FrancophonIA/ELRC3.0 huggingface dataset:
English: If you take more Ongentys than you should, tell your doctor or pharmacist, or go to a hospital immediately.
Danish: Hvis du har taget flere Ongentys, end du skulle, skal du straks kontakte din læge, apotekspersonalet eller et hospital.
English: A study conducted in healthy subjects showed that there were no changes in repaglinide's exposure when repaglinide was administered following multiple once-daily administration of opicapone 50 mg.
Danish: Et studie med raske forsøgspersoner viste, at der ikke skete nogen ændring i eksponeringen for repaglinid, når repaglinid blev administrereret efter adskillige administrationer af opicapon 50 mg en gang dagligt.
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10, 30 or 90 capsules.
Danish: Hvide flasker af polyethylen med høj densitet (HDPE) med børnesikrede låg af polypropylen (PP) indeholdende 10, 30 eller 90 kapsler.
English: White high density polyethylene (HDPE) bottles with polypropylene (PP) child resistant closures containing 10 or 30 capsules.
Danish: Hvide flasker af polyethylen med høj densitet (HDPE) med børnesikrede låg af polypropylen (PP) indeholdende 10 eller 30 kapsler.
English: Shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Danish: Shellac, titandioxid (E171), propylenglycol, ammoniak, simeticon
English: Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain in extremity
Danish: Muskeltrækninger, muskuloskeletal stivhed, myalgi, ekstremitetssmerter
English: For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Danish: Det bør overvejes at udføre en generel undersøgelse hos patienter, som udvikler progredierende anoreksi, asteni og vægttab inden for relativt kort tid, herunder af patientens leverfunktion.
English: Shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Danish: Shellac, propylenglycol, ammoniak, indigocarmin (E132)
English: Breast-feeding should be discontinued during treatment with Ongentys.
Danish: Amning skal ophøre under behandling med Ongentys.
English: Ongentys may increase their effect; - medicines used to treat allergic reactions such as adrenaline.
Danish: Ongentys kan øge virkningen af disse lægemidler; - lægemidler til behandling af allergiske reaktioner, som f.eks. adrenalin.
English: Blisters: Store in the original blister in order to protect from moisture.
Danish: Blistre: Opbevares i den originale blister for at beskytte mod fugt.
English: ongentys 25 mg (only on the outer packaging)
Danish: ongentys 25 mg (kun på den ydre emballage)
English: Each hard capsule contains 148.2 mg of lactose (as monohydrate).
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver hård kapsel indeholder 148,2 mg lactose (som monohydrat).
English: ongentys 50 mg (only on the outer packaging)
Danish: ongentys 50 mg (kun på den ydre emballage)
English: Dyskinesia
Danish: Dyskinesier
English: There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B).
Danish: Der er begrænset klinisk erfaring hos patienter med moderat leverinsufficiens (Child-Pugh klasse B).
English: After oral administration, the apparent total body clearance of opicapone at a dose of 50 mg was 22 L/h, with an inter-subject variability of 45%.
Danish: Efter oral administration var opicapons tilsyneladende totale clearance fra kroppen 22 l/time ved en dosis på 50 mg med en inter-individuel variation på 45 %.
English: Capsule content
Danish: Kapslens indhold
English: Do not use this medicine after the expiry date which is stated on the bottle/blister/carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: There is no experience with opicapone when used concomitantly with the MAO-B inhibitor safinamide.
Danish: Der er ingen erfaring med samtidig brug af opicapon og MAO-B-hæmmeren safinamid.
English: At clinically relevant concentrations, opicapone is not expected to inhibit OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, BCRP, P-gp/MDR1, BSEP, MATE1 and MATE2-K transporters as suggested by in vitro and in vivo studies.
Danish: Som antydet af in vitro- og in vivo-studier forventes opicapon, ved klinisk relevante koncentrationer, ikke at hæmme OAT1-, OAT3-, OATP1B1-, OATP1B3-, OCT1-, OCT2-, BCRP-, P-gp/MDR1-, BSEP-, MATE1- og MATE2-K-transportører.
English: No dose adjustment is needed for elderly patients (see section 5.2).
Danish: Dosisjustering er ikke nødvendig hos ældre patienter (se pkt.
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A).
Danish: Dosisjustering er ikke nødvendig hos patienter med let leverinsufficiens (Child-Pugh klasse A).
English: After oral administration, the apparent volume of distribution of opicapone at a dose of 50 mg was 29 L with an inter-subject variability of 36%.
Danish: Efter oral administration var den tilsyneladende fordelingsvolumen af opicapon 29 l ved en dosis på 50 mg, med en variation mellem forsøgspersonerne på 36 %.
English: Uncommon: may affect up to 1 in 100 people - palpitations or irregular heartbeat - blocked ear - dry eye - pain or swelling of the abdomen - indigestion - weight loss - loss of appetite - increased levels of triglycerides (fats) in your blood - muscle twitching, stiffness or pain - pain in arms or legs - altered sense of taste - excessive body movements - fainting - anxiety - depression - hearing things which do not exist - nightmares - sleep disorder - abnormal colour of urine - need to wake and pass urine at night - shortness of breath - high or low blood pressure
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 patienter - hjertebanken eller uregelmæssig hjerterytme (puls) - tilstoppede ører - tørre øjne - smerter eller hævelse i maveregionen - fordøjelsesbesvær - vægttab - appetitløshed - forhøjede triglycerider (fedtstoffer) i blodet - muskeltrækninger, muskelstivhed eller muskelsmerter - smerter i arme og ben - ændret smagssans - overdrevne kropsbevægelser - besvimelse - angst - depression - høre noget, som ikke eksisterer - mareridt - søvnbesvær - unormal farve af urin - behov for vandladning om natten - kortåndethed - højt eller lavt blodtryk
English: Opicapone exposure increased in a dose proportional manner following once-daily multiple dose administration up to 50 mg opicapone.
Danish: Opicapon-eksponering øges dosisproportionalt efter administration af multiple en gang dagligt-doser på op til 50 mg opicapon.
English: Ongentys taken with levodopa may make you feel light-headed, dizzy, or sleepy.
Danish: Når du tager Ongentys sammen med levodopa, kan du føle dig svimmel eller søvnig.
English: It is not known if Ongentys passes into breast milk in humans.
Danish: Det er ukendt, om Ongentys udskilles i mælken hos mennesker.
English: Indigo carmine aluminium lake (E132) Erythrosine (E127)
Danish: Indigocarmin (E132) Erythrosin (E127) Titandioxid (E171)
English: - The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, titanium dioxide (E171), propylene glycol, ammonia, simethicone
Danish: - Øvrige indholdsstoffer: o kapslens indhold: lactosemonohydrat, natriumstivelsesglykolat (type A), pregelatineret majsstivelse og magnesiumstearat o kapselskal: gelatine, indigocarmin (E132), erythrosin (E127) og titandioxid (E171) prægeblæk: shellac, titandioxid (E171), propylenglykol, ammoniak, simeticon
English: Ongentys may increase their effect; - medicines used to treat heart failure such as dobutamine, dopamine or dopexamine.
Danish: Ongentys kan øge virkningen af disse lægemidler; - lægemidler til behandling af hjertesvigt, som f.eks. dobutamin, dopamin eller dopexamin.
English: Because of this, concomitant use of opicapone with MAO inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease is contraindicated.
Danish: Derfor er samtidig brug af opicapon og MAO-hæmmere (f.eks. phenelzin, tranylcypromin og moclobemid) med undtagelse af dem, der bruges i behandlingen af Parkinsons sygdom, kontraindiceret.
English: - The other ingredients are: o capsule content: lactose monohydrate, sodium starch glycolate (Type A), pregelatinized maize starch and magnesium stearate o capsule shell: gelatine, indigo carmine aluminium lake (E132), erythrosine (E127) and titanium dioxide (E171) o printing ink: shellac, propylene glycol, ammonia, indigo carmine aluminium (E132)
Danish: - Øvrige indholdsstoffer: o kapslens indhold: lactosemonohydrat, natriumstivelsesglykolat (type A), pregelatineret majsstivelse og magnesiumstearat o kapselskal: gelatine, indigocarmin (E132), erythrosin (E127) og titandioxid (E171) o prægeblæk: shellac, propylenglykol, ammoniak, indigocarmin (E132)
English: Therefore, their concomitant use should be considered with appropriate caution.
Danish: Der bør derfor udvises passende forsigtighed ved brug af denne kombination.
English: HDPE BOTTLE
Danish: HDPE-FLASKE
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients (see section 5.2).
Danish: Der er ingen klinisk erfaring hos patienter med svær leverinsufficiens (Child-Pugh klasse C), og Ongentys frarådes derfor til disse patienter (se pkt.
English: For other adverse events, the levodopa and/or opicapone dose could be adjusted.
Danish: Dosis af levodopa og/eller opicapon kunne justeres ved andre bivirkninger.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ongentys.
Danish: Ongentys indeholder lactose og bør ikke anvendes hos patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactose-malabsorption.
English: Other medicines and Ongentys
Danish: Brug af anden medicin sammen med Ongentys
English: Concomitant use with monoamine oxidase (MAO-A and MAO-B) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide) other than those for the treatment of Parkinson's disease (see section 4.5).
Danish: Samtidig brug af monoaminoxidasehæmmere (MAO-A og MAO-B) (f.eks. phenelzin, tranylcypromin og moclobemid) undtagen dem, der bruges i behandlingen af Parkinsons sygdom (se pkt.
English: HDPE bottles: Keep the bottle tightly closed in order to protect from moisture.
Danish: HDPE-flasker: Hold flasken tæt tillukket for at beskytte mod fugt.
English: - if you have a tumour of the adrenal gland (known as phaeochromocytoma), or of the nervous system (known as paraganglioma), or any other tumour which increase the risk of severe high blood pressure; - if you have ever suffered from neuroleptic malignant syndrome which is a rare reaction to antipsychotic medicines; - if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury; - if you are taking certain antidepressants called monoamine-oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine or moclobemide).
Danish: - hvis du er allergisk over for opicapon eller et af de øvrige indholdsstoffer i Ongentys (angivet i punkt 6) - hvis du har en tumor i binyrerne (kaldet fæokromocytom) eller i nervesystemet (kaldet paragangliom) eller en anden tumor, som øger risikoen for meget højt blodtryk - hvis du nogen sinde har haft malignt neuroleptikasyndrom, som er en sjælden reaktion på medicin mod psykoser - hvis du nogen sinde har lidt af en sjælden muskellidelse, der kaldes rabdomyolyse, som ikke skyldes en skade
English: Dizziness, Headache, Somnolence
Danish: Svimmelhed, hovedpine, døsighed
English: Ongentys should be taken once-daily at bedtime at least one hour before or after levodopa combinations.
Danish: Den anbefalede dosis opicapon er 50 mg. Ongentys skal tages én gang dagligt ved sengetid mindst en time før eller efter levodopakombinationen.
English: Pharmacokinetic results showed that opicapone is rapidly absorbed, with a tmax of 1.0 h to 2.5 h following once-daily multiple-dose administration up to 50 mg opicapone.
Danish: Farmakokinetiske resultater viste, at opicapon absorberes hurtigt med en tmax på 1,0-2,5 timer efter administration af flere, en gang dagligt-doser på op til 50 mg opicapon.
English: Malta/Nederland/Norge/Österreich/Polska/Portugal/
Danish: Lietuva/Luxembourg/Luxemburg/Magyarország/ Malta/Nederland/Norge/Österreich/Polska/Portugal/ România/Slovenija/Slovenská republika/ Suomi/Finland/Sverige/United Kingdom
English: Dose adjustments of antiparkinsonian therapy
Danish: Dosisjustering af antiparkinsonbehandlingen
English: In healthy subjects, the opicapone elimination half-life (t1/2) was 0.7 h to 3.2 h following once-daily multiple-dose administration up to 50 mg opicapone.
Danish: Hos raske forsøgspersoner var opicapons eliminationshalveringstid (t1/2) 0,7-3,2 timer efter administration af multiple en gang dagligt-doser på op til 50 mg opicapon.
English: There is no relationship between exposure of opicapone and body weight over the range of 40-100 kg.
Danish: I intervallet 40-100 kg er der ingen sammenhæng mellem eksponering for opicapon og kropsvægt.
English: Ongentys may increase its effect; - medicines containing quinidine, a medicine used to treat abnormal heart rhythms or malaria.
Danish: Ongentys kan øge virkningen af disse lægemidler; - lægemidler, der indeholder kinidin, som anvendes til behandling af unormal hjerterytme eller malaria.
English: Keep the bottle tightly closed in order to protect from moisture
Danish: Hold flasken tæt tillukket for at beskytte mod fugt.
English: Decreased appetite, Hypertriglyceridaemia
Danish: Appetitløshed, hypertriglyceridæmi
English: Monoamino oxidase (MAO) inhibitors
Danish: Monoaminoxidasehæmmere (MAO-hæmmere)
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Danish: Der er ingen klinisk erfaring hos patienter med svær leverinsufficiens (Child-Pugh klasse C) (se pkt.
English: Blisters: 10, 30 or 90 capsules.
Danish: Blister: 10, 30 eller 90 kapsler.
English: Bottles: 10, 30 or 90 capsules.
Danish: Flasker: 10, 30 eller 90 kapsler.
English: A study conducted in healthy volunteers showed that when a single dose of 50 mg opicapone was coadministered (within 1 hour) with a single dose of quinidine (600 mg), systemic exposure of opicapone decreased by 37% (AUC0-tlast).
Danish: Et studie med raske forsøgspersoner viste, at systemisk eksponering for opicapon reduceredes med 37 % (AUC0-tlast), når en enkeltdosis 50 mg opicapon blev administreret samtidig med (inden for 1 time) en enkeltdosis kinidin (600 mg).
English: Blisters: 10 or 30 capsules.
Danish: Blister: 10 eller 30 kapsler.
English: Responders, n (%) 65 (47.8)
Danish: Respondenter, n (%)
English: Bottles: 10 or 30 capsules.
Danish: Flasker: 10 eller 30 kapsler.
English: Bottles: Keep the bottle tightly closed in order to protect from moisture.
Danish: Flasker: Hold flasken tæt tillukket for at beskytte mod fugt.
English: Study 2 OFF-time reduction
Danish: Studie 2 Reduktion i OFF-tid
English: Study 1 OFF-time reduction
Danish: Studie 1 Reduktion i OFF-tid
English: Animal studies with opicapone do not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier med opicapon indikerer ikke reproduktionstoksicitet (se pkt.
English: Study 1 Change in OFF-time
Danish: Studie 1 Ændring i OFF-tid
English: Study 2 Change in OFF-time
Danish: Studie 2 Ændring i OFF-tid
English: Following once-daily multiple oral doses of opicapone in the dose range of 5 to 50 mg, opicapone sulphate presented a long terminal phase with elimination half-life values ranging from 94 h to 122 h and, as a consequence of this long terminal elimination half-life, opicapone sulphate presented a high accumulation ratio in plasma, with values close of up to 6.6.
Danish: Efter multiple orale, en gang dagligt-doser af opicapon i dosisområdet 5 til 50 mg viste opicaponsulfat en lang terminal fase med eliminationshalveringstider i området 94-122 timer.
English: Ongentys 50 mg hard capsules are dark blue, approximately 19 mm length, with “OPC 50” and “Bial” printed on the capsules.
Danish: Ongentys 50 mg hårde kapsler er mørkeblå, ca. 19 mm lang, med "OPC 50" og "Bial" præget på kapslerne.
English: How to take Ongentys
Danish: Sådan skal du tage Ongentys
English: Ongentys 25 mg hard capsules are light blue, approximately 19 mm length, with “OPC 25” and “Bial” printed on the capsules.
Danish: Ongentys 25 mg hårde kapsler er lyseblå, ca. 19 mm lang, med "OPC 25" og "Bial" præget på kapslerne.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Du skal kontakte din læge, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: OPA/Al/PVC//Al blisters containing 10, 30 or 90 capsules Not all pack sizes may be marketed.
Danish: OPA/Al/PVC//Al-blistre med 10, 30 eller 90 kapsler.
English: The pharmacokinetics of opicapone was evaluated in elderly subjects (aged 65-78 years old) after 7day multiple-dose administration of 30 mg. An increase in both the rate and extent of systemic exposure was observed for the elderly population when compared to the young population.
Danish: Opicapons farmakokinetik blev evalueret hos ældre forsøgspersoner (65-78 år) efter administration af en dosis på 30 mg i 7 dages.
English: Chromaturia, Nocturia
Danish: Kromaturi, nykturi
English: A.
Danish: Æ
English: Opicapone showed a marked (>90%) and long-lasting (>24 hours) COMT inhibition in healthy subjects after administration of 50 mg opicapone.
Danish: Efter administration af 50 mg opicapon blev der vist en markant (> 90 %) og langvarig (> 24 timer) COMT-hæmning hos raske forsøgspersoner.
English: What you need to know before you take Ongentys 3.
Danish: Det skal du vide, før du begynder at tage Ongentys Sådan skal du tage Ongentys Bivirkninger
English: Ongentys may increase their effects; - medicines for high cholesterol such as rosuvastatin, simvastatin, atorvastatin or pravastatin Ongentys may increase their effects; - medicines that affect the immune system such as methotrexate.
Danish: Ongentys kan øge virkningen af disse lægemidler; - lægemidler mod for højt kolesterol, som f.eks. rosuvastatin, simvastatin, atorvastatin eller pravastatin.
English: Eye disorders
Danish: Tilstoppede ører
English: Ongentys 25 mg hard capsules
Danish: Ongentys 25 mg hårde kapsler
English: Ongentys 50 mg hard capsules
Danish: Ongentys 50 mg hårde kapsler
English: Printing ink
Danish: Muskelspasmer
English: - muscle spasm - dizziness - headache - sleepiness - difficulty falling or staying asleep - strange dreams - experiencing or seeing things which do not exist (hallucinations) - a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting
Danish: Almindelig: kan forekomme hos op til 1 ud af 10 patienter - forstoppelse - mundtørhed - opkastninger - forhøjet niveau af enzymet kreatinkinase i blodet - ufrivillige muskelsammentrækninger - svimmelhed - hovedpine - døsighed - besvær med at falde i søvn eller sove igennem - underlige drømme - sanseoplevelser, som ikke er virkelige (hallucinationer) - blodtryksfald, når du rejser dig op, hvilket forårsager svimmelhed eller besvimelse
English: The bioavailability of opicapone was significantly higher in patients with moderate chronic hepatic impairment and no safety concerns were observed.
Danish: Opicapons farmakokinetik blev evalueret hos raske forsøgspersoner og hos patienter med moderat kronisk leverinsufficiens efter administration af en enkelt dosis på 50 mg. Opicapons biotilgængelighed var signifikant højere hos patienter med moderat kronisk leverinsufficiens, men der blev ikke observeret sikkerhedsmæssige problemer.
English: EU/1/15/1066/001 10 hard capsules EU/1/15/1066/008 30 hard capsules
Danish: EU/1/15/1066/001 10 hårde kapsler EU/1/15/1066/008 30 hårde kapsler
English: Each hard capsule contains 50 mg of opicapone.
Danish: Hver hård kapsel indeholder 50 mg opicapon.
English: Each hard capsule contains 25 mg of opicapone.
Danish: Hver hård kapsel indeholder 25 mg opicapon.
English: EU/1/15/1066/009 10 hard capsules EU/1/15/1066/010 30 hard capsules
Danish: EU/1/15/1066/009 10 hårde kapsler EU/1/15/1066/010 30 hårde kapsler
English: EU/1/15/1066/005 10 hard capsules EU/1/15/1066/006 30 hard capsules EU/1/15/1066/007 90 hard capsules
Danish: EU/1/15/1066/005 10 hårde kapsler EU/1/15/1066/006 30 hårde kapsler EU/1/15/1066/007 90 hårde kapsler
English: EU/1/15/1066/002 10 hard capsules EU/1/15/1066/003 30 hard capsules EU/1/15/1066/004 90 hard capsules
Danish: EU/1/15/1066/002 10 hårde kapsler EU/1/15/1066/003 30 hårde kapsler EU/1/15/1066/004 90 hårde kapsler
English: Ongentys 25 mg capsules opicapone
Danish: Ongentys 25 mg kapsler opicapon
English: Other levodopa medicines
Danish: Andre lægemidler
English: Constipation, Dry mouth, Vomiting
Danish: Obstipation, mundtørhed, opkastning
English: Ongentys 50 mg capsules opicapone
Danish: Ongentys 50 mg kapsler opicapon
English: If you take more Ongentys than you should
Danish: Hvis du har taget for mange Ongentys
English: Each capsule contains 25 mg of opicapone.
Danish: Hver kapsel indeholder 25 mg opicapon.
English: Dark blue capsules, size 1, approximately 19 mm, imprinted “OPC 50” on the cap and “Bial” on the body.
Danish: Mørkeblå kapsler, størrelse 1, ca. 19 mm, med "OPC 50" præget på hætten og "Bial" præget på selve kapslen.
English: • Periodic safety update reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØ • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Light blue capsules, size 1, approximately 19 mm, imprinted “OPC 25” on the cap and “Bial” on the body.
Danish: Lyseblå kapsler, størrelse 1, ca. 19 mm, med "OPC 25" præget på hætten og "Bial" præget på selve kapslen.
English: Each capsule contains 50 mg of opicapone.
Danish: Hver kapsel indeholder 50 mg opicapon.
English: Ongentys 50 mg hard capsules opicapone
Danish: Ongentys 50 mg hårde kapsler opicapon
English: Ongentys 25 mg hard capsules opicapone
Danish: Ongentys 25 mg hårde kapsler opicapon
English: Date of first authorisation: 24 February 2009 Date of latest renewal: 24 February 2014
Danish: Dato for første markedsføringstilladelse: 24 februar 2009 Dato for seneste fornyelse: 24 februar 2014
English: Data were as follows (values in brackets show the 95% confidence intervals):
Danish: Data var som følger (værdierne i parentes viser 95 % konfidensintervallerne):
English: Store in refrigerator.
Danish: Opbevares i køleskab.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil
English: INTANZA is a vaccine.
Danish: INTANZA er en vaccine.
English: Intradermal 15µg A/H3N2
Danish: Intrakutan 15µg A/H3N2
English: *In some cases, local redness lasted up to 7 days.
Danish: * I visse tilfælde varede lokal rødme ved i op til 7 dage
English: The use of INTANZA should be based on official recommendations.
Danish: INTANZA skal anvendes i overensstemmelse med officielle anbefalinger.
English: Pharmacotherapeutic group: Influenza vaccines, ATC code: J07BB02
Danish: Farmakoterapeutisk klassifikation: Influenzavaccine, ATC-kode: J07BB02
English: INTANZA 15 µg/strain 2017/2018 Influenza vaccine
Danish: INTANZA 15 µg/stamme 2017 /2018 Influenzavaccine
English: Children and adolescents INTANZA is not recommended for use in children and adolescents below 18 years.
Danish: Børn og unge Det frarådes at bruge INTANZA til børn og teenagere under 18 år.