FrancophonIA/ELRC3.0 huggingface dataset:
English: Transplant patients receiving immunosuppressive regimens (e.g. systemic tacrolimus) are at increased risk for developing lymphoma; therefore patients who receive Protopy and who develop lymphadenopathy should be monitored to ensure that the lymphadenopathy resolves.
Estonian: Immunosupressiivsel raviskeemil (nt süsteemne takroliimus) transplantatsiooniga patsientidel on suurenenud risk lümfoomi tekkeks; seetõttu tuleks Protopy'ut saavaid patsiente lümfadenopaatia puhul hoolikalt jälgida, et olla kindel lümfadenopaatia lahenemises.
English: Herpes viral infections (herpes simplex dermatitis [eczema herpeticum], herpes simplex [cold sores], Kaposi's varicelliform eruption)
Estonian: Sage: Herpesviirus infekstioonid (herpes simplex dermatiit [eczema herpeticum], herpes simplex
English: Hard paraffin
Estonian: Kõva parafiin
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.
Estonian: Kolmanda mitmekeskuselise, topeltpimeda, randomiseeritud uuringu eesmärk oli hinnata 0,03% takroliimus salvi efektiivsust ja ohutust üks või kaks korda päevas manustatuna võrreldes 1% hüdrokortisoon salvi manustamisega kaks korda päevas mõõduka või raske atoopilise dermatiidiga lastel.
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.
Estonian: Atoopilise dermatiidiga patsientidel seostati takroliimus salvi kasutamisel nahakahjustuste paranemist vähenenud Fc retseptorite ekspressiooniga Langerhansi rakkudes ja nende liigse stimuleeriva toime vähenemisega T-rakkudele.
English: Median mEASI as Percentage of Baseline mean AUC (Primary Endpoint)§
Estonian: Keskmine mEASI protsendina algtaseme keskmisest AUC-st (Esmane tulemusnäitaja)§
English: A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
Estonian: A. TOOTMISLOA HOIDJA, KES VASTUTAB RAVIMIPARTII
English: Protopy alters the abnormal immune response and relieves the skin inflammation and the itch.
Estonian: Protopy salv mõjutab ebanormaalset immuunvastust ja leevendab naha põletikku ja sügelust.
English: Treat each affected region of your skin until the eczema has gone away.
Estonian: Ravige igat haigestunud nahapiirkonda kuni ekseem on kadunud.
English: Approximately half of the patients who use Protopy have some type of skin irritation where they have applied the ointment.
Estonian: Umbes pooltel Protopy salvi kasutavatel patsientidel ilmnevad manustamiskohal mingit tüüpi nahaärrituse nähud.
English: Also speak to your doctor before using Protopy if you have any skin malignancies (tumours) or if you have a weakened immune system (immuno-compromised) whatever the cause.
Estonian: Pidage enne Protopy salvi kasutamist nõu oma arstiga ka juhul, kui teil on mõni pahaloomuline nahakasvaja või mistahes põhjusel tekkinud immuunsüsteemi nõrgenemine.
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).
Estonian: Statistiliselt oluline eelis paranemiseks oli 0,03% takroliimus salvi kasutamisel üks kord ja kaks korda päevas võrreldes hüdrokortisoonatsetaat salviga (p<0,001 mõlemal juhul).
English: In transplant patients, prolonged systemic exposure to intense immunosuppression following systemic administration of calcineurin inhibitors has been associated with an increased risk of developing lymphomas and skin malignancies.
Estonian: Transplantatsioonipatsientidel on pikaajalist süsteemset kokkupuudet intensiivse immunosupressiooniga transplantatsioonipatsientidel pärast kaltsineuriini inhibiitorite süsteemset manustamist seostatud suurenenud riskiga lümfoomide ja pahaloomuliste nahakasvajate tekkeks.
English: Vaccinations should not be given during treatment and for a certain time after treatment with Protopy.
Estonian: Ravi ajal ja teatud perioodil pärast Protopy ravi ei tohi vaktsineerida.
English: Data from healthy human subjects indicate that there is little or no systemic exposure to tacrolimus following single or repeated topical application of tacrolimus ointment.
Estonian: Tervetel inimestel teostatud uurnigute andmed näitavad, et pärast ühekordset või korduvat takroliimuse lokaalset manustamist on selle süsteemne sisaldus väike või puudub üldse.
English: Burning sensation and itching are very common (> 10%).
Estonian: Väga sageli (>10%) esineb põletustunnet ja sügelust.
English: Sensation of warmth, pain, paraesthesia and rash at the site of application were also commonly observed.
Estonian: Samuti täheldati sageli soojustunnet, valu, paresteesiad ja löövet süstekohas.
English: Median mEASI Percentage Decrease (Primary Endpoint)§ Improvement ≥ 90% in Physician's Global Evaluation § higher values = greater improvement
Estonian: Paranemine ≥90% arsti üldise hinnangu põhjal (Physician's Global Evaluation) § suuremad väärtused = suurem paranemine
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.
Estonian: Kui kliiniline seisund lubab, tuleks püüda manustamissagedust vähendada, või kasutada nõrgemat Protopy 0,03% salvi.
English: There are no adequate data from the use of tacrolimus ointment in pregnant women.
Estonian: Takroliimus salvi kasutamise kohta rasedatel ei ole piisavalt andmeid.
English: You should inform your doctor if you have swollen lymph nodes at initiation of treatment.
Estonian: Teavitage oma arsti sellest, kui teil esineb ravi alustamise hetkel lümfisõlmede suurenemine.
English: HOW TO USE PROTOPY
Estonian: KUIDAS PROTOPY`UT KASUTADA
English: Repeated topical administration of tacrolimus ointment or the ointment vehicle to rats, rabbits and micropigs was associated with slight dermal changes such as erythema, oedema and papules.
Estonian: Korduva manustamise toksilisus ja lokaalne taluvus Takroliimus salvi või salvi vehiikli korduv lokaalne manustamine rottidele, küülikutele ja minisigadele oli seotud kergete nahamuutuste nagu erüteemi, turse ja paapulite tekkega.
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).
Estonian: Kuuekuulises mitmekeskuselises topeltpimedas randomiseeritud uuringus manustati 0,1% takroliimus salvi kaks korda päevas keskmise või raske atoopilise dermatiidiga täiskasvanutele, võrdluseks kasutati kortikosteroidide lokaalsel manustamisel baseeruvat raviskeemi (0,1% hüdrokortisoonbutüraat kehatüvele ja jäsemetele ning 1% hüdrokortisoonatsetaat näole ja kaelale).
English: In the second trial, children aged from 2 to 15 years with moderate to severe atopic dermatitis received twice daily treatment for three weeks of 0.03% tacrolimus ointment, 0.1% tacrolimus ointment or 1% hydrocortisone acetate ointment.
Estonian: Teises uuringus mõõduka kuni raske atoopilise dermatiidiga 2 kuni 15 aastastel lastel kasutati raviks kaks korda päevas 0,03% takroliimus salvi, 0,1% takroliimus salvi või 1% hüdrokortisoonatsetaat salvi.
English: Improvement ≥ 90% in Physician's
Estonian: Paranemine ≥90% arsti üldise hinnangu põhjal (Physician's
English: Marketing Authorisation Holder: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673 München, Germany.
Estonian: Müügiloa hoidja: Astellas Pharma GmbH, Neumarkter Str. 61, D-81673 München, Saksamaa.
English: Protopy ointment is not approved for children younger than 2 years of age.
Estonian: Eriline ettevaatus on vajalik ravimiga Protopy Protopy salvi kasutamist alla 2 aasta vanustel lastel ei ole heaks kiidetud.
English: Treatment with Protopy may be repeated if symptoms reappear.
Estonian: Sümptomid taastekkimisel võib Protopy ravi korrata.
English: In a photocarcinogenicity study, albino hairless mice were chronically treated with tacrolimus ointment and UV radiation.
Estonian: Fotokartsinogeensuse uuringutes kasutati takroliimus salvi koos UV kiiritusega karvkatteta albiino hiirtel.
English: Since commercial availability a very small number of people who have used Protopy ointment have had malignancies (for example, skin or lymphoma).
Estonian: Ravimi müügiletulekust saadik on väga väikesel arvul Protopy salvi kasutanud inimestest tekkinud pahaloomuline kasvaja (näiteks nahavähk või lümfoom).
English: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk.
Estonian: Andmed uuringutest inimestel näitavad, et süsteemse manustamise järgselt eritub takroliimus rinnapiima.
English: Use in children (2 years of age and above)
Estonian: Kasutamine lastel (2 aastased ja vanemad)
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.
Estonian: Protopy 0,03% salvi kasutatakse mõõduka kuni raske atoopilise dermatiidi (ekseemi) raviks täiskasvanutel, kes ei reageerinud piisavalt või ei talu tavapärast ravi, näiteks paikseid kortikosteroide, ja lastel (2 aastased ja vanemad), kes ei ole reageerinud piisavalt või ei talu tavapärast ravi, näiteks paikseid kortikosteroide.
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).
Estonian: Turustamisjärgne kogemus: takroliimuse salvi kasutavatel patsientidel on kirjeldatud pahaloomulise kasvaja (sh naha ja muud tüüpi lümfoomi) ja nahavähi juhtusid (vt lõik 4.4).
English: INFORMATION IN BRAILLE Protopy 0.03%
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Protopy 0.03%
English: The safety of Protopy ointment has not been established in patients with generalised erythroderma.
Estonian: Protopy salvi ohutus generaliseerunud erütrodermiaga patsientidel ei ole teada.
English: The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent.
Estonian: Protopy'u toimeaine takroliimusmonohüdraat on immuunmoduleeriv aine.
English: Protopy is available in two strengths (Protopy 0.03% and Protopy 0.1% ointment).
Estonian: Protopy on saadaval kahes tugevuses (Protopy 0,03% ja Protopy 0,1% salv).
English: INFORMATION IN BRAILLE Protopy 0.1%
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) Protopy 0.1%
English: Do not cover the skin being treated with bandages or wraps.
Estonian: Ärge katke ravitavat nahapiirkonda sidemete või mähistega.
English: Skin burning, herpes simplex, alcohol intolerance (facial flushing or skin sensitivity after alcohol intake), skin tingling, hyperaesthesia, acne and fungal dermatitis occurred more often in the tacrolimus treatment group.
Estonian: Tacroliimus ravi saavas rühmas ilmnesid sagedamini põletustunne nahal, herpes simplex, alkoholitalumatus (näoõhetus või naha tundlikkuse suurenemine alkoholi võtmise järgselt), nahakihelus, hüperesteesia, akne ja naha seeninfektsioon.
English: What Protopy is and what it is used for 2.
Estonian: 1. Mis ravim on Protopy ja milleks seda kasutatakse 2. Mida on vaja teada enne Protopy'u kasutamist 3.
English: Alcohol intolerance (facial flushing or skin irritation after consumption of an alcoholic beverage) was common.
Estonian: Sageli esines alkoholi talumatust (näoõhetus või nahaärritus pärast alkoholi manustamist).
English: Response rate of ≥ 60% improvement in mEASI (Primary
Estonian: Vastus: ≥60% paranemine mEASI järgi (Esmane tulemusnäitaja)§§
English: However, a link to Protopy ointment treatment has not been confirmed or refuted on the available evidence so far.
Estonian: Samas ei ole olemasolevate andmete põhjal kindlaks tehtud ega välistatud selle seost Protopy salvi kasutamisega.
English: What Protopy looks like and contents of the pack Protopy is a white to slightly yellowish ointment.
Estonian: Protopy on valge kuni kergelt kollakas salv.
English: HOW TO STORE PROTOPY
Estonian: KUIDAS PROTOPY`UT SÄILITADA
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.
Estonian: Protopy 0,1% salvi kasutatakse mõõduka kuni raske atoopilise dermatiidi (ekseemi) raviks täiskasvanutel, kes ei reageerinud piisavalt või ei talu tavapärast ravi, näiteks paikseid kortikosteroide.
English: Protopy 0.03% Ointment Tacrolimus monohydrate
Estonian: Protopy 0,03% salv Takroliimusmonohüdraat
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Estonian: MANUSTAMISVIIS Enne kasutamist lugege hoolikalt pakendi infolehte.
English: Protopy 0.1% Ointment Tacrolimus monohydrate
Estonian: Protopy 0,1% salv Takroliimusmonohüdraat
English: The use of Protopy ointment under occlusion has not been studied in patients.
Estonian: Protopy salvi kasutamist oklusiivselt kaetuna ei ole uuritud.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS 1 g Protopy 0,03% salvi sisaldab 0,3 mg takroliimust takroliimusmonohüdraadina (0,03%).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.1% ointment contains 1.0 mg of tacrolimus as tacrolimus monohydrate (0.1%).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS 1 g Protopy 0,1% salvi sisaldab 1,0 mg takroliimust takroliimusmonohüdraadina (0,1%).
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 0.3 mg tacrolimus (as monohydrate),
Estonian: TOIMEAINE SISALDUS 1 g salvi sisaldab: 0,3 mg takroliimust (monohüdraadina),
English: A potential interaction between vaccination and application of Protopy ointment has not been investigated.
Estonian: Vaktsinatsiooni ja Protopy salvi manustamise koostoimeid ei ole uuritud.
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.
Estonian: Mõõduka kuni raske atoopilise dermatiidi ravi täiskasvanutel, kes ei reageeri piisavalt või ei talu konventsionaalseid ravimeid, näiteks lokaalseid kortikosteroide.
English: PHARMACEUTICAL FORM AND CONTENTS Ointment
Estonian: RAVIMVORM JA PAKENDI SUURUS
English: However, a link to Protopy ointment treatment has not been shown.
Estonian: Samas ei ole kindlaks tehtud selle seost Protopy salvi kasutamisega.
English: STATEMENT OF ACTIVE SUBSTANCE 1 g ointment contains: 1.0 mg tacrolimus (as monohydrate),
Estonian: TOIMEAINE SISALDUS 1 g salvi sisaldab: 1,0 mg takroliimust (monohüdraadina),
English: Tacrolimus monohydrate
Estonian: Takroliimusmonohüdraat
English: METHOD AND ROUTE OF ADMINISTRATION Cutaneous use
Estonian: MANUSTAMISVIIS JA -TEE Välispidine
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.1% OINTMENT (10 g TUBE)
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL PROTOPY 0,1% SALV (10 g TUUB)
English: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Germany
Estonian: Astellas Pharma GmbH Neumarkter Str. 61 D-81673 München Saksamaa
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.
Estonian: Mõõduka kuni raske atoopilise dermatiidi ravi lastel (2 aastased ja vanemad), kes ei reageerinud piisavalt konventsionaalsetele ravimitele, näiteks lokaalsetele kortikosteroididele.
English: The use of Protopy at the same time as other preparations to be used on the skin or while taking oral corticosteroids (e.g. cortisone) or medicines which affect the immune system has not been studied.
Estonian: Protopy salvi kasutamist samaaegselt teiste nahal kasutatavate ravimitega või suukaudsete kortikosteroididega (näit.
English: Reduced sperm function was noted in male rats at high subcutaneous doses of tacrolimus.
Estonian: Suurte subkutaansete takroliimuse annuste juurel leiti sperma funktsioonihäireid isastel rottidel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PROTOPY 0.03% OINTMENT (10 g TUBE)
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL PROTOPY 0,03% SALV (10 g TUUB)
English: Astellas Pharma B.V. Elisabethhof 19
Estonian: Elisabethhof 19
English: The active substance is tacrolimus monohydrate.
Estonian: Toimeaine on takroliimusmonohüdraat.
English: Possible side effects 5.
Estonian: Võimalikud kõrvaltoimed 5 Kuidas Protopy'ut säilitada 6.
English: Protopy ointment should be applied as a thin layer to affected areas of the skin.
Estonian: Protopy salvi määritakse õhukese kihina haigestunud nahapiirkondadele.
English: Formal topical drug interaction studies with tacrolimus ointment have not been conducted.
Estonian: Takroliimuse salviga ei ole teostatud ravimite lokaalsete koostoimete uuringuid.
English: One gram of Protopy 0.1% ointment contains 1.0 mg tacrolimus (as tacrolimus monohydrate).
Estonian: Üks gramm Protopy 0,1% salvi sisaldab 1,0 mg takroliimust (takroliimusmonohüdraadina).
English: One gram of Protopy 0.03% ointment contains 0.3 mg tacrolimus (as tacrolimus monohydrate).
Estonian: Üks gramm Protopy 0,03% salvi sisaldab 0,3 mg takroliimust (takroliimusmonohüdraadina).
English: Metabolism
Estonian: Imendumine
English: General disorders and administration site conditions Very common: Application site burning, application site pruritus Common:
Estonian: Üldised häired ja manustamiskoha reaktsioonid Väga sage:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.1% OINTMENT (10 g, 30 g, 60 g CARTON)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PROTOPY 0,1% SALV (10 g, 30 g, 60 g PAPPKARP)
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/003
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/003
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/006 10 g
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/006 10 g
English: There was no evidence of systemic accumulation of tacrolimus in patients (adults and children) treated for prolonged periods (up to one year) with tacrolimus ointment.
Estonian: Patsientidel, keda raviti takroliimus salviga pika aja jooksul (kuni üks aasta), ei tekkinud takroliimuse süsteemse kogunemise ilminguid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PROTOPY 0.03% OINTMENT (10 g, 30 g, 60 g CARTON)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PROTOPY 0,03% SALV (10 g, 30 g, 60 g PAPPKARP)
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/005 10 g
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/005 10 g
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/003 30 g
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/003 30 g
English: PHARMACEUTICAL FORM Ointment
Estonian: Toimemehhanism ja farmakodünaamilised toimed
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/001
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/001
English: MARKETING AUTHORISATION NUMBERS EU/1/02/202/001 30 g
Estonian: MÜÜGILOA NUMBRID EU/1/02/202/001 30 g
English: Apply Protopy as a thin layer to affected areas of your skin.
Estonian: Määrige Protopy salvi õhukese kihina kahjustatud nahapiirkondadele.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.1% OINTMENT (30 g, 60 g TUBE)
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PROTOPY 0,1% SALV (30 g, 60 g TUUB)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING PROTOPY 0.03% OINTMENT (30 g, 60 g TUBE)
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PROTOPY 0,03% SALV (30 g, 60 g TUUB)
English: Liquid paraffin
Estonian: RAVIMVORM Salv
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.03% ointment
Estonian: RAVIMPREPARAADI NIMETUS Protopy 0,03% salv
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.03% Ointment
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Protopy 0,03% Salv
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Protopy 0.1% Ointment
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Protopy 0,1% Salv
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients.
Estonian: Täiskasvanutele on saadaval kaks erineva tugevusega Protopy preparaati (Protopy 0,03% ja Protopy 0,1% salv).
English: Facial flushing or skin irritation after drinking alcohol is also common.
Estonian: Alkoholi joomise järgselt tekib sageli näoõhetus ja naha ärritus.
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.1% Ointment
Estonian: RAVIMPREPARAADI NIMETUS Protopy 0,1% salv
English: NAME OF THE MEDICINAL PRODUCT Protopy 0.1% ointment
Estonian: RAVIMPREPARAADI NIMETUS Protopy 0,1% Salv
English: RELEASE
Estonian: Salv
English: If ingested, general supportive measures may be appropriate.
Estonian: Aeg-ajalt võib kõrvaltoimena tekkida akne.
English: The effect of treatment with Protopy ointment on the developing immune system of children, especially the young, has not yet been established and this should be taken into account when prescribing to this age group (see section 4.1).
Estonian: Seda tuleks arvestada ravi määramisel antud vanuserühmas (vt lõik 4.1).
English: Two strengths of Protopy (Protopy 0.03% and Protopy 0.1% ointment) are available for adult patients (16 years of age and older).
Estonian: Täiskasvanud patsientidele (16 aastased ja vanemad) on saadaval kaks erineva tugevusega Protopy preparaati (Protopy 0,03% ja Protopy 0,1% salv).
English: Application site warmth, application site erythema, application site pain, application site irritation, application site paraesthesia, application site rash
Estonian: Põletustunne ja sügelus manustamiskohal Sage: Soojustunne, erüteem, valu, ärritus, paresteesia ja lööve manustamiskohal
English: At the first signs of recurrence (flares) of the disease symptoms, treatment should be reinitiated.
Estonian: Ravi tuleb taasalustada haiguse ägenemise esimeste nähtude ilmnemisel.
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.
Estonian: Euroopa Komisjon väljastas Ultratardi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Novo Nordisk A/S 7. oktoobril 2002.
English: The patient's blood sugar should be tested regularly to find the lowest effective dose.
Estonian: Patsiendi veresuhkru taset tuleb pidevalt kontrollida, et leida tõhusalt toimiv vähim annus.
English: They recommended that Ultratard be given marketing authorisation.
Estonian: Ultratardile soovitati anda müügiluba.
English: This summary was last updated in 10-2006.©EMEA 2006
Estonian: Kokkuvõtte viimane uuendus: 10-2006.
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.
Estonian: I tüüpi suhkurtõve puhul on annus vahemikus 0,5-1,0 IU/kg (murdeeaeelikutel 0,7-1,0 IU/kg), II tüüpi suhkurtõve puhul on annus 0,30,6 IU/kg.
English: Ultratard is supplied as 40 or 100 IU strengths in vials.
Estonian: Ultratard on saadaval viaalides, tugevusega 40 või 100 IU.
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.
Estonian: Uuringutel mõõdeti veresuhkru taset või teatud aine (glükosüleeritud hemoglobiin, HbA1c) sisaldust, mis näitab, kui hästi reguleerib organism veresuhkru sisaldust.