FrancophonIA/ELRC3.0 huggingface dataset:
English: Ambrohexal 30 mglösbare Tabletten effervescent tablet oral use
Slovenian: Austria ambroksolijev klorid Ambrohexal 30 mglösbare Tabletten šumeča tableta
English: 39116 Magdeburg Germany
Slovenian: 39116 Magdeburg Germany ambroksolijev klorid, doksiciklinijev hiklat
English: Ambroxol ratio 6 mg/ml solucion oral EFG
Slovenian: Spain ambroksolijev klorid Formulamucol 6 mg/ml solución oral EFG
English: oromucosal spray oromucosal use
Slovenian: oralno pršilo oralna uporaba
English: Ambroxolol hydrochloride
Slovenian: Cyprus ambroksolijev klorid Hyvotex
English: Via Beato Sebastiano Valfre 4, 10121 Torino Italy
Slovenian: Via Beato Sebastiano Valfre 4, 10121 Torino Italy ambroksolijev klorid Ambroxolo Pharmentis inhalacijska raztopina za nebulator za inhaliranje
English: Ambroxolo ABC
Slovenian: Italy ambroksolijev klorid Ambroxolo ABC
English: Croatia bromhexinum Bisolex 2 mg/ml otopina 2 mg/ml oral drops, solution oral use
Slovenian: Bisolex 2 mg/ml otopina 2 mg/ml peroralne kapljice, raztopina
English: Bisolvon drank, 8 mg/5 ml
Slovenian: The Netherlands bromheksinijev klorid Bisolvon drank, 8 mg/5 ml
English: Mucoangin lozenge
Slovenian: Mucosolvan peroralni gumi
English: IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten
Slovenian: The Netherlands bromheksinijev klorid IDYL Hoesttabletten Broomhexine HCl 8 mg, tabletten
English: Croatia bromhexinum Bisolex 4 mg/5 ml sirup 4 mg/5 ml
Slovenian: Bisolex 4 mg/5 ml sirup 4 mg/5 ml
English: Mede 27035 Pavia Italy
Slovenian: Mede 27035 Pavia Italy ambroksolijev klorid Tauxolo
English: BROMFLUEX 8 mg
Slovenian: Romania bromheksinijev klorid BROMFLUEX 8 mg
English: Deflegmin oral drops, solution oral use
Slovenian: Lösung peroralne kapljice, raztopina
English: Broomhexine HCl drank 8 mg/5 ml, drank
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCl drank 8 mg/5 ml, drank
English: JUMBO hoesttabletten broomhexine HCl 8 mg, tabletten
Slovenian: The Netherlands bromheksinijev klorid JUMBO hoesttabletten broomhexine HCl 8 mg, tabletten
English: Ambroksolijev klorid BerlinChemie 6 mg/ml peroralna raztopina
Slovenian: Czech Republic ambroksolijev klorid Ambrobene 6 mg/ml
English: Croatia ambroxolum Mucosolvan 75 mg kapsule s produljenim oslobađanjem prolonged-release capsule
Slovenian: Spain ambroksolijev klorid Mucosan Retard 75 mg cápsulas de liberación prolongada kapsula s podaljšanim sproščanjem, trda
English: Broomhexine HCl drank 4 mg/5 ml, drank
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCl drank 4 mg/5 ml, drank
English: 4879 AC ETTEN LEUR The Netherlands bromhexine hydrochloride
Slovenian: 4879 AC ETTEN LEUR The Netherlands bromheksinijev klorid Broomhexine HCl CF 8 mg, tabletten
English: Bromhexine Sopharma
Slovenian: Bulgaria bromheksinijev klorid Bromhexine Sopharma
English: Broomhexine HCl Apotex 8 mg, tabletten
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCl Apotex 8 mg, tabletten
English: Bisolaryn gegen Halzschmerzen 20 mg Pastillen pastille oromucosal use
Slovenian: Spain ambroksolijev klorid Lizipadol 20 mg pastillas para chupar pastila oralna uporaba
English: 55216 Ingelheim Am Rhein Germany bromhexine hydrochloride
Slovenian: 55216 Ingelheim Am Rhein Germany bromheksinijev klorid BISOLVON
English: SURBRONC L.P. 75 mg, gélule à libération prolongée hard capsule, prolonged relase
Slovenian: 75 mg, gélule à libération prolongée trda kapsula, podaljšano sproščanje
English: Latvia ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany
Slovenian: Latvija ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany ambroksolijev klorid Brontex 30 mg tablets
English: Broomhexinehydrochloride 8 mg tabletten Samenwerkende Apothekers
Slovenian: The Netherlands bromheksinijev klorid Broomhexinehydrochloride 8 mg tabletten
English: Ambroxol Genericon 60 mg lösliche Tabletten effervescent tablet oral use
Slovenian: Austria ambroksolijev klorid Ambroxol Genericon 60 mg lösliche Tabletten šumeča tableta
English: Ambroxol-ratiopharm Hustentropfen oral drops, solution oral use
Slovenian: Germany ambroksolijev klorid Ambroxol-ratiopharm Hustentropfen peroralne kapljice, raztopina
English: 2333 CR LEIDEN The Netherlands bromhexine hydrochloride
Slovenian: 2333 CN LEIDEN The Netherlands bromheksinijev klorid C1000 Hoestdrank Extra Sterk Broomhexine HCI
English: Slovak Republic ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Slovenian: Slovaška ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany ambroksolijev klorid Ambrobene 30 mg
English: Broomhexine HCl Sandoz 0,8 mg/ml, drank
Slovenian: 1327 AH ALMERE The Netherlands bromheksinijev klorid Broomhexine HCl Sandoz 0,8 mg/ml, drank
English: Belgium D.J.
Slovenian: D.J.
English: Motosol Retard 75 mg cápsulas de liberación prolongada prolonged-release capsule, hard
Slovenian: Spain ambroksolijev klorid Motosol Retard 75 mg cápsulas de liberación prolongada kapsula s podaljšanim sproščanjem, trda
English: Ambroxine oromucosal spray inhalation use
Slovenian: Italy ambroksolijev klorid Amobronc inhalacijska raztopina za nebulator za inhaliranje
English: Ambrosan 15mg/5ml Sirup 3 mg/ml
Slovenian: Czech Republic ambroksolijev klorid Ambrosan 15mg/5ml Sirup 3 mg/ml
English: C1000 Hoestdrank Broomhexine HCl 4mg/5ml, drank
Slovenian: 2333 CN LEIDEN The Netherlands bromheksinijev klorid C1000 Hoestdrank Broomhexine HCl 4mg/5ml, drank
English: Broomhexine HCl 8 PCH, tabletten 8 mg
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCl 8 PCH, tabletten 8 mg
English: Mucosolvan 15 mgLutschpastillen lozenge
Slovenian: Austria ambroksolijev klorid Mucosolvan 15 mgLutschpastillen pastila
English: Pharmachemie B.V. Swensweg 5
Slovenian: Nizozemska Sameko BV Archimedesweg 2
English: Germany Denk Pharma GmbH & Co. KG
Slovenian: Denk Pharma GmbH & Co.
English: D-55216 Ingelheim am Rhein Germany bromhexine hydrochloride
Slovenian: D-55216 Ingelheim am Rhein Germany bromheksinijev klorid Bisolvon 8 mg tablete
English: Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank
Slovenian: 2333 CN LEIDEN The Netherlands bromheksinijev klorid Kruidvat HOESTDRANK Extra sterk Boomhexine HCl 8 mg/5 ml suikervrij, drank
English: 30-38 1106 Budapest Hungary
Slovenian: 30-38 1106 Budapest Hungary ambroksolijev klorid Halixol 30 mg
English: Verovškova 57, 1000 Ljubljana Slovenia
Slovenian: Verovškova 57, 1000 Ljubljana Slovenia ambroksolijev klorid Ambroxol Sandoz
English: Ambroxol 30 TT Temmler Trinktabletten
Slovenian: 35039 Marburg Germany ambroksolijev klorid Ambroxol 30 TT Temmler Trinktabletten
English: Ambroxol 15 TT Temmler Trinktabletten soluble tablet
Slovenian: 35039 Marburg Germany ambroksolijev klorid Ambroxol 15 TT Temmler Trinktabletten tableta za peroralno raztopino
English: Ambroksols Stirol 75 mg prolonged-release tablets prolonged-release tablet
Slovenian: STIROLBIOFARM BALTIKUM SIA, Rasas iela 5, Riga, Latvia ambroksolijev klorid Ambroksols Stirol 75 mg prolonged-release tablets tableta s podaljšanim sproščanjem
English: NEDAC SORBO Hoesttabletten Broomhexine HCl 8 mg, tabletten
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCl 8 mg, tabletten
English: 55216 Ingelheim am Rhein Germany bromhexine hydrochloride
Slovenian: 55216 Ingelheim Am Rhein Germany bromheksinijev klorid BISOLVON STRONG
English: Bromhexin 12 KM-kapky 12 mg/ml oral drops, solution oral use
Slovenian: Germany bromheksinijev klorid Bromhexin 12 KM-kapky 12 mg/ml peroralne kapljice, raztopina
English: Ambroxol Aristo Hustensaft 30 mg/5 ml
Slovenian: Romania ambroksolijev klorid AMBROXOL 30 mg/5 ml
English: Croatia ambroxolum Flavamed forte 60 mg šumeće tablete effervescent tablet oral use
Slovenian: Germany ambroksolijev klorid Flavamed šumivé tablety 60 mg šumeča tableta
English: Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 Ulm Germany
Slovenian: Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 Ulm Germany ambroksolijev klorid Ambroxolo Ratiopharm 30 mg/10 ml
English: Mucosolvan Bambini suppository rectal use
Slovenian: Italy ambroksolijev klorid Mucosolvan Bambini svečka rektalna uporaba
English: Via Vittor Pisani, 20 20124 Milano Italy
Slovenian: Via Vittor Pisani, 20 20124 Milano Italy ambroksolijev klorid Ambroxolo Mylan Generics 15 mg/5 ml
English: Ambroxol Stada Hustensaft 15mg/5ml, Lösung zum Einnehmen solution
Slovenian: 61118 Bad Vilbel Germany ambroksolijev klorid Ambroxol Stada Hustensaft 15mg/5ml, Lösung zum
English: Germany Aristo Pharma GmbH Wallenroder Str. 8-10
Slovenian: Aristo Pharma GmbH Wallenroder Str. 8-10 13435 Berlin Germany ambroksolijev klorid Ambroxin-Tropfen
English: Ambrohexal S Hustenlöser 60mg Filmtabletten film-coated tablet oral use
Slovenian: 83607 Holzkirchen Germany ambroksolijev klorid Ambrohexal S Hustenlöser 60mg Filmtabletten filmsko obložena tableta
English: Germany Cyathus Exquirere PharmaforschungsGmbH Rudolfplatz 2/1/8
Slovenian: Cyathus Exquirere PharmaforschungsGmbH Rudolfplatz 2/1/8
English: Ambroxol Genericon 30 mg Tabletten
Slovenian: Austria ambroksolijev klorid Ambroxol Genericon 30 mg Tabletten
English: Croatia bromhexinum Bisolvon 8 mg tablete
Slovenian: The Netherlands bromheksinijev klorid Bisolvon tabletten, 8 mg 8 mg
English: Ambroxole hydrochloride
Slovenian: Ampraksolijev hidroklorid
English: Mucosolvan Tabletten 30 mg
Slovenian: Mucosolvan 30 mg tablete 30 mg
English: Ambroxol Heumann Tropfen 7,5mg oral drops
Slovenian: 90449 Nürnberg Germany ambroksolijev klorid Ambroxol Heumann Tropfen 7,5mg peroralne kapljice peroralna uporaba
English: 4879 AC Etten-Leur The Netherlands bromhexine hydrochloride
Slovenian: 4879 AC ETTEN-LEUR The Netherlands bromheksinijev klorid Hoestdrank Broomhexine HCl 8 mg/5 ml HTP
English: 82049 Großhesselohe Germany
Slovenian: 82049 Großhesselohe Germany ambroksolijev klorid Ambroxol Brause 60
English: Lithuania PRO.MED.CS Praha a.s. Telčska 1140 00 Praha, Czech Republic
Slovenian: Telčska 1140 00 Praha, Czech Republic ambroksolijev klorid Ambrosan
English: Mucosolvan prolonged-release capsule, hard
Slovenian: Italy ambroksolijev klorid Mucosolvan kapsula s podaljšanim sproščanjem, trda
English: Medovent Elixir Syrup 15mg/5ml
Slovenian: 3505 Limassol, Cyprus ambroksolijev klorid Medovent Elixir Syrup 15mg/5ml
English: Ambroxol Krewel Meuselbach Sirup 15mg/5ml
Slovenian: Czech Republic ambroksolijev klorid AMBROSAN 15mg/5 ml sirup
English: 65824 Schwalbach / Taunus Germany
Slovenian: 65824 Schwalbach / Taunus Germany ambroksolijev klorid Wick Schleimlöser 75 Einmal Täglich
English: Ambroxol Inhalat nebuliser solution inhalation use
Slovenian: Italy ambroksolijev klorid Mucosolvan inhalacijska raztopina za nebulator za inhaliranje
English: Ambrohexal S Brausetablette effervescent tablet oral use
Slovenian: Austria ambroksolijev klorid Ambroxol Genericon Saft peroralna tekočina peroralna uporaba
English: Ambroxol WICK Schleimlöser für Kinder 3mg/ml Lösung zum Einnehmen
Slovenian: 65824 Schwalbach / Taunus Germany ambroksolijev klorid Ambroxol WICK Schleimlöser für Kinder 3mg/ml Lösung zum
English: Germany acis Arzneimittel GmbH Lil-Dagover-Ring 7
Slovenian: Nemčija acis Arzneimittel GmbH Lil-Dagover-Ring 7 82031 Grünwald Germany ambroksolijev klorid Ambroxol acis Tropfen
English: Ambroxol 60 Heumann Brausetabletten effervescent tablet oral use
Slovenian: 90449 Nürnberg Germany ambroksolijev klorid Ambroxol 60 Heumann Brausetabletten šumeča tableta
English: Sulfamethoxazole + Trimethoprim + Balsam Tolú syrup
Slovenian: Lamiaco-Lejona Vizcaya Spain bromheksinijev klorid + natrijev benzoat + sulfametoksazol + trimetoprim + Balsam Tolú syrup
English: Croatia ambroxolum Mucosolvan 30 mg tablete 30 mg
Slovenian: Spain ambroksolijev klorid Mucosan 30 mg comprimidos
English: Broomhexine HCI 8 mg Sameko, tabletten
Slovenian: The Netherlands bromheksinijev klorid Broomhexine HCI SAM 8 mg, tabletten
English: What is asthma?
Slovenian: Kaj je astma?
English: Sixty percent of patients were not on any other controller therapy.
Slovenian: Šestdeset odstotkov bolnikov ni bilo na nobenem drugem kontrolnem zdravljenju.
English: A treatment effect was achieved after the first dose.
Slovenian: Učinek zdravljenja je bil dosežen po prvem odmerku.
English: Characteristics in Patients.
Slovenian: Značilnosti pri bolnikih.
English: This effect was not seen at the recommended dose of 10 mg once daily.
Slovenian: Tega učinka ni bilo pri priporočenem odmerku 10 mg enkrat na dan.
English: 2770-192 Paço d' Arcos Portugal
Slovenian: 2770-192 Paço d' Arcos Portugalska
English: However, in very rare cases, individuals have reported drowsiness or dizziness.
Slovenian: Vendar pa so v zelo redkih primerih posamezniki poročali o dremavosti ali omotici.
English: Patients who develop these symptoms should be reassessed and their treatment regimens evaluated.
Slovenian: Bolnike, pri katerih se ti simptomi pojavijo, je treba ponovno obravnavati in ovrednotiti njihovo zdravljenje.
English: With prolonged treatment, the safety profile did not change in these patients either.
Slovenian: S podaljšanim zdravljenjem se varnostni profil tudi pri teh bolnikih ni spremenil.
English: IMPORTANT: Never store any granule/food mixture for use at a later time.
Slovenian: POMEMBNO: Nikoli ne shranite mešanice zrnc in hrane za kasnejšo uporabo.
English: 00-867 Warszawa Poland
Slovenian: 00-867 Varšava Poljska
English: Tell your doctor about any medical problems or allergies your child has now or has had.
Slovenian: Svojega zdravnika seznanite z vsemi zdravstvenimi težavami ali alergijami, ki jih ima ali jih je imel vaš otrok.
English: The effect in both studies was demonstrated at the end of the once-daily dosing interval.
Slovenian: Učinek so v obeh študijah dokazali na koncu enkrat dnevnega dozirnega intervala.
English: In addition, concentrations of radiolabeled material at 24 hours post-dose were minimal in all other tissues.
Slovenian: Poleg tega so bile koncentracije radioaktivno označenega materiala 24 ur po odmerku v vseh drugih tkivih minimalne.
English: 1407 Sofia Bulgaria
Slovenian: 1407 Sofija Bolgarija
English: • hyperactivity
Slovenian: • hiperaktivnost
English: Montelukast is more than 99% bound to plasma proteins.
Slovenian: Montelukast je v več kot 99 % vezan na plazemske proteine.
English: Donau-City-Straße 6 1220 Wien
Slovenian: Donau-City-Straße 6 1220 Dunaj Avstrija
English: 11415 Tallinn Estonia
Slovenian: 11415 Talin
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SINGULAIR AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SINGULAIR IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: The possibility that leukotriene receptor antagonists may be associated with emergence of Churg-Strauss syndrome can neither be excluded nor established.
Slovenian: Možnost, da so antagonisti levkotrienskih receptorjev lahko povezani s pojavom Churg-Straussovega sindroma ne more biti ne izključena ne potrjena.
English: Tatoiou Street, Nea Erythrea, 146 71, Greece
Slovenian: Tatoiou Street, Nea Erythrea, 146 71, Grčija
English: The mean oral bioavailability is 73% and is decreased to 63% by a standard meal.
Slovenian: Povprečna peroralna biološka uporabnost je 73 % in se pri standardnem obroku zmanjša na 63 %.
English: However, individual responses to medication may vary.
Slovenian: Vendar pa se lahko posamezniki različno odzivajo.
English: These cases usually, but not always, have been associated with the reduction or withdrawal of oral corticosteroid therapy.
Slovenian: Ti primeri so bili običajno, a ne vedno, povezani z zmanjšanjem ali ukinitvijo peroralnega zdravljenja s kortikosteroidi.
English: This narrowing of airways worsens and improves in response to various conditions.
Slovenian: To zožanje dihalnih poti se poslabša ali izboljša glede na različna stanja.
English: Skanstes 13, second floor, LV- 1013, Riga Latvia
Slovenian: Skanstes 13, second floor, LV- 1013, Riga Latvija
English: Istituto Gentili S.p.A Via B. Croce, 37 56125 Pisa Italy
Slovenian: Istituto Gentili S.p.A Via B. Croce, 37 56125 Pisa Italija
English: Via G. Fabbroni, 6 00191 Roma Italy
Slovenian: Via G. Fabbroni, 6 00191 Rim
English: Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines, including those obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če vaš otrok jemlje ali je pred kratkim jemal katerokoli zdravilo, tudi če se ste ga dobili brez recepta.
English: For children 2 to 5 years of age:
Slovenian: Za otroke, stare 2 do 5 let:
English: Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with SINGULAIR may affect some patients' ability to drive or operate machinery.
Slovenian: Določeni neželeni učinki (kot sta omotica in dremavost), o katerih so sicer zelo redko poročali pri zdravilu SINGULAIR, lahko vplivajo na sposobnost nekaterih bolnikov za vožnjo ali upravljanje strojev.
English: Pharmacotherapeutic group: Leukotriene receptor antagonist ATC-code: R03D C03
Slovenian: Farmakoterapevtska skupina: antagonisti levkotrienskih receptorjev Oznaka ATC: R03D C03
English: The indications given in these SPCs are the most restrictive among the approved indications in EU member states, and are approved in the most number of countries.
Slovenian: Indikacije v teh povzetkih glavnih značilnosti zdravila so najbolj omejujoče od vseh odobrenih indikacij v državah članicah EU in so odobrene v večini držav.
English: No abnormalities were seen in rats.
Slovenian: Pri podganah niso opazili nobenih nenormalnosti.
English: Packaged in polyamide/PVC/aluminum blister package in:
Slovenian: Pakirano v poliamidni/PVC/aluminijast pretisni omot in sicer:
English: • If your child's asthma or breathing gets worse, tell your doctor immediately.
Slovenian: • Če se astma ali dihanje pri vašem otroku poslabša, se takoj posvetujte z zdravnikom.
English: The mean oral bioavailability is 64%.
Slovenian: Povprečna peroralna biološka uporabnost je 64 %.
English: Corp clădire C1, Etaj 3, Sector 1, Bucureşti Romania
Slovenian: Corp clădire C1, Etaj 3, Sector 1, Bukarešta Romunija
English: MSD Magyarország Kft. 1123 Budapest, Alkotás u. 50., Hungary
Slovenian: MSD Magyarország Kft. 1123 Budimpešta, Alkotás u. 50., Madžarska
English: After opening the sachet, the full dose of SINGULAIR granules must be administered immediately (within 15 minutes).
Slovenian: Po odprtju je treba celoten odmerek SINGULAIR zrnc zaužiti takoj (v 15 minutah).
English: The clinical and laboratory findings observed were consistent with the safety profile in adults and paediatric patients.
Slovenian: Klinični in laboratorijski izvidi so bili skladni z varnostnim profilom pri odraslih in pediatričnih bolnikih.
English: Studies in rats have shown that montelukast is excreted in milk (see section 5.3).
Slovenian: Študije pri podganah so pokazale, da se montelukast izloča v mleko (glejte poglavje 5.3).
English: • This medicine has been prescribed for your child. Do not pass it on to others.
Slovenian: • Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Animal studies do not indicate harmful effects with respect to effects on pregnancy or embryonal/foetal development.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na nosečnost ali razvoj zarodka/ploda.
English: This effect was consistent throughout the 12week study period.
Slovenian: Ta učinek je trajal celih 12 tednov študije.
English: If an acute attack occurs, a short-acting inhaled β-agonist should be used.
Slovenian: V primeru akutnega napada je treba uporabiti kratko delujoči inhalacijski agonist beta.
English: Furthermore, the latest variation procedure was finalised on 10th September 2007, and the SPCs that were then approved are in line with the proposals of the MAH in this referral.
Slovenian: Poleg tega je bil zadnji postopek variacije končan 10. septembra 2007 in povzetki glavnih značilnosti zdravila, odobreni v omenjenem postopku, so v skladu s predlogi imetnika dovoljenja za promet v okviru tega napotitvenega postopka.
English: See the leaflet for further information.
Slovenian: Za dodatne informacije glejte navodilo za uporabo.
English: After careful deliberations, the CHMP considered that the clinical data to support the add-on therapy in very young children are sufficient for approval, taking into account that this formulation was approved for use in children aged 6 months to 2 years in approximately 52 countries, including 17 of 27 European Union (EU) Member States (first approval in 2002) plus Iceland and Norway.
Slovenian: Po temeljitem posvetovanju je CHMP menil, da so klinični podatki, predloženi v podporo dodatnemu zdravljenju pri zelo majhnih otrocih, zadostni za odobritev ob upoštevanju, da je bila ta oblika odobrena za uporabo pri otrocih, starih od 6 mesecev do 2 let, v približno 52 državah, vključno s 17 od 27 držav članic Evropske unije (EU) (prva odobritev leta 2002) ter v Islandiji in Norveški.
English: Granules 7 x 1 sachet 20 x 1 sachet 28 x 1 sachet 30 x 1 sachet
Slovenian: 7 x 1 vrečka 20 x 1 vrečka 28 x 1 vrečka 30 x 1 vrečka
English: Some medicines may affect how SINGULAIR works, or SINGULAIR may affect how your child's other medicines work.
Slovenian: Nekatera zdravila lahko vplivajo na delovanje zdravila SINGULAIR ali pa zdravilo SINGULAIR lahko vpliva na delovanje drugih zdravil, ki jih jemlje vaš otrok.
English: All other sections of the SPCs will be harmonised as approved in the Mutual Recognition Procedure.
Slovenian: Vsa druga poglavja povzetkov glavnih značilnosti zdravila bodo usklajena, kot so bila odobrena v postopku medsebojnega priznavanja.
English: Montelukast has been evaluated in clinical studies as follows:
Slovenian: Montelukast so v kliničnih študijah preizkušali:
English: If satisfactory response is not achieved, an additional or different therapy should be considered.”
Slovenian: Če ni dosežen zadovoljiv odziv, je treba preučiti možnosti dodatnega ali drugačnega zdravljenja.“
English: If an attack occurs, follow the instructions your doctor has given you for your child.
Slovenian: Če pride do napada, morate upoštevati navodila, ki vam jih je za tak primer dal otrokov zdravnik.
English: - the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Slovenian: - povzetki glavnih značilnosti zdravila, označevanje in navodila za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
English: Patients should be advised to continue taking SINGULAIR even if their asthma is under control, as well as during periods of worsening asthma.
Slovenian: Bolnikom je treba svetovati, da z jemanjem zdravila SINGULAIR nadaljujejo, čeprav je astma pod nadzorom, in tudi v obdobjih poslabšanja bolezni.
English: Leukotrienes cause narrowing and swelling of airways in the lungs.
Slovenian: Levkotrieni povzročajo zoženje in otekanje dihalnih poti v pljučih.
English: Patients should be periodically evaluated for their asthma control.
Slovenian: Pri bolnikih je treba periodično ocenjevati nadzor astme.
English: Both were of doubleblind, randomised, parallel-group type.
Slovenian: Obe študiji sta bili dvojno slepi, randomizirani in s paralelnimi skupinami.
English: The percentage reduction in yearly EE rate was 31.9%, with a 95% CI of 16.9, 44.1.
Slovenian: Odstotek zmanjšanja letnega deleža EP je bil 31,9 % s 95-odstotnim IZ (16,9, 44,1).
English: This indication with regard to younger paediatric patients is largely based on these data, taking into account the pharmacokinetics of montelukast (rapid absorption) and data in adults showing the rapid onset of effect.
Slovenian: Ta indikacija za mlajše otroke temelji v veliki meri na teh podatkih ob upoštevanju farmakokinetike montelukasta (hitra absorpcija) in podatkih pri odraslih, ki kažejo hiter nastop učinka.
English: The effect of montelukast on asthma was modest, but consistent across the spectrum of variables, and in line with results obtained from studies on adults and older children.
Slovenian: Učinek montelukasta na astmo je bil zmeren, vendar dosleden pri vseh spremenljivkah, ter v skladu z rezultati študij pri odraslih in starejših otrocih.
English: Absorption.
Slovenian: Absorpcija.