qanastek/EMEA-V3 huggingface dataset:
3.4% for Botox in the pooled sample and 10% for Xeomin vs.
3. 4% għal Botox fil - kampjun meħud flimkien u 10% għal Xeomin vs.
8.2% in the cervical dystonia Phase III study, respectively).
8. 2% fl- istudju dwar distonja ċervikali ta ’ Fażi III, rispettivament).
No statistical differences were found between both treatment groups.
Ma nsatbet ebda differenza statistika bejn iż- żewġ gruppi tat- trattament.
Of note, the only severe case of dysphagia occurred in a Botox treated patient.
Ta ’ min wieħed jinnota li l- uniku każ sever ta ’ disfaġja seħħ f’ pazjent ittrattat b’ Botox.
The second most frequent (at least possibly related) AE ptosis was reported in a comparable degree (1.9% for Xeomin vs.
It- tieni ptożi ta ’ AE l- aktar frekwenti (għallinqas possibbilment relatat) kienet rapportata fi grad komparabbli (1. 9% għal Xeomin vs.
1.8% for Botox in the pooled sample and 6.1% for Xeomin vs.
1. 8% għal Botox fil- kampjun miġbur flimkien u 6. 1% għal Xeomin vs.
4.6% for Botox in the blepharospasm Phase III study) and occurred in BPS patients only.
4. 6% għal Botox fl- istudju ta ’ blefarospażmu ta ’ Fażi III) u seħħ f’ pazjenti b’ BPS biss.
Treatment– related muscular weakness was observed in 1.1% of all patients randomised to Xeomin vs.
Dgħjufija muskolari relatata mat- trattament ġiet osservata f’ 1. 1% tal- pazjenti kollha magħżulin b’ mod każwali biex jieħdu Xeomin vs.
0.2% of all Botox patients, whereas the Phase Ib study MRZ-0113 showed no difference in the diffusion of both preparations in adjacent muscles.
0. 2% tal- pazjenti fuq Botox kollha, filwaqt li l- istudju ta ’ Fażi Ib 11 MRZ- 0113 ma wera ebda differenza fid- diffużjoni taż- żewġ preparazzjonijiet f’ muskoli maġenb xulxin.
The incidence of Serious Adverse Events was low in all studies, with a similar frequency in both treatment groups.
L- inċidenza ta ’ Episodji Avversi Serji kienet waħda baxxa fl- istudji kollha, bi frekwenza simili fiż - żewġ gruppi ta ’ trattament.
No drug-related SAE was reported, there were no withdrawals due to adverse events.
Ebda SAE relatat mal- mediċina ma ġie rrapportat, ma kien hemm ebda rtirar dovut għal episodji avversi.
10 In addition to the list of follow-up measures discussed and requested by the CMDh, the CHMP requested the following follow-up measures to be submitted to the National Competent Authorities and to be assessed under the co-ordination of the RMS: • To perform a post-marketing study to confirm the safety and efficacy of Xeomin after repeated injections (up to 6 injection sessions).
Barra mil- lista ta ’ miżuri ta ’ follow- up diskussi u mitlubin mill- CMDh, il- CHMP talab li l- miżuri ta ’ follow- up li ġejjin jiġu ppreżentati lill- Awtoritajiet Kompetenti Nazzjonali u li dawn jiġu vvalutati taħt il- koordinament tal- RMS: • Li jsir studju ta ’ wara t- tqegħid fis- suq sabiex jiġu kkonfermati s- sigurtà u l- effikaċja ta ’ Xeomin wara injezzjonijiet ripetuti (sa 6 sessjonijiet ta ’ injezzoni).
• To submit the results of a pharmacodynamic study in which “ spread” of neurotoxin is quantified in comparison to two other Botox preparations.
• Li jiġu ppreżentati r- riżultati ta ’ studju farmakodinamiku li fih, “ it- tixrid ” ta ’ newrotossin jiġi kkwantifikat meta mqabbel ma ’ żewġ preparazzjonijiet ta ’ Botox oħrajn.
• 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.
• Li jiġu ppreżentati r- riżultati tat- testijiet tal- HDA skedati kollha ta ’ l- istudju ta ’ l- ispastiċità tal - parti ta ’ fuq tad- driegħ (MRZ 0410) u ta ’ l- istudju ta ’ distonja ċervikali (MRZ 0408) wara l- kxif ta ’ l- istudji rispettivi.
• To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials. o Information on usage patterns and on types of prescribers/ users of Xeomin in order to identify if and at what type of clinics off-label cosmetic use is taking place, especially in the EU. 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.
Strateġiji dettaljati għall- edukazzjoni tat- tobba inkluż tekniki adegwati ta ’ injezzjoni, dożi o u nuqqas ta ’ qlib bejn prodott u ieħor kif ukoll programmi għal monitoraġġ kontinwat u mtejjeb ta ’ reazzjonijiet mifruxin fl- użu kliniku u fil- provi kliniċi.
Specifically this information should include advice to seek immediate medical help in the event of swallowing, speech or respiratory difficulties arise. o Specifically include toxin spread events in their sentinel list of events for active monitoring. o Evaluation of the spread reactions, specifically as part of future studies. o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
Għandhom jittieħdu passi sabiex jiġi żgurat li l- pazjenti jiġu informati b’ mod adegwat o dwar il- kwistjonijiet ta ’ sigurtà assoċjati ma ’ dawn il- prodotti, eż.
11 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Tikkettjar adegwat u fuljetti għall- pazjenti.
• the scope of the referral was the potential risk to public health concerning the need for data in repeated administration and data on immunogenicity for Xeomin • the posology of Xeomin • the safety profile of Xeomin in the two Phase III clinical trials
B’ mod speċifiku, din l- informazzjoni għandha tinkludi parir sabiex wieħed ifittex għajnuna medika minnufih fil- każ li jkollu diffikultà biex jibla ’, jitkellem jew biex jieħu nifs.
based on the documentation submitted by the Marketing Authorisation Holder and the scientific discussion within the Committee,
Speċifikament jinkludi episodji ta ’ tixrid ta ’ tossini fil- lista ta ’ episodju sentinella o tagħhom għal monitoraġġ attiv.
the CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, Labelling and Package Leaflet are set out in Annex III for Xeomin.
Evalwazzjoni tar- reazzjonijiet tat- tixrid, speċifikament bħala parti minn studji futuri. o Impenn biex l- Awtoritajiet Kompetenti Nazzjonali jiġu mwissija jekk ikun hemm bidla o sinifikanti fir- rata ta ’ rapportaġġ.
12 ANNEX III
12 RAĠUNIJIET GĦAL EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
fuq il- bażi tad- dokumentazzjoni ppreżentata mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u d- diskussjoni xjentifika fi ħdan il- Kumitat,
13 SUMMARY OF PRODUCT CHARACTERISTICS
13 ANNESS III
14 1.
14 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
Xeomin 100 LD50 units powder for solution for injection [See Annex I - To be completed nationally]
Xeomin 100 LD50 unitajiet ta ’ trab għal soluzzjoni għall- injezzjoni
1 vial contains 100 LD50 units* of Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
1 kunjett fih 100 LD50 unità * ta ’ Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħieles minn proteini complexing.
* One unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
* unità waħda tikkorrispondi għall- medjan tad- doża letali (LD50) meta l- prodott rikostitwit ikun injettat fil- peritonew fil- ġrieden taħt kundizzjonijiet preskritti.
Due to differences in the LD50 assay, these units are specific to Xeomin and are not interchangeable with other Botulinum toxin preparations.
Minħabba d- differenzi fl- assaġġ LD50, dawn l- unitajiet huma speċifiċi għal Xeomin u ma jistgħux jinbidlu ma ’ preparazzjonijiet oħrajn tat- tossina Botulinum.
White powder
Trab abjad
Xeomin is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Xeomin hu indikat għall- immaniġġjar sintomatiku ta ’ blefarospażmu u distonja fil- għonq ta ’ forma fil- biċċa l- kbira tagħha rotazzjonali (torticollis spażmodika) fl- adulti.
Unit doses recommended for Xeomin are not interchangeable with those for other preparations of Botulinum toxin.
Dożi ta ’ l- unità rrakkomandati għal Xeomin ma jistgħux jinbidlu ma ’ dawk għal preparazzjonijiet oħrajn ta ’ tossina Botulinum.
Xeomin may only be used by physicians with suitable qualifications and proven experience in the application of Botulinum toxin and in the use of the necessary equipment, e. g.
Xeomin jista ’ jintuża biss minn tobba bi kwalifikazzjonijiet adattati u b’ esperjenza li tkun tista ’ tiġi ppruvata fl- għoti tat- tossina Botulinum u fl- użu tat- tagħmir meħtieġ, eż.
EMG (electromyography).
EMG (elettromijografija).
Reconstituted Xeomin is intended for intramuscular injection.
Xeomin rikostitwit hu intenzjonat għal injezzjoni ġol- muskoli.
The optimum dosage and number of injection sites in the treated muscle should be determined by the physician individually for each patient.
L- aħjar dożaġġ u n- numru ta ’ siti ta ’ l- injezzjoni fil- muskolu li jkun ikkurat, għandhom ikunu stabbiliti mit- tabib individwalment għal kull pazjent.
A titration of the dose should be performed.
Għandha ssir titrazzjoni tad- doża.
For instructions on reconstitution / dilution of the vials, see section 6.6.
Għal struzzjonijiet dwar ir- rikostituzzjoni/ dilwizzjoni tal- kunjetti, ara sezzjoni 6. 6.
After reconstitution, Xeomin should be used for only one injection session and for only one patient.
Wara r - rikostituzzjoni, Xeomin għandu jintuża biss għal sessjoni waħda ta ’ l- injezzjoni u għal pazjent wieħed biss.
A decrease or increase in the Xeomin dose is possible by administering a smaller or larger injection volume.
It- tnaqqis jew iż- żieda fid- doża ta ’ Xeomin huma possibbli billi tagħti volum ta ’ l- injezzjoni iżgħar jew ikbar.
The smaller the injection volume the less pressure sensation and the less spread of Botulinum neurotoxin type A in the injected muscle occurs.
Dan hu ta ’
This is of benefit in reducing effects on nearby muscles when small muscle groups are being injected.
16 benefiċċju biex tnaqqas effetti fuq muskoli fil- qrib meta gruppi ta ’ muskoli żgħar ikunu qed jiġu injettati.
15 Blepharospasm After reconstitution, the Xeomin solution is injected using a suitable sterile needle (e. g.
Blefarospażmu Wara r- rikostituzzjoni, is- soluzzjoni ta ’ Xeomin tkun injettata bl- użu ta ’ labra sterili adattata (eż.
27-30 gauge/ 0.30-0.40 mm).
27- 30 gauge/ 0. 30- 0. 40 mm).
Electromyographic guidance is not necessary.
Il- gwida elettromijografika mhix meħtieġa.
An injection volume of approximately 0.05 to 0.1 ml is recommended.
Volum ta ’ l- injezzjoni ta ’ madwar 0. 05 sa 0. 1 ml hu rrakomandat.
Xeomin is injected into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis oculi of the lower lid.
Xeomin ikun injettat ġol- orbicularis oculi medjali u laterali tal- kappell tal- għajn, in- naħa ta ’ fuq u t’ isfel.
Additional sites in the brow area, the lateral orbicularis and in the upper facial area may also be injected if spasms here interfere with vision.
Siti addizzjonali fiż- żona tal- ħaġeb ta ’ l- għajn, l- orbicularis laterali u fin- naħa ta ’ fuq taż- żona tal- wiċċ, jistgħu wkoll ikunu injettati jekk l- ispażmi hawnhekk ixekklu l- vista.
The initial recommended dose is 1.25-2.5 U (0.05-0.1 ml volume) at each site.
Id- doża inizjali rrakomandata hi ta ’ 1. 25- 2. 5 U (volum ta ’ 0. 05- 0. 1 ml) f’ kull sit.
The initial dose should not exceed 25 U per eye.
Id- doża tal- bidu m’ għandhiex taqbeż 25 U f’ kull għajn.
In the management of blepharospasm, total dosing should not exceed 100 U every 12 weeks.
Fl- immaniġġjar ta ’ blefarospażmu, id- dożaġġ totali m’ għandux jaqbeż 100 U kull 12- il ġimgħa.
Injections near the levator palpebrae superioris should be avoided to reduce the occurrence of ptosis.
M’ għandhomx jingħataw injezzjonijiet qrib il- levator palpebrae superioris, biex jitnaqqas ir - riskju ta ’ ptosi.
Diplopia may develop as a result of Botulinum neurotoxin type A diffusion into the inferior oblique.
Id- diplopja tista ’ tiżviluppa bħala riżultat tad- diffużjoni ta ’ Botulinum newrotossina ta ’ tip A fil- muskolu oblikwu inferjuri.
Avoiding medial injections into the lower lid may reduce this adverse reaction.
Jekk tevita injezzjonijiet medjali f’ tebqet il - għajn tan- naħa t’ isfel, wieħed jista ’ jnaqqas din ir- reazzjoni mhux mixtieqa.
The median first onset of effect is observed within four days after injection.
Is- sinjali bikrin ta ’ l- effett jidhru f’ medja ta ’ erbat ijiem wara l- injezzjoni.
The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
L- effett ta ’ kull kura ġeneralment idum madwar 3- 4 xhur, madankollu, jista ’ idum għal żmien li jkun itwal jew iqsar b’ mod sinifikanti.
The treatment can be repeated if required.
Il- kura tista ’ tkun ripetuta jekk ikun hemm bżonn.
At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient – usually defined as an effect that does not last longer than two months.
F’ sessjonijiet tal- kura ripetuta, id- doża tista ’ tiżdied sad- doppju tan- normal jekk ir- rispons għall - kura inizjali jkun ikkunsidrat li hu insuffiċjenti – normalment dan hu definit bħala li l- effett ma jdumx aktar minn xahrejn.
However, there appears to be no additional benefit obtainable from injecting more than 5.0 U per site.
Madankollu, ma jidher li hemm l- ebda benefiċċju addizzjonali li jista ’ jinkiseb billi tinjetta aktar minn 5. 0 U f’ kull sit.
Normally, no additional benefit is conferred by treating more frequently than every three months.
Normalment, l- ebda benefiċċju addizzjonali ma jinkiseb jekk tati l- kura aktar minn darba kull tliet xhur.
Spasmodic torticollis In the management of spasmodic torticollis, Xeomin dosing must be tailored to the individual patient, based on the patient’ s head and neck position, location of possible pain, muscle hypertrophy, patient’ s body weight, and response to the injection.
Torticollis spażmodika Fl- immaniġġjar ta ’ torticollis spażmodika, id- dożaġġ ta ’ Xeomin irid ikun imfassal għall- pazjent individwali, ibbażat fuq il- pożizzjoni tar- ras u ta ’ l- għonq tal- pazjent, il- post fejn jista ’ jkun l - uġigħ, l- ipertrofija tal- muskoli, kemm jiżen il- pazjent, u r- rispons għall- injezzjoni.
A suitable sterile needle (e. g.
Labra sterili adattata (eż.
22 gauge/ 0.70 mm needle may be used for injections into deeper musculature.
25- 30 gauge/ 0. 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.
An injection volume of approximately 0.1 to 0.5 ml is recommended.
Il - volum ta ’ l- injezzjoni rrakkomandat huwa ta ’ madwar 1 sa 0. 5 ml.
In the management of spasmodic torticollis, Xeomin is usually injected into the sternocleidomastoid, levator scapulae, scalenus, splenius capitis, and/ or the trapezius muscle(s).
Fl- immaniġġjar ta ’ torticollis spażmodika, Xeomin hu normalment injettat ġol- muskoli sternocleidomastoid, levator scapulae, scalenus, splenius capitis, u/ jew it- trapezius.
This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment.
Din il- lista dan mhix kompleta, għax kull wieħed mill- muskoli li huma responsabbli għall- kontroll tal - pożizzjoni tar- ras jista ’ jkun involut, u għalhekk jeħtieġ il- kura.
If difficulties arise isolating single muscles, injections should be performed using electromyographic guidance.
Jekk ikun hemm diffikulta ’ biex jintlaħaq xi muskolu partikulari, l- injezzjonijiet għandhom jitwettqu bl- użu ta ’ gwida elettromijografika.
The muscle mass and the degree of hypertrophy or atrophy are factors to be taken into consideration when selecting the appropriate dose.
Il- piż tal- muskoli u l- grad ta ’ ipertrofija jew atrofija huma fatturi li jridu jiġu kkunsidrati meta tintgħażel id- doża adattata.
In practice, the maximum total dose is usually not more than 200 U.
Fil- prattika, id- doża massima totali normalment ma tkunx ta ’ aktar minn 200 U.
Doses of up to 300 U may be given.
Dożi sa 300 U jistgħu jingħataw.
No more than 50 U should be given at any one injection site.
Mhux aktar minn 50 U għandhom jingħataw fi kwalunkwe sit wieħed ta ’ l - injezzjoni.
Multiple injection sites permit Xeomin more uniform coverage of the innervated areas of the dystonic muscle and are especially useful in larger muscles.
Siti multipli ta ’ l- injezzjoni jippermettu lil Xeomin jilħaq in- nervitura tal- muskoli distoniċi, u huma utli b’ mod speċjali f’ muskoli akbar.
The optimum number of injection sites is dependent upon the size of the muscle to be chemically denervated.
L- aħjar numru ta ’ siti ta ’ l- injezzjoni jiddependi fuq id- daqs tal- muskolu li jkun ser jiddgħajjef kimikament.
The sternocleidomastoid should not be injected bilaterally as there is an increased risk of adverse reactions (in particular dysphagia) when bilateral injections or doses in excess of 100 U are administered into this muscle.
17 L- isternocleidomastoid m’ għandux ikun injettat fuq iż- żewġ naħat għax hemm żieda fir- riskju ta ’ reazzjonijiet avversi (b’ mod partikulari d- disfaġja) meta injezzjonijiet bilaterali jew dożi ta ’ iktar minn 100 U jingħataw ġo dan il- muskolu.
16 The median first onset of effect is observed within seven days after injection.
L- ewwel sinjali ta ’ l- effett ikun osservat f’ medja ta ’ sebat ijiem wara l- injezzjoni.
The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
L- effett ta ’ kull kura ġeneralment idum madwar 3- 4 xhur, madankollu, jista ’ jdum għal żmien li jkun itwal jew iqsar b’ mod sinifikanti.
The period between each treatment session should be at least 10 weeks.
Il- perijodu bejn kull sessjoni ta ’ kura għandu jkun ta ’ mill- anqas 10 ġimgħat.
All indications If no treatment effect occurs within a month after the initial injection, the following measures should be taken:
L- indikazzjonijiet kollha Jekk l- ebda effett tal- kura ma jseħħ fi żmien xahar wara l- ewwel injezzjoni ’, il- miżuri li ġejjin għandhom jittieħdu:
clinical verification of the neurotoxin effect on the injected muscle: e. g. an electromyographic investigation in a specialised facility
il- verifika klinika ta ’ l- effett tan- newrotossina fuq il- muskolu injettat: eż. investigazzjoni elettromijografika f’ post speċjalizzat
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
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 ’ l - injezzjoni, muskolu miġbud, antagonist dgħajjef wisq, possibbilment żvilupp ta ’ antikorpi
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:
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) 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
1) l- aġġustament fid- doża fir- rigward ta ’ l - analiżi 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
The patient should be regarded as a primary non-responder in cases of first injection failure.
Il- pazjent għandu jitqies bħala non- responder primarju f’ każ li l- ewwel injezzjoni ma tirnexxix.
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.
Ma kienx investigat jekk non- rispons sekondarju minħabba l- iżvilupp ta ’ antikorpi huwiex inqas frekwenti bit- terapija bi Xeomin milli bil- kura bi preparazzjonjiet konvenzjonali li jkun fihom il- kumpless tat- tossina Botulinum ta ’ tip A.
In cases of non-response, alternative therapies should be considered.
Fil- każ ta ’ non- rispons, terapiji alternattivi għandhom jiġu kkunsidrati.
Xeomin has not been studied in the paediatric population and is therefore not recommended in the paediatric age group until further data become available.
Xeomin ma kienx studjat fil- popolazzjoni pedjatrika u għalhekk mhux irrakkomandat fil- grupp ta ’ l- età pedjatrika sakemm informazzjoni addizzjonali ssir disponibbli.
Hypersensitivity to the active substance Botulinum neurotoxin type A or to any of the excipients.
Sensittività eċċessiva għas- sustanza attiva Botulinum newrotossina ta ’ tip A jew għal xi sustanzi mhux attivi.
Generalised disorders of muscle activity (e. g. myasthenia gravis, Lambert-Eaton syndrome).
Disturbi ġeneralizzati ta ’ l- attività tal- muskoli (eż. mijastenja gravis, is- sindromu ta ’ Lambert - Eaton).
Presence of infection at the proposed injection site.
Il- preżenza ta ’ infezzjoni fis- sit propost ta ’ l- injezzjoni.
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.
Effetti sekondarji relatati mal- firxa ta ’ tossina Botulinum li tkun imbiegħda mill- post fejn ingħatat kienu rrappurtati (ara sezzjoni 4. 8), li xi kultant irriżultaw f’ mewt, li f’ xi każijiet kienu assoċjati ma ’ disfaġja, pnewmonja u/ jew debbulizza sinifikanti.
Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Il- pazjenti kkurati b’ dożi terapewtiċi jista ’ jkollhom dgħjufija esaġerata fil- muskoli.
Patients with underlying neurological disorders including swallowing difficulties are at increased risk of these side effects.
Pazjenti b’ disturbi bażiċi newroloġiċi li jinkludu diffikultajiet biex tibla ’, ikollhom aktar riskju ta ’ dawn l - effetti sekondarji.
The Botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.
Il- prodott tat- tossina Botulinum għandu jintuża taħt is- superviżjoni ta ’ speċjalista f’ dawn il- pazjenti u għandu jintuża biss jekk il- benefiċċju tal- kura jkun ikkunsidrat li jiżboq ir- riskju.
Patients with a history of dysphagia and aspiration should be treated with extreme caution.
Pazjenti bi storja medika ta ’ disfaġja u aspirazzjoni għandhom ikunu kkurati b’ attenzjoni estrema.
Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.
18 Il- pazjenti jew il- persuni li jieħdu ħsieb il- pazjenti għandhom jingħataw parir biex ifittxu kura medika immedjata jekk ikun hemm disturbi biex tibla ’, fid- diskors, jew respiratorji.
An anaphylactic reaction may occur rarely after injection of Botulinum neurotoxin type A (see section 4.8).
Reazzjoni anafilattika tista ’ sseħħ b’ mod rari wara l- injezzjoni ta ’ Botulinum newrotossina ta ’ tip A (ara sezzjoni 4. 8).
Adrenaline and other medical aids for treating anaphylaxis should be available.
L- adrenalina u għajnuniet mediċi oħrajn għall- kura ta ’ l- anafilassi għandhom ikunu disponibbli.
Extra caution is
Qabel ma jagħti Xeomin, it- tabib irid isir familjari ma ’ l- anatomija tal- pazjent u ma ’ kwalunkwe bidliet fl- anatomija minħabba proċeduri kirurġiċi li jkunu saru fil- passat.
17 required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Attenzjoni addizzjonali hi meħtieġa meta tinjetta f’ postijiet li huma qrib ta ’ strutturi sensittivi bħall- arterja karotid u l - apiċi tal- pulmun.
There is limited experience in treatment-naïve patients and long-term treatment.
Hemm esperjenza limitata f’ pazjenti li huma naïve għall- kura u l- kura fit- tul.
Xeomin should be used with caution: • if bleeding disorders of any type occur • in patients receiving anticoagulant therapy • in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction • in targeted muscles which display pronounced weakness or atrophy.
Xeomin għandu jintuża bl- attenzjoni.: • jekk iseħħu disturbi ta ’ ħruġ ta ’ demm ta ’ kwalunkwe tip • f’ pazjenti li kienu qed jirċievu terapija b’ mediċini li jraqqu d- demm • f’ pazjenti li jbatu minn sklerosi laterali amijotrofika jew mard ieħor li jirriżultaw f’ disfunzjoni newromuskolari periferali • jekk wieħed għandu ħsieb li jinjetta muskoli li juru dgħjufija jew atrofija prominenti
The recommended single doses of Xeomin should not be exceeded and the intervals between injections should not be shortened.
Id- dożi waħdiet irrakomandati ta ’ Xeomin m’ għandhomx jinqabżu, u l- intervalli ta ’ bejn l - injezzjonijiet m’ għandhomx jitqassru.
The clinical effects of Botulinum neurotoxin type A can increase or decrease by repeated injections.
L- effetti kliniċi ta ’ Botulinum newrotossina ta ’ tip A jistgħu jiżdiedu jew jitnaqqsu minn injezzjonijiet ripetuti.
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.
Ir- raġunijiet possibbli huma t- tekniċi differenti tar- rikostituzzjoni, l - intervalli magħżula ta ’ l- injezzjoni, il- muskoli li fihom issir l- injezzjoni u attività tat- tossina li tvarja marġinalment, li tirriżulta mill- proċedura ta ’ l- ittestjar bijoloġiku li tkun intużat, jew minn non- rispons sekondarju.
Too frequent dosing of Botulinum toxin may result in antibody formation which may lead to resistance to treatment (see section 4.2).
Dożaġġ frekwenti wisq ta ’ tossina Botulinum tista ’ tirriżulta li jsiru antikorpi li jistgħu iwasslu għalkura bla effett (ara sezzjoni 4. 2).
Previously akinetic or sedentary patients should be reminded to gradually resume activities following the injection of Xeomin.
Pazjenti li qabel kienu akinetiċi jew sedentarji għandhom ikunu mfakkra biex ikomplu l - attivitajiet wara l- injezzjoni ta ’ Xeomin.
Xeomin contains albumin, a derivative of human blood.
Xeomin fih l- albumina, derivattiv tad- demm uman.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/ removal of viruses.
Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill- użu ta ’ prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l- għażla tad- donaturi, screening ta ’ donazzjonijiet individwali u ta ’ pools tal - plażma għal markaturi speċifiċi ta ’ infezzjoni u li jittieħdu passi effettivi tal- manifattura għall - inattivazzjoni/ tneħħija ta ’ viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Minkejja dan, meta jingħataw prodotti mediċinali ppreparati minn demm jew plażma umana, il- possibbiltà li orġaniżmi infettivi jiġu trasmessi, ma tistax tiġi eskluża għal kollox.
There are no reports of viral transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.
M’ hemm l- ebda rapporti ta ’ trasmissjonijiet virali bl- albumina li kienet immanifatturata skond speċifikazzjonijiet tal- Farmakopea Ewropea bi proċessi stabbiliti.
Blepharospasm 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.
Blefarospażmu Minħabba l- effett antikolinerġiku ta ’ Botulinum newrotossina ta ’ tip A, Xeomin għandu jintuża bl- attenzjoni f’ pazjenti b’ riskju li jiżviluppaw glawkoma tat- tip angle closure.
In order to prevent ectropion, injections into the lower lid area should be avoided, and vigorous treatment of any epithelial defect is necessary.
Sabiex jiġi evitat ectropion, injezzjonijiet fiż- żona ta ’ tebqet il- għajn tan- naħa t’ isfel għandhom ikunu evitati, u kura sħiħa ta ’ kwalunkwe difett epiteljali hi meħtieġa.
This may require protective drops, ointments, soft bandage contact lenses, or closure of the eye by patching or similar means.
Dan jista ’ jikkonsisti fi qtar protettiv, ingwenti, soft bandage contact lenses, jew l- għeluq ta ’ l- għajn permezz ta ’ patching jew mezzi simili.
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).
Teptip ta ’ l- għajnejn imnaqqas wara l- injezzjoni b’ Xeomin ġol- muskolu orbicularis jista ’ jwassal li tinkixef il- kornea, difetti epiteljali persistenti u ulċerazzjoni tal- kornea, speċjalment 19 f’ pazjenti b’ disturbi tan- nervaturi kranjali (nervaturi tal- wiċċ).
Careful testing of corneal sensation should be performed in patients with previous eye operations.
L- ittestjar bl- attenzjoni tas - sensazzjoni tal- kornea għandu jitwettaq f’ pazjenti li fil- passat kellhom operazzjonijiet f’ għajnejhom.
Ecchymosis easily occurs in the soft tissues of the eyelid.
L- ekkimożi sseħħ faċilment fit- tessut artab ta ’ tebqet il- għajn.
Immediate gentle pressure at the injection site can limit that risk.
Pressjoni ġentili immedjata fis- sit ta ’ l- injezzjoni tista ’ tillimita dak ir- riskju.
18 Spasmodic torticollis Patients should be informed that injections of Xeomin for the management of spasmodic torticollis may cause mild to severe dysphagia with the risk of aspiration and dyspnoea.
Torticollis spażmodika Il- pazjenti għandhom ikunu infurmati li injezzjonijiet ta ’ Xeomin għall- immaniġġjar ta ’ torticollis spażmodika jistgħu jikkawżaw disfaġja minn ħafifa sa severa, bir- riskju ta ’ aspirazzjoni u dispnea.
Medical intervention may be necessary (e. g. in the form of a gastric feeding tube) (see also section 4.8).
Jista ’ jkun meħtieġ intervent mediku (eż. fis- sura ta ’ tubu gastriku ta ’ l - ikel) (ara wkoll sezzjoni 4. 8).
Dysphagia can last for up to two to three weeks after injection, but a duration of up to five months has been reported in one case.
Id- disfaġja tista ’ ddum minn tnejn sa tliet ġimgħat wara l - injezzjoni, iżda tul ta ’ żmien ta ’ ħames xhur kien irrappurtat f’ każ wieħed.
Limiting the dose injected into the sternocleidomastoid muscle to less than 100 U may decrease the occurrence of dysphagia.
Li tillimita d- doża injettata fil- muskolu sternocleidomastoid għal inqas minn 100 U jista ’ jnaqqas li jkun hemm disfaġja.
Patients with smaller neck muscle mass, or patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk.
Pazjenti li għandhom inqas ħxuna tal- muskoli ta ’ l- għonq, jew pazjenti li jeħtieġu injezzjonijiet kull naħa fil- muskoli sternocleidomastoid huma f’ riskju akbar.
The occurrence of dysphagia is attributable to the spread of the pharmacological effect of Xeomin as the result of the neurotoxin spread into the oesophageal musculature.
L- okkorrenza tad - disfaġja hi attribwibbli għall- firxa ta ’ l- effett farmakoloġiku ta ’ Xeomin bħala riżultat tal- firxa tan- newrotossina ġol- muskolatura esofagali.
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.
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).
Therefore the concomitant use of Xeomin with aminoglycosides or spectinomycin requires special care.
Għalhekk, l- użu fl- istess ħin ta ’ Xeomin ma ’ aminoglycosides jew spectinomycin jeħtieġ attenzoni speċjali.
Peripheral muscle relaxants should be used with caution, if necessary reducing the starting dose of relaxant, or using an intermediate-acting substance such as vecuronium or atracurium rather than substances with longer lasting effects.
Ir- rilassanti tal- muskoli periferali għandhom jintużaw bl- attenzjoni, u jekk ikun meħtieġ, titnaqqas id- doża tal- bidu tar- rilassant, jew tintuża sustanza li taħdem b’ mod intermedju bħal vecuronium jew atracurium, minflok jintużaw sustanzi li għandhom effetti li jdumu aktar.
4-Aminochinolines may reduce the effect of Xeomin.
4- Aminochinolines jistgħu inaqqsu l- effett ta ’ Xeomin.
There are no adequate data from the use of Botulinum neurotoxin type A in pregnant women.
Tqala M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ Botulinum newrotossina ta ’ tip A f’ nisa tqal.
Therefore, Xeomin should not be used during pregnancy unless clearly necessary and unless the potential benefit justifies the risk.
Għalhekk, Xeomin m’ għandux jintuża waqt it- tqala ħlief jekk ikun meħtieġ b’ mod ċar u ħlief jekk il- benefiċċju potenzjali jiġġustifika r- riskju.
It is not known whether Botulinum neurotoxin type A is excreted into the breast milk.
Treddigħ Mhux magħruf jekk Botulinum newrotossina ta ’ tip A titneħħiex fil- ħalib tas- sider.
Therefore, the use of Xeomin during lactation cannot be recommended.
Għalhekk, l- użu ta ’ Xeomin matul it- treddigħ ma jistax ikun irrakomandat.
Xeomin has minor or moderate influence on the ability to drive and use machines.
Xeomin għandu influwenza żgħira jew moderata fuq il- ħila li wieħed isuq u juża l- magni.
Due to the nature of the diseases being treated, the ability to drive and to operate machines can be reduced.
Minħabba n- natura tal- mard li jkun qed jiġi kkurat, il- ħila li ssuq u tħaddem il- magni, tista ’ titnaqqas.
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.
Minħabba d- dewmien tal- bidu tagħhom, xi ftit mill- effetti terapewtiċi u/ jew avversi ta ’ Xeomin jistgħu wkoll jinterferixxu mal- ħila li ssuq u tħaddem il- makkinarju.
Consequently affected persons should avoid these tasks until their faculties are fully recovered.
Konsegwentement, il- persuni affettwati għandhom jevitaw dawn l- attivitajiet sakemm il- ħiliet tagħhom jiġu lura għan- normal.
4.8 Undesirable effects
20 4. 8 Effetti mhux mixtieqa
Undesirable effects may occur from misplaced injections of Botulinum neurotoxin type A temporarily paralysing nearby muscle groups.
L- effetti mhux mixtieqa jistgħu iseħħu minn injezzjonijiet ta ’ Botulinum newrotossina ta ’ tip A li ma jkunux ingħataw fis- sit li suppost, li jistgħu jipparalizzaw temporanjament gruppi ta ’ muskoli fil- qrib.
Large doses may cause paralysis in muscles distant to the injection site.
Dożi kbar jistgħu jikkawżaw paralisi f’ muskoli mbiegħda mis- sit ta ’ l- injezzjoni.
Usually, undesirable effects are observed within the first week after treatment and are temporary in nature.
Normalment, l- effetti mhux mixtieqa jkunu osservati matul l- ewwel ġimgħa wara l- kura, u n - natura tagħhom tkun temporanja.
They may be restricted to the area around the injection site (e. g. local pain, tenderness at the injection site, and injection site haemorrhage).
Jistgħu ikunu ristretti għaż- żona madwar is- sit ta ’ l - injezzjoni (eż. uġigħ lokali, sensittività fis- sit ta ’ l- injezzjoni, u emorraġija fis- sit ta ’ l - injezzjoni).
19 Frequency by different indications Based on clinical experience information on the frequency of adverse reactions for the individual indications is given below.
Frekwenza skond indikazzjonijiet differenti Ibbażat fuq l- esperjenza klinika, informazzjoni dwar il- frekwenza ta ’ reazzjonijiet avversi għall- indikazzjonijiet individwali qed tingħata hawn taħt.
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).
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).
Blepharospasm The following adverse reactions were reported with Xeomin:
Blefarospażmu Dawn ir- reazzjonijiet avversi li ġejjin kienu rrappurtati bi Xeomin:
Nervous system disorders Uncommon:
Disturbi fis- sistema nervuża Mhux komuni: parestesija, uġigħ ta ’ ras
paraesthesia, headache
Disturbi fl- għajnejn
ptosis, dry eyes conjunctivitis
ptosi, għajnejn xotti
Gastrointestinal disorders Uncommon:
Mhux komuni: konġuntivite
Skin and subcutaneous tissue disorders Uncommon:
Disturbi gastro- intestinali Mhux komuni: ħalq xott
Musculoskeletal Uncommon:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: raxx tal- ġilda
and connective tissue disorders muscle weakness
Disturbi muskolu- skeletrali u tal- connective tissue Mhux komuni: dgħjufija fil- muskoli.
Injury, poisoning and procedural complications Uncommon:
Korriment, avvelenament u komplikazzjonijiet ta ’ xi proċedura Mhux komuni: ferita imposta
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.
Flimkien ma ’ dan, l- effetti mhux mixtieqa li ġejjin u l- frekwenzi rispettivi tagħhom huma magħrufa għall- kompożizzjoni komparattiv li fih il- kumpless tat- tossina Botulinum ta ’ tip A konvenzjonali li jintuża fi provi kliniċi b’ Xeomin.
It is possible that these undesirable effects may also occur with Xeomin.
Hu possibbli li dawn l- effetti mhux mixtieqa jistgħu iseħħu wkoll b’ Xeomin.
Nervous system disorders Uncommon:
Disturbi fis- sistema nervuża Mhux komuni: sturdament, paralisi tal- wiċċ
dizziness, facial paralysis
Disturbi fl- għajnejn
superficial punctate keratitis, lagophthalmos, eye irritation, photophobia, lacrimation
keratite punctate superfiċjali, lagophthalmos, irritazzjoni fl- għajnejn, fotofobia, lakrimazzjoni
Uncommon:
Mhux komuni: keratite, ectropion, diplopja, entropion, disturbi fil- vista, vista mċajpra
keratitis, ectropion, diplopia, entropion, visual disturbance, blurred vision swelling of eyelid angle closure glaucoma, corneal ulceration
nefħa ta ’ tebqet il- għajn glawkoma tat- tip angle closure, ulċerazzjoni tal- kornea
Skin and subcutaneous tissue disorders Uncommon:
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: dermatite
and connective tissue disorders
21 Disturbi muskolu- skeltrali u tal- connective tissue Mhux komuni: dgħjufija fil- muskoli tal- wiċċ
General disorders and administration site conditions Uncommon:
Spażmodika Dawn ir- reazzjonijiet avversi li ġejjin kienu rrappurtati b’ Xeomin:
Nervous system disorders Uncommon:
Disturbi fis- sistema nervuża Mhux komuni: uġigħ ta ’ ras, rogħda
Uncommon:
Disturbi fl- għajnejn Mhux komuni: uġigħ fl- għajnejn
Respiratory, thoracic and mediastinal disorders Uncommon:
Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni: disfonija
Uncommon:
Disturbi gastro- intestinali Komuni:
disorders dysphagia diarrhoea, dry mouth, vomiting, colitis
disfaġja
Skin and subcutaneous tissue disorders Uncommon:
Mhux komuni: dijarea, ħalq xott, rimettar, kolite
skin rash, erythema, pruritus, sweating increased
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Mhux komuni: raxx tal- ġilda, eritema, ħakk, żieda fl- għaraq
Uncommon:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
and connective tissue disorders muscle weakness, back pain skeletal pain, myalgia
dgħjufija fil- muskoli, uġigħ fid- dahar
General disorders and administration site conditions Uncommon:
Mhux komuni: uġigħ skeletriku, mijalġja
asthenia, injection site inflammation, injection site tenderness
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Mhux komuni: astenja, infjammazzjoni fis- sit ta ’ l- injezzjoni, sensittività fis- sit ta ’ l- injezzjoni
It is possible that these undesirable effects may also occur with Xeomin.
Hu possibbli li dawn l- effetti mhux mixtieqa jistgħu jseħħu wkoll b’ Xeomin.
dizziness, numbness, drowsiness
sturdament, tmewwit, ngħas
Uncommon:
Disturbi fl- għajnejn Mhux komuni: diplopja, ptosi
diplopia, ptosis
Disturbi respiratorji, toraċiċi u medjastinali Komuni:
Respiratory, thoracic and mediastinal disorders Common:
rinite, infezzjoni ta ’ l- apparat respiratorju ta ’ fuq
Uncommon:
Mhux komuni: dispnea, bdil fil- vuċi
Gastrointestinal Common:
Disturbi gastro- intestinali Komuni:
disorders nausea, oral dryness
dardir, nixfa fil- ħalq
skin sores
feriti fil- ġilda
Musculoskeletal Common:
Disturbi muskolu- skeltrali u tal- connective tissue Komuni:
and connective tissue disorders stiffness, hypertonia
ebusija, ipertonija
General disorders and administration site conditions Very common: pain, local weakness Common:
Disturbi ġenerali u kundizzjonijiet ta ’ mnejn jingħata Komuni ħafna: uġigħ, dgħjufija lokali Komuni:
Uncommon:
Mhux komuni: deni
Dysphagia may persist
L- immaniġġjar ta ’ torticollis spażmodika jista ’ jikkawża disfaġja bi gradi varji ta ’ severità, bil - potenzjal għal aspirazzjoni li jista ’ jkun hemm bżonn ta ’ intervent mediku.
21 for two to three weeks after injection, but has been reported in one case to last five months.
Id- disfaġja tista ’ tippersisti għal minn tnejn sa tliet ġimgħat wara l- injezzjoni, iżda f’ każ wieħed kien irrappurtat li damet ħames xhur.
Dysphagia appears to be dose-dependent.
Id- disfaġja tidher li tiddependi mid- doża.
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.
Fi provi kliniċi bil- kumpless tat - tossina Botulinum ta ’ tip A, kien irrappurtat li d- disfaġja sseħħ inqas b’ mod frekwenti b’ dożi totali taħt 200 U f ’ kull sessjoni ta ’ kura.
General The following additional information is based on publications on conventional preparations containing the Botulinum toxin type A complex.
Ġenerali L- informazzjoni addizzjonali li ġejja hi bbażata fuq pubblikazzjonijiet fuq preparazzjonijiet konvenzjonali li fihom il- kumpless tat- tossina Botulinum ta ’ tip A.
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).
Effetti sekondarji relatati mal- firxa ta ’ tossina li tkun imbiegħda mill- post fejn ingħatat kienu rrappurtati b’ mod rari ħafna (dgħjufija eċċessiva fil- muskoli, disfaġja, pnewmonite ta ’ l - aspirazzjoni b’ riżultat fatali f’ xi każijiet) (ara sezzjoni 4. 4).
Dysphagia has been reported following injection to sites other than the cervical musculature.
Id- disfaġja kienet irrappurtata wara injezzjoni f’ siti oħra minbarra l- muskolatura fil- għonq.
There have been rare reports of undesirable effects related to cardiovascular system, such as arrhythmia and myocardial infarction, some with fatal outcomes.
Kien hemm rapporti rari ta ’ effetti mhux mixtieqa relatati mas- sistema kardjovaskulari, bħal arritmija u infart mijokardijaku, x’ uħud b’ riżultati fatali.
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.
Jibqa ’ mhux ċar jekk dawn l- imwiet kinux ikkaġunati minn preparazzjonijiet konvenzjonali li fihom il- kumpless tat- tossina Botulinum ta ’ tip A, jew jekk kinux ikkawżati minn mard kardjovaskulari li kien jeżisti minn qabel.
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.
Każ ta ’ newropatija periferali kien irrappurtat f’ raġel wara li rċieva erba ’ korsijiet ta ’ injezzjonijiet ta ’ preparazzjoni konvenzjonali li kien fiha l- kumpless ta ’ tip A tat- tossina Botulinum (għal spażmu fl- għonq u fid- dahar, u wġigħ sever) fuq perjodu ta ’ 11- il ġimgħa.
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.
Kien hemm pazjenta li żviluppat brachial plexopathy jumejn wara l- injezzjoni ta ’ preparazzjoni konvenzjonali li kien fiha l- kumpless ta ’ tip A tat- tossina Botulinum, għall- kura ta ’ distonja fil- għonq, bil- fejqan li seħħ wara ħames xhur.
Erythema multiforme, urticaria, psoriasis-like rash, pruritus, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Wara injezzjoni ta ’ kumpless ta ’ tip A tat- tossina Botulinum, l- EMG wera żieda fil- tferfir f’ xi muskoli distanti li ma kienx assoċjat ma ’ dgħjufija fil- muskoli jew ma ’ tipi oħrajn ta ’ anormalitajiet elettrofiżjoloġiċi.
Following injection of conventional Botulinum toxin type A complex, EMG showed increased jitter in some distant muscles which was not associated with muscle weakness or other types of electrophysiological abnormalities.
4. 9 Doża eċċessiva
Symptoms of overdose:
Sintomi ta ’ doża eċċessiva:
Increased doses of Botulinum neurotoxin type A may result in pronounced neuromuscular paralysis distant from the injection site.
Żieda fid- dożi ta ’ Botulinum newrotossina ta ’ tip A tista ’ tirriżulta f’ paralisi newromuskolari prominenti li tkun imbiegħda mis- sit ta ’ l- injezzjoni.
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.
Is- sintomi ta ’ doża eċċessiva ma jidhrux immedjatament wara l- injezzjoni, u jistgħu jinkludu dgħjufija ġenerali, ptosi, diplopja, diffikultajiet biex tibla ’ u biex titkellem, jew paralisi tal- muskoli respiratorji li tirriżulta fi pnewmonja minħabba l- aspirazzjoni.
Measures in cases of overdose:
Miżuri f’ każijiet ta ’ doża eċċessiva:
In case of an overdose the patient must be monitored medically for several days.
F’ każ ta ’ doża eċċessiva, il- pazjent irid ikun immonitorjat mit- tobba għal diversi jiem.
If signs of intoxication appear, hospitalisation with general supportive measures is necessary.
Jekk jidhru sinjali ta ’ intossikazzjoni, ikun meħtieġ li l- pazjent jiddaħħal l- isptar u jingħata miżuri ġenerali ta ’ appoġġ.
Intubation and assisted ventilation will become necessary until improvement if paralysis of the respiratory muscles occurs.
Jekk ikun hemm paraliżi tal- muskoli respiratorji, l- intubazzjoni u ventilazzjoni assistita ser ikunu meħtieġa sakemm titjieb il- kundizzjoni..
Muscle relaxant, peripherally acting agent, ATC code:
Rilassant tal- muskoli, mediċina li taħdem b’ mod periferali, Kodiċi ATC:
Botulinum neurotoxin type A blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine.
Botulinum newrotossina ta ’ tip A jimblokka t- trasmissjoni kolinerġika fil- junction newromuskolari billi jinibixxi l- ħruġ ta ’ acetylcholine.
The nerve terminals of the neuromuscular junction no longer respond to nerve impulses, and secretion of the neurotransmitter is prevented (chemical denervation).
It- truf tan- nervituri tal- junction newromuskolari ma jirrispondux aktar għall- impulsi tan- nervituri, u l- firxa tan- newrotrasmettitur tiġi evitata (dinervazzjoni kimika).