qanastek/EMEA-V3 huggingface dataset:
Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
L- irkuprar tat- trasmissjoni ta ’ l- impulsi tkun stabbilita mill - ġdid bil- formazzjoni ta ’ truf ġodda tan- nervituri u ta ’ motor endplates.
The mechanism of action by which Botulinum neurotoxin type A exerts its effects on cholinergic nerve terminals can be described by a three-step sequential process which includes the following steps:
Il- mekkaniżmu ta ’ l- azzjoni li bih Botulinum newrotossina ta ’ tip A jeżercita l- effetti tiegħu fuq it- terminali tan- nervaturi kolinerġiċi, jista ’ jiġi mfisser permezz ta ’ proċess sekwenzjali li fih tliet passi li jinkludi l- passi li ġejjin:
binding to the cholinergic nerve terminals entry or internalisation into the nerve terminal and inhibition of acetylcholine release by intracellular poisoning within the nerve terminal.
a) it- twaħħil mat- terminali tan- nervaturi kolinerġiċi b) id- dħul jew l- internalizzazzjoni ġot- terminali tan- nervaturi u ċ) l- inibizzjoni tal- ħruġ ta ’ acetylcholine permezz ta ’ avvelenament intraċellulari fit - terminal tan- nervaturi.
The heavy chain of the Botulinum neurotoxin type A binds with an exceptionally high selectivity and affinity to receptors only found on cholinergic terminals.
Il- katina tqila tal- Botulinum newrotossina ta ’ tip A teħel b’ selettività u affinità eċċezzjonalment għoljin mar- riċetturi li jinsabu biss fuq it- terminali kolinerġiċi.
After internalisation of the neurotoxin the light chain cleaves very specifically a target protein (SNAP 25) that is essential for the release of acetylcholine.
Wara l - internalizzazzjoni tan- newrotossina, il- katina l- ħafifa twettaq cleaving speċifiku ħafna tal - proteina fil- mira (SNAP 25) li hi essenzjali għall- ħruġ ta ’ acetylcholine.
Recovery after injection normally takes place within 3-4 months as nerve terminals sprout and reconnect with the endplate.
L- irkuprar wara l- injezzjoni normalment iseħħ fi żmien 3- 4 xhur hekk kif it- terminali tan - nervaturi jiżviluppaw u jerġgħu jikkonnettjaw ma ’ l- endplate.
a) General characteristics of the active substance:
a) Karatteristiċi ġenerali tas- sustanza attiva:
Classic kinetic and distribution studies cannot be conducted with Botulinum neurotoxin type A because the active substance is applied in such small quantities (picograms per injection), and because it binds so rapidly and irreversibly to cholinergic nerve terminals.
Studji klassiċi kinetiċi u dwar id- distribuzzjoni ma jistgħux isiru b’ Botulinum newrotossina ta ’ tip A minħabba li s- sustanza tingħata fi kwantitajiet żgħar ħafna (pikogrammi f’ kull injezzjoni), u minħabba li teħel tant malajr u b’ mod irriversibbli mat- terminali tan- nervaturi kolinerġiċi.
Native Botulinum toxin is a high molecular weight complex, which, in addition to the neurotoxin (150 kD) contains other non-toxic proteins, like haemagglutinins and non- haemagglutinins.
It- tossina tal- Botulinum nattiva hi kumpless b’ piż molekulari għoli, li, flimkien man - newrotossina (150 kD) fiha proteini oħrajn mhux tossiċi, bħal emagglutinini u non - emagglutinini.
In contrast to conventional preparations containing the Botulinum toxin type A complex, Xeomin contains pure (150 kD) neurotoxin since it is free of complexing proteins.
B’ kuntrast mal- preparazzjonijiet konvenzjonali li fihom il- kumpless tat- tossina Botulinum ta ’ tip A, Xeomin fih newrotossina pura (150 kD), għax hu ħieles mill- proteini li jagħmlu l- kumpless.
Like many other proteins of its size, Botulinum neurotoxin type A has been shown to undergo retrograde axonal transport after intramuscular injection.
Bħal ħafna proteini oħrajn tad- daqs tagħha, intwera li Botulinum newrotossina ta ’ tip A, tgħaddi minn trasport axonal retrogradu wara injezzjoni ġol- muskoli.
Retrograde transsynaptic passage of active Botulinum neurotoxin type A into the central nervous system however has not been found.
Madankollu, ma ġiex identifikat il- passaġġ retrogradu transsinattiku ta ’ Botulinum newrotossina attiva ta ’ tip A ġos - sistema nervuża ċentrali.
Receptor-bound Botulinum neurotoxin type A is endocytosed into the nerve terminal prior to reaching its target (SNAP 25) and will eventually be degraded intracellularly.
Botulinum newrotossina ta ’ tip A imwaħħla mar- riċettur, tkun endocytosed ġon- nervaturi terminali qabel ma tilħaq il- mira tagħha (SNAP 25), u eventwalment ser tkun iddegradata fiċ - ċelluli.
Free circulating Botulinum neurotoxin type A molecules which have not bound to presynaptic cholinergic nerve terminal receptors will be phagocytosed or pinocytosed and degraded like any other free circulating protein.
Il- molekuli ta ’ Botulinum newrotossina ta ’ tip A li jkunu jiċċirkolaw b’ mod ħieles, li ma jkunux weħlu mar- riċetturi tat- terminali tan- nervaturi kolinerġiċi presynaptic, ser ikunu phagocytosed jew pinocytosed u jkunu ddegradati bħal kwalunkwe proteina li tiċċirkola mod ħieles.
b) Distribution of the active substance in patients:
b) Distribuzzjoni tas- sustanza attiva fil- pazjenti:
Human pharmacokinetic studies with Xeomin have not been performed for the reasons detailed above.
Studji farmakokinetiċi umani b’ Xeomin ma twettqux għal raġunijiet deskritti hawn fuq.
5.3 Preclinical safety data
24 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
23 Non-clinical data reveal no special hazard for humans based on conventional studies of cardiovascular safety pharmacology.
Informazzjoni li mhix klinika ma turi l- ebda periklu speċjali għall- bnedmin, ibbażata fuq studji konvenzjonali dwar il- farmakoloġija tas- sigurtà kardjovaskulari.
The findings made in repeat-dose toxicity studies conducted with Xeomin were mainly related to its pharmacodynamic action.
Is- sejbiet li kienu osservati fi studji dwar it- tossiċità meta jingħataw dożi ripetuti ta ’ Xeomin, kienu primarjament relatati ma ’ l- azzjoni farmakodinamika tiegħu.
No evidence of local intolerability was noted.
L- ebda evidenza ta ’ intollerabilità lokali ma kienet osservata.
Reproductive toxicity studies with Xeomin, performed in rabbits, did not show adverse effects on male or female fertility nor direct effects on embryo-foetal development.
Studji dwar it- tossiċità riproduttiva b’ Xeomin, li twettqu fil- fniek, ma wrew l- ebda effetti avversi fuq il- fertilità fl- irġiel jew fin- nisa, u lanqas effetti diretti fuq l- iżvilupp embrijo- fetali.
However, the administration of Xeomin at dose levels exhibiting clear maternal toxicity at weekly to biweekly intervals increased the number of abortions in a prenatal toxicity study in rabbits.
Madankollu, l- għoti ta ’ Xeomin f’ livelli ta ’ doża li juru tossiċità materna ċara f’ intervalli ta ’ minn ġimgħa sa ġimagħtejn, żied in- numru ta ’ aborti fi studju dwar it- tossiċità ta ’ qabel it- twelid fil- fniek.
A continuous systemic exposure of the dams during the (unknown) sensitive phase of the organogenesis as a pre-requisite for the induction of teratogenic effects cannot necessarily be assumed.
Espożizzjoni sistemika kontinwa tad - dams matul il- fażi sensittiva (mhux magħrufa) ta ’ l- organoġenesi bħala pre- rekwiżit għall - induzzjoni ta ’ effetti teratoġeniċi, ma tistax tkun issoponuta.
No genotoxicity, carcinogenicity and pre- and postnatal development studies have been conducted with Xeomin.
Ma saru l- ebda studji b’ Xeomin dwar il- ġenotossiċità, il- karċinoġeneċità u l- iżvilupp ta ’ qabel u wara t- twelid.
Human albumin Sucrose
Albumina umana Sucrose
3 years Reconstituted solution:
3 snin Soluzzjoni rrikostitwita:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C.
L- istabbilità kimika u fiżika waqt l- użu intweriet għal 24 siegħa f’ temperatura ta ’ minn 2 sa 8°C.
Do not store above 25°C For storage conditions of the reconstituted medicinal product, see section 6.3.
Għall- kundizzjonijiet tal- ħażna tal- prodott mediċinali rrikostitwit (ara sezzjoni 6. 3)
Vial (type 1 glass) with rubber stopper (bromobutyl rubber) and tamper-proof seal (aluminium) in pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Kunjett (ħġieġ ta ’ tip 1) b’ tapp tal- lastku (lastku tal- bromobutyl) u b’ siġill ma jistax isir tbagħbis fih (aluminju) f’ pakkett b’ 1 (pakkett b’ unità waħda), 2, 3 jew 6 kunjetti (pakketti multipli).
A clinical pack is also available with 6 vials.
Pakkett kliniku hu wkoll disponibbli b’ 6 kunjetti.
Xeomin is reconstituted prior to use with sterile unpreserved sodium chloride 9 mg/ ml (0.9%) solution for injection.
Xeomin hu rrikostitwit qabel l- użu b’ soluzzjoni għall- injezzjoni sterili mhux ippreservata ta ’ sodium chloride 9 mg/ ml (0. 9%).
Reconstitution and dilution should be performed with good practice, particularly with respect to asepsis.
Ir- rikostituzzjoni u dilwizzjoni għandhom jitwettqu bi prattika tajba, partikularment fir- rigward ta ’ asepsis.
24 It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage.
25 Tkun prattika tajba li twettaq ir- rikostituzzjoni tal- kunjett u l- preparazzjoni tas- siringa fuq xugamani tal- karta b’ inforra tal- plastik biex tilqa ’ għal xi tixrid li jista ’ jkun hemm.
An appropriate amount of solvent (see dilution table) is drawn up into a syringe.
Ammont adattat ta ’ solvent (ara t- tabella tad- dilwizzjoni) jinġibed ġo siringa.
The exposed portion of the rubber stopper of the vial is cleaned with alcohol (70%) prior to insertion of the needle.
Il- porzjon espost tat- tapp tal - lastku tal- kunjett jitnaddaf bl- alkoħol (70%) qabel iddaħħal il- labra.
The solvent must be injected gently into the vial.
Is- solvent irid ikun injettat bil- mod ġol- kunjett.
The vial must be discarded, if the vacuum does not pull the solvent into the vial.
Jekk il- vacuum ma jiġbidx is- solvent ġol- kunjett, il- kunjett irid jintrema.
Reconstituted Xeomin is a clear colourless solution free of particulate matter.
Xeomin irrikostitwit hu soluzzjoni ċara u bla kulur, mingħajr frak.
Xeomin should not be used if the reconstituted solution (prepared as above) has a cloudy appearance or contains floccular or particulate matter.
Xeomin m’ għandux jintuża jekk is- soluzzjoni rrikostitwita (ippreparata kif deskritt hawn fuq) ikollha dehra mċajpra jew ikun fiha materjal f’ sura ta ’ partikuli jew frak.
The recommended dilutions are indicated in the following table:
Id- dilwizzjonijiet irrakomandati huma indikati fit- tabella li ġejja:
9 mg/ ml (0.9%) solution
Solvent miżjud (sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni)
Resulting dose in units per 0.1 ml
Doża li tirriżulta f’ unitajiet f’ kull 0. 1 ml
0.5 ml 1.0 ml 2.0 ml 4.0 ml 8.0 ml
0. 5 ml 1. 0 ml 2. 0 ml 4. 0 ml 8. 0 ml
20.0 U 10.0 U 5.0 U 2.5 U 1.25 U
20. 0 U 10. 0 U 5. 0 U 2. 5 U 1. 25 U
stored for more than 24 hours as well as any unused
Kwalunkwe soluzzjoni għall- injezzjoni li tkun inħażnet għal aktar minn 24 siegħa, kif ukoll kwalunkwe soluzzjoni għall- injezzjoni mhux użata, għandhom jintremew.
For safe disposal, unused vials should be reconstituted with a small amount of water and then autoclaved.
Għal rimi sigur, il- kunjetti mhux użati għandhom jiġu rrikostitwiti b’ ammont żgħir ta ’ ilma u mbagħad ikunu sterilizzati taħt pressjoni għolja.
Any used vials, syringes, and spillage etc. should be autoclaved and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
Kwalunkwe kunjetti, siringi użati, u tixrid eċċ. għandhom ikunu autoclaved, u kwalunkwe residwu ta ’ Xeomin għandu jkun diżattivat billi tintuża soluzzjoni dilwita ta ’ sodium hydroxide (0. 1 N NaOH).
[See Annex I - To be completed nationally]
ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
{Name and address }< {tel }> < {fax }> < {e-mail }>
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Németország Telefon: +49- 69/ 15 03- 1 Fax: +49- 69/ 15 03- 200
26 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
26 TIKKETTA
Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins
Xeomin 100 LD50 unitajiet ta ’ trab għal soluzzjoni għall- injezzjoni Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħieles minn proteini complexing
1 vial contains 100 LD50 units of Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins
1 kunjett fih 100 LD50 unità ta ’ Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħieles minn proteini complexing
Human albumin, sucrose
Albumina umana, sucrose
Powder for solution for injection 1 vial
Trab għal soluzzjoni għall- injezzjoni Kunjett 1
For intramuscular use.
Għall- użu ġol- muskoli.
OTHER SPECIAL WARNING(S); IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
After reconstitution: the product may be stored for a maximum of 24 hours at 2°C to 8°C.
Wara r- rikostituzzjoni: il- prodott jista ’ jinħażen għal massimu ta ’ 24 jum f’ temperatura ta ’ 2°C sa 8°C.
For safe disposal, unused vials should be reconstituted with a small amount of water then sterilised under high pressure.
Għal rimi sigur, il- kunjetti mhux użati għandhom jiġu rikostitwiti b’ ammont żgħir ta ’ ilma u mbagħad ikunu sterilizzati taħt pressjoni għolja.
[See Annex I - To be completed nationally]
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
{Name and Address }< {tel }> < {fax }> < {e-mail }>
Merz Pharmaceuticals GmbH 60048 Frankfurt/ Main Il- Ġermanja
1 vial contains 100 LD50 units of Clostridium Botulinum neurotoxin type A (150kD), free of complexing proteins
1 kunjett fih 100 LD50 unità ta ’ Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħieles minn proteini complexing.
Powder for solution for injection 1 vial
Trab għal soluzzjoni għall- injezzjoni, Kunjett 1
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON FOR MULTI PACK WITH 2, 3, 6 VIALS
KARTUNA GĦAL PAKKETT MULTIPLU BI 2, 3, 6 KUNJETTI
Powder for solution for injection 2 vials 3 vials 6 vials
Trab għal soluzzjoni għall- injezzjoni 2 kunjetti 3 kunjetti 6 kunjetti
CARTON FOR CLINICAL PACK WITH 6 VIALS
KARTUNA GĦAL PAKKETT KLINIKU B’ 6 KUNJETTI
For hospital use only
Trab għal soluzzjoni għall- injezzjoni 6 kunjetti Pakkett kliniku Għall- użu fl- isptar biss
NAME OF THE ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
MM/ JJJJ
MM/ SSSS
100 LD50 units
100 LD50 unità
INFORMATION FOR THE USER
39 Fuljett ta ’ Tagħrif Informazzjoni għal min qed jagħmel użu minnha
Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Xeomin 100 LD50 unitajiet ta ’ trab għal soluzzjoni għall- injezzjoni Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħieles minn proteini complexing.
You may need to read it again. • If you have further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
What Xeomin is and what it is used for 2.
X’ inhu Xeomin u għalxiex jintuża 2.
Before you use Xeomin 3.
Qabel ma tuża Xeomin 3.
How to use Xeomin 4.
Kif għandek tuża Xeomin 4.
How to store Xeomin 6.
Kif taħżen Xeomin 6.
WHAT XEOMIN IS AND WHAT IT IS USED FOR
X’ INHU XEOMIN U GĦALXIEX JINTUŻA
Xeomin is a medicine that relaxes the muscles.
Xeomin hi mediċina li tirrilassa l- muskoli skeletriċi (rilassant tal- muskoli periferali).
Xeomin is used for the treatment of the following conditions in adults: • eyelid spasm (blepharospasm) • twisted neck (spasmodic torticollis)
Xeomin jintuża għall- kura ta ’ dawn il- kundizzjonijiet fl- adulti: • spażmu ta ’ tebqet il- għajn (blefarospażmu) • għonq mgħawweġ (torticollis spażmodika)
BEFORE YOU USE XEOMIN
QABEL MA TUŻA XEOMIN
• if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin (see section 6 “ Further information”) • if you suffer from generalised disorders of muscle activity (e. g. myasthenia gravis, Lambert-Eaton syndrome) • if an infection is present at the injection site.
Tużax Xeomin: • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal Botulinum newrotossina ta ’ tip A jew għal xi sustanzi oħra ta ’ Xeomin (ara Sezzjoni 6 “ Aktar tagħrif ”). • jekk tbati minn disturbi ġeneralizzati ta ’ l- attività tal- muskoli (eż. mijastenja gravis, is- sindrome ta ’ Lambert- Eaton) • jekk hemm infezzjoni fis- sit propost ta ’ l- injezzjoni.
This disease leads to a wasting of muscle tissue.
Oqgħod attent ħafna b’ Xeomin Għid lit- tabib tiegħek: • jekk tbati minn kwalunkwe tip ta ’ disturbi ta ’ ħruġ ta ’ demm • jekk qed tirċievi sustanzi li ma jħallux id- demm jagħqad (terapija b’ mediċini li jraqqu d- demm) • jekk tbati minn dgħjufija prominenti jew volum imnaqqas tal- muskoli fil- muskolu fejn tkun ser tieħu l- injezzjoni • jekk tbati minn marda msejħa sklerosi amijotrofika laterali.
39 • if you suffer from any disease that disturbs the interaction between nerves and skeletal muscles (peripheral neuromuscular dysfunction) • if you have or have had swallowing difficulties
Din il- marda twassal għall- qerda ta ’ tessut tal- muskoli. • jekk tbati minn kwalunkwe mard li tiddisturba l- interazzjoni bejn in- nervaturi u l- muskoli skeletriċi (disfunzjoni newromuskolari periferali) • jekk għandek jew kellek diffikultajiet biex tibla ’
In cases of repeated injections with Xeomin, the therapeutic effect of the product may vary.
40 F’ każijet ta ’ injezzjonijiet ripetuti b’ Xeomin, l- effett terapewtiku tal- prodott jista ’ jvarja.
The possible reasons for an increase or decrease are: • different techniques of preparation of the product by your doctor • different treatment intervals • injections into another muscle • marginally varying effectiveness of the active substance of Xeomin • non-response/ therapy failure during the course of treatment.
Ir- raġunijiet possibbli għal żieda jew tnaqqis huma: • tekniċi differenti mit- tabib tiegħek li jippreparaw il- prodott • intervalli differenti tal- kura • injezzjonijiet f’ muskolu ieħor • effettività li tvarja marġinalment tas- sustanza attiva ta ’ Xeomin • non- rispons/ il- falliment tat- terapija matul il- kors tal- kura.
If you have been inactive for a long period of time, any activity should be started gradually after the Xeomin injection.
Jekk kont inattiv/ a għal perjodu twil ta ’ żmien, kwalunkwe attività għandha tinbeda gradwalment wara l- injezzjoni ta ’ Xeomin.
If you develop swallowing difficulties, speech or breathing disorders, please contact medical emergency services or ask your relatives to do so (see section 4).
Jekk tiżviluppa diffikultajiet biex tibla ’, jew disturbi f’ kif titkellem jew biex tieħu n- nifs, jekk jogħġbok ikkuntattja lis- servizzi ta ’ l- emerġenza medika, jew għid lill- qraba tiegħek biex jagħmlu dan (ara sezzjoni 4).
The use of Xeomin in children and adolescents has not yet been investigated and is therefore not recommended.
L- użu ta ’ Xeomin fit- tfal u fl- adolexxenti ma kienx investigat s’ issa, u għalhekk mhuwiex irrakomandat.
Eyelid spasm (blepharospasm) Please inform your doctor prior to any treatment, if you: • have had an eye surgery.
Spażmu ta ’ tebqet il- għajn (blefarospażmu) Jekk jogħġbok informa lit- tabib tiegħek qabel kwalunkwe kura, jekk inti: • kellek operazzjoni f’ għajnejk.
Your doctor will then take additional precautions. • are at risk of developing a disease called angle closure glaucoma.
It- tabib tiegħek ser jieħu prekawzjonijiet addizzjonali. • f’ riskju li tiżviluppa marda msejħa glawkoma tat- tip angle closure.
This disease can cause the inner eye pressure to rise and may lead to a damaging of your optic nerve.
Din il- marda tista ’ tikkawża l- pressjoni fl- intern ta ’ l- għajn biex tiżdied, u dan jista ’ jwassal li ssir ħsara fin- nerv prinċipali t’ għajnejk.
Your doctor will know if you are at risk.
It- tabib tiegħek ser ikun jaf jekk inti tkunx f’ riskju.
During treatment, small punctuated bleedings may occur in the soft tissues of the eyelid.
Matul il- kura, tikek żgħar ta’ demm jistgħu jfiġġu fit- tessut artab ta ’ tebqet il- għajn.
Your doctor can limit these by immediately applying gentle pressure at the injection site.
It- tabib tiegħek jista ’ jillimitahom billi japplika pressjoni ġentili immedjata fis- sit ta ’ l- injezzjoni.
After you receive a Xeomin injection into your eye muscle your blinking rate may be reduced.
Wara li tirċievi injezzjoni ta ’ Xeomin ġol- muskolu t’ għajnejk, ir- rata tat- teptip t’ għajnejk tista ’ tonqos.
This can lead to an overlong exposure of the transparent front part of the eye (cornea).
Dan jista ’ jwassal għal espożizzjoni twila wisq tal- parti trasparenti tan- naħa ta ’ quddiem ta ’ l- għajn (kornea).
This exposure may lead to a damaging of the surface and an inflammation (corneal ulceration).
Din l- espożizzjoni tista ’ twassal għal ħsara fil- wiċċ ta ’ l- għajn u infjammazzjoni (ulċerazzjoni tal- kornea).
This can occur more often if you suffer from disorders of your facial nerves.
Dan jista ’ jiġri aktar ta ’ spiss jekk inti tbati minn disturbi fin- nervituri ta ’ wiċċek.
Twisted neck (spasmodic torticollis) After the injection you may develop mild to severe swallowing difficulties.
Għonq mgħawweġ (torticollis spażmodika) Wara l- injezzjoni, inti tista ’ tiżviluppa diffikultajiet biex tibla ’ li jistgħu ikunu minn ħfief sa severi.
This may lead to problems with breathing and you may have a higher risk of inhaling foreign substances or fluids.
Dan jista ’ jwassal għal problemi biex tieħu n- nifs, u jista ’ jkollok riskju ogħla li tiġbed sustanzi jew fluwidi barranin man- nifs.
Foreign substances in your lungs may lead to an inflammation or infection (pneumonia). Your doctor will give you special medical treatment if needed (e. g. in the form of artificial nutrition).
It- tabib tiegħek ser jagħtik kura medika speċjali jekk ikun meħtieġ (eż. fis- sura ta ’ nutrizzjoni artifiċjali).
Swallowing difficulties can last for up to two to three weeks after injection, for one patient a duration of up to five months is known.
Diffikultajiet biex tibla ’ jistgħu idumu minn tnejn sa tliet ġimgħat wara l- injezzjoni, iżda hu magħruf li f’ pazjent wieħed, id- diffikultajiet damu sa ħames xhur.
Theoretically, the effect of Xeomin may be increased by: • aminoglycoside antibiotics • medicinal products that interfere with the transfer of an impulse from a nerve to a muscle, e. g. tubocurarine-type muscle relaxants that weaken the muscles.
Teoretikament, l- effett ta ’ Xeomin jista ’ jiżdied b ’: • antibijotiċi aminoglycoside • prodotti mediċinali li jfixklu t- trasferiment ta ’ messaġġ minn nerv għal muskolu, eż. rilassanti tal- muskoli tat- tip tubocurarine li jdgħajfu l- muskoli skeletriċi.
40 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.
This is also relevant for medicinal products that weaken the muscle.
Dan hu rilevanti wkoll għal prodotti mediċinali li jdgħajfu l- muskolu.
Your doctor may reduce the starting dose of relaxant, or use an intermediate-action substance rather than substances with longer lasting effects.
41 jnaqqas id- doża tal- bidu tar- rilassant, jew użu ta ’ sustanza li taħdem b’ mod intermedju minflok jintużaw sustanzi li għandhom effetti li jdumu aktar.
Theoretically, the effect of Xeomin may be reduced by: • certain anti-malaria / anti-rheumatic medicines (4-Aminochinolines).
Teoretikament, l- effett ta ’ Xeomin jista ’ jitnaqqas minn: • ċerti mediċini kontra l- malarja/ anti- rewmatiċi (4- Aminochinolines).
If you are pregnant, Xeomin should not be used, unless your doctor could decide whether there is a clear necessity and whether the potential benefit justifies the risk.
Jekk inti tqila, Xeomin m’ għandux jintuża, ħlief jekk it- tabib tiegħek jista ’ jiddeċiedi jekk hemmx ħtieġa ċara u jekk il- benefiċċju potenzjali jiġġustifikax ir- riskju.
It is not known whether the active substance of Xeomin is excreted into the breast milk.
Mhux magħruf jekk is- sustanza attiva ta ’ Xeomin titneħħiex fil- ħalib tas- sider.
Therefore, the use of Xeomin in breast-feeding women is not recommended.
Għalhekk, l- użu ta ’ Xeomin f’ nisa li jkunu qed ireddgħu mhuwiex irrakkomandat.
Due to the nature of your disease being treated, the ability to drive and to operate machines can be reduced.
Minħabba n- natura tal- marda tiegħek li qed tiġi kkurata, il- ħila li ssuq u tħaddem il- magni, tista ’ titnaqqas.
Some of the therapeutic and/ or side effects of Xeomin may also interfere with the ability to drive and operate machinery.
Xi ftit mill- effetti terapewtiċi u/ jew sekondarji ta ’ Xeomin jistgħu wkoll jinterferixxu mal- ħila li ssuq u tħaddem il- makkinarju.
Consequently you should avoid driving and operating machinery until your faculties are fully recovered.
Għalhekk, m’ għandekx issuq u tħaddem il- makkinarju sakemm il- ħiliet tiegħek jiġu lura għan- normal għal kollox.
HOW TO USE XEOMIN
KIF TUŻA XEOMIN
Xeomin may only be used by health care professionals experienced in the application of Botulinum toxin.
Xeomin jista ’ jintuża biss minn professjonisti fil- qasam tal- kura tas- saħħa b’ esperjenza fl- għoti tat - tossina Botulinum.
Dissolved Xeomin is intended for injections into the muscle.
Xeomin maħlul hu intenzjonat għal injezzjonijiet ġol- muskoli.
The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor individually for you.
L- aħjar dożaġġ u n- numru ta ’ siti ta ’ l- injezzjoni fil- muskolu għall- kura, ser jintgħażlu mit- tabib tiegħek speċifikament għalik.
The results of initial treatment with Xeomin should be evaluated and may lead to dose adjustment until the desired therapeutic effect is achieved.
Ir- riżultat tal- kura inizjali b’ Xeomin għandu jkun evalwat, u jista ’ jwassal għal aġġustament fid- doża sakemm jintlaħaq l- effett terapewtiku mixtieq.
If you have the impression that the effect of Xeomin is too strong or too weak, let your doctor know.
Jekk għandek l- impressjoni li l- effett ta ’ Xeomin hu qawwi jew dgħajjef wisq, kellem lit- tabib tiegħek.
In cases where no therapeutic effect is apparent, alternative therapies should be taken into consideration.
F’ każijiet fejn l- ebda effett terapewtiku ma jkun apparenti, terapiji alternattivi għandhom jiġu kkunsidrati.
Your body may develop antibodies after you received Botulinum toxin type A preparations.
Ġismek jista ’ jiżviluppa antikorpi wara li inti tkun irċivejt preparazzjonijiet ta ’ tossina Botulinum ta ’ tip A.
Antibodies may reduce the therapeutic effectiveness of the product.
L- antikorpi jistgħu inaqqsu l- effikaċja terapewtika tal- prodott.
Eyelid spasm (blepharospasm) Usually, the first onset of effect is observed within four days after injection.
Spażmu ta ’ tebqet il- għajn (blefarospażmu) Normalment, l- ewwel l- bidu ta ’ l- effett ikun osservat fi żmien 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 ’ jdum aktar jew anqas b’ mod sinifikanti.
The treatment can be repeated if required.
Il- kura tista ’ tkun ripetuta jekk ikun meħtieġ.
Normally, no additional benefit is conferred by treating more frequently than every three months.
Normalment, l- ebda benefiċċju addizzjonali ma jinkiseb billi tikkura aktar minn darba kull tliet xhur.
Twisted neck (spasmodic torticollis) Usually, the first onset of effect is observed within seven days after injection.
Għonq mgħawweġ (torticollis spażmodika) Normalment, l- ewwel sinjal ta ’ l- effett ikun osservat fi żmien erbat ijiem wara l- injezzjoni.
If more Xeomin is used than should be
Jekk jintuża aktar Xeomin milli suppost
41 Symptoms of overdose Symptoms of overdose are not apparent immediately after the injection and may be general weakness, drooping eyelid, double vision, swallowing and speech difficulties, and pneumonia.
42 Sintomi ta ’ doża eċċessiva Sintomi ta ’ doża eċċessiva mhumiex apparenti immedjatament wara l- injezzjoni, u jistgħu ikunu dgħjufija ġenerali, tebqet il- għajn imdendla, tara doppju, diffikultajiet biex tibla ’ u biex titkellem, u pnewmonja.
Measures in cases of overdose In case you feel symptoms of overdose please seek medical emergency services immediately or ask your relatives to do so, and have yourself admitted to hospital.
Miżuri f’ każijiet ta ’ doża eċċessiva Fil- każ li tħoss sintomi ta ’ doża eċċessiva, jekk jogħġbok fittex lis- servizzi ta ’ l- emerġenza medika immedjatament, jew għid lill- qraba tiegħek biex jagħmlu dan, u mur fi sptar.
Medical supervision for up to several days and assisted ventilation may be necessary.
Superviżjoni medika li ddum sa diversi jiem, u ventilazzjoni assistita tista ’ tkun meħtieġa.
Like all medicines, Xeomin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xeomin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects may occur from misplaced injections of Xeomin temporarily paralysing nearby muscle groups.
L- effetti sekondarji jistgħu iseħħu minn injezzjonijiet ta ’ Xeomin li jipparalizzaw temporanjament gruppi ta ’ muskoli fil- qrib.
Usually, side effects are observed within the first week after treatment and are temporary in nature.
Normalment, l- effetti sekondarji 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).
If you develop swallowing difficulties, speech or breathing disorders, please contact medical emergency services immediately or ask your relatives to do so.
Jekk tiżviluppa diffikultajiet biex tibla ’, jew disturbi f’ kif titkellem jew biex tieħu n- nifs, jekk jogħġbok ikkuntattja lis- servizzi ta ’ l- emerġenza medika immedjatament jew għid lill- qraba tiegħek biex jagħmlu dan.
As with any medicine, an allergic reaction may occur with Xeomin.
Bħal ma jiġri bi kwalunkwe mediċina, tista ’ sseħħ reazzjoni allerġika b’ Xeomin.
An allergic reaction can cause any of the following symptoms: • difficulty in breathing • swelling of the hands, feet, ankles, face, lips, mouth or throat.
Reazzjoni allerġika tista ’ tikkawża kwalunkwe mis- sintomi li ġejjin: • diffikultà biex tieħu n- nifs • nefħa ta ’ l- idejn, saqajn, għekiesi, wiċċ, xufftejn, ħalq jew gerżuma.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you suffer from any of these symptoms.
Għid lit- tabib tiegħek immedjatament jew mur fis- sezzjoni ta ’ l- emerġenza ta ’ l- eqreb sptar jekk ikollok kwalunkwe minn dawn is- sintomi.
The following side effect probabilities and allocated frequencies are used for the categorisation of side effects:
Il- probabbilitajiet ta ’ l- effetti sekondarji li ġejjin u l- frekwenzi allokati jintużaw għal kategorizzazzjoni ta ’ l- effetti sekondarji:
more than 1 per 10 treated people
iktar minn 1 minn kull 10 persuni kkurati komuni ħafna
less than 1 per 10, but more than 1 per 100 treated people less than 1 per 100, but more than 1 per 1,000 treated people less than 1 per 1,000, but more than 1 per 10,000 treated people less than 1 per 10,000 treated people, incl. isolated cases
inqas minn 1 minn kull 10, iżda iktar minn 1 komuni minn kull 100 persuna kkurata inqas minn 1 minn kull 100, iżda iktar minn 1 mhux komuni minn kull 1, 000 persuna kkurata inqas minn 1 minn kull 1, 000, iżda iktar minn 1 rari minn kull 10, 000 persuna kkurata inqas minn 1 kull 10, 000 persuna kkurata, li rari ħafna jinkludu każijiet iżolati
Eyelid spasm (blepharospasm) The following side effects were reported with Xeomin:
Spażmu ta ’ tebqet il- għajn (blefarospażmu) L- effetti sekondarji li ġejjin kienu rrappurtati bi Xeomin:
drooping eyelid (ptosis), dry eyes
tebqet il- għajn imdendla (ptosi), għajnejn xotti 43
muscle weakness, pins and needles (paraesthesia), headache, inflammation of the conjunctiva (conjunctivitis), dry mouth, skin rash, inflicted injury
Mhux komuni: dgħjufija fil- muskoli, sensazzjoni bħal qisu xi ħadd qed iniggżek bil- labar (parestesija), uġigħ ta ’ ras, infjammazzjoni tal- konġuntiva (konġuntivite), ħalq xott, raxx tal- ġilda, ferita imposta
Additionally, the following side effects are known for the comparative compound containing conventional Botulinum toxin type A complex used in the clinical trials with Xeomin.
Flimkien ma ’ dan, l- effetti sekondarji li ġejjin huma magħrufa għall- kompożizzjoni komparattiv li fih il- kumpless tat- tossina Botulinum ta ’ tip A konvenzjonali li jintuża fil- provi kliniċi b’ Xeomin.
It is possible that these side effects may also occur with Xeomin:
Hu possibbli li dawn l- effetti sekondarji jistgħu jseħħu wkoll b’ Xeomin.
special form of inflammation of the cornea (superficial punctate keratitis), inability to close eye (lagophthalmos), eye irritation, fear of light (photophobia), tearing (lacrimation)
forma speċjali ta ’ infjammazzjoni tal- kornea (keratite punctate superfiċjali), ma tkunx tista ’ tagħlaq għajnejk (lagophthalmos), irritazzjoni fl- għajnejn, biża ’ mid- dawl (fotofobia), dmugħ (lakrimazzjoni)
facial paralysis, facial muscle weakness, inflammation of the cornea (keratitis), everted margin of the lid (ectropion), double vision (diplopia), inverted margin of the lid (entropion), visual disturbance, blurred vision, dizziness, inflammatory skin reaction (dermatitis), tiredness
Mhux komuni: paralisi tal- wiċċ, dgħjufija fil- muskoli tal- wiċċ, infjammazzjoni tal- kornea (keratite), it- tarf ta ’ tebqet il- għajn ta ’ ġewwa barra (ectropion), tara doppju (diplopja), it- tarf ta ’ tebqet il- għajn maqlub (entropion), disturb tal- vista, vista mċajpra, sturdament, reazzjoni infjammatorja tal- ġilda (dermatite), għeja
Rare: swelling of eyelid
Rari: nefħa ta ’ tebqet il- għajn
disease of the vision nerve, usually associated with an increased pressure inside the eye (angle closure glaucoma), corneal ulceration
marda tan- nervituri tal- vista, normalment assoċjata ma ’ żieda fil- pressjoni ġol- għajn (glawkoma tat- tip angle closure), ulċerazzjoni tal- kornea
Twisted neck (spasmodic torticollis) The following side effects were reported with Xeomin:
Għonq mgħawweġ (torticollis spażmodika) L- effetti sekondarji li ġejjin kienu rrappurtati bi Xeomin:
swallowing difficulties (dysphagia), muscle weakness, back pain
diffikultajiet biex tibla ’ (disfaġja), dgħjufija fil- muskoli, uġigħ fid- dahar
speech disorders (dysphonia), weakness (asthenia), muscle pain (myalgia), headache, shaking (tremor), eye pain, diarrhoea, dry mouth, vomiting, inflammation of the colon (colitis), skin rash, skin redness (erythema), itching (pruritus), sweating increased, skeletal pain, injection site inflammation, injection site tenderness
Mhux komuni: vuċi tistema ’ stramba (disfonija), dgħjufija (astenja), uġigħ fil- muskoli (mijalġja), uġigħ ta ’ ras, rogħda, uġigħ fl- għajnejn, dijarrea, ħalq xott, rimettar, infjammazzjoni tal- kolon (kolite), raxx tal- ġilda, ħmura tal- ġilda (eritema), ħakk (prurite), żieda fl- għaraq, uġigħ fl- għadam, infjammazzjoni fis- sit ta ’ l- injezzjoni, sensittività fis- sit ta ’ l- injezzjoni
Additionally, the following side effects are known for the comparative compound containing conventional Botulinum toxin type A complex used in the clinical trials with Xeomin.
Flimkien ma ’ dawn, l- effetti sekondarji li ġejjin huma magħrufa għall- kompożizzjoni komparattiv li fih il- kumpless tat- tossina Botulinum ta ’ tip A konvenzjonali li jintuża fil- provi kliniċi b’ Xeomin.
Very common: pain, local weakness
Komuni ħafna: uġigħ, dgħjufija lokali
generalised weakness, flu like symptoms, malaise, dizziness, numbness, sleepiness (drowsiness), nasal inflammation (rhinitis), upper respiratory tract infection, nausea, oral dryness, skin sores, stiffness, increased muscle tone (hypertonia)
telqa ġeneralizzata, sintomi bħal dawk ta ’ l- influwenza, telqa, sturdament, tmewwit, irqad (ngħas), infjammazzjoni nażali (rinite), infezzjoni fl- apparat respiratorju ta ’ fuq, dardir, nixfa orali, feriti fil- ġilda, ebusija, żieda fis- sodizza tal- muskoli (ipertonija)
breathing difficulties (dyspnoea), double vision (diplopia), drooping eyelid (ptosis), voice alteration, fever
Mhux komuni: diffikultajiet biex tieħu n- nifs (dispnea), tara doppju (diplopja), tebqet il- għajn imdendla (ptosi), bidla fil- vuċi, deni
The treatment of twisted neck may cause swallowing difficulties with varying degrees of severity.
Il- kura ta ’ għonq mgħawweġ tista ’ tikkawża diffikultajiet biex tibla ’ bi gradi diversi ta ’ severità.
These may lead to breathing in foreign materials, which may require medical intervention.
Dan jista ’ jwassal li wieħed jista’ jtiġbed materjal barrani man- nifs, li jista ’ jkollu bżonn ta ’ intervent mediku.
Swallowing difficulties may persist for two to three weeks after injection, but has been reported in one case to last five months.
Id- diffikultajiet biex tibla ’ jistgħu jippersistu għal minn tnejn sa tliet ġimgħat wara l- injezzjoni, iżda f’ każ wieħed kien irrappurtat li damu ħames xhur.
Swallowing difficulties appear to be dose-dependent.
Id- diffikultajiet biex tibla ’ jidher li jiddependu mid - doża.
In clinical trials with Botulinum toxin type A complex, it was reported that swallowing difficulties occur less frequently with low doses.
Fi provi kliniċi bil- kumpless tat- tossina Botulinum ta ’ tip A, kien irrappurtat li d- diffikultajiet biex tibla ’ huma anqas komuni b’ dożi baxxi.
General The following additional information is based on publications on conventional preparations containing the Botulinum toxin type A complex.
44 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 (excessive muscle weakness, swallowing difficulties, lung infection or inflammation due to the inhalation of foreign substances (aspiration pneumonitis) with fatal outcome in some cases).
Effetti sekondarji relatati mal- firxa ta ’ tossina li tkun imbiegħda mis- sit ta ’ l- għoti kienu rrappurtati b’ mod rari ħafna (dgħjufija eċċessiva fil- muskoli, diffikultajiet biex tibla ’, infezzjoni fil- pulmun jew infjammazzjoni minħabba l- ġbid man- nifs ta ’ sustanzi barranin (pnewmonite ta ’ l- aspirazzjoni) b’ riżultat fatali f’ xi każijiet).
43 There are rare reports on side effects related to the cardiovascular system, such as irregular heartbeat (arrhythmia) and heart attack, some of them with fatal outcome.
Hemm rapporti rari fuq l- effetti sekondarji relatati mas- sistema kardjovaskulari, bħal taħbit irregolari tal- qalb (arritmija) u attakk tal- qalb, li xi wħud minnhom kellhom riżultat fatali.
It remains unclear whether these deaths were induced by conventional preparations containing the Botulinum toxin type A complex or caused by a pre-existing cardiovascular disease.
Jibqa ’ mhux ċar jekk dawn l- imwiet kinux ikkaġunati minn preparazzjonijiet konvenzjonali li jkun fihom il- kumpless tat - tossina Botulinum ta ’ tip A, jew jekk kinux ikkawżati minn mard kardjovaskulari li kien jeżisti minn qabel.
Rare reports of severe allergic (anaphylactic) reactions after injection of a conventional preparation containing the Botulinum toxin type A complex have been received.
Inkitbu rapporti rari ta ’ reazzjonijiet severi allerġiċi (anafilattiċi) wara injezzjoni ta ’ preparazzjoni konvenzjonali li fiha kumpless tat- tossina Botulinum ta ’ tip A.
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 perijodu ta ’ 11- il ġimgħa.
A female patient developed a nerve lesion affecting the arm (brachial plexopathy) two days after injection of a conventional preparation containing the Botulinum toxin type A complex for the treatment of twisted neck, with recovery after five months.
Kien hemm pazjenta li żviluppat leżjoni tan- nerv li affettwat id- driegħ (brachial plexopathy) jumejn wara l- injezzjoni ta ’ preparazzjoni konvenzjonali li kien fiha l- kumpless ta ’ tip A tat- tossina Botulinum, għall- kura ta’ għonq mgħawweġ, bil- fejqan li seħħ wara ħames xhur.
Various forms of skin eruptions (erythema multiforme, urticaria, psoriasis-like rash), itching, 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.
Forom varji ta ’ eruzzjonijiet tal- ġilda (eritema multiforme, urtikarja, raxx qisu psorijasi), ħakk, u reazzjonijiet allerġiċi, kienu deskritti bl- użu ta ’ preparazzjonijiet konvenzjonali li jkun fihom il - kumpless tat- tossina Botulinum ta ’ tip A, iżda mhux ċar jekk il- kawża kinetx l- injezzjoni.
HOW TO STORE XEOMIN
KIF TAĦŻEN XEOMIN
Do not use Xeomin after the expiry date which is stated on the carton and vial label after “ EXP”.
Tużax Xeomin wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun u fuq il- folja wara “ JIS ”.
Do not store above 25°C Reconstituted solution:
Taħżinx f’ temperatura ’ l fuq minn 25°C.
Store in a refrigerator (2 - 8°C)
Aħżen fi friġġ (2 - 8°C)
Your doctor will reconstitute the medicine with physiological saline before use.
It- tabib tiegħek ser jirrikostitwixxi l- mediċina b’ soluzzjoni fiżjoloġika ta ’ melħ fl- ilma qabel l- użu.
This reconstituted solution may be stored for up to 24 hours at 2 to 8 °C.
Din is- soluzzjoni rrikostitwita tista ’ tinħażen sa 24 siegħa f’ temperatura bejn 2 u 8 °C.
Nevertheless the product should be used immediately.
Madankollu, il - prodott għandu jintuża immedjatament.
Your doctor should not use Xeomin if the vial reconstituted according to the instructions has a cloudy appearance or contains e. g. floccular or particulate matter.
It- tabib m’ għandux juża Xeomin jekk il- kunjett irrikostitwit skond l- istruzzjonijiet ikun imċajpar jew ikun fih, eż. materjal f’ sura ta ’ partikuli jew frak.
What Xeomin contains
AKTAR TAGĦRIF
• The active substance is Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
X’ fih Xeomin • Is- sustanza attiva hi Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħielsa minn proteini complexing.
1 vial contains 100 LD50 units Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
45 1 kunjett fih 100 LD50 unità * ta ’ Clostridium Botulinum newrotossina ta ’ tip A (150 kD), ħielsa minn proteini complexing.
One LD50 unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Unità waħda ta ’ LD50 tikkorrispondi għall- medjan tad- doża letali (LD50) meta l- prodott rikostitwit ikun injettat b’ mod intraperitoneali fil- ġrieden taħt kundizzjonijiet definiti.
Due to differences in the LD50 assay, these units are specific to Xeomin and are not applicable to other Botulinum toxin preparations.
Minħabba d- differenzi fl- assaġġ LD50, dawn l- unitajiet huma speċifiċi għal Xeomin u mhumiex applikabbli għall- preparazzjonijiet oħrajn tat- tossina Botulinum.
• The other ingredients are: human albumin, sucrose 44 What Xeomin looks like and contents of the pack
• Is- sustanzi l- oħra huma: albumina umana, sucrose
Xeomin is presented as a powder for solution for injection.
Xeomin hu ppreżentat bħala trab għal soluzzjoni għall- injezzjoni.
When dissolved Xeomin is a clear and colourless solution which is free of particulate matter.
Meta jinħall, Xeomin hu soluzzjoni ċara u bla kulur, mingħajr frak.
Pack sizes of 1 (single unit pack), 2, 3 or 6 vials (multi-packs).
Daqsijiet tal- pakketti ta ’ 1 (pakkett b’ unità waħda), 2, 3 jew 6 kunjetti (pakkett multiplu).
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Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 60318 Frankfurt/ Main Németország Telefon: +49- 69/ 15 03- 1 Fax: +49- 69/ 15 03- 200
Merz Pharma GmbH & Co.
Manifattur Merz Pharma GmbH & Co.
KGaA Eckenheimer Landstraße 100 60318 Frankfurt/ Main Germany Phone: +49-69/ 15 03-1 Fax: +49-69/ 15 03-200
KGaA Eckenheimer Landstraße 100 60318 Frankfurt/ Main Il- Ġermanja Telefon: +49- 69/ 15 03- 1 Fax: +49- 69/ 15 03- 200
The smaller the injection volume the less pressure sensation and less spread of Botulinum neurotoxin type A in the injected muscle occurs.
Aktar ma jkun żgħir il- volum ta ’ l- injezzjoni, inqas ser tkun is- sensazzjoni ta ’ pressjoni u inqas il - firxa ta ’ Botulinum newrotossina ta ’ tip A fil- muskoli injettati.
This is of benefit in reducing effects on nearby muscles when small muscle groups are being injected.
Dan hu ta ’ benefiċċju fit- tnaqqis ta ’ effetti fuq muskoli fil- qrib meta gruppi ta ’ muskoli żgħar ikunu qed jiġu injettati.
It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage.
Tkun prattika tajba li twettaq ir- rikostituzzjoni tal- kunjett u l- preparazzjoni tas- siringa fuq xugamani tal - karta b’ inforra tal- plastik biex tilqa ’ għal xi tixrid li jista ’ jkun hemm.
An appropriate amount of solvent (see dilution table) is drawn up into a syringe.
Ammont adattat ta ’ solvent (ara t - tabella tad- dilwizzjoni) jinġibed ġo siringa.
The exposed portion of the rubber stopper of the vial is cleaned with alcohol (70%) prior to insertion of the needle.
Il- porzjon espost tat- tapp tal- lastku tal- kunjett jitnaddaf bl - alkoħol (70%) qabel iddaħħal il- labra.
The vial must be discarded, if the vacuum does not pull the solvent into the vial.
Il- kunjett irid jintrema, jekk il- vacuum ma jiġbidx is- solvent ġol- kunjett.
The recommended dilutions are indicated in the following table:
Id- dilwizzjonijiet irrakkomandati huma indikati fit- tabella li ġejja:
Solvent added (sodium chloride 9 mg/ ml (0.9%) solution for injection)
Solvent miżjud
units per 0.1 ml
Doża li tirriżulta f’ unitajiet f’ kull 0. 1 ml
Any used vials, syringes, and spillage etc. should be sterilised under high pressure and any residual Xeomin inactivated using diluted sodium hydroxide solution (0.1 N NaOH).
(sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni)
London, 25 October 2007 EMEA/ CHMP/ 350251/ 2007
Londra, 25 ta ’ Ottubru 2007 EMEA/ CHMP/ 350251/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN):
OPINJONI SKOND L- ARTIKOLU 29( 4) 1 REFERENZA GĦAL Xeomin Denominazzjoni Komuni Internazzjonali (INN - Internatinal Non- proprietary Name):
Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Xeomin, 100 unitajiet fi trab LD50 għal soluzzjoni f’ injezzjoni, huwa indikat għal ġestjoni ta ’ symptomatika ta ’ blepharospasm u dystonia ċervikali ta ’ forma predominantement rotazzjonali (spasmodic torticollis) f’ adulti.
Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005.
Merz Pharmaceuticals GmbH issottomettiet applikazzjonijiet għar- rikonoxximent reċiproku ta ’ Xeomin, 100 unitajiet fi trab LD50 għal soluzzjoni f’ injezzjoni, abbażi ta ’ awtorizzazzjoni għat- tqegħid fis- suq mill - Ġermanja fil- 31 ta ’ Mejju 2005.
The Mutual Recognition Procedure started on 24 October 2006.
Il- Proċedura ta ’ l- Għarfien Reċiproku bdiet fl- 24 ta ’ Ottubru 2006.