qanastek/EMEA-V3 huggingface dataset:
White to off-white powder.
Trab abjad jew abjad jagħti fil- ġriż.
Treatment
Kura
Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see section 4.4 and section 5.1):
Għall- kura ta 'l- infezzjonijiet li ġejjin ikkawżati minn batteri li huma magħrufa jew x’ aktarx li jkunu suxxettibbli għal ertapenem u meta t- terapija parenterali hija meħtieġa (ara sezzjoni 4. 4 u sezzjoni 5. 1):
• Intra-abdominal infections • Community acquired pneumonia • Acute gynaecological infections • Diabetic foot infections of the skin and soft tissue (see section 4.4)
• Infezzjonijiet intra- addominali • Pnewmonja li tittieħed mill- komunità • Infezzjonijet ġinekoloġiċi akuti • Infezzjonijiet dijabetiċi tal- ġilda u tat- tessut artab fis- saqajn, (ara sezzjoni 4. 4)
Prevention
Prevenzjoni
INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
INVANZ hu indikat fl- adulti għall- profilassi ta 'infezzjoni fis- sit kirurġiku wara operazzjoni mhux obbligatorja tal- kolon u r- rektum.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata attenzjoni għal- linji gwida uffiċjali dwar il- mod xieraq kif għandhom jintużaw il - mediċini antibatteriċi.
Adults and adolescents (13 to 17 years of age):
Adulti u adolexxenti (13 sa 17- il sena):
The dose of INVANZ is 1 gram (g) given once a day by the intravenous route (see section 6.6).
Id- doża ta 'INVANZ hi ta' 1 gramma (g) mogħtija fil- vina darba kuljum (ara sezzjoni 6. 6).
Prophylaxis of surgical site infection following elective colorectal surgery in adults:
Profilassi ta 'l- infezzjoni fis- sit ta' l- operazzjoni wara operazzjoni fil- kolon u r- rektum fl- adulti:
To prevent surgical site infections, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
Għal prevenzjoni ta 'infezzjonijiet fis- sit ta' l- operazzjoni, id- dożaġġ rakkomandat hu ta '1g mogħti bħala doża waħda ġol- vini li jrid isir sa siegħa qabel l- inċiżjoni kirurġika.
For Infants and children (3 months to 12 years of age):
Għat- Trabi u tfal (minn 3 xhur sa 12- il sena):
The dose of INVANZ is 15 mg/ kg given twice daily (not to exceed 1 g/ day) by the intravenous route (see section 6.6).
Id- doża ta 'INVANZ hi ta' 15mg/ kg mogħtija darbtejn (li ma tridx taqbeż il- 1g/ kuljum) ġol- vini (ara sezzjoni 6. 6)..
INVANZ is not recommended for use in children below 3 months of age due to a lack of data on safety and efficacy (see sections 4.4; 5.1 and section 5.2).
INVANZ mhux irrakkomandat għall- użu fit- tfal taħt it- 3 xhur peress li m’ hemmx informazzjoni biżżejjed dwar is- sigurtà u l- effikaċja tiegħu (ara sezzjonijiet 4. 4; 5. 1 u sezzjoni 5. 2).
Intravenous administration:
Amministrazzjoni ġol- vini:
INVANZ should be infused over a period of 30 minutes.
INVANZ għandu jiġi infuż fuq medda ta '30 minuta.
2 The usual duration of therapy with INVANZ is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s).
2 It- terapija ta 'INVANZ is- soltu ddum bejn 3 u 14- il jum imma tista' tvarja skond it- tip u s- severità ta 'l - infezzjoni u l- patoġenu/ i li jikkawżawha.
When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
Meta jkun indikat klinikament, minflok għandha tintuża mediċina antibatterika orali f' waqtha jekk ikun ġie osservat titjib kliniku.
Renal insufficiency:
Insuffiċjenza tal- kliewi:
INVANZ may be used for the treatment of infections in adult patients with renal insufficiency.
INVANZ jista 'jintuża għall- kura ta' infezzjonijiet f' pazjenti b' insuffiċjenza tal- kliewi.
In patients whose creatinine clearance is > 30 ml/ min/ 1.73 m2, no dosage adjustment is necessary.
F' pazjenti li t - tneħħija tal- krejatinina tagħhom hija > 30 mi/ min/ 1. 73 m2, m’ hemmx bżonn ta ’ tibdil fid- doża.
There are inadequate data on the safety and efficacy of ertapenem in patients with advanced renal insufficiency to support a dose recommendation.
M' hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja ta 'ertapenem f' pazjenti b' insuffiċjenza avvanzata tal- kliewi biex issir rakkomandazzjoni dwar id- doża.
Therefore, ertapenem should not be used in these patients.
Għalhekk, ertapenem m' għandux jintuża għal dawn il- pazjenti.
(See section 5.2.) There are no data in children and adolescents with renal insufficiency.
(Ara sezzjoni 5. 2.) M’ hemmx tagħrif dwar is- sigurtà u l- effikaċja fit- tfal u l- adolexxenti b' insuffiċjenza tal- kliewi.
Patients on haemodialysis:
Pazjenti bid- dijalisi tad- demm:
There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation.
M' hemmx biżżejjed tagħrif dwar is- sigurtà u l- effikaċja ta 'ertapenem f' pazjenti bid- dijalisi tad- demm biex issir rakkomandazzjoni dwar id- doża.
Therefore, ertapenem should not be used in these patients.
Għalhekk, ertapenem m' għandux jintuża għal dawn il - pazjenti.
No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
M' hemmx għalfejn issir bidla fid- doża għal pazjenti b’ indeboliment tal- fwied (ara sezzjoni 5. 2).
The recommended dose of INVANZ should be administered, except in cases of advanced renal insufficiency (see Renal insufficiency).
Għandha tingħata d- doża rakkomandata ta 'INVANZ, ħlief f' każijiet ta' insuffiċjenza avvanzata tal - kliewi (ara Insuffiċjenza tal- kliewi).
• Hypersensitivity to the active substance or to any of the excipients • Hypersensitivity to any other carbapenem antibacterial agent • Severe hypersensitivity (e. g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e. g., penicillins or cephalosporins).
• Sensittività eċċessiva għas- sustanza attiva jew xi waħda mis- sustanzi mhux attivi • Sensittività eċċessiva għal xi mediċina antibatterika ta ’ carbapenem • Sensittività eċċessiva serja (eż. reazzjoni anafilattika, reazzjoni serja fil- ġilda) għal xi tip ieħor ta 'mediċina antibatterika beta- lactam (eż. penicillins jew cephalosporins).
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Ġew rappurtati reazzjonijiet serji u xi kultant fatali ta ’ sensittività eċċessiva (anafilattiċi) f' pazjenti li kienu qed jingħataw terapija bil- beta- lactams.
These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens.
Dawn ir- reazzjonijiet x’ aktarx li jseħħu l- aktar f' min għandu storja personali ta 'sensittività għal iktar minn allerġen wieħed.
Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
Qabel ma tinbeda t- terapija b’ ertapenem, għandu jsir studju bir- reqqa dwar ir- reazzjonijiet ta ’ sensittività eċċessiva li seta 'kien hemm qabel għal penicillins, cephalosporins, beta- lactams oħra u allerġeni oħra (ara sezzjoni 4. 3).
If an allergic reaction to ertapenem occurs, discontinue the therapy immediately.
Jekk isseħħ reazzjoni allerġika għal ertapenem, it- terapija għandha titwaqqaf minnufih.
Serious anaphylactic reactions require immediate emergency treatment.
Reazzjonijiet serji anafilattiċi jeħtieġu kura ta 'emerġenza immedjata.
As with other antibiotics, prolonged use of ertapenem may result in overgrowth of non-susceptible organisms.
Bħal f' antibijotiċi oħra, jekk ertapenem jintuża fit- tul jista 'jkun hemm żvilupp żejjed ta' organiżmi li mhumiex suxxettibbli.
Repeated evaluation of the patient's condition is essential.
Huwa essenzjali li ssir evalwazzjoni ripetuta tal- kundizzjoni tal- pazjent.
If superinfection occurs during therapy, appropriate measures should be taken.
Jekk isseħħ superinfezzjoni waqt it- terapija, għandhom jittieħdu l- miżuri meħtieġa.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including ertapenem, and may range in severity from mild to life-threatening.
Kolite assoċjata mat- teħid ta 'l- antibijotiċi u kolite psewdomembranika ġew assoċjati ma' kważi l - mediċini antibijotiċi kollha, inkluż ertapenem, u jistgħu jkunu minn dawk ħfief sa dawk ta 'periklu għall- ħajja.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
Għalhekk, huwa importanti li tiġi kkunsidrata din id- dijanjosi meta l- pazjenti jkollhom id - dijarea wara li jibdew jieħdu l- mediċini antibatteriċi.
Discontinuation of therapy with INVANZ and the administration of specific treatment for Clostridium difficile should be considered.
Għandu jiġi kkunsidrat jekk għandhiex titwaqqaf it- terapija b’ INVANZ u jekk għandhiex tingħata kura speċifika għal Clostridium difficile.
Medicinal products that inhibit peristalsis should not be given.
M' għandhomx jingħataw prodotti mediċinali li jimpedixxu l- peristalsi.
Seizures have been reported during clinical investigation in adult patients treated with ertapenem sodium (1g once a day) during therapy or in the 14-day follow-up period.
Puplesiji kienu rrappurtati matul l- investigazzjoni klinika f' pazjenti adulti kkurati b' ertapenem sodium (1g darba kuljum) matul it- terapija jew fil- perjodu ta '14- il jum ta' wara.
Seizures occurred most commonly in elderly patients and those with pre-existing CNS disorders (e. g., brain lesions or history of seizures) and/ or compromised renal function.
Il- puplesiji seħħew l- aktar f' pazjenti anzjani u f' dawk li kellhom mard fis- sistema nervuża ċentrali (CNS) li kien jeżisti minn qabel (eż. feriti fil- moħħ jew storja personali ta 'puplesiji) u/ jew funzjoni renali kompromessa.
Similar observations have been made in the post- marketing environment.
Osservazzjonijiet simili saru fl- ambjent ta 'wara t- tqegħid fis- suq..
3 The efficacy of INVANZ in the treatment of community acquired pneumonia due to penicillin- resistant Streptococcus pneumoniae has not been established.
3 Ma ġietx stabbilita l- effikaċja ta 'INVANZ fil- kura tal- pnewmonja li tittieħed mill- komunità minħabba Streptococcus pneumoniae li hu reżistenti għall- penicillin.
There is relatively little experience with ertapenem in children less than two years of age.
Hemm relattivament ftit esperjenza b' ertapenem fi tfal ta 'inqas minn sentejn.
In this age group, particular care should be taken to establish the susceptibility of the infecting organism(s) to ertapenem.
F' dan il- grupp ta 'età, attenzjoni partikulari trid tingħata biex tiġi stabbilita s- suxxettibbilità għall- organiżmu( i) għal ertapenem.
No data are available in children under 3 months of age.
M’ hemmx informazzjoni disponibbli għal tfal ta ’ taħt it- 3 xhur.
Experience in the use of ertapenem in the treatment of severe infections is limited.
L- esperjenza fl- użu ta 'ertapenem fil- kura ta' infezzjonijiet serji hija limitata.
In clinical studies for the treatment of community-acquired pneumonia, in adults, 25% of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index > III).
Fi studji kliniċi għall - kura tal- pnewmonja li tittieħed mill- komunità, fl- adulti, 25% tal- pazjenti li setgħu jiġu evalwati u li ngħataw ertapenem kellhom mard serju (definit fuq l- indiċi tas- severità tal- pnewmonja bħala > III).
In a clinical study for the treatment of acute gynaecologic infections, in adults, 26% of evaluable patients treated with ertapenem had severe disease (defined as temperature ≥ 39°C and/ or bacteraemia); ten patients had bacteraemia.
Fi studju kliniku għall- kura ta 'l- infezzjonijiet ġinekoloġiċi akuti, fl- adulti, 26% tal- pazjenti li setgħu jiġu evalwati u li ngħataw ertapenem kellhom mard qawwi (definit bħala temperatura ≥ 39°C u/ jew batterimija); għaxar pazjenti kellhom il- batterimija.
Of evaluable patients treated with ertapenem in a clinical study for the treatment of intra- abdominal infections, in adults, 30% had generalized peritonitis and 39% had infections involving sites other than the appendix including the stomach, duodenum, small bowel, colon, and gallbladder; there were limited numbers of evaluable patients who were enrolled with APACHE II scores ≥ 15 and efficacy in these patients has not been established.
Fi studju kliniku għall- kura ta 'infezzjonijiet intra - addominali, fl- adulti, mill- pazjenti li setgħu jiġu evalwati u li ngħataw ertapenem, 30% kellhom peritonite ġeneralizzata u 39% kellhom infezzjonijiet f' siti oħra barra l- appendiċi li jinkludu l- istonku, id- duwodenu, il- musrana ż- żgħira, il- kolon, u l- bużżieqa tal- marrara; kien hemm numru limitat ta' pazjenti li setgħu jiġu evalwati li ddaħħlu fl- istudju b' punteġġi APACHE II ≥ 15 u l- effikaċja f' dawn il- pazjenti ma setgħetx tiġi stabbilita.
Efficacy of ertapenem in the treatment of diabetic foot infections with concurrent osteomyelitis has not been established.
L- effikaċja ta 'ertapenem fil- kura ta' infezzjonijiet dijabetiċi tas- saqajn flimkien ma 'l- ostjomelite fl - istess ħin ma ġietx stabbilita.
Based on the data available it cannot be excluded that in the few cases of surgical interventions exceeding 4 hours, patients could be exposed to sub-optimal Ertapenem concentrations and consequently to a risk of potential treatment failure.
Ibbażat fuq l- informazzjoni disponibbli, ma jistax jiġi eskluż li fil- ftit każijiet ta 'interventi kirurġiċi li jaqbżu l- 4 sigħat, il- pazjenti jistgħu jiġu esposti għal konċentrazzjonijiet ta' Ertapenem li jkunu inqas minn dawk ideali u konsegwentement għal riskju ta 'falliment potenzjali tal- kura.
Therefore, caution should be exercised in such unusual cases.
Għalhekk, għandha tingħata attenzjoni f' dawn il- każijiet mhux tas- soltu.
This medicinal product contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Dan prodott mediċinali fih madwar 6. 0mEq (madwar 137mg) ta 'sodium f' kull doża ta' 1. 0g u dan għandu jiġi kkunsidrat minn pazjenti fuq dieta kkontrollata tas- sodium.
Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
Mhux mistenni li jkun hemm interazzjonijiet ta 'prodotti mediċinali kkawżati minn inibizzjoni fit - tneħħija permezz tal- P- glycoprotein jew permezz tas- CYP (ara sezzjoni 5. 2.)
Penem and carbapenem antibacterial agents may decrease the serum levels of valproic acid.
Il- mediċini antibatteriċi penem u carbapenem jistgħu jnaqqsu l- livelli ta 'valproic acid fis- serum.
Monitoring of serum levels of valproic acid should be considered if ertapenem is to be co- administered with valproic acid.
Jekk ertapenem se jingħata flimkien ma 'valproic acid, għandu jiġi kkunsidrat il- monitoraġġ tal- livelli ta' valproic acid fis- serum.
Adequate and well-controlled studies have not been performed in pregnant women.
Ma sarux studji adegwati u kkontrollati tajjeb fuq nisa waqt it- tqala.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development.
Studji fuq l- annimali ma jindikawx effetti diretti jew indiretti ta 'ħsara fit- tqala, l- iżvilupp ta' l- embriju jew il- fetu, il- ħlas jew l - iżvilupp wara t- twelid.
However, ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus.
Madankollu, ertapenem m' għandux jintuża waqt it- tqala sakemm il- benefiċċju huwa ikbar mir- riskju possibbli għall- fetu.
Ertapenem is excreted in human milk.
Ertapenem jitneħħa fil- ħalib ta 'l- omm.
Because of the potential for adverse reactions on the infant, mothers should not breast-feed their infants while receiving ertapenem.
Minħabba l- potenzjal għal reazzjonijiet avversi fuq it- tarbija, l - ommijiet m' għandhomx ireddgħu lit- trabi tagħhom waqt li qed jkunu qed jingħataw ertapenem.
INVANZ may influence patients' ability to drive and use machines.
INVANZ jista ’ jinfluwenza l- ħila tal- pazjent biex isuq u jħaddem magni.
Patients should be informed that dizziness and somnolence have been reported with INVANZ (see section 4.8).
Il- pazjenti għandhom jiġu informati li sturdament u ngħas ġew irrapportati b’ INVANZ (ara sezzjoni 4. 8).
Adults 18 years of age and older:
Adulti ta ’ ’ l fuq minn 18- il sena:
4 The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem.
It- total ta 'pazjenti li ġew ikkurati b’ ertapenem fi studji kliniċi huwa ta ’ iktar minn 2, 200 li minnhom 2, 150 ngħataw doża ta' 1g ta 'ertapenem.
Adverse reactions (i. e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20% of patients treated with ertapenem.
Reazzjonijiet avversi (i. e. dawk li huma kkunsidrati mill - investigatur li huma possibbilment, probabbilment, jew definittivament marbuta mal- prodott mediċinali) kienu rrappurtati f' madwar 20% tal- pazjenti li ħadu ertapenem.
Treatment was discontinued due to adverse reactions in 1.3% of patients.
Il- kura ma tkomplietx minħabba reazzjonijiet avversi f' 1. 3% tal- pazjenti.
An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
476 pazjenti oħra ingħataw ertapenem f’ doża ewlenija ta '1g qabel l- operazzjoni fi studju kliniku għal profilassi ta' infezzjonijiet fis- sit ta 'l - operazzjoni wara operazzjonijiet fil- kolon u r- rektum.
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8%), infused vein complication (4.5%) and nausea (2.8%).
F' pazjenti li ngħataw INVANZ biss, ir- reazzjonijiet avversi l- iktar komuni li ġew irrappurtati waqt it - terapija u fil- follow- up għal 14- il jum wara li twaqqfet il- kura kienu: dijarea (4. 8%), kumplikazzjonijiet fil- vina li fiha saret l- infużjoni (4. 5%) u dardir (2. 8%).
For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: elevations in ALT (4.6%), AST (4.6%), alkaline phosphatase (3.8%) and platelet count (3.0%).
Żidiet fl- ALT (4. 6%), AST (4. 6%), alkaline phosphatase (3. 8%) u għadd tal- plejtlets (3. 0%)
Children and adolescents (3 months to 17 years of age):
Tfal u adolexxenti (minn 3 xhur sa 17- il sena):
The total number of patients treated with ertapenem in clinical studies was 384.
In- numru totali ta 'pazjenti kkurati b' ertapenem fi studji kliniċi kien ta' 384.
The overall safety profile is comparable to that in adult patients.
Il- profil tas- sigurtà totali hu komparabbli ma 'dak f' pazjenti adulti.
Adverse reactions (i. e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20.8% of patients treated with ertapenem.
Reazzjonijiet avversi (i. e. dawk li huma kkunsidrati mill - investigatur li huma possibbilment, probabbilment, jew definittivament marbuta mal- prodott mediċinali) kienu rrappurtati f' madwar 20. 8% tal- pazjenti kkurati b' ertapenem.
Treatment was discontinued due to adverse reactions in 0.5% of patients.
Il- kura twaqqfet minħabba reazzjonijiet f' 0. 5% tal- pazjenti.
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2%) and infusion site pain (6.1%).
Għall- pazjenti li ngħataw INVANZ biss, l- iktar reazzjonijiet avversi komuni li kienu rrappurtati matul it- terapija u matul l- 14- il jum ta 'follow- up wara li twaqqfet il- kura kienu: dijarea (5. 2%) u uġigħ fil - parti fejn saret l- infużjoni (6. 1%).
For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0%), and elevations in ALT (2.9%) and AST (2.8%).
Għall- pazjenti li ngħataw INVANZ biss, l- anomaliji tal- laboratorju l- iktar komuni li ġew irrappurtati u r- rati ta 'inċidenza rispettivi matul it- terapija u matul l- 14- il jum ta' follow- up wara li twaqqfet il- kura kienu: tnaqqis fl- għadd tan- newtrofili (3. 0%), u żidiet fl- ALT (2. 9%) u fl- AST (2. 8%).
For patients who received only INVANZ, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped:
Għall- pazjenti li rċivew INVANZ biss, ir- reazzjonijiet avversi li ġejjin kienu rrappurtati matul it - terapija u matul l- 14- il jum ta 'follow- up wara li twaqqfet il- kura:
Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1000); Very rare (< 1/ 10,000)
Komuni (≥1/ 100 sa < 1/ 10); Mhux komuni (≥ 1/ 1000 sa < 1/ 100); Rari (≥ 1 / 10, 000 sa < 1/ 1000); Rari ħafna (< 1/ 10, 000)
Adults 18 years of age and older
Infezzjonijiet u impestazzjonijiet:
Infections and infestations:
Mard tad- demm u - sistema limfatika:
Blood and lymphatic disorders:
Mard marbut mal - metaboliżmu u n- nutrizzjoni:
Metabolism and nutrition disorders:
Mard tas- sistema nervuża:
Uncommon:
Adulti ta '18- il sena jew iktar Mhux komuni:
Oral candidiasis Rare:
Kandidjasite tal - halq Rari:
Neutropenia, thrombocytopenia Uncommon:
Newtropenja, tromboċitopenja Mhux komuni:
Anorexia Rare:
Anoreksja Rari:
Nervous system disorders:
Ipogliċemija Komuni:
Dizziness, somnolence, insomnia, confusion, seizure (see section 4.4) Rare:
Sturdament, ngħas, nuqqas ta ’ rqad, konfużjoni, puplesija (ara sezzjoni 4. 4) Rari:
Agitation, anxiety, depression, tremor
Aġitazzjoni, ansjetà, dipressjoni, rogħda
Arrhythmia, tachycardia
Tfal u adolexxenti (minn 3 xhur sa 17- il sena) Mhux komuni:
Vascular Disorders:
Uġigħ ta ’ ras
Haemorrhage, increased blood pressure 5
5 Mard tal- qalb:
Uncommon:
Mard vaskulari:
Hot flush, hypertension, petechiae
Mard respiratorju, toraċiku u medjastinali:
Respiratory, thoracic and mediastinal disorders:
Mard gastro- intestinali:
Dyspnoea, pharyngeal discomfort Rare:
Bradikardija tas - sinus Rari:
Nasal congestion, cough, epistaxis, pneumonia, rales/ rhonchi, wheezing
Arritmija, takikardija Komuni:
Gastrointestinal disorders:
Flebite/ tromboflebite Mhux komuni:
Common:
Pressjoni baxxa Rari:
Diarrhoea, nausea, vomiting Uncommon:
Emorraġija, żieda fil - pressjoni tad- demm Mhux komuni:
Common:
Dispnea, skonfort tal- farinġi Rari:
Diarrhoea Uncommon:
Dijarea, dardir, rimettar Mhux komuni:
Faeces discoloured, melaena
Stitikezza,
Rare:
Mhux komuni:
Cholecystitis, jaundice, liver disorder
Fwawar, pressjoni għolja, tbenġil Komuni:
Skin and subcutaneous tissue disorders:
Tibdil fil- kulur
Common:
Problemi biex tibla ', inkontinenza ta' l- ippurgar Rari:
Rash, pruritus Uncommon:
Dermatite tal- ħrieqi Komuni:
Erythema, urticaria Rare:
Raxx, ħakk tal- ġilda Mard tal- ġilda u tat- tessuti ta ’ Mhux komuni:
Dermatitis, dermatomycosis, desquamation, postoperative wound infection
Eritema, raxx Mhux komuni: eritema, urtikarja taħt il- ġilda:
Common:
Rari:
Erythema, rash
Dermatite, dermatomikosi, tqaxxir, infezzjoni tal- feriti wara l - operazzjoni Rari:
Musculoskeletaland connective tissue disorders:
Infezzjoni fl- apparat Mard tal- kliewi u tas- sistema urinarju, insuffiċjenza renali, urinarja: insuffiċjenza renali akuta Mhux komuni:
Renal and urinary disorders:
Vaġinite Mard tas- sistema riproduttiva Rari:
Rare:
Komuni:
Muscle cramp, shoulder pain Rare:
Kumplikazzjoni tal - vina infuża Mhux komuni:
Reproductive system and breast disorders:
Ħruġ ta 'fluwidu
Uncommon:
Komuni:
Vaginitis Rare:
Uġigħ fil- parti ta 'l - infużjoni Mhux komuni:
Abortion, genital bleeding
Ħruq fis- sit ta 'l -
Laboratory test findings:
mis- sit ta ’ l- injezzjoni, uġigħ ta ’ infużjoni, ħakk fis- sit ta 'l - żaqq, kandidjasite, astenja/ għeja infużjoni, eritema fis- sit ta' l - Sejbiet tat- testijiet tal - laboratorju:
Extravasation, abdominal pain, candidiasis, asthenia/ fatigue, fungal infection, fever, oedema/ swelling, chest pain, taste perversion Rare:
kbira, infezzjoni fungali, deni, edema/ nefħa, uġigħ fis- sider, tibdil fit- togħma Rari:
Allergy, injection-site induration, malaise, pelvic peritonitis, scleral disorder, syncope
Allerġija, ebusija fis- sit ta 'l- injezzjoni, telqa, peritonite pelvika, mard sklerali, sinkope
Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth
infużjoni, eritema fis- sit ta 'l - injezzjoni, sħana fis- sit ta' l - infużjoni
Chemistry:
Kimika:
Elevations in ALT, AST, alkaline phosphatase Uncommon:
Żidiet fl- ALT, AST, alkaline phosphatase Mhux komuni:
Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose Rare:
Żidiet fil - bilirubin totali fis- serum, bilirubin dirett tas- serum, bilirubin indirett tas- serum, krejatinina tas- serum, urea tas - serum, glukosju tas- serum
Elevations in ALT and AST
Żidiet fl- ALT u AST
Elevation in platelet 6
6 Rari: tnaqqis fil- bikarbonat tas - serum, krejatinina tas- serum, u potassju tas- serum; żidiet fil - LDH tas- serum, fosfru tas - serum, potassju tas- serum
Decreases in
Ematologija:
count Uncommon:
Komuni:
Decreases in white blood cells, platelet count, segmented neutrophils, haemoglobin and haematocrit; increases in eosinophils, activated partial thromboplastin time, prothrombin time, segmented neutrophils, and white blood cells Rare:
Żieda fl- għadd tal -
neutrophil count Uncommon:
Komuni:
Increases in platelet count, activated partial thromboplastin time, prothrombin time, decreases in haemoglobin
Tnaqqis fl- għadd tan -
Urinalysis:
Analiżi ta 'l- awrina:
Uncommon:
Mixxellanja:
Increase in urobilinogen
Esperjenza ta ’ wara t- tqegħid fis- suq:
Miscellaneous:
Mard tas- sistema immunitarja:
Post Marketing Experience:
Disturbi psikjatriċi Mard tas- sistema nervuża:
Uncommon:
plejtlets Mhux komuni:
Positive Clostridium difficile toxin
Tnaqqis fil- limfoċiti; żidiet fil- newtrofili band, limfoċiti, meta, monoċiti, majeloċiti, limfoċiti atipiċi Mhux komuni:
Immune system disorder:
Żieda fl- urobilinogen Mhux komuni:
Anaphylaxis including anaphylactoid reactions
Tossina tal - Clostridium difficile pożittiva Anafilassi li tinkludi reazzjonijiet anafilattojdi Tibdil fl- istatus mentali Alluċinazzjonijiet
Psychiatric disorders:
newtrofili Mhux komuni:
Altered mental status Hallucinations
Żidiet fl- għadd tal- plejtlets, ħin parzjali attivat tat- tromboplastin, ħin tal - protrombin, tnaqqis fl - emoglobina
No specific information is available on the treatment of overdose with ertapenem.
M' hemmx informazzjoni speċifika dwar il- kura ta 'doża eċċessiva ta' ertapenem.
Overdosing of ertapenem is unlikely.
Li tittieħed doża eċċessiva ta 'ertapenem huwa improbabbli.
Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity.
Meta ngħatat minn ġol- vina doża ta '3g kuljum għal 8 ijiem lil voluntiera f' saħħithom, dan ma wassalx għal tossiċità sinifikanti.
In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions.
Fi studji kliniċi fl- adulti, meta ngħatat bi żball doża sa 3g kuljum, dan ma wassalx għal reazzjonijiet avversi importanti.
In paediatric clinical studies, a single IV dose of 40 mg/ kg up to a maximum of 2 g did not result in toxicity.
Fi studji kliniċi pedjatriċi, doża ewlenija IV ta ’ 40mg/ kg sa massimu ta ’ 2g ma rriżultatx f’ tossiċità.
However, in the event of an overdose, treatment with INVANZ should be discontinued and general supportive treatment given until renal elimination takes place.
Madankollu, f' każ ta 'doża eċċessiva, il- kura b’ INVANZ għandha titwaqqaf u għandha tingħata kura ġenerali ta’ appoġġ sakemm id- doża titneħħa mill- kliewi.
Ertapenem can be removed to some extent by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
Ertapenem jista 'jitneħħa sa ċertu punt bid- dijalisi tad- demm (ara sezzjoni 5. 2); madankollu, m' hemmx informazzjoni dwar kif id- dijalisi tad- demm tista' tintuża bħala kura għal doża eċċessiva.
General properties
Propjetajiet ġenerali
Pharmacotherapeutic group: carbapenems, ATC code:
Kategorija farmakoterapewtika: carbapenems, Kodiċi ATC:
Mode of action Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).
Kif jaħdem Ertapenem jinibixxi s- sintesi tal- ħajt taċ- ċellula batterika wara li jingħaqad mal- proteini li jintrabtu mal- penicillin (PBPs).
In Escherichia coli, affinity is strongest to PBPs 2 and 3.
F' Escherichia coli, ir- rabta hija l- iktar b' saħħitha ma ’ PBPs 2 u 3.
Pharmacokinetic/ Pharmacodynamic (PK/ PD) relationship Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of ertapenem exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in pre- clinical PK/ PD studies.
Relazzjoni Farmakokinetika/ Farmakodinamika (PK/ PD) Bħal mediċini oħrajn beta- lactam kontra l- mikrobi, il- ħin li l- konċentrazzjoni tal- plażma ta 'ertapenem jaqbeż l- MIC ta' l- organiżmu li qed jinfetta, kien muri li jikkorelata l- aħjar ma 'l- effikaċja PK/ PD fi studji pre- kliniċi.
Mechanism of Resistance For species considered susceptible to ertapenem, resistance was uncommon in surveillance studies in Europe.
Mekkaniżmu tar- Reżistenza Għal speċi li huma kkunsidrati bħala suxxettibbli għal ertapenem, ir- reżistenza ma kinitx komuni fi studji ta 'sorveljanza fl- Ewropa.
In resistant isolates, resistance to other antibacterial agents of the carbapenem class was seen in some but not all isolates.
F' iżolati reżistenti, kien hemm reżistenza għal mediċini oħra ta 'kontra l- batterji tal- klassi ta' carbapenem f' xi iżolati, imma mhux kollha.
Ertapenem is effectively stable to hydrolysis by most classes of beta- lactamases, including penicillinases, cephalosporinases and extended spectrum beta-lactamases, but not metallo-beta-lactamases.
Ertapenem hu effettivament stabbli għall- idrolisi mill- biċċa l- kbira tal- klassijiet ta 'beta- lactamases, li jinkludu penicillinases, cephalosporinases u extended spectrum beta- lactamases, iżda mhux metallo- beta- lactamases.
Methicillin-resistant staphylococci and enterococci are resistant to ertapenem, owing to PBP target insensitivity; P. aeruginosa and other non-fermentative bacteria are generally resistant, probably owing to limited penetration and to active efflux.
Staphylococci reżistenti għal methicillin u enterococci huma reżistenti għal ertapenem, minħabba li huma insensittivi fil- mira għal PBP; P. aeruginosa u batterji oħrajn li mhumiex fermentattivi huma ġeneralment reżistenti, probabbilment minħabba penetrazzjoni limitata u effluss attiv.
Resistance is uncommon in Enterobacteriaceae and the drug is generally active against those with extended-spectrum beta-lactamases (ESBLs).
Ir- reżistenza mhix komuni f' Enterobacteriaceae u l- mediċina hi ġeneralment attiva kontra dawk bl - extended- spectrum beta- lactamases (ESBLs).
AmpC types) are present in conjunction with reduced permeability, arising by the loss of one or more outer membrane porins, or with up-regulated efflux.
Madankollu, ir- reżistenza tista 'tkun osservata meta l - ESBLs jew beta- lactamases qawwija oħrajn (eż. tipi ta' AmpC) ikunu preżenti flimkien ma 'permeabilità mnaqqsa, li tinħoloq minħabba t- telfa ta' wieħed jew iktar porins tal- membrana esterna, jew ma 'effluss up- regulated.
Resistance can also arise via the acquisition of betalactamases with significant carbapenem-hydrolysing activity (e. g.
Ir- reżistenza tista 'wkoll tinħoloq permezz ta' l- akkwist ta 'betalactamases b' attività sinifikanti carbapenem hydrolysing (eż.
IMP and VIM metallo-beta-lactamases or KPC types), though these are rare.
IMP u VIM metallo- beta- lactamases jew tipi ta 'KPC), għalkemm dawn huma rari.
The mechanism of action of ertapenem differs from that of other classes of antibiotics, such as quinolones, aminoglycosides, macrolides and tetracyclines.
Il- mekkaniżmu ta 'l- azzjoni ta' ertapenem hu differenti minn dak ta 'klassijiet oħra ta' antibijotiċi, bħal quinolones, aminoglycosides, macrolides u tetracyclines.
There is no target-based cross-resistance between ertapenem and these substances.
M' hemm l- ebda reżistenza inkroċjata target based bejn ertapenem u dawn is- sustanzi.
However, micro-organisms may exhibit resistance to more than one class of antibacterial agents when the mechanism is, or includes, impermeability to some compounds and/ or an efflux pump.
Madankollu, il- mikro- organiżmi jistgħu juru reżistenza għal iktar minn klassi waħda ta 'mediċini kontra l- batterji meta l- mekkaniżmu ikun, jew jinkludi, l - impermeabilità għal xi komposti u/ jew pompa ta' l- effluss.
The EUCAST MIC breakpoints are as follows:
Il- breakpoints ta 'l- NCCLS MIC huma kif ġej:
S≤ 0.5 mg/ l and R > 1 mg/ l • Streptococcus A, B, C, G:
S≤ 0. 5 mg/ l u R > 1 mg/ l • Streptococcus A, B, C, G:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Streptococcus pneumoniae:
S ≤0. 5 mg/ l u R > 0. 5 mg/ l • Streptococcus pneumoniae:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Haemophilus influenzae:
S ≤0. 5 mg/ l u R > 0. 5 mg/ l • Haemophilus influenzae:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • M. catarrhalis:
S ≤0. 5 mg/ l u R > 0. 5 mg/ l • M. catarrhalis:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Gram negative anaerobes:
S ≤0. 5 mg/ l u R > 0. 5 mg/ l • Anerobi gram negattivi:
S ≤ 1mg/ l and R > 1 mg/ l • Non species related breakpoints:
S ≤ 1mg/ l u R > 1 mg/ l • Breakpoints mhux relatati ma ’ l- ispeċi:
S≤ 0.5 mg/ l and R > 1 mg/ l (NB:
S≤ 0. 5 mg/ l u R > 1 mg/ l (NB:
Susceptibility of staphylococci to ertapenem is inferred from the methicillin susceptibility)
Is- suxxettibilità ta ’ staphylococci għal ertapenem hija kundizzjonali fuq is- suxxettibbiltà għal methicillin)
The prescribers are informed that local MIC breakpoints, if available, should be consulted.
Min jagħti riċetta għal dan il- prodott huwa infurmat li għandha ssir referenza għal breakpoints lokali ta 'l- MIC, jekk jeżistu.
8 Microbiological Susceptibility
8 Suxxettibilitċa Mikrobijoloġika
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.
Il- prevalenza ta 'żvilupp ta' reżistenza miksuba tista 'tvarja ġeografikament u skond iż- żmien għal speċi selettivi, u ta' min li wieħed ikollu informazzjoni lokali dwar reżistenza, speċjalment fil- kura ta 'infezzjonijiet qawwija.
Localized clusters of infections due to carbapenem-resistant organisms have been reported in the European Union.
Fl- Unjoni Ewropea ġew irrappurtati ġemgħat lokalizzati ta 'infezzjonijiet minħabba organiżmi reżistenti għal carbapenem.
The information below gives only approximate guidance on the probability as to whether the micro-organism will be susceptible to ertapenem or not.
L- informazzjoni li ġejja tagħti biss indikazzjoni approssimattiva tal- probabbiltà ta’ jekk il- mikro- organiżmu hux suxxettibbli għal ertapenem jew le.
9 Commonly susceptible species:
9 Speċi li huma komunement suxxettibbli:
Gram-positive aerobes:
Erobi Gram pożittivi:
Methicillin-susceptible-staphylococci (including Staphylococcus aureus)* Streptococcus agalactiae* Streptococcus pneumoniae*† Streptococcus pyogenes Gram-negative aerobes:
Staphylococci suxxettibbli għal methicillin (inkluż Staphylococcus aureus) * Streptococcus agalactiae * Streptococcus pneumoniae * † Streptococcus pyogenes Erobi Gram- negattivi:
Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli* Haemophilus influenzae* Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae* Moraxella catarrhalis* Morganella morganii Proteus mirabilis* Proteus vulgaris Serratia marcescens Anaerobes:
Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli * Haemophilus influenzae * Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae * Moraxella catarrhalis * Morganella morganii Proteus mirabilis Proteus vulgaris Serratia marcescens Anerobi:
Bacteroides fragilis and species in the B. fragilis Group* Clostridium species (excluding C. difficile)* Eubacterium species* Fusobacterium species* Peptostreptococcus species* Porphyromonas asaccharolytica* Prevotella species* Species for which acquired resistance may be a problem:
Bacteroides fragilis u speċi fil- Grupp B. fragilis * L- ispeċi Clostridium (ħlief C. difficile) * L- ispeċi Eubacterium * L- ispeċi Fusobacterium * L- ispeċi Peptostreptococcus * Porphyromonas asaccharolytica * L- ispeċi Prevotella * Speċi li għalihom ir- reżistenza akkwistata tista 'tkun problema:
Methicillin-resistant staphylococci +# Inherently resistant organisms:
Staphylococci reżistenti għal methicillin + # Organiżmi reżistenti b' mod inerenti:
Gram-positive aerobes:
Erobi gram pożittivi:
Corynebacterium jeikeium Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Corynebacterium jeikeium Enterococci inkluż Enterococcus faecalis u Enterococcus faecium Erobi gram negattivi:
Aeromonas species Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa Stenotrophomonas maltophilia Anaerobes:
L- ispeċi Aeromonas L- ispeċi Acinetobacter Burkholderia cepacia Pseudomonas aeruginosa Stenotrophomonas maltophilia Anerobi:
Lactobacillus species Others:
L- ispeċi Lactobacillus Oħrajn:
Chlamydia species Mycoplasma species Rickettsia species Legionella species * Activity has been satisfactorily demonstrated in clinical studies. † The efficacy of INVANZ in the treatment of community acquired pneumonia due to penicillin- resistant Streptococcus pneumoniae has not been established. + frequency of acquired resistance > 50% in some Member States # Methicillin-resistant staphylococci (including MRSA) are always resistant to betalactams.
L- ispeċi Chlamydia L- ispeċi Mycoplasma L- ispeċi Rickettsia L- ispeċi Legionella * L- attività intweriet b' mod sodisfaċenti fi studji kliniċi. † Ma ġietx stabbilita l- effikaċja ta 'INVANZ fil- kura tal- pnewmonja li tittieħed mill- komunita` permezz ta' Streptococcus pneumoniae li hija reżistenti għal penicillin. + frekwenza ta 'reżistenza akkwistata > 50% f' xi Stati Membri # Staphylococci reżistenti għal methicillin (li jinkludu l- MRSA) huma dejjem reżistenti għall - betalactams.
10 Information from clinical studies
Informazzjoni minn studji kliniċi
Efficacy in Pediatric Studies Ertapenem was evaluated primarily for pediatric safety and secondarily for efficacy in randomized comparative, multicenter studies in patients 3 months to 17 years of age.
10 Effikaċja fi Studji Pedjatriċi Ertapenem kien evalwat l- ewwel għas- sigurtà pedjatrika u t- tieni għall- effikaċja fi studji randomized, komparattivi u multiċentriċi f' pazjenti ta 'bejn it- 3 xhur u s- 17- il sena.
The proportion of patients with a favorable clinical response assessment at posttreatment visit in the clinical MITT population is shown below:
Il- proporzjon ta 'pazjenti b' evalwazzjoni ta' rispons kliniku favorevoli fil- viżta ta 'wara l- kura fil - popolazzjoni klinika MITT jinsab hawn taħt:
Disease Stratum †
Saff tal- Mard †
Age Stratum
Saff ta 'l- Età
Community Acquired Pneumonia (CAP)
Pnewmonja li Tittieħed mill - Komunità (CAP)
3 to 23 months
3 sa 23 xhur
2 to 12 years 13 to 17 years
2 sa 12- il sena 13 sa 17- il sena
Disease Stratum
Saff tal- Mard
Intraabdominal Infections (IAI)
Infezzjonijiet Intra - addominali (IAI)
2 to 12 years
2 sa 12- il sena
13 to 17 years
13 sa 17- il sena
Acute Pelvic Infections (API) †
Infezzjonijiet Pelviċi Akuti (API) †
This includes 9 patients in the ertapenem group (7 CAP and 2 IAI), 2 patients in the ceftriaxone group (2 CAP), and 1 patient with IAI in the ticarcillin/ clavulanate group with secondary bacteremia at entry into the study.
Dan jinkludi 9 pazjenti fil- grupp ta 'ertapenem (7 CAP u 2 IAI), 2 pazjenti fil- grupp ta' ceftriaxone (2 CAP), u pazjent 1 b' IAI fil- grupp ta 'ticarcillin/ clavulanate li kellu batteremija sekondarja meta ddaħal fl- istudju.
Plasma concentrations Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 9 micrograms/ ml at 12 hour postdose, and 1 microgram/ ml at 24 hour postdose.
Konċentrazzjonijiet fil- plażma Konċentrazzjonijiet medji fil- plażma ta 'ertapenem wara infużjoni ewlenija fil- vina ta' 1g fuq perjodu ta '30 minuta f' adulti żgħażagħ f' saħħithom (25 sa 45 sena) kienu ta' 155 mikrogrammi/ ml (Cmax) 30 minuta wara d- doża (wara li spiċċat l- infużjoni), 9 mikrogrammi/ ml wara 12- il siegħa mid- doża, u 1 mikrogramm/ ml wara 24 siegħa mid- doża.
Area under the plasma concentration curve (AUC) of ertapenem in adults increases nearly dose- proportionally over the 0.5 to 2 g dose range.
L- erja taħt il- kurva tal- konċentrazzjoni fil- plażma (AUC) ta 'ertapenem fl- adulti tiżdied kważi proporzjonalment mad- doża f' medda ta' doża minn 0. 5 sa 2g.
There is no accumulation of ertapenem in adults following multiple intravenous doses ranging from 0.5 to 2 g daily.
M' hemm l- ebda akkumulazzjoni ta 'ertapenem fl- adulti wara dożi multipli mogħtija ġol- vina li jvarjaw minn 0. 5 sa 2g kuljum.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/ kg (up to a maximum dose of 1 g) dose in patients 3 to 23 months of age were 103.8 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 13.5 micrograms/ ml at 6 hour postdose, and 2.5 micrograms/ ml at 12 hour postdose.
Konċentrazzjonijiet medji tal- plażma ta 'ertapenem wara doża waħda ta' infużjoni ġol- vini ta '30 minuta ta' 15mg/ kg (sa doża massima ta '1g) f' pazjenti li kellhom minn 3 sa 23 xahar kienu ta' 103. 8 mikrogrammi/ ml (Cmax) 30 minuta wara d- doża (tmiem ta 'l- infużjoni), 13. 5 mikrogrammi/ ml 6 sigħat wara d- doża, u 2. 5 mikrogrammi/ ml 12- il siegħa wara d- doża.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/ kg (up to a maximum dose of 1 g) dose in patients 2 to 12 years of age were 113.2 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 12.8 micrograms/ ml at 6 hour postdose, and 3.0 micrograms/ ml at 12 hour postdose.
Konċentrazzjonijiet medji tal- plażma ta 'ertapenem wara doża ewlenija ta' infużjoni ġol- vina ta '30 minuta ta' 15mg/ kg (sa doża massima ta '1g) f' pazjenti li kellhom minn sentejn sa 12- il sena kienu ta' 113. 2 mikrogrammi/ ml (Cmax) 30 minuta wara d- doża (tmiem ta 'l- infużjoni), 12. 8 mikrogrammi/ ml 6 sigħat wara d- doża, u 3. 0 mikrogrammi/ ml 12- il siegħa wara d- doża.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 20 mg/ kg (up to a maximum dose of 1 g) dose in patients 13 to 17 years of age were 170.4 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 7.0 micrograms/ ml at 12 hour postdose, and 1.1 microgram/ ml at 24 hour postdose.
Konċentrazzjonijiet medji tal- plażma ta 'ertapenem wara doża ewlenija ta' infużjoni ġol- vina ta '30 minuta ta' 20mg/ kg (sa doża massima ta '1g) f' pazjenti li kellhom minn 13 sa 17- il sena kienu ta' 170. 4 mikrogrammi/ ml (Cmax) 30 minuta wara d- doża (tmiem ta 'l- infużjoni), 7. 0 mikrogrammi/ ml 12 sigħat wara d- doża, u 1. 1 mikrogrammi/ ml 24 siegħa wara d- doża.
11 Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in three patients 13 to 17 years of age were 155.9 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), and 6.2 micrograms/ ml at 12 hour postdose.
11 Konċentrazzjonijiet medji tal- plażma ta 'ertapenem wara doża ewlenija ta' infużjoni ġol- vina ta '30 minuta ta' 1g fi tliet pazjenti li kellhom minn 13 sa 17- il sena kienu ta '155. 9 mikrogrammi/ ml (Cmax) 30 minuta wara d- doża (tmiem ta' l- infużjoni), u 6. 2 mikrogrammi/ ml 12- il siegħa wara d- doża.
Distribution Ertapenem is highly bound to human plasma proteins.
Distribuzzjoni Ertapenem jintrabat ħafna mal- proteini fil- plażma tal- bniedem.
In healthy young adults (25 to 45 years of age), the protein binding of ertapenem decreases, as plasma concentrations increase, from approximately 95% bound at an approximate plasma concentration of < 50 micrograms/ ml to approximately 92% bound at an approximate plasma concentration of 155 micrograms/ ml (average concentration achieved at the end of infusion following 1 g intravenously).
F' adulti żagħżagħ f' saħħithom (25 sa 45 sena) l- irbit ta 'ertapenem mal- proteina jonqos hekk kif jiżdiedu l- konċentrazzjonijiet fil- plażma, bejn wieħed u ieħor minn rabta ta' 95% meta jkun hemm konċentrazzjoni approssimattiva fil- plażma ta '< 50 mikrogrammi/ ml sa rabta ta' bejn wieħed u ieħor 92% meta jkun hemm konċentrazzjoni approssimattiva fil- plażma ta '155 mikrogrammi/ ml (konċentrazzjoni medja fl- aħħar ta' l- infużjoni wara 1g mogħtija fil- vina).
The volume of distribution (Vdss) of ertapenem in adults is approximately 8 litres (0.11 liter/ kg) and approximately 0.2 liter/ kg in paediatric patients 3 months to 12 years of age and approximately 0.16 liter/ kg in paediatric patients 13 to 17 years of age.
Il- volum ta 'distribuzzjoni (Vdss) ta' ertapenem fl- adulti huwa ta 'bejn wieħed u ieħor 8 litri (0. 11 litru/ kg) u ta ’ madwar 0. 2 litru/ kg f’ pazjenti pedjatriċi li għandhom minn 3 xhur sa 12- il sena, u madwar 0. 16 litru/ kg kg f’ pazjenti pedjatriċi li għandhom minn 13 sa 17- il sena.
Concentrations of ertapenem achieved in adult skin blister fluid at each sampling point on the third day of 1 g once daily intravenous doses showed a ratio of AUC in skin blister fluid:
Il- konċentrazzjonijiet ta 'ertapenem li ntlaħqu f' kull punt minn fejn ittieħed il- kampjun ta' fluwidu minn bużżieqa fil- ġilda fl- adulti li nkisbu fit- tielet jum ta 'dożi ta' 1g mogħtija fil- vina darba kuljum, urew proporzjon ta 'AUC fil- fluwidu tal- bużżieqa tal- ġilda:
AUC in plasma of 0.61.
AUC fil- plażma ta '0. 61.
In-vitro studies indicate that the effect of ertapenem on the plasma protein binding of highly protein bound medicinal products (warfarin, ethinyl estradiol, and norethindrone) was small.
Studji in- vitro jindikaw li l- effett ta 'ertapenem fuq il- ħila ta' l- irbit mal- proteini tal- plażma fi prodotti mediċinali li għandhom irbit qawwi mal- proteini (warfarin, ethinyl estradiol, norethindrone) huwa żgħir.
The change in binding was < 12% at peak plasma ertapenem concentration following a 1 g dose.
Il- bidla fl- irbit kienet < 12% fl- ogħla konċentrazzjonijiet ta 'ertapenem fil- plażma wara doża ta' 1g.
In vivo, probenecid (500 mg every 6 hours) decreased the bound fraction of ertapenem in plasma at the end of infusion in subjects administered a single 1 g intravenous dose from approximately 91% to approximately 87%.
In vivo, probenecid (500mg kull 6 sigħat) naqqas il- parti marbuta ta 'ertapenem fil- plażma fl- aħħar ta' l- infużjoni f' pazjenti li ngħataw doża waħda ta '1g fil- vina, minn bejn wieħed u ieħor 91% sa bejn wieħed u ieħor 87%.
The effects of this change are anticipated to be transient.
L- effetti ta 'din il- bidla huma mistennija jkunu temporanji.
A clinically significant interaction due to ertapenem displacing another medicinal product or another medicinal product displacing ertapenem is unlikely.
Mhux probabbli li jkun hemm interazzjoni klinikament sinifikanti minħabba li ertapenem jieħu post prodott mediċinali ieħor jew prodott mediċinali ieħor jieħu post ertapenem.
In-vitro studies indicate that ertapenem does not inhibit P-glycoprotein-mediated transport of digoxin or vinblastine and that ertapenem is not a substrate for P-glycoprotein-mediated transport.
Studji in- vitro jindikaw li ertapenem ma jfixkilx il- ġarr ta ’ digoxin jew vinblastine permezz tal- P - glycoprotein, u li ertapenem mhux sottostrat għall- ġarr permezz tal- P- glycoprotein.