natgillin/translations-raw huggingface dataset:
25 micrograms of salmeterol (as xinafoate) and 125 micrograms of fluticasone propionate per actuation
v enem odmerku je 25 mikrogramov salmeterola (kot ksinafoat) in 125 mikrogramov flutikazonijevega propionata
EMEA/ CHMP/ 123439/ 2006/ EN 8.
EMEA/ CHMP/ 123439/ 2006/ SL 8.
Seretide Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Seretide Evohaler in povezana imena (Glejte Dodatek I) 25/ 250 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom [Glejte Dodatek I – Izpolni država članica]
25 micrograms of salmeterol (as xinafoate) and 250 micrograms of fluticasone propionate per actuation
v enem odmerku je 25 mikrogramov salmeterola (kot ksinafoat) in 250 mikrogramov flutikazonijevega propionata
Do not puncture, break or burn even when apparently empty
Vsebnika ne smete prebosti, poškodovati ali vreči v ogenj, četui menite, da je vsebnik prazen.
Seretide Evohaler and associated names (see Annex I) 25/ 50 microgram/ dose pressurised inhalation, suspension Seretide Evohaler and associated names (see Annex I) 25/ 125 microgram/ dose pressurised inhalation, suspension Seretide Evohaler and associated names (see Annex I) 25/ 250 microgram/ dose pressurised inhalation, suspension [See Annex I – To be completed nationally]
Seretide Evohaler in povezana imena (glejte Dodatek I) 25/ 50 mikrogramov/ odmerek, inhalacijska suspenzija pod tlakom Seretide Evohaler in povezana imena (glejte Dodatek I) 25/ 125 mikrogramov / odmerek, inhalacijska suspenzija pod tlakom Seretide Evohaler in povezana imena (glejte Dodatek I) 25/ 250 mikrogramov / odmerek, inhalacijska suspenzija pod tlakom
Before you take Seretide 3.
Kaj morate vedeti, preden boste vzeli zdravilo Seretide 3.
How to take Seretide 4.
Kako jemati zdravilo Seretide 4.
How to store Seretide 6.
Shranjevanje zdravila Seretide 6.
Seretide does not work in controlling sudden attacks of breathlessness and wheezing where you would need to use your fast acting ‘ rescue’ medication.
Vendar pa Seretide ne more obvladati nenadnih napadov težkega in piskajočega dihanja: v takšnem primeru morate uporabiti hitrodelujoče "olajševalno" zdravilo.
BEFORE YOU TAKE SERETIDE
Kaj morate vedeti, preden boste vzeli zdravilo Seretide
Do not take Seretide If you are allergic (hypersensitive) to salmeterol xinafoate, fluticasone propionate or to the other ingredient Norflurane (HFA 134a).
Ne uporabljajte zdravila Seretide Če ste alergični na (preobčutljivi za) salmeterolijev ksinafoat, flutikazonijev propionata ali norfluran (HFA 134a), ki je pomožna snov v zdravilu).
Take special care with Seretide Your doctor will supervise your treatment more closely if you have medical conditions such as heart disease including an irregular or fast heart beat, overactive thyroid gland, high blood pressure, diabetes mellitus (Seretide may increase your blood sugar), low potassium in your blood or if you are being, or have been treated for have tuberculosis (TB).
Bodite posebno pozorni pri uporabi zdravila Seretide Zdravnik bo vaše zdravljenje spremljal natančneje, če imate kakšno zdravstveno težavo, npr. bolezen srca (vključno z nerednim ali hitrim srčnim utripom), čezmerno dejavno ščitnico, visok krvni tlak, diabetes mellitus (Seretid lahko zviša krvni sladkor), nizek kalij v krvi ali se zdravite oz. ste se zdravili zaradi tuberkuloze.
Seretide should not be taken with medicines called β -blockers (such as atenolol, propranolol, sotalol), unless your doctor tells you to do so.
Seretida ne smete jemati z zdravili, ki jih imenujemo zaviralci β (takšni so npr. atenolol, propranolol, sotalol), razen če tako naroči zdravnik.
Pregnancy and breast-feeding You should ask your doctor for advice before taking Seretide whilst you are pregnant or breastfeeding.
Nosečnost in dojenje Če ste noseči ali dojite, se pred uporabo Seretida posvetujte z zdravnikom.
Driving and using machines The possible side effects associated with Seretide are unlikely to affect your ability to drive or use machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi možni neželeni učinki, povezani s Seretidom, neugodno vplivali na vašo sposobnost upravljanja vozil in strojev.
Dosage It is very important that you take your Seretide every day as directed, until you are advised to stop by your doctor.
Odmerjanje Zelo važno je, da Seretide uporabljate vsak dan, kot vam je predpisal zdravnik, dokler vam ne naroči, da ga nehajte uporabljati.
Seretide Evohaler is for inhalation by mouth only.
Seretide Evohaler je namenjen le za peroralno vdihavanje.
Two puffs twice a day Two puffs twice a day Two puffs twice a day
Dva vdiha dvakrat na dan Dva vdiha dvakrat na dan Dva vdiha dvakrat na dan
Children 4 to 12 years of age
EMEA/ CHMP/ 123439/ 2006/ SL Otroci v starosti od 4 do 12 let
It is very important to follow your doctor’ s instructions as to how many puffs to inhale and how often to take your medicine.
Zelo pomembno je, da upoštevate zdravnikova navodila o številu potrebnih vdihov in pogostnosti uporabe zdravila.
If your asthma gets worse or is not well controlled (you will feel wheezy and need more of your fast acting ‘ rescue’ medicine), do not increase the number of puffs of Seretide you take.
Če se vam astma poslabša ali ni dobro obvladana (kar pomeni, da ste pogosteje zasopli in morate pogosteje uporabljati hitrodelujoče "olajševalno" zdravilo), ne povečujte števila vdihov Seretida.
The can has a counter attached to show you how many puffs of medicine are left.
Na pločevinki je nameščen števec, ki kaže, koliko vdihov zdravila je še preostalo.
If your inhaler has not been used for a week or more remove the mouthpiece cover, shake the inhaler well and release two puffs into the air.
Če inhalatorja niste uporabljali teden dni ali več, odstranite pokrovček ustnika, inhalator dobro pretresite in sprostite dva vdiha v zrak.
It is important to start to breathe in as slowly as possible just before using your inhaler.
Pomembno je, da začnete pred uporabo inhalatorja vdihovati, kolikor je mogoče počasi.
Important, do not rush steps 4 to 7:
Pomembno je, da korakov od 4 do 7 ne opravite prehitro:
Do not
Izdihnite, kolikor je mogoče, ne da bi bilo neprijetno.
- Remove the mouthpiece cover.
Ko je na števcu številka 000, inhalator nehajte uporabljati.
- Do not remove the metal can from the plastic casing during cleaning or at any other time.
Nikdar ne poskušajte spreminjati številk na števcu ali števca sneti s pločevinke.
EMEA/ CHMP/ 123439/ 2006/ EN
EMEA/ CHMP/ 123439/ 2006/ SL Čiščenje inhalatorja
gland.
Da boste inhalator očistili:
Do not stop taking Seretide suddenly as this could make your asthma worse and could cause problems with the body’ s hormones.
Seretida ne nehajte jemati nenadoma, ker to lahko poslabša astmo in povzroči težave s hormoni v telesu.
EMEA/ CHMP/ 123439/ 2006/ EN
EMEA/ CHMP/ 123439/ 2006/ SL Zelo redki: dobi jih manj kot 1 na 10. 000 oseb, ki
43/ 45
41/ 43 jemljejo to zdravilo.
- Increases in the amount of sugar (glucose) in your blood (hyperglycaemia).
- Znaki alergije, npr. srbenje, otekanje (ponavadi obraza, ustnic, jezika ali žrela), težko dihanje,
If you have
piskanje ali kašelj (bronhospazem).
diabetes, more frequent blood sugar monitoring and possibly adjustment of your usual diabetic treatment may be required.
- Seretide lahko neugodno vpliva na normalno nastajanje steroidnih hormonov v telesu, zlasti če
- Feeling anxious, disturbed sleep and behavioural changes, such as being unusually active and
Posledice so upočasnjena rast pri otrocih in mladostnikih, redčenje kosti, katarakta, glavkom, večanje telesne mase, visok krvni tlak in okrogel ("lunast") obraz (Cushingov sindrom).
irritable (mainly in children).
Povedati morate zdravniku,
The metal can contains a pressurised liquid.
Pločevinka vsebuje tekočino pod tlakom.
- The active substance(s) are 25 micrograms salmeterol (as xinafoate) and 50, 125 or 250
- Zdravilni učinkovini sta 25 mikrogramov salmeterola (kot ksinafoata) in 50, 125 ali 250
Pressurised inhalation, suspension.
mikrogramov flutikazonijevega propionata.
Not all pack sizes may be marketed.
- Pomožna snov je norfluran (HFA 134a).
Glaxo Wellcome Production
EMEA/ CHMP/ 123439/ 2006/ SL Izgled zdravila Seretide in vsebina pakiranja
Zone Industrielle No.2, 23 Rue Lavoisier, la madeleine, 27000 Evreux, France.
Pločevinka pod tlakom vsebuje belo do kremasto suspenzijo za inhaliranje.
Tel: +33 2 3223 5500 Fax: +33 2 3223 5558
Izdelovalec:
Austria Belgium Denmark Finland France Germany Greece Iceland Ireland Italy Luxembourg The Netherlands Portugal Spain Sweden United Kingdom
Avstrija Belgija Danska Finska Francija Nemčija Grčija Islandija Irska Italija Luksemburg Nizozemska Portugalska Španija Švedska Velika Britanija
Seretide Dosieraerosol Seretide Seretide Seretide Evohaler Seretide atmadisc Seretide Inhaler Seretide Seretide Evohaler Seretide Seretide Seretide Seretide Inalador Seretide Seretide Evohaler Seretide Evohaler
Seretide Dosieraerosol Seretide Seretide Seretide Evohaler Seretide atmadisc Seretide Inhaler Seretide Seretide Evohaler Seretide Seretide Seretide Seretaide Inalador Seretide Seretide Evohaler Seretide Evohaler
BACKGROUND INFORMATION Seretide Evohaler and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β -agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting 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-agonist.
OSNOVNE INFORMACIJE Zdravilo Sertide Evohaler in z njim povezana imena (glejte Dodatek I), ki vsebuje salmeterol in flutikazon propionat, kombinacijo fiksnih odmerkov dolgo delujočega β- agonista (LABA) salmeterola in inhalacijskega kortikosteroida (ICS) flutikazon propionata (FP), je indicirano za običajno zdravljenje astme, kadar je uporaba kombiniranega zdravila (dolgo delujočega beta- 2- agonista in inhalacijskega kortikosteroida) ustrezna: pri bolnikih, pri katerih z inhalacijskimi kortikosteroidi in » po potrebi « z inhalacijskim kratko delujočim beta- 2- agonistom ni mogoče doseči zadostnega nadzora bolezni, ali pri bolnikih, pri katerih je bilo mogoče že z inhalacijskimi kortikosteroidi in dolgo delujočim beta- 2- agonistom vzpostaviti zadosten nadzor bolezni.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged *Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged * Opomba: informacije, podane v tem dokumentu in v dodatkih, odražajo zgolj mnenje CHMP z dne 27. aprila 2006.
Chewable tablets Oral use
Žvečljive tablete
GmbH Donau-City-Straße 6 1220 Wien Austria
GmbH Donau- City- Straße 6 1220 Dunaj Avstrija
Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sherp & Dohme Chaussée de Waterloo 1135 B- 1180 Bruselj Belgija
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem Nizozemska
Czech Republic
Izmišljeno ime
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Talin Estonija
Waarderweg 39 P. O. BOX 581 2031 BN Haarlem The Netherlands
Waarderweg 39 P. O. BOX 581 2031 BN Haarlem Nizozemska
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, The Netherlands
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem, Nizozemska
Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540 Haar Germany
Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540 Haar Nemčija
Singulair mini
SINGULAIR mini Kautabletten
Oral
uporaba
Hungary
uporaba
1123 Budapest, Alkotás u.
1123 Budimpešta, Alkotás u.
50., Hungary
50., Madžarska
Ireland
uporaba
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU, Velika Britanija
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU Velika Britanija
Chewable Tablets
Žvečljive tablete
Fabbroni, 6 00191 Roma Italy
Fabbroni, 6 00191 Rim Italija
Croce, 37 56125 Pisa Italy
Croce, 37 56125 Pisa Italija
SIA « Merck Sharp & Dohme Latvija » Skanstes 13, second floor, LV- 1013, Riga Latvia
SIA « Merck Sharp & Dohme Latvija » Skanstes 13, second floor, LV - 1013, Riga Latvija
Lithuania
Jakost
Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Chaussée de Waterloo 1135 B - 1180 Bruselj Belgija
Merck Sharp & Dohme Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
Merck Sharp & Dohme Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU Velika Britanija
Merck Sharp & Dohme Hertfordshire Road,
Merck Sharp & Dohme Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU Velika Britanija
Norway
Jakost
Chł odna 51 00-867 Warszawa Poland
Chłodna 51 00- 867 Varšava Poljska
Box 214 2770-192 Paço d 'Arcos Portugal
Box 214 2770- 192 Paço d 'Arcos Portugalska
7 Member State
7 Država članica
1A, Corp clă dire C1, Etaj 3, Sector 1, Bucureş ti Romania
Bucureşti- Ploieşti, nr. 1A, Corp clădire C1, Etaj 3, Sector 1, Bukarešta Romunija
MERCK SHARP &
Žvečljive tablete
Chewable tablets Oral use
Peroralna uporaba
Merck Sharp & Dohme, Smartinska 140, SI-1000 Ljubljana Slovenia
Merck Sharp & Dohme, Smartinska 140, SI- 1000 Ljubljana Slovenija
Box 581, 2003 PC Haarlem The Netherlands
Box 581, 2003 PC Haarlem Nizozemska
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027 – Madrid Spain
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027 – Madrid Španija
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027- Madrid Spain
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027 - Madrid Španija
Sweden
8 Država članica
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Imetnik dovoljenja za promet z zdravilom
Singulair
Izmišljeno ime
4 mg
Jakost
Granules
Farmacevtska oblika
Oral
Pot uporabe zdravila
Chewable tablets
Zrnca
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, the Velika Britanija
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
It is a leukotriene-1 receptor antagonist.
Zdravilna učinkovina v zdravilu Singulair je montelukast natrij, ki je antagonist receptorja za levkotrien- 1.
Since 2002, the MRP indications also include the monotherapy of 4 mg paediatric formulations in the treatment of mild asthma in exceptional cases, i. e. when inhaled corticosteroids cannot be used.
Od leta 2002 so indikacije v okviru postopka medsebojnega priznavanja vključevale tudi monoterapijo s 4 mg pediatrično obliko za blago astmo v izjemnih primerih, tj. ko kortikosteroidov za inhaliranje ni možno uporabiti.
Quality The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Kakovost Imetnik dovoljenja za promet je predložil usklajena modula 3 v formatu CTD za zdravili Singulair 4 mg zrnca in 4 mg žvečljive tablete.
Moreover the MAH submitted a proposal for harmonised chemical-pharmaceutical sections of the SPC and PL.
Poleg tega je imetnik dovoljenja za promet predložil predlog usklajenih kemijsko- farmacevtskih poglavij povzetkov glavnih značilnosti zdravila in navodila za uporabo.
SPC Harmonisation The MAH selected the sections which presented major divergences and were the scope of the harmonisation through the referral procedure.
Uskladitev povzetkov glavnih značilnosti zdravila Imetnik dovoljenja za promet je izbral poglavja, ki so se najbolj razlikovala in so bila predmet usklajevanja v postopku napotitve.
The following sections of the SPCs were presented for harmonisation:
Za uskladitev so bila predložena naslednja poglavja povzetkov glavnih značilnosti zdravila:
4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.3 Contraindications, 4.4 Special Warnings and Precautions for Use, 4.8 Undesirable effects, and 6.5 Shelf life.
4. 1 Terapevtske indikacije, 4. 2 Odmerjanje in način uporabe, 4. 3 Kontraindikacije, 4. 4 Posebna opozorila in previdnostni ukrepi, 4. 8 Neželeni učinki in 6. 5 Rok uporabnosti.
The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
Povzetki glavnih značilnosti zdravila, ki jih je predlagal imetnik dovoljenja za promet, so bili v postopku medsebojnega priznavanja odobreni v „ starih “ državah članicah ter v CY in IS.
Add-on use Singulair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “ as-needed” short acting β -agonists provide inadequate clinical control of asthma, in patients aged 6 months to 5 years.
Klinična učinkovitost: uporaba kot dodatno zdravljenje Zdravilo Singulair je indicirano za zdravljenje astme kot dodatno zdravljenje pri bolnikih, starih od 6 mesecev do 5 let z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β- agonisti, uporabljenimi po potrebi.
The Applicant/ MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/ 138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (2- 5 years old, 6-14 years old) according to ICH E11 guideline.
Predlagatelj/ imetnik dovoljenja za promet je predložil dokazno dokumentacijo za to indikacijo 4 mg peroralna zrnca pri otrocih, starih od 6 mesecev do 2 let, ki je temeljila na farmakokinetičnih podatkih
Further efficacy reports of two clinical 11 studies (P176 and P072-02; double-blind, randomized, placebo-controlled, parallel group) were presented for both 4mg OG and CT formulations.
Predstavljeni sta bili tudi poročili o učinkovitosti iz dveh kliničnih študij (P176 in P072- 02; dvojno zaslepljeni, randomizirani, nadzorovani s placebom, z vzporednimi skupinami) za obliki 4 mg peroralna zrnca in žvečljive tablete.
The Applicant/ MAH also made reference to an original application concerning the 10 mg film-coated tablet and 5 mg CT, which presents the results of two placebo-controlled clinical studies in more than 1600 adult patients with mild-to-moderate asthma.
Predlagatelj/ imetnik dovoljenja za promet je omenil tudi prvotno vlogo za 10 mg filmsko obložene tablete in 5 mg žvečljive tablete, kjer so predstavljeni rezultati dveh s placebom nadzorovanih kliničnih študij pri več kot 1600 odraslih bolnikih z blago do zmerno astmo.
Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Dokazali so, da montelukast (10 mg enkrat dnevno pred spanjem) v primerjavi s placebom izboljša dihalne funkcije, zmanjša simptome astme in rabo beta- agonista ter izboljša kakovost življenja.
In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/ day).
V treh aktivno kontroliranih študijah pri skoraj 1000 odraslih bolnikih z blago do zmerno astmo so dokazali, da je učinek montelukasta (10 mg enkrat dnevno) večji od placeba, vendar manjši od vdihanega beklometazona dipropionata (400 µg/ dan).
The Applicant/ MAH also made reference to an original application concerning 5 mg CT, which presented the results of a study in 336 paediatric patients (age 6 to 14 years).
Predlagatelj/ imetnik dovoljenja za promet je navedel tudi prvotno vlogo za 5 mg žvečljive tablete, kjer so predstavljeni rezultati študije pri 336 otrocih (starih od 6 do 14 let).
Given that the efficacy data from children aged 6 months to 2 years of age is not considered very robust, the CHMP requested, that the Applicant/ MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Ker podatki o učinkovitosti pri otrocih, starih od 6 mesecev do 2 let, niso dovolj robustni je Odbor za zdravila za uporabo v humani medicini (CHMP) zahteval, da predlagatelj/ imetnik dovoljenja za promet v poglavju 4. 2 navede bolj podrobno navodilo, kako spremljati in vrednotiti učinek zdravljenja.
The following revision to Section 4.2 of Singulair 4 mg OG SPC was finally accepted:
Sprejet je bil naslednji popravek poglavja 4. 2 povzetka glavnih značilnosti zdravila Singulair 4 mg peroralna zrnca:
Patients should be evaluated after 2 to 4 weeks for response to montelukast.
Odziv na montelukast pri bolniku je treba ovrednotiti po 2 do 4 tednih zdravljenja.
Subsequently, Section 4.4 of Singulair 4mg OG SPC was revised to include the following wording:
Naknadno je bilo popravljeno poglavje 4. 4 povzetka glavnih značilnosti zdravila Singulair 4 mg peroralna zrnca z vključitvijo naslednjega besedila:
The diagnosis of persistent asthma in very young children (6 months – 2 years) should be established by a paediatrician or pulmonologist.
Diagnozo perzistentne astme pri zelo majhnih otrocih (6 mesecev – 2 leti) mora postaviti pediater ali pulmolog.
In a trend voting after the Applicant/ MAH’ s Oral Explanation, the majority of the CHMP (26+2 positive, 3 negative votes) was in favour of accepting the indication as proposed by the Applicant/ MAH, including the treatment of very young patients (6 months to 2 year old) when diagnosis of persistent asthma has been established.
V glasovanju po ustni obrazložitvi predlagatelja/ imetnika dovoljenja za promet je bila večina Odbora (26+2 za, 3 proti) za sprejem indikacije, kakor jo je predlagal predlagatelj/ imetnik dovoljenja za promet, z vključitvijo zdravljenja zelo majhnih otrok (starih od 6 mesecev do 2 let), če je postavljena diagnoza perzistentne astme.
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom" as-needed "short acting β -agonists provide inadequate clinical control of asthma".
„ Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih bolnikih, starih od 2 do 5 let, z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β- agonisti, uporabljenimi po potrebi. “
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom" as-needed "short acting β -agonists provide inadequate clinical control of asthma".
„ Zdravilo SINGULAIR je indicirano za zdravljenje astme kot dodatno zdravljenje pri tistih bolnikih, starih od 6 mesecev do 5 let, z blago do zmerno perzistentno astmo, ki bolezni ne morejo zadostno
12 Clinical Efficacy:
12 nadzorovati z vdihavanjem kortikosteroidov in s kratkotrajno delujočimi β- agonisti, uporabljenimi po potrebi. “