FrancophonIA/ELRC3.0 huggingface dataset:
English: *Including all allergic reactions within 12 hours after asparaginase infusion and all adverse events with CTCAE terms syncope (fainting), hypotension, rash, flushing, pruritus, dyspnoea, injection site reaction or airway obstruction within 24 hours after asparaginase infusion
Maltese: * Tinkludi r-reazzjonijiet allerġiċi kollha fi żmien 12-il siegħa wara l-infużjoni ta' asparaginase u l-avvenimenti avversi kollha bit-termini CTCAE sinkope (ħass ħażin), pressjoni baxxa, raxx, fwawar, ħakk, qtugħ ta' nifs, reazzjoni fis-sit tal-injezzjoni jew ostruzzjoni fil-passaġġ tal-arja fi żmien 24 siegħa wara l-infużjoni ta' asparaginase
English: The metabolism of asparaginase is not known but thought to occur via degradation within the reticulohistiocytic system and by serum proteases.
Maltese: Il-metaboliżmu ta' asparaginase mhuwiex magħruf iżda hu maħsub li jseħħ permezz ta' degradazzjoni fis-sistema retikuloistijoċitika u mill-proteases fis-serum.
English: Data on efficacy and safety of Spectrila in adults are limited.
Maltese: Dejta dwar l-effikaċja u s-sigurtà ta' Spectrila fl-adulti huma limitati.
English: Handling
Maltese: LISTA
English: Not evaluable
Maltese: U KWANTITATTIVA
English: Spectrila 10,000 U powder for concentrate for solution for infusion
Maltese: Spectrila 10,000 U trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: • History of pancreatitis, serious haemorrhage or serious thrombosis with prior asparaginase therapy.
Maltese: • Storja medika ta' pankreatite, emorraġija serja jew trombożi serja b'terapija b'asparaginase fil-passat
English: Glucocorticoids
Maltese: Disturbi tal-koagulazzjoni
English: To aid traceability of rASNase batches and distinction between different ASNase and rASNase products, the product information should include in section 4.4 of the SmPC and relevant section of the PL a prominent statement that the name and batch number of the administered product should be clearly recorded in the patient records.
Maltese: Biex tgħin it-traċċabilità ta' lottijiet ta' rASNase u d-distinzjoni bejn prodotti differenti ta' ASNase u rASNase, l-informazzjoni tal-prodott għandha tinkludi fis-sezzjoni 4.4 tal-SmPC u fis-sezzjoni rilevanti tal-PL, dikjarazzjoni prominenti li l-isem u n-numru tal-lott tal-prodott mogħti għandhom ikunu rreġistrati b'mod ċar fir-rekords tal-pazjent.
English: Adverse central nervous system reactions observed in patients treated with asparaginase-containing therapy protocols include changes in EEG, seizures, dizziness, somnolence, coma and headache.
Maltese: Reazzjonijiet avversi tas-sistema nervuża ċentrali osservati f'pazjenti kkurati bi protokolli ta' terapija li jkun fihom asparaginase, jinkludu tibdil fl-EEG, aċċessjonijiet, sturdament, ngħas, koma u wġigħ ta' ras.
English: No anti-asparaginase antibodies were detected in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Maltese: Ma ġew osservati l-ebda antikorpi anti-asparaginase f'ħadd mit-12-il tarbija li kellhom < 1 sena matul il-kura bi Spectrila (studju MC-ASP.6/INF).
English: • high blood levels of amylase and lipase
Maltese: • livelli għoljin ta' amylase u lipase fid-demm
English: Frequency and symptom
Maltese: Frekwenza u sintomu
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Maltese: Il-kwantità kkalkulata ta' asparaginase, tinħall b'mod addizzjonali f'minn 50 sa 250 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: Acquired or genetically decreased physiologic coagulation inhibitors (protein C, protein S, antithrombin) are also described in relation to vascular complications.
Maltese: Inibituri tal-koagulazzjoni fiżjoloġika akkwistati jew ġenetikament imnaqqsa (proteina Ċ, proteina S, antithrombin) huma wkoll deskritti fir-rigward ta' kumplikazzjonijiet vaskulari.
English: Reference asparaginase
Maltese: Asparaginase ta' referenza
English: The reconstituted solution is stable for 2 days when stored at 2 °C - 8 °C.
Maltese: Is-soluzzjoni rikostitwita hi stabbli għal jumejn meta tinħażen f'temperatura ta' 2°C - 8°C.
English: • Medicines which are metabolised in the liver, because the risk of side effects may increase.
Maltese: • Mediċini li jiġu metabolizzati fil-fwied, minħabba r-riskju ta' effetti sekondarji, jistgħu jiżdiedu.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for asparaginase (centrally authorised product), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal asparaginase (prodott awtorizzat ċentralment), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Chemical and physical in-use stability has been demonstrated for 2 days at 2 °C - 8 °C.
Maltese: JIS: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal jumejn f'temperatura ta' 2°C - 8°C.
English: Tremor
Maltese: Tilqim
English: • decreased function of the thyroid gland or the parathyroid glands
Maltese: • tnaqqis fil-funzjoni tal-glandola tat-tirojde jew tal-glandoli tal-paratirojde
English: Spectrila is for administration by intravenous infusion only.
Maltese: Spectrila jingħata bħala injezzjoni ġo vina.
English: Frequent evaluation of coagulation parameters is important before and during asparaginase treatment.
Maltese: Evalwazzjoni frekwenti tal-parametri tal-koagulazzjoni hi importanti qabel u waqt il-kura b'asparaginase.
English: • Pre-existing known coagulopathy (e.g. haemophilia).
Maltese: • Koagulopatija magħrufa li kienet teżisti minn qabel (eż. emofilija).
English: It is usually given with other anti-cancer medicines.
Maltese: Normalment jingħata ma' mediċini oħrajn kontra l-kanċer.
English: Hypersensitivity including flushing, rash, hypotension, oedema/angioedema, urticaria, dyspnoea Common
Maltese: Sensittività eċċessiva li tinkludi fwawar, raxx, pressjoni baxxa, edema/anġjoedema, urtikarja, qtugħ ta' nifs Komuni
English: Thrombosis especially cavernous sinus thrombosis or deep vein thrombosis, haemorrhage
Maltese: • reazzjoni allerġika serja li tikkawża diffikultà biex tieħu n-nifs jew sturdament,
English: Treatment is symptomatic and supportive.
Maltese: Il-kura hi sintomatika u ta' appoġġ.
English: The mean ± SD terminal half-life (elimination half-life) of asparaginase activity in serum was 25.8 ± 9.9 h, with a range between 14.2 and 44.2 h.
Maltese: Il-medja ± SD tal-half-life terminali (half-life tal-eliminazzjoni) tal-attività ta' asparaginase fis-serum kienet ta' 25.
English: Caution is therefore needed when anticoagulants (e.g. coumarin, heparin, dipyridamole, acetylsalicylic acid or nonsteroidal anti-inflammatory medicinal products) or glucocorticoids are given at the same time.
Maltese: Għalhekk, il-kawtela hi meħtieġa meta antikoagulanti (eż. coumarin, eparina, dipyridamole, acetylsalicylic acid jew prodotti mediċinali antiinfjammatorji mhux sterojdi) jew glukokortikojdi jingħataw fl-istess ħin.
English: There have been reports of transitory secondary hypothyroidism probably caused by a decrease in the serum thyroxin-binding globulin due to asparaginase-induced protein synthesis inhibition.
Maltese: Kien hemm rapporti ta' ipotirojdiżmu sekondarju temporanju, probabbilment ikkawżat minn tnaqqis fil-globulina li teħel ma' thyroxin fis-serum minħabba inibizzjoni tas-sintesi tal-proteini indotta minn asparaginase.
English: Laboratory in vitro and in vivo data indicate that the efficacy of high-dose cytarabine is reduced by prior administration of asparaginase.
Maltese: Dejta tal-laboratorju in vitro u in vivo tindika li l-effikaċja ta' doża għolja ta' cytarabine titnaqqas millgħoti ta' qabel ta' asparaginase.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 10,000 units of asparaginase*.
Maltese: Kull kunjett fih 10,000 unità ta' asparaginase*.
English: Concomitant use of glucocorticoids and/ or anticoagulants with asparaginase may increase the risk of a change in coagulation parameters (see section 4.4).
Maltese: L-użu fl-istess ħin ta' glukokortikojdi u/jew antikoagulanti ma' asparaginase jista' jżid ir-riskju ta' tibdil fil-parametri tal-koagulazzjoni (sezzjoni 4.4).
English: Clinical symptoms include abdominal pain, nausea, vomiting and anorexia.
Maltese: Is-sintomi kliniċi jinkludu wġigħ addominali, dardir, rimettar u anoreksja.
English: • seizures, severe impairment of consciousness including coma, and stroke
Maltese: • aċċessjonijiet, indeboliment sever ta' koxjenza li jinkludu koma u puplesija
English: General
Maltese: Jena
English: • feeling sick (nausea), being sick (vomiting), stomach ache or watery stools (diarrhoea)
Maltese: • tħossok imqalla' (dardir), tiremetti, uġigħ fl-istonku jew ippurgar maħlul (dijarea)
English: Each pack contains either 1 or 5 vials.
Maltese: Kull pakkett fih jew 1 jew 5 kunjetti.
English: • Hypersensitivity to the active substance, any native (non-pegylated) E. coli-asparaginase preparation or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, kwalunkwe preparazzjoni nattiva (mhux pegilata) ta'
English: Symptomatic thromboses related to the use of central venous catheters have been described, too.
Maltese: Trombożijiet sintomatiċi relatati mal-użu ta' kateters venużi ċentrali ġew deskritti wkoll.
English: Reversible posterior leukoencephalopathy syndrome Reversible posterior leukoencephalopathy syndrome (RPLS) may occur rarely during treatment with any asparaginase.
Maltese: Is-sindrome ta' lewkoenċefalopatija posterjuri riversibbli (RPLS) jista' jseħħ b'mod rari matul il-kura bi kwalunkwe asparaginase.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C - 8 °C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax immedjatament, iż-żmien tal-ħażna waqt l-użu u l-kundizzjonijiet ta' qabel l-użu huma rresponsabbiltà tal-utent, u normalment ma jkunux itwal minn 24 siegħa f'temperatura ta' 2°C - 8°C, ħlief jekk ir-rikostituzzjoni/dilwizzjoni ma tkunx saret f'kundizzjonijiet asettiċi kkontrollati u vverifikati.
English: After reconstitution each ml contains 2,500 units of asparaginase.
Maltese: Wara r-rikostituzzjoni, kull ml ikun fih 2,500 unità ta' asparaginase.
English: • changes in the electroencephalogram (a trace of the electrical activity of your brain)
Maltese: • tibdil fl-elettroenċefalogramma (sinjal li juri l-attività elettrika tal-moħħ tiegħek)
English: All 12 patients (100 %) were in CR after induction treatment.
Maltese: It-12-il pazjent kollha (100%) kienu f'nuqqas komplet ta' mard (completre remission, CR) wara l-kura ta' induzzjoni.
English: These patients should no longer be treated with any asparaginase preparation (see also sections 4.3 and 4.8).
Maltese: Dawn il-pazjenti m'għandhomx jibqgħu jiġu kkurati bi kwalunkwe preparazzjoni ta' asparaginase (ara wkoll sezzjonijiet 4.3 u 4.8).
English: In clinical trials with asparaginase, trough asparaginase serum activity levels greater than 100 U/l were achieved in the majority of patients which nearly always correlated with a complete depletion of asparagine in serum and cerebrospinal fluid (CSF).
Maltese: Relazzjoni(jiet) farmakokinetika/farmakodinamika Fil-provi kliniċi b'asparaginase, l-inqas livelli ta' attività ta' asparaginase fis-serum akbar minn 100
English: • Glucocorticoids (anti-inflammation medicines that dampen down your immune system) since the simultaneous use of glucocorticoids and asparaginase may increase the formation of blood clots (thrombosis).
Maltese: • Glukokortikojdi (mediċini kontra l-infjammazzjoni li jdagħjfu lis-sistema immunitarja tiegħek) minħabba li l-użu fl-istess ħin ta' glukokortikojdi u asparaginase jista' jżid il-formazzjoni talemboli tad-demm (trombożi).
English: Spectrila should be prescribed and administered by physicians and health care personnel experienced in the use of antineoplastic products.
Maltese: Spectrila għandu jiġi preskritt u jingħata minn tobba u staff fil-qasam mediku b'esperjenza fl-użu ta' prodotti antineoplastiċi.
English: Because of a higher frequency of comorbidities such as liver and/or renal impairment, patients > 55 years of age usually tolerate asparaginase treatment worse than paediatric patients.
Maltese: Minħabba frekwenza ogħla ta' komorbiditajiet bħal indeboliment tal-fwied u/jew tal-kliewi, pazjenti ta' > 55 sena normalment jittolleraw kura b'asparaginase agħar minn pazjenti pedjatriċi.
English: Since Spectrila is usually used in combination therapy with other antineoplastic agents, the demarcation from undesirable effects of other medicinal products is often difficult.
Maltese: Billi Spectrila normalment jintuża f'terapija kombinata flimkien ma' sustanzi antineoplastiċi oħrajn, id-demarkazzjoni minn effetti mhux mixtieqa ta' prodotti mediċinali oħrajn ta' spiss tkun diffiċli.
English: Thereafter, asparagine serum levels increased again and returned to normal values within 1 - 3 weeks.
Maltese: Wara dan, il-livelli ta' asparagine fisserum reġgħu żdiedu u marru lura għall-valuri normali f' 1 - 3 ġimgħat.
English: Therefore, vincristine should be given 3 to 24 hours before administration of asparaginase in order to minimise toxicity.
Maltese: Għalhekk, vincristine għandu jingħata minn 3 sa 24 siegħa qabel l-għoti ta' asparaginase sabiex tiġi mminimizzata t-tossiċità.
English: In addition to asparagine, asparaginase is also able to cleave the amino acid glutamine to glutamic acid and ammonia, however with much less efficiency.
Maltese: Minbarra asparagine, asparaginase hu kapaċi wkoll li jifred l-amino acid glutamine għal glutamic acid u ammonia, madankollu b'ħafna inqas effiċjenza.
English: A few cases of asparaginase-induced parotitis have been reported in the literature.
Maltese: Ftit każijiet ta' parotite indotta minn asparaginase ġew irrappurtati fil-letteratura.
English: MRD status at end of induction treatment MRD negative
Maltese: Status ta' MRD fit-tmiem tal-kura ta' induzzjoni
English: Hyperglycaemic conditions
Maltese: Indeboliment tal-kliewi
English: G20210A-variation, methylenetetrahydrofolate reductase [MTHFR] T677T-genotype, increased lipoprotein A, hyperhomocysteinaemia).
Maltese: Biex jinħall il-kontenut, ilkunjett jiddawwar bil-mod (biex tiġi evitata l-formazzjoni ta' ragħwa minħabba ċ-ċaqliq bis-saħħa).
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Maltese: Il-kwantità kkalkulata ta' asparaginase, tinħall b'mod addizzjonali f'minn 50 sa 250 ml ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni.
English: Hepatic steatosis
Maltese: Steatożi tal-fwied
English: • if you have severe liver function problems,
Maltese: • jekk għandek problemi severi fil-funzjoni tal-fwied,
English: BATCH NUMBER
Maltese: Numru ta' pazjenti
English: Mild to moderate changes in blood lipid values (e.g. increased or decreased cholesterol, increased triglyceride, increased VLDL fraction and decreased LDL, increased lipoprotein lipase activity) are very commonly observed in patients treated with asparaginase, which in most cases present without clinical symptoms.
Maltese: Tibdil minn ħafif sa moderat fil-valuri tal-lipidi fid-demm (eż. żieda jew tnaqqis fil-kolesterol, żieda fit-triglycerides, żieda fil-frazzjoni ta' VLDL u tnaqqis f'LDL, żieda fl-attività ta' lipoprotein lipase), jiġi osservat b'mod komuni ħafna f'pazjenti kkurati b'asparaginase, li fil-biċċa l-kbira tal-każijiet, jidhru mingħajr sintomi kliniċi.
English: Pancreatitis with fatal outcome, pancreatic pseudocyst
Maltese: Pankreatite b'riżultat fatali, psewdoċista fil-frixa Disturbi fil-fwied u fil-marrara Rari
English: • blood clotting disorders such as bleeding, disseminated intravascular coagulation (DIC) or formation of blood clots (thrombosis),
Maltese: • disturbi fit-tagħqid tad-demm bħal emorraġija, koagulazzjoni intravaskulari mifruxa (DIC) jew il-formazzjoni ta' emboli tad-demm (trombożi),
English: Similarly to adults, the recommended dose in children and adolescents aged 1 - 18 years is 5,000 U per m² BSA given every third day.
Maltese: Bħal f'adulti, id-doża rakkomandata fit-tfal u fl-adolexxenti li għandhom 1 - 18-il sena hi ta' 5,000 U kull m² BSA mogħtija kull tielet jum.
English: • If you get any side effects, talk to your doctor or nurse.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew l-infermier tiegħek.
English: Symptoms of RPLS essentially include elevated blood pressure, seizures, headaches, changes in mental state and acute visual impairment (primarily cortical blindness or homonymous hemianopsia).
Maltese: Sintomi ta' RPLS essenzjalment jinkludu pressjoni għolja tad-demm, aċċessjonijiet, uġigħ ta' ras, tibdil fl-istat mentali u indeboliment akut tal-vista (l-aktar, għama kortikali jew emjanopsija omonima).
English: • feeling of tiredness
Maltese: • uġigħ ta' ras
English: Since an indirect interaction between components of the oral contraception and asparaginase cannot be ruled out, oral contraceptives are not considered sufficiently safe in such clinical situation (see section 4.6).
Maltese: Billi interazzjoni indiretta bejn il-komponenti tal-kontraċezzjoni orali u asparaginase ma tistax tiġi eskluża, il-kontraċettivi orali mhumiex ikkunsidrati li huma siguri biżżejjed f'sitwazzjoni klinika bħal din (ara sezzjoni 4.6).
English: Very common Hyperglycaemia, hypoalbuminaemia
Maltese: Sindrome ta' lewkoenċefalopatija posterjuri riversibbli
English: The powder is white and it is supplied in a clear glass vial with a rubber stopper and an aluminium seal and a plastic flip-off cap.
Maltese: It-trab hu abjad u jiġi fornut f'kunjett ta' ħġieġ ċar b'tapp tal-lastku u siġill tal-aluminju, u għatu flipoff tal-plastik.
English: Additionally it may decrease insulin secretion from pancreatic β-cells and impair insulin receptor function.
Maltese: Barra minn hekk, jista' jnaqqas it-tnixxija tal-insulina minn ċelluli β pankreatiċi u jindebbolixxi l funzjoni tar-riċetturi tal-insulina.
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni):
English: Uncommon side effects (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna):
English: Preferably, levels should be measured three days after the last asparaginase administration, i.e. usually directly before the next dose of asparaginase is given.
Maltese: Preferibbilment, il-livelli għandhom jitkejlu tliet ijiem wara laħħar għoti ta' asparaginase, i.e. normalment dritt qabel ma tingħata d-doża li jmiss ta' asparaginase.
English: Uncommon Hyperuricaemia, hyperammonaemia
Maltese: Mhux komuni Iperuriċemija, iperammonaemija
English: The daily amount of asparaginase needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.
Maltese: L-ammont ta' kuljum ta' asparaginase meħtieġ għal kull pazjent jista' jiġi dilwit f'volum finali ta' 50 - 250 ml sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni.
English: • hyperglycaemic conditions.
Maltese: • Żomm dan il-fuljett.
English: Hypoalbuminaemia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Hyperglycaemia and hypoglycaemia
Maltese: X'inhu Spectrila u għalxiex jintuża
English: The daily amount of Spectrila needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Maltese: L-ammont ta' kuljum ta' Spectrila meħtieġ għal kull pazjent jista' jiġi dilwit f'volum finali ta' 50250 ml sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-infużjoni.
English: No allergic reactions were observed in any of the 12 infants < 1 year of age during treatment with Spectrila (study MC-ASP.6/INF).
Maltese: Ma ġew osservati l-ebda reazzjonijiet allerġiċi f'ħadd mit-12-il tarbija li kellhom <1 sena matul il-kura bi Spectrila (studju MC-ASP.6/INF).
English: Complete asparagine depletion in serum Yes
Maltese: Numru ta' pazjenti Tnaqqis komplet ta' asparagine fis-serum
English: This syndrome is characterised in magnetic resonance imaging (MRI) by reversible (from a few days to months) lesions/oedema, primarily in the posterior region of the brain.
Maltese: Dan is-sindrome jiġi kkaratterizzat fil-magnetic resonance imaging (MRI) minn leżjonijiet/edema riversibbli (minn ftit jiem sa xhur), l-aktar fir-reġjun ta' wara tal-moħħ.
English: Marketing Authorisation Holder and Manufacturer medac
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur medac
English: As a result of impaired protein synthesis, the serum protein level (especially albumin) decreases very commonly in patients treated with asparaginase (see section 4.4).
Maltese: B'riżultat tal-indeboliment tas-sintesi tal-proteini, il-livell ta' proteini fis-serum (speċjalment albumina), jonqos b'mod komuni ħafna f'pazjenti kkurati b'asparaginase (ara sezzjoni 4.4).
English: Inhibition of protein synthesis secondary to the asparaginase-induced depletion of asparagine has been shown to attenuate the cytotoxic effect of MTX which requires cell replication for its antineoplastic activity.
Maltese: Minn aspett mikrobijoloġiku, il-prodott għandu jintuża immedjatament.
English: Section 6 - Contents of the pack and other information
Maltese: Taqsima 6 - Kontenut tal-pakkett u informazzjoni oħra
English: For EpiPen/Nepipe and associated names
Maltese: Għal EpiPen/Nepipe u ismijiet assoċjati
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: Il-Fuljett ta' Tagħrif jista jiġi aġġornat sussegwentement mill-awtoritajiet kompetenti tal-Istat Membru, bi qbil mal-Istat Membru ta' Riferiment, kif jixraq, b'mod konformi mal-proċeduri stabbiliti f'Kapitlu 4 ta' Titlu III ta' Direttiva 2001/83/KE.
English: In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Maltese: Fin-nuqqas ta' titjib kliniku jew jekk ikun hemm deterjorament, tista' tingħata t-tieni injezzjoni b'[isem ivvintat] addizzjonali bejn 5 minuti sa 15-il minuta wara l-ewwel injezzjoni.
English: All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Maltese: Il-pazjenti kollha li huma ordnati [Isem ivvintat] għandhom jingħataw istruzzjonijiet sew biex jifhmu l-indikazzjonijiet għall-użu u l-mod korrett ta' amministrazzjoni (ara sezzjoni 6.6).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: Anness III Emendamenti għas-sezzjonijiet relevanti tas-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif
English: Section 6.5 - Nature and contents of container [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Maltese: Taqsima 6.5 - In-natura tal-kontenitur u ta' dak li hemm ġo fih [Din it-taqsima għandha tiġi emendata biex tirrifletti d-daqs tal-labra espost tal-apparat] [Għandu jitlesta fil-pajjiż stess]
English: [The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
Maltese: [L-MAH(s) għandu jipprovdi dijagramma aħjar fl-istruzzjonijiet għal użu billi jżid id-daqs u jiżgura li turi b'mod ċar li l-injezzjoni għanda tkun fil-parti antero-laterali tal-koxxa]
English: Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Maltese: Taqsima 4.2 - Pożoloġija u metodu ta' kif għandu jingħata [Din it-taqsima għandha tiġi emendata biex tirrifletti l-kliem li ġej]