natgillin/translations-raw huggingface dataset:
Fourteen days after administration the mean cefovecin concentration in plasma was 18 µg/ml.
Štirinajst dni po dajanju je bila povprečna koncentracija v plazmi 18 µg/ml.
A single subcutaneous injection.
Enkratno subkutano dajanje.
Each 10 ml vial of diluent contains:
Ena 10 ml viala z vehiklom vsebuje:
Coagulase negative Staphylococcus spp.4
Koagulaza negativni Staphylococcus spp.
Urinary tract infections in dogs and cats: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Infekcije urinarnega trakta pri psih in mačkah: Enkratno subkutano dajanje 8 mg/kg telesne teže (1 ml na 10 kg telesne teže).
19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216)
19,17 mg metilparahidroksibenzoata (E218) 2,13 mg propilparahidroksibenzoata (E216)
To reconstitute, withdraw of the required volume of the supplied diluent from its vial (for 23 ml vial containing 852 mg of lyophilised powder reconstitute using 10 ml of diluent, or for 5 ml vial containing 340 mg of lyophilised powder reconstitute using 4 ml of diluent) and add to the vial containing the lyophilised powder.
852 mg liofiliziranega praška, uporabite 10 ml vehikla, za 5 ml vialo, ki vsebuje 340 mg liofiliziranega praška, uporabite 4 ml vehikla) v vialo z liofiliziranim praškom.
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
s.c. Pred uporabo preberite navodilo za uporabo.
Dosing Table
Tabela za odmerjanje
7.67 mg methyl parahydroxybenzoate (E218) 0.85 mg propyl parahydroxybenzoate (E216)
7,67 mg metilparahidroksibenzoata (E218) 0,85 mg propilparahidroksibenzoata (E216)
or Porphyromonas spp.
in Porphyromonas spp.
6.5 Nature and composition of immediate packaging
6.5 Vrsta ovojnine in vsebina Prašek:
Cefovecin exhibits in-vitro activity against Staphylococcus pseudintermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Cefovecin kaže in-vitro učinkovitost proti Staphylococcus pseudintermedius in Pasteurella multocida,
QUANTITY OF THE ACTIVE SUBSTANCE(S) 340 mg cefovecin
340 mg cefovecina
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po rekonstituciji v skladu z navodili: 28 dni
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dogs and cats: 8 mg cefovecin/kg body weight (1 ml/10 kg body weight).
Psi in mačke: 8 mg cefovecina/ kg telesne teže (1 ml/10 kg telesne teže).
Urinary tract infections in dogs and cats: A single subcutaneous injection.
Infekcije urinarnega trakta pri psih in mačkah:
Severe infections of the gingival and periodontal tissues in dogs: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Infekcije kože in mehkega tkiva pri psih: Enkratno subkutano dajanje 8 mg/kg telesne teže (1 ml na 10 kg telesne teže).
QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol in water for injections.
13 mg/ml benzilalkohola v vodi za injekcije
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Benzyl alcohol
Metilparahidroksibenzoat (E218) Propilparahidroksibenzoat (E216)
ADVERSE REACTIONS
POSEBNA OPOZORILA
C. STATEMENT OF THE MRLs Not applicable.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.
Fusobacterium spp., Bacteroides spp., Prevotella oralis, β-hemolitičnimi Streptococci in/ali s Staphylococcus pseudintermedius.
NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Convenia 80 mg/ml prašek in vehikel za raztopino za injiciranje za pse in mačke cefovecin
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Zdravilo shranjujte nedosegljivo otrokom.
NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder for solution for injection for dogs and cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Convenia 80 mg/ml prašek za raztopino za injiciranje za pse in mačke
PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON (CONTAINING LYOPHILISED POWDER VIAL AND DILUENT VIAL) 23 ml Vial - 5 ml Vial
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (VSEBUJE VIALO Z LIOFILIZIRANIM PRAŠKOM IN VIALO Z VEHIKLOM)
1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol
Po rekonstituciji, skladni z navodili, raztopina za injiciranje vsebuje 80,0 mg/ml cefovecina (v obliki natrijeve soli) 1,8 mg/ml metilparahidroksibenzoat a(E218) 0,2 mg/ml propilparahidroksibenzoat a(E216) 12,3 mg/ml benzilalkohola
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (5 ml LYOPHILISED POWDER VIAL)
NALEPKA (5 ML VIALA Z LIOFILIZIRANIM PRAŠKOM)
Animal Weight (Dogs and Cats) Volume to be Administered 2.5 kg
Teža živali (psi in mačke)
STATEMENT OF THE MRLs
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 23 ml vial of lyophilised powder contains: Active substance:
Ena 23 ml viala z liofiliziranim praškom vsebuje:
If required, an additional dose may be administered 14 days after the first injection.
Če je potrebno, dajanje zdravila ponovite čez 14 dni.
Diluent:
Vehikel:
10.8 ml water for injections
13 mg/ml benzilalkohola 10,8 ml vode za injekcije
NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Convenia 80 mg/ml prašek in vehikel za raztopino za injiciranje za pse in mačke
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM ”
PACKAGE LEAFLET: Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Convenia 80 mg/ml prašek za raztopino za injiciranje za pse in mačke
WITHDRAWAL PERIOD(S)
KOLIČINA UČINKOVIN(E)
Min
pes
ROUTE(S) OF ADMINISTRATION
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
Other information about Varuby
Druge informacije o zdravilu Varuby
What measures are being taken to ensure the safe and effective use of Varuby?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Varuby?
The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Varuby je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What is Varuby and what is it used for?
Kaj je zdravilo Varuby in za kaj se uporablja?
What benefits of Varuby have been shown in studies?
Kakšne koristi je zdravilo Varuby izkazalo v študijah?
What are the risks associated with Varuby?
Kakšna tveganja so povezana z zdravilom Varuby?
It is not intended to provide practical advice on how to use Varuby.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Why is Varuby approved?
Zakaj je bilo zdravilo Varuby odobreno?
This is a summary of the European public assessment report (EPAR) for Varuby.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Varuby.
The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache.
Najpogostejša neželena učinka zdravila Varuby (ki lahko prizadeneta od 1 do 2 osebe od 100) sta utrujenost in glavobol.
Varuby can only be obtained with a prescription and is available as 90-mg tablets.
Predpisovanje in izdaja zdravila Varuby je le na recept, na voljo pa je v obliki 90-miligramskih tablet.
Overall, therefore, Varuby's benefits are greater than its risks and it has been recommended for approval for use in the EU.
Na splošno so koristi zdravila Varuby večje od z njim povezanih tveganj, zato je bilo zdravilo odobreno za uporabo v EU.
The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors.
Zdravilna učinkovina v zdravilu Varuby, rolapitant, deluje tako, da zavira receptorje za nevrokinin-1 (NK1).
In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist).
V obeh študijah (ena je vključevala 532 bolnikov in druga 555 bolnikov) so preskušanci prejemali tudi deksametazon in granisetron (antagonist receptorja 5-HT3).
There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).
Zapoznela slabost in bruhanje se nista pojavila pri 71 % (475 od 666) bolnikov, ki so prejemali zdravilo Varuby v primerjavi z 62 % (410 od 666) bolnikov, ki so prejemali placebo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Varuby have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Varuby upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting.
Pri kemoterapiji se sprošča snov v telesu (snov P), ki se veže na te receptorje in spodbuja zapoznelo slabost in bruhanje.
In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting.
Poleg tega so bili neželeni učinki obvladljivi in podobni tistim, ki jih običajno opazimo pri zdravilih za preprečevanje slabosti in bruhanja.
For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Varuby naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
By blocking the receptors, Varuby can prevent this effect.
Zdravilo Varuby lahko z zaviranjem receptorjev prepreči ta učinek.
Varuby acts against delayed nausea and vomiting (when the symptoms occur 24 hours or more after the cancer treatment) and is given with other medicines that help control more immediate nausea and vomiting.
Zdravilo Varuby preprečuje zapoznelo slabost in bruhanje (kadar se simptomi pojavijo 24 ur ali več po zdravljenju raka) ter se daje skupaj z drugimi zdravili, ki bolje pomagajo obvladovati takojšnjo slabost in bruhanje.
Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy.
Zdravilo Varuby je bilo prav tako učinkovitejše od placeba v tretji glavni študiji, kadar se je Varuby uporabljalo v kombinaciji z deksametazonom in granisetronom pri bolnikih z zmerno emetogeno kemoterapijo.
Two tablets are swallowed on the first day of each cycle of chemotherapy, 2 hours or less before chemotherapy starts.
Na prvi dan vsakega cikla kemoterapije, tj. dve uri ali manj pred začetkom kemoterapije, je treba pogoltniti dve tableti.
Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer).
Varuby je zdravilo, ki se uporablja za preprečevanje navzeje (slabosti) in bruhanja pri odraslih bolnikih z rakom, ki prejemajo kemoterapijo (zdravila za zdravljenje raka).
For more information about treatment with Varuby, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Varuby preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Varuby contains the active substance rolapitant.
Zdravilo Varuby vsebuje zdravilno učinkovino rolapitant.
Although a number of medicines are approved in the EU for management of chemotherapy-associated nausea and vomiting significant numbers of patients still experience it, and management of nausea in particular remains a challenge.
Čeprav so v EU odobrena številna zdravila za obvladovanje slabosti in bruhanja, povezanega s kemoterapijo, se pojavita pri precejšnjem številu bolnikov, zato to še vedno predstavlja poseben izziv.
Patients taking Varuby must not take St John's wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.
Bolniki, ki jemljejo zdravilo Varuby, ne smejo jemati šentjanževke (rastlinskega pripravka za zdravljenje depresije), saj lahko to zmanjša učinek zdravila.
Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.
Zdravilo Varuby se daje skupaj z deksametazonom in antagonistom receptorja 5-HT3 (drugima vrstama zdravila za preprečevanje slabosti in bruhanja), vendar je njihov način dajanja odvisen od vrste kemoterapije.
For the full list of all side effects and restrictions with Varuby, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Varuby glejte navodilo za uporabo.
When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.
Kadar se to zdravilo uporabi skupaj z zdravili, ki imajo drugačen mehanizem delovanja za preprečevanje takojšnje slabosti in bruhanja, lahko to prispeva k daljšemu obvladovanju teh simptomov po kemoterapiji.
Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).
Ob upoštevanju rezultatov obeh študij se pri 71 % (382 od 535) bolnikov, ki so prejemali zdravilo Varuby, slabost in bruhanje nista pojavila od 24 do 120 ur po kemoterapiji, v primerjavi s 60 % (322 od 535) bolnikov v skupini, ki je prejemala placebo.
Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.
Ker različni kemoterapevtiki povzročajo različne stopnje slabosti in bruhanja, se zdravilo Varuby uporablja pri bolnikih, ki prejemajo visoko in zmerno emetogeno kemoterapijo (ki povzroča bruhanje).
How is Varuby used?
Kako se zdravilo Varuby uporablja?
Varuby produced an improvement in the control of delayed nausea and vomiting when added to other standard treatments.
Z jemanjem zdravila Varuby je prišlo do boljšega obvladovanja zapoznele slabosti in bruhanja, kadar se je zdravilo uporabljajo skupaj z drugimi oblikami standardnega zdravljenja.
How does Varuby work?
Kako zdravilo Varuby deluje?
In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy.
V dveh glavnih študijah je bilo zdravilo Varuby pri preprečevanju zapoznele slabosti in bruhanja po visoko emetogeni kemoterapiji učinkovitejše od placeba (zdravila brez zdravilne učinkovine).
Article 29(4) of Directive 2001/83/EC, as amended.
Člen 29(4) Direktive 2001/83/ES, kot je bila spremenjena.
London, 14 July 2008 EMEA/CHMP/151554/2008
London, 14. julij 2008 EMEA/CHMP/151554/2008
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Pierre Demolis.
Poročevalec je bil dr. Ian Hudson, soporočevalec pa dr. Pierre Demolis.
A positive opinion was adopted by consensus on 19 March
Pozitivno mnenje je bilo soglasno sprejeto dne 19. marca
The Mutual Recognition Procedure started on 2 May 2007.
Postopek medsebojnega priznavanja se je pričel 2. maja 2007.
The final opinion was converted into a Decision by the European Commission on 11 July 2008.
Končno mnenje je bilo dne 11. julija 2008 spremenjeno v odločbo Evropske komisije.
Repeat use: Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Ponovna uporaba: Avstrija, Bolgarija, Ciper, Španija, Francija, Italija, Malta in Portugalska.
The Marketing Authorisation Holder provided written explanations on 16 January 2008.
Imetnik dovoljenja za promet je dne 16. januarja 2008 posredoval tudi pisna pojasnila.
The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Arbitražni postopek se je pričel s sprejemom seznama vprašanj dne 15. novembra 2007.
The Reference Member State was United Kingdom and the Concerned Member States were: First wave: Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden
Prvi val: Belgija, Češka, Danska, Estonija, Finska, Nemčija, Grčija, Madžarska, Islandija, Irska, Latvija, Litva, Luksemburg, Nizozemska, Norveška, Poljska, Slovaška, Slovenija in Švedska.
These Member States and the applicant / MAH were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Te države članice in predlagatelj/imetnik dovoljenja za promet z zdravilom niso mogli doseči soglasja glede medsebojnega priznavanja dovoljenja za promet, ki ga je odobrila referenčna država članica.
The United Kingdom referred the reasons of disagreement to the EMEA on 25 October 2007.
Združeno kraljestvo je dne 25. oktobra 2007 Evropski agenciji za zdravila posredovalo razloge za nesoglasje.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names International Non-Proprietary Name (INN): ciclesonide
ODBOR ZA ZDRAVILA ZA UPORABO V HUMANI MEDICINI (CHMP) MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA Alvesco in z njim povezana imena Mednarodno nelastniško ime (INN): ciklesonid
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Seznam zadevnih imen zdravila je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II, skupaj s povzetkom glavnih značilnosti zdravila v Dodatku III.
During their March 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Alvesco and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
CHMP je na svojem zasedanju v maju 2008 na podlagi vseh posredovanih podatkov in znanstvene razprave v odboru soglasno sprejel mnenje, da je razmerje med koristmi in tveganji pri uporabi zdravila Alvesco in z njim povezanih imen pozitivno, ter da zadržki Francije ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom ter da je potrebno povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo referenčne države članice ustrezno spremeniti.
In light of this, the applicant/MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Predlagatelj/imetnik dovoljenja za promet je tako predlagal študijo, ki bi odgovorila na odprta vprašanja o dolgoročni uporabi dnevnega odmerka 320 µg in 640 µg.
Additionally, the applicant/MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Poleg tega so predlagatelja/imetnika dovoljenja za promet z zdravilom pozvali, da si zagotovi ustrezno znanstveno svetovanje na področju načrtovanja in izvedbe študije (študij), ki bodo zagotovile nadaljnje informacije o uporabi večjih odmerkov zdravila Alvesco pri zdravljenju hude astme.
Altana Pharma AG submitted applications for mutual recognition of Alvesco and associated names, 40µg, 80 µg and 160 µg pressurised inhalation, solution on the basis of the marketing authorisation granted by United Kingdom on 14 April 2004.
Družba Altana Pharma AG je predložila vlogo za medsebojno priznavanje zdravila Alvesco in z njim povezana imena 40 µg, 80 µg in 160 µg inhalacijska raztopina pod tlakom, na podlagi dovoljenja za promet z zdravilom Alvesco, ki ga je dne 14. aprila 2004 odobrilo Združeno kraljestvo.
Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Bistvene razlike so se pokazale v zvezi s trenutno odobrenim odmerjanjem za nadzorovanje poslabšanj pri hudi astmi ter zaradi potrebe po študiji, ki bi primerjala dnevne odmerke 160 µg, 320 µg in 640 µg z namenom dokazati zmanjšano pogostnost poslabšanj pri bolnikih s hudo astmo pri zdravljenju z večjimi odmerki.
The data supporting this application, as interpreted according with the CHMP guidance, did not support authorization of regular daily doses in excess of 160 µg in the treatment populations, and this was considered to be of serious public health concern.
Podatki, predloženi v podporo tej vlogi, glede na smernice CHMP niso potrdili upravičenosti rednih dnevnih odmerkov, večjih kot 160 µg, pri zdravljenih skupinah bolnikov, kar predstavlja resen zadržek za javno zdravje.
The applicant/MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
Predlagatelj/imetnik dovoljenja za promet je ob zaključku postopka usklajevalne skupine CMDh potrdil tudi posodobljeno besedilo za poglavje 5.1, ki vključuje podrobnejši opis študije M1-140 ter popolnoma posodobljena navodila za uporabo.
Alvesco and associated names, 40 µg, 80 µg and 160 µg pressurised inhalation, solution is a glucocorticoid used to treat obstructive airway disease.
Zdravilo Alvesco in z njim povezana imena 40 µg, 80 µg in 160 µg inhalacijska raztopina pod tlakom, je raztopina glukokortikoidov, namenjena zdravljenju obstruktivnih bolezni dihal.
The product contains ciclesonide which is delivered by a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as a propellant.
Zdravilo vsebuje ciklesonid, ki ga odmerjamo z inhalatorjem pod tlakom, ki vsebuje etanolni hidrofluoroalkan kot pogonski plin.
In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/MAH has shown that a dose of 640µg/d (given 320µg/d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v humani medicini (CMDh) je ob zaključku postopka spremenila predlagano spremembo besedila v poglavju 4.2 tako, da poglavje sedaj vsebuje opombo, da so rezultati 12-tedenske študije za hudo astmo pokazali, da dnevni odmerek 640 µg (dan v odmerku 320 µg dvakrat na dan) sicer kaže manjšo pojavnost poslabšanj stanja, vendar pa ne izboljšuje delovanja pljuč.
The Applicant commits to the following:
Imetnik se zavezuje, da bo:
Final height data were not available.
Končni podatki o višini niso bili na voljo.
Long-term safety data in children and adolescents are not available.
Dolgoročni podatki o varnosti pri otrocih in mladostnikih niso na voljo.