natgillin/translations-raw huggingface dataset:
TEPADINA is supplied as 100 mg powder for concentrate for solution for infusion.
Zdravilo TEPADINA je na voljo kot 100 mg prašek za koncentrat za raztopino za infundiranje.
Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C -8°C and for 4 hours when stored at 25°C.
Dokazano je bilo, da je po redčenju raztopina kemijsko in fizikalno stabilna 24 ur, če je bila hranjena pri 2 °C -8 °C in 4 ure, če je bila hranjena pri 25 °C.
Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C-8°C and for 4 hours when stored at 25°C.
Dokazano je bilo, da je po redčenju raztopina kemijsko in fizikalno stabilna 24 ur, če je bila hranjena pri 2 °C-8 °C, in 4 ure, če je bila hranjena pri 25 °C.
Live virus and bacterial vaccines must not be administered to a patient receiving an immunosuppressive chemotherapeutic agent and at least three months must elapse between discontinuation of therapy and vaccination.
Posebne interakcije s tiotepo Živa virusna in bakterijska cepiva se ne smejo uporabljati pri bolnikih, ki prejemajo zdravilo za zaviranje imunske odzivnosti.
TEPADINA is supplied as 15 mg powder for concentrate for solution for infusion.
Zdravilo TEPADINA je na voljo kot 15 mg prašek za koncentrat za raztopino za infundiranje.
The recommended dose in haematological diseases 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 3 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.
Priporočeni odmerek pri hematoloških boleznih je od 185 mg/m2 na dan (5 mg/kg/dan) do 481 mg/m2 na dan (13 mg/kg/dan), razdeljen na eno ali dve infuziji na dan, in se daje 1 do 3 zaporedne dni pred alogensko PKMC, odvisno od kombinacije z drugimi kemoterapevtiki, ne da bi se presegel skupni največji kumulativni odmerek 555 mg/m2 (15 mg/kg) v času celotnega pripravljalnega zdravljenja.
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.
Priporočeni odmerek je 250 mg/m2/dan (6,76 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 500 mg/m2 (13,51 mg/kg) v času celotnega pripravljalnega zdravljenja.
After reconstitution with 1.5 ml of water for injection, each ml contains 10 mg thiotepa.
Po rekonstituciji z 1,5 ml vode za injekcije en ml raztopine vsebuje 10 mg tiotepe.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 26.7% have been reported.
Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: poročali so o vrednostih RRM med 0 in 26,7 %.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 2.5% to 29% have been reported.
Z režimom povezana umrljivost (RRM: Regimen Related Mortality) in s presaditvijo povezana umrljivost (TRM: Transplant related Mortality): poročali so o vrednostih RRM od 2,5 do 29 odstotkov.
In some of the conditioning treatments evaluated, relapse rates lower than 60% have also been reported at 5 years.
Pri nekaterih ocenjenih pripravljalnih zdravljenjih so poročali tudi o stopnjah ponovitve,
TEPADINA 15 mg powder for concentrate for solution for infusion
TEPADINA 15 mg prašek za koncentrat za raztopino za infundiranje
TRM values ranged from 0% to 7.4% confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with solid tumours.
Vrednosti TRM so od 0 do 7,4 odstotkov, kar potrjuje varnost pripravljalnega zdravljenja s tiotepo za avtologno PKMC pri odraslih bolnikih s čvrstimi tumorji.
This leaflet was last revised in:
Pogostnost je opredeljena kot sledi:
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.
Priporočeni odmerek je od 200 mg/m2 na dan (8 mg/kg/dan) do 250 mg/m2 na 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.
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.
Vrednosti TRM so bile med 0 in 30 %, kar potrjuje varnost pripravljalnega zdravljenja s tiotepo za alogensko PKMC pri pediatričnih bolnikih s hematološkimi boleznimi.
TEPADINA can impair male and female fertility.
Zdravilo TEPADINA lahko zmanjša plodnost moških in žensk.
TEPADINA 100 mg powder for concentrate for solution for infusion
TEPADINA 100 mg prašek za koncentrat za raztopino za infundiranje
Frequencies are defined as: very common (≥1/10), common ((≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
< 1/1.000), zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
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.
Vrednosti TRM so bile med 0 in 18 %, kar potrjuje varnost pripravljalnega zdravljenja s tiotepo za avtologno PKMC pri pediatričnih bolnikih s čvrstimi tumorji.
Hearing impaired Ototoxicity Tinnitus
vključno z motnjami labirinta motnje sluha ototoksičnost tinitus
Idiopathic pneumonia syndrome Pulmunary haemorrage Pulmonary oedema
Bolezni dihal, prsnega koša in mediastinalnega prostora pljučnica sindrom idiopatske pnevmonije pljučna krvavitev pljučni edem epistaksa hipoksija zastoj dihanja
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.
REFRAKTARNA CITOPENIJA Priporočeni odmerek je 125 mg/m2/dan (5 mg/kg/dan) v obliki ene infuzije na dan, ki se daje tri zaporedne dni pred alogensko PKMC, ne da bi se presegel skupni največji kumulativni odmerek 375 mg/m2 (15 mg/kg) v času celotnega pripravljalnega zdravljenja.
Allogeneic HPCT
ALOGENSKA PKMC
ALLOGENEIC HPCT
Alogenska PKMC
Dysuria Oliguria Renal failure Cystitis Haematuria
Bolezni sečil hemoragični cistitis dizurija oligurija odpoved ledvic cistitis hematurija
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.
LIMFOM V OSREDNJEM ŽIVČEVJU Priporočeni odmerek je 185 mg/m2 na dan (5 mg/kg/dan) v obliki ene infuzije na dan in 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
After reconstitution with 10 ml of water for injection, each ml contains 10 mg thiotepa.
Po rekonstituciji z 10 ml vode za injekcije en ml raztopine vsebuje 10 mg tiotepe.
TEPADINA posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.
PKMC (avtologna ali alogenska) in bolezen.
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.
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.
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.
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.
GERM CELL TUMOURS
GERMINALNI TUMORJI
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.
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.
Respiratory, thoracic and mediastinal disorders
- zvišana raven jetrnih, ledvičnih in prebavnih encimov
(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.
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.
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.
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.
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.
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.
Idiopathic pneumonia syndrome Epistaxis
Očesne bolezni konjuktivitis katarakta
TEPADINA 100 mg powder for concentrate for solution for infusion Thiotepa
TEPADINA 100 mg prašek za koncentrat za raztopino za infundiranje tiotepa
TEPADINA must be reconstituted with 10 ml of sterile water for injection.
Rekonstitucija Zdravilo TEPADINA se rekonstituira z 10 ml sterilne vode za injekcije.
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.
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.
TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Rekonstitucija Zdravilo TEPADINA se rekonstituira z 1,5 ml sterilne vode za injekcije.
TEPADINA 15 mg powder for concentrate for solution for infusion Thiotepa
TEPADINA 15 mg prašek za koncentrat za raztopino za infundiranje tiotepa
BREAST CANCER
RAK DOJK
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported.
Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: Poročali so o vrednostih RRM od 0 do 2 odstotkov.
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.
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.
PREPARATION GUIDE TEPADINA 100 mg powder for concentrate for solution for infusion
NAVODILO ZA PRIPRAVO TEPADINA 100 mg prašek za koncentrat za raztopino za infundiranje
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.
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.
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.
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.
Haemorrhage Embolism
REFRAKTARNA CITOPENIJA
Pancytopenia Granulocytopenia
Shranjevanje zdravila TEPADINA
Thrombocytopenia Febrile neutropenia Anaemia
Bolezni krvi in limfatičnega sistema trombocitopenija febrilna nevtropenija anemija pancitopenija granulocitopenija
PREPARATION GUIDE TEPADINA 15 mg powder for concentrate for solution for infusion
NAVODILO ZA PRIPRAVO TEPADINA 15 mg prašek za koncentrat za raztopino za infundiranje
Stomatitis Vomiting Diarrhoea Abdominal pain
Žilne bolezni limfedem hipertenzija krvavitev embolija
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.
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.
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).
(busulfana, fludarabina in ciklofosfamida) (glejte poglavje 4.8).
Arrhythmia
ZDRAVILA
Azoospermia Amenorrhoea Vaginal haemorrhage
Motnje reprodukcije in dojk azoospermija amenoreja vaginalna krvavitev menopavzalni simptomi neplodnost pri ženskah neplodnost pri moških
Asthenia Chills
Bolezni jeter,
How TEPADINA is given
Kako se zdravilo TEPADINA uporablja
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)
- delna izguba gibanja - zastoj srca - slabost, bruhanje, driska - vnetje ustne sluznice (mukozitis)
SICKLE CELL ANAEMIA
ALOGENSKA PKMC Hematološke bolezni
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.
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.
Toxic shock syndrome
citotoksično zdravilo
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2.5% have been reported.
Z režimom povezana umrljivost in s presaditvijo povezana umrljivost: poročali so o vrednostih RRM med 0 in 2,5 %.
Generalised oedema
OVOJNINAH VIALA
Infections and infestations
Linearnost/Nelinearnost
- 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
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
Blood urea increased Blood electrolytes abnormal Prothrombin time ratio increased
- nenormalne vrednosti elektrolitov v krvi - zvečanje telesne mase
Confusional state Mental status changes
- zmanjšanja aktivnost hipofize - stanje zmedenosti
The areas harmonised include:
Uskladiti je treba naslednja področja:
The European Commission issued a decision on this opinion on 11/11/2016.
Evropska komisija je sklep v zvezi s tem mnenjem izdala 11. novembra 2016.
Clenil is marketed in the following EU Member States: France, Germany, Greece, Ireland and Italy.
Zdravilo Clenil se trži v naslednjih državah članicah EU: Francija, Nemčija, Grčija, Irska in Italija.
The lowest dose needed to control symptoms should be used.
Uporabiti je treba najnižji odmerek, potreben za obvladanje simptomov.
The amended information to doctors and patients is available here.
Dopolnjene informacije za zdravstvene delavce in bolnike so na voljo tukaj.
It is also available under the trade names of Becloneb, Beclospin and Sanasthmax.
Na voljo je tudi pod trgovskimi imeni Becloneb, Beclospin in Sanasthmax.
Regular follow-up is recommended to review the treatment response.
Priporoča se redno spremljanje, da se oceni odziv na zdravljenje.
Clenil has been authorised in the EU via national procedures.
Zdravilo Clenil je bilo v EU odobreno po nacionalnih postopkih.
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).
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).
On 15 September 2016, the European Medicines Agency completed a review of Clenil.
Evropska agencija za zdravila je 15. septembra 2016 zaključila pregled zdravila Clenil.
The duration of treatment should not exceed 3 months, unless a diagnosis of asthma is likely.
Trajanje zdravljenja ne sme presegati 3 mesecev, razen če kaže na diagnozo astme.
The starting dose of Clenil depends on the frequency and severity of symptoms and it can be adjusted until symptoms are under control.
Začetni odmerek zdravila Clenil je odvisen od pogostnosti in resnosti simptomov ter se lahko prilagodi, dokler simptomi niso nadzorovani.
The company that markets these medicines is Chiesi and associated companies.
Ta zdravila tržijo družba Chiesi in povezana podjetja.
Why was Clenil reviewed?
Zakaj je bilo zdravilo Clenil pregledano?
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.
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.