FrancophonIA/ELRC3.0 huggingface dataset:
English: Although it had been suggested adult doses would be difficult to give accurately as a 1 mg/ml solution because of the large number of drops required, there should be no problem if the Committee's recommendation were followed that liquid dose forms be given by a measuring device such as a graduated oral syringe.
Danish: Skønt det var blevet hævdet, at det ville være vanskeligt at dosere nøjagtigt til voksne med en opløsning af styrken 1 mg/ml på grund af det nødvendige store antal dråber, burde dette ikke være et problem, hvis man fulgte udvalgets anbefaling om at anvende en doseringsanordning såsom en oral sprøjte med målestreger.
English: Metoclopramide is a medicine that acts as an antiemetic (a medicine used to relieve nausea and vomiting) by acting on the part of the brain that triggers the sensation of sickness.
Danish: Metoclopramid er et lægemiddel, der mindsker kvalme og opkastning (et antiemetikum), idet det påvirker den del af hjernen, der udløser kvalmefornemmelse.
English: At the request of a manufacturer of higher strength oral solutions, the Committee reconsidered the evidence behind its view that oral solutions above 1 mg/ml should no longer be available, and the arguments and proposals to minimise the risk that were supplied by the company, specifically a restriction on the use of the higher strength solution in children.
Danish: På anmodning af en fremstiller af orale opløsninger af højere styrke foretog udvalget en fornyet overvejelse, dels af dokumentationen til grund for udvalgets standpunkt om, at orale væsker med styrke 1 mg/ml burde tages af markedet, dels af virksomhedens argumenter og forslag til minimering af risikoen, specielt begrænsning af anvendelsen af den højere styrke opløsning hos børn.
English: • Data on the use of metoclopramide in acute chemotherapy-induced nausea and vomiting (CINV) were limited and suggested that metoclopramide was inferior to 5-HT3 antagonists and required high doses which are associated with a greatly increased risk of adverse effects.
Danish: • De foreliggende begrænsede data om anvendelsen af metoclopramid ved akut kemoterapiinduceret kvalme og opkastning tydede på, at metoclopramid var underlegent i forhold til 5-HT3-antagonister og krævede høje doser, som er forbundet med stærkt øget bivirkningsrisiko.
English: Metoclopramide-containing medicines have been authorised separately in individual Member States of the EU, with differing licensed indications such as nausea and vomiting of various causes (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders (conditions in which the normal passage of food through the gut is delayed).
Danish: Lægemidler indeholdende metoclopramid er godkendt separat i hver enkelt EU-medlemsstat med forskellige godkendte indikationer såsom kvalme og opkastning af forskellige årsager (f.eks. efter kemoterapi eller strålebehandling, efter operationer eller i forbindelse med migræne) samt sygdomme med forsinkelse af den normale tarmpassage af føden (forstyrrelser i den gastrointestinale motilitet).
English: There was more consistent evidence of comparability with 5-HT3 antagonists when used for delayed CINV.
Danish: Der var mere samstemmende evidens for sammenligneligheden med 5-HT3-antagonister ved forsinket kemoterapiinduceret kvalme og opkastning.
English: • In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapyinduced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).
Danish: • Hos voksne er metoclopramid fortsat indiceret til forebyggelse af postoperativ kvalme og opkastning, stråleterapiinduceret kvalme og opkastning, forsinket (men ikke-akut) kemoterapiinduceret kvalme og opkastning samt symptomatisk behandling af kvalme og opkastning, bl.a. ved akut migræne (hvor det desuden kan anvendes til at fremme absorptionen af orale analgetika).
English: • In children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV.
Danish: • Hos børn er metoclopramid kun godkendt som andetvalg til forebyggelse af forsinket kemoterapiinduceret kvalme og opkastning samt behandling af manifest postoperativ kvalme og opkastning.
English: French medicines regulatory agency highlighted that despite various risk minimisation measures implemented over the years, side effects had continued to be reported.
Danish: I 2011 foretog den franske lægemiddelstyrelse en national gennemgang vedrørende børn, hvor det fremhævedes, at der fortsat var blevet indberettet bivirkninger trods de forskellige risikominimeringsforanstaltninger, der var indført i årenes løb.
English: This followed a review by the EU Member States of metoclopramide-containing medicines in children, under Article 45 of the Paediatric Regulation 1901/2006, which in 2010 identified the risk of neurological side effects and recommended a number of risk minimisation measures.
Danish: Dette fulgte efter medlemsstaternes gennemgang af lægemidler indeholdende metoclopramid til børn i henhold til artikel 45 i forordning (EF) nr. 1901/2006 om lægemidler til pædiatrisk brug.
English: the Committee recommended use for the prevention and treatment of nausea and vomiting such as that associated with chemotherapy, radiotherapy, surgery and in the management of migraine.
Danish: Til voksne anbefalede udvalget anvendelse til forebyggelse og behandling af kvalme og opkastning såsom ved kemoterapi, stråleterapi og operationer samt ved behandling af migræne.
English: • Metoclopramide is used to prevent or treat nausea and vomiting (feeling or being sick), including nausea and vomiting that may result from anticancer medicines or radiation treatment, surgery, or an attack of migraine.
Danish: • Metoclopramid anvendes til forebyggelse og behandling af kvalme og opkastning, herunder kvalme og opkastning forårsaget af kræftmedicin, strålebehandling, operationer og migræneanfald.
English: • Metoclopramide is known to sometimes cause short-term side effects on the nervous system that result in unintentional movements such as twitches and nervous tics and these are commoner in children and young people, and at high doses.
Danish: • Metoclopramid giver undertiden kortvarige bivirkninger på nervesystemet med ufrivillige bevægelser såsom nervøse trækninger.
English: Extrapyramidal disorders were more likely to occur after several doses, although usually early in treatment, and were less likely at slower infusion rates when metoclopramide was given intravenously.
Danish: Ekstrapyramidale forstyrrelser forekom oftere efter gentagne doser, sædvanligvis dog tidligt i behandlingen.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4R on 31 July 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Versican Plus Pi/L4R den 31. juli 2014.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Danish: Den hyppigste bivirkning (som optræder hos mere end 1 ud af 100 hunde) med Versican Plus Pi/L4R er kortvarig hævelse på op til 5 cm, der kan forekomme på injektionsstedet efter vaccinationen.
English: The field study showed that after vaccination with Versican Plus Pi/L4R the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%.
Danish: Feltundersøgelsen viste, at efter vaccination med Versican Plus Pi/L4R opnåede mellem 73 og 97 % af hundene en beskyttende mængde antistoffer mod parainfluenzavirus, mellem 59 og 96 % mod Leptospira og mellem 86 og 100 % mod rabiesvirus.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4R exceed the risks for the approved indications and recommended that Versican Plus Pi/L4R be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved Versican Plus Pi/L4R overstiger risiciene til de godkendte anvendelser, og anbefalede udstedelse af en markedsføringstilladelse for Versican Plus Pi/L4R.
English: The effectiveness of Versican Plus Pi/L4R was investigated in a field study involving 129 dogs.
Danish: Effektiviteten af Versican Plus Pi/L4R blev undersøgt i en feltundersøgelse med 129 hunde.
English: This will help protect them against kennel cough, leptospirosis and rabies.
Danish: Derved opnås bedre beskyttelse mod kennelhoste, leptospirose og rabies.
English: Versican Plus Pi/L4R is used to protect dogs against:
Danish: Versican Plus Pi/L4R anvendes til at beskytte hunde mod:
English: When Versican Plus Pi/L4R is given to dogs the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Danish: Når Versican Plus Pi/L4R gives til hunde, registrerer dyrenes immunsystem de pågældende virus og bakterier som “fremmede” og reagerer ved at danne antistoffer mod dem.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Afvejningen af fordele og risici (benefit/riskforholdet) fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: Versican Plus Pi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2, inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa) as well as rabies virus.
Danish: Versican Plus Pi/L4R er en veterinær vaccine, der indeholder levende (svækkede) stammer af hundeparainfluenzavirus type 2 og inaktiverede (dræbte) stammer af Leptospira-bakterier (Icterohaemorrhagiae, Canicola, Bratislava og Grippotyphosa) og rabiesvirus.
English: Versican Plus Pi/L4R is a vaccine.
Danish: Versican Plus Pi/L4R er en vaccine.
English: The canine parainfluenza virus in Versican Plus Pi/L4R is alive but has been attenuated (weakened) so that it does not cause disease; it is combined with killed (inactivated) strains of Leptospira bacteria and rabies virus.
Danish: Hundeparainfluenzavirus i Versican Plus Pi/L4R er levende, men er svækkede, så de ikke kan fremkalde sygdom, og vaccinen er kombineret med dræbte (inaktiverede) stammer af Leptospira-bakterier og rabiesvirus.
English: Versican Plus Pi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Danish: Versican Plus Pi/L4R fås som en frysetørret pellet (et lyofilisat) med opløsningsvæske (solvens) til indsprøjtning.
English: • rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death.
Danish: • rabies (hundegalskab), en virussygdom, der kan overføres til mennesker (en zoonose) og angriber hjerne og rygmarv med døden til følge.
English: For revaccination a single dose of Versican Plus Pi/L4R is required annually.
Danish: Der kræves årlig revaccination med en enkelt dosis af Versican Plus Pi/L4R.
English: Versican Plus Pi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Danish: Versican Plus Pi/L4R indeholder aluminiumhydroxid, der er et adjuvans, dvs. det forstærker immunreaktionen.
English: Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine
Danish: Vaccine mod hundeparainfluenzavirus (levende, svækkede) og hundeleptospirose (inaktiveret) og rabies
English: Other information about Versican Plus Pi/L4R:
Danish: Andre oplysninger om Versican Plus Pi/L4R:
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation);
Danish: • leptospirose, en bakteriesygdom, der kan overføres gennem inficeret urin og medføre blødning,
English: Why has Versican Plus Pi/L4R been approved?
Danish: Hvorfor blev Versican Plus Pi/L4R godkendt?
English: What is the risk associated with Versican Plus Pi/L4R?
Danish: Hvilken risiko er der forbundet med Versican Plus Pi/L4R?
English: What is Versican Plus Pi/L4R?
Danish: Hvad er Versican Plus Pi/L4R?
English: How has Versican Plus Pi/L4R been studied?
Danish: Hvordan blev Versican Plus Pi/L4R undersøgt?
English: What is Versican Plus Pi/L4R used for?
Danish: Hvad anvendes Versican Plus Pi/L4R til?
English: How does Versican Plus Pi/L4R work?
Danish: Hvordan virker Versican Plus Pi/L4R?
English: What benefit has Versican Plus Pi/L4R shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Versican Plus Pi/L4R?
English: 301/302 - Edifício
Danish: Sala 301/302 - Edifício
English: Co. Tipperary Ireland
Danish: Co. Tipperary Irland
English: LEMESOS, CYPRUS
Danish: LEMESOS, CYPERN
English: Powder for oral suspension Oral gp - genéricos portugueses, Lda.
Danish: Pulver til oral suspension Oral anvendelse gp - genéricos portugueses, Lda.
English: 635 00 Brno, Czech Republic
Danish: 635 00 Brno, Den Tjekkiske republik
English: Zentiva a.s. , Praha, Czech Republik
Danish: Zentiva a.s. , Praha, Den Tjekkiske republik
English: 140 62 Praha 4, Czech Republic
Danish: 140 62 Praha 4, Den Tjekkiske republik
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Slovakia
Danish: Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Slovakiet
English: Gewerbestrasse 18-20 A2102 Bisamberg, Austria MESULID
Danish: Gewerbestrasse 18-20 A2102 Bisamberg, Østrig MESULID
English: B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, United Kingdom
Danish: B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, Storbritannien
English: 123 rue Jules Guesde 92309 LEVALLOISPERRET Cedex France
Danish: 123 rue Jules Guesde 92309 LEVALLOISPERRET Cedex Frankrig
English: 102 37 Praha 10 Dolni Mecholupy, Czech Republic
Danish: 102 37 Praha 10 Dolni Mecholupy, Den Tjekkiske republik
English: Alegre, 1306, 3º - Sala
Danish: Campo Alegre, 1306, 3º
English: PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 Ireland
Danish: PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 Irland
English: CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, CYPRUS
Danish: CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, CYPERN
English: CSC Pharmaceuticals Handels GmbH, Wien, Austria
Danish: CSC Pharmaceuticals Handels GmbH, Wien, Østrig
English: Medicom International s.r.o., Brno, Czech Republik
Danish: Medicom International s.r.o., Brno, Den Tjekkiske republik
English: PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI
Danish: PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI DIMESUL
English: PHARMACEUTICALS EPE, GREECE PENTELIS AVENUE 3436, ATHENS, 15234
Danish: PHARMACEUTICALS EPE, GRÆKENLAND PENTELIS AVENUE 34-36, ATHENS, 15234
English: SANDOZ GMBH, KUNDL, AUSTRIA BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA
Danish: SANDOZ GMBH, KUNDL, ØSTRIG BIOCHEMIESTRASSE 10, A-6250, KUNDL ØSTRIG
English: LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO
Danish: LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122
English: BIOMEDICA-CHEMICA A.E.
Danish: BIOMEDICACHEMICA A.E.
English: 6 Km MARKOPOULOUKOROPI AVENUE, MARKOPOULO, MESOGEION, 19003
Danish: MARKOPOULOUKOROPI AVENUE, MARKOPOULO, MESOGEION, 19003
English: RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO
Danish: RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121
English: Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italy
Danish: Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italien
English: Aviator Belghiru Nr. 9, 8700 Constanta, Jud.
Danish: MAGISTRA C & C, Str. Aviator Belghiru Nr. 9, 8700 Constanta, Jud.
English: 60 ml 5% Drops
Danish: 60 ml 5% Orale dråber
English: Rua da Quinta das Romeiras, 104 - 7º 1495-236 Algés
Danish: Rua da Quinta das Romeiras, 104 - 7º 1495-236 Algés Vitolide
English: PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, CYPRUS
Danish: PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, CYPERN
English: ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA
Danish: FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA AREUMA
English: Rua do Campo
Danish: Rua do
English: COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, CYPRUS
Danish: COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, CYPERN
English: Ljubljana Slovenia
Danish: Ljubljana Slovenien Aulin
English: AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO
Danish: FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO DELFOS
English: Laboratori Guidotti S. P. A., Via Trieste 40, I56126 Pisza, Italy
Danish: Laboratori Guidotti S. P. A., Via Trieste 40, I56126 Pisza, Italien
English: P T HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, CYPRUS
Danish: P T HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, CYPERN
English: FARMACEUTICI SpA, VIA CACCIAMALI, 3436-38/B, 25125 BRESCIA ISODOL
Danish: FARMACEUTICI SpA, VIA CACCIAMALI, 3436-38/B, 25125
English: LAB.FARMACEUTICO Srl, VILLA SAYONARA;
Danish: LAB.FARMACEUTICO Srl, VILLA
English: THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601
Danish: THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601 LEMESOS, CYPERN
English: CZCzech Republic
Danish: CZ - Den Tjekkiske republik
English: BOX 42, KORINTHOS, 20100
Danish: COSMOPHARM EPE P.O. BOX 42, KORINTHOS, 20100
English: Oral suspension
Danish: ORAL SUSPENSION ORAL ANVENDELSE
English: Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Cyprus
Danish: Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Cypern
English: Rua Prof. Henrique de Barros - Edifício Sagres3º A 2685-338 Prior Velho
Danish: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres3º A 2685-338 Prior Velho
English: Medochemie Ltd., P. O. Box 51409 CY-3505 Limassol, Cyprus
Danish: Medochemie Ltd., P. O. Box 51409 CY3505 Limassol, Cypern
English: FARMAC.IND.FAR.BIO.
Danish: FARMAC.IND.FAR.BIO .Srl Via DEI
English: Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, Italy
Danish: Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, Italien
English: LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, Italy
Danish: LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, Italien
English: LABORMED PHARMA SRL,Splaiul Independentei Nr. 319, Sector 6, Bucuresti
Danish: Independentei Nr. 319, Sector 6, Bucuresti
English: Granules for oral suspension Oral use
Danish: Granulat til oral suspension Oral anvendelse
English: HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 Ireland
Danish: HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 Irland
English: Powder for oral suspension oral
Danish: Pulver til oral suspension Oral anvendelse
English: Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, Ireland
Danish: Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, Irland
English: Granules for oral use
Danish: GRANULAT TIL ORAL ANVENDELSE OPLØSNING
English: DERVENAKIWN 4, PALLINI, ATTIKIS
Danish: PHARMATHEN INTERNATIONAL S.A. GRÆKENLAND, DERVENAKIWN 4, PALLINI, ATTIKIS
English: Nimesulida Isartrox 100 mg Comprimidos 100 mg
Danish: Nimesulida Isartrox 100 mg
English: Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, Ireland
Danish: Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, Irland
English: Nimesulida Baldacci 100 mg Comprimidos 100 mg
Danish: Nimesulida Baldacci 100 mg
English: Nimesulida Farmoz 100 mg Comprimidos 100 mg
Danish: Nimesulida Farmoz 100 mg
English: Nimesulida Sandoz 100 mg Comprimidos 100 mg
Danish: Nimesulida Sandoz 100 mg
English: Nimesulida Mepha 100 mg Comprimidos 100 mg
Danish: Nimesulida Mepha 100 mg
English: A., Via Livornese 897, La Vettola, 56010 Pisa, Italy
Danish: Laboratori Guidotti S. P. A., Via Livornese 897, La Vettola, 56010 Pisa, Italien
English: Suppository rectal use
Danish: Rektal anvendelse
English: Granules for oral suspension oral use
Danish: Granulat til oral opløsning Oral anvendelse
English: Nimesulida Gerilide 100 mg Comprimidos 100 mg
Danish: Nimesulida Gerilide 100 mg
English: Nimesulida Germed 100 mg Comprimidos 100 mg
Danish: Nimesulida Germed 100 mg
English: Nimesulida Neuride 100 mg Comprimidos 100 mg
Danish: Nimesulida Neuride 100 mg
English: Helsinn Birex Pharm. Ltd. Damastown
Danish: Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15
English: Nimesulida Ciclum 100 mg Comprimidos 100 mg
Danish: Nimesulida Ciclum 100 mg
English: Powder for oral suspension Oral
Danish: Pulver til oral opløsning Oral anvendelse
English: Granules for oral solution ORAL
Danish: GRANULAT TIL ORAL OPLØSNING
English: Nimesulida Generis 100 mg Comprimidos 100 mg
Danish: Nimesulida Generis 100 mg
English: Nimesulida Nilmide 100 mg Comprimidos 100 mg
Danish: Nimesulida Nilmide 100 mg
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Smyšlený) název Síla
English: Immediate Packaging
Danish: Velikosti balení
English: Route of Administration
Danish: Cesta podání
English: 336 (3x112) tablets
Danish: 336 tabletter (3x112) tabletter
English: You may not get any of them.
Danish: Du får måske ikke nogen af dem.
English: Unopened packs: 2 years.
Danish: Uåbnede pakninger: 2 år
English: This will depend on your condition and how old you are.
Danish: Det vil afhænge af din tilstand, og hvor gammel du er.
English: The usual doses are given below.
Danish: De sædvanlige doser er angivet nedenfor.
English: Treatment, if needed, is symptomatic.
Danish: Behandlingen er, hvis nødvendig, symptomatisk.
English: Unknown mechanism
Danish: Ukendt mekanisme
English: • Seeing, feeling or hearing things that are not there (hallucinations).
Danish: • Se, føle eller høre ting, der ikke er der (hallucinationer).
English: Combination pack (I+II):
Danish: Kombinationspakning (I + II):
English: This study does not support any information for children aged less than 4 years.
Danish: Dette forsøg giver ingen informationer om børn under 4 år.
English: Do not be concerned by this list of possible side effects.
Danish: Vær ikke bekymret over denne liste af bivirkninger.
English: The clinical relevance of this interaction is uncertain.
Danish: Den kliniske relevans af denne interaktion er uafklaret.
English: Alopecia, photosensitivity
Danish: Alopeci, fotosensibilitet
English: The dose for children is based on the child's weight and the doctor will decide the correct dose.
Danish: Dosis til børn afhænger af barnets vægt, og lægen vil finde frem til den rigtige dosis.
English: Digoxin toxicity has been rarely reported.
Danish: Digoxintoksicitet er sjældent blevet rapporteret.
English: Children and adolescents over 4 years of age
Danish: Børn og unge over 4 år
English: DO NOT USE milk or carbonated water.
Danish: BRUG IKKE mælk eller kulsyreholdige vand.
English: • Changes in blood tests that check how the liver is working.
Danish: • Ændringer i de blodprøver, der viser, hvordan leveren fungerer.
English: The treatment should be supervised by a specialist.
Danish: Behandlingen bør foregå under supervision af en specialist.
English: Contact your doctor if you are not free from symptoms after this period.
Danish: Kontakt din læge, hvis du ikke er symptomfri efter denne periode.
English: Do not take Losec for more than 14 days without consulting a doctor.
Danish: Du må ikke tage Losec i mere end 14 dage uden at tale med en læge.
English: Hepatitis with or without jaundice
Danish: Hepatitis med eller uden gulsot