FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of cardiovascular safety pharmacology.
Maltese: Informazzjoni li mhix klinika ma turi l-ebda periklu speċjali għall-bnedmin, ibbażata fuq studji konvenzjonali dwar il-farmakoloġija tas-sigurtà kardjovaskulari.
English: In non-clinical studies, the pharmacological effect (i.e. degree of the paralytic activity, effect on motility, effect on paralysis over time, duration) of Xeomin was compared to Botox: - The paralytic activity of Xeomin and Botox was assessed in the mouse regional paralysis test, after 3 repeated intramuscular injections at 6 and 13 week intervals up to a dose of 0.64 Lethal Dose Unit (LDU)/animal for Xeomin and Botox (approx. 32 LDU/kg).
Maltese: - L-attività paralitika ta' Xeomin u Botox ġiet valutata fit-test tal-paraliżi reġjonali tal-ġrieden, wara tliet injezzjonijiet fil-muskoli b'intervalli ta' 6 u 13-il ġimgħa sa doża ta' 0.64
English: For intramuscular use
Maltese: Disturbi gastro-intestinali
English: 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)
Maltese: 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)
English: Botox has a protein content of 5 ng/100U, i.e. the 150 kDa neurotoxin and non-effective complexing proteins, and quickly dissociates into the neurotoxin and the complexing proteins after administration.
Maltese: Botox għandu kontenut talproteini ta' 5 ng/100U, jiġifieri n-newrotossin tal-150 kDa u proteini komplessanti mhux effettivi.
English: Antibodies may reduce the therapeutic effectiveness of the product.
Maltese: L-antikorpi jistgħu inaqqsu l-effikaċja terapewtika tal-prodott.
English: Medical intervention may be necessary (e.g. in the form of a gastric feeding tube) (see also section 4.8).
Maltese: Jista' jkun meħtieġ intervent mediku (eż. fis-sura ta' tubu gastriku ta' likel) (ara wkoll sezzjoni 4.8).
English: The submitted clinical trial programme consisted of:
Maltese: Il-programm ta' l-istudju kliniku sottomess kien jikkonsisti minn:
English: 8.0 ml
Maltese: 30-0.40 mm).
English: In practice, the maximum total dose is usually not more than 200 U. Doses of up to 300 U may be given.
Maltese: Fil-prattika, id-doża massima totali normalment ma tkunx ta' aktar minn 200 U.
English: o Evaluation of the spread reactions, specifically as part of future studies.
Maltese: o Evalwazzjoni tar-reazzjonijiet tat-tixrid, speċifikament bħala parti minn studji futuri.
English: From a quality point of view, Xeomin is highly purified and differs from the drug substance in Botox® and Dysport® in that it is free of complexing proteins (haemagglutinins).
Maltese: Mill-aspett ta' kwalità, Xeomin hu purifikat ħafna u differenti mis-sustanza mediċinali f'Botox® u Dysport® fis-sens li ma fihx proteini komplessanti (haemagglutinins).
English: Side effects related to spread of toxin distant from the site of administration have been reported very rarely (exaggerated muscle weakness, dysphagia, aspiration pneumonitis with fatal outcome in some cases) (see section 4.4).
Maltese: Effetti sekondarji relatati mal-firxa ta' tossina li tkun imbiegħda mill-post fejn ingħatat kienu rrappurtati b'mod rari ħafna (dgħjufija eċċessiva fil-muskoli, disfaġja, pnewmonite ta' laspirazzjoni b'riżultat fatali f'xi każijiet) (ara sezzjoni 4.4).
English: Resulting dose in units per 0.1 ml
Maltese: Doża li tirriżulta f'unitajiet f'kull 0.1 ml
English: Based on clinical experience information on the frequency of adverse reactions for the individual indications is given below.
Maltese: Ibbażat fuq l-esperjenza klinika, informazzjoni dwar il-frekwenza ta' reazzjonijiet avversi għall-indikazzjonijiet individwali qed tingħata hawn taħt.
English: • The other ingredients are: human albumin, sucrose
Maltese: • Is-sustanzi l-oħra huma: albumina umana, sucrose
English: skin sores
Maltese: Studju Fażi
English: 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.
Maltese: 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 fiċċelluli.
English: Excipient(s):
Maltese: FIS-SOMMARJU(I)
English: The following additional information is based on publications on conventional preparations containing the Botulinum toxin type A complex.
Maltese: L-informazzjoni addizzjonali li ġejja hi bbażata fuq pubblikazzjonijiet fuq preparazzjonijiet konvenzjonali li fihom il-kumpless tat-tossina Botulinum ta' tip A.
English: The primary efficacy variable was the decrease from baseline of the most relevant (i.e. highest amplitude) surface electromyography (EMG) level in the dystonic sternocleidomastoid muscle during maximal voluntary activation 14 days post-injection.
Maltese: L-effikaċja primarja kienet definita bħala t-tnaqqis mil-livell bażi ta' l-iktar livell relevanti (jiġifieri bl-ogħla mewġa) ta' elettromijografija (EMG) fil-muskolu sterncleidomastoid distoniku waqt lattivazzjoni volontarja massima 14-il jum wara l-injezzjoni.
English: In both treatment groups, 4 patients with a positive HDA result at baseline had a negative result at the final visit.
Maltese: Fiż-żewġ gruppi ta' trattament, 4 pazjenti b'riżultat bażi pożittiv ta' l-HDA kellhom riżultat negattiv fiż-żjara finali.
English: In Phase II dose finding trial, the efficacy in patients with rotational cervical dystonia at three doses (10, 20 and 30 U) of Xeomin was compared to the optimal dose of Botox (30 U).
Maltese: Fl-istudju tat-Tieni Fażi għas-sejbien tad-doża, l-effikaċja f'pazjenti b'distonja ċervikali rotazzjonali għal tliet dożi (10, 20 u 30 U) ta' Xeomin tqabblet mad-doża ottima ta' Botox (30 U).
English: Uncommon: 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
Maltese: 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
English: The nerve terminals of the neuromuscular junction no longer respond to nerve impulses, and secretion of the neurotransmitter is prevented (chemical denervation).
Maltese: It-truf tan-nervituri tal-junction newromuskolari ma jirrispondux aktar għall-impulsi tan-nervituri, u l-firxa tan-newrotrasmettitur tiġi evitata (dinervazzjoni kimika).
English: One LD50 unit corresponds to the median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions.
Maltese: 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.
English: • To submit a Risk Management Plan, according to the current guideline, including: o Detailed strategies for educating physicians including appropriate injection techniques, dosing and lack of interchangeability between products as well as programmes for continued and improved monitoring of spread reactions in clinical use and in clinical trials.
Maltese: • Li jiġi ppreżentat Pjan ta' Ġestjoni tar-Riskji, skond il-linja gwida attwali, inkluż: o Strateġiji dettaljati għall-edukazzjoni tat-tobba inkluż tekniki adegwati ta' injezzjoni, dożi u nuqqas ta' qlib bejn prodott u ieħor kif ukoll programmi għal monitoraġġ kontinwat u mtejjeb ta' reazzjonijiet mifruxin fl-użu kliniku u fil-provi kliniċi.
English: dysphagia Uncommon: diarrhoea, dry mouth, vomiting, colitis
Maltese: Mhux komuni: dijarea, ħalq xott, rimettar, kolite
English: • In the upper limb spasticity study (MRZ 0410) 144 patients entered the second injection cycle, in which doses up to 400 U of Xeomin are administered.
Maltese: • Fl-istudju dwar l-ispastiċità tad-driegħ (MRZ 0410) 144 pazjent daħlu fit-tieni ċiklu ta' injezzjoni, li fiha jingħataw dożi sa 400 U ta' Xeomin.
English: The applicant has submitted the total number of adverse events with no distinction between adverse events related or not related.
Maltese: L-applikant ippreżenta n-numru totali ta' episodji avversi mingħajr distinzjoni bejn episodji avversi relatati u mhux relatati.
English: • Phase III Cervical Dystonia Study (MRZ 0013)
Maltese: III f'distonja ċervikali (MRZ 60201
English: An injection volume of approximately 0.05 to 0.1 ml is recommended.
Maltese: Volum ta' l-injezzjoni ta' madwar 0.05 sa 0.1 ml hu rrakomandat.
English: Xeomin is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Maltese: Xeomin hu indikat għall-immaniġġjar sintomatiku ta' blefarospażmu u distonja fil-għonq ta' forma fil-biċċa l-kbira tagħha rotazzjonali (torticollis spażmodika) fl-adulti.
English: One case with severe dysphagia was reported in the Botox group.
Maltese: Każ wieħed b'disfaġja severa ġie rrapportat fil-grupp ta' Botox.
English: This reconstituted solution may be stored for up to 24 hours at 2 to 8 °C.
Maltese: Din is-soluzzjoni rrikostitwita tista' tinħażen sa 24 siegħa f'temperatura bejn 2 u 8 °C.
English: (MRZ/BTC-0013) and blepharospasm (MRZ/BTC-0003) respectively)
Maltese: • Żewġ studji tat-Tielet Fażi (studju wieħed f'kull waħda mill-indikazzjonijiet intiżi, torticollis spasmodika (MRZ/BTC-0013) u blefarospażmu (MRZ/BTC-0003) rispettivament)
English: Powder for solution for injection 2 vials
Maltese: Trab għal soluzzjoni għall-injezzjoni 2 kunjetti
English: No drug-related SAE was reported, there were no withdrawals due to adverse events.
Maltese: Ebda SAE relatat mal-mediċina ma ġie rrapportat, ma kien hemm ebda rtirar dovut għal episodji avversi.
English: Of the Xeomin patients with a negative mouse hemidiaphragm assay (HDA) result at baseline, indicating that no neutralising antibodies are present, 2 individuals had a positive result (<5 mU/mL) at the final visit.
Maltese: Mill-pazjenti li ngħataw Xeomin b'riżultat bażi negattiv fil-hemidiaphragm assay (HDA) tal-ġrieden, li jindika li l-ebda antikorpi newtralizzanti ma huma preżenti, żewġ individwi kellhom riżultat pożittiv (<5 mU/mL) fl-aħħar żjara.
English: Uncommon: 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
Maltese: 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
English: PHARMACEUTICAL PARTICULARS
Maltese: Merz Pharmaceuticals
English: This may require protective drops, ointments, soft bandage contact lenses, or closure of the eye by patching or similar means.
Maltese: Dan jista' jikkonsisti fi qtar protettiv, ingwenti, soft bandage contact lenses, jew l-għeluq ta' l-għajn permezz ta' patching jew mezzi simili.
English: The applicant has committed to perform a post-marketing surveillance study, in which immunogenicity of Xeomin will be further investigated after repeated administration (up to 6 injection sessions) .
Maltese: L-applikant impennja ruħu li jwettaq studju ta' wara t-tqegħid fis-suq, li fih, l-immunoġeniċità ta' Xeomin hija investigata aktar fil-fond wara amministrazzjoni ripetuta (sa 6 sessjonijiet ta' injezzjonijiet).
English: 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.
Maltese: 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.
English: Eyelid spasm (blepharospasm)
Maltese: Spażmu ta' tebqet il-għajn (blefarospażmu)
English: Twisted neck (spasmodic torticollis) The following side effects were reported with Xeomin:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati bi Xeomin:
English: 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.
Maltese: 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 ilkumpless tat-tossina Botulinum ta' tip A, iżda mhux ċar jekk il-kawża kinetx l-injezzjoni.
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C.
Maltese: L-istabbilità kimika u fiżika waqt l-użu intweriet għal 24 siegħa f'temperatura ta' minn 2 sa 8°C.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 1 VIAL WHEN THIS IS PART/COMPONENT OF A MULTIPACK WITH 2, 3, 6 VIALS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA GĦALL-KUNJETT WIEĦED META DAN IKUN PARTI/KOMPONENT TA' PAKKETT MULTIPLU BI 2, 3, 6 KUNJETTI
English: After reconstitution, the Xeomin solution is injected using a suitable sterile needle (e.g. 27-30 gauge/0.30-0.40 mm).
Maltese: Labra sterili adattata (eż. 25-30 gauge/0.
English: Musculoskeletal and connective tissue disorders Uncommon: muscle weakness
Maltese: Disturbi muskolu-skeletrali u tal-connective tissue Mhux komuni: dgħjufija fil-muskoli.
English: Thus, up to now no case of secondary therapy failure can be derived from the ongoing studies, in which Xeomin (or placebo) has been used repetitively in a total of 213 patients, even though Xeomin doses are partially very high (which is usually a risk factor of antibody formation).
Maltese: Xeomin (jew plaċebo) ripetittivament f'total ta' 213 pazjent, anki jekk id-dożi ta' Xeomin huma parzjalment għoljin ħafna (li normalment huwa fattur ta' riskju ta' formazzjoni ta' antikorpi).
English: Twisted neck (spasmodic torticollis)
Maltese: Għonq mgħawweġ (torticollis spażmodika)
English: Dissolved Xeomin is intended for injections into the muscle.
Maltese: Xeomin rikostitwit hu intenzjonat għal injezzjoni ġol-muskoli.
English: The applicant is requested to submit the results of all scheduled HDA tests of the upper limb spasticity study (MRZ 0410) and the cervical dystonia study (MRZ 0408) after unblinding of the respective studies.
Maltese: L-applikant huwa mitlub jippreżenta r-riżultati tat-testijiet tal-HDA skedati kollha ta' l-istudju ta' lispastiċità tal-parti ta' fuq tad-driegħ (MRZ 0410) u ta' l-istudju tad-distonja ċervikali (MRZ 0408) wara l-kxif ta' l-istudji rispettivi.
English: Xeomin has not been studied in the paediatric population and is therefore not recommended in the paediatric age group until further data become available.
Maltese: Xeomin ma kienx studjat fil-popolazzjoni pedjatrika u għalhekk mhux irrakkomandat fil-grupp ta' l-età pedjatrika sakemm informazzjoni addizzjonali ssir disponibbli.
English: Most of the adverse events were of mild or moderate severity in both groups.
Maltese: Ħafna mill-episodji avversi kienu ta' severità ħafifa jew moderata fiż-żewġ gruppi.
English: • twisted neck (spasmodic torticollis)
Maltese: • għonq mgħawweġ (torticollis spażmodika)
English: Erythema multiforme, urticaria, psoriasis-like rash, pruritus, and allergic reactions have been described with the use of conventional preparations containing the Botulinum toxin type A complex, but their causal relationship remains unclear.
Maltese: 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 l-kawża proprija tagħhom tibqa' mhix ċara.
English: • To submit the results of all scheduled HDA tests of the upper limb spasticity study (MRZ 0410) and the cervical dystonia study (MRZ 0408) after unblinding of the respective studies.
Maltese: • Li jiġu ppreżentati r-riżultati tat-testijiet tal-HDA skedati kollha ta' l-istudju ta' l-ispastiċità talparti ta' fuq tad-driegħ (MRZ 0410) u ta' l-istudju ta' distonja ċervikali (MRZ 0408) wara l-kxif ta' l-istudji rispettivi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR MULTI PACK WITH 2, 3, 6 VIALS
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA GĦAL PAKKETT MULTIPLU BI 2, 3, 6 KUNJETTI
English: Three patients discontinued the studies prematurely due to adverse events considered as unrelated to study drug.
Maltese: Tliet pazjenti waqfu mill-istudji qabel minħabba episodji avversi meqjusin mhux relatati mal-mediċina ta' l-istudju.
English: Blepharospasm The following adverse reactions were reported with Xeomin:
Maltese: Blefarospażmu Dawn ir-reazzjonijiet avversi li ġejjin kienu rrappurtati bi Xeomin:
English: • To perform a post-marketing study to confirm the safety and efficacy of Xeomin after repeated injections (up to 6 injection sessions).
Maltese: • Li jsir studju ta' wara t-tqegħid fis-suq sabiex jiġu kkonfermati s-sigurtà u l-effikaċja ta' Xeomin wara injezzjonijiet ripetuti (sa 6 sessjonijiet ta' injezzoni).
English: special form of inflammation of the cornea (superficial punctate keratitis), inability to close eye (lagophthalmos), eye irritation, fear of light (photophobia), tearing (lacrimation)
Maltese: forma speċjali ta' infjammazzjoni tal-kornea (keratite punctate superfiċjali), ma tkunx tista' tagħlaq għajnejk (lagophthalmos), irritazzjoni fl-għajnejn, biża' mid-dawl (fotofobia), dmugħ (lakrimazzjoni)
English: Reduced blinking following Xeomin injection into the orbicularis muscle can lead to corneal exposure, persistent epithelial defects and corneal ulceration, especially in patients with cranial nerve disorders (facial nerve).
Maltese: Teptip ta' l-għajnejn imnaqqas wara l-injezzjoni b'Xeomin ġol-muskolu orbicularis jista' jwassal li tinkixef il-kornea, difetti epiteljali persistenti u ulċerazzjoni tal-kornea, speċjalment f'pazjenti b'disturbi tan-nervaturi kranjali (nervaturi tal-wiċċ).
English: • In the blepharospasmus study (MRZ 0433) one patient has entered the second injection cycle.
Maltese: • Fl-istudju dwar il-blefarospażmu (MRZ 0433) pazjent wieħed daħal fit-tieni ċiklu ta' linjezzjonijiet.
English: • if you are allergic (hypersensitive) to Botulinum neurotoxin type A or any of the other ingredients of Xeomin (see section 6 “Further information”)
Maltese: • 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”).
English: Like many other proteins of its size, Botulinum neurotoxin type A has been shown to undergo retrograde axonal transport after intramuscular injection.
Maltese: Bħal ħafna proteini oħrajn tad-daqs tagħha, intwera li Botulinum newrotossina ta' tip A, tgħaddi minn trasport axonal retrogradu wara injezzjoni ġol-muskoli.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 6 vials
Maltese: U KONTENUT Trab għal soluzzjoni għall-injezzjoni 6 kunjetti
English: • in patients suffering from amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction
Maltese: • jekk tbati minn kwalunkwe mard li tiddisturba l-interazzjoni bejn in-nervaturi u l-muskoli skeletriċi (disfunzjoni newromuskolari periferali)
English: • are at risk of developing a disease called angle closure glaucoma.
Maltese: • f'riskju li tiżviluppa marda msejħa glawkoma tat-tip angle closure.
English: - In LPT12444, in week 36, three weeks after the final injection, the ELISA test (indicating the presence of antibodies against Botulinum neurotoxin type A) revealed that seven of the 20 rabbits treated with Botox showed a positive response and four of these rabbits displayed BoNT/A neutralising activity in the hemidiaphragm assay (HDA indicating if antibodies are neutralising or non-neutralising).
Maltese: - F'LPT12444, fis-36 ġimgħa, tliet ġimgħat wara l-injezzjoni finali, it-test ELISA (li juri l-preżenza ta' antikorpi ta' kontra newrotossin tal-Botulinium tat-Tip A) wera li sebgħa mill-għoxrin fenek ittrattati b'Botox kellhom rispons pożittiv u erbgħa minn dawn il-fniek u erbgħa minn dawn il-fniek urew attività newtralizzanti BoNT/A fil-hemidiaphragm assay (HDA li juri jekk l-antikorpi humiex newtralizzanti jew le).
English: Overall, safety data from 908 participants have been included in these trials, 466 subjects were treated with Xeomin and 442 subjects were treated with Botox.
Maltese: B'mod ġenerali, it-tagħrif dwar issigurtà minn 908 parteċipanti ġie nkluż f'dawn il-provi kliniċi, 466 suġġett ġew trattati b'Xeomin u 442 suġġett ġew trattati b'Botox.
English: Content (concentration)
Maltese: Mhux komuni: konġuntivite
English: Take special care with Xeomin
Maltese: QABEL MA TUŻA XEOMIN
English: Xeomin100 LD50 units powder for solution for injection Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins
Maltese: Xeomin 100 LD50 unitajiet ta' trab għal soluzzjoni għall-injezzjoni Clostridium Botulinum newrotossina ta' tip A (150 kD), ħieles minn proteini complexing
English: In the cervical dystonia study (MRZ 0408) in which doses up to 240 U of Xeomin are administered, 63 patients received the 2nd injection, 27 patients received the 3rd, and 6 patients received the 4th injection, respectively.
Maltese: U ta' Xeomin, 63 pazjent irċevew t-2 injezzjoni, 27 pazjent irċevew t-3 injezzoni u 6 pazjenti rċevew r-4 injezzjoni, rispettivament.
English: Of the Botox patients 4 individuals with a negative result at baseline had a positive result (<5 mU/mL in 3 patients, >5 mU/mL in 1 patient) at the final visit.
Maltese: Mill-erba' pazjenti li ngħataw Botox, 4 individwi b'riżultat bażi negattiv kellhom riżultat pożittiv (<5 mU/mL fi tliet pazjenti, >5 mU/mL f'pazjent wieħed) fl-aħħar żjara.
English: HOW TO STORE XEOMIN
Maltese: X'fih Xeomin
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include careful selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard biex jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, screening ta' donazzjonijiet individwali u ta' pools talplażma għal markaturi speċifiċi ta' infezzjoni u li jittieħdu passi effettivi tal-manifattura għallinattivazzjoni/tneħħija ta' viruses.
English: Electromyographic guidance is not necessary.
Maltese: EMG (elettromijografija).
English: 1 vial contains 100 LD50 units Clostridium Botulinum neurotoxin type A (150 kD), free of complexing proteins.
Maltese: 1 kunjett fih 100 LD50 unità* ta' Clostridium Botulinum newrotossina ta' tip A (150 kD), ħieles minn proteini complexing.