FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa.
Slovenian: Po rekonstituciji z 10 ml vode za injekcije en ml raztopine vsebuje 10 mg tiotepe.
English: TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
Slovenian: PKMC (avtologna ali alogenska) in bolezen.
English: The recommended dose 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.
Slovenian: Priporočeni odmerek je od 125 mg/m2 na dan (3,38 mg/kg/dan) do 300 mg/m2 na dan (8,10 mg/kg/dan) v obliki ene infuzije na dan, ki se daje 2 do 4 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 900 mg/m2 (24,32 mg/kg) v času celotnega pripravljalnega zdravljenja.
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.
Slovenian: Priporočeni odmerek je od 150 mg/m2 na dan (4,05 mg/kg/dan) do 250 mg/m2 na dan (6,76 mg/kg/dan) v obliki ene infuzije na dan in se daje 3 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 750 mg/m2 (20,27 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: GERM CELL TUMOURS
Slovenian: GERMINALNI TUMORJI
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.
Slovenian: Priporočeni odmerek pri čvrstih tumorjih je od 150 mg/m2 na dan (6 mg/kg/dan) do 350 mg/m2 na dan (14 mg/kg/dan) v obliki ene infuzije na dan in se daje 2 do 3 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 1050 mg/m2 (42 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: - zvišana raven jetrnih, ledvičnih in prebavnih encimov
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.
Slovenian: 300 mg/m2 na dan (8,10 mg/kg/dan) v obliki ene infuzije na dan, ki se daje 2 do 4 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 900 mg/m2 (24,32 mg/kg) v času celotnega pripravljalnega zdravljenja.
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.
Slovenian: Priporočeni odmerek je od 125 mg/m2 na dan (3,38 mg/kg/dan) do 250 mg/m2 na dan (6,76 mg/kg/dan), razdeljen na eno ali dve infuziji na dan, in se daje 3 do 4 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 750 mg/m2 (20,27 mg/kg) v času celotnega pripravljalnega zdravljenja.
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.
Slovenian: Priporočeni odmerek je od 250 mg/m2 na dan (10 mg/kg/dan) do 350 mg/m2 na dan (14 mg/kg/dan) v obliki ene infuzije na dan in se daje 3 zaporedne dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 1050 mg/m2 (42 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Idiopathic pneumonia syndrome Epistaxis
Slovenian: Očesne bolezni konjuktivitis katarakta
English: TEPADINA 100 mg powder for concentrate for solution for infusion Thiotepa
Slovenian: TEPADINA 100 mg prašek za koncentrat za raztopino za infundiranje tiotepa
English: TEPADINA must be reconstituted with 10 ml of sterile water for injection.
Slovenian: Rekonstitucija Zdravilo TEPADINA se rekonstituira z 10 ml sterilne vode za injekcije.
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.
Slovenian: Priporočeni odmerek pri čvrstih tumorjih je od 120 mg/m2 na dan (3,24 mg/kg/dan) do 250 mg/m2 na dan (6,76 mg/kg/dan), razdeljen na eno ali dve infuziji na dan, in se daje 2 do 5 zaporednih dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 800 mg/m2 (21,62 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Slovenian: Rekonstitucija Zdravilo TEPADINA se rekonstituira z 1,5 ml sterilne vode za injekcije.
English: TEPADINA 15 mg powder for concentrate for solution for infusion Thiotepa
Slovenian: TEPADINA 15 mg prašek za koncentrat za raztopino za infundiranje tiotepa
English: BREAST CANCER
Slovenian: RAK DOJK
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported.
Slovenian: Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: Poročali so o vrednostih RRM od 0 do 2 odstotkov.
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.
Slovenian: TALASEMIJA Priporočeni odmerek je 370 mg/m2/dan (10 mg/kg/dan), razdeljen na dve infuziji na dan pred alogensko PKMC, ne da bi se presegel skupni največji kumulativni odmerek 370 mg/m2 (10 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: PREPARATION GUIDE TEPADINA 100 mg powder for concentrate for solution for infusion
Slovenian: NAVODILO ZA PRIPRAVO TEPADINA 100 mg prašek za koncentrat za raztopino za infundiranje
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.
Slovenian: LEVKEMIJA Priporočeni odmerek je 250 mg/m2/dan (10 mg/kg/dan), razdeljen na dve infuziji na dan pred alogensko PKMC, ne da bi se presegel skupni največji kumulativni odmerek 250 mg/m2 (10 mg/kg) v času celotnega pripravljalnega zdravljenja.
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 (10 mg/kg), during the time of the entire conditioning treatment.
Slovenian: LIMFOM Priporočeni odmerek pri limfomu je 370 mg/m2/dan (10 mg/kg/dan), razdeljen na dve infuziji na dan pred alogensko PKMC, ne da bi se presegel skupni največji kumulativni odmerek 370 mg/m2 (10 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Haemorrhage Embolism
Slovenian: REFRAKTARNA CITOPENIJA
English: Pancytopenia Granulocytopenia
Slovenian: Shranjevanje zdravila TEPADINA
English: Thrombocytopenia Febrile neutropenia Anaemia
Slovenian: Bolezni krvi in limfatičnega sistema trombocitopenija febrilna nevtropenija anemija pancitopenija granulocitopenija
English: PREPARATION GUIDE TEPADINA 15 mg powder for concentrate for solution for infusion
Slovenian: NAVODILO ZA PRIPRAVO TEPADINA 15 mg prašek za koncentrat za raztopino za infundiranje
English: Stomatitis Vomiting Diarrhoea Abdominal pain
Slovenian: Žilne bolezni limfedem hipertenzija krvavitev embolija
English: The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered from 3 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.
Slovenian: Priporočeni odmerek pri čvrstih tumorjih je od 120 mg/m2 na dan (3,24 mg/kg/dan) do 250 mg/m2 na dan (6,76 mg/kg/dan), kot ena infuzija na dan ali razdeljen na dve infuziji na dan, in se daje 2 do 5 zaporednih dni pred avtologno PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 800 mg/m2 (21,62 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Thiotepa might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents (busulfan, fludarabine and cyclophosphamide) (see section 4.8).
Slovenian: (busulfana, fludarabina in ciklofosfamida) (glejte poglavje 4.8).
English: Arrhythmia
Slovenian: ZDRAVILA
English: Azoospermia Amenorrhoea Vaginal haemorrhage
Slovenian: Motnje reprodukcije in dojk azoospermija amenoreja vaginalna krvavitev menopavzalni simptomi neplodnost pri ženskah neplodnost pri moških
English: Asthenia Chills
Slovenian: Bolezni jeter,
English: How TEPADINA is given
Slovenian: Kako se zdravilo TEPADINA uporablja
English: Uncommon side effects (may affect up to 1 in 100 people) - inflammation and exfoliation of the skin (erythrodermic psoriasis) - delirium, nervousness, hallucination, agitation - gastrointestinal ulcer - inflammation of the muscular tissue of the heart (myocarditis) - abnormal heart condition (cardiomyopathy)
Slovenian: - delna izguba gibanja - zastoj srca - slabost, bruhanje, driska - vnetje ustne sluznice (mukozitis)
English: SICKLE CELL ANAEMIA
Slovenian: ALOGENSKA PKMC Hematološke bolezni
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.
Slovenian: Priporočeni odmerek je 185 mg/m2 na dan (5 mg/kg/dan) v obliki ene infuzije na dan, ki se daje dva zaporedna dneva pred avtologno PKMC, ne da bi se presegel skupni največji kumulativni odmerek 370 mg/m2 (10 mg/kg) v času celotnega pripravljalnega zdravljenja.
English: Toxic shock syndrome
Slovenian: citotoksično zdravilo
English: Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2.5% have been reported.
Slovenian: Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: poročali so o vrednostih RRM med 0 in 2,5 %.
English: Generalised oedema
Slovenian: OVOJNINAH VIALA
English: Infections and infestations
Slovenian: Linearnost/Nelinearnost
English: - increased susceptibility to infection - whole-body inflammatory state (sepsis) - decreased counts of white blood cells, platelets and red blood cells (anaemia) - the transplanted cells attack your body (graft versus host disease) - dizziness, headache, blurred vision - uncontrolled shaking of the body (convulsion) - sensation of tingling, pricking or numbness (paraesthesia) - partial loss of movement - cardiac arrest - nausea, vomiting, diarrhoea - inflammation of the mucosa of the mouth (mucositis) - irritated stomach, gullet, intestine - inflammation of the colon - anorexia, decreased appetite - high glucose in the blood - skin rash, itching, shedding - skin colour disorder (do not confuse with jaundice - see below) - redness of the skin (erythema) - hair loss - back and abdominal pain, pain - muscle and joint pain - abnormal electrical activity in the heart (arrhythmia) - inflammation of lung tissue - enlarged liver - altered organ function - blocking of a liver vein (Veno-Occlusive Disease, VOD) - yellowing of the skin and eyes (jaundice) - hearing impaired - lymphatic obstruction - high blood pressure - increased liver, renal and digestive enzymes - abnormal blood electrolytes - weight gain - fever, general weakness, chills - bleeding (haemorrhage) - nasal bleeding - general swelling due to fluid retention (oedema) - pain or inflammation at the injection site - eye infection (conjunctivitis) - decreased sperm cell count - vaginal bleeding - absence of menstrual periods (amenorrhea) - memory loss - delaying in weight and height increase - bladder disfunction - underproduction of testosterone - insufficient production of thyroid hormone - deficient activity of the pituitary gland - confusional state
Slovenian: Preiskave zvečanje telesne mase zvečane vrednosti bilirubina v krvi zvečana vrednost transaminaz zvečana vrednost amilaze v krvi zvečanje vrednosti kreatinina v krvi zvečanje vrednosti sečnine v krvi zvečana vrednost gamaglutamiltransferaze zvečane vrednosti alkalne fosfataze v krvi zvečane vrednosti aspartataminotransferaze
English: C.
Slovenian: PC:
English: Blood urea increased Blood electrolytes abnormal Prothrombin time ratio increased
Slovenian: - nenormalne vrednosti elektrolitov v krvi - zvečanje telesne mase
English: Confusional state Mental status changes
Slovenian: - zmanjšanja aktivnost hipofize - stanje zmedenosti
English: The areas harmonised include:
Slovenian: Uskladiti je treba naslednja področja:
English: The European Commission issued a decision on this opinion on 11/11/2016.
Slovenian: Evropska komisija je sklep v zvezi s tem mnenjem izdala 11. novembra 2016.
English: Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy.
Slovenian: Zdravilo Clenil se trži v naslednjih državah članicah EU: Francija, Nemčija, Grčija, Irska in Italija.
English: The lowest dose needed to control symptoms should be used.
Slovenian: Uporabiti je treba najnižji odmerek, potreben za obvladanje simptomov.
English: The amended information to doctors and patients is available here.
Slovenian: Dopolnjene informacije za zdravstvene delavce in bolnike so na voljo tukaj.
English: It is also available under the trade names of Becloneb, Beclospin and Sanasthmax.
Slovenian: Na voljo je tudi pod trgovskimi imeni Becloneb, Beclospin in Sanasthmax.
English: Regular follow-up is recommended to review the treatment response.
Slovenian: Priporoča se redno spremljanje, da se oceni odziv na zdravljenje.
English: Clenil has been authorised in the EU via national procedures.
Slovenian: Zdravilo Clenil je bilo v EU odobreno po nacionalnih postopkih.
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).
Slovenian: Največji dnevni odmerek je 3 200 mikrogramov pri odraslih in mladostnikih (do 1 600 mikrogramov dvakrat dnevno) in 1 600 mikrogramov pri otrocih, mlajših od 12 let (do 800 mikrogramov dvakrat dnevno).
English: On 15 September 2016, the European Medicines Agency completed a review of Clenil.
Slovenian: Evropska agencija za zdravila je 15. septembra 2016 zaključila pregled zdravila Clenil.
English: The duration of treatment should not exceed 3 months, unless a diagnosis of asthma is likely.
Slovenian: Trajanje zdravljenja ne sme presegati 3 mesecev, razen če kaže na diagnozo astme.
English: The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control.
Slovenian: Začetni odmerek zdravila Clenil je odvisen od pogostnosti in resnosti simptomov ter se lahko prilagodi, dokler simptomi niso nadzorovani.
English: The company that markets these medicines is Chiesi and associated companies.
Slovenian: Ta zdravila tržijo družba Chiesi in povezana podjetja.
English: Why was Clenil reviewed?
Slovenian: Zakaj je bilo zdravilo Clenil pregledano?
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.
Slovenian: Uporablja se tudi za zdravljenje ponavljajočega se sopenja (piskajoč zvok pri dihanju, ki ga povzročijo zožene dihalne poti ali vnetje) pri otrocih, mlajših od 5 let.
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).
Slovenian: Odbor je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavji 4.6 (Plodnost, nosečnost in dojenje), 4.8 (Neželeni učinki) in 5.1 (Farmakodinamične lastnosti).
English: In children with recurrent wheezing the response to treatment should be carefully monitored; if no benefit is observed within 2-3 months, Clenil should be discontinued.
Slovenian: Pri otrocih s ponavljajočim se sopenjem je treba odziv na zdravljenje pazljivo spremljati; če koristi niso opažene v 2-3 mesecih, je treba uporabo zdravila Clenil prekiniti.
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.
Slovenian: Če v 2-3 mesecih ni opaziti nobenih koristi zdravljenja ali če diagnoza astme ni verjetna, je treba uporabo zdravila Clenil prekiniti, da se izognemo nepotrebni dolgotrajni izpostavljenosti inhalacijskim kortikosteroidom in povezanim tveganjem pri otrocih.
English: Having harmonised the indication, the CHMP also harmonised recommendations on the doses.
Slovenian: Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o odmerjanju.
English: Clenil is a medicine used for the maintenance treatment of asthma in adults and children.
Slovenian: Clenil je zdravilo, ki se uporablja za vzdrževalno zdravljenje astme pri odraslih in otrocih.
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).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Clenil v Evropski uniji (EU).
English: Clenil contains the active substance beclometasone dipropionate (which belongs to a group of antiinflammatory medicines commonly known as ‘corticosteroids').
Slovenian: Zdravilo Clenil vsebuje zdravilno učinkovino beklometazon dipropionat (ki spada v skupino protivnetnih zdravil, splošno znanih kot kortikosteroidi).
English: The CHMP agreed that Clenil can be used for the maintenance treatment of asthma in adults and children when the use of pressurised or dry powder inhalers is unsatisfactory or inappropriate.
Slovenian: Odbor CHMP se je strinjal, da se zdravilo Clenil lahko uporablja za vzdrževalno zdravljenje astme pri odraslih in otrocih, ko je uporaba inhalatorjev pod tlakom ali s praškom nezadovoljiva ali neustrezna.
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.
Slovenian: Na voljo je v obliki suspenzije, ki se daje z inhaliranjem s pomočjo nebulatorja, pri astmi pa se uporablja le, ko uporaba drugih ročnih inhalatorjev ni ustrezna.
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.
Slovenian: Vendar pa je menil, da se zdravilo Clenil lahko uporablja za zdravljenje ponavljajočega se sopenja pri otrocih, mlajših od 5 let, saj je ta uporaba podprta z ustreznimi podatki.
English: Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension) EMA/612121/2016 Rev.1
Slovenian: Vprašanja in odgovori o zdravilu Clenil in povezanih imenih (beklometazon dipropionat, 400- in 800-mikrogramska inhalacijska suspenzija za nebulator) EMA/612121/2016 rev.1
English: In children up to 5 years of age, the decision to start Clenil for the treatment of recurrent wheezing should be determined by the severity and frequency of the wheezing episodes.
Slovenian: Pri otrocih, mlajših od 5 let, se odločitev za začetek zdravljenja z zdravilom Clenil za zdravljenje ponavljajočega se sopenja sprejme na podlagi resnosti in pogostnosti epizod sopenja.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo uskladiti po vsej EU.
English: Questions and answers on Clenil and associated names (beclometasone dipropionate, 400 and 800 microgram nebuliser suspension)
Slovenian: Vprašanja in odgovori o zdravilu Clenil in povezanih imenih (beklometazon dipropionat, 400- in 800-mikrogramska inhalacijska suspenzija za nebulator)
English: The Committee agreed that Clenil should no longer be used to treat common bronchostenotic conditions (narrowing of the airways in the lungs) because of the lack of rigorous evidence from adequately designed clinical studies.
Slovenian: Prav tako se je strinjal, da se zdravilo Clenil ne sme več uporabljati za zdravljenje običajnih stanj bronhostenoze (zoženja dihalnih poti v pljučih) zaradi pomanjkanja natančnih dokazov iz ustrezno zasnovanih kliničnih študij.
English: The CHMP also agreed that Clenil should no longer be used to treat allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example hay fever or allergy to dust mites) because the available data do not support this use and other medicines available as nasal sprays may be better tolerated.
Slovenian: Odbor CHMP se je tudi strinjal, da se zdravilo Clenil ne sme več uporabljati za zdravljenje alergijskega rinitisa (vnetja nosne votline, ki ga povzroči alergija, npr. senenega nahoda ali alergije na pršice), saj razpoložljivi podatki ne podpirajo te uporabe in bolniki druga zdravila, na voljo v obliki pršil za nos, morda bolje prenašajo.
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.
Slovenian: Da bi italijanska regulativna agencija za zdravila uskladila dovoljenja za promet z zdravilom Clenil in povezanimi imeni v EU, je 19. junija 2015 zadevo napotila na odbor CHMP.