qanastek/EMEA-V3 huggingface dataset:
However, the pharmacological characteristics do not indicate any need to adjust the dose.
Iżda, il- karatteristiċi farmakoloġiċi ma jindikaw l- ebda ħtieġa sabiex id- doża tiġi mibdula.
Individuals with other known neuromuscular diseases (e. g.
Individwi b’ mard newromuskolari magħruf ieħor (eż.
ALS or peripheral neuropathy) or known neuromuscular junctional disorders (e. g. myasthenia gravis or Lambert-Eaton syndrome) should not be given NeuroBloc.
ALS jew newropatija periferali) jew problemi magħrufa newromuskolari tal- ġogi (eż. myasthenia gravis jew sindromu Lambert- Eaton) m ’ għandhomx jingħataw NeuroBloc.
NeuroBloc is recommended for intramuscular administration only.
NeuroBloc huwa rrakkommandat biex jiġi mogħti bħala injezzjoni minn ġol- muskoli biss.
Particular caution should be paid to ensure that it is not injected into a blood vessel.
Għandha tingħata attenzjoni sabiex jiġi żgurat li ma jiġix injettat fil- vini/ arterji.
Following repeated administration of NeuroBloc, development of an immune response can occur due to production of neutralising antibodies to Botulinum Toxin Type B.
Wara amministrazzjoni ripetuta ta ’ NeuroBloc, jista ’ jseħħ żvilupp ta ’ respons immuni minħabba l - produzzjoni ta ’ antikorpi newtralizzanti għal Botulinum Toxin Tip B.
Tolerance, thought to be due to the development of an immune response, may occur uncommonly.
Tolleranza, maħsuba li hija dovuta għall- iżvilupp ta ’ respons immuni, tista ’ sseħħ b’ mod mhux komuni.
As with all injected medicines, caution should be used in patients with bleeding disorders or receiving anticoagulant therapy.
Bħal f’ kull mediċina injettata, għandha tintuża kawtela f’ pazjenti bi problemi ta ’ fsada jew li qegħdin jirċievu terapija antikoagulanti.
Neuromuscular effects related to spread of toxin, distant from the site of administration have been reported (see section 4.8).
Kienu rrappurtati effetti newromuskolari relatati mal- firxa tat- tossina, l- bogħod mis- sit ta ’ l- injezzjoni (ara sezzjoni 4. 8).
Patients treated with therapeutic doses may experience exaggerated muscle weakness.
Pazjenti kkurati b’ dożi terapewtiċi jistgħu jesperjenzaw indebboliment esaġerat tal- muskoli.
There have been spontaneous reports of dysphagia, aspiration pneumonia and/ or potentially fatal respiratory disease, after treatment with botulinum toxin type A/ B.
Kien hemm rapporti spontanji ta ’ disfaġija, pnewmonja ta ’ aspirazzjoni u/ jew marda respiratorja potenzalment fatali, wara kura b’ botulinum toxin tip A/ B.
Patients with underlying neuromuscular disorders including swallowing disorders are at increased risk of these undesirable effects.
Pazjenti b’ mard newromuskolari diġa eżistenti inkluż disturbi biex tibla ’ huma f’ riskju akbar għal dawn l- effetti mhux mixtieqa.
In patients with neuromuscular disorders or history of dysphagia and aspiration, botulinum toxins should be used under close medical supervision and only if the benefit clearly outweighs the risk.
F’ pazjenti b’ disturbi newromuskolari jew b’ passat ta ’ disfaġija u aspirazzjoni, tossini ta ’ botulinum għandhom jiġu wżat taħt superviżjoni medika mill- qrib u biss jekk il- benefiċċju huwa ferm akbar mir- riskju.
Following NeuroBloc treatment, all patients and caregivers should be advised to seek medical attention for respiratory difficulties, choking or any new or worsening dysphagia.
Wara kura b’ NeuroBloc, l- pazjenti u dawk li qed jikkuraw kollha għandhom jiġu rakkomandati biex ifitċu attenzjoni medika għal diffikultajiet respiratorji, fgar jew xi disfaġija ġdida jew li qed tmur għal agħar.
Dysphagia has been reported following injection to sites other than the cervical musculature.
Disfaġija kienet irrappurtata wara injezzjoni f’ siti oħra barra l- muskolatura ċervikali.
The initial starting dose of 10,000 U (or 5000 U) is relevant only to NeuroBloc (Botulinum Toxin Type B).
Id- doża tal- bidu ta ’ 10, 000U (jew 5000 U) hija relevanti biss għal NeuroBloc (Botulinum Toxin Tip B).
These dosage units are specific to NeuroBloc only and are not relevant to preparations of Botulinum Toxin Type A.
Dawn l- unitajiet ta ’ dożaġġ huma speċifiċi għal NeuroBloc biss u mhumiex relevanti għall - preparazzjonijiet ta ’ Botulinum Toxin Tip A.
The unit dose recommendations for Botulinum Toxin Type A are significantly lower than those for NeuroBloc and administration of Botulinum Toxin Type A at the unit dose recommended for NeuroBloc may result in systemic toxicity and life-threatening clinical sequelae.
Ir- rakkommandazzjonijiet għall- unità ta ’ doża għal Botulinum Toxin Tip A huma ferm inqas minn dawk għal NeuroBloc u l- għoti ta ’ Botulinum Toxin Tip A f’ unità ta ’ doża rakkommandata għal NeuroBloc tista ’ tirriżulta f’ tossiċità sistemika u riżultati li jheddu l- ħajja.
3 4.5 Interactions with other medicinal products and other forms of interaction
3 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
The effect of administering different botulinum neurotoxin serotypes concurrently is unknown.
L- effett ta ’ l- għoti ta ’ serotipi ta ’ newrotossini ta ’ botulinum differenti flimkien, mhux magħruf.
However, in clinical trials, NeuroBloc was administered 16 weeks after the injection of Botulinum Toxin Type A.
Madankollu, fi provi kliniċi, NeuroBloc ġie mogħti 16- il ġimgħa wara l- injezzjoni ta ’ Botulinum Toxin Tip A.
Co-administration of NeuroBloc and aminoglycosides or agents interfering with neuromuscular transmission (e. g. curare-like compounds) should be considered with caution.
L- għoti ta ’ NeuroBloc flimkien ma ’ aminoglycosides jew sustanzi li jinterferixxu ma ’ trasmissjoni newromuskolari (eż. sustanżi li jixbħu lil curare) għandha tiġi kkunsidrata b’ attenzjoni.
Animal studies are insufficient with respect to effects on pregnancy and embryonal/ foetal development.
Studji fuq bhejjem m’ humiex biżżejjed rigward l- effetti fuq it- tqala u fuq l - iżvilupp ta ’ l- embriju/ fetu.
NeuroBloc should not be used during pregnancy unless clearly necessary.
NeuroBloc m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
It is unknown whether Botulinum Toxin Type B is excreted in human breast milk.
Mhux magħruf jekk Botulinum Toxin Tip B joħroġx fil- ħalib tas- sider uman.
The excretion of Botulinum Toxin Type B in milk has not been studied in animals.
It- tneħħija ta ’ Botulinum Toxin Tip B fil- ħalib ma ġietx studjata fl- annimali.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with NeuroBloc should be made taking into account the benefit of breast-feeding to the child and the benefit of NeuroBloc therapy to the women.
Deċisjoni dwar jekk jitkompliex/ jitwaqqafx it - treddigħ jew titkompliex/ titwaqqafx il- kura b’ NeuroBloc għandha ssir b’ kunsiderazzjoni tal- benefiċċju tat- treddigħ għat- tarbija u l- benefiċċju tal- kura b’ NeuroBloc għall- mara.
However, the pharmacological characteristics do not indicate that they would be affected.
Madankollu, il- karatteristiċi farmakoloġiċi ma jindikawx li dawn jistgħu jiġu effettwati.
Undesirable effects, typically dry mouth, dysphagia and blurred vision, may occur following NeuroBloc injection.
Jistgħu jseħħu effetti mhux mixtieqa, tipikament nixfa fil- ħalq, disfaġja u vista mċajpra, wara injezzjoni b’ NeuroBloc.
The two most commonly reported undesirable effects in clinical studies among patients with prior Botulinum Toxin Type A exposure were dry mouth and dysphagia, which were reported at a frequency of 41% and 29%, respectively.
L- aktar żewġ effetti mhux mixtieqa komuni rrapportati fi studji kliniċi fost pazjenti b’ espożizzjoni minn qabel għal Botolinium Toxin Tip A kienu nixfa fil- ħalq u disfaġja, li ġew irrapportati bi frekwenza ta ’ 41% u 29% rispettivament.
Data from clinical studies indicate that there is a tendency for the proportion of treatments associated with dysphagia to increase with higher doses injected into the sternocleidomastoid muscle.
Tagħrif minn studji kliniċi jindika li hemm it - tendenza li, l- proporzjon tal- kura assoċjati ma ’ disfaġja, jiżdied ma ’ dożi ogħla injettati fil- muskolu sternoklejdomastojd.
Injection site pain was also reported.
Ġie rrapportat ukoll uġigħ fil- post ta ’ l- injezzjoni.
The two most commonly reported undesirable effects in a Phase IV comparative clinical study among toxin naïve patients treated with NeuroBloc 10,000 U to 15,000 U were dry mouth and dysphagia, which were reported at a frequency of 44% and 35%, respectively.
Fi studju kliniku komparattiv ta ’ Fażi IV, fost pazjenti ġodda għat- tossina, kkurati b’ NeuroBloc 10, 000 U sa 15, 000 U, l- aktar żewġ effetti mhux mixtieqa rrappurtati b’ mod komuni kienu ħalq xott u disfaġija, li kienu rrappurtati bi frekwenza ta ’ 44% u 35%, rispettivament.
Adverse reactions seen in all trials are listed below according to MedDRA system organ class and in decreasing frequency which is defined as follows:
Reazzjonijiet avversi li ġraw fil- provi kollha huma elenkati taħt skond is- sistema tal- klassifika ta ’ l - organi MedDRA u b’ frekwenza li tonqos li hija mfissra kif ġej:
Very Common (> 1/ 10); Common (> 1/ 100 to < 1/10); Uncommon (> 1/1000 to < 1/100).
Komuni Ħafna (> 1/ 10); Komuni (> 1/ 100 sa < 1/ 10); Mhux Komuni (> 1/ 1000 sa < 1/ 100).
Patients with Prior Botulinum Toxin Type A Exposure
Pazjenti b’ Espożizzjoni minn Qabel għal Botulinum Toxin Tip A
4 System Organ Class Nervous system disorders
Disturbi fis- sistema nervuża
Very Common dry mouth
ħalq xott
Common torticollis (worsening from baseline), taste perversion
tortikollis (tirkadi mil- linja bażi), perverżjoni tat- togħma
voice alteration
tibdil fl- vuċi
Gastrointestinal disorders Musculoskeletal connective tissue and bone disorders
Disturbi gastro- intestinali Disturbi muskolu- skeltrali u tal - connective tissue
dysphagia
disfaġja
dyspepsia myasthenia
dispepsja mijastenja
injection site pain
uġigħ fis- sit ta ’ l - injezzjoni
neck pain
Uġigħ fl- għonq
Patients Naïve to Botulinum Toxins
Pazjenti Ġodda għat- Tossini ta ’ Botulinum
System Organ Class Nervous system disorders Eye disorders:
Sistema tal- Klassifika ta ’ l- Organi
Respiratory thoracic and mediastinal disorders
Disturbi fis- sistema nervuża Disturbi fl- għajnejn Disturbi respiratorji, toraċiċi u medjastinali
Very Common dry mouth, headache
ħalq xott, uġigħ ta ’ ras
Common torticollis blurred vision dysphonia
tortikollis vista mċajpra disfonja
Gastrointestinal disorders General disorders and administration site conditions
Disturbi gastro- intestinali Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
dyspepsia injection site pain
li mhuwiex assoċjat ma ’
In common with Botulinum Toxin Type A, electrophysiological jitter, which is not associated with clinical weakness or other electrophysiological abnormalities, may be experienced in some distant muscles.
dgħjufija klinika jew ma ’ anormalitajiet elettrofiżjoloġiċi oħra, jista ’ jseħħ f’ xi muskoli distanti.
Post marketing experience Side effects related to spread of toxin distant from the site of administration have been reported (exaggerated muscle weakness, dysphagia, dyspnoea, aspiration pneumonia with fatal outcome in some cases) (see section 4.4).
Esperjenza ta ’ wara t- tqegħid fis- suq Effetti sekondarji relatati mal- firxa tat- tossina l- bogħod mis- sit ta ’ l- għotja kienu rrappurtati (indebboliment esaġerat fil- muskoli, disfaġja, dispnea, pnewmonja ta ’ aspirazzjoni b’ riżultat fatali f’ xi każijiet) (ara sezzjoni 4. 4).
The following effects have also been reported during post marketing use: abnormal accommodation, ptosis, vomiting, constipation, flu-like symptoms, and asthenia.
L- effetti li ġejjin kienu rrappurati wkoll waqt l- użu ta ’ wara t- tqegħid fis- suq: akkomodazzjoni mhux normali, ptosi, rimettar, stitikezza, sintomi bħal ta ’ l- influwenza u astenja.
Cases of overdose (some with signs of systemic toxicity) have been reported.
Ġew irrapportati każi ta ’ doża eċċessiva (wħud b’ sinjali ta ’ tossiċità sistemika).
In the event of an overdose, general medical supportive measures should be instituted.
F’ każ ta ’ doża eċċessiva, għandhom jiġu stabbiliti miżuri mediċi ġenerali ta ’ appoġġ.
Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults.
Dożi sa 15, 000 U b’ mod mhux frekwenti rriżultaw f’ tossiċità sistemika klinikament sinifikanti f’ adulti.
However, in children (non-approved use) clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients.
Madankollu, fi tfal (użu mhux approvat) tossiċità sistemika klinikament sinifikanti seħħet f’ dożi approvati għall- kura ta ’ pazjenti adulti.
If botulism is clinically suspected, hospitalisation for the monitoring of respiratory function (incipient respiratory failure) may be required.
Jekk ikun hemm suspett kliniku ta ’ botuliżmu, jista ’ jkun hemm bżonn li l- pazjent jittieħed l - isptar sabiex il- funzjoni respiratorja tiegħu tiġi mmonitorjata (bidu ta ’ insuffuċjenza respiratorja).
In the event of an overdose or injection into a muscle that normally compensates for the cervical dystonia, it is conceivable that the dystonia may worsen.
Fil- każ ta ’ doża eċċessiva jew injezzjoni f’ muskolu li normalment tikkumpensa għad- distonja ċervikali, wieħed jifhem li d- distonja tista ’ tmur għall- agħar.
As with other botulinum toxins spontaneous recovery will occur over a period of time.
Bħal f’ tossini ta ’ botulinum oħrajn, l - irkupru spontanju jseħħ fuq perjodu ta ’ żmien.
Pharmacotherapeutic group: muscle relaxant, peripherally acting agent, ATC code:
Kategorija Farmakoterapewtika: rilassant tal- muskoli, sustanza li taħdem fuq il- periferiji, Kodiċi ATC:
NeuroBloc is a neuromuscular blocking agent.
NeuroBloc huwa sustanza li timblokka n- newromuskoli.
The mechanism of action of NeuroBloc in blocking neuromuscular conduction occurs by a three-step process:
Il- mekkaniżmu ta ’ azzjoni ta ’ NeuroBloc fl - imblukkar tat- trasmissjoni newromuskolari sseħħ fi proċess ta ’ tlett fażijiet:
Extracellular binding of the toxin to specific acceptors on motor nerve terminals 2.
Tgħaqqid ekstraċellulari tat- tossina ma ’ aċċettaturi speċifiċi fuq it- terminali tan- nervi motorji 2.
Internalisation and release of the toxin into the cytosol of the nerve terminals 3.
Internalizzazzjoni u rilaxx tat- tossina fis- cytosol tat- terminali tan- nervaturi 3.
Inhibition of acetylcholine release from nerve terminals at the neuromuscular junction
Inibizzjoni tar- rilaxx ta ’ acetylcholine minn terminali tan- nervaturi fil- junctions newromuskolari
When injected directly into a muscle, NeuroBloc causes a localised paralysis that gradually reverses over time.
Meta injettat direttament fil- muskolu, NewroBloc jikkawża paraliżi lokalizzata li tgħaddi b’ mod gradwali.
The mechanism by which muscle paralysis is reversed over time remains unknown, but may be associated with the intraneuronal turnover of the affected protein and/ or sprouting of the nerve ending.
Il- mekkaniżmu li bih il- paraliżi muskolari jgħaddi maż- żmien jibqa ’ mhux magħruf, iżda jista ’ jkun assoċjat ma ’ radd lura intranewronali tal- proteina affettwata u/ jew inbit tat- tarf tan- nerv.
Two Phase III randomised, multicentre, double-blind, placebo-controlled studies were conducted in patients with cervical dystonia.
5 Ġew imwettqa żewġ studji ta ’ Fażi III ikkontrollati bi plaċebo, randomised, double- blind, multiċentrali, f’ pazjenti b’ distonja ċervikali.
Both studies enrolled adult patients (≥ 18 years) who had a history of receiving Botulinum Toxin Type A.
Iż- żewġ studji rreġistraw pazjenti adulti (≥ 18- il sena) li kellhom passat ta ’ għotja ta ’ Botulinum Toxin Tip A.
The first study enrolled patients who were clinically resistant to type A toxin (A-non responders), confirmed by a Frontalis Type A test.
L- ewwel studju rreġistra pazjenti li kienu klinikament reżistenti għat- tossina tat- tip A (Pazjenti li ma jirrispondux għal A), ikkonfermati b’ test Frontalis tat- tip A.
The second study enrolled patients who continued to respond to type A toxin (A-responders).
It- tieni studju rreġistra pazjenti li komplew jirrispondu għat- tossina tat- tip A (Pazjenti li jirrispondu għal A).
On enrolment all patients had Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) -Total scores of 20 or greater with at least two muscles involved, no neck contractures or other causes of decreased neck range of motion, and no history of any other neuromuscular disorder.
Mar- reġistrazzjoni, il- pazjenti kollha kellhom Punteġġi totali ta ’ Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) – ta ’ 20 jew aktar b’ ta ’ l- anqas żewġ muskoli nvoluti, mingħajr ebda kontrazzjonijiet ta ’ l- għonq jew kawżi oħra ta ’ firxa mnaqqsa ta ’ moviment ta ’ l- għonq, u ebda storja ta ’ kwalunkwe disturb newromuskolari oħra.
The TWSTRS is comprised of three sub-scales which examine severity, pain and disability.
It- TWSTRS huwa magħmul minn tliet sub- skali li jeżaminaw is- severità, l- uġigħ u d- disabilità.
In the first study, type A resistant patients (A-non responders) were randomised to receive placebo or 10,000 U of NeuroBloc and in the second, type A toxin responsive patients (A-responders) were randomised to receive placebo, 5000 U or 10,000 U of toxin.
Fl- ewwel studju, pazjenti reżistenti għat- tip A (Pazjenti li ma jirrispondux għal A) kienu randomised sabiex jirċievu plaċebo jew 10, 000 U ta ’ NeuroBloc u fit- tieni, pazjenti li jirrispondu għat- tossina tat - Tip A (Pazjenti li jirrispodu għal A) kienu randomised sabiex jirċievu plaċebo, 5000 U jew 10, 000 U tat- tossina.
Study drug was injected on a single occasion into 2 to 4 of the following muscles: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus and scalene.
Il- mediċina taħt studju ġiet injettata f’ okkażjoni waħda fi tnejn jew f’ erbgħa mill- muskoli li ġejjin: splenius capitus, sternocleidomastoid, levator scapulae, trapezius, semispinalis capitus u scalene.
The total dose was divided between the selected muscles and 1 to 5 injections per muscle were administered.
Id- doża totali ġiet maqsuma bejn il- muskoli magħżula u ġew mogħtija minn injezzjoni sa 5 injezzjonijiet għal kull muskolu.
There were 77 subjects enrolled into the first study and 109 into the second.
Kien hemm 77 pazjent irreġistrat fl- ewwel studju u 109 fit- tieni.
Patient evaluations continued for 16 weeks post injection.
Evalwazzjonijiet tal- pazjent baqgħu għaddejjin għal 16- il ġimgħa wara l- injezzjoni.
The primary efficacy outcome variable for both studies was the TWSTRS-Total score (range of possible scores is 0-87) at Week 4.
Il- varjabbli tar- riżultat primarju ta ’ l- effikaċja għaż- żewġ studji kien il- punteġġ Totali TWSTRS (il - firxa tal- punteġġi possibbli hija 0- 87) fir- 4 Ġimgħa.
The secondary endpoints included Visual Analogue Scales (VAS) to quantify the Patient Global Assessment of change and the Physician Global Assessment of change, both from baseline to Week 4.
Il- miri sekondarji inkludew Skala Analoga Viżwali (VAS) sabiex tikkwantifika l- Istima tal- bidla Globali tal- Pazjent u l- Istima tal- bidla Globali tat- Tabib, it- tnejn mill- linja bażi ta ’ referenza sar- 4 Ġimgħa.
On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Fuq dawn iż- żewġ skali, punteġġi ta ’ 50 ma jindikaw ebda bidla, 0 ħafna agħar, u 100 ħafna aħjar.
Results of comparisons of the primary and secondary efficacy variables are summarised in Table 1.
Riżultati ta ’ tqabbil tal- varjabbli ta ’ l - effikaċja primarji u sekondarji huma mogħtija fil- qosor f’ Tabella 1.
Analysis of the TWSTRS sub scales revealed significant effects on the severity of cervical dystonia and its associated pain and disability.
Analiżi tas- sub skali tat- TWSTRS wrew effetti sinnifikanti fuq il- gravità ta ’ distonja ċervikali u l- uġigħ u d- diżabilità assoċjati magħha.
Exploratory analyses of these studies suggested that the majority of patients who showed a beneficial response by the fourth week had returned to their baseline status between 12 to 16 weeks after their injection.
Analiżi ta ’ esplorazzjoni fuq dawn l- istudji ssuġġeriet li l- maġġoranza tal- pazjenti li wrew respons għall- aħjar sar- raba ’ ġimgħa marru lura għall- istat tal- linja bażi ta ’ referenza tagħhom bejn 12 sa 16- il ġimgħa wara l- injezzjoni tagħhom.
Efficacy Results from Phase III NeuroBloc Studies
Riżultati ta ’ l- Effikaċja minn Studji ta’ Fażi III dwar NeuroBloc
(A-Resistant Patients)
(Pazjenti Reżistenti għal A)
(A-Responsive Patients)
(Pazjenti li Jirrispondu għal A)
Assessments TWSTRS-Total
Stimi Totali TWSTRS
Placebo n = 38
Plaċebo n = 38
10,000 U Placebo n = 39 n = 36
10, 000 U Plaċebo n = 39 n = 36
10,000 U n = 37
10, 000 U n = 37
Mean At Baseline Mean at Week 4 Change from Baseline P-Value* Patient Global
46. 4
51.2 49.2 -2.0
49. 2 - 2. 0
52.8 43.6 41.8 39.3 -11.1 -4.3 0.0001
41. 8 39. 3 - 11. 1 - 4. 3
46.4 37.1 -9.3 0.0115
35. 2 - 11. 7
46.9 35.2 -11.7 0.0004
Valur P * Pazjent Globali
Mean at Week 4 P-Value* Physician Global
Medja fir- 4 Ġimgħa Valur P * Tabib Globali
39.5
39. 5
60.2 43.6 0.0001
60. 2 43. 6 0. 0001
60.6 0.0010
60. 6 0. 0010
64.6 0.0001
64. 6 0. 0001
Mean at Week 4 P-Value*
Medja fir- 4 Ġimgħa Valur P *
47.9
47. 9
60.6 52.0 0.0001
60. 6 52. 0 0. 0001
65.3 0.0011
65. 3 0. 0011
64.2 0.0038
64. 2 0. 0038
* Analysis of covariance, two-tailed tests, α = 0.05
* Analażi ta ’ kovarjanza, testijiet two- tailed, α = 0. 05
A further exploratory analysis of duration of effect employed data from a Phase II study in addition to the Phase III data described.
6 Analiżi ta ’ esplorazzjoni oħra ta ’ tul ta ’ l- effett użat tagħrif minn studju tat- II Fażi barra mill - informazzjoni tat- III Fażi deskritta.
In the patients who responded to treatment (those who experienced an improvement in TWSTRS greater than 20% over baseline) the following duration of effect was observed at doses of 5000 and 10,000 U.
Fil- pazjenti li rrispondew għal- kura (dawk li kellhom titjib fi TWSTRS ta ’ aktar minn 20% fuq il- linja bażi ta ’ referenza) ġie osservat it- tul ta ’ l- effett li ġej f’ dożi ta ’ 5000 u 10, 000 U.
Duration of Effect in Responders
Tul ta ’ l- Effett f’ Pazjenti li Rrispondew
Duration Of Effect (% Responders)
Tul ta ’ l- Effett (% ta ’ Pazjenti li Rrispondew)
43
4 Ġimgħat 43
22
8 Ġimgħat 22
16
Ġimgħa 16
19
Ġimgħa 19
10,000 U Overall
10, 000 U Total
In open-label studies, doses up to 15,000 U were given to patients at intervals of not less than 12 weeks.
Fi studji open- label, ġew mogħtija dożi sa 15, 000 U lil pazjenti f’ intervalli ta ’ mhux inqas minn 12- il ġimgħa.
The proportion of patients who responded to these injections was similar to that in the key controlled studies.
Il- proporzjon ta ’ pazjenti li rrispondew għal dawn l- injezzjonijiet kien bħal dak fl- istudji prinċipali b 'kontrolli.
A Phase IV randomised, multicentre, double-blind study was conducted to compare the efficacy of NeuroBloc (10,000 U) to Botulinum Toxin Type A (150 U) in patients with cervical dystonia who have never previously received a botulinum toxin product.
Studju ta ’ Fażi IV randomised, multicentre, u double- blind twettaq biex iqabbel l- effikaċja ta ’ NeuroBloc (10, 000 U) ma ’ Botulinum Toxin Tip A (150 U) f’ pazjenti b’ distonija ċervikali li qatt ma kienu rċevew minn qabel prodott b’ botulinum toxin.
Final analysis was carried out on a total of 93 enrolled botulinum naive patients (46 in the NeuroBloc group) following a single injection, into 2 of 4 predetermined muscles.
Twettqet analiżi finali fuq total ta ’ 93 pazjent, ġdid għal botulinum (46 fil- grupp b’ NeuroBloc) wara injezzjoni waħda, ġo 2 minn 4 muskoli ddeterminati minn qabel.
Baseline assessments, including TWSTRS and VAS pain evaluation by patient and investigator, were repeated at 4, 8 and 12 weeks after treatment.
Analiżi tal- linja bażi, inkluż valutazzjoni TWSTRS u VAS ta ’ l- uġigħ mill - pazjent u l- investigatur, kienu ripetuti f’ ġimgħat numru 4, 8 u 12 wara l- kura.
The primary efficacy analysis demonstrates the noninferiority of NeuroBloc to Type A toxin as shown by the TWSTRS total score at session 1, week 4, for the PP population.
L- analiżi primarja ta ’ l- effikaċja turi n- nuqqas ta ’ inferjorità ta ’ NeuroBloc għat- tossina ta ’ Tip A kif muri mill- punteġġ totali ta ’ TWSTRS fl- ewwel sessjoni, ġimgħa 4, għall- popolazzjoni PP.
Excluding site 121, the mean scores for NeuroBloc and Type A toxin were 32.7 (SD 11.61) and 36.0 (SD 11.71) respectively with a 95% CI of 29.3, 36.2 and 32.6, 39.4 respectively.
Minbarra sit 121, il- punteġġi medji għal NeuroBloc u għat- tossina ta ’ Tip A kienu 32. 7 (SD 11. 61) u 36. 0 (SD 11. 71) rispettivament b’ 95% CI ta ’ 29. 3, 36. 2 u 32. 6, 39. 4 rispettivament.
The upper limit of the 1-sided CI in the LS mean difference (NeuroBloc - type A toxin) in the TWSTRS total score at week 4 of session 1 for the PP population (excluding site 121) was 0.6 which is well within the predefined criterion for noninferiority of 4 points in the mean difference between groups adjusted for baseline for the TWSTRS.
Il- limitu ta ’ fuq ta ’ CI ta ’ naħa waħda fid- differenza medja ta ’ LS (NeuroBloc – tossina Tip A) fil- punteġġ totali ta ’ TWSTRS f’ ġimgħa 4 ta ’ l- ewwel sessjoni għall- popolazzjoni PP (minbarra sit 121) kien 0. 6 li kien sew fil- kriterju determinat minn qabel għan- nuqqas ta ’ inferjorità ta ’ 4 punti fid- differenza medja bejn gruppi irranġati għal- linja bażi għal TWSTRS.
These findings led to an identical conclusion when site 121 was included.
Dawn is- sejbiet wasslu għal konklużjoni identika meta sit 121 kien inkluż.
7 The robustness of this analysis was confirmed by additional analyses that calculated the 1-sided 97.5% CI, analyses using the unadjusted scores, and analyses using the ITT and interim CSR PP populations.
Ir- robustezza ta ’ din l- analiżi kienet ikkonfermata minn aktar analiżi li kkalkulat 97. 5% CI ta ’ naħa waħda, analiżi bl- użu ta ’ punteġġi mhux irranġati, u analiżi bl- użu ta ’ ITT u popolazzjonijiet interim ta ’ CSR PP.
In this regard the noninferiority of NeuroBloc compared to Botulinum Toxin Type A is also supported by a responder analysis using the ITT population, which showed that a similar percentages of subjects showed any improvement in the TWSTRS score at Week 4 of Session 1 (86% NeuroBloc and 85% Botox), as did subjects who experienced at least a 20% decrease from baseline in the TWSTRS score at Week 4 of Session 1 (51% NeuroBloc, 47% Botox).
F’ dan ir- rigward, in- nuqqas ta ’ inferjorità ta ’ NeuroBloc meta mqabbel ma ’ Botulinum Toxin Tip A hija msaħħa wkoll minn analiżi ta ’ dawk li rrispondew bl- użu ta ’ popolazzjoni ITT, li wriet persentaġġi simili ta ’ pazjenti wrew kull titjib fil- punteġġ TWSTRS f’ Ġimgħa 4 ta ’ l- Ewwel Sessjoni (86% NeuroBloc u 85% Botox), kif urew individwi li esperjenzaw tnaqqis ta ’ mill- inqas 20% mil- linja bażi fil- punteġġ TWSTRS f’ Ġimgħa 4 ta ’ l - Ewwel Sezzjoni (51% NeuroBloc, 47% Botox).
A Phase IV open label study has been conducted to evaluate the safety, immunogenicity and effect of repeated doses of NeuroBloc in subjects with cervical dystonia (CD) who were previously treated with Botulinum Toxin Type A.
Studju open- label ta ’ Fażi IV twettaq biex jivvaluta is- sigurtà, l- immunoġeniċità u l- effett ta ’ dożi ripetuti ta ’ NeuroBloc f’ soġġetti b’ distonija ċervikali (CD) li kienu ttrattati qabel għal Botulinum Toxin Tip A.
The primary objectives of the open label study were to evaluate the safety, immunogenicity and effect of repeat doses of NeuroBloc in subjects with CD who were already resistant to Botulinum Toxin Type A compared to subjects who were responsive to Botulinum Toxin Type A..
L- miri primarji ta ’ l- istudju open label kienu li jiġu evalwati s- sigurtà, l- immunoġeniċità u l- effett ta ’ dożi ripetuti ta ’ NeuroBloc f’ soġġeti b’ CD li diġà kienu reżistenti għal Botulinum- Toxin Tip A, meta mqabbla ma ’ suġġetti li rrispondew għal Botulinum Toxin Tip A.
A total of 130 subjects were enrolled, comprising 67 Type A resistant and 63 type A responsive.
Total ta ’ 130 pazjent ġew rekrutati li kienu jikkonsistu minn 67 pazjent reżistenti għat- tip A u 63 responsivi għal tip A.
Subjects were given a starting dose of 10,000 Units of NeuroBloc at their first treatment, then subsequent doses modified at increments of 2,500 or 5,000 units to a maximum of 25,000 units with a dosage interval of at least 12 weeks.
Is- suġġetti ngħataw doża tal- bidu ta ’ 10, 000 Unità ta ’ NeuroBloc fl - ewwel kura, u wara dożi sussegwenti modifikati f’ żidiet ta ’ 2, 500 jew 5, 000 unita sa massimu ta ’ 25, 000 unita b’ intervall ta ’ dożaġġ ta ’ mill- inqas 12- il ġimgħa.
Eight of the 67 Type A resistant subjects (11.9%) had developed neutralising antibodies to Botulinum Toxin Type B within completion of 4 treatment cycles of NeuroBloc and 15 out of 67 subjects (22.4%) had developed neutralising antibodies at the time of interim study analysis.
7 Tmienja mis- 67 soġġett reżistenti għat- tip A (11. 9%) kienu żviluppaw antikorpi li jinnewtralizzaw Botulinum Toxin Type B wara t- tmiem ta ’ l- 4 ċikli ta ’ kura ta ’ NeuroBloc u 15 minn 67 (22. 4%) tas- soġġetti fil- ħin ta ’ l- analiżi ta ’ l- istudju interim.
The earliest development of neutralising antibodies was seen in 2 out of 67 subjects (3%) 6-9 months after the start of NeuroBloc treatment.
L- iktar żvilupp bikri ta ’ antikorpi newtralizzanti deher fi 2 mis- 67 (3%) tas- soġġetti 6- 9 xhur wara l- bidu tal- kura b’ NeuroBloc.
NeuroBloc treatment was associated with a low incidence of development of neutralising antibodies to Botulinum Toxin Type B during the first year of treatment.
Kura b’ NeuroBloc kienet assoċjata ma ’ inċidenza baxxa ta ’ iżvilupp ta ’ antikorpi newtralizzanti għal Botulinum Toxin Tip B waqt l- ewwel sena ta ’ kura.
The presence of antibodies does not necessarily mean resistance to treatment as the number of patients truly resistant is likely to be much lower than the results indicate.
Il- preżenza ta ’ antikorpi mhux neċessarjament ifisser reżistenza għall- kura minħabba li n- numru ta ’ pazjenti li fil- verità jkunu reżistenti jkun probabbilment ħafna inqas milli ndikaw ir- riżulati.
Therefore patients resistant to Botulinum Toxin Type A may benefit from treatment with NeuroBloc and continue to experience this benefit over a long time period.
Għalhekk pazjenti reżistenti għal Botulinum Toxin Tip A jistgħu jibbenefikaw minn kura b’ NeuroBloc u jkomplu jesperjenzaw dan il- benefiċċju fuq tul ta ’ żmien twil.
NeuroBloc injected intramuscularly produces localised muscle weakness by chemical denervation.
NeuroBloc injettat ġol- muskoli jipproduċi dgħjufija lokalizzata fil- muskoli permezz ta ’ denervazzjoni kimika.
Following local intramuscular injection of NeuroBloc serious adverse events that may have been due to systemic effects of Botulinum Toxin Type B, were observed in 12% of adverse drug reaction cases reported during the post-marketing experience (including the following adverse events: dry mouth, dysphagia and blurred vision).
Wara injezzjoni lokali ġol- muskoli ta ’ NeuroBloc episodji avversi serji li setgħu kienu minħabba l- effetti sistemiċi ta ’ Botulinum Toxin Tip B, kienu osservati fi 12% tal- każijiet ta ’ reazzjoni avversa tal- mediċina rrappurtati waqt l- esperjenza ta ’ wara t- tqegħid fis- suq (inkluż l- episodji avversi li ġejjin: ħalq xott, disfaġja u vista mċajpra)..
However, no pharmacokinetic or Absorption, Distribution, Metabolism and Excretion (ADME) studies have been performed.
Madankollu, ma saru l- ebda studji farmakokinetiċi jew studji ta ’ Assorbiment, Distribuzzjoni, Metaboliżmu u ta ’ Eliminazzjoni (ADME).
Single dose pharmacology studies in cynomolgus monkeys have shown no effects other than the anticipated dose-dependent paralysis of injected muscles, together with some diffusion of toxin at high doses producing similar effects in neighbouring non-injected muscles.
Studji farmakoloġiċi ta ’ doża waħda fix- xadini cynomolgus ma wrew l- ebda effetti għajr il- paraliżi mistennija dipendenti fuq id- doża tal- muskoli injettati, flimkien ma ’ xi firxa ta ’ tossina f’ dożi għoljin li jipproduċu effetti simili fil- muskoli tal- madwar mhux injettati.
Single dose intramuscular toxicology studies have been performed in cynomolgus monkeys.
Ġew imwettqa studji tossikoloġiċi intramuskolari ta ’ doża waħda fix- xadini cynomolgus.
The systemic No Observed Effect Level (NOEL) was shown to be approximately 960 U/ kg.
Il- Livell tad - Doża bl- Ebda Effett Osservat (NOEL) sistemiku ġie muri li hu madwar 960 U/ kg.
The dose resulting in death was 2400 U/ kg.
Id- doża li rriżultat f’ mewt kienet ta ’ 2400 U/ kg.
8 Because of the nature of the product, no animal studies have been carried out to establish the carcinogenic effects of NeuroBloc.
Minħabba n- natura tal- prodott, ma saru l- ebda studji fuq l- annimali sabiex jiġu stabbiliti l- effetti karċinoġeniċi ta ’ NeuroBloc.
Standard tests to investigate the mutagenicity of NeuroBloc have not been performed.
Ma saru l- ebda testijiet stàndard sabiex tiġi investigata l- mutaġeniċità ta ’ NeuroBloc.
Development studies in rats and rabbits have shown no evidence of foetal malformations or changes to fertility.
Studji ta ’ l- iżvilupp fil- firien u fil- fniek ma wrew l- ebda evidenza ta ’ malformazzjonijiet tal- fetu jew tibdil fil- fertilità.
In the development studies, the No Observed Adverse Effect Dose Level (NOAEL) in rats was 1000 U/ kg/ day for maternal effects and 3000 U/ kg/ day for foetal effects.
Fl- istudji ta ’ l- iżvilupp, il- Livell tad- Doża bl- Ebda Effett Avvers Osservat (NOAEL) fil- firien kien ta ’ 1000 U/ kg/ ġurnata għal effetti fuq l- omm u 3000 U/ kg/ ġurnata għal effetti fuq il- fetu.
In rabbits, the NOAEL was 0.1 U/ kg/ day for maternal effects and 0.3 U/ kg/ day for foetal effects.
Fil- fniek, in- NOAEL kien ta ’ 0. 1 U/ kg/ ġurnata għal effetti fuq l- omm u 0. 3 U/ kg/ ġurnata għal effetti fuq il- fetu.
In the fertility studies the NOAEL was 300 U/ kg/ day for general toxicity in both males and females and 1000 U/ kg/ day for fertility and reproductive performance.
Fl- istudji tal- fertilità NOAEL kien ta ’ 300 U/ kg/ ġurnata għal tossiċità ġenerali kemm fl - irġiel kif ukoll fin- nisa u ta ’ 1000 U/ kg/ ġurnata għal fertilità u rendiment riproduttiv.
Disodium succinate Sodium chloride Human serum albumin (containing sodium caprylate andsodium acetyltryptophanate as excipients) Hydrochloric acid for pH adjustment) Water for injections
Disodium succinate, Sodium chloride Human serum albumin (li fiħ sodium caprylate u sodium acetyltryptophanate bħala sustanzi mhux attivi) Hydrochloric acid għal aġġustament tal- pH), Ilma għall- injezzjonijiet.
In the absence of incompatibility studies, NeuroBloc must not be mixed with other medicinal products.
8 Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jablux miegħu, NeuroBloc ma jistax jitħallat ma ’ prodotti mediċinali oħra.
From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination the product should be used immediately.
Mill- aspett mikrobijoloġiku, sakemm il- metodu ta ’ ftugħ/ dilwizzjoni ma teskludix r- riskju ta ’ kontaminazzjoni b’ mikrobi, l- prodott għandu jintuża minnufiħ.
Store in a refrigerator (2oC - 8oC).
Aħżen fi friġġ (2oC - 8oC).
Within its shelf-life, the product may be stored below 25oC for up to 3 months, without being refrigerated again during this period, and must be withdrawn if not used after this.
Matul iż- żmien li jdum tajjeb, il- prodott jista ’ jinħażen taħt temperatura ta ’ 25oC sa 3 xhur, mingħajr ma jitpoġġa fil- friġġ mill- ġdid matul dan il- perjodu, u għandu jintrema jekk ma jintużax wara dan il - perjodu.
NeuroBloc is supplied in 3.5 ml Type I glass vials, with siliconised grey butyl rubber stoppers oversealed by aluminium crimped caps.
NeuroBloc huwa disponnibli f’ kunjetti tal- ħġieġ tat- Tip I ta ’ 3. 5 ml, b’ tappijiet tal- lastiku butyl griżi issiġġilati b’ għotjien ta ’ l- aluminju magħfusin bil- pressa.
Carton containing a single vial containing 0.5 ml, 1.0 ml or 2.0 ml of solution.
Kartuna fiha kunjett wieħed li fih 0. 5 ml, 1. 0 ml jew 2. 0 ml ta ’ soluzzjoni.
9 NeuroBloc is provided as a clear and colourless to light yellow sterile injectable solution in vials for single use only.
NeuroBloc huwa pprovdut bħala soluzzjoni għall- injezzjoni, sterili, ċara u bla kulur sa isfar ċar, f’ kunjetti għall- użu ta ’ darba biss.
Any unused solution should be discarded (see instructions below).
Kull soluzzjoni li ma tintużax għandha tintrema (ara l - istruzzjonijiet isfel).
Vials should be visually inspected prior to use.
Il- kunjetti għandhom jiġu spezzjonati viżwalment qabel l- użu.
If the NeuroBloc solution is not clear and colourless/ light yellow or if the vial appears damaged the product should be discarded as Medical Biohazardous Waste in accordance with local requirements.
Jekk is- soluzzjoni NeuroBloc ma tkunx ċara u bla kulur/ isfar ċar jew jekk il- kunjett jidher li għandu l- ħsara il- prodott għandu jintrema bħala Skart Mediku Bijoperikoluż kif jitolbu l- liġijiet lokali.
The solution in the vials is ready for use.
Is- soluzzjoni fil- kunjetti hija lesta sabiex tintuża.
Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach – 2 ml (0.5%):
Iddikontamina kull tixrid b’ 10% soluzzjoni kawstika, jew b’ soluzzjoni ta ’ sodium hypochlorite (bliċ tal- chlorine għall- użu fid- djar – 2 ml (0. 5%):
1 litre water) solution.
1 litru ilma).
Wear waterproof gloves and soak up the liquid with an appropriate absorbent.
Ilbes ingwanti li ma jgħaddix ilma minnhom u xxotta l- likwidu b’ assorbent addattat.
Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.
Poġġi t- tossina assorbita f’ borża ta ’ l- awtoklavi, issiġillaha u pproċessaha bħala Skart Mediku Bioperikoluż kif jitolbu l- liġijiet lokali.
Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire
EU/ 1/ 00/ 166/ 001 – 2500 U EU/ 1/ 00/ 166/ 002 – 5000 U EU/ 1/ 00/ 166/ 003 – 10,000 U
EU/ 1/ 00/ 166/ 001 – 2, 500 U EU/ 1/ 00/ 166/ 002 – 5, 000 U EU/ 1/ 00/ 166/ 003 – 10, 000 U
Date of first authorisation:
Data ta ’ l- ewwwel awtorizzazzjoni:
22 January 2001 Date of latest renewal:
22 ta ’ Jannar 2001 Data ta ’ l- aħħar tiġdid:
22 January 2006
22 ta ’ Jannar 2006
Name and address of the manufacturer of the biological active substance
Isem u indirizz tal- manifattur tas- sustanza( i) bijoloġika( ċi) attiva( i)
Solstice Neurosciences Inc 701 Gateway Blvd, South San Francisco California 94080 USA
Solstice Neurosciences Inc 701 Gateway Blvd, South San Francisco California 94080 L- Istati Uniti
Name and address of the manufacturer responsible for batch release
Isem u ndirizz tal- manifattur responsabbli mill- ħruġ tal- lott
Eisai Manufacturing Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN United Kingdom
Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN Ir- Renju Unit
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
- KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU
Summary of Product Characteristics, section 4.2).
Karatteristiċi tal- Prodott fil - Qosor, sezzjoni 4. 2)
14 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 0.5 ml vial
14 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
NeuroBloc 5000 U/ ml solution for injection Botulinum Toxin Type B
NeuroBloc 5000 U/ ml soluzzjoni għall- injezzjoni
Composition:
Kompożizzjoni:
One ml contains 5000 U Botulinum Toxin Type B (2500 U per vial)
Millilitru fih 5000 U Botulinum Toxin Tip B (2500 U kull kunjett)
LIST OF EXCIPIENTS
3. lista TA ’ SUSTANZI MHUX ATTIVI
Disodium succinate, sodium chloride, human serum albumin, sodium caprylate, sodium acetyltryptophanate, hydrochloric acid and water for injections.
Disodium succinate, sodium chloride, human serum albumin, sodium caprylate, sodium acetyltryptophanate, hydrochloric acid u ilma għall- injezzjonijiet.
1 x 0.5 ml vial, 2500 U
Kunjett 1 x 0. 5 ml, 2500 U
SPECIAL WARNINGS THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
SPECIAL STORAGE PRECAUTIONS
KUNDIZZJONI SPEĊJALI TA ’ KIF JINĦAŻEN
For the purpose of ambulatory use, the product may be removed from the refrigerator for one single period of up to 3 months at a temperature not above 25oC without exceeding the expiry date.
Għal skopijiet ta ’ użu ambulatorju, il- prodott jista ’ jinħareġ mill- friġġ għal perjodu wieħed sa 3 xhur f’ temperatura ta ’ mhux aktar minn 25oC mingħajr ma tinqabeż id- data ta ’ skadenza.
At the end of this period, the product should not be put back in the refrigerator and should be disposed of..
Fit- tmiem ta ’ dan il- perjodu, il- prodott m’ għandux jitpoġġa lura fil- friġġ u għandu jintrema.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIAL DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTT MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
Read package leaflet for special precautions for handling and disposal.
Aqra il- fuljett ta ’ tagħrif għall- prekawzjonijiet speċjali għall- immaniġġjar u għar- rimi.
Marketing Authorisation Holder:
Sid l- Awtorizzazzjoni għat- tqegħid fis- suq:
Eisai Limited Mosquito Way Hatfield Herts AL10 9SN United Kingdom
Eisai Limited Mosquito Way Hatfield Herts AL10 9SN Ir- Renju Unit
LOT:
Lott:
16 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 0.5 ml vial
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NeuroBloc 5000 U/ ml solution for injection IM
NeuroBloc5000 U/ ml soluzzjoni għall- injezzjoni IM
CONTENTS BY WEIGHT, VOLUME OR BY UNIT
IL- KONTENUT SKOND IL- PIŻ, VOLUM, JEW PARTI INDIVIDWALI.
2500 U
2500 U TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
17 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 1.0 ml vial
Kartuna ta ’ barra il- kunjett ta ’ 1. 0 ml
NeuroBloc 5000 U/ ml Solution for injection Botulinum Toxin Type B
NeuroBloc 5000 U/ ml Soluzzjoni għall- injezzjoni Botulinum Toxin Tip B
STATEMENT OF ACTIVE SUBSTANCES
DIKJARAZZJONI TAS- SUSTANZ( I) ATTIVA
One ml contains 5000 U Botulinum Toxin Type B (5000 U per vial)
Millilitru fih 5000 U ta ’ Botulinum Toxin Tip B (5000 U kull kunjett)
1 x 1.0 ml vial, 5000 U
Kunjett 1 x 1. 0 ml, 5000 U
SPECIAL STORAGE PRECAUTIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
19 Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
20 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 1.0 ml vial
Tikketta tal- kunjett, kunjett ta ’ 1. 0 ml
NeuroBloc 5000 U/ ml solution for injection IM
NeuroBloc 5000 U/ ml soluzzjoni għall- injezzjoni IM
5000 U
5000 U TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
21 PARTICULARS TO APPEAR ON OUTER PACKAGING Outer carton 2.0 ml vial
Kartuna ta ’ barra il- kunjett ta ’ 2. 0 ml
NeuroBloc 5000 U/ ml Solution for injection Botulinum Toxin Type B
NeuroBloc 5000 U/ ml soluzzjoni għall- injezzjoni Botulinum Toxin Tip B
One ml contains 5000 U of Botulinum Toxin Type B (10,000 U per vial)
Millilitru fih 5000 U ta ’ Botulinum Toxin Tip B (10, 000 U kull kunjett)
1 x 2.0 ml vial, 10,000 U
Kunjett 1 x 2. 0 ml, 10, 000 U
Read package leaflet for special precautions for handling and disposal.
Aqra l- fuljett ta ’ tagħrif għall- prekawzjonijiet speċjali għall- immaniġġjar u għar- rimi.
Justification for not including Braille accepted
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 2.0 ml vial
Tikketta tal- kunjett, kunjett ta ’ 2. 0 ml
10,000 U
10, 000 U B.
INFORMATION FOR THE USER NeuroBloc 5000 U/ ml Solution for Injection Botulinum Toxin Type B
NeuroBloc 5000 U/ ml Soluzzjoni għall- injezzjoni Botulinum Toxin Tip B
may harm them, even if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
What NeuroBloc is and what it is used for 2.
X’ inhu NeuroBloc u għalxiex jintuża 2.
Before you are given NeuroBloc 3.
Qabel ma tieħu NeuroBloc 3.
How you will be given NeuroBloc 4.
Kif għandek tieħu NeuroBloc 4.
Possible side effects 5.
Effetti Sekondarji li jista ’ jkollu 5.
How to store NeuroBloc 6.
Kif taħżen NeuroBloc 6.
WHAT NEUROBLOC IS AND WHAT IT IS USED FOR
X’ INHU NEUROBLOC U GĦALXIEX JINTUŻA
NeuroBloc is a toxin produced by bacteria called Clostridium botulinum.
NeuroBloc huwa tossina magħmul mill- batterja msejħa Clostridium botulinum.
NeuroBloc reduces the release of the ‘ chemical messenger’, acetylcholine, which is made by nerves and tells your muscles to contract.
NeuroBloc inaqqas il- ħruġ tal - ‘ messaġier kimiku ’, acetylcholine, li jsir miċ- ċelluli tan- nervi u jgħid lil muskoli tiegħek biex jinġibed.
If nerves are prevented from releasing this messenger, abnormal muscle contractions may be reduced or completely stopped.
Jekk in- nervi ma jitħallewx jerħu dan il- messaġġier, il- kontrazzjonijiet anormali tal- muskolu jistgħu jitnaqqsu jew jitwaqqfu għal kollox.
NeuroBloc is used to treat cervical dystonia (torticollis).
NeuroBloc jiġi wżat biex jikkura distonja ċervikali (torticollis).
If you have cervical dystonia, you experience contractions of the neck and/ or shoulder muscles that you cannot control.
Jekk għandek distonja ċervikali, int tħoss tiġbid fl- għonq u/ jew fil- muskoli ta ’ l- ispalla li ma tistax tikkontrolla.
BEFORE YOU ARE GIVEN NEUROBLOC
QABEL MA TUŻA NEUROBLOC
You should not receive / be given NeuroBloc:
M’ għandekx tirċievi/ tingħata NeuroBloc: jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal xi sustanza f’ din il- mediċina
- if you are allergic to any of the ingredients in this medicine
- jekk tbati minn xi marda tan- nervi jew tal- muskoli speċjalment waħda li tikkaġuna dgħjufija fil -
- if you suffer from a disease of the nerves or muscles especially one causing muscle weakness
muskoli
- if you are pregnant or breast-feeding
- jekk int tqila jew qed tredda ’
In these cases, please tell your doctor.
F’ dawn il- każijiet, jekk jogħġbok għid lit- tabib tiegħek.
Take special care with NeuroBloc and tell you doctor:
Oqgħod attent ħafna b’ NeuroBloc u għid lit- tabib tiegħek:
- if you suffer from a bleeding disorder such as haemophilia
- jekk tbati minn xi problema ta ’ fsada bħal emofilja
- when you are receiving medication such as warfarin, to prevent your blood clotting.
- jekk tieħu mediċina bħal warfarin, biex twaqqaf id- demm tiegħek milli jaqgħad.
- if you have lung problems
- jekk għandek problemi fil- pulmun
Rarely severe
- jekk ikollok xi diffikultà biex tibla ’ qabel jew wara l- injezzjoni tiegħek ta ’ NeuroBloc.
swallowing problems can result in breathing food or liquids into your lungs and cause pneumonia which might be fatal.
Rarament, problemi severi biex tibla ’ jistgħu jwasslu għat- teħid man- nifs ta ’ ikel jew likwidi ġol- pulmun tiegħek li jikkawżaw pnewmonja li tista ’ tkun fatali.
NeuroBloc is not approved for use in children.
NeuroBloc mhux approvat għall- użu fit- tfal.
You should not normally be given NeuroBloc if you are under 18 years old.
Ġeneralment, jekk int taħt l- età ta ’ 18- il sena m' għandekx tingħata NeuroBloc.
26 Please tell your doctor if you are taking antibiotics for an infection.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu antibijotiċi għall- infezzjoni.
If you are going to have an operation, please tell your doctor if you have been given NeuroBloc as it can interfere with medicines you may be given before a general anaesthetic.
Jekk ħa tagħmel xi operazzjoni, jekk jogħġbok għid lit- tabib tiegħek jekk ingħatajt NeuroBloc minħabba li dan jista ’ jinterferixxi ma ’ mediċini li jistgħu ingħatawlek qabel anestesija ġenerali.
Also inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.