FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant acknowledged that AUC 0-tlast and AUC 0-inf were below the accepted range, indicating that the two preparations were not PK equivalent for total drug exposure.
Slovenian: Predlagatelj je potrdil, da sta bili AUC 0-tlast in AUC 0-inf precej pod sprejemljivim razponom, kar kaže, da pripravka nista bila farmakokinetično enakovredna v smislu skupne izpostavljenosti zdravilu.
English: Results from animal studies do not supersede comparative PK data from a clinical study in the evaluation of abridged products.
Slovenian: Rezultati iz študij na živalih pri ocenjevanju zdravil s skrajšanim postopkom ne nadomeščajo komparativnih farmakokinetičnih podatkov iz klinične študije.
English: The mouse thigh infection model study was considered to be representative of deep seated infections and provides a comparison of the tissue penetration characteristics of Teicoplanin Hospira and Targocid.
Slovenian: Model okužbe stegna mišk se je štel za reprezentativnega za globoke okužbe, hkrati pa omogoča primerjavo zmogljivosti prodiranja zdravil Teicoplanin Hospira in Targocid v tkivo.
English: Subsequently, therapeutic drug monitoring is important to ensure that dose regimens are optimized and that it is recommended that teicoplanin are monitored and dosage adjusted to ensure trough levels of at least 20mg/L.
Slovenian: Priporoča se, da se teikoplanin spremlja in odmerek prilagaja s ciljem najnižje ravni vsaj 20 mg/L.
English: Therefore, the Applicant considers Teicoplanin Hospira to be a generic of Targocid.
Slovenian: Zato predlagatelj meni, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
English: It was however noted that tissue concentrations of drug components were not measured and that regarding the toxicology, it cannot be concluded whether the products are comparable as the histopathology was investigated only for Teicoplanin Hospira.
Slovenian: Glede toksikologije pa ni možno ugotoviti, ali so zdravila primerljiva, saj je bila histopatologija raziskana le za zdravilo Teicoplanin Hospira.
English: The study concluded that the biological activity of Teicoplanin Hospira is equivalent to that of Targocid and therefore confirmed that the minor differences in the composition of individual active components of teicoplanin do not affect the biological activity.
Slovenian: Teicoplanin Hospira enakovredna zdravilu Targocid, in s tem potrdili, da majhne razlike v sestavi posamezne zdravilne učinkovine teikoplanina ne vplivajo na biološko aktivnost.
English: However, the validity and sensitivity of free AUC and PK/PD parameters in the evaluation of a generic product have not been established, and this approach contravenes the CHMP guideline on the Investigation of Bioavailability and Bioequivalence.
Slovenian: Vendar veljavnost in občutljivost parametrov AUC prostega zdravila ter farmakokinetike in farmadinamike pri ocenjevanju generičnega zdravila niso bili dokazani.
English: Phase 1 Clinical PK/PD
Slovenian: Klinična farmakokinetika in farmakodinamika faze 1
English: The related substances resulting from the fermentation process are well documented and the Applicant undertook a toxicity study program to demonstrate a similar safety profile to that of the originator.
Slovenian: Predlagatelj je tudi opravil program študij toksičnosti za dokaz podobnosti varnostnega profila z originatorskim zdravilom.
English: However, these results are not considered to demonstrate that Teicoplanin Hospira is a generic of Targocid, with regards to overall similarity.
Slovenian: Vendar ti rezultati ne štejejo za dokaz, da je zdravilo Teicoplanin Hospira generično zdravilo zdravila Targocid.
English: The nature of the active substance and the fermentation process used may lead to subcomponent differences, affecting the lipophilicity of the drug and as such the PK and indeed, the PK data indicates that for AUC, bioequivalence could not be shown.
Slovenian: Narava zdravilne učinkovine in uporabljenega fermentacijskega procesa lahko povzroči razlike v podkomponentah, kar vpliva na lipofilnost zdravila in s tem na farmakokinetiko.
English: It must therefore be demonstrated that the subcomponent ratio differences do not result in efficacy and/or safety differences and the CHMP is of the opinion that the clinical and non-clinical data and the bioequivalence trials provided are insufficient to demonstrate this.
Slovenian: CHMP meni, da predloženi klinični in neklinični podatki ter preskušanja biološke enakovrednosti ne zadostujejo za dokaz omenjenega.
English: Intravenous use 200 mg/vial
Slovenian: 200 mg prašek in vehikel za intravenska uporaba
English: The free drug AUC/MIC for the sum of TA2 subcomponents for Teicoplanin Hospira was within 2% of the Targocid value and the totality of the pre-clinical MIC studies combined with the mouse thigh study and the identical bactericidal serum titres give re-assurance that the microbiological activity of the two products is the same and that pharmacodynamically, the two products can be considered equivalent.
Slovenian: AUC/MIK prostega zdravila za vsoto podkomponent TA2 zdravila Teicoplanin Hospira je bila znotraj 2 % vrednosti pri zdravilu Targocid, celovitost predkliničnih študij MIK
English: However, AUC 0-tlast and AUC 0-inf were lower for Teicoplanin Hospira, indicating that PK equivalence was not shown for the total (bound plus unbound) drug exposure.
Slovenian: Predlagatelj je potrdil, da sta bili AUC 0-tlast in AUC 0-inf precej pod sprejemljivim razponom, kar kaže, da pripravka nista bila farmakokinetično enakovredna v smislu skupne izpostavljenosti zdravilu (vezana in nevezana).
English: This means that it works on the immune system (the body's natural defences).
Slovenian: To pomeni, da deluje na imunski sistem (naravne obrambne mehanizme telesa).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protopic on 28 February 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Protopic, veljavno po vsej Evropski uniji, odobrila dne 28. februarja 2002.
English: If there is no improvement after two weeks, the doctor should consider other treatment options.
Slovenian: Če po dveh tednih zdravljenja ni znakov izboljšanja, mora zdravnik pretehtati druge možnosti zdravljenja.
English: Protopic treatment should begin as soon as symptoms appear.
Slovenian: Zdravljenje z zdravilom Protopic je treba začeti takoj, ko se pojavijo simptomi.
English: Generally, improvement is seen within one week of starting treatment.
Slovenian: Izboljšanje je praviloma opazno v enem tednu po začetku zdravljenja.
English: The full EPAR for Protopic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Protopic je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Protopic.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Protopic.
English: Tacrolimus has been used since the mid-1990s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Slovenian: Takrolimus se od sredine devetdesetih let prejšnjega stoletja uporablja za preprečevanje zavrnitve presadka pri bolnikih po presaditvi (ko imunski sistem napade presajeni organ).
English: ‘Atopic' means that the dermatitis is linked to an allergy.
Slovenian: „Atopičen“ pomeni, da je dermatitis povezan z alergijo.
English: The main measure of effectiveness was the number of flare-ups the patients had over a year.
Slovenian: Glavno merilo učinkovitosti je bilo število ponovnih izbruhov bolezni pri bolnikih v enem letu.
English: The main measure of effectiveness was the improvement in the eczema seen at the end of the studies, after three or 12 weeks, using a scoring system that looks at all of the symptoms of atopic dermatitis.
Slovenian: Glavno merilo učinkovitosti je bilo izboljšanje ekcema na koncu študije po treh ali 12 tednih na podlagi sistema točkovanja, ki zajema vse simptome atopičnega dermatitisa.
English: For more information about treatment with Protopic, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Protopic preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: Protopic is an ointment that contains the active substance tacrolimus (0.1% and 0.03%).
Slovenian: Zdravilo Protopic je mazilo, ki vsebuje zdravilno učinkovino takrolimus (0,1 % in 0,03 %).
English: The CHMP decided that Protopic's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Protopic večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Protopic tacrolimus
Slovenian: Protopic takrolimus
English: All of the patients had atopic dermatitis that had responded to a maximum of six weeks of previous treatment with Protopic.
Slovenian: Vsi bolniki so imeli atopični dermatitis, ki se je odzval na največ šesttedensko predhodno zdravljenje z zdravilom Protopic.
English: Protopic should be prescribed by a doctor with experience in the diagnosis and treatment of atopic dermatitis.
Slovenian: Zdravilo Protopic lahko predpiše zdravnik, ki imajo izkušnje s postavljanjem diagnoze in zdravljenjem atopičnega dermatitisa.
English: What benefit has Protopic shown during the studies?
Slovenian: Kakšne koristi je zdravilo Protopic izkazalo med študijami?
English: In children, this should include suspension of treatment to allow the doctor to assess whether continued treatment for the disease is necessary.
Slovenian: Pri otrocih je treba zdravljenje prekiniti, da lahko zdravnik ugotovi, ali je nadaljnje zdravljenje potrebno.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Protopic.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Protopic, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: While Protopic 0.03% can be used in all patients over two years of age, Protopic 0.1% is only used in adults and adolescents over 16 years of age.
Slovenian: Medtem ko se lahko zdravilo Protopic v odmerku 0,03 % uporablja pri vseh bolnikih, starejših od dveh let, se lahko v odmerku 0,1 % uporablja samo pri odraslih in mladostnikih, starejših od 16 let.
English: The doctor should review the need to continue maintenance treatment after a year.
Slovenian: Zdravnik mora po enem letu pretehtati, ali je treba vzdrževalno zdravljenje nadaljevati.
English: The way in which Protopic works in atopic dermatitis is not fully understood.
Slovenian: Način delovanja zdravila Protopic pri atopičnem dermatitisu še ni popolnoma znan.
English: Other information about Protopic
Slovenian: Druge informacije o zdravilu Protopic:
English: Protopic should not be used in people who may be hypersensitive (allergic) to tacrolimus, any of the other ingredients or macrolides.
Slovenian: Zdravila Protopic ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) takrolimus, katero koli drugo sestavino zdravila ali makrolide.
English: Protopic is used in patients aged two years and above who do not respond well to or do not tolerate conventional treatments such as locally applied corticosteroids.
Slovenian: Zdravilo Protopic se uporablja pri bolnikih, starih dve leti ali več, ki se na običajna zdravljenja, kot je uporaba lokalnih kortikosteroidov, ne odzivajo ustrezno ali jih ne prenašajo.
English: Maintenance treatment with Protopic has been studied in two main studies involving 224 patients aged 16 years or over, and 250 aged from two to 15 years.
Slovenian: Vzdrževalno zdravljenje z zdravilom Protopic so raziskali v dveh glavnih študijah, v katerih je bilo vključenih 224 bolnikov, starejših od 16 let, in 250 bolnikov, starih od dveh do 15 let.
English: The most common side effects with Protopic (seen in more than 1 patient in 10) are a burning sensation and itching at the application site.
Slovenian: Najpogostejša neželena učinka zdravila Protopic (opažena pri več kot 1 bolniku od 10) sta pekoč občutek in srbenje na mestu nanosa.
English: In the treatment of flare-ups of atopic dermatitis, Protopic was more effective than hydrocortisone at producing improvements in symptoms, although it also produced more burning than hydrocortisone.
Slovenian: Pri zdravljenju izbruhov atopičnega dermatitisa je bilo zdravilo Protopic pri izboljšanju simptomov sicer učinkovitejše od hidrokortizona, vendar je povzročilo tudi bolj pekoč občutek kot hidrokortizon.
English: Protopic can also be used to prevent flare-ups of the disease or prolong the time that patients are free from flare-ups.
Slovenian: Zdravilo se lahko uporablja tudi za preprečevanje ponovnih izbruhov bolezni ali podaljšanje časa, ko bolniki nimajo izbruhov.
English: Children should use Protopic 0.03% twice a day for up to three weeks before reducing the frequency to once a day.
Slovenian: Pri otrocih je treba zdravilo Protopic 0,03 % uporabljati dvakrat na dan do tri tedne, preden se pogostost jemanja zmanjša na odmerek enkrat na dan.
English: In maintenance treatment, it is used in patients who usually have four or more flareups per year and who have had a response to an initial course of Protopic used twice a day for up to six weeks.
Slovenian: V okviru vzdrževalnega zdravljenja se uporablja pri bolnikih, ki so običajno imeli štiri ali več ponovnih izbruhov na leto in ki so se odzvali na začetno zdravljenje z zdravilom Protopic dvakrat na dan šest tednov zapored.
English: If there are signs of a flare-up, treatment should revert to twice a day as above.
Slovenian: Če se pojavijo znaki ponovnega izbruha bolezni, je treba zdravljenje nadaljevati dvakrat na dan, kot je navedeno zgoraj.
English: What is the risk associated with Protopic?
Slovenian: Kakšna tveganja so povezana z zdravilom Protopic?
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness and dryness).
Slovenian: Pri atopičnem dermatitisu čezmerna reakcija imunskega sistema kože povzroči njeno vnetje (srbenje, pordelost in izsušenost).
English: Tacrolimus reduces the activity of the immune system, helping to relieve the skin inflammation and the itching.
Slovenian: Takrolimus umiri dejavnost imunskega sistema, kar olajša vnetje kože in srbenje.
English: The active substance in Protopic, tacrolimus, is an immunomodulator.
Slovenian: Zdravilna učinkovina zdravila Protopic, takrolimus, je imunomodulator.
English: For the full list of all the side effects reported with Protopic, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Protopic, glejte navodilo za uporabo.
English: The use of Protopic in the treatment of flare-ups has been studied in six main studies involving 1,202 patients over the age of 16 years, and 1,535 aged from two to 16 years.
Slovenian: Uporabo zdravila Protopic za zdravljenje izbruhov bolezni so raziskovali v šestih glavnih študijah, v katere sta bila vključena 1 202 bolnika, stara več kot 16 let, in 1 535 bolnikov, starih od dveh do 16 let.
English: In the longer study, Protopic could be used repeatedly without losing its effectiveness.
Slovenian: V daljši študiji so zdravilo Protopic uporabljali večkrat brez zmanjšanja učinkovitosti.
English: The studies compared twice-weekly Protopic with placebo, although both groups of patients could use Protopic whenever they had a flare-up of the disease.
Slovenian: V študijah so dvakrat tedensko uporabo zdravila Protopic primerjali s placebom, čeprav sta lahko obe skupini bolnikov ob ponovnih izbruhih bolezni uporabili zdravilo Protopic.
English: When used for flare-ups, Protopic can be used for short-term and intermittent long-term treatment, but it should not be used continuously on a long-term basis.
Slovenian: Zdravilo Protopic se pri ponovnih izbruhih lahko uporablja za kratkoročno in dolgoročno zdravljenje z vmesnimi presledki, pri dolgoročnem zdravljenju pa se ne sme uporabljati neprenehoma.
English: Protopic was compared either with placebo (a dummy treatment) or with hydrocortisone (a corticosteroid often used for eczema).
Slovenian: Zdravilo Protopic so primerjali s placebom (zdravilom brez zdravilne učinkovine) ali hidrokortizonom (kortikosteroidom, ki se pogosto uporablja za zdravljenje ekcemov).
English: When used as maintenance treatment, Protopic should be applied twice a week to areas of the skin commonly affected by the disease.
Slovenian: Če se zdravilo Protopic uporablja za vzdrževalno zdravljenje, ga je treba dvakrat na teden nanesti na tiste predele kože, ki jih bolezen običajno prizadene.
English: In maintenance treatment, Protopic was more effective than placebo at reducing the number of flare-ups.
Slovenian: Pri vzdrževalnem zdravljenju je bilo zdravilo Protopic pri zmanjšanju izbruhov bolezni učinkovitejše od placeba.
English: In both studies, the patients with moderate to severe disease who were using Protopic had an average of one flare-up over a year, compared with three in those using placebo.
Slovenian: V obeh študijah je pri bolnikih z zmerno do hudo obliko bolezni, ki so uporabljali zdravilo Protopic, ta povprečno ponovno izbruhnila enkrat na leto, v primerjavi s tremi ponovitvami pri bolnikih, ki so uporabljali placebo.
English: Each affected area is treated twice a day with Protopic until the skin is clear.
Slovenian: Vsak prizadeti predel kože je treba z zdravilom Protopic namazati dvakrat na dan, dokler spremembe na koži ne izginejo.
English: Why has Protopic been approved?
Slovenian: Zakaj je bilo zdravilo Protopic odobreno?
English: Another study looked at the repeated use of Protopic for up to four years in about 800 patients.
Slovenian: V drugi študiji, ki je trajala do štiri leta, so pri 800 bolnikih proučili ponavljajočo se uporabo zdravila Protopic.
English: The ointment should be applied as a thin layer to the skin.
Slovenian: Na kožo je treba nanesti tanko plast mazila.
English: Adults should start treatment with Protopic 0.1% twice a day but should switch to less frequent application or use of the lower strength (0.03%) as the condition improves.
Slovenian: Pri odraslih je treba zdravilo Protopic, 0,1 % v začetku nanašati dvakrat na dan, vendar naj bolniki po izboljšanju stanja zdravilo uporabljajo redkeje ali uporabljajo zdravilo z manjšo jakostjo
English: Protopic is used to treat ‘flare-ups' (recurrence or worsening) of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin).
Slovenian: Zdravilo Protopic se uporablja za zdravljenje izbruhov (ponovitve ali poslabšanja) zmernega do hudega atopičnega dermatitisa (ekcema, srbečega kožnega izpuščaja s pordelostjo).
English: What is Protopic used for?
Slovenian: Za kaj se zdravilo Protopic uporablja?
English: How has Protopic been studied?
Slovenian: Kako je bilo zdravilo Protopic raziskano?
English: What is Protopic?
Slovenian: Kaj je zdravilo Protopic?
English: How does Protopic work?
Slovenian: Kako zdravilo Protopic deluje?
English: How is Protopic used?
Slovenian: Kako se zdravilo Protopic uporablja?
English: (See section 4.5).
Slovenian: (Glejte poglavje 4.5).
English: Open.
Slovenian: Odprite.
English: Age over 65 years
Slovenian: Starost več kot 65 let
English: • Several seconds later you may hear a 2nd click.
Slovenian: • Nekaj sekund zatem boste morda slišali drugi klik.
English: Median Time to Failure (months)
Slovenian: Srednji čas do neuspeha (meseci)
English: Not known (frequency cannot be estimated from available data):
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: Please read the instructions carefully and follow them step by step.
Slovenian: Navodila natančno preberite in jih upoštevajte korak za korakom.
English: You may hear a 1st click.
Slovenian: Morda boste slišali prvi klik.
English: Risk Management Plan (RMP)
Slovenian: • Načrt za obvladovanje tveganj (RMP)
English: Wait 15-30 minutes
Slovenian: Počakajte 15-30 minut
English: Fewer than half of at-risk subjects had an event
Slovenian: Manj kot polovica rizičnih preiskovancev je imela dogodek
English: Investigations*
Slovenian: Preiskave*
English: confidence interval)
Slovenian: interval zaupanja)
English: Sometimes, fast injections can be painful.
Slovenian: Hitro injiciranje je včasih lahko boleče.
English: • The needle is clean.
Slovenian: • Igla je čista.
English: Use a plaster if you want to.
Slovenian: Če želite, lahko uporabite obliž.
English: The needle is hidden below the green base.
Slovenian: Igla je skrita pod zeleno osnovo.
English: Failure to perform the following steps as described may cause contamination which may lead to infection of your child.
Slovenian: V primeru, da v nadaljevanju navedenih korakov ne boste izvedli tako kot je opisano, lahko pride do kontaminacije, ki lahko povzroči infekcijo vašega otroka.
English: ASDAS Inactive Disease hs-CRPd,f,g
Slovenian: ASDAS neaktivna bolezen hs-CRPd,f,g
English: The Patient Reminder Cards should contain the following key elements:
Slovenian: Opozorilna kartica za bolnika bi morala vsebovati naslednje ključne elemente:
English: • Let go of the skin in your hand.
Slovenian: • Spustite kožo v roki.
English: DO NOT use the same site that was used for the last injection.
Slovenian: NE UPORABITE istega mesta, kot ste ga uporabili za zadnje injiciranje.
English:  Remember to wash your hands!
Slovenian:  Ne pozabite si umiti rok!
English: Maintenance Dose Starting at Week 4
Slovenian: Vzdrževalni odmerek z začetkom v 4. tednu
English: Be careful not to squirt the liquid medication into your eye.
Slovenian: Pazite, da si tekočega zdravila ne brizgnete v oko.
English: Be careful that it does not fall over.
Slovenian: Pazite, da se ne prevrne.
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja zelo natančno pretehtati.
English: This is important to get the proper dose.
Slovenian: To je pomembno, da boste dobili pravilen odmerek.
English: 1 vial
Slovenian: 1 vialo
English: Tell your doctor as soon as possible if you notice any of the following:
Slovenian: Zdravniku čim prej povejte, če opazite kaj od naslednjega:
English: • Throw away all other used items into your regular household waste.
Slovenian: • Zavrzite vse ostale uporabljene predmete v običajen koš za odpadke.
English: This may mean there is an infection and therefore you should contact your doctor.
Slovenian: Te spremembe lahko pomenijo okužbo, zato morate kontaktirati zdravnika.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Sledljivost Z namenom, da bi izboljšali sledljivost bioloških zdravil, morata biti ime in številka serije uporabljenega zdravila jasno zabeležena.
English: Monoclonal antibodies are proteins that attach to a specific target.
Slovenian: Monoklonska protitelesa so beljakovine, ki se vežejo na specifičen cilj.
English: This step is important to get the proper dose.
Slovenian: Ta korak je pomemben, da boste dobili pravilen odmerek.
English: Seek medical attention urgently if you notice any of the following:
Slovenian: Takoj poiščite zdravniško pomoč, če opazite kaj od naslednjega:
English: PGA: Clear/minimal
Slovenian: PGA: čisto/minimalno
English: • nervous system problems
Slovenian: • težave živčnega sistema
English: Choose an injection site on your body.
Slovenian: Izberite mesto za injiciranje na svojem telesu.
English: Results from the overall UC-II study population are shown in Table 28.
Slovenian: Rezultate celotne populacije v študiji UC-II prikazuje preglednica 28.