natgillin/translations-raw huggingface dataset:
Rengøring af Diskos Tør mundstykket af med en tør klud.
Wipe the mouthpiece of the Diskus with a dry tissue to clean it.
• CHMP fandt det dog acceptabelt, at produktresuméets afsnit 4.2 indeholder en anbefaling om kortvarig forsøgsvis brug af fastdosiskombinationen af salmeterol og fluticason som initial vedligeholdelsesbehandling af voksne og unge patienter med moderat persisterende astma og tvingende behov for hurtig astmakontrol,
• the CHMP agreed, however, that a recommendation for a short term trial with the fixed dose combination of salmeterol and fluticasone propionate as initial maintenance therapy in adults and adolescents with moderate persistent asthma for whom rapid control of asthma is essential, in section 4.2 of the SPC is acceptable.
Metaboliske og ernæringsmæssige lidelser Hyperglykæmi
Metabolism & Nutrition Disorders
Seretide bør ikke tages sammen med beta-blokkere (fx atenolol, propranolol, sotalol), med mindre din læge har ordineret det. Nogle typer medicin mod virus og svamp (fx ritonavir, ketoconazol og itraconazol) kan øge mængden af fluticasonpropionat i kroppen og derved øge risikoen for bivirkninger.
Some types of antiviral and antifungal medication (such as ritonavir, ketoconazole and itraconazole) may increase the amount of fluticasone propionate in your body and therefore increase your risk of having side effects.
Alfred-Nobel-Str. 10 D-40789 Monheim, Tyskland atmadisc forte 50µg/500µg Diskus
D-40789 Monheim Germany atmadisc forte 50µg/500µg Diskus
Meget almindelig bivirkning (det sker hos flere end 1 ud af 10 patienter): - Hovedpine, aftager som regel ved fortsat behandling.
Very Common effects: this means that more than 1 in 10 people taking the medicine are affected.
I dyrereproduktionsundersøgelser er der set misdannelser (hareskår, knogledeformiteter) efter administration af glukokortikoider.
In animal reproduction studies, glucocorticosteroids have been shown to induce malformations (cleft palate, skeletal malformations).
Diskus indeholder folieblisterbånd med Seretide inhalationspulver.
The Diskus device holds blisters containing Seretide in powder form.
Du bør ikke anvende Seretide - hvis du er overfølsom over for salmeterol, fluticasonpropionat eller lactose.
If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient lactose monohydrate.
Dosis skal titreres til laveste effektive dosis.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Muskelkramper Artralgi.
Muscle cramps Arthralgia Myalgia
Seretide virker ikke på pludselige anfald af åndenød og hvæsende vejrtrækning, den har ikke en øjeblikkelig virkning.
Do not use Seretide to treat a sudden attack of breathlessness or wheezing as it will not help you immediately.
I en undergruppe bestående af patienter, der ikke før havde fået steroider, gik der 16 dage, før patienterne var velkontrollerede, hvorimod der gik 23 dage med inhalationssteroid alene.
In the subset of steroid naive asthmatics the time to an individual Well Controlled week was 16 days in the Seretide treatment compared to 23 days following treatment with ICS.
Kliniske afprøvninger med Seretide til KOL
Seretide COPD clinical trials
Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire SG12 ODJ, United Kingdom.
Bilkørsel og betjening af maskiner Seretide påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
The possible side effects associated with Seretide are unlikely to affect your ability to drive or use machines.
Lidelser i luftveje, thorax og mediastinum Svælgirritation.
Respiratory, Thoracic & Mediastinal Disorders
Seponering hos patienter med KOL kan føre til symptomer og bør kun ske i samråd med lægen.
For patients with COPD cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician.
Dosisknappen går automatisk tilbage til startposition.
The lever will return to its original position and is reset.
Hovedpine
Headache Tremor
Der er ikke set yderligere bivirkninger ved samtidig brug af de to stoffer.
There is no incidence of additional adverse events following concurrent administration of the two compounds.
- Muskelkramper.
- Muscle cramps.
Forøgelsen af den systemiske påvirkning er ligefrem proportional med størrelsen af dosis.
There is a linear increase in systemic exposure with increasing inhaled dose.
UDLØBSDATO Anvendes senest
EXPIRY DATE
Disse virkninger forsvinder som regel ved fortsat behandling.
- Headache, although this side effect usually lessens as treatment continues.
Tal med din læge om dette.
please tell your doctor or pharmacist.
Bivirkningerne er inddelt i henhold til organklasser og efter hyppighed.
Adverse events which have been associated with salmeterol fluticasone propionate are given below, listed by system organ class and frequency.
Til behandling af astma, hvor behandling med en kombinationsprodukt (langtidsvirkende ß2-agonist og inhalationssteroid) er hensigtsmæssig: - hos patienter, der ikke er velkontrollerede på inhalationssteroid og korttidsvirkende ß2-agonist ved behov,
Seretide is indicated in the regular treatment of asthma where use of a combination product (longacting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2
Patienter, der har været i behandling med høje doser steroider, er i risiko for nedsat binyrebarkfunktion i længere tid.
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk.
Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, katarakt, glaukom
Endocrine Disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density, Cataract, Glaucoma
Eventuel systemisk påvirkning kan omfatte Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, fald i knogletæthed, katarakt og glaukom.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.
Akut binyrebarkinsufficiens kan opstå på grund af traume, operation, infektion eller for hurtig nedsættelse af dosis og kan føre til spisevægring, mavesmerter, vægttab, træthed, hovedpine, kvalme, opkastning, hypotension, opmærksomhedstab, hypoglykæmi og kramper.
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures.
GlaxoSmithKline Oy, Piispansilta 9A, P.O. Box 24, FIN-02231 Espoo, Finland
Box 24 FIN-02231 Espoo Finland
4.8 ”Bivirkninger”), som skal tages med i overvejelserne, når medicinen udskrives til diabetes-patienter.
There have been very rare reports of increases in blood glucose levels (see 4.8 Undesirable Effects) and this should be considered when prescribing to patients with a history of diabetes mellitus.
I meget sjældne tilfælde er disse tilstande set ved doser på 500-1000 mikg.
Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000mcg.
Indehaveren af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen [Se bilag I - Udfyldes nationalt]
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [See Annex I - To be completed nationally]
Yderligere information om dette lægemiddel er tilgængelig på Lægemiddelstyrelsens hjemmeside: www.laegemiddelstyrelsen.dk
<Detailed information on this medicine is available on the web site of {MA/Agency}>
Kun til inhalation.
Use of the inhaler
GlaxoSmithKline Pharma A/S, Nykær 68, DK-2605 Brøndby, Danmark
GlaxoSmithKline Pharma A/S, Nykær 68
Når dosisknappen trykkes i bund, bliver en blister brudt og pulveret frigjort til inhalation.
Every time the lever is pulled back a blister is opened and the powder made ready for you to inhale.
Overfølsomhedsreaktioner, fx hududslæt
Cutaneous hypersensitivity reactions
I en interaktionsundersøgelse med fluticasonpropionat givet intranasalt til raske personer, øgede ritonavir (en stærkt potent cytochrom P450 3A4-hæmmer) 100 mg 2 gange dagligt plasmakoncentrationen af fluticasonpropionat flere hundrede gange, og det resulterede i stærkt nedsatte serumkortisolkoncentrationer.
In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) 100 mg b.i.d.
Sug ind så hurtigt og dybt som muligt gennem munden.
- Put the mouthpiece to your lips; breathe in steadily and deeply through the Diskus, not through your nose.
Lot no
Lot
Akut overdosering kan resultere i midlertidig suppression af binyrebarkfunktionen.
Acute: Acute inhalation of fluticasone propionate doses in excess of those recommended may lead to temporary suppression of adrenal function.
Sådanne symptomer bør føre til overvejelse om højere steroiddosis.
Consideration should be given to increasing corticosteroid therapy.
Salmeterol 50 mikrogram som salmeterolxinafoat kombineret med enten 100 mikrogram, 250 mikrogram eller 500 mikrogram fluticasonpropionat.
50 micrograms of salmeterol (as salmeterol xinafoate) and 100, 250 or 500 micrograms of fluticasone propionate.
Almindelig Meget sjælden
Common Common Very Rare
Da Seretide indeholder salmeterol og fluticasonpropionat, må der forventes samme bivirkninger som ved administration af disse stoffer.
As Seretide contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected.
Ømhed i tunge og svælg samt hæshed.
Soreness of the tongue, throat and hoarseness of the voice.
hjertearytmi, diabetes mellitus, ubehandlet hypokaliæmi og tyreotoksikose.
Seretide should be administered with caution in patients with severe cardiovascular disorders, including heart rhythm abnormalities, diabetes mellitus, untreated hypokalaemia or thyrotoxicosis.
Systemisk påvirkning kan opstå efter inhalation af steroider, især ved høje doser givet i længere perioder, men det er langt mindre sandsynligt end ved peroral steroidbehandling.
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods.
Hvis symptomerne kan kontrolleres ved behandling med Seretide i laveste styrke to gange dagligt, kan behandling med inhalationssteroid alene eventuelt forsøges, eller de patienter, der også har behov for langtidsvirkende ß2-agonister, kan titreres ned til Seretide én gang dagligt.
Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone.
Din læge kan ordinere behandling af svamp, samtidig med at du tager Seretide.
Your doctor may prescribe additional anti fungal medication to treat the thrush.
Meget sjælden bivirkning (det sker hos mindre end 1 ud af 10.000 patienter): - Overfølsomhedsreaktioner, fx kløe, hævelse (som regel i ansigtet, på læber, tunge eller i svælget), åndenød, hvæsen eller hoste (bronkospasme).
- Signs of allergy, such as itching, swelling (usually of the face, lips, tongue or throat), difficulty in breathing, wheezing or coughing (bronchospasm).
Almindelig Ikke almindelig Meget sjælden
Common Uncommon Very Rare
CHMP drøftede på grundlag af rapportørens og medrapportørens evalueringsrapporter og de af indehaverne af markedsføringstilladelsen forelagte oplysninger hensigtsmæssigheden af initial vedligeholdelsesbehandling med brug af fastdosiskombinationen.
A discussion on the appropriateness of initial maintenance therapy with the fixed dose combination took place in CHMP based on the Rapporteur's and Co-Rapporteur's Assessment Reports and the data presented by the Marketing Authorisation Holders (MAHs).
**) Total kontrol blev defineret som: ingen symptomer, ingen brug af korttidsvirkende ß2-agonister (behovsmedicin), ≥ 80 % af forventet lungefunktion, ingen natlig opvågnen, ingen eksacerbationer og ingen bivirkninger, der førte til ændring i behandlingen.
No ICS (SABA alone) Low dose ICS ( ≤500mcg BDP or equivalent/day) Medium dose ICS (>500-1000mcg BDP or equivalent/day) Pooled results across the 3 treatment levels *Well controlled asthma; occasional symptoms or SABA use or less than 80% predicted lung function plus no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy **Total control of asthma; no symptoms, no SABA use, greater than or equal to 80% predicted lung function, no night-time awakenings, no exacerbations and no side effects enforcing a change in therapy
For at opnå fuld effekt af Diskus skal den bruges hver dag - også i perioder uden symptomer.
Patients should be made aware that Seretide Diskus must be used daily for optimum benefit, even when asymptomatic.
Inhalationsbehandlingen med fluticasonpropionat bør minimere behovet for perorale steroider.
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
10 x 60 afdelte doser.
10 x 60 inhalations
3 x 60 afdelte doser.
3 x 60 inhalations
2 x 60 afdelte doser.
2 x 60 inhalations
Eventuelle systemiske bivirkninger er Cushings syndrom, cushingoide træk, binyrebarksuppression, væksthæmning hos børn og unge, nedsat knogletæthed, katarakt og glaukom (se pkt.
Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma (see 4.4 Special Warnings and Precautions For Use).
6.6 Særlige forholdsregler ved bortskaffelse Diskus frigiver pulver til inhalation i lungerne.
The Diskus releases a powder which is inhaled into the lungs.
Seretide inhalationspulver leveres i Diskus, som indeholder en foliestrimmel med blistre med de enkelte doser.
The inhalation powder is contained in blisters held on a formed PVC coated base, with a peelable foil laminate lid.
Skub dosisknappen helt i bund - til det siger klik.
Slide the lever away from you as far as it will go until it clicks.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 250 mikrogram pr. dosis
STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
Der bør udvises forsigtighed ved lungetuberkulose, som ved al anden inhalationsbehandling med kortikosteroider.
As with all inhaled medication containing corticosteroids, Seretide should be administered with caution in patients with pulmonary tuberculosis.
Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13,B-1332 Genval, Belgien
Luxembourg GlaxoSmithKline s.a./n.v., Rue du Tilleul 13
Hvis binyrebarkfunktionen er nedsat på grund af tidligere brug af systemiske steroider bør der især udvises forsigtighed ved igangsættelse af behandling med Seretide.
Care should be taken when transferring patients to Seretide therapy, particularly if there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy.
Farmakoterapeutisk klassifikation: Astmamiddel med bronkodilaterende og antiinflammatorisk virkning beregnet til inhalation, R 03 AK 06
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic Group: Adrenergics and other anti-asthmatics.
1 inhalation af 50 mikg salmeterol og 100 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 100 mikrogram pr. dosis
STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 100 micrograms of fluticasone propionate per actuation
Seretide Diskus og andre navne (se bilag I) 50/250 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]
Seretide Diskus and associated names (see Annex I) 50/250 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Ikke almindelig Meget sjælden
Common Very Rare Very Rare
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Salmeterol som salmeterolxinafoat 50 mikrogram og fluticasonpropionat 500 mikrogram pr. dosis
STATEMENT OF ACTIVE SUBSTANCE(S) 50 micrograms of salmeterol (as xinafoate) and 500 micrograms of fluticasone propionate per actuation
Det anbefales at finde den mest hensigtsmæssige dosis inhalationssteroid, før der anvendes en fast kombination hos patienter med svær astma.
Seretide 50/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed combination can be used in patients with severe asthma.
Seretide Diskus og andre navne (se bilag I) 50/500 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]
Seretide Diskus and associated names (see Annex I) 50/500 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Eller 1 inhalation af 50 mikg salmeterol og 250 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
Eller 1 inhalation af 50 mikg salmeterol og 500 mikg fluticasonpropionat 2 gange daglig.
One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Seretide Diskus og andre navne (se bilag I) 50/100 mikrogram/dosis inhalationspulver, afdelt [Se bilag I - Udfyldes nationalt]>
Seretide Diskus and associated names (see Annex I) 50/100 microgram/dose inhalation powder, predispensed [See Annex I - To be completed nationally]
Denne indlægsseddel fortæller:
The overall study results showed:
Hel brugsanvisningen er beskrevet i indlægssedlen i pakningen.
The strip is contained in a moulded plastic device.
KOL
FP
GlaxoSmithKline s.a./n.v., Rue du Tilleul 13, B-1332 Genval, Belgien
Belgium GlaxoSmithKline s.a./n.v., Rue du Tilleul 13
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Diskus er en plasticbeholder med pvc-lamineret folieblisterbånd med inhalationspulver i: 28 afdelte doser.
PHARMACEUTICAL FORM AND CONTENTS Inhalation powder, pre-dispensed 1 x 28 inhalations
Her er den anbefalede dosis 50 mikrogram salmeterol og 100 mikrogram fluticasonpropionat 2 gange daglig.
In these cases, the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily.
Overfølsomhed over for indholdsstofferne (se pkt.
Seretide is contraindicated in patients with hypersensitivity (allergy) to any of the active substances or to the excipient (see 6.1 List of Excipients).
Almindelig bivirkning (det sker hos mellem 1 og 10 ud af 100 patienter): - Svamp (ømme, hvid-gullige, hævede pletter) i mund og svælg.
Common effects: means that between 1 in 10 and 1 in 100 people taking the medicine are affected.
Produktets udseende og pakningsstørrelse
SUMMARY OF PRODUCT CHARACTERISTICS
Vær opmærksom på, at dosisknappen kun trykkes ned, når den skal bruges, da den bryder blistrene, og medicin ellers kan gå tabt.
Do not play with the lever as this opens the blisters and wastes medicine.
HVAD DU SKAL GØRE, FØR DU BEGYNDER AT TAGE SERETIDE
BEFORE YOU TAKE SERETIDE
Endokrine lidelser
Cardiac Disorders
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Celvapan den 4. marts 2009.
The European Commission granted a marketing authorisation valid throughout the European Union for Celvapan on 4 March 2009.
Der er udarbejdet en risikostyringsplan for at sikre, at Celvapan anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Celvapan is used as safely as possible.
Den fuldstændige EPAR for Celvapan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Celvapan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Celvapan.
This is a summary of the European Public Assessment Report (EPAR) for Celvapan.
Den ene undersøgelse omfattede 408 raske voksne, hvoraf halvdelen var over 60 år (202 fik en fuld dosis Celvapan og resten fik en halv dosis), og den anden undersøgelse omfattede 167 raske børn i alderen seks måneder til 17 år (101 fik en fuld dosis Celvapan og resten fik en halv dosis).
One study involved 408 healthy adults, half of whom were over 60 years of age (202 received a full dose of Celvapan, the others a half dose) and the second involved 167 healthy children aged between six months and 17 years (101 received a full dose of Celvapan, the others a half dose).
Virusset er blevet inaktiveret (dræbt), så det ikke er sygdomsfremkaldende.
The virus has been inactivated (killed) so that it does not cause any disease.
Vacciner virker ved at »lære« immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare organismen mod en sygdom.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Celvapan er en vaccine.
Celvapan is a vaccine.
Hvilken risiko er der forbundet med Celvapan?
What is the risk associated with Celvapan?
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Celvapan skal anvendes.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for
Celvapan må ikke gives til personer, der har haft en anafylaktisk reaktion (svær overfølsomhedsreaktion) over for en af vaccinens komponenter eller over for nogen af de sporstoffer, den indeholder (meget lavt indhold), f.eks. formaldehyd, benzonase eller sukrose.
Celvapan must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
I begge undersøgelserne viste den fulde dosis af vaccinen at frembringe en tilstrækkelig beskyttende mængde antistoffer i overensstemmelse med de kriterier, som er fastsat af CHMP.
In both studies, the full dose of the vaccine was shown to bring about protective levels of antibodies to a satisfactory level in line with the criteria laid down by the CHMP.
influenzavaccine (H1N1)v (hel virion, verocelleafledt, inaktiveret)
influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Der er gennemført to hovedundersøgelser, som så på, hvorvidt to doser Celvapan H1N1 givet med tre ugers mellemrum kunne udløse en immunrespons.
Two main studies have been carried out that looked at the ability of two doses of Celvapan H1N1 given three weeks apart to trigger an immune response.
Hvis du ønsker yderligere oplysninger om behandling med Celvapan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Celvapan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP besluttede, at fordelene ved Celvapan opvejer risiciene, og anbefalede udstedelse af en
The CHMP decided that Celvapan's benefits of are greater than its risks and recommended that it be