FrancophonIA/ELRC3.0 huggingface dataset:
English: In the additional studies, adding Tesavel to glimepiride (with and without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in the patients adding placebo.
Maltese: Fl-istudji ulterjuri, iż-żieda ta' Tesavel mal-glimepiride (bil-metformina jew mingħajrha) ikkaġunat tnaqqis fil-livelli tal-HbA1c ta' 0.45% wara 24 ġimgħa, apparagun ma' żieda ta' 0.28% fil-pazjenti li żiedu l-plaċebo.
English: In patients with moderately or severely reduced kidney function the dose of Tesavel should be reduced.
Maltese: F'pazjenti li jkollhom tnaqqis moderat jew gravi fil-funzjoni tal-kliewi d-doża ta' Tesavel għandha titbaxxa.
English: When taken on their own, Tesavel and metformin produced similar reductions in HbA1c levels, but the effectiveness of Tesavel seemed to be slightly lower than that of metformin.
Maltese: Meta ttieħdu waħedhom, Tesavel u l-metformina pproduċew tnaqqis simili fil-livelli tal-HbA1c, iżda l-effikaċja ta' Tesavel dehret li kienet ftit inqas minn dik tal-metformina.
English: If Tesavel is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Tesavel jittieħed mas-sulfonilurea jew malinsulina, jista' jenħtieġ li d-doża tas-sulfonilurea jew tal-insulina titbaxxa ħalli jitnaqqas ir-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;
Maltese: • flimkien mal-metformina jew ma' agonista PPAR gamma (tip ieħor ta' mediċina kontra d-dijabete), bħat-tijażolidinedjonu, fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti bl-agonista PPAR gamma waħdu;
English: How has Tesavel been studied?
Maltese: Kif ġie studjat Tesavel?
English: • in combination with both metformin and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Maltese: • flimkien jew mal-metformina, u mas-sulfonilurea jew agonista PPAR gamma fuq pazjenti li ma jkunux ikkontrollati b'mod sodisfaċenti biż-żewġ mediċini;
English: • two studies compared Tesavel with other antidiabetes medicines.
Maltese: • żewġ studji qabblu lil Tesavel ma' mediċini oħra kontra d-dijabete.
English: It works by blocking the breakdown of ‘incretin' hormones in the body.
Maltese: Din taħdem billi timblokka ttkissir tal-ormoni ‘inkretini' fil-ġisem.
English: Other information about Tesavel
Maltese: Kif jintuża Tesavel?
English: Further information on Xofigo 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: Xofigo received a marketing authorisation valid throughout the EU on 13 November 2013.
Maltese: Xofigo rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Novembru 2013.
English: The medicine is slowly injected into a vein usually for up to one minute.
Maltese: Il-mediċina tiġi injettata ġo vina bil-mod, normalment tul minuta.
English: Xofigo contains the active substance radium-223 dichloride.
Maltese: Xofigo fih is-sustanza attiva radium-223 dichloride.
English: Injections are repeated every 4 weeks for a total of 6 injections.
Maltese: L-injezzjonijiet jiġu ripetuti kull 4 ġimgħat għal total ta' 6 injezzjonijiet.
English: Other information about Xofigo
Maltese: Informazzjoni oħra dwar Xofigo
English: Xofigo must not be used with the medicine abiraterone acetate and the corticosteroids prednisone or prednisolone.
Maltese: Xofigo ma jistax jintuża mal-mediċina aċetat tal-abiraterone u mal-kortikosterojdi prednisone jew malprednisolone.
English: Xofigo was compared with placebo (a dummy treatment) as an addition to standard care in a main study involving 921 men with cancer of the prostate that had spread to the bones and for which suppression of male hormones using medicines or surgery did not work.
Maltese: Xofigo tqabbel ma' plaċebo (kura finta) bħala addizzjoni għal kura standard fi studju prinċipali li involva 921 raġel b'kanċer tal-prostata li kien infirex fl-għadam, li għalihom is-suppressjoni tal-ormoni maskili permezz ta' mediċini jew tal-kirurġija ma ħadmitx.
English: The active substance in Xofigo, radium-223, emits short-range radiation known as alpha particles.
Maltese: Is-sustanza attiva f'Xofigo, ir-radium-223, temetti radjazzjoni ta' medda qasira magħrufa bħala partiċelli alfa.
English: Patients given Xofigo lived on average for 14.9 months, compared with 11.3 months for those given placebo.
Maltese: Il-pazjenti li ngħataw Xofigo għexu madwar 14.9 xhur, meta mqabbel ma' 11.3 xhur għal dawk li ngħataw plaċebo.
English: Xofigo can increase the risk of having fractures.
Maltese: Xofigo jista' jżid ir-riskju ta' fratturi.
English: Xofigo is used on its own or in combination with a medicine known as an ‘LHRH analogue'.
Maltese: Xofigo jintuża waħdu jew flimkien ma' mediċina magħrufa bħala “LHRH analogue”.
English: As for all medicines, data on the use of Xofigo are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Xofigo hija ssorveljata kontinwament.
English: Xofigo is a radiopharmaceutical (a medicine containing a radioactive substance) that is used to treat adults with cancer of the prostate (a gland of the male reproductive system).
Maltese: Xofigo huwa radjufarmaċewtiku (mediċina li jkun fiha sustanza radjuattiva) li jintuża fil-kura ta' adulti b'kanċer tal-prostata (glandola tas-sistema riproduttiva maskili).
English: What are the risks associated with Xofigo?
Maltese: X'inhuma r-riskji assoċjati ma' Xofigo?
English: The most common side effects with Xofigo (which may affect more than 1 in 10 people) are diarrhoea, nausea (feeling sick), vomiting, thrombocytopenia (low blood-platelet counts) and bone fractures.
Maltese: L-effetti sekondarji l-aktar komuni b'Xofigo (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea, nawsja (tħossok ma tiflaħx), rimettar, tromboċitopenija (għadd baxx ta' pjastrini taddemm) u fratturi tal-għadam.
English: The most serious side effects were thrombocytopenia and neutropenia (low levels of neutrophils, a type of white blood cell that fights infection).
Maltese: L-effetti sekondarji l-aktar serji kienu tromboċitopenija u newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm li tiġġieled l-infezzjonijiet).
English: Xofigo is used when castration (to stop the production of male hormones) by surgery or with medicines does not work, and when the cancer has spread to the bones (bone metastases) and is causing symptoms such as pain, but has not spread to other internal organs.
Maltese: Xofigo jintuża meta l-kastrazzjoni (biex titwaqqaf il-produzzjoni tal-ormoni maskili) kirurġika jew permezz tal-mediċini ma taħdimx, u meta l-kanċer ikun infirex fl-għadam (metastasi tal-għadam) u jkun qed jikkawża sintomi bħal uġigħ, iżda ma jkunx infirex f'organi interni oħra.
English: The company that markets Xofigo will have to conduct studies to further characterise the safety profile of the medicine, in particular with regard to the risk of fractures and the risk of new metastases that do not affect the bone in patients treated with Xofigo.
Maltese: Il-kumpanija li tqiegħed Xofigo fis-suq se jkollha twettaq studji biex tkompli tikkaratterizza l-profil tas-sigurtà tal-mediċina, b'mod partikolari rigward ir-riskju ta' fratturi u r-riskju ta' metastasi ġodda li ma jaffettwawx l-għadam f'pazjenti li jingħataw kura b'Xofigo.
English: Patients were given up to 6 injections at 1-month intervals and were followed up for 3 years from the first injection.
Maltese: Il-pazjenti ngħataw sa 6 injezzjonijiet f'intervalli ta' xahar, u ġew osservati għal tliet snin wara l-ewwel injezzjoni.
English: For the full list of side effects of Xofigo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Xofigo, ara l-fuljett ta' tagħrif.
English: How does Xofigo work?
Maltese: Kif jintuża Xofigo?
English: What measures are being taken to ensure the safe and effective use of Xofigo?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Xofigo?
English: The signs and symptoms of progressive disease such as bone pain also took longer to develop in patients given Xofigo.
Maltese: Barra minn hekk, issinjali u s-sintomi tal-mard progressiv, bħall-uġigħ fl-għadam, damu aktar biex żviluppaw f'pazjenti li ngħataw Xofigo.
English: Xofigo has been shown to prolong life and delaying signs and symptoms of progressive disease.
Maltese: Xofigo ntwera li jista' jtawwal il-ħajja u jdewwem is-sinjali u ssintomi tal-mard progressiv.
English: Treatment of hypercholesterolaemia
Maltese: Kura ta' iperkolesterolemija
English: • You have a high cholesterol level.
Maltese: • Għandek livell ta' kolesterol għoli.
English: Children younger than 6 years
Maltese: Tfal iżgħar minn 6 snin
English: For each age group, the LS mean percent reductions from baseline values in LDL-C were -43% (Baseline: 234 mg/dL, Month 24: 124 mg/dL), -45% (Baseline: 234 mg/dL, 124 mg/dL ), and -35% (Baseline: 241 mg/dL, Month 24: 153 mg/dL) in the 6 to <10, 10 to <14, and 14 to <18 age groups, respectively.
Maltese: Għal kull grupp ta' età, it-tnaqqis perċentwali medju f'LS mill-valuri tal-linja bażi f'LDL-C kien -43% (Linja bażi: 234 mg/dL, Xahar 24: 124 mg/dL), -45% (Linja bażi: 234 mg/dL, 124 mg/dL ), u -35% (Linja bażi: 241 mg/dL, Xahar 24: 153 mg/dL) fil-gruppi ta' età ta' bejn 6 snin u <10, 10 sa <14, u 14 sa <18, rispettivament.
English: Rosuvastatin 5 mg, 10 mg, and 20 mg also achieved statistically significant mean changes from baseline for the following secondary lipid and lipoprotein variables: HDL-C, TC, non-HDL-C,LDL-C/HDLC, TC/HDL-C, TG/HDL-C, non HDL C/HDL-C, ApoB, ApoB/ApoA-1.
Maltese: HDL-C, TC, mhux-HDL-C,LDL-C/HDL-C, TC/HDL-C, TG/HDL-C, mhux HDL C/HDL-C, ApoB, ApoB/ApoA-1.
English: This trial (n=176) was not suited for comparison of rare adverse drug events.
Maltese: Din il-prova (n=176) ma kinitx xierqa għal tqabbil ta' avvenimenti avversi rari relatati mal-mediċina.
English: Use in children and adolescents aged 6-17 years
Maltese: Użu fit-tfal u fl-adolexxenti ta' bejn 6 - 17-il sena
English: After 24 months of treatment with rosuvastatin, the LS mean percent reduction from the baseline value in LDL-C was -43% (Baseline: 236 mg/dL, Month 24: 133 mg/dL).
Maltese: Wara 24 xahar ta' kura b'rosuvastatin, it-tnaqqis perċentwali medju fl-LS mill-valur tal-linja bażi f'LDL-C kien ta' -43% (Linja bażi: 236 mg/dL, Xahar 24: 133 mg/dL).
English: The usual start dose is 5 mg.
Maltese: Id-doża tal-bidu normali hija ta' 5 mg.
English: In a double-blind, randomized, multi-centre, placebo-controlled, 12-week study (n=176, 97 male and 79 female) followed by a 40-week (n=173, 96 male and 77 female), open-label, rosuvastatin dosetitration phase, patients 10-17 years of age (Tanner stage II-V, females at least 1 year postmenarche) with heterozygous familial hypercholesterolaemia received rosuvastatin 5, 10 or 20 mg or placebo daily for 12 weeks and then all received rosuvastatin daily for 40 weeks.
Maltese: Fi studju ta' 12-il ġimgħa, ikkontrollat bi plaċebo, b'aktar minn ċentru wieħed, randomizzat, double-blind (n=176, 97 raġel u 79 mara) segwit minn fażi ta' titrazzjoni tad-doża ta' rosuvastatin ta' 40 ġimgħa (n=173, 96 raġel u 77 mara), open-label, pazjenti ta' bejn 10 u 17-il sena (fażi ta' Tanner II-V, nisa ta' mill-inqas sena wara l-ewwel mestrwazzjoni tagħhom) b'iperkolesterolemija familjali eterożigotika rċevew rosuvastatin 5, 10 jew 20 mg jew plaċebo kuljum għal 12-il ġimgħa u mbagħad ilkoll irċevew rosuvastatin kuljum għal 40 ġimgħa.
English: Adults, adolescents and children aged 6 years or older with primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Maltese: Adulti, adolexxenti u tfal ta' 6 snin jew aktar b'iperkolesterolemija primarja (tip II inkluż iperkolesterolemija familjali eterożigotika) jew dislipidemija mħallta (tip IIb) bħala żieda mad-dieta fejn ir-rispons għad-dieta u kuri mhux farmakoloġiċi oħrajn (eż. eżerċizzju, tnaqqis fil-piż) mhuwiex adegwat.
English: LDL-C was reduced 38.3%, 44.6%, and 50.0% by rosuvastatin 5, 10 and 20 mg, respectively, compared to 0.7% for placebo.
Maltese: 6%, u 50.0% b'rosuvastatin 5, 10 u 20 mg rispettivament, meta mqabbel ma' 0.7% għal plaċebo.
English: How to take CRESTOR [Existing information on the paediatric population should be replaced with the following:]
Maltese: Kif gћandek tieћu CRESTOR [L-informazzjoni eżistenti dwar il-popolazzjoni pedjatrika għandha tiġi sostitwita b'li ġej:]
English: CRESTOR 40 mg tablet should not be used by children.
Maltese: CRESTOR 40 mg pillola ma għandux jintuża minn tfal.
English: • In children 10 to 17 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-20 mg orally once daily.
Maltese: • Fi tfal ta' bejn 10 snin u 17-il sena b'iperkolesterolemija familjali eterożigotika, il-medda tad-doża normali hija 5-20 mg oralment darba kuljum.
English: • In children 6 to 9 years of age with heterozygous familial hypercholesterolaemia, the usual dose range is 5-10 mg orally once daily.
Maltese: • Fi tfal ta' bejn 6 snin u 9 snin b'iperkolesterolemija familjali eterożigotika, il-medda tad-doża normali hija 5-10 mg oralment darba kuljum.
English: Children and adolescents 6 to 17 years of age (Tanner Stage <II-V) In children and adolescents with heterozygous familial hypercholesterolaemia the usual start dose is 5 mg daily.
Maltese: Tfal u adoloxxenti ta' 6 sa 17-il sena (Fażi ta' Tanner <II-V) Fi tfal u adolexxenti b'iperkolesterolemija familjali eterożigotika, il-medda tad-doża normali hija 5 mg kuljum.
English: In a clinical trial of children and adolescents receiving rosuvastatin for 52 weeks, CK elevations >10xULN and muscle symptoms following exercise or increased physical activity were observed more frequently compared to observations in clinical trials in adults (see Section 4.8).
Maltese: Fi prova klinika ta' tfal u adolexxenti li jirċievu rosuvastatin għal 52 ġimgħa, elevazzjonijiet fis-CK >10xULN u sintomi fil-muskolu wara eżerċizzju jew attività fiżika miżjuda ġew osservati b'mod aktar frekwenti meta mqabbla ma' osservazzjonijiet fi provi kliniċi fl-adulti (ara Sezzjoni 4.8).
English: Rosuvastatin was also studied in a 2-year open-label, titration-to-goal study in 198 children with heterozygous familial hypercholesterolaemia aged 6 to 17 years (88 male and 110 female, Tanner stage <II-V).
Maltese: Rosuvastatin ġie studjat ukoll fi studju fuq sentejn, b'tikketta mikxufa, b'titrazzjoni sal-mira f'198 tifel/tifla b'iperkolesterolemija familjali eterożigotika ta' 6 snin sa 17-il sena (88 irġiel u 110 nisa, fażi ta' Tanner <II-V).
English: The maximum daily dose of CRESTOR is 10 mg for children aged 6 to 9 years and 20 mg for children aged 10 to 17 years.
Maltese: Id-doża massima ta' kuljum ta' CRESTOR hija 10 mg għal tfal ta' bejn 6 u 9 snin u 20 mg għal tfal ta' bejn 10 u 17-il sena.
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: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentament mill-awtoritajiet kompetenti talIstat Membru, b'kollaborazzjoni mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbilit filKapitolu 4 tat-Titlu III tad-Direttiva 2001/83/KE.
English: The evaluation of linear growth (height), weight, BMI (body mass index), and secondary characteristics of sexual maturation by Tanner staging in paediatric patients 6 to 17 years of age taking rosuvastatin is limited to a two-year period.
Maltese: L-evalwazzjoni tat-tkabbir lineari (tul), piż, BMI (indiċi tal-massa tal-ġisem), u karatteristiċi sekondarji tal-maturazzjoni sesswali skont il-fażi ta' Tanner f'pazjenti pedjatriċi ta' 6 sa 17-il sena li jieħdu rosuvastatin hija limitata għal perjodu ta' sentejn.
English: Patients aged 6 to 9 years (n=64) could titrate to a maximum dose of 10 mg once daily and patients aged 10 to 17 years (n=134) to a maximum dose of 20 mg once daily.
Maltese: Pazjenti ta' bejn 6 u 9 snin (n=64) jistgħu jagħmlu titrazzjoni sa doża massima ta' 10 mg darba kuljum u pazjenti ta' bejn 10 snin u 17-il sena (n=134) jistgħu jagħmlu titrazzjoni sa doża massima ta' 20 mg darba kuljum.
English: Crestor is used in adults, adolescents and children 6 years or older to treat high cholesterol.
Maltese: CRESTOR jintuża fl-adulti, adolexxenti u tfal ta' 6 snin jew aktar biex jikkura kolesterol għoli.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rosuvastatin in all subsets of the paediatric population in the treatment of homozygous familial hypercholesterolaemia, primary combined (mixed) dyslipidaemia and in the prevention of cardiovascular events (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji b'rosuvastatin fi tfal ta' bejn 0 sa inqas minn 6 snin fil-kura tal-iperkolesterolemija primarja (inkluż iperkolesterolemija eterożigotika) u fi tfal ta' bejn 0 sa inqas minn 18-il sena fil-kura ta' iperkolesterolemija familjali omożigotika, dislipidemija kkombinata (mħallta) primarja) u fil-prevenzjoni ta' episodji kardjovaskulari (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Experience in children with homozygous familial hypercholesterolaemia is limited to a small number of children aged between 8 and 17 years.
Maltese: L-esperjenza fi tfal b'iperkolesterolemija familjali eterożigotika hija limitata għal numru żgħir ta' tfal ta' bejn 8 u 17-il sena.
English: • If the patient is under 6 years old: CRESTOR should not be given to children younger than 6 years.
Maltese: • Jekk il-pazjent għandu inqas minn 6 snin: CRESTOR ma għandux jingħata lil tfal li għandhom inqas minn 6 snin.
English: The starting dose for all patients was 5 mg rosuvastatin once daily.
Maltese: Id-doża tal-bidu għall-pazjenti kollha kienet 5 mg rosuvastatin darba kuljum.
English: [The wording of the indication for treatment of hypercholesterolaemia should be replaced with the following:]
Maltese: [Il-formolazzjoni tal-kliem tal-indikazzjoni għall-kura tal-iperkolesterolemija għandha tiġi sostitwita b'li ġej:]
English: Titration should be conducted according to the individual response and tolerability in paediatric patients, as recommended by the paediatric treatment recommendations (see Section 4.4).
Maltese: Titrazzjoni għandha ssir skont ir-rispons tal-individwu u t-tollerabilità f'pazjenti pedjatriċi, kif irrakkomandat mir-rakkomandazzjonijiet tal-kura pedjatrika (ara Sezzjoni 4.4).
English: At study entry, approximately 30% of the patients were 10-13 years and approximately 17%, 18%, 40%, and 25% were Tanner stage II, III, IV, and V, respectively.
Maltese: Fid-dħul għall-istudju, madwar 30% tal-pazjenti kellhom bejn 10 u 13-il sena u bejn wieħed u ieħor 17%, 18%, 40%, u 25% kienu fil-fażi
English: At the end of the 40-week, open-label, titration to goal, dosing up to a maximum of 20 mg once daily, 70 of 173 patients (40.5%) had achieved the LDL-C goal of less than 2.8 mmol/l.
Maltese: Fi tmiem l-40 ġimgħa, tikketta mikxufa, titrazzjoni sal-mira, id-dożaġġ 'il fuq sa massimu ta' 20 mg darba kuljum, 70 minn 173 pazjent (40.5%) laħqu l-mira ta' LDL-C ta' inqas minn 2.8 mmol/l.
English: 5.2 Pharmacokinetic properties [Existing information on the paediatric population should be replaced with the following:] Paediatric population: Two pharmacokinetic studies with rosuvastatin (given as tablets) in paediatric patients with heterozygous familial hypercholesterolaemia 10-17 or 6-17 years of age (total of 214
Maltese: Żewġ studji tal-farmakokinetika b'rosuvastatin (mogħti bħala pilloli) f'pazjenti pedjatriċi b'iperkolesterolemija familjali eterożigotika ta' 10-17-il sena jew 6-17-il sena (total ta' 214-il pazjent) wera li l-espożizzjoni f'pazjenti pedjatriċi tidher li hija komparabbli ma' jew aktar baxxa minn dik f'pazjenti adulti.
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR CRESTOR AND ASSOCIATED NAMES
Maltese: EMENDI LI GĦANDHOM JIĠU INKLUŻI FIS-SEZZJONIJIET RELEVANTI
English: EMA/169448/2015 EMEA/H/C/002846
Maltese: EMEA/H/C/002846
English: 85.5% of patients treated with Sivextro in the first study and 88.0% in the second study were cured, compared with 86.0% and 87.7% respectively of patients treated with linezolid.
Maltese: 5% tal-pazjenti kkurati b'Sivextro fl-ewwel studju u 88.0% fit-tieni studju fiequ, meta mqabbel ma' 86.0% u 87.7% rispettivament tal-pazjenti kkurati b'linezolid.
English: The full EPAR and risk management plan summary for Sivextro 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: It contains the active substance tedizolid.
Maltese: Fih is-sustanza attiva tedizolid.
English: The recommended dose is 200 mg once a day for 6 days.
Maltese: Id-doża rrakkomandata hija 200 mg darba kuljum għal 6 ijiem.
English: The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone.
Maltese: Is-sustanza attiva f'Sivextro, tedizolid, hija tip ta' antibijotiku imsejjaħ oxazolidinone.
English: This is a summary of the European public assessment report (EPAR) for Sivextro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Sivextro.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sivextro on 23 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Sivextro valida fl-Unjoni Ewropea kollha fit-23 ta' Marzu 2015.
English: Why is Sivextro approved?
Maltese: Għaliex ġie approvat Sivextro?
English: Sivextro has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work.
Maltese: Sivextro ntwera li jaħdem kontra batterji (bħal Staphylococcus aureus reżistenti għall-metiċillina (MRSA)) li kontrihom ma jaħdmux antibijotiċi standard.
English: Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1,333 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections.
Maltese: Sivextro tqabbel ma' linezolid (oxazolidinone ieħor) f'żewġ studji ewlenin li jinvolvu total ta' 1,333 pazjent b'infezzjonijiet batteriċi akuti tal-ġilda u tal-istrutturi tal-ġilda, bħal ċellulite, axxessi tal-ġilda u infezzjonijiet fil-ġrieħi.
English: Other information about Sivextro
Maltese: Informazzjoni oħra dwar Sivextro
English: Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg).
Maltese: Sivextro jiġi fi trab li jissawwar f'soluzzjoni li tingħata b'infużjoni (dripp) ġo vina u bħala pilloli (200 mg).
English: In both studies patients received 6 days of treatment with Sivextro which was compared with a 10-day treatment of linezolid.
Maltese: Fiż-żewġ studji, ilpazjenti rċevew 6 ijiem ta' kura b'Sivextro li tqabbel ma' kura ta' 10 ijiem ta' linezolid.
English: A list of bacteria against which Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).
Maltese: Lista ta' batterji li Sivextro huwa attiv kontrihom tinstab fissommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).