FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy.
Maltese: It-tabib tiegħek se jinfurmak dwar il-miżuri kollha marbuta ma kontraċezzjoni effettiva u dwar ir-riskju possibbli ta' tqala.
English: Do not take X if: - you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception - you are breast feeding
Maltese: - inti allerġiku għal thiocolchicoside jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6) - inti tqila, tista' tinqabad tqila jew taħseb li tista' tkun tqila - inti mara ta' età li jista' jkollok it-tfal u mintix qed tuża kontraċezzjoni - inti qed tredda'
English: [the currently approved wording should be deleted and replaced by the following] 30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose.
Maltese: [il-kliem approvat s'issa għandu jitneħħa u minfloku jitqiegħed dan li ġej] 30 pillola/kapsula għad-doża ta' 4 mg u 14-il pillola/kapsula għad-doża ta' 8 mg. 10 kunjetti / ampolli għad-doża ta '4 mg / 2 ml.
English: Distribution The apparent volume of distribution of thiocolchicoside is estimated around 42.7 L after an IM administration of 8 mg. No data are available for both metabolites.
Maltese: Il-volum apparenti ta' distribuzzjoni ta' thiocolchicoside huwa stmat li huwa madwar 42.7 L wara għoti ġol-muskolu ta' 8 mg.
English: PL
Maltese: TIKKETTAR
English: - After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%.
Maltese: - Wara għoti mill-ħalq, il-biċċa l-kbira tar-radjuattività totali titneħħa mal-ippurgar (79%) filwaqt li ttneħħija mal-awrina tirrapreżenta biss 20%.
English: Posology o For the oral form 4 mg and 8 mg: The recommended and maximal dose is 8 mg every 12 hours (i.e. 16 mg per day).
Maltese: Id-doża rrakkomandata u massima hija ta' 4 mg kull 12-il siegħa (i.e. 8 mg kuljum).
English: Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
Maltese: Il-pazjenti għandhom jiġu infurmati b'attenzjoni dwar ir-riskju possibbli jekk ikun hemm tqala u dwar miżuri ta' kontraċezzjoni effettiva li għandhom jiġu segwiti.
English: This is based on laboratory studies (see section 2 “Warnings and precautions”).
Maltese: Dan huwa bbażat fuq studji fil-laboratorju (ara sezzjoni 2 “Twissijiet u prekawzjonijiet”).
English: Adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards.
Maltese: Tfal u adolexxenti Tagħtix din il-mediċina lil tfal u adolexxenti ta' taħt 'il 16-il sena minħabba tħassib dwar sigurtà.
English: Thiocolchicoside must not be used - in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1 - during the entire pregnancy period - during lactation - in women of childbearing potential not using contraception.
Maltese: Thiocolchicoside m'għandux jintuża - f'pazjenti li għandhom sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill eċċipjenti elenkati fis-sezzjoni 6.1 - waqt il-perjodu kollu tat-tqala - waqt it-treddigħ - f'nisa ta' età li jista' jkollhom it-tfal li mhumiex qed jużaw kontraċezzjoni.
English: There are limited data on the use of thiocolchicoside in pregnant women.
Maltese: Hemm dejta limitata dwar l-użu ta' thiocolchicoside f'nisa tqal.
English: Since it passes into the mother's milk, the use of thiocolchicoside is contraindicated during breastfeeding (see section 4.3).
Maltese: Għandhom jiġu evitati dożi li jaqbżu d-dożi rrakkomandati jew użu fit-tul (ara sezzjoni 4.4).
English: Unisol 10% Oral solution
Maltese: Unisol 10% Soluzzjoni Orali Soluzzjoni Orali
English: Unisol 10% Oral Solution contains 100 mg enrofloxacin as active ingredient per 1 ml product.
Maltese: Unisol 10% Soluzzjoni Orali fih 100 mg enrofloxacin bħala sustanza attiva f'kull 1 ml tal-prodott.
English: Gran Vía Carlos III, 98 - 7ª 08028 Barcelona Spain
Maltese: Universal Farma, S.L. Gran Vía Carlos III, 98 - 7ª 08028 Barċellona SPANJA
English: Application of the CVMP guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 and GL38 results in an estimate of PECsurfacewater of 0.019 µg/l.
Maltese: L-applikazzjoni tal-linja gwida tas-CVMP fuq il-Valutazzjoni tal-Impatt Ambjentali għall-Prodotti Mediċinali Veterinarji f'appoġġ għal-linji gwida VICH GL6 u GL38 tirriżulta fi stima talPECilma tal-wiċċ ta' 0.019 µg/l.
English: A study, published in the peer-reviewed and open literature (Nowara et al 1997)1 indicated that enrofloxacin and other fluoroquinolones are strongly adsorbed to soils with high content in clay minerals of montmorillonite and kaolinite, basically through electrostatic interactions between ionized carboxylated groups of fluoroquinolones and exchangeable cations within clay layers.
Maltese: 2.1.2 Adsorbiment u disorbiment tal-ħamrija Studju, ippubblikat f'letteratura miftuħa u rreveduta minn pari (Nowara et al 1997)1 indika li enrofloxacin u fluoroquinolones oħrajn jiġu adsorbiti bil-qawwa minn ħamrija b'kontenut għoli ta' minerali tat-tafal ta' montmorillonite u kaolinite, bażikament permezz ta' interazzjonijiet elettrostatiċi bejn gruppi karbossilati jonizzati ta' fluoroquinolones u katjoni li jistgħu jiġu skambjati fi ħdan is-saffi tat-tafal.
English: The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Unisol 10% Oral Solution for broiler chickens (10 mg/kg bw/day, for 5 days) above 100 µg/kg, thus requiring a Phase II assessment.
Maltese: Il-valutazzjoni tar-riskji ambjentali ta' Fażi I li segwiet il-linja gwida VICH irriżultat f'Konċentrazzjoniet Ambjentali Imbassrin (Predicted Environmental Concentrations - PECs) filħamrija għal Unisol 10% Soluzzjoni Orali għall-flieles brojler (10 mg/kg piż tal-ġisem kuljum, għal 5 ijiem) ta' aktar minn 100 µg/kg, b'hekk kienet meħtieġa valutazzjoni ta' Fażi
English: Gran Vía Carlos III, 98 - 7ª 08028 Barcelona
Maltese: Il-Polonja Universal Farma, S.L. Gran Vía Carlos III, 98 - 7ª 08028 Barċellona
English: During the decentralised procedure concerns were raised that Unisol 10% Oral Solution may present a potential serious risk to the environment regarding risk to blue-green algae and to terrestrial plants.
Maltese: Waqt il-proċedura deċentralizzata tqajjem tħassib li Unisol 10% Soluzzjoni Orali jista' jippreżenta periklu potenzjali serju għall-ambjent rigward riskju għall-alki blu-ħodor u pjanti ta' l-art.
English: The applicant provided an environmental risk assessment for Unisol 10% Oral Solution that followed in general the established guidelines and recommendations.
Maltese: L-applikant ipprovda valutazzjoni tar-riskji ambjentali għal Unisol 10% Soluzzjoni Orali li segwiet b'mod ġenerali l-linji gwida u r-rakkomandazzjonijiet stabbiliti.
English: Effect studies and calculation of PNEC values
Maltese: Valutazzjoni tar-riskji ambjentali
English: Oral solution 100mg/ml
Maltese: 9 µg/l.
English: Absolute Difference
Maltese: Differenza Assoluta
English: (% CI) (0.0, 12.8) (17.5, 31.8) (17.1, 32.2) (11.4,
Maltese: (% CI) (0.0, 12.8) (17.5, 31.8) (17.1, 32.2) (11.4, ValurP
English: Glabellar lines
Maltese: Linji glabellari
English: Co. Meath, K32YD60
Maltese: Meath, K32YD60
English: September 2020
Maltese: Settembru 2020
English: Human albumin, sodium chloride
Maltese: Albumina umana, sodium chloride
English: 100 Units
Maltese: INDIVIDWALI 100 Unità
English: NUCEIVA (N=245) GLS=0 at Day 30 at Maximum Contraction
Maltese: NUCEIVA (N=245) GLS=0 f'Jum 30 f'Kontrazzjoni Massima
English: Placebo BOTOX NUCEIVA
Maltese: Plaċebo BOTOX NUCEIVA
English: KOREA, REPUBLIC OF
Maltese: IR-REPUBBLIKA TAL-KOREA
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoloskeletali u tat-tessut konnettiv
English: There are limited clinical data with NUCEIVA in patients older than 65 years (see section 5.1).
Maltese: Pazjenti anzjani Id-data klinika b'NUCEIVA f'pazjenti ta' aktar minn 65 sena hija limitata (ara sezzjoni 5.1).
English: Uncommon events occurred in between 2 and 7 subjects.
Maltese: Avvenimenti mhux komuni seħħew f'bejn 2 u 7 individwi.
English: BOTOX Vs.
Maltese: BOTOX kontra
English: GLS=1 at Day 30 at Maximum Contraction
Maltese: GLS=1 f'Jum 30 f'Kontrazzjoni Massima
English: Table 1 The NUCEIVA related adverse reactions are classified by System Organ Class and frequency defined as follows: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Komuni ħafna (≥ 1/100), komuni (≥ 1/100 sa <1/10), mhux komuni (≥ 1/1,000 sa <1/100), rari (≥ 1/10,000 sa <1/1,000), rari ħafna
English: INFORMATION IN BRAILLE UNIQUE IDENTIFIER - 2D BARCODE UNIQUE IDENTIFIER - HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: Daewoong Pharmaceutical Co. Limited 35-14 Jeyakgongdan 4-gil Hyangnam-eup
Maltese: Jeyakgongdan 4-gil Hyangnam-eup
English: Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe Two days after injection, 12.2% (6/49) of placebo, 57.0% (139/244) Botox treated patients and 54.2% (130/240) of NUCEIVA were considered by investigators as treatment responders (none or mild severity at maximum frown).
Maltese: Jumejn wara l-injezzjoni, 12.2 % (6/49) tal-pazjenti li ngħataw plaċebo, 57.0 % (139/244) tal-pazjenti li ngħataw kura b'Botox u 54.2 % (130/240) ta' dawk li ngħataw NUCEIVA tqiesu mill-investigaturi bħala dawk li rrispondew għall-kura (l-ebda linja jew severità ħafifa f'kontrazzjoni massima tal muskoli tal-ħuġbejn).
English: System Organ Class
Maltese: Sistema tal-Klassifika talO i
English: 2 (Moderate) Number Percentage 3 (Severe) Number Percentage Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe.
Maltese: Skala tal-Linji Glabellari (GLS) 0=l-ebda linja, 1=ħfief, 2=moderati, 3=severi.
English: NUCEIVA Vs. BOTOX
Maltese: NUCEIVA kontra BOTOX
English: Reconstituted NUCEIVA (100 Units/2.5 mL) is injected using a sterile 30 gauge needle.
Maltese: NUCEIVA rikostitwit (100 Unità/2.5 mL) jiġi injettat bl-użu ta' labra sterili b'gejġ ta' 30.
English: Intraocular pressure test
Maltese: Test tal-pressjoni intraokulari
English: Dysaesthesia, head discomfort, hypoaesthesia, paraesthesia, sensory disturbance
Maltese: Disestesija, skumdità fir-ras, ipoestesija, parastesija, disturb sensorjali
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 2 - 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 72 siegħa f'temperatura ta' bejn 2˚C u 8˚C.
English: Resulting dose (Units per 0.1 mL) 4.0 U
Maltese: (Unitajiet f'kull 0.1 mL) 4.0
English: NUCEIVA contains the active substance botulinum toxin type A.
Maltese: NUCEIVA fih is-sustanza attiva tossina tal-botulinju tat-tip A.
English: Introduction of an in vitro method as a replacement for the potency assay of the Nuceiva finished product.
Maltese: L-introduzzjoni ta' metodu in vitro bħala sostituzzjoni għall-assaġġ ta' potenza tal prodott lest ta' Nuceiva.
English: Gastrointestinal disorders Diarrhea
Maltese: Disturbi gastrointestinali
English: Each vial contains 100 Units botulinum toxin type A produced by Clostridium botulinum.
Maltese: Kull kunjett fih 100 Unità tat-tossina tal-botulinju tat-Tip A prodotta minn Clostridium botulinum.
English: CF31 3RT, United Kingdom
Maltese: CF31 3RT, Ir-Renju Unit
English: Localised pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling/oedema, erythema, localised infection, bleeding and/or bruising have been associated with the injection.
Maltese: Uġigħ lokalizzat, infjammazzjoni, parastesija, ipoestesija, sensittività, nefħa/edema, eritema, infezzjoni lokalizzata, fsada u/jew tbenġil ġew assoċjati mal-injezzjoni.
English: Pharmacotherapeutic group: Muscle relaxants, other muscle relaxants, peripherally acting agents, ATC code: M03AX01.
Maltese: Rilassanti tal-muskoli, rilassanti tal-muskoli oħra, aġenti li jaġixxu b'mod periferali, kodiċi ATC:
English: Application related adverse reactions
Maltese: Reazzjonijiet avversi relatati mal-applikazzjoni
English: Pruritis
Maltese: UŻU
English: Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within the nerve endings, thereby leading to denervation of the muscle and a flaccid paralysis.
Maltese: It-tossina tal-botulinju tat-tip A (newrotossina ta' Clostridium botulinum) timblokka r-rilaxx tal aċetilkolina periferali fit-truf tan-nervituri kolinerġiċi presinattiċi billi taqsam is-SNAP-25, proteina integrali għad-docking u għar-rilaxx b'suċċess tal-aċetilkolina minn vesikuli li jinsabu fit-truf tannervituri, u b'hekk twassal għad-denervazzjoni tal-muskolu u paraliżi mpaħpħa.
English: - Very rarely, an allergic reaction can occur after the injection of botulinum toxin.
Maltese: - Rarament ħafna, jista' jkun hemm reazzjoni allerġika wara l-injezzjoni tat-tossina tal-botulinju.
English: Most side effects are of mild to moderate severity.
Maltese: Ħafna mill-effetti sekondarji huma ħfief jew moderati fis-severità.
English: It prevents muscles from contracting, leading to a temporary paralysis.
Maltese: Din twaqqaf lill-muskoli milli jikkuntrattaw, li twassal għal paraliżi temporanja.
English: Asthopenia, blepharospasm, brow ptosis, eyelid oedema, eye swelling, vision blurred
Maltese: Astopenija, blefarospażmu, ptosi tal-ħuġbejn, edema filkappell tal-għajn, nefħa flgħajnejn, vista mċajpra
English: Generalised disorders of muscle activity (e.g. myasthenia gravis or Eaton Lambert Syndrome) Infection or inflammation at the proposed injection sites.
Maltese: Disturbi ġeneralizzati tal-attività tal-muskoli (eż. mijastenija gravi jew is-Sindrome ta' Eaton Lambert)
English: NUCEIVA Vs.
Maltese: NUCEIVA kontra
English: The anatomy and anatomical land marks of procerus corrugator supercilli muscles and the surrounding vasucular and nervous structures in the glabellar region must be understood prior to administration of NUCEIVA.
Maltese: riferiment anatomiċi tal-muskoli korrugatur, supercilli u tal-muskoli procerus u tal-istrutturi vaskulari u nervużi madwarhom fir-reġjun glabellari.
English: 4 Units
Maltese: Unitajiet (4
English: NUCEIVA is used for the temporary improvement in the appearance of vertical lines between the eyebrows.
Maltese: NUCEIVA jintuża għat-titjib temporanju fl-apparenza ta' linji vertikali bejn il-ħuġbejn.
English: How to store NUCEIVA 6.
Maltese: Kif taħżen NUCEIVA 6.
English: Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g. neuromuscular blocking medicinal products).
Maltese: Teoretikament, l-effett tat-tossina tal-botulinju jista' jkun potenzjat minn antibijotiċi aminoglikosidi, spektinomiċina, jew prodotti mediċinali oħra li jinterferixxu mat-trażmissjoni newromuskolari (eż. prodotti mediċinali li jimblukkaw is-sistema newromuskolari).
English: Undesirable effects of the substance class botulinum toxin type A
Maltese: Effetti mhux mixtieqa tas-sustanza tal-klassi tat-tossina tal-botulinju tat-tip A
English: Hypersensitivity reactions
Maltese: sensittività
English: NUCEIVA 100 Units powder for solution for injection
Maltese: NUCEIVA 100 Unità trab għal soluzzjoni għall-injezzjoni
English: There is a risk of eyelid ptosis following treatment (see section 4.2).
Maltese: Wara l-kura hemm riskju tal-iżvilupp ta' ptosi tal-kappell tal-għajnejn (ara sezzjoni 4.2).
English: Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided.
Maltese: Għandu jiġi evitat li l-injezzjoni tingħata fi strutturi anatomiċi vulnerabbli, bħalma huma n-nervituri u l-vażi tad-demm.
English: Note: Of the 1659 subjects treated with NUCEIVA, rare events occurred in 1 subject only.
Maltese: Nota: Mill-1659 individwu li ngħataw kura b'NUCEIVA, avvenimenti rari seħħew f'individwu wieħed 1 biss.
English: NUCEIVA 100 Units powder for solution for injection botulinum toxin type A
Maltese: NUCEIVA 100 Unità trab għal soluzzjoni għall-injezzjoni tossina tal-botulinju tat-tip A
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni tal-prodott mediċinali, ara s-sezzjoni 6.3. 6.5
English: A total of 922 patients participated in two 1 year open label uncontrolled studies, and over the course of these studies, the average patient received 3 treatments.
Maltese: Total ta' 922 pazjent ipparteċipaw f'żewġ studji mhux ikkontrollati b'tikketta miftuħa ta' sena 1, u matul dawn l-istudji, il-pazjent medju rċieva 3 trattamenti.
English: It is used in adults less than 65 years of age in whom those facial lines have an important psychological impact.
Maltese: Jintuża f'adulti ta' inqas minn 65 sena li fuqhom dawk il-linji tal-wiċċ għandhom impatt psikoloġiku importanti.
English: In the absence of adverse reactions during the initial treatment, an additional course of treatment can be performed subject to a minimum interval of 3 months between the initial and repeat treatment.
Maltese: Fin-nuqqas ta' reazzjonijiet avversi waqt il-kura inizjali, jista' jingħata kors ta' kura addizzjonali sakemm ikun hemm intervall minimu ta' 3 xhur bejn il-kura inizjali u dik ripetuta.
English: The recommended injection per muscle site is 4 U/0.1 mL.
Maltese: L-injezzjoni rakkomandata f'kull sit f'muskolu hija ta' 4 U/0.1 mL.
English: Muscle twitching, musculoskeletal pain, myalgia, neck pain
Maltese: Spażmi fil-muskoli, uġigħ muskoloskeletali, mijalġija, uġigħ flgħonq
English: Four Units (4 U/ 0.1 mL) are administered in each of the 5 injection sites (see Figure 1): 2 injections in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units.
Maltese: U/0.1 mL) jiġu injettati f'kull wieħed mill-5 siti ta' injezzjoni (ara l-Figura 1): Żewġ injezzjonijiet f'kull muskolu korrugatur (l-aspett medjali inferjuri u l-aspett medjali superjuri) u injezzjoni waħda fil-muskolu procerus għal doża totali ta' 20 unità.
English: Doses recommended in units are different from other botulinum toxin preparations.
Maltese: Id-dożi rrakkomandati f'unitajiet huma differenti minn preparazzjonijiet oħra tat-tossina tal-botulinju.
English: OTHER
Maltese: tnemnim
English: Responders for the Exploratory Efficacy Endpoint
Maltese: Rispondenti għall-Punt ta' Tmiem Esploratorju li
English: Resulting dose (Units per 0.1 mL)
Maltese: 4 Unitajiet/0.1 mL.
English: Muscle atrophy is expected after repeated botulinum treatment secondary to the flaccid paralysis of the treated muscles.
Maltese: Atrofija muskolari hija mistennija wara kura ripetuta bil-botulinju sekondarja għall-paraliżi mpaħpħa tal-muskoli trattati.
English: • Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
Maltese: • L-injezzjonijiet fil-korrugatur laterali għandhom isiru talanqas 1 cm 'il fuq mil-linja supraorbitali mgħaddma.
English: ≤1 (i.e., none or mild) Number Percentage >1 (i.e., moderate or severe) Number Percentage Glabellar Line Scale (GLS); 0=no lines, 1=mild, 2=moderate, 3=severe.
Maltese: Skala tal-Linji Glabellari (GLS) 0=l-ebda linja, 1=ħfief, 2=moderati, 3=severi
English: Package leaflet: Information for the user NUCEIVA 100 Units powder for solution for injection botulinum toxin type A
Maltese: Informazzjoni għall-utent NUCEIVA 100 Unità trab għal soluzzjoni għall-injezzjoni tossina tal-botulinju tat-tip A
English: Rarely occurring injection site events that have been reported include erythema, paraesthesia, pruritis, pain and tenderness.
Maltese: Avvenimenti rari li ġew irrapportati fis-sit tal-injezzjoni jinkludu eritema, parastesija, ħakk, uġigħ u sensittività.
English: There is no relevant use of NUCEIVA in the paediatric population.
Maltese: Ma hemm l-ebda użu rilevanti ta' NUCEIVA fil-popolazzjoni pedjatrika.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose; this means it is essentially ‘sodium- free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol ta' sodju (23 mg) f'kull doża, jiġifieri hija essenzjalment ‘ħielsa mis-sodju'.
English: Baseline GLS Category at Rest
Maltese: Kategorija GLS fil-linja bażi bil
English: Pack size of one.
Maltese: Pakkett ta' wieħed.
English: Vial (Type I glass) fitted with a stopper (chlorobutyl rubber) and a seal (aluminium).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Kunjett (ħġieġ tat-Tip I) b'tapp (gomma tal-klorobutil) u siġill (aluminju).
English: • Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
Maltese: • Uċuħ kontaminati għandhom jiġu mnaddfa b'materjal assorbenti mxarrab f'soluzzjoni ta' ipoklorit tas-sodju (soluzzjoni Javel) u mbagħad jiġu xxuttati.
English: Amount of diluent added to 100 Unit vial (sodium chloride 9 mg/ml (0.9%) solution for injection) 2.5 mL
Maltese: (soluzzjoni għall-injezzjoni ta' sodium chloride ta' 9 mg/ml (0.9 %) ) 2.5 mL
English: There are limited phase 3 clinical data with NUCEIVA in patients older than 65 years.
Maltese: Id-data klinika minn studji tal-fażi 3 b'NUCEIVA f'pazjenti ta' aktar minn 65 sena hija limitata.
English: Administration instructions for Glabellar Lines seen at maximum frown Reconstituted NUCEIVA (100 Units/2.5 mL) is injected using a sterile 30 gauge needle.
Maltese: Struzzjonijiet għall-għoti għal Linji Glabellari li jidhru f'kontrazzjoni massima tal-muskoli tal-ħuġbejn NUCEIVA rikostitwit (100 Unità/2.5 mL) jiġi injettat bl-użu ta' labra sterili b'gejġ ta' 30.
English: Table 3 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction for NUCEIVA Treated Subjects, by Baseline GLS Score at Maximum Contraction, ITT Population
Maltese: Glabellari ta' 0 (l-ebda linja) jew 1 (ħfief) f'Jum 30 minn Valutazzjoni tal-Investigatur f'Kontrazzjoni Massima għal Suġġetti li Ngħataw Kura b'NUCEIVA, skont il-Punteġġ GLS filLinja
English: CI)
Maltese: C.
English: Muscle atrophy
Maltese: Muskoli tal-Wiċċ Rilassati
English: Table 2 - Primary Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction, PP Population
Maltese: Glabellari ta' 0 (l-ebda linja) jew 1 (ħfief) f'Jum 30 minn Valutazzjoni tal-Investigatur f'Kontrazzjoni Massima, Popolazzjoni PP
English: You will be injected with the recommended volume of 0.1 millilitre (ml) (4 Units) of NUCEIVA into each of 5 injection sites.
Maltese: Ser tiġi injettat/a bil-volum rakkomandat ta' 0.1 millilitru (ml) (4 Unitajiet) ta' NUCEIVA f'kull wieħed mill-5 siti ta' injezzjoni.
English: NUCEIVA is not recommended for use in patients over 65 years of age.
Maltese: NUCEIVA mhuwiex rakkomandat għall-użu f'pazjenti ta' aktar minn 65 sena.
English: The potential impact of NUCEIVA on fertility has not been investigated in animals.
Maltese: L-impatt potenzjali ta' NUCEIVA fuq il-fertilità ma ġiex investigat fuq l-annimali.
English: Table 4 - Exploratory Efficacy Endpoint - Glabellar Line Scale Score of 0 (none) or 1 (mild) at Day 30 by Investigator Assessment at Maximum Contraction for NUCEIVA Treated Subjects, by Baseline GLS Categories at Rest, ITT Population
Maltese: Glabellari ta' 0 (l-ebda linja) jew 1 (ħfief) f'Jum 30 minn Valutazzjoni tal-Investigatur f'Kontrazzjoni Massima għal Suġġetti li Ngħataw Kura b' NUCEIVA, skont il-Kategoriji GLS fil-Linja Bażi bil-Muskoli tal-Wiċċ Rilassati, Popolazzjoni ITT