pemetrexed maintenance (N=663) and PARAMOUNT continuation pemetrexed maintenance (N=539) studies.
Danish: (pemetrexed vedligeholdelsesbehandling(n=663))ogPARAMOUNT(pemetrexed induktionsbehandling efterfulgt af pemetrexed-vedligeholdesbehandling (n=539)).
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Indlægsseddel: Information til brugeren Pemetrexed Hospira 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Hospira 500 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Hospira 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm3 and platelets should be ≥ 100,000 cells/mm3.
Danish: Det absolutte neutrofiltal (ANC) skal være ≥1.500 celler/mm
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev den mediane OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for pemetrexed-armen og 13,6 måneder for placeboarmen, hazard ratio=0,71 (95 % CI = 0,56 - 0,88, p=0,002).
English: What Pemetrexed Hospira contains
Danish: Pemetrexed Hospira indeholder:
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN: n=663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: n=539).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 1,000 mg presentation
Danish: YDRE KARTON 1.000 mg
English: Pemetrexed Hospira in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Hospira er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Den mediane OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (N = 481) var 15,5 måneder for pemetrexed-armen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95 % CI = 0,56 - 0,88, p = 0,002).
English: Pemetrexed Hospira is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Hospira er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Time to treatment failure (TTTF - months)
Danish: Median HR (95 %-CI) Tid til behandlingssvigt (TTTF - måneder) (N = 283)
English: The recommended dose of Pemetrexed Hospira is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Pemetrexed Hospira i kombination med cisplatin Den anbefalede dosis af Pemetrexed Hospira er 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Hospira 100 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Stomatitis
Danish: Mavesmerter
English: Kidney failure
Danish: Hudirritation ogkløe
English: Hospira and cisplatin) a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998)
Danish: 50 % af tidligere dosis (både Pemetrexed Hospira og cisplatin) Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥CTC grad 2 blødning.
English: Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Hospira 500 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Reconstitute each 1,000 mg vial with 40 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 1.000 mg hætteglas med 40 ml natriumchloridopløsning 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion: Each vial contains 1,000 milligrams of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Hospira 1.000 mg pulver til koncentrat til infusionsvæske, opløsning: Hvert hætteglas indeholder 1.000 milligram pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Common Neuropathy-sensory Taste disturbance
Danish: Nervesystemet Almindelig Sensorisk neuropati
English: Each 100 mg vial contains approximately 11 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert 100 mg hætteglas indeholder ca. 11 mg natrium.
English: Driving and using machines Pemetrexed Hospira may make you feel tired.
Danish: Pemetrexed kan muligvis gøre Dem træt.
English: Each 500 mg vial contains approximately 54 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert 500 mg hætteglas indeholder ca. 54 mg natrium.
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 100 mg hætteglas med 4,2 ml natriumchloridopløsning 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Each 1,000 mg vial contains approximately 108 mg sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert 1.000 mg hætteglas indeholder ca. 108 mg natrium.
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Rekonstituer hvert 500 mg hætteglas med 20 ml natriumchloridopløsning 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Haemoglobin decreased
Danish: Nedsat hæmoglobi
English: Pemetrexed Hospira 100 mg powder for concentrate for solution for infusion
Danish: Pemetrexed Hospira 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Danish: Hætteglas med 1.000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Danish: Hætteglas med 500 mg rekonstitueres med 20 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel.
English: After reconstitution, each vial contains 25 mg/ml of pemetrexed
Danish: Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative.
Danish: Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1,000 mg presentation
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: Allergic reaction: skin rash / burning or prickling sensation Infection including sepsis
Danish: Almindelig (kan forekommerhos op til 1 ud af10 personer) Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse Infektion,inklusivesepsis (blodforgiftning) Feber
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 mg presentation
Danish: YDRE KARTON 100 mg
English: A multi-centre, randomised, double-blind, placebo-controlled Phase-3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (N = 441) with that of placebo plus BSC (N = 222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first-line doublet therapy containing cisplatin or carboplatin in combination with gemcitabine, paclitaxel, or docetaxel.
Danish: Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (JMEN) sammenlignede virkning og sikkerhed af vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC) (N = 441) med placebo plus BSC (N = 222) hos patienter med lokalt fremskreden (trin
English: Very common (may affect more than 1 in 10 people)
Danish: Megetalmindelig(kan forekommehos flere end 1 ud af10 personer) Lavt antal hvide blodlegemer
English: This should be taken into consideration if you are on a strictly controlled sodium diet.
Danish: Hvis De er på natriumeller saltfattig diæt, skal De tage hensyn hertil.
English: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1,000 mg
Danish: HÆTTEGLASETIKET 1.000 mg
English: Horizon
Danish: Cisplatin
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt: hyppigheden kan ikke vurderes udfra forhåndenværende data Hævelse i de nedre lemmer med smerte og rødme Øget urinproduktion
English: Breast-feeding
Danish: Pemetrexed
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Danish: hvis De ammer, skal De afbryde amningen under behandlingen med Pemetrexed Hospira.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 1,000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Hospira 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 500 mg presentation
Danish: YDRE KARTON 500 mg
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Hospira 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Hospira 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Cisplatin (N = 222)
Danish: (N = 222)
English: Loss of sensation
Danish: Udslæt/hudafskalning
English: Cisplatin (N = 163)
Danish: (N = 163)
English: London, 14 August 2008 EMEA/CHMP/524284/2008
Danish: London, den 14. august 2008 EMEA/CHMP/524281/2008
English: Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Danish: Octegra, filmovertrukne tabletter, indeholder 400 mg moxifloxacin som hydrochlorid.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Octegra and associated names International non-proprietary name (INN): moxifloxacin BACKGROUND INFORMATION *
Danish: UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 6, STK. 12 Octegra og tilknyttede navne Internationalt fællesnavn (INN): moxifloxacin BAGGRUNDSOPLYSNINGER*
English: 1 September 2014 EMA/465179/2014
Danish: Den 1. september 2014 EMA/465179/2014
English: Restrictions on the use of domperidone-containing medicines
Danish: Begrænsninger for anvendelsen af lægemidler indeholdende domperidon
English: Some products will be withdrawn from the market because their strength does not match the new doses.
Danish: Nogle produkter skal trækkes tilbage fra markedet, fordi deres styrke ikke svarer til de nye doser.
English: • Data in support of other indications were extremely limited.
Danish: • Data til dokumentation af andre indikationer var yderst begrænsede.
English: In general, safety reviews indicate that about 40% of such reports are in patients over 60 years of age.
Danish: Samlet viser gennemgangene af sikkerheden, at omkring 40 % af sådanne indberetninger omfatter patienter over 60 år.
English: The benefits in these indications were therefore not considered to outweigh the risk.
Danish: Fordelene ved disse indikationer blev derfor ikke anset for at opveje risikoen.
English: They are available as tablets, oral suspension and suppositories under various trade names (such as Motilium).
Danish: De leveres som tabletter, oral suspension og suppositorier under forskellige handelsnavne (såsom Motilium).
English: • Domperidone should be used at the lowest effective dose for the shortest possible duration.
Danish: • Domperidon bør anvendes i den laveste effektive dosis i kortest mulig tid.
English: • Patients or carers who have any concerns should speak to a healthcare professional.
Danish: • Patienter eller omsorgsgivere, der har spørgsmål, bør henvende sig til en sundhedsperson.
English: This is in line with the data coming from drug-drug interaction studies, and from spontaneous reporting.
Danish: Dette er på linje med data fra undersøgelser af lægemiddelinteraktioner og fra spontane indberetninger.
English: The recommendations were originally made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) at its meeting of 3-6 March, after a careful evaluation of the available evidence on the benefits and risks of such medicines.
Danish: Anbefalingerne blev oprindeligt fremsat af EMA's Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) på dettes møde den 3. til 6. marts efter nøje vurdering af den foreliggende dokumentation om sådanne lægemidlers fordele og risici.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom op til tre gange dagligt.
English: The product information for domperidone-containing products has been updated, and a letter has been sent to healthcare professionals explaining the new recommendations.
Danish: Produktinformationen for produkter indeholdende domperidon er blevet ajourført, og der udsendt et brev til sundhedspersoner med redegørelse for de nye anbefalinger.
English: The product information has been amended appropriately.
Danish: Produktinformationen er blevet ændret i henhold hertil.
English: The review of domperidone was initiated on 1 March 2013 at the request of the Belgian medicines authority, the Federal Agency for Medicines and Health Products (FAGG-AFMPS), under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler indeholdende domperidon blev indledt den 1. marts 2013 på anmodning af den belgiske lægemiddelstyrelse, Agence Fédérale des Médicaments et des Produits de Santé (FAGG-AFMPS), i henhold til artikel 31 i direktiv 2001/83/EF.
English: The injectable form of domperidone was withdrawn in 1985 because of such side effects.
Danish: Injektionspræparatet af domperidon blev trukket tilbage i 1985 som følge af sådanne bivirkninger.
English: A review of these data was first conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Disse oplysninger blev først gennemgået af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Appropriate risk minimisation measures have therefore been included in the product information to address this issue.
Danish: Der er derfor indsat passende risikominimeringsforanstaltninger i produktinformationen for at imødegå dette problem.
English: There were limited data to support paediatric use in this indication, and although the mechanism of action is not expected to differ between adults and children studies to provide further data to support efficacy in the paediatric population have been requested.
Danish: Der var kun begrænsede data til støtte for pædiatrisk anvendelse ved denne indikation, og skønt virkningsmekanismen ikke forventes at afvige mellem voksne og børn, er der anmodet om undersøgelser for at tilvejebringe yderligere data til støtte for virkningen hos den pædiatriske population.
English: There have been concerns that it might increase the risk of side effects on the heart, including dangerously irregular heartbeats in some patients.
Danish: Der har været betænkeligheder ved, at det kan øge risikoen for bivirkninger på hjertet, herunder farlig uregelmæssig hjerterytme hos nogle patienter.
English: However, cases of heart problems in patients using the medicine continued to be reported, and the PRAC was therefore asked to examine whether the benefits still outweighed the risks for these medicines in their approved uses and forms, and whether their marketing authorisations should be maintained or changed across the EU.
Danish: Der blev imidlertid fortsat indberettet tilfælde med hjerteproblemer hos patienter, der anvendte lægemidlet, og PRAC blev derfor anmodet om at undersøge, om fordelene stadig opvejede risiciene for disse lægemidler med de godkendte anvendelser og former, og om markedsføringstilladelserne for dem burde opretholdes eller ændres i EU.
English: These recommendations are based on careful consideration of data on the safety and efficacy of domperidone from various sources.
Danish: Disse anbefalinger er baseret på nøje vurdering af data fra forskellige kilder vedrørende sikkerheden og virkningen af domperidon.
English: The available evidence of efficacy was not sufficient to support its use for other indications.
Danish: Den foreliggende evidens for virkningen var ikke tilstrækkelig til anvendelse til andre indikationer.
English: • Domperidone is a medicine that has been used for various stomach and digestive problems.
Danish: • Domperidon er et lægemiddel, der er blevet anvendt til forskellige mave- og fordøjelsesproblemer.
English: The review of domperidone was carried out at the request of the Belgian medicines authority over concerns about the medicine's effects on the heart.
Danish: Gennemgangen af domperidon blev foretaget på anmodning af den belgiske lægemiddelstyrelse på grund af betænkeligheder vedrørende lægemidlets virkninger på hjertet.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh repræsenterer EU's medlemsstater og har ansvaret for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: On 23 April 2014, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed recommendations to restrict the use of domperidone-containing medicines.
Danish: Den 23. april 2014 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - human (CMDh) anbefalinger om begrænsning af anvendelsen af lægemidler indeholdende domperidon.
English: In addition, it should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects).
Danish: Desuden må det ikke bruges sammen med andre lægemidler, der har tilsvarende virkninger på hjertet, eller som begrænser nedbrydningen af domperidon i kroppen (og dermed øger risikoen for bivirkninger).
English: Treatment should generally only be given for up to one week.
Danish: Behandlingen bør sædvanligvis kun gives op til en uge.
English: • Formulations not consistent with the new dosage recommendations will be withdrawn from the market, as will combinations of domperidone with cinnarizine.
Danish: • Formuleringer, der ikke er i overensstemmelse med de nye dosisanbefalinger, skal trækkes tilbage fra markedet, hvilket også gælder kombinationer af domperidon med cinnarizin.
English: Domperidone-containing medicines have been authorised in most EU Member States via national procedures since the 1970s and are widely available as over-the-counter or prescription-only medicines.
Danish: Lægemidler indeholdende domperidon har været godkendt i de fleste EU-medlemsstater via nationale procedurer siden 1970'erne og er bredt tilgængelige i håndkøb eller på recept.
English: Where suitable products are available for children, doses should be calculated depending on bodyweight and given with a device that allows accurate measuring.
Danish: Når egnede produkter er til rådighed for børn, bør doserne beregnes efter legemsvægt og gives ved hjælp af en anordning, der giver mulighed for nøjagtig afmåling.
English: Although the scope of the review did not cover use outside the licensed indications (off-label use) the principles behind these recommendations should be considered whenever domperidone is used.
Danish: Selv om gennemgangen ikke omfattede andre anvendelser end de godkendte indikationer, bør principperne i anbefalingerne altid følges, når domperidon anvendes.