FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose limiting toxicities included skin ulcerations, surface exudates, and acanthosis in the rat and chronic active inflammation and degeneration of the oesophagus associated with varying degrees of gastroenteropathy in dogs.
Maltese: Tossiċitajiet li jillimitaw id-doża kienu jinkludu ulċerazzjoni tal-ġilda, effużjonijiet fis-superfiċje, u akantożi fil-far u infjammazzjoni kronika attiva u deġenerazzjoni talesofagu assoċjati ma' gradi varji ta' gastroenteropatija li fil-klieb.
English: In vitro data indicate cobimetinib is not an inhibitor of OAT1, OAT3 or OCT2.
Maltese: Dejta in vitro tindika li cobimetinib mhux inibitur ta' OAT1, OAT3 jew OCT2.
English: Study GO28141 is a multi-centre, randomised, double-blind, placebo-controlled, Phase III study to evaluate the safety and efficacy of Cotellic in combination with vemurafenib as compared to vemurafenib plus placebo, in previously untreated patients with BRAF V600 mutation-positive unresectable locally advanced (Stage IIIc) or metastatic melanoma (Stage IV).
Maltese: III, b'aktar minn ċentru wieħed, randomised, double-blind u kkontrollat bil-plaċebo, biex jevalwa s-sigurtà u l-effikaċja ta' Cotellic flimkien ma' vemurafenib meta mqabbel ma' vemurafenib flimkien mal-plaċebo, f'pazjenti li ma kinux ikkurati qabel b'melanoma avanzata lokalment li ma tistax titneħħa (Stadju IIIc) jew metastatika (Stadju IV) pożittiva għall mutazzjoni BRAF V600.
English: The objective response rate (ORR) in the Cotellic plus vemurafenib arm was 67.6% vs 44.8% in the placebo plus vemurafenib arm.
Maltese: valur p = 0.0003). Ir-rata ta' rispons oġġettiv (ORR - objective response rate) fil-grupp ta' Cotellic flimkien ma' vemurafenib kienet ta' 67.6% kontra 44.8% fil-grupp ta' plaċebo flimkien ma' vemurafenib.
English: The 1-year (75 %) and 2-year (48 %) OS estimates for the Cotellic plus vemurafenib arm were greater than those for placebo plus vemurafenib arm (64 % and 38 % respectively).
Maltese: L-istimi ta' OS ta' sena (75 %) u sentejn (48 %) għall-grupp ta' Cotellic flimkien ma' vemurafenib kienu akbar minn dawk għall-grupp tal-plaċebo flimkien ma' vemurafenib (64 % u 38 %
English: Very Common
Maltese: Normali
English: 3rd Appearance
Maltese: ANNESS III
English: Recommended Cotellic daily dose
Maltese: Doża rakkomandata ta' Cotellic
English: NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets
Maltese: Cotellic 20 mg pilloli miksija b'rita
English: The median PFS for BRAFi-naïve patients was 13.8 months, with median follow-up time of 20.6 months.
Maltese: PFS medjana għall-pazjenti li qatt ma ħadu BRAFi qabel kienet ta' 13.8 xhur, bi żmien medjan ta' segwitu ta' 20.6 xhur.
English: Batch
Maltese: Bojod
English: Cutaneous squamous cell carcinoma has been reported with a lower frequency in the Cotellic plus vemurafenib arm vs placebo plus vemurafenib arm (all Grade: 3% vs 13%).
Maltese: Cotellic flimkien ma' vemurafenib kontra l-grupp tal-plaċebo flimkien ma' vemurafenib (kull Grad: 3% kontra 13%).
English: Women of childbearing potential should be advised to use two effective contraceptive methods, such as a condom or other barrier method (with spermicide, if available) during treatment with Cotellic and for at least three months following treatment discontinuation.
Maltese: kontraċezzjoni, bħal kondom jew metodu ieħor ta' barriera (bi spermiċida, jekk disponibbli) waqt ilkura b'Cotellic u għal mill-inqas tliet xhur wara t-twaqqif tal-kura.
English: Serous retinopathy can be managed with treatment interruption, dose reduction or with treatment discontinuation (see Table 1 in section 4.2).
Maltese: Retinopatija seruża tista' tiġi mmaniġġjata permezz ta' interruzzjoni tal-kura, tnaqqis fid-doża jew waqfien tal-kura (ara Tabella 1 f'sezzjoni 4.2).
English: Grade 3 liver laboratory abnormalities should be managed with vemurafenib treatment interruption or dose reduction.
Maltese: Anormalitajiet ta' grad 3 fit-testijiet tal-laboratorju tal-fwied għandhom jiġu mmaniġġjati permezz ta' interruzzjoni tal-kura b'vemurafenib jew tnaqqis fid-doża.
English: Grade 2 (intolerable) or Grade ≥3 non-acneiform or maculopapular rash: Cotellic dosing can be continued without modification if clinically indicated.
Maltese: Raxx mhux akniformi jew makulopapulari ta' Grad 2 (intollerabbli) jew ta' Grad ≥3: Id-dożaġġ ta' Cotellic jista' jitkompla mingħajr modifikazzjoni jekk indikat klinikament.
English: The majority of events were Grades 1 or 2, with Grade ≥3 events occurring in 4% of patients in the Cotellic plus vemurafenib arm vs 0% in the placebo plus vemurafenib arm.
Maltese: Il-maġġoranza talavvenimenti kienu ta' Grad 1 jew 2, b'avvenimenti ta' Grad ≥3 jseħħu f'4% tal-pazjenti fil-grupp ta'
English: Following intravenous administration of a 2 mg dose of cobimetinib, the mean plasma clearance (CL) was 10.7 L/hr.
Maltese: Mortalità seħħet f'annimali frieħ b'doża (3 mg/kg) li ma wasslitx għall-mortalità f'annimali adulti.
English: No clinical DDI studies have been conducted to assess this finding, and clinically relevant inhibition of intestinal BCRP cannot be ruled out.
Maltese: Ma saru l-ebda studji kliniċi ta' DDI biex tiġi evalwata din issejba, u inibizzjoni klinikament rilevanti ta' BCRP intestinali ma tistax tiġi eskluża.
English: This can be a sign of muscle damage (rhabdomyolysis) (see also “Muscle problems” in Section 4).
Maltese: Dan jista' jkun sinjal ta' ħsara fil-muskoli (rabdomajolisi) (ara wkoll “Problemi fil-muskoli” f'iezzjoni 4).
English: Signs or symptoms of rhabdomyolysis warrant an appropriate clinical evaluation and treatment as indicated, along with Cotellic dose modification or discontinuation according to the severity of the adverse reaction (see section 4.2 and 4.4).
Maltese: Sinjali jew sintomi ta' rabdomajolisi jeħtieġu evalwazzjoni klinika xierqa u trattament kif indikat, kif ukoll modifikazzjoni fid-doża ta' Cotellic jew waqfien skont is-severità tar-reazzjoni avversa (ara sezzjoni 4.2 u 4.4).
English: LVEF value
Maltese: TAGĦRIF
English: Left ventricular dysfunction
Maltese: Disfunzjoni tal-ventriklu tax-xellug
English: Changes in reported laboratory data
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The median PFS for patients who had progressed on vemurafenib was 2.8 months, with median follow-up time of 8.1 months.
Maltese: PFS medjana għall-pazjenti li kellhom progressjoni fuq vemurafenib kienet ta' 2.8 xhur, bi żmien ta' segwitu medjan ta' 8.1 xhur.
English: Grade 3 and 4 CPK elevations, including asymptomatic elevations over baseline, also occurred in patients receiving Cotellic with vemurafenib in clinical trials (see section 4.8).
Maltese: F'pazjenti li kienu qed jirċievu Cotellic flimkien ma' vemurafenib fi provi kliniċi kien hemm ukoll żidiet ta' CPK ta' grad 3 u 4, inklużi żidiet bla sintomi 'l fuq mil-linja bażi (ara sezzjoni 4.8).
English: The sequencing of treatments following progression on a BRAF inhibitor therapy has not been established.
Maltese: L-issekwenzjar ta' trattamenti wara progressjoni waqt terapija b'inibitur ta' BRAF ma ġiex stabbilit.
English: Cotellic dosing can be continued without modification.
Maltese: Id-dożaġġ ta' Cotellic jista' jitkompla mingħajr modifikazzjoni.
English: * Please refer to the paragraph Haemorrhage in the “Description of selected adverse reactions” section ** Please refer to the paragraph Cutaneous squamous cell carcinoma, keratoacanthoma and hyperkeratosis in the “Description of selected adverse reactions” section.
Maltese: * Jekk jogħġbok irreferi għall-paragrafu Emorraġija fis-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” ** Jekk jogħġbok irreferi għall-paragrafu Karċinoma taċ-ċelluli skwamużi tal-ġilda, keratoakantoma u iperkeratożi fis-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: For Grade 1 and 2 liver laboratory abnormalities, Cotellic and vemurafenib should be continued at the prescribed dose.
Maltese: Għal anormalitajiet tal-laboratorju tal-fwied ta' Grad 1 u 2, Cotellic u vemurafenib għandhom jitkomplew bid-doża preskritta.
English: The primary analysis for Study GO28141 was conducted with a data cut-off date of 09 May 2014.
Maltese: L-analiżi primarja għall-Istudju GO28141 twettqet b'data meta waqqfet tinġabar id-dejta ta' 09 ta'
English: Based on a population pharmacokinetic analysis, gender, race, ethnicity, baseline ECOG, mild and moderate renal impairment did not affect the pharmacokinetic of cobimetinib.
Maltese: Ibbażat fuq analiżi tal-farmakokinetika tal-popolazzjoni, sess, razza, etniċità, ECOG fil-linja bażi,
English: Dose modification advice for left ventricular dysfunction Permanent discontinuation of Cotellic treatment should be considered if cardiac symptoms are attributed to Cotellic and do not improve after temporary interruption.
Maltese: Għandu jiġi kkunsidrat twaqqif permanenti tal-kura b'Cotellic jekk is-sintomi kardijaċi huma attribwiti għal Cotellic u ma jitjibux wara interruzzjoni temporanja.
English: If during treatment the QTc exceeds 500 msec, please refer to the vemurafenib SmPC sections 4.2 and
Maltese: Jekk matul it-trattament il-QTc jaqbeż il-500 msec, jekk jogħġbok irreferi għas-sezzjonijiet 4.2 u 4.4 tal-SmPC ta' vemurafenib.
English: Vemurafenib dosing can be continued when Cotellic treatment is modified.
Maltese: Vemurafenib jista' jitkompla meta t-trattament b'Cotellic jiġi modifikat.
English: The effects of Cotellic in people younger than 18 years old are not known.
Maltese: L-effetti ta' Cotellic f'persuni iżgħar minn 18il sena mhumiex magħrufa.
English: Vemurafenib dosing can be continued when Cotellic treatment is modified (if clinically indicated).
Maltese: Id-dożaġġ ta' vemurafenib jista' jitkompla meta l-kura ta' Cotellic tiġi modifikata (jekk indikat klinikament).
English: Rhabdomyolysis has been reported in patients receiving Cotellic (see section 4.8).
Maltese: Tnaqqis fl-LVEF mil-linja bażi kien irrappurtat f'pazjenti li kienu qed jirċievu Cotellic (ara sezzjoni 4.8).
English: Global health status / health-related quality of life by patient-report were measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30).
Maltese: Rapport tal-istat globali tas-saħħa / kwalità tal-ħajja relatata mas-saħħa skont il-pazjent ġew imkejla bl-użu tal-Kwestjonarju tal-Kwalità tal-Ħajja EORTC - Core 30 (QLQ-C30).
English: Rhabdomyolysis and CPK elevations
Maltese: Intolleranza għal-lactose
English: Oxidation by CYP3A and glucuronidation by UGT2B7 appear to be the major pathways of cobimetinib metabolism.
Maltese: Bijotrasformazzjoni Ossidazzjoni permezz ta' CYP3A u glukuronidazzjoni permezz ta' UGT2B7 jidrhu li huma r-rotot ewlenin tal-metaboliżmu ta' cobimetinib.
English: If you stop taking Cotellic
Maltese: Doża ta' kuljum rakkomandata ta' Cotellic
English: Liver value abnormalities should be monitored by liver laboratory tests before initiation of combination treatment and monthly during treatment, or more frequently as clinically indicated (see section 4.2).
Maltese: Anormalitajiet fil-valuri tal-fwied għandhom jigu ssorveljati permezz ta' testijiet tal-fwied tallaboratorju qabel tinbeda l-kura kombinata u kull xahar waqt il-kura, jew aktar spiss kif indikat klinikament (ara sezzjoni 4.2).
English: Recommended Cotellic dose modification
Maltese: Funzjoni tad-Distribuzzjoni tas-Sopravivenza
English: Pyrexia, Chills
Maltese: FULJETT TA' TAGĦRIF
English: Vemurafenib treatment can be continued when Cotellic treatment is modified, if clinically indicated.
Maltese: Kura b'vemurafenib tista' titkompla meta tiġi modifikata l-kura b'Cotellic, jekk ikun indikat klinikament.
English: · It is used in combination with another anti-cancer medicine called vemurafenib.
Maltese: Jintuża flimkien ma' mediċina oħra kontra l-kanċer imsejħa vemurafenib. ·
English: nefadozone for depression amiodarone for an uneven heartbeat diltiazem, verapamil for high blood pressure imatinib for cancer carbamazepine, phenytoin for fits (seizures)
Maltese: nefadozone għad-dipressjoni amiodarone għal taħbit tal-qalb irregolari diltiazem, verapamil għall-pressjoni għolja imatinib għall-kanċer carbamazepine, phenytoin għall-aċċessjonijiet
English: c
Maltese: g
English: Manage Grade 4 liver laboratory abnormalities with treatment interruption, dose reduction or with treatment discontinuation of both Cotellic and vemurafenib (see section 4.2).
Maltese: Immaniġġja anormalitajiet tal-laboratorju tal-fwied ta' Grad 4 b'interruzzjoni tat-trattament, tnaqqis fid-doża jew bi twaqqif tat-trattament kemm ta' Cotellic kif ukoll ta' vemurafenib (ara sezzjoni 4.2).
English: Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Very common (may affect more than 1 in 10 people) · increased skin sensitivity to sunlight · skin rash · feeling sick (nausea) · fever · chills · increased liver enzymes (shown in blood tests) · abnormal blood test results related to creatine phosphokinase, an enzyme found mainly in heart, brain and skeletal muscle · vomiting · skin rash with a flat discoloured area or raised bump like acne · high blood pressure · anaemia (a low level of red blood cells) · bleeding · abnormal thickening of the skin.
Maltese: M'hemm l-ebda evidenza ta' xi interazzjoni bejn mediċina u oħra klinikament sinifikanti bejn cobimetinib u vemurafenib f'pazjenti b'melanoma li ma tistax titneħħa jew metastatika u għalhekk mhux rakkomandat aġġustament fid-doża.
English: Cotellic targets a protein called “MEK” that is important in controlling cancer cell growth.
Maltese: Cotellic jimmira proteina msejħa “MEK” li hija importanti fil-kontroll tat-tkabbir taċ-ċelluli talkanċer.
English: Includes both chorioretinopathy and retinal detachment events indicative of serous retinopathy (see section 4.4) b Combined figure includes reports of photosensitivity reaction, sunburn, solar dermatitis, actinic elastosis
Maltese: Ċifra kkombinata tinkludi rapporti ta' reazzjoni ta' fotosensittività, ħruq mix-xemx, dermatite solari, elastożi aktinika
English: Film-coated tablet.
Maltese: fid-doża ta' Cotellic.
English: When administered to pregnant rats, cobimetinib caused embryolethality and foetal malformations of the great vessels and skull at systemic exposures similar to human exposure at recommended dose.
Maltese: Meta ngħata lil firien tqal, cobimetinib ikkawża mewt tal-embriju u malformazzjonijiet tal-kanali lkbar u tal-kranju fil-fetu b'esponimenti sistemiċi simili għall-espożizzjoni fil-bniedem bid-doża rakkomandata.
English: Cobimetinib plus Vemurafenib (n = 247)
Maltese: Vemurafenib + Cobimetinib (N = 247) Vemurafenib + Plaċebo (N = 248)
English: Mild CYP3A inhibitors: Cobimetinib can be co-administered with mild inhibitors of CYP3A without dose adjustment.
Maltese: Inibituri moderati ta' CYP3A (see sezzjoni 4.4.): Għandu jkun hemm kawtela jekk cobimetinib jingħata flimkien ma' inibituri moderati ta' CYP3A.
English: In juvenile rats, cobimetinib administration resulted in similar changes as seen in the pivotal toxicity studies in adults, including reversible degenerative changes in the thymus and liver, decreased spleen and thyroid/parathyroid weights, increased phosphorus, bilirubin and red blood cell mass and decreased triglycerides.
Maltese: F'firien frieħ, l-għoti ta' cobimetinib wassalgħal bidliet simili għal dawk osservati fl-istudji pivitali dwar l-effett tossiku fl-adulti, inkluż bidliet deġenerattiv riversibbli fit-timu u fil-fwied, piż tal-milsa u tat-tirojde/paratirojde imnaqqas, żieda fil fosfru, bilirubina u fil-massa taċ-ċelluli ħomor tad-demm u tnaqqis fit-trigliċeridi.
English: The median estimate for investigator-assessed PFS was 9.9 months for the Cotellic plus vemurafenib arm vs. 6.2 months for the placebo plus vemurafenib arm.
Maltese: L-istima medjana ta' PFS evalwata mill-investigatur kienet ta' 9.9 xhur għall-grupp ta' Cotellic flimkien ma' vemurafenib kontra 6.2 xhur għall-grupp ta' plaċebo flimkien ma' vemurafenib.
English: Table 1 below gives general Cotellic dose modification guidance.
Maltese: Tabella 1 taħt tagħti gwida ġenerali dwar modifikazzjoni fid-doża ta' Cotellic.
English: The majority of events were Grade 1 or 2 and non-serious.
Maltese: Il-maġġoranza tal-avvenimenti kienu ta' Grad 1 jew 2 u ma kinux serji.
English: Dose adjustment is not recommended for mild to moderate renal impairment based on the results of the population pharmacokinetic analysis.
Maltese: indeboliment ħafif u moderat tal-kliewi ma affettwawx il-farmakokinetika ta' cobimetinib.
English: Table 3 lists adverse reactions considered associated with the use of Cotellic.
Maltese: Tabella 3 telenka r-reazzjonijiet avversi kkunsidrati bħala marbuta mal-użu ta' Cotellic.
English: For strong CYP3A inhibitors used short-term (7 days or less), consider interrupting cobimetinib therapy during the duration of inhibitor use.
Maltese: Għal inibituri qawwija ta' CYP3A użati għal żmien qasir (7 ijiem jew inqas), ikkunsidra interruzzjoni tat-terapija ta'
English: The fraction absorbed was ~88% indicating high absorption and first pass metabolism.
Maltese: 88% li jindika assorbiment għoli u metaboliżmu tal-ewwel passaġġ.
English: What Cotellic looks like and contents of the pack Cotellic film-coated tablets are white, round with “COB” debossed on one side.
Maltese: Id-dehra ta' Cotellic u l-kontenuti tal-pakkett Cotellic pilloli miksija b'rita huma bojod, tondi b'“COB” imnaqqxa fuq naħa waħda.
English: Cotellic is not recommended for children and adolescents.
Maltese: Cotellic mhuwiex rakkomandat għal tfal u adolexxenti.
English: Grade ≤3: After rhabdomyolysis has been ruled out, Cotellic dosing does not need to be modified.
Maltese: Grad ≤3: Wara li tkun ġiet eskluża rabdomijolisi, id-dożaġġ ta' Cotellic m'għandux għalfejn jiġi modifikat.
English: See the end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 dwar kif għandhom jiġu rappurtati effetti sekondarji.
English: Take the medicine package and this leaflet with you.
Maltese: Ħu l-pakkett tal-mediċina u dan ilfuljett miegħek.
English: The safety and efficacy of Cotellic in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cotellic fit-tfal u l-adolexxenti b'età inqas minn 18-il sena ma ġewx stabbiliti.
English: On average, 94% of the dose was recovered within 17 days.
Maltese: Bħala medja, 94% tad-doża kienet irkuprata fi żmien 17-il ġurnata.
English: Dose modification advice for haemorrhage
Maltese: Modifikazzjoni rakkomandata fid-doża ta'
English: Package leaflet: Information for the patient Cotellic 20 mg film-coated tablets cobimetinib
Maltese: Waqqaf il-kura sa Grad ≤ 1, ibda l-kura mill-ġdid b'20 mg darba kuljum (pillola waħda)
English: Scores for all functioning domains and most symptoms (appetite loss, constipation, nausea and vomiting, dyspnoea, pain, fatigue) showed that the mean change from baseline was similar between the two treatment arms and did not demonstrate a clinically meaningful change (all scores were ≤ 10 point change from baseline).
Maltese: Punteġġi għad-dominji funzjonali kollha u l-biċċa l-kbira tas-sintomi (telf t'aptit, stitikezza, dardir u rimettar, qtugħ ta' nifs, uġigħ, għeja) urew li l-bidla medja mil-linja bażi kienet simili bejn iż-żewġ gruppi ta' kura u ma wrewx bidla klinikament sinifikanti (il-punteġġi kollha kienu bidla ta' ≤ 10 punti mil-linja bażi).
English: EU (MA) Number
Maltese: Numru ta' l-EU (MA) Isem (ivvintat)
English: 12 September 2013
Maltese: 12 ta' Settembru 2013
English: What is Targocid?
Maltese: X'inhu Targocid?
English: Targocid is an antibiotic that contains the active substance teicoplanin.
Maltese: Targocid huwa antibijotiku li fih is-sustanza attiva teicoplanin.
English: On 30 May 2013, the European Medicines Agency completed a review of Targocid.
Maltese: Fit-30 ta' Mejju 2013, l-Aġenzija Ewropa għall-Mediċini temmet reviżjoni ta' Targocid.
English: The Committee also harmonised other sections of the SmPC, including sections 4.3 (contraindications), 4.5 (interactions with other medicines), 4.6 (use in pregnancy and breast feeding), 4.8 (undesirable effects), 5.1 (pharmacodynamic properties), 5.2 (pharmacokinetic properties) and 5.3 (preclinical safety data).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħra tal-SmPC, fosthom is-sezzjonijiet 4.3 (kontraindikazzjonijiet), 4.5 (interazzjoni ma' prodotti mediċinali oħra), 4.6 (użu fit-tqala u ttreddigħ), 4.8 (effetti mhux mixtieqa), 5.1 (proprjetajiet farmakodinamiċi), 5.2 (tagħrif farmakokinetiku) u 5.3 (tagħrif ta' qabel l-użu kliniku dwar is-sigurtà).
English: • peritonitis (inflammation of the peritoneum, the membrane lining the abdominal cavity) in patients undergoing ‘continuous ambulatory peritoneal dialysis';
Maltese: • peritonite (infjammazzjoni tal- peritonew, il-membrana li tiksi l-kavità addominali) f'pazjenti li għaddejjin minn ‘dijaliżi peritoneali ambulatorja kontinwa';
English: Targocid is also available in the EU under other trade names: Targosid, Teicomid.
Maltese: Targocid huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħra: Targosid, Teicomid.
English: The active substance, teicoplanin, is one of a group of antibiotics known as glycopeptides.
Maltese: Is-sustanza attiva, teicoplanin, hija waħda minn grupp ta' antibijotiċi magħrufa bħala glikopeptidi.
English: Targocid was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Targocid kien identifikat li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Uman (CMDh).
English: Other possible effects for which treatment may need to be stopped or altered include infusion-related reactions called ‘red man syndrome', severe skin rashes, thrombocytopenia (low blood-levels of cells called platelets that are important for clotting), kidney damage, and effects on hearing.
Maltese: Effetti oħra possibbli li għalihom il-kura tista' teħtieġ titwaqqaf jew titbiddel jinkludu reazzjonijiet relatati malinfużjoni msejħa s-‘sindromu ta' red man', raxx sever fil-ġilda, trombocitopenija (livelli baxxi fid-demm ta' ċelluli msejħa plejtlits li huma importanti għat-tagħqid), ħsara fil-kliewi, u effetti fuq is-smigħ.
English: The Committee did not recommend the use of Targocid to prevent infections.
Maltese: Il-Kumitat ma rrakkomandax l-użu ta' Targocid għall-prevenzjoni ta' infezzjonijiet.
English: The company that markets these medicines is Sanofi-Aventis.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Sanofi-Aventis.
English: • complicated urinary tract infections (infections of the structures that carry urine);
Maltese: • infezzjonijiet ikkumplikati fl-apparat urinarju (infezzjonijiet tal-istrutturi li jġorru l-awrina);
English: Why was Targocid reviewed?
Maltese: Għaliex ġie rivedut Targocid?
English: On 17 November 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Targocid in the EU.
Maltese: Fis-17 ta' Novembru 2011, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Targocid fl-UE.
English: Targocid is authorised in the EU via national procedures.
Maltese: Targocid huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: These include the fact that Targocid may cause serious life-threatening hypersensitivity (allergic) reactions which require immediate cessation of the medicine and emergency treatment; care is needed in patients who are allergic to another antibiotic, vancomycin, as they may be at greater risk.
Maltese: Dawn jinkludu l-fatt li Targocid jista' jikkawża reazzjonijiet serji ta' sensittività eċċessiva (allerġiċi) u ta' periklu għall-ħajja li jeħtieġu twaqqif immedjat tal-mediċina u kura ta' emerġenza; hemm il-ħtieġa ta' attenzjoni f'pazjenti li huma allerġiċi għal antibijotiku ieħor, vancomycin, peress li jistgħu jkunu f'riskju akbar.
English: For certain types of infections, a higher initial dose of 12 mg per kg body-weight twice daily (used in a few member states of the EU), was agreed by the CHMP.
Maltese: Għal ċerti tipi ta' infezzjonijiet, ġiet miftiehma doża inizjali ogħla ta' 12 mg għal kull kg tal-piż tal-ġisem darbtejn kuljum (użata fi ftit Stati Membri tal-UE), mis-CHMP.