FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency by different indications
Maltese: Frekwenza skond indikazzjonijiet differenti
English: Phone: +49-69/15 03-1
Maltese: Telefon: +49-69/15 03-1
English: [See Annex I - To be completed nationally]
Maltese: [To be completed nationally]
English: Safety profile
Maltese: Profil tas-sigurtà
English: • marginally varying effectiveness of the active substance of Xeomin
Maltese: • effettività li tvarja marġinalment tas-sustanza attiva ta' Xeomin
English: b) Distribution of the active substance in patients:
Maltese: b) Distribuzzjoni tas-sustanza attiva fil-pazjenti:
English: Human albumin Sucrose
Maltese: Albumina umana Sucrose
English: 95 % CI of differences between related adverse effect proportions (Xeomin versus Botox)
Maltese: 95 % CI ta' differenzi bejn proporzjonijiet ta' effett avvers relatat (Xeomin vs Botox)
English: 2 Jankovic J, Hunter C, Dolimbek BZ, Dolimbek GS, Adler CH, Brashear A, et al. Clinicoimmunologic aspects of botulinum toxin type B
Maltese: 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 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).
Maltese: Il-kategoriji tal-frekwenza huma definiti kif ġej: komuni ħafna (≥1/10); komuni (≥1/100, <1/10); mhux komuni (≥1/1,000, <1/100), rari (≥1/10,000, <1/1,000); rari ħafna (<1/10,000).
English: 5.2 Pharmacokinetic properties a) General characteristics of the active substance:
Maltese: .2 Tagħrif farmakokinetiku a) Karatteristiċi ġenerali tas-sustanza attiva:
English: Solvent added (sodium chloride 9 mg/ml (0.9%) solution for injection)
Maltese: Solvent miżjud (sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni)
English: Blepharospasm
Maltese: Blefarospażmu
English: Germany
Maltese: Németország
English: • aminoglycoside antibiotics
Maltese: • antibijotiċi aminoglycoside
English: 6 vials
Maltese: 6 kunjetti
English: stiffness, hypertonia
Maltese: ebusija, ipertonija
English: The most frequently reported adverse event was ptosis (Xeomin 6.1%; Botox 4.6%).
Maltese: L-aktar episodju avvers irrapportat b'mod frekwenti kien ptożi (Xeomin 6.1%; Botox 4.6%).
English: • Overall Comparison of Adverse Events in Phase I - III Studies A total of five clinical trials (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013, MRZ-0003) have been completed to provide data on the safety and efficacy of Xeomin.
Maltese: • Tqabbil globali ta' l-Episodji Avversi fl-Istudji ta' Fażi I - III B'kollox saru ħames provi kliniċi (BTC-9901, MRZ-0113, BTC-9801, MRZ-0013, MRZ-0003) sabiex jipprovdu tagħrif fuq is-sigurtà u l-effikaċja ta' Xeomin.
English: For Botox, 57 out of 232 patients (24.6%) reported a total of 90 adverse events.
Maltese: Għal Botox, 57 pazjent minn 232 patients (24.6%) irrapportaw total ta' 90 episodju avvers.
English: No statistical differences were found between both treatment groups.
Maltese: Ma nsatbet ebda differenza statistika bejn iż-żewġ gruppi tat-trattament.
English: In the management of spasmodic torticollis, Xeomin is usually injected into the sternocleidomastoid, levator scapulae, scalenus, splenius capitis, and/or the trapezius muscle(s).
Maltese: Fl-immaniġġjar ta' torticollis spażmodika, Xeomin hu normalment injettat ġol-muskoli sternocleidomastoid, levator scapulae, scalenus, splenius capitis, u/jew it-trapezius.
English: In cases of nonresponse, alternative therapies should be taken into consideration.”
Maltese: F'każijiet ta' nuqqas ta' rispons, għandhom jitqiesu terapiji alternattivi.”
English: Spasmodic torticollis
Maltese: Torticollis spażmodika
English: The initial recommended dose is 1.25-2.5 U (0.05-0.1 ml volume) at each site.
Maltese: Id-doża inizjali rrakomandata hi ta' 1.25-2.5 U (volum ta' 0.05-0.1 ml) f'kull sit.
English: LIST OF EXCIPIENTS Human albumin, sucrose
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Albumina umana, sucrose
English: This study showed the non-inferiority of Xeomin (70-300 U) compared to Botox (70-300 U).
Maltese: Dan l-istudju wera li Xeomin (70-300 U) ma kienx inferjuri għal Botox (70-300 U).
English: Eye disorders Uncommon: diplopia, ptosis
Maltese: Mhux komuni: diplopja, ptosi
English: Symptoms of overdose:
Maltese: Sintomi ta' doża eċċessiva:
English: Patients with related adverse effects
Maltese: Pazjent b'effetti avversi relatati
English: Of the 908 participants, 239 thereof experienced adverse events (AEs).
Maltese: Mid-908 parteċipanti, 239 minnhom esperjenzaw episodji avversi (AEs).
English: 4-Aminochinolines may reduce the effect of Xeomin.
Maltese: 4-Aminochinolines jistgħu inaqqsu l-effett ta' Xeomin.
English: • non-response/therapy failure during the course of treatment.
Maltese: • non-rispons/il-falliment tat-terapija matul il-kors tal-kura.
English: For Botox, 45 out of 152 patients (29.6%) reported a total of 62 adverse events.
Maltese: Għal Botox, 45 pazjent minn 152 (29.6%) irrapportaw total ta' 62 episodju avvers.
English: Xeomin contains albumin, a derivative of human blood.
Maltese: Xeomin fih l-albumina, derivattiv tad-demm uman.
English: • One Phase II study (MRZ/BTC-9801)
Maltese: • Studju wieħed tat-Tieni Fażi (MRZ/BTC-9801)
English: Pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Maltese: Daqsijiet tal-pakketti ta' 1 (pakkett b'unità waħda), 2, 3 jew 6 kunjetti (pakkett multiplu).
English: For instructions on reconstitution / dilution of the vials, see section 6.6.
Maltese: Għal struzzjonijiet dwar ir-rikostituzzjoni/dilwizzjoni tal-kunjetti, ara sezzjoni 6.6.
English: 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.
Maltese: Saru żewġ studji mhux kliniċi fil-fniek, LPT10929 u LPT12444 b'amministrazzjoni ripetuta b'doża għolja ta' Xeomin (25 LDU għal kull annimal f'LPT10929 u 16-40LDU għal kull annimal f'LPT12444) b'intervalli qosra ħafna : - F'LPT10929, fit-12-il ġimgħa ta' l-istudju, ġimagħtejn wara l-aħħar aministrazzjoni, instabu antikorpi newtralizzanti tan-newrotossin tal-Botulinum tat-tip A f'erbgħa mit-tmint ifniek ittrattati b'Botox li baqgħu ħajjin, iżda fl-ebda wieħed mill-għaxart ifniek li baqgħu ħajjin wara li ngħataw Xeomin.
English: - The influence of Xeomin and Botox on motility (static and active movements) was assessed within an acute intravenous toxicity study in mice up to 68 LDU/kg.
Maltese: - L-influwenza ta' Xeomin u Botox fuq il-motilità (movimenti statiċi u attivi) kienet valutata fi studju dwar it-tossiċità intravenuża akuta fil-ġrieden sa 68 LDU/kg.
English: In 2003, Jankovic compared 130 patients treated for cervical dystonia with original Botox (25ng protein/100 U before 1998), 42 of whom were exposed only to the original Botox and 119 treated with the current Botox (5ng protein/100 U since 1998).
Maltese: Fl-2003, Jankovic qabbel 130 pazjent trattati għad-distonja ċervikali bil-Botox oriġinali (25ng ta' proteini kull 100 U qabel l-1998), li 42 minnhom kienu esposti biss għall-Botox oriġinali u 119 kienu trattati bil-Botox kurrenti (5ng proteini kull 100 U mill-1998).
English: 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).
Maltese: L-aktar AE frekwenti possibbilment relatat kien disfaġja (5.2% għal Xeomin vs. 3.4% għal Botox filkampjun meħud flimkien u 10% għal Xeomin vs. 8.2% fl-istudju dwar distonja ċervikali ta' Fażi
English: In this trial, 40 out of 148 patients (27.0%) treated with Xeomin reported a total of 57 adverse events.
Maltese: F'din il-prova, 40 pazjent minn 148 (27.0%) trattati b'Xeomin irrapportaw total ta' 57 episodju avvers.
English: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Germany
Maltese: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Németország
English: Theoretically, the effect of Xeomin may be reduced by: • certain anti-malaria / anti-rheumatic medicines (4-Aminochinolines).
Maltese: • ċerti mediċini kontra l-malarja/anti-rewmatiċi (4-Aminochinolines).
English: The most frequently reported adverse event was dysphagia (Xeomin 10.8%; Botox 8.2%; p=0.29).
Maltese: Botox 8.2%; p=0.29).
English: The following side effect probabilities and allocated frequencies are used for the categorisation of side effects:
Maltese: Il-probabbilitajiet ta' l-effetti sekondarji li ġejjin u l-frekwenzi allokati jintużaw għal kategorizzazzjoni ta' l-effetti sekondarji:
English: In this trial, 65 out of 231 patients (28.1%) treated with Xeomin reported a total of 110 adverse events.
Maltese: F'din il-prova, 65 pazjent minn 231 (28.1%) ittrattati b'Xeomin irrapportaw total ta' 110 episodju avvers.
English: The period between each treatment session should be at least 10 weeks.
Maltese: Il-perijodu bejn kull sessjoni ta' kura għandu jkun ta' mill-anqas 10 ġimgħat.
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).
Maltese: Kunjett (ħġieġ ta' tip 1) b'tapp tal-lastku (lastku tal-bromobutyl) u b'siġill ma jistax isir tbagħbis fih (aluminju) f'pakkett b'1 (pakkett b'unità waħda), 2, 3 jew 6 kunjetti (pakketti multipli).
English: • if you suffer from generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
Maltese: • jekk tbati minn disturbi ġeneralizzati ta' l-attività tal-muskoli (eż. mijastenja gravis, is-sindrome ta' Lambert-Eaton )
English: A clinical pack is also available with 6 vials.
Maltese: Pakkett kliniku hu wkoll disponibbli b'6 kunjetti.
English: Unopened vial: 3 years
Maltese: Il-kunjett mhux miftuħ: 3 snin
English: • the posology of Xeomin
Maltese: • il-posoloġija ta' Xeomin
English: Generalised disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
Maltese: Disturbi ġeneralizzati ta' l-attività tal-muskoli (eż. mijastenja gravis, is-sindromu ta' LambertEaton).
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Maltese: L-KITBA [To be completed nationally]
English: The difference of the total number of adverse events related or not related between Xeomin and Botox was not statistically significant.
Maltese: Id-differenza tan-numru totali ta' episodji avversi relatati u mhux relatati bejn Xeomin u Botox ma kinitx statistikament sinjifikanti.
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.
Maltese: 30-0.50 mm) tintuża għal injezzjonijiet ġol-muskoli superfiċjali, u, eż. labra 22 gauge/0.70 mm tista' tintuża għal injezzjonijiet ġo muskolatura aktar fonda.
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.
Maltese: Dan it-tagħrif tqassam fi 3 sottogruppi: pazjenti b'HAD negattiv, pazjenti b'antikorpi pożittiv < 5 mU/mL u pazjenti b'antikorpi pożittivi > 5 mU/mL.
English: Eyelid spasm (blepharospasm) The following side effects were reported with Xeomin:
Maltese: Spażmu ta' tebqet il-għajn (blefarospażmu) L-effetti sekondarji li ġejjin kienu rrappurtati bi Xeomin:
English: - 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
Maltese: - il-verifika klinika ta' l-effett tan-newrotossina fuq il-muskolu injettat: eż. investigazzjoni elettromijografika f'post speċjalizzat - l-analiżi tal-raġuni għaliex ma kienx hemm effett xieraq, eż. iżolament batut tal-muskoli intenzjonati li tkun ser issir l-injezzjoni fihom, doża baxxa wisq, teknika batuta ta' linjezzjoni, muskolu miġbud, antagonist dgħajjef wisq, possibbilment żvilupp ta' antikorpi - l-evalwazzjoni ta' Botulinum newrotossina ta' tip A bħala terapija xierqa - jekk l-ebda reazzjonijiet avversi ma jkunu seħħew matul il-kura inizjali, kors addizzjonali ta' kura jista' jsir taħt il-kundizzjonijiet li ġejjin: 1) l-aġġustament fid-doża fir-rigward ta' lanaliżi ta' l-aktar każ riċenti ta' non-rispons, 2) il-gwida EMG, 3) li l-intervall minimu rrakomandat bejn il-kura inizjali u dik ripetuta ma jinqabiżx
English: Xeomin is reconstituted prior to use with sterile unpreserved sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Xeomin hu rrikostitwit qabel l-użu b'soluzzjoni għall-injezzjoni sterili mhux ippreservata ta' sodium chloride 9 mg/ml (0.9%).
English: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main
Maltese: Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/Main Il-Ġermanja
English: Injury, poisoning and procedural complications Uncommon: inflicted injury
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Mhux komuni: ferita imposta
English: Up to now the FIA (Fluorescence Immuno Assay) screening test revealed no trend of a development of antibodies after Xeomin injection.
Maltese: Sa llum, it-test ta' skrining tal-FIA (Assaġġ Immuno Fluworexxenti) ma kixef ebda tendenza ta' żvilupp ta' antikorpi wara injezzjoni ta' Xeomin.
English: • if you suffer from a disease called amyotrophic lateral sclerosis.
Maltese: • jekk tbati minn marda msejħa sklerosi amijotrofika laterali.
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.
Maltese: Teoretikament, l-effett ta' Botulinum newrotossina jista' jkun imsaħħaħ minn antibijotiċi aminoglycoside jew prodotti mediċinali oħrajn li jfixklu t-trasmissjoni newromuskolari, eż. mediċini tat-tip tubocurarine li jmewtu l-muskoli (rilassanti).
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Miżuri f'każijiet ta' doża eċċessiva
English: In the blepharospasmus study (MRZ 0433) 6 patients received the 2nd injection.
Maltese: Fl-istudju tal-blefarospażmu (MRZ 0433) 6 pazjenti rċevew t-2 injezzjoni.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEOMIN <(see Annex I)> - Quality issues
Maltese: XJENTIFIKA TA' XEOMIN <(ara l-Anness I)> - Kwistjonijiet ta' Kwalità
English: Respiratory, thoracic and mediastinal disorders Uncommon: dysphonia
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: disfonija
English: The rate of serious adverse events (SAEs) in all studies was 2.1% with Xeomin and 2.7% with Botox.
Maltese: Ir-rata ta' episodji avversi serji (SAEs) fl-istudji kollha kienet ta' 2.1% b'Xeomin u 2.7% b'Botox.
English: (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.
Maltese: 20062, Barnes et al, 20053) li jappoġġjaw l-ipoteżi li l-ammont ta' antikorpi hu korrelatat ma' lammont tat-tagħbija tal-proteini klostridjali u għalhekk jista' jkun hemm riskju iżgħar għal pazjenti ttrattati b'Xeomin li jiżviluppaw nuqqas ta' rispons sekondarju.
English: 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.
Maltese: It-tieni ptożi ta' AE l-aktar frekwenti (għallinqas possibbilment relatat) kienet rapportata fi grad komparabbli (1.9% għal Xeomin vs. 1.8% għal Botox fil-kampjun miġbur flimkien u 6.1% għal Xeomin vs. 4.6% għal Botox fl-istudju ta' blefarospażmu ta' Fażi
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.
Maltese: Fl-aħħar nett, l-SPC propost għal Xeomin ma jurix riskju potenzjalment aktar baxx ta' antikorpi malprodott: “Għadu ma ġiex investigat jekk nuqqas ta' rispons sekondarju minħabba l-iżvilupp ta' antikorpi huwiex inqas frekwenti taħt terapija b'Xeomin milli taħt terapija bi preparazzjonijiet konvenzjonali li fihom il-kumpless Botulinum neurotoxin tip A.
English: All of the SAEs were assessed as unrelated to treatment.
Maltese: LSAEs kollha ġew ivvalutati bħala mhux relatati mat-trattament.
English: The recommended dilutions are indicated in the following table:
Maltese: Id-dilwizzjonijiet irrakomandati huma indikati fit-tabella li ġejja:
English: The management of spasmodic torticollis may cause dysphagia with varying degrees of severity with the potential for aspiration which may require medical intervention.
Maltese: L-immaniġġjar ta' torticollis spażmodika jista' jikkawża disfaġja bi gradi varji ta' severità, bilpotenzjal għal aspirazzjoni li jista' jkun hemm bżonn ta' intervent mediku.
English: Phase III study in blepharospasm, (MRZ
Maltese: III f' blefarospażmu, (MRZ
English: superficial punctate keratitis, lagophthalmos, eye irritation, photophobia, lacrimation Uncommon: keratitis, ectropion, diplopia, entropion, visual disturbance, blurred vision Rare:
Maltese: Mhux komuni: keratite, ectropion, diplopja, entropion, disturbi fil-vista, vista mċajpra Rari:
English: Injections near the levator palpebrae superioris should be avoided to reduce the occurrence of ptosis.
Maltese: M'għandhomx jingħataw injezzjonijiet qrib il-levator palpebrae superioris, biex jitnaqqas irriskju ta' ptosi.
English: - 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.
Maltese: - L-effett paralitiku ta' Xeomin u Botox ġie analizzat permezz ta' elettromijografija (EMG) in vivo fix-xadini rġiel wara injezzjoni waħdanija ta' 16 LDU/kg fil-muskolu gluteu medju tax-xellug.
English: Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
Maltese: L-irkuprar tat-trasmissjoni ta' l-impulsi tkun stabbilita millġdid bil-formazzjoni ta' truf ġodda tan-nervituri u ta' motor endplates.
English: Extra caution is required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Maltese: Attenzjoni addizzjonali hi meħtieġa meta tinjetta f'postijiet li huma qrib ta' strutturi sensittivi bħall-arterja karotid u lapiċi tal-pulmun.
English: • The active substance is Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Maltese: • Is-sustanza attiva hi Clostridium Botulinum newrotossina ta' tip A (150 kD), ħielsa minn proteini complexing.
English: Medical supervision for up to several days and assisted ventilation may be necessary.
Maltese: Superviżjoni medika li ddum sa diversi jiem, u ventilazzjoni assistita tista' tkun meħtieġa.
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
Maltese: MRZ/BTC-9901 u MRZ/BTC-0113, li minnhom it-tieni wieħed sar wara t-tlestija ta' l-istudji tat-Tielet Fażi
English: Botox and Xeomin are different drug substances in terms of clostridial protein content, although both contain the same 150 kDa neurotoxin, which is the actual active substance.
Maltese: Botox u Xeomin huma mediċini differenti f'termini tal-kontenut tal-proteini klostridjali, għalkemm ittnejn fihom l-istess newrotossin tal-150 kDa, li hi s-sustanza attiva attwali.
English: Immediate gentle pressure at the injection site can limit that risk.
Maltese: Pressjoni ġentili immedjata fis-sit ta' l-injezzjoni tista' tillimita dak ir-riskju.
English: o Specifically include toxin spread events in their sentinel list of events for active monitoring.
Maltese: o Speċifikament jinkludi episodji ta' tixrid ta' tossini fil-lista ta' episodju sentinella tagħhom għal monitoraġġ attiv.
English: After reconstitution: the product may be stored for a maximum of 24 hours at 2°C to 8°C.
Maltese: Wara r-rikostituzzjoni: il-prodott jista' jinħażen għal massimu ta' 24 jum f'temperatura ta' 2°C sa 8°C.
English: • different treatment intervals
Maltese: • intervalli differenti tal-kura
English: No evidence of local intolerability was noted.
Maltese: L-ebda evidenza ta' intollerabilità lokali ma kienet osservata.
English: Patients with a history of dysphagia and aspiration should be treated with extreme caution.
Maltese: Pazjenti bi storja medika ta' disfaġja u aspirazzjoni għandhom ikunu kkurati b'attenzjoni estrema.
English: Side effects may occur from misplaced injections of Xeomin temporarily paralysing nearby muscle groups.
Maltese: L-effetti sekondarji jistgħu iseħħu minn injezzjonijiet ta' Xeomin li jipparalizzaw temporanjament gruppi ta' muskoli fil-qrib.
English: • eyelid spasm (blepharospasm)
Maltese: • spażmu ta' tebqet il-għajn (blefarospażmu)
English: disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration
Maltese: marda tan-nervituri tal-vista, normalment assoċjata ma' żieda fil-pressjoni ġol-għajn (glawkoma tat-tip angle closure), ulċerazzjoni tal-kornea
English: Pharmacotherapeutic group: Muscle relaxant, peripherally acting agent, ATC code: M03AX01
Maltese: Rilassant tal-muskoli, mediċina li taħdem b'mod periferali, Kodiċi ATC:
English: Limiting the dose injected into the sternocleidomastoid muscle to less than 100 U may decrease the occurrence of dysphagia.
Maltese: Li tillimita d-doża injettata fil-muskolu sternocleidomastoid għal inqas minn 100 U jista' jnaqqas li jkun hemm disfaġja.
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.
Maltese: komuni ħafna iktar minn 1 minn kull 10 persuni kkurati komuni inqas minn 1 minn kull 10, iżda iktar minn 1 minn kull 100 persuna kkurata mhux komuni inqas minn 1 minn kull 100, iżda iktar minn 1 minn kull 1,000 persuna kkurata rari inqas minn 1 minn kull 1,000, iżda iktar minn 1 minn kull 10,000 persuna kkurata rari ħafna inqas minn 1 kull 10,000 persuna kkurata, li jinkludu każijiet iżolati
English: a) binding to the cholinergic nerve terminals b) entry or internalisation into the nerve terminal and c) inhibition of acetylcholine release by intracellular poisoning within the nerve terminal.
Maltese: a) it-twaħħil mat-terminali tan-nervaturi kolinerġiċi b) id-dħul jew l-internalizzazzjoni ġot-terminali tan-nervaturi u ċ) l-inibizzjoni tal-ħruġ ta' acetylcholine permezz ta' avvelenament intraċellulari fit terminal tan-nervaturi.