FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa.
Croatian: Nakon pripreme za primjenu s 1,5 ml vode za injekcije, svaki ml sadrži 10 mg tiotepe.
English: TRM values ranged from 0% to 21% at 1 year, confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with haematological diseases.
Croatian: TRM vrijednosti su u rasponu od 0% do 21% nakon 1 godine, potvrđujući sigurnost pripremnog liječenja s tiotepom za autologne TKMS u odraslih bolesnika s hematološkim bolestima.
English: Fertility
Croatian: Tinitus
English: Accord Healthcare B.V. Tel: +31 30 850 6014
Croatian: Tel: +31 30 850 6014
English: Erythema Desquamation Pigmentation disorder
Croatian: Poremećaji pigmentacije
English: The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2
Croatian: Preporučena doza je 370 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m
English: Concomitant use not recommended
Croatian: Kontraindicirana istodobna primjena
English: TEPADINA 100 mg powder for concentrate for solution for infusion
Croatian: TEPADINA 100 mg prašak za koncentrat za otopinu za infuziju
English: TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Croatian: TEPADINA se mora rekonstituirati s 1,5 ml sterilne vode za injekcije.
English: Each TEPADINA vial must be reconstituted with 1.5 ml of sterile water for injection.
Croatian: Svaka bočica lijeka TEPADINA mora biti rekonstituirana s 1,5 ml sterilne vode za injekcije.
English: Dizziness Headache Vision blurred Encephalopathy Convulsion Paraesthesia
Croatian: Omaglica Glavobolja Zamagljen vid Encefalopatija Konvulzije Parestezija
English: The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je 370 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije primjenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m (10 mg/kg), tijekom cijelog pripremnog liječenja.
English: TEPADINA 15 mg powder for concentrate for solution for infusion
Croatian: TEPADINA 15 mg prašak za koncentrat za otopinu za infuziju
English: TRM values ranged from 0% to 18% confirming the safety of the conditioning treatments including thiotepa for autologous HPCT in paediatric patients with solid tumours.
Croatian: TRM vrijednosti su bile u rasponu od 0% do 18%, potvrđujući sigurnost pripremnih terapija s tiotepom za autologne TKMS u pedijatrijskih bolesnika sa solidnim tumorima.
English: Caution must be used in patients with history of renal diseases and periodic monitoring of renal function should be considered during therapy with thiotepa.
Croatian: Tijekom terapije s tiotepom, potreban je oprez u bolesnika s anamnezom bolesti bubrega i treba razmotriti periodično praćenje bubrežne funkcije.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 26.7% have been reported.
Croatian: Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 26,7%.
English: CENTRAL NERVOUS SYSTEM (CNS) LYMPHOMA The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Croatian: LIMFOM SREDIŠNJEG ŽIVČANOG SUSTAVA (CNS) Preporučena doza je 185 mg/kg/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 uzastopna dana prije autologne TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 370 mg/m
English: After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa.
Croatian: Nakon pripreme za primjenu s 10 ml vode za injekcije, svaki ml sadrži 10 mg tiotepe.
English: Cognitive disorder Cerebral haemorrhage
Croatian: Zatajenje bubrega Hemoragijski cistitis
English: 20867 Caponago (MB) Italy Tel: +39 02 40700445 adienne@adienne.com
Croatian: Tel: +39 02 40700445 adienne@adienne.com
English: The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 185 mg/m2/dan (5 mg/kg/dan) do 481 mg/m2/dan (13 mg/kg/dan) podijeljena u jednu ili dvije dnevne infuzije, primijenjene tijekom 1 do 2 uzastopna dana prije alogene TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 555 mg/m
English: The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je 250 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije primjenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 250 mg/m (10 mg/kg), tijekom cijelog pripremnog liječenja.
English: The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 200 mg/m2/dan (8 mg/kg/dan) do 250 mg/m2/dan (10 mg/kg/dan) podijeljena u dvije dnevne infuzije, primijenjene prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 250 mg/m
English: What you need to know before you use TEPADINA Do not use TEPADINA
Croatian: Što je TEPADINA i za što se koristi Što morate znati prije nego počnete primjenjivati lijek TEPADINA
English: Investigation
Croatian: Pretrage
English: TEPADINA must be reconstituted with 10 ml of sterile water for injection.
Croatian: TEPADINA se mora rekonstituirati s 10 ml sterilne vode za injekcije.
English: TRM values ranged from 0% to 30% confirming the safety of the conditioning treatment including thiotepa for allogeneic HPCT in paediatric patients with haematological diseases.
Croatian: TRM vrijednosti su bile u rasponu od 0% do 30% potvrđujući sigurnost pripremnih terapija s tiotepom za alogene TKMS u pedijatrijskih bolesnika s hematološkim bolestima.
English: Dysuria Oliguria Renal failure Cystitis Haematuria
Croatian: Oligurija Zatajenje bubrega Cistitis
English: TEPADINA is supplied as 15 mg powder for concentrate for solution for infusion.
Croatian: TEPADINA dolazi u obliku 15 mg praška za koncentrat za otopinu za infuziju.
English: TEPADINA 100 mg powder for concentrate for solution for infusion Thiotepa
Croatian: TEPADINA 100 mg prašak za koncentrat za otopinu za infuziju tiotepa
English: Rash Pruritus Alopecia
Croatian: Svrbež Alopecija
English: Engraftment: It has been achieved with all reported conditioning regimens including thiotepa.
Croatian: Prihvat transplantata: Prihvat je postignut kod svih pripremnih terapija sa tiotepom.
English: TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion.
Croatian: TEPADINA dolazi u obliku 100 mg praška za koncentrat za otopinu za infuziju.
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 2.5% to 29% have been reported.
Croatian: Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 2,5% do 29%.
English: Hearing impaired
Croatian: Oštećenje sluha
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported.
Croatian: Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 2%.
English: Injection site inflammation Injection site pain Mucosal inflammation
Croatian: Upala na mjestu injiciranja Bol na mjestu injiciranja
English: PRESENTATION
Croatian: Primjena
English: Haemorrhage
Croatian: TALASEMIJA
English: TEPADINA 15 mg powder for concentrate for solution for infusion Thiotepa
Croatian: TEPADINA 15 mg prašak za koncentrat za otopinu za infuziju tiotepa
English: TEPADINA is used to prepare patients for bone marrow transplantation.
Croatian: TEPADINA se koristi za pripremu bolesnika za transplantaciju koštane srži; djeluje uništavajući stanice koštane srži.
English: Disposal
Croatian: Deskvamacija
English: ALLOGENEIC HPCT
Croatian: ALOGENA TKMS
English: Allogeneic HPCT
Croatian: Alogena TKMS
English: Immedica Pharma AB Puh/Tel: +46 (0)8 533 39 500
Croatian: Suomi/Finland Immedica Pharma AB Puh/Tel: +46 (0)8 533 39 500
English: Preparation of TEPADINA
Croatian: Priprema lijeka TEPADINA
English: Tachycardia Cardiac failure
Croatian: Tahikardija Zatajivanje srca
English: SICKLE CELL ANAEMIA
Croatian: Pireksija Astenija Zimica
English: How to store TEPADINA
Croatian: Kako čuvati lijek TEPADINA
English: Intracranial aneurysm Extrapyramidal disorder
Croatian: Intrakranijska aneurizma Ekstrapiramidni poremećaji Kognitivni poremećaji Cerebralno krvarenje
English: The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
Croatian: LIMFOM Preporučena doza je u rasponu od 125 mg/m2/dan (3,38 mg/kg/dan) do 300 mg/m2/dan (8,10 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 do 4 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 900 mg/m
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2.5% have been reported.
Croatian: Mortalitet vezan za terapiju (RRM - Regimen Related Mortality ) i mortalitet vezan za transplantaciju (TRM - Transplant Related Mortality): prijavljene su RRM vrijednosti u rasponu od 0% do 2,5%.
English: The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 125 mg/m2/dan (3,38 mg/kg/dan) do 250 mg/m2/dan (6,76 mg/kg/dan) podijeljena u jednu ili dvije dnevne infuzije, primijenjene tijekom 3 do 4 uzastopnih dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 750 mg/m
English: Cataract
Croatian: Katarakta
English: The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.
Croatian: REFRAKTORNA CITOPENIJA Preporučena doza je 125 mg/m2/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 3 uzastopna dana prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze 375 mg/m
English: The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 150 mg/m2/dan (6 mg/kg/dan) do 350 mg/m2/dan (14 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 do 3 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 1050 mg/m
English: The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je 125 mg/m2/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 uzastopna dana prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze 250 mg/m
English: Each TEPADINA vial must be reconstituted with 10 ml of sterile water for injection.
Croatian: Rekonstitucija TEPADINA se mora rekonstituirati s 10 ml sterilne vode za injekcije.
English: The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 150 mg/m2/dan (4,05 mg/kg/dan) do 250 mg/m2/dan (6,76 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 3 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 750 mg/m
English: (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.
Croatian: 300 mg/m2/dan (8,10 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 do 4 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 900 mg/m
English: Enteritis Intestinal obstruction
Croatian: Oštećenje bubrega
English: The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 2 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.
Croatian: Preporučena doza je u rasponu od 120 mg/m2/dan (3,24 mg/kg/dan) do 250 mg/m2/dan (6,76 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 3 do 5 uzastopnih dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 800 mg/m
English: The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.
Croatian: TUMORI CNS-a Preporučena doza je u rasponu od 250 mg/m2/dan (10 mg/kg/dan) do 350 mg/m2/dan (14 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 3 uzastopna dana prije autologne TKMS ovisno o kombinaciji s drugim kemoterapijskim lijekovima, bez prekoračenja ukupne maksimalne kumulativne doze od 1050 mg/m
English: The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.
Croatian: MULTIPLI MIJELOM Preporučena doza je 185 mg/m2/dan (5 mg/kg/dan) u jednoj dnevnoj infuziji prije alogene TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 185 mg/m
English: Tel.: +48 22 577 28 00
Croatian: Accord Healthcare Polska Sp. z o.o. Tel.: +48 22 577 28 00
English: Pulmonary oedema Cough
Croatian: Plućni edem Epistaksa
English: Tel: +48 22 577 28 00
Croatian: Accord Healthcare Polska Sp. z o.o. Tel: +48 22 577 28 00
English: Arrhythmia
Croatian: Dojenje
English: The recommended dose is 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 500 mg/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.
Croatian: RAK JAJNIKA Preporučena doza je 250 mg/m2/dan (6,76 mg/kg/dan) u jednoj dnevnoj infuziji, primjenjenoj tijekom 2 uzastopna dana prije autologne TKMS, bez prekoračenja ukupne maksimalne kumulativne doze od 500 mg/m
English: Cardiac disorders
Croatian: Srčani poremećaji Aritmija
English: Hypopituitarism
Croatian: Hipopituitarizam
English: The European Commission issued a decision on this opinion on 11/11/2016.
Croatian: Europska komisija objavila je odluku o tom mišljenju 11. 11. 2016.
English: Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy.
Croatian: Clenil je stavljen u promet u sljedećim državama članicama EU-a: Francuskoj, Njemačkoj, Grčkoj, Irskoj i Italiji.
English: The areas harmonised include:
Croatian: Područja koja se trebaju uskladiti obuhvaćaju:
English: EMA/612121/2016 Rev.1 EMEA/H/A-30/1418
Croatian: EMA/612121/2016 Rev.1 EMEA/H/C/-30/1418
English: It is also available under the trade names of Becloneb, Beclospin and Sanasthmax.
Croatian: Također je dostupan pod trgovačkim nazivima Becloneb, Beclospin i Sanasthmax.
English: The lowest dose needed to control symptoms should be used.
Croatian: Potrebno je primjenjivati najnižu dozu potrebnu za kontroliranje simptoma.
English: Why was Clenil reviewed?
Croatian: Zašto je Clenil ponovno ocjenjivan?
English: Regular follow-up is recommended to review the treatment response.
Croatian: Preporučuje se redovno praćenje radi ocjene odgovora na liječenje.
English: The maximum daily dose is 3,200 micrograms in adults and adolescents (up to 1,600 micrograms taken twice a day) and 1,600 micrograms in children below 12 years (up to 800 micrograms taken twice a day).
Croatian: Maksimalna dnevna doza jest 3 200 mikrograma u odraslih osoba i adolescenata (do 1 600 mikrograma koji se uzimaju dvaput na dan) te 1 600 mikrograma u djece mlađe od 12 godina (do 800 mikrograma koji se uzimaju dvaput na dan).
English: The duration of treatment should not exceed 3 months, unless a diagnosis of asthma is likely.
Croatian: Trajanje liječenja ne smije biti dulje od tri mjeseca, osim ako postoji vjerojatnost za dijagnozu astme.
English: What is Clenil?
Croatian: Što je Clenil?
English: Clenil has been authorised in the EU via national procedures.
Croatian: Lijek Clenil odobren je u EU-u u okviru nacionalnih postupaka.
English: It is also used to treat recurrent wheezing (whistling sound made while breathing, caused by narrowed airways or inflammation) in children up to 5 years of age.
Croatian: Također se primjenjuje za liječenje ponavljajućeg piskanja (zvuk zviždanja prilikom disanja prouzročen suženim dišnim putovima ili upalom) u djece u dobi do pet godina.
English: The Committee also harmonised other sections of the SmPC including sections 4.6 (fertility, pregnancy and lactation), 4.8 (side effects), and 5.1 (pharmacodynamics).
Croatian: Odbor je također uskladio druge dijelove Sažetka opisa svojstava lijeka, uključujući dijelove 4.6. (plodnost, trudnoća i dojenje), 4.8. (nuspojave) i 5.1. (farmakodinamika).
English: The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control.
Croatian: Početna doza lijeka Clenil ovisi o učestalosti i ozbiljnosti simptoma te se može prilagođavati dok su simptomi pod kontrolom.
English: Clenil is a medicine used for the maintenance treatment of asthma in adults and children.
Croatian: Clenil je lijek koji se primjenjuje u terapiji održavanja za liječenje astme u odraslih osoba i djece.
English: The company that markets these medicines is Chiesi and associated companies.
Croatian: Te lijekove stavlja u promet tvrtka Chiesi i povezane tvrtke.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je dovelo do odstupanja među državama članicama u pogledu načina primjene lijeka, što je vidljivo u razlikama među sažecima opisa svojstava lijeka, označivanju i uputama o lijeku u državama u kojima se lijek stavlja u promet.
English: Having harmonised the indication, the CHMP also harmonised recommendations on the doses.
Croatian: Nakon usklađivanja indikacija CHMP je također uskladio preporuke o načinu doziranja.
English: However, the Committee considered that Clenil can be used to treat recurrent wheezing in children up to 5 years of age because this use is supported by adequate data.
Croatian: Međutim, Odbor je smatrao da se lijek Clenil može primjenjivati za liječenje ponavljajućeg piskanja u djece u dobi do pet godina jer je ova primjena poduprta odgovarajućim podacima.
English: On 19 June 2015, the Italian medicines regulatory agency referred the matter to the CHMP in order to harmonise the marketing authorisations for Clenil and associated names in the EU.
Croatian: Talijanska regulatorna agencija za lijekove uputila je 19. lipnja 2015. predmet CHMP-u radi usklađivanja odobrenja za stavljanje u promet lijeka Clenil i povezanih naziva u EU-u.
English: If no treatment benefit is observed within 2-3 months or if a diagnosis of asthma is not likely, Clenil should be discontinued to avoid unnecessary long-term exposure to inhaled corticosteroids and associated risks in children.
Croatian: Ako unutar 2 - 3 mjeseca nisu zabilježene koristi liječenja ili dijagnoza astme nije vjerojatna, potrebno je obustaviti liječenje lijekom Clenil radi sprečavanja nepotrebnog dugotrajnog izlaganja djece inhalacijskim kortikosteroidima i povezanim rizicima.
English: It is available as a suspension given by inhalation though a nebuliser device, and in asthma it should only be used when the use of other hand-held inhalers is not appropriate.
Croatian: Dostupan je u obliku suspenzije koja se daje udisanjem s pomoću nebulizatora, a u slučaju astme treba se primjenjivati samo ako primjena drugih ručnih inhalatora nije odgovarajuća.
English: Clenil contains the active substance beclometasone dipropionate (which belongs to a group of antiinflammatory medicines commonly known as ‘corticosteroids').
Croatian: Clenil sadržava djelatnu tvar beklometazon dipropionat (koji pripada skupini protuupalnih lijekova pod zajedničkim nazivom „kortikosteroidi”).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Clenil in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija o propisivanju lijeka Clenil u Europskoj uniji (EU).