FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline.
Maltese: Jekk inti allerġiku għal antibijotiċi tal-kategorija ta' tetracyclines (eż., minocycline, doxycycline, eċċ.), tista' tkun allerġiku għal tigecycline.
English: • Abscess (collection of pus), infections
Maltese: • Axxessi (ġbir ta' materja), infezzjonijiet
English: Tygacil 50 mg powder for infusion Tigecycline
Maltese: Tygacil 50 mg trab għall-infużjoni Tigecycline
English: Tigecycline pharmacokinetics was investigated in two studies.
Maltese: Il-farmakokinetiċi ta' Tigecycline ġew investigati f'żewġ studji.
English: No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ f'pazjenti b'indeboliment epatiku ħafif sa moderat (Child Pugh A u Child Pugh B).
English: Uncommon side effects are (may affect up to 1 in 100 people):
Maltese: Effetti sekondarji mhux komuni huma (li jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: During treatment with Tygacil:
Maltese: Matul kura b'Tygacil:
English: Posology
Maltese: Pożologija
English: Tigecycline is able to overcome the two major tetracycline resistance mechanisms, ribosomal protection and efflux.
Maltese: Tigecycline huwa kapaċi jegħleb iż-żewġ mekkaniżmi ta' reżistenza maġġuri, protezzjoni ribosomali u effluss.
English: Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1):
Maltese: Tygacil hu indikat fl-adulti u fi tfal mill-età ta' tmien snin għat-trattament tal-infezzjonijiet li ġejjin (ara sezzjonijiet 4.4 u 5.1):
English: Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.
Maltese: Pazjenti li għandhom sensittività eċċessiva għall-klassi ta' antibijotiċi tetracyclines jista' jkollhom sensittività eċċessiva għal tigecycline.
English: In repeated dose toxicity studies in rats and dogs, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets, in association with bone marrow hypocellularity, and adverse renal and gastrointestinal effects have been seen with tigecycline at exposures of 8 and 10 times the human daily dose based on AUC in rats and dogs, respectively.
Maltese: Fi studji ta' effett tossiku minn dożi ripetuti fil-firien u fil-klieb, żvujtar/atrofija limfojde tal-glandoli limfatiċi, il-milsa u t-thymus, tnaqqis fl-eritroċiti, retikuloċiti, lewkoċiti, u plejtlits, f'assoċjazzjoni tal-ipoċellularità tal-mudullun, u effetti avversi renali u gastrointestinali ġew murija b'tigecycline f'esponimenti ta' 8 sa 10 darbiet id-doża umana ta' kuljum ibbażata fuq l-AUC fil-firien u fil-klieb, rispettivament.
English: Metabolism and nutrition disorders hypoglycaemia, hypoproteinaemia
Maltese: Disturbi filmetaboliżmu u n-nutrizzjoni ipogliċemija, ipoprotenimja
English: Via Franco Gorgone Z.I.
Maltese: Wyeth Lederle S.r.l. Via Franco Gorgone Z.I. 95100 Catania (CT) L-Italja
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: • Nausea, vomiting, diarrhoea.
Maltese: • Nawsja, rimettar, dijarea
English: Pathogens of the family Proteeae (Proteus spp., Providencia spp., and Morganella spp.)
Maltese: Patoġeni tal-familja Proteeae (Proteus spp., Providencia spp., u Morganella spp.) huma ġeneralment anqas suxxettibbli għal tigecycline mill-membri l-oħra ta' Enterobacteriaceae.
English: Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline (see section 5.2).
Maltese: L-għoti flimkien ta' inibituri ta' P-gp (eż., ketoconazole jew cyclosporine) jew indutturi ta' P-gp (eż., rifampicin) jista' jaffettwa lfarmakokinetika ta' tigecycline (ara sezzjoni 5.2).
English: How to store Tygacil
Maltese: X'fih Tygacil
English: Vascular disorders phlebitis thrombophlebitis
Maltese: Disturbi vaskulari flebite tromboflebite
English: Investigations elevated amylase in serum, increased blood urea nitrogen (BUN)
Maltese: Investigazzjonij iet żieda fl-amylase fisserum, żidiet fl-urea nitrogen fid-demm (BUN)
English: In humans, the steady-state volume of distribution of tigecycline averaged 500 to 700 L (7 to 9 L/kg), indicating that tigecycline is extensively distributed beyond the plasma volume and concentrates into tissues.
Maltese: Fil-bnedmin, il-volum ta' distribuzzjoni ta' tigecycline fi stat fiss kellu medja ta' 500 sa 700 l (7 sa 9 l/kg), li jindika li tigecycline huwa estensivament iddistribwit lill hemm mill-volum tal-plażma u jikkonċentra ruħu fit-tessuti.
English: In an open-label, single ascending dose PK study, the safety of tigecycline was investigated in 25 children aged 8 to 16 years who recently recovered from infections.
Maltese: Fi studju PK open-label, dwar doża waħda tiżdied, is-sigurtà ta' tigecycline ġiet investigata f'25 tifel u tifla li kellhom minn 8 sa 16-il sena li riċentement kienu rkupraw minn infezzjonijiet.
English: The second study was performed in children aged 8 to 11 years who received multiple doses of tigecycline (0.75, 1, or 1.25 mg/kg up to a maximum dose of 50 mg) every 12 hours administered intravenously over 30 minutes.
Maltese: It-tieni studju sar fuq tfal ta' bejn 8 u 11-il sena li rċevew dożi multipli ta' tigecycline (0.75, 1, jew 1.25 mg/kg sa doża massima ta' 50 mg) kull 12-il siegħa mogħtija ġol-vini fuq perjodu ta' 30 minuta.
English: In addition, tigecycline did not show NADPH-dependency in the inhibition of CYP2C9, CYP2C19, CYP2D6 and CYP3A, suggesting the absence of mechanism-based inhibition of these CYP enzymes.
Maltese: Barra minn hekk, tigecycline ma weriex dipendenza fuq NADPH għall-inibizzjoni ta' CYP2C9, CYP2C19, CYP2D6 u CYP3A, li jissuġerixxi l-assenza ta' inibizzjoni msejsa fuq mekkaniżmu għal dawn l-enżimi tat-tip CYP.
English: The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide.
Maltese: Il-pH jista' jiġi aġġustat b'hydrochloric acid, u jekk meħtieġ b'sodium hydroxide
English: Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, and Lactated Ringer's solution for injection.
Maltese: Soluzzjonijiet għal ġol-vini kompatibbli jinkludu: soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%), soluzzjoni għall-injezzjoni ta' dextrose 50 mg/ml (5%), u soluzzjoni Lactated Ringer's għall-injezzjoni.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju jiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The adverse reaction profile of tigecycline in these 58 subjects was generally consistent with that in adults, with the exception of nausea (48.3 %), vomiting (46.6 %) and elevated lipase in serum (6.9 %) which were seen at greater frequencies in children than in adults.
Maltese: Il-profil tar-reazzjonijiet avversi ta' tigecycline f'dawn it-58 individwu ġeneralment kien konsistenti ma' dak fl-adulti, bl-eċċezjoni tad-dardir (48.3%), rimettar (46.6%) u livelli għoljin ta' lipase fis-serum (6.9%) li ġew osservati fi frekwenzi akbar fit-tfal milli fl-adulti.
English: In clinical trials in cSSTI, the most common type of infection in tigecycline treated-patients was cellulitis (58.6 %), followed by major abscesses (24.9 %).
Maltese: Fi provi kliniċi f'cSSTI, l-aktar tip ta' infezzjonijiet komuni f'pazjenti ttrattati b'tigecycline kienu ċellulite (58.6%) segwiti b'axxessi maġġuri (24.9%).
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Maltese: Il-breakpoints tal-konċentrazzjoni inibitorja minima (MIC) stabbiliti mill-Kummissjoni Ewropea fuq Ittestjar ta' Suxxettibbilità Antimikrobjali (EUCAST) huma kif ġejjin:
English: This in vitro information is consistent with the lack of effect of tigecycline on digoxin clearance noted in the in vivo drug interaction study described above (see section 4.5).
Maltese: Din linformazzjoni in vitro hija konsistenti man-nuqqas ta' effett ta' tigecycline fuq l-ikklerjar ta' digoxin innotat fl-istudju dwar l-interazzjoni in vivo deskritta hawn fuq (ara sezzjoni 4.5).
English: * single dose AUC0-∞, multiple dose AUC0-12h
Maltese: * AUC0--∞ ta' doża waħda, AUC0-12h ta' doża multipla
English: The potential contribution of P-gp-mediated transport to the in vivo disposition of tigecycline is not known.
Maltese: Il-kontribut potenzjali tat-trasport medjat ta' P-gp lejn id-dispożizzjoni in vivo ta' tigecycline mhux magħruf.
English: C-labelled material recovered in urine and faeces, but a glucuronide, an N-acetyl metabolite and a tigecycline epimer were also present.
Maltese: C li kien miksub mill-ġdid mill-awrina u lippurgar, iżda kien hemm ukoll glucuronide, metabolit N-acetyl u epimer ta' tigecycline.
English: The powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, dextrose 50 mg/ml (5 %) solution for injection, or Lactated Ringer's solution for injection to achieve a concentration of 10 mg/ml of tigecycline.
Maltese: It-trab għandu jiġi rrikostitwit b'5.3 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%), soluzzjoni għall-injezzjoni ta'dextrose 50 mg/ml (5%), jew soluzzjoni Lactated Ringer's għallinjezzjoni biex tinkiseb konċentrazzjoni ta' 10 mg/ml ta' tigecycline.
English: Renal clearance is approximately 13 % of total clearance.
Maltese: Ir-rata ta' tneħħija renali hija bejn wieħed u ieħor 13% tat-tneħħija totali.
English: • Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson
Maltese: • Raxx tal-ġilda, li jista' jwassal għal iffurmar ta' bżieżaq u ta' tqaxxir tal-ġilda serju (Sindrome ta' Stevens-Johnson)
English: Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
Maltese: Kellem littabib tiegħek dwar il-bżonn ta' metodu addizzjonali ta' kontraċezzjoni meta tirċievi Tygacil.
English: Tigecycline, a glycylcycline antibiotic, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome.
Maltese: Tigecycline, antibijotiku glycylcycline, jinibixxi t-traduzzjoni tal-proteina fil-batterji billi jorbot massottounità tar-ribosomi 30S u jimblokka d-dħul ta' molekuli ta' amino-acyl tRNA fis-sit A tarribosoma.
English: • Acute pancreatitis (inflamed pancreas which may result in severe abdominal pain, nausea, and vomiting)
Maltese: • Pankreatite akuta (frixa infjammata li tista' tikkaġuna uġigħ addominali qawwi, dardir u rimettar)
English: This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.
Maltese: Din id-doża tingħata ġol-vina (direttament f'demmek) fuq perjodu ta' 30 sa 60 minuta.
English: • Low fibrinogen levels in the blood (a protein involved in blood clotting)
Maltese: • Livelli baxxi ta' fibrinoġen fid-demm (proteina li hija involuta fl-għaqid tad-demm)
English: Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).
Maltese: Tygacil għandu jintuża biss f'sitwazzjonijiet meta antibijotiċi alternattivi oħrajn mhumiex adattati (ara sezzjonijiet 4.4, 4.8 u 5.1).
English: Tygacil will be given to you by a doctor or a nurse.
Maltese: Tygacil ser jingħatlek minn tabib jew infermier.
English: These effects were observed at exposures of 14 and 3 times the human daily dose based on the AUC in rats and dogs respectively.
Maltese: Dawn l-effetti kienu osservati f'esponimenti ta' 14 u 3 darbiet id-doża umana ta' kuljum bbażata fuq l-AUC fil-firien u l-klieb, rispettivament.
English: Very limited safety data were available from two PK studies (see section 5.2).
Maltese: Dejta dwar is-sigurtà limitata ħafna kienet disponibbli minn żewġ studji PK (ara sezzjoni 5.2).
English: Do not use Tygacil
Maltese: Tużax Tygacil
English: Tigecycline may have adverse reactions similar to tetracycline class antibiotics.
Maltese: Tigecycline jista' jkollu reazzjonijiet avversi simili bħal dawk tal-klassi ta' antibijotiċi tetracyclines.
English: As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes (see section 4.4).
Maltese: .Kif inhu magħruf għal klassi ta' antibijotiċi tetracyclines, tigecycline jista' ukoll jinduċi difetti dentali permanenti (telf ta' kulur u difetti fl-enamel) u dewmien fil-proċessi ta' ossifikazzjoni fil-feti, esposti in utero waqt l-aħħar nofs tal-ġestazzjoni, u fi tfal taħt l-età ta' tmien snin minħabba larrikkament fit-tessuti b'rata għolja ta' ċaqliq tal-kalċju u formazzjoni ta' kumplessi ta' kelat tal-kalċju (ara sezzjoni 4.4).
English: No overall differences in pharmacokinetics were observed between healthy elderly subjects and younger subjects (see section 4.2).
Maltese: Ma kien hemm l-ebda differenza osservata fil-farmakokinetika bejn individwi anzjani b'saħħithom u individwi iżgħar (ara sezzjoni 4.2).
English: Clearance, weight-normalised clearance, and AUC were not appreciably different among patients with different body weights, including those weighing ≥125 kg. AUC was 24 % lower in patients weighing ≥125 kg. No data is available for patients weighing 140 kg and more.
Maltese: AUC kien 24% inqas f'pazjenti li jiżnu ≥ 125 kg.
English: Tigecycline is administered intravenously and therefore has 100 % bioavailability.
Maltese: Tigecycline huwa mogħti ġol-vina u għalhekk għandu bijodisponibilità ta' 100%.
English: Based on an in vitro study tigecycline is a P-gp substrate.
Maltese: Abbażi ta' studju in vitro, tigecycline huwa sustrat ta' P-gp.
English: A course of treatment usually lasts for 5 to 14 days.
Maltese: Kors ta' trattament ġeneralment idum sejjer għal 5 sa 14-il jum.
English: Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and antianabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Maltese: Reazzjonijiet avversi tal-klassi ta' tetracyclines jistgħu jinkludu fotosensittività, psewdotumur ċerebri, pankreatite u azzjoni anti-anabolika li tista' twassal għal żieda fil-BUN, ażotemja, aċidosi u iperfosfatemja (ara sezzjoni 4.4).
English: • Tell your doctor immediately if you develop symptoms of an allergic reaction.
Maltese: • Għid lit-tabib tiegħek minnufih jekk tiżviluppa sintomi ta' reazzjoni allerġika.
English: Clinical cure was assessed between 10 and 21 days after the administration of the last dose of treatment.
Maltese: Il-kura klinika ġiet evalwata bejn 10 u 21 jum wara l-għoti tal-aħħar doża tal-kura.
English: It should be noted that the MIC distributions for organisms of the genera Bacteroides and Clostridium are wide and may include values in excess of 2 mg/L tigecycline.
Maltese: Għandu jiġi nnotat li distribuzzjonijiet MIC għal organiżmi tal-ġenera Bacteroides u Clostridium huma wiesa' u jistgħu jinkludu valuri li jkunu aktar minn 2 mg/l tigecycline.
English: • Sepsis (severe infection in the body and blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis)
Maltese: • Sepsis (infezzjoni severa fil-ġisem u fiċ-ċirkolazzjoni tad-demm)/xokk settiku (kundizzjoni medika serja li tista' twassal għal falliment multiplu ta' organi u l-mewt bħala riżultat ta' sepsis)
English: Anaerobes
Maltese: Anafilassi
English: Clinical experience in the use of tigecycline for the treatment of infections in paediatric patients aged 8 years and older is very limited (see sections 4.8 and 5.1).
Maltese: L-esperjenza klinika fl-użu ta' tigecycline għall-kura ta' infezzjonijiet f'pazjenti pedjatriċi li jkollhom 8 snin u aktar hi limitata ħafna (ara sezzjonijiet 4.8 u 5.1).
English: Tygacil 50 mg powder for solution for infusion Tigecycline
Maltese: Tygacil 50 mg trab għal soluzzjoni għall-infużjoni Tigecycline
English: In in vitro studies, no antagonism has been observed between tigecycline and other commonly used antibiotic classes.
Maltese: Fi studji in vitro, l-ebda antagoniżmu ma ġie osservat bejn tigecycline u kategoriji oħra ta' antibijotiċi użati b'mod komuni.
English: Storage after preparation
Maltese: Ħażna wara l-preparazzjoni
English: Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment epatiku serju (Child Pugh C) għandhom jiġu ttrattati b' kawtela u ssorveljati għar-reazzjoni għat-trattament (ara sezzjonijiet 4.4 u 5.2).
English: The target AUC0-12h in adults after the recommended dose of 100 mg loading and 50 mg every 12 hours, was approximately 2500 ng•h/mL.
Maltese: L-AUC0-12h fil-mira fl-adulti wara d-doża tal-bidu rakkomandata ta' 100 mg u 50 mg kull 12-il siegħa, kien ta' madwar 2500 ng•h/mL.
English: Each vial contains 50 mg tigecycline.
Maltese: Kull kunjett fih 50 mg ta' tigecycline.
English: Liver function tests, coagulation parameters, haematology parameters, amylase and lipase should be monitored prior to treatment initiation with tigecycline and regularly while on treatment.
Maltese: Testijiet tal-funzjoni tal-fwied, parametri tal-koagulazzjoni, parametri ematoloġiċi, amylase u lipase, għandhom jiġu mmonitorjati qabel ma tinbeda l-kura bi tigecycline u regolarment matul il-kura.
English: In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50%.
Maltese: F'pazjenti (li jinkludu tfal) b'indeboliment epatiku serju (Child Pugh C), id-doża ta' tigecycline għandha tiġi mnaqqsa b'50%.
English: Attention should be paid to possible dehydration.
Maltese: Wieħed għandu joqgħod attent għal deidratazzjoni possibbli.
English: • Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN).
Maltese: • Żieda fl-amylase, li hu enzima li jinsab fil-glandoli tal-bżieq u l-frixa, żieda fin-nitroġenu tal urea fid-demm (BUN)
English: The following active substances should not be administered simultaneously through the same Y-site as tigecycline: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole and intravenous solutions that could result in an increase of pH above 7.
Maltese: Amphotericin B, kumpless lipidu ta' amphotericin B, diazepam, esomeprazole, omeprazole u soluzzjonijiet ġol-vini li jistgħu jirriżultaw f'żieda tal-pH fuq 7.
English: The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
Maltese: Il-profil tarreazzjonijiet avversi ta' tigecycline f'dawn il-25 individwu ġeneralment kien konsistenti ma' dak fladulti.
English: • Increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood)
Maltese: • Żieda fl-enzimi tal-fwied, iperbilirubinemija (eċċess tal-pigment tal-bila fid-demm)
English: No significant effect of a single intravenous dose of tigecycline 50 mg or 200 mg on QTc interval was detected in a randomized, placebo- and active-controlled four-arm crossover thorough QTc study of 46 healthy subjects.
Maltese: Ma ġie osservat l-ebda effett sinifikanti ta' doża waħda ġol-vini ta' tigecycline 50 mg jew 200 mg fuq l-intervall tal-QTc fi studju bir-reqqa dwar il-QTc, tat-tip crossover, li fih il-parteċipanti ntgħażlu b'mod każwali, li kien ikkontrollat bi placebo u b'mediċina attiva, li kien fih erba' taqsimiet u li sar fuq 46 suġġett b'saħħtu.
English: A limited number of patients were enrolled with co-morbid factors such as diabetes (25.8 %), peripheral vascular disease (10.4 %), intravenous substance abuse (4.0 %), and HIVpositive infection (1.2 %).
Maltese: 4%), abbuż ta' sustanzi fil-vini (4.0%), u infezzjoni pożittiva bl-HIV (1.2%), kienu rreġistrati.
English: Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.
Maltese: Konsiderazzjoni għandha tingħata għal waqfien tat-trattament b'tigecycline f'każijiet issuspettati li żviluppaw pankreatite.
English: Powder for solution for infusion 10 vials
Maltese: Trab għal soluzzjoni għall-infużjoni 10 kunjetti
English: In clinical trials, the most common medicinal product-related treatment emergent adverse reactions were reversible nausea (21 %) and vomiting (13 %), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
Maltese: Fi provi kliniċi, l-aktar reazzjonijiet avversi komuni relatati mal-prodott mediċinali li ħarġu kienu nawsja riversibbli (21%) u rimettar (13%), li ġeneralment seħħew kmieni (fil-jiem 1-2 tat-trattament) u kienu ġeneralment ħfief jew moderati fis-severità.
English: • Pruritus (itching), rash
Maltese: • Ħakk, raxx
English: After reconstitution, 1 ml contains 10 mg of tigecycline.
Maltese: Wara r-rikostituzzjoni, kull ml fih 10 mg ta' tigecycline.
English: Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.
Maltese: L-għoti ġol-vina ta' tigecycline f'doża waħdanija ta' 300 mg fuq 60 minuta f'voluntieri b'saħħithom irriżultat f'inċidenza ogħla ta' nawsja u rimettar.
English: Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment (see section 4.8).
Maltese: Marbut mat-trattament b'tigecycline kien hemm każijiet (frekwenza: mhux komuni) ta' pankreatite akuta, li tista' tkun serja (ara sezzjoni 4.8).
English: Digoxin did not affect the pharmacokinetic profile of tigecycline.
Maltese: Digoxin ma affettwax il-profil farmakokinetiku ta' tigecycline.
English: Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.8).
Maltese: Reazzjonijiet bħal dawn jistgħu jinkludu fotosensittività, psewdotumur ċerebri, pankreatite, u azzjoni antianabolika li twassal għal żieda fil-BUN, ażotemija, aċidożi, u iperfosfatemija (ara sezzjoni 4.8).
English: Tygacil should not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and because tigecycline may be associated with permanent teeth discolouration (see sections 4.2 and 4.8).
Maltese: Tygacil m'għandux jintuża fi tfal taħt l-età ta' 8 snin minħabba nuqqas ta' dejta dwar is-sigurtà u leffikaċja f'dan il-grupp ta' età u minħabba li tigecycline jista' jiġi assoċjat ma' telf ta' kulur tas-snien permanenti (ara sezzjonijiet 4.2 u 4.8).
English: Each 5 ml Tygacil vial contains 50 mg of tigecycline.
Maltese: Kull kunjett ta' 5 ml ta' Tygacil fih 50 mg ta' tigecycline.
English: Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days.
Maltese: Tfal lijkollhom minn 8 sa <12-il sena: 1.2 mg/kg ta' tigecycline kull 12-il siegħa ġol-vina sa doża massima ta' 50 mg kull 12-il siegħa għal 5 sa 14-il jum.