natgillin/translations-raw huggingface dataset:
It is used in the following ways: to treat and prevent flea infestations in cats and dogs, by killing adult fleas, their larvae and their eggs on the animal, and in the litters of pregnant or nursing cats or dogs.
Uporablja se za: zdravljenje in preprečevanje infestacij z bolhami pri mačkah in psih, tako da uniči odrasle bolhe, njihove ličinke in jajčeca na živali ter v leglih brejih ali doječih mačk ali psic.
Therefore, the Agency's view was that, as for Stronghold, the benefit of Evicto outweighs the identified risk and it can be authorised for use in the EU.
Zato je menila, da koristi zdravila Evicto enako kot pri zdravilu Stronghold odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How has Evicto been studied?
Kako je bilo zdravilo Evicto raziskano?
How is Evicto used?
Kako se zdravilo Evicto uporablja?
How does Evicto work?
Kako zdravilo Evicto deluje?
The precautions are the same as for the reference medicine since Evicto is a generic medicine.
Ker je zdravilo Evicto generično zdravilo, so previdnostni ukrepi enaki kot pri referenčnem zdravilu.
They are used over a period of 2 to 4 weeks.
Uporabljajo se dva do štiri tedne.
20 October 2015
oktober 2015
Their frequency is unknown.
Njihova pogostnost ni znana.
or hybrids of both species.
oziroma hibridov obeh vrst.
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
To pomeni, da je kljub nezadostnim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na navedeni način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
Committee on Herbal Medicinal Products (HMPC)
Odbor za zdravila rastlinskega izvora (HMPC)
Betula pendula Roth and/or Betula pubescens Ehrh., folium
Betula pendula Roth in/ali Betula pubescens Ehrh., folium
Although there are few clinical studies, including a study in 15 patients with urinary tract infections which suggested a positive effect on the urinary infection, data are too limited to be used as evidence.
Čeprav obstaja nekaj kliničnih študij, vključno s študijo, v katero je bilo vključenih 15 bolnikov z okužbami spodnjih sečil in ki je pokazala pozitiven učinek na okužbo, so podatki nezadostni, da bi jih bilo mogoče uporabiti kot dokaz učinkovitosti.
Birch leaf medicines should only be used in adults and adolescents above 12 years of age.
Zdravila, ki vsebujejo list breze, se lahko uporabljajo samo pri odraslih in mladostnikih, starejših od 12 let.
This summary is not intended to provide practical advice on how to use medicines containing birch leaf.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo list breze.
Birch leaf EMA/482160/2015
List breze EMA/482160/2015
They must also not be used in patient with conditions where a reduced fluid intake is recommended (such as severe heart or kidney disease).
Poleg tega se ne smejo uporabljati pri bolnikih s stanji, pri katerih je priporočeno zmanjšano uživanje tekočine (kot je huda srčna ali ledvična bolezen).
Birch leaf is the common name for the leaves of the tree Betula pendula Roth and/or Betula pubescens Ehrh.
List breze je splošno ime za liste drevesa Betula pendula Roth in/ali Betula pubescens Ehrh.
Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as water or alcohol).
Ekstrakti se pripravljajo z uporabo tehnike, s katero se spojine iz rastlinskega materiala ekstrahirajo tako, da se najprej raztopijo v topilu (npr. vodi ali alkoholu).
Further information on the risks associated with birch leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo list breze, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of birch leaf.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo lista breze.
The leaves for medicinal use are obtained either from trees that have been cultivated or found in the wild.
Listi za medicinsko uporabo se pridobivajo z dreves, ki so bila gojena ali divje rastoča.
Side effects that have been reported with birch leaf medicines include diarrhoea, feeling or being sick, and allergic reactions such as itching, rash and stuffy and runny nose.
Neželeni učinki, o katerih so poročali pri uporabi zdravil, ki vsebujejo list breze, vključujejo drisko, slabost ali bruhanje ter alergične reakcije, kot so srbenje, izpuščaji ter zamašen nos in izcedek iz nosu.
What is birch leaf?
Kaj je list breze?
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing birch leaf.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo list breze.
Information on the use and licensing of birch leaf medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo list breze, v državah članicah EU se obrnite na pristojni nacionalni organ.
The HMPC conclusions on the use of birch leaf medicines to increase the production of urine are based on their ‘traditional use' in minor urinary tract problems.
Zaključki odbora HMPC o uporabi zdravil, ki vsebujejo list breze, za povečanje tvorbe urina temeljijo na njihovi „tradicionalni uporabi“ pri blagih težavah s spodnjimi sečili.
If symptoms persist during treatment, a doctor or a qualified
Če simptomi med zdravljenjem ne pojenjajo, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
Any applications for the licensing of medicines containing birch leaf have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo list breze, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Herbal medicines containing birch leaf preparations are usually available as herbal tea or in solid and liquid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo pripravke lista breze, so navadno na voljo kot zdravilni čaj ali v tekočih in trdnih oblikah, ki se zaužijejo peroralno (skozi usta).
Further information on the HMPC assessment of birch leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo list breze, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC concluded that, on the basis of its long-standing use, birch leaf medicines can be used in minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine, in order to achieve flushing of the urinary tract.
Odbor HMPC je na podlagi dolgotrajne uporabe lista breze zaključil, da se lahko zdravila, ki vsebujejo list breze, uporabljajo za lajšanje blažjih težav s spodnjimi sečili(organi za odvajanje urina), tako da povečajo tvorbo urina, kar omogoči izpiranje spodnjih sečil.
What evidence supports the use of birch leaf medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo list breze?
How are birch leaf medicines approved in the EU?
Kako so zdravila, ki vsebujejo list breze, odobrena v EU?
For dry extracts the solvent is then evaporated to obtain the extract.
Za pridobivanje suhih ekstraktov se nato topilo izpari.
Birch leaf medicines must not be used in patients who are hypersensitive (allergic) to birch leaf or birch pollen.
Zdravila, ki vsebujejo list breze, se ne smejo uporabljati pri bolnikih, ki so preobčutljivi (alergični) na list breze ali cvetni prah breze.
For more information about treatment with birch leaf medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo list breze, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with birch leaf medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo list breze?
Birch leaf preparations are obtained by powdering or comminuting (reducing into tiny pieces) the dried leaf, or as dry or liquid extracts.
Pripravki iz lista breze se izdelujejo z drobljenjem posušenih listov v majhne koščke ali prah ter kot suhi ali tekoči ekstrakti.
For practical information about using birch leaf medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
Other information about birch leaf medicines
Druge informacije o zdravilih, ki vsebujejo list breze
Hence, the HMPC conclusions on the use of birch leaf medicines are based on their long-standing use.
Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo list breze, zato temeljijo na njihovi dolgotrajni uporabi.
Birch leaf
List breze
Detailed instruction on how to take birch leaf medicines and who can use them can be found in the package leaflet that comes with the medicine.
zdravil, ki vsebujejo list breze, in o tem, kdo sme ta zdravila jemati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
Children from birth to 23 months:
Otroci od rojstva do starosti 23 mesecev:
Frequency not known (cannot be estimated from the available data)
Pogostnost neznana (je ni mogoče oceniti iz razpoložljivih podatkov).
Date of first authorisation:
Datum prve odobritve:
This is a longterm treatment, possibly lasting for months or years.
Gre za dolgotrajno zdravljenje, ki lahko traja mesece ali leta.
2900 Komarom HUNGARY
2900 Komarom MADŽARSKA
Interaction with food
Medsebojno delovanje s hrano
9/l) (see section 4.5).
9/l) (glejte poglavje 4.5).
Your doctor will calculate the dose you need and tell you how many tablets to take each day.
Vaš zdravnik bo izračunal odmerek, ki ga potrebujete, in vam bo povedal koliko tablet boste vzeli vsak dan.
The dosing recommendations for elderly patients are the same as described above.
Priporočeno odmerjanje za starejše je enako zgoraj opisanemu.
In the clinical setting, this effect may be more pronounced.
V klinični praksi je ta učinek lahko bolj izrazit.
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano {MM/LLLL}
However, the initial dose should be the same as in adults, followed by individual titration.
Vendar pa naj bo začetni odmerek enak kot pri odraslih, sledi pa naj mu individualna titracija.
The study enrolled 145 adult and 21 paediatric patients.
V študijo je bilo vključenih 145 odraslih in 21 pediatričnih bolnikov.
• The recommended doses and the rules for starting treatment
• priporočene odmerke in pravila za začetek zdravljenja
No effect on the offspring was noted.
Učinka na mladiče niso opazili.
Similar findings were observed in neonatal and juvenile animals.
Podobne ugotovitve so zabeležili pri novorojenih in mladih živalih.
- This medicine has been prescribed only for you or your child. Do not pass it on to others.
- Zdravilo je bilo predpisano vam osebno ali vašemu otroku in ga ne smete dajati drugim.
and Once (1×)
in enkrat (1x)
Over time, the excess iron can damage important organs such as the liver and heart.
Sčasoma lahko presežek železa poškoduje pomembne organe, kot so jetra in srce.
The educational programme is aimed to inform healthcare professionals and patients to minimise the risks of:
Izobraževalni program je namenjen predstavitvi informacij zdravstvenim delavcem in bolnikom z namenom zmanjševanja tveganja glede:
Some side effects could be serious and need immediate medical attention.
Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravniško pomoč.
However, this dosing recommendation was not prospectively assessed in the clinical studies.
Vendar pa tega priporočila za odmerjanje niso prospektivno ocenili v kliničnih študijah.
This age group may therefore require higher doses than are necessary in adults.
Zato so pri tej starostni skupini lahko potrebni višji odmerki kot pri odraslih.
• If you experience partial loss of vision,
• če pride do delne izgube vida,
In children younger than 6 years old exposure was about 50% lower than in adults.
Pri otrocih mlajših od 6 let, je bila izpostavljenost približno 50 % nižja kot pri odraslih.
These are derived from spontaneous reports for which it is not always possible to reliably establish frequency or a causal relationship to exposure to the medicinal product.
Izhajajo iz spontanih poročil, pri katerih ni vedno mogoče zanesljivo določiti pogostnosti ali vzročne povezave z izpostavljenostjo zdravilu.
Acute pancreatitis has been reported, particularly in children and adolescents.
Poročali so o akutnem pankreatitisu, zlasti pri otrocih in mladostnikih.
Value 1
vrednost 1
A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Vaš zdravnik vam bo morda svetoval višji ali nižji začetni odmerek glede na vaše individualne potrebe zdravljenja.
At the time of prescription, patients should be advised of the signs and symptoms of severe skin reactions, and be closely monitored.
Ob predpisovanju zdravila je treba bolnike opozoriti na znake in simptome hudih kožnih reakcij in jih skrbno spremljati.
Take your next dose as scheduled.
Naslednji odmerek vzemite kot ponavadi.
Adverse reactions are ranked below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Neželeni učinki so spodaj razvrščeni po naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
• Abnormal level of acid in blood
• nenormalna vsebnost kisline v krvi
The potential for toxicity to reproduction was assessed in rats and rabbits.
Možnost za toksičen vpliv na sposobnost razmnoževanja so ocenjevali na podganah in kuncih.
Older people (age 65 years and over)
Starejši ljudje (stari 65 let ali več)
Doses (in mg/kg) must be calculated and rounded to the nearest whole tablet size.
Odmerke (v mg/kg) je treba izračunati in zaokrožiti na najbližjo vrednost jakosti tablete.
The safety and efficacy of Deferasirox Mylan in children from birth to 23 months of age have not been established.
Varnost in učinkovitost zdravila Deferasiroks Mylan pri otrocih od rojstva do starosti 23 mesecev nista bili dokazani.
Metabolic acidosis
metabolična acidoza
Females have a moderately lower apparent clearance (by 17.5%) for deferasirox compared to males.
Ženske imajo zmerno nižji navidezni očistek (za 17,5 %) deferasiroksa v primerjavi z moškimi.
It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio.
Je trovalenten ligand, ki veže železo z visoko afiniteto v razmerju 2:1.
The film-coated tablets should be swallowed whole with some water.
Filmsko obložene tablete je treba pogoltniti cele z nekaj vode.
[Bottles]:
[Plastenke]:
If you feel dizzy after taking Deferasirox Mylan, do not drive or operate any tools or machines until you are feeling normal again.
Če ste po jemanju zdravila Deferasiroks Mylan omotični, ne vozite in ne upravljajte nobenih naprav ali strojev, dokler se ne počutite spet normalno.
However, repeated blood transfusions can cause a build-up of excess iron.
Vendar pa večkratne transfuzije krvi lahko povzročijo kopičenje presežka železa.
• Take Deferasirox Mylan once a day, every day, at about the same time each day with some water.
• Vzemite zdravilo Deferasiroks Mylan enkrat na dan, vsakodnevno in sicer približno ob istem času, z nekaj vode.
Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox Mylan treatment”).
Vaš zdravnik bo redno spremljal vaše stanje in preverjal, ali zdravljenje učinkuje v skladu s pričakovanji (glejte tudi poglavje 2: “Spremljanje vašega zdravljenja z zdravilom Deferasiroks Mylan”).
It is not known if deferasirox is secreted into human milk.
Ni znano, ali se deferasiroks izloča v človeško mleko.
In 250 patients who were followed for up to five years, no further decrease in mean creatinine clearance levels was observed.
Pri 250 bolnikih, ki so jih spremljali do pet let, v naslednjih letih niso opažali nadaljnjega zniževanja povprečne vrednosti očistka kreatinina.
Upon multiple dosing exposure increased by an accumulation factor of 1.3 to 2.3.
Po večkratnem odmerjanju se je izpostavljenost povečala za akumulacijski faktor 1,3 do
X and Y are the days (to be determined) when pre-treatment measurements should be performed.
vrednost 2 X in Y sta dneva (ki ju je treba določiti) za izvedbo meritev pred zdravljenjem.
Concomitant administration of deferasirox and busulfan resulted in an increase of busulfan exposure (AUC), but the mechanism of the interaction remains unclear.
Sočasna uporaba deferasiroksa z busulfanom je povečala izpostavljenost busulfanu (AUC), vendar ostaja mehanizem te interakcije nejasen.
Some side effects could become serious.
Nekateri neželeni učinki lahko postanejo resni.
If you stop taking it, the excess iron will no longer be removed from your body (see also above section “How long to take Deferasirox Mylan”).
Če zdravilo prenehate jemati, se presežek železa ne bo več izločal iz vašega telesa (glejte tudi poglavje zgoraj “Kako dolgo jemati zdravilo Deferasiroks Mylan”).
Safety monitoring schedules for renal and liver parameters are recommended.
Za spremljanje varnosti je priporočeno pripraviti razpored določanja ledvičnih in jetrnih parametrov.
• Change in the colour of the skin
• spremembe barve kože
Elderly patients (≥65 years of age)
Starejši bolniki (stari ≥65 let)
• If you vomit blood and/or have black stools,
• če bruhate kri in/ali imate črno blato,
As the patient grows the doctor will adjust the dose.
Z rastjo otroka zdravnik prilagaja odmerek.
If possible, evaluation of the pharmacokinetics (AUC, clearance) of a busulfan test dose should be performed to allow dose adjustment.
Če je mogoče, je treba izvesti oceno farmakokinetičnih parametrov (AUC, očistka) poskusnega odmerka busulfana za osnovo prilagajanja odmerka.
If you think you may be allergic, ask your doctor for advice.
Če mislite, da bi bili lahko alergični, se posvetujte s svojim zdravnikom.
This imbalance occurred because patients on deferoxamine were allowed to remain on their pre-study dose even if it was higher than the protocol specified dose.
Do te neuravnoteženosti je prišlo zato, ker so bolnikom, ki so že pred študijo jemali deferoksamin, dovolili obdržati enak odmerek v študiji, čeprav je bil višji kot ga je sicer določal protokol.
The Cmax was increased by 30% (90% CI: 20.3% - 40.0%); however a clinical exposure/response analysis revealed no evidence of clinically relevant effects of such an increase.
Cmax je sicer višja za 30 % (90-odstotni interval zaupanja: 20,3 % - 40,0 %), vendar rezultati analize klinične izpostavljenosti/odziva ne kažejo klinično pomembnih učinkov tega zvišanja.
Do not take a double dose on the next day to make up for the forgotten tablet(s).
Naslednjega dne ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto (oziroma prejšnje tablete).
The mean elimination half-life (t½) ranged from 8 to 16 hours.
Povprečen razpolovni čas izločanja (t1/2) je bil med 8 in 16 urami.
The causes of the rises in serum creatinine have not been elucidated.
Vzroki zviševanja koncentracije kreatinina v serumu še niso pojasnjeni.
In animal studies, deferasirox was found to be rapidly and extensively secreted into maternal milk.
V študijah na živalih se je pokazalo, da se deferasiroks hitro in v veliki meri izloča v materino mleko.
Of the paediatric patients 52 were aged 2 to 5 years.
Od pediatričnih bolnikov jih je bilo 52 starih od 2 do 5 let.
• Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.
• nenormalen izvid preiskave urina (beljakovine v urinu) Če imate s katerim koli od navedenih učinkov resne težave, obvestite svojega zdravnika.
• If you experience severe upper stomach pain (pancreatitis), stop taking this medicine and tell your doctor straight away.
• če pride do hude bolečine v zgornjem delu trebuha (vnetje trebušne slinavke), prenehajte jemati to zdravilo in takoj obvestite svojega zdravnika.
Patients with estimated creatinine clearance <60 ml/min.
Bolniki z oceno očistka kreatinina <60 ml/min.
Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, France
Mylan S.A.S 117 Allée des Parcs Saint-Priest 69800, Francija
Do not take Deferasirox Mylan - if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Deferasiroks Mylan - če ste alergični na deferasiroks ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver.
Poleg tega boste morda opravili preiskavo z MR (magnetno resonančnim) slikanjem, s katero je mogoče določiti količino železa v vaših jetrih.
Deferasirox was not carcinogenic when administered to rats in a 2-year study and transgenic p53+/− heterozygous mice in a 6-month study.
Deferasiroks ni bil karcinogen, ko so ga uporabili pri podganah v 2-letni študiji in transgenskih p53+/- heterozigotnih miših v 6-mesečni študiji.
Manufacturer Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Izdelovalec Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, Velika Britanija
If you have questions about how long to take Deferasirox Mylan, talk to your doctor.
Če imate vprašanja o tem, kako dolgo jemati zdravilo Deferasiroks Mylan, se pogovorite s svojim zdravnikom.
There are no data available on the retreatment of patients who reaccumulate iron after having achieved a satisfactory body iron level and therefore retreatment cannot be recommended.
O ponovnem zdravljenju bolnikov, pri katerih pride znova do kopičenja železa zatem, ko so dosegli zadovoljivo raven železa v telesu, ni nobenih podatkov, zato ponovnega zdravljenja ne priporočamo.
The safety of deferasirox in combination with other iron chelators has not been established.
Varnost uporabe deferasiroksa v kombinaciji z drugimi kelatorji železa ni bila ugotovljena.
An erroneously administered single dose of 90 mg/kg led to Fanconi syndrome which resolved after treatment.
Pomotoma apliciran enkratni odmerek 90 mg/kg je povzročil Fanconijev sindrom, ki pa je po zdravljenju izzvenel.
Deferasirox is mainly glucuronidated by UGT1A1 and to a lesser extent UGT1A3.
Glukuronidacija deferasiroksa poteka predvsem z UGT1A1, manj pa z UGT1A3.
Contraindicated
kontraindicirano