qanastek/EMEA-V3 huggingface dataset:
Most of the reported cases developed after at least one week of treatment.
Il- maġġoranza tal- każijiet rapportati żviluppaw wara ta ’ lanqas ġimgħa ta ’ kura.
Cases have been reported in patients without known risk factors for pancreatitis.
Każijiet ġew rapportati f’ pazjenti mingħajr fatturi ta ’ riskju magħrufa għal pankreatite.
Patients usually improve after tigecycline discontinuation.
Il- pazjenti ġeneralment jitjiebu wara li jieqfu jieħdu tigecycline.
Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.
Konsiderazzjoni għandha tingħata għal waqfien tat- trattament b’ tigecycline f’ każijiet suspettati li żviluppaw pankreatite.
Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.
L- esperjenza fl- użu ta ’ tigecycline għal trattament ta ’ infezzjonijiet f’ pazjenti diġà morda b’ mard serju hija ristretta.
In clinical trials in complicated skin and soft tissue infections, the most common type of infection in tigecycline treated-patients was cellulitis (59%), followed by major abscesses (27.5%).
Fi provi kliniċi f’ infezzjonijiet ikkumplikati tal- ġilda u tat- tessuti rotob, l- aktar tip ta ’ infezzjonijiet komuni f’ pazjenti trattati b’ tigecycline kienu ċellulite (59%) segwita b’ axxessi maġġuri (27. 5%).
Patients with severe underlying disease, such as those that were immunocompromised, patients with decubitus ulcer infections, or patients that had infections requiring longer than 14 days of treatment (for example, necrotizing fasciitis), were not enrolled.
Pazjenti diġà morda b’ mard serju, bħal dawk li kienu immunokompromessi, pazjenti b’ infezzjonijiet ta ’ ulċeri decubitus, jew pazjenti li kellhom infezzjonijiet li kienu jeħtieġu trattament għal aktar minn 14- il jum (per eżempju, faxxitis li tinnekrotizza), ma kinux irreġistrati.
Few patients with diabetic foot infections (5%) were enrolled.
Xi ftit pazjenti b’ infezzjonijiet dijabetiċi fis - saqajn (5%) kienu rreġistrati.
A limited number of patients were enrolled with co-morbid factors such as diabetes (20%), peripheral vascular disease (7%), intravenous drug abuse (2%), and HIV-positive infection (1%).
Għadd ristrett ta ’ pazjenti b’ fatturi ko- morbużi bħal ma huma dijabete (20%), mard vaskulari periferali (7%), abbuż ta ’ droga intravenuża (2%), u infezzjoni pożittiva bl- HIV (1%), kienu reġistrati.
Limited experience is also available in treating patients with concurrent bacteraemia (3%).
Hemm ukoll esperjenza ristretta fit- trattament ta ’ pazjenti b’ batterimja konkomitanti (3%).
Therefore, caution is advised when treating such patients.
Għalhekk, huwa rakkomandat sabiex tintuża l- kawtela meta pazjenti bħal dawn ikunu qegħdin jiġu ttrattati.
3 In clinical trials in complicated intra-abdominal infections, the most common type of infection in tigecycline treated-patients was complicated appendicitis (51%), followed by other diagnoses less commonly reported such as complicated cholecystitis (14%), intra-abdominal abscess (10%), perforation of intestine (10%) and gastric or duodenal ulcer perforation less than 24 hours (5%).
3 Fi provi kliniċi f’ infezzjonijiet intra- addominali kkumplikati, l- aktar tip ta ’ infezzjoni komuni f’ pazjenti ttrattati b’ tigecycline kienu appediċite kkumplikata (51%), segwita b' dijanjosijiet anqas komuni rrapportati bħal koliċistite kkumplikata (14%), axxess intra- adominali (10%), perforazzjoni tal- musrana (10%) u perforazzjoni ta ’ ulċeri gastriċi u duwodenali ta ’ anqas minn 24 siegħa (5%).
Of these patients, 76% had associated diffuse peritonitis (surgically-apparent peritonitis).
Minn dawn il- pazjenti, 76% kellhom assoċjata peritonite mxerrda (peritonite evidenti kirurġikament).
There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores > 15 (4%), or with surgically apparent multiple intra-abdominal abscesses (10%).
Kien hemm għadd ristrett ta ’ pazjenti diġà morda b’ mard serju bħal ma huma pazjenti immunokompromessi, pazjenti bi skors APACHE II > 15 (4%), jew b’ axxessi multipli intra- addominali evidenti kirurġikament (10%).
Limited experience is also available in treating patients with concurrent bacteraemia (6%).
Hemm ukoll esperjenza ristretta fit- trattament ta ’ pazjenti b’ batterimja konkomitanti (6%).
Therefore, caution is advised when treating such patients.
Għalhekk, huwa avżat biex tintuża l- kawtela meta pazjenti bħal dawn ikunu qegħdin jiġu ttrattati..
Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
Għandha tingħata konsiderazzjoni għal użu ta ’ terapija antibatterika meta tigelycine ikun se jiġi mogħti ’ l- pazjenti li jkunu morda serjament b’ infezzjonijiet intra- addominali kkumplikati (cIAI) sekondarji għal perforazzjoni tal- musrana klinikament evidenti jew pazjenti bil- bidu ta ’ sepsis jew xokk septiku (ara sezzjoni 4. 8).
The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established.
L- effett ta ’ kolestasi fil- farmakokinetiċi ta ’ tigecycline ma ġietx stabbilita sewwa.
Biliary excretion accounts for approximately 50% of the total tigecycline excretion.
Eliminazzjoni biljari tagħti spjegazzjoni għal bejn wieħed u ieħor 50% ta ’ l- eliminazzjoni totali ta ’ tigecycline.
Therefore, patients presenting with cholestasis should be closely monitored.
Għalhekk, pazjenti li jippreżentaw b’ kolestasi għandhom jiġu ssorveljati mill- qrib.
Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Il- ħin tal- protrombin jew xi test antikoagulanti ieħor li jkun adattat għandu jiġi użat biex jissorvelja pazjenti jekk tigecycline jiġi mogħti ma ’ antikoagulanti (ara sezzjoni 4. 5).
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening.
Kolite psewdomembranuża kienet irrapportata fi kważi l- mediċini antibatteriċi kollha u tista ’ tvarja fis- serjetà minn ħafifa sa li tkun ta ’ theddid għal ħajja.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
Għalhekk, huwa importanti li tikkunsidra din id- dijanjosi f’ pazjenti li jippreżentaw b’ dijarrea waqt jew wara l- għoti ta ’ kull mediċina antibatterika (ara sezzjoni 4. 8).
The use of tigecycline may result in overgrowth of non-susceptible organisms, including fungi.
L- użu ta ’ tigecycline jista ’ jirriżulta fi tkabbir żejjed ta ’ orġaniżmi li ma jkunux suxxettibbli, inklużi fungi.
Patients should be carefully monitored during therapy.
Pazjenti għandhom jiġu sorveljati mill- qrib waqt t- terapija.
If super infection occurs, appropriate measures should be taken (see section 4.8).
Miżuri adegwati għandhom jittieħdu jekk ikun hemm soprainfezzjoni (ara sezzjoni 4. 8).
Results of studies in rats with tigecycline have shown bone discolouration.
Riżultati ta ’ studji b’ tigecycline fil- firien urew tidnis tal- kulur ta ’ l- għadam.
Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Fil- bnedmin, tigecycline jista ’ jkun assoċjat ma ’ tindis tal- kulur tas- snien permanenti jekk jintuża waqt l- iżvilupp tas- snien (ara sezzjoni 4. 8).
Tygacil should not be used in children under 8 years of age because of teeth discolouration, and is not recommended in adolescents below 18 years due to the lack of data on safety and efficacy (see sections 4.2 and 4.8).
Tygacil m’ għandux jintuża fi tfal taħt l- età ta ’ 8 snin minħabba tindis tal- kulur tas- snien, u mhuwiex irrakkomandat f’ adolexxenti taħt it- 18- il sena minħabba nuqqas ta ’ dejta fuq is- sigurtà u l- effikaċja (ara sezzjonijiet 4. 2 u 4. 8).
Interaction studies have only been performed in adults.
Studji dwar interazzjonijiet ġew magħmula biss fuq aduti
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.
L- għoti flimkien ta ’ tigecycline u warfarin (doża- waħda ta '25 mg) lil suġġetti 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.
The mechanism of this interaction is still not elucidated.
Il- mekkaniżmu ta ’ din l- interazzjoni għadu ma ġiex spjegat.
Available data does not suggest that this interaction may result in significant INR changes.
Id- dejta disponibbli ma tissuggerix li din l- interazzjoni tista ’ tirriżulta f’ tibdiliet sinifikativi fl- INR.
However, since tigecycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT), the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants (see section 4.4).
Madankollu, peress li tigecycline jista ’ jtawwal kemm il- ħin tal- protrombin (PT) u kemm l- ħin tat- tromboplastin attivat parzjalment (aPTT), it- testijiet ta ’ koagulazzjoni rilevanti għandhom ikunu sorveljati mill- qrib meta tigecycline ikun mogħti fl- istess ħin ma ’ antikoagulanti (ara sezzjoni 4. 4).
Warfarin did not affect the pharmacokinetic profile of tigecycline.
Warfarin ma affettwatx il- profil farmakokinetiku ta ’ tigecycline.
4 Tigecycline is not extensively metabolised.
4 Tigecycline mhuwiex metabolizzat estensivament.
Therefore, clearance of tigecycline is not expected to be affected by active substances that inhibit or induce the activity of the CYP450 isoforms.
Għalhekk, it- tneħħija ta ’ tigecycline mhix mistennija li tkun effettwata mis- sustanzi attivi li jinibixxu jew jinduċu l- attività ta ’ l- iżoformi CYP450.
In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes (see section 5.2).
Tigecycline in vitro, mhuwiex inibitur kompettiv u lanqas inibitur irriversibbli ta ’ l- isoformi ta ’ CYP450 (ara sezzjoni 5. 2).
Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults.
Fid- dożaġġ irrakkomandat tigecycline ma jaffettwax ir- rata u l- estensjoni ta ’ l- assorbiment, jew t- tneħħija ta ’ digoxin (0. 5 mg segwiti b’ 0. 25 mg kuljum) meta jiġi mogħti lill- adulti f’ saħħithom.
Digoxin did not affect the pharmacokinetic profile of tigecycline.
Digoxin ma affettwatx il- profil farmakokinetiku ta ’ tigecycline.
Therefore, no dosage adjustment is necessary when tigecycline is administered with digoxin.
Għalhekk, l- ebda aġġustament fid- doża ma huwa meħtieġ meta tigecycline jiġi mogħti ma ’ digoxin.
In in vitro studies, no antagonism has been observed between tigecycline and other commonly used antibiotic classes.
Fi studji in vitro, l- ebda antagoniżmu ma ġie osservat bejn tigecycline u kategoriji oħra ta ’ antibijotiċi użati komunement.
Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.
L- użu flimkien ta 'antibijotiċi ma' kontraċettivi orali jistgħu jġagħlu l- kontraċettivi jkunu anqas effettivi.
There are no adequate data from the use of tigecycline in pregnant women.
M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ tigecycline waqt it- tqala.
Results from animal studies have shown tigecycline may cause foetal harm when administered during pregnancy (see section 5.3).
Riżultati minn studji fuq bhejjem urew li tigecycline jista 'jikkaġuna ħsara fil- fetu meta jiġi mogħti waqt it- tqala (ara sezzjoni 5. 3).
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).
Kif inhu magħruf għal klassi ta ’ antibijotiċi tetraċiklini, tigecycline jista ’ ukoll jinduċi difetti dentali permanenti (tindis tal- kulur u difetti fl- enamel) u dewmien fil - proċessi ta ’ ossifikazzjoni fil- feti, esponuti in utero waqt l- aħħar nofs tal- ġestazzjoni, u fi tfal taħt l- età ta ’ tmin snin minħabba l- arrikkament fit- tessuti b’ rata għolja ta ’ ċaqliq tal- kalċju u formazzjoni ta ’ kumplessi ta ’ kelat tal- kalċju (ara sezzjoni 4. 4).
Tigecycline should not be used during pregnancy unless clearly necessary.
Tigecycline m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar.
It is not known whether this medicinal product is excreted in human milk.
Mhux magħruf jekk dan il- prodott mediċinali jiġix eliminat fil- ħalib uman.
In animal studies tigecycline is excreted into milk of lactating rats.
Fi studji fl- annimali tigecycline huwa eliminat fil- ħalib ta ’ firien li jkunu qegħdin ireddgħu.
Because a potential risk to the breast-feeding infant cannot be ruled out, when treating with tigecycline, caution should be exercised and interruption of breast-feeding should be considered (see section 5.3).
Minħabba li r- riskju potenzjali għat- tarbija li tkun qed titreddgħa ma jistax jiġi eliminat, għandha tiġi eżerċitata l- kawtela u t- twaqqif tat - treddigħ għandu jiġi kkunsidrat, waqt trattament b’ tigecycline (ara sezzjoni 5. 3).
No studies on the effects of tigecycline on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Dizziness may occur and this may have an effect on driving and use of machines (see section 4.8).
Stordamenti jistgħu jseħħu u dawn jista 'jkollhom effett fuq is- sewqan u t- tħaddim ta' magni (ara sezzjoni 4. 8).
The total number of patients treated with tigecycline in Phase 3 clinical studies was 1415.
L- għadd totali ta ’ pazjenti ttrattati b’ tigecycline fi provi kliniċi ta 'Fażi 3 kien ta' 1415.
Adverse reactions were reported in approximately 41% of patients treated with tigecycline.
Reazzjonijiet avversi ġew rapportati f' madwar 41% tal- pazjenti trattati b' tigecycline.
Treatment was discontinued due to adverse reactions in 5% of patients.
It- trattament ġie mwaqqaf minħabba reazzjonijiet avversi f' 5% tal- pazjenti.
In clinical trials, the most common drug-related treatment emergent adverse reactions were reversible nausea (20%) and vomiting (14%), which usually occurred early (on treatment days 1-2) and were generally mild or moderate in severity.
Fi provi kliniċi, l- aktar reazzjonijiet avversi komuni relatati mal- mediċina li ħarġu kienu nawsja riversibbli (20%) u rimettar (14%), li ġeneralment seħħew kmieni (fil- jiem 1- 2 tat- trattament) u kienu ġeneralment ħfief jew moderati fis- severità.
Adverse reactions reported with Tygacil, including clinical trials and post-marketing experience, are listed below:
5 Reazzjonijiet avversi rapportati b’ Tygacil, fil- provi kliniċi u esperjenza wara t- tqegħid fis- suq, huma elenkati hawn isfel:
Frequency categories are expressed as:
Il- kategoriji ta ’ frekwenza huma mfissra bħala:
Very common (≥ 1/ 10); Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1,000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1,000); Very Rare (< 1/ 10,000)
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)
5 For adverse reactions identified from post-marketing experience with Tygacil derived from spontaneous reports for which the frequency cannot be estimated, the frequency grouping is categorized as not known.
Għal reazzjonijiet avversi identifikati minn esperjenza ta ’ wara t- tqegħid fis- suq b’ Tygacil derivati minn rapporti spontaneji li għalihom il- frekwenza ma tistax tiġi stmata, huwa kategorizzati bħala mhux magħruf.
Infections and infestations:
Infezzjonijiet u infestazzjonijiet Komuni:
Abscess, infections Uncommon:
Axxess, infezzjonijiet Mhux komuni:
Sepsis/ septic shock
Sepsis/ xokk settiku
In Phase 3 clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with tigecycline (6.7%) vs comparators (4.6%).
Fi studji kliniċi ta 'Fażi 3, każijiet ta' reazzjonijiet avversi relatati ma 'infezzjonijiet kienu aktar rapportati frekwentament għal suġġetti trattati b' tigecycline (6. 7%) vs komparaturi (4. 6%).
Significant differences in sepsis/ septic shock with tigecycline (1.5%) vs comparators (0.5%) were observed.
Kienu osservati differenzi sinifikanti f' sepsis/ xokk settiku b' tigecycline (1. 5%) vs komparaturi (0. 5%).
Prolonged activated partial thromboplastin time (aPTT), Prolonged prothrombin time (PT) Uncommon:
Mhux komuni:
Increased International Normalised Ratio (INR) Not known: thrombocytopenia
Proporzjon Normalizzat Internazzjonali (INR) ogħla Mhux magħruf: tromboċitopenja
Immune system disorders:
Disturbi marbuta mas- sistema immuni:
Anaphylaxis/ anaphylactoid reactions (see sections 4.3 and 4.4)
Anafilassi/ reazzjonijiet anafilattojdi (ara sezzjonijiet 4. 3 u 4. 4)
Metabolism and nutrition disorders:
Disturbi marbuta mal- metaboliżmu u nutrizzjon:
Hypoproteinaemia
Ipoprotenimja
Dizziness
Stordamenti
Vascular disorders:
Disturbi vaskulari Komuni:
Phlebitis Uncommon:
Flebite Mhux komuni:
Gastrointestinal disorders:
Disturbi gastro- intestinali Komuni ħafna: nawsja, rimettar, dijarea Komuni:
Abdominal pain, dyspepsia, anorexia Uncommon:
Uġigħ addominali, dispepsja, anoreksja Mhux komuni:
Acute pancreatitis
Pankreatite akuta
Hepato-biliary disorders:
Disturbi epato- biljari:
Elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia
Komuni: aspartate aminotransferase (AST) elevat fis- serum, u alanine aminotransferase (ALT) elevat fis- serum, iperbilirubinemija
AST and ALT abnormalities in Tygacil-treated patients were reported more frequently in the post therapy period than in those in comparator-treated patients, which occurred more often on therapy.
F’ pazjenti ttrattati b’ Tygacil annormalitajiet fl- AST u ALT li seħħew aktar ta ’ spiss fuq it- terapija kienu rrapportati aktar ta ’ spiss fil- perijodu ta ’ wara t- terapija milli f’ dawk f’ pazjenti ttrattati b’ komparaturi.
Jaundice, liver injury, mostly cholestatic
Suffejra, feriti fil- fwied, il- biċċa l- kbira tagħhom kolestatiċi
6 Skin and subcutaneous tissue disorders:
6 Disturbi tal- ġilda u tessuti subkutaneji:
Pruritus, rash
Ħakk, raxx
General disorders and administration site conditions:
Disturbi ġenerali u kundizzjonijiet ta 'mnejn jittieħed Komuni:
Injection site reaction, injection site inflammation, injection site pain, injection site oedema, injection site phlebitis
Uġigħ ta 'ras Mhux komuni: reazzjoni fis- sit ta' l- injezzjoni, infjammazzjoni fil- lok ta 'l- injezzjoni, uġigħ fil- lok ta' l- injezzjoni, edema fil- lok ta 'l- injezzjoni, flebite fil- lok ta' l- injezzjoni
Elevated amylase in serum, increased blood urea nitrogen (BUN)
Żieda fl- amylase fis- serum, żidiet fil- urea nitrogen fid- demm (BUN)
In Phase 3 cSSSI and cIAI studies, death occurred in 2.3% (32/ 1383) of patients receiving tigecycline and 1.6% (22/ 1375) of patients receiving comparator drugs.
Fi studji ta 'Fażi 3 cSSSI u cIAI, seħħet il- mewt fi 2. 3% (32/ 1383) tal- pazjenti li jkunu qegħdin jingħataw tigecycline u f’ 1. 6% (22/ 1375) tal- pazjenti li qegħdin jingħataw mediċini komparaturi.
Antibiotic Class Effects:
Effetti tal- Klassi Antibijotika:
Pseudomembranous colitis which may range in severity from mild to life threatening (see section 4.4)
Kolite psewdomembranuża li tista ’ tvarja fis- severità minn ħafifa sa ta ’ periklu għal ħajja (ara sezzjoni 4. 4)
Overgrowth of non-susceptible organisms, including fungi (see section 4.4)
Tkabbir żejjed ta ’ organiżmi li mhumiex suxxettibli, li jinkludu fungi (ara sezzjoni 4. 4)
Tetracycline Class Effects:
Effetti għal Klassi ta ’ Tetracyclines:
Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics.
Antibijotiċi tal- klassi ta ’ glycylcycline huma strutturalment simili għal antibijotiċi tal- klassi ta ’ tetracyclines.
Tetracycline class adverse reactions may include photosensitivity, pseudotumour cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia (see section 4.4).
Reazzjonijiet avversi tal- klassi tat- tetracyclines jistgħu jinkludu fotosensittività, pseudotumour cerebri, pankreatite u azzjoni anti- anabolika li tista ’ twassal għal żieda fil- BUN, ażotemja, aċidosi u iperfosfatemja (ara sezzjoni 4. 4).
Tigecycline may be associated with permanent tooth discolouration if used during tooth development (see section 4.4).
Tigecycline jista ’ jkun assoċjat ma ’ tibdil fil- kulur tas- snien jekk jintuża waqt l- iżvilupp tas- snien (ara sezzjoni 4. 4)
No specific information is available on the treatment of overdosage.
L- ebda tagħrif mhu disponibbli dwar it- trattament ta 'doża eċċessiva.
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.
L- għoti ġol- vina ta 'tigecycline f' doża waħdanija ta' 300 mg fuq 60 minuta f' voluntieri b' saħħothom irriżultat f' inċidenza ogħla ta 'nawsja u rimettar.
Tigecycline is not removed in significant quantities by haemodialysis.
Tigecycline ma jiġiex eliminat fi kwantitajiet sinifikanti b' emodijalisi.
Tetracyclines, ATC code:
Tetraċiklini; Kodiċi ATC:
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.
Mod ta 'azzjoni Tigecycline, antibijotiku glycylcycline, jinibixxi t- traduzzjoni tal- proteina fil- batterji billi jorbot mas - subunit tar- ribosomi 30S u jimblokka d- dħul ta ’ molekuli ta ’ amino- acyl tRNA fis- sit A tar- ribosoma.
This prevents incorporation of amino acid residues into elongating peptide chains.
Dan jimpeddixxi l- inkorporazzjoni ta ’ residwi ta ’ aċidi amminiċi fi ktajjen ta ’ peptide mtawwla.
7 In general, tigecycline is considered bacteriostatic.
B' mod ġenerali, Tigecycline huwa kkunsidrat batterjostatiku.
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.
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.
Tigecycline is able to overcome the two major tetracycline resistance mechanisms, ribosomal protection and efflux.
7 Mekkaniżmu ta 'reżistenza Tigecycline huwa kapaċi jgħeleb iż- żewġ mekkaniżmi ta ’ reżistenza maġġuri, protezzjoni ribosomali u effluss.
However, it is vulnerable to chromosomally-encoded multidrug efflux pumps of Proteeae (see below) and Pseudomonas aeruginosa (MexXY-OprM efflux system).
Madankollu, huwa vulnerabbli għall- pompi ta ’ l- effluss ta ’ ħafna mediċini li jkunu mdaħħlin f’ kodiċi kromożomali ta ’ Proteeae (ara hawn taħt) u Pseudomonas aeruginosa (sistema ta ’ effluss MexXY- OprM).
There is no target-based cross-resistance between tigecycline and most classes of antibiotics.
M’ hemm l- ebda reżistenza inkroċjata bbażata fuq il- bersall bejn tigecycline u l - maġġoranza tal- klassijiet ta ’ l- antibijotiċi.
Pathogens of the family Proteeae (Proteus spp., Providencia spp., and Morganella spp.) are generally less susceptible to tigecycline than other members of the Enterobacteriaceae.
Patoġeni tal- familja Proteeae (Proteus spp., Providencia spp., u Morganella spp.) huma ġeneralment anqas suxxettibbli mill- membri l- oħra ta 'Enterobacteriaceae.
In addition, some acquired resistance has been detected in Klebsiella pneumoniae, Enterobacter aerogenes, and Enterobacter cloacae.
Barraminhekk, xi reżistenza miksuba nsabet fi Klebsiella pneumoniae, Enterobacter aerogenes, u Enterobacter cloacae.
Decreased susceptibility in both groups has been attributed to the overexpression of the non-specific AcrAB multi-drug efflux pump.
Tnaqqis fis- suxxettibbilità fiż- żewġ gruppi ġiet attribwita għall- espressjoni żejda tal- pompa ta ’ l- effluss AcrAB mhux speċifika ta ’ ħafna mediċini.
Decreased susceptibility in Acinetobacter baumannii has been attributed to the overexpression of the AdeABC efflux pump.
Tnaqqis fis- suxxettibbilità ta ’ Acinetobacter baumannii kien attribwit għall- espressjoni żejda tal- pompa ta ’ l- effluss AdeABC.
Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Breakpoints Il- breakpoints tal- konċentrazzjoni inibitorja minima (MIC) stabbiliti mill- Kummissjoni Ewropea fuq Ittestjar ta ’ Suxxettibbilità Antimikrobjali (EUCAST) huma kif ġejjin:
S ≤ 0.5 mg/ L and R > 0.5 mg/ L Streptococcus spp. other than S. pneumoniae S ≤ 0.25 mg/ L and R > 0.5 mg/ L Enterococcus spp.
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.
S ≤ 0.25 mg/ L and R > 0.5 mg/ L Enterobacteriaceae S ≤ 1(^) mg/ L and R > 2 mg/ L (^) Tigecycline has decreased in vitro activity against Proteus, Providencia, and Morganella spp.
S ≤ 0. 25 mg/ L u R > 0. 5 mg/ L Enterobacteriaceae S ≤ 1( ^) mg/ L u R > 2 mg/ L (^) Tigecycline għandu tnaqqis fl- attività kontra Proteus, Providencia, u Morganella spp. in vitro.
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.
Hemm evidenza klinika ta ’ effikaċja għal batterji anerobiċi f’ infezzjonijiet polimikrobjali intra - addominali, iżda l- ebda korrelazzjoni bejn valuri MIC, dejta PK/ PD u riżultat kliniku.
Therefore, no breakpoint for susceptibility is given.
Għalhekk, ma tingħata l- ebda breakpoint għas- suxxettibbilità.
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.
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.
There is limited evidence of the clinical efficacy of tigecycline against enterococci.
Hemm evidenza ristretta dwar l- effikaċja klinika ta ’ tigecycline minn enterococci.
However, polymicrobial intra-abdominal infections have shown to respond to treatment with tigecycline in clinical trials.
Madankollu, infezzjonijiet polimikrobjali intra- addominali ġew murija li jirrispondu għat- trattament b’ tigecycline fi provi kliniċi.
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Suxxettibbilità Il- prevalenza ta ’ reżistenza miksuba tista ’ tvarja ġeografikament u biż- żmien fi speċi magħżula, u informazzjoni lokali fuq ir- rezistenza hija mixtieqa, partikolarment meta jkunu qegħdin jiġu ttrattati infezzjonijiet serji.
As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Għandu jiġi mfittex parir ta ’ espert, kif ikun neċessarju, meta l- prevalenza lokali ta ’ reżistenza hija tali li l- utilità tal- mediċina f’ ta ’ l- anqas ċerti tipi ta ’ infezzjonijiet hija kwestjonabbli.
Commonly Susceptible Species Enterococcus spp .† Staphylococcus aureus* Staphylococcus epidermidis 8 Pathogen
8 Patoġenu
Staphylococcus haemolyticus Streptococcus agalactiae* Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes* Viridans group streptococci Citrobacter freundii* Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae* Escherichia coli* Klebsiella oxytoca* Klebsiella pneumoniae* Serratia marcescens Clostridium perfringens† Peptostreptococcus spp .† Prevotella spp.
Speċijiet Komunament Suxxettibbli Enterococcus spp. † Staphylococcus aureus * Staphylococcus epidermidis Staphylococcus haemolyticus Streptococcus agalactiae * Streptococcus anginosus group * (li jinkludu S. anginosus, S. intermedius u S. constellatus) Streptococcus pyogenes * Streptococci tat- tip Viridans Citrobacter freundii * Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae * Escherichia coli * Klebsiella oxytoca * Klebsiella pneumoniae * Serratia marcescens Clostridium perfringens † Peptostreptococcus spp. † Prevotella spp.
Species for which acquired resistance may be a problem Acinetobacter baumannii Bacteroides fragilis group† Burkholderia cepacia Morganella morganii Providencia spp.
Specijiet li għalihom ir- reżistenza miksuba tista 'tkun problema Acinetobacter baumannii Il- grupp ta' Bacteroides fragilis † Burkholderia cepacia Morganella morganii Providencia spp.
Inherently resistant organisms Pseudomonas aeruginosa * denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies. † see section 5.1, Breakpoints above.
Organiżmi reżistenti inerentament Pseudomonas aeruginosa * tfisser speċi li kontra tagħha huwa kkonsidrat li l- attività ġiet murija sodisfaċenti fl- istudji kliniċi. † ara sezzjoni 5. 1, Breakpoints hawn fuq.
Tigecycline is administered intravenously and therefore has 100% bioavailability.
Assorbiment Tigecycline huwa mogħti ġol- vina u għalhekk għandu bijodisponibilità ta '100%.
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 µg/ ml).
Distribuzzjoni L- irbit tal- proteina fil- plażma ta ’ tigecycline in vitro tvarja minn bejn wieħed u ieħor 71% għal 89% f’ konċentrazzjonijiet osservati fi provi kliniċi (0. 1 sa 1. 0 μg/ ml).
Animal and human pharmacokinetic studies have demonstrated that tigecycline readily distributes to tissues.
Studji farmakokinetiċi fl- annimali u fil- bnedmin urew li tigecycline malajr jiddistribwixxi ruħu fit- tessuti.
In rats receiving single or multiple doses of 14C-tigecycline, radioactivity was well distributed to most tissues, with the highest overall exposure observed in bone marrow, salivary glands, thyroid gland, spleen, and kidney.
Fil- firien li jkunu qegħdin jingħataw dożi waħdanin jew multipli ta ’ 14C- tigecycline kien distribwit sewwa fil- parti l- kbira tat- tessuti, bl- aktar esponiment għoli osservat fil- mudullun, il- glandoli salivarji, il- glandola tirojde, il- milsa, u l- kilwa.
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.
Fil- bnedmin, il- volum ta ’ stat fiss ta ’ distribuzzjoni ta ’ tigecycline 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.
9 No data are available on whether tigecycline can cross the blood-brain barrier in humans.
9 Ma hemm l- ebda dejta fuq jekk tigecycline jistax jaqsam il- barriera tad- demm- moħħ fil- bnedmin.
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.
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.
The steady-state AUC0-12h was 2349±850 ng• h/ ml.
L- AUC0- 12h fi stat fiss kienet ta ’ 2349±850 ng• h/ ml.
On average, it is estimated that less than 20% of tigecycline is metabolised before excretion.
Metaboliżmu Huwa kkalkulat li bejn wieħed u ieħor anqas minn 20% ta ’ tigecycline huwa metabolizzat qabel l- eskrezzjoni.
In healthy male volunteers, following the administration of 14C-tigecycline, unchanged tigecycline was the primary 14 C-labelled material recovered in urine and faeces, but a glucuronide, an N-acetyl metabolite and a tigecycline epimer were also present.
Wara l- għoti ta ’ 14C- tigecycline lil voluntiera rġiel b’ saħħithom, tigecycline mhux mibdul kien il- materjal primarju ttikkettat b' 14C li kien miksub mill- ġdid mill- awrina u l- ippurgar, iżda kien hemm ukoll glucuronide, metabolit N- acetyl u epimer ta ’ tigecycline.
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:
Studji in vitro f’ mikrożomi tal- fwied uman indikaw li tigecycline ma jimpedixxix l- metaboliżmu medjat minn xi waħda minn dawn l- iżoformi 6 cytochrome P450 (CYP) li ġejjin:
1A2, 2C8, 2C9, 2C19, 2D6, and 3A4 by competitive inhibition.
1A2, 2C8, 2C9, 2C19, 2D6, u 3A4 permezz ta ’ impediment kompetittiv.
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.
Barraminhekk, tigecycline ma wriex 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.
The recovery of the total radioactivity in faeces and urine following administration of 14C-tigecycline indicates that 59% of the dose is eliminated by biliary/ faecal excretion, and 33% is excreted in urine.
Eliminazzjoni L- irkupru tar- radjuattività totali fl- ippurgar u l- awrina wara l- għoti ta ’ 14 C- tigecycline indika li 59% tad- doża hija eliminata permezz ta ’ eliminazzjoni biljari/ fekali, u 33% hija eliminata fl- awrina.
Overall, the primary route of elimination for tigecycline is biliary excretion of unchanged tigecycline.
Fuq kollox, ir- rotta primarja ta ’ eliminazzjoni għal tigecycline hija eliminazzjoni biljari ta ’ tigecycline mhux mibdul.
Glucuronidation and renal excretion of unchanged tigecycline are secondary routes.
Glukuronidazzjoni u eliminazzjoni renali ta ’ tigecycline mhux mibdul huma rotot sekondarji.
The total clearance of tigecycline is 24 L/ h after intravenous infusion.
Wara infużjoni intravenuża, ir- rata ta 'tneħħija totali ta ’ tigecycline hi ta ’ 24 L/ siegħa.
Renal clearance is approximately 13% of total clearance.
Ir- rata ta 'tneħħija renali hija bejn wieħed u ieħor 13% tat- tneħħija totali.
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.
Tigecycline juri eliminazzjoni poliesponenzjali mis - serum b’ half- life ta ’ eliminazzjoni terminali medja ta ’ 42 siegħa wara dożi multipli għalkemm teżisti varjabilita ’ interindividwali għolja.
Special populations
Popolazzjonijiet Speċjali:
Hepatic Insufficiency The single-dose pharmacokinetic disposition of tigecycline was not altered in patients with mild hepatic impairment.
Insuffiċjenza epatika Id- dispożozzjoni farmakokinetika ta ’ doża waħda ta ’ tigecycline ma kinitx mibdula f’ pazjenti b’ indeboliment epatiku ħafif.
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).
Madankollu, t- tneħħija sistemika ta ’ tigecycline kienet imnaqqsa b’ 25% u 55% u l- half- life ta ’ tigecycline kienet imtawwla bi 23% u 43% f’ pazjenti b’ indeboliment epatiku moderat sa serju (Child Pugh B u C), rispettivament (ara sezzjoni 4. 2).
Renal Insufficiency The single dose pharmacokinetic disposition of tigecycline was not altered in patients with renal insufficiency (creatinine clearance < 30 ml/ min, n=6).
Insuffiċjenza Renali Id- dispożizzjoni farmakokinetika ta ’ doża waħda ta ’ tigecycline ma kinitx mibdula f’ pazjenti b’ indeboliment renali (tneħħija tal- kreatinina 30 ml/ min, n=6).
In severe renal impairment, AUC was 30% higher than in subjects with normal renal function (see section 4.2).
F’ indeboliment renali serju l- AUC kienet 30% ogħla milli f’ suġġetti b’ funzjoni renali normali (ara sezzjoni 4. 2).
Elderly Patients No overall differences in pharmacokinetics were observed between healthy elderly subjects and younger subjects (see section 4.2).
Pazjenti Anzjani Ma kien hemm l- ebda differenza osservata fil- farmakokinetiċi bejn suġġetti anzjani b' saħħithom u suġġetti iżgħar (ara section 4. 2).
10 Paediatric Patients The pharmacokinetics of tigecycline in patients less than 18 years of age has not been established (see section 4.2).
Pazjenti Pedjatriċi Il- farmakokinetiċi ta 'tigecycline f' pazjenti li għandhom inqas minn 18- il sena ma ġewx stabbiliti (ara sezzjoni 4. 2).
Gender There were no clinically relevant differences in the clearance of tigecycline between men and women.
10 Ġeneru Ma kienx hemm differenzi kliniċi rilevanti fir- rata ta 'tneħħija ta' tigecycline bejn l- irġiel u n- nisa.
AUC was estimated to be 20% higher in females than in males.
L- AUC kienet stmata li kienet 20% ogħla fin- nisa milli fl- irġiel.
Race There were no differences in the clearance of tigecycline based on race.
Razza Ma hemmx differenza fir- rata ta 'eliminazzjoni msejsa fuq ir- razza.
Weight Clearance, weight-normalised clearance, and AUC were not appreciably different among patients with different body weights, including those weighing ≥ 125 kg.
Piż Ir- rata ta 'tneħħija, tneħħija normalizzata skond il- piż, u l- AUC mhumiex daqshekk differenti fost pazjenti b' piżijiet differenti, li jinkludu dawk li jiżnu ≥ 125 kg.
AUC was 24% lower in patients weighing ≥ 125 kg.
AUC kien 24% inqas f' pazjenti li jiżnu ≥ 125 kg.
No data is available for patients weighing 140 kg and more.
L- ebda dejta mhi disponibbli għal pazjenti li jiżnu 140 kg u aktar.
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.
Fi studji ta ’ tossiċità ta ’ doża ripetuta fil- firien u fil- klieb, żvujtar/ atrofija limfojde tal- glandoli limfatiċi, il - milsa u t- thymus, tnaqqis fl- eritroċiti, retikuloċiti, lewkoċiti, u plejtlets, f’ assoċjazzjoni ta ’ l- 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.
These alterations were shown to be reversible after two weeks of dosing.
Dawn it- tibdiliet kienu murija li kienu riversibbli wara ġimgħatejn ta ’ iddożar.
Bone discolouring was observed in rats which was not reversible after two weeks of dosing.
Tindis tal- kulur ta ’ l- għadam li ma kienx riversibbli wara ġimgħatejn ta ’ l- iddożar kien osservat fil- firien.
Results of animal studies indicate that tigecycline crosses the placenta and is found in foetal tissues.
Riżultati ta ’ stħarriġ fl- annimali ndikaw li tigecycline jaqsam is- sekonda u jinstab fit- tessuti fetali.
In reproduction toxicity studies, decreased foetal weights in rats and rabbits (with associated delays in ossification) and foetal loss in rabbits have been observed with tigecycline.
Fi studji ta ’ tossiċità riproduttiva, tnaqqis fil- piżijiet fetali fil- ġrieden u l- fniek (b’ ittardjar assoċjat fl- ossifikazzjoni) u telf fetali fil- fniek ġew osservati b’ tigecycline.
Tigecycline was not teratogenic in the rat or rabbit.
Tigecycline ma kienx teratoġeniku fil- far u fil- fenek.
Results from animal studies using 14C-labelled tigecycline indicate that tigecycline is excreted readily via the milk of lactating rats.
Riżultati minn studji fl- annimali bl- użu ta ’ tigecycline ittikketjat b’ 14C indikaw li tigecycline huwa eliminat mal- ħalib ta ’ firien li jkunu qegħdin ireddgħu.
Consistent with the limited oral bioavailability of tigecycline, there is little or no systemic exposure to tigecycline in the nursing pups as a result of exposure via maternal milk.
Ma hemm l- ebda jew hemm ftit esponiment sistemiku għal tigecycline fil- ġriewi li jkunu qegħdin jitreddgħu bħala riżultat għal esponiment mal- ħalib matern, konsistenti ma ’ bijodisponibilità orali ristretta ta ’ tigecycline.
Lifetime studies in animals to evaluate the carcinogenic potential of tigecycline have not been performed, but short-term genotoxicity studies of tigecycline were negative.
Studji li jdumu sejrin tul għomor sabiex jiġi valutat il- potenzjal karċinoġeniku ma twettqux, imma studji ġenotossiċi fuq perijodu ta 'żmien qasir ta' tigecycline kienu negattivi.
Bolus intravenous administration of tigecycline has been associated with a histamine response in animal studies.
L- għoti ta ’ bolus intravenuż ta ’ tigecycline kien assoċjat ma ’ reazzjoni ta ’ ħistamina fi stħarriġ fl- annimali.
These effects were observed at exposures of 14 and 3 times the human daily dose based on the AUC in rats and dogs respectively.
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.
No evidence of photosensitivity was observed in rats following administration of tigecycline.
L- ebda evidenza ta 'fotosenesittività ma ġiet osservata fil- firien wara l- għoti ta' tigecycline.
Lactose monohydrate Hydrochloric acid, sodium hydroxide (for pH adjustment)
Lactose monohydrate Hydrochloric acid, sodium hydroxide (għall- aġġustament ta ’ pH)
The following active substances should not be administered simultaneously through the same Y-site as Tygacil:
Is- sustanzi attivi li ġejjin m’ għandhomx jingħataw fl- istess ħin minn ġo l- istess sit- Y bħal Tygacil:
Amphotericin B, amphotericin B lipid complex, and diazepam.
Amphotericin B, kumpless lipidu ta ’ amphotericin B u diazepam.
Tygacil must not be mixed with other medicinal products for which compatibility data are not available (see section 6.6).
11 Tygacil m' għandux jitħallat ma 'prodotti mediċinali oħra li għalihom dejta ta' kompatibilità mhix disponibbli (ara sezzjoni 6. 6).
Once reconstituted and diluted in the bag or other suitable infusion container (e. g. glass bottle), tigecycline should be used immediately.
Ġaladarba ikun rikostitwit u dilwit fil- borża jew r- reċipjent ta 'l- infużjoni ieħor adattat (eż. flixkun tal- ħġieġ), tigecycline għandu jintuża minnufih.
Store at or below 25°C.
Żomm f’ temperatura ta ’ 25oC jew inqas.
For storage conditions of the reconstituted product see section 6.3.
Għall- kundizzjonijiet ta 'ħażna tal- prodott mediċinali rikonstitwit, ara sezzjoni 6. 3.
5 ml Type 1 clear glass vials fitted with grey butyl rubber stoppers and snap-off aluminium crimp seals.
Kunjetti tal- ħġieġ ta 'Tip 1 ċari ta' 5 ml b' tappijiet tal- latku butyl griżi u b' siġilli ippjegati ta 'l- aluminju li jinqalgħu bis- suba'.
Tygacil is distributed in a ten vial tray pack.
Tygacil huwa distribwit f' pakkett fi trej ta 'għaxar kunjetti.
The lyophilised powder should be reconstituted with 5.3 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection to achieve a concentration of 10 mg/ ml of tigecycline.
It- trab lijofilizzat għandu jiġi rikostitwit b’ 5. 3 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- injezzjoni ta’ dextrose 50 mg/ ml (5%) biex tinkiseb konċentrazzjoni ta ’ 10 mg/ ml ta ’ tigecycline.
The vial should be gently swirled until the medicinal product is dissolved.
Il- kunjett għandu jiġi ġentilment imdawwar sakemm il- prodott mediċinali jinħall.
Thereafter, 5 ml of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 ml intravenous bag for infusion or other suitable infusion container (e. g., glass bottle).
Minn hemm 'il quddiem, 5 ml ta ’ soluzzjoni rikostitwita għandha tiġi immedjatament miġbuda mill- kunjett u miżjuda ma ’ borża għal infużjoni intravenuża ta ’ 100 ml jew reċipjent ieħor adattat għall - infuzzjoni (eż. flixkun tal- ħġieġ).
For a 100 mg dose, reconstitute using two vials into a 100 ml intravenous bag or other suitable infusion container (e. g., glass bottle).
Għal doża ta ’ 100 mg, irrikostitwixxi billi tuża żewġ kunjetti f’ borża intravenuża ta ’ 100 ml jew xi reċipjent ieħor adattat għall- infuzzjoni (eż. flixkun tal- ħġieġ).
The vial contains a 6% overage.
Il- kunjett fiħ 6% overage.
Thus, 5 ml of reconstituted solution is equivalent to 50 mg of the active substance.
Għalhekk, 5 ml ta ’ soluzzjoni rikostitwita hija ekwivalenti għal 50 mg tas- sustanza attiva.
The reconstituted solution should be yellow to orange in colour; if not, the solution should be discarded.
Is- soluzzjoni rikostitwita għandha tkun minn ta ’ kulur isfar sa oranġjo; jekk le, is- soluzzjoni għandha tiġi mormija.
Parenteral products should be inspected visually for particulate matter and discolouration (e. g., green or black) prior to administration.
Prodotti parenterali għandhom jiġu spezzjonati viżwalment għal frak u tindis fil- kulur (eż. aħdar jew iswed) qabel ma jingħataw.
Tygacil may be administered intravenously through a dedicated line or through a Y-site.
Tygacil jista ’ jiġi mogħti ġol- vina minn ġo pajp iddedikat jew minn ġo sit- Y.
If the same intravenous line is used for sequential infusion of several active substances, the line should be flushed before and after infusion of Tygacil with either sodium chloride 9 mg/ ml (0.9%) solution for injection or dextrose 50 mg/ ml (5%) solution for injection.
Jekk l- istess pajp intravenuż hu użat għall- infuzjoni sekwenzjali ta ’ bosta sustanzi attivi, il- pajp għandu jiġi maħsul qabel jew wara l- infużjoni ta ’ Tygacil jew b’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew dextrose 50 mg/ ml (5%) għall- injezzjoni.
Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see section 6.2)
Għandha ssir injezzjoni b’ infużjoni kompatibbli ma ’ tigecycline u xi prodott( i) mediċinali ieħor( oħrajn) permezz ta ’ dan il- pajp komuni (ara sezzjoni 6. 2).
This medicinal product is for single use only; any unused solution should be discarded.
Dan il- prodott mediċinali għandu jintuża darba biss; kull soluzzjoni li ma tintużax għandha tintrema.
Compatible intravenous solutions include: sodium chloride 9 mg/ ml (0.9%) solution for injection and dextrose 50 mg/ ml (5%) solution for injection.
12 Soluzzjonijiet intravenużi kompatibbli jinkludu: soluzzjoni għall- injezzjoni ta 'sodium chloride 9 mg/ ml (0. 9%) u soluzzjoni għall- injezzjoni dextrose 50 mg/ ml (5%).
12 dopamine HCl, gentamicin, haloperidol, Lactated Ringer’ s, lidocaine HCl, morphine, norepinephrine, piperacillin/ tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin..
Meta jkun mgħoti minn ġo sit- Y, il- kompatibbilità ta ’ Tygacil dilwit 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, morphine, norepinephrine, piperacillin/ tazobactam (formulazzjoni EDTA), potassium chloride, propofol, ranitidine HCl, theophylline, u tobramycin.
Huntercombe Lane South Taplow, Maidenhead Berkshire, SL6 0PH United Kingdom
Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Ir- Renju Unit
24 April 2006.
24 t' April 2006.
The Marketing Authorisation Holder must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fis- suq għandu jiżgura li s- sistema ta' farmakoviġilanza qiegħda f' postha u qed taħdem qabel mal- prodott jitqiegħed fis- suq.