natgillin/translations-raw huggingface dataset:
eller clopidogrel.
gemfibrozil or clopidogrel.
Denne interaktion kunne ikke forudsiges på grundlag af det nuværende kendskab til disse lægemidlers metabolisme.
These interactions could not have been predicted on what is currently known about the metabolism of these drugs.
- CPMP mente, at den manglende forudsigelighed af potentiel lægemiddelinteraktion samt
- the CPMP considered that the lack of predictability of potential drug interactions and the difficulties
problemerne med at forhindre samtidig ordinering af andre potentielt interagerende produkter udgør en fortsat risiko.
in preventing co-prescription with other potentially interacting products constitutes a continuing risk.
- Udvalget mente på basis af den foreliggende dokumentation, at lægemidler indeholdende cerivastatin
- the Committee, based on present evidence, considered the risk/ benefit balance of cerivastatin
udviser et ugunstigt risk/ benefit- forhold.
containing medicinal products to be unfavourable.
anbefaler CPMP, at markedsføringstilladelserne for lægemidler indeholdende cerivastatin, som er tilladt i henhold til den gensidige anerkendelsesprocedure (se bilag I), tilbagekaldes, da det anser disse lægemidler for at være skadelige ved normal brug.
containing Medicinal Products authorised under the Mutual Recognition Procedure (see Annex I) since it considers that such medicinal products are harmful under normal conditions of use.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE Medlemsstat
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Indehaver af markedsføringstilladelse
Pharmaceutical
Navn
State
Styrke Lægemiddelform Indgivelsesvej
Authorisation Holder
Indhold (Koncentration)
administration
Nederlandene (Holland) (RMS)
(concentration)
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença 2705- 906 Terrugem SNT Portugal
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
2 mg/ ml Infusionsvæske, Intravenøs opløsning anvendelse
Solution for infusion
Østrig
AT
Tyskland
DE
Irland
IE
Italien
IT
Det Forenede Kongerige (Storbritannien)
UK
Estrada do Rio da Mó n. º 8, 8A e 8B – Fervença
Estrada do Rio da Mó, nº8, 8A & 8B, Fervença, 2705-906 Terrugem SNT, PORTUGAL
Ciprofloxacin Hikma 200 mg/ 100 ml Solution for
Ciprofloxacin Hikma 2mg/ ml 200mg/ 100ml Solution for Infusion
3 BILAG II
2 ANNEX II
4 FAGLIGE KONKLUSIONER
3 SCIENTIFIC CONCLUSIONS
Behandlingen af komplicerede urinvejsinfektioner består i dag i empirisk behandling med et bredspektret antibiotikum (fluorquinolon) og mulig efterfølgende behandling i 10- 14 dage på grundlag af urindyrkning og følsomhed.
Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 10- 14 days based on urine culture and sensitivity.
For at undgå behandlingssvigt og resistensdannelse må patientens compliance og doseringen være tilstrækkelig.
In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient’ s compliance and dosing be adequate.
Ansøgeren/ indehaveren af markedsføringstilladelsen forelagde ikke kliniske data til besvarelse af CHMP' s spørgsmål om benefit/ risk- forholdet for den ansøgte dosering ved urinvejsinfektioner og den maksimale daglige dosis til voksne, idet der er tale om en generisk ansøgning (referencelægemidlet/ det oprindelige lægemiddel er Ciproxin (Bayer)).
The applicant/ MAH did not submit any clinical data to address the CHMP questions related to the risk/ benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″ generic″ application (reference product/ originator Ciproxin from Bayer).
Den af ansøgeren forelagte publicerede litteratur og resistensdata giver i det væsentlige tilfredsstillende dokumentation både for virkningen og for sikkerheden (idet der med denne dosering er større sandsynlighed for undgåelse af resistensdannelse uden stigning i bivirkningsfrekvensen) af ciprofloxacin i en dosering på 200- 400 mg to gange dagligt til behandling af komplicerede urinvejsinfektioner.
The body of published literature and resistance data presented by the applicant provided adequate justification, both from an efficacy and safety (more likely to prevent bacterial resistance and no increase in adverse reactions) viewpoint, for the dosing regimen of 200-400 mg ciprofloxacin twice daily for the treatment of complicated UTI.
Da produktet er en opløsning til intravenøs infusion, bør indikationen indskrænkes til behandling af komplicerede urinvejsinfektioner.
This product being a solution intended for intravenous infusion, should be restricted to the treatment of complicated UTI’ s.
De publicerede data viser, at den ansøgte maksimale dosis på 400 mg intravenøst tre gange dagligt resulterer i bedre forebyggelse af resistensudvikling uden væsentlig forøgelse af bivirkningerne ved behandling af alvorlige og livstruende infektioner i andre organsystemer, og disse data giver ikke anledning til at slutte, at denne gunstige benefit/ risk- profil vil være væsentligt anderledes ved behandling af komplicerede urinvejsinfektioner
From the published data, which have demonstrated for the proposed maximum dose 400 mg intravenous three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/ benefit profile would differ significantly in the treatment of complicated UTIs.
5 BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- den af ansøgeren forelagte litteratur understøtter en dosis på 200- 400 mg to gange dagligt til
- The literature provided by the applicant support a dose of 200 – 400 mg twice daily in the treatment of
behandling af komplicerede urinvejsinfektioner og en maksimal daglig dosis til voksne på 400 mg tre gange dagligt
complicated urinary tract infections and a maximum adult daily dose of 400 mg three times daily.
5. 1 i produktresuméet, herunder afgrænsningerne af indikationerne,
- The requested amendments to section 5.1 of the Summary of Product Characteristics including the
kan godtages
breakpoints relevant to the indications are acceptable.
anbefalede CHMP, at indikationen bør være komplicerede urinvejsinfektioner med en anbefalet dosis på 200- 400 mg to gange dagligt.
The CHMP has recommended that the indication should be complicated urinary tract infections with a recommended dose of 200 – 400 mg twice daily.
CHMP anbefalede derfor udstedelse af markedsføringstilladelse( r) og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel.
The CHMP has therefore recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
6 PRODUKTRESUME
4 ANNEX III
Ciprofloxacin Hikma 200 mg/ 100 ml, infusionsvæske, opløsning [Udfyldes nationalt]
Ciprofloxacin Hikma 200 mg/ 100 ml, solution for infusion [To be completed nationally]
Ciprofloxacin- laktat, der svarer til 2 mg ciprofloxacin.
Ciprofloxacin lactate equivalent to 2 mg ciprofloxacin.
6. 1.
Excipient 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion For a full list of excipients, see section 6.1.
Infusionsvæske, opløsning Klar, farveløs til let gullig opløsning Opløsningens pH:
Solution for infusion Clear, colourless to slightly yellow solution pH of the solution:
Ciprofloxacin Hikma er beregnet til behandling af alvorlige og/ eller livstruende infektioner forårsaget af ciprofloxacin- følsomme patogener.
Ciprofloxacin Hikma is indicated for the treatment of serious and/ or life-threatening infections caused by ciprofloxacin-susceptible pathogens.
Følgende indikationer kan overvejes til behandling med Ciprofloxacin Hikma, når oral behandling ikke er mulig eller er upålidelig:
The following indications can be considered for treatment with Ciprofloxacin Hikma when oral therapy is not possible or not reliable:
- komplicerede urinvejsinfektioner
- complicated urinary tract infections
- infektioner af nedre luftveje, herunder lungebetændelse forårsaget af aerobe gram- negative
- infections of the lower respiratory tract including pneumonia caused by aerobic gram-negative
I tilfælde med Streptococcus pneumoniae infektioner er ciprofloxacin ikke førstevalgslægemiddel.
bacteria, in case of Streptococcus pneumoniae infections ciprofloxacin is not the substance of first choice.
- komplicerede hud - og bløddelsinfektioner
- complicated skin and soft tissue infections
- osteomyelitis
- osteomyelitis
Ciprofloxacin Hikma kan også administreres ved behandling af akutte infektioner i de nedre luftveje forårsaget af Pseudomonas aeruginosa hos børn mellem 5- 17 år med cystisk fibrose.
Ciprofloxacin Hikma may also be administered in the treatment of acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children aged 5-17 years with cystic fibrosis.
Dosering til voksne er 200 – 400 mg ciprofloxacin to gange dagligt.
The adult dosage is 200 - 400 mg ciprofloxacin twice daily.
Osteomyelitis:
Osteomyelitis:
5. 1).
7 5.1).
Behandlingens gennemsnitlige varighed er 4- 6 uger.
Average duration of treatment can be 4-6 weeks.
8 Nedsat nyrefunktion:
Impaired renal function:
Hos patienter med en kreatininclearance i området 31 – 60 ml/ minut/ 1, 73 m2 eller en serumkreatininkoncentration i området 124 – 174 µmol/ l er den maksimale daglige intravenøse dosis 800 mg.
In patients with a creatinine clearance in the range 31 - 60 ml/ minute/ 1.73 m2 or a serum creatinine concentration in the range 124 - 174 µmol/ l, the maximum daily intravenous dose is 800 mg.
Hvis kreatininclearance er ≤ 30 ml/ minut/ 1, 73 m2, eller serumkreatininkoncentrationen er ≥ 175 µmol/ l, er den maksimale daglige intravenøse dosis 400 mg.
If creatinine clearance is ≤ 30 ml/ minute/ 1.73 m2 or the serum creatinine concentration is ≥ 175 µmol/ l, the maximum daily intravenous dose is 400 mg.
Hos patienter i hæmodialyse eller CAPD er den maksimale daglige intravenøse dosis også 400 mg.
In patients on haemodialysis or CAPD, the maximum daily intravenous dose is also 400 mg.
Dosis gives på dialysedagene efter hæmodialysen.
On the dialysis days, the dose is given after the haemodialysis session.
Det er ikke nødvendigt at justere dosis i tilfælde med nedsat leverfunktion.
In case of impaired hepatic function it is not necessary to adjust the dosage.
Nedsat nyre - og leverfunktion:
Impaired renal and hepatic function:
Akutte infektioner i de nedre luftveje forårsaget af Pseudomonas aeruginosa hos børn og unge (5- 17 år) med cystisk fibrose:
Acute lower respiratory tract infections caused by Pseudomonas aeruginosa in children and adolescents (5-17
Intravenøs administration af 15 mg/ kg legemsvægt to gange dagligt eller 10 mg/ kg legemsvægt tre gange dagligt (maksimalt 1200 mg pr. dag).
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day).
Intravenøs administration af 15 mg/ kg legemsvægt to gange dagligt eller 10 mg/ kg legemsvægt tre gange dagligt (maksimalt 1200 mg pr. dag), dernæst oral administration to gange dagligt.
Twice daily intravenous administration of 15 mg/ kg bodyweight, or 10 mg/ kg bodyweight three times daily (maximum of 1200 mg per day), then twice daily oral administration.
Doseringen hos børn med nedsat nyre - og/ eller leverfunktion er ikke blevet undersøgt.
The dosage in children with impaired renal and/ or hepatic function has not been investigated.
6. 2 og 6. 6.
For information on mixing with other solutions: see sections 6.2 and 6.6.
Generelt bør akutte og kroniske infektioner (f. eks. osteomyelitis og prostatitis, osv.), hvor den kausative organisme vides at være følsom over for ciprofloxacin, behandles i mindst tre dage, efter tegn og symptomer på infektionen er forsvundet.
Generally, acute and chronic infections (e. g. osteomyelitis and prostatitis, etc), where the causative organism is known to be sensitive to ciprofloxacin, should be treated for at least three days after the signs and symptoms of the infection have disappeared.
Andre specifikke situationer som f. eks. osteomyelitis og behandling af pædiatriske patienter er anført i dette punkt.
Other specific situations such as osteomyelitis and paediatric patients are stated under Posology.
Ciprofloxacin Hikma er kontraindiceret til: • patienter med hypersensitivitet over for ciprofloxacin, derivater af quinolincarboxylsyre eller nogle af hjælpestofferne • børn under 5 år.
Ciprofloxacin Hikma is contraindicated in: • patients with a hypersensitivity to ciprofloxacin, quinoline carboxylic acid derivatives or to any of the excipients
Se også pkt.
8 • children under 5 years of age.
4. 4 med hensyn til sikkerheden og brugen af ciprofloxacin til børn • børn og unge i voksealderen bortset fra behandlingen af akutte exacerbationer af cystisk fibrose hos børn i alderen 5- 17 år • graviditet og amning • patienter med tendonsygdom i forbindelse med administration af fluorquinolon i anamnesen • samtidig administration af ciprofloxacin og tizanidin 9 4. 4 Særlige advarsler og forsigtighedsregler vedrørende brugen
With regard to the safety and use of ciprofloxacin in children, see also section 4.4 • children and growing adolescents except for the treatment of acute pulmonary exacerbations of cystic fibrosis in children aged 5 to 17 years. • pregnancy and lactation • patients with a history of tendon disorder related to fluoroquinolone administration • Concurrent administration of ciprofloxacin and tizanidine
Nyre og urinveje:
Renal and urinary system:
Derfor bør ciprofloxacin anvendes med forsigtighed til disse patienter.
Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones, and so ciprofloxacin should be used with caution in these patients.
Hos patienter med epilepsi eller andre beskadigelser af centralnervesystemet (f. eks. nedsat krampetærskel, tidligere anfald, nedsat cerebral blodgennemstrømning, forandringer i hjernestrukturen eller slagtilfælde), må ciprofloxacin kun anvendes efter nøje afvejning af fordelene i forhold til risikoen, da muligheden for bivirkninger, der stammer fra centralnervesystemet medfører øget risiko for disse patienter.
In patients with epilepsy or other lesions of the central nervous system (e. g. reduced convulsion threshold, a history of epileptic seizures, diminished cerebral blood flow, changes in brain structure or stroke), ciprofloxacin is only to be used after carefully weighing the benefits against the risk, because the possibility of central nervous side effects puts these patients at increased risk.
4. 8), skal der udvises forsigtighed ved behandling af patienter med risiko for torsade de pointes- arytmier.
Since ciprofloxacin is associated with very rare cases of QT prolongation (see section 4.8) caution should be exercised when treating patients at risk for torsade de pointes arrhythmia.
Som ved andre lægemidler i denne gruppe er det rapporteret, at ciprofloxacin forårsager ledsygdomme i de vægtbærende led hos ikke- udvoksede dyr.
As for other medicinal products in this group, ciprofloxacin has been reported to cause joint disorders in weight-bearing joints of immature animals.
4. 1).
Therefore, the use of ciprofloxacin in children is generally not recommended, except for cystic fibrosis patients (see section 4.1).
Mave- tarmkanalen:
Gastrointestinal tract:
Transaminase - eller alkalinefosfatasekoncentrationerne kan midlertidigt stige, eller der kan forekomme cholestatisk icterus især hos patienter med tidligere leverskade.
The transaminase or alkaline phosphatase concentrations may temporarily increase or cholestatic icterus might occur, especially in patients with previous liver damage.
Knogler, led, muskler og bindevæv:
Musculoskeletal system:
Hvis der er tegn på tendinitis (f. eks. smertefuld hævelse) skal administration af ciprofloxacin eller andre fluorquinoloner straks indstilles, og den berørte ekstremitet bør aflastes og en læge konsulteres.
9 If there is any indication of tendinitis (e. g. painful swelling) the administration of ciprofloxacin or other fluoroquinolones must immediately be discontinued, the affected extremity should not be strained and a physician must be consulted.
Særligt hos ældre patienter, der tidligere har fået systemisk behandling med glucokortikoider, er der rapporteret om meget sjældne tilfælde af delvis eller total ruptur (sædvanligvis af achilles- senen).
Very rarely, a partial or total rupture (in particular of the Achilles tendon) has been reported, especially in elderly patients who were previously treated systemically with glucocorticoids.
Ciprofloxacin kan forårsage en forværring af Myastenia gravis- symptomer.
Ciprofloxacin may cause an exacerbation of Myastenia gravis symptoms.
Hvis dette
Therefore, it is recommended to avoid prolonged exposure to sunlight or UV light during treatment with ciprofloxacin.
10 imidlertid ikke er muligt, bør patienten bruge en solcreme.
However, if this is not possible the patient is recommended to use a sun-protection cream.
Anafylaktiske/ anafylaktoide reaktioner kan i meget sjældne tilfælde udvikle sig til livstruende shock, nogle gange selv efter den første administration af ciprofloxacin.
Anaphylactic/ anaphylactoid reactions can in very rare cases develop into life-threatening shock, sometimes even after the first administration of ciprofloxacin.
Da ciprofloxacin har nogen aktivitet mod Mycobacterium tuberculosis, kan der forekomme falsk - negative kulturer, når prøverne tages under behandling med ciprofloxacin.
Because ciprofloxacin has some activity against Mycobacterium tuberculosis, false-negative cultures may occur when the specimens are obtained during ciprofloxacin treatment.
Ciprofloxacin Hikma indeholder 15, 4 mmol (354 mg) natrium pr.
Ciprofloxacin Hikma contains 15.4 mmol (354 mg) sodium per 100 ml of solution for infusion.
Probenecid Probenecid hæmmer nyreudskillelsen af ciprofloxacin, hvilket resulterer i en stigning af plasmakoncentrationen af ciprofloxacin.
Probenecid Probenecid inhibits the renal excretion of ciprofloxacin resulting in an increase in the plasma concentration of ciprofloxacin.
CYP1A2 Ciprofloxacin hæmmer CYP1A2 og kan derfor forårsage øget serumkoncentration af samtidigt administrerede stoffer, der metaboliseres af dette enzym (f. eks. theophyllin, clozapin, tacrin, ropinirol, tizanidin).
CYP1A2 Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e. g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
Andre derivater af xanthin Forhøjede serumkoncentrationer af disse derivater af xanthin blev rapporteret ved samtidig administration af ciprofloxacin og kaffein eller pentoxifyllin (oxpentifyllin).
Other xanthine derivatives On concurrent administration of ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Phenytoin Samtidig administration af ciprofloxacin og phenytoin kan resultere i forhøjede eller reducerede serumniveauer af phenytoin, således at overvågning af medicinniveauer tilrådes.
10 Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Methotrexat Renal tubulær transport af methotrexat kan hæmmes af konkomitant administration af ciprofloxacin og potentielt føre til forhøjede plasmaniveauer af methotrexat.
Methotrexate Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate.
Dette kan øge risikoen for methotrexat - associerede toksiske reaktioner.
This may increase the risk of methotrexate associated toxic reactions.
Patienter, som får behandling med methotrexat, bør derfor overvåges nøje, når konkomitant ciprofloxacin- behandling er indiceret.
Therefore, patients receiving methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.
Cyclosporin Efter konkomitant administration af ciprofloxacin og cyclosporin er en forbigående stigning af serumkreatininkoncentrationen blevet observeret i enkeltstående tilfælde.
Cyclosporine Following concomitant administration of ciprofloxacin and cyclosporine a transient increase of the serum creatinine concentration has been observed in separate cases.
11 Orale antikoagulanter (f. eks. warfarin) I lighed med andre quinoloner kan ciprofloxacin forstærke virkningen af derivater af coumarin, herunder warfarin.
Oral anticoagulants (e. g. warfarin) Ciprofloxacin, like other quinolones, may enhance the effect of coumarin derivates including warfarin.
Glibenclamid Ved samtidig anvendelse kan ciprofloxacin i nogle tilfælde øge virkningen af glibenclamid (hypoglykæmi).
Glibenclamide When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
NSAID Dyreforsøg har vist, at samtidig administration af meget høje doser af fluorquinoloner og visse NSAID’ er (men ikke acetylsalicylsyre) kan fremkalde krampeanfald.
NSAIDs Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
Mexiletin Samtidig administration af ciprofloxacin og mexiletin kan føre til forhøjede plasmakoncentrationer af mexiletin.
Mexiletine Simultaneous administration of ciprofloxacin and mexiletine can lead to increased plasma concentrations of mexiletine.
Præmedikation Opiatpræmedikation (f. eks. papaveretum) eller opiatpræmedikation, der bruges med antikolinerg præmedikation (f. eks. atropin eller hyoscin), bør ikke anvendes sammen med ciprofloxacin, da serumniveauerne af ciprofloxacin reduceres.
Premedicants It is recommended that opiate premedicants, (e. g. papaveretum) or opiate premedicants used with anticholinergic premedicants, (e. g. atropine or hyoscine) are not used concomitantly with ciprofloxacin, as the serum levels of ciprofloxacin are reduced.
Det er påvist, at samtidig administration af ciprofloxacin og præmedikation af benzodiazepin- typen ikke påvirker ciprofloxacin- plasmaniveauer.
Co-administration of ciprofloxacin and benzodiazepine premedicants has been shown not to affect ciprofloxacin plasma levels.
Det anbefales at overvåge behandling med benzodiazepin meget nøje, da en nedsat clearance af diazepam med en forlænget halveringstid er observeret ved samtidig administration af ciprofloxacin og diazepam og i meget sjældne tilfælde med midazolam.
However, since decreased clearance of diazepam, with a prolonged half-life have been reported during co-administration of ciprofloxacin and diazepam, and in very rare cases with midazolam, careful monitoring of benzodiazepine therapy is recommended.
Graviditet Ciprofloxacin Hikma er kontraindiceret under graviditet.
Pregnancy Use during pregnancy is contraindicated.
Hos unge dyr og prænatale dyr, der er blevet eksponeret for quinoloner, er der observeret virkninger på ikke- udvokset brusk (se pkt.
In juvenile and prenatal animals exposed to quinolones effects on immature cartilage have been observed (see section 5.3).
4. 3).
Since the risks for humans are unknown Ciprofloxacin Hikma must not be administered during pregnancy (see section 4.3).
Amning:
11 Lactation:
4. 3).
Due to the risk of arthropathy and other potentially severe toxicity in the infant, ciprofloxacin is contraindicated during lactation (see section 4.3).
Når der opstår uønskede virkninger på centralnervesystemet, f. eks. svimmelhed, er det forbudt at føre motorkøretøj eller betjene maskiner.
When undesirable effects on the central nervous system, like dizziness, occur, it is prohibited to drive a vehicle or to operate machines.