FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.
Danish: Der er indberettet meget sjældne tilfælde af længerevarende (med forløb over måneder eller år) invaliderende og potentielt irreversible alvorlige bivirkninger som påvirker forskellige, nogle gange flere, organsystemer (muskoloskeletale, nerverelaterede, psykiatriske og sansemæssige) hos patienter, der har fået quinoloner og fluoroquinoloner uanset alder og allerede eksisterende risikofaktorer.
English: The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of your doctor.
Danish: Den anbefalede dosis er 450 mg oralt hver 12. time i sammenlagt 5-14 dage efter lægens vurdering.
English: Peak concentrations for the mild and moderate renal impairment patients were similar to that of healthy subjects, whereas peak concentrations were 2.1-fold, 5.9-fold and 6.4-fold higher for patients with severe renal impairment and ESRD on haemodialysis with and without haemodialysis after dosing, respectively.
Danish: De maksimale koncentrationer hos patienter med let og moderat nedsat nyrefunktion svarede til dem for raske forsøgspersoner, hvorimod de maksimale koncentrationer var henholdsvis 2,1; 5,9 og 6,4 gange højere for patienter med svært nedsat nyrefunktion, ESRD i hæmodialyse med hæmodialyse efter dosering og ESRD i hæmodialyse uden hæmodialyse efter dosering.
English: Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial.
Danish: Quofenix pulver til koncentrat til infusionsvæske, opløsning, leveres i et klart 20 ml hætteglas (glas).
English: The mean systemic exposure (AUC) increased 2.2-fold, 5.3-fold, 8.5-fold and 29.8-fold for patients with moderate impairment, severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Danish: Middelværdien for den systemisk eksponering (AUC) blev øget 2,2; 5,3; 8,5 og 29,8 gange for patienter med henholdsvis moderat nedsat funktion, svært nedsat funktion, ESRD med hæmodialyse efter dosering og ESRD uden hæmodialyse efter dosering sammenlignet med den normale kontrolgruppe.
English: If you stop taking Quofenix
Danish: Hvis du holder op med at tage Quofenix
English: Oedema peripheral Local swelling Fatigue
Danish: Pyreksi Perifert ødem Lokal hævelse Træthed Kulderystelser
English: In vitro data indicate that delafloxacin at clinically relevant concentrations does not inhibit cytochrome P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4/5 nor UDP glucuronosyltransferases isoforms UGT1A1 and UGT2B7.
Danish: In vitro data indikerer, at delafloxacin ved klinisk relevante koncentrationer ikke hæmmer cytokrom P450 CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4/5 eller UDP glukuronosyltransferase-isoformerne UGT1A1 og UGT2B7.
English: Diarrhoea Vomiting Nausea
Danish: Diarré Opkastning Kvalme
English: • Cloudy urine because of the presence of solid component
Danish: • Uklar urin som følge af faste stoffer i urinen
English: The reconstituted vial contains 300 mg per 12 mL of delafloxacin as a clear yellow to amber coloured solution.
Danish: Det rekonstituerede hætteglas indeholder 300 mg delafloxacin pr. 12 ml og fremstår som en klar gul til ravfarvet opløsning.
English: Obese patients (≥ 30 kg/m2 BMI)
Danish: Adipøse patienter (BMI ≥ 30 kg/m
English: • Haematocrit decreased (reduction of an indicator of amount of blood cells)
Danish: • Nedsatte hæmatokritværdier (reduktion i en indikator for mængden af blodceller)
English: This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
Danish: Denne alvorlige bivirkning er en ikke almindelig bivirkning og kan forekomme hos op til 1 ud af 100 personer.
English: • Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely.
Danish: • Der kan i sjældne tilfælde forekomme ledsmerter og hævede led, eller der kan opstå inflammation i sener, eller de kan sprænge.
English: Blood creatine phosphokinase increased
Danish: Øget kreatininfosfokinase i blodet
English: Tendonitis (see section 4.4) Musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness Muscle spasm
Danish: Tendinitis (se pkt 4.4) Muskuloskeletale smerter (f.eks. smerter i ekstremiteterne, rygsmerter, nakkesmerter), muskelsvaghed Muskelkramper
English: • If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
Danish: • Hvis du er allergisk over for andre antibakterielle lægemidler indeholdende fluoroquinoloner eller quinoloner.
English: Quofenix 450 mg tablets delafloxacin
Danish: Quofenix 450 mg tabletter delafloxacin
English: abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence, discoloured faeces
Danish: maveubehag/-smerter eller fordøjelsesbesvær, tør mund, luftafgang fra tarmen, misfarvet afføring)
English: Quofenix must not be used if you are pregnant or breast-feeding.
Danish: Du må ikke bruge Quofenix, hvis du er gravid eller ammer.
English: • Seasonal allergy
Danish: • Sæsonbetinget allergi
English: These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
Danish: Disse alvorlige bivirkninger er ikke almindelige bivirkninger og kan forekomme hos op til 1 ud af 100 personer.
English: • Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
Danish: • Hævelse, rødme eller smerter rundt kanylen, som bruges til at føre medicinen ind i venen
English: Quofenix 450 mg tablets
Danish: Quofenix 450 mg tabletter.
English: • Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus)
Danish: Streptococcus anginosus, Streptococcus intermedius og Streptococcus constellatus)
English: • Low blood glucose levels
Danish: • Lavt blodsukker
English: Unit dose laminated aluminium/aluminium foil blisters.
Danish: Enkeltdosisblisterpakninger af aluminum/aluminumfolie.
English: • Staphylococcus aureus (including methicillin-resistant [MRSA])
Danish: methicillin-resistant (MRSA))
English: Quofenix is a beige to mottled beige, oblong biconvex tablets, with RX3341 debossed on one side.
Danish: Udseende og pakningsstørrelser Beige til beigemarmorerede, aflange bikonvekse tabletter præget med RX3341 på den ene side.
English: The vial contains light yellow to tan cake powder.
Danish: Hætteglasset indeholder et lysegult til lysebrunt kompakt pulver.
English: Previous history of tendon disorders related to fluoroquinolone administration.
Danish: Senelidelser, der relaterer sig til administration af fluoroquinolon, i anamnesen.
English: When taking this medicine
Danish: Når du tager dette lægemiddel
English: Each tablet contains delafloxacin meglumine equivalent to 450 mg delafloxacin.
Danish: Hver tablet indeholder delafloxacin meglumin svarende til 450 mg delafloxacin.
English: If you forget to take Quofenix
Danish: Hvis du har glemt at tage Quofenix
English: • Sensations like numbness, tingling, pins and needles
Danish: • Fornemmelser som følelsesløshed, snurren, prikken og stikken
English: The mean peak exposure (Cmax) increased about 2-fold, 5-fold and 7-fold for patients with severe impairment and ESRD with and without haemodialysis after dosing, respectively compared to the normal control group.
Danish: Middelværdien for den maksimale eksponering (Cmax) blev øget omtrent 2, 5 og 7 gange for henholdsvis patienter med svært nedsat funktion, patienter med ESRD med hæmodialyse efter dosering og patienter med ESRD uden hæmodialyse efter dosering, sammenlignet med den normale kontrolgruppe.
English: Hyperhidrosis Cold sweat Night sweat
Danish: Hyperhidrose Koldsved
English: • Low red blood cell count (reduction of amount of blood cells)
Danish: • Lavt antal røde blodlegemer (reduktion i mængden af blodceller)
English: • You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms.
Danish: Det kan for eksempel være smerter, en brændende eller snurrende fornemmelse, følelsesløshed og/eller svaghed, især i fødder og ben eller hænder og arme.
English: Each vial contains 2480 mg of sulfobutylbetadex sodium.
Danish: Hvert hætteglas indeholder 2480 mg sulfobutylether-beta-cyclodextrinnatrium.
English: Τηλ: +30 210 8316111-13
Danish: MENARINI HELLAS AE Τηλ: +30 210 8316111-13
English: Hypoglycaemia (see section 4.4) Hyperglycaemia (see section 4.4) Decreased appetite
Danish: 4.4) Hyperglykæmi (se pkt.
English: EU/1/19/1393/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/19/1393/001
English: • Pain and swelling of the tendons
Danish: • Smerter i sener og hævede sener
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIALS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE (HÆTTEGLAS)
English: Description of selected adverse drug reactions
Danish: Beskrivelse af udvalgte bivirkninger
English: • Streptococcus mitis group (including Streptococcus cristatus, Streptococcus gordonii,
Danish: Streptococcus cristatus, Streptococcus gordonii,
English: Each tablet contains 450 mg of delafloxacin (as meglumine).
Danish: Hver tablet indeholder 450 mg delafloxacin (som meglumin).
English: If you have any further questions on the use of this medicine, ask your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see section
Danish: Der er indberettet meget sjældne tilfælde af længerevarende (op til måneder eller år), invaliderende og potentielt irreversible, alvorlige bivirkninger, der kan påvirke flere, nogle gange mange, systemorganklasser og sanser (herunder bivirkninger som f.eks. tendinitis, seneruptur, artralgi, ekstremitetssmerter, gangforstyrrelse, neuropatier forbundet med paræstesi, depression, træthed, hukommelsesbesvær, søvnforstyrrelser samt svækket hørelse, syn, smags- og lugtesans) i forbindelse med brug af quinoloner og fluoroquinoloner, i nogle tilfælde uafhængigt af allerede eksisterende risikofaktorer (se pkt.
English: The recommended regimen of delafloxacin is 450 mg oral every 12 hours for a total duration of 5 to 14 days at the discretion of the physician.
Danish: Det anbefalede doseringsregime for delafloxacin er 450 mg oralt hver 12. time i sammenlagt 514 dage efter lægens vurdering.
English: Fluoroquinolone-insusceptible microorganisms may result in superinfection with the use of delafloxacin.
Danish: Ved brug af delafloxacin kan mikroorganismer, der ikke påvirkes af fluoroquinoloner, medføre en superinfektion.
English: • Low white blood cell count (reduction of amount of blood cells)
Danish: • Lavt antal hvide blodlegemer (reduktioni mængden af blodceller)
English: The pharmacokinetics of delafloxacin is not significantly altered with age; therefore, dose adjustment is not necessary based on age.
Danish: Delafloxacins farmakokinetik ændres ikke signifikant med alderen.
English: As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported (see section 4.8), usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin.
Danish: Som for alle quinoloner er der indberettet tilfælde af blodsukkerforstyrrelser, herunder både hypoglykæmi og hyperglykæmi (se pkt.
English: This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
Danish: De omfatter smerter i sener, muskler og led i arme og ben, gangbesvær, unormale fornemmelser som for eksempel stikken og prikken, en snurrende eller kildrende fornemmelse, følelsesløshed elle en brændende følelse (paræstesi), føleforstyrrelser herunder forringet syn, smags- og lugtesans og hørelse, depression, hukommelsesbesvær, voldsom træthed svære søvnforstyrrelser.
English: The plasma protein binding of delafloxacin is approximately 84%; it primarily binds to albumin.
Danish: Delafloxacins plasmaproteinbinding er ca. 84 %.
English: Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Danish: Der har været meget sjældne tilfælde af længerevarende (op til måneder eller år) eller vedvarende bivirkninger som for eksempel inflammation i sener, bristede sener, ledsmerter, smerter i ben eller arme, gangbesvær, unormale fornemmelser som for eksempel en prikkende og stikkende følelse, en snurrende, kildrende, brændende fornemmelse, følelsesløshed eller smerter (neuropati), depression, træthed, søvnforstyrrelser, hukommelsesbesvær samt nedsat hørelse, syn, smags- og lugtesans i forbindelse med brug af antibiotika indeholdende quinoloner og fluoroquinoloner, i nogle tilfælde uafhængigt af allerede eksisterende risikofaktorer.
English: Each vial contains delafloxacin meglumine equivalent to 300 mg delafloxacin.
Danish: Hvert hætteglas indeholder delafloxacin meglumin svarende til 300 mg delafloxacin.
English: Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
Danish: Luxembourg/Luxemburg Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545
English: No genotoxicity hazard was identified in vitro and it was negative in vivo at the highest possible dose
Danish: Der blev ikke fundet nogen genotoksicitetsrisiko in vitro, og den var negativ in vivo ved den højest mulige dosis, dvs. ≥ 15 gange den estimerede plasmaeksponering for mennesker på basis af AUC.
English: What you need to know before you take Quofenix 3.
Danish: Det skal du vide, før du begynder at tage Quofenix 3.
English: Flatulence
Danish: Flatulens
English: Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Danish: Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
English: - The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).
Danish: Øvrige indholdsstoffer: meglumin, sulfobutylether-beta-cyclodextrinnatrium, dinatriumedetat, natriumhydroxid (til pH-justering), saltsyre; koncentreret (til pH-justering).
English: Before you are given this medicine
Danish: Før du får dette lægemiddel
English: Hepatic impairment No dosage adjustment is necessary (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
English: • Reduced tactile sensation at the mouth
Danish: • Nedsat følesans i munden
English: Quofenix 300 mg powder for concentrate for solution for infusion delafloxacin
Danish: Quofenix 300 mg pulver til koncentrat til infusionsvæske, opløsning delafloxacin
English: Sulfobutylbetadex sodium
Danish: Sulfobutylether-beta-cyclodextrinnatrium Dinatriumedetat
English: • Reduced kidneys function
Danish: • Nedsat nyrefunktion
English: What you need to know before you are given Quofenix 3.
Danish: Det skal du vide, før du får Quofenix 3.
English: • Low haemoglobin level (anaemia)
Danish: • Lavt hæmoglobinniveau (blodmangel)
English: Each vial of powder contains 300 mg of delafloxacin (as meglumine).
Danish: Hvert hætteglas med pulver indeholder 300 mg delafloxacin (som meglumin).
English: When you are given this medicine
Danish: Når du får dette lægemiddel
English: How to use Quofenix
Danish: Sådan skal du bruge Quofenix
English: • High blood glucose levels
Danish: • Højt blodsukker
English: • Allergic skin reaction
Danish: • Allergisk hudreaktion
English: This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.
Danish: Quofenix indeholder cyclodexdrin Dette lægemiddel indeholder 2.480 mg sulfobutylether-beta-cyclodextrinnatrium i hvert hætteglas.
English: How to take Quofenix
Danish: Sådan skal du tage Quofenix
English: Vision blurred Dry eye
Danish: Sløret syn Tørre øjne
English: The highest daily oral dose administered in clinical studies was 1600 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Danish: De patienter, der fik denne dosis, fik ingen bivirkninger eller markante kliniske fund ved laboratorietests i løbet af studiet.
English: How to store Quofenix 6.
Danish: Sådan skal du bruge Quofenix 4.
English: Dosing in patients with severe renal impairment (CrCl of <30 mL/min) should be decreased to 200 mg intravenously every 12 hours; alternatively patients should receive 450 mg delafloxacin orally every 12 hours (see section 4.4 and 5.2).
Danish: Dosering til patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) skal nedsættes til 200 mg intravenøst hver 12. time.
English: • Muscle weakness in the extremities
Danish: • Muskelsvaghed i ben eller arme
English: Quofenix 300 mg powder for concentrate for solution for infusion
Danish: Quofenix 300 mg pulver til koncentrat til infusionsvæske, opløsning.
English: • Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Danish: 4.4) Muskeloskeletale smerter (f.eks. smerter i ekstremiteterne, rygsmerter, nakkesmerter), muskelsvaghed
English: Wound complication
Danish: Sårkomplikationer
English: • sucralfate
Danish: • sukralfat
English: The highest daily intravenous dose administered in clinical studies was 1200 mg; the patients who receive this dose did not have any adverse drug reactions or notable clinical laboratory test findings during the study.
Danish: Den højeste daglige dosis, der blev administreret intravenøst i kliniske studier, var 1200 mg.
English: Quofenix 300mg
Danish: INFORMATION I BRAILLE-SKRIFT Quofenix 300 mg
English: Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid, concentrated.
Danish: Meglumin, sulfobutylether-beta-cyclodextrinnatrium, dinatriumedetat, natriumhydroxid (til pHjustering), saltsyre, koncentreret (til pH-justering).
English: (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue and severe sleep disorders.
Danish: gangbesvær, unormale fornemmelser som for eksempel stikken og prikken, en snurrende eller kildrende fornemmelse, følelsesløshed elle en brændende følelse (paræstesi), føleforstyrrelser herunder forringet syn, smags- og lugtesans og hørelse, depression, hukommelsesbesvær, voldsom træthed svære søvnforstyrrelser.
English: Quofenix 450 mg
Danish: INFORMATION I BRAILLE-SKRIFT Quofenix 450 mg
English: Hypersensitivity (see section 4.4) Seasonal allergy
Danish: 4.4) Sæsonbetinget allergi
English: Disodium edetate
Danish: Perifert ødem
English: • Insomnia
Danish: • Nattesved
English: Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible.
Danish: Længerevarende, alvorlige, invaliderende bivirkninger, der kan være vedvarende Antibiotika indeholdende fluoroquinoloner eller quinoloner har været forbundet med meget sjældne, men alvorlige bivirkninger.
English: Abdominal pain
Danish: Abdominalsmerter Dyspepsi
English: Fluoroquinolones form chelates with alkaline earth and transition metal cations.
Danish: Kelerende stoffer: antacida, sukralfat, metalkationer, multivitaminer Fluoroquinoloner danner kelater med alkaliske jord- og overgangsmetalkationer.
English: Muscle spasm
Danish: Muskelkramper
English: • Abnormal sweat
Danish: • Unormal svedafsondring
English: What you need to know before you take Quofenix Do not take Quofenix:
Danish: Det skal du vide, før du begynder at tage Quofenix
English: Renal and urinary disorders
Danish: Krystaller i urinen
English: If you miss a dose of Quofenix
Danish: Hvis du har fået for meget Quofenix
English: - If you have any further questions, ask your doctor or pharmacist or nurse.
Danish: - Spørg lægen, apotekepersonalet eller sygeplejersken, hvis der er mere, du vil vide.
English: Presyncope
Danish: Præsynkope
English: Each tablet contains 39 mg of sodium.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 39 mg natrium.
English: Dizziness
Danish: Sinuitis
English: Sinusitis
Danish: Nattesved
English: No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2).
Danish: Det er ikke nødvendigt at justere dosis til patienter med let til svært nedsat nyrefunktion (se pkt.
English: • Itchiness, red rash
Danish: • Kløe, rødt udslæt
English: • Heartburn/acid regurgitation
Danish: • Halsbrand/sure opstød
English: What you need to know before you are given Quofenix You must not be given Quofenix:
Danish: Det skal du vide, før du får Quofenix
English: • Medical device occlusion
Danish: • Tilstopning af det medicinske udstyr
English: • Reduced kidney function
Danish: Nedsat nyrefunktion
English: Oral use blister (PVC/Alu) 56 tablets
Danish: Oral anvendelse blister (PVC/Alu) 56 tabletter
English: (Invented) name Strength Pharmaceutical form Route of administration Immediate packaging
Danish: (Særnavn) Navn Styrke
English: Overall conclusion and benefit -risk balance
Danish: Samlet konklusion og benefit/risk-forhold
English: Gastrointestinal intolerance such as nausea also occurs.
Danish: Gastrointestinal intolerance såsom kvalme forekommer ligeledes.
English: No bioequivalence is required for intravenous generic products and no such data was therefore submitted.
Danish: Der kræves ikke bioækvivalens for intravenøse generiske produkter, hvorfor der ikke var indsendt sådanne data.
English: Overall summary of the scientific evaluation of nicardipine-containing products for intravenous use (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder nicardipin til intravenøst brug (se bilag I)
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
English: • The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data;
Danish: • udvalget gennemgik alle foreliggende data, herunder besvarelserne fra indehaverne af markedsføringstilladelse, publicerede undersøgelser og data efter markedsføring,
English: Regarding the treatment of severe hypertension in pregnancy, the CHMP took into account the limited study data, the lack of long-term study data on morbidity and mortality and the recommendations of current guidelines.
Danish: Vedrørende behandling af svær hypertension under graviditet tog CHMP hensyn til de begrænsede undersøgelsesdata, de manglende langsigtede undersøgelsesdata om morbiditet og mortalitet og anbefalingerne i nugældende retningslinjer.