natgillin/translations-raw huggingface dataset:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR SINGLE UNIT PACK (1 VIAL)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PAKIRANJE ENE ENOTE (1 VIALE)
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.
Ni znano, ali so te smrti povzročili običajna zdravila s kompleksom botulinskega toksina tipa A ali pa obstoječa kardiovaskularna bolezen.
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.
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.
In clinical trials with Botulinum toxin type A complex, it was reported that swallowing difficulties occur less frequently with low doses.
V kliničnih preskušanjih s kompleksom botulinskega toksina tipa A so poročali, da so težave pri požiranju manj pogoste pri majhnih odmerkih.
Measures in cases of overdose
Ukrepi pri prevelikem odmerjanju
swallowing difficulties (dysphagia), muscle weakness, back pain
težave pri požiranju (disfagija), mišična šibkost, bolečina v hrbtu
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.
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.
Do not use Xeomin
Ne uporabljajte zdravila xeomin
• if you suffer from pronounced weakness or decreased muscle volume in the muscle where you will receive the injection
• če imate izrazito šibke ali zmanjšane mišice, v katere vam bodo injicirali zdravilo,
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.
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).
Xeomin has minor or moderate influence on the ability to drive and use machines.
Zdravilo Xeomin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
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.
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.
There is limited experience in treatment-naïve patients and long-term treatment.
Izkušnje pri bolnikih, ki nikoli prej niso bili zdravljeni ali se zdravijo dolgotrajno, so omejene.
For safe disposal, unused vials should be reconstituted with a small amount of water then sterilised under high pressure.
Za varno odstranjevanje je treba neuporabljene viale rekonstituirati z malo vode in nato sterilizirati pod velikim tlakom.
Careful testing of corneal sensation should be performed in patients with previous eye operations.
Pri bolnikih s predhodnim kirurškimi posegi na očeh je treba previdno preskusiti kornealno zaznavo.
The following side effect probabilities and allocated frequencies are used for the categorisation of side effects:
Pri razvrščanju neželenih učinkov so uporabljene njihove naslednje verjetnosti in pogostnosti:
• marginally varying effectiveness of the active substance of Xeomin
• nekoliko spreminjajoča se učinkovitost zdravilne učinkovine v zdravilu Xeomin;
Due to differences in the LD50 assay, these units are specific to Xeomin and are not applicable to other Botulinum toxin preparations.
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.
For Botox, 45 out of 152 patients (29.6%) reported a total of 62 adverse events.
Pri bolnikih, zdravljenih z zdravilom Botox, je 45 izmed 152 bolnikov (29,6 %) poročalo o skupno 62 neželenih dogodkih.
In the blepharospasmus study (MRZ 0433) 6 patients received the 2nd injection.
Pri študiji blefarospazma (MRZ 0433) je 6 bolnikov prejelo 2. injekcijo.
Blepharospasm
Blefarospazem
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.
Nativni botulinski toksin je kompleks z veliko molsko maso, ki poleg nevrotoksina (150 kD) vsebuje druge netoksične beljakovine, kot so hemaglutinini in nehemaglutinini.
There have been rare reports of undesirable effects related to cardiovascular system, such as arrhythmia and myocardial infarction, some with fatal outcomes.
Obstajajo poročila o neželenih učinkih, povezanih s kardiovaskularnim sistemom, kot sta aritmija in miokardni infarkt, včasih s smrtnim izidom.
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.
ravni površinske elektromiografske meritve (EMG) glede na izhodiščno vrednost v distonični sternokleidomastoidni mišici med maksimalno prostovoljno aktivacijo 14 dni po injiciranju.
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.
Nevrotoksin tipa A, vezan na receptorje, se endocitira v živčne končiče, preden doseže ciljni protein (SNAP 25), in se nazadnje intracelularno razgradi.
Large doses may cause paralysis in muscles distant to the injection site.
Veliki odmerki lahko povzročijo paralizo mišic, ki so oddaljene od mesta injiciranja.
Reconstituted Xeomin is intended for intramuscular injection.
Rekonstituirano zdravilo Xeomin je namenjeno intramuskularnemu injiciranju.
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.
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.
Xeomin is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Zdravilo Xeomin je indicirano za simptomatsko obravnavanje blefarospazma in cervikalne distonije, predvsem rotacijske oblike (spastični tortikolis), pri odraslih.
An almost identical percentage of patients in both treatment groups reported AEs (26.6% in the Xeomin group and 26.0% in the Botox group).
O neželenih dogodkih je poročal skoraj enak delež bolnikov iz obeh skupin (26,6 % iz skupine z zdravilom Xeomin ter 26,0 % iz skupine z zdravilom Botox).
Pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Velikosti pakiranj po 1 (pakiranje z eno enoto), 2, 3 ali 6 vial (pakiranja z več enotami).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR MULTI PACK WITH 2, 3, 6 VIALS
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA VEČKRATNO PAKIRANJE Z 2, 3, 6 VIALAMI
The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor individually for you.
Optimalni odmerek in število mest injiciranja v zdravljeni mišici bo posebej za vas določil zdravnik.
Symptoms of overdose:
Znaki prevelikega odmerjanja:
Dissolved Xeomin is intended for injections into the muscle.
Raztopljeno zdravilo Xeomin je namenjeno injiciranju v mišico.
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica ]
INFORMATION IN BRAILLE Justification for not including Braille accepted
INFORMATION IN BRAILLE Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
After the injection you may develop mild to severe swallowing difficulties.
Po injiciranju se lahko pojavijo blage do hude težave pri požiranju.
A case of peripheral neuropathy has been reported in a male after receiving four sets of injections of a conventional preparation containing the Botulinum toxin type A complex (for neck and back spasm, and severe pain) over an 11 week period.
O enem primeru periferne nevropatije so poročali pri moškem, ki je v 11 tednih prejel štiri nize injekcij običajnega zdravila s kompleksom botulinskega toksina tipa A (za spazem hrbta in vratu ter hudo bolečino).
For safe disposal, any unused vials should be dissolved with a small amount of water and then sterilised under high pressure (autoclaved).
Za varno odstranjevanje je treba neuporabljeno vsebino vial razredčiti z malo vode in nato sterilizirati pod visokim tlakom (avtoklavirati).
It is not known whether the active substance of Xeomin is excreted into the breast milk.
Ni znano, ali zdravilna učinkovina v zdravilu Xeomin prehaja v materino mleko.
The second most frequent (at least possibly related) AE ptosis was reported in a comparable degree (1.9% for Xeomin vs. 1.8% for Botox in the pooled sample and 6.1% for Xeomin vs. 4.6% for Botox in the blepharospasm Phase III study) and occurred in BPS patients only.
O drugem najpogostejšem (vsaj morebiti povezanim z zdravljenjem) neželenem dogodku, ptozi, so poročali podobno pogosto (1,9 % pri zdravilu Xeomin napram 1,8 % pri zdravilu Botox v združenem vzorcu ter 6,1 % pri zdravilu Xeomin napram 4,6 % pri zdravilu Botox v študiji III. faze za blefarospazem), pojavljala pa se je le pri bolnikih z blefarospazmom.
Therefore, no valid conclusions can be drawn from the resulting data with respect to immunogenicity of Xeomin compared to Botox.
Posledično iz rezultatov ni mogoče priti do veljavnega zaključka glede imunogenosti zdravila Xeomin v primerjavi z zdravilom Botox.
Any used vials, syringes, and spillage etc. should be autoclaved and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Vse uporabljene viale, brizge, prelito tekočino itd. je treba avtoklavirati, preostalo zdravilo Xeomin pa inaktivirati z razredčeno raztopino natrijevega hidroksida (0,1 N NaOH).
• Clinical data
• Klinični podatki
Do not store above 25°C.
Neodprte viale: Shranjujte pri temperaturi do 25 °C.
There are rare reports on side effects related to the cardiovascular system, such as irregular heartbeat (arrhythmia) and heart attack, some of them with fatal outcome.
Obstajajo redka poročila o neželenih učinkih, povezanih s srčno-žilnim sistemom, kot sta neredni srčni utrip (aritmija) in srčna kap, v nekaterih primerih s smrtnim izidom.
Botox has a protein content of 5 ng/100U, i.e. the 150 kDa neurotoxin and non-effective complexing proteins, and quickly dissociates into the neurotoxin and the complexing proteins after administration.
Zdravilo Botox ima vsebnost beljakovin 5 ng/100 e, tj. 150 kDa nevrotoksin in neučinkujoče kompleksirajoče beljakovine, ter po aplikaciji hitro disociira v nevrotoksin in kompleksirajoče beljakovine.
The following additional information is based on publications on conventional preparations containing the Botulinum toxin type A complex.
Naslednje informacije temeljijo na objavah o običajnih zdravilih, ki vsebujejo kompleks botulinskega toksina tipa A.
For Botox, 57 out of 232 patients (24.6%) reported a total of 90 adverse events.
Pri bolnikih, zdravljenih z zdravilom Botox, je 57 izmed 232 bolnikov (24,6 %) poročalo o skupno 90 neželenih dogodkih.
Additionally, the following undesirable effects and accordingly their frequencies are known for the comparative compound containing conventional Botulinum toxin type A complex used in clinical trials with Xeomin.
Poleg tega so naslednji neželeni učinki in njihova pogostnost znani iz uporabe primerjalne spojine, ki vsebuje običajni kompleks botulinskega toksina tipa A, uporabili pa so jo pri kliničnih preskušanjih zdravila Xeomin.
The most frequent at least possibly related AE was dysphagia (5.2% for Xeomin vs. 3.4% for Botox in the pooled sample and 10% for Xeomin vs. 8.2% in the cervical dystonia Phase III study, respectively).
Najpogostejši, vsaj morebiti z zdravljenjem povezani neželeni dogodek je bila disfagija (5,2 % za zdravilo Xeomin v primerjavi s 3,4 % za zdravilo Botox v združenem vzorcu ter 10 % za zdravilo Xeomin v primerjavi z 8,2 % za zdravilo Botox v študiji III. faze za cervikalno distonijo).
A decrease or increase in the Xeomin dose is possible by administering a smaller or larger injection volume.
Odmerek zdravila Xeomin se lahko manjša ali veča z manjšanjem ali večanjem prostornine injiciranega zdravila.
HOW TO USE XEOMIN
KAKO UPORABLJATI ZDRAVILO XEOMIN
If you are pregnant, Xeomin should not be used, unless your doctor could decide whether there is a clear necessity and whether the potential benefit justifies the risk.
Zdravila Xeomin med nosečnostjo ne smete uporabljati, razen če zdravnik oceni, da je zdravljenje nujno in da morebitna korist odtehta tveganje.
It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage.
Rekonstitucijo in pripravo brizge je treba opraviti na papirnatih brisačah, obloženih s plastiko, da se vpije morebitno razlitje.
If you develop swallowing difficulties, speech or breathing disorders, please contact medical emergency services immediately or ask your relatives to do so.
Če se pojavijo težave pri požiranju ali motnje govora ali dihanja, pokličite nujno zdravniško pomoč ali prosite družinske člane, da to storijo.
Therefore, the use of Xeomin during lactation cannot be recommended.
Zato uporaba zdravila Xeomin med dojenjem ni priporočena.
HDA tests are performed at baseline and repeatedly during the course of the study and the results which are, amongst others, available for 107 patients after the 2nd injection cycle and for 73 patients four weeks after 3rd injection did not show any neutralising antibodies.
Rezultati, ki so med drugim na voljo za 107 bolnikov po 2. ciklu injiciranja in 73 bolnikov 4 tedne po 3. ciklu injiciranja, pa ne izkazujejo nevtralizirajočih protiteles.
This can lead to an overlong exposure of the transparent front part of the eye (cornea).
To lahko povzroči predolgo izpostavljenost prosojnega sprednjega dela očesa (roženice).
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).