natgillin/translations-raw huggingface dataset:
Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Bolnikom s to boleznijo primanjkuje encima, imenovanega glukocerebrozidaza, zaradi česar se glikosfingolipid, imenovan glukozilceramid, kopiči v različnih delih telesa, kot so vranica, jetra ali kosti.
The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, decreased appetite, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
Najpogostejši neželeni učinki zdravila Zavesca (opaženi pri več kot 1 od 10 bolnikov) so izguba telesne mase, zmanjšan tek, tremor (tresavica), driska, napenjanje (vetrovi) in bolečine v trebuhu.
The survey showed that Zavesca led to a stabilisation or a decrease in the rate at which symptoms got worse in about three-quarters of the patients.
Raziskava je pokazala, da se je z zdravilom Zavesca hitrost slabšanja simptomov ustalila ali zmanjšala pri približno treh četrtinah bolnikov.
The benefits of Zavesca were maintained over three years of continuous treatment.
Koristi zdravila Zavesca se v treh letih neprekinjenega jemanja niso spremenile.
In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
V študiji Niemann-Pickove bolezni tipa C je bilo izboljšanje sunkovitosti gibov z očmi podobno pri bolnikih, ki so jemali zdravilo Zavesca in tistih, ki ga niso.
By preventing the enzyme from working, miglustat can reduce the production of glycosphingolipids in cells.
S preprečevanjem delovanja encima miglustat zmanjša tvorjenje glikosfingolipidov v celicah.
What is Zavesca used for?
Za kaj se zdravilo Zavesca uporablja?
A lower dose should be used in patients with reduced kidney function.
Pri bolnikih z zmanjšanim delovanjem ledvic se uporablja manjši odmerek.
Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Zdravilo Zavesca se uporablja pri bolnikih, pri katerih je standardno encimsko nadomestno zdravljenje (ERT) neprimerno.
Treatment with Zavesca should be started and monitored by doctors who are experienced in the management of Gaucher or Niemann-Pick type C disease.
Zdravljenje z zdravilom Zavesca mora uvesti in nadzorovati zdravnik z izkušnjami z zdravljenjem Gaucherjeve ali Niemann-Pickove bolezni.
However, there were signs of improvement in swallowing ability and intellectual function in the patients treated with Zavesca.
Vendar pa so bili pri bolnikih, ki so prejemali zdravilo Zavesca, opaženi znaki izboljšanja pri požiranju in intelektualni sposobnosti.
For the full list of all side effects reported with Zavesca, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zavesca, glejte navodilo za uporabo.
Zavesca is a medicine that contains the active substance miglustat.
Zavesca je zdravilo, ki vsebuje zdravilno učinkovino miglustat.
What is Zavesca?
Kaj je zdravilo Zavesca?
The active substance in Zavesca, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Zdravilna učinkovina zdravila Zavesca, miglustat, prepreči delovanje encima, imenovanega glukozilceramid sintaza.
How has Zavesca been studied?
Kako je bilo zdravilo Zavesca raziskano?
How is Zavesca used?
Kako se zdravilo Zavesca uporablja?
For type 1 Gaucher disease, Zavesca was investigated in one main study involving 28 adults with mild to moderate disease who were unable or unwilling to receive ERT.
Zdravilo Zavesca so za zdravljenje Gaucherjeve bolezni tipa 1 proučevali v eni glavni študiji z 28 odraslimi z blago do zmerno boleznijo, ki se niso mogli ali hoteli zdraviti z ERT. Glavni del študije je trajal eno leto, 13 bolnikov pa je zdravilo jemalo še nadaljnji dve leti.
How does Zavesca work?
Kako zdravilo Zavesca deluje?
The procedure was concluded and on 11 July 2014 the European Commission adopted a Decision1.
Postopek se je zaključil in 11. julija 2014 je Evropska komisija sprejela sklep
The European Commission issued a decision on 22 August 2016.
Evropska komisija je sklep izdala 22. avgusta 2016.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/110)
What are lincomycin and spectinomycin?
Kaj sta linkomicin in spektinomicin?
The full changes made to the product information for powders for use in the drinking water are detailed in Annex III of the CVMP opinion on the 'All documents' tab.
Vse spremembe informacij o zdravilu za praške za dajanje v vodo za pitje so opisane v Prilogi III mnenja odbora CVMP pod zavihkom „Vsi dokumenti“.
No amendments to the currently approved withdrawal periods for pigs and chicken for the aforementioned powders for use in the drinking water were considered necessary.
Spremembe trenutno odobrenih karenc za prašiče in piščance za omenjene praške za dajanje v vodo za pitje niso bile potrebne.
In September 2012 Belgium initiated a referral procedure under Article 34 of Directive 2001/82/EC for Linco-Spectin 100, powder for use in the drinking water for pigs and chickens (EMEA/V/A/088).
Septembra 2012 je Belgija sprožila napotitveni postopek v skladu s členom 34 Direktive 2001/82/ES za zdravilo Linco-Spectin 100, prašek za uporabo v vodi za pitje za prašiče in piščance (EMEA/V/A/088).
Commission Decision concerning, in the framework of Article 34 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for “Linco-Spectin 100 and its associated names”, veterinary medicinal products which contain the active substances “Lincomycin and spectinomycin” ((2014)5053 of 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Sklep Komisije o dovoljenjih za promet z zdravili za uporabo v veterinarski medicini „Linco-Spectin 100 in z njim povezana imena“, ki vsebujejo zdravilni učinkovini „linkomicin in spektinomicin“, v skladu s členom 34 Direktive 2001/82/ES Evropskega parlamenta in Sveta ((2014)5053 z dne 11. julija 2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Linkomicin je linkozamidni antibiotik in je proizvod bakterije Streptomyces lincolnensis, ki zavira sintezo beljakovin.
Why were veterinary medicinal products containing a combination of lincomycin and spectinomycin reviewed?
Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo kombinacijo linkomicina in spektinomicina?
Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the EU to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of the development of resistance.
Belgija je po izidu omenjenega napotitvenega postopka v skladu s členom 34 za zdravilo LincoSpectin 100 upoštevala, da je spodbujanje učinkovite in razumne rabe kombinacije linkomicina in spektinomicina pri zdravilih za peroralno dajanje v veterinarski medicini in s tem omejevanje tveganja za razvoj odpornosti v interesu Evropske unije.
For pigs and poultry three pharmaceutical forms for oral administration exist with a combination of lincomycin and spectinomycin - premixes for medicated feeding stuff, powders to be administered with the feed and powders for use in the drinking water.
Za prašiče in perutnino obstajajo tri farmacevtske oblike za peroralno dajanje s kombinacijo linkomicina in spektinomicina - predmešanice za zdravilno krmno mešanico, praški za dajanje v krmo in praški za dajanje v vodo za pitje.
Proprietary data and scientific references on efficacy and residue depletion were provided by the marketing authorisation holders in this Article 35 referral procedure.
Imetniki dovoljenja za promet z zdravili so v tem napotitvenem postopku v skladu s členom 35 predložili lastniške podatke o učinkovitosti in izločanju ostankov ter znanstvena sklicevanja nanje.
Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Zato je 5. maja 2015 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo kombinacijo linkomicina in spektinomicina za peroralno dajanje prašičem in/ali perutnini.
The lincosamides are considered to be bacteriostatic agents.
Linkozamidi spadajo med bakteriostatike.
Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis; it has bacteriostatic activity and is active against some aerobic gram-negative bacteria, gram-positive cocci and Mycoplasma spp.
Spektinomicin je aminociklitolni antibiotik in je proizvod bakterije Streptomyces spectabilis; deluje bakteriostatično in proti nekaterim aerobnim po gramu negativnim bakterijam, po gramu pozitivnim kokom in mikroorganizmom rodu Mycoplasma spp.
Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
Linkomicin deluje proti po gramu pozitivnim bakterijam, nekaterim anaerobnim po gramu negativnim bakterijam in mikroorganizmom rodu Mycoplasma spp.
On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Evropska agencija za zdravila (agencija) je 19. maja 2016 zaključila pregled varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini, ki vsebujejo kombinacijo linkomicina in spektinomicina za peroralno dajanje prašičem in/ali perutnini, ter protimikrobne odpornosti proti njim.
The CVMP recommended that all marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin be withdrawn throughout the European Union (EU).
Odbor CVMP je priporočil umik vseh dovoljenj za promet z zdravili za predmešanice za zdravilno krmno mešanico in praške za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, po vsej Evropski uniji (EU).
Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin, to be administered with the feed, is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP zaključil, da je splošno razmerje med tveganji in koristmi predmešanic za zdravilno krmno mešanico in praškov za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, negativno, saj pri uporabi teh zdravil v priporočenih režimih odmerjanja obstaja visoko tveganje za selekcijo in razvoj odpornosti zaradi izpostavljenosti nizkim ravnem protimikrobnih učinkovin v daljših časovnih obdobjih.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je splošno razmerje med tveganji in koristmi predmešanic za zdravilno krmno mešanico in praškov za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina, negativno, saj pri uporabi teh zdravil v priporočenih režimih odmerjanja obstaja visoko tveganje za selekcijo in razvoj odpornosti zaradi izpostavljenosti nizkim ravnem protimikrobnih učinkovin v daljših časovnih obdobjih.
The CVMP recommended that the marketing authorisations for powders containing a combination of lincomycin and spectinomycin for use in the drinking water should be varied in order to amend the product information accordingly.
Odbor CVMP je priporočil spremembo dovoljenj za promet z zdravili za praške za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina, da bo mogoče ustrezno spremeniti informacije o zdravilu.
EMA/462762/2016
avgust 2016
The CVMP recommended the withdrawal of the marketing authorisations for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin to be administered with feed.
Odbor CVMP je priporočil umik dovoljenj za promet z zdravili za predmešanice za zdravilno krmno mešanico in praške za dajanje v krmo, ki vsebujejo kombinacijo linkomicina in spektinomicina.
The CVMP also concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and recommended harmonised indications, dosing regimens and warning sentences on prudent use.
Odbor CVMP je tudi zaključil, da je splošno razmerje med tveganji in koristmi praškov za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina, pozitivno, ter priporočil usklajene indikacije, režime odmerjanja in opozorilne stavke o preudarni uporabi.
The CVMP was requested to assess the available data and to review the indications, dosage regimens and withdrawal periods for pigs and poultry in order to ensure consumer safety, efficacious treatment in pigs, chickens and other poultry species, as well as a lower risk of the development of antimicrobial resistance to lincomycin and spectinomycin.
Odbor CVMP je bil zaprošen, da zaradi zagotavljanja varnosti potrošnikov, učinkovitega zdravljenja prašičev, piščancev in drugih vrst perutnine ter nižjega tveganja za razvoj protimikrobne odpornosti proti linkomicinu in spektinomicinu oceni razpoložljive podatke ter pregleda indikacije, režime odmerjanja in obdobja karence za prašiče in perutnino.
The CVMP further concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and agreed harmonised indications, dosing regimens and warning sentences on prudent use.
Odbor CVMP je tudi zaključil, da je splošno razmerje med tveganji in koristmi praškov za dajanje v vodo za pitje, ki vsebujejo kombinacijo linkomicina in spektinomicina, pozitivno, ter potrdil usklajene indikacije, režime odmerjanja in opozorilne stavke o preudarni uporabi.
See ‘Conditions you need to look out for' in Section 4.
Glejte ‘Stanja na katera morate biti pozorni' v poglavju 4.
Date of latest renewal: 11 July 2005
Datum zadnjega podaljšanja dovoljenja za promet: 11. julij 2005
− At the request of the EMEA.
− na zahtevo Evropske agencije za zdravila (EMEA).
In very rare cases a fatal outcome has been reported.
zelo redkih primerih so poročali tudi o smrtnih izidih.
The chances of this happening may be higher in people, particularly women, taking Avandia for more than one year.
Verjetnost, da se to zgodi, je lahko večja pri tistih osebah, zlasti ženskah, ki jemljejo zdravilo Avandia več kot eno leto.
These small changes are not clinically significant and, therefore, it is not necessary to administer rosiglitazone at any particular time in relation to meals.
Te majhne spremembe niso klinično pomembne, zato rosiglitazona ni treba jemati ob kakšnem posebnem času glede na obroke.
Rosiglitazone may be given once or twice a day.
Rosiglitazon lahko dajemo enkrat ali dvakrat na dan.
The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
Volumen porazdelitve rosiglitazona je pri zdravih prostovoljcih znašal približno 14 litrov.
• if you have liver disease
• če imate bolezen jeter
- diabetic ketoacidosis or diabetic pre-coma.
- z diabetično ketoacidozo ali diabetičnim predkomatoznim stanjem.
The available data do not support efficacy in the paediatric population and therefore such use is not recommended.
Razpoložljivi podatki ne podpirajo učinkovitosti pri otrocih, zato tovrstne uporabe ne priporočamo.
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit yearly PSURs unless otherwise decided by the CHMP.
Po podaljšanju dovoljenja za promet bo imetnik dovoljenja za promet predložil PSURe enkrat na leto, če CHMP ne odloči drugače.
AVANDIA has no or negligible influence on the ability to drive and use machines.
AVANDIA nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
It is not known whether breastfeeding will lead to exposure of the infant to drug.
Ni znano, ali bi imelo dojenje za posledico izpostavljenost dojenčka zdravilu.
In the event of an overdose, it is recommended that appropriate supportive treatment should be initiated, as dictated by the patient's clinical status.
V primeru zaužitja prevelikega odmerka je priporočljivo začeti s primernim podpornim zdravljenjem, skladno s kliničnim stanjem bolnika.
• getting tired easily after light physical activity such as walking
hitro utrujenost po lahki telesni aktivnosti, kot je hoja.
• small increases in blood cholesterol, increased amount of fats in the blood
• manjše zvišanje vrednosti holesterola v krvi, zvišanje vrednosti maščob v krvi
• swollen ankles or feet.
oteklino gležnjev ali nog.
If you stop taking Avandia, your blood sugar will not be controlled, and you may become unwell.
Če prenehate jemati zdravilo Avandia, krvni sladkor ne bo več nadzorovan, vaše zdravstveno stanje pa se lahko poslabša.
Du Terras 53100 Mayenne France or
Du Terras 53100 Mayenne Francija ali
Rosiglitazone may be taken with or without food.
Rosiglitazon se lahko jemlje s hrano ali brez nje.
− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
− v 60 dneh po pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja).
The severity can increase, leading to confusion and loss of consciousness.
Stanje se lahko poslabša in pojavita se zmedenost ter nezavest.
Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
Pogostnost je definirana kot: redki ≥ 1/10.000, < 1/1.000 in zelo redki < 1/10.000, vključno s posameznimi primeri.
The terminal half-life for radioactivity was about 130 hours indicating that elimination of metabolites is very slow.
Končna razpolovna doba radioaktivno označenega zdravila znaša približno 130 ur, kar priča o tem, da je izločanje presnovkov zelo počasno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 July 2000
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 11. julij 2000
Although hormonal imbalance has been seen in preclinical studies (see section 5.3), no significant undesirable effects associated with menstrual disorders have been observed.
Čeprav so v predkliničnih študijah opazili hormonsko neravnovesje (glejte poglavje 5.3), pa tu niso opazili nobenih značilnih neželenih učinkov v zvezi z menstrualnimi motnjami.
Î Tell your doctor as soon as possible if you get any of these symptoms - either for the first time or if they get worse.
Î Čimprej obvestite svojega zdravnika, če se pojavi katerikoli od teh simptomov - bodisi prvič ali pa če se simptom poslabša.
Rosiglitazone has been detected in the milk of experimental animals.
Rosiglitazon so zasledili v mleku poskusnih živali.
The protein binding of the major metabolite (para-hydroxy-sulphate) is very high (>99.99%).
Stopnja vezave glavnega presnovka (parahidroksisulfata) na proteine je zelo visoka (> 99,99 %).
Avandia can be used alone or in combination with other medicines to treat diabetes (such as metformin or a sulphonylurea).
Zdravilo Avandia se lahko uporablja samo ali skupaj z drugimi zdravili za zdravljenje sladkorne bolezni (npr. metformin ali sulfonilsečnina).
Frequency categories do not account for other factors including varying study duration, pre-existing conditions and baseline patient characteristics.
V kategorijah pogostnosti niso upoštevani drugi dejavniki, vključno z različnim trajanjem študij, prejšnjimi stanji bolnikov in njihovimi značilnostmi ob izhodišču.
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• oteklino, včasih obraza ali ust (angioedem), kar povzroča težave pri dihanju
No long-term efficacy and safety data are available in paediatric patients.
Dolgoročni podatki o učinkovitosti in varnosti pri otrocih nisi na voljo.
However, this raises no safety concern regarding target or special populations as hepatic impairment is contraindicated and the phase III clinical studies included a considerable number of elderly patients and patients with mild to moderate renal impairment.
Vendar to ne vzbuja nikakršnih skrbi za varnost ciljnih ali posebnih skupin bolnikov, saj so jetrna obolenja kontraindicirana, klinične študije III. faze pa so vključevale znatno število starostnikov in bolnikov z blagimi do zmernimi motnjami v delovanju ledvic.
Î Check with your doctor, as Avandia may not be suitable for you.
Î Posvetujte se s svojim zdravnikom, saj zdravilo Avandia v tem primeru za vas morda ni primerno.
Individual CL/F in the paediatric population was in the same range as individual adult data.
Podatki o CL/F pri posameznem otroku so bili v enakem razponu kot podatki pri posameznem odraslem bolniku.
Use of rosiglitazone is contraindicated in patients with:
Uporaba rosiglitazona je kontraindicirana pri bolnikih:
WHAT AVANDIA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO AVANDIA IN ZA KAJ GA UPORABLJAMO
Rosiglitazone should not be used during pregnancy.
Rosiglitazona med nosečnostjo ne smemo uporabljati.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
V skladu s smernicami Odbora za zdravila za uporabo v humani medicini za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja predložen hkrati z naslednjim posodobljenim poročilom o varnosti zdravila (PSUR).
If you are pregnant or could be pregnant, tell your doctor.
Če ste noseči ali bi lahko bili noseči, o tem obvestite svojega zdravnika še preden začnete jemati zdravilo
Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
V primerjavi z izhodiščem je izboljšanje HbA1c doseglo statistični pomen le v skupini, ki je prejemala metformin.
Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Stopnja vezave rosiglitazona na plazemske proteine je zelo visoka (približno 99,8 %) in nanjo ne vplivata koncentracija zdravila ali bolnikova starost.
Like all medicines, Avandia can cause side effects, but not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Avandia neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Children and adolescents: Population pharmacokinetic analysis including 96 paediatric patients aged 10 to 18 years and weighing 35 to 178 kg suggested similar mean CL/F in children and adults.
Otroci in mladostniki: Populacijska farmakokinetična analiza za 96 otrok, starih od 10 do 18 let in s telesno maso od 35 do 178 kg kaže, da je srednji CL/F pri otrocih in odraslih podoben.
The usual starting dose is 4 mg a day.
Običajni začetni odmerek je 4 mg na dan.
This can be taken as one 4 mg tablet once a day, or as one 2 mg tablet taken twice a day.
Takšen odmerek lahko vzamete v obliki ene 4 mg tablete enkrat na dan ali dveh 2 mg tablet dvakrat na dan.
Avandia tablets contain a small amount of lactose.
Avandia tablete vsebujejo majhno količino laktoze.