FrancophonIA/ELRC3.0 huggingface dataset:
English: - In LPT12444, in week 36, three weeks after the final injection, the ELISA test (indicating the presence of antibodies against Botulinum neurotoxin type A) revealed that seven of the 20 rabbits treated with Botox showed a positive response and four of these rabbits displayed BoNT/A neutralising activity in the hemidiaphragm assay (HDA indicating if antibodies are neutralising or non-neutralising).
Slovenian: - Pri LPT12444 je v 36. tednu študije, tri tedne po končnem injiciranju, test ELISA (izkazujoč prisotnost protiteles proti nevrotoksinu botulinu tipa A) pokazal, da je sedem od 20 zajcev, ki so prejemali zdravilo Botox, izkazovalo pozitiven odziv, štirje od teh zajcev pa so izkazovali nevtralizirajočo aktivnost proti BoNT/A pri testu HDA (hemidiaphragm assay) (pri čemer HDA pokaže, ali so protitelesa nevtralizirajoča ali nenevtralizirajoča).
English: Based on clinical experience information on the frequency of adverse reactions for the individual indications is given below.
Slovenian: Spodaj so podane informacije o pogostnosti neželenih učinkov za posamezne indikacije, pridobljene na podlagi kliničnih izkušenj.
English: The optimum dosage and number of injection sites in the treated muscle should be determined by the physician individually for each patient.
Slovenian: Optimalni odmerek in število mest injiciranja v zdravljeni mišici mora zdravnik določiti za vsakega bolnika posebej.
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally] Medicinal product subject to medical prescription.
Slovenian: NAČIN IZDAJANJA ZDRAVILA [Izpolni država članica] Izdaja zdravila je le na recept.
English: For safe disposal, unused vials should be reconstituted with a small amount of water and then autoclaved.
Slovenian: Za varno odstranjevanje je treba neuporabljene viale rekonstituirati z malo vode in nato avtoklavirati.
English: The nonclinical data clearly demonstrated that one unit of Xeomin is equipotent to one unit of Botox and a clear dose-response was shown in two species.
Slovenian: Neklinični podatki jasno kažejo, da je ena enota zdravila Xeomin ekvipotentna eni enoti zdravila Botox, na dveh živalskih vrstah pa je bila prikazana povezava med odmerkom in odzivom.
English: Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
Slovenian: Splošne motnje mišične aktivnosti (npr. miastenija gravis, Lambert-Eatonov sindrom).
English: Do not use Xeomin after the expiry date which is stated on the carton and vial label after “EXP”.
Slovenian: Zdravila Xeomin ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki poleg oznake "Uporabno do".
English: This exposure may lead to a damaging of the surface and an inflammation (corneal ulceration).
Slovenian: Ta izpostavljenost lahko povzroči poškodbe površine in vnetje (razjede na roženici).
English: Swallowing difficulties appear to be dose-dependent.
Slovenian: Videti je, da so težave pri požiranju odvisne od odmerka.
English: Thus, up to now no case of secondary therapy failure can be derived from the ongoing studies, in which Xeomin (or placebo) has been used repetitively in a total of 213 patients, even though Xeomin doses are partially very high (which is usually a risk factor of antibody formation).
Slovenian: Tako do sedaj na podlagi potekajočih študij, pri katerih se zdravilo Xeomin (ali placebo) uporablja s ponovitvami pri skupno 213 bolnikih, ni bilo mogoče sklepati na sekundarno neuspešnost zdravljenja, čeprav so odmerki zdravila Xeomin deloma visoki (kar je običajno dejavnik tveganja za nastanek protiteles).
English: If you develop swallowing difficulties, speech or breathing disorders, please contact medical emergency services or ask your relatives to do so (see section 4).
Slovenian: Če se pojavijo težave pri požiranju ali motnje govora ali dihanja, pokličite nujno zdravniško pomoč ali prosite družinske člane, da to storijo (glejte poglavje 4).
English: The heavy chain of the Botulinum neurotoxin type A binds with an exceptionally high selectivity and affinity to receptors only found on cholinergic terminals.
Slovenian: Težka veriga botulinskega nevrotoksina tipa A se izjemno selektivno in z veliko afiniteto veže na receptorje, ki jih najdemo samo na holinergičnih končičih.
English: Therefore, the use of Xeomin in breast-feeding women is not recommended.
Slovenian: Zato uporaba zdravila Xeomin pri ženskah, ki dojijo, ni priporočena.
English: In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital.
Slovenian: Če začutite znake prevelikega odmerjanja, takoj poiščite nujno medicinsko pomoč ali prosite družinske člane, da to storijo, in pojdite v bolnišnico.
English: Vial (type 1 glass) with rubber stopper (bromobutyl rubber) and tamper-proof seal (aluminium) in pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Slovenian: Viala (steklo vrste 1) z gumijastim zamaškom (bromobutilna guma) in tesnilom, odpornim proti odpiranju (aluminij), v pakiranjih po 1 (pakiranje z eno enoto), 2, 3 ali 6 vial (pakiranje z več enotami).
English: Free circulating Botulinum neurotoxin type A molecules which have not bound to presynaptic cholinergic nerve terminal receptors will be phagocytosed or pinocytosed and degraded like any other free circulating protein.
Slovenian: Proste molekule botulinskega nevrotoksina tipa A, ki se ne vežejo na receptorje na presinaptičnih holinergičnih živčnih končičih, bodo fagocitirane ali pinocitirane in razkrojene kot vsi drugi prosto cirkulirajoči proteini.
English: Reduced blinking following Xeomin injection into the orbicularis muscle can lead to corneal exposure, persistent epithelial defects and corneal ulceration, especially in patients with cranial nerve disorders (facial nerve).
Slovenian: Zmanjšano mežikanje po injiciranju zdravila Xeomin v orbikularno mišico lahko povzroči izpostavljenost roženice, stalne okvare epitelija in ulceracijo roženice, zlasti pri bolnikih z okvarami karnialnega živca (facialnega živca).
English: Presence of infection at the proposed injection site.
Slovenian: Okužba na predvidenem mestu injiciranja.
English: One LD50 unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Slovenian: Ena enota LD50 ustreza mediani smrtnega odmerka (LD50), kadar se rekonstituirano zdravilo intraperitonealno injicira v miši pod določenimi pogoji.
English: * One unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Slovenian: * Ena enota ustreza mediani smrtnega odmerka (LD50), kadar se rekonstituirano zdravilo intraperitonealno injicira v miši pod določenimi pogoji.
English: Theoretically, the effect of Botulinum neurotoxin may be potentiated by aminoglycoside antibiotics or other medicinal products that interfere with neuromuscular transmission e.g. tubocurarine-type muscle relaxants.
Slovenian: Teoretično se lahko učinek botulinskega nevrotoksina okrepi z aminoglikozidnimi antibiotiki ali drugimi zdravili, ki ovirajo nevromuskulaturni prenos, npr. tubokuraninskimi mišičnimi relaksanti.
English: No drug-related SAE was reported, there were no withdrawals due to adverse events.
Slovenian: Poročali niso o nobenih resnih neželenih dogodkih, povezanih z zdravilom, ravno tako ni bilo prekinitev zdravljenja zaradi neželenih dogodkov.
English: For instructions on reconstitution / dilution of the vials, see section 6.6.
Slovenian: Navodila za rekonstitucijo/redčenje vsebine vial so v poglavju 6.6.
English: Xeomin may only be used by health care professionals experienced in the application of Botulinum toxin.
Slovenian: Zdravilo Xeomin smejo uporabljati samo zdravniki, izkušeni v uporabi botulinskega toksina.
English: In cases where no therapeutic effect is apparent, alternative therapies should be taken into consideration.
Slovenian: Kadar je očitno, da zdravljenje ni učinkovito, je treba pretehtati možnost drugega zdravljenja.
English: The possible reasons are different techniques of reconstitution, the chosen injection intervals, the injected muscles and marginally varying toxin activity resulting from the biological testing procedure employed or secondary non-response.
Slovenian: Razlogi za to so lahko različne tehnike rekonstitucije, izbrani presledki med injiciranji, mišice, v katere se zdravilo injicira, in mejna nihanja aktivnosti toksina zaradi biološke raznolikosti ali sekundarne neodzivnosti.
English: Measures in cases of overdose:
Slovenian: Ukrepi pri prevelikem odmerjanju:
English: • To submit the results of all scheduled HDA tests of the upper limb spasticity study (MRZ 0410) and the cervical dystonia study (MRZ 0408) after unblinding of the respective studies.
Slovenian: • Predložitev rezultatov vseh načrtovanih testov HDA iz študije spastičnosti v zgornjih okončinah (MRZ 0410) in študije cervikalne distonije (MRZ 0408) po razkritju zadevnih študij.
English: [See Annex I - To be completed nationally]
Slovenian: [Izpolni država članica]
English: For intramuscular use
Slovenian: Za intramuskularno uporabo.
English: If more Xeomin is used than should be
Slovenian: Če ste uporabili večji odmerek zdravila Xeomin, kot bi smeli
English: special form of inflammation of the cornea (superficial punctate keratitis), inability to close eye (lagophthalmos), eye irritation, fear of light (photophobia), tearing (lacrimation)
Slovenian: posebna oblika vnetja roženice (površinski pikčasti keratitis), nezmožnost zaprtja očesa (lagoftalmus), draženje oči, strah pred svetlobo (fotofobija), solzenje (lakrimacija)
English: Like all medicines, Xeomin can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Xeomin neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: The exposed portion of the rubber stopper of the vial is cleaned with alcohol (70%) prior to insertion of the needle.
Slovenian: Pred vstavitvijo igle očistite izpostavljeni del gumijastega zamaška z alkoholom (70 %).
English: All of the SAEs were assessed as unrelated to treatment.
Slovenian: Vsi resni neželeni dogodki so bili ocenjeni kot nepovezani z zdravljenjem.
English: Symptoms of overdose are not immediately apparent post-injection and may include general weakness, ptosis, diplopia, swallowing and speech difficulties or paralysis of the respiratory muscles resulting in an aspiration pneumonia.
Slovenian: Simptomi prevelikega odmerjanja niso opazni takoj po injiciranju, mednje pa lahko spadajo splošna šibkost, ptoza, diplopija, težave pri požiranju ali govoru ali paraliza dihalnih mišic, ki povzroča aspiracijsko pljučnico.
English: In this trial, 65 out of 231 patients (28.1%) treated with Xeomin reported a total of 110 adverse events.
Slovenian: Pri tej študiji je 65 izmed 231 bolnikov (28,1 %), ki so prejemali zdravilo Xeomin, poročalo o skupno 110 neželenih dogodkih.
English: In this trial, 40 out of 148 patients (27.0%) treated with Xeomin reported a total of 57 adverse events.
Slovenian: Pri tej študiji je 40 izmed 148 bolnikov (27,0 %), ki so prejemali zdravilo Xeomin, poročalo o skupno 57 neželenih dogodkih.
English: What Xeomin is and what it is used for Before you use Xeomin How to use Xeomin Possible side effects How to store Xeomin Further information
Slovenian: Kaj je zdravilo Xeomin in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Xeomin Kako uporabljati zdravilo Xeomin Možni neželeni učinki
English: Symptoms of overdose are not apparent immediately after the injection and may be general weakness, drooping eyelid, double vision, swallowing and speech difficulties, and pneumonia.
Slovenian: Znaki prevelikega odmerjanja niso očitni takoj po injiciranju, lahko pa se pojavijo splošna šibkost, povešene veke, dvojni vid, težave pri požiranju in govoru ter pljučnica.
English: Reproductive toxicity studies with Xeomin, performed in rabbits, did not show adverse effects on male or female fertility nor direct effects on embryo-foetal development.
Slovenian: Študije vpliva na sposobnost razmnoževanja zdravila Xeomin, opravljene pri kuncih, niso pokazale neželenih učinkov na plodnost samcev ali samic niti učinkov na razvoj zarodka in ploda.
English: Batch:
Slovenian: JRS:
English: Lastly, the proposed SPC for Xeomin does not claim a potentially lower risk of development of antibodies with the product: “It has not been investigated whether secondary non-response due to the development of antibodies is less frequent under Xeomin therapy than under treatment with conventional preparations containing the Botulinum neurotoxin type A complex.
Slovenian: Končno pa predlagani povzetek glavnih značilnosti zdravila za zdravilo Xeomin ne obljublja morebitnega manjšega tveganja za razvoj protiteles pri uporabi izdelka: "Ni bilo raziskano, ali je sekundarni neodziv zaradi razvoja protiteles pri zdravljenju z zdravilom Xeomin manj pogost kot pri zdravljenju s klasičnimi pripravki, vsebujočimi kompleks nevrotoksina botulina tipa A. V primeru neodziva je treba razmisliti o alternativnih terapijah.
English: In addition, the HDA titer increased from <5 mU/mL to >5 mU/mL in 2 patients in each treatment group.
Slovenian: Poleg tega je HDA titer pri 2 bolnikih iz vsake skupine narasel z <5 me/ml na >5 me/ml.
English: Consequently you should avoid driving and operating machinery until your faculties are fully recovered.
Slovenian: Posledično se morate izogibati tem opravilom, dokler se te sposobnosti ne povrnejo v celoti.
English: • One Phase II study (MRZ/BTC-9801)
Slovenian: faze (MRZ/BTC-9801)
English: The rate of serious adverse events (SAEs) in all studies was 2.1% with Xeomin and 2.7% with Botox.
Slovenian: Pogostost resnih neželenih dogodkov je bila v vseh študijah 2,1 % pri zdravilu Xeomin in 2,7 % pri zdravilu Botox.
English: In order to prevent ectropion, injections into the lower lid area should be avoided, and vigorous treatment of any epithelial defect is necessary.
Slovenian: Treba se je izogibati injiciranju v območje spodnje veke, da se prepreči ektropij, vsako okvaro epitelija pa je treba takoj zdraviti.
English: In non-clinical studies, the pharmacological effect (i.e. degree of the paralytic activity, effect on motility, effect on paralysis over time, duration) of Xeomin was compared to Botox: - The paralytic activity of Xeomin and Botox was assessed in the mouse regional paralysis test, after 3 repeated intramuscular injections at 6 and 13 week intervals up to a dose of 0.64 Lethal Dose Unit (LDU)/animal for Xeomin and Botox (approx. 32 LDU/kg).
Slovenian: Pri nekliničnih študijah so farmakološki učinek (tj. stopnjo paralitične aktivnosti, vpliv na motiliteto, vpliv na paralizo v teku časa, trajanje) zdravila Xeomin primerjali z zdravilom Botox: - paralitično aktivnost zdravil Xeomin in Botox so ocenjevali s testom področne paralize pri miših, po 3 ponovljenih intramuskularnih injekcijah v 6- in 13-tedenskih intervalih v odmerku do 0,64 smrtnega odmerka (LDU)/žival zdravil Xeomin in Botox (pribl.
English: Any used vials, syringes, and spillage etc. should be sterilised under high pressure and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Slovenian: Vse uporabljene viale, brizge, prelito tekočino itd. je treba sterilizirati pod visokim tlakom, preostalo zdravilo Xeomin pa inaktivirati z razredčeno raztopino natrijevega hidroksida (0,1 N NaOH).
English: In Phase II dose finding trial, the efficacy in patients with rotational cervical dystonia at three doses (10, 20 and 30 U) of Xeomin was compared to the optimal dose of Botox (30 U).
Slovenian: faze za določitev odmerka so pri bolnikih s cervikalno distonijo z rotacijo glave primerjali učinkovitost zdravila Xeomin v treh odmerkih (10, 20 in 30 e) z optimalnim odmerkom zdravila Botox (30 e).
English: 100 LD50 units
Slovenian: LD50
English: A suitable sterile needle (e.g. 25-30 gauge/0.30-0.50 mm) is used for injections into superficial muscles, and an e.g. 22 gauge/0.70 mm needle may be used for injections into deeper musculature.
Slovenian: Za injiciranje v superficialne mišice se uporablja ustrezna sterilna igla (npr. velikosti 25−30/0,30−0,50 mm), za injiciranje v globlje mišice pa se lahko uporabi npr. igla velikosti 22/0,70 mm. Priporočena prostornina injiciranega zdravila je približno 0,1 do 0,5 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE UNIT PACK (1 VIAL)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PAKIRANJE ENE ENOTE (1 VIALE)
English: It remains unclear whether these deaths were induced by conventional preparations containing the Botulinum toxin type A complex or caused by pre-existing cardiovascular disease.
Slovenian: Ni znano, ali so te smrti povzročili običajna zdravila s kompleksom botulinskega toksina tipa A ali pa obstoječa kardiovaskularna bolezen.
English: Of the Xeomin patients with a negative mouse hemidiaphragm assay (HDA) result at baseline, indicating that no neutralising antibodies are present, 2 individuals had a positive result (<5 mU/mL) at the final visit.
Slovenian: Izmed bolnikov, zdravljenih z zdravilom Xeomin, z negativnim izhodiščnim rezultatom testa HDA, izkazujočim, da ni prisotnih nevtralizirajočih protiteles, sta imela ob končnem pregledu pozitiven rezultat (<5 me/ml) dva posameznika.
English: In clinical trials with Botulinum toxin type A complex, it was reported that swallowing difficulties occur less frequently with low doses.
Slovenian: V kliničnih preskušanjih s kompleksom botulinskega toksina tipa A so poročali, da so težave pri požiranju manj pogoste pri majhnih odmerkih.
English: Measures in cases of overdose
Slovenian: Ukrepi pri prevelikem odmerjanju
English: swallowing difficulties (dysphagia), muscle weakness, back pain
Slovenian: težave pri požiranju (disfagija), mišična šibkost, bolečina v hrbtu
English: Side effects related to spread of Botulinum toxin distant from the site of administration have been reported (see section 4.8), sometimes resulting in death, which in some cases was associated with dysphagia, pneumonia and/or significant debility.
Slovenian: Poročali so o neželenih učinkih, povezanih z razširjanjem botulinskega toksina v mesta, oddaljena od mesta injiciranja (glejte poglavje 4.8), ki se včasih končajo s smrtjo, ki je bila povezana z disfagijo, pnevmonijo in/ali pomembno slabotnostjo.
English: Do not use Xeomin
Slovenian: Ne uporabljajte zdravila xeomin
English: • if you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection
Slovenian: • če imate izrazito šibke ali zmanjšane mišice, v katere vam bodo injicirali zdravilo,
English: Of the Botox patients 4 individuals with a negative result at baseline had a positive result (<5 mU/mL in 3 patients, >5 mU/mL in 1 patient) at the final visit.
Slovenian: Izmed bolnikov, zdravljenih z zdravilom Botox, so imeli ob končnem pregledu pozitiven rezultat 4 posamezniki z negativnim izhodiščnim rezultatom (<5 me/ml 3 bolniki, >5 me/ml 1 bolnik).
English: Xeomin has minor or moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Xeomin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
English: In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 63 patients received the 2nd injection, 27 patients received the 3rd, and 6 patients received the 4th injection, respectively.
Slovenian: Pri študiji cervikalne distonije (MRZ 0408), v katerem se dajejo odmerki do 240 enot zdravila Xeomin, je 63 bolnikov prejelo 2. injekcijo, 27 bolnikov 3. injekcijo in 6 bolnikov 4. injekcijo.
English: There is limited experience in treatment-naïve patients and long-term treatment.
Slovenian: Izkušnje pri bolnikih, ki nikoli prej niso bili zdravljeni ali se zdravijo dolgotrajno, so omejene.
English: For safe disposal, unused vials should be reconstituted with a small amount of water then sterilised under high pressure.
Slovenian: Za varno odstranjevanje je treba neuporabljene viale rekonstituirati z malo vode in nato sterilizirati pod velikim tlakom.
English: Careful testing of corneal sensation should be performed in patients with previous eye operations.
Slovenian: Pri bolnikih s predhodnim kirurškimi posegi na očeh je treba previdno preskusiti kornealno zaznavo.
English: The following side effect probabilities and allocated frequencies are used for the categorisation of side effects:
Slovenian: Pri razvrščanju neželenih učinkov so uporabljene njihove naslednje verjetnosti in pogostnosti:
English: • marginally varying effectiveness of the active substance of Xeomin
Slovenian: • nekoliko spreminjajoča se učinkovitost zdravilne učinkovine v zdravilu Xeomin;
English: Due to differences in the LD50 assay, these units are specific to Xeomin and are not applicable to other Botulinum toxin preparations.
Slovenian: Zaradi razlik v preskusih za določanje vrednosti LD50 so te enote specifične za zdravilo Xeomin in ne veljajo za druga zdravila, ki vsebujejo botulinski toksin.
English: For Botox, 45 out of 152 patients (29.6%) reported a total of 62 adverse events.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Botox, je 45 izmed 152 bolnikov (29,6 %) poročalo o skupno 62 neželenih dogodkih.
English: In the blepharospasmus study (MRZ 0433) 6 patients received the 2nd injection.
Slovenian: Pri študiji blefarospazma (MRZ 0433) je 6 bolnikov prejelo 2. injekcijo.
English: Blepharospasm
Slovenian: Blefarospazem
English: Native Botulinum toxin is a high molecular weight complex, which, in addition to the neurotoxin (150 kD) contains other non-toxic proteins, like haemagglutinins and nonhaemagglutinins.
Slovenian: Nativni botulinski toksin je kompleks z veliko molsko maso, ki poleg nevrotoksina (150 kD) vsebuje druge netoksične beljakovine, kot so hemaglutinini in nehemaglutinini.
English: There have been rare reports of undesirable effects related to cardiovascular system, such as arrhythmia and myocardial infarction, some with fatal outcomes.
Slovenian: Obstajajo poročila o neželenih učinkih, povezanih s kardiovaskularnim sistemom, kot sta aritmija in miokardni infarkt, včasih s smrtnim izidom.
English: The primary efficacy variable was the decrease from baseline of the most relevant (i.e. highest amplitude) surface electromyography (EMG) level in the dystonic sternocleidomastoid muscle during maximal voluntary activation 14 days post-injection.
Slovenian: ravni površinske elektromiografske meritve (EMG) glede na izhodiščno vrednost v distonični sternokleidomastoidni mišici med maksimalno prostovoljno aktivacijo 14 dni po injiciranju.
English: Receptor-bound Botulinum neurotoxin type A is endocytosed into the nerve terminal prior to reaching its target (SNAP 25) and will eventually be degraded intracellularly.
Slovenian: Nevrotoksin tipa A, vezan na receptorje, se endocitira v živčne končiče, preden doseže ciljni protein (SNAP 25), in se nazadnje intracelularno razgradi.
English: Large doses may cause paralysis in muscles distant to the injection site.
Slovenian: Veliki odmerki lahko povzročijo paralizo mišic, ki so oddaljene od mesta injiciranja.
English: Reconstituted Xeomin is intended for intramuscular injection.
Slovenian: Rekonstituirano zdravilo Xeomin je namenjeno intramuskularnemu injiciranju.
English: In clinical trials with Botulinum toxin type A complex it was reported that dysphagia occurs less frequently with total doses below 200 U per treatment session.
Slovenian: V kliničnih preskušanjih s kompleksom botulinskega toksina tipa A so poročali, da je disfagija manj pogosta pri skupnih odmerkih pod 200 e. na cikel zdravljenja.
English: Xeomin is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Slovenian: Zdravilo Xeomin je indicirano za simptomatsko obravnavanje blefarospazma in cervikalne distonije, predvsem rotacijske oblike (spastični tortikolis), pri odraslih.