FrancophonIA/ELRC3.0 huggingface dataset:
English: A combination product with cinnarizine (an antihistamine) is available in some Member States for the treatment of motion sickness.
Danish: Et kombinationsprodukt med antihistaminet cinnarizin markedsføres i visse medlemsstater til behandling af transportsyge.
English: • Although the results of the thorough QT study with domperidone indicate that it does not significantly prolong the QTc interval when administered to healthy subjects at 10 mg and 20 mg four times daily, there are limitations in the study that restrict the conclusions that can be drawn.
Danish: • Selv om resultaterne af den gennemgribende QT-undersøgelse viser, at domperidon ikke forlænger QTc-intervallet væsentligt, når det gives til raske voksne i doser på 10 og 20 mg fire gange dagligt, indskrænker undersøgelsens begrænsninger de konklusioner, der kan drages af den
English: Domperidone works by blocking receptors for the neurotransmitter dopamine found in the gut and in the part of the brain linked to vomiting.
Danish: Domperidon virker ved at blokere receptorerne for neurotransmitteren dopamin, der findes i tarmen og i de dele af hjernen, der medvirker ved opkastning.
English: The medicine should not normally be used for longer than one week.
Danish: Lægemidlet må normalt ikke anvendes længere end én uge.
English: Some of these studies also supported a greater risk in patients over 60 years of age or who were taking high doses (over 30 mg/day).
Danish: Nogle af disse undersøgelser talte også for en større risiko for patienter over 60 år, som fik høje doser (over 30 mg dagligt).
English: In particular, there was little evidence in support of the long-term efficacy of domperidone in dyspepsia and gastro-oesophageal reflux disorder.
Danish: Navnlig var der kun ringe evidens for den langsigtede virkning af domperidon ved dyspepsi og gastroøsofageal reflukssygdom.
English: This comprised non-clinical and clinical data, both published and unpublished, including a thorough QT study, cumulative review of case reports of cardiac disorders and vascular investigations from the safety databases for domperidone products, pharmacoepidemiological studies, and published and unpublished efficacy studies.
Danish: Disse bestod af ikke-kliniske og kliniske data, både publicerede og upublicerede, herunder en gennemgribende QT-undersøgelse, en kumulativ gennemgang af caserapporter om hjertesygdom og karundersøgelser fra sikkerhedsdatabaser for produkter indeholdende domperidon, farmakoepidemiologiske undersøgelser og publicerede og upublicerede undersøgelser af virkningen.
English: Products supplying a dose of 20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as should combination products with cinnarizine (an antihistamine) where available.
Danish: Produkter, der giver en dosis på 20 mg gennem munden, og stikpiller på 10 eller 60 mg frarådes nu anvendt og skal trækkes tilbage, hvilket også gælder kombinationsprodukter med cinnarizin (et antihistamin), hvor disse er på markedet.
English: In order to accurately measure doses to paediatric patients, oral suspensions should be given using an adapted graduated oral syringe.
Danish: For at give mulighed for en afmålt dosis til pædiatriske patienter bør orale suspensioner gives ved hjælp af en oral sprøjte med målestreger.
English: • Because a review has shown that the risks of domperidone are greatest at high doses or when it is used for a longer period, the medicine should only be approved for use in low doses to treat symptoms of nausea and vomiting (feeling or being sick).
Danish: • Da en gennemgang har vist, at risiciene med domperidon er størst ved høje doser eller ved anvendelse i længere tid, bør det kun være godkendt til anvendelse i lave doser til behandling af symptomerne ved kvalme og opkastning.
English: Of 57 reported cardiovascular fatalities, 27 had other risk factors, while 13 had either an implausible relationship to domperidone administration or an alternative aetiology.
Danish: Af 57 indberettede kardiovaskulære dødsfald fandtes der at foreligge andre risikofaktorer i 27 tilfælde, mens der i 13 tilfælde enten ikke var sandsynlig sammenhæng med administration af domperidon eller forelå anden ætiologi.
English: As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende beslutning, der er gyldig i hele EU.
English: This helps to prevent nausea (feeling sick) and vomiting.
Danish: Dette forebygger kvalme og opkastning.
English: Domperidone will no longer be authorised to treat other conditions such as bloating or heartburn.
Danish: Domperidon vil ikke længere være godkendt til behandling af andre tilstande, såsom oppustethed eller halsbrand.
English: As the CMDh position was adopted by majority vote, the CMDh position was sent to the European Commission, which endorsed it and issued a final legally binding decision valid throughout the EU on 1 September 2014.
Danish: Eftersom CMDh vedtog dette standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og den 1. september 2014 vedtog en retligt bindende beslutning, der er gyldig i hele EU.
English: The CMDh, a medicines regulatory body representing the EU Member States, agreed that these medicines should only be used to relieve symptoms of nausea and vomiting, that doses and length of treatment should be restricted and that they should be adjusted carefully by the patient's weight where available for use in children.
Danish: CMDh, der er en lægemiddelmyndighed, som repræsenterer EU's medlemsstater, vedtog, at sådanne lægemidler kun bør anvendes til lindring af symptomerne ved kvalme og opkastning, at doser og behandlingsvarighed bør begrænses, og at deres anvendelse bør tilpasses nøje efter patientens vægt, når de er til rådighed for anvendelse til børn.
English: • A review of the safety database of the originator product involving 342 serious reports of cardiac events or vascular investigations highlighted the high frequency of associated cardiovascular risk factors, cardiovascular history, and concomitant medications associated with cardiac arrhythmias in the patients concerned.
Danish: • En gennemgang af sikkerhedsdatabasen fra det oprindelige produkt, der omfattede 342 indberetninger af alvorlige kardiale hændelser eller vaskulære undersøgelser, understregede den højere frekvens af tilknyttede kardiovaskulære risikofaktorer, kardiovaskulær anamnese og samtidig medicinering forbundet med kardiale arytmier hos de pågældende patienter.
English: The CMDh confirmed by majority the PRAC recommendation that domperidone-containing medicines should remain available and may continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and adolescents weighing 35 kg or more.
Danish: CMDh bekræftede ved en flertalsafgørelse PRAC's anbefaling om, at lægemidler indeholdende domperidon fortsat burde være til rådighed og anvendes i EU til behandling af symptomerne ved kvalme og opkastning, men at den anbefalede dosis bør nedsættes til 10 mg gennem munden op til tre gange dagligt for voksne og unge med legemsvægt over 35 kg.
English: Domperidone-containing medicines have been authorised nationally in individual Member States of the EU for the treatment of nausea and vomiting of various causes but also for the management of symptoms such as bloating, discomfort and heartburn.
Danish: Lægemidler indeholdende domperidon er i de enkelte EU-medlemsstater blevet godkendt nationalt til behandling af kvalme og opkastning af forskellige årsager, men desuden til behandling af symptomer, såsom oppustethed, utilpashed og halsbrand.
English: Adults may also be given 30 mg twice daily rectally as suppositories.
Danish: Voksne kan stadig få 30 mg to gange dagligt som suppositorier.
English: • The benefit-risk balance of domperidone remains positive in the relief of the symptoms of nausea and vomiting.
Danish: • Benefit/risk-forholdet for domperidon er fortsat positivt til lindring af symptomerne ved kvalme og opkastning.
English: • Overall there was sufficient evidence to support the use of oral domperidone 10 mg up to three times a day in a general indication of treatment of nausea and vomiting in adults.
Danish: • Overordnet var der tilstrækkelig evidens for anvendelse af oralt domperidon, 10 mg, op til tre gange dagligt, til den generelle indikation behandling af kvalme og opkastning hos voksne.
English: Those who are taking domperidone long-term or in higher doses, or for conditions other than nausea and vomiting, should consult their doctor at their next scheduled appointment or speak to their pharmacist to discuss their treatment.
Danish: Hvis man får domperidon i lang tid eller i højere doser, eller hvis man får det for andre tilstande end kvalme og opkastning, bør man for at drøfte behandlingen tale med lægen ved næste planlagte besøg eller med apotekspersonalet.
English: • Epidemiological studies mostly suggest that domperidone exposure was associated with an increase in risk for sudden cardiac death or ventricular arrhythmia.
Danish: • De fleste epidemiologiske undersøgelser viser, at eksponering for domperidon er forbundet med øget risiko for pludselig hjertedød eller ventrikulære arytmier.
English: The maximum treatment duration should not usually exceed one week.
Danish: Normalt bør behandlingsvarigheden ikke overstige en uge.
English: A higher risk was observed in patients older than 60 years, adults taking daily oral doses of more than 30 mg, and those taking QT-prolonging medicines or CYP3A4 inhibitors concomitantly.
Danish: Risikoen er fundet at være højere hos patienter over 60 år, ved dagsdosis over 30 mg til voksne og ved samtidig brug af QT-forlængende lægemidler eller CYP3A4-hæmmere.
English: It must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects.
Danish: Det må ikke gives ved moderat eller svær leverfunktionsnedsættelse, ved unormal elektrisk aktivitet i hjertet eller unormal hjerterytme eller ved forhøjet risiko for sådanne virkninger.
English: Measuring devices will be included with liquid formulations to allow accurate dosing by bodyweight.
Danish: Flydende formuleringer skal leveres med måleanordninger, der muliggør nøjagtig dosering efter legemsvægt.
English: Serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously been evaluated by the EMA and the product information updated with relevant warnings.
Danish: EMA har tidligere vurderet alvorlige virkninger på hjertet med domperidon, herunder en ændring i hjertets elektriske aktivitet (forlængelse af QT-intervallet) og uregelmæssig hjerterytme (arytmier), og produktinformationen er blevet ført ajour med passende advarsler.
English: These patients may also be given the medicine as suppositories of 30 mg twice daily.
Danish: Disse patienter kan desuden få lægemidlet som stikpiller i en dosis af 30 mg to gange dagligt.
English: • The new recommended dose in adults (and adolescents ≥ 35 kg where licensed) is 10 mg orally up to three times daily (maximum dose of 30 mg daily).
Danish: • Den nye anbefalede dosis til voksne (og unge ≥ 35 kg, når denne indikation er godkendt) er 10 mg oralt op til tre gange dagligt (maksimal dagsdosis 30 mg).
English: Products licensed in children and adolescents weighing less than 35 kg should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three times daily.
Danish: Produkter, der er godkendt til børn og unge med legemsvægt under 35 kg, bør gives i en dosis af 0,25 mg/kg legemsvægt gennem munden
English: • Where suitable domperidone products are available for children, the recommended dose is 0.25 mg/kg bodyweight up to three times daily by mouth.
Danish: • Hvor der er passende domperidon-produkter til rådighed til børn, er den anbefalede dosis 0,25 mg/kg legemsvægt oralt op til tre gange dagligt.
English: • Domperidone products are contraindicated in patients with severe hepatic impairment, conditions where cardiac conduction is, or could be, impaired or where there is underlying cardiac disease such as congestive heart failure, and when co-administered with QT-prolonging medicines or potent CYP3A4 inhibitors.
Danish: • Produkter indeholdende domperidon er kontraindiceret ved svær leverfunktionsnedsættelse, sygdomme, hvor hjertets overledning er eller kan være nedsat, underliggende kardial sygdom, såsom venstresidig hjerteinsufficiens, og koadministration af QT-forlængende lægemidler eller potente CYP3A4-hæmmere.
English: • The recommended dose in adults is 10 mg by mouth up to three times a day, or 30 mg as a suppository twice a day.
Danish: • Den normale dosis til voksne er 10 mg gennem munden op til tre gange dagligt eller 30 mg som en stikpille to gange dagligt.
English: • Patients with certain existing heart problems, or who are taking certain other medicines that enhance the effects of domperidone or reduce its breakdown in the body, should not take domperidone.
Danish: • Patienter skal ikke bruge domperidon, hvis de har visse hjerteproblemer eller får visse andre lægemidler, der forstærker virkningen af domperidon eller begrænser dets nedbrydning i kroppen.
English: • A significant number of cases have been reported with concomitant or co-suspect medication known to prolong QT interval, CYP3A4 inhibitors, or potassium-wasting diuretics.
Danish: • Der er indberettet et betydeligt antal tilfælde i forbindelse med samtidig eller anden suspekt medicinering, der vides at forlænge QT-intervallet, CYP3A4-hæmmere eller kaliumdepleterende diuretika.
English: • A review of the evidence confirms a small increased risk of serious cardiac adverse drug reactions related to the use of domperidone, including QTc prolongation, torsade de pointes, serious ventricular arrhythmia and sudden cardiac death.
Danish: • En gennemgang af den foreliggende dokumentation fastslår, at der er let øget risiko for alvorlige kardiale bivirkninger med domperidon, herunder QTc-forlængelse, torsade de pointes, svære ventrikulære arytmier og pludselig hjertedød.
English: • There is no good evidence to support the use of domperidone for other conditions such as bloating and heartburn, and so it is no longer authorised to treat these conditions.
Danish: • Der er ikke god dokumentation for anvendelse af domperidon til andre tilstande, såsom oppustethed og halsbrand.
English: BUDAPEST TÓ U. 1-5 Hungary
Danish: BUDAPEST TÓ U. 1-5 Ungarn
English: Letališka 29 A 1000 Ljubljana Slovenia
Danish: Letališka 29 A 1000 Ljubljana Slovenien
English: 11317 Tallinn, Estonia
Danish: 11317 Tallinn, Estland
English: 104 25 Stockholm Sweden
Danish: 104 25 Stockholm Sverige
English: 2970 Hørsholm Denmark
Danish: 2970 Hørsholm Danmark
English: Heinzelova 70, 10000 Zagreb, Croatia
Danish: Heinzelova 70, 10000 Zagreb, Kroatien
English: A.Juozapaviciaus 6/2, LT-09310 Vilnius, Lithuania
Danish: A.Juozapaviciaus 6/2, LT-09310 Vilnius, Litauen
English: Einsteinova 24, 85101 Bratislava Slovak Republic
Danish: Einsteinova 24, 85101 Bratislava Slovakiet
English: Viale L. Bodio 37/b 20158 Milan, Italy
Danish: Viale L. Bodio 37/b 20158 Milan, Italien
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Kampenringweg 45 D-E 2803 PE Gouda The Netherlands
Danish: Kampenringweg 45 D-E 2803 PE Gouda
English: Estonia sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
Danish: Estland sanofi-aventis Estonia OÜ Pärnu mnt. 139 E/2
English: Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector
Danish: Strada Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9, Sector 2, Bucureşti, Romænien
English: Sanofi-aventis Cyprus Ltd. 14, Charalambou Mouskou Strovolos, 2015
Danish: Sanofi-aventis Kypern Ltd. 14, Charalambou Mouskou Strovolos, 2015
English: SANOFI BULGARIA EOOD 90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor Sofia 1784, Bulgaria
Danish: SANOFI BULGARIEN EOOD 90 Tsarigradsko chaussee Blvd. Office building Capital Fort, section A, 10th floor Sofia 1784, Bulgarien
English: Greece sanofi-aventis AEBE 348, Syngrou Av. - Building A, 176 74 Kallithea - Athens Greece
Danish: Grækenland sanofi-aventis AEBE 348, Syngrou Av. - Building A, 176 74 Kallithea - Athens Grækenland
English: Denmark sanofi-aventis Denmark A/S Slotsmarken 13
Danish: Danmark sanofi-aventis Danmark A/S Slotsmarken 13
English: Austria sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A-1220 Vienna, Austria
Danish: Østrig sanofi-aventis GmbH, Leonard-Bernstein-Straße 10, A1220 Vienna, Østrig
English: Sanofi-aventis Ireland Ltd T/A SANOFI
Danish: Sanofi-aventis Irland Ltd T/A SANOFI
English: Sanofi Romania SRL,
Danish: Sanofi Romænien SRL,
English: Latvia sanofi - aventis Latvia SIA
Danish: Letland sanofi - aventis Letland SIA
English: Netherlands sanofi-aventis Netherlands B.V.
Danish: Holland sanofi-aventis Netherlands B.V.
English: Sanofi-Aventis France 82, Avenue Raspail 94250 Gentilly France
Danish: Sanofi-Aventis Frankrig 82, Avenue Raspail 94250 Gentilly Frankrig
English: Sanofi-aventis France 82 avenue Raspail 94250 Gentilly FRANCE
Danish: Sanofi-aventis Frankrig 82 avenue Raspail 94250 Gentilly Frankrig
English: Solution for injection Extracorporeal use
Danish: Ekstrakorporal anvendelse
English: 150 mg (15000 IU)
Danish: 150 mg (15.000 IE)
English: 120 mg (12000 IU)
Danish: 120 mg (12.000 IE)
English: Solution for injection Intravenous use
Danish: Intravenøs anvendelse
English: Spain sanofi-aventis, S.A. C/ Josep Pla, 2 08019 Barcelona Spain
Danish: Spanien sanofi-aventis, S.A. C/ Josep Pla, 2
English: Belgium Sanofi Belgium Leonardo Da Vincilaan 19
Danish: Sanofi Belgien Leonardo Da Vincilaan 19 1831 Diegem, Belgien
English: 100 mg (10 000 IU)
Danish: 100 mg (10.000 IE)
English: Croatia sanofi-aventis Croatia d.o.o.
Danish: Kroatien sanofi-aventis Kroatien d.o.o.
English: 80 mg (8000 IU)
Danish: 80 mg (8.000 IE)
English: 40 mg (4000 IU)
Danish: 40 mg (4.000 IE)
English: 60 mg (6000 IU)
Danish: 60 mg (6.000 IE)
English: 10 000 anti-Xa IU /1.0 ml (100 mg/1 ml)
Danish: 10.000 anti-Xa IE /1,0 ml (100 mg/1 ml)
English: 300 mg (30 000 NE/3 ml
Danish: 300 mg (30.000 IE/3 ml
English: 30 000 anti-Xa IU /3.0 ml (300 mg/3 ml)
Danish: 30.000 anti-Xa IE /3,0 ml (300 mg/3 ml)
English: 4000 anti-Xa IU /0.4 ml (40 mg/0.4 ml)
Danish: 4.000 anti-Xa IE /0,4 ml (40 mg/0,4 ml)
English: 8000 anti-Xa IU /0.8 ml (80 mg/0.8 ml)
Danish: 8.000 anti-Xa IE /0,8 ml (80 mg/0,8 ml)
English: 2000 anti-Xa IU /0.2 ml (20 mg/0.2 ml)
Danish: 2.000 anti-Xa IE /0,2 ml (20 mg/0,2 ml)
English: 20 mg (2000 IU)
Danish: 20 mg (2.000 IE)
English: 100 mg (10 000 NE/1 ml)
Danish: 100 mg (10.000 IE/1 ml)
English: 6000 anti-Xa IU /0.6 ml (60 mg/0.6 ml)
Danish: 6.000 anti-Xa IE /0,6 ml (60 mg/0,6 ml)
English: 60 mg (6000 NE /0.6 ml)
Danish: 60 mg (6.000 IE /0,6 ml)
English: 40 mg (4000 NE /0.4 ml)
Danish: 40 mg (4.000 IE /0,4 ml)
English: 0.6 ml; 0.8 ml; 1.0 ml (100 mg/ml equivalent to 10 000 anti-Xa IU/ml)
Danish: 0,6 ml; 0,8 ml; 1,0 ml (100 mg/ml ækvivalent til 10.000 anti-Xa IE/ml)
English: 80 mg (8000 NE /0.8 ml)
Danish: 80 mg (8.000 IE /0,8 ml)
English: Clexane 20 mg Klinik
Danish: Clexane 20 mg Klinik 20 mg
English: 20 mg (2000 NE /0.2 ml)
Danish: 20 mg (2.000 IE /0,2 ml)
English: 0.8 ml; 1.0 ml (150 mg/ml equivalent to 15000 anti-Xa IU/ml)
Danish: 0,8 ml; 1,0 ml (150 mg/ml ækvivalent til 15.000 anti-Xa IE/ml)
English: Clexane 40 mg Klinik
Danish: Clexane 40 mg Klinik 40 mg
English: 1 ml (150 mg/ml equivalent to 15000 IU anti-Xa activity/ml)
Danish: 1 ml (150 mg/ml ækvivalent til 15.000 IE anti-Xa activity/ml)
English: 0.8 ml (150 mg/ml equivalent to 15000 IU anti-Xa activity/ml)
Danish: 0,8 ml (150 mg/ml ækvivalent til 15.000 IE anti-Xa activity/ml)
English: Clexane 2000 IU anti-Xa/0,2 ml otopina za injekciju u napunjenoj štrcaljki
Danish: Clexane 2000 IU antiXa/0,2 ml otopina za injekciju u napunjenoj štrcaljki
English: Clexane 2 000 antiXa TV/0,2 ml injekcinis tirpalas užpildytame švirkšte
Danish: Clexane 2 000 anti-Xa TV/0,2 ml injekcinis tirpalas užpildytame švirkšte
English: Clexane 8000 IU anti-Xa/0,8 ml otopina za injekciju u napunjenoj štrcaljki
Danish: Clexane 8000 IU antiXa/0,8 ml otopina za injekciju u napunjenoj štrcaljki
English: Clexane 8 000 antiXa TV/0,8 ml injekcinis tirpalas užpildytame švirkšte
Danish: Clexane 8 000 anti-Xa TV/0,8 ml injekcinis tirpalas užpildytame švirkšte
English: 150 mg/1.0 ml Solution for injection Subcutaneous use
Danish: 150 mg/1,0 ml Injektionsvæske, opløsning
English: Clexane 4000 IU anti-Xa/0,4 ml otopina za injekciju u napunjenoj štrcaljki
Danish: Clexane 4000 IU antiXa/0,4 ml otopina za injekciju u napunjenoj štrcaljki
English: Clexane 4 000 antiXa TV/0,4 ml injekcinis tirpalas užpildytame švirkšte
Danish: Clexane 4 000 anti-Xa TV/0,4 ml injekcinis tirpalas užpildytame švirkšte
English: 100 mg/1.0 ml Solution for injection Subcutaneous use; Intravenous use
Danish: 100 mg/1,0 ml Injektionsvæske, opløsning
English: Clexane 6000 IU anti-Xa/0,6 ml otopina za injekciju u napunjenoj štrcaljki
Danish: Clexane 6000 IU antiXa/0,6 ml otopina za injekciju u napunjenoj štrcaljki
English: Clexane 6 000 antiXa TV/0,6 ml injekcinis tirpalas užpildytame švirkšte
Danish: Clexane 6 000 anti-Xa TV/0,6 ml injekcinis tirpalas užpildytame švirkšte
English: 1 ml (100 mg/ml equivalent to 10000 IU anti-Xa activity/ml)
Danish: 1 ml (100 mg/ml ækvivalent til 10.000 IE anti-Xa activity/ml)
English: 0.8 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Danish: 0,8 ml (100 mg/ml ækvivalent til 10.000 IE anti-Xa activity/ml)
English: 0.2 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Danish: 0,2 ml (100 mg/ml ækvivalent til 10.000 IE anti-Xa activity/ml)
English: Sanofi Malta Ltd 3rd Floor, Avantech Building,
Danish: Sanofi Malta Ltd 3rd Floor, Avantech Building, St.Julian's Road, San Gwann SGN 2805, Malta
English: 0.4 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Danish: 0,4 ml (100 mg/ml ækvivalent til 10.000 IE anti-Xa activity/ml)
English: 0.6 ml (100 mg/ml equivalent to 10 000 IU anti-Xa activity/ml)
Danish: 0,6 ml (100 mg/ml ækvivalent til 10.000 IE anti-Xa activity/ml)
English: United-Kingdom
Danish: Luxemborg
English: 120 mg/0.8 ml Solution for injection Subcutaneous use
Danish: 120 mg/0,8 ml Injektionsvæske, opløsning
English: 10 single doses of 40 mg)
Danish: 400,00 mg/3 ml (ækvivalent 10 enkeltdoser af 40 mg)
English: Invented name Strengths Pharmaceutical forms Route of administration Packaging
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Fungitraxx on 12/03/2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fungitraxx den 12/03/2014.
English: In case of accidental contact with the eyes, they should be rinsed thoroughly with water.
Danish: Ved utilsigtet kontakt med øjnene skal de skylles grundigt med vand.
English: These effects are usually mild and related to the dose, and can be managed by reducing the dose or if necessary stopping treatment.
Danish: Disse bivirkninger er sædvanligvis milde og dosisafhængige og kan håndteres ved at nedsætte dosis eller om nødvendigt ophøre med behandlingen.
English: Vomiting, loss of appetite and weight loss are common in treated birds (seen in up to 1 in 10 birds).
Danish: Opkastning, appetitløshed og vægttab er almindeligt forekommende hos behandlede fugle (optræder hos op til 1 ud af 10 fugle).