FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that Zavicefta should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see section 4.4).
Danish: Det anbefales, at Zavicefta kun anvendes til behandling af infektioner forårsaget af aerobe Gram-negative mikroorganismer hos voksne patienter med begrænsede behandlingsmuligheder efter rådføring med en læge med passende erfaring i håndtering af infektionssygdomme (se pkt.
English: The colour of Zavicefta infusion solution is pale yellow and free of particles.
Danish: Zavicefta-infusionsvæske er lysegul og fri for partikler.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farmakokinetisk/farmakodynamisk (PK/PD) forhold
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Danish: Vigtigt: Se produktresuméet inden ordination.
English: Zavicefta is indicated for the treatment of the following infections in adults (see sections 4.4 and 5.1):
Danish: Zavicefta er indiceret til behandling af følgende infektioner hos voksne (se pkt.
English: A dose of 1000 mg/250 mg or 750 mg/187.5 mg is achieved with 6.0 mL or 4.5 mL aliquots, respectively.
Danish: Der opnås en dosis på 1000 mg/250 mg eller 750 mg/187,5 mg ved voluminer på henholdsvis 6,0 ml eller 4,5 ml.
English: Excipient with known effect: each vial contains 6.44 mmol of sodium (approximately 148 mg).
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hvert hætteglas indeholder 6,44 mmol (ca. 148 mg) natrium.
English: Non-susceptible organisms
Danish: Ikke-følsomme mikroorganismer
English: Tell your doctor straight away if you notice any of the serious side effects above.
Danish: Fortæl det straks til lægen, hvis du får nogen af ovenstående alvorlige bivirkninger.
English: Nausea and diarrhoea were usually mild or moderate in intensity.
Danish: Kvalme og diarré var normalt af let eller moderat sværhedsgrad.
English: The reconstituted solution is pale yellow solution and free of particles.
Danish: Det rekonstituerede koncentrat er en lysegul opløsning fri for partikler.
English: The antimicrobial activity of ceftazidime against specific pathogens has been shown to best correlate with the percent time of free-drug concentration above the ceftazidime/avibactam minimum inhibitory concentration over the dose interval (%fT >MIC of ceftazidime/avibactam).
Danish: Det er vist, at den antimikrobielle aktivitet af ceftazidim mod specifikke patogener korrelerer bedst med den procentdel af tiden i dosisintervallet, hvor den fri lægemiddelkoncentration er over den mindste hæmmende koncentration for ceftazidim/avibactam (%fT >MIC for ceftazidim/avibactam).
English: Severe hypersensitivity (e.g. anaphylactic reaction, severe skin reaction) to any other type of β-lactam antibacterial agent (e.g. penicillins, monobactams or carbapenems).
Danish: Alvorlig overfølsomhed (fx anafylaktisk reaktion, alvorlig hudreaktion) over for nogen β-laktam-antibiotika (fx penicilliner, monobactamer eller carbapenemer).
English: This diagnosis should be considered in patients who present with diarrhoea during or subsequent to the administration of Zavicefta (see section 4.8).
Danish: Denne diagnose skal overvejes hos patienter, som får diarré under eller efter behandling med Zavicefta (se pkt.
English: Elderly No dosage adjustment is required in elderly patients (see section 5.2).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: The reconstituted solution must be further diluted to produce Zavicefta solution for infusion.
Danish: Det rekonstituerede koncentrat skal fortyndes yderligere for at fremstille Zavicefta-infusionsvæsken.
English: • The other ingredient is sodium carbonate (anhydrous).
Danish: • Øvrige indholdsstoffer: natriumcarbonat (vandfri).
English: Carcinogenicity studies have not been conducted with ceftazidime.
Danish: Der er ikke udført karcinogenicitetsstudier med ceftazidim.
English: Each vial contains ceftazidime pentahydrate equivalent to 2 g ceftazidime and avibactam sodium equivalent to 0.5 g avibactam.
Danish: Hvert hætteglas indeholder ceftazidimpentahydrat svarende til 2 g ceftazidim og avibactamnatrium svarende til 0,5 g avibactam.
English: Very common: (may affect more than 1 in 10 people)
Danish: Meget almindelig: (kan forekomme hos flere end 1 ud af 10 personer)
English: • an increase in the level of some types of substances in your blood (called “creatinine” and
Danish: • forhøjet niveau af nogle typer stoffer i blodet (kreatinin og urinstof).
English: • significant decrease in the type of white blood cells used to fight infection - shown in blood tests
Danish: • betydeligt fald i typen af hvide blodlegemer, der bruges til at bekæmpe infektioner - kan ses i blodprøver
English: Keep this leaflet.
Danish: Se i pkt.
English: Aspartate aminotransferase increased
Danish: Forhøjet aspartataminotransferase
English: Sodium carbonate (anhydrous)
Danish: Natriumcarbonat (vandfri)
English: What Zavicefta is
Danish: Hvad er Zavicefta
English: Infusion time
Danish: Infusionstid
English: Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations.
Danish: Avibactam og ceftazidim viste ingen in vitro CYP-induktion ved klinisk relevante koncentrationer.
English: Penetration of ceftazidime into the intact blood-brain barrier is poor.
Danish: Ceftazidim penetrerer kun i ringe grad den intakte blod-hjerne-barriere.
English: Pyrexia
Danish: Pyreksi
English: People with kidney problems
Danish: Personer med nyreproblemer
English: The reconstituted vial should be used immediately.
Danish: Efter rekonstitution skal hætteglasset anvendes straks.
English: Hospital-acquired pneumonia including ventilator-associated pneumonia Gram-negative micro-organisms
Danish: Nosokomiel pneumoni, herunder respiratorassocieret pneumoni Gram-negative mikroorganismer
English: The contents of Zavicefta vial should be reconstituted with 10 mL of sterile water for injections.
Danish: Indholdet i et Zavicefta-hætteglas skal rekonstitueres med 10 ml sterilt vand til injektionsvæsker.
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many class D enzymes.
Danish: Avibactam hæmmer ikke klasse B-enzymer (metallo-β-laktamaser) og er ikke i stand til at hæmme mange af klasse D-enzymerne.
English: Complicated intra-abdominal infections Gram-negative micro-organisms
Danish: Komplicerede intra-abdominale infektioner Gram-negative mikroorganismer
English: What you need to know before you use Zavicefta
Danish: Det skal du vide, før du begynder at bruge Zavicefta
English: • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
Danish: • Nosokomiel pneumoni, herunder respiratorassocieret pneumoni (VAP)
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne anført i pkt.
English: Complicated urinary tract infections
Danish: Komplicerede urinvejsinfektioner
English: Dilute before use
Danish: Fortyndes inden anvendelse.
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many of the class D enzymes (see section
Danish: Avibactam inhiberer ikke klasse Benzymer (metallo-β-laktamaser) og er ikke i stand til at hæmme mange af klasse D-enzymerne (se pkt.
English: The pharmacokinetics of ceftazidime in patients with severe hepatic impairment has not been established.
Danish: Ceftazidims farmakokinetik hos patienter med svært nedsat leverfunktion er ikke fastlagt.
English: Appropriate infusion diluents include: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer's solution.
Danish: Egnede infusionsvæsker til fortynding omfatter: natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, glucose 50 mg/ml (5 %) injektionsvæske, natriumchlorid 4,5 mg/ml og glucose 25 mg/ml injektionsvæske (0,45 % natriumchlorid og 2,5 % glucose) eller Ringer-lactat-opløsning.
English: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function.
Danish: Samtidig behandling med høje doser af cefalosporiner og nefrotoksiske lægemidler såsom aminoglykosider eller potente diuretika (fx furosemid) kan påvirke nyrefunktionen negativt.
English: • The active substances are ceftazidime and avibactam.
Danish: • Aktive stoffer: ceftazidim og avibactam.
English: No dosage adjustment is required in patients with mild renal impairment (estimated CrCL ≥ 51≤ 80 mL/min) (see section 5.2).
Danish: Dosisjustering er ikke nødvendig til patienter med let nedsat nyrefunktion (estimeret CrCL ≥ 51≤ 80 ml/min) (se pkt.
English: Neutropenia
Danish: Neutropeni
English: Table 1 Recommended intravenous dose for patients with estimated CrCL ≥ 51 mL/min Type of infection
Danish: Tabel 1 Anbefalet intravenøs dosis til patienter med estimeret CrCL ≥ 51 ml/min Infektionstype
English: 0.75 g/0.1875 g Every 48 hours
Danish: 0,75 g/0,1875 g
English: • you are allergic to other cephalosporin antibiotics
Danish: • du er allergisk over for andre antibiotika fra cefalosporingruppen
English: Instructions for the reconstitution of Zavicefta vial are summarized below:
Danish: Nedenfor findes en vejledning til rekonstitution af Zavicefta-hætteglas:
English: After dilution
Danish: Efter fortynding
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to ceftazidime/avibactam in vitro.
Danish: I kliniske studier er der vist virkning på følgende patogener, som var følsomme for ceftazidim/avibactam in vitro.
English: • a water tablet called furosemide
Danish: • vanddrivende medicin kaldet furosemid
English: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function (see section 4.4).
Danish: Samtidig behandling med høje doser af cefalosporiner og nefrotoksiske lægemidler såsom aminoglykosider eller potente diuretika (fx furosemid) kan påvirke nyrefunktionen negativt (se pkt.
English: Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro.
Danish: Avibactam viste ingen betydelig hæmning af CYP-enzymer in vitro.
English: Blood creatinine increased
Danish: Forhøjet kreatinin i blodet
English: CARTON
Danish: KARTON
English: Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins.
Danish: Chloramphenicol og ceftazidim og andre cefalosporiner har antagonistisk virkning in vitro.
English: Pseudomembran ous colitis
Danish: Pseudomembranøs colitis
English: Anaphylactic reaction
Danish: Anafylaktisk reaktion
English: It inhibits both Ambler class A and class C β-lactamases and some class D enzymes, including extended-spectrum β-lactamases (ESBLs), KPC and OXA-48 carbapenemases, and AmpC enzymes.
Danish: herunder β-lactamaser med udvidet spektrum (ESBL'er), KPC- og OXA-48-carbapenemaser og AmpC-enzymer.
English: Uncommon: (may affect up to 1 in 100 people)
Danish: Ikke almindelig: (kan forekomme hos op til 1 ud af 100 personer)
English: Common: (may affect up to 1 in 10 people)
Danish: Almindelig: (kan forekomme hos op til 1 ud af 10 personer)
English: An infusion bag may contain any of the following: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, sodium chloride 4.5 mg/mL and dextrose 25 mg/mL solution for injection (0.45% sodium chloride and 2.5% dextrose) or Lactated Ringer's solution.
Danish: Infusionsposen kan indeholde en af følgende injektionsvæsker: natriumchlorid 9 mg/ml (0,9 %), glucose 50 mg/ml (5 %), natriumchlorid 4,5 mg/ml og glucose 25 mg/ml (0,45 % natriumchlorid og 2,5 % glucose), eller Ringer-lactat-infusionsvæske.
English: Agranulocytosis
Danish: Agranulocytose
English: Spectrum of activity of ceftazidime/avibactam
Danish: Spektrum for aktiviteten af ceftazidim/avibactam
English: powder for concentrate for solution for infusion 10 vials
Danish: pulver til koncentrat til infusionsvæske, opløsning 10 hætteglas
English: Talk to your doctor or nurse before using Zavicefta if:
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Zavicefta, hvis
English: Dose of ceftazidime/avibactam
Danish: Dosis af ceftazidim/avibactam
English: Approximate ceftazidime/avibactam concentration (mg/mL)
Danish: Omtrentlig koncentration af ceftazidim/avibactam (mg/ml)
English: • decrease in the number of red blood cells (haemolytic anaemia) - shown in blood tests
Danish: • nedsat antal røde blodlegemer (hæmolytisk anæmi) - kan ses i blodprøver
English: Table 2 Recommended intravenous doses for patients with estimated CrCL ≤ 50 mL/min Estimated CrCL (mL/min)
Danish: Tabel 2 Anbefalede intravenøse doser til patienter med estimeret CrCL ≤ 50 ml/min Estimeret CrCL (ml/min)
English: Introduce the syringe needle through the vial closure and inject 10 mL of sterile water for injections.
Danish: Stik sprøjtens kanyle ned gennem hætteglassets prop og injicer 10 ml sterilt vand til injektionsvæsker.
English: Resistant
Danish: Resistent
English: The pharmacokinetics of avibactam in patients with any degree of hepatic impairment has not been studied.
Danish: Der er ikke foretaget undersøgelser af avibactams farmakokinetik hos patienter med nogen som helst grad af nedsat leverfunktion.
English: • increase in the amount of some enzymes produced by your liver - shown in blood tests
Danish: • stigning i antallet af nogle enzymer, der dannes i leveren - kan ses i blodprøver
English: Angioedema
Danish: Angioødem
English: Complicated urinary-tract infections Gram-negative micro-organisms
Danish: Komplicerede urinvejsinfektioner Gram-negative mikroorganismer
English: Approximately 97% of the avibactam dose is recovered in the urine, 95% within 12 h. Less than 1% of ceftazidime is excreted via the bile and less than 0.25% of avibactam is excreted into faeces.
Danish: Mindre end 1 % ceftazidim udskilles via galde, og mindre end 0,25 % avibactam udskilles i fæces.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution eller fortynding af lægemidlet, se pkt.
English: Via Alessandro Fleming 2 Verona 37135
Danish: Via Alessandro Fleming 2
English: Eosinophilia
Danish: Eosinofili
English: This is because you may get an abnormal result with a test called “DAGT” or “Coombs”.
Danish: Dette skyldes, at en prøve, der hedder “DAGT” eller “Coombs”, kan give et forkert resultat.
English: Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options (see sections 4.2, 4.4 and 5.1).
Danish: Zavicefta er også indiceret til behandling af infektioner forårsaget af aerobe gramnegative mikroorganismer hos voksne patienter med begrænsede behandlingsmuligheder (se pkt.
English: Hypersensitivity to any cephalosporin antibacterial agent.
Danish: Overfølsomhed over for cefalosporin-antibiotika.
English: Hepatic impairment No dosage adjustment is required in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Zavicefta.
Danish: Hvis noget af ovenstående gælder for dig, skal du tale med lægen, inden du bruger Zavicefta.
English: Blood lactate dehydrogenase Increased
Danish: Forhøjet laktatdehydrogenase i blodet
English: Tell your doctor or nurse if you notice any of the side effects listed above.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du får nogen af ovenstående bivirkninger.
English: What Zavicefta is used for
Danish: Hvad bruges Zavicefta til
English: CrCL estimated using the Cockcroft-Gault formula
Danish: CrCL estimeret ved anvendelse af Cockcroft-Gault-formlen Dosisanbefalinger er baseret på farmakokinetiske modeller Terminal nyresygdom
English: Dosage strength ceftazidime/avibactam (mg)
Danish: Doseringsstyrke ceftazidim/avibactam (mg)
English: If you use more Zavicefta than you should
Danish: Hvis du har fået for meget Zavicefta
English: Pseudomonas aeruginosa
Danish: Enterobacteriaceae Pseudomonas aeruginosa
English: Ceftazidime is excreted unchanged into the urine by glomerular filtration; approximately 80-90% of the dose is recovered in the urine within 24 h. Avibactam is excreted unchanged into the urine with a renal clearance of approximately 158 mL/min, suggesting active tubular secretion in addition to glomerular filtration.
Danish: Avibactam udskilles uomdannet i urinen med en renal clearance på ca. 158 ml/min, hvilket tyder på aktiv tubulær sekretion ud over glomerulær filtration.
English: Resistance
Danish: Resistens
English: How to use Zavicefta
Danish: Sådan skal du bruge Zavicefta
English: Nausea
Danish: Kvalme
English: Driving and using machines Zavicefta may make you feel dizzy.
Danish: Zavicefta kan gøre dig svimmel.
English: Lymphocytosis
Danish: Lymfocytose
English: What Zavicefta looks like and contents of the pack Zavicefta is a white to yellow powder for concentrate for solution for infusion in a vial.
Danish: Zavicefta er et hvidt til gult pulver til koncentrat til infusionsvæske, opløsning, i et hætteglas.
English: • decrease in the number of some types of blood cells (called “leucocytes”) - shown in blood tests
Danish: • nedsat antal af nogle typer blodlegemer (leukocytter) - kan ses i blodprøver
English: Table 1 shows the recommended intravenous dose for patients with estimated creatinine clearance (CrCL) ≥ 51 mL/min (see sections 4.4 and 5.1).
Danish: Tabel 1 viser den anbefalede intravenøse dosis til patienter med estimeret kreatininclearance (CrCL) ≥ 51 ml/min (se pkt.
English: • increase in the number of a type of blood cell (called “lymphocytes”) - shown in blood tests
Danish: • øget antal af en type blodlegeme (lymfocytter) - kan ses i blodprøver
English: Table 2 shows the recommended dose adjustments for patients with estimated CrCL ≤ 50 mL/min (see sections 4.4 and 5.2).
Danish: Tabel 2 viser de anbefalede dosisjusteringer til patienter med estimeret CrCL ≤ 50 ml/min (se pkt.
English: Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion
Danish: Zavicefta 2 g/0,5 g pulver til koncentrat til infusionsvæske, opløsning
English: Abdominal pain
Danish: Abdominalsmerter
English: If you miss a dose of Zavicefta If you think you have missed a dose, tell your doctor or nurse straight away.
Danish: Hvis en dosis er glemt Fortæl det straks til lægen eller sundhedspersonalet, hvis du tror, at du mangler at få en dosis.
English: ZAVICEFTA 2 g/0.5 g powder for concentrate ceftazidime/avibactam
Danish: ZAVICEFTA 2 g/0,5 g pulver til koncentrat ceftazidim/avibactam i.v.
English: Tell your doctor before using Zavicefta if any of the above apply to you.
Danish: Tal med lægen eller sundhedspersonalet, før du bruger Zavicefta, hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl).
English: What Zavicefta contains
Danish: Zavicefta indeholder:
English: Leukopenia
Danish: Leukopeni
English: Haemolytic anaemia
Danish: Hæmolytisk anæmi
English: • an infection of the lungs called “pneumonia”
Danish: • lungebetændelse (infektion i lungerne)
English: ZAVICEFTA 2 g/0.5g powder for concentrate for solution for infusion ceftazidime/avibactam
Danish: ZAVICEFTA 2 g/0,5 g pulver til koncentrat til infusionsvæske, opløsning ceftazidim/avibactam
English: What you need to know before you use Zavicefta 3.
Danish: Det skal du vide, før du begynder at bruge Zavicefta Sådan skal du bruge Zavicefta Bivirkninger
English: Susceptible
Danish: Følsom
English: VIAL LABEL
Danish: ETIKET TIL HÆTTEGLAS
English: Thrombocytosis
Danish: Trombocytose
English: Hepatic impairment
Danish: Akut nyreskade
English: Infusion site thrombosis
Danish: Trombose på infusionsstedet
English: Infusion site phlebitis
Danish: Flebitis på infusionsstedet
English: • infections of the bladder or kidneys called “urinary tract infections”
Danish: • urinvejsinfektioner (infektioner i blæren eller nyrerne)
English: • change in the number of some types of blood cells (called “eosinophils” and “thrombocytes”)
Danish: • ændret antal af visse typer blodlegemer (eosinofiler og blodplader) - kan ses i blodprøver
English: Blood urea increased
Danish: Forhøjet urinstof i blodet
English: Dose recommendations are based on pharmacokinetic modelling Ceftazidime and avibactam are removed by haemodialysis (see sections 4.9 and 5.2).
Danish: Ceftazidim og avibactam fjernes ved hæmodialyse (se pkt.
English: • tingling or numbness
Danish: • kvalme eller opkastning
English: Jaundice
Danish: Paræstesi
English: • feeling sick (nausea) or being sick (vomiting)
Danish: • hævet, kløende udslæt på huden (nældefeber)
English: Nephrotoxicity
Danish: Nefrotoksicitet
English: Tell your doctor that you are taking Zavicefta if you are going to have any tests.
Danish: Hvis du skal have taget en eller anden prøve, skal du fortælle lægen, at du bruger Zavicefta.
English: The following indications have been justified:
Danish: Der er fremlagt begrundelse for følgende indikationer:
English: No PSURs were submitted as the product is not yet marketed.
Danish: Ingen PSUR blev fremsendt, da produktet endnu ikke er blevet markedsført.
English: Strength / Active substance (INN)
Danish: Lægemiddelform Styrke/aktivt stof (INN)
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Danish: Følgelig gælder de samme konklusioner med hensyn til virkning og sikkerhed for begge lægemidler.
English: Dopharma also described the history of the product since 1987, the year of its first authorisation in the Netherlands.
Danish: Dopharma redegjorde ligeledes for produktets historie siden 1987, det år, hvor den første tilladelse blev givet i Nederlandene.
English: Introduction and background
Danish: Indledning og baggrund
English: Calves and Pigs
Danish: Kalve og svin
English: Oral explanations were provided on 15 July 2008 and the CVMP Opinion was adopted on 16 July 2008.
Danish: Den mundtlige redegørelse blev fremsat den 15. juli 2008, og CVMP's udtalelse blev vedtaget den 16. juli 2008.
English: The Netherlands (REG NL 10411)
Danish: Nederlandene (REG NL 10411)
English: Sodium salicylate
Danish: Natriumsalicylat
English: The aim of the assessment was to establish whether marketing authorisations and applications included in the referral procedure should be granted, maintained, suspended, varied or revoked with view to the grounds for referral.
Danish: Formålet med vurderingen var at fastslå, om de markedsføringstilladelser og ansøgninger, der var omfattet af proceduren for den indbragte sag, skulle udstedes, opretholdes, suspenderes, ændres eller tilbagekaldes på grundlag af begrundelserne for indbringelsen.
English: As a generic product only part I and not part IV of the dossier was submitted.
Danish: Da der er tale om et generisk produkt, blev kun del I og ikke del IV af dossieret fremsendt.
English: Dopharma submitted all requested parts of the dossier (Part I, Part IV and PSURs).
Danish: Dopharma fremsendte alle de dele af dossieret, der blev anmodet om (del I, del IV og PSUR).
English: Pivotal documents, including the SPC, should be presented in English.
Danish: Centrale dokumenter, herunder produktresuméet, indsendes på engelsk.
English: Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008)
Danish: Den decentrale procedure, forudsat at der er indbragt en sag i henhold til artikel 33 (CD 17. april 2008)
English: The Netherlands (REG NL 8913)
Danish: Nederlandene (REG NL 8913)
English: Member State / Marketing Authorisation Number
Danish: Medlemsstat/Nummer på markedsføringstilladelse