FrancophonIA/ELRC3.0 huggingface dataset:
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Maltese: Injezzjoni waħda taħt il-ġilda b'doża ta' 0.2 mg ta' meloxicam/kg ta' piż tal-ġisem (fi kliem ieħor 0.4 ml/10 kg ta' piż tal-ġisem).
English: Ceva Santé Animale - Z.I.
Maltese: Ceva Santé Animale - Z.I. Très le Bois - 22600
English: EU numbers Invented name Strengths Pharmaceutical Forms
Maltese: Numru ta' l-EU Isem inventat
English: Route of administration Packaging
Maltese: Daqs talpakkett
English: 0.75 mg/ml Solution for infusion
Maltese: Qawwa Għamla farmaċewtika
English: 2 mg/ml
Maltese: Mnejn jingħata
English: Packaging Content (concentration)
Maltese: 50 flixkun ta' doża (lajofiliżejt) u 50 flixkun ta' ml (solvent)
English: EMA/CHMP/774318/2018 EMEA/H/C/004682
Maltese: EMA/522792/2018 EMEA/H/C/004682
English: It is also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Maltese: Dan jintuża wkoll f'pazjenti li wirtu l-mutazzjoni F508del minn ġenitur wieħed u li għandhom ukoll waħda mill-mutazzjonijiet li ġejjin fis-CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Aktar informazzjoni fuq id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Each tablet contains 100 mg tezacaftor and 150 mg ivacaftor.
Maltese: Kull pillola fiha 100 mg tezacaftor u 150 mg ivacaftor.
English: Further information on Symkevi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Symkevi is available as tablets.
Maltese: Symkevi jiġi bħala pilloli.
English: Other information about Symkevi
Maltese: Informazzjoni oħra dwar Symkevi
English: As for all medicines, data on the use of Symkevi are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Symkevi hija ssorveljata kontinwament.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Maltese: Wara 24 ġimgħa ta' kura, il-pazjenti li ħadu l-mediċini kellhom żieda medja fil-FEV1 ta' 3.4 punti perċentwali meta mqabbel ma' tnaqqis ta' 0.6 punti perċentwali f'pazjenti li ħadu l-plaċebo.
English: What are the risks associated with Symkevi?
Maltese: X'inhuma r-riskji assoċjati ma' Symkevi?
English: Patients who took Symkevi and ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took ivacaftor alone and a reduction of 0.3 percentage points in patients who took placebo.
Maltese: Il-pazjenti li ħadu Symkevi u ivacaftor kellhom żieda medja fil-FEV1 ta' 6.5 punti perċentwali meta mqabbel ma' żieda ta' 4.4 punti perċentwali f'pazjenti li ħadu ivacaftor waħdu u tnaqqis ta' 0.3 punti perċentwali f'pazjenti li ħadu l-plaċebo.
English: Cystic fibrosis is rare, and Symkevi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 February 2017.
Maltese: Il-fibrożi ċistika hija rari, u Symkevi ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-27 ta' Frar 2017.
English: Lung function was measured after 4 weeks and 8 weeks of treatment.
Maltese: Il-funzjoni tal-pulmun tkejlet wara 4 ġimgħat u 8 ġimgħat ta' kura.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Maltese: Il-fibrożi ċistika hija kkawżata minn mutazzjonijiet fil-ġene CFTR.
English: One of the active substances in Symkevi, tezacaftor, increases the number of CFTR proteins on the cell surface and the other, ivacaftor, increases the activity of the defective CFTR protein.
Maltese: Waħda mis-sustanzi attivi f'Symkevi, tezacaftor, iżżid in-numru ta' proteini CFTR fuq il-wiċċ taċ-ċellola u l-oħra, ivacaftor, iżżid l-attività tal-proteina CFTR difettuża.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Maltese: Ilfibrożi ċistika hija marda ereditarja li għandha effetti severi fuq il-pulmuni, fuq is-sistema diġestiva u fuq organi oħrajn.
English: Symkevi is used in patients who have a mutation (change) called F508del in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Maltese: Symkevi jintuża f'pazjenti li għandhom mutazzjoni (bidla) imsejħa F508del fil-ġene għal proteina msejħa "regolatur tal-konduttanza transmembranja tal-fibrożi ċistika" (CFTR).
English: In the latter group, there is a lack of authorised therapies.
Maltese: terapiji awtorizzati.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Maltese: L-ewwel studju involva 510 pazjenti bil-fibrożi ċistika li wirtu l-mutazzjoni F508del miż-żewġ ġenituri.
English: Symkevi contains the active substances tezacaftor and ivacaftor.
Maltese: Symkevi fih is-sustanzi attivi tezacaftor u ivacaftor.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Maltese: It-tieni studju involva 248 pazjent bil-fibrożi ċistika li wirtu l-mutazzjoni F508del minn ġenitur wieħed u li għandhom ukoll mutazzjoni CFTR oħra.
English: Symkevi should be taken together with another medicine containing 150 mg ivacaftor alone.
Maltese: Symkevi għandu jittieħed flimkien ma' mediċina oħra li fiha 150 mg ivacaftor biss.
English: How does Symkevi work?
Maltese: Kif jintuża Symkevi?
English: What measures are being taken to ensure the safe and effective use of Symkevi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Symkevi?
English: The recommended daily dose is one tablet of Symkevi in the morning and one ivacaftor tablet (150 mg) in the evening, about 12 hours later.
Maltese: Id-doża rakkomandata ta' kuljum hija pillola waħda ta' Symkevi filgħodu u pillola waħda ta' ivacaftor (150 mg) filgħaxija, madwar 12-il siegħa wara.
English: In the former group, Symkevi could especially be a treatment option for those who cannot take a combination of ivacaftor and lumacaftor (another cystic fibrosis medicine), due to side effects or interactions with other medicines they are taking.
Maltese: Fl-ewwel grupp, Symkevi jista' jkun speċjalment għażla ta' kura għal dawk li ma jistgħux jieħdu kombinazzjoni ta' ivacaftor u lumacaftor (mediċina oħra għall-fibrożi ċistika), minħabba effetti sekondarji jew interazzjonijiet ma' mediċini oħra li jkunu qegħdin jieħdu.
English: This gene makes the CFTR protein, which works on the surface of cells to regulate the production of mucus and digestive juices.
Maltese: Dan il-ġene jipproduċi l-proteina CFTR, li taħdem fuq il-wiċċ taċ-ċelloli biex tirregola l-produzzjoni tal-mukus u l-likwidi diġestivi.
English: The doses of Symkevi and ivacaftor may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Maltese: Id-dożi ta' Symkevi u ivacaftor jistgħu jkunu jeħtieġu li jiġu aġġustati jekk il-pazjent ikun qiegħed jieħu wkoll tip ta' mediċina msejħa "inibitur ta' CYP3A moderat jew qawwi", bħal ċerti antibijotiċi jew mediċini għal infezzjonijiet fungali.
English: Symkevi taken together with ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above.
Maltese: Symkevi meħud flimkien ma' ivacaftor intwera li huwa effettiv biex itejjeb il-funzjoni tal-pulmun f'żewġ studji ewlenin ta' pazjenti bil-fibrożi ċistika li għandhom 12-il sena u aktar.
English: Symkevi is a medicine used to treat cystic fibrosis in patients aged 12 years and above.
Maltese: Symkevi huwa mediċina li tintuża biex tikkura fibrożi ċistika f'pazjenti li għandhom 12-il sena u aktar.
English: For the full list of side effects and restrictions with Symkevi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Symkevi, ara l-fuljett ta' tagħrif.
English: Symkevi is an effective treatment for patients with cystic fibrosis who have inherited the F508del mutation from both parents or patients who have the F508del mutation from one parent and certain other mutations.
Maltese: Symkevi huwa kura effettiva għal pazjenti bil-fibrożi ċistika li wirtu l-mutazzjoni F508del miż-żewġ ġenituri jew pazjenti li għandhom il-mutazzjoni F508del minn ġenitur wieħed u ċerti mutazzjonijiet oħra.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 July 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Lulju 2018
English: Further information on Sutent's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar l-użi attwali ta' Sutent tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Maltese: Is-sustanza attiva f'Sutent, is-sunitinib, hija inibitur tal-proteina kinażi.
English: What is Sutent?
Maltese: X'inhu Sutent?
English: Sutent has been authorised since July 2006 and contains the active substance sunitinib.
Maltese: Sutent ilu awtorizzat minn Lulju 2006 u fih is-sustanza attiva sunitinib.
English: • gastrointestinal stromal tumour (a cancer of the stomach and bowel);
Maltese: • tumuri stromali gastrointestinali (kanċer tal-istonku u tal-musrana);
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas);
Maltese: • tumuri newroendokrinali pankreatiċi (tumuri taċ-ċelloli li jipproduċu l-ormoni fil-frixa);
English: On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.
Maltese: Fis-26 ta' Ġunju 2018, Pfizer Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għallUżu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għall-estensjoni tal-użu ta' Sutent għall-kura ta' pazjenti f'riskju għoli li l-kanċer tal-kliewi jerġa' jitfaċċa wara kirurġija.
English: The company presented results of a main study comparing Sutent with placebo (a dummy treatment) in 615 patients at high risk of their kidney cancer coming back after surgery.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni li qabbel Sutent ma' plaċebo (kura finta) f'615-il pazjent f'riskju għoli li l-kanċer tal-kliewi tagħhom jerġa' jitfaċċa wara kirurġija.
English: What was Sutent expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Sutent?
English: How does Sutent work?
Maltese: Kif jaħdem Sutent?
English: Sutent is a cancer medicine currently authorised for treating the following cancers:
Maltese: Sutent huwa mediċina ta' kontra l-kanċer attwalment awtorizzata għall-kura tal-kanċers li ġejjin:
English: • metastatic renal cell carcinoma (kidney cancer that has spread to other parts of the body).
Maltese: • karċinoma metastatika taċ-ċelloli renali (kanċer tal-kliewi li jkun infirex għal partijiet oħra tal ġisem).
English: Based on the review of the data, at the time of the withdrawal, the CHMP had given a negative opinion, recommending that the marketing authorisation for Sutent not be changed to add the treatment of patients at high risk of kidney cancer returning after surgery.
Maltese: Abbażi tar-reviżjoni tad-data, fi żmien l-irtirar, is-CHMP kien ta opinjoni negattiva billi rrakkomanda li lawtorizzazzjoni għat-tqegħid fis-suq għal Sutent ma tinbidilx biex tiżdied il-kura ta' pazjenti f'riskju għoli li l-kanċer tal-kliewi jerġa' jitfaċċa wara kirurġija.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing because the data provided do not allow the CHMP to conclude that the benefit outweighs the risks.
Maltese: Fl-ittra li bagħtet lill-Aġenzija biex tgħarrafha bl-irtirar tal-applikazzjoni, il-kumpanija sostniet li kienet qiegħda tirtira minħabba li d-data pprovduta ma tippermettix lis-CHMP jikkonkludi li l-benefiċċju jegħleb ir-riskji.
English: This means that it blocks specific enzymes known as protein kinases that are involved in the growth and spread of cancer cells and the development of new blood vessels supplying them.
Maltese: Dan ifisser li timblokka enzimi speċifiċi magħrufa bħala proteini kinażi li huma involuti fit-tkabbir u fit-tixrid ta' ċelloli tal-kanċer u fliżvilupp ta' vażi tad-demm ġodda li jissupplixxuhom.
English: When data from patients at highest risk of cancer returning were looked at separately, the benefits of Sutent were still not convincing.
Maltese: Meta d-data minn pazjenti fl-ogħla riskju li l-kanċer tagħhom jerġa' jitfaċċa ġiet eżaminata separatament, il-benefiċċji ta' Sutent xorta kienu għadhom mhux konvinċenti.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Sutent in the treatment of patients at high risk of kidney cancer returning after surgery did not outweigh its risks.
Maltese: Għalhekk, fi żmien l-irtirar, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Sutent għall-kura ta' pazjenti f'riskju għoli li l-kanċer tal-kliewi tagħhom jerġa' jitfaċċa wara kirurġija ma kinux jegħlbu r-riskji tiegħu.
English: Adolescents and adults (>12 years old)
Maltese: Adolexxenti u adulti (>12-il sena)
English: Crospovidone type B Mannitol
Maltese: Crospovidone tip B Mannitol
English: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne France
Maltese: Centre Spécialités Pharmaceutiques 76-78 avenue du Midi 63800 Cournon d'Auvergne Franza
English: 10 to 15 kg:
Maltese: minn 10 sa 15il kg:
English: N=150 N=151 N=97
Maltese: N=151 N=97
English: Group I 1
Maltese: Grupp I 1
English: ORPHELIA Pharma SAS Teл.
Maltese: ORPHELIA Pharma SAS
English: 1 to 1.5 g/day
Maltese: 1 sa 1.5 g/jum
English: 0.5 x 100 mg tablet morning 0.5 x 100 mg tablet evening 0.5 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1 x 100 mg tablet evening 1 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 1.5 x 100 mg tablet evening 1.5 x 100 mg tablet morning 2 x 100 mg tablet evening 2 x 100 mg tablet morning 2 x 100 mg tablet evening 2.5 x 100 mg tablet morning 2.5 x 100 mg tablet evening 3 x 100 mg tablet morning 3 x 100 mg tablet evening 3.5 x 100 mg tablet morning 3.5 x 100 mg tablet evening 3.5 x 100 mg tablet morning 4 x 100 mg tablet evening 4.5 x 100 mg tablet morning 4.5 x 100 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg tablet evening 1 x 500 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening 30 1 x 500 mg and 1 x 100 mg tablet morning 1 x 500 mg and 1 x 100 mg tablet evening
Maltese: 1 x 100 mg pillola filgħodu 1 x 100 mg pillola filgħaxija 1 x 100 mg pillola filgħodu 1.5 x 100 mg pillola filgħaxija 1.5 x 100 mg pillola filgħodu 1.5 x 100 mg pillola filgħaxija 1.5 x 100 mg pillola filgħodu 2 x 100 mg pillola filgħaxija 2 x 100 mg pillola filgħodu 2 x 100 mg pillola filgħaxija 2.5 x 100 mg pillola filgħodu 2.5 x 100 mg pillola filgħaxija 3 x 100 mg pillola filgħodu 3 x 100 mg pillola filgħaxija 3.5 x 100 mg pillola filgħodu 3.5 x 100 mg pillola filgħaxija 3.5 x 100 mg pillola filgħodu 4 x 100 mg pillola filgħaxija 4.5 x 100 mg pillola filgħodu 4.5 x 100 mg pillola filgħaxija 1 x 500 mg pillola filgħodu 1 x 500 mg pillola filgħaxija 1 x 500 mg pillola filgħodu 1 x 500 mg u 1 x 100 mg pillola filgħaxija
English: D-22335 Hamburg Tel.: +49 (0) 40 591 01 0 E-Mail: epi.info@desitin.de
Maltese: +49 (0) 40 591 01 0 E-Mail: epi.info@desitin.de
English: Visual Field Defects (VFD)
Maltese: Difetti fil-Kamp Viżiv (Visual Field Defects, VFD)
English: Date of first authorisation: 20 September 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2018
English: Pharmacotherapeutic group: Antiepileptics, fatty acid derivatives, ATC code: N03AG04
Maltese: Antiepilettiċi, derivattivi tal-aċidu grass, Kodiċi ATC: N03AG04
English: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS France
Maltese: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS Franza
English: Resistant partial epilepsy (focal onset seizures)
Maltese: Epilessija parzjali reżistenti (aċċessjonijiet tal-bidu fokali)
English: The active substance is vigabatrin.
Maltese: - Is-sustanza attiva hi vigabatrin.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Maltese: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Monotherapy for infantile spasms (West's Syndrome)
Maltese: Monoterapija għal spażmi infantili (sindrome ta' West).
English: 10, rue Bouché Thomas ZAC d'Orgemont F-49000 Angers France
Maltese: 10, rue Bouché Thomas ZAC d'Orgemont F-49000
English: It may harm them, even if their signs of illness are the same as your child's.
Maltese: sigħat fit-trabi tat-twelid u fit-trabi, u siegħa fit-tfal.
English: Group III
Maltese: Grupp III
English: However, during controlled clinical studies, a gradual reduction of 16-33% in the plasma concentration of phenytoin has been observed.
Maltese: Madankollu, waqt studji kliniċi kkontrollati, ġie osservat tnaqqis gradwali ta' 16-33% fil-konċentrazzjoni ta' phenytoin fil-plażma.
English: Oral and gastric use.
Maltese: Użu orali u gastriku.
English: Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid).
Maltese: Vigabatrin huwa inibitur irriversibbli selettiv ta' GABA transaminase, l-enzima responsabbli għat tkissir tal-GABA (aċidu gamma-aminobutirriku).
English: Musculoskel etal and connective tissue disorders arthralgia
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja
English: Pharmacokinetic properties of vigabatrin have been investigated in groups of six neonates (age 1526 days), six infants (age 5-22 months) and six children (age 4.6-14.2 years) with refractory epilepsy.
Maltese: Il-proprjetajiet farmakokinetiċi ta' vigabatrin ġew investigati fi gruppi ta' sitt trabi tat-twelid (ta' età bejn 15 u 26 jum), sitt trabi (ta' bejn 5 xhur u 22 xahar) u sitt itfal (ta' bejn 4.6-14.2 snin) b'epilessija refrattorja.
English: Vigabatrin can cause permanent vision loss.
Maltese: Vigabatrin jista' jikkawża telf permanenti tal-vista.
English: Marketing Authorisation Holder ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS
Maltese: ORPHELIA Pharma SAS 85 boulevard Saint-Michel 75005 PARIS
English: Some patients may experience an increase in seizure frequency, including status epilepticus with vigabatrin.
Maltese: Ċerti pazjenti jistgħu jkollhom aktar aċċessjonijiet, inkluż status epilepticus b'vigabatrin.
English: These responses are delayed and reduced beyond the normal limits.
Maltese: Dawn irreazzjonijiet ikunu ttardjati u mnaqqsa aktar mil-limiti normali.
English: 500 mg tablet size: 16.0 mm x 9.0 mm
Maltese: Daqs ta' pillola ta' 500 mg: 16.0 mm x 9.0 mm
English: 100 mg tablet size: 9.4 mm x 5.3 mm
Maltese: Daqs ta' pillola ta' 100 mg: 9.4 mm x 5.3 mm
English: Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin therapy have VFDs.
Maltese: Id-data miġbura mill-istħarriġ ta' prevalenza tindika li daqs 1/3 tal-pazjenti li ngħataw terapija b'vigabatrin għandhom VFDs.
English: The mean Cl/F of active S-enantiomer of vigabatrin in infants and children was 0.591 l/h/kg and 0.446 l/h/kg respectively.
Maltese: enantiomer attiv ta' vigabatrin fit-trabi u fit-tfal kien 0.591 L/siegħa/kg u 0.446 L/siegħa/kgrispettivament.
English: Vigabatrin may lead to a decrease in measured plasma activity of alanine aminotransferase (ALT) and to a lesser extent, aspartate aminotransferase (AST).
Maltese: Vigabatrin jista' jwassal għal tnaqqis fl-attività tal-plażma mkejla tal-alanina aminotransferażi (ALT) u sa ċertu punt inqas, tal-aspartat aminotransferażi (AST).
English: As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome P450 metabolising-enzymes, interactions with other medicinal products are unlikely.
Maltese: Peress li vigabatrin la huwa metabolizzat u lanqas marbut mal-proteini u mhuwiex induttur ta' enzimi li jimmetabolizzaw iċ-ċitokroma epatiku P450, mhux probabbli li jkun hemm interazzjonijiet ma' prodotti mediċinali oħrajn.
English: Vigabatrin is eliminated via renal excretion with a terminal half-life of 5-8 hours.
Maltese: Vigabatrin jiġi eliminat permezz tat-tneħħija mill-kliewi b'nofs ħajja terminali ta' 5-8 sigħat.
English: Starting dose of 40 mg/kg/day
Maltese: 40 mg/kg/jum
English: In resistant partial epilepsy (focal onset seizures), the recommended starting dose is 40 milligrams per kilogram daily.
Maltese: Fl-epilessija parzjali reżistenti (aċċessjonijiet tal-bidu fokali), id-doża inizjali rakkomandata hija ta' 40 milligramma għal kull kilogramma kuljum.
English: Ös te rreich
Maltese: Doża inizjali ta'
English: Hepatic impairment
Maltese: Mediċini oħra u Kigabeq
English: The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been monitored during controlled clinical trials and no clinically significant interactions have been detected.
Maltese: Il-konċentrazzjonijiet ta' carbamazepine, phenobarbital, u sodium valproate fil-plażma ukoll ġew immonitorjati waqt provi kliniċi kkontrollati u ma nstabet ebda interazzjoni klinikament sinifikanti.
English: Method of administration
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: Proposed doses for second titration step (100 mg/kg/day) (Day 6)
Maltese: Dożi proposti għat-tieni pass ta' titrazzjoni (100 mg/kg/jum) (is-Sitt Jum)
English: Psychiatric disorders agitation, aggression, nervousness, depression, paranoid reaction hypomania, mania, psychotic disorder suicide attempt hallucination
Maltese: aggressjoni, nervi, dipressjoni, reazzjoni paranojdi ipomanija, manija, disturb psikotiku attentat ta'
English: Starting dose of 50 mg/kg/day
Maltese: 50 mg/kg/jum
English: Rarely seen events include suicide attempts, encephalopathy and retinal disorders.
Maltese: Avvenimenti li rarament jidhru huma attentati ta' suwiċidju, enċefalopatija u disturbi fir-retina.
English: Mean terminal half-life of vigabatrin was about 7.5 hours in neonates, 5.7 hours in infants and 5.5 hours in children.
Maltese: In-nofs ħajja terminali medja ta' vigabatrin kienet madwar 7.5 sigħat fit-trabi tat-twelid, 5.7 sigħat fit-trabi u 5.5 sigħat fit-tfal.
English: Kigabeq 100 mg soluble tablets EU/1/18/1302/001
Maltese: EU/1/18/1302/001 Kigabeq pillola li tinħall 100 mg EU/1/18/1302/002 Kigabeq pillola li tinħall500 mg
English: Laboratory data indicate that vigabatrin treatment does not lead to renal toxicity.
Maltese: Id-data tal-laboratorju tindika li t-trattament b'vigabatrin ma twassalx għal tossiċità tal-kliewi.
English: Pack size: 50 soluble tablets.
Maltese: Daqs tal-pakkett: 50 pillola li tinħall.
English: Group II 2
Maltese: Grupp II2
English: Oral clearance (Cl/F) of vigabatrin is approximately 7 l/h (i.e. 0.10 l/h/kg).
Maltese: Ittneħħija orali (Cl/F) ta' vigabatrin hija madwar 7 L/siegħa (jiġifieri 0.10
English: INFORMATION IN BRAILLE Kigabeq 500 mg
Maltese: Kigabeq 500 mg
English: No metabolites have been identified in plasma.
Maltese: Ma ġewx identifikati metaboliti fil-plażma.