FrancophonIA/ELRC3.0 huggingface dataset:
English: Eravacycline did affect mating and fertility in male rats at clinically relevant exposures (see section 5.3).
Maltese: Eravacycline ma affettwax it-tgħammir u l-fertilità fil-firien irġiel f'esponimenti klinikament rilevanti (ara sezzjoni 5.3).
English: Antibiotic class adverse reactions include pseudomembranous colitis, and overgrowth of nonsusceptible organisms, including fungi (see section 4.4).
Maltese: Reazzjonijiet avversi tal-klassi ta' antibijotiċi jinkludu kolite psewdomembrana u tkabbir eċċessiv ta' organiżmi mhux suxxettibbli, inklużi fungi (ara sezzjoni 4.4).
English: Table 1 Example calculations for weights ranging from 40 kg to 200 kg
Maltese: Tabella 1 Eżempji ta' kalkoli għal piżijiet li jvarjaw bejn 40 kg sa 200 kg Piż tal pazjent
English: The geometric least square mean AUC0-inf for eravacycline was decreased by 4.0% for subjects with ESRD versus healthy subjects with 90% CI -14.0, 12.3.
Maltese: Il-medja tal-inqas kwadru ġeometriku tal-AUC0-inf għal eravacycline naqset b'4.0% għal individwi b'ESRD meta mqabbla ma' individwi b'saħħithom b'CI ta' 90% ta' -14.0, 12.3.
English: Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ.
Maltese: Reżistenza għal eravacycline ġiet osservata f'mutazzjonijiet li fihom Enterococcus f'rpsJ.
English: Ferentino Italy
Maltese: Ferentino
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni ta' eravacycline, ma kienet osservata l-ebda differenza klinikament rilevanti fil-farmakokinetika ta' eravacycline fir-rigward tal-età.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi huma kklassifikati skont is-sistema tal-klassifika tal-organi MEDRA u skont il-frekwenza Ilkategoriji tal-frekwenzi huma derivati skont il-konvenzjonijiet li ġejjin: 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).
English: Eravacycline dosing
Maltese: Doża ta' eravacycline
English: Dizziness may occur following administration of eravacycline (see section 4.8).
Maltese: Jista' jkun hemm sturdament wara l-għoti ta' eravacycline (ara sezzjoni 4.8).
English: This medicinal product may pose a risk to the environment (See section 5.3).
Maltese: Dan il-prodott mediċinali jista' jkun ta' riskju għall-ambjent (Ara sezzjoni 5.3).
English: In vitro, eravacycline and its metabolites are not inhibitors or inducers of CYP enzymes or transport proteins (see section 5.2).
Maltese: In vitro, eravacycline u l-metaboliti tiegħu mhumiex inibituri jew indutturi ta' enzimi jew ta' proteini tat-trasport ta' CYP (ara sezzjoni 5.2).
English: For patients weighing 50 kg - 100 kg:
Maltese: Għal pazjenti li jiżnu bejn ≥ 50 kg - 100 kg:
English: Name and address of the manufacturer(s) responsible for batch release Patheon Italia S.p.A.
Maltese: GĦALL-ĦRUĠ TAL-LOTT Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Patheon Italia S.p.A.
English: Infusion-site erythema, pain/tenderness, phlebitis and thrombophlebitis were observed with intravenous eravacycline in clinical trials (see section 4.8).
Maltese: Fi provi kliniċi ġew osservati eritema, uġigħ/sensittività, flebite u tromboflebite fis-sit tal-infużjoni b'eravacycline fil-vini (ara sezzjoni 4.8).
English: The mean (%CV) volume of distribution at steady-state in healthy normal volunteers following 1 mg/kg every 12h is approximately 321 L (6.35), which is greater than total body water.
Maltese: Ilvolum medju (%CV) ta' distribuzzjoni fi stat fiss f'voluntiera normali b'saħħithom wara 1 mg/kg kull 12-il siegħa huwa ta' madwar 321 L (6.35), li huwa akbar mit-total ta' ilma fil-ġisem.
English: 10mL Type I glass vial with chlorobutyl rubber stopper and aluminium cap.
Maltese: Kunjett tal-ħġieġ tat-Tip I ta' 10mL b'tapp tal-gomma klorobutil u għatu tal-aluminju.
English: General disorders and administration site conditions Infusion site reactionsc a. Thrombophlebitis includes the preferred terms thrombophlebitis and infusion site thrombosis b. Phlebitis includes the preferred terms phlebitis, infusion site phlebitis, superficial phlebitis and injection site phlebitis c. Infusion site reactions includes the preferred terms injection site erythema, infusion site hypoaesthesia,
Maltese: Tromboflebite tinkludi t-termini preferuti tromboflebite u trombożi fis-sit tal-infużjoni b. Flebite tinkludi t-termini preferuti flebite, flebite fis-sit tal-infużjoni, flebite superfiċjali u flebite fis-sit tal-injezzjoni c.
English: Each vial contains 50 mg eravacycline After reconstitution 1 mL contains 10 mg eravacycline.
Maltese: Kull kunjett fih 50 mg ta' eravacycline Wara r-rikostituzzjoni, 1 mL ikun fih 10 mg ta' eravacycline.
English: Concomitant administration of the strong CYP3A inhibitor itraconazole altered the pharmacokinetics of eravacycline, increasing Cmax by approximately 5% and AUC0-24 by approximately 23%, and decreasing clearance.
Maltese: L-għoti konkomitanti tal-inibitur qawwi ta' CYP3A itraconazole biddel il-farmakokinetika ta' eravacycline, billi żied is-Cmax b'madwar 5% u l-AUC0-24 b'madwar 23%, u naqqas l-eliminazzjoni.
English: Rash Hyperhidrosis
Maltese: Raxx Iperidrożi
English: No data are available for patients weighing more than 137 kg.
Maltese: Ma hemm l-ebda data disponibbli għal pazjenti b'piż ta' aktar minn 137 kg.
English: In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5).
Maltese: F'pazjenti li jkunu qed jingħataw indutturi qawwija ta' CYP3A4 b'mod konkomitanti l-iskeda taddożaġġ rakkomandata hija ta' 1.5 mg/kg ta' eravacycline kull 12-il siegħa għal bejn 4 u 14-il jum (ara sezzjonijiet 4.4 u 4.5).
English: Pancreatitis Diarrhoea
Maltese: TAL-PRODOTT MEDIĊINALI
English: Concomitant use of strong CYP3A4 inducers
Maltese: Użu konkomitanti ta' indutturi qawwija ta' CYP3A4
English: The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL.
Maltese: Il-volum ikkalkulat tas-soluzzjoni rikostitwita għandu jiżdied mal-borża tal-infużjoni sa konċentrazzjoni fil-mira ta' 0.3 mg/mL, f'medda ta' 0.2 sa 0.6 mg/mL.
English: • Feeling lightheaded or faint
Maltese: • Tintilef minn sensik
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John's Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).
Maltese: John's Wort (rimedju erbali li jintuża għall-kura tad-dipressjoni u lansjetà) itraconazole (mediċina għall-kura ta' infezzjonijiet fungali), ritonavir, atazanavir, lopinavir u saquinavir (mediċini li jintużaw għall-kura ta' infezzjonijiet virali), u cyclosporine (mediċina li tintuża biex trażżan is-sistema immunitarja).
English: Phlebitis b
Maltese: Flebiteb
English: EU/1/18/1312/001 EU/1/18/1312/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1312/002
English: Concomitant administration of the strong CYP 3A4/3A5 inducer rifampicin altered the pharmacokinetics of eravacycline, decreasing exposure by approximately 32% and increasing clearance by approximately 54%.
Maltese: L-għoti konkomitanti tal-induttur qawwi ta' CYP 3A4/3A5 rifampicin biddel il-farmakokinetika ta' eravacycline, billi naqqas l-esponiment b'madwar 32% u żied l-eliminazzjoni b'madwar 54%.
English: In embryo-foetal studies, no adverse effects were observed in rats at exposures comparable to clinical exposure or in rabbits at exposures 1.9-fold higher than the clinical exposure (based on AUC) in rats and rabbits respectively.
Maltese: Fi studji embrijo-fetali, ma kien osservat l-ebda effett negattiv fil-firien f'esponimenti komparabbli ma' esponiment kliniku jew fil-fniek f'esponimenti ta' 1.9 darbiet ogħla mill-esponiment kliniku (abbażi tal-AUC) fil-firien u fil-fniek rispettivament.
English: How you will be given Xerava 4.
Maltese: Kif ser tingħata Xerava 4.
English: These findings were reversible following a 70-day (10-week) recovery period, equivalent to a spermatogenic cycle in the rat.
Maltese: Dawn is-sejbiet kienu riversibbli wara perjodu ta' rkupru ta' 70 jum (10 ġimgħat), ekwivalenti għal ċiklu spermatoġeniku fil-firien.
English: The eravacycline dose should be increased by approximately 50% (1.5 mg/kg IV q12h) when co-administered with rifampicin or other strong CYP3A inducers such as phenobarbital, carbamazepine, phenytoin and St. John's Wort (see sections 4.2 and 4.4).
Maltese: Id-doża ta' eravacycline għandha tiżdied b'madwar 50% (1.5 mg/kg IV q12h) meta jingħata flimkien ma' rifampicin jew ma' indutturi qawwija oħra ta' CYP3A bħal phenobarbital, carbamazepine, phenytoin u St.
English: The observations included degeneration of the seminiferous tubules, oligospermia, and cellular debris in the epididymides, spermatid retention in the seminiferous tubules, increase of spermatid head retention in Sertoli cells, and vacuolation of Sertoli cells and decreased sperm counts.
Maltese: L-osservazzjonijiet kienu jinkludu deġenerazzjoni tat-tubi seminiferi, oligospermja, u frak ċellulari fl-epididimidi, żamma ta' spermatidi fit-tubi seminiferi, żamma akbar ta' rjus ta' spermatidi fiċ-ċelloli Sertoli, u vakulazzjoni taċ-ċelloli Sertoli u tnaqqis fl-għadd tal-isperma.
English: Patient weight (kg)
Maltese: (kg)
English: Component of a multipack, can't be sold seperately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
Maltese: L-ebda aġġustament fid-doża mhuwa meħtieġ f'pazjenti b'indeboliment tal-fwied (ara sezzjonijiet 4.4, 4.5 u 5.2).
English: • Inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
Maltese: • Infjammazzjoni u uġigħ ikkawżati minn emboli tad-demm fis-sit tal-injezzjoni (tromboflebite)
English: Environmental risk assessment studies have shown that Xerava may pose a risk for the aquatic compartment.
Maltese: Studji dwar il-valutazzjoni tar-riskju ambjentali wrew li Xerava jista' jippreżenta riskju għall kompartiment akwatiku.
English: Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
Maltese: L-esponiment jista' jiżdied f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh tal-Klassi Ċ).
English: - The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), aċidu idrokloriku (għall-aġġustament tal-pH) u idrossidu tas-sodju (għall-aġġustament tal-pH).
English: Serious and occasionally fatal hypersensitivity reactions are possible and have been reported with other tetracycline class antibiotics (see section 4.3).
Maltese: Reazzjonijiet serji u kultant fatali ta' sensittività eċċessiva huma possibbli u ġew irrapportata b'antibijotiċi oħrajn tal-klassi ta' tetracyclines (ara sezzjoni 4.3).
English: The mean pharmacokinetic parameters of eravacycline after single and multiple intravenous infusions (60 minutes) of 1 mg/ kg administered to healthy adults every 12 hours are presented in Table 2.
Maltese: Il-proprjetajiet farmakokinetiċi medji ta' eravacycline wara infużjoni unika u wara diversi infużjonijiet fil-vina (60 minuta) ta' 1 mg/kg mogħtija lil adulti b'saħħithom kull 12-il siegħa huma ppreżentati fitTabella 2.
English: As for other tetracycline class antibiotics, eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses exposed in utero during the 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes (see sections 4.4 and 5.3).
Maltese: Fir-rigward ta' antibijotiċi oħra tal-klassi ta' itetracyclines, eravacycline jista' jwassal għal difetti permanenti fis-snien (telf ta' kulur u difetti fl-enamel) u dewmien fil-proċessi ta' ossifikazzjoni fil-feti esposti in utero waqt it-tieni u t-tielet trimestru, minħabba l-akkumulazzjoni fit-tessuti b'rata għolja ta' formazzjoni u ta' telf ta' kalċju u l-formazzjoni ta' kumplessi ta' kelat tal-kalċju (ara sezzjonijiet 4.4 u 5.3). Xerava ma għandux jintuża waqt it-tqala ħlief jekk il-kondizzjoni klinika tal-mara teħtieġ kura b'eravacycline.
English: Xerava is used to treat adults with a complicated infection in the abdomen.
Maltese: Xerava jintuża għall-kura ta' adulti b'infezzjoni komplikata fl-addome.
English: Eravacycline is administered intravenously and therefore has 100% bioavailability.
Maltese: Eravacycline jingħata ġol-vini u għalhekk għandu bijodisponibilità ta' 100%.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for eravacycline are:
Maltese: Il-valuri kritiċi tal-konċentrazzjoni minima inibitorja (MIC) stabbiliti mill-Kumitat Ewropew dwar itTestijiet tas-Suxxettibbiltà Antimikrobika (EUCAST) għal eravacycline huma:
English: In clinical trials in cIAI, there were no immunocompromised patients, and the majority of patients (80%) had APACHE II scores <10 at baseline; 5.4% of the patients had concurrent bacteraemia at baseline; 34% of the patients had complicated appendicitis.
Maltese: II ta' <10 fil-linja bażi; 5.4% tal-pazjenti kellhom batterimja konkorrenti fil-linja bażi; 34% tal-pazjenti kellhom appendiċite komplikata.
English: Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.
Maltese: Reazzjonijiet avversi tal-klassi ta' itetracyclines jinkludu fotosensittivitàpseudotumor cerebri, u azzjoni antianabolika li wasslu għal żieda ta' nitroġenu tal-urea fid-demm (BUN), ażotemija, aċidożi, u iperfosfatemja.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Maltese: Idrossidu tas-sodju (għall-aġġustament tal-pH) Aċidu idrokloriku (għall-aġġustament tal-pH)
English: Each vial contains 50 mg eravacycline.
Maltese: Kull kunjett fih 50 mg ta' eravacycline.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for cIAI that were susceptible to eravacycline in vitro:
Maltese: Attività antibatterika kontra patoġeni rilevanti oħrajn Data in vitro tindika li l-patoġenu li ġej mhuwiex suxxettibbli għal eravacycline:
English: Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Maltese: Jekk ikun hemm suspett ta' pankreatite, eravacycline għandu jitwaqqaf.
English: Powder for concentrate for solution for infusion 1 vial.
Maltese: U KONTENUT Trab għal konċentrat għal soluzzjoni għall-infużjoni 1 kunjett
English: Xerava is given by an infusion (drip) directly into your vein.
Maltese: Xerava jingħata bħala infużjoni (dripp) direttament ġol-vina tiegħek.
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 12 hours at 25°C.
Maltese: L-istabilità kimika u fiżika waqt l-użu wara r-rikostituzzjoni fil-kunjett intweriet għal 60 minuta f'temperatura ta' 25°C.
English: Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline.
Maltese: Eravacycline mhuwiex substrat għall-pompa ta' MepA fi Staphylococcus aureus li ġie deskritt bħala mekkaniżmu ta' reżistenza għal tigecycline.
English: Doses more than 2- or 4-fold higher than the clinical exposure (based on AUC) were associated with maternal toxicity (clinical observations and reduced body weight gain and food consumption), and reduced foetal body weights and delays in skeletal ossification in both species and abortion in the rabbit.
Maltese: Dożi ta' aktar mid-doppju jew ta' aktar minn erba' darbiet l-esponiment kliniku (abbażi tal-AUC) kienu assoċjati ma' tossiċità materna (osservazzjonijiet kliniċi u tnaqqis fiż-żieda tal-piż tal-ġisem u fil-konsum tal-ikel), u tnaqqis fil-piż tal-ġisem tal-fetu u dewmien fl-ossifikazzjoni skeletali fiż-żewġ speċi u abort fil-fniek.
English: This is called ‘overgrowth' or ‘superinfection'.
Maltese: Dan jissejjaħ ‘tkabbir żejjed' jew ‘superinfezzjoni'.
English: Skin and subcutaneous tissue disorders
Maltese: Mikro-organiżmi mhux suxxettibbli
English: How to store Xerava
Maltese: X'inhu Xerava
English: Recommended infusion bag size
Maltese: Daqs rakkomandat talborża tal-infużjoni
English: After reconstitution each mL contains 10 mg eravacycline.
Maltese: Wara r-rikostituzzjoni kull mL fih 10 mg ta' eravacycline.
English: It is, therefore, unlikely that you will miss a dose.
Maltese: Għalhekk, huwa improbabbli li ser tingħata doża aktar milli suppost.
English: Prolonged use may result in the overgrowth of non-susceptible micro-organisms, including fungi.
Maltese: L-użu fit-tul jista' jwassal għat-tkabbir eċċessiv ta' mikro-organiżmi mhux suxxettibbli, inklużi fungi.
English: The safety and efficacy of Xerava in children and adolescents less than 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Xerava fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Xerava 50 mg powder for concentrate for solution for infusion eravacycline
Maltese: Xerava 50 mg trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.
Maltese: It-tabib tiegħek jista' jżidlek id-doża (1.5 mg/kg kull 12-il siegħa) jekk tkun qed tieħu mediċini oħra inkluż rifampicin, phenobarbital, carbamazepine, phenytoin, jew St.
English: Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
Maltese: Eravacycline jista' jingħata irrispettivament mill-ħin tal-emodijalisi (ara sezzjoni 5.2).
English: However, patients receiving strong CYP3A inhibitors (for example ritonavir, itraconazole, clarithromycin) with a combination of factors that may increase the exposure, such as severe hepatic impairment and/or obesity should be monitored for adverse reactions (see sections 4.4 and 4.8).
Maltese: Madankollu, pazjenti li jkunu qed jingħataw inibituri qawwija ta' CYP3A (pereżempju ritonavir, itraconazole, clarithromycin) b'kombinazzjoni ta' fatturi li jistgħu jżidu l-esponiment, bħal indeboliment sever talfwied u/jew obeżità għandhom jiġu mmonitorjati għal reazzjonijiet avversi (ara sezzjonijiet 4.4 u 4.8).
English: For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Għall-għoti, is-soluzzjoni rikostitwita għandha tiġi dilwita ulterjorment b'soluzzjoni ta' klorur tassodju ta' 9 mg/mL (0.9%) għall-injezzjoni.
English: Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Xerava għandu jiġi rikostitwit b'ilma għall-injezzjonijiet u jiġi sussegwentement dilwit b'soluzzjoni ta' klorur tas-sodju ta' 9 mg/mL (0.9%) għall-injezzjoni.
English: - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline.
Maltese: − jekk inti allerġiku għal xi antibijotiċi itetracyclines (eż. minocycline u doxycycline) għaliex tista' tkun allerġiku wkoll għal eravacycline.
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in AUC by gender were observed for eravacycline.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni ta' eravacycline, ma kienet osservata l-ebda differenza klinikament rilevanti fl-AUC abbażi tas-sess għal eravacycline.
English: The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
Maltese: L-iskeda tad-dożaġġ rakkomandata ta' Xerava hija ta' 1 mg/kg kull 12-il siegħa għal bejn 4 u 14-il jum.
English: Pancreatitis has been reported with eravacycline and other tetracycline class antibiotics, and has been severe in some cases (see section 4.8).
Maltese: Kien hemm rapporti ta' pankreatite b'eravacycline u b'antibijotiċi oħra tal-klassi ta' itetracyclines, u f'xi każijiet kienet severa (ara sezzjoni 4.8).
English: Susceptibility testing breakpoints
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: In repeated dose toxicity studies in rats, dogs and monkeys, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets (dog and monkey), in association with bone marrow hypocellularity, and adverse gastrointestinal effects (dog and monkey) were observed with eravacycline.
Maltese: Fi studji dwar it-tossiċità b'dożi ripetuti fil-firien, fil-klieb u fix-xadini, kien osservat tnaqqis tallimfojde/atrofija tal-glandoli limfatiċi tal-milsa u tal-glandola fit-toraċi tnaqqis fl-eritroċiti, firretikuloċiti, fil-lewkoċiti, u fil-plejtlits (klieb u xadini), b'rabta ma' ipoċellularità tal-mudullun, u effetti gastrointestinali avversi (klieb u xadini) b'eravacycline.
English: Medicinal product subject to medical prescription.
Maltese: Ma għandhomx jingħataw prodotti mediċinali li jinibixxu l-peristalsi.
English: In clinical trials, treatment-related diarrhoea occurred in 0.7% of patients; all cases were mild in severity.
Maltese: Fi provi kliniċi, dijarea relatata mal-kura seħħet f'0.7% tal-pazjenti; il-każijiet kollha kienu ta' severità ħafifa.
English: The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.
Maltese: Is-soluzzjoni rikostitwita tinġibed mill-kunjett u tiżdied mal-borża tal-infużjoni ta' soluzzjoni ta' klorur tas-sodju ta' 9 mg/mL (0.9%) għall-injezzjoni ġewwa l-isptar.
English: Findings on the male reproductive organs were also observed in rats in the repeated dose toxicity studies for 14 days or 13 weeks at exposures more than 10- or 5-fold the clinical exposure based on AUC.
Maltese: Sejbiet dwar l-organi riproduttivi maskili kienu osservati wkoll filfirien fl-istudji dwar it-tossiċità b'dożi ripetuti għal 14-il jum jew għal 13-il ġimgħa f'esponimenti ta' aktar minn 10 jew 5 darbiet l-esponiment kliniku abbażi tal-AUC.
English: Other medicines and Xerava
Maltese: Mediċini oħra u Xerava
English: Total volume to be diluted (mL)
Maltese: Volum totali li jrid jiġi dilwit (mL)
English: In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa
Maltese: Għalhekk interazzjonijiet ma' prodotti mediċinali li huma substrati għal dawn l-enzimi jew trasportaturi huma improbabbli.
English: Eravacycline (and metabolites) is excreted in the milk of lactating rats.
Maltese: Eravacycline (u l-metaboliti tiegħu) jiġi eliminat fil-ħalib ta' firien li qed ireddgħu.
English: Within the range of eravacycline multiple intravenous doses studied clinically, the pharmacokinetic parameters AUC and Cmax demonstrate linearity, but with increasing doses the increase in both AUC and Cmax are slightly less than dose-proportional.
Maltese: Fil-medda ta' dożi multipli ta' eravacycline fil-vini li ġew studjati klinikament, l-AUC u s-Cmaxtalproprjetajiet farmakokinetiċi juru linearità, iżda b'żieda fid-dożi ż-żieda kemm fl-AUC u fis-Cmax hija kemxejn inqas minn proporzjonali għad-doża.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Maltese: Id-data ta' meta tiskadi tirreferi għall-aħħar ġurnata ta' dak ix-xahar.