natgillin/translations-raw huggingface dataset:
If you notice any of the following effects stop the injection and tell your doctor immediately: rash, itching, wheezing, difficulty in breathing, swelling of the eyelids, face, lips, throat or tongue, low blood pressure, fast pulse 
težave pri dihanju, otekanje vek, obraza, ustnic, žrela ali jezika, nizek krvni tlak, hiter srčni utrip.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection 
FARMACEVTSKA OBLIKA IN VSEBINA
Please tell your doctor about your treatment with Zutectra prior to any vaccination. 
Pred vsakim cepljenjem obvestite svojega zdravnika, da ste bili zdravljeni z zdravilom Zutectra.
Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin 
Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi humani imunoglobulin proti hepatitisu tipa B
Transmissible agents 
Prenosljivi povzročitelji bolezni
NN: {number} [national reimbursement number or other national number identifying the medicinal product] 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety. 
Obstajajo opogumljajoče klinične izkušnje o neprenašanju virusa hepatitisa tipa A ali parvovirusa B19
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
How to inject Zutectra by yourself or by caregiver 
Samoinjiciranje zdravila Zutectra ali injiciranje s strani negovalnega osebja
6.6 Special precautions for disposal and other handling This medicinal product should be brought to room temperature (approx. 23°C-27°C) before use. 
6.4 Posebna navodila za shranjevanje Zdravilo shranjujte in prevažajte na hladnem (2°C-8 C).
Most adverse drug reactions (ADRs) were mild to moderate in nature. 
Povzetek varnostnega profila Večina neželenih učinkov je bilo blage do zmerne narave.
* single case reports Adverse reactions observed with other human immunoglobulin preparations 
Pri uporabi drugih pripravkov s humanimi imunoglobulini so poročali o naslednjih dodatnih simptomih:
The solution should be administered immediately after opening the syringe. 
2 leti Raztopino je treba aplicirati takoj po odprtju injekcijske brizge.
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe 
Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi
5.1 Pharmacodynamic properties 
FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti
PHARMACEUTICAL FORM Solution for injection 
NAČIN IZDAJANJA ZDRAVILA
NAME OF THE MEDICINAL PRODUCT Zutectra 500 IU solution for injection in pre-filled syringe Human hepatitis B immunoglobulin 
Navodilo za uporabo Zutectra 500 i.e. raztopina za injiciranje v napolnjeni injekcijski brizgi humani imunoglobulin proti hepatitisu tipa B
Tabulated list of adverse reactions 
Lokalne reakcije na mestih vboda
INFORMATION IN BRAILLE Zutectra 500 IU 
PODATKI V BRAILLOVI PISAVI
This medicine has been prescribed for you only. 
Izdaja zdravila je le na recept.
Antibody levels >100 IU/l should be maintained. 
> 100 i.e./l.
Immune system disorders 
Organski sistem po MedDRA Neželeni učinki
ES-08960 Sant Just Desvern Barcelona Tel: + 34 935 952 661 
Barcelona Tel: + 34 935 952 661
If you use more Zutectra than you should 
Če ste uporabili večji odmerek zdravila Zutectra, kot bi smeli Posledice prevelikega odmerjanja niso znane.
You should rotate the injection site at every injection. 
Vsakič izberite drugo mesto za injiciranje.
Water for injections 
INJEKCIJSKA BRIZGA
• Periodic Safety Update Reports 
* poročila o posamičnih primerih
Injection site reactions like pain, urticaria at injection site, haematoma and erythema 
Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja, kot so bolečina, urtikarija na mestu injiciranja, hematom in eritem pogosti izčrpanost, utrujenost redki*
Prevention of hepatitis B virus (HBV) re-infection in HBsAg and HBV-DNA negative adult patients at least one week after liver transplantation for hepatitis B induced liver failure. 
negativnih odraslih bolnikih vsaj en teden po presaditvi jeter zaradi s hepatitisom tipa B izzvane odpovedi jeter.
Kolarova 7, 10000 Zagreb T: +385 1 2303 446 
T: +385 1 2303 446
PT-1050 139 Lisboa 
PT-1050 139 Lisboa Tel: + 351 21 193 14 20
Find a clean place where you can spread out all the items you are going to use: 
Določite čisto mesto, kamor lahko položite vse, kar boste potrebovali: dve alkoholni krpici, eno injekcijsko brizgo zdravila Zutectra,
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Nervous system disorders 
Bolezni živčevja glavobol občasni
This will depend on your individual need. 
Odvisen bo od vaših osebnih potreb.
In most cases, either in the morning or in the evening - as one or two puffs once a day. 
V večini primerov, bodisi zjutraj ali zvečer - kot en ali dva vpiha enkrat dnevno.
This product was submitted under article 10.3 of the Directive 2001/83/EC. 
To zdravilo je bilo predloženo v skladu s členom 10(3) Direktive 2001/83/ES.
Please remember: 
Zapomnite si:
It is important that you take Alvesco regularly every day, even if you feel better. 
Pomembno je, da zdravilo Alvesco jemljete redno vsak dan, tudi če se počutite bolje.
Dosing recommendation for adults and adolescents: 
Priporočeni odmerki za odrasle in mladostnike:
These patients are partially controlled as per the latest GINA guidelines. 
Ti bolniki so delno nadzorovani v skladu z najnovejšimi smernicami GINA.
How much Alvesco should I take each day? 
Koliko zdravila Alvesco moram vzeti vsak dan?
In most cases you can continue with your treatment. 
V večini primerov se zdravljenje lahko nadaljuje.
Follow your doctor's instructions very carefully. 
Zelo natančno upoštevajte zdravnikova navodila.
CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE 
POGOJI, OCENJENI KOT KLJUČNI ZA VARNO IN UČINKOVITO UPORABO ZDRAVILA, VKLJUČNO S FARMAKOVIGILANCO
Patients experiencing these symptoms should stop using the medicine and seek immediate medical attention. 
Bolniki, ki imajo te simptome morajo prenehati uporabljati zdravilo in poiskati takojšnjo zdravniško pomoč.
SCIENTIFIC CONCLUSIONS 
ZNANSTVENI ZAKLJUČKI
During the mutual recognition procedure, the regulatory authorities of France were of the opinion that the product raised a potential serious risk to public health on safety and efficacy grounds. 
Med postopkom medsebojnega priznavanja so regulatorni organi Francije izrazili mnenje, da zdravilo pomeni možno resno tveganje za javno zdravje na podlagi varnosti in učinkovitosti.
This is usually seen in patients taking high doses over a long period of time. 
To se običajno pojavi pri bolnikih, ki dalj časa jemljejo visoke odmerke.
The conditions for the Marketing Authorisation are set out in Annex IV. 
Pogoji za dovoljenje za promet so navedeni v Dodatku IV.
The National Competent Authorities, coordinated by the Reference Member State shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder: 
Pristojni nacionalni organi, ki jih koordinira referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
This is important as traces of medicine could remain in the container even if you have the impression that it might be empty. 
To je pomembno, ker lahko sledi zdravila ostanejo v vsebniku, tudi če je videti prazen.
The medicinal product is for inhalation use only. 
Zdravilo se uporablja samo za inhaliranje.
Study MI-129 did not define an adequate primary endpoint in accordance with the current guidelines for asthma. 
Študija MI-129 ni podala ustreznega primarnega pokazatelja v skladu s trenutnimi smernicami za astmo.
The container should not be punctured, broken or burned even if it seems empty. 
Vsebnika nikoli ne prebadajte, ne poškodujte in ne sežigajte, četudi je videti prazen.
However, this note also refers to the lack of data available to confirm that this approach has additional therapeutic effects after 3 months with the highest dose available. 
To navodilo se nanaša tudi na pomanjkanje razpoložljivih podatkov, ki bi potrdili, da bo imel ta pristop ob prejemanju največjega razpoložljivega odmerka po 3 mesecih dodatne terapevtske učinke.
• If you have just started to use this medicine instead of, or as well as, taking corticosteroid tablets, see section 2, Patients who are already taking corticosteroid tablets. 
• Če ste pravkar začeli uporabljati to zdravilo namesto kortikosteroidov v obliki tablet ali tablete še vedno jemljete, glejte poglavje 2, Bolniki, ki že jemljejo kortikosteroide v obliki tablet.
If necessary, your doctor may also prescribe corticosteroid tablets and/or, in the case of an infection, an antibiotic. 
Zdravnik vam po potrebi lahko predpiše tudi kortikosteroide v obliki tablet in/ali, v primeru okužbe, antibiotik.
Do not store above 50°C. 
Shranjujte pri temperaturi do 50°C.
Adolescents who are receiving treatment for a long period of time should have their height checked regularly by their doctor. 
Pri mladostnikih, ki dalj časa prejemajo zdravljenje, morajo zdravniki redno preverjati telesno višino.
If your doctor decides to stop treatment or if the inhaler is empty, return it to your pharmacist for safe disposal. 
Če se zdravnik odloči prekiniti zdravljenje ali če se inhalator izprazni, ga vrnite farmacevtu, ki ga bo varno odstranil.
The side effects you may experience are: 
Neželeni učinki, ki se lahko pojavijo, so:
The following issues were raised concerning this application: 
V zvezi s to vlogo so bila izpostavljena naslednja vprašanja:
The expected benefits of your medicine will usually be greater than the risks of suffering any harmful side effects. 
Pričakovane koristi jemanja zdravila so običajno večje od tveganj škodljivih neželenih učinkov.
As with most inhaled medicines in pressurised containers, the healing effect of this medicinal product may become smaller when the container is cold. 
Kot pri večini zdravil za inhaliranje, ki so v vsebnikih pod tlakom, je lahko zdravilni učinek zdravila manjši, kadar je vsebnik ohlajen.
The treatment period and primary endpoint appear adequate to measure the potential benefit of higher doses of ciclesonide. 
Obdobje zdravljenje in primarni pokazatelj sta ustrezna za merjenje možnih koristi večjih odmerkov ciklesonida.
Such a study must comply with the Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma CPMP/EWP/2922/01. 
Takšna študija mora biti v skladu z navodilom za klinično raziskovanje zdravil za zdravljenje astme (Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma) CPMP/EWP/2922/01.
Pharmaceutical Form Route of administration 
Farmacevtska oblika Pot uporabe zdravila
- If you have any further questions, ask your doctor or pharmacist. 
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
Uncommon side effects (fewer than 1 in every 100 patients treated): 
Občasni neželeni učinki (pojavijo se pri manj kot enem od 100 bolnikov):
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ALVESCO AND ASSOCIATED NAMES (see Annex I) 
SPLOŠNI POVZETEK ZNANSTVENE OCENE ZDRAVILA ALVESCO IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
However, Alvesco delivers the same level of dose from minus 10°C to plus 40°C. 
Vendar inhalator zdravila Alvesco dovaja enako stopnjo odmerka pri temperaturi v razponu od minus 10°C do plus 40°C.
When should I use my Alvesco inhaler? 
Kdaj moram uporabljati inhalator Alvesco?
Alvesco may affect the normal production of corticosteroids in your body. 
Zdravilo Alvesco lahko vpliva na normalno nastajanje kortikosteroidov v telesu.
• An increased dosage of Alvesco may become necessary for a short period of time in patients who suffer a severe worsening of their asthma symptoms. 
• Povečan odmerek zdravila Alvesco lahko postane nujen za kratko časovno obdobje pri bolnikih s hudim poslabšanjem simptomov astme.
Your doctor will have spoken to you about how much of your medicine you need to take each day. 
Zdravnik se bo z vami pogovoril o tem, kolikšen bo vaš dnevni odmerek zdravila.
If growth rate is slowed, your doctor will adjust your treatment if possible to the lowest dose at which effective control of asthma is maintained. 
Če se rast upočasni, bo vaš zdravnik prilagodil vaše zdravljenje na najnižji možni odmerek, ki še zagotavlja učinkoviti nadzor astme.
If you have been taking steroid tablets before or during the use of Alvesco, the risk of side effects from the tablets may continue for a period of time. 
Če ste jemali steroide v obliki tablet pred uporabo zdravila Alvesco ali med njo, se lahko tveganje za pojav neželenih učinkov še nekaj časa nadaljuje.
Both ciclesonide doses resulted in comparable FEV1 values at 12 weeks. 
Pri obeh odmerkih ciklesonida sta bili vrednosti FEV1 po 12 tednih primerljivi.
After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo. 
Po stimulaciji z 1 in 250 mikrogrami kozintropina niso opazili pomembnih sprememb v ravni kortizola v plazmi v primerjavi s placebom.
Regular check-ups will also identify any side effects early on and reduce the chances of them worsening. 
Ob rednih pregledih se bodo že v začetni fazi pojavili morebitni neželeni učinki, pri čemer se bo zmanjšala možnost poslabšanja.
Do not use your inhaler after the expiry date which is stated on the label and the carton after EXP. 
Inhalatorja ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "Uporabno do".
The risk/benefit analysis of the use of higher doses of ciclesonide in the treatment of severe asthmatics, as the supportive data, interpreted according to the CHMP guidelines, do not allow authorization of regular daily doses in excess of 160 micrograms in the intended populations. 
Analiza tveganj in koristi uporabe večjih odmerkov ciklesonida pri zdravljenju hudih astmatikov, glede na to, da podporni podatki, razloženi v skladu s smernicami CHMP, ne omogočajo odobritve rednih dnevnih odmerkov nad 160 mikrogramov pri zdravljenih populacijah.
These rare side effects may include: - reduced rate of growth in adolescents - a thinning of the bones - possible clouding of the lens of the eye (cataracts) causing blurred vision - loss of vision caused by abnormally high pressure in the eye (glaucoma) - moon-shaped face, weight gain in the upper body and thinning arms and legs (Cushingoid features or Cushing syndrome). 
Med temi redkimi neželenimi učinki so lahko: - upočasnitev rasti pri mladostnikih - tanjšanje kosti - morebitna zamegljenost leče v očesu (katarakte), ki povzroča zamegljen vid - izguba vida zaradi nenormalno visokega tlaka v očesu (glavkom) - lunast obraz, povečanje telesne teže v zgornjem delu telesa in tanjšanje rok in nog
In addition the CHMP was concerned with introducing the notion of switching from moderate to high dose inhaled corticosteroids to higher doses of Alvesco, as this was not in the original submission. 
Poleg tega je CHMP izrazil pomisleke glede uvajanja prehoda z zmernega do visokega odmerka inhaliranih kortikosteroidov na večje odmerke zdravila Alvesco, saj to ni bilo vključeno v prvotno vlogo.
• bad taste, burning, inflammation, irritation, dryness of mouth or throat 
• neprijeten okus, pekoč občutek, vnetje, draženje, suha usta ali grlo;
As a conclusion to the evaluation, the CHMP was of the opinion that the proposed wording for Section 4.2 at the end of CMDh would continue to be adequate with the following amendment: 
Ob zaključku vrednotenja je CHMP menil, da bo besedilo poglavja 4.2, predlagano ob zaključku postopka v okviru CMDh, še naprej ustrezno ob naslednjem dopolnilu:
The container contains a pressurised liquid. 
Vsebnik vsebuje tekočino pod tlakom.
POSSIBLE SIDE EFFECTS 
Možni neželeni učinki
Possible side effects 
MOŽNI NEŽELENI UČINKI
The CHMP was of the opinion that the MAH had identified a feasible target patient population in the response. 
CHMP je menil, da je imetnik dovoljenja za promet z zdravilom v odgovoru navedel primerno ciljno populacijo bolnikov.
Corticosteroid tablets can lead to more side effects than a corticosteroid inhaler such as Alvesco. 
Kortikosteroidi v obliki tablet lahko povzročijo več neželenih učinkov kot kortikosteroidi v obliki inhalatorja kot je Alvesco.
• In some patients a dose reduction to 80 micrograms, once daily, may be an adequate dose for maintaining effective control of their asthma. 
• Pri nekaterih bolnikih je lahko zmanjšanje odmerka na 80 mikrogramov enkrat dnevno ustrezno za vzdrževanje učinkovitega nadzora astme.
Whereas: 
Ob upoštevanju naslednjega:
- Your doctor will adjust your dose to the minimum necessary to control your asthma. 
- Zdravnik bo odmerek prilagodil do najmanjšega odmerka, ki je potreben, da bo astma nadzorovana.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT(S), MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES 
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
The side effects seen with Alvesco are usually mild. 
Neželeni učinki, ki se pojavijo pri uporabi zdravila Alvesco, so ponavadi blagi.
• skin rash and/or eczema causing itching and redness. 
• kožni izpuščaj in/ali ekcem, ki povzroča srbenje in rdečico.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
- You should start to notice an improvement in your symptoms (wheezing, tight chest and coughing) within 24 hours. 
- Simptomi (sopenje, stiskanje v prsnem košu in kašelj) bi se morali v 24 urah opazno izboljšati.
The scientific rationale for difference of opinion regarding the proposed SPC Type II variations' wording of ciclesonides' dose effectiveness on reducing the frequency of exacerbations in severe asthma as drafted in Sections 4.2 and 5.1 by the RMS on the 19th October 2007 following the CMDh hearing. 
Znanstvena osnova za razhajajoča se mnenja v zvezi s predlaganim besedilom spremembe tipa II povzetka glavnih značilnosti zdravila glede učinkovitosti odmerka ciklosonidov pri zmanjševanju pogostosti napadov pri hudi astmi, kot ga je v poglavjih 4.2 in 5.1 zasnovala referenčna država članica (RMS) 19. oktobra 2007 po obravnavi v okviru CMDh.
In this leaflet the information is arranged as follows: 
Navodilo vsebuje naslednje informacije:
Like all medicines, Alvesco can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo Alvesco neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Applicant 
Predlagatelj
This can be up to 640 micrograms per day, delivered as 320 micrograms twice daily but no data confirming the additional therapeutic effect after 3 months with these higher doses are available. 
Lahko prejmejo do 640 mikrogramov dnevno, razdeljeno na 320 mikrogramov dvakrat dnevno; vendar podatkov, ki bi potrjevali dodaten terapevtski učinek uporabe višjih odmerkov po 3 mesecih, ni na voljo.
Compared to placebo, treatment with ciclesonide 320, 640, and 1280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen. 
V primerjavi s placebom, zdravljenje s 320, 640 in 1280 mikrogrami ciklesonida dnevno ni statistično znatno zmanjšalo 24-urne povprečne koncentracije kortizola v plazmi (AUC(0-24)/24ur) niti ni bil učinek odvisen od odmerka.
Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist. 
12 tedenske dvojno slepe raziskave pri odraslih in mladostnikih, kontrolirane s placebom, so pokazale, da je zdravljenje s ciklesonidom izboljšalo delovanje pljuč, izmerjeno s FEV1, povečalo največji pretok zraka med izdihom, izboljšalo nadzor nad simptomi astme in zmanjšalo potrebo po inhalaciji beta-2 agonista.
ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION(S) 
DODATEK IV POGOJI DOVOLJENJ(A) ZA PROMET Z ZDRAVILOM
A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment. 
V kontrolirani raziskavi so po 7 dneh zdravljenja primerjali 24-urno vrednost AUC kortizola v plazmi pri 26 odraslih bolnikih z astmo.
Inhaled ciclesonide treatment was also shown to attenuate the increase in inflammatory cells (total eosinophils) and inflammatory mediators in induced sputum. 
Dokazano je bilo tudi, da zdravljenje z inhaliranjem ciklesonida zmanjša širitev celičnega vnetja (skupni eozinofilci) in vnetne mediatorje pri induciranem izpljunku.
The revised Summary of Product Characteristics, labelling and package leaflet are set out in Annex III of the Opinion for Alvesco and associated names (see Annex I). 
Popravljen povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so podani v Dodatku III mnenja za zdravilo Alvesco in z njim povezana imena (glejte Dodatek I).
Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-desmethylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite. 
Po peroralni inhalaciji se ciklesonid zaradi encimskega delovanja v pljučih pretvori v glavni metabolit (C21-des-metilpropionilciklesonid), ki ima izrazito protivnetno delovanje in se zato šteje za aktivni metabolit.
The CHMP was concerned with the MAH's continued reliance on the results of study MI-140 and its recognized insufficiencies: a short term study of 3 months instead of a minimum of 6 months; the lack of a 320µg/d arm; and the debatable value of improvement in severe exacerbations at the higher 640 dose with no further improvement in lung function. 
CHMP je izrazil pomisleke glede stalnega opiranja imetnika dovoljenja za promet z zdravilom na rezultate študije MI-140 in glede njenih prepoznanih pomanjkljivosti: kratkoročna študija v trajanju 3 mesecev namesto najmanj 6 mesecev; odsotnost kraka z odmerkom 320 µg/dan; sporna vrednost izboljšanja pri hudih izbruhih pri večjem 640 µg-odmerku brez nadaljnjega izboljšanja funkcije pljuč.
- The proposed wording for Section 5.1 of the SPC at the end of the CMDh procedure has been amended to include more detail on Study M1 140. 
- predlagano besedilo poglavja 5.1 povzetka glavnih značilnosti zdravila je bilo ob zaključku postopka v okviru CMDh dopolnjeno tako, da vključuje več podrobnosti o študiji M1 140;
the CHMP has recommended the granting of the Marketing Authorisation(s) for Alvesco and associated names, with amendments to the relevant sections of the Product Information and with commitments to be fulfilled. 
je CHMP priporočil odobritev dovoljenj(a) za promet z zdravilom Avesco in z njim povezanih imen, z dopolnili ustreznih poglavij informacij o zdravilu in obveznostmi, ki jih bo treba izpolniti.
• hoarseness, cough after inhalation, increase in wheezing after inhalation 
• hripavost, kašelj po inhaliranju, močnejše sopenje po inhaliranju;
The MAH was asked to explain the different feasible scientific approaches for conducting a well designed study comparing 160 µg, 320 µg and 640 µg in order to clarify the efficacy/safety ratio of 160 µg compared to 320 µg and 640 µg in severe asthmatics. 
Imetnik dovoljenja za promet je bil pozvan, da razloži različne primerne znanstvene pristope za izvedbo dobro zasnovane študije, v kateri bi primerjali odmerke 160 µg, 320 µg in 640 µg, da bi tako razjasnili razmerje med učinkovitostjo in varnostjo odmerka 160 µg v primerjavi s 320 µg in 640 µg pri hudih astmatikih.