FrancophonIA/ELRC3.0 huggingface dataset:
English: ACE inhibitors or aliskiren (see also information under the headings “Do not take Copalia” and “Warnings and precautions”); diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce); lithium (a medicine used to treat some types of depression); potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels; certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Danish: Det gælder især for den medicin, som er beskrevet herunder: - hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Copalia” og ”Advarsler og forsigtighedsregler”); - diuretika (en type medicin, som også kaldes ”vanddrivende tabletter”, og som forhøjer den mængde urin, du producerer); - medicin til behandling af visse typer depression (lithium); - kaliumbesparende diuretika, kaliumtilskud, salterstatninger, som indeholder kalium eller andre stoffer, der kan øge indholdet af kalium i blodet; - en bestemt type smertestillende medicin, som kaldes non-steroide anti-inflammatoriske lægemidler (NSAID'er) eller selektive cyclooxygenase-2-hæmmere (COX-2-hæmmere).
English: Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Danish: Der skal udvises forsigtighed, når Copalia gives til patienter med nedsat leverfunktion eller biliære obstruktive lidelser (se pkt.
English: This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Copalia.
Danish: Det skyldes, at grapefrugt og grapefrugtjuice kan føre til en øget mængde af det aktive stof, amlodipin, i blodet.
English: Copalia is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.
Danish: Copalia bruges til at behandle forhøjet blodtryk hos voksne, som ikke kan få deres blodtryk passende kontrolleret med enten amlodipin eller valsartan alene.
English: In this study (baseline blood pressure 171/113 mmHg), a Copalia regimen of 5 mg/160 mg titrated to 10 mg/160 mg reduced sitting blood pressure by 36/29 mmHg as compared to 32/28 mmHg with a regimen of lisinopril/hydrochlorothiazide 10 mg/12.5 mg titrated to 20 mg/12.5 mg.
Danish: I dette studie (baseline blodtryk 171/113 mmHg) nedsatte Copalia 5 mg/160 mg titreret op til 10 mg/160 mg blodtrykket i siddende stilling med 36/29 mmHg.
English: Copalia 10 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone or with Copalia 5 mg/160 mg.
Danish: Copalia 10 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 10 mg eller valsartan 160 mg alene eller med Copalia 5 mg/160 mg.
English: (It is also better to avoid Copalia in early pregnancy, see Pregnancy section).
Danish: - hvis du er mere end 3 måneder henne i graviditeten (brug af Copalia tidligt i graviditeten bør også undgås, se afsnittet om Graviditet).
English: Copalia can be used with or without food.
Danish: Copalia kan tages uden hensyn til fødeindtagelse.
English: How to take Copalia
Danish: Sådan skal du tage Copalia
English: Copalia 5 mg/80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Danish: Copalia 5 mg/80 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 80 mg alene.
English: When switching eligible elderly hypertensive patients (see section 4.1) to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Danish: 4.1) skiftes til amlodipin eller Copalia, skal den laveste tilgængelige dosis af henholdsvis amlodipin-monoterapi eller amlodipinkombination anvendes.
English: Copalia 10 mg/160 mg tablets are oval and light yellow with “NVR” on one side and “UIC” on the other side.
Danish: Copalia 10 mg/160 mg tabletter er ovale og lysegule, præget med ”NVR” på den ene side og ”UIC” på den anden side.
English: Copalia 5 mg/160 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 160 mg alone.
Danish: Copalia 5 mg/160 mg kan gives til patienter, hvis blodtryk ikke er tilstrækkeligt kontrolleret med amlodipin 5 mg eller valsartan 160 mg alene.
English: No dosage adjustment is required for patients with mild to moderate renal impairment.
Danish: CopaliaDet er ikke nødvendigt at justere dosis hos patienter med let til moderat nedsat nyrefunktion.
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets
Danish: Copalia 5 mg/80 mg filmovertrukne tabletter Copalia 5 mg/160 mg filmovertrukne tabletter Copalia 10 mg/160 mg filmovertrukne tabletter
English: Copalia 5 mg/160 mg tablets are oval and dark yellow “NVR” on one side and “ECE” on the other side.
Danish: Copalia 5 mg/160 mg tabletter er ovale og mørkegule, præget med ”NVR” på den ene side og ”ECE” på den anden side.
English: When switching eligible hypertensive patients (see section 4.1) with hepatic impairment to amlodipine or Copalia, the lowest available dose of amlodipine monotherapy or of the amlodipine component, respectively, should be used.
Danish: 4.1) med nedsat leverfunktion skiftes til amlodipin eller Copalia, skal den laveste tilgængelige dosis af henholdvis amlodipin-monoterapi eller amlodipinkombination anvendes.
English: Copalia 5 mg/80 mg film-coated tablets
Danish: Copalia 5 mg/80 mg filmovertrukne tabletter
English: Copalia 10 mg/160 mg film-coated tablets
Danish: Copalia 10 mg/160 mg filmovertrukne tabletter
English: Copalia 5 mg/80 mg film-coated tablets Copalia 5 mg/160 mg film-coated tablets Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Copalia 5 mg/80 mg filmovertrukne tabletter Copalia 5 mg/160 mg filmovertrukne tabletter Copalia 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: Copalia 10 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Copalia 10 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: No information is available regarding the use of Copalia during breast-feeding, therefore Copalia is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Danish: I stedet foretrækkes alternative behandlinger med bedre dokumenterede sikkerhedsprofiler ved amning, især ved amning af et nyfødt spædbarn eller et for tidligt født spædbarn.
English: EU/1/06/372/034 280 film-coated tablets (4x70) EU/1/06/372/037 280 film-coated tablets (20x14)
Danish: EU/1/06/372/034 280 filmovertrukne tabletter (4x70) EU/1/06/372/037 280 filmovertrukne tabletter (20x14)
English: EU/1/06/372/036 280 film-coated tablets (4x70) EU/1/06/372/039 280 film-coated tablets (20x14)
Danish: EU/1/06/372/036 280 filmovertrukne tabletter (4x70) EU/1/06/372/039 280 filmovertrukne tabletter (20x14)
English: EU/1/06/372/035 280 film-coated tablets (4x70) EU/1/06/372/038 280 film-coated tablets (20x14)
Danish: EU/1/06/372/035 280 filmovertrukne tabletter (4x70) EU/1/06/372/038 280 filmovertrukne tabletter (20x14)
English: Copalia 5 mg/160 mg film-coated tablets
Danish: Copalia 5 mg/160 mg filmovertrukne tabletter
English: What Copalia looks like and contents of the pack Copalia 5 mg/80 mg tablets are round and dark yellow with “NVR” on one side and “NV” on the other side.
Danish: Copalia 5 mg/80 mg tabletter er runde og mørkegule, præget med ”NVR” på den ene side og ”NV” på den anden side.
English: What Copalia is and what it is used for What you need to know before you take Copalia How to take Copalia
Danish: Det skal du vide, før du begynder at tage Copalia Sådan skal du tage Copalia Bivirkninger
English: Copalia 5 mg/80 mg film-coated tablets amlodipine/valsartan
Danish: Copalia 5 mg/80 mg filmovertrukne tabletter amlodipin/valsartan
English: Copalia 5 mg/160 mg film-coated tablets amlodipine/valsartan
Danish: Copalia 5 mg/160 mg filmovertrukne tabletter amlodipin/valsartan
English: EU/1/06/372/001 7 film-coated tablets EU/1/06/372/002 14 film-coated tablets EU/1/06/372/003 28 film-coated tablets EU/1/06/372/004 30 film-coated tablets EU/1/06/372/005 56 film-coated tablets EU/1/06/372/006 90 film-coated tablets EU/1/06/372/007 98 film-coated tablets EU/1/06/372/008 280 film-coated tablets EU/1/06/372/025 56x1 film-coated tablet (unit dose) EU/1/06/372/026 98x1 film-coated tablet (unit dose) EU/1/06/372/027 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/372/001 7 filmovertrukne tabletter EU/1/06/372/002 14 filmovertrukne tabletter EU/1/06/372/003 28 filmovertrukne tabletter EU/1/06/372/004 30 filmovertrukne tabletter EU/1/06/372/005 56 filmovertrukne tabletter EU/1/06/372/006 90 filmovertrukne tabletter EU/1/06/372/007 98 filmovertrukne tabletter EU/1/06/372/008 280 filmovertrukne tabletter EU/1/06/372/025 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/026 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/027 280x1 filmovertrukket tablet (enhedsdosis)
English: EU/1/06/372/017 7 film-coated tablets EU/1/06/372/018 14 film-coated tablets EU/1/06/372/019 28 film-coated tablets EU/1/06/372/020 30 film-coated tablets EU/1/06/372/021 56 film-coated tablets EU/1/06/372/022 90 film-coated tablets EU/1/06/372/023 98 film-coated tablets EU/1/06/372/024 280 film-coated tablets EU/1/06/372/031 56x1 film-coated tablet (unit dose) EU/1/06/372/032 98x1 film-coated tablet (unit dose) EU/1/06/372/033 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/372/017 7 filmovertrukne tabletter EU/1/06/372/018 14 filmovertrukne tabletter EU/1/06/372/019 28 filmovertrukne tabletter EU/1/06/372/020 30 filmovertrukne tabletter EU/1/06/372/021 56 filmovertrukne tabletter EU/1/06/372/022 90 filmovertrukne tabletter EU/1/06/372/023 98 filmovertrukne tabletter EU/1/06/372/024 280 filmovertrukne tabletter EU/1/06/372/031 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/032 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/033 280x1 filmovertrukket tablet (enhedsdosis)
English: If you take more Copalia than you should
Danish: Hvis du har taget for meget Copalia
English: EU/1/06/372/009 7 film-coated tablets EU/1/06/372/010 14 film-coated tablets EU/1/06/372/011 28 film-coated tablets EU/1/06/372/012 30 film-coated tablets EU/1/06/372/013 56 film-coated tablets EU/1/06/372/014 90 film-coated tablets EU/1/06/372/015 98 film-coated tablets EU/1/06/372/016 280 film-coated tablets EU/1/06/372/028 56x1 film-coated tablet (unit dose) EU/1/06/372/029 98x1 film-coated tablet (unit dose) EU/1/06/372/030 280x1 film-coated tablet (unit dose)
Danish: EU/1/06/372/009 7 filmovertrukne tabletter EU/1/06/372/010 14 filmovertrukne tabletter EU/1/06/372/011 28 filmovertrukne tabletter EU/1/06/372/012 30 filmovertrukne tabletter EU/1/06/372/013 56 filmovertrukne tabletter EU/1/06/372/014 90 filmovertrukne tabletter EU/1/06/372/015 98 filmovertrukne tabletter EU/1/06/372/016 280 filmovertrukne tabletter EU/1/06/372/028 56x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/029 98x1 filmovertrukket tablet (enhedsdosis) EU/1/06/372/030 280x1 filmovertrukket tablet (enhedsdosis)
English: Copalia is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Dette er især vigtigt, hvis dit barn er nyfødt eller blev født for tidligt.
English: Lifmior is identical to Enbrel, which has been authorised in the EU since 3 February 2000.
Danish: Lifmior er identisk med Enbrel, der har været godkendt i EU siden den 3. februar 2000.
English: The full EPAR for Lifmior can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lifmior findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Lifmior.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lifmior.
English: Lifmior is given as an injection under the skin.
Danish: Lifmior gives som en injektion under huden.
English: In adults, the usual recommended dose is 25 mg twice a week or 50 mg once a week.
Danish: Den anbefalede dosis til voksne er 25 mg to gange om ugen eller 50 mg én gang om ugen.
English: In children, the dose will depend on body weight.
Danish: Dosis til børn afhænger af barnets vægt.
English: In rheumatoid arthritis, five studies have been carried out involving around 2,200 patients.
Danish: I forbindelse med reumatoid artrit er der udført fem undersøgelser, der omfattede omkring 2 200 patienter.
English: Other information about Lifmior
Danish: Andre oplysninger om Lifmior
English: What measures are being taken to ensure the safe and effective use of Lifmior?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lifmior?
English: Lifmior must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections.
Danish: Lifmior må ikke anvendes til patienter, som har eller er med risiko for sepsis (når bakterier og toksiner cirkulerer i blodet og begynder at beskadige organerne), eller til patienter med infektioner.
English: It contains the active substance etanercept.
Danish: Det indeholder det aktive stof etanercept.
English: The CHMP therefore concluded that Lifmior's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede derfor, at fordelene ved Lifmior er større end risiciene, og udvalget anbefalede udstedelse af markedsføringstilladelse for Lifmior.
English: Lifmior is an anti-inflammatory medicine for treating the following diseases:
Danish: Lifmior er et antiinflammatorisk lægemiddel til behandling af følgende sygdomme:
English: Lifmior is mostly used when these conditions are severe or moderately severe, or when other treatments have not worked well enough.
Danish: Lifmior anvendes hovedsagelig, når disse sygdomstilstande er alvorlige eller moderat alvorlige, eller når andre behandlinger har været utilstrækkelige.
English: What is Lifmior and what is it used for?
Danish: Hvad er Lifmior, og hvad anvendes det til?
English: A fifth study showed that Lifmior on its own or in combination with methotrexate was more effective than methotrexate alone.
Danish: En femte undersøgelse viste, at Lifmior, både alene og i kombination med methotrexat, var mere effektivt end methotrexat alene.
English: Why is Lifmior approved?
Danish: Hvorfor blev Lifmior godkendt?
English: The active substance in Lifmior, etanercept, is a protein that has been designed to block the activity of a substance called tumour necrosis factor (TNF).
Danish: Det aktive stof i Lifmior, etanercept, er et protein, der er opbygget, så det blokerer aktiviteten af et stof kaldet tumornekrosefaktor (TNF).
English: It is not intended to provide practical advice on how to use Lifmior.
Danish: Det er ikke en praktisk vejledning i, hvordan Lifmior bør anvendes.
English: Further studies have been carried out in over 2,300 patients with other inflammatory diseases (juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and axial spondyloarthritis).
Danish: Der er udført yderligere undersøgelser af 2 300 patienter med andre inflammatoriske sygdomme (juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylitis, plaque psoriasis og aksial spondylartrit).
English: These studies also showed that Lifmior produced a greater improvement in symptoms than placebo after three to four months using various standard rating scores such as ACR, ASAS and PASI.
Danish: Disse undersøgelser viste også, at Lifmior gav større bedring i symptomerne end placebo efter tre til fire måneder ved hjælp af forskellige standardiserede vurderingsscorer såsom ACR, ASAS og PASI.
English: By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Danish: Ved at blokere TNF bedrer etanercept inflammationen og de andre symptomer på sygdommen.
English: Lifmior is effective at reducing symptoms in several inflammatory conditions and its side effects are considered manageable.
Danish: Lifmior er effektivt til at mindske symptomerne i forbindelse med flere betændelsestilstande, og dets bivirkninger vurderes at være håndterbare.
English: What is the risk associated with Lifmior?
Danish: Hvilken risiko er der forbundet med Lifmior?
English: The most common side effects with Lifmior (seen in more than 1 patient in 10) are injection site reactions (including bleeding, bruising, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections).
Danish: De hyppigste bivirkninger ved Lifmior (som optræder hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet (herunder blødning, blå mærker, rødme, kløe, smerte og hævelse) og infektioner (bl.a. forkølelser, lungeinfektion, blærebetændelse og hudinfektioner).
English: Patients developing a serious infection should stop Lifmior treatment.
Danish: Patienter, der får en alvorlig infektion, skal stoppe med at tage Lifmior.
English: Several studies have shown that Lifmior is more effective at reducing symptoms of inflammatory conditions than placebo (a dummy treatment) or a comparator medicine.
Danish: Flere undersøgelser har vist, at Lifmior er mere effektivt til at mindske symptomerne på betændelsestilstande end placebo (en virkningsløs behandling) eller et sammenligningslægemiddel.
English: The company that markets Lifmior will provide educational material for doctors expected to prescribe the product to teach patients how to use the pre-filled pen correctly and a special alert card for patients so they can recognise serious side effects and know when to seek urgent attention from their doctor.
Danish: Virksomheden, der markedsfører Lifmior, skal udarbejde en informationspakke til de læger, som forventes at ordinere lægemidlet, for at vise patienterne, hvordan den fyldte pen anvendes korrekt, og et særligt 'Patientkort', for at de kan være opmærksomme på alvorlige bivirkninger og vide, hvornår de skal søge akut lægehjælp.
English: Three of these studies in patients who had taken arthritis medicines in the past showed about two-thirds of the patients who received Lifmior had a reduction in symptoms of 20% or more after three months based on a standard rating score (ACR 20).
Danish: Tre af disse undersøgelser hos patienter, der tidligere havde fået lægemidler mod artrit, viste, at Lifmior bevirkede en symptomlettelse på 20 % eller mere hos omkring to tredjedele af patienterne efter tre måneder på grundlag af en standardiseret vurderingsscore (ACR 20).
English: In a fourth study of rheumatoid arthritis patients who had not taken methotrexate before, those receiving 25 mg Lifmior twice a week had less joint damage than those taking methotrexate alone after 12 and 24 months.
Danish: I en fjerde undersøgelse af patienter med reumatoid artrit, der ikke tidligere havde fået methotrexat, var omfanget af ledskaderne mindre hos de patienter, der fik 25 mg Lifmior to gange om ugen, efter 12 og 24 måneder end hos dem, der kun fik methotrexat.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Lifmior is used for.
Danish: Behandling iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af de sygdomme, som Lifmior anvendes til.
English: The patient or carer can give the injection if they have been trained appropriately.
Danish: Injektionen kan gives af patienten selv eller af omsorgsgiveren, hvis de er behørigt instrueret heri.
English: For more information about treatment with Lifmior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lifmior, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: • certain forms of juvenile idiopathic arthritis (inflammation of joints in children and adolescents)
Danish: • visse former for juvenil idiopatisk artrit (inflammation af led hos børn og unge)
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Lifmior is used to treat.
Danish: Dette stof er en medvirkende årsag til betændelsestilstande og findes i høje koncentrationer hos patienter med de sygdomme, der behandles med Lifmior.
English: This compared with around a quarter of the patients receiving placebo.
Danish: Hos de patienter, som fik placebo, var den tilsvarende andel omkring en fjerdedel.
English: For detailed information on the use of Lifmior in all conditions, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Lifmior i forbindelse med alle sygdomstilstande fremgår af produktresuméet (også en del af denne EPAR).
English: What benefits of Lifmior have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lifmior?
English: • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.
Danish: • aksial spondylartrit (en kronisk inflammatorisk sygdom i rygsøjlen) hos voksne, når der ved røntgen ikke ses nogen abnormiteter.
English: For practical information about using Lifmior, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lifmior, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Lifmior, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Lifmior fremgår af indlægssedlen.
English: How is Lifmior used?
Danish: Hvordan anvendes Lifmior?
English: • rheumatoid arthritis (a disease causing inflammation of the joints) alone or with methotrexate in adults
Danish: • reumatoid artrit (en lidelse, der forårsager inflammation af leddene), alene eller i kombination med methotrexat, hos voksne
English: How does Lifmior work?
Danish: Hvordan virker Lifmior?
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children
Danish: • plaque psoriasis (en sygdom, der giver rød, skællende hud) hos voksne og børn
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults
Danish: • ankyloserende spondylitis (en sygdom, der medfører inflammation af leddene i rygsøjlen) hos voksne
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults
Danish: • psoriasisartrit (psoriasis med inflammation af leddene) hos voksne
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lifmior have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Lifmior.
English: • The Instanyl nasal spray dose strengths cannot be compared with other Fentanyl products.
Danish: - Styrken af en Instanyl næsespray kan ikke sammenlignes med andre fentanylprodukter.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, SOM SKAL IMPLEMENTERES AF MEDLEMSLANDET