natgillin/translations-raw huggingface dataset:
This is given as an intravenous injection (into a vein) for three days in a row before chemotherapy and/ or radiotherapy and three days in a row after chemotherapy and/ or radiotherapy for a total of six doses.
Kepivance se uporablja v intravenski injekciji (injekciji v veno), in sicer tri dni zapored pred kemoterapijo in/ ali radioterapijo ter tri dni zapored po kemoterapiji/ radioterapiji, tako da bolnik skupaj dobi šest odmerkov.
Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Pred injiciranjem je dovoljeno Kepivance največ eno uro pustiti, da doseže sobno temperaturo, a ga je treba zaščititi pred svetlobo.
Kepivance left at room temperature for more than 1 hour must be disposed of.
Kepivance, ki je bil na sobni temperaturi več kot 1 uro, je treba zavreči.
Do not shake Kepivance.
Zdravila Kepivance ne stresajte.
Like all medicines, Kepivance can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Kepivance neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very common (more than 1 in every 10 patients) side effects are: • skin rash, itching and redness (pruritus and erythaema); • an increase in the thickness in the mouth or tongue; • change in colour of the mouth or tongue; • generalised swelling (oedema); • pain; • fever; • aching joints (arthralgia); and • altered taste.
Zelo pogosti (več kot 1 na 10 bolnikov) neželeni učinki so: • izpuščaj na koži, srbenje in pordelost (pruritus in eritem); • zadebelitev ust ali jezika, • spremenjena barva ust ali jezika, • splošna oteklost (edemi), • bolečine, • vročina, • boleči sklepi (artralgija) in • motnje okušanja.
Other side effects seen in patients are: • redness, bumps or swelling of the tongue; • swelling (oedema) of the face or mouth; • darkening of an area of skin (hyperpigmentation); and • allergic reactions.
Drugi neželeni učinki, ki so se pojavili pri bolnikih, so: • pordelost, bule ali oteklost jezika, • oteklost (edem) obraza ali ust, • potemnelost predela kože (hiperpigmentacija) in • alergijske reakcije.
19 Some patients have had an increase in lipase and amylase levels (digestive enzymes) in their blood, which do not require treatment and usually return to normal after stopping treatment with Kepivance.
Zdravljenje zaradi tega ni bilo potrebno; vrednosti so se po koncu terapije z zdravilom Kepivance ponavadi normalizirale.
HOW TO STORE KEPIVANCE
SHRANJEVANJE ZDRAVILA KEPIVANCE
Do not use Kepivance after the expiry date which is stated on the carton and vial label, after EXP.
Kepivance ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali, z oznako "Upor. do:".
Store in a refrigerator (2°C – 8°C).
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
What Kepivance contains
Ena viala vsebuje 6, 25 mg palifermina.
The other ingredients of Kepivance are mannitol, sucrose, L-histidine, polysorbate 20 and diluted hydrochloric acid.
Pomožne snovi v zdravilu Kepivance so manitol, saharoza, L- histidin, polisorbat 20 in razredčena klorovodikova kislina.
Kepivance is a white powder supplied in vials.
Kepivance je bel prašek v vialah.
20 Kepivance should be reconstituted with 1.2 ml water for injections.
20 Kepivance je treba pripraviti z 1, 2 ml vode za injekcije.
Before injection‚ Kepivance may be allowed to reach room temperature for a maximum of 1 hour but should be protected from light.
Pred injiciranjem lahko Kepivance največ 1 uro pustite, da doseže sobno temperaturo, vendar ga morate zaščititi pred svetlobo.
Keppra is a medicine containing the active substance levetiracetam.
Zdravilo Keppra vsebuje zdravilno učinkovino levetiracetam.
It is available as oblong tablets (blue:
Na voljo je v obliki podolgovatih tablet (modre:
250 mg; yellow:
250 mg, rumene:
500 mg; orange:
500 mg, oranžne:
750 mg; white:
750 mg in bele:
1000 mg), as an oral solution (100 mg/ ml), and as a concentrate to be made up into a solution for infusion (drip into a vein, 100 mg/ ml).
1000 mg), kot peroralna raztopina (100 mg/ ml) in kot koncentrat, ki se pripravi v raztopino za infundiranje (kapalna infuzija v veno, 100 mg/ ml).
Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures (fits) with or without secondary generalisation.
Zdravilo Keppra se lahko uporablja kot samostojno zdravilo pri bolnikih od 16. leta starosti, ki imajo na novo diagnosticirano epilepsijo, za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell, or vision, numbness or a sudden sense of fear.
To je vrsta epilepsije, pri kateri prevelika električna aktivnost na samo eni strani možganov povzroči simptome, kot so nenadni sunkoviti gibi enega dela telesa, motnje sluha, voha ali vida, odrevenelost ali nenaden občutek strahu.
Secondary generalisation occurs when the overactivity later reaches the whole brain.
Sekundarna generalizacija nastane, ko prekomerna aktivnost pozneje zajame celotne možgane.
Keppra can also be used as adjunctive therapy in patients who already receive other anti-epileptic medicines to treat: • partial onset seizures with or without generalisation in patients from four years of age, • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy, • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Zdravilo Keppra je mogoče uporabljati kot dopolnilno terapijo pri bolnikih, ki že prejemajo druga zdravila proti epilepsiji, za zdravljenje: • napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih od 4. leta starosti dalje • miokloničnih napadov (kratki, krču podobni sunkoviti gibi mišice ali skupine mišic) pri bolnikih od 12. leta starosti z juvenilno mioklonično epilepsijo. • primarno generaliziranih tonično- kloničnih napadov (veliki napadi, vključno z izgubo zavesti) pri bolnikih od 12. leta starosti dalje z idiopatsko generalizirano epilepsijo (vrsta epilepsije, za katero se domneva, da je genetskega izvora).
When Keppra is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Ob samostojni uporabi zdravila Keppra je začetni odmerek 250 mg dvakrat dnevno, ki se dva tedna pozneje poveča na 500 mg dvakrat dnevno.
The dose can be further increased at two-week intervals according to the patient’ s response, to a maximum dose of 1,500 mg twice a day.
Odmerki se lahko nadalje povečujejo v dvotedenskih intervalih v skladu z odzivom bolnika vse do največjega odmerka 1500 mg dvakrat dnevno.
When Keppra is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Ob dodajanju zdravila Keppra drugemu zdravilu za zdravljenje epilepsije je začetni odmerek pri bolnikih, starejših od 12 let, ki tehtajo več kot 50 kg, 500 mg dvakrat dnevno.
The daily dose can be increased up to 1,500 mg twice a day.
Dnevni odmerek je mogoče povečati do največ 1500 mg dvakrat dnevno.
In children aged four 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/ kg twice a day.
Pri otrocih od 4. do 17. leta, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg/ kg telesne mase dvakrat dnevno, ki ga je mogoče povečati vse do 30 mg/ kg telesne mase dvakrat dnevno.
The oral solution is recommended when starting treatment in children weighing less than 20 kg.
Peroralna raztopina se priporoča v začetku zdravljenja otrok, ki tehtajo manj kot 20 kg.
Keppra tablets may be taken with or without food and are swallowed with liquid.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Tablete Keppra se lahko jemljejo s hrano ali brez nje in se pogoltnejo s tekočino.
The oral solution may be mixed in a glass of water before taking.
Peroralno raztopino se lahko pred zaužitjem zmeša s kozarcem vode.
Keppra can be given as an infusion using the same doses at the same frequency when the use of the tablets or the oral solution is temporarily not possible.
Zdravilo Keppra se lahko daje kot infuzija v enakih odmerkih in enako pogosto, kadar uporaba tablet ali peroralne raztopine začasno ni mogoča.
The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called the synaptic vesicle protein 2A, which is found in the space between nerves (synapses) and stops the release of chemical messengers between nerve cells.
Natančen način delovanja levetiracetama je še vedno nejasen, toda zdi se, da vpliva na beljakovino, imenovano sinaptični vezikularni protein 2A, ki se nahaja v prostoru med živčnimi celicami (sinapsah), in zavira sproščanje kemičnih prenašalcev med živčnimi celicami.
The effectiveness of Keppra as an add-on treatment in partial onset seizures has been studied in three main studies in a total of 904 patients.
Učinkovitost zdravila Keppra kot dopolnilnega zdravljenja pri napadih parcialnega izvora je bila preučevana v treh glavnih študijah na skupaj 904 bolnikih.
In these studies, Keppra at doses of 1,000, 2,000 or 3,000 mg per day, was compared with placebo (a dummy treatment) over 12 to 14 weeks.
V teh študijah so zdravilo Keppra v odmerkih 1000 mg, 2000 mg ali 3000 mg na dan primerjali s placebom (zdravilom brez zdravilne učinkovine) v obdobju 12 do 14 tednov.
All patients were taking at least one other anti-epileptic medicine.
Vsi bolniki so jemali še najmanj eno drugo zdravilo proti epilepsiji.
Keppra has also been studied in 101 children aged four to 17 years, where it was compared with placebo.
Zdravilo Keppra so preučevali tudi pri 101 otrocih med 4. in 17. letom starosti, kjer so ga primerjali s placebom.
In all studies, the main measure of effectiveness was the reduction in weekly partial seizure rate.
V vseh študijah je bilo glavno merilo učinkovitosti zmanjšanje tedenske stopnje napadov parcialnega izvora.
In myoclonic seizures, the effectiveness of Keppra was studied in 122 patients, who received either Keppra or placebo in addition to their normal anti-epileptic medicine.
Pri miokloničnih napadih so učinkovitost zdravila Keppra preučevali na 122 bolnikih, ki so prejemali ali zdravilo Keppra ali placebo poleg svojega običajnega zdravila proti epilepsiji.
The study lasted up to 30 weeks, and looked at the seizure rates before and during the study to see if they had decreased.
Študija je trajala do 30 tednov, v njenem okviru pa so preučevali stopnjo napadov pred in med študijo, da bi ugotovili ali se je le- ta zmanjšala.
In primary generalised tonic-clonic seizures, the effectiveness of Keppra was compared with that of placebo in 164 patients aged between four and 65 years.
Pri primarno generaliziranih tonično- kloničnih napadih so učinkovitost zdravila Keppra primerjali s placebom pri 164 bolnikih, starih od 4 do 65 let.
The study looked at the change in seizure rate between the start of the study and the 20-week period when the patients were taking their full dose.
V študiji so opazovali stopnjo napadov ob začetku študije ter po 20 tednih, ko so bolniki prejemali svoj polni odmerek.
The effectiveness of Keppra used on its own was studied in 579 patients, who received either Keppra or carbamazepine (another anti-epileptic medicine) for up to two years.
Učinkovitost zdravila Keppra ob samostojni uporabi je bila preučevana na 579 bolnikih, ki so prejemali zdravilo Keppra ali karbamezapin (drugo zdravilo proti epilepsiji) do dve leti.
The study measured how many patients remained free of seizures for six months once they had reached their effective dose.
V okviru študije so preučevali, koliko bolnikov je ostalo brez napadov šest mesecev od takrat, ko so dosegli učinkovit odmerek.
What benefit has Keppra shown during the studies?
Kakšne koristi je zdravilo Keppra izkazalo med raziskavami?
As add-on treatment, Keppra was more effective than placebo.
Kot dopolnilno zdravljenje je bilo zdravilo Keppra bolj učinkovito od placeba.
For partial onset seizures, placebo treatment reduced the weekly seizure rate by 6.1% to 7.2%, while the reduction with Keppra at a dose of 1000 mg/ day was between 17.7% and 32.5%, depending on the study.
Pri napadih parcialnega izvora je zdravljenje s placebom zmanjšalo tedensko stopnjo napadov za 6, 1% do 7, 2%, medtem ko je bilo zmanjšanje z zdravilom Keppra 1000 mg/ dan med 17, 7% in 32, 5%, odvisno od študije.
With Keppra at a dose of 2000 mg, the reduction was 26.5%, and with 3000 mg, it was 37.1 or 39.9%.
Pri zdravilu Keppra v odmerku 2000 mg je bilo zmanjšanje 26, 5%, v odmerku 3000 mg pa 37, 1 ali 39, 9%.
In the study in children, the reduction in weekly seizure rate was 43.3% in the group of children who received Keppra, and 16.3% in the placebo group.
Pri študiji na otrocih je bilo zmanjšanje tedenske stopnje napadov 43, 3% v skupini otrok, ki so prejemali zdravilo Keppra, in 16, 3% v skupini, ki je jemala placebo.
For myoclonic seizures, 58.3% of the patients who received Keppra had at least a halving of the number of seizure days per week, compared with 23.3% of the patients who received placebo.
Pri miokloničnih napadih se je pri 58, 3% bolnikov, ki so prejemali zdravilo Keppra, število dni z napadi na teden najmanj razpolovilo, v primerjavi s 23, 3% pri bolnikih, ki so prejemali placebo.
For tonic-clonic seizures, there was an average reduction in seizure rate of 28.2% in the patients taking placebo, compared with 56.5% in those taking Keppra.
Pri tonično- kloničnih napadih je bila povprečno zmanjšanje v stopnji napadov 28, 2% pri bolnikih, ki so jemali placebo, v primerjavi z 56, 5% tistih, ki so jemali zdravilo Keppra.
However, there were too few children aged below 12 to support the use of Keppra for this type of seizure in patients below this age.
Vendar pa je bilo otrok, mlajših od 12 let premalo, da bi bila potrjena uporaba zdravila Keppra za to vrsto napadov pri bolnikih te starosti.
Keppra was as effective as carbamazepine in keeping patients free of seizures when taken on its own for partial onset seizures.
Zdravilo Keppra je bilo enako učinkovito kot karbamazepin pri ohranjanju stanja brez napadov, kadar je bilo uporabljeno samostojno pri napadih parcialnega izvora.
In both groups, 73% of patients experienced no seizures for six months once on an adequate dose.
V obeh skupinah je bilo 73% bolnikov brez napadov šest mesecev od začetka prejemanja ustreznega odmerka.
The most common side effects with Keppra (seen in more than 1 patient in 10) are somnolence (sleepiness) and asthenia (weakness) or fatigue (tiredness).
Najpogostejši neželeni učinki pri zdravilu Keppra (opaženi pri več kot 1 od 10 bolnikov) so zaspanost in astenija (šibkost) ali utrujenost.
For the full list of all side effects reported with Keppra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Keppra, glejte Navodilo za uporabo.
Keppra should not be used in people who may be hypersensitive (allergic) to levetiracetam or other pyrrolidone derivatives (medicines with a similar structure), or to any of the other ingredients.
Zdravila Keppra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) levetiracetam ali na druge pirolidonske derivate (zdravila s podobno strukturo) ali na katero koli drugo sestavino zdravila.
juvenile myoclonic epilepsy, and primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Keppra kot monoterapije pri zdravljenju napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri na novo diagnosticiranih bolnikih, starejših od 16 let, kot tudi kot dopolnilne terapije pri zdravljenju napadov parcialnega izvora ali miokloničnih napadov pri bolnikih z juvenilno mioklonično epilepsijo ter pri primarno generaliziranih tonično- kloničnih napadih pri bolnikih z idiopatsko generalizirano epilepsijo, večje od z njim povezanih tveganj.
The Committee recommended that Keppra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Keppra odobri dovoljenje za promet.
The marketing authorisation was renewed on 29 September 2005.
Dovoljenje za promet je bilo podaljšano dne 29. septembra 2005.
The marketing authorisation holder is UCB Pharma SA.
Imetnik dovoljenja za promet z zdravilom je družba UCB Pharma SA.
The full EPAR for Keppra is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Keppra je na voljo tukaj.
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Številka EU EU/ 1/ 00/ 146/ 001 EU/ 1/ 00/ 146/ 002 EU/ 1/ 00/ 146/ 003 EU/ 1/ 00/ 146/ 004 EU/ 1/ 00/ 146/ 005 EU/ 1/ 00/ 146/ 006 EU/ 1/ 00/ 146/ 007 EU/ 1/ 00/ 146/ 008 EU/ 1/ 00/ 146/ 009 EU/ 1/ 00/ 146/ 010 EU/ 1/ 00/ 146/ 011 EU/ 1/ 00/ 146/ 012 EU/ 1/ 00/ 146/ 013 EU/ 1/ 00/ 146/ 014 EU/ 1/ 00/ 146/ 015 EU/ 1/ 00/ 146/ 016 EU/ 1/ 00/ 146/ 017 EU/ 1/ 00/ 146/ 018 EU/ 1/ 00/ 146/ 019 EU/ 1/ 00/ 146/ 020 EU/ 1/ 00/ 146/ 021 EU/ 1/ 00/ 146/ 022 EU/ 1/ 00/ 146/ 023 EU/ 1/ 00/ 146/ 024 EU/ 1/ 00/ 146/ 025 EU/ 1/ 00/ 146/ 026 EU/ 1/ 00/ 146/ 027
Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra
Izmišljeno ime Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra Keppra
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jakost 250 mg 250 mg 250 mg 250 mg 250 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg 500 mg 750 mg 750 mg 750 mg 750 mg 750 mg 750 mg 1000 mg 1000 mg 1000 mg 1000 mg 1000 mg 1000 mg 1000 mg 100 mg/ ml
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farmacevtska oblika filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta peroralna raztopina
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
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ovojnina pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) pretisni omot (alu/ PVC) steklenica (steklo)
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velikost pakiranja 20 30 50 60 100 10 20 30 50 60 100 120 200 20 30 50 60 80 100 10 20 30 50 60 100 200 1 steklenica + 1 graduirana brizga
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Keppra Keppra Keppra
Keppra Keppra
100 mg/ ml 750 mg 250 mg
750 mg 250 mg
Oral solution Film-coated tablet Film-coated tablet
filmsko obložena tableta filmsko obložena tableta koncentrat za pripravo
Oral use Oral use Oral use
peroralna uporaba peroralna uporaba
bottle (glass) blister (alu/ PVC) blister (alu/ PVC)
pretisni omot (alu/ PVC) pretisni omot (alu/ PVC)
1 bottle + 1 oral syringe 200 200
200 200
Concentrate for solution for infusion
raztopine za infundiranje
1 1.
DODATEK 1
Keppra 250 mg film-coated tablets.
Keppra 250 mg filmsko obložene tablete
Blue, oblong, scored and debossed with the code “ ucb” and “ 250” on one side.
Modra, podolgovata, z zarezo tableta z vtisnjeno oznako “ ucb˝ in ˝250 ” na eni strani.
Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.
Keppra je indicirana za samostojno zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri bolnikih, od 16. leta starosti, z na novo diagnosticirano epilepsijo.
Keppra is indicated as adjunctive therapy • in the treatment of partial onset seizures with or without secondary generalisation in adults and children from 4 years of age with epilepsy. • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. • in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Keppra je indicirana za dopolnilno zdravljenje • napadov parcialnega izvora s sekundarno generalizacijo ali brez nje pri odraslih in otrocih, od 4. leta starosti, z epilepsijo. • miokloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z juvenilno mioklonično epilepsijo. • primarno generaliziranih tonično- kloničnih napadov pri odraslih in mladostnikih, od 12. leta starosti, z idiopatsko generalizirano epilepsijo.