FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi eċċipjenti elenkati fis-sezzjoni 6.1. Tqala (ara sezzjoni 4.6)
English: There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi's anaemia.
Maltese: L-esperjenzi kliniċi huma limitati dwar l-użu tal-busulfan bħala komponiment tar-regimen kondizzjonarju qabel l-HSCT fit-tfal li għandhom anemja Fanconi.
English: What Busilvex is and what it is used for What you need to know before you use Busilvex How to use Busilvex
Maltese: Ma kien hemm l-ebda evidenza ta l-effett induttiv ta' fenitojin fuq id-dejta ta' Busilvex.
English: The residual medicinal product must not be flushed in the administration tubing as rapid infusion of Busilvex has not been tested and is not recommended.
Maltese: Il-prodott mediċinali m'għandux jiġi fflaxxjat fit-tubi tal-amministrazzjoni għax qatt ma sar test talinfużjoni rapida tal-Busilvex u dan mhux irrakkomandat.
English: Busilvex will be administered once daily during 2 or 3 consecutive days prior to transplant.
Maltese: Busilvex se jingħata darba kuljum matul 2 jew 3 ijiem konsekuttivi qabel it-trapjant.
English: No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.
Maltese: Ma kienet osservata l-ebda interazzjoni meta l-busulfan ingħaqad ma' antijemitiċi 5 -HT3 bħal ngħidu aħna ondansetron jew granisetron.
English: It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Maltese: Kienet ikkunsidrata bħala mwiet li jistgħu jkunu attribwibbli għal effetti sekondarji wara HPCT u mhux relatati mar-rikaduta/progressjoni tat-tumuri malinni ematoloġiċi sottostanti.
English: Vomiting Dyspepsia Ascites
Maltese: Katarretta Traqqiq talkornea
English: Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Maltese: Dawn jinkludi l-infezzjoni u l-marda tat-trapjant-kontra r-riċevitur (GVHD) li għalkemm mhumiex direttament relattati, kienu l-kawżi maġġuri tal-morbidità u l-mortalità, speċjalment fil-każ ta' HPCT alloġeniku.
English: The most serious side effects of Busilvex therapy or the transplant procedure may include decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion), infection, liver disorders including blocking of a liver vein, graft versus host disease (the graft attacks your body) and pulmonary complications.
Maltese: L-aktar effetti oħra serji tat-terapija Busilvex jew tal-proċedura tat-trapjant għandhom mnejn jinkludu tnaqqis fil-għadd taċ-ċelluli tad-demm li jkunu qed jiċċirkulaw (l-effett intiż tal-mediċina biex jippreparak għall-infużjoni tiegħek tat-trapjant), infezzjoni, mard tal-fwied inkluż l-imblokkar tal-vina tal-fwied, marda tat-trapjant kontra r-riċevitur (it-trapjant jattakka l-ġismek) u komplikazzjonijiet pulmonari.
English: Other medicines and Busilvex
Maltese: Mediċini oħra u Busilvex
English: Busilvex must not be put into an intravenous bag that does not contain sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Maltese: Busilvex għandu jkun miżjud bl-ilma qabel ma jintuża jew b'soluzzjoni tal-klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni tal-glukows ta' 5% għall-injezzjoni.
English: Calculation of the quantity of Busilvex to be diluted and of the diluent Busilvex must be diluted prior to use with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose solution for injection 5%.
Maltese: Il-Busilvex m'għandux jitpoġġa ġo borza li tintuża għal ġol-vini li ma fihiex soluzzjoni ta' klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni ta' glukows ta' 5% għall-injezzjoni.
English: No specific clinical trial was carried out to assess drug-drug interaction between intravenous busulfan and itraconazole or metronidazole.
Maltese: Ma sar l-ebda esperiment speċifiku kliniku biex jassessja l-interazzjoni bejn mediċina u oħra bejn busulfan mogħti ġol-vini u itrakonażol jew metronidazole.
English: In adults and children studies, data with Busilvex were obtained when using concomitant administration of either phenytoin or benzodiazepines for seizure prophylaxis.
Maltese: Pazjenti għandhom jirċievu profilassi anti-konvulsanti adegwata.
English: The median duration of neutropenia was 6 days and 9 days for autologous and allogeneic patients.
Maltese: It-tul ta' żmien medjan tan-newtropenija kien ta' 6 ġranet u 9 ġranet għall-pazjenti awtologużi u pazjenti alloġenejiċi.
English: Diluted solution:
Maltese: Soluzzjoni maħlula:
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodot, sezzjoni 4.2)
English: Cases of TMA after high doses of busulfan i.v.
Maltese: Mediċini qabel ma tibda tirċievi l-Busilvex:
English: Seizure
Maltese: Ipossja
English: In this case infusion sets with minimal priming space should be used (i.e. 0.3-0.6 ml), primed with medicinal product solution prior to beginning the actual Busilvex infusion and then flushed with sodium chloride 9 mg/ml (0.9%) solution for injection or glucose (5%) solution for injection.
Maltese: 3-0.6 ml), ippramjat b'soluzzjoni ta' droga qabel il-bidu tal-infużjoni attwali tal-Busilvex u mbagħad tkun ifflaxxjata b'soluzzjoni tal-klorid tas-sodju ta' 9 mg/ml (0.9%) għall-injezzjoni jew soluzzjoni tal-glukows (5%) għall-injezzjoni.
English: Busilvex should not be given by rapid intravenous, bolus or peripheral injection.
Maltese: Busilvex m'għandux jingħata permezz ta' injezzjoni minn ġol-vina, bolus jew injezzjoni periferali.
English: † see section 5.1, Breakpoints above.
Maltese: † ara sezzjoni 5.1, Breakpoints fuq.
English: * (see section 4.4)
Maltese: * (ara sezzjoni 4.4)
English: Gram-negative Aerobes Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
Maltese: Aerobi gram-negattivi Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
English: • Complicated intra-abdominal infections (cIAI).
Maltese: • Infezzjonijiet intra-addominali kkumplikati (cIAI).
English: Indication n/N (%)
Maltese: Indikazzjoni n/N (%)
English: Bacteroides fragilis group†
Maltese: Grupp Bacteroides fragilis†
English: Tigecycline has decreased in vitro activity against Proteus, Providencia, and Morganella spp.
Maltese: Tigecycline għandu tnaqqis fl-attività kontra Proteus, Providencia, u Morganella spp.
English: Antibiotic class effects
Maltese: Effetti tal-klassi antibijotika
English: cIAI cSSTI Overall
Maltese: cIAI cSSTI
English: Gram-negative Aerobes
Maltese: Aerobi Gram-negattivi
English: mg/L and R  2 mg/L
Maltese: mg/l u R > 2 mg/l
English: Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes*
Maltese: Il-grupp ta' Streptococcus anginosus * (li jinkludu S. anginosus, S. intermedius u S. constellatus) Streptococcus pyogenes*
English: Significant differences in sepsis/septic shock with tigecycline (2.2 %) vs comparators (1.1 %) were observed.
Maltese: Differenzi sinifikanti f'sepsis/septic shock kienu osservati b'tigecycline (2.2 %) vs il-prodotti ta' paragun (1.1 %).
English: The steady-state AUC0-12h was 2349±850 ng•h/ml.
Maltese: L-AUC0-12h fi stat fiss kienet ta' 2349±850 ng•h/ml.
English: There is limited evidence of the clinical efficacy of tigecycline against enterococci.
Maltese: Hemm evidenza ristretta dwar l-effikaċja klinika ta' tigecycline kontra enterococci.
English: Tygacil may interfere with the contraceptive pill (birth control pill).
Maltese: Tygacil jista' jinterferixxi mal-pillola kontraċettiva (pillola li tikkontrolla t-twelidijiet).
English: Note: The vial contains a 6 % overage.
Maltese: Nota: Il-kunjett fih 6% overage.
English: S  0.25 mg/L and R  0.5 mg/L Enterobacteriaceae S  1
Maltese: S  0.25 mg/l u R > 0.5 mg/l Enterobacteriaceae S  1
English: Of these patients, 77.8 % had surgically-apparent peritonitis.
Maltese: Minn dawn il-pazjenti, 77.8% kellhom peritonite evidenti kirurġikament.
English: Infections and infestations sepsis/septic shock, pneumonia, abscess, infections
Maltese: Infezzjonijiet u infestazzjonijiet sepsis/xokk settiku, pulmonite, axxess, infezzjonijiet
English: What Tygacil contains The active substance is tigecycline.
Maltese: Is-sustanza attiva hi tigecycline.
English: ADR identified post-marketing
Maltese: ADR identifikata wara t-tqegħid fis-suq
English: Clinical Cure, mITT Population 0.75 mg/kg
Maltese: Kura Klinika, Popolazzjoni mITT 0.75 mg/kg 1 mg/kg 1.25 mg/kg
English: At 4 times the minimum inhibitory concentration (MIC), a 2-log reduction in colony counts was observed with tigecycline against Enterococcus spp., Staphylococcus aureus, and Escherichia coli.
Maltese: F'4 darbiet tal-konċentrazzjoni inibitorja minima (MIC), tnaqqis 2-log fl-għadd tal-kolonji kien osservat b'tigecycline kontra Enterococcus spp., Staphylococcus aureus, u Escherichia coli.
English: Sodium hydroxide (for pH adjustment)
Maltese: Sodium hydroxide (għall-aġġustament ta' pH)
English: Tigecycline is vulnerable to chromosomally-encoded multi-drug efflux pumps of Proteeae and Pseudomonas aeruginosa.
Maltese: Tigecycline hu vulnerabbli għal pompi tal-effluss chromosomally-encoded multidrug ta' Proteeae u Pseudomonas aeruginosa.
English: C-tigecycline indicates that 59 % of the dose is eliminated by biliary/faecal excretion, and 33 % is excreted in urine.
Maltese: C-tigecycline indika li 59% tad-doża hija eliminata permezz ta' eliminazzjoni biljari jew fl-ippugar, u 33% hija eliminata fl-awrina.
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
English: Multiple dose
Maltese: Doża multipla
English: Date of latest renewal: 22 February 2016.
Maltese: Data tal-aħħar tiġdid: 22 ta' Frar 2016.
English: Tigecycline is administered only by intravenous infusion over 30 to 60 minutes (see sections 4.4 and 6.6).
Maltese: Tigecycline huwa mogħti biss permezz ta' infużjoni fil-vini fuq perjodu ta' 30 sa 60 minuta (ara sezzjonijiet 4.4 u 6.6).
English: In clinical pharmacology studies using the therapeutic dosage regimen of 100 mg followed by 50 mg q12h, serum tigecycline steady-state Cmax was 866±233 ng/ml for 30-minute infusions and 634±97 ng/ml for 60-minute infusions.
Maltese: Fi studji farmakoloġiċi kliniċi bl-użu ta' reġimen tad-dożaġġ terapewtiku ta' 100 mg segwit minn 50 mg kull 12-il siegħa, Cmax fi stat fiss ta' tigecycline fis-serum kienet 866±233 ng/ml għal infużjonijiet ta' 30 minuta u 634±97 ng/ml għal infużjonijiet ta' 60 minuta.
English: (Cyprus Branch), Τηλ: +357 22 817690
Maltese: Pfizer ΕΛΛΑΣ Α.Ε. (Cyprus Branch), Τηλ: +357 22 817690
English: Abdominal pain may be indicative of pancreatitis.
Maltese: Uġigħ addominali jista' jkun indikazzjoni ta' pankreatite.
English: When administered through a Y-site, compatibility of tigecycline diluted in sodium chloride 0.9 % for injection is demonstrated with the following medicinal products or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer's, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
Maltese: Meta jkun mogħti minn ġo sit-Y, il-kompatibbilità ta' tigecycline iddilwit f'sodium chloride 0.9% għall-injezzjoni tintwera bil-prodotti mediċinali jew dilwenti li ġejjin: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer's, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (formulazzjoni EDTA), potassium chloride, propofol, ranitidine HCl, theophylline u tobramycin.
English: Dose Normalized to 1 mg/kg Mean ± SD Tigecycline Cmax and AUC in Children Age (yr)
Maltese: Doża Normalizzata sa 1 mg/kg Medja ± SD Tigecycline Cmax u AUC fi Tfal Età (snin)
English: However, systemic clearance of tigecycline was reduced by 25 % and 55 % and the half-life of tigecycline was prolonged by 23 % and 43 % in patients with moderate or severe hepatic impairment (Child Pugh B and C), respectively (see section 4.2).
Maltese: Madankollu, it-tneħħija sistemika ta' tigecycline kienet imnaqqsa b'25% u 55% u l-half-life ta' tigecycline kienet imtawla bi 23% u 43% f'pazjenti b'indeboliment epatiku moderat sa serju (Child Pugh B u C), rispettivament (ara sezzjoni 4.2).
English: Tigecycline is not extensively metabolised.
Maltese: Tigecycline mhuwiex immetabolizzat estensivament.
English: The in vitro plasma protein binding of tigecycline ranges from approximately 71 % to 89 % at concentrations observed in clinical studies (0.1 to 1.0 mcg/ml).
Maltese: L-irbit tal-proteina ta' tigecycline fil-plażma in vitro tvarja minn bejn wieħed u ieħor 71% għal 89% f'konċentrazzjonijiet osservati fi provi kliniċi (0.1 sa 1.0 mcg/ml).
English: Date of first authorisation: 24 April 2006.
Maltese: Data tal-ewwel awtorizzazzjoni: 24 t'April 2006.
English: Warfarin did not affect the pharmacokinetic profile of tigecycline.
Maltese: Warfarin ma affettwax ilprofil farmakokinetiku ta' tigecycline.
English: Biliary excretion accounts for approximately 50 % of the total tigecycline excretion.
Maltese: Eliminazzjoni biljari tagħti spjegazzjoni għal bejn wieħed u ieħor 50% tal-eliminazzjoni totali ta' tigecycline.
English: In clinical trials in cIAI, the most common type of infection in tigecycline-treated patients was complicated appendicitis (50.3 %), followed by other diagnoses less commonly reported such as complicated cholecystitis (9.6 %), perforation of intestine (9.6 %), intra-abdominal abscess (8.7 %), gastric or duodenal ulcer perforation (8.3 %), peritonitis (6.2 %) and complicated diverticulitis (6.0 %).
Maltese: Fi provi kliniċi f'cIAI, l-aktar tip ta' infezzjoni komuni f'pazjenti ttrattati b'tigecycline kienu appediċite kkumplikata (50.3%), segwita b'dijanjosijiet anqas komuni rrappurtati bħal koliċistite kkumplikata (9.6%), perforazzjoni tal-musrana (10%), axxess intra-adominali (8.7%), u perforazzjoni ta' ulċeri gastriċi u duwodenali (8.3%), peritonite (6.2%) u divertikulite kkumplikata (6.0%).
English: Thus, 5 ml of reconstituted solution is equivalent to 50 mg of the active substance.
Maltese: Għalhekk, 5 ml ta' soluzzjoni rrikostitwita hija ekwivalenti għal 50 mg tas-sustanza attiva.
English: Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.
Maltese: Antibijotiċi tal-klassi ta' glycylcycline huma strutturalment simili għal antibijotiċi tal-klassi ta' tetracyclines.
English: In vitro studies in human liver microsomes indicate that tigecycline does not inhibit metabolism mediated by any of the following 6 cytochrome P450 (CYP) isoforms: 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4 by competitive inhibition.
Maltese: Studji in vitro f'mikrosomi tal-fwied uman indikaw li tigecycline ma jimpedixxix l-metaboliżmu medjat minn xi waħda minn dawn is-6 isoformi taċ-ċitokroma P450 (CYP) li ġejjin: 1A2, 2C8, 2C9, 2C19, 2D6, u 3A4 permezz ta' impediment kompetittiv.
English: The first study enrolled children aged 8-16 years (n=24) who received single doses of tigecycline (0.5, 1, or 2 mg/kg, up to a maximum dose of 50 mg, 100 mg, and 150 mg, respectively) administered intravenously over 30 minutes.
Maltese: L-ewwel studju rrekluta tfal ta' bejn 8 u 16-il sena (n=24) li rċevew dożi singoli ta' tigecycline (0.5, 1, jew 2 mg/kg, sa doża massima ta' 50 mg, 100 mg, u 150 mg, rispettivament) mogħtija ġol-vini fuq perjodu ta' 30 minuta.
English: In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes (see section 5.2).
Maltese: Tigecycline in vitro, mhuwiex inibitur kompetittiv u lanqas inibitur irriversibbli tal-isoformi ta' CYP450 (ara sezzjoni 5.2).
English: Gastrointestinal disorders nausea, vomiting, diarrhoea abdominal pain, dyspepsia, anorexia acute pancreatitis (see section 4.4)
Maltese: Disturbi gastrointestinali nawsja, rimettar, dijarea uġigħ addominali, dispepsja, anoreksja pankreatite akuta (ara sezzjoni 4.4)
English: * (see sections 4.3 and
Maltese: * (ara sezzjonijiet 4.3 u
English: Each vial contains lactose monohydrate.
Maltese: Kull kunjett fih lactose monohydrate.
English: Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients (see section 4.4).
Maltese: Tigecycline preferibbilment għandu jingħata fuq tul ta' infużjoni ta' 60 minuta f'pazjenti pedjatriċi (ara sezzjoni 4.4).
English: Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40 % and 23 %, and an increase in AUC by 68 % and 29 %, respectively.
Maltese: L-għoti flimkien ta' tigecycline u warfarin (doża waħda ta' 25 mg) lil individwi b'saħħithom irriżulta fi tnaqqis fir-rata ta' eliminazzjoni ta' R-warfarin u S-warfarin b'40% u 23%, u żieda fl-AUC b'68% u 29%, rispettivament.
English: Lactose monohydrate Hydrochloric acid
Maltese: Lactose monohydrate
English: Tabulated list of adverse reactions
Maltese: Lista tar-reazzjonijiet avversi f'tabella
English: Nervous system disorders dizziness
Maltese: Disturbi fissistema nervuża sturdament
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA12.
Maltese: Antibatteriċi għal użu sistemiku, tetracyclines, Kodiċi ATC:
English: Gram-positive Aerobes
Maltese: Aerobi Gram-pożittivi
English: • Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite)
Maltese: • Uġigħ addominali, dispepsja (uġigħ fl-istonku u indiġestjoni), anoreksja (imur l-aptit)
English: Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
Maltese: Adolexxenti li jkollhomminn 12 sa <18-il sena: 50 mg ta' tigecycline kull 12-il siegħa għal 5 sa 14-il jum.
English: There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores  15 (3.3 %), or with surgically apparent multiple intra-abdominal abscesses (11.4 %).
Maltese: pazjenti diġà morda b'mard serju bħal ma huma pazjenti immunokompromessi, pazjenti b'punteġġi APACHE II > 15 (3.34%), jew b'axxessi multipli intra-addominali evidenti kirurġikament (11.4%).
English: Tetracycline class effects
Maltese: Effetti għal klassi ta' tetracyclines
English: The other ingredients are lactose monohydrate, hydrochloric acid, and sodium hydroxide.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, hydrochloric acid, u sodium hydroxide
English: For anaerobic bacteria there is clinical evidence of efficacy in polymicrobial intra-abdominal infections, but no correlation between MIC values, PK/PD data and clinical outcome.
Maltese: Hemm evidenza klinika ta' effikaċja għal batterji anerobiċi f'infezzjonijiet polimikrobjali intraaddominali, iżda l-ebda korrelazzjoni bejn valuri MIC, dejta PK/PD u riżultat kliniku.
English: Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients.
Maltese: Tigecycline preferibbilment għandu jingħata fuq tul ta' infużjoni ta' 60 minuta f'pazjenti pedjatriċi.
English: Skin and subcutaneous tissue disorders pruritus, rash severe skin reactions, including Stevens-Johnson Syndrome
Maltese: Disturbi filġilda u fittessuti ta' taħt il-ġilda ħakk, raxx reazzjonijiet severi tal-ġilda, inkluż isSindromu ta' Stevens-Johnson
English: Tigecycline shows a polyexponential elimination from serum with a mean terminal elimination half-life after multiple doses of 42 hours although high interindividual variability exists.
Maltese: Tigecycline juri eliminazzjoni poliesponenzjali mis-serum b'half-life ta' eliminazzjoni terminali medja ta' 42 siegħa wara dożi multipli għalkemm teżisti varjabilità għolja bejn individwi differenti.
English: Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline (see sections 4.3 and 4.8).
Maltese: Anafilassi/reazzjonijiet anafilattojdi, li potenzjalment jistgħu jkunu ta' periklu għal ħajja, ġew irrappurtati b'tigecycline (ara sezzjonijiet 4.3 u 4.8).
English: The safety of tigecycline was also investigated in an open-label, ascending multi-dose PK study in 58 children aged 8 to 11 years with cSSTI (n=15), cIAI (n=24) or community-acquired pneumonia (n=19).
Maltese: Is-sigurtà ta' tigecycline ġiet investigata wkoll fi studju PK open-label, dwar dożi multipli jiżdiedu li sar fuq 58 tifel u tifla li kellhom minn 8 sa 11-il sena b'cSSTI (n=15), cIAI (n=24) jew pnewmonja akkwiżita f'komunità (n=19).
English: Decreased susceptibility in Acinetobacter baumannii has been attributed to the overexpression of the AdeABC efflux pump.
Maltese: Tnaqqis fis-suxxettibbilità ta' Acinetobacter baumannii kien attribwit għall-espressjoni żejda tal-pompa tal-effluss AdeABC.
English: • Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4);
Maltese: • Infezzjonijiet tal-ġilda u tessuti rotob ikkumplikati (cSSTI), li jeskludu infezzjonijiet dijabetiċi tas-saqajn (ara sezzjoni 4.4);
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tigecycline/metabolites in milk (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' tigecycline /metaboliti fil-ħalib tas-sider (gћad-dettalji ara 5.3).
English: The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance 30 ml/min, n=6).
Maltese: Id-dispożizzjoni farmakokinetika ta' doża waħda ta' tigecycline ma kinitx mibdula f'pazjenti b'indeboliment renali (tneħħija tal-kreatinina 30 ml/min, n=6).
English: In Phase 3 and 4 cSSTI and cIAI clinical studies, infection-related serious adverse reactions were more frequently reported for subjects treated with tigecycline (7.1 %) vs comparators (5.3 %).
Maltese: Fil-fażi 3 u 4 tal-istudji kliniċi cSSTI u cIAI, reazzjonijiet avversi serji relatati ma' infezzjoni kienu rrapurtati aktar frekwenti f'suġġetti kkurati b'tigecycline (7.1 %) vs il-prodotti ta' paragun (5.3 %).
English: In severe renal impairment, AUC was 30 % higher than in subjects with normal renal function (see section 4.2).
Maltese: F'indeboliment renali serju l-AUC kienet 30% ogħla milli f'individwi b'funzjoni renali normali (ara sezzjoni 4.2).
English: In an open-label, ascending multiple-dose study, 39 children aged 8 to 11 years with cIAI or cSSTI were administered tigecycline (0.75, 1, or 1.25 mg/kg).
Maltese: Fi studju open-label, dwar dożi multipli jiżdiedu, 39 tifel u tifla li kellhom minn 8 sa 11-il sena b'cIAI jew cSSTI ingħataw tigecycline (0.75, 1, jew 1.25 mg/kg).
English: Hepatobiliary disorders elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia jaundice, liver injury, mostly cholestatic hepatic failure
Maltese: Disturbi filfwied u filmarrara aspartate aminotransferase (AST) elevat fisserum, u alanine aminotransferase (ALT) elevat fisserum, iperbilirubinemija suffejra, feriti filfwied, il-biċċa lkbira minnhom kolestatiċi insuffiċjenza epatika
English: S  0.5 mg/L and R  0.5 mg/L Streptococcus spp.
Maltese: S  0.5 mg/l u R > 0.5 mg/l Streptococcus spp. li mhux S.pneumoniae S  0.25 mg/l u R > 0.5 mg/l Enterococcus spp.
English: In all Phase 3 and 4 (cSSTI and cIAI) studies, death occurred in 2.4 % (54/2216) of patients receiving tigecycline and 1.7% (37/2206) of patients receiving active comparators.
Maltese: Fil-fażijiet 3 u 4 kollha ta' l-istudji (cSSTI u cIAI), kien hemm każijiet ta' mewt f'2.4 % (54/2216) talpazjenti li qed jirċievu tigecycline u f'1.7% (37/2206) tal-pazjenti li qed jirċievu l-mediċini ta' paragun attivi.