natgillin/translations-raw huggingface dataset:
Therefore, in addition to the PRAC recommendation to vary the marketing authorisations, the CMDh also agreed that if a marketing authorisation cannot be varied in line with the terms of the CMDh agreement, member states may consider the revocation of that marketing authorisation.
Zato je poleg priporočila odbora PRAC za spremembo dovoljenj za promet z zdravili prav tako soglašala, da lahko države članice razmislijo o razveljavitvi dovoljenja za promet z zdravilom v primeru, da dovoljenja za promet z zdravilom ni mogoče spremeniti skladno s pogoji sporazuma skupine CMDh.
Similarly, it was not recommended to use codeine in children whose breathing could be compromised including children with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
Podobno njegova uporaba ni priporočljiva pri otrocih, pri katerih je lahko dihanje ogroženo, vključno z otroci z nevromuskularnimi motnjami, hudimi srčnimi ali respiratornimi stanji, okužbami zgornjih dihal ali pljuč, več poškodbami ali obsežnimi kirurškimi posegi.
The PRAC initiated a review of the benefit-risk balance of codeine in the treatment of cough and/or cold in paediatric patients.
Odbor PRAC je uvedel pregled razmerja med tveganji in koristmi kodeina pri zdravljenju kašlja in/ali prehlada pri pediatričnih bolnikih.
This included contraindication in patients of any age known to be CYP2D6 ultra-rapid metabolisers and in women of all ages who are breastfeeding.
To vključuje kontraindikacije pri bolnikih katere koli starosti, ki izjemno hitro presnavljajo prek encima CYP2D6, in doječe matere katere koli starosti.
The PRAC took into account that the enzymatic systems responsible for the metabolism of codeine in children older than 12 years of age can be considered comparable to that of adults.
Odbor PRAC je upošteval, da so encimski sistemi, odgovorni za presnovo kodeina pri otrocih, starejših od 12 let, primerljivi z encimskimi sistemi pri odraslih.
Therefore, the PRAC recommended the variation to the terms of the marketing authorisation for medicinal products containing codeine for cough and/or cold in children referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Odbor PRAC je zato priporočil spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo kodein in se uporabljajo proti kašlju in/ali prehladu pri otrocih, ki so navedena v Prilogi I, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III k priporočilu odbora PRAC.
Based on all the above, the PRAC recommended restrictions of the use of codeine for cough and/or cold in the paediatric population.
Odbor PRAC je na podlagi zgornjih navedb priporočil omejitve uporabe kodeina proti kašlju in/ali prehladu pri pediatrični populaciji.
The CMDh, having considered the PRAC recommendation, agrees with the overall scientific conclusions by the PRAC and agreed that the marketing authorisation(s) for should be revoked or varied, as applicable.
Po proučitvi priporočila odbora PRAC se je skupina CMDh strinjala z njegovimi splošnimi znanstvenimi zaključki in tudi s tem, da je treba dovoljenja za promet z zdravili, ki vsebujejo kodein, preklicati ali spremeniti, kot je primerno.
The PRAC considered that children below 12 years are at special risk of life-threatening respiratory depression and therefore, contraindicated the use of codeine in children below 12 years.
Menil je, da so otroci, mlajši od 12 let, izpostavljeni posebnemu tveganju smrtno nevarne respiratorne depresije, zato mora biti uporaba kodeina pri otrocih, mlajših od 12 let, kontraindicirana.
• The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for codeine containing medicinal products for the treatment of cough and/or cold in children.
• odbor PRAC je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES, ki je bila na podlagi farmakovigilančnih podatkov sprožena za zdravila, ki vsebujejo diacerein;
Cough serves as a physiologic function to clear airways of obstructive or irritating material or to warn of noxious substances in inspired air.
Gre za fiziološko funkcijo, ki iz dihalnih poti odstranjuje obstruktivni ali dražeči material ali svari pred škodljivimi snovmi v vdihanem zraku.
• The PRAC, in line with the restrictions introduced during the codeine referral for pain relief in children, also concluded that all codeine containing medicinal products for the treatment of cough and/or cold should be contraindicated in women when breastfeeding, as well as in patients known to be CYP2D6 ultra-rapid metabolisers.
• skladno z omejitvami, uvedenimi med napotitvenim postopkom za kodein, ki se uporablja za lajšanje bolečine pri otrocih, je odbor PRAC sklenil, da morajo biti vsa zdravila, ki ga vsebujejo, za zdravljenje kašlja in/ali prehlada kontraindicirana pri doječih materah ter bolnikih, ki izjemno hitro presnavljajo prek encima CYP2D6,
The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products containing codeine for cough and/or cold in children remains favourable, subject to the inclusion of the restrictions, warnings and other agreed changes to the product information.
je odbor PRAC posledično zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo kodein in se uporabljajo proti kašlju in/ali prehladu pri otrocih, še naprej ugodno, če se upoštevajo omejitve, opozorila in druge dogovorjene spremembe informacij o zdravilu.
Having noted all of the above, the PRAC concluded that the benefit-risk balance of codeine-containing products indicated in cough and/or cold in children remains favourable, subject to the agreed restrictions, contraindications, warnings and other changes to the product information as set out in Annex III to the opinion.
Ob upoštevanju vsega zgoraj omenjenega je odbor PRAC zaključil, da razmerje med tveganji in koristmi za zdravila, ki vsebujejo kodein in so indicirana za kašelj in/ali prehlad pri otrocih, ostaja ugodno, če se upoštevajo dogovorjene omejitve, kontraindikacije, opozorila in druge spremembe informacij o zdravilu, kot so navedene v Prilogi III k temu mnenju.
The PRAC further concluded that codeine should be contraindicated in paediatric patients below 18 years of age undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome as well as in women during breast-feeding and in patients known to be CYP2D6 ultra-rapid metabolisers.
Prav tako je sklenil, da mora biti kontraindiciran za zdravljenje sindroma obstruktivne apneje v spanju pri pediatričnih bolnikih, mlajših od 18 let, ki so prestali tonzilektomijo/adenoidektomijo, in pri doječih materah ter bolnikih, ki izjemno hitro presnavljajo prek encima CYP2D6.
In addition, another randomised clinical trial (Taylor et al, 1993) in children with codeine, dextromethorphan as an active comparator, and a placebo group showed that neither codeine nor dextromethorphan were significantly better then placebo for the symptomatic treatment of cough in children under 12 years of age.
1993) pri otrocih s kodeinom, dekstrometorfanom kot primerjalno zdravilno učinkovino in placebom pokazalo, da kodein in dekstrometorfan nista bila pomembno boljša kot placebo pri simptomatskem zdravljenju kašlja pri otrocih, mlajših od 12 let.
In total, fourteen reports of codeine intoxication in children related to the treatment of cough and respiratory infection were identified in the published literature.
V objavljeni literaturi so odkrili skupno štirinajst primerov zastrupitve s kodeinom pri otrocih, povezanih z zdravljenjem kašlja in okužbe dihal.
The PRAC further considered that in children aged 12 years to 18 years for whom respiratory function might be compromised including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures, codeine is not recommended as these conditions may worsen symptoms of morphine toxicity.
Prav tako je menil, da njegova uporaba ni priporočljiva pri otrocih, starih od 12 do 18 let, z ogroženo respiratorno funkcijo, vključno z otroci z nevromuskularnimi motnjami, hudimi srčnimi ali respiratornimi stanji, okužbami zgornjih dihal ali pljuč, več poškodbami ali obsežnimi kirurškimi posegi, saj lahko ta stanja poslabšajo simptome toksičnosti morfina.
Whereas EMs or UMs are at risk of morphine toxicity, PMs may be at an increased risk of a lack of therapeutic effect.
Osebe z obsežno in izredno hitro presnovo so izpostavljene tveganju za toksičnost morfina, tiste z upočasnjeno presnovo pa večjemu tveganju za pomanjkanje terapevtskega učinka.
The PRAC further considered that in children aged 12 years to 18 years with compromised respiratory function the use of codeine is not recommended.
Prav tako je menil, da uporaba kodeina ni priporočljiva pri otrocih, starih od 12 do 18 let, z ogroženo respiratorno funkcijo;
In 2012, the Taylor et al study was included in a Cochrane review of non-prescription/over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings; this review additionally identified two randomised controlled trials where codeine was tested in adults (Eccles et al, 1992; Freestone C, 1997): codeine was found to be no more effective than placebo.
vključena v Cochranov pregled zdravil brez recepta za zdravljenje akutnega kašlja pri otrocih in odraslih v ambulantnem okolju; pri tem pregledu so opredelili dve dodatni randomizirani nadzorovani preskušanji, v katerih so kodein preskušali pri odraslih (Eccles in sod.
Two studies (Kelly et al, 1963 and Jaffe et al, 1983), which did not include a placebo control group, suggested that efficacy was no greater for codeine than the other antitussives but that the incidence of side effects in the codeine group was higher than in the comparator group.
1983), ki nista vključili kontrolne skupine s placebom, sta pokazali, da učinkovitost kodeina ni bila večja kot pri drugih antitusikih, vendar pa je bila incidenca neželenih učinkov v skupini s kodeinom večja kot v primerjalni skupini.
Therefore, consideration should be given at National level for this contraindication to be included in the labelling of codeine products approved only for adults via variation application submitted by the respective marketing authorisation holders.
Zato je treba na nacionalni ravni, z vlogo za spremembo, ki jo predložijo zadevni imetniki dovoljenj za promet z zdravilom, to kontraindikacijo vključiti v označevanje zdravil, ki vsebujejo kodein in so odobrena le za odrasle.
In this regard the PRAC noted that all codeine containing products approved for adults regardless of the indication, should have these contraindications included in their labelling.
Glede tega je poudaril, da je treba te kontraindikacije vključiti v označevanje vseh zdravil, ki vsebujejo kodein in so odobrena za odrasle, ne glede na indikacijo.
Therefore, the PRAC recommends child resistant containers (CRC) for all oral liquid codeine containing medicinal products.
Zato za vsa peroralna tekoča zdravila, ki vsebujejo kodein, priporoča vsebnike, varne za otroke.
A randomised clinical trial (Jaffe G et al, 1983) and an epidemiological study (De Blasio F et al, 2012) did not show a significant effect of the treatment with codeine in cough and/or cold in children.
1983) in epidemiološka študija (De Blasio F. in sod.
The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti zadostne in zadovoljive podatke, ki potrjujejo biološko enakovrednost njegovega zdravila in referenčnega zdravila v enem letu od sklepa Evropske komisije.
The National Competent Authorities of Member States shall ensure that the following conditions are fulfilled by the MAH:
Nacionalni pristojni organi držav članic bodo zagotovili, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
Annex III Conditions for lifting the suspension of the Marketing Authorisations
Priloga III
Further information on Febuxostat Krka can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
Nadaljnje informacije o zdravilu Febuksostat Krka so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/febuxostat-krka.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Adenuric, and do not need to be repeated for Febuxostat Krka.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Adenuric, zato jih ni treba ponoviti za zdravilo Febuksostat Krka.
What measures are being taken to ensure the safe and effective use of Febuxostat Krka?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Febuksostat Krka?
Febuxostat Krka should be started 2 days before chemotherapy and continued for at least 7 days.
Zdravljenje z zdravilom Febuksostat Krka je treba začeti dva dni pred kemoterapijo in nadaljevati najmanj sedem dni.
This usually reduces blood uric acid levels within 2 weeks, but the dose can be increased to 120 mg once a day if blood uric acid levels remain high (above 6 mg per decilitre) after 2 to 4 weeks.
To običajno zniža koncentracijo sečne kisline v krvi v dveh tednih, vendar pa je mogoče v primeru, če ostane koncentracija sečne kisline v krvi po dveh do štirih tednih visoka (nad 6 mg na deciliter), odmerek povečati na 120 mg enkrat na dan.
Attacks of gout can still occur during the first few months of treatment, so it is recommended that patients take other medicines to prevent attacks of gout for at least the first 6 months of treatment with Febuxostat Krka.
V prvih nekaj mesecih zdravljenja še vedno lahko pride do zagonov protina, zato je priporočljivo, da bolnik vsaj prvih šest mesecev zdravljenja z zdravilom Febuksostat Krka jemlje druga zdravila za njihovo preprečevanje.
Because Febuxostat Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Febuksostat Krka generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
As for every medicine, the company provided studies on the quality of Febuxostat Krka.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Febuksostat Krka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Febuxostat Krka have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Febuksostat Krka upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Why is Febuxostat Krka authorised in the EU?
Zakaj je bilo zdravilo Febuksostat Krka odobreno v EU?
The European Medicines Agency concluded that, in accordance with EU requirements, Febuxostat Krka has been shown to have comparable quality and to be bioequivalent to Adenuric.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Febuksostat Krka primerljivo raven kakovosti kot referenčno zdravilo Adenuric ter da mu je bioekvivalentno.
For more information about using Febuxostat Krka, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Febuksostat Krka glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Febuxostat Krka (febuxostat)
Febuksostat Krka (febuksostat)
This means that Febuxostat Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Adenuric.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Adenuric.
Side effects reported with Febuxostat Krka are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Febuksostat Krka, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Febuxostat Krka is available as tablets (80 and 120 mg) and can only be obtained with a prescription.
Zdravilo Febuksostat Krka je na voljo v obliki tablet (80 in 120 mg), njegovo predpisovanje in izdaja je le na recept.
What are the benefits and risks of Febuxostat Krka?
Kakšne so koristi in tveganja zdravila Febuksostat Krka?
An overview of Febuxostat Krka and why it is authorised in the EU
Pregled zdravila Febuksostat Krka in zakaj je odobreno v EU
As for all medicines, data on the use of Febuxostat Krka are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Febuksostat Krka stalno spremljajo.
Febuxostat Krka is used in patients who have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones', larger deposits of urate crystals that can cause joint and bone damage).
Zdravilo Febuksostat Krka se uporablja pri bolnikih, ki kažejo znake odlaganja kristalov, vključno s protinskim artritisom (bolečino in vnetjem v sklepih) ali tofi („kamni“večjimi skupki kristalov urata, ki lahko povzročijo poškodbe sklepov in kosti).
Febuxostat Krka is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are receiving chemotherapy (medicines to treat cancer) and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
Zdravilo Febuksostat Krka se uporablja tudi za zdravljenje in preprečevanje visokih ravni sečne kisline v krvi pri odraslih s krvnim rakom, ki prejemajo kemoterapijo (zdravila za zdravljenje raka) in so izpostavljeni tveganju za sindrom tumorske lize (zapletu zaradi razgradnje rakavih celic, ki povzroči nenadno povečanje sečne kisline v krvi, kar lahko privede do okvare ledvic).
For the treatment of long-term hyperuricaemia, the recommended dose of Febuxostat Krka is 80 mg once a day.
Pri zdravljenju dolgotrajne hiperurikemije je priporočeni odmerek zdravila Febuksostat Krka 80 mg enkrat na dan.
Keeping uric acid levels low for long enough can also shrink tophi.
Dovolj dolgo vzdrževanje koncentracije sečne kisline na nizki ravni lahko zmanjša tudi velikost tofov.
By reducing the production of uric acid, Febuxostat Krka can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up.
Z zmanjševanjem tvorbe sečne kisline lahko zdravilo Febuksostat Krka zniža njeno koncentracijo v krvi in jo vzdržuje na nizki ravni ter tako ustavi kopičenje kristalov.
Febuxostat Krka contains the active substance febuxostat and is a ‘generic medicine'.
Zdravilo Febuksostat Krka vsebuje učinkovino febuksostat in je „generično zdravilo“.
What is Febuxostat Krka and what is it used for?
Kaj je zdravilo Febuksostat Krka in za kaj se uporablja?
Febuxostat Krka is a medicine used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate' in the blood).
Zdravilo Febuksostat Krka se uporablja za zdravljenje odraslih z dolgotrajno hiperurikemijo (visokimi koncentracijami sečne kisline ali urata v krvi).
Therefore, the Agency's view was that, as for Adenuric, the benefit of Febuxostat Krka outweighs the identified risk and it can be authorised for use in the EU.
Zato je agencija menila, da koristi zdravila Febuksostat Krka, enako kot pri zdravilu Adenuric, odtehtajo znana tveganja in se zdravilo lahko odobri v EU.
How is Febuxostat Krka used?
Kako se zdravilo Febuksostat Krka uporablja?
Febuxostat Krka treatment should not be stopped if an attack of gout occurs.
V primeru zagona protina se zdravljenje z zdravilom Febuksostat Krka ne sme prekiniti.
The active substance in Febuxostat Krka, febuxostat, reduces the formation of uric acid.
Učinkovina v zdravilu Febuksostat Krka, febuksostat, zmanjša tvorjenje sečne kisline.
Other information about Febuxostat Krka
Druge informacije o zdravilu Febuksostat Krka
How does Febuxostat Krka work?
Kako zdravilo Febuksostat Krka deluje?
For example in the morning at breakfast, with lunch at mid-day and with dinner in the evening.
Na primer, zjutraj ob zajtrku, opoldne pri kosilu in zvečer pri večerji.
This may cause allergic reactions.
To lahko povzroči alergijske reakcije.
The registry should also be used to generate data on long-term effectiveness.
Register je treba uporabiti tudi za ustvarjanje podatkov o dolgotrajni učinkovitosti.
Date of first authorisation: 8 September 2015
Datum pridobitve: 8. september 2015
Patients should be regularly monitored according to local clinical practice.
Bolnike je treba redno spremljati skladno z lokalno klinično prakso.
When needed, supportive symptomatic treatment should be given.
Po potrebi je treba nuditi podporno simptomatsko zdravljenje.
EAP and CRS
EAP in CRS
- Take the tablets at the same time of day each day.
- Tablete vsak dan vzemite ob istem času.
This can lead to some improvement in lost eyesight.
To lahko nekoliko izboljša izgubljen vid.
Take the next dose at the usual time.
Naslednji odmerek vzemite ob običajnem času.
Currently available data are described in sections 5.1 and 5.2, but no recommendation on posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
The safety of idebenone in pregnant women has not been established.
Varnosti idebenona pri nosečnicah niso dokazali.
Exclusion of this patient yielded similar results as in the ITT population; as could be expected, the difference between idebenone and placebo arm was slightly larger.
Izključitev tega bolnika je dala podobne rezultate kot v populaciji ITT; kot je bilo pričakovati, je bila razlika med skupinama z idebenonom in placebom rahlo večja.
Studies in rats have shown that idebenone is excreted into maternal milk.
Študije na podganah so pokazale, da se idebenon izloča v materino mleko.
- This eye problem is inherited - this means it runs in families.
- Ta težava z očmi je dedna, kar pomeni, da se prenaša v družini.
This change in colour is harmless - it does not mean your treatment needs to change.
Ta sprememba barve je neškodljiva, tj. zdravljenja ni treba spreminjati.
Change in urine colour
Sprememba barve urina
There is no specific antidote for idebenone.
Ni specifičnega antidota za idebenon.
Frequency groupings are defined to the following convention: very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).
Pogostnost je opredeljena na naslednji način: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
This will take into account the benefit of breast-feeding to the child and the benefit of the medicine for you.
Pri tem bo upošteval korist dojenja za otroka in korist zdravila za vas.
No data are available in these populations.
Pri teh skupinah bolnikov podatki niso na voljo.
Analysis according to Mixed Model of Repeated Measures
Analiza v skladu z mešanim modelom ponovljenih meritev.
The recommended dose is 2 tablets three times a day - this is a total of 6 tablets per day.
Priporočeni odmerek je 2 tableti trikrat na dan (skupno 6 tablet na dan).
You can also report side effects directly via the national reporting system in Appendix V. By reporting side effecs you can help provide more information on the safety of this medicine.
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.