natgillin/translations-raw huggingface dataset:
• Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch. • Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
• Nežno upognite obliž in odstranite prvo plast zaš itne folije, ki pokriva lepljivo površino obliža. • Brez da se dotaknete lepljive površine, nežno stisnite obliž z lepljivim delom navzdol na del trebuha, bokov ali zadnjice, kamor želite obliž nalepiti.
Step 4:
23 etrti korak:
Apply the second half of the patch to your skin.
Nalepite drugo polovico obliža na kožo.
• Bend the patch back over itself.
• Obliž zapognite nazaj.
Press down on the liner firmly. • Push the liner forward a little to loosen the edge. • Grab the loose edge at either corner and peel off the second piece of the liner.
Trdno pritisnite na folijo za nanos. • Folijo potisnite nekoliko naprej, da se rob odpusti. • Primite kot odpuš enega roba in odlepite drugi del folije.
Try not to touch the sticky surface of the patch. • Press the entire patch firmly onto the skin with your fingertips.
Pri tem se ne dotikajte lepljive površine obliža. • Obliž trdno pritisnite na kožo s konicami prstov.
Press for at least 10 seconds to make sure the patch will stay in place.
Pritiskajte vsaj 10 sekund in se prepri ajte, da bo ostal na svojem mestu.
Be sure all of it sticks to your skin, even around the edges. • Discard the protective liners.
Prepri ajte se, da je obliž v celoti nalepljen na kožo, tudi ob robovih. • Zavrzite zaš itno plast.
You should wear each patch all the time until you apply a new one.
Obliž nosite ves as, vse dokler ne nanesete novega.
Baths, showers, swimming and exercise should not affect the patch as long as you don ’ t rub the patch as you wash.
Kopanje, prhanje, plavanje in vadba ne bi smeli vplivati na obliž, razen e ga med umivanjem drgnete.
Avoid soaking in a hot bath for a long period of time, which can make the patch come off.
Ne kopajte se v vro i vodi dalj asa, saj se lahko obliž odlepi.
If the patch comes off:
e se obliž odlepi:
If the patch starts to lift off your skin, apply a little bit of pressure using your fingertips.
Obliž, ki se za ne dvigovati, pritisnite na kožo s konicami prstov.
If not, take it off and put a new patch on a new spot.
Izdelan je tako, da se ponovno prilepi, zato se le redko povsem odlepi. e se to zgodi, ga skušajte ponovno nalepiti na isto mesto. e je povsod dobro prilepljen, ga pustite na koži. e ne, ga snemite in na novo mesto nanesite nov obliž.
No matter what day this happens, continue with the twice-a-week schedule that you have marked on your patch box.
Ne glede na to, kateri dan se to zgodi, se držite vašega urnika nanosa dvakrat tedensko, kot ste ozna ili na škatlici.
If you forget to change the patch after 3-4 days:
e po 3- 4 dneh pozabite zamenjati obliž:
No matter what day this happens, continue with the same twice-a-week schedule for your next patch, even if it means changing the new patch before 3 to 4 days have elapsed.
Ne glede na to, kateri dan se to zgodi, se držite vašega urnika nanosa dvakrat tedensko za naslednji obliž, etudi to pomeni, da ga boste morali zamenjati preden prete ejo 3 ali 4 dnevi.
24 How to Remove
Kako odstraniti obliž
When changing the patch, remove the old patch slowly.
Pri menjavi po asi odstranite stari obliž.
Fold it in half (sticky sides together) and throw it away to keep out of the reach of children and pets.
Prepognite ga na polovico (lepljive strani skupaj) in zavrzite nedosegljivo otrokom in doma im živalim.
If irritation persists, please contact your doctor.
Na mestu nanosa se lahko pojavi blaga rde ica, ki po nekaj urah po odstranitvi obliža izgine. e se razdraženost kože ne pomiri, se posvetujte z zdravnikom.
Rings of adhesive that become soiled may require a medical adhesive removal pad that should be available from your pharmacist.
Za odstranitev umazanih obro ev odve nega lepila okoli obliža je v lekarni na voljo posebno sredstvo za odstranjevanje lepila.
Alcohol or other strong solvents may cause skin irritation and should not be used.
Alkohol ali druga mo na topila lahko razdražijo kožo, zato jih ne uporabljajte.
After use the patch still contains substantial quantities of active ingredients.
Uporabljen obliž še vedno vsebuje znatne koli ine zdravilne u inkovine, ki lahko škodljivo vplivajo na organizme v vodnem okolju.
Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
Zato ga po uporabi prepognite z lepljivo stranjo navznoter, da je membrana iz katere se u inkovina sproš a prekrita, vstavite v originalno vre ko in zavrzite tako, da ni dosegljiv otrokom.
Any used or unused patches should be discarded according to local requirements or returned to the pharmacy.
24 Vse uporabljene ali neuporabljene obliže odstranite v skladu z lokalnimi zahtevami ali jih vrnite v lekarno.
Used patches should not be flushed down the toilet nor placed in liquid waste disposal systems
Uporabljenih obližev ni dovoljeno splakniti v kanalizacijo ali odstraniti v sistem teko ih odpadkov.
Like all medicines Kentera can have side effects.
Kot vsa zdravila lahko tudi Kentera povzro i neželene u inke.
Patients using Kentera may experience the following very common (1 in ten persons) side effect: itching around the site of patch application.
Pri bolniki, ki uporabljajo Kentera, je zelo pogost (pri eni od deset oseb) neželen u inek srbe ica okoli mesta nanosa.
They may also experience the following common (1 in 100 persons) side effects: redness or rash at the site of patch application; dry mouth constipation, diarrhea, upset stomach, stomach pain, headache, or sleepiness, urinary tract infections, blurred vision, and dizziness.
Drug pogost neželen u inek (pri eni od sto oseb) je rde ica ali izpuš aj na mestu nanosa obliža, suha usta, zaprtje, driska, razdražen želodec, bole ine v trebuhu, glavobol ali nespe nost, okužbe se il, zamegljen vid in zaspanost.
Finally, those using Kentera may experience the following uncommon (1 in 1000 persons): upper respiratory tract or fungal infections, palpitations, hot flashes, back pain, urinary retention, difficulty urinating, common cold, and accidental injury.
Pri uporabnikih obliža Kentera se redko (pri eni od tiso oseb) pojavi okužba zgornjega respiratornega trakta ali glivi na okužba, nemiren utrip srca, vro inski vali, bole ine hrbta, zastajanje urina, težave pri uriniranju, pogosti prehladi in poškodbe.
If you notice any side effects not mentioned in this leaflet please inform your doctor or pharmacist.
e opazite katerikoli neželen u inek, ki ni omenjen v tem navodilu, obvestite zdravnika ali farmacevta.
Do not use Kentera after the date shown on the sachet and the carton.
Obližev Kentera ne uporabljajte po datumu navedenem na vre ki in škatlici.
France BOUCHARA RECORDATI Laboratories Tél: +33 (0) 1 45 19 10 00
25 France BOUCHARA RECORDATI Laboratories Tél: +33 (0) 1 45 19 10 00
Suomi/ Finland Orion Corporation Puh/ Tel: + 358 10 4261
26 Suomi/ Finland Orion Corporation Puh/ Tel: + 358 10 4261
What is Kepivance?
Kaj je zdravilo Kepivance?
Kepivance is a vial containing a powder to be made into a solution for injection.
Zdravilo Kepivance je viala, ki vsebuje prašek za pripravo raztopine za injiciranje.
Each vial contains 6.25 mg of the active substance palifermin.
Vsaka viala vsebuje 6, 25 mg zdravilne učinkovine palifermin.
What is Kepivance used for?
Za kaj se zdravilo Kepivance uporablja?
Kepivance is used to decrease the frequency, duration and severity of oral mucositis (inflammation of the lining of the mouth ranging from soreness and redness to severe ulceration).
Zdravilo Kepivance se uporablja za zmanjšanje pojavnosti, trajanja in izrazitosti oralnega mukozitisa (vnetja ustne sluznice, ki lahko zajema vse od občutljivosti in pordelosti do resnih razjed).
Kepivance is used in patients who are likely to develop severe mucositis because they have blood cancer, and are being treated with myeloablative therapy (treatments that destroy the bone marrow) and an autologous stem cell transplant (a transplant of their own blood-producing cells).
Zdravilo Kepivance se uporablja pri bolnikih, pri katerih se bo po vsej verjetnosti razvil hud mukozitis, ker imajo krvnega raka in se zdravijo z mieloablacijsko terapijo (vrsta zdravljenja, ki uničuje kostni mozeg) in presajanjem avtolognih matičnih celic (presadek njihovih lastnih krvotvornih celic).
How is Kepivance used?
Kako se zdravilo Kepivance uporablja?
The use of Kepivance should be supervised by a doctor who has experience in anti-cancer therapy.
Uporabo zdravila Kepivance mora nadzirati zdravnik, ki ima izkušnje z zdravljenjem raka.
It is given as an intravenous injection (into a vein) at a dose of 60 micrograms per kilogram body weight per day, for a total of six doses.
Zdravilo se daje z intravensko injekcijo (v veno) v odmerku 60 mikrogramov na kilogram telesne mase na dan, in sicer vsega skupaj šest odmerkov.
Three doses are given on three consecutive days before myeloablative therapy, finishing 24 to 48 hours before the therapy.
Tri odmerke bolnik prejme tri zaporedne dni pred začetkom mieloablacijske terapije, pri čemer prejme zadnjega teh odmerkov 24 do 48 ur pred terapijo.
The remaining three doses are given on three consecutive days after myeloablative therapy, with the first dose given on the day of the stem cell transplant.
Preostale tri odmerke bolnik prejme na tri zaporedno sledeče dni po mieloablacijski terapiji, pri čemer prvi odmerek prejme na dan presajevanja matičnih celic.
Kepivance has not been studied in children, adolescents or the elderly.
Zdravila Kepivance niso raziskovali pri otrocih, mladostnikih ali starostnikih.
How does Kepivance work?
Kako zdravilo Kepivance deluje?
The active substance in Kepivance, palifermin, is a growth factor that stimulates the ‘ epithelial’ cells that line the mouth and gastrointestinal tract to grow and develop.
Zdravilna učinkovina zdravila Kepivance je palifermin, rastni faktor, ki spodbuja celice povrhnjice ustne votline in prebavil k rasti in razvoju.
Palifermin is very similar to a natural growth factor found in the body called keratinocyte growth factor (KGF).
Palifermin je zelo podoben naravnemu rastnemu faktorju, prisotnem v telesu, ki ga imenujemo keratinocitni rastni faktor (KGF).
Epithelial cells in the mouth are normally replaced by the body every few days.
Telo navadno nadomesti celice povrhnjice vsakih nekaj dni.
In patients receiving chemotherapy or radiotherapy, the cells are not replaced as quickly, and this leads to the development of mucositis.
Pri bolnikih, ki prejemajo kemoterapijo ali radioterapijo, se celice ne nadomeščajo tako hitro, kar pripelje do razvoja mukozitisa.
Kepivance stimulates the growth of these cells, helping to reduce the incidence, severity and duration of oral mucositis in cancer patients undergoing intensive therapy.
Zdravilo Kepivance spodbuja rast teh celic in pomaga zmanjševati pojavnost, resnost in trajanje oralnega mukozitisa pri bolnikih z rakom, ki so podvrženi intenzivni terapiji.
Palifermin is produced by a method known as ‘ recombinant DNA technology’.
Učinkovino palifermin se izdeluje z metodo, ki jo imenujemo „ tehnologija rekombinantne DNA “.
The palifermin is made by a bacterium that has received a gene (DNA), which makes it able to produce palifermin.
Palifermin proizvajajo bakterije, ki so prejele gen (DNA) za izdelavo te učinkovine.
The replacement palifermin acts in same way as naturally produced KGF.
Nadomestni palifermin deluje na enak način kot naravni KGF.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 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 How has Kepivance been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 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 Kako je bilo zdravilo Kepivance raziskano?
Kepivance has been studied in 212 patients receiving high-dose cytotoxic therapy for a blood cancer (mostly non-Hodgkin’ s lymphoma).
Zdravilo Kepivance so raziskali pri 212 bolnikih, pri katerih so zdravili krvnega raka s citotoskičnim zdravljenjem z velikimi odmerki (v večini primerov ne- Hodgkinov limfom).
Palifermin was compared with placebo (a dummy treatment).
Palifermin so primerjali s placebom (zdravilom brez zdravilne učinkovine).
The main measure of effectiveness was the number of days during which patients experienced severe oral mucositis.
Glavno merilo učinkovitosti je bilo število dni, v katerih se je pri bolnikih pojavil hud oralni mukozitis.
What benefit has Kepivance shown during the studies?
Kakšne koristi je zdravilo Kepivance izkazalo med raziskavami?
The average length of time for which patients had severe oral mucositis was significantly less with Kepivance (3.7 days) than with placebo (10.4 days).
Povprečen čas, ko so bolniki imeli hud oralni mukozitis, je bil znatno krajši v primeru uporabe zdravila Kepivance (3, 7 dni) kot v primerih uporabe placeba (10, 4 dni).
Patients receiving Kepivance also reported less mouth and throat soreness with improved swallowing, drinking, eating and talking.
Bolniki, ki so prejemali Kepivance, so poročali tudi o zmanjšanju vnetja ust in grla in izboljšanju požiranja, pitja, prehranjevanja ter govorjenja.
What is the risk associated with Kepivance?
Kakšna tveganja so povezana z zdravilom Kepivance?
The most common side effects with Kepivance (seen in more than 1 patient in 10) are taste perversion (altered taste), mouth/ tongue thickness or discolouration, rash, pruritus (itching), erythema (redness), arthralgia (joint pain), oedema (fluid retention), pain and fever.
Najpogostejši neželeni učinki, povezani z zdravilom Kepivance (opaženi pri več kot 1 bolniku od 10), so motnje okušanja (spremenjen okus), zadebelitev ali razbarvanje ust/ jezika, izpuščaji, pruritus (srbenje), eritem (rdečina), artralgija (bolečina v sklepih), edem (zadrževanje tekočine), bolečina in vročina.
For the full list of all side effects reported with Kepivance, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kepivance, glejte Navodilo za uporabo.
Kepivance should not be used in people who may be hypersensitive (allergic) to palifermin, proteins produced by Escherichia coli (a bacterium) or any of the other ingredients.
Zdravila Kepivance ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) palifermin, beljakovino, ki jo tvori Escherichia coli (bakterija), ali katerokoli drugo sestavino zdravila.
Why has Kepivance been approved?
Zakaj je bilo zdravilo Kepivance odobreno?
The Committee for Medicinal products for Human Use (CHMP) decided that Kepivance’ s benefits are greater than its risks when used to decrease the incidence, duration and severity of oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with a high incidence of severe mucositis and requiring autologous stem cell support.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristni učinki zdravila Kepivance večji od z njim povezanih tveganj pri uporabi za zmanjšanje pojavnosti, trajanja in intenzivnosti oralnega mukozitisa pri bolnikih s hematološkimi malignimi obolenji, zdravljenih z mieloablacijsko terapijo, ki je povezana z visoko pojavnostjo hudega mukozitisa, in ki potrebujejo podporo z avtolognimi matičnimi celicami.
They recommended that Kepivance be given marketing authorisation.
Odbor zato je priporočil odobritev dovoljenja za promet z zdravilom Kepivance.
Other information about Kepivance:
Druge informacije o zdravilu Kepivance:
The European Commission granted a marketing authorisation valid throughout the European Union for Kepivance to Amgen Europe B. V. on 25 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Kepivance, veljavno po vsej Evropski uniji, odobrila družbi Amgen Europe B. V. dne 25. oktobra 2005.
The full EPAR for Kepivance is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kepivance je na voljo tukaj.
This summary was last updated in 03-2007.
Povzetek je bil nazadnje posodobljen 03- 2007.
Strength
Farmacevtska oblika
Pharmaceutical Form
Pot uporabe
Kepivance 6.25 mg powder for solution for injection.
Kepivance 6, 25 mg prašek za raztopino za injiciranje
Each vial contains 6.25 mg of palifermin.
Ena viala vsebuje 6, 25 mg palifermina.
Palifermin is a human keratinocyte growth factor (KGF), produced by recombinant DNA technology in Escherichia coli.
Palifermin je humani keratinocitni rastni faktor (KGF - keratinocyte growth factor), pridobljen s tehnologijo rekombinantne DNA iz Escherichie coli.
Reconstituted Kepivance contains 5 mg/ ml of palifermin.
Pripravljeni Kepivance vsebuje 5 mg/ ml palifermina.
Powder for solution for injection (powder for injection).
Prašek za raztopino za injiciranje (prašek za injekcijo).
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with a high incidence of severe mucositis and requiring autologous haemopoietic stem cell support.
Kepivance je indiciran za zmanjšanje incidence, trajanja in izrazitosti oralnega mukozitisa pri bolnikih s hematološkimi malignomi, zdravljenih z mieloablacijsko terapijo, ki je povezana z veliko incidenco hudega mukozitisa, in ki potrebujejo podporo z avtolognimi hemopoetskimi matičnimi celicami.
Kepivance treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Zdravljenje s Kepivancom lahko izvaja samo zdravnik z izkušnjami pri zdravljenju raka.
The recommended dosage of Kepivance is 60 micrograms/ kg/ day, administered as an intravenous bolus injection for three consecutive days before and three consecutive days after myeloablative therapy for a total of six doses (see below).
Priporočeni odmerek Kepivanca je 60 mikrogramov/ kg/ dan v intravenski bolusni injekciji, in sicer tri dni zapored pred mieloablacijsko terapijo in tri dni zapored po njej, tako da dobi bolnik skupaj šest odmerkov (glejte spodaj).
Kepivance should not be administered subcutaneously due to poor local tolerability.
Zaradi slabega lokalnega prenašanja Kepivanca ne smete dajati subkutano.
Reconstituted Kepivance should not be left at room temperature for more than one hour, and should be protected from light.
Pripravljenega Kepivanca ne smete pustiti na sobni temperaturi več kot eno uro in ga morate zaščititi pred svetlobo.
Prior to administration, visually inspect the solution for discolouration and particulate matter before administration, see section 6.6.
Pred aplikacijo morate pregledati, da raztopina ni obarvana in ne vsebuje delcev, glejte poglavje 6. 6.
Pre- myeloablative therapy:
Pred mieloablacijsko terapijo:
The first three doses should be administered prior to myeloablative therapy, with the third dose 24 to 48 hours before myeloablative therapy.
Prve tri odmerke je treba uporabiti pred mieloablacijsko terapijo, in sicer tako, da bolnik dobi tretji odmerek v 24 do 48 urah pred mieloablacijsko terapijo.
Post- myeloablative therapy:
Po mieloablacijski terapiji:
The last three doses should be administered post myeloablative therapy; the first of these doses should be administered after, but on the same day of haematopoietic stem cell infusion and at least four days after the most recent Kepivance administration.
Prvega od njih je treba aplicirati po infundiranju hematopoetskih matičnih celic, vendar še isti dan in obenem vsaj štiri dni po zadnji prejšnji aplikaciji Kepivanca.
The safety and efficacy of Kepivance in children and adolescent patients have not been established, Kepivance should not be used in children or adolescents until further data become available.
Varnost in učinkovitost Kepivanca pri otrocih in mladostnikih nista ugotovljeni, zato ga pri njih ne uporabljajte, dokler ni na voljo dodatnih podatkov.
Dose adjustment in patients with renal impairment is not necessary (see section 5.2).
Prilagoditev odmerka pri bolnikih z okvaro ledvic ni potrebna (glejte poglavje 5. 2).
Safety and efficacy has not been evaluated in patients with hepatic impairment (see section 5.2).
Varnost in učinkovitost pri bolnikih z okvaro jeter nista ovrednoteni (glejte poglavje 5. 2).
Safety and efficacy has not been evaluated in the elderly (see section 5.2).
Varnost in učinkovitost pri starejših bolnikih nista ovrednoteni (glejte poglavje 5. 2).
Hypersensitivity to palifermin or to any of the excipients, or to Escherichia coli-derived proteins.
Preobčutljivost za palifermin, katerokoli pomožno snov ali beljakovine, pridobljene iz bakterije Escherichia coli.
Kepivance should not be administered within 24 hours before, during infusion of, or within 24 hours after administration of cytotoxic chemotherapy.
Kepivanca ne smete uporabiti v 24 urah pred, med ali v 24 urah po apliciranju citotoksične kemoterapije.
In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in an increased severity and duration of oral mucositis.
V kliničnem preskušanju je uporaba Kepivanca v 24 urah pred ali po kemoterapiji povečala izrazitost oralnega mukozitisa in podaljšala njegovo trajanje.
If heparin is used to maintain an intravenous line, sodium chloride solution should be used to rinse the line prior to and after Kepivance administration, see section 6.2.
Če za vzdrževanje intravenske linije uporabljate heparin, je treba linijo pred aplikacijo Kepivanca in po njej izprati z raztopino natrijevega klorida, glejte poglavje 6. 2.
To date no evidence of an increase in lens opacities has been observed in patients treated with Kepivance in clinical studies.
Doslej v kliničnih študijah niso zabeležili večjega števila motnjav v leči pri bolnikih, zdravljenih s Kepivancom.
The long-term safety of Kepivance has not been fully evaluated with respect to overall survival, progression free survival and secondary malignancies.
Dolgoročna varnost Kepivanca ni povsem ugotovljena, kar zadeva celotno preživetje, preživetje brez napredovanja in sekundarne malignome.
Kepivance is a growth factor that stimulates the proliferation of KGF receptor expressing epithelial cells.
Kepivance je rastni faktor, ki spodbuja proliferacijo epitelijskih celic z eksprimiranimi receptorji KGF.
The safety and efficacy of Kepivance has not been established in patients with KGF receptor expressing non-haematological malignancies.
Varnost in učinkovitost Kepivanca nista ugotovljeni pri bolnikih z nehematološkimi malignomi, ki imajo eksprimirane receptorje KGF.
No interaction studies have been conducted with Kepivance.
Študije o medsebojnem delovanju s Kepivancom niso bile izvedene.
As a protein therapeutic, the risk for Kepivance to interact with other medicinal products is low.
Ker je Kepivance beljakovinsko zdravilo, je tveganje za medsebojno delovanje z drugimi zdravili majhno.
In-vitro and in-vivo data suggests that palifermin binds to unfractionated as well as low molecular weight heparins, which should be used with care in patients who are concomitantly administered palifermin.
Podatki in vitro in in vivo kažejo, da se palifermin veže tako na nefrakcionirane kot na nizkomolekularne heparine; pri bolnikih, ki sočasno dobivajo palifermin, morate zato oboje uporabljati previdno.
The clinical relevance is unclear.
Klinični pomen te vezave ni jasen.
There are no adequate data from the use of Kepivance in pregnant women.
O uporabi Kepivanca pri nosečnicah ni zadostnih podatkov.
Studies in animals have shown reproductive and developmental toxicity (see section 5.3).
Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja in razvoj (glejte poglavje 5. 3).
The potential risk to the human embryo or foetus is unknown.
Možno tveganje za človeški
3 It is not known whether Kepivance is excreted in human milk, therefore Kepivance should not be administered to women who are breast-feeding.
Zdravila Kepivance med nosečnostjo ne smete uporabljati, razen če je nujno potrebno.