FrancophonIA/ELRC3.0 huggingface dataset:
English: 95 % CI of differences between related adverse effect proportions (Xeomin versus Botox)
Slovenian: 95 % IZ razlik med deleži povezanih neželenih dogodkov (Xeomin v primerjavi z Botoxom)
English: It should be noted that some adverse events have only been reported in patients who received Xeomin, such as dysphagia (reported in one patient in each of the Xeomin groups versus no patients in the Botox group).
Slovenian: Omeniti je potrebno, da so o nekaterih neželenih dogodkih poročali le pri bolnikih, ki so prejemali zdravilo Xeomin, npr. o disfagiji (o kateri so poročali pri enem bolniku iz vsake skupine, ki je prejemala zdravilo Xeomin, v primerjavi z nobenim bolnikom iz skupine, ki je prejemala zdravilo Botox).
English: o Information on usage patterns and on types of prescribers/users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU.
Slovenian: o informacijami o vzorcih uporabe in tipih predpisovalcev/uporabnikov zdravila Xeomin, da bi tako identificirali ali in v kakšnem tipu klinik prihaja do "off-label" uporabe (za namene, ki niso navedeni v registraciji zdravila) za kozmetične namene, zlasti v EU;
English: • different treatment intervals
Slovenian: • različni presledki med posameznimi zdravljenji;
English: dizziness, numbness, drowsiness
Slovenian: omotica, otrplost, dremavost
English: In cases of repeated injections with Xeomin, the therapeutic effect of the product may vary.
Slovenian: Pri ponavljajočih se injekcijah zdravila Xeomin se lahko zdravilni učinek zdravila razlikuje.
English: The fact that the Phase III studies were performed in patients pretreated with Botox is adequately addressed in the SPC, which now states that ‘there is limited experience in treatment-naïve patients'.
Slovenian: Dejstvo, da je bila študija III. faze izvedena z bolniki, ki so bili predhodno zdravljeni z zdravilom Botox, je v povzetku glavnih značilnosti zdravila ustrezno upoštevano, saj ta sedaj navaja, da "obstaja le malo izkušenj z uporabo pri predhodno nezdravljenih bolnikih".
English: Immediate gentle pressure at the injection site can limit that risk.
Slovenian: Takojšnji nežen pritisk na mesto injiciranja lahko zmanjša tveganje za njen pojav.
English: Xeomin may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin and in the use of the necessary equipment, e.g. EMG (electromyography).
Slovenian: Zdravilo Xeomin smejo uporabljati samo zdravniki z ustreznimi kvalifikacijami in dokazanimi izkušnjami pri uporabi botulinskega toksina ter uporabi nujne opreme, npr. EMG (elektromiografija).
English: Patients should be informed that injections of Xeomin for the management of spasmodic torticollis may cause mild to severe dysphagia with the risk of aspiration and dyspnoea.
Slovenian: Bolnike je treba obvestiti, da injiciranje zdravila Xeomin pri obravnavanju spastičnega tortikolisa lahko povzroči blago do hudo disfagijo s tveganjem za pojav aspiracije in dispneje.
English: Fax: +49-69/15 03-200
Slovenian: Faks: +49-69/15 03-200
English: This study showed the non-inferiority of Xeomin (70-300 U) compared to Botox (70-300 U).
Slovenian: Ta študija je pokazala, da zdravilo Xeomin (70-300 enot) ni slabše od zdravila Botox (70-300 enot).
English: Post-marketing experience revealed no different or new safety signals for Xeomin compared to other Botulinum toxin containing medicinal products.
Slovenian: Postmarketinške izkušnje niso razkrile nikakršnih drugačnih ali novih varnostnih znakov za zdravilo Xeomin v primerjavi z drugimi zdravili, vsebujočimi botulinski toksin.
English: After internalisation of the neurotoxin the light chain cleaves very specifically a target protein (SNAP 25) that is essential for the release of acetylcholine.
Slovenian: Po vstopu nevrotoksina lahka veriga specifično razcepi ciljni protein (SNAP 25), ki je nujen za sproščanje acetilholina.
English: Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Slovenian: Pri bolnikih, ki prejmejo terapevtske odmerke, lahko pride do pretirane mišične šibkosti.
English: are available, showing one positive test result at baseline and before 3rd injection and two positive results four weeks after 1st injection and before 2nd injection.
Slovenian: Sedaj so zadevni rezultati na voljo ter izkazujejo en pozitiven rezultat ob izhodišču in pred 3. injiciranjem ter dva pozitivna rezultata 4 tedne po 1. injiciranju in pred 2. injiciranjem.
English: The treatment of twisted neck may cause swallowing difficulties with varying degrees of severity.
Slovenian: Zdravljenje zvitega vratu lahko povzroči težave pri požiranju različnih stopenj.
English: Taken altogether, the data from the non-clinical and clinical development program, which has been designed with support of Scientific Advice, provided sufficient evidence that a 1:1 dose ratio between Xeomin and Botox with respect to efficacy and safety can be concluded and the adoption of the dosage which has been established for Botox is adequately justified.
Slovenian: Kombinirani podatki iz nekliničnega in kliničnega razvojnega programa, ki je bil oblikovan ob podpori oddelka za znanstveno svetovanje, so prispevali zadosten dokaz, da je mogoče z ozirom na učinkovitost in varnost potrditi odmerjanje v razmerju 1:1 med zdraviloma Xeomin in Botox ter da je uporaba odmerjanja, določenega za zdravilo Botox, zadostno utemeljena.
English: Avoiding medial injections into the lower lid may reduce this adverse reaction.
Slovenian: Izogibanje medialnim injekcijam v spodnjo veko lahko zmanjša pogostnost te neželene reakcije.
English: Patients with underlying neurological disorders including swallowing difficulties are at increased risk of these side effects.
Slovenian: Pri bolnikih z obstoječimi nevrološkimi motnjami, vključno s težavami pri požiranju, je tveganje za pojav teh neželenih učinkov večje.
English: Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate-acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.
Slovenian: Periferne mišične relaksante je treba uporabljati previdno in po potrebi zmanjšati začetni odmerek relaksanta ali uporabiti hitro delujoča zdravila, npr. vekuronij ali atrakurij, namesto zdravil z dolgotrajnim učinkom.
English: Antibodies may reduce the therapeutic effectiveness of the product.
Slovenian: Protitelesa lahko zmanjšajo zdravilni učinek zdravila.
English: • Non-clinical data
Slovenian: • Neklinični podatki
English: In the non-clinical study, Xeomin was not more or less immunogenic than Botox even at dose levels clearly exceeding the recommended human dose.
Slovenian: Pri neklinični študiji zdravilo Xeomin ni bilo bolj ali manj imunogeno od zdravila Botox niti pri odmerkih, ki so bistveno presegali priporočeni odmerek za uporabo pri ljudeh.
English: The Botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.
Slovenian: Pri teh bolnikih je treba zdravila z botulinskim toksinom uporabljati pod nadzorom specialista, uporabljati pa se smejo samo, če korist zdravljenja odtehta tveganje.
English: Classic kinetic and distribution studies cannot be conducted with Botulinum neurotoxin type A because the active substance is applied in such small quantities (picograms per injection), and because it binds so rapidly and irreversibly to cholinergic nerve terminals.
Slovenian: Klasičnih študij kinetike in porazdelitve pri botulinskem nevrotoksinu tipa A ni možno opraviti, ker se zdravilna učinkovina uporablja v tako majhnih količinah (v pikogramih na injiciranje), in ker se hitro in ireverzibilno veže na holinergične živčne končiče.
English: The optimum number of injection sites is dependent upon the size of the muscle to be chemically denervated.
Slovenian: Optimalno število mest injiciranja je odvisno od velikosti mišice, ki jo želite kemijsko denervirati.
English: METHODS AND ROUTE(S) OF ADMINISTRATION For intramuscular use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intramuskularno uporabo.
English: the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, Labelling and Package Leaflet are set out in Annex III for Xeomin.
Slovenian: CHMP priporočil podelitev dovoljenja za promet z zdravilom Xeomin, za katerega so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo podani v Dodatku III za zdravilo Xeomin.
English: The initial recommended dose is 1.25-2.5 U (0.05-0.1 ml volume) at each site.
Slovenian: Začetni priporočeni odmerek je 1,25−2,5 e. (0,05−0,1 ml) v vsako mesto.
English: • if an infection is present at the injection site.
Slovenian: • če je na mestu injiciranja okužba.
English: After reconstitution, the Xeomin solution is injected using a suitable sterile needle (e.g. 27-30 gauge/0.30-0.40 mm).
Slovenian: Po rekonstituciji se raztopina zdravila Xeomin injicira z ustrezno sterilno iglo (npr. velikosti 27−30/0,30−0,40 mm).
English: The most frequently reported adverse event was dysphagia (Xeomin 10.8%; Botox 8.2%; p=0.29).
Slovenian: Neželeni dogodek, o katerem so najpogosteje poročali, je bila disfagija (Xeomin 10,8 %; Botox 8,2 %; p=0,29).
English: Limiting the dose injected into the sternocleidomastoid muscle to less than 100 U may decrease the occurrence of dysphagia.
Slovenian: Omejitev odmerka, ki se injicira v sternokleidomastoidno mišico, na manj kot 100 e. lahko zmanjša pogostnost disfagije.
English: Your doctor may reduce the starting dose of relaxant, or use an intermediate-action substance rather than substances with longer lasting effects.
Slovenian: Zdravnik vam lahko zmanjša začetni odmerek relaksanta ali uporabi zdravilo s takojšnjim delovanjem namesto zdravila z dolgotrajnim delovanjem.
English: • Safety data
Slovenian: • Podatki o varnosti
English: The management of spasmodic torticollis may cause dysphagia with varying degrees of severity with the potential for aspiration which may require medical intervention.
Slovenian: Obravnavanje spastičnega tortikolisa lahko povzroči disfagijo različnih stopenj, z možnostjo aspiracije, zaradi katere je potreben zdravniški poseg.
English: There are no adequate data from the use of Botulinum neurotoxin type A in pregnant women.
Slovenian: Ni zadostnih podatkov o uporabi botulinskega nevrotoksina tipa A pri nosečnicah.
English: Recovery after injection normally takes place within 3-4 months as nerve terminals sprout and reconnect with the endplate.
Slovenian: Do okrevanja po injiciranju po navadi pride po 3 do 4 mesecih, ko poženejo novi živčni končiči in se ponovno vzpostavi povezava z motorično ploščico.
English: Up to now the FIA (Fluorescence Immuno Assay) screening test revealed no trend of a development of antibodies after Xeomin injection.
Slovenian: Doslej presejalni test FIA (fluorescenčni imunski test) ni odkril nikakršnega trenda razvoja protiteles po injiciranju zdravila Xeomin.
English: In addition, two adverse events have been assessed as related to study medication, versus none in the Botox group.
Slovenian: Nadalje sta bila dva neželena dogodka ocenjena kot povezana s preučevanim zdravilom v primerjavi z nobenim iz skupine, ki je prejemala zdravilo Botox.
English: In 2003, Jankovic compared 130 patients treated for cervical dystonia with original Botox (25ng protein/100 U before 1998), 42 of whom were exposed only to the original Botox and 119 treated with the current Botox (5ng protein/100 U since 1998).
Slovenian: Leta 2003 je Jankovic primerjal 130 bolnikov, zdravljenih zaradi cervikalne distonije z originalnim zdravilom Botox (25 ng beljakovin/100 e pred letom 1998), med katerimi je bilo 42 bolnikov izpostavljenih le originalnemu zdravilu Botox, 119 pa zdravljenih s sedanjih zdravilom Botox (5 ng beljakovin/100 e od leta 1998 dalje).
English: An appropriate amount of solvent (see dilution table) is drawn up into a syringe.
Slovenian: Ustrezno količino vehikla (glejte tabelo za redčenje) povlecite v brizgo.
English: • if you suffer from any type of bleeding disorders
Slovenian: • če imate kakršne koli motnje strjevanja krvi;
English: The applicant presented efficacy data of Phase III study in spasmodic torticollis.
Slovenian: Vlagatelj je predložil podatke o učinkovitosti iz študije III. faze za spastični tortikolis.
English: o Specifically include toxin spread events in their sentinel list of events for active monitoring.
Slovenian: o dogodke, povezane s širjenjem toksina, je treba izrecno vključiti v seznam dogodkov za aktivno spremljanje;
English: During treatment, small punctuated bleedings may occur in the soft tissues of the eyelid.
Slovenian: Med zdravljenjem se lahko v mehkih tkivih veke pojavijo majhne točkaste krvavitve.
English: Therefore, Xeomin should not be used during pregnancy unless clearly necessary and unless the potential benefit justifies the risk.
Slovenian: Zato se zdravilo Xeomin ne sme uporabljati med nosečnostjo, razen če je nujno in če morebitne koristi opravičijo tveganje.
English: • Overall Comparison of Adverse Events in Phase I - III Studies A total of five clinical trials (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013, MRZ-0003) have been completed to provide data on the safety and efficacy of Xeomin.
Slovenian: • Celostna primerjava neželenih učinkov v študijah I. - III. faze Za pridobitev podatkov o varnosti in učinkovitosti zdravila Xeomin je bilo izvedenih skupno pet kliničnih preizkušanj (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013, MRZ-0003).
English: Multiple injection sites permit Xeomin more uniform coverage of the innervated areas of the dystonic muscle and are especially useful in larger muscles.
Slovenian: Injiciranje na več mestih omogoča zdravilu Xeomin enakomernejše pokritje oživčenih območij distoničnih mišic, zlasti pa je uporabno pri večjih mišicah.
English: The clinical effects of Botulinum neurotoxin type A can increase or decrease by repeated injections.
Slovenian: Klinični učinek botulinskega nevrotoksina tipa A se lahko s ponavljajočim se injiciranjem poveča ali zmanjša.
English: What Xeomin looks like and contents of the pack
Slovenian: Izgled zdravila Xeomin in vsebina pakiranja
English: A titration of the dose should be performed.
Slovenian: Odmerek je treba titrirati.
English: • To perform a post-marketing study to confirm the safety and efficacy of Xeomin after repeated injections (up to 6 injection sessions).
Slovenian: • Izvedba postmarketinške študije za potrditev varnosti in učinkovitosti zdravila Xeomin po ponovljenem injiciranju (do 6 injiciranj).
English: In practice, the maximum total dose is usually not more than 200 U. Doses of up to 300 U may be given.
Slovenian: V praksi največji skupni odmerek po navadi ni večji od 200 e..
English: The sternocleidomastoid should not be injected bilaterally as there is an increased risk of adverse reactions (in particular dysphagia) when bilateral injections or doses in excess of 100 U are administered into this muscle.
Slovenian: Injiciranje v sternokleidomastoidno mišico se ne sme opraviti bilateralno, saj je tveganje za pojav neželenih učinkov (zlasti disfagije) pri bilateralnem injiciranju odmerkov, večjih od 100 e., v to mišico večje.
English: Retrograde transsynaptic passage of active Botulinum neurotoxin type A into the central nervous system however has not been found.
Slovenian: Vendar retrogradnega transsinaptičnega prehoda aktivnega botulinskega nevrotoksina tipa A v osrednje živčevje niso opazili.
English: In the management of spasmodic torticollis, Xeomin dosing must be tailored to the individual patient, based on the patient's head and neck position, location of possible pain, muscle hypertrophy, patient's body weight, and response to the injection.
Slovenian: Pri obravnavanju spastičnega tortikolisa je treba odmerjanje zdravila Xeomin prilagoditi posameznemu bolniku, glede na položaj njegove glave in vratu, mesto morebitne bolečine, mišično hipertrofijo, telesno maso in odziv na injiciranje.
English: In the Phase III study MRZ-0003 in patients with blepharospasm, no patient in both treatment groups had a HDA antibody titer higher than 1 mU/l at baseline or at final visit.
Slovenian: V študiji III. faze MRZ-0003 z bolniki z blefarospazmom ni imel noben bolnik iz nobene skupine HDA titer protiteles večji od 1 me/l bodisi v izhodišču ali ob končnem pregledu.
English: The study failed with respect to the determination of the optimal therapeutic dose of Xeomin in the treatment of spasmodic torticollis, as no statistically significant treatment differences (overall or pair-wise) were observed, but similar effectiveness of Xeomin and Botox in EMG measurements could be demonstrated.
Slovenian: Študija ni bila uspešna z vidika določitve optimalnega terapevtskega odmerka zdravila Xeomin pri zdravljenju spastičnega tortikolisa, saj niso opazili nikakršnih statistično značilnih razlik med posameznimi zdravljenji (celokupno ali paroma), vendar pa je bilo pri meritvi z EMG mogoče dokazati podobno učinkovitost zdravil Xeomin in Botox.
English: This disease leads to a wasting of muscle tissue.
Slovenian: Ta bolezen povzroča propadanje mišičnega tkiva;
English: Usually, undesirable effects are observed within the first week after treatment and are temporary in nature.
Slovenian: Navadno se neželeni učinki pojavijo v prvem tednu po zdravljenju in so začasni.
English: All adverse events were of mild or moderate severity except one case of treatment-related ptosis in the Xeomin and one case of unrelated myocardial infarction in the Botox group.
Slovenian: Vsi neželeni dogodki, o katerih so poročali, so bili blage ali zmerne resnosti, z izjemo enega primera z zdravljenjem povezane ptoze v skupini z zdravilom Xeomin ter enega primera z zdravljenjem nepovezanega miokardnega infarkta v skupini z zdravilom Botox.
English: Following injection of conventional Botulinum toxin type A complex, EMG showed increased jitter in some distant muscles which was not associated with muscle weakness or other types of electrophysiological abnormalities.
Slovenian: Po injiciranju običajnega kompleksa botulinskega toksina tipa A je preiskava EMG pokazala povečane trzljaje v nekaterih oddaljenih mišicah, ki niso bili povezani z mišično šibkostjo ali drugimi vrstami elektrofizioloških anomalij.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of cardiovascular safety pharmacology.
Slovenian: Neklinični podatki na podlagi običajnih kardiovaskularnih študij farmakološke varnosti ne kažejo posebnega tveganja za človeka.
English: The most frequently reported adverse event was ptosis (Xeomin 6.1%; Botox 4.6%).
Slovenian: Neželeni dogodek, o katerem so najpogosteje poročali, je bila ptoza (Xeomin 6,1 %; Botox 4,6 %).
English: Blocking antibodies were detected in 4 of 42 (9.5%) patients treated only with original Botox and in none of the patients treated with only the current Botox, despite a higher mean dose of current Botox per visit than original Botox.
Slovenian: Blokirajoča protitelesa so bila opažena pri 4 izmed 42 (9,5 %) bolnikov, zdravljenih le z originalnim zdravilom Botox, ter pri nobenem izmed bolnikov, zdravljenih le s sedanjim zdravilom Botox, in sicer navkljub večjemu povprečnemu odmerku sedanjega zdravila Botox na obisk kot originalnega.
English: If you have been inactive for a long period of time, any activity should be started gradually after the Xeomin injection.
Slovenian: Če dolgo časa niste bili telesno dejavni, morate po injiciranju zdravila Xeomin postopno začeti s telesno aktivnostjo.
English: The two related adverse events were reported in the same patient who received 30/60 U of Xeomin (one injection site pain and one dysphagia).
Slovenian: O obeh povezanih neželenih dogodkih so poročali pri istem bolniku, ki je prejel 30/60 enot zdravila Xeomin (bolečina na mestu injiciranja in disfagija).
English: Like many other proteins of its size, Botulinum neurotoxin type A has been shown to undergo retrograde axonal transport after intramuscular injection.
Slovenian: Kot veliko drugih proteinov te velikosti je tudi botulinski nevrotoksin tipa A po intramuskularnem injiciranju podvržen retrogradnem aksonskem transportu.
English: Of the 908 participants, 239 thereof experienced adverse events (AEs).
Slovenian: Izmed 908 udeležencev je pri 239 prišlo do neželenih dogodkov.
English: Therefore the concomitant use of Xeomin with aminoglycosides or spectinomycin requires special care.
Slovenian: Zato je pri sočasni uporabi zdravila Xeomin in aminoglikozidov ali spektinomicina potrebna posebna previdnost.
English: An injection volume of approximately 0.05 to 0.1 ml is recommended.
Slovenian: Priporočena prostornina injiciranega zdravila je približno 0,05 do 0,1 ml.
English: Treatment-related muscular weakness was observed in 1.1% of all patients randomised to Xeomin vs. 0.2% of all Botox patients, whereas the Phase Ib study MRZ-0113 showed no difference in the diffusion of both preparations in adjacent muscles.
Slovenian: Z zdravljenjem povezano oslabelost mišic so opazili pri 1,1 % vseh bolnikov, naključno dodeljenih v skupino z zdravilom Xeomin, v primerjavi z 0,2 % vseh bolnikov, zdravljenih z zdravilom Botox, medtem ko študija faze Ib MRZ-0113 ni izkazala nobenih razlik pri difuziji obeh preparatov v sosednje mišice.
English: By reason of these facts it is implausible, that injection of Xeomin would lead to more frequent secondary therapeutic failures than Botox.
Slovenian: Na podlagi teh dejstev ni verjetno, da bi injiciranje zdravila Xeomin vodilo do pogostejše sekundarne neuspešnosti zdravljenja kot zdravilo Botox.
English: The nerve terminals of the neuromuscular junction no longer respond to nerve impulses, and secretion of the neurotransmitter is prevented (chemical denervation).
Slovenian: Živčni končiči motoričnih ploščic se ne odzivajo na živčne impulze, zato se prepreči izločanje nevrotransmiterja (kemijska denervacija).
English: • if you suffer from generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
Slovenian: • če imate splošne okvare mišične aktivnosti (npr. miastenijo gravis, Lambert-Eatonov sindrom),
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEOMIN <(see Annex I)> - Quality issues
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA XEOMIN (glejte Dodatek I)
English: The occurrence of dysphagia is attributable to the spread of the pharmacological effect of Xeomin as the result of the neurotoxin spread into the oesophageal musculature.
Slovenian: Pojav disfagije se lahko pripiše širjenju farmakološkega učinka zdravila Xeomin, ki je posledica širjenja nevrotoksina v mišice ezofagusa.
English: Due to the very low number in each group, results of this Phase II study were not considered to be useful from a safety point a view.
Slovenian: Glede na zelo majhno število v posamezni skupini rezultati te študije II.
English: General disorders and administration site conditions Very common: pain, local weakness Common:
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosti: bolečina, lokalna šibkost Pogosti:
English: However, there is no indication of a higher antigenic potential of Xeomin compared to Botox.
Slovenian: Vendar pa tudi ni nikakršnih znakov za večji antigenski potencial zdravila Xeomin v primerjavi z zdravilom Botox.
English: Botox and Xeomin are different drug substances in terms of clostridial protein content, although both contain the same 150 kDa neurotoxin, which is the actual active substance.
Slovenian: Botox in Xeomin sta z vidika vsebnosti proteinov Clostridium različni zdravili, čeprav obe vsebujeta isti 150 kDa nevrotoksin, ki predstavlja dejansko zdravilno učinkovino.
English: The numbers of adverse events in Phase II study and in Phase III dystonia Study are submitted in the following Table:
Slovenian: faze in študiji III. faze za distonijo so podana v naslednji tabeli:
English: It is possible that these undesirable effects may also occur with Xeomin.
Slovenian: Možno je, da se ti neželeni učinki pojavijo tudi pri uporabi zdravila Xeomin.
English: Solvent added (sodium chloride 9 mg/ml (0.9%) solution for injection)
Slovenian: Količina dodanega vehikla (natrijev klorid 9 mg/ml (0,9 %) raztopino za injiciranje)