FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with atopic dermatitis, improvement of skin lesions during treatment with tacrolimus ointment was associated with reduced Fc receptor expression on Langerhans cells and a reduction of their hyperstimulatory activity towards T cells.
Slovenian: Pri bolnikih z atopičnim dermatitisom sta izboljšanje kožnih sprememb med zdravljenjem z mazilom s takrolimusom spremljala zmanjšana ekspresija receptorjev Fc na Langerhansovih celicah in zmanjšanje njihovega hiperstimulacijskega delovanja na celice T. Mazilo s takrolimusom pri človeku ne vpliva na
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 g
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
English: The other ingredients are white soft paraffin, liquid paraffin, propylene carbonate, white beeswax and hard paraffin.
Slovenian: Pomožne snovi so beli vazelin, tekoči parafin, propilenkarbonat, beli vosek in trdi parafin.
English: Slightly lower body weight gain in females was the only systemic change observed in micropigs at high ointment concentrations (3%).
Slovenian: Edina sistemska sprememba, ki so jo pri velikih koncentracijah mazila (3%) ugotavljali pri mikroprašičkih, je bilo nekoliko manjše pridobivanje telesne teže samic.
English: Protopy contains the active substance tacrolimus, a calcineurin inhibitor.
Slovenian: Protopy vsebuje zdravilno učinkovino takrolimus, ki zavira kalcinevrin.
English: Talk to your doctor before using Protopy.
Slovenian: Pred uporabo Protopya se posvetujte z zdravnikom.
English: There is no experience with concomitant use of systemic steroids or immunosuppressive agents.
Slovenian: Izkušenj s sočasno uporabo sistemskih steroidov ali
English: Tacrolimus 0.03% Once daily (N=207)
Slovenian: Takrolimus 0,03% Enkrat na dan (N=207)
English: The purpose of the third multicentre, double-blind, randomised study was the assessment of efficacy and safety of 0.03% tacrolimus ointment applied once or twice a day relative to twice daily administration of 1% hydrocortisone acetate ointment in children with moderate to severe atopic dermatitis.
Slovenian: Namen tretje multicentrične, dvojno slepe randomizirane raziskave je bila ocena učinkovitosti in varnosti 0,03% mazila s takrolimusom, uporabljenega enkrat ali dvakrat na dan, v primerjavi z uporabo 1% mazila s hidrokortizonacetatom pri otrocih z zmernim do hudim atopičnim dermatitisom.
English: LIST OF EXCIPIENTS white soft paraffin, liquid paraffin, propylene carbonate, white beeswax, hard paraffin.
Slovenian: beli vazelin, tekoči parafin, propilenkarbonat, beli vosek, trdi parafin.
English: An attempt should be made to reduce the frequency of application or to use the lower strength Protopy 0.03% ointment if the clinical condition allows.
Slovenian: Če klinično stanje dopušča, je treba pogostnost uporabe poskusiti zmanjšati ali uporabiti pripravek z manjšo jakostjo, tj. Protopy 0,03% mazilo.
English: Use in adults (16 years of age and above)
Slovenian: Uporaba pri odraslih (16 let in več)
English: Facial flushing or skin irritation after drinking alcohol is also common.
Slovenian: Pogosta sta tudi zardevanje obraza in draženje kože po pitju alkohola.
English: Tacrolimus is extensively metabolised in the liver and although blood concentrations are low following topical therapy, the ointment should be used with caution in patients with hepatic failure (see section 5.2).
Slovenian: Po lokalnem zdravljenju je koncentracija v krvi sicer majhna, vednar je treba mazilo pri bolnikih z odpovedjo jeter vseeno uporabljati previdno (glejte poglavje 5.2).
English: While using Protopy, drinking alcohol may cause the skin or face to become flushed or red and feel hot.
Slovenian: Uporaba zdravila Protopy skupaj s hrano in pijačo Med uporabo Protopya lahko pitje alkohola povzroči, da koža na obrazu pordi in je vroča na otip.
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an
Slovenian: Neprenašanje alkohola (zardevanje obraza ali draženje kože po pitju alkoholnih
English: Treatment with Protopy may be repeated if symptoms reappear.
Slovenian: Če se simptomi znova pojavijo, je mogoče zdravljenje s Protopyom ponoviti.
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravljenje s Protopyom morajo uvesti zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem
English: The active substance is tacrolimus monohydrate.
Slovenian: Zdravilna učinkovina je takrolimus monohidrat.
English: Tacrolimus 0.03% (N=189)
Slovenian: Takrolimus 0,03% (N=189)
English: Acne is an uncommon side effect.
Slovenian: Občasen neželen učinek so akne.
English: 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).
Slovenian: 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).
English: Rabbits were shown to be especially sensitive to intravenous administration of tacrolimus, reversible cardiotoxic effects being observed.
Slovenian: Ugotovljeno je, da so kunci posebej občutljivi za intravensko uporabljeni takrolimusa; opažali so
English: PHARMACEUTICAL FORM AND CONTENTS Ointment
Slovenian: Izgled zdravila Protopy in vsebina pakiranja
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Apply Protopy as a thin layer to affected areas of your skin.
Slovenian: Protopy na tanko namažite na prizadete predele kože.
English: Emollients should not be applied to the same area within 2 hours of applying Protopy ointment.
Slovenian: V 2 urah od uporabe mazila Protopy se na istem predelu ne sme aplicirati emoliensov.
English: A white to slightly yellowish ointment.
Slovenian: Protopy je belo do rahlo rumenkasto mazilo.
English: Protopy is not recommended for use in children below age of 2 years until further data are available.
Slovenian: Zaradi nezadostnih podatkov uporaba Protopya pri otrocih pod 2 leti ni priporočljiva.
English: Tacrolimus 0.1% (N=186)
Slovenian: Takrolimus 0,1% (N=186)
English: Paraesthesias and dysaesthesias (hyperaesthesia, burning sensation) Metabolism and nutrition disorders Common:
Slovenian: Parestezije in dizestezije (hiperestezija, pekoč občutek)
English: Since commercial availability a very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Slovenian: Odkar je zdravilo dostopno na trgu, so se pri zelo maloštevilnih bolnikih, ki so uporabljali mazilo Protopy, pojavili malignomi (npr. na koži ali limfom).
English: Global Evaluation § Topical corticosteroid regimen = 0.1% hydrocortisone butyrate on trunk and extremities, 1% hydrocortisone acetate on face and neck §§ higher values = greater improvement
Slovenian: § Lokalno zdravljenje s kortikosteroidom = 0,1% hidrokortizonbutirat na trupu in udih, 1%
English: 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.
Slovenian: 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.
English: DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Slovenian: {DD/MM/LLLL}
English: Before commencing treatment with Protopy ointment, clinical infections at treatment sites should be cleared.
Slovenian: Klinične okužbe na mestih zdravljenja je treba pred začetkom zdravljenja z mazilom Protopy odpraviti.
English: Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Slovenian: Protopy je na voljo v dveh jakostih (Protopy 0,03% in Protopy 0,1% mazilo).
English: Protopy is available in two strengths, Protopy 0.03% and Protopy 0.1% ointment.
Slovenian: Protopy je na voljo v dveh jakostih: kot Protopy 0,03% in Protopy 0,1% mazilo.
English: Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Slovenian: Toplota na mestu uporabe, eritem na mestu uporabe, bolečine na mestu uporabe, draženje na mestu uporabe, parestezije na mestu uporabe, izpuščaj na mestu uporabe
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g mazila Protopy 0,03% vsebuje 0,3 mg takrolimusa v obliki takrolimus monohidrata (0,03%).
English: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Germany
Slovenian: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Nemčija
English: Protopy 0.03% Ointment Tacrolimus monohydrate
Slovenian: Protopy 0,03% mazilo Takrolimus monohidrat
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 g mazila Protopy 0,1% vsebuje 1,0 mg takrolimusa v obliki takrolimus monohidrata (0,1%).
English: Response rate of ≥ 60% improvement in mEASI (Primary
Slovenian: Mediano zmanjšanje odstotka mEASI (primarna končna točka)§
English: Protopy 0.1% Ointment Tacrolimus monohydrate
Slovenian: Protopy 0,1% mazilo Takrolimus monohidrat
English: Table 3 Efficacy at week 3
Slovenian: Tabela 3 Učinkovitost po 3 tednih Hidrokortizonacetat
English: B CONDITIONS OF THE MARKETING AUTHORISATION
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
English: 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.
Slovenian: Zdravljenje zmernega do hudega atopičnega dermatitisa pri odraslih, ki se na konvencionalne terapije, kot so lokalni kortikosteroidi, ne odzovejo ustrezno ali jih ne prenesejo.
English: Astellas Pharma B.V. Elisabethhof 19
Slovenian: Elisabethhof 19
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.1% OINTMENT (10 g TUBE)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PROTOPY 0,1% MAZILO (10 g TUBA)
English: Tacrolimus monohydrate
Slovenian: Takrolimus monohidrat Za dermalno uporabo
English: General disorders and administration site conditions Very common: Application site burning, application site pruritus Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.03% OINTMENT (10 g TUBE)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH PROTOPY 0,03% MAZILO (10 g TUBA)
English: 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.
Slovenian: 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%.
English: One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Slovenian: En gram mazila Protopy 0,03% vsebuje 0,3 mg takrolimusa (v obliki takrolimus monohidrata).
English: 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.
Slovenian: Zdravljenje zmernega do hudega atopičnega dermatitisa pri otrocih (starih 2 leti ali več), ki se na konvencionalne terapije, kot so lokalni
English: One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Slovenian: En gram mazila Protopy 0,1% vsebuje 1,0 mg takrolimusa (v obliki takrolimus monohidrata).
English: 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.
Slovenian: Če imate predvideno fototerapijo (zdravljenje s svetlobo), zdravniku povejte, da uporabljate Protopy.
English: Marketing Authorisation Holder: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673 München, Germany.
Slovenian: Imetnik dovoljenja za promet z zdravilom: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 g mazila vsebuje: 1,0 mg takrolimusa (v obliki monohidrata),
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 g mazila vsebuje: 0,3 mg takrolimusa (v obliki monohidrata),
English: Astellas Pharma S.A.
Slovenian: Astellas Pharma B.V.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.03% Ointment
Slovenian: IME ZDRAVILA IN POT UPORABE Protopy 0,03% mazilo
English: White soft paraffin
Slovenian: Beli vazelin Tekoči parafin Propilenkarbonat Beli vosek Trdi parafin
English: Protopy ointment should be applied as a thin layer to affected areas of the skin.
Slovenian: Na prizadete predele kože je treba nanesti tanko plast mazila Protopy.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.1% Ointment
Slovenian: IME ZDRAVILA IN POT UPORABE Protopy 0,1% mazilo
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Slovenian: Za odrasle bolnike sta na voljo dve jakosti Protopya (Protopy 0,03% in Protopy 0,1% mazilo).
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.03% Ointment
Slovenian: IME ZDRAVILA Protopy 0,03% mazilo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Slovenian: PODATKI NA ZUNANJI OVOJNINI PROTOPY 0,1% MAZILO (10 g, 30 g, 60 g ŠKATLA)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
Slovenian: PODATKI NA PRIMARNI OVOJNINI PROTOPY 0,03% MAZILO (30 g, 60 g TUBA)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
Slovenian: PODATKI NA PRIMARNI OVOJNINI PROTOPY 0,1% MAZILO (30 g, 60 g TUBA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Slovenian: PODATKI NA ZUNANJI OVOJNINI PROTOPY 0,03% MAZILO (10 g, 30 g, 60 g ŠKATLA)
English: Liquid paraffin
Slovenian: Folikulitits, srbenje
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
Slovenian: Za odrasle bolnike (bolnike, stare vsaj 16 let) sta na voljo dve jakosti Protopya (Protopy 0,03% in Protopy 0,1% mazilo).
English: 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).
Slovenian: V šestmesečni multicentrični, dvojno slepi randomizirani raziskavi so 0,1% mazilo s takrolimusom dvakrat na dan aplicirali odraslim z zmernim do hudim atopičnim dermatitisom.
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.1% Ointment
Slovenian: IME ZDRAVILA Protopy 0,1% mazilo
English: PHARMACEUTICAL FORM Ointment
Slovenian: Mehanizem delovanja in farmakodinamični učinki
English: UAB Sirowa Vilnius Švitrigailos g. 11b LT-03228 Vilnius Tel. +370 (5) 2394155
Slovenian: UAB Sirowa Vilnius Švitrigailos g. 11b
English: Nervous system disorders Common:
Slovenian: Sistemsko razpoložljivi takrolimus se
English: Co. Kerry,
Slovenian: County Kerry, Irska
English: RELEASE
Slovenian: Zdravljenje
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Slovenian: Pri uporabi zdravila Protopy natančno upoštevajte zdravnikova navodila.
English: This summary was last updated in 10-2006.©EMEA 2006
Slovenian: Ta povzetek je bil nazadnje posodobljen 10-2006.©EMEA 2006
English: Other information about Ultratard:
Slovenian: Druge informacije o zdravilu Ultratard:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ultratard to Novo Nordisk A/S in on 7 October 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Ultratard, veljavno po vsej Evopski uniji, odobrila družbi Novo Nordisk A/S dne 7. oktobra 2002.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil opravljene raziskave, na podlagi česar je oblikoval priporočila glede uporabe zdravila.
English: By controlling the blood sugar, the symptoms and complications of diabetes are reduced.
Slovenian: Z nadzorovanjem sladkorja v krvi se zmanjšajo simptomi in zapleti, povezani s sladkorno boleznijo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ULTRATARD EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) ULTRATARD Povzetek EPAR za javnost
English: The Committee for Medicinal products for Human Use (CHMP) decided that Ultratard's benefits are greater than its risks for the treatment of diabetes.
Slovenian: 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.
English: If convenient it may also be given in the abdominal wall (tummy), the buttocks or the deltoid region (shoulder).
Slovenian: Če je ustrezno, se lahko daje tudi v abdominalno steno (trebuh), zadnjico ali predel deltoidne mišice (rame).
English: What is the risk associated with Ultratard?
Slovenian: Kakšna tveganja so povezana z zdravilom Ultratard?
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood sugar.
Slovenian: Sladkorna bolezen je bolezen, pri kateri telo ne tvori dovolj insulina za nadzor sladkorja v krvi.
English: 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.
Slovenian: 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.
English: Ultratard is used in patients with diabetes mellitus.
Slovenian: Ultratard se uporablja pri bolnikih s sladkorno boleznijo.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Slovenian: Nadomestni insulin deluje na enak način kot naravno proizvedeni insulin in omogoča, da lahko glukoza vstopi iz krvi v celice.
English: What benefit has Ultratard shown during the studies?
Slovenian: Kakšne koristi je zdravilo Ultratard izkazalo med raziskavami?
English: Ultratard should not be used in people who may be hypersensitive (allergic) to insulin human (rDNA) or to any of the other ingredients.
Slovenian: Zdravila Ultratard ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) humani insulin (rDNA) ali katero koli drugo sestavino.
English: 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.
Slovenian: 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.
English: Ultratard is given subcutaneously (under the skin) by injection, usually in the thigh.
Slovenian: Zdravilo Ultratard se daje subkutano (pod kožo) z injekcijo, navadno v stegno.
English: Ultratard is an insulin suspension for injection.
Slovenian: Zdravilo Ultratard je suspenzija insulina za injiciranje.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Ultratard has been studied in both type 1 and type 2 diabetes, and it has been compared to other types of insulin (porcine, human).
Slovenian: Zdravilo Ultratard so raziskali tako za sladkorno bolezen tipa 1 kot tudi tipa 2 in ga primerjali z drugimi vrstami insulina (prašičjim, humanim).
English: Why has Ultratard been approved?
Slovenian: Zakaj je bilo zdravilo Ultratard odobreno?
English: Ultratard is supplied as 40 or 100 IU strengths in vials.
Slovenian: Ultratard je na voljo v vialah v jakosti 40 ali 100 mednarodnih enot (IE).
English: The insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Slovenian: Insulin izdelajo kvasovke, ki so prejele ustrezni gen (DNA), s pomočjo katerega postanejo sposobne tvoriti insulin.
English: They recommended that Ultratard be given marketing authorisation.
Slovenian: Zato je priporočil, da se za zdravilo Ultratard podeli dovoljenje za promet z zdravilom.
English: Ultratard may cause hypoglycaemia (low blood sugar).
Slovenian: Zdravilo Ultratard lahko povzroči hipoglikemijo (nizko koncentracijo sladkorja v krvi).
English: 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.
Slovenian: 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.