natgillin/translations-raw huggingface dataset:
Post-marketing: cases of malignancies, including cutaneous and other types of lymphoma, and skin cancers, have been reported in patients using tacrolimus ointment (see section 4.4).
Pomarketinško: pri bolnikih, ki so uporabljali mazilo s takrolimusom, so opisani primeri malignomov, vključno s kožnimi, in druge vrste limfomov ter kožni rak (glejte poglavje 4.4).
Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimusa; opažali so
PHARMACEUTICAL FORM AND CONTENTS Ointment
Izgled zdravila Protopy in vsebina pakiranja
Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Protopy 0,03% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo, in pri otrocih (starih 2 leti ali več), ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno.
A statistically significant better improvement was shown for once daily and twice daily 0.03% tacrolimus ointment compared to twice daily hydrocortisone acetate ointment (p<0.001 for both).
Za 0,03% mazilo s takrolimusom, uporabljano enkrat ali dvakrat na dan, je bilo v primerjavi z mazilom s hidrokortizonacetatom dvakrat na dan dokazano statistično značilno večje izboljšanje (p<0,001 za oba načina uporabe).
Apply Protopy as a thin layer to affected areas of your skin.
Protopy na tanko namažite na prizadete predele kože.
Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
V 2 urah od uporabe mazila Protopy se na istem predelu ne sme aplicirati emoliensov.
A white to slightly yellowish ointment.
Protopy je belo do rahlo rumenkasto mazilo.
Protopy is not recommended for use in children below age of 2 years until further data are available.
Zaradi nezadostnih podatkov uporaba Protopya pri otrocih pod 2 leti ni priporočljiva.
Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) Metabolism and nutrition disorders Common:
Parestezije in dizestezije (hiperestezija, pekoč občutek)
Since commercial availability a very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali mazilo Protopy, pojavili malignomi (npr. na koži ali limfom).
Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
§ Lokalno zdravljenje s kortikosteroidom = 0,1% hidrokortizonbutirat na trupu in udih, 1%
Protopy 0.1% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Protopy 0,1% mazilo se uporablja za zdravljenje zmernega do hudega atopičnega dermatitisa (ekcema) pri odraslih, ki se na konvencionalne načine zdravljenja, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenašajo.
DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
{DD/MM/LLLL}
Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Klinične okužbe na mestih zdravljenja je treba pred začetkom zdravljenja z mazilom Protopy odpraviti.
Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Protopy je na voljo v dveh jakostih (Protopy 0,03% in Protopy 0,1% mazilo).
Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Protopy je na voljo v dveh jakostih: kot Protopy 0,03% in Protopy 0,1% mazilo.
Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Toplota na mestu uporabe, eritem na mestu uporabe, bolečine na mestu uporabe, draženje na mestu uporabe, parestezije na mestu uporabe, izpuščaj na mestu uporabe
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g mazila Protopy 0,03% vsebuje 0,3 mg takrolimusa v obliki takrolimus monohidrata (0,03%).
Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Germany
Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Nemčija
Protopy 0.03% Ointment Tacrolimus monohydrate
Protopy 0,03% mazilo Takrolimus monohidrat
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g mazila Protopy 0,1% vsebuje 1,0 mg takrolimusa v obliki takrolimus monohidrata (0,1%).
Response rate of ≥ 60% improvement in mEASI (Primary
Mediano zmanjšanje odstotka mEASI (primarna končna točka)§
Protopy 0.1% Ointment Tacrolimus monohydrate
Protopy 0,1% mazilo Takrolimus monohidrat
Table 3 Efficacy at week 3
Tabela 3 Učinkovitost po 3 tednih Hidrokortizonacetat
B CONDITIONS OF THE MARKETING AUTHORISATION
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids.
Zdravljenje zmernega do hudega atopičnega dermatitisa pri odraslih, ki se na konvencionalne terapije, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenesejo.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.1% OINTMENT (10 g TUBE)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PROTOPY 0,1% MAZILO (10 g TUBA)
Tacrolimus monohydrate
Takrolimus monohidrat Za dermalno uporabo
General disorders and administration site conditions Very common: Application site burning, application site pruritus Common:
Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.03% OINTMENT (10 g TUBE)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PROTOPY 0,03% MAZILO (10 g TUBA)
Depending on the response of your eczema your doctor will decide if the frequency of application can be reduced or the lower strength, Protopy 0.03% ointment, can be used.
Če se simptomi znova pojavijo, je treba ponovno začeti uporabljati Protopy 0,1% dvakrat na dan. Glede na odziv ekcema bo zdravnik presodil, ali je mogoče pogostnost uporabe zmanjšati ali uporabiti manjšo jakost, mazilo Protopy 0,03%.
One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopy 0,03% vsebuje 0,3 mg takrolimusa (v obliki takrolimus monohidrata).
Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.
Zdravljenje zmernega do hudega atopičnega dermatitisa pri otrocih (starih 2 leti ali več), ki se na konvencionalne terapije, kot so lokalni
One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
En gram mazila Protopy 0,1% vsebuje 1,0 mg takrolimusa (v obliki takrolimus monohidrata).
If you are prescribed light therapy, inform your doctor that you are using Protopy as it is not recommended to use Protopy and light therapy at the same time.
Če imate predvideno fototerapijo (zdravljenje s svetlobo), zdravniku povejte, da uporabljate Protopy.
Marketing Authorisation Holder: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673 München, Germany.
Imetnik dovoljenja za promet z zdravilom: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673
STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 g mazila vsebuje: 1,0 mg takrolimusa (v obliki monohidrata),
STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 g mazila vsebuje: 0,3 mg takrolimusa (v obliki monohidrata),
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.03% Ointment
IME ZDRAVILA IN POT UPORABE Protopy 0,03% mazilo
White soft paraffin
Beli vazelin Tekoči parafin Propilenkarbonat Beli vosek Trdi parafin
Protopy ointment should be applied as a thin layer to affected areas of the skin.
Na prizadete predele kože je treba nanesti tanko plast mazila Protopy.
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.1% Ointment
IME ZDRAVILA IN POT UPORABE Protopy 0,1% mazilo
Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Za odrasle bolnike sta na voljo dve jakosti Protopya (Protopy 0,03% in Protopy 0,1% mazilo).
NAME OF THE MEDICINAL PRODUCT Protopy 0.03% Ointment
IME ZDRAVILA Protopy 0,03% mazilo
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
PODATKI NA ZUNANJI OVOJNINI PROTOPY 0,1% MAZILO (10 g, 30 g, 60 g ŠKATLA)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
PODATKI NA PRIMARNI OVOJNINI PROTOPY 0,03% MAZILO (30 g, 60 g TUBA)
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
PODATKI NA PRIMARNI OVOJNINI PROTOPY 0,1% MAZILO (30 g, 60 g TUBA)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
PODATKI NA ZUNANJI OVOJNINI PROTOPY 0,03% MAZILO (10 g, 30 g, 60 g ŠKATLA)
Liquid paraffin
Folikulitits, srbenje
Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
Za odrasle bolnike (bolnike, stare vsaj 16 let) sta na voljo dve jakosti Protopya (Protopy 0,03% in Protopy 0,1% mazilo).
In a six-month multicentre double-blind randomised trial, 0.1% tacrolimus ointment was administered twice-a-day to adults with moderate to severe atopic dermatitis and compared to a topical corticosteroid based regimen (0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck).
V šestmesečni multicentrični, dvojno slepi randomizirani raziskavi so 0,1% mazilo s takrolimusom dvakrat na dan aplicirali odraslim z zmernim do hudim atopičnim dermatitisom.
NAME OF THE MEDICINAL PRODUCT Protopy 0.1% Ointment
IME ZDRAVILA Protopy 0,1% mazilo
PHARMACEUTICAL FORM Ointment
Mehanizem delovanja in farmakodinamični učinki
Nervous system disorders Common:
Sistemsko razpoložljivi takrolimus se
Co. Kerry,
County Kerry, Irska
RELEASE
Zdravljenje
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Pri uporabi zdravila Protopy natančno upoštevajte zdravnikova navodila.
This summary was last updated in 10-2006.©EMEA 2006
Ta povzetek je bil nazadnje posodobljen 10-2006.©EMEA 2006
Other information about Ultratard:
Druge informacije o zdravilu Ultratard:
The European Commission granted a marketing authorisation valid throughout the European Union, for Ultratard to Novo Nordisk A/S in on 7 October 2002.
Evropska komisija je dovoljenje za promet z zdravilom Ultratard, veljavno po vsej Evopski uniji, odobrila družbi Novo Nordisk A/S dne 7. oktobra 2002.
In type 1 diabetes, the dosage varies between 0.5 and 1.0 IU/kg (0.7 and 1.0 IU/kg in children before puberty), in type 2 diabetes the dosage is 0.3 to 0.6 IU/kg.
Pri sladkorni bolezni tipa 1 se odmerek giblje med 0,5 in 1,0 IE/kg (0,7 in 1,0 IE/kg pri predpubertetnih otrocih), pri sladkorni bolezni tipa 2 pa znaša odmerek med 0,3 do 0,6 IE/kg.
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
By controlling the blood sugar, the symptoms and complications of diabetes are reduced.
Z nadzorovanjem sladkorja v krvi se zmanjšajo simptomi in zapleti, povezani s sladkorno boleznijo.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ULTRATARD EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) ULTRATARD Povzetek EPAR za javnost
The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard's benefits are greater than its risks for the treatment of diabetes.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Ultratard pri zdravljenju sladkorne bolezni večje od z njim povezanih tveganj.
If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder).
Če je ustrezno, se lahko daje tudi v abdominalno steno (trebuh), zadnjico ali predel deltoidne mišice (rame).
What is the risk associated with Ultratard?
Kakšna tveganja so povezana z zdravilom Ultratard?
Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar.
Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina za nadzor sladkorja v krvi.
The studies measured the level of fasting blood sugar or a substance (glycosylated haemoglobin, HbA1c), which gives an indication of how well the blood sugar is controlled.
V raziskavah so merili raven sladkorja v krvi na tešče ali tiste snovi (glikoziliranega hemoglobina, HbA1c) v krvi, ki kaže, kako dobro je raven sladkorja v krvi nadzorovana.
Ultratard is used in patients with diabetes mellitus.
Ultratard se uporablja pri bolnikih s sladkorno boleznijo.
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Nadomestni insulin deluje na enak način kot naravno proizvedeni insulin in omogoča, da lahko glukoza vstopi iz krvi v celice.
What benefit has Ultratard shown during the studies?
Kakšne koristi je zdravilo Ultratard izkazalo med raziskavami?
Ultratard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Zdravila Ultratard ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) humani insulin (rDNA) ali katero koli drugo sestavino.
Ultratard is a long-acting insulin, it can be given as a once daily or twice daily injection, with or without a fast-acting insulin (at meal times), according to the doctor's recommendation.
Zdravilo Ultratard je insulin z dolgotrajnim delovanjem in ga lahko dajemo z injekcijo enkrat ali dvakrat dnevno z ali brez insulina s hitrim delovanjem (pri obrokih) v skladu z navodili zdravnika.
Ultratard is given subcutaneously (under the skin) by injection, usually in the thigh.
Zdravilo Ultratard se daje subkutano (pod kožo) z injekcijo, navadno v stegno.
Ultratard is an insulin suspension for injection.
Zdravilo Ultratard je suspenzija insulina za injiciranje.
Ultratard doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).
Odmerke zdravila Ultratard bo morda potrebno prilagoditi, če se jemlje istočasno s katerim od drugih zdravil, ki vplivajo na koncentracijo sladkorja v krvi (celoten seznam le-teh najdete v Navodilih za uporabo).
Ultratard can be used in type 1 diabetes, when the pancreas cannot produce insulin, and in type 2 diabetes, when the body is not able to use insulin effectively.
Zdravilo Ultratard se lahko uporablja za zdravljenje sladkorne bolezni tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina, in sladkorne bolezni tipa 2, pri kateri telo ni zmožno učinkovito uporabiti insulina.
Ultratard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Zdravilo Ultratard so raziskali tako za sladkorno bolezen tipa 1 kot tudi tipa 2 in ga primerjali z drugimi vrstami insulina (prašičjim, humanim).
Why has Ultratard been approved?
Zakaj je bilo zdravilo Ultratard odobreno?
Ultratard is supplied as 40 or 100 IU strengths in vials.
Ultratard je na voljo v vialah v jakosti 40 ali 100 mednarodnih enot (IE).
The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Insulin izdelajo kvasovke, ki so prejele ustrezni gen (DNA), s pomočjo katerega postanejo sposobne tvoriti insulin.
They recommended that Ultratard be given marketing authorisation.
Zato je priporočil, da se za zdravilo Ultratard podeli dovoljenje za promet z zdravilom.
Ultratard may cause hypoglycaemia (low blood sugar).
Zdravilo Ultratard lahko povzroči hipoglikemijo (nizko koncentracijo sladkorja v krvi).
Ultratard contains insulin mixed with another substance, zinc, in particles from which the insulin is absorbed much more slowly during the day; and this gives Ultratard a longer duration of action.
Zdravilo Ultratard vsebuje insulin, pomešan z drugo snovjo, in sicer z delci cinka, iz katerega se insulin tekom dneva absorbira mnogo počasneje, kar podaljša čas delovanja zdravila Ultratard.
The patient's blood sugar should be tested regularly to find the lowest effective dose.
Za določitev najnižjega učinkovitega odmerka je potrebno redno spremljati bolnikovo raven sladkorja v krvi.
Ultratard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulin.
Z uporabo zdravila Ultratard se je znižala raven HbA1c, kar kaže na to, da je bila raven sladkorja v krvi omejena na podobno raven kot pri uporabi drugih vrst humanega insulina.
Ultratard was effective for both Type 1 and Type 2 diabetes.
Zdravilo Ultratard se je izkazalo kot učinkovito tako za sladkorno bolezen tipa 1 kot tudi tipa 2.
Ultratard contains the active ingredient insulin human (rDNA).
Zdravilo Ultratard vsebuje zdravilno učinkovino humani insulin (rDNA).
The full EPAR for Ultratard is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ultratard je na voljo tukaj.
How has Ultratard been studied?
Kako je bilo zdravilo Ultratard raziskano?
Ultratard is a replacement insulin which identical to the insulin made by the pancreas .The active ingredient of Ultratard, insulin human (rDNA), is produced by a method known as ‘recombinant technology'.
Zdravilno učinkovino zdravila Ultratard, humani insulin (rDNA), izdelujejo z metodo, znano pod imenom “rekombinantna tehnologija”.
For the full description of the side effects reported with Ultratard, please see the Package Leaflet.
Celovit opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Ultratard, najdete v Navodilih za uporabo.
How does Ultratard work?
Kako zdravilo Ultratard deluje?
What is Ultratard used for?
Za kaj se zdravilo Ultratard uporablja ?
How is Ultratard used?
Kako se zdravilo Ultratard uporablja?
What is Ultratard?
Kaj je zdravilo Ultratard?
The European Commission issued a Decision on 22 September 2011.
Evropska komisija je odločbo izdala dne 22. septembra 2011.
Why was Canazole reviewed?
Zakaj je bilo zdravilo Canazole pregledano?
However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 25 November 2010.
Vendar se državi članici nista uspeli dogovoriti in irska regulativna agencija za zdravila je dne 25. novembra 2010 zadevo napotila na CHMP v arbitražo.
It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Deluje s preprečevanjem nastajanja ergosterola, ki je pomemben del celične stene glivic.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the currently available data were not sufficient to show therapeutic equivalence with the reference medicine and that further data would need to be generated.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da trenutno razpoložljivi podatki ne zadostujejo za dokaz terapevtske enakovrednosti z referenčnim zdravilom in da je treba pridobiti dodatne informacije.
The company which recently marketed this product wanted the authorisation to be recognised in the United Kingdom (the ‘concerned Member State').
Družba, ki je tržila to zdravilo, je želela, da se dovoljenje za promet prizna v Združenem kraljestvu („zadevni državi članici“).
What is Canazole?
Kaj je zdravilo Canazole?
In addition, the Committee has also recommended that the marketing authorisation for Canazole in Ireland be suspended until further studies are done.
Poleg tega je Odbor priporočil tudi, da se dovoljenje za promet z zdravilom Canazole na Irskem začasno umakne, dokler se ne izvedejo dodatne študije.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Canazole.
Evropska agencija za zdravila je zaključila arbitražni postopek, uveden zaradi nestrinjanja držav članic Evropske unije (EU) glede pridobitve dovoljenja za promet z zdravilom Canazole.
Pinewood Laboratories Ltd submitted Canazole for mutual recognition on the basis of the initial authorisation granted by Ireland on 8 December 2000.
Družba Pinewood Laboratories Ltd je za zdravilo Canazole začela postopek z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Irskem dne 8. decembra 2000.
The marketing authorisation in Ireland should also be suspended.
Dovoljenje za promet z zdravilom na Irskem je prav tako treba začasno umakniti.
Canazole is a generic medicine based on a ‘reference medicine', Canesten, which is authorised in the United Kingdom.
Zdravilo Canazole je generično zdravilo na osnovi „referenčnega zdravila“ Canesten, ki je odobreno v Združenem kraljestvu.
Questions and answers on Canazole (clotrimazole cream 1%) EMA/837098/2011
Vprašanja in odgovori v zvezi z zdravilom Canazole (klotrimazol krema 1 %) EMA/206825/2011
It is used to treat skin infections caused by fungi, such as thrush, ringworm or athlete's foot.
Uporablja se za zdravljenje kožnih okužb z glivicami, kot so sor, dermatofitoza ali atletsko stopalo.
The grounds for the referral were that the United Kingdom did not agree that Canazole cream and Canesten cream are similar enough to have therapeutic equivalence.
Podlaga za napotitev je bilo nestrinjanje Združenega kraljestva s trditvijo, da sta zdravilo Canazole krema in zdravilo Canesten krema dovolj podobna, da bi bila terapevtsko enakovredna.
Canazole is a cream that contains the active substance clotrimazole (1%).
Zdravilo Canazole je krema, ki vsebuje zdravilno učinkovino klotrimazol (1 %).
The active substance in Canazole, clotrimazole, is an antifungal medicine that belongs to the group called triazoles.
Zdravilna učinkovina v zdravilu Canazole, klotrimazol, je protiglivično zdravilo, ki spada v skupino triazolov.
The CHMP therefore concluded that the benefits of Canazole do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member State.
CHMP je zato zaključil, da koristi zdravila Canazole ne odtehtajo z njim povezanih tveganj, in priporočil, da se v zadevni državi članici dovoljenje za promet ne odobri.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Canazole do not outweigh its risks, and the marketing authorisation granted in Ireland cannot be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Canazole ne odtehtajo z njim povezanih tveganj, zato dovoljenje za promet z zdravilom, odobreno na Irskem, ni mogoče priznati v ostalih državah članicah EU.
Without ergosterol, the fungus is killed or prevented from spreading.
Glivica brez ergosterola odmre oziroma se ne razmnožuje več.