natgillin/translations-raw huggingface dataset:
Almindelige bivirkninger (kan forekomme hos færre end 1 ud af 10 personer) tumorsmerter nedsat funktion af skjoldbruskkirtlen, hvilket kan medføre træthed eller vægtstigning, nedsat funktion (hypopituitarisme) af eller betændelseslignende reaktion (hypofysitis) i hypofysen, der er placeret nederst i hjernen væskemangel forvirring nerveskader (medfører smerter, svaghed og kramper), svimmelhed, hovedpine sløret syn, øjensmerter lavt blodtryk, forbigående rødme i ansigtet og på halsen, intens varmefølelse med svedudbrud og hurtig hjertebanken åndenød (dyspnø), hoste blødning i maven eller tarmene, tarmbetændelse (tyktarmsbetændelse), forstoppelse, halsbrand, mavesmerter unormal leverfunktion betændelseslignende reaktion (inflammation) på indersiden af visse organer inflammation og rødme på huden, farveændringer som pletter på huden (vitiligo), nældefeber (kløende, hævet udslæt), hårtab eller udtynding af håret, voldsom nattesved, tør hud muskelsmerter og ledsmerter (artralgi), muskelkramper kulderystelser, manglende energi, væskeansamlinger (hævelse), smerter influenza‑lignende sygdom vægttab
Common (may affect up to 1 in 10 people) tumour pain underactive function of the thyroid gland which can cause tiredness or weight gain, underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain dehydration confusion damage to the nerves (causing pain, weakness and cramps), dizziness, headache, blurred vision, pain in the eye low blood pressure, temporary redness of the face and neck, feeling of intense heat with sweating and rapid heart beat shortness of breath (dyspnoea), cough bleeding in the stomach or intestine, inflammation of the intestines (colitis), constipation, heartburn, stomach pain abnormal function of the liver inflammation of the inner surface lining of a particular organ inflammation and redness of the skin, skin colour change in patches (vitiligo), hives (itchy, bumpy rash), hair loss or thinning, excessive sweating at night, dry skin pain in muscles and joints(arthralgia), muscle spasms shivering, lack of energy, oedema (swelling), pain flu-like illness weight loss
meningisme, myokarditis, perikardieeffusion, kardiomyopati, autoimmun hepatitis, erythema nodosum, autoimmun pancreatitis, hyperpituitarisme, hypoparatyroidisme, infektiøs peritonitis, episcleritis, scleritis, Raynaudfænomen, palmar-plantar erythrodysæstesi syndrom, cytokinfrigivelsessyndrom, sarkoidose, nedsat gonadotropin, leukopeni, polycytæmi, lymfocytose, okulær myositis og neurosensorisk høretab.
These additional reactions occurred at a frequency of < 1% unless otherwise noted: meningism, myocarditis, pericardial effusion, cardiomyopathy, autoimmune hepatitis, erythema nodosum, autoimmune pancreatitis, hyperpituitarism, hypoparathyroidism, infectious peritonitis, episcleritis, scleritis, Raynaud's phenomenon, palmar-plantar erythrodysaesthesia syndrome, cytokine release syndrome, sarcoidosis,
Ved grad 3 eller 4 pneumonitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 2-4 mg/kg/dag.
For Grade 3 or 4 pneumonitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 2 to 4 mg/kg/day methylprednisolone equivalents.
Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,55 (0,40; 0,75) Nivolumab versus ipilimumab - hazard ratio: 0,54 (0,40; 0,73) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 1,02 (0,73; 1,43)
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.55 (0.40, 0.75) Nivolumab vs. Ipilimumab - hazard ratio: 0.54 (0.40, 0.73) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 1.02 (0.73, 1.43)
Hvis der opstår forværring, eller der ikke sker bedring på trods af initiering af kortikosteroider, skal kortikosteroiddosis øges op til en dosis ækvivalent med methylprednisolon 24 mg/kg/dag, og ipilimumab i kombination med nivolumab skal seponeres permanent.
If worsening or no improvement occurs despite initiation of corticosteroids, corticosteroid dose should be increased to 2 to 4 mg/kg/day methylprednisolone equivalents and ipilimumab in combination with nivolumab must be permanently discontinued.
Hos melanom-patienter, der blev behandlet med ipilimumab 3 mg/kg i kombination med nivolumab 1 mg/kg, var hyppigheden af nefritis eller nedsat nyrefunktion 5,1 % (23/448).
In patients treated with ipilimumab 3 mg/kg in combination with nivolumab 1 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
Undersøgelser
Investigationsb
YERVOY 5 mg/ml koncentrat til infusionsvæske, opløsning 2.
NAME OF THE MEDICINAL PRODUCT YERVOY 5 mg/ml concentrate for solution for infusion 2.
Nivolumab+ipilimumab versus ipilimumab - hazard ratio: 0,59 (0,42; 0,82) Nivolumab versus ipilimumab - hazard ratio: 0,84 (0,61; 1,16) Nivolumab+ipilimumab versus nivolumab - hazard ratio: 0,70 (0,49; 0,99)
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.59 (0.42, 0.82) Nivolumab vs. Ipilimumab - hazard ratio: 0.84 (0.61, 1.16) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.70 (0.49, 0.99)
De regimer, der indeholdt ipilimumab, viste en statistisk signifikant fordel over for gp100-kontrolgruppen i forhold til OS. Hazard ratio (HR) for OS var 0,66 (95 % CI: 0,51; 0,87; p = 0,0026) til fordel for ipilimumab monoterapi sammenlignet med gp100.
The hazard ratio (HR) for comparison of OS between ipilimumab monotherapy and gp100 was 0.66 (95% CI: 0.51, 0.87; p = 0.0026).
Ved grad 4 diarré eller colitis skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
For Grade 4 diarrhoea or colitis, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Dosis/doser udsættes, indtil symptomerne forsvinder, og behandling med kortikosteroider er afsluttetb
Withhold dose(s) until symptoms resolve and management with corticosteroids is completeb
Alle behandlede patienter
Two patients in the 10
Ipilimumab kan forårsage inflammation i de endokrine organer, som manifesterer sig som hypophysitis, hypopituitarisme, binyrebarkinsufficiens og hypotyroidisme (se pkt.
Ipilimumab can cause inflammation of the endocrine system organs, manifesting as hypophysitis, hypopituitarism, adrenal insufficiency, and hypothyroidism (see section 4.8), and patients may present with nonspecific symptoms, which may resemble other causes such as brain metastasis or underlying disease.
Almindelig dehydrering, hypokaliæmi Ikke almindelig hyponatriæmi, alkalose, hypophosphatæmi, tumorlysesyndrom, hypocalcæmid
Uncommon hyponatremia, alkalosis, hypophosphatemia, tumour lysis syndrome, hypocalcaemiad Psychiatric disorders
Sjælden polymyositisd Nyrer og urinveje Ikke almindelig nyresvigtb, glomerulonephritisc, autoimmun nefritisd, renal tubulær acidose, hæmaturid
Musculoskeletal and connective tissue disorders Common arthralgia, myalgia, musculoskeletal painf, muscle spasms Uncommon polymyalgia rheumatica, myositisd, arthritis, muscular weaknessd Rare polymyositisd Renal and urinary disorders Uncommon renal failureb, glomerulonephritisc, autoimmune nephritisd, renal tubular acidosis, haematuriad
Ved behandlingsstart var karakteristika velbalancerede på tværs af grupperne.
Baseline characteristics were well balanced across groups.
I fase 3‑studiet MDX010-20, (se pkt.
In the Phase 3 study MDX010-20, (see section 5.1), patients received a median of 4 doses (range 1-4).
Ipilimumab som monoterapi (se pkt.
Ipilimumab as monotherapy (see section 4.2)
Aktivt stof: Ipilimumab.
What YERVOY contains The active substance is ipilimumab.
Ikke almindelig paraneoplastisk syndrom Blod og lymfesystem Almindelig anæmi, lymfopeni Ikke almindelig hæmolytisk anæmib, trombocytopeni, eosinofili, neutropeni
Uncommon paraneoplastic syndrome Blood and lymphatic system disorders Common anaemia, lymphopenia
Ved grad 3 diarré eller colitis, som observeres med ipilimumab i kombination med nivolumab, skal behandlingen seponeres permanent, og kortikosteroider skal initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
Grade 3 diarrhoea or colitis observed with ipilimumab in combination with nivolumab requires permanent discontinuation of treatment and initiation of corticosteroids at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Ikke almindelig sarkoidose Ikke kendt afstødning af transplanterede solide organerh
Solid organ transplant rejection
1 hætteglas indeholder 200 mg ipilimumab.
Each vial contains 200 mg ipilimumab.
Ved grad 4 stigning i serumkreatinin skal ipilimumab i kombination med nivolumab seponeres permanent, og kortikosteroider bør initieres med en dosis ækvivalent med methylprednisolon 12 mg/kg/dag.
For Grade 4 serum creatinine elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
4.8), bør patienter, som har brug for samtidig behandling med antikoagulantia, monitoreres tæt.
Since gastrointestinal haemorrhage is an adverse reaction with ipilimumab (see section 4.8), patients who require concomitant anticoagulant therapy should be monitored closely.
Ikke almindelig pleuraeffusion Mave-tarm-kanalen Meget almindelig colitisa, diarré, opkastning, kvalme, abdominalsmerter diarre, opkastning, kvalme
Uncommon pleural effusion Gastrointestinal disorders Very common colitisa, diarrhoea, vomiting, nausea,
du tidligere har haft en betændelseslignende reaktion (inflammation) i lungerne.
if you have any history of inflammation of the lungs
Ved grad 3 eller 4 forhøjelse af aminotransferase eller total-bilirubin seponeres ipilimumab i kombination med nivolumab permanent, og kortikosteroider initieres med en dosis ækvivalent med methylprednisolon 1-2 mg/kg/dag.
For Grade 3 or 4 transaminase or total bilirubin elevation, ipilimumab in combination with nivolumab must be permanently discontinued, and corticosteroids should be initiated at a dose of 1 to 2 mg/kg/day methylprednisolone equivalents.
Ipilimumab skal seponeres permanent hos patienter med meget svær (Grad 4) udslæt eller svær (Grad 3) pruritus (se pkt.
Ipilimumab must be permanently discontinued in patients with a very severe (Grade 4) rash or severe (Grade 3) pruritus (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg/day) should be initiated immediately.
Samtidig administration af vemurafenib
Concurrent administration with vemurafenib
Der er observeret alvorligt udslæt med ipilimumab i kombination med nivolumab (se pkt.
Severe rash has been observed with ipilimumab in combination with nivolumab (see section 4.8).
4.2), og intravenøs behandling med systemisk højdosis kortikosteroid (f.eks. methylprednisolon 2 mg/kg dagligt eller tilsvarende) bør straks initieres.
For patients with Grade 3 or 4 transaminase or total bilirubin elevation, treatment must be permanently discontinued (see section 4.2), and systemic high-dose intravenous corticosteroid therapy (e.g. methylprednisolone 2 mg/kg daily or equivalent) should be initiated immediately.
øget antal eosinofiler (en bestemt type af hvide blodlegemer) allergisk reaktion, reaktioner i forbindelse med infusion af medicinen nedsat udskillelse af de hormoner, der dannes i binyrerne (kirtler placeret over nyrerne), nedsat funktion (hypopituitarisme) af hypofysen eller betændelseslignende reaktion (hypofysitis) i hypofysen (sidder nederst i hjernen), hævelse af skjoldbruskkirtlen, sukkersyge (diabetes) dehydrering betændelseslignende reaktion i leveren betændelseslignende reaktion i nerverne (som medfører følelsesløshed, svaghed, snurrende fornemmelse eller brændende smerter i arme og ben), svimmelhed øjenbetændelse (med rødme og smerter), sløret syn hurtig hjerterytme (puls) forhøjet blodtryk (hypertension) betændelseslignende reaktion i lungerne (pneumonitis, med hoste og vejrtrækningsbesvær), blodpropper, væske omkring lungerne, hoste mundsår og forkølelsessår (stomatitis), betændelseslignende reaktion i bugspytkirtlen (pancreatitis), forstoppelse, mundtørhed pletvise farveændringer af huden (vitiligo), tør hud, hudrødme, unormalt hårtab eller udtynding af håret, nældefeber (kløende, hævet udslæt) en betændelseslignende reaktion (inflammation) i led (artritis), muskelkramper, muskelsvaghed nyresvigt (inklusive pludseligt tab af nyrefunktion) væskeansamlinger (hævelse), smerter, brystsmerter, kulderystelser
Common (may affect up to 1 in 10 people) serious lung infection (pneumonia), infections of the upper respiratory tract, inflammation of the eye (conjunctivitis) increase of eosinophils (type of white blood cells) allergic reaction, reactions related to the infusion of the medicine decreased secretion of hormones produced by adrenal glands (glands situated above the kidneys), underactive function (hypopituitarism) or inflammation (hypophysitis) of the pituitary gland situated at the base of the brain, swelling of the thyroid gland, diabetes dehydration inflammation of the liver inflammation of the nerves (causing numbness, weakness, tingling or burning pain of the arms and legs), dizziness inflammation of the eye which causes redness or pain, blurred vision rapid heart beat high blood pressure (hypertension) inflammation of the lungs (pneumonitis, characterised by coughing and difficulty breathing), blood clots, fluid around the lungs, cough mouth ulcers and cold sores (stomatitis), inflammation of the pancreas (pancreatitis), constipation, dry mouth skin colour change in patches (vitiligo), dry skin, redness of the skin, unusual hair loss or thinning, hives (itchy, bumpy rash)
YERVOY indeholder:
These include:
YERVOY-dosisa udsættes hos patienter med følgende bivirkninger.
When to withhold dose of YERVOY as monotherapy Withhold YERVOY dosea in patients with the following immune-related adverse reactions.
Patienterne i kombinationsarmen fik nivolumab 1 mg/kg i.v.
Patients in the combination arm received nivolumab 1 mg/kg over 60 minutes and ipilimumab 3 mg/kg over
Se produktresuméet for nivolumab for at få yderligere oplysninger om advarsler og forsigtighedsregler forbundet med behandling med nivolumab.
For additional information on warnings and precautions associated with nivolumab treatment, please refer to the nivolumab SmPC.
Immunrelaterede hudbivirkninger
Immune-related skin adverse reactions
Sjælden temporal arteritisd Luftveje, thorax og mediastinum
Respiratory, thoracic and mediastinal disorders Very common dyspnoea
Yderligere data om lægemidlets sikkerhed på lang sigt vil blive indsamlet efter markedsføringen.
Further data on the long-term safety of the medicine will be collected post-marketing.
Hvis der ikke opstår bivirkninger i løbet af det første behandlingsforløb, kan indsprøjtningerne gentages, når der er gået minimum tre måneder.
If no side effects are experienced during the initial treatment, the injections can be repeated after at least 3 months.
Andre oplysninger om Nuceiva
Other information about Nuceiva
Yderligere information om Nuceiva findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/nuceiva.
Further information on Nuceiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nuceiva.
Som for alle lægemidler bliver data vedrørende brugen af Nuceiva løbende overvåget.
As for all medicines, data on the use of Nuceiva are continuously monitored.
Lægemidlet indsprøjtes på fem forskellige steder over og mellem øjenbrynene.
The medicine is injected in 5 different places above and between the eyebrows.
30 dage efter behandlingen havde 87 % (205 ud af 235) af de voksne, der fik Nuceiva, enten lette eller ingen lodrette rynker mellem øjenbrynene sammenlignet med 83 % (202 ud af 244) af de patienter, der fik et andet lægemiddel indeholdende botulinumtoksin type A, og 4 % (2 ud af 48) af de patienter, der fik placebo.
Thirty days after treatment, 87% (205 out of 235) of adults who received Nuceiva had either mild or no vertical lines between the eyebrows, compared with 83% (202 out of 244) of patients who received another medicine containing botulinum toxin type A and 4% (2 out of 48) of patients who were given placebo.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Nuceiva opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency decided that Nuceiva's benefits are greater than its risks and it can be authorised for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nuceiva?
What measures are being taken to ensure the safe and effective use of Nuceiva?
Alvorlige bivirkninger omfatter hængende øjenlåg, immunreaktioner (når kroppens forsvarssystem danner antistoffer mod botulinumtoksin, som forhindrer lægemidlet i at virke), spredning af toksinet til andre dele af kroppen (hvilket kan medføre muskelsvaghed, vejrtræknings- eller synkebesvær og forstoppelse), udvikling eller forværring af lidelser, der påvirker musklerne og nerverne, og overfølsomhedsreaktioner (allergiske reaktioner).
Serious side effects include drooping eyelids, immune responses (when the body's defence system produces antibodies against the botulinum toxin which stop the medicine from working), spread of the toxin to other parts of the body (which may lead to muscle weakness, difficulty breathing or swallowing, and constipation), development or worsening of disorders affecting the muscles and nerves, and hypersensitivity (allergic) reactions.
De indberettede bivirkninger ved Nuceiva vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Nuceiva are carefully evaluated and any necessary action taken to protect patients.
Bivirkningerne ved Nuceiva er som forventet af denne type lægemiddel og giver ikke anledning til større betænkeligheder.
The side effects seen with Nuceiva are as expected from this type of medicine and do not raise any major concerns.
En oversigt over Nuceiva, og hvorfor det er godkendt i EU
An overview of Nuceiva and why it is authorised in the EU
Toksinet reducerer frigivelsen af acetylkolin, som er et kemisk signalstof, der medfører muskelsammentrækning.
The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
De hyppigste bivirkninger ved Nuceiva (som kan forekomme hos op til 1 ud af 10 personer) er hovedpine og hængende øjenlåg.
The most common side effects with Nuceiva (which may affect up to 1 in 10 people) include headache and drooping eyelids.
Hvad er Nuceiva, og hvad anvendes det til?
What is Nuceiva and what is it used for?
Nuceiva (botulinumtoksin type A)EMA/249428/2019
Nuceiva (botulinum toxin type A) EMA/249428/2019
Lægemidlet fås kun på recept og skal gives af en læge med ekspertise i behandling lodrette rynker mellem øjenbrynene og anvendelse af det relevante udstyr.
The medicine can only be obtained with a prescription and must be given by a doctor with expertise in the treatment of vertical lines between the eyebrows and the use of the required equipment.
Hvis du ønsker mere information om anvendelsen af Nuceiva, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
For more information about using Nuceiva, see the package leaflet or contact your doctor or pharmacist.
Hvorfor er Nuceiva godkendt i EU?
Why is Nuceiva authorised in the EU?
Nuceiva må ikke anvendes til personer med sygdomme, der påvirker musklerne, såsom myasthenia gravis eller Eaton Lambert-syndrom, og personer, der har en infektion eller betændelse på det planlagte injektionssted.
Nuceiva must not be used in people with diseases affecting the muscles, such as myasthenia gravis or Eaton-Lambert syndrome, and those who have an infection or inflammation at the planned site of injection.
Hvilke risici er der forbundet med Nuceiva?
What are the risks associated with Nuceiva?
Nuceiva er påvist at gøre de lodrette rynker mellem øjenbrynene mindre synlige i et hovedstudie, som omfattede 540 voksne med moderate til svære lodrette rynker, som påvirkede deres humør eller medførte symptomer på angst eller depression.
Nuceiva has been shown to make the vertical lines between the eyebrows less noticeable in a main study involving 540 adults with moderate or severe vertical lines that affected their mood or caused symptoms of anxiety or depression.
Det anvendes hos voksne personer på under 65 år med moderate til svære ansigtsrynker, og som er stærkt psykisk påvirket af disse rynker.
It is used in adults less than 65 years of age who have moderate to severe facial lines and in whom those lines are having a significant psychological impact.
punktsskala, kaldet glabellalinjeskalaen (GLS), hvor 0 = ingen rynker, 1 = let, 2 = moderat og 3 = svær.
The effectiveness of treatment was measured using a standard 4-point scale, called glabellar line scale (GLS), where 0 = no lines, 1 = mild, 2 =moderate and 3 = severe.
Det aktive stof i Nuceiva, botulinumtoksin type A, produceres af bakterien Clostridium botulinum.
The active substance in Nuceiva, botulinum toxin type A, is produced by the bacterium Clostridium botulinum.
Nuceiva er mindst lige så effektivt som et andet lægemiddel indeholdende botulinumtoksin type A og mere effektivt end placebo hos voksne med moderate til svære lodrette rynker mellem øjenbrynene.
Nuceiva is at least as effective as another medicine containing botulinum toxin type A and more effective than placebo in adults with moderate to severe vertical lines between the eyebrows.
Nuceiva er et lægemiddel, som anvendes til midlertidigt at forbedre udseendet af lodrette rynker mellem øjenbrynene.
Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows.
Når Nuceiva indsprøjtes direkte i musklerne over og mellem øjenbryderne, får det musklerne til at slappe af, hvilket gør de lodrette rynker mindre synlige.
When Nuceiva is injected directly into the muscles above and between the eyebrows, it causes the muscles to relax, helping to make the vertical lines less noticeable.
Nuceiva (botulinumtoksin type A)
Nuceiva (botulinum toxin type A)
Den fuldstændige liste over bivirkningerne ved Nuceiva fremgår af indlægssedlen.
For the full list of side effects of Nuceiva, see the package leaflet.
Nuceiva blev i studiet sammenlignet med et andet lægemiddel indeholdende botulinumtoksin type A og placebo (en uvirksom behandling).
In the study, Nuceiva was compared with another medicine containing botulinum toxin type A and placebo (a dummy treatment).
Hvordan anvendes Nuceiva?
How is Nuceiva used?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Nuceiva.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuceiva have been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser studierne, at der er ved Nuceiva?
What benefits of Nuceiva have been shown in studies?
Nuceiva indeholder det aktive stof botulinumtoksin type A.
Nuceiva contains the active substance botulinum toxin type A.
Hvordan virker Nuceiva?
How does Nuceiva work?
Nuceiva indsprøjtes i de pandemuskler, der, når de trækker sig sammen, danner de lodrette rynker mellem øjenbrynene.
Nuceiva is given by injection into the muscles in the forehead whose contractions cause the vertical lines between the eyebrows.
(Særnavn) Navn Styrke Lægemiddelform Administration Emballage
Invented name Strength Pharmaceutical form Route of administration Immediate Packaging
Dette sammendrag blev sidst ajourført i 09-2013.
This summary was last updated in 09/2013.
Den fuldstændige EPAR for Ultibro Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Ultibro Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.