natgillin/translations-raw huggingface dataset:
Det skal du vide, før du begynder at tage Quofenix 3.
What you need to know before you take Quofenix 3.
Flatulens
Flatulence
Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.
Øvrige indholdsstoffer: meglumin, sulfobutylether-beta-cyclodextrinnatrium, dinatriumedetat, natriumhydroxid (til pH-justering), saltsyre; koncentreret (til pH-justering).
- The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).
Før du får dette lægemiddel
Before you are given this medicine
Nedsat leverfunktion Dosisjustering er ikke nødvendig (se pkt.
Hepatic impairment No dosage adjustment is necessary (see section 5.2).
• Nedsat følesans i munden
• Reduced tactile sensation at the mouth
Quofenix 300 mg pulver til koncentrat til infusionsvæske, opløsning delafloxacin
Quofenix 300 mg powder for concentrate for solution for infusion delafloxacin
Sulfobutylether-beta-cyclodextrinnatrium Dinatriumedetat
Sulfobutylbetadex sodium
• Nedsat nyrefunktion
• Reduced kidneys function
Det skal du vide, før du får Quofenix 3.
What you need to know before you are given Quofenix 3.
• Lavt hæmoglobinniveau (blodmangel)
• Low haemoglobin level (anaemia)
Hvert hætteglas med pulver indeholder 300 mg delafloxacin (som meglumin).
Each vial of powder contains 300 mg of delafloxacin (as meglumine).
Når du får dette lægemiddel
When you are given this medicine
Sådan skal du bruge Quofenix
How to use Quofenix
• Højt blodsukker
• High blood glucose levels
• Allergisk hudreaktion
• Allergic skin reaction
Quofenix indeholder cyclodexdrin Dette lægemiddel indeholder 2.480 mg sulfobutylether-beta-cyclodextrinnatrium i hvert hætteglas.
This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.
Sådan skal du tage Quofenix
How to take Quofenix
Sløret syn Tørre øjne
Vision blurred Dry eye
De patienter, der fik denne dosis, fik ingen bivirkninger eller markante kliniske fund ved laboratorietests i løbet af studiet.
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.
Sådan skal du bruge Quofenix 4.
How to store Quofenix 6.
Dosering til patienter med svært nedsat nyrefunktion (CrCl < 30 ml/min) skal nedsættes til 200 mg intravenøst hver 12. time.
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).
• Muskelsvaghed i ben eller arme
• Muscle weakness in the extremities
Quofenix 300 mg pulver til koncentrat til infusionsvæske, opløsning.
Quofenix 300 mg powder for concentrate for solution for infusion
4.4) Muskeloskeletale smerter (f.eks. smerter i ekstremiteterne, rygsmerter, nakkesmerter), muskelsvaghed
• Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
Sårkomplikationer
Wound complication
• sukralfat
• sucralfate
Den højeste daglige dosis, der blev administreret intravenøst i kliniske studier, var 1200 mg.
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.
INFORMATION I BRAILLE-SKRIFT Quofenix 300 mg
Quofenix 300mg
Meglumin, sulfobutylether-beta-cyclodextrinnatrium, dinatriumedetat, natriumhydroxid (til pHjustering), saltsyre, koncentreret (til pH-justering).
Meglumine, sulfobutylbetadex sodium, disodium edetate, sodium hydroxide, hydrochloric acid, concentrated.
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.
(paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue and severe sleep disorders.
INFORMATION I BRAILLE-SKRIFT Quofenix 450 mg
Quofenix 450 mg
4.4) Sæsonbetinget allergi
Hypersensitivity (see section 4.4) Seasonal allergy
Perifert ødem
Disodium edetate
• Nattesved
• Insomnia
Længerevarende, alvorlige, invaliderende bivirkninger, der kan være vedvarende Antibiotika indeholdende fluoroquinoloner eller quinoloner har været forbundet med meget sjældne, men alvorlige bivirkninger.
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.
Abdominalsmerter Dyspepsi
Abdominal pain
Kelerende stoffer: antacida, sukralfat, metalkationer, multivitaminer Fluoroquinoloner danner kelater med alkaliske jord- og overgangsmetalkationer.
Fluoroquinolones form chelates with alkaline earth and transition metal cations.
Muskelkramper
Muscle spasm
• Unormal svedafsondring
• Abnormal sweat
Det skal du vide, før du begynder at tage Quofenix
What you need to know before you take Quofenix Do not take Quofenix:
Krystaller i urinen
Renal and urinary disorders
Hvis du har fået for meget Quofenix
If you miss a dose of Quofenix
- Spørg lægen, apotekepersonalet eller sygeplejersken, hvis der er mere, du vil vide.
- If you have any further questions, ask your doctor or pharmacist or nurse.
Præsynkope
Presyncope
Hjælpestof(fer), som behandleren skal være opmærksom på: Hver tablet indeholder 39 mg natrium.
Each tablet contains 39 mg of sodium.
Sinuitis
Dizziness
Nattesved
Sinusitis
Det er ikke nødvendigt at justere dosis til patienter med let til svært nedsat nyrefunktion (se pkt.
No dose adjustment is necessary in patients with mild to severe renal impairment (see section 4.4 and 5.2).
• Kløe, rødt udslæt
• Itchiness, red rash
• Halsbrand/sure opstød
• Heartburn/acid regurgitation
Det skal du vide, før du får Quofenix
What you need to know before you are given Quofenix You must not be given Quofenix:
• Tilstopning af det medicinske udstyr
• Medical device occlusion
Nedsat nyrefunktion
• Reduced kidney function
Oral anvendelse blister (PVC/Alu) 56 tabletter
Oral use blister (PVC/Alu) 56 tablets
(Særnavn) Navn Styrke
(Invented) name Strength Pharmaceutical form Route of administration Immediate packaging
Samlet konklusion og benefit/risk-forhold
Overall conclusion and benefit -risk balance
Gastrointestinal intolerance såsom kvalme forekommer ligeledes.
Gastrointestinal intolerance such as nausea also occurs.
Der kræves ikke bioækvivalens for intravenøse generiske produkter, hvorfor der ikke var indsendt sådanne data.
No bioequivalence is required for intravenous generic products and no such data was therefore submitted.
Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder nicardipin til intravenøst brug (se bilag I)
Overall summary of the scientific evaluation of nicardipine-containing products for intravenous use (see Annex I)
Bilag II Videnskabelige konklusioner og begrundelse for ændringen af betingelserne for markedsføringstilladelserne
Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
• udvalget gennemgik alle foreliggende data, herunder besvarelserne fra indehaverne af markedsføringstilladelse, publicerede undersøgelser og data efter markedsføring,
• The Committee reviewed all available data, including the responses submitted by the marketing authorisation holders, published studies and post-marketing data;
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.
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.
På baggrund af de konstaterede afvigelser i den nationalt godkendte produktinformation fandt CHMP desuden, at det ville være i Fællesskabets interesse at harmonisere produktoplysningerne i hele EU.
In view of the identified divergences in the nationally approved product information, the CHMP also considered it to be of community interest to harmonise the product information across the EU.
CHMP gennemgik den brede indikation hypertension i den perioperative periode bestående af den præoperative fase, selve operationen og den postoperative periode.
The CHMP reviewed the broad indication for hypertension in the peri-operative period, which includes the pre-operative phase, the time of surgery itself and the post-operative period.
Der blev ikke fundet egnede risikominimeringsforanstaltninger til mindskelse af de tilknyttede risici i betragtning af patientpopulations art og de mulige akutte omstændigheder, som intravenøst nicardipin anvendes under.
No suitable risk minimisation measures were identified to reduce the associated risks, given the nature of the patient population and the possible emergency setting in which IV nicardipine is used.
Intravenøst nicardipin kan desuden fortsat anvendes ved malign arteriel hypertension/hypertensiv encefalopati; pga. risikoen for forhøjet intrakranielt tryk anbefalede CHMP imidlertid tilføjelse af en advarsel om denne risiko.
Intravenous nicardipine can also continue to be used in malignant arterial hypertension/hypertensive encephalopathy; however, due to the risk of intracranial pressure elevation, the CHMP recommended the addition of a warning on this risk.
Referencemedlemsstaten besluttede derfor at suspendere DCP-proceduren på dag 210 og indledte en procedure i medfør af artikel 31 i direktiv 2001/83/EF med anmodning til Udvalget for Lægemidler til Mennesker (CHMP) om at gennemgå benefit/risk-forholdet for alle produkter indeholdende nicardipin til intravenøs anvendelse og at præcisere de data, der ligger til grund for markedsføringstilladelsen for disse produkter.
The RMS therefore decided to suspend the DCP procedure at day 210 and triggered a procedure under Article 31 of Directive 2001/83/EC, requesting the Committee for Medicinal Products for Human Use (CHMP) to review the benefit-risk of all intravenous nicardipine-containing products for intravenous use and to clarify the data supporting the licensing of these products.
I sin vurdering tog CHMP alle foreliggende data i betragtning, herunder publicerede undersøgelser, oversigter i artikler og retningslinjer, ekspertudtalelser, brugerundersøgelser, nationale retningslinjer samt sikkerhedsdata fra overvågning efter markedsføring og databaser hos indehaveren af markedsføringstilladelsen.
The CHMP considered all data available in its assessment, including published studies, article and guideline reviews, expert statements, user surveys, national guidelines as well as safety data from post-marketing and marketing authorisation holder databases.
CHMP foretog desuden væsentlige revisioner af afsnittet om dosering i produktinformationen, således at anbefalingerne til særlige populationer bringes på linje med den nuværende viden om anvendelse af intravenøst nicardipin.
The CHMP also made significant revisions to the posology section of the product information, including bringing the recommendations in special populations in line with current knowledge of the use of intravenous nicardipine.
For hypotension fandt CHMP, at anvendelse af intravenøst nicardipin til denne indikation ikke længere er relevant i den nuværende kirurgiske og anæstetiske praksis.
With regards to hypotension, the CHMP considered that the use of intravenous nicardipine for this indication is no longer relevant in the context of current surgical and anaesthetic practice.
Nicardipin er en calciumantagonist af dihydropyridintypen, der primært virker via perifer vasodilatation i glatmuskulaturen i karrene frem for i hjertemusklen.
Nicardipine is a calcium channel blocker of the dihydropyridine type which is primarily effective via peripheral vasodilatation in vascular smooth muscle rather than cardiac muscle.
I betragtning af de begrænsede data om virkning og den overordnede sikkerhedsprofil fandt CHMP derfor, at indikationerne knyttet til hypotension bør slettes fra produktinformationen.
Considering the limited efficacy data and overall safety profile, the CHMP therefore considered that the indications in hypotension should be removed from the product information.
Begrundelse for ændringen af betingelserne for markedsføringstilladelsen Ud fra følgende betragtninger:
Grounds for the variation to the terms of the marketing authorisation Whereas
Desuden blev rejst væsentlige betænkeligheder ved administration af intravenøst nicardipin som bolusinjektion eller direkte intravenøs administration på grund af den højere potentielle risiko for iatrogen hypotension, navnlig ved præeklampsi.
Additionally, significant concerns were raised regarding the administration of IV nicardipine by bolus dose injection or direct intravenous administration due to a higher potential risk of iatrogenic hypotension, in particular in pre-eclampsia.
Efter gennemgang af de foreliggende sikkerhedsdata bemærkede CHMP, at de almindeligste bivirkninger og de, der oftest medfører seponering af lægemidlet, er virkninger på hjerte-karsystemet og nervesystemet knyttet til lægemidlets forventede vasodilaterende effekt, dvs. hovedpine, hypotension, rødme, ødem og takykardi.
Having reviewed the available safety data, the CHMP noted that most common adverse effects and those that most frequently result in drug discontinuance are cardiovascular and nervous system effects related to the expected vasodilator effects of the drug, in particular headache, hypotension, flushing, oedema and tachycardia.
• i betragtning at de konstaterede alvorlige begrænsninger i dataene om virkning og den overordnede sikkerhedsprofil af nicardipin fandt udvalget, at fordelene for visse indikationers vedkommende ikke længere kunne anses for at overstige risiciene, og at disse indikationer derfor bør slettes,
• The Committee considered that in view of the identified serious limitations of the efficacy data and the overall safety profile of nicardipine, the benefits were no longer considered to outweigh the risks for some indications, which should therefore be removed;
CHMP konkluderede, at der kun foreligger data til støtte for anvendelse af nicardipin ved postoperativ hypertension.
The CHMP concluded that data is only available to support the use of nicardipine in the post-operative hypertension indication setting.
Efter modtagelse af en ansøgning om markedsføringstilladelse ved den decentrale procedure (DCP) for et generisk produkt indeholdende nicardipin til intravenøs (IV) anvendelse (10 mg/10 ml injektionsvæske, opløsning) og efter vurdering af ansøgningens dossier fandt referencemedlemsstaten (RMS) Det Forenede Kongerige de forelagte kliniske data utilstrækkelige til fastlæggelse af virkning, sikkerhed og overordnet benefit/risk-forhold af nicardipin til de ansøgte indikationer.
Following the submission of a marketing authorisation application under the decentralised procedure (DCP) for a generic nicardipine-containing product for intravenous (IV) use (10 mg/10ml solution for injection) and the assessment of the application dossier, the reference member state (RMS) UK considered the clinical data submitted to be insufficient to determine the efficacy, safety and overall benefit-risk of IV nicardipine in the proposed indications.
CHMP konkluderede derfor, at intravenøs anvendelse af nicardipin kun bør ske ved kontinuerlig infusion og ikke ved bolusinjektion på baggrund af ovennævnte sikkerhedsmæssige betænkeligheder.
The CHMP therefore concluded that nicardipine for intravenous use should only be administered by continuous infusion and not by bolus dose administration, due to the abovementioned safety concerns.
Udvalget konkluderede følgelig, at benefit/risk-forholdet for lægemidler indeholdende nicardipin fortsat er positivt under forudsætning af de vedtagne begrænsninger samt advarsler og andre ændringer af produktinformationen.
The Committee, as a consequence, concluded that the benefit-risk balance of intravenous nicardipinecontaining medicinal products remains positive, taking into account the restrictions, warnings and other changes to the product information.
CHMP fandt, at der overordnet foreligger tilstrækkelig evidens for sikkerheden og virkningen af lægemidler indeholdende nicardipin til intravenøs behandling af postoperativ hypertension og akut livstruende hypertension under nærmere bestemte omstændigheder med passende specialintervention og overvågning, hvor anvendelsen forestås af specialister.
The CHMP considered that overall, sufficient evidence is available on the safety and efficacy of nicardipine containing medical products for IV use in the treatment of post-operative hypertension and treatment of acute life-threatening hypertension in specific settings, with appropriate specialist intervention and monitoring and when used by specialists.
Der er sikkerhedsmæssige betænkeligheder forbundet med anvendelse af nicardipin ved venstresidig hjerteinsufficiens samt ved formodet koronararteriesygdom, hvorfor nicardipin ikke længere bør anvendes til akut svær hypertension med ledsagende dekompenseret insufficiens af venstre ventrikel og lungeødem.
There are safety concerns associated with the use of nicardipine in patients with left ventricular heart failure as well as in patients with suspected coronary artery disease and therefore nicardipine should no longer be used for acute severe hypertension with accompanying left ventricular decompensation and pulmonary oedema.
• udvalget fandt, at de foreliggende data om virkning støtter intravenøs anvendelse af nicardipin til behandling af akut livstruende hypertension og postoperativ hypertension,
• The Committee considered that the available efficacy data is supportive of the use of nicardipine for intravenous use in the treatment of acute life-threatening hypertension and post-operative hypertension;
På baggrund af den foreliggende evidens og den aktuelle medicinske viden om anvendelsen af intravenøst nicardipin og i betragtning af de potentielt alvorlige bivirkninger ved anvendelse af nicardipin fandt CHMP, at benefit/risk-forholdet for intravenøst nicardipin er negativt til visse indikationer som følge af de alvorlige begrænsninger i dataene om virkning.
In view of the available evidence and current medical knowledge on the use of intravenous nicardipine, and considering the potentially serious adverse reactions associated with the use of nicardipine, the CHMP considered that the benefit-risk balance of IV nicardipine is negative in some indications due to serious limitations of the efficacy data.
Disse bivirkninger svarer til dem, der optræder med andre calciumantagonister af dihydropyridintypen og blev ikke anset for at influere negativt på benefit/risk-forholdet for intravenøst nicardipin.
These adverse effects are consistent with other dihydropyridine calcium channel blockers and were not considered to impact negatively on the benefit-risk balance of IV nicardipine.
CHMP fandt, at intravenøs anvendelse af nicardipin har en rolle ved aortadissektion baseret på de forelagte oplysninger, evidensen for udbredt anvendelse, ekspertudtalelserne og fraværet af nye sikkerhedssignaler hos denne patientpopulation; ud fra den foreliggende evidens anbefalede CHMP imidlertid, at det anvendes som andetvalgspræparat, når behandling med korttidsvirkende betablokkere ikke er egnet, eller kombineret med en betablokker, når betablokade alene ikke er effektiv.
The CHMP considered that there is a role for intravenous nicardipine in aortic dissection based on the information submitted, the evidence of widespread use, the expert statements and the absence of new safety signals in this patient population; however, in line with the available evidence, the CHMP recommended the clinical use as second line treatment, when short acting beta-blocker therapy is not suitable, or in combination with a beta-blocker when beta-blockade alone is not effective.
Skønt nicardipin i nogle medlemsstater anvendes som førstevalgspræparat, fandt CHMP, at en indikation som andetvalgspræparat er passende for intravenøst nicardipin til præeklampsi, og fastlagde indikationen svær præeklampsi, når andre intravenøse antihypertensiva frarådes anvendt eller er kontraindiceret.
Despite being used as a first line treatment in some member states, the CHMP considered a second-line indication to be appropriate for IV nicardipine for pre-eclampsia and agreed on an indication in severe pre-eclampsia, when other intravenous antihypertensive agents are not recommended or are contra-indicated.
• udvalget anbefalede, at produktinformationen opdateres, herunder de terapeutiske indikationer, og tilrådede, at nicardipin på grund af sikkerhedsbetænkeligheder kun administreres ved kontinuerlig infusion og ikke ved bolusinjektion, konkluderede udvalget, at benefit/risk-forholdet for lægemidler indeholdende nicardipin til intravenøs anvendelse fortsat er positivt under normale anvendelsesbetingelser under forudsætning af de vedtagne ændringer af produktinformationen.
• The Committee considered that the product information should be updated, including with regard to the therapeutic indications and advised that nicardipine should only be administered by continuous infusion and not by bolus dose administration, due to safety concerns.
Desuden fandt referencemedlemsstaten betydelige afvigelser mellem de forelagte oplysninger og oplysningerne om dosering og sikkerhed i det foreslåede produktresumé.
In addition, significant discrepancies between the information submitted and the posology and safety information in the proposed Summary of product characteristics (SmPC) were also identified by the RMS.
Den sædvanlige dosis er 40 mg en gang dagligt, der fortrinsvis tages om morgenen.
The usual dose is 40 mg once a day, taken preferably in the morning.
Yderligere oplysninger fremgår af resuméet af riskostyringsplanen.
Further information can be found in the summary of the risk management plan.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Neofordex findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Neofordex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det gør det ved at virke sammen med forskellige proteiner (nuklear faktor kB og caspase 9), der regulerer celledød.
It does this by interacting with different proteins (nuclear factor kB and caspase 9) that regulate cell death.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Neofordex.
This is a summary of the European public assessment report (EPAR) for Neofordex.
Det betyder, at det svarer til et referencelægemiddel, der indeholder samme aktive stof, men Neofordex fås i en højere styrke.
This means that it is similar to a reference medicine containing the same active substance, but Neofordex is available at a higher strength.
Der er udarbejdet en risikostyringsplan for at sikre, at Neofordex anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Neofordex is used as safely as possible.
Mindre almindelige, men alvorlige, bivirkninger omfatter lungebetændelse (pneumoni) og andre infektioner, samt psykiske sygdomme såsom depression.
Less common but serious side effects include pneumonia (infection of the lungs) and other infections and psychiatric disorders such as depression.
Neofordex fås som 40 mg tabletter.
Neofordex is available as 40 mg tablets.
Andre oplysninger om Neofordex
Other information about Neofordex
Multipelt myelom er kræfttype, der udgår fra hvide blodlegemer kaldet plasmaceller, som er en del af kroppens naturlige forsvar (immunsystemet).
Multiple myeloma is a cancer of a type of white blood cell called plasma cells, which are part of the immune system (the body's natural defences).