FrancophonIA/ELRC3.0 huggingface dataset:
English: Consequently affected persons should avoid these tasks until their faculties are fully recovered.
Slovenian: Posledično se morajo osebe izogibati tem opravilom, dokler se te sposobnosti ne povrnejo v celoti.
English: • have had an eye surgery.
Slovenian: • imeli kirurški poseg na očesu.
English: • Two Phase III studies (one study in each of the intended indication, spasmodic torticollis
Slovenian: • dve študiji III. faze (po ena študija za vsako predvideno indikacijo, spastični tortikolis
English: • non-response/therapy failure during the course of treatment.
Slovenian: • neodzivnost na zdravljenje/neuspešnost zdravljenja med njegovim izvajanjem.
English: These findings must be interpreted cautiously because all patients were not systematically tested for Botulinum toxin antibodies.
Slovenian: Te rezultate je treba interpretirati previdno, saj vsi bolniki niso bili sistematično testirani na protitelesa proti botulinskemu toksinu.
English: The frequency categories are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnost neželenih učinkov je opredeljena na naslednji način: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1,000, < 1/100), redki (≥ 1/10.000, < 1/1.000); zelo redki (< 1/10.000).
English: Xeomin contains albumin, a derivative of human blood.
Slovenian: Zdravilo Xeomin vsebuje albumin, derivat človeške krvi.
English: • injections into another muscle
Slovenian: • injiciranje v drugo mišico;
English: Unopened vial: 3 years
Slovenian: Neodprte viale: 3 leta.
English: The recommended dilutions are indicated in the following table:
Slovenian: Priporočene razredčitve so navedene v naslednji tabeli:
English: The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
Slovenian: Učinek vsakega zdravljenja na splošno traja 3-4 mesece, lahko pa tudi bistveno manj ali dlje.
English: 4-Aminochinolines may reduce the effect of Xeomin.
Slovenian: 4-aminokinolini lahko zmanjšajo učinek zdravila Xeomin.
English: (peripheral neuromuscular dysfunction)
Slovenian: (periferno nevromuskulatorno disfunkcijo);
English: A clinical pack is also available with 6 vials.
Slovenian: Na voljo je tudi klinično pakiranje s 6 vialami.
English: Three patients discontinued the studies prematurely due to adverse events considered as unrelated to study drug.
Slovenian: Trije bolniki so predčasno prekinili udeležbo v študijah zaradi neželenih dogodkov, ocenjenih kot nepovezanih z obravnavanim zdravilom.
English: In the management of blepharospasm, total dosing should not exceed 100 U every 12 weeks.
Slovenian: Pri obravnavanju blefarospazma skupni odmerek ne sme preseči 100 e. vsakih 12 tednov.
English: This is also relevant for medicinal products that weaken the muscle.
Slovenian: To velja tudi za zdravila, ki oslabijo mišice.
English: Reconstitution and dilution should be performed with good practice, particularly with respect to asepsis.
Slovenian: Rekonstitucijo in redčenje je treba opraviti v skladu z dobro prakso, zlasti glede aseptičnosti.
English: The HDA tests of the available samples were still in analysis, when the applicant's response was circulated.
Slovenian: Analiza testov HDA razpoložljivih vzorcev je ob razpošiljanju odgovora vlagatelja še potekala.
English: 0.5 ml 1.0 ml 2.0 ml 4.0 ml
Slovenian: 0,5 ml 1,0 ml 2,0 ml 4,0 ml 8,0 ml e. e. e. e. e.
English: • To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials.
Slovenian: • Predložitev načrta za obvladovanje tveganj v skladu z veljavno smernico, vključno s: o podrobno strategijo za izobraževanje zdravnikov, ki vključuje ustrezno tehniko injiciranja, odmerjanje in neobstoj medsebojne zamenljivosti med izdelki, kakor tudi programe za kontinuiran in izboljšan nadzor širjenja pri klinični uporabi in kliničnih preizkušanjih;
English: In each of the ongoing studies, data are still blinded, but no secondary therapy failures due to antibody development have been reported up to now.
Slovenian: Pri vsaki od potekajočih študij so podatki še vedno slepi (nerazkriti), vendar pa doslej še niso poročali o nobenem sekundarnem neuspehu zdravljenja zaradi razvoja protiteles.
English: Medical intervention may be necessary (e.g. in the form of a gastric feeding tube) (see also section 4.8).
Slovenian: Morda bo potreben zdravniški poseg (npr. v obliki gastrične sonde za hranjenje) (glejte tudi poglavje 4.8).
English: • the scope of the referral was the potential risk to public health concerning the need for data in repeated administration and data on immunogenicity for Xeomin
Slovenian: • predmet napotitve je bilo potencialno tveganje za javno zdravje v zvezi s potrebo po podatkih o ponovljeni uporabi in podatkih o imunogenosti zdravila Xeomin,
English: stiffness, hypertonia
Slovenian: otrplost, hipertonija
English: Clinical pack.
Slovenian: Klinično pakiranje.
English: Patients with smaller neck muscle mass, or patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk.
Slovenian: Bolniki z manjšo maso vratnih mišic ali bolniki, pri katerih je potrebno bilateralno injiciranje v sternokleidomastoidne mišice, so izpostavljeni večjemu tveganju.
English: Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.
Slovenian: Vso raztopino za injiciranje, ki je bila shranjena več kot 24 ur, in neuporabljeno raztopino za injiciranje je treba zavreči.
English: • swelling of the hands, feet, ankles, face, lips, mouth or throat.
Slovenian: • otekanje rok, stopal, gležnjev, obraza, ustnic, ust ali grla.
English: The solvent must be injected gently into the vial.
Slovenian: Vehikel morate nežno vbrizgati v vialo.
English: Your doctor will know if you are at risk.
Slovenian: Zdravnik bo vedel, ali pri vas obstaja nevarnost za pojav te bolezni.
English: If you have the impression that the effect of Xeomin is too strong or too weak, let your doctor know.
Slovenian: Če menite, da je učinek zdravila Xeomin premočan ali prešibak, se posvetujte z zdravnikom.
English: • if you suffer from a disease called amyotrophic lateral sclerosis.
Slovenian: • če imate bolezen, imenovano amiotrofična lateralna skleroza.
English: • different techniques of preparation of the product by your doctor
Slovenian: • različne tehnike priprave zdravila;
English: • if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin (see section 6 “Further information”)
Slovenian: • če ste alergični na (preobčutljivi za) botulinski nevrotoksin tipa A ali katero koli sestavino zdravila Xeomin (glejte poglavje 6 “Dodatne informacije”),
English: In contrast, one animal treated with Xeomin was tested positively in the ELISA test, but no neutralising activity was detected in the HDA.
Slovenian: V nasprotju s tem je bila ena žival, ki je prejemala zdravilo Xeomin, pozitivna na testu ELISA, vendar pa na testu HDA nevtralizirajoča aktivnost ni bila ugotovljena.
English: Theoretically, the effect of Xeomin may be reduced by: • certain anti-malaria / anti-rheumatic medicines (4-Aminochinolines).
Slovenian: Teoretično lahko učinek zdravila Xeomin zmanjšajo: • nekatera zdravila proti malariji in antirevmatiki (4-aminokinolini).
English: Most of the adverse events were of mild or moderate severity in both groups.
Slovenian: Večina neželenih dogodkov v obeh skupinah je bila blage ali zmerne resnosti.
English: The submitted clinical trial programme consisted of:
Slovenian: Predloženi program kliničnih preizkušanj so tvorile:
English: No genotoxicity, carcinogenicity and pre- and postnatal development studies have been conducted with Xeomin.
Slovenian: Študij genotoksičnosti, kancerogenosti in pre- in postnatalnega razvoja z zdravilom Xeomin niso opravili.
English: There are no reports of viral transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
Slovenian: Poročil o prenosu virusov z albuminom, izdelanim z uveljavljenimi postopki po specifikacijah Evropske farmakopeje, ni.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF
Slovenian: IME ZDRAVILA IN POT(I) UPORABE
English: very common more than 1 per 10 treated people common less than 1 per 10, but more than 1 per 100 treated people uncommon less than 1 per 100, but more than 1 per 1,000 treated people rare less than 1 per 1,000, but more than 1 per 10,000 treated people very rare less than 1 per 10,000 treated people, incl.
Slovenian: manj kot pri 1 od 10 zdravljenih oseb, vendar več kot pri 1 od 100 zdravljenih oseb občasni manj kot pri 1 od 100 zdravljenih oseb, vendar več kot pri 1 od 1.000 zdravljenih oseb redki manj kot pri 1 od 1.000 zdravljenih oseb, vendar več kot pri 1 od 10.000 zdravljenih oseb zelo redki manj kot pri 1 od 10.000 zdravljenih oseb, vključno s posameznimi primeri
English: The applicant has submitted the total number of adverse events with no distinction between adverse events related or not related.
Slovenian: Vlagatelj je predložil skupno število neželenih dogodkov brez delitve na povezane ali nepovezane neželene dogodke.
English: The period between each treatment session should be at least 10 weeks.
Slovenian: Med dvema cikloma zdravljenja mora biti vsaj 10 tednov.
English: Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
Slovenian: Prenos impulza se na novo vzpostavi s tvorbo novih živčnih končičev in motoričnih ploščic.
English: - Efficacy issues
Slovenian: - Vidiki učinkovitosti
English: Based on the results, it could be concluded that pharmacological effect of Xeomin and Botox are almost comparable in animals.
Slovenian: Na podlagi teh podatkov je mogoče skleniti, da sta farmakološka učinka zdravil Xeomin in Botox pri živalih skoraj primerljiva.
English: The results of initial treatment with Xeomin should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved.
Slovenian: Rezultate začetnega zdravljenja z zdravilom Xeomin je treba oceniti in po potrebi prilagoditi odmerek, dokler ni dosežen želeni terapevtski učinek.
English: Phone: +49-69/15 03-1
Slovenian: Telefon: +49-69/15 03-1
English: This may lead to problems with breathing and you may have a higher risk of inhaling foreign substances or fluids.
Slovenian: To lahko povzroči težave pri dihanju in morda bo tveganje za vdihovanje tujkov ali tekočin večje.
English: Your doctor can limit these by immediately applying gentle pressure at the injection site.
Slovenian: Zdravnik jih lahko omeji s takojšnjim nežnim pritiskom na mesto injiciranja.
English: A continuous systemic exposure of the dams during the (unknown) sensitive phase of the organogenesis as a pre-requisite for the induction of teratogenic effects cannot necessarily be assumed.
Slovenian: Ni možno z gotovostjo domnevati, da je neprekinjena sistemska izpostavljenost mladičev med (neznano) občutljivo fazo organogeneze predpogoj za pojav teratogenih učinkov.
English: This can occur more often if you suffer from disorders of your facial nerves.
Slovenian: Poškodbe so lahko pogostejše, če imate motnje obraznih živcev.
English: Extra caution is required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Slovenian: Posebna previdnost je potrebna pri injiciranju zdravila v mesta, ki so blizu občutljivih struktur, kot so karotidna arterija ali pljučni vršički.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 LD50 units
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 100 enot LD50
English: Prior to administering Xeomin the physician must make himself familiar with the patient's anatomy and any alterations to the anatomy due to prior surgical procedures.
Slovenian: Pred injiciranjem zdravila Xeomin se mora zdravnik seznaniti z bolnikovo anatomijo in vsemi spremembami anatomije zaradi predhodnih kirurških posegov.
English: For hospital use only
Slovenian: Samo za uporabo v bolnišnicah.
English: • If you have further questions, please ask your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
English: • if you receive substances that prevent the blood from clotting (anticoagulant therapy)
Slovenian: • če jemljete zdravila za preprečevanje strjevanja krvi (antikoagulante);
English: Xeomin is used for the treatment of the following conditions in adults:
Slovenian: Zdravilo Xeomin se uporablja za zdravljenje naslednjih bolezni pri odraslih:
English: Overall, safety data from 908 participants have been included in these trials, 466 subjects were treated with Xeomin and 442 subjects were treated with Botox.
Slovenian: Skupno so bili v ta preizkušanja vključeni podatki o varnosti 908 udeležencev, izmed katerih je bilo 466 oseb zdravljenih z zdravilom Xeomin, 442 oseb pa z zdravilom Botox.
English: This may require protective drops, ointments, soft bandage contact lenses, or closure of the eye by patching or similar means.
Slovenian: Za zdravljenje bodo morda potrebne zaščitne kapljice, mazila, mehke zaščitne kontaktne leče ali zaprtje očesa s povojem ali podobnim sredstvom.
English: One hundred and ten patients are in the 3rd and 13 patients in the 4th injection cycle.
Slovenian: 110 bolnikov se trenutno nahaja v 3. ciklu, 13 bolnikov pa v 4. ciklu injiciranja.
English: Theoretically, the effect of Xeomin may be increased by:
Slovenian: Teoretično lahko učinek zdravila Xeomin okrepijo:
English: The use of Xeomin in children and adolescents has not yet been investigated and is therefore not recommended.
Slovenian: Uporabe zdravila Xeomin pri otrocih in mladostnikih niso preizkušali, zato ni priporočena.
English: After reconstitution, Xeomin should be used for only one injection session and for only one patient.
Slovenian: Po rekonstituciji se lahko zdravilo Xeomin uporabi samo za eno injiciranje in samo pri enem bolniku.
English: If difficulties arise isolating single muscles, injections should be performed using electromyographic guidance.
Slovenian: Če se pri izolaciji posameznih mišic pojavijo težave, je treba injiciranje opraviti z elektromiografskim vodenjem.
English: 2 Jankovic J, Hunter C, Dolimbek BZ, Dolimbek GS, Adler CH, Brashear A, et al. Clinicoimmunologic aspects of botulinum toxin type B
Slovenian: 2 Jankovic J, Hunter C, Dolimbek BZ, Dolimbek GS, Adler CH, Brashear A, et al. Clinicoimmunologic aspects of botulinum toxin type B treatment of cervical dystonia.
English: The findings made in repeat-dose toxicity studies conducted with Xeomin were mainly related to its pharmacodynamic action.
Slovenian: Ugotovitve pri študijah toksičnosti pri ponavljajočih se odmerkih, opravljene z zdravilom Xeomin, so bile večinoma povezane z njegovim farmakološkim delovanjem.
English: Patients with a history of dysphagia and aspiration should be treated with extreme caution.
Slovenian: Bolnike z disfagijo in aspiracijo v anamnezi je treba zdraviti izjemno previdno.
English: • if you suffer from any disease that disturbs the interaction between nerves and skeletal muscles
Slovenian: • če imate druge bolezni, ki ovirajo medsebojno delovanje med živci in skeletnimi mišicami
English: Injections near the levator palpebrae superioris should be avoided to reduce the occurrence of ptosis.
Slovenian: Injekcijam v bližini mišice levator palpebrae superioris se je treba izogibati, da se zmanjša pogostnost ptoze.
English: • Two Phase I studies MRZ/BTC-9901 and MRZ/BTC-0113, of which the latter was performed after completion of the Phase III studies
Slovenian: • dve študiji I. faze MRZ/BTC-9901 in MRZ/BTC-0113, med katerima je bila druga izvedena po zaključku študij III. faze
English: Xeomin has not been studied in the paediatric population and is therefore not recommended in the paediatric age group until further data become available.
Slovenian: Zdravila Xeomin pri pediatrični populaciji niso raziskovali, zato uporaba tega zdravila pri pediatrični populaciji ni priporočena, dokler novi podatki ne bodo na voljo.
English: The informational value of the Phase III studies concerning immunogenicity is limited, as the patients were pretreated with Botox, and Xeomin was administered only once.
Slovenian: Informacijska vrednost študij III. faze v zvezi z imunogenostjo je omejena, saj so bili bolniki predhodno zdravljeni z zdravilom Botox, zdravilo Xeomin pa je bilo aplicirano le enkrat.
English: Xeomin has been developed with the aim of reducing the risk of formation of neutralising antibodies, which may lead to secondary therapy failure.
Slovenian: Zdravilo Xeomin je bilo razvito z namenom zmanjšanja tveganja za nastanek nevtralizirajočih protiteles, ki utegnejo privesti do sekundarne neuspešnosti zdravljenja.
English: This disease can cause the inner eye pressure to rise and may lead to a damaging of your optic nerve.
Slovenian: Ta bolezen lahko povzroči zvišanje očesnega tlaka in lahko poškoduje optični živec.
English: The recommended single doses of Xeomin should not be exceeded and the intervals between injections should not be shortened.
Slovenian: Priporočeni enkratni odmerek zdravila Xeomin se ne sme preseči, presledki med injiciranji pa se ne smejo skrajšati.
English: The study proposed is an open, single arm study in which 74 patients with cervical dystonia (naïve and pre-treated) are planned.
Slovenian: Predlagana študija je odprta neprimerjalna študija, v kateri je načrtovana udeležba 74 bolnikov s cervikalno distonijo (predhodno zdravljenih in nezdravljenih).
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Med standardnimi ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človekove krvi ali plazme, so izbira darovalcev, presejalno testiranje posamezne krvi ali plazme in skupin plazme za specifične označevalce ter uporaba učinkovitih izdelovalnih tehnik za inaktivacijo/odstranitev virusov.
English: At present there are three ongoing clinical studies with Xeomin (all of which have a placebocontrolled single injection main period and subsequent extension periods, in which only Xeomin is administered).
Slovenian: Trenutno potekajo tri klinične študije z zdravilom Xeomin (pri čemer imajo vse med njimi s placebom kontrolirano glavno obdobje z enkratnim injiciranjem ter nadaljnja razširitvena obdobja, v katerih se daje le zdravilo Xeomin).
English: They may be restricted to the area around the injection site (e.g. local pain, tenderness at the injection site, and injection site haemorrhage).
Slovenian: Lahko so omejeni na območje okoli mesta injiciranja (npr. lokalna bolečina, občutljivost na mestu injiciranja in krvavitev na mestu injiciranja).
English: Nevertheless, the mean change of surface EMG level in the sternocleidomastoid muscle, which is to be regarded as an objective parameter, showed a clear dose-trend of Xeomin.
Slovenian: Navkljub temu je povprečna sprememba ravni površinske EMG meritve v sternokleidomastoidni mišici, ki jo je mogoče obravnavati kot objektivni parameter, izkazovala jasno odvisnost od odmerka za zdravilo Xeomin.
English: (MRZ/BTC-0013) and blepharospasm (MRZ/BTC-0003) respectively)
Slovenian: (MRZ/BTC-0013) oziroma blefarospazem (MRZ/BTC-0003).
English: • aminoglycoside antibiotics
Slovenian: • aminoglikozidni antibiotiki;
English: Too frequent dosing of Botulinum toxin may result in antibody formation which may lead to resistance to treatment (see section 4.2).
Slovenian: Zaradi prepogostega odmerjanja botulinskega toksina lahko pride do nastanka protiteles, ki lahko povzročijo odpornost na zdravljenje (glejte poglavje 4.2).
English: • To submit the results of a pharmacodynamic study in which “spread” of neurotoxin is quantified in comparison to two other Botox preparations.
Slovenian: • Predložitev rezultatov študije farmakodinamike, v kateri je širjenje nevrotoksina ovrednoteno glede na dva druga pripravka zdravila Botox.
English: These data were divided into 3 subgroups: patients with HDA negative, patients with positive antibodies < 5 mU/mL and patients with positive antibodies > 5 mU/mL.
Slovenian: Ti podatki so bili razdeljeni na 3 podskupine: bolniki z negativnim izvidom HDA, bolniki z < 5 me/ml pozitivnih protiteles ter bolniki z > 5 me/ml pozitivnih protiteles.
English: The difference of the total number of adverse events related or not related between Xeomin and Botox was not statistically significant.
Slovenian: Razlika v skupnem številu neželenih dogodkov, povezanih ali nepovezanih, med zdraviloma Xeomin and Botox statistično ni bila značilna.
English: The most common AEs (i.e. with an incidence of ≥1%) were dysphagia, ptosis, back and skeletal pain and muscle weakness, the majority of them assessed as mild or moderate.
Slovenian: Najpogostejši neželeni dogodki (tj. s pogostostjo ≥1%) so bili disfagija, ptoza, bolečina v hrbtu in kosteh ter oslabelost mišic, pri čemer je bila večina ocenjenih kot blagih ali zmernih.
English: In both treatment groups, 4 patients with a positive HDA result at baseline had a negative result at the final visit.
Slovenian: V obeh obravnavanih skupinah so 4 bolniki s pozitivnim izhodiščnim izvidom HDA imeli ob končnem pregledu negativen rezultat.
English: Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.
Slovenian: Bolnikom in oskrbnikom je treba svetovati, naj takoj poiščejo nujno zdravniško pomoč, če se pojavijo težave pri požiranju, govoru ali dihanju.
English: (Invented) Name
Slovenian: Izmišljeno ime Jakost
English: As with any medicine, an allergic reaction may occur with Xeomin.
Slovenian: Kot pri vseh zdravilih se lahko tudi pri zdravilu Xeomin pojavijo alergijske reakcije.
English: Adrenaline and other medical aids for treating anaphylaxis should be available.
Slovenian: Na voljo je treba imeti adrenalin in drugo zdravniško pomoč za zdravljenje anafilakse.
English: The immunological reactions on Xeomin were specifically investigated in the Phase III study MRZ0013 in patients with cervical dystonia.
Slovenian: Imunske reakcije na zdravilo Xeomin so namensko preučevali v študiji III. faze MRZ-0013 pri bolnikih s cervikalno distonijo.
English: Please inform your doctor prior to any treatment, if you:
Slovenian: Pred zdravljenjem obvestite zdravnika, če ste:
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: These may lead to breathing in foreign materials, which may require medical intervention.
Slovenian: To lahko povzroči vdihavanje tujkov, zaradi česar je potreben zdravniški poseg.
English: Resulting dose in units per 0.1 ml
Slovenian: Končni odmerek v enotah na 0,1 ml
English: This is of benefit in reducing effects on nearby muscles when small muscle groups are being injected.
Slovenian: To je koristno, ker se zmanjša učinek na sosednje mišice, kadar se zdravilo injicira v majhne skupine mišic.
English: Data of changes in TWSTRS-Severity score in patients with hemidiaphragm assay (HAD) positive group between control visit (3 weeks after one injection) and final visit (12 weeks after one injection) were submitted.
Slovenian: Predloženi so bili podatki o spremembah rezultata podlestvice za resnost (TWSTRS-Severity) pri bolnikih iz skupine pozitivnih na testu HDA (hemidiaphragm assay) med kontrolnim pregledom (3 tedne po eni injekciji) in končnim pregledom (12 tednov po eni injekciji).