natgillin/translations-raw huggingface dataset:
Medicines that can damage your heart (e.g. anthracyclines).
- zdravila, ki lahko poškodujejo vaše srce (npr. antraciklini), - zdravila, ki zavirajo nastajanje krvnih celic in krvnih ploščic v kostnem mozgu (mielosupresivne učinkovine),
- Infections of the upper airways.
- okužbe zgornjih dihal,
o a bone marrow disorder that causes abnormally shaped blood cells and leads to leukaemia
o bolezen kostnega mozga, ki povzroča neobičajno oblikovane krvne celice in povzroča levkemijo (mielodisplastični sindrom).
Treatment of blast crisis in (chronic) myeloid leukaemia Single dose therapy in relapse
Akutna mieloična levkemija Zdravljenje z eno učinkovino pri relapsu
- Mucosal inflammation.
in poliploidije.
The recommended initial dosage of mitoxantrone used as a single agent is 14 mg/m2 of body surface area,
Zdravljenje z eno učinkovino Priporočeni začetni odmerek mitoksantrona kot edine učinkovine je 14 mg/m2 telesne površine, dan v enkratnem intravenskem odmerku, ki se ga lahko ponovi v 21-dnevnih presledkih.
DATE OF REVISION OF THE TEXT
POSTOPEK UPORABE
Pregnancy, breast-feeding and fertility
Bolezni jeter, žolčnika in žolčevodov
- Fever or infections.
- okužbe sečil,
In metastatic breast cancer, combinations of Novantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Pri metastatskem raku dojke so se kombinacije zdravila Novantrone z drugimi citotoksičnimi učinkovinami, vključno s ciklofosfamidom in
Antivitamin K, in particular if you are taking Novantrone because you have cancer.
- zdravila, ki zavirajo imunski sistem (imunosupresivna zdravila), - antivitamin K, zlasti ob jemanju zdravila Novantrone v primeru raka,
Novantrone will be given to you under supervision of a doctor experienced in the use of cytotoxic chemotherapy agents.
Odmerjanje in način uporabe Zdravilo Novantrone boste prejemali pod nadzorom zdravnika, izkušenega v uporabi citotoksičnih kemoterapevtikov.
- Chest pain, breathlessness, changes in your heartbeat (fast or slow), fluid retention (swelling) in the ankles or legs (potential signs or symptoms of heart problems).
- zadihanost (vključno s težkim dihanjem ponoči), kašelj, zadrževanje tekočine (otekanje) v gležnjih ali nogah, atrijska fibrilacija (nepravilen srčni utrip).
- Abnormal results of blood tests to check liver and kidney functions (elevated creatinine and urea nitrogen concentration in the blood).
o odmiranje tkivnih celic, kar lahko pripelje do potrebe po odstranitvi odmrlih celic in presaditvi kože, - nenormalni rezultati krvnih preiskav za preverjanje delovanja jeter in ledvic (povišani kreatinin in vrednosti dušika sečnine v krvi), - poškodbe ledvic, kar povzroči otekanje in šibkost (nefropatija),
Erythema
Levkopenija
4.9 Overdose
navedenem v Prilogi V. 4.9 Preveliko odmerjanje
Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Če niste prepričani, ali je vaše zdravilo eno od zgoraj naštetih, se posvetujte s svojim zdravnikom ali farmacevtom.
Repeat this cleaning process 3 times.
Postopek čiščenja trikrat ponovite.
After first opening: 2 months
3 leta Po prvem odprtju: 2 mesece
Juvenile animals studies
Študije pri mladih živalih
• Ringing in the ears;
• zvenenje v ušesih,
Date of first authorisation: 21.04.2009 Date of latest renewal: 22.01.2014
Datum prve odobritve: 21. april 2009 Datum zadnjega podaljšanja: 22. januar 2014
In the double-blind period of the phase II study, evaluation of efficacy was a secondary objective.
V dvojno slepem obdobju študije faze II je bila ocenitev učinkovitosti sekundarni cilj.
• Inability to speak or write or understand spoken or written language;
• nezmožnost govora, pisanja ali razumevanja izgovorjenih ali napisanih besed,
Once you have opened the bottle, you must not use it longer than 2 months
Odprte steklenice ne uporabljajte dlje kot 2 mesece.
Not to be sold separatley.
Ni namenjen ločeni prodaji.
However, due to inter-individual variability, the effect may be clinically relevant in some individuals.
Vendar je lahko zaradi velikih razlik med posamezniki ta učinek pri nekaterih posameznih klinično pomemben.
At this age the intrinsic activity of the elimination process has not yet reached maturation.
V tej starosti intrinzična dejavnost procesa izločanja še ni dozorela.
You may need to apply some pressure to insert it securely.
Morda boste za varno vstavitev morali nekoliko pritisniti.
Tell your doctor if you are taking:
Povejte zdravniku, če jemljete:
The median relative change was larger in the previous placebo group (-51.4%) than in the previous ESL group (
ki je prej prejemala placebo (-51,4 %), kot v skupini, ki je prej prejemala eslikarbazepinacetat (
Do not stop taking your oral suspension suddenly.
Peroralne suspenzije ne prenehajte jemati nenadoma.
Body weight was shown to have an effect on volume of distribution and clearance.
Pokazalo se je, da ima telesna masa učinek na razdelitveni volumen in očistek.
• Difficulty in concentration;
• težave pri koncentraciji,
Although the robustness of these post-hoc subgroup analyses is limited, the data suggest an age and dose dependent increase in effect size.
Čeprav je bila robustnost teh post-hoc analiz podskupin omejena, podatki kažejo na od starosti in odmerka odvisno zvečanje učinkovitosti.
Apart from this, sodium levels should be determined during routine laboratory examination.
Poleg tega je treba raven natrija določiti tudi pri rutinskih laboratorijskih preiskavah.
If you are not sure if the medicines you are taking could have this effect, discuss with your doctor.
Če niste prepričani, ali lahko katera koli zdravila, ki jih jemljete, imajo takšen učinek, se posvetujte z zdravnikom.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezanem z zmanjševanjem tveganja).
A delay in the sexual development of the F1 generation was observed in peri/postnatal studies in mice and rats.
Zakasnitev spolnega razvoja generacije F1 so opazili v peri-/postnatalnih študijah pri miših in podganah.
Contact your doctor immediately:
Takoj se posvetujte z zdravnikom:
In children from 2 to 6 years of age, the use of eslicarbazepine acetate is not recommended.
Pri otrocih, starih od 2 do 6 let, se uporaba eslikarbazepinacetata ne priporoča.
Post-hoc subgroup analyses for the phase III study were conducted by age strata and above 6 years, as well as by dose.
Analize podskupin post-hoc za študijo faze III so izvedli stratificirano po starosti in nad 6 let ter za odmerek.
Please tell your doctor:
Povejte zdravniku:
NN: (only for outer packaging)
NN: (samo zunanja ovojnina)
The frequency of the HLA-A*3101 allele varies widely between ethnic populations.
Pogostnost alela HLA-A*3101 se pri različnih etničnih populacijah močno razlikuje.
Therefore, patients should be advised that their physical and/or mental abilities needed for operating machinery or driving may be impaired and they are recommended not to do so until it has been established that their ability to perform such activities is not affected.
Zato je treba bolnike obvestiti, da so lahko njihove fizične in/ali mentalne sposobnosti, ki so potrebne za upravljanje strojev ali vožnjo, zmanjšane, in jim priporočiti, da se tem dejavnostim izogibajo, dokler se ne ugotovi, da ni vpliva na njihovo zmožnost opravljanja teh dejavnosti.
If they happen to you stop taking Zebinix and tell a doctor or go to a hospital immediately, as you may need urgent medical treatment:
Če se pojavijo, nehajte jemati zdravilo Zebinix in takoj povejte zdravniku ali pojdite v bolnišnico, saj morda potrebujete nujno zdravniško pomoč:
Furthermore, a role of age independently of weight with regards to clearance of eslicarbazepine acetate could not be excluded, in particular for the youngest age group (2-6 years).
Tudi vloge starosti, neodvisno od telesne mase, na očistek eslikarbazepinacetata ni bilo možno izključiti, zlasti ne v najmlajši starostni skupini (2 do 6 let).
In repeat-dose studies in juvenile dogs, the toxicity profile was comparable to that observed in adult animals.
V študijah pri ponavljajočih odmerkih pri mladih psih je bil profil toksičnosti primerljiv s tistim, ki so ga opazili pri odraslih živalih.
Step 6: If you see any air bubbles in the oral syringe, push the plunger upwards just far enough to completely push out any large air bubbles.
6. korak: Če v odmerni brizgi vidite zračne mehurčke, potisnite bat toliko navzdol, da povsem iztisnete vse velike zračne mehurčke.
• Decrease of appetite;
• zmanjšan apetit,
• if you suffer from confusion, worsening of seizures or decreased consciousness which can be signs of low blood salt levels.
• če se pojavijo zmedenost, poslabšanje epileptičnih napadov ali zmanjšana zavest, kar so lahko znaki nizke ravni soli v krvi.
The data shows that the incidence of adverse reactions in this population (65.3 %) is similar to the general population enrolled in the double-blind epilepsy studies (66.8%).
Podatki kažejo, da je incidenca neželenih učinkov v tej populaciji (65,3 %) podobna kot pri splošni populaciji, vključeni v dvojno slepe študije o epilepsiji (66,8 %).
Step 10: Rinse the empty oral syringe after each use into a glass of clean water.
10. korak: Prazno odmerno brizgo po vsaki uporabi izperite v kozarcu čiste vode.
Linearity/non-linearity
Linearnost / Nelinearnost
Elderly (over 65 years of age) If you are elderly and taking Zebinix on its own the dose of 1,600 mg is not a suitable dose for you.
Starejši bolniki (stari več kot 65 let) Če ste starejši in zdravilo Zebinix jemljete samostojno, odmerek 1.600 mg ni primeren za vas.
Dermatitis allergic (uncommon, 0.8%) was reported only in the paediatric population.
O alergijskem dermatitisu (občasen, 0,8 %) so poročali le pri pediatrični populaciji.
Both studies were double-blind and placebo controlled with a duration of maintenance of 8 weeks (study 208) and 12 weeks (study 305), respectively.
Obe študiji sta bili dvojno slepi in nadzorovani s placebom, z obdobjem vzdrževanja 8 tednov (študija 208) oz. 12 tednov (študija 305).
The target dose was 30 mg/kg/day in study 208 and 20 mg/kg/day in study 305.
Ciljni odmerek je bile 30 mg/kg/dan v študiji 208 in 20 mg/kg/dan v študiji 305.
The majority of adverse reactions were reported in <3% of subjects in any treatment group.
Pogostnost večine neželenih učinkov je bila < 3 % pri preskušancih v kateri koli terapevtski skupini.
Within each frequency category, adverse reactions are presented in order of decreasing seriousness.
V vsaki kategoriji pogostosti so neželeni učinki navedeni po padajoči resnosti.
• Difficulty in sleeping;
• težave s spanjem,
The mechanism for this reduction is unknown, but could be due to interference of transporter activity for rosuvastatin alone or in combination with induction of its metabolism.
Mehanizem tega znižanja ni znan, možno pa je, da je posledica same motnje v delovanju transporterjev za rosuvastatin ali pa v kombinaciji z indukcijo presnove rosuvastatina.
• if you suffer from a certain type of heart rhythm disorder (second or third degree atrioventricular (AV) block).
• če imate določeno vrsto motnje srčnega ritma (atrioventrikularni (AV) blok druge ali tretje stopnje).
HLA-A*3101 allele has a prevalence of 2 to 5% in European populations and about 10% in Japanese population.
HLA-A*3101 je med 2 in 5 % pri evropski populaciji in približno 10 % pri populaciji japonske narodnosti.
Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas ali vašega otroka pomembne podatke!
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions.
Pri predpisovanju je treba bolnike seznaniti z znaki in simptomi ter jih natančno spremljati glede kožnih reakcij.
HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations
Alel HLA-B* 1502 - pri populaciji Han kitajske, tajske ali druge azijske narodnosti
Gently pull the plunger back downwards to the dose prescribed by your doctor.
Nežno povlecite bat nazaj navzdol do odmerka, ki vam ga je predpisal zdravnik.
Zebinix has minor to moderate influence on the ability to drive and use machines.
Zdravilo Zebinix ima blag do zmeren vpliv na sposobnost vožnje in upravljanja strojev.
There are insufficient data supporting a recommendation for HLA-A*3101 screening before starting carbamazepine or chemically-related compounds treatment.
Ni dovolj podatkov, ki bi podprli priporočilo za presejalni pregled za HLA-A*3101 pred začetkom zdravljenja s karbamazepinom ali sorodnimi kemijskimi spojinami.
(≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and not known (frequency cannot be estimated from available data).
≥ 1/100 do < 1/10), občasni (od ≥ 1/1000 do < 1/100) in neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
Doses could be adjusted based on tolerability and treatment response.
Odmerke je bilo možno prilagajati na podlagi prenašanja in odziva na zdravljenje.
Swallow the tablet with a glass of water.
Tablete pogoltnite cele, s kozarcem vode.
Check with your doctor or pharmacist, if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.
Posvetujte se z zdravnikom ali farmacevtom, če se dolgotrajno zdravite z antiepileptiki, ste imeli osteoporozo ali jemljete steroide.
• Reduction in white blood cells which makes infections more likely;
• zmanjšanje števila levkocitov, zaradi katerega so okužbe verjetnejše,
Not known (frequency cannot be estimated from available data) side effects are:
Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
• if you suffer from a heart disease such as heart failure or heart attack, or have any heart rhytm disorder.
• če imate bolezen srca, kot sta srčno popuščanje ali srčna kap ali če imate motnjo srčnega ritma.
A small number of people being treated with antiepileptics have had thoughts of harming or killing themselves.
Majhno število ljudi, ki so jemali antiepileptike, je imelo misli o samopoškodovanju ali samomoru.
oral suspension
peroralna suspenzija
Taking into consideration the limitations of open label uncontrolled data, the long-term response to eslicarbazepine acetate in the open-label parts of the study was overall maintained.
Ob upoštevanju omejitev nekontroliranih podatkov iz nezaslepljenega dela velja, da se je dolgoročni odziv na eslikarbazepinacetat v nezaslepljenih delih študije na splošno ohranil.
The European Medicines Agency has deferred the obligation to submit the results of studies with Zebinix in one or more subsets of the paediatric population in the treatment of epilepsy with partial onset seizures (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zebinix za eno ali več podskupin pediatrične populacije za zdravljenje epilepsije z napadi parcialnega izvora (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
(only for outer packaging)
(samo zunanja ovojnina)
• if you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval.
• če jemljete katero koli zdravilo, ki lahko povzroči spremembe elektrokardiograma (EKG), imenovane podaljšanje intervala PR.
The overall proportion of patients with exacerbation
Skupni delež bolnikov s poslabšanjem (povečanjem
A study in adult patients with mild to severe renal impairment showed that clearance is dependent on renal function.
Študija pri odraslih bolnikih z blago do hudo ledvično okvaro je pokazala, da je očistek odvisen od delovanja ledvic.
In patients of Han Chinese or Thai origin the risk of serious skin reactions associated with carbamazepine or chemically-related compounds may be predicted by testing a blood sample of these patients.
Pri bolnikih Han kitajske ali tajske narodnosti je mogoče tveganje za resne kožne reakcije, ki je povezano s karbamazepinom ali sorodnimi kemijskimi spojinami, napovedati s testiranjem vzorca krvi pri teh bolnikih.
Shake the bottle for at least 10 seconds and remove the child resistant closure by pushing it down and turning it counter-clockwise (to the left).
2. korak: Steklenico vsaj 10 sekund dobro pretresajte in odstranite za otroke varno zaporko tako, da jo potisnete navzdol in obračate v nasprotni smeri urnega kazalca (v levo).
• if you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain.
• če imate epileptične napade, ki se začnejo z razširjenim razelektrenjem, ki zajame obe polovici možganov.
• The other ingredients are povidone K29/32, croscarmellose sodium and magnesium stearate.
• Druge sestavine so povidon K 29/32, premreženi natrijev karmelozat in magnezijev stearat.
If you forget to take a dose, take it as soon as you remember and carry on as usual.
Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite, in nadaljujte jemanje kot ponavadi.
No dose adjustment is needed in the elderly population provided that the renal function is not disturbed.
Prilagajanje odmerka pri starejši populaciji ni potrebno, če delovanje ledvic ni moteno.
A total of 39% patients in study 305 were up titrated to the maximum possible dose (30 mg/kg/day).
bolnikov v študiji 305 je bilo titriranih do največjega možnega odmerka (30 mg/kg/dan).
• High blood pressure or severe increase in blood pressure;
• visok krvni tlak ali hudo zvišanje krvnega tlaka,
If the patients have developed such reactions, treatment with Zebinix must not be restarted in these patients at any time.
Če so se pri bolnikih razvile te reakcije, se pri njih zdravljenja z zdravilom Zebinix ne sme več ponovno začeti.
Push the plunger all the way down.
Bat potisnite do konca navzdol.
• Poor memory or forgetfulness;
• slab spomin ali pozabljivost,
A total of 50 of the 72 subjects starting the study completed the 26-week treatment period that corresponds to a retention rate of 69.4% (see section 4.2 for information on elderly use).
Skupaj 50 od 72 oseb, ki so študijo začele, je 26-tedensko obdobje zdravljenja zaključilo, kar ustreza stopnji zadržanja 69,4 % (glejte poglavje 4.2 za podatke o uporabi pri starejših).
Pharmacotherapeutic group: Antiepileptics, carboxamide derivatives, ATC code: N03AF04 Mechanism of action
Farmakoterapevtska skupina: antiepileptiki, derivati karboksamida, oznaka ATC: N03AF04 Mehanizem delovanja
Based on this outcome, update of section 4.9 to reflect new information from overdose cases is recommended.
Zato se priporoča posodobitev poglavja 4.9, tako da bo odražalo nove informacije, ugotovljene iz primerov prevelikega odmerjanja.
This will create pressure inside the bottle that will help the dosing of the suspension, forcing it to leave from the bottle to the oral syringe.
Tako nastane tlak v steklenici, ki pomaga pri odmerjanju suspenzije tako, da jo potisne iz steklenice v odmerno brizgo.
Children above 6 years of age
Otroci, stari več kot 6 let
The safety profile of eslicarbazepine acetate was generally similar between adult and paediatric patients, except for agitation (common, 1.3%) and abdominal pain (common, 2.1%) which were more common in children than in adults.
Varnostni profil eslikarbazepinacetata je bil na splošno podoben med odraslimi in pediatričnimi bolniki, razen agitacije (pogosti, 1,3 %) in bolečine v trebuhu (pogosti, 2,1 %), ki sta bili pri otrocih pogostejši kot pri odraslih.
Press the plugger down slowly to release Zebinix into the mouth.
Bat počasi pritiskajte navzdol, da se zdravilo Zebinix izlije v usta.
Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population.
Zaradi zelo malo podatkov pri starejših bolnikih na monoterapiji kot režimu zdravljenja z odmerkom 1.600 mg ta odmerek za to populacijo ni priporočljiv.
Multipack: 180 (2 packs of 90) tablets
Skupno pakiranje: 180 (2 pakiranji po 90) tablet.
No change in exposure to carbamazepine or its metabolite carbamazepine-epoxide was noted.
Spremembe v izpostavljenosti karbamazepinu ali njegovemu presnovku karbamazepin-epoksidu pa niso zaznali.
The recommended starting dose is 10 mg/kg/day once daily.
Priporočeni začetni odmerek je 10 mg/kg/enkrat dnevno.
If you have kidney problems you will usually be given a lower dose of Zebinix.
Če imate težave z ledvicami, vam bodo ponavadi dali manjši odmerek zdravila Zebinix.
Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy.
Zdravilo Zebinix se lahko jemlje kot monoterapija ali doda k že obstoječemu antiepileptičnemu zdravljenju.
• Skin changes (e.g. red skin);
• spremembe na koži (npr. rdeča koža),
Store the bottle and the oral syringe together in the carton until next use.
Steklenico in odmerno brizgo shranjujte skupaj v škatli do naslednje uporabe.
This is just in case any of them interfere with how Zebinix works or how Zebinix interferes with their effect.
To je samo opozorilo, če bi katero koli od njih motilo delovanje zdravila Zebinix ali če bi zdravilo Zebinix vplivalo na njihov učinek.
• Feeling low in energy or tired;
• občutek pomanjkanja energije ali utrujenosti,
• Difficulty in coordinating movements (ataxia);
• težave s koordinacijo gibov (ataksija),
All subjects were randomized to the lowest dose level and only if a seizure occurred subjects were to be escalated to the next dose level.
Vsi preskušanci so bili randomizirani v skupino z najnižjo ravnjo odmerka, in le če je prišlo do epileptičnega napada, so bili razporejeni v skupino z naslednjo ravnjo odmerka.
Research has shown an increased risk of birth defects in children of women taking antiepileptic medicines.
Raziskave so pokazale zvečano tveganje za okvare ploda pri otrocih žensk, ki jemljejo zdravila za zdravljenje epilepsije.
Considering that changes in body weight can influence the treatment decision and are of particular importance in epilepsy which itself may be associated with overweight/obesity this information should adequately be reflected in SmPC and PIL.
Glede na to, da lahko spremembe telesne mase vplivajo na odločitev glede zdravljenja in da so še posebej pomembne pri epilepsiji, ki je sama lahko povezana s preveliko telesno maso/debelostjo, morajo biti te informacije ustrezno izražene v povzetku glavnih značilnosti zdravila in navodilu za uporabo.
• rosuvastatin, a medicine used to lower cholesterol level;
• rosuvastatin, zdravilo za zniževanje ravni holesterola v krvi;
This time delay must be taken into account when Zebinix is being used just prior to or in combination with other medicinal products that require dose adjustment when co-administered with Zebinix.
Ta časovni zamik je treba upoštevati, kadar se zdravilo Zebinix uporablja tik pred drugimi zdravili, pri katerih je ob sočasni uporabi z zdravilom Zebinix treba prilagoditi odmerek, ali v kombinaciji z njimi.
Your doctor will decide how long you should take Zebinix.
Zdravnik se bo odločil, koliko časa morate jemati zdravilo Zebinix.
If at any time you have these thoughts, when taking Zebinix, contact your doctor immediately.
Če boste kadar koli med jemanjem zdravila Zebinix imeli takšne misli, takoj obvestite zdravnika.
If patients of these ethnic origins are tested positive for HLA- B*1502 allele, the use of eslicarbazepine acetate may be considered if the benefits are thought to exceed risks.
Če so testi pri bolnikih tega porekla pozitivni za alel HLA- B*1502, je mogoče o uporabi eslikarbazepinacetata razmisliti, če so pričakovane koristi večje od tveganj.