natgillin/translations-raw huggingface dataset:
In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the committee, the CHMP adopted harmonised sets of Product Information documents for the various presentations of Diflucan and associated names, taking into account the pharmaceutical forms.
CHMP je na osnovi ocene predlogov in odgovorov imetnika dovoljenja za promet z zdravilom ter po razpravi znotraj Odbora ob upoštevanju farmacevtskih oblik sprejel usklajene sklope dokumentacije informacij o zdravilu za različne oblike zdravila Diflucan in povezanih imen.
• Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
• dermatomikoze, vključno s tinea pedis, tinea corporis, tinea cruris, tinea versicolor in kožne kandidne okužbe, kadar je potrebno sistematsko zdravljenje;
The CHMP accepted that the supporting data were only for the indication of cryptococcal meningitis which was implemented in the SPC and not the general cryptococcosis indication.
CHMP je potrdil, da podatki podpirajo samo indikacijo kriptokokni meningitis, kar je tudi navedeno v povzetku glavnih značilnosti zdravila, ne pa tudi splošne indikacije kriptokokoze.
Diflucan is indicated in adults for the treatment of:
Zdravilo Diflucan je indicirano pri odraslih za preprečevanje:
Finally and summarising here the CHMP adopted the following sets of indications for Diflucan and associated names for capsules (50mg, 100mg, 150mg, 200mg), solution for infusion (IV), syrup, powder for oral suspension.
CHMP je tako sprejel naslednje sklope indikacij za zdravilo Diflucan in povezana imena za kapsule (50 mg, 100 mg, 150 mg, 200 mg), raztopino za infundiranje (i.v.
Powder for Suspension
), sirup, prašek za peroralno suspenzijo.
In the paediatric population fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), systemic candidiasis and cryptococcal infections and the prevention of fungal infection in at-risk immunocompromised children following cytotoxic chemotherapy or radiotherapy.
Pri pediatrični populaciji se flukonazol uporablja za zdravljenje mukozne kandidiaze (orofaringealna, ezofagealna), sistemske kandidiaze in kriptokoknih okužb ter za preprečevanje glivičnih okužb pri ogroženih, imunsko oslabljenih otrocih po citotoksični kemoterapiji ali radioterapiji.
Diflucan (fluconazole) is indicated in the following fungal infections in adults (see section 5.1):
Zdravilo Diflucan (flukonazol) je indicirano za naslednje glivične okužbe (glejte poglavje 5.1):
• Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
• kronične oralne atrofične kandidiaze (razjede v ustih), kadar zobna higiena ali topično zdravljenje ne zadostujeta;
Doses of 3 mg/Kg in children have proved effective against fungal infections in immunocompromised children and also for the treatment of paediatric patients with serious fungal infections, such as cryptococcal meningitis.
Zaradi tega je režim odmerjanja pri otrocih enak kakor pri odraslih Odmerek 3 mg/kg se je pokazal učinkovit pri zdravljenju glivičnih okužb pri imunsko oslabljenih otrocih in pri zdravljenju pediatričnih bolnikov s hudimi glivičnimi okužbami, kot je na primer kriptokokni meningitis.
Following all the changes in the SPC there are several corresponding changes to the Package Leaflet After the corrections were implemented a Readability Testing was performed which was submitted and assessed during the referral procedure.
Po vnosu popravkov je bil izveden tudi test berljivosti, ki je bil nato predložen in ocenjen v napotitvenem postopku.
Dermatomycoses include Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor, Tinea unguinium (onychomycosis) and dermal Candida infections.
Dermatomikoze vključujejo tinea pedis, tinea cruris, tinea versicolor, tinea unguinium (onikomikoza) in kožne okužbe s Candido.
The indication of relapse prevention in immunocompromised (HIV and cancer) patients was investigated.
Preučevali so tudi indikacijo za preprečevanje ponovitev pri imunsko oslabelih (HIV in rakavih) bolnikih.
As the treatment of genital candidiasis requires a single 150 mg dose of fluconazole, a convenient presentation containing a single 150 mg fluconazole capsule is available in some Member States (MSs) only for the indication of genital candidiasis, more specifically for the treatment of acute vaginal candidiasis and candidal balanitis.
Zdravljenje genitalne kandidiaze poteka z enojnim 150-miligramskim odmerkom flukonazola in v nekaterih državah članicah je na voljo priročna oblika kapsule, ki vsebuje 150-miligramski odmerek, samo za indikacijo genitalne kandidiaze, natančneje za zdravljenje akutne vaginalne kandidiaze in kandidnega balanitisa.
The CHMP noted that adolescent posology had been omitted; none of the national SPCs described the posology for this age group.
CHMP je menil, da odmerjanje pri mladostnikih manjka, saj v nobenem nacionalnem povzetku glavnih značilnosti zdravila ni bilo opisano odmerjanje za to starostno skupino.
Moreover fluconazole has become established as a standard treatment for the prevention of breakthrough infections in neutropenic patients.
Flukonazol je tako postal uveljavljen kot običajno zdravilo za preprečevanje izbruhov okužb pri nevtropeničnih bolnikih.
The pharmacokinetic profile of fluconazole in children has a well understood relationship to that in adults when volume of distribution and clearance are taken into account.
Farmakokinetični profil flukozanola je glede volumna porazdelitve in očistka pri otrocih razumljen podobno kot pri odraslih.
The indication of the genital candidiasis and more specifically the vulvovaginal candidiasis in adult women and the candidal balanitis in adult men was authorised in some MS for the 150 mg, one capsule presentation due to the convenience of one dose treatment.
V nekaterih državah članicah je za indikacijo genitalne kandidiaze, in sicer natančneje vulvovaginalne kandidiaze pri odraslih ženskah in kandidnega balanitisa pri odraslih moških, odobreno zdravljenje s 150-miligramsko kapsulo zaradi prikladnosti zdravljenja z enim odmerkom.
For the 150 mg, one capsule presentation
Ena kapsula, 150 mg
These studies demonstrated that oral fluconazole is an effective and well-tolerated antimycotic agent against Tinea corporis, Tinea cruris, Tinea pedis, Tinea versicolor and onychomycosis.
Te študije so pokazale, da je peroralna uporaba flukonazola učinkovita in da se flukonazol kot antimikotik pri inea corporis, tinea cruris, tinea pedis,
The results are supportive of fluconazole as an appropriate treatment for mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
Rezultati podpirajo flukonazol kot primerno zdravljenje za kandidiazo sluznic, vključno z orofaringealno in ezofagealno kandidiazo, kandidurijo in kronično mukokutano kandidiazo.
For the one 150 mg capsule presentation the section 4.1 of the SPC is agreed by the CHMP as follows:
Za obliko 150-miligramskih kapsul je CHMP potrdil naslednje besedilo v poglavju 4.1 povzetka glavnih značilnosti zdravila:
N/A
DODATEK II
The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Pregledani so bili metoda, statistični pristop in predloženi podatki.
Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients.
Zdravilo Diflucan se uporablja za zdravljenje mukozne kandidiaze (orofaringealne, ezofagealne), invazivne kandidiaze, kriptokoknega meningitisa in za preprečevanje kandidnih okužb pri imunsko oslabljenih bolnikih.
The CHMP agreed that fluconazole is indicated in the prophylaxis of candidal infections in immunocompromised children.
CHMP je potrdil, da se flukonazol indicira za preprečevanje kandidnih okužb pri imunsko oslabljenih otrocih.
Oral use
Navodilo za uporabo
Fluconazole is available for oral use in the 50 mg, 100 mg, 150 mg and 200 mg capsule formulation, in the 5 mg/mL syrup formulation, and in the 50 mg or 200 mg/5 mL powder for oral suspension on reconstitution with water formulation.
Flukozanol je na voljo za peroralno uporabo v obliki 50-, 100-, 150- in 200-miligramskih kapsul, v obliki sirupa 5 mg/ml ter v obliki praška za peroralno suspenzijo, ki se pripravi z rekonstitucijo z vodo.
• Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
• mukozne kandidiaze, vključno z orofaringealno in ezofagealno kandidiazo, kandidurijo ter kronično mukokutano kandidiazo;
The CHMP is in agreement in separating the treatment from the prophylaxis of the relapse on Oropharyngeal Candidiasis and presenting the posology accordingly.
CHMP se je strinjal z ločitvijo zdravljenja in profilakso ponovitev pri orofaringealni kandidiazi ter v skladu s tem tudi z navedbo odmerjanja.
The inclusion of the wording on the interaction of itraconazole (another triazole) in the PI of saquinavir and taking into account the recent labelling changes for saquinavir (contraindication for concomitant administration with other QTc interval prolonging drugs) was amended.
Ob upoštevanju nedavnih sprememb označevanja za sakvinavir (kontraindicirana sočasna uporaba z drugimi zdravili, ki podaljšujejo interval QTc) je bila v informacije o zdravilni učinkovini sakvinavir dopolnjena vključitev besedila o medsebojnem delovanju z itrakonazolom (drugi triazol).
2 mg/ml
v obliki 2 mg/ml solne raztopine.
The Core Safety Profile was considered when harmonising the listed adverse reactions between national SPCs of Diflucan.
Pri usklajevanju navedenih neželenih učinkov med nacionalnimi povzetki glavnih značilnosti zdravila Diflucan se je upošteval Glavni varnostni profil.
• the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Diflucan and associated names (see Annex I).
• povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in znanstvene razprave v Odboru;
• Candidal balanitis when local therapy is not appropriate.
• kandidnega balanitisa, kadar lokalno zdravljenje ni primerno;
Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia; however, drug-related adverse events were more frequent with amphotericin B. The CHMP concluded that fluconazole is a safe and effective medicinal product in prophylaxis or treatment for invasive candidiasis compared to other therapies.
Vendar pa so bili neželeni učinki, povezani z uporabo zdravila, pogostejši pri amfotericinu B. CHMP je sklenil, da je flukonazol varno in učinkovito zdravilo za preprečevanje ali zdravljenje invazivne kandidiaze v primerjavi z drugimi zdravili.
(onychomycosis) it was concluded that fluconazole is indicated only when other agents are not considered appropriate.
Dogovorjeno je bilo, da se pri tinea unguinium (onikomikoza) flukozanol uporablja samo, kadar druga zdravila niso primerna.
Fluconazole is available also for intravenous (IV) use in the 2 mg/mL saline solution formulation.
Flukonazol je na voljo tudi za intravensko uporabo (i.v.)
Prophylaxis of candidal infections in immunocompromised children Data supporting the indication for fluconazole prevention of fungal infection in immunocompromised patients in the paediatric International Registration Dossier (1993) were derived from three studies in children; one study determined the efficacy of fluconazole versus nystatin therapy alone, one study versus oral polyenes (nystatin or amphotericin B) and the third study versus ketoconazole.
Podatki v podporo flukonazolu pri indikaciji za preprečevanje glivičnih okužb pri imunsko oslabljenih bolnikih v pediatrični Dokumentaciji za registracijo zdravil (1993) so bili pridobljeni iz treh študij z otroki.
• Acute vaginal candidiasis when local therapy is not appropriate.
• akutna vaginalna kandidiaza, kadar lokalno zdravljenje ni primerno; • kandidni balanitis, kadar lokalno zdravljenje ni primerno.
Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. Concomitant use of fluconazole with saquinavir was contraindicated accordingly with a cross reference to section 4.3 of the PI. All the above changes were accepted by the CHMP and apply to all formulations.
Sočasna uporaba flukonazola s sakvinavirjem je bila kontraindicirana v skladu s sklicem na poglavje 4.3
Pharmaceutical form
informacij o zdravilu.
Date of first authorisation: 12 September 2008 Date of latest renewal: 9 April 2013
Datum prve odobritve: 12. september 2008 Datum zadnjega podaljšanja: 9. april 2013
Safety features will be implemented until 9/2/2019.
Zaščitni elementi bodo uvedeni do 9. 2. 2019
Out of these 87 patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
Od teh 87 bolnikov jih 82,8 % ni spremenilo odmerka, 13,8 % ga je povečalo, 3,4 % pa zmanjšalo.
In open continuation trials lasting for more than three years there were no signs of decreasing efficacy.
V odprtih nadaljevalnih preskušanjih, ki so trajala več kot tri leta, ni bilo znakov upadanja učinkovitosti.
The absolute bioavailability is greater than 90%.
Absolutna biološka uporabnost je več kot 90 %.
Take care if you are using any medicines that calm you down (have a sedative effect) or if you are drinking alcohol.
Bodite previdni, če jemljete kakršnakoli zdravila, ki vas pomirijo (imajo sedativni učinek), ali če pijete alkohol.
In this case, you will have to take the tablets only once or twice a day.
V tem primeru boste tablete jemali samo 1-krat ali 2-krat na dan.
Please note:
Opomba:
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
Pramipexole was not genotoxic.
Pramipeksol ni bil genotoksičen.
The three strips are marked with "Week 1", "Week 2" and "Week 3".
Pretisni omoti so označeni s "1. teden", "2. teden" in "3. teden.
The frequency category is probably not greater than "uncommon".
Njihova kategorija pogostnosti verjetno ni višja od kategorije "občasni".
The increase in Cmax is not considered clinically relevant.
Povečanje Cmax ne velja za klinično pomembno.
This is to avoid postural hypotension (a fall in blood pressure on standing up).
To je potrebno, da bi se izognili posturalni hipotenziji (padcu krvnega tlaka pri vstajanju).
Parkinson's disease
Parkinsonovo boleznijo.
Patients should be informed about this before tapering the dopamine agonist, and monitored regularly thereafter.
Bolnike je treba o tem obvestiti pred začetkom zmanjševanja odmerka dopaminskega agonista, nato pa jih je treba redno spremljati.
Common (≥1/100 to
Pogosti (≥1/100 do
Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05.
Farmakoterapevtska skupina: antiparkinsoniki, agonisti dopamina, oznaka ATC: N04BC05.
This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
To velja tudi za zdravila rastlinskega izvora, biohrano ali prehranska dopolnila, ki ste jih dobili brez recepta.
Lowest maintenance dose Highest maintenance dose
Najmanjši vzdrževalni odmerek Največji vzdrževalni odmerek
A decreased body weight by 30 kg results in an increase in Cmax of 45%.
Če se telesna masa zmanjša za 30 kg, se Cmax poveča za 45 %.
This finding is not clinically relevant to man.
Ta ugotovitev ni klinično pomembna za ljudi.
Do not take Oprymea: - if you are allergic to pramipexole or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Oprymea: - če ste alergični na pramipeksol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In case of severe cardiovascular disease, care should be taken.
V primeru hudih kardiovaskularnih obolenj moramo biti previdni.
The absolute bioavailability is greater than 90% and the maximum plasma concentrations occur between 1 and 3 hours.
Absolutna biološka uporabnost znaša več kot 90 %, najvišja plazemska koncentracija pa je dosežena v eni do treh urah.
If patients report such an observation, the physician should reassess patient's response to therapy.
Če bolniki poročajo o takšnem opažanju, mora zdravnik ponovno oceniti bolnikov odziv na zdravljenje.
The tablet can be divided into equal doses.
Tableta se lahko deli na enaka odmerka.
The tablets may be taken either with or without food and should be taken each day at about the same time.
Tablete lahko jemljejo s hrano ali brez nje, treba pa jih je jemati vsak dan ob približno isti uri.
Hallucinations or somnolence can occur.
Pojavijo se lahko halucinacije in zaspanost.
Total exposure (AUC) was not affected by concomitant food intake.
Celotna izpostavljenost (AUC) ob sočasnem jemanju hrane ni bila spremenjena.
What Oprymea is and what it is used for
Kaj je zdravilo Oprymea in za kaj ga uporabljamo
The effect of Oprymea on the unborn child is not known.
Učinek zdravila Oprymea na nerojenega otroka ni znan.
- Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
- spremenjeno ali povečano spolno zanimanje in vedenje, ki vam ali drugim povzroča znatno zaskrbljenost, na primer povečan libido;
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Bolniki, pri katerih se je že pojavila zaspanost in/ali nenadna epizoda spanja, ne smejo voziti ali upravljati strojev.
Uncommon (≥1/1,000 to
Občasni (≥1/1.000 do
In rats, the concentration of active substance-related radioactivity was higher in breast milk than in plasma.
Pri podganah je bila koncentracija radioaktivno označene zdravilne učinkovine večja v mleku kot v plazmi.
Other medicines and Oprymea
Druga zdravila in zdravilo Oprymea
Patients should be informed that (mostly visual) hallucinations can occur.
Bolnikom moramo povedati, da lahko pride do halucinacij (večinoma vidnih).
The latter finding was not observed in pigmented rats, nor in a 2-year albino mouse carcinogenicity study or in any other species investigated.
Zadnje ugotovitve niso opazili niti pri pigmentiranih podganah niti v raziskavi kancerogenosti pri 2letnih albino miših ali katerikoli drugi raziskovani vrsti.
Patients with kidney disease If you have severe kidney disease, Oprymea may not be a suitable treatment for you.
Bolniki z ledvično boleznijo Če imate hudo ledvično bolezen, zdravilo Oprymea morda za vas ni primerno zdravilo.
Maintenance of efficacy was shown in patients treated for 33 weeks.
Pri bolnikih, ki so se zdravili 33 tednov, so pokazali ohranitev učinkovitosti.
What you need to know before you take Oprymea
Kaj morate vedeti, preden boste vzeli zdravilo Oprymea
While body weight has no impact on the AUC, it was found to influence the volume of distribution and therefore the peak concentrations Cmax.
Telesna masa ne vpliva na AUC, vpliva pa na volumen porazdelitve in s tem na največjo koncentracijo (Cmax).
The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Morebitne učinke pramipeksola na rodila so raziskovali pri podganah in zajcih.
If during treatment your kidney problems get worse, you should contact your doctor as soon as possible.
Če se vam bodo ledvične težave med zdravljenjem povečale, se morate čim prej posvetovati z zdravnikom.
The Oprymea treatment initiation pack is only to be used for the beginning of the treatment with Oprymea.
Pakiranje za začetno zdravljenje zdravila Oprymea se uporablja samo na začetku zdravljenja z zdravilom Oprymea.
Tell your doctor if you experience any of these behaviors; he will discuss ways of managing or reducing the symptoms.
Obvestite svojega zdravnika, če opazite katero od navedenih vedenjskih sprememb; z vami se bo pogovoril o načinih obvladovanja ali zmanjšanja simptomov.
- treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
- zdravljenje simptomov zmernega do hudega primarnega sindroma nemirnih nog pri odraslih.
Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
O slabosti in utrujenosti so med zdravljenjem s pramipeksolom pogosteje poročali pri ženskah (20,8 % in 10,5 %) kot pri moških (6,7 % in 7,3 %).
The tablets should be swallowed whole with water, and must not be chewed, divided or crushed.
Tablete je potrebno pogoltniti cele z vodo in jih ni dovoljeno žvečiti, razdeliti ali zdrobiti.
Stimulation of the dopamine receptors triggers nerve impulses in the brain that help to control body movements.
Spodbujanje teh receptorjev sproži v možganih živčne impulze, ki nadzorujejo telesne gibe.
Sudden onset of sleep and somnolence
Nenaden nepremagljiv spanec in zaspanost
Therefore, interactions with other medicinal products affecting plasma protein binding or elimination by biotransformation are unlikely.
Zato so interakcije z drugimi zdravili, ki bi vplivale na vezavo na plazemske proteine ali na izločanje z biotransformacijo, malo verjetne.
Approximately 90% of C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Približno 90 % odmerka, označenega s C, se izloči skozi ledvice, medtem ko v blatu najdemo manj kot 2 % odmerka.
Adverse events occurring in at least 5% of patients in the pramipexole group and more common in the pramipexole-treated patients than in patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection (7.0%, placebo 5.0%).
Neželeni dogodki, ki so se v skupini s pramipeksolom pojavili pri najmanj 5 % bolnikov, in so bili pri bolnikih, ki so se zdravili s pramipeksolom, pogostejši kot pri placebu, so bili: glavobol (27,9 %, placebo 25,0 %), zaspanost (7,0 %, placebo 5,0 %), siljenje na bruhanje (18,6 %, placebo 10,0 %), bruhanje (11,6 %, placebo 0,0 %), bolečina v zgornjem delu trebuha (7,0 %, placebo 5,0 %), ortostatska hipotenzija (9,3 %, placebo 5,0 %), mialgija (9,3 %, placebo 5,0 %), motnja spanja (7,0 %, placebo 0,0 %), dispneja (7,0 %, placebo 0,0 %) in okužba zgornjih dihalnih poti (7,0 %, placebo 5,0%).
Investigations weight decrease including decreased appetite weight increase
Preiskave zmanjšanje telesne mase, vključno z zmanjšanjem apetita povečanje telesne mase
Rare: - Mania (agitation, feeling elated or over-excited)
Redki: - manija (agitacija, vznesenost ali prevelika vznemirjenost).
If this happens, your doctor may want to change your medication.
Če pride do tega, vam bo zdravnik morda zamenjal zdravilo.
There is no pharmacokinetic interaction with selegiline and levodopa.
Farmakokinetičnih interakcij s selegilinom in levodopo ni.
The Oprymea treatment initiation pack contains three blister strips of tablets - one strip for each of the first three weeks of your treatment.
Pakiranje za začetno zdravljenje zdravila Oprymea vsebuje tri pretisne omote s tabletami - po en pretisni omot za vsak teden začetnega tritedenskega zdravljenja.
Your doctor may need to adjust or stop your dose.
Vaš zdravnik vam bo morda moral prilagoditi odmerek ali zdravilo ukiniti.
This leaflet was last revised in.
Navodilo je bilo nazadnje revidirano dne .