natgillin/translations-raw huggingface dataset:
Because of the anticholinergic effect of Botulinum neurotoxin type A, Xeomin should be used with caution in patients at risk of developing an angle closure glaucoma. 
Zaradi antiholinergičnega učinka botulinskega toksina tipa A je treba zdravilo Xeomin pri bolnikih, pri katerih obstaja tveganje za nastanek glavkoma z zaprtim zakotjem, uporabljati previdno.
Xeomin should not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or particulate matter. 
Zdravila Xeomin ne smete uporabiti, če je rekonstituirana raztopina (pripravljena po zgornjih navodilih) videti motna ali če vsebuje kosmiče ali delce.
Overall, the safety data shows that the prevalence of adverse events (AEs) was nearly identical in the Xeomin and in the Botox group (26.6% vs. 26%, respectively). 
Podatki o varnosti kažejo, da je prevalenca neželenih dogodkov skorajda enaka v skupini, ki je prejemala zdravilo Xeomin, kot v skupini, ki je prejemala zdravilo Botox (26,6 % v primerjavi s
Rare reports of severe allergic (anaphylactic) reactions after injection of a conventional preparation containing the Botulinum toxin type A complex have been received. 
Obstajajo redka poročila o hudih alergijskih (anafilaktičnih) reakcijah po injiciranju običajnega zdravila s kompleksom botulinskega toksina tipa A.
From a quality point of view, Xeomin is highly purified and differs from the drug substance in Botox® and Dysport® in that it is free of complexing proteins (haemagglutinins). 
Z vidika kakovosti je zdravilo Xeomin visoko prečiščeno ter se od zdravilne učinkovine v zdravilih Botox in Dysport loči po tem, da ne vsebuje kompleksirajočih beljakovin
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C. 
Rekonstituirana raztopina: Raztopina ostane kemično in fizikalno stabilna 24 ur, če je shranjena pri temperaturi od 2 °C do 8 °C.
The patient should be regarded as a primary non-responder in cases of first injection failure. 
Če prvo injiciranje spodleti, je treba bolnika obravnavati, kot da se primarno ne odziva.
• Phase III Cervical Dystonia Study (MRZ 0013) 
• Študija III. faze za cervikalno distonijo (MRZ 0013)
generalised weakness, flu like symptoms, malaise Uncommon: fever 
splošna šibkost, simptomi, podobni gripi, slabotnost
o Steps to be taken to ensure that patients are adequately informed of the safety issues associated with these products, e.g. adequate labelling and patient brochures. 
o potrebnimi koraki, da bi zagotovili, da so bolniki ustrezno informirani o vidikih varnosti pri teh izdelkih, npr. ustrezno označevanje in brošure za bolnike; te informacije morajo vključevati izrecen napotek, naj bolniki takoj poiščejo zdravniško pomoč v primeru nastopa težav s požiranjem, govorom ali dihanjem;
After reconstitution: the product may be stored for a maximum of 24 hours at 2°C to 8°C. 
Po rekonstituciji: zdravilo se lahko shranjuje največ 24 ur pri temperaturi 2 °C do 8 °C.
Unit doses recommended for Xeomin are not interchangeable with those for other preparations of Botulinum toxin. 
Odmerki enot, priporočeni za zdravilo Xeomin, se ne smejo zamenjati z odmerki za druga zdravila botulinskega toksina.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL WHEN THIS IS PART/COMPONENT OF A CLINICAL PACK WITH 6 VIALS 
ŠKATLA ZA 1 VIALO, KADAR JE TO DEL/SESTAVNI DEL KLINIČNEGA PAKIRANJA S 6 VIALAMI
Dysphagia has been reported following injection to sites other than the cervical musculature. 
O disfagiji so poročali po injiciranju v mesta zunaj vratne muskulature.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR CLINICAL PACK WITH 6 VIALS 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA KLINIČNO PAKIRANJE S 6 VIALAMI
However, the administration of Xeomin at dose levels exhibiting clear maternal toxicity at weekly to biweekly intervals increased the number of abortions in a prenatal toxicity study in rabbits. 
Vendar je uporaba zdravila Xeomin v študijah prenatalne toksičnosti pri odmerkih, ki povzročajo toksičnost za matere v eno- in dvotedenskih presledkih, povečala število abortusov.
• Phase III Blepharospasm Study 
• Študija III. faze za blefarospazem
Xeomin has a protein content of only 0,6 ng/100U as it only consists of the 150 kDa neurotoxin, free from complexing proteins. 
Zdravilo Xeomin vsebuje le 0,6 ng/100 e beljakovin, saj vsebuje le 150 kDa nevrotoksin, ne pa tudi kompleksirajočih beljakovin.
Spasmodic torticollis 
Spastični tortikolis
The applicant has committed to perform a post-marketing surveillance study, in which immunogenicity of Xeomin will be further investigated after repeated administration (up to 6 injection sessions) . 
Vlagatelj se je zavezal, da bo izvedel postmarketinško študijo, v kateri bo imunogenost zdravila Xeomin po ponovljeni uporabi (do 6 injiciranj) še nadalje raziskana.
Undesirable effects may occur from misplaced injections of Botulinum neurotoxin type A temporarily paralysing nearby muscle groups. 
Neželene učinke lahko povzroči injiciranje botulinskega nevrotoksina tipa A v napačno mesto, kar začasno paralizira bližnje skupine mišic.
Injury, poisoning and procedural complications Uncommon: inflicted injury 
Poškodbe in zastrupitve in zapleti pri posegih Občasni:
• The other ingredients are: human albumin, sucrose 
• Pomožni snovi sta humani albumin, saharoza.
skin sores 
rane na koži
Side effects related to spread of toxin distant from the site of administration have been reported very rarely (excessive muscle weakness, swallowing difficulties, lung infection or inflammation due to the inhalation of foreign substances (aspiration pneumonitis) with fatal outcome in some cases). 
Zelo redko so poročali o neželenih učinkih, povezanih z razširjanjem botulinskega toksina na mesta, oddaljena od mesta injiciranja (pretirana mišična šibkost, težave pri požiranju, okužbe ali vnetja pljuč zaradi vdihavanja tujkov (aspiracijski pnevmonitis) s smrtnim izidom v nekaterih primerih).
Xeomin is reconstituted prior to use with sterile unpreserved sodium chloride 9 mg/ml (0.9%) solution for injection. 
Pred uporabo je treba zdravilo Xeomin rekonstituirati s sterilim natrijevim kloridom 9 mg/ml (0,9 %) raztopino za injiciranje brez dodanih konzervansov.
However, in clinical trials the related adverse events were numerically more frequent in the Xeomin group compared to the Botox group. 
Vendar pa so bili pri kliničnih preizkušanjih z zdravljenjem povezani neželeni dogodki številčno pogostejši v skupini z zdravilom Xeomin kot v skupini z zdravilom Botox.
Merz Pharma GmbH & Co. KGaA Eckenheimer Landstraße 100 60318 Frankfurt/Main Germany 
Merz Pharma GmbH & Co. KGaA Eckenheimer Landstraße 100 60318 Frankfurt/Main Nemčija
3 vials 
2 viali
Reconstituted Xeomin is a clear colourless solution free of particulate matter. 
Rekonstituirano zdravilo Xeomin je bistra brezbarvna raztopina brez delcev.
It is not known whether Botulinum neurotoxin type A is excreted into the breast milk. 
Ni znano, ali se botulinski nevrotoksin tipa A izloča v materino mleko.
Previously akinetic or sedentary patients should be reminded to gradually resume activities following the injection of Xeomin. 
Predhodno akinetične bolnike ali bolnike, ki se ne gibajo, je treba po injiciranju zdravila Xeomin spodbujati k aktivnosti.
After you receive a Xeomin injection into your eye muscle your blinking rate may be reduced. 
Po injiciranju zdravila Xeomin v očesno mišico se bo morda zmanjšala pogostnost mežikanja.
The mechanism of action by which Botulinum neurotoxin type A exerts its effects on cholinergic nerve terminals can be described by a three-step sequential process which includes the following steps: 
Mehanizem delovanja botulinskega nevrotoksina tipa A na holinergične živčne končiče poteka v treh zaporednih korakih: a)
- clinical verification of the neurotoxin effect on the injected muscle: e.g. an electromyographic investigation in a specialised facility - analysis of the reason for non-response, e.g. poor isolation of the muscles intended to be injected, too low dose, poor injection technique, fixed contracture, too weak antagonist, possible development of antibodies - review of Botulinum neurotoxin type A treatment as an adequate therapy - if no adverse reactions have occurred during the initial treatment, an additional course of treatment can be performed under the following conditions: 1) dose adjustment with regard to analysis of the most recent failure to respond, 2) EMG-guidance, 3) the recommended minimum interval between the initial and repeat treatment is not exceeded 
klinična potrditev učinka nevrotoksina na mišico, v katero je injiciran: npr. z elektromiografskim pregledom v specializirani ustanovi analiza razlogov za odsotnost odziva, npr. slaba izolacija mišic, v katere naj bi bilo zdravilo injicirano, premajhen odmerek, slaba tehnika injiciranja, fiksna kontraktura, prešibek antagonist, morebiten nastanek protiteles ponovna ocena ustreznosti zdravljenja z botulinskim nevrotoksinom tipa A
• In the blepharospasmus study (MRZ 0433) one patient has entered the second injection cycle. 
• v študiji blefarospazma (MRZ 0433) je v drugi cikel injiciranja vključen 1 bolnik.
• are at risk of developing a disease called angle closure glaucoma. 
• izpostavljeni tveganju za pojav bolezni, imenovane glavkom z zaprtim zakotjem.
An anaphylactic reaction may occur rarely after injection of Botulinum neurotoxin type A (see section 4.8). 
Po injiciranju botulinskega nevrotoksina tipa A redko lahko pride do anafilaktične reakcije (glejte poglavje 4.8).
Due to the latency of onset, some of the therapeutic and/or adverse effects of Xeomin may also interfere with the ability to drive and operate machinery. 
Zaradi zamika pri začetku delovanja ter nekaterih terapevtskih ali neželenih učinkov ali obojega lahko tudi zdravilo Xeomin vpliva na sposobnost vožnje in upravljanja strojev.
• In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 31 patients entered the second injection cycle. 
• v študiji cervikalne distonije (MRZ 0408), v kateri se daje do 240 e zdravila Xeomin, je v drugi cikel injiciranja vključenih 31 bolnikov;
Two non-clinical studies, LPT10929 and LPT12444 with repeated high dose administration of Xeomin (25 LDU/animal in LPT10929 and 16-40LDU/animal in LPT12444) at very short injection intervals were performed in rabbits: - In LPT10929, in study week 12, two weeks after the last administration, Botulinum neurotoxin type A neutralising antibodies were found in 4 of 8 surviving rabbits treated with Botox, but in none of the 10 surviving rabbits treated with Xeomin. 
Dve neklinični študiji, LPT10929 in LPT12444, sta bili izvedeni s ponovljeno uporabo velikega odmerka zdravila Xeomin (25 LDU/žival pri LPT10929 in 16-40 LDU/žival pri LPT12444) v zelo kratkih intervalih injiciranja, in sicer na zajcih:
Side effects related to spread of toxin distant from the site of administration have been reported very rarely (exaggerated muscle weakness, dysphagia, aspiration pneumonitis with fatal outcome in some cases) (see section 4.4). 
Zelo redko so poročali o neželenih učinkih, povezanih z razširjanjem toksina v mesta, oddaljena od mesta injiciranja (pretirana mišična šibkost, disfagija, aspiracijski pnevmonitis, včasih s smrtnim izidom) (glejte poglavje 4.4).
Of note, the only severe case of dysphagia occurred in a Botox treated patient. 
Edini resni primer disfagije je nastopil pri bolniku, zdravljenem z zdravilom Botox.
A female patient developed brachial plexopathy two days after injection of a conventional preparation containing the Botulinum toxin type A complex for the treatment of cervical dystonia, with recovery after five months. 
Pri eni bolnici se je razvila brahialna pleksopatija dva dni po injiciranju običajnega zdravila s kompleksom botulinskega toksina tipa A za zdravljenje cervikalne distonije.
Human pharmacokinetic studies with Xeomin have not been performed for the reasons detailed above. 
Porazdelitev zdravilne učinkovine pri bolnikih: Študij farmakokinetike zdravila Xeomin pri človeku niso opravili zaradi zgoraj navedenih vzrokov.
Take special care with Xeomin 
Bodite posebno pozorni pri uporabi zdravila Xeomin
This reconstituted solution may be stored for up to 24 hours at 2 to 8 °C. 
Ta rekonstituirana raztopina se lahko hrani do 24 ur, če je shranjena pri temperaturi od 2 °C do 8 °C.
In the management of spasmodic torticollis, Xeomin is usually injected into the sternocleidomastoid, levator scapulae, scalenus, splenius capitis, and/or the trapezius muscle(s). 
Pri obravnavanju spastičnega tortikolisa se zdravilo Xeomin po navadi injicira v sternokleidomastoidno mišico, mišico dvigalko lopatice, skalensko mišico, splenius capitis, in/ali trapezasto mišico/mišice.
The smaller the injection volume the less pressure sensation and less spread of Botulinum neurotoxin type A in the injected muscle occurs. 
Če je prostornina injiciranega zdravila manjša, je manjši tudi občutek pritiska in botulinski nevrotoksin tipa A se manj razširi po mišici, v katero je injiciran.
Hypersensitivity to the active substance Botulinum neurotoxin type A or to any of the excipients. 
Preobčutljivosti za zdravilno učinkovino, botulinski nevrotoksin tipa A ali katero koli pomožno snov.
LIST OF EXCIPIENTS Human albumin, sucrose 
SEZNAM POMOŽNIH SNOVI Humani albumin, saharoza
• the safety profile of Xeomin in the two Phase III clinical trials based on the documentation submitted by the Marketing Authorisation Holder and the scientific discussion within the Committee, 
• varnostni profil zdravila Xeomin v dveh kliničnih preizkušanjih III. faze,
Additionally, the following side effects are known for the comparative compound containing conventional Botulinum toxin type A complex used in the clinical trials with Xeomin. 
Poleg tega so naslednji neželeni učinki znani iz uporabe primerjalne spojine, ki vsebuje običajni kompleks botulinskega toksina tipa A, uporabili pa so jo pri kliničnih preskušanjih zdravila Xeomin.
(Jankovic et al, 20031, 20062, Barnes et al, 20053) to support the hypothesis that the amount of antibodies is correlated to the amount of clostridial protein load and thus, that there might be a lower risk for patients treated with Xeomin to develop secondary non-response. 
V podporo hipotezi, da je količina protiteles v korelaciji s količino proteinov Clostridium, so bile navedene objavljene klinične študije (Jankovic et al, 20031, 20062, Barnes et al, 20053), odtod pa sledi, da utegne pri bolnikih, zdravljenih z zdravilom Xeomin, obstajati manjše tveganje za nastop sekundarnega neodziva.
Symptoms of overdose 
Znaki prevelikega odmerjanja
• medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e.g. 
• zdravila, ki ovirajo prenos signala iz živca v mišico, npr. tubokuraninski mišični relaksanti, ki oslabijo mišice.
In contrast to conventional preparations containing the Botulinum toxin type A complex, Xeomin contains pure (150 kD) neurotoxin since it is free of complexing proteins. 
V nasprotju z običajnimi zdravili s kompleksom botulinskega toksina tipa A vsebuje zdravilo Xeomin čisti nevrotoksin (150 kD) brez beljakovin, ki tvorijo komplekse.
The only severe case of dysphagia occurred in the Botox group. 
Edini resni primer disfagije je nastopil v skupini, zdravljeni z zdravilom Botox.
It is possible that these side effects may also occur with Xeomin: 
Možno je, da se ti neželeni učinki pojavijo tudi pri uporabi zdravila Xeomin:
The vial must be discarded, if the vacuum does not pull the solvent into the vial. 
Če vakuum vehikla ne povleče v vialo, morate vialo zavreči.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL WHEN THIS IS PART/COMPONENT OF A MULTIPACK WITH 2, 3, 6 VIALS 
ŠKATLA ZA 1 VIALO, KADAR JE TO DEL/SESTAVNI DEL PAKIRANJA Z 2, 3, 6 VIALAMI
One death (colon carcinoma), assessed as unrelated to study treatment (Botox), was reported during the Phase II cervical dystonia study. 
faze za cervikalno distonijo so poročali o enem smrtnem primeru (karcinom kolona), ki je bil ocenjen kot nepovezan z obravnavanim zdravljenem (Botox).
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 toxin type A complex. 
Ni bilo raziskano, ali je sekundarna odsotnost odziva zaradi nastanka protiteles pri zdravljenju z zdravilom Xeomin manj pogosta kot pri zdravljenju z običajnimi zdravili, ki vsebujejo kompleks botulinskega toksina tipa A. Če se bolnik ne odziva, je treba pretehtati možnost uporabe drugih oblik zdravljenja.
The applicant is requested 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. 
Od vlagatelja je bilo zahtevano, da po razkritju zadevnih študij predloži rezultate vseh načrtovanih testov HDA iz študije spastičnosti v zgornjih okončinah (MRZ 0410) in študije cervikalne distonije (MRZ 0408).
Your doctor should not use Xeomin if the vial reconstituted according to the instructions has a cloudy appearance or contains e.g. floccular or particulate matter. 
Zdravnik ne sme uporabiti zdravila Xeomin, če je rekonstituirana raztopina, pripravljena po navodilih, videti motna ali če vsebuje kosmiče ali delce.
Phase III study in blepharospasm, (MRZ 
Študija III. faze za blefarospazem (MRZ
drooping eyelid (ptosis), dry eyes 
povešene veke (ptoza), suhe oči
Side effects may occur from misplaced injections of Xeomin temporarily paralysing nearby muscle groups. 
Neželeni učinki se lahko pojavijo zaradi injiciranja zdravila Xeomin v napačno mesto, kar začasno ohromi bližnje skupine mišic.
Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site. 
Povečani odmerki botulinskega nevrotoksina tipa A lahko povzročijo izrazito nevromuskulatorno paralizo na mestih, ki so oddaljena od mesta injiciranja.
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Germany 
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Nemčija
Foreign substances in your lungs may lead to an inflammation or infection (pneumonia).Your doctor will give you special medical treatment if needed (e.g. in the form of artificial nutrition). 
Zdravnik vas bo po potrebi ustrezno zdravil (npr. v obliki umetnega hranjenja).
• In the upper limb spasticity study (MRZ 0410) 144 patients entered the second injection cycle, in which doses up to 400 U of Xeomin are administered. 
• v študijo spastičnosti v zgornjih okončinah (MRZ 0410) je 144 bolnikov vključenih v drugi cikel injiciranja, v katerem se daje do 400 e zdravila Xeomin;
Patients with related adverse effects 
Bolniki, ki so imeli z zdravljenjem povezane neželene dogodke
The muscle mass and the degree of hypertrophy or atrophy are factors to be taken into consideration when selecting the appropriate dose. 
Pri izbiri ustreznega odmerka je treba upoštevati dejavnike, kot sta mišična masa in stopnja hipertrofije ali atrofije.
In the upper limb spasticity study (MRZ 0410) 144 patients entered the 2nd injection cycle, in which doses up to 400 U of Xeomin are administered. 
V študiji spastičnosti v zgornjih okončinah (MRZ 0410) je 144 bolnikov vključenih v drugi cikel injiciranja, v katerem se daje do 400 enot zdravila Xeomin.
generalised weakness, flu like symptoms, malaise, dizziness, numbness, sleepiness (drowsiness), nasal inflammation (rhinitis), upper respiratory tract infection, nausea, oral dryness, skin sores, stiffness, increased muscle tone (hypertonia) 
splošna šibkost, simptomi, podobni gripi, slabotnost, omotica, otrplost, zaspanost (dremavost), vnetje nosu (rinitis), okužba zgornjih dihal, slabost, suha usta, rane na koži, otrdelost, povečana napetost mišic (hipertonija)
A female patient developed a nerve lesion affecting the arm (brachial plexopathy) two days after injection of a conventional preparation containing the Botulinum toxin type A complex for the treatment of twisted neck, with recovery after five months. 
Pri eni bolnici se je razvila lezija živca, ki je prizadela roko dva dni po injiciranju običajnega pripravka s kompleksom botulinskega toksina tipa A za zdravljenje zvitega vratu.
What Xeomin contains 
Kaj vsebuje zdravilo xeomin
Some of the therapeutic and/or side effects of Xeomin may also interfere with the ability to drive and operate machinery. 
Zaradi nekaterih terapevtskih ali neželenih učinkov ali obojega lahko zdravilo Xeomin vpliva tudi na sposobnost vožnje in upravljanja strojev.
Considering the data from the non-clinical studies, the early Phase I study and its conclusions, and the Phase II study - although limited conclusions could be drawn from it, the dosage of Xeomin in both Phase III studies was based on the established dose of Botox. 
faze - četudi je bilo na njeni podlagi mogoče priti le do omejenih zaključkov - je odmerjanje zdravila Xeomin v obeh študijah III. faze temeljilo na odmerku, določenem za zdravilo Botox.
Unopened vial: Do not store above 25°C For storage conditions of the reconstituted medicinal product, see section 6.3. 
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration 
bolezen optičnega živca, po navadi povezana z zvišanim tlakom v notranjosti očesa
Swallowing difficulties may persist for two to three weeks after injection, but has been reported in one case to last five months. 
Težave pri požiranju lahko trajajo dva do tri tedne po injiciranju, v enem primeru pa so poročali tudi o pet mesecev trajajočih težavah.
Xeomin is presented as a powder for solution for injection. 
Zdravilo Xeomin je prašek za raztopino za injiciranje.
Uncommon: breathing difficulties (dyspnoea), double vision (diplopia), drooping eyelid (ptosis), voice alteration, fever 
težave pri dihanju (dispneja), dvojni vid (diplopija), povešene veke (ptoza), sprememba glasu, zvišana telesna temperatura
The applicant submitted three non-clinical, two Phase I, one Phase II and one Phase III studies to demonstrate that a safe posology has been established for Xeomin. 
Vlagatelj je z namenom dokazati, da je bilo za zdravilo Xeomin določeno varno odmerjanje, predložil tri neklinične študije, dve študiji I. faze, eno II.
Publications of clinical studies have been mentioned 
Tabela 1: Seznam kliničnih študij
- The paralytic efficacy of Xeomin and Botox was analysed by electromyography (EMG) in vivo in male monkeys after a single intramuscular injection of 16 LDU/kg in the left gluteus medius muscle. 
32 LDU/kg); - vpliv zdravil Xeomin in Botox na motiliteto (statične in aktivne gibe) je bil ocenjen v okviru študije akutne intravenske toksičnosti pri miših z odmerki do 68 LDU/kg; - paralitična učinkovitost zdravil Xeomin in Botox je bila analizirana z elektromiografijo (EMG) in vivo na samcih opic po enkratni intramuskularni injekciji 16 LDU/kg v levo srednjo glutealno mišico.
Strength 
utrujenost
Due to the nature of the diseases being treated, the ability to drive and to operate machines can be reduced. 
Sposobnost upravljanja vozil in strojev je lahko zmanjšana zaradi narave bolezni, zaradi katere se zdravite.
nausea, oral dryness Skin and subcutaneous tissue disorders Common: 
navzea, suha usta Bolezni kože in podkožja Pogosti:
Thus, related adverse effects occurred more frequently in the Xeomin group compared to Botox. 
Torej so bili z zdravljenjem povezani neželeni dogodki pogostejši v skupini z zdravilom Xeomin kot v skupini z zdravilom Botox.
However, as one of the two positive results four weeks after 1st injection and before 2nd injection was found in a patient pretreated with 
Vendar pa z ozirom na dejstvo, da je bil en od dveh pozitivnih rezultatov 4 tedne po 1. injiciranju in pred 2. injiciranjem ugotovljen pri bolniku, predhodno zdravljenem z zdravilom Botox, ter da so podatki še vedno slepi, iz teh rezultatov ni mogoče sklepati o imunogenosti zdravila Xeomin.