FrancophonIA/ELRC3.0 huggingface dataset:
English: Absorption Following administration of either a single dose of 0.58 mg of Xiapex to 16 patients with Dupuytren's contracture, or two concurrent injections of 0.58 mg of Xiapex in the same hand in 12 patients with Dupuytren's contracture, no quantifiable levels of Xiapex were detected in plasma from 5 minutes to 30 days post injection.
Slovenian: Absorpcija Po aplikaciji bodisi enkratnega odmerka 0,58 mg zdravila Xiapex 16 bolnikom z Dupuytrenovo kontrakturo ali dveh sočasnih injekcij po 0,58 mg zdravila Xiapex v isto roko 12 bolnikom z Dupuytrenovo kontrakturo v času od 5 minut do 30 dni po injiciranju ni bilo zaznati merljivih nivojev zdravila Xiapex v plazmi.
English: • After a 30 second rest period, repeat the penile modelling technique for a total of 3 modelling attempts at 30 seconds for each attempt.
Slovenian: • Nato ga sprostite in počakajte 30 sekund, preden tehniko modeliranja penisa ponovite, in sicer skupaj izvedite 3 poskuse s po 30 sekundami za vsak poskus.
English: Baseline disease characteristics of patientsa with Peyronie's Disease (PD)
Slovenian: Značilnosti bolezni ob izhodišču pri bolnikiha s Peyroniejevo boleznijo (PB)
English: This is a condition where adult men have a ‘plaque' that can be felt and a curve to their penis.
Slovenian: To je bolezen, pri kateri imajo odrasli moški ‘plak', ki se ga lahko otipa, in ukrivljenost penisa.
English: • 0.25 ml of reconstituted Xiapex for cords affecting a MP joint or • 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint.
Slovenian: • 0,25 ml rekonstituiranega zdravila Xiapex za vozliče, ki prizadenejo MP sklep, ali • 0,20 ml rekonstituiranega zdravila Xiapex za vozliče, ki prizadenejo PIP sklep.
English: The overall safety profile was similar in the two Phase 3 double-blind placebo-controlled studies (832 male patients, 551 patients received Xiapex) and in an open-label Phase 3 study (189 male patients) of patients who had previously received placebo in the controlled studies.
Slovenian: Splošni varnostni profil je bil podoben v dveh dvojno slepih, s placebom nadzorovanih študijah 3. faze (832 bolnikov moškega spola, 551 bolnikov je prejemalo zdravilo Xiapex) in v odprti študiji 3. faze (189 bolnikov moškega spola) pri bolnikih, ki so predhodno v nadzorovanih študijah prejemali placebo.
English: Severe penile haematoma was also reported as an adverse reaction in 39 of 1044 patients (3.7%) in the controlled and uncontrolled clinical studies in Peyronie's disease.
Slovenian: O hudem hematomu penisa kot neželenem učinku so poročali pri 39 od 1.044 bolnikov (3,7 %) v nadzorovanih in nenadzorovanih kliničnih študijah pri Peyroniejevi bolezni.
English: Xiapex also demonstrated a clinically significant benefit compared to placebo in decreasing the degree of contracture and increasing both the range of motion from baseline for all joints treated (MP plus PIP, MP only, PIP only) and the subject global assessment of treatment satisfaction.
Slovenian: Zdravilo Xiapex je pokazalo tudi klinično pomembne koristi v primerjavi s placebom pri zmanjšanju stopnje kontrakture in zvečanju razpona gibanja glede na izhodišče za vse zdravljene sklepe (MP in PIP, samo MP, samo PIP), kot tudi pri globalni oceni zadovoljnosti z zdravljenjem preskušanca.
English: The syringe and needle used for reconstitution are thereafter removed and discarded.
Slovenian: Brizgo in iglo, ki ste ju uporabili za rekonstitucijo, potem odstranite in zavrzite.
English: Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord.
Slovenian: Poskušajte se izogniti temu, da bi s konico igle prebodli vozlič, da zmanjšate možnost injiciranja zdravila Xiapex v druga tkiva.
English: • blood pressure increased
Slovenian: • zvišanje krvnega tlaka
English: Peyronie's disease: The treatment area should be identified and marked with a surgical marker on the erected penis.
Slovenian: Peyroniejeva bolezen: predel zdravljenja morate določiti na nabreklem penisu in ga označiti s kirurškim markerjem.
English: Pre-existing reduced peripheral circulation, e.g. Raynaud syndrome, and the use of epinephrine combined with local anaesthetics in these patients may contribute to this (see also section 4.8).
Slovenian: npr. Raynaudov sindrom, in uporaba adrenalina v kombinaciji z lokalnimi anestetiki (glejte tudi poglavje 4.8).
English: b “skin laceration” includes “injection site laceration” and “laceration” c “oedema peripheral” includes “injection site oedema” and “oedema” d see also section 4.4
Slovenian: c “periferni edem” vključuje “edem na mestu injiciranja” in “edem” d glejte tudi poglavje 4.4
English: Primary efficacy endpoint was fixed flexion contracture in the treated joint pair subgroup.
Slovenian: Primarni opazovani dogodek učinkovitosti je bila popravljena fleksijska kontraktura v podskupini zdravljenega para sklepov.
English: • increased liver enzymes
Slovenian: • povečane vrednosti jetrnih encimov;
English: Cases of digital phalangeal fractures have been reported after finger manipulation procedure.
Slovenian: Poročali so o primerih falangealnih zlomov po postopku obravnave prstov.
English: PDQ bother**
Slovenian: Težave zaradi PDQ**
English: Xiapex is supplied in a pack containing 1 vial of Xiapex powder and 1 vial of solvent.
Slovenian: Zdravilo Xiapex je na voljo v pakiranju, ki vsebuje po 1 vialo praška zdravila Xiapex in 1 vialo z vehiklom.
English: At a follow-up visit 1 to 3 days after the second injection of each treatment cycle, perform a penile modelling procedure (as described below) on the flaccid penis to stretch and elongate the plaque that Xiapex has disrupted:
Slovenian: Ob kontrolnem obisku 1 do 3 dni po drugi injekciji vsakega cikla zdravljenja opravite postopek modeliranja penisa (kot je opisano spodaj) pri mlahavem penisu, da zdravljeni plak, ki ga je zdravilo Xiapex prekinilo, raztezate in podaljšate:
English: When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion must not be more than 2 to 3 mm in depth and not more than 4 mm distal to the palmar digital crease.
Slovenian: Kadar injiciramo v vozlič PIP sklepa petega prsta, vbod z iglo ne sme biti globlji od 2 do 3 mm in mora biti oddaljen manj kot 4 mm distalno od palmarne gube.
English: The mITT population was defined as all randomized subjects who had both a penile curvature deformity measurement and a PDQ assessment at baseline and at one or more subsequent time points.
Slovenian: Populacija mITT je bila opredeljena kot vse randomizirane osebe, ki so imele izmerjeno deformacijo ukrivljenosti penisa in oceno PDQ ob izhodišču in na eni ali več naslednjih časovnih točkah.
English: Please consult a doctor immediately if you experience any signs or symptoms of a serious allergic reaction, e.g., wide spread redness or rash, swelling, tightness in the throat or difficulty breathing.
Slovenian: Nemudoma se posvetujte s svojim zdravnikom, če se pri vas pojavijo kakršnikoli znaki ali simptomi resnih alergijskih reakcij, npr. rdečina ali izpuščaj po celem telesu, oteklina, tiščanje v žrelu ali težave pri dihanju.
English: Xiapex is injected by your doctor into the cord in your finger/hand or plaque in your penis and works by breaking down the collagen in the cord or plaque.
Slovenian: Zdravilo Xiapex vam zdravnik injicira v vozlič v prstu/roki ali v plak v penisu in deluje tako, da razgrajuje kolagen v vozliču ali plaku.
English: Xiapex is a lyophilized product for parenteral administration containing collagenase clostridium histolyticum which is comprised of two collagenases in a defined mass ratio.
Slovenian: Zdravilo Xiapex je liofiliziran izdelek za parenteralno aplikacijo, ki vsebuje kolagenazo clostridium histolyticum, ki jo sestavljata dve kolagenazi v določenem masnem razmerju.
English: Xiapex should be injected into the target plaque when the penis is in a flaccid state.
Slovenian: Zdravilo Xiapex je treba injicirati v ciljni plak, ko je penis v mlahavem stanju.
English: • collection of blood outside of a blood vessel on scrotum
Slovenian: • kopičenje krvi zunaj krvne žile na skrotumu
English: 1 vial of solvent
Slovenian: 1 viala vehikla
English: Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), patients should be instructed to:
Slovenian: Po postopku (postopkih) iztegovanja prstov in namestitvi opornice bolniku (z zdravljenim sklepom v maksimalni ekstenziji) je treba bolnikom naročiti:
English: Total FFC (°)
Slovenian: Skupaj PFK (°)
English: At five years after the initial injection of Xiapex the majority of subjects (>90%) were seropositive for anti-AUX-I and anti-AUX-II antibodies.
Slovenian: Pet let po začetni injekciji zdravila Xiapex je bila večina oseb (> 90 %) seropozitivnih za protitelesa proti AUX-I in proti AUX-II.
English: Xiapex demonstrated a clinically significant benefit compared to placebo in the proportion of patients achieving the primary endpoint of a reduction in the contracture of all joints treated to 5° or less, approximately 4 weeks after the last injection (MP plus PIP, MP only, PIP only).
Slovenian: Zdravilo Xiapex je pokazalo klinično pomembne koristi v primerjavi s placebom v deležu bolnikov, ki so dosegli primarni opazovan dogodek zmanjšanja kontrakture vseh zdravljenih sklepov na 5° ali manj, približno 4 tedne po zadnjem injiciranju (MP in PIP, samo MP, samo PIP).
English: AUX-I and AUX-II are single polypeptide chains consisting of approximately 1000 amino acids of known sequence with a molecular weight of 114 kDa and 113 kDa respectively as determined by mass spectrometry.
Slovenian: Kot je ugotovljeno z masno spektrometrijo sta AUX-I in AUX-II enojni polipeptidni verigi, ki ju sestavlja približno 1.000 aminokislin znanega zaporedja, z molekulskimi masami 114 kDa in 113 kDa.
English: A finger extension procedure was performed if needed, approximately 24 hours after injection to facilitate disruption of the cord.
Slovenian: Če je bilo to potrebno, je bil napravljen postopek iztegovanja prsta, približno 24 ur po injiciranju, da je bila olajšana prekinitev vozliča.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xiapex in all subsets of the paediatric population in the treatment of Dupuytren's contracture (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Xiapex za zdravljenje Dupuytrenove kontrakture za vse podskupine pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Injections in up to two cords or two affected joints in the same hand can be administered according to the injection procedure during a treatment visit.
Slovenian: Injiciranje v do dva vozliča ali dva prizadeta sklepa iste roke je možno v skladu s postopkom injiciranja med obiskom za zdravljenje.
English: This medicine must only be injected into the collagen cord in your hand by your doctor.
Slovenian: To zdravilo vam lahko zdravnik injicira samo v kolagenski vozlič v roki.
English: There were no other clinically relevant differences between two concurrent injections of Xiapex in the same hand and up to three single injections of Xiapex in the types of adverse events reported (i.e., most adverse events were local to the treated extremity and of mild or moderate intensity).
Slovenian: Drugih klinično pomembnih razlik med dvema sočasnima injekcijama zdravila Xiapex v isto roko in do tremi enkratnimi injekcijami zdravila Xiapex med vrstami poročanih neželenih učinkov ni bilo (tj. večina neželenih učinkov je bilo lokalnih v zdravljeni okončini in blage do zmerne intenzivnosti).
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart.
Slovenian: Če je bolezen povzročila več kontraktur, je možno dodatne vozliče zdraviti ob drugih obiskih za zdravljenje s približno 4-tedenskim časovnim zamikom.
English: b p-value < 0.05.
Slovenian: b vrednost p < 0,05
English: Patients with Dupuytren's contractures that adhere to the skin may be at higher risk of skin lesions as a result of the pharmacological effect of Xiapex and the finger extension procedure on the skin overlying the targeted cord.
Slovenian: Bolniki z Dupuytrenovimi kontrakturami, ki se držijo kože, imajo večje tveganje za kožne spremembe na koži, ki leži nad tarčnim vozličem, kot posledica farmakoloških učinkov zdravila Xiapex in postopka iztegovanja prsta.
English: Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.
Slovenian: Injekcije in postopek iztegovanja prstov se sme ponoviti do trikrat na posamezen vozlič v približno 4-tedenskih intervalih.
English: The site chosen for injection must be the area where the contracting cord is maximally separated from the underlying flexor tendons and where the skin is not intimately adhered to the cord.
Slovenian: Mesto injiciranja mora biti izbrano tako, da je v predelu, kjer je kontrakcijski vozlič najbolj oddaljen od spodaj ležečih kit upogibalk in kjer koža ni pričvrščena neposredno na vozlič.
English: Following each of two intralesional administrations, separated by 24 hours, of Xiapex 0.58 mg into the penile plaque of 19 patients with Peyronie's disease, plasma levels of AUX-I and AUX-II in patients with quantifiable levels (82% and 40% for AUX-I and AUX-II, respectively) were minimal and shortlived.
Slovenian: Po dveh intralezijskih aplikacijah 0,58 mg zdravila Xiapex v plak penisa pri 19 bolnikih s Peyroniejevo boleznijo s 24-urnim presledkom, so bile ravni AUX-I in AUX-II v plazmi pri bolnikih z merljivimi ravnmi (82 % za AUX-I in 40 % za AUX-II) minimalne in kratkotrajne.
English: There is no relevant use of Xiapex in children and adolescents aged 0-18 years for the treatment of Dupuytren's contracture or Peyronie's disease.
Slovenian: Zdravilo Xiapex ni primerno za uporabo pri otrocih in mladostnikih, starih 0-18 let, za zdravljenje Dupuytrenove kontrakture ali Peyroniejeve bolezni.
English: For Peyronie's disease, Xiapex breaks down the collagen in the plaque that is causing your erect penis to curve, which may help the previously bent erection to become straighter and enable you to feel less bothered by your disease.
Slovenian: Pri Peyroniejevi bolezni zdravilo Xiapex razgradi kolagen v plaku, ki povzroča ukrivljenost penisa med erekcijo, in lahko pomaga predhodno upognjeni erekciji, da postane bolj ravna, ter lajšanju težav,
English: Figure 3: Illustration how to stretch your penis
Slovenian: Slika 3: Prikaz raztezanja penisa
English: Injection of Xiapex into collagen containing structures may result in damage to those structures, and possible permanent injury such as tendon rupture or ligament damage.
Slovenian: Injiciranje zdravila Xiapex v strukture, ki vsebujejo kolagen, utegne poškodovati te strukture in povzročiti trajno poškodbo, na primer rupturo kite ali poškodbo ligamenta.
English: • swollen face
Slovenian: • oteklina obraza
English: Dupuytren's contracture
Slovenian: Dupuytrenova kontraktura
English: • skin wound at the site of injection
Slovenian: • kožna rana na mestu injiciranja;
English: Six weeks after the eighth injection (fourth treatment cycle) of Xiapex >99% of Xiapex-treated patients developed high titers of antibodies to both AUX-I and AUX-II.
Slovenian: Šest tednov po osmi injekciji (četrti cikel zdravljenja) zdravila Xiapex je > 99 % bolnikov, zdravljenih z zdravilom Xiapex, razvilo visoke titre protiteles proti AUX-I in
English: • skin wound, blood blister
Slovenian: • kožna rana, krvav mehur;
English: Do not invert the vial or shake the solution.
Slovenian: Viale ne obračajte in ne stresajte raztopine.
English: The active substance in Xiapex is collagenase clostridium histolyticum, and this collagenase is produced using the microorganism Clostridium histolyticum.
Slovenian: Učinkovina v zdravilu Xiapex je encim kolagenaza clostridium histolyticum in ta kolagenaza se proizvaja s pomočjo mikroorganizma Clostridium histolyticum.
English: If the disease has resulted in multiple contractures, additional cords may be treated at other treatment visits approximately 4 weeks apart, as determined by your doctor.
Slovenian: Če se bolezen kaže s številnimi kontrakturami, se lahko dodatni vozliči zdravijo ob drugih obiskih za zdravljenje s približno 4-tedenskim časovim zamikom, kot bo določil zdravnik.
English: Approximately 24-72 hours after injection, a finger extension procedure may be performed, as necessary, to facilitate cord disruption.
Slovenian: Približno 24 - 72 ur po injiciranju lahko začnete izvajati postopek iztegovanja prstov, kot bo potrebno, da boste pospešili prekinitev vozliča.
English: • collection of blood outside the blood vessels
Slovenian: • kopičenje krvi zunaj krvnih žil
English: Administration of a local anaesthetic medicinal product prior to injection of Xiapex is not recommended, as it may interfere with proper placement of the injection.
Slovenian: Aplikacija lokalnega anestetika pred injiciranjem zdravila Xiapex ni priporočljiva, ker lahko vpliva na primeren položaj injiciranja.
English: Some patients with Dupuytren's contracture developed IgE-anti-drug antibodies in greater proportions and higher titers with successive Xiapex injections.
Slovenian: Pri nekaterih bolnikih z Dupuytrenovo kontrakturo so se razvila protitelesa IgE proti zdravilu v večjem deležu in z višjimi titri pri naknadnih injekcijah zdravila Xiapex.
English: There is no experience in the use of Xiapex in breast-feeding women therefore the use of Xiapex is not recommended during breast-feeding.
Slovenian: Izkušenj z uporabo zdravila Xiapex pri doječih ženskah ni, zato se uporaba zdravila Xiapex med dojenjem ne priporoča.
English: Dupuytren's contracture: The joint to be treated (MP or PIP) should be confirmed as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
Slovenian: Dupuytrenova kontraktura: sklep, ki ga boste zdravili (MP ali PIP), je treba potrditi, saj je volumen vehikla, ki je potreben za rekonstitucijo, določen glede na vrsto sklepa (za PIP sklep je potreben manjši volumen za injiciranje).
English: • painful glands near the elbows or under the arm
Slovenian: • boleče bezgavke blizu komolca ali pod pazduho;
English: While the patient's wrist is in the flexed position, a moderate stretching pressure should be applied to the injected cord by extending the finger for approximately 10 to 20 seconds.
Slovenian: Ko je bolnikovo zapestje v skrčenem položaju, je treba izvajati zmeren raztezni pritisk na injicirani vozlič tako, da za približno 10 do 20 sekund iztegujete prst.
English: With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord.
Slovenian: S svojo dominantno roko namestite iglo v vozlič in pazite, da bo ostala v vozliču.
English: At the follow-up visit approximately 24-72 hours after injection, it should be determined if the contracture has resolved.
Slovenian: Na kontrolnem obisku približno 24 - 72 ur po injiciranju je treba preveriti, ali je kontraktura odpravljena.
English: There was no evidence of accumulation following two sequential injections of Xiapex administered 24 hours apart.
Slovenian: Znakov kopičenja po dveh zaporednih injekcijah zdravila Xiapex s 24-urnim presledkom ni bilo.
English: No formal medicinal product interaction studies with Xiapex have been performed.
Slovenian: Študij medsebojnega delovanja zdravila Xiapex z drugimi zdravili niso izvedli.
English: • fever, general pain, discomfort, tiredness, feeling hot, malaise, flu-like illness
Slovenian: • vročina, splošna bolečina, nelagodje, utrujenost, občutek vročine, splošno slabo počutje,
English: In addition to the in-office penile modelling procedure, patients should be provided instructions on the appropriate technique to self-perform penile modelling activities at home each day for the 6-week period following the physician penile plaque modelling visit of each treatment cycle, according to the detailed instructions provided in the package leaflet.
Slovenian: Poleg ambulantnega postopka modeliranja penisa je treba bolnikom dati navodila za ustrezno tehniko za samoizvajanje aktivnosti modeliranja penisa doma, vsak dan za obdobje 6 tednov po obisku vsakega cikla zdravljenja, na katerem zdravnik opravi modeliranje plaka penisa, v skladu s podrobnimi navodili iz navodila za uporabo.
English: Mean percent change in penile curvature deformity from baseline to week 52 - Studies 1 and 2
Slovenian: Povprečna sprememba deformacije ukrivljenosti penisa v odstotkih od izhodišča do 52. tedna - študiji 1 in 2 Študija 1
English: While the patient's wrist is in the flexed position, apply moderate stretching pressure to the injected cord by extending the finger for approximately 10 to 20 seconds.
Slovenian: Ko je bolnikovo zapestje v skrčenem položaju, izvajajte zmeren raztezni pritisk na injiciran vozlič tako, da za približno 10 do 20 sekund iztegujete prst.
English: Apply antiseptic at the site of the injection and allow the skin to dry.
Slovenian: Na mesto injiciranja nanesite antiseptik in počakajte, da se koža osuši.
English: There is no experience in the use of Xiapex in pregnant women therefore the use of Xiapex is not recommended in pregnancy, and treatment should be postponed until after pregnancy.
Slovenian: Izkušenj z uporabo zdravila Xiapex pri nosečnicah ni, zato uporaba zdravila Xiapex v času nosečnosti ni priporočljiva in je treba zdravljenje odložiti na čas po nosečnosti.
English: A phase 4, non-treatment, long-term follow-up study (AUX-CC-810) was undertaken to evaluate the efficacy and safety up to 5 years after the first injection of Xiapex in the pivotal 12-month doubleblind placebo-controlled phase 3 studies or in the 9-month open-label phase 3 studies.
Slovenian: Izvedli so dolgoročno študijo spremljanja brez zdravljenja, 4. faze, (AUX-CC-810), s katero so ocenili učinkovitost in varnost do 5 let po prvi injekciji zdravila Xiapex v ključnih 12-mesečnih dvojno slepih, s placebom nadzorovanih študijah 3. faze ali v 9-mesečnih odprtih študijah 3. faze.
English: There were no clinically meaningful differences in the incidence of adverse events following treatment with Xiapex based on the severity of baseline erectile dysfunction or concomitant phosphodiesterase type 5 (PDE5) inhibitor use.
Slovenian: Klinično pomembnih razlik v incidenci neželenih učinkov po zdravljenju z zdravilom Xiapex na podlagi resnosti erektilne disfunkcije ob izhodišču ali sočasne uporabe zaviralca fosfodiesteraze tipa 5
English: What Xiapex looks like and contents of the pack
Slovenian: Izgled zdravila Xiapex in vsebina pakiranja
English: In the two double-blind, placebo-controlled phase 3 studies in Peyronie's disease, 65.5% of Xiapex-treated patients developed penile haematoma and 14.5% developed penile ecchymosis.
Slovenian: V dveh dvojno slepih, s placebom nadzorovanih študijah 3. faze za Peyroniejevo bolezen se je pri 65,5 % bolnikov, zdravljenih z zdravilom Xiapex, razvil hematom penisa, pri 14,5 % pa se je razvila ekhimoza penisa.
English: Total fixed flexion contracture and range of motion following administration of two concurrent injections of Xiapex 0.58 mg in the same hand, mITT population, study AUXCC-867 (first treatment cycle)
Slovenian: Skupna popravljena fleksijska kontraktura in razpon gibanja po dajanju dveh sočasnih injekcij zdravila Xiapex 0,58 mg v isto roko, populacija mITT, študija AUX-CC-867 (prvi cikel zdravljenja)
English: Apply a dressing as necessary.
Slovenian: Po potrebi ga obvežite.
English: Cumulative Nominal Recurrence by Joint Type (%)
Slovenian: Skupna nominalna ponovitev glede na vrsto sklepa (%)
English: • The need to inform the patient about the signs and symptoms associated with the treatment and when to seek attention from the health care provider.
Slovenian: • opomnik, da je potrebno poročanje o neželenih učinkih, vključno z napakami pri uporabi zdravila, • potreba po informiranju bolnikov o znakih in simptomih, ki so povezani z zdravljenjem, ter o tem, kdaj morajo poiskati pomoč zdravstvenih delavcev, • povzetek glavnih značilnosti zdravila in navodilo za uporabo.