natgillin/translations-raw huggingface dataset:
Pres sprøjtens stempel langsomt ned for at give medicinen, uden at patienten får den galt i halsen.
Press the plunger of the syringe in slowly to expel the medicine without causing choking.
Dette kaldes Jarisch-Herxheimers reaktion.
This is known as the Jarisch-Herxheimer reaction.
• Jarisch-Herxheimers reaktion.
• Jarisch-Herxheimer reaction.
125 mg granulat til oral suspension Belgien, Frankrig, Luxembourg, Spanien, Storbritannien - Zinnat Tyskland - Elobact
125 mg granules for oral suspension France, Spain, United Kingdom - Zinnat Germany - Elobact
Tal med lægen eller apotekspersonalet, hvis du tager nogle af disse typer af medicin.
Tell your doctor or pharmacist if you are taking any medicine like this.
Samtidig anvendelse af orale antikoagulantia kan medføre forhøjet INR (International Normalised Ratio).
Concomitant use with oral anticoagulants may give rise to increased INR.
500 mg 2 gange daglig i 14 dage (interval 10 til 21 dage)
500 mg twice daily for 14 days (range of 10 to 21 days)
Hvis du tager p-piller, skal du også bruge prævention, der danner en barriere (såsom kondom), mens du tager Zinnat.
If you are taking the contraceptive pill while you are being treated with Zinnat you also need to use a barrier method of contraception (such as condoms).
Idet der er større sandsynlighed for, at ældre patienter har nedsat nyrefunktion, skal dosis justeres i forhold til nyrefunktion (se pkt.
Elderly patients are more likely to have decreased renal function; therefore, the dose should be adjusted in accordance with the renal function in the elderly (see section 4.2).
Jarisch-Herxheimers reaktion
Jarisch-Herxheimer reaction
Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking any other medicines, if you've started taking any recently or you start taking new ones.
dsreaktioner skal behandling med cefuroxim straks afbrydes og assende procedurer påbegyndes.
In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.
Vejledning i brug af doseringssprøjte (hvis en medfølger)
Directions for using the dosing syringe (if supplied)
• huden og bløddele.
• the skin and soft tissues.
Inden for hver frekvenskategori er bivirkninger angivet med de alvorligste først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Da der kan forekomme falsk negative resultater for ferricyanidtest, anbefales det at anvende enten glucoseoxidasemetoder el
As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil.
Arter, der normalt er følsomme Grampositive aerober:
Commonly susceptible species Gram-positive aerobes:
Tryk den helt ned, indtil tilpasningsstykket passer fuldstændigt.
Press it down completely until the collar fits in the neck firmly.
• hydrolyse ved hjælp af beta-laktamaser, herunder (men ikke begrænset til) extended spectrumbeta-laktamaser (ESBL'er) og AmpC-enzymer, der kan induceres eller undergå stabil udvikling i visse aerobe gramnegative bakteriearter
• hydrolysis by beta-lactamases; including (but not limited to) by extended-spectrum beta-lactamases
• mellemøret
• middle ear
Cefuroxim må kun anvendes under amning efter afvejning af fordele og risici.
Cefuroxime should only be used during breastfeeding after benefit/risk assessment by the physician in charge.
500 mg 2 gange daglig
500 mg twice daily
• Pyelonefritis.
• Pyelonephritis.
Virkning og anvendelse Det skal du vide, før du tager Zinnat Sådan skal du tage Zinnat Bivirkninger
What Zinnat is and what it is used for What you need to know before you take Zinnat How to take Zinnat
Hvis du har sukkersyge, skal du tage højde for sukkerindholdet i Zinnat i din kostplan.
If you are diabetic you need to take this into account for your diet.
Efter dosis er givet, skal hætten skrues på flasken igen uden at fjerne tilpasningsstykket.
After giving the dose replace the bottle cap without removing the plastic collar.
Placer sprøjten i munden med spidsen af sprøjten ind mod kinden.
Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Positiv Coombs' test, trombocytopeni, leukopeni (nogle gange udtalt)
Blood and lymphatic system disorders eosinophilia positive Coomb's test, thrombocytopenia, leukopenia (sometimes profound)
Pres sprøjtens stempel langsomt ned og giv dig/barnet tid til at synke.
Slowly push the plunger in, allowing time to swallow.
Antibiotika-associeret pseudomembranøs colitis, som i sværhedsgrad kan spænde fra let til livstruende, er blevet rapporteret ved anvendelse af næsten alle antibiotika, inklusive cefuroxim.
Antibacterial agent-associated pseudomembranous colitis have been reported with nearly all antibacterial agents, including cefuroxime and may range in severity from mild to life threatening.
4.4 og 5.1).
5 to 7.5
UDLØBSDATO EXP {MM ÅÅÅÅ}
EXPIRY DATE EXP {MM YYYY}
DATO FOR ÆNDRING AF TEKSTEN DDMMÅÅÅÅ [Udfyldes nationalt]
DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
10 mg/kg 2 gange daglig til højst 125 mg 2 gange daglig
10 mg/kg twice daily to a maximum of 125 mg twice daily
Antal breve pr. dosis
No. of sachets per dose
Streptococcus pyogenes Streptococcus agalactiae
Streptococcus pyogenes Streptococcus agalactiae Gram-negative aerobes:
Sæt sprøjten fast i tilpasningsstykket.
Insert the syringe firmly into the adapter.
125 mg/5 ml, 250 mg/5 ml granulat til oral suspension og 125 mg, 250 mg, 500 mg granulat til oral suspension
125 mg/5 mL, 250 mg/5 mL granules for oral suspension and 125 mg, 250 mg, 500 mg granules for oral suspension
250 mg 2 gange daglig
250 mg twice daily
3-6 måneder 6 måneder til 2 år 2-18 år
40 to 60 6 months to 2 years 60 to 120 2.5 to 5 2 to 18 years
Det skal du vide, før du tager Zinnat
What you need to know before you take Zinnat Don't take Zinnat:
Cefuroxims farmakokinetik er lineær over det orale dosisinterval 125-1.000 mg. Der opstod ingen akkummulering af cefuroxim efter gentagne orale doser på 250-500 mg.
Cefuroxime axetil oral suspension was not bioequivalent to cefuroxime axetil tablets when tested in healthy adults and therefore is not substitutable on a milligramper-milligram basis (see section 4.2).The pharmacokinetics of cefuroxime is linear over the oral dosage range of 125 to 1000 mg. No accumulation of cefuroxime occurred following repeat oral doses of 250 to 500 mg.
Mave-tarmkanalen Diarré, kvalme, abdominalsmerter
Gastrointestinal disorders diarrhoea, nausea, abdominal pain vomiting pseudomembranous colitis
Seponering af cefuroximbehandling og specifik behandling mod Clostrid d
Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered.
125 mg, 250 mg, 500 mg filmovertrukken tablet Filmovertrukken tablet (tablet) [Udfyldes nationalt]
125 mg, 250 mg, 500 mg film-coated tablets Film-coated tablet (tablet) [To be completed nationally]
Tabel 5: Anbefalede doser af Zinnat ved nedsat nyrefunktion
Recommended doses for Zinnat in renal impairment
Hovedpine, svimmelhed
Hepatic impairment
Italien- Zoref
Italy- Zoref
Italien - Zoref
Italy - Zoref
125 mg filmovertrukne tabletter
125 mg film-coated tablets
Fjern hætten på flasken og sæt tilpasningsstykket for sprøjten ned i flaskehalsen.
Remove the bottle cap and insert the syringe-collar assembly into the neck of the bottle.
125 mg, 250 mg, 500 mg granulat til oral suspension For trinvis vejledning i klargøring af Zinnat breve, se Vejledning til rekonstitution sidst i denne indlægsseddel.
125 mg, 250 mg, 500 mg granules for oral suspension For step-by-step instructions on how to make up Zinnat sachets see Instructions for reconstitution at the end of this leaflet.
Dosisjustering ikke nødvendigt (standarddosis m g til 500 mg administreret 2 gange daglig).
1.4-2.4 no dose adjustment necessary (standard dose of 125 mg to 500 mg given twice daily)
Du må ikke tage Zinnat, før du har talt med lægen, hvis du mener, at dette gælder for dig.
If you think this applies to you, don't take Zinnat until you have checked with your doctor.
Sådan skal du tage Zinnat
How to take Zinnat
Vend flasken og sprøjten opret igen.
Invert the bottle and syringe.
• Ukomplicerede bløddelsinfektioner.
• Uncomplicated skin and soft tissue infections.
250 mg filmovertrukne tabletter
250 mg film-coated tablets
125 mg, 250 mg, 500 mg granulat til oral suspension Vejledning i fremstilling af suspension fra breve Tøm granulatet fra brevet i et glas.
125 mg, 250 mg, 500 mg granules for oral suspension Directions for making up suspension from sachets Empty granules from sachet into a glass.
Hæmolytisk anæmi
haemolytic anaemia
Drug fever, serumsyge, anafylakse, Jarisch-Herxheimers reaktion
disorders anaphylaxis, Jarisch-Herxheimer reaction
15 mg/kg 2 gange daglig til højst 250 mg 2 gange daglig i 14 dage (10 til 21 dage)
15 mg/kg twice daily to a maximum of 250 mg twice daily for 14 days (10 to 21 days)
125 mg, 250 mg, 500 mg granulat til oral suspension Granulat til oral suspension [Udfyldes nationalt]
125 mg, 250 mg, 500 mg granules for oral suspension Granules for oral suspension [To be completed nationally]
Vend flasken om igen til opret position.
Turn the bottle and syringe into an upright position.
125 mg/5 ml, 250 mg/5 ml granulat til oral suspension Omryst flasken inden brug.
125 mg/5 mL, 250 mg/5 mL granules for oral suspension Shake the bottle before use.
250 mg granulat til oral suspension
250 mg granules for oral suspension
125 mg/5ml, 250 mg/5ml granulat til oral suspension
125 mg/5mL, 250 mg/5mL granules for oral suspension
Hud og subkutane væv
Uncomplicated skin and soft tissue infections
• halsen
• headache
15 mg/kg 2 gange daglig til højst 250 mg 2 gange daglig i 10 til 14 dage
15 mg/kg twice daily to a maximum of 250 mg twice daily for 10 to 14 days
125 mg/5 ml, 250 mg/5 ml granulat til oral suspension Granulat til oral suspension [Udfyldes nationalt]
125 mg/5 mL, 250 mg/5 mL granules for oral suspension Granules for oral suspension [To be completed nationally]
15 mg/kg 2 gange daglig til højst 250 mg 2 gange daglig
15 mg/kg twice daily to a maximum of 250 mg twice daily
Gulsot (hovedsageligt kolestatisk), hepatitis
Hepatobiliary disorders transient increases of hepatic enzyme levels jaundice (predominantly cholestatic), hepatitis
• urinvejene
• dizziness
Zinnat og relaterede navne (se bilag I) 125 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 500 mg granulat til oral suspension [Se bilag I - Udfyldes nationalt]
Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension [See Annex I - To be completed nationally]
125 mg/5ml granulat til oral suspension
125 mg/5mL granules for oral suspension
250 mg/5 ml granulat til oral suspension Indeholder 2,3 g saccharose pr. 5 ml dosis
Contains 2.3 g of sucrose per 5 mL dose
.3 Kontraindikationer verfølsomhed over for cefuroxim eller over for et eller flere af hjælpestofferne anført i pkt.
Hypersensitivity to cefuroxime or to any of the excipients listed in section 6.1.
250 mg/5ml granulat til oral suspension
250 mg/5mL granules for oral suspension
Zinnat og relaterede navne (se bilag I) 125 mg/5 ml granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg/5 ml granulat til oral suspension [Se bilag I - Udfyldes nationalt]
NAME OF THE MEDICINAL PRODUCT Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension [See Annex I - To be completed nationally] Cefuroxime
Vend flasken på hovedet.
Turn the bottle the correct way up.
DDMMÅÅÅÅ [Udfyldes nationalt]
[To be completed nationally]
Zinnat og relaterede navne (se bilag I) 125 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 250 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 500 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt]
Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally]
Forbigående stigning i leverenzymer er observeret.
Transient rises in serum liver enzymes have been observed which are usually reversible.
) over for alle andre beta ktamantibiotika (penicilliner, monobaktamer og carbapenemer).
History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).
Danmark, Finland, Frankrig, Holland, Irland, Litauen, Polen, Rumænien, Slovakiet, Spanien, Storbritannien, Tjekkiet, Tyskland, Ungarn - Zinnat Tyskland - Elobact
Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Lithuania, Netherlands, Poland, Romania, Slovakia, Spain, United Kingdom - Zinnat Germany - Elobact
500 mg filmovertrukne tabletter
500 mg film- coated tablets
Lad tilpasningsstykket være i flasken og luk flasken tæt til igen med hætten.
Close the bottle tightly with the cap, leaving the adaptor in place.
Belgien, Bulgarien, Cypern, Finland, Irland, Italien, Luxembourg, Malta, Polen, Slovakiet, Slovenien, Spanien, Storbritannien, Tjekkiet, Østrig - Zinnat
Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Finland, Ireland, Italy, Luxembourg, Malta, Poland, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
6.2 Uforligeligheder [Udfyldes nationalt]
PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
inistreres til patienter med ke alvorlig overfølsomhed over for andre beta-laktamer i anamnesen.
Caution should be used if cefuroxime is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Zinnat og relaterede navne (se bilag I) 125 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 250 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 500 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 125 mg/5 ml granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg/5 ml granulat til oral suspension Zinnat og relaterede navne (se bilag I) 125 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 500 mg granulat til oral suspension
Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension
Zinnat og relaterede navne (se bilag I) 125 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 250 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 500 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 125 mg/5 ml granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg/5 ml granulat til oral suspension Zinnat og relaterede navne (se bilag I) 125 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 500 mg granulat til oral suspension [Se bilag I - Udfyldes nationalt]
Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 250 mg/5 mL granules for oral suspension Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension [SeeAnnex I - To be completed nationally]
• kvalme • udslæt.
• feeling sick
125 mg, 250 mg, 500 mg filmovertrukne tabletter Slug Zinnat tabletter hele med lidt vand.
125 mg, 250 mg, 500 mg film-coated tablets
Zinnat og relaterede navne (se bilag I) 125 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 250 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 500 mg filmovertrukne tabletter Zinnat og relaterede navne (se bilag I) 125 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 250 mg granulat til oral suspension Zinnat og relaterede navne (se bilag I) 500 mg granulat til oral suspension
Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension
Belgien, Bulgarien, Cypern, Danmark, Estland, Finland, Frankrig, Holland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat Tyskland - Elobact
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat Germany - Elobact
Candidaovervækst
Candida overgrowth
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION {DD month YYYY} [To be completed nationally]
6.1. atienter med verificeret overfølsomhed over for cefalosporiner.
Patients with known hypersensitivity to cephalosporin antibiotics.
Belgien, Bulgarien, Danmark, Estland, Frankrig, Holland, Irland, Island, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Sverige, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat
Austria, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat
Blodfortyndende medicin (orale antikoagulantia).
Oral anticoagulants
Belgien, Bulgarien, Cypern, Danmark, Estland, Frankrig, Holland, Irland, Italien, Letland, Litauen, Luxembourg, Malta, Polen, Rumænien, Slovakiet, Slovenien, Spanien, Storbritannien, Tjekkiet, Tyskland, Ungarn, Østrig - Zinnat
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Fjern hætten og forseglingen.
Remove the cap and the heat-seal membrane.
på 125
90 to 180
Belgien, Italien, Luxembourg, Spanien, Storbritannien, Østrig - Zinnat Italien - Oraxim
250 mg granules for oral suspension Austria, Italy, Spain, United Kingdom - Zinnat Italy - Oraxim
2 fyldte penne
2 pre-filled pens
6 (3 x 2) fyldte penne (multipakning)
6 (3 x 2) prefilled pens (multipack)
Startpakke: 1 fyldt sprøjte (63µg) + 1 fyldt sprøjte (94µg)
Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Startpakke: 1 fyldt pen (63µg) + 1 fyldt pen (9µg)
Initiation pack: 1 pre-filled pen (63 µg) + 1 pre-filled pen (94 µg)
Den 20. december 2013 EMA/13239/2014 Corr. 1
20 December 2013 EMA/13239/2014 Corr. 1
Patienter, der har spørgsmål, bør drøfte dem med lægen eller apotekspersonalet.
Patients who have any questions should discuss them with their doctor or pharmacist.
Detaljerede anbefalinger for patienter og sundhedspersoner er givet nedenfor.
Detailed recommendations for patients and healthcare professionals are available below.
Ændringerne har hovedsagelig til formål at nedsætte risikoen for neurologiske bivirkninger
Changes aim mainly to reduce the risk of neurological side effects
Gennemgangen af lægemidler indeholdende metoclopramid blev indledt i december 2011 på anmodning af Frankrig i henhold til artikel 31 i direktiv 2001/83/EF.
The review of metoclopramide-containing medicines was initiated in December 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
• Ekstrapyramidale forstyrrelser udgjorde næsten halvdelen af alle spontant indberettede bivirkninger i en fremstillers database (1 749 tilfælde ud af 4 005 indtil december 2011).
• Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011).
Det er kontraindiceret til børn under 1 år.
Use is contraindicated in children under 1 year of age.
Produktinformationen er ændret tilsvarende, og de ordinerende læger har på nationalt plan fået tilsendt yderligere information.
The product information has been amended appropriately, and prescribers sent further communication at a national level.
• Intravenøse formuleringer med koncentration over 5 mg/ml og suppositorier indeholdende 20 mg skal ligeledes trækkes tilbage.
• Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.
Der har desuden været meget sjældne tilfælde af alvorlige bivirkninger fra hjertet eller kredsløbet, navnlig efter injektion.
There have also been very rare cases of serious effects on the heart or circulation, particularly after injection.
Lægemidler indeholdende metoclopramid har været godkendt ved nationale procedurer i alle EU's medlemsstater og har været på markedet i mange år under forskellige handelsnavne.
Metoclopramide-containing medicines have been authorised by national procedures in all the Member States of the EU and have been available for many years under different trade names.
• Metoclopramid bør ikke længere anvendes til børn under 1 år.
• Metoclopramide should no longer be used in children under 1 year old.
• Intravenøse doser bør administreres som en langsom bolus over mindst 3 minutter for at mindske risikoen for bivirkninger.
• Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
Efter denne gennemgang og afgivelsen af CHMP's oprindelige udtalelse gjorde en af de virksomheder, der fremstiller lægemidler indeholdende metoclopramid, sin ret gældende til at anmode om en fornyet overvejelse af udtalelsen, hvilket fandt sted behørigt.
Following this assessment and the issuing of the CHMP's original opinion, one of the companies producing metoclopramide-containing medicines exercised its legal right to ask for a re-examination of the opinion, which was duly carried out.
ANSM anmodede CHMP om at gennemgå fordele og risici ved disse lægemidler hos alle aldersgrupper og anbefale ensartede indikationer i hele EU.
ANSM asked the CHMP to review the benefits and risks of these medicines in all age groups and to recommend consistent indications across the EU.
Der var desuden et betydeligt antal indberetninger om overdosering hos børn, navnlig med orale flydende formuleringer.
There were also a significant number of reports of overdose in children, particularly with oral liquid formulations.