FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Maltese: 3 Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 5.17 mmol/l) li żdiedu għal għoljin (≥
English: NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 20 mg orodispersible tablets Olanzapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 20 mg olanzapine
English: Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart.
Maltese: Sintomi oħra jistgħu jkunu: konfużjoni akuta, aċċessjonijiet (epilessija), koma, taħlita ta' dawn is-sintomi, deni, nifs aktar mgħaġġel, għaraq, ebusija tal-muskoli u ħedla jew ngħas, tnaqqis fil-frekwenza ta' nifsijiet,
English: NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 10 mg orodispersible tablets
Maltese: Olazax Disperzi 10 mg:
English: Abdominal distension9 Pancreatitis11
Maltese: Distonja (tinkludi okuloġirazzjoni)11 Diskineżja tardiva11
English: males and females females Gynaecomastia/breast enlargement in males General disorders and administration site conditions Asthenia Fatigue Oedema Pyrexia10
Maltese: Ginekomastija/tkabbir żejjed tas-sider fl-irġiel
English: Patients treated with any antipsychotic medicines, including olanzapine, should be observed for signs and symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus or with risk factors for diabetes mellitus should be monitored regularly for worsening of glucose control.
Maltese: Pazjenti kkurati b'mediċini antipsikotiċi, inkluż Olazax Disperzi, għandhom ikunu taħt osservazzjoni għal sinjali u sintomi ta' ipergliċemija (bħal polidipsja, polijurja, polifaġja u debbulizza) u pazjenti bid-dijabete mellitus jew li għandhom fatturi ta' riskju għad-dijabete mellitus għandhom jiġu segwiti b'mod regolari f'każ li l-kontroll tal-glukosju jmur għall-agħar.
English: Dysarthria Stuttering11
Maltese: kolestatiku jew tat-tnejn flimkien)11
English: The mean increase in olanzapine Cmax following fluvoxamine was 54 % in female nonsmokers and 77 % in male smokers.
Maltese: Iż-żjieda medja f'olanzapine Cmax wara t-teħid ta' fluvoxamine kienet 54% fin-nisa li ma jpejpux u 77% fl-irġiel li jpejpu.
English: Dementia-related psychosis and/or behavioural disturbances Olanzapine is not recommended for use patients with dementia-related psychosis and/or behavioural disturbances because of an increase in mortality and the risk of cerebrovascular accident.
Maltese: Olanzapine mhux irrakkomandat għall-użu f'pazjenti b'psikożi relatata mad-demenzja u/jew disturbi fil-komportament, dovut għal żieda fil-mortalità u r-riskju ta' inċident ċerebro-vaskulari.
English: Elderly A lower starting dose (5 mg/day) is not routinely indicated but should be considered for those 65 and over when clinical factors warrant (see section 4.4).
Maltese: Doża anqas tal-bidu (5 mg/ġurnata) mhux indikata normalment imma għandha tiġi kkunsidrata għal dawk li għandhom 65 jew fuqhom meta fatturi kliniċi jindikaw hekk (ara wkoll taqsima 4.4).
English: Mutagenicity
Maltese: Newtropenja
English: The daily dose of Olazax Disperzi is between 5 mg and 20 mg.
Maltese: Id-doża ta' kuljum ta' Olazax Disperzi hija bejn 5 mg u 20 mg.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 15 mg orodispersible tablets Olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 15 mg olanzapine.
English: In a co-therapy study of patients treated with lithium or valproate for a minimum of 2 weeks, the addition of olanzapine 10 mg (co-therapy with lithium or valproate) resulted in a greater reduction in symptoms of mania than lithium or valproate monotherapy after 6 weeks.
Maltese: ġimgħatejn, iż-żjieda ta' olanzapine 10 mg (terapija flimkien ma' lithium jew valproate) wara 6 ġimgħat irriżultat f'tnaqqis akbar tas-sintomi tal-manija milli b'monoterapija b'lithium jew b'valproate.
English: Mean infant exposure (mg/kg) at steady state was estimated to be 1.8 % of the maternal olanzapine dose (mg/kg).
Maltese: (mg/kg) medja fit-trabi fl-istat fiss kienet stimata li kienet 1.8% tad-doża ta' olanzapine fl-omm.
English: NN: {number}
Maltese: NN:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 10 mg orodispersible tablets Olanzapine STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg olanzapine.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg olanzapine.
English: Excipient with known effect: Each orodispersible tablet contains 0.69 mg aspartame For the full list of excipients see section 6.1
Maltese: Kull pillola li tinħall fil-ħalq fiha 0.69 mg ta' aspartame
English: Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death;; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains and prolonged and/or painful erection.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna) jinkludu titbaxxa t-temperatura normali tal-ġisem; ritmi mhux normali tal-qalb; mewt għall-għarrieda u inspjegabbli; infjammazjoni tal-frixa li tikkawża wġigħ qawwi fl-istonku, deni u taqlib; mard tal-fwied li jidher bħala sfurija tal ġilda u tal-abjad tal-għajnejn; mard fil-muskoli li jippreżenta ruħu bħala wġigħ li m'għandux spjegazzjoni; u erezzjoni mtawla u/jew bl-uġigħ.
English: Amenorrhea Breast enlargement Galactorrhea in
Maltese: Mewta kardijaka għal għarrieda
English: What Olazax Disperzi contains - The active substance is olanzapine - Each tablet contains 5 mg, 7.5 mg, 10 mg, 15 mg, or 20 mg olanzapine
Maltese: - Kull Olazax Disperzi pillola li tinħall fil-ħalq fiha 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg olanzapine - Is-sustanzi l-oħrajn huma mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
English: Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l - < 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Maltese: Innotat għal livelli normali waqt is-sawm fil-linja bażi (< 1.69 mmol/l) li żdiedu għal għoljin (≥
English: Tardive dyskinesia11
Maltese: Rabdomijoliżi11
English: Excipient with known effect: Each orodispersible tablet contains 0.46 mg aspartame For the full list of excipients see section 6.1
Maltese: Kull pillola li tinħall fil-ħalq fiha 0.46 mg ta' aspartame
English: Haematologic toxicity
Maltese: Tossiċità ematoloġika:
English: Excipient with known effect: Each orodispersible tablet contains 0.35 mg aspartame For the full list of excipients see section 6.1
Maltese: Kull pillola li tinħall fil-ħalq fiha 0.35 mg ta' aspartame
English: Changes in fasting triglycerides from borderline at baseline (≥ 1.69 mmol/l< 2.26 mmol/l) to high (≥ 2.26 mmol/l) were very common.
Maltese: < 2.26 mmol/l) għal għoljin (≥ 2.26 mmol/l) kienu komuni ħafna.
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Maltese: Sinjali kliniċi inkludew sedazzjoni, atassja,
English: 56 orodispersible tablets
Maltese: 56 pillola li tinħall fil-ħalq
English: Transient, asymptomatic elevations of hepatic aminotransferases , alanine transferase (ALT), aspartatetransferase (AST) have been seen commonly, especially in early treatment.
Maltese: Livelli għolja ta' aminotransferases tal-fwied, ALT, AST, temporanji u mingħajr sintomi kienu komuni, speċjalment fil-bidu tal-kura.
English: Elevated triglyceride levels
Maltese: GĦAMLA KWALITATTIVA
English: Neuroleptic malignant syndrome (see section
Maltese: Żieda fil-piż klinikament sinifikanti
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % verses 1.5 %, respectively).
Maltese: darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia).
Maltese: Każijiet rari li ġew rappurtati bħala NMS kienu rrappurtati f'assoċjazzjoni ma' olanzapine ukoll. Manifestazzjonijiet kliniċi ta' NMS huma deni għoli, ebusija tal-muskoli, stat mentali alterat u evidenza ta' instabbiltà awtonomika (pressjoni tad-demm jew tal-polz irregolari, takikardija, dijaforeżi,
English: Discontinuati on
Maltese: Disperzi.
English: In placebo-controlled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementia-related psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % vrs 1.5 %,
Maltese: Fi studji kliniċi kkontrollati bil-plaċebo (li damu minn 6 sa 12-il ġimgħa ), fuq pazjenti anzjani (età medja 78 sena) li kellhom psikożi relatata mad-demenzja u/jew disturbi fil-komportament, kien hemm żieda ta'
English: This may be harmful for people with phenylketonuria.
Maltese: It-tnaqqis gradwali tad-doża għandu jiġi kkunsidrat meta titwaqqaf olanzapine.
English: There is a risk of feeling drowsy when you are given Olazax Disperzi.
Maltese: Hemm ir-riskju li tħossok imħeddel meta tingħata Olazax Disperzi.
English: NAME OF THE MEDICINAL PRODUCT Olazax Disperzi 7.5 mg orodispersible tablets Olanzapine
Maltese: Olazax Disperzi 7.5 mg pilloli li jinħallu fil-ħalq
English: Olanzapine-treated patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated doses of haloperidol.
Maltese: Pazjenti kkurati b' olanzapine kellhom inċidenza tal-marda ta' Parkinson, ta' l-akatiżja u tad-distonja aktar baxxa ikkumparata ma' dożi titrati ta' haloperidol.
English: High Gamma Glutamyltransferase10 High uric acid 10
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: Intravenous use, subcutaneous use Vial (glass) 20 ml
Maltese: Kunjett (ħġieġ) 20 ml
English: Route of administration
Maltese: Mod ta' Amministra -zzjoni
English: EU (MA) Number Invented name
Maltese: Numru tal-UE Isem kummer ċjali
English: Not applicable
Maltese: Tiżmim
English: Dogs and cats
Maltese: Perjodu -ta'
English: EU/1/15/990/001 EU/1/15/990/002
Maltese: EU/1/15/990/002
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Santen Oy
English: The difference was not statistically significant (p=0.326).
Maltese: Iddifferenza ma kinitx statistikament sinifikanti (p=0.326).
English: 27 RUE DE LA LOMBARDIERE, ZI LA LOMBARDIERE 07100 ANNONAY
Maltese: 27 RUE DE LA LOMBARDIERE, ZI LA LOMBARDIERE 07100
English: SANTEN Oy Niittyhaankatu 20 33720 Tampere Finland
Maltese: SANTEN Oy Niittyhaankatu 20 33720 Tampere Il-Finlandja
English: Effects on the immune system
Maltese: Effetti fuq is-sistema immuni
English: Santen Tél: +33 (0) 1 70 75 26 84
Maltese: Tél: +33 (0) 1 70 75 26 84
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE ikervis
English: 0.3 mL
Maltese: OĦRAJN 0.3 mL
English: Luxembourg/Luxemburg
Maltese: Luxembourg/Luxemburg Santen Oy
English: 67 patients were enrolled (37.9% of the 177 patients having ended Sansika).
Maltese: Kienu rreġistrati 67 pazjent (37.9% ta' 177 pazjent li spiċċaw Sansika).
English: 5 single-dose containers.
Maltese: 5 kontenituri ta' doża waħda.
English: Date of first authorisation: 19 March 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwl awtorizzazzjoni: 19 ta' Marzu 2015
English: One mL of emulsion contains 0.05 mg cetalkonium chloride (see section 4.4).
Maltese: Ml wieħed ta' emulsjoni fih 0.05 mg ta' cetalkonium chloride (ara sezzjoni 4.4).
English: There is no data on the effects of IKERVIS on human fertility.
Maltese: M'hemmx dejta dwar l-effetti ta' IKERVIS fuq il-fertilità umana.
English: Pack sizes: 30 and 90 single-dose containers.
Maltese: Daqsijiet tal-pakkett: 30 u 90 kontenitur b'doża waħda.
English: Blood concentrations of IKERVIS were measured using a specific high-pressure liquid chromatography-mass spectrometry assay.
Maltese: Konċentrazzjonijiet fid-demm ta' IKERVIS kienu mkejla permezz ta' analiżi speċifika ta' high-pressure liquid chromatography-mass spectrometry.
English: EXCELVISION Rue de la Lombardière ZI la Lombardière
Maltese: Manifattur EXCELVISION Rue de la Lombardière ZI la Lombardière F-07100 Annonay
English: Santen Oy Tél/Tel : +32 (0) 24019172
Maltese: Tél/Tel : +32 (0) 24019172
English: Excipients: medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Maltese: Eċċipjenti: trigliċeridi ta' katina medja, cetalkonium chloride, glycerol, tyloxapol, poloxamer 188, sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: They are ranked according to system organ class and classified according to the following convention: 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), or not known (cannot be estimated from the available data).
Maltese: Huma kklassifikati skont il-klassi tas-sistemi u tal-organi u kklassifikati skont il-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), jew mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Santen Oy Tel: +421 (01) 23 332 5519
Maltese: Tel: +421 (01) 23 332 5519
English: The most common adverse reactions were eye pain (19.2%), eye irritation (17.8%), lacrimation (6.4%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.
Maltese: L-aktar reazzjonijiet avversi komuni kienu uġigħ flgħajnejn (19.2%), irritazzjoni fl-għajnejn (17.8%), dmugħ (6.4%), iperimija fl-għajnejn (5.5%) u eritema tal-kappell tal-għajn (1.7%) li ġeneralment kienu temporanji u seħħew waqt it-tqattir.
English: poloxamer 188, sodium hydroxide (to adjust pH) and water for injections.
Maltese: poloxamer 188, sodium hydroxide (għall-aġġustament tal-pH) u ilma għall-injezzjonijiet.
English: It is likely to be attributable to ciclosporin.
Maltese: Huwa probabbli li hija kkawżata minn ciclosporin.
English: Santen Oy Tel.: +36 (06) 16777305
Maltese: Tel.: +36 (06) 16777305
English: Santen Oy Tel: +371 677 917 80
Maltese: Tel: +371 677 917 80
English: A reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen-DR (HLADR) expression (an exploratory endpoint), was observed at Month 6 in favour of IKERVIS (p=0.021).
Maltese: Tnaqqis fl-infjammazzjoni tas-superfiċje tal-għajn evalwat bl-espressjoni tal-Antiġenu DR talLewkoċiti Umani (HLA-DR - Human Leukocyte Antigen-DR) kien osservat f'Xahar 6 favur IKERVIS (p=0.021).
English: To reduce the systemic absorption, see section 4.2.
Maltese: Biex jitnaqqas l-assorbiment sistemiku, ara sezzjoni 4.2.
English: SantenPharma AB Tlf: +45 78737843
Maltese: Tlf: +45 78737843
English: Santen Oy Tel: +420 234 102 170
Maltese: Tel: +420 234 102 170
English: Santen Oy Tel: +370 37 366628
Maltese: Tel: +370 37 366628
English: CLINICAL PARTICULARS 4.1 Therapeutic indication
Maltese: 4.1 Indikazzjoni terapewtika
English: SantenPharma AB Tlf: +47 21939612
Maltese: Tlf: +47 21939612
English: - The other ingredients are medium-chain triglycerides, cetalkonium chloride, glycerol, tyloxapol,
Maltese: - Is-sustanzi l-oħra huma trigliċeridi ta' katina medja, cetalkonium chloride, glycerol, tyloxapol,
English: After 6 months of ocular instillation of IKERVIS once per day, 327 patients had values below the lower limit of detection (0.050 ng/mL) and 35 patients were below the lower limit of quantification (0.100 ng/mL).
Maltese: Wara 6 xhur ta' tqattir ta' IKERVIS darba kuljum fl-għajnejn, 327 pazjent kellhom valuri taħt il-limitu l-aktar baxx ta' identifikazzjoni (0.050 ng/ml) u 35 pazjent kienu taħt il-limitu l-aktar baxx ta' kwantifikazzjoni (0.100 ng/mL).
English: IKERVIS contains the active ingredient, ciclosporin.
Maltese: X'fih IKERVIS - Is-sustanza attiva hi ciclosporin.
English: Ciclosporin has been shown to inhibit the production and/or release of pro-inflammatory cytokines, including interleukin 2 (IL-2) or T-cell growth factor (TCGF).
Maltese: Ciclosporin intwera li jinibixxi l-produzzjoni u/jew ir-reħa ta' ċitokini pro-infjammatorji, inkluż interleukin-2 (IL-2) jew il-fattur tat-tkabbir taċ-ċellula T (TCGF - T-cell growth factor).
English: This may result in a decrease in systemic undesirable effects and an increase in local activity (see section 4.4).
Maltese: Dan jista' jwassal għal tnaqqis fl-effetti mhux mixtieqa sistemiċi u żieda fl-attività lokali (ara sezzjoni 4.4).
English: The primary endpoint was the proportion of patients achieving by Month 6 at least a twograde improvement in keratitis (CFS) and a 30% improvement in symptoms, measured with the Ocular Surface Disease Index (OSDI).
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti li sa 6 xhur kisbu titjib ta' mill-inqas żewġ gradi filkeratite (CFS) u titjib ta' 30% fis-sintomi, imkejla permezz tal-Indiċi tal-Marda tas-Superfiċje talGħajn (OSDI - Ocular Surface Disease Index).
English: Santen Oy Tel: + 351 308 805 912
Maltese: Tel: +351 308 805 912
English: Patients spent more time on CFS grade 2 (Median 12.7 weeks/year) and grade 1 (Median 6.6 weeks/year) than CFS grade 3 (Median 2.4 weeks/year), CFS grades 4 and 5 (Median time 0 week/year).
Maltese: Il-pazjenti qatgħu aktar ħin b'CFS ta' grad 2 (medjan 12.7 ġimgħat/sena) u grad 1 (Medjan 6.6 ġimgħat/sena) minn CFS ta' grad 3 (Medjan 2.4 ġimgħat/sena), u CFS ta' grad 4 u 5 (ħin Medjan 0 ġimgħat/sena).
English: Santen Oy Tel: +31 (0) 207139206
Maltese: Tel: +31 (0) 207139206
English: Mechanism of action and pharmacodynamic effects Ciclosporin (also known as ciclosporin A) is a cyclic polypeptide immunomodulator with immunosuppressant properties.
Maltese: Ciclosporin (magħruf ukoll bħala ciclosporin A) huwa immunomodulatur polipeptid ċikliku bi kwalitajiet immunosoppressivi.
English: Uncommon Keratitis bacterial, herpes zoster ophthalmic.
Maltese: Keratite kkawżata minn batterja, herpes zoster fl-għajnejn.
English: Santen Oy Tel: +43 (0) 720116199
Maltese: Tel: +43 (0) 720116199
English: It is supplied in single-dose containers made of a low-density polyethylene (LDPE).
Maltese: Huwa fornut f'kontenituri ta' doża waħda magħmula minn polyethylene ta' densità baxxa (LDPE - low-density polyethylene).
English: In the 12 month, double-masked, vehicle controlled, pivotal clinical trial (SANSIKA study), 246 Dry Eye Disease (DED) patients with severe keratitis (defined as a corneal fluorescein staining (CFS) score of 4 on the modified Oxford scale) were randomised to one drop of IKERVIS or vehicle daily at bedtime for 6 months.
Maltese: Fil-prova klinika pivitali ta' 12-il xahar, double-masked u kkontrollata bil-likwidu mingħajr mediċina (studju SANSIKA), 246 pazjent bil-Marda tal-Għajnejn Xotti (DED - Dry Eye Disease) b'keratite severa (definita bħala punteġġ ta' tlewwin tal-kornea permezz ta' fluorescein (CFS- corneal fluorescein staining) ta' 4 fuq l-iskala modifikata ta' Oxford) kienu randomised għal qatra waħda ta' IKERVIS jew tal-likwidu mingħajr mediċina darba kuljum qabel l-irqad għal 6 xhur.
English: Sodium hydroxide (to adjust pH) Water for injections
Maltese: Sodium hydroxide (għall-aġġustament tal-pH)
English: Santen Oy Tel: + 353 (0) 16950008
Maltese: Tel: +353 (0) 16950008
English: Suomi/Finland
Maltese: Suomi/Finland Santen Oy
English: 30 single-dose containers 90 single-dose containers
Maltese: 30 kontenitur b'doża waħda 90 kontenitur b'doża waħda
English: The mean change from baseline in the 100-point OSDI score was -13.6 with IKERVIS and -14.1 with vehicle at Month 6 (p=0.858).
Maltese: Il-bidla medja mil-linja bażi fil-punteġġ OSDI ta' 100 punt kienet ta' -13.6 b'IKERVIS u ta' -14.1 billikwidu mingħajr mediċina f'Xahar 6 (p=0.858).
English: Combination with other medicinal products that affect the immune system Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of ciclosporin on the immune system (see section 4.4).
Maltese: Kombinazzjoni ma' prodotti mediċinali oħra li jaffettwaw is-sistema immuni L-għoti ta' IKERVIS flimkien ma' qtar għall-għajnejn li fihom kortikosterojdi jista' jsaħħaħ l-effetti ta' ciclosporin fuq is-sistema immuni (ara sezzjoni 4.4).
English: Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections.
Maltese: Pazjenti li jirċievu terapiji immunosoppressivi, inkluż ciclosporin, għandhom riskju akbar ta' infezzjonijiet.
English: Santen Oy Τηλ: + 358 (0) 3 284 8111
Maltese: Τηλ: +358 (0) 3 284 8111
English: Medium-chain triglycerides Cetalkonium chloride Glycerol
Maltese: Trigliċeridi ta' katina medja Cetalkonium chloride
English: IKERVIS is supplied in 0.3 mL single-dose, low-density polyethylene (LDPE) containers presented in a sealed laminate aluminium pouch.
Maltese: IKERVIS huwa fornut f'kontenituri ta' 0.3 mL b'doża waħda magħmula minn polyethylene ta' densità baxxa (LDPE - low-density polyethylene) ippreżentati f'borża żgħira tal-aluminju laminata u ssiġillata.
English: Seven patients had measurable values (from 0.105 to 1.27 ng/mL), all considered to be negligible values.
Maltese: Seba' pazjenti kellhom valuri li setgħu jitkejlu (minn 0.105 sa 1.27 ng/mL), kollha meqjusa bħala valuri negliġibbli.
English: No significant changes have been observed in the other secondary endpoints (TBUT, lissamine green staining and Schirmer test, NEI-VFQ and EQ-5D) over the course of the extension study.
Maltese: Matul il-kors tal-istudju ta' estensjoni ma kienx osservat tibdil sinifikanti fil-punti finali sekondarji loħra (TBUT, lissamine green staining u t-test Schirmer, NEI-VFQ u EQ-5D).
English: Other medicines and IKERVIS
Maltese: Mediċini oħra u IKERVIS
English: The mean change from baseline in ocular discomfort score (assessed using a Visual Analogic Scale) was -12.82 with IKERVIS and -11.21 with vehicle (p=0.808).
Maltese: Il-bidla medja mil-linja bażi fil-punteġġ ta' skonfort fl-għajn (stmata bl-użu ta' Skala Analoġika Viżiva) kienet ta' -12.82 b'IKERVIS u ta' -11.21 bil-likwidu mingħajr mediċina (p=0.808).
English: The median global VAS score increased from the time treatment was first stopped (23.3%) to the time treatment was restarted (45.1%).
Maltese: Il-punteġġ globali medjan ta' VAS żdied minn meta t-trattament twaqqaf għall-ewwel darba (23.3%) sa meta t-trattament inbeda mill-ġdid (45.1%).
English: Uncommon Conjunctival oedema, lacrimal disorder, eye discharge, eye pruritus, conjunctival irritation, conjunctivitis, foreign body sensation in eyes, deposit eye, keratitis, blepharitis, corneal decompensation, chalazion, corneal infiltrates, corneal scar, eyelid pruritus, iridocyclitis.
Maltese: Edima fil-konġuntiva, disturb fid-dmugħ, nixxija millgħajn, ħakk fl-għajn, irritazzjoni fil-konġuntiva, konġuntivite, sensazzjoni ta' oġġett barrani fl-għajnejn, depożitu fl-għajn, keratite, blefarite, dikumpensazzjoni tal-kornea, kalażjon, infiltrati fil-kornea, ċikatriċi filkornea, ħakk fil-kappell tal-għajn, iridoċiklite.
English: Ophthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies.
Maltese: Prodotti mediċinali għall-għajnejn, li jaffettwaw is-sistema immuni, inkluż ciclosporin, jistgħu jaffettwaw id-difiża tal-ospitanti kontra infezzjonijiet lokali u kontra tumuri malinni.
English: • Twist off the cap (picture 1).
Maltese: • Neħħi l-għatu billi ddawwar (stampa 1).