qanastek/EMEA-V3 huggingface dataset:
Metabolism In healthy young adults (23 to 49 years of age), after intravenous infusion of radiolabelled 1 g ertapenem, the plasma radioactivity consists predominantly (94%) of ertapenem.
Metaboliżmu F' adulti żagħżagħ f' saħħithom (23 sa 49 sena), wara l- influżjoni fil- vina ta '1g ta' ertapenem radjutikkettat, ir- radjoattività fil- plażma tikkonsisti kważi għal kollox (94%) f' ertapenem.
The major metabolite of ertapenem is the ring-opened derivative formed by dehydropeptidase-I-mediated hydrolysis of the beta-lactam ring.
L- ikbar metabolit ta 'ertapenem huwa derivattiv b’ ċirku miftuħ iffurmat bl- idrolisi permezz ta ’ dehydropeptidase- I taċ- ċirku beta- lactam.
In-vitro studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the six major CYP isoforms:
Studji in vitro tal- mikrosomi tal- fwied tal- bniedem jindikaw li ertapenem ma jfixkilx il- metaboliżmu li jseħħ permezz tas- sitt isoforms CYP prinċipali:
1A2, 2C9, 2C19, 2D6, 2E1 and 3A4.
1A2, 2C9, 2C19, 2D6, 2E1 u 3A4.
Elimination Following administration of a 1 g radiolabelled intravenous dose of ertapenem to healthy young adults (23 to 49 years of age), approximately 80% is recovered in urine and 10% in faeces.
Tneħħija Wara li ngħatat doża ewlenija fil- vina ta '1g ta' ertapenem radjutikkettat lill- adulti żagħżagħ f' saħħithom (23 - 49 sena), bejn wieħed u ieħor 80% nstabet fl- awrina u 10% fl- ippurgar.
Of the 80% recovered in urine, approximately 38% is excreted as unchanged ertapenem and approximately 37% as the ring-opened metabolite.
Mit- 80% misjub fl- awrina, bejn wieħed u ieħor 38% jitneħħa bħala ertapenem mhux mibdul u bejn wieħed u ieħor 37% bħala l- metabolit b’ ċirku miftuħ.
In healthy young adults (18 to 49 years of age) and patients 13 to 17 years of age given a 1 g intravenous dose, the mean plasma half-life is approximately 4 hours.
F' adulti żagħżagħ f' saħħithom (18 sa 49 sena) u pazjenti it- 13 u s- 17 il- sena li ngħataw doża fil- vina ta '1g, il- medja tal- half- life fil- plażma hija ta' 4 sigħat.
The mean plasma half-life in children 3 months to 12 years of age is approximately 2.5 hours.
Fit- tfal bejn it- 3 xhur sat- 12 il- sena il - medja tal- half life fil- plażma hija bejn wieħed u ieħor ta '2. 5 sigħat.
Average concentrations of ertapenem in urine exceed 984 micrograms/ ml during the period 0 to 2 hours postdose and exceed 52 micrograms/ ml during the period 12 to 24 hours post-administration.
Il- konċentrazzjonijiet medji ta 'ertapenem fl- awrina jaqbżu d- 984 mikrogramma/ ml fil- perjodu ta' sagħtejn wara d- doża u jaqbżu t - 52 mikrogramma/ ml fil- perjodu ta 'bejn it- 12 u l- 24 siegħa mid- doża.
Gender The plasma concentrations of ertapenem are comparable in men and women.
Sess Il- konċentrazzjonijiet ta 'ertapenem fil- plażma huma komparabbli fl- irġiel u n- nisa.
12 Elderly Plasma concentrations following a 1 g and 2 g intravenous dose of ertapenem are slightly higher (approximately 39% and 22%, respectively) in healthy elderly adults (≥ 65 years) relative to young adults (< 65 years).
12 Anzjani Il- konċentrazzjonijiet ta 'ertapenem fil- plażma wara doża fil- vina ta' 1g u 2 g huma ftit ogħla (bejn wieħed u ieħor 39% u 22% rispettivament) f' adulti anzjani f' saħħithom (≥ 65 sena) meta mqabbla ma 'adulti żagħżagħ (< 65 sena).
In the absence of advanced renal insufficiency, no dosage adjustment is necessary in elderly patients.
Meta ma jkunx hemm insuffiċjenza avvanzata fil- kliewi, m' hemmx bżonn bidla fid- doża għal pazjenti anzjani.
Paediatric Patients Plasma concentrations of ertapenem are comparable in paediatric patients 13 to 17 years of age and adults following a 1 g once daily intravenous dose.
Pazjenti Pedjatrici Il- konċentrazzjonijiet tal- plażma ta 'ertapenem huma komparabbli f' pazjenti pedjatrici li għandhom minn 13 sa 17- il sena u fl- adulti wara doża ta' 1g ġol- vini darba kuljum.
Following the 20 mg/ kg dose (up to a maximum dose of 1 g), the pharmacokinetic parameter values in patients 13 to 17 years of age were generally comparable to those in healthy young adults..
Wara doża ta '20mg/ kg (sa doża massima ta' 1g), il- valuri tal- parametri farmakokinetiċi f' pazjenti li kellhom minn 13 sa 17- il sena kienu ġeneralment komparabbli ma 'dawk f' adulti żgħar f' saħħithom.
To provide an estimate of the pharmacokinetic data if all patients in this age group were to receive a 1 g dose, the pharmacokinetic data were calculated adjusting for a 1 g dose, assuming linearity.
Biex tipprovdi stima ta 'l- informazzjoni farmakokinetika jekk il- pazjenti kollha f' dan il- grupp ta' età kellhom jirċievu doża ta '1g, l- informazzjoni farmakokinetika kienet ikkalkulata billi sar aġġustament għal doża ta' 1g doża, jekk wieħed jassumi l- linearità.
A comparison of results show that a 1 g once daily dose of ertapenem achieves a pharmacokinetic profile in patients 13 to 17 years of age comparable to that of adults.
Paragun tar- riżultati juri li doża ta '1g ta' ertapenem kuljum twettaq profil farmakokinetiku f' pazjenti li għandhom minn 13 sa 17- il sena, li hu komparabbli ma 'dak ta' l- adulti.
The ratios (13 to 17 years/ Adults) for AUC, the end of infusion concentration and the concentration at the midpoint of the dosing interval were 0.99, 1.20, and 0.84, respectively.
Il- proporzjonijiet (13 sa 17- il sena/ Adulti) għall- AUC, it- tmiem tal - konċentrazzjoni ta 'l- infużjoni u l- konċentrazzjoni f' nofs l- intervall tad- dożaġġ kienu ta' 0. 99, 1. 20, u 0. 84, rispettivament.
Plasma concentrations at the midpoint of the dosing interval following a single 15 mg/ kg intravenous dose of ertapenem in patients 3 months to 12 years of age are comparable to plasma concentrations at the midpoint of the dosing interval following a 1 g once daily intravenous dose in adults (see Plasma concentrations).
Konċentrazzjonijiet tal- plażma f' nofs l- intervall tad- dożaġġ wara doża ewlenija ta 'infużjoni ġol- vina ta' 15mg/ kg ta 'ertapenem f' pazjenti li kellhom minn 3 xhur sa 12- il sena, huma komparabbli għall - konċentrazzjonijiet tal- plażma f' nofs l- intervall tad- dożaġġ wara doża ewlenija ta' infużjoni ġol- vina ta '1g kuljum fl- adulti (ara Konċentrazzjonijiet tal- plażma).
The plasma clearance (ml/ min/ kg) of ertapenem in patients 3 months to 12 years of age is approximately 2-fold higher as compared to that in adults.
It- tneħħija mill- plażma (ml/ min/ kg) ta 'ertapenem f' pazjenti ta' minn 3 xhur sa 12- il sena hi madwar darbtejn iżjed meta mqabbla ma 'dik fl - adulti.
At the 15 mg/ kg dose, the AUC value and plasma concentrations at the midpoint of the dosing interval in patients 3 months to 12 years of age were comparable to those in young healthy adults receiving a 1 g intravenous dose of ertapenem.
Fid- doża ta '15mg/ kg, il- valur ta' l- AUC u konċentrazzjonijiet tal- plażma f' nofs l- intervall tad - dożaġġ f' pazjenti li kellhom minn 3 xhur sa 12- il sena, kienu komparabbli ma 'dawk f' adulti żgħar f' saħħithom li kienu qed jieħdu doża ta' 1g ta 'ertapenem ġol- vina.
Hepatic Insufficiency The pharmacokinetics of ertapenem in patients with hepatic insufficiency have not been established.
Insuffiċjenza tal- Fwied Il- farmakokinetika ta 'ertapenem f' pazjenti b' insuffiċjenza tal- fwied ma ġietx stabbilita.
Due to the limited extent of hepatic metabolism of ertapenem, its pharmacokinetics are not expected to be affected by hepatic impairment.
Minħabba li ertapenem ftit jiġi metaboliżżat fil- fwied, il- karatteristiċi farmakonetika tiegħu mhux mistennija li tiġi affettwata bl' insuffiċjenza fil- fwied.
Therefore, no dosage adjustment is recommended in patients with hepatic impairment.
Għalhekk, m' hemmx għalfejn bdil fid- doża għal pazjenti b' insuffiċjenza fil- fwied.
Renal Insufficiency Following a single 1 g intravenous dose of ertapenem in adults, AUCs of total ertapenem (bound and unbound) and of unbound ertapenem are similar in patients with mild renal insufficiency (Clcr 60 to 90 ml/ min/ 1.73 m2) compared with healthy subjects (ages 25 to 82 years).
Insuffiċjenza tal- Kliewi Wara doża ewlenija ta 'ertapenem fil- vina fl- adulti, l- AUC ta' ertapenem totali (kemm marbut kif ukoll maħlul) u ta 'ertapenem maħlul huwa simili f' pazjenti b' insuffiċjenza ħafifa tal- kliewi (Clcr 60 sa 90ml/ min/ 1. 73m2) meta mqabbel ma' dak f’ nies f' saħħithom (minn 25 sa 82 sena).
AUCs of total ertapenem and of unbound ertapenem are increased in patients with moderate renal insufficiency (Clcr 31 to 59 ml/ min/ 1.73 m2) approximately 1.5-fold and 1.8-fold, respectively, compared with healthy subjects.
L- AUCs ta 'ertapenem totali u ertapenem maħlul jiżdied f' pazjenti li għandhom insuffiċjenza moderata tal- kliewi (Clcr 31 sa 59ml/ min/ 1. 73m2) bejn wieħed u ieħor 1. 5 darbiet u 1. 8 darbiet rispettivament, meta mqabbla ma' dak f’ nies f' saħħithom.
AUCs of total ertapenem and of unbound ertapenem are increased in patients with advanced renal insufficiency (Clcr 5 to 30 ml/ min/ 1.73 m2) approximately 2.6-fold and 3.4-fold, respectively, compared with healthy subjects.
L- AUCs ta 'ertapenem totali u ertapenem maħlul jiżdiedu f' pazjenti li għandhom insuffiċjenza qawwija tal- kliewi (Clcr 5 sa 30ml/ min/ 1. 73m2) bejn wieħed u ieħor 2. 6 darbiet u 3. 4 darbiet rispettivament, meta mqabbla ma' dawk f’ nies f' saħħithom.
AUCs of total ertapenem and of unbound ertapenem are increased in patients who require haemodialysis approximately 2.9-fold and 6.0-fold, respectively, between dialysis sessions, compared with healthy subjects.
L- AUCs ta 'ertapenem totali u ertapenem maħlul jiżdiedu f' pazjenti li għandhom bżonn id- dijalisi tad- demm bejn wieħed u ieħor 2. 9 darbiet u 6. 0 darbiet rispettivament, bejn sessjonijiet ta' dijalisi, meta mqabbla ma 'dawk f’ nies f' saħħithom.
Following a single 1 g intravenous dose given immediately prior to a haemodialysis session, approximately 30% of the dose is recovered in the dialysate.
Wara doża ewlenija fil- vina ta '1g eżatt qabel is- sessjoni tal- dijalisi tad - demm, bejn wieħed u ieħor 30% tad- doża nkisbet mid- dijalizzat.
There are no data in paediatric patients with renal insufficiency.
M’ hemm l- ebda informazzjoni dwar pazjenti pedjatriċi b’ insuffiċjenza tal- kliewi.
There are inadequate data on the safety and efficacy of ertapenem in patients with advanced renal insufficiency and patients who require haemodialysis to support a dose recommendation.
M' hemmx tagħrif biżżejjed dwar is- sigurtà u l- effikaċja ta 'ertapenem f' pazjenti li għandhom insuffiċjenza avvanzata tal- kliewi u f' pazjenti li għandhom bżonn id- dijalisi tad- demm biex issir rakkomandazzjoni ta' doża.
Therefore, ertapenem should not be used in these patients.
Għalhekk, ertapenem m' għandux jintuża f' dawn il- pazjenti.
5.3 Preclinical safety data
13 5. 3 Tagħrif pre- kliniku dwar is- sigurtà tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated-dose toxicity, genotoxicity and toxicity in reproduction.
Tagħrif mhux kliniku bbażat fuq studji konvenzjonali dwar is- sigurtà, il- farmakoloġija, it- tossiċità ta 'dożi ripetuti, il- ġenotossiċità u t- tossiċità fir- riproduzzjoni, ma juri l- ebda periklu speċjali għall - bnedmin.
Decreased neutrophil counts, however, occurred in rats that received high doses of ertapenem, which was not considered a significant safety issue.
Fil- firien li ngħataw dożi għolja ta 'ertapenem, madankollu, kien hemm numru mnaqqas ta' newtrofili, li ma kienx ikkunsidrat bħala aspett sinifikanti tas- sigurtà.
13 Long-term studies in animals to evaluate the carcinogenic potential of ertapenem have not been performed.
Ma sarux studji fit- tul fuq l- annimali biex jevalwaw il- potenzjal karċinoġeniku ta 'ertapenem.
Sodium hydroxide (E524) to adjust pH to 7.5
Sodium hydroxide (E524) biex jaġġusta l- pH għal 7. 5.
Do not use solvents or infusion fluids containing dextrose for reconstitution or administration of ertapenem sodium.
M' għandhomx jintużaw solventi jew fluwidi għall- infużjoni li fihom dextrose biex jiġi rikostitwit jew jingħata ertapenem sodium.
After reconstitution:
Wara rikonstituzzjoni:
Diluted solutions should be used immediately.
Is- soluzzjonijiet dilwiti għandhom jintużaw minnufih.
If not used immediately, in use storage times are the responsibility of the user.
Jekk ma jintużawx minnufih, iż- żmien tal- ħażna huwa r- responsabbiltà ta 'min qed juża l- prodott.
Diluted solutions (approximately 20 mg/ ml ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2 to 8°C (in a refrigerator).
Soluzzjonijiet dilwiti (bejn wieħed u ieħor 20mg/ ml ta ’ ertapenem) huma fiżikament u kimikament stabbli ghal 6 sigħat fit- temperatura tal- kamra (25°C) jew għal 24 siegħa f’ temperatura ta ’ bejn 2°C u 8°C (fil- friġġ).
Solutions should be used within 4 hours of their removal from the refrigerator.
Is- soluzzjonijiet għandhom jintużaw fi żmien 4 sigħat minn meta jinħarġu mill- friġġ.
For storage instructions after reconstitution:, see section 6.3.
Għal istruzzjonijiet dwar il- ħażna wara rikostituzzjoni, ara sezzjoni 6. 3.
Do not freeze solutions of INVANZ.
Soluzzjonijiet ta 'INVANZ m' għandhomx jiġu ffriżati.
20 ml Type I glass vials with a grey butyl stopper and a white plastic cap on a coloured aluminium band seal.
Kunjetti tal- ħġieġ tat- Tip I ta 'l- 20ml b' tapp griż tal- butyl u għatu abjad tal- plastik b' siġill magħmul minn ċirku ta' l- aluminju kkulurit.
Supplied in packs of 1 vial or 10 vials.
Jiġi f' pakketti ta 'kunjett wieħed jew 10 kunjetti.
Not all pack sizes may be marketed.
Mhux id- daqsijiet tal- pakketti kollha jistgħu jkunu għall- bejgħ.
6.6 Special precautions for disposal and other handling
14 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
Reconstituted solutions should be diluted in sodium chloride 9 mg/ ml (0.9%) solution immediately after preparation.
Soluzzjonijiet rikostitwiti għandhom jiġu dilwiti f’ soluzzjoni 9mg/ ml (0. 9%) ta ’ sodium chloride minnufih wara l- preparazzjoni.
Preparation for intravenous administration:
Preparazzjoni biex tingħata fil- vina:
INVANZ must be reconstituted and then diluted prior to administration.
INVANZ irid jiġi rikostitwit u mbagħad dilwit qabel ma jingħata.
Adults and adolescents (13 to 17 years of age):
Adulti u adolexxenti (minn 13 sa 17- il sena):
Reconstitution:
Rikostituzzjoni:
Reconstitute the contents of a 1 g vial of INVANZ with 10 ml of water for injection or sodium chloride 9 mg/ ml (0.9%) solution to yield a reconstituted solution of approximately 100 mg/ ml.
Il- kontenut ta 'kunjett ta' 1g ta 'INVANZ għandu jiġu rikostitwit ma' 10ml ta 'ilma għall - injezzjoni jew ma' 9mg/ ml (0. 9%) ta 'soluzzjoni ta ’ sodium chloride biex jagħmlu soluzzjoni rikostitwita ta' bejn wieħed u ieħor 100mg/ ml.
Shake well to dissolve.
Ħawwad sew biex jinħall.
(See section 6.4.) 2.
(Ara sezzjoni 6. 4) 2.
Dilution:
Dilwizzjoni:
For a 50 ml bag of diluent:
Għal borża tal- 50ml ta 'dilwent:
For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 ml bag of sodium chloride 9 mg/ ml (0.9%) solution; or For a 50 ml vial of diluent:
Għal doża ta '1g, ittrasferixxi minnufih il- kontenut tal- kunjett rikostitwit f' borża tal- 50ml ta' 9mg/ ml (0. 9%) ta 'soluzzjoni ta ’ sodium chloride, jew Għal kunjett ta' l- 50ml ta 'dilwent:
For a 1 g dose, withdraw 10 ml from a 50 ml vial of sodium chloride 9 mg/ ml (0.9%) solution and discard.
Għal doża ta '1g, iġbed 10ml minn kunjett tal- 50ml ta' 9mg/ ml (0. 9%) f' soluzzjoni ta ’ sodium chloride u armi.
Transfer the contents of the reconstituted 1 g vial of INVANZ to the 50 ml vial of sodium chloride 9 mg/ ml (0.9%) solution.
Ittrasferixxi l- kontenut tal- kunjett tal- 1g ta 'INVANZ fil- kunjett tal- 50ml ta' 9mg/ ml (0. 9%) f’ soluzzjoni ta ’ sodium chloride.
Infusion:
Infużjoni:
Infuse over a period of 30 minutes.
L- infużjoni għandha ddum 30 minuta.
Children (3 months to 12 years of age):
Tfal (minn 3 xhur sa 12- il sena):
Reconstitute the contents of a 1 g vial of INVANZ with 10 ml of water for injection or sodium chloride 9 mg/ ml (0.9%) solution to yield a reconstituted solution of approximately 100 mg/ ml.
Irrikostitwixxi l- kontenut ta 'kunjett ta' 1g ta 'INVANZ b' 10ml ta' ilma għall- injezzjoni jew soluzzjoni ta '9mg/ ml (0. 9%) ta' sodium chloride biex toħloq soluzzjoni rikostitwita ta 'madwar 100mg/ ml.
(See section 6.4.) 2.
Ħawwad sew biex jinħall (Ara sezzjoni 6. 4.) 2.
For a bag of diluent:
Għal borża bil- dilwent:
Transfer a volume equal to 15 mg/ kg of body weight (not to exceed 1 g/ day) to a bag of sodium chloride 9 mg/ ml (0.9%) solution for a final concentration of 20 mg/ ml or less; or For a vial of diluent:
Ittrasferixxi volum ta '15mg/ kg ta' piż korporju (li ma jridx jaqbeż il - 1g/ kuljum) f' borża b' soluzzjoni ta '9mg/ ml (0. 9%) ta' sodium chloride għal konċentrazzjoni finali ta '20mg/ ml jew inqas; jew Għal kunjett bil- dilwent:
Transfer a volume equal to 15 mg/ kg of body weight (not to exceed 1 g/ day) to a vial of sodium chloride 9 mg/ ml (0.9%) solution for a final concentration of 20 mg/ ml or less.
Ittrasferixxi volum ta '15mg/ kg ta' piż korporju (li ma jridx jaqbeż il - 1g/ kuljum) f’ kunjett b' soluzzjoni ta '9mg/ ml (0. 9%) ta' sodium chloride għal konċentrazzjoni finali ta '20mg/ ml jew inqas.
Compatibility of INVANZ with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated.
Intweriet il- kompatibilità ta 'INVANZ ma' soluzzjonijiet li jingħataw fil- vina li fihom sodium tal - heparin u potassium chloride.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits.
Soluzzjonijiet rikostitwiti għandhom jiġu eżaminati viżwalment għal frak jew għal tibdil fil- kulur qabel ma jingħataw, kull meta jippermetti l- kontenitur.
Solutions of INVANZ range from colourless to pale yellow.
Soluzzjonijiet ta 'INVANZ jistgħu jkunu minn bla kulur sa sofor ċari.
Variations of colour within this range do not affect potency.
Il- bidliet fil- kulur f' din il- medda ma jaffettwawx il- qawwa tal- prodott.
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Renju Unit.
MARKETING AUTHORISATION NUMBER(S)
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
18 April 2002 Date of latest renewal:
18 ta ’ April 2002 Data ta ’ l- aħħar tiġdid:
18 April 2007
18 ta ’ April 2007
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea Dwar il- mediċini (EMEA) http: // www. emea. eu. int /.
16 ANNEX II
16 ANNESS II
Cherokee (Danville) Plant 100 Avenue C Riverside, Pennsylvania, USA 17868
Cherokee (Danville) Plant 100 Avenue C Riverside, Pennsylvania, Stati Uniti ta ’ l- Amerika 17868
F-63963 Clermont-Ferrand Cedex 9, France.
F- 63963 Clermont- Ferrand Cedex 9, Franza.
The Marketing Authorisation Holder will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq ikompli jissottometti PSURs kull sena għajr meta speċifikat mod ieħor mill- CHMP..
18 ANNEX III
18 ANNESS III
OUTER CARTON
KAXXA TA 'BARRA
INVANZ 1 g Powder for concentrate for solution for infusion Ertapenem
INVANZ 1g Trab għal konċentrat għas- soluzzjoni għall- infużjoni Ertapenem
1.0 g ertapenem equivalent to 1.046 g ertapenem sodium.
1. 0 g ta ’ ertapenem ekwivalenti għal 1. 046g ta ’ ertapenem sodium.
Sodium bicarbonate (E500); sodium hydroxide (E524) to adjust pH to 7.5.
Sodium bicarbonate (E500), sodium hydroxide (E524) biex jaġġusta l- pH għal 7. 5.
1 vial 10 vials
1 Kunjett 10 kunjetti
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif qabel tuża l- prodott.
Intravenous use after reconstitution and dilution.
Jingħata fil- vina wara li jkun rikostitwit u dilwit.
Do not store above 25°C
Taħżinx f’ temperatura ’ l fuq minn 25°C
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Renju Unit
EU/ 1/ 02/ 216/ 001 1 vial EU/ 1/ 02/ 216/ 002 10 vials
EU/ 1/ 02/ 216/ 001 kunjett 1 EU/ 1/ 02/ 216/ 002 10 kunjetti
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
INVANZ 1 g Powder for concentrate for solution for infusion Ertapenem Intravenous use.
INVANZ 1g Trab għal konċentrat għas- soluzzjoni għall- infużjoni Ertapenem Jingħata fil- vina
INVANZ 1 g powder for concentrate for solution for infusion (ertapenem)
INVANZ 1g trab għal konċentrat għas- soluzzjoni għall- infużjoni (Ertapenem)
Read all of this leaflet carefully before you start taking this medicine.
Aqra sew dan il- fuljett kollu, għax fih tagħrif importanti għalik
if their symptoms are the same as yours.
anki jekk ikollhom l- istess sintomi bhal tiegħek.
please tell your doctor or your pharmacist.
elenkati f' dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What INVANZ is and what it is used for 2.
X’ inhu INVANZ u għalxiex jintuża 2.
Before you take INVANZ 3.
Qabel ma tieħu INVANZ 3.
How to take INVANZ 4.
Kif għandek tieħu INVANZ 4.
How to store INVANZ 6.
Kif taħżen INVANZ 6.
WHAT INVANZ IS AND WHAT IT IS USED FOR
X’ INHU INVANZ U GĦALXIEX JINTUŻA?
INVANZ is an injectable antibiotic which will always be prepared and given to you by a doctor or another healthcare professional.
INVANZ huwa antibijotiku li jittieħed b' injezzjoni li trid tiġi ppreparata u tingħata minn tabib jew xi professjonista mediku ieħor.
INVANZ contains ertapenem which is an antibiotic of the beta-lactam group.
INVANZ fih ertapenem li hu antibijotiku tal- grupp beta- lactam.
It has the ability to kill a wide range of bacteria (germs) that cause infections in various parts of the body.
Għandu l- kapaċità li joqtol firxa wiesgħa ta 'batterji (mikrobi) li jikkawżaw l- infezzjonijiet f' diversi partijiet tal- ġisem.
Your doctor has prescribed INVANZ because you have one (or more) of the following types of infection: • Infection in the abdomen • Infection affecting the lungs (pneumonia) • Gynaecological infections • Skin infections of the foot in diabetic patients.
It- tabib tiegħek tak riċetta għal INVANZ għax għandek waħda (jew iktar) mit- tipi ta 'infezzjonijiet li ġejjin: • Infezzjoni fiż- żaqq • Infezzjoni li taffettwa l- pulmuni (pnewmonja) • Infezzjonijiet ġinekoloġiċi • Infezzjonijiet tal- ġilda fis- saqajn f' pazjenti dijabetiċi. • Prevenzjoni:
• Prevention: Prevention of surgical site infections following surgery of the colon or rectum.
Il- prevenzjoni ta 'infezzjonijiet fis- sit ta' l- operazzjoni wara operazzjoni tal- kolon jew tar- rektum.
BEFORE YOU ARE TAKE INVANZ
QABEL MA TIEĦU INVANZ
Do not take INVANZ
Tieħux INVANZ
- if you are allergic to the active substance (ertapenem) or any of the other ingredients of
- jekk inti allerġiku/ a għas- sustanza attiva (ertapenem) jew għal xi waħda mis- sustanzi l- oħra ta '
- if you are allergic to antibiotics such as penicillines, cephalosporins or carbapenems.
- jekk inti allerġiku/ a għall- antibijotiċi bħal penicillines, cephalosporins jew carbapenems.
Take special care with INVANZ Tell your doctor about any medical condition you have or have had including:
Oqgħod attent ħafna b’ INVANZ Għid lit- tabib tiegħek dwar kwalunkwe kundizzjoni medika li għandek jew li kellek, li tinkludi:
- Kidney disease (see Patients with kidney disease)
- Mard tal- kliewi (ara Pazjenti b' mard tal- kliewi)
- Allergies to any medicines, including antibiotics
- Allerġiji għal xi mediċina, li jinkludu l- antibijotiċi
- Colitis or any other gastrointestinal disease.
- Kolite jew kwalunkwe marda oħra gastro- intestinali.
- Central nervous system disorders, such as localized tremors, or seizures.
- Mard tas- sistema nervuża ċentrali, bħal rogħda lokalizzata, jew puplesiji.
25 Patients with kidney disease
25 Pazjenti b’ mard tal- kliewi
It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
Hu importanti ħafna li t- tabib tiegħek ikun jaf jekk għandekx mard tal- kliewi u jekk qed tirċievi kura bid- dijalisi.
Children and adolescents (3 months to 17 years of age) INVANZ can be given to children 3 months of age and older.
Tfal u adolexxenti (3 xhur sa 17- il sena) INVANZ jista 'jingħata lil tfal li għandhom 3 xhur jew iktar.
Experience with INVANZ is limited in children less than two years of age.
L- esperjenza b' INVANZ hi limitata fi tfal ta 'inqas minn sentejn.
In this age group your doctor will decide on the potential benefit of its use.
F' dan il- grupp ta 'età, it- tabib tiegħek ser jiddeċiedi dwar il- benefiċċju potenzjali ta' l- użu tiegħu.
There is no experience in children under 3 months of age.
M' hemmx esperjenza fi tfal ta 'taħt it- 3 xhur.
Elderly INVANZ works well and is well tolerated by most older and younger adult patients.
Anzjani INVANZ jaħdem tajjeb u hu ttolerat tajjeb mill- biċċa l- kbira tal- pazjenti adulti anzjani u adulti żgħar.
The recommended dosage of INVANZ can be administered without regard to age.
Id- dożaġġ rakkomandat ta 'INVANZ jista' jingħata mingħajr ma jingħata każ ta 'l- età.
Taking other medicines Always tell your doctor about all medicines that you are taking or plan to take, including those obtained without a prescription.
Meta tieħu mediċini oħra Dejjem għid lit- tabib tiegħek dwar il- mediċini kollha li qed tieħu jew li qed tippjana li tieħu, inklużi dawk li anke dawk mingħajr riċetta.
Pregnancy and breast-feeding It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.
Tqala u treddigħ Hu importanti li tgħid lit- tabib tiegħek jekk inti tqila jew jekk qed tippjana li toħroġ tqila qabel ma 'tieħu INVANZ.
INVANZ has not been studied in pregnant women.
Ma sarx studju dwar INVANZ f' nisa tqal.
INVANZ should not be used during pregnancy unless your doctor decides the potential benefit justifies the potential risk to the foetus.
INVANZ m' għandux jintuża waqt it- tqala ħlief jekk it- tabib tiegħek jiddeċiedi li l- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
It is important that you tell your doctor if you are breast-feeding or if you intend to breast-feed before receiving INVANZ.
Hu importanti li tgħid lit- tabib tiegħek jekk inti qed tredda 'jew jekk għandek il- ħsieb li tredda' qabel tibda tieħu INVANZ.
Women who are receiving INVANZ should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected.
Nisa li qed jieħdu INVANZ m' għandhomx ireddgħu, għax dan instab fil- ħalib uman, u t- tarbija li tkun qed terda 'tista' għalhekk tkun affettwata.
Driving and using machines Do not drive or use any tools or machines until you know how you react to the medicine.
Sewqan u tħaddim ta ’ magni Issuqx u tħaddimx tagħmir jew magni sakemm tkun taf kif tirreaġixxi għal mediċina.
Certain side effects, such as dizziness and sleepiness, have been reported with INVANZ, which may affect some patients ’ ability to drive or operate machinery.
Ċerti effetti sekondarji, bħall- isturdament u ngħas, kienu rrappurtati b' INVANZ, li jistgħu jaffettwaw l- ħila ta 'ċerti pazjenti li jsuqu jew li jħaddmu l- makkinarju.
Important information about some of the ingredients of INVANZ:
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'INVANZ:
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 il- 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.
HOW TO TAKE INVANZ
KIF TIEĦU INVANZ
INVANZ will always be prepared and given to you by a doctor or another healthcare professional.
INVANZ ser ikun dejjem ippreparat u jingħatalek minn tabib jew persuna oħra professjonali fil- qasam tal- mediċina.
INVANZ is given intravenously (into a vein).
INVANZ jingħata fil- vina.
The normal dose of INVANZ for adults and adolescents 13 years of age and older is 1 gram (g) given once a day.
Id- doża normali ta ’ INVANZ għall- adulti u adolexxenti minn 13- il sena ’ l fuq hi ta ’ 1 gramma (g) mogħtija darba kuljum.
The normal dose for children 3 months to 12 years of age is 15 mg/ kg given twice daily (not to exceed 1 g/ day).
Id- doża normali għat- tfal minn 3 xhur sa 12- il sena hi ta ’ 15mg/ kg mogħtija darbtejn kuljum (ma tridx taqbeż il- 1g/ kuljum).
INVANZ is not recommended in children under 3 months of age, as no data are available.
INVANZ mhux rakkomandat fi tfal li għandhom inqas minn 3 xhur, għax m’ hemmx informazzjoni disponibbli.
Your doctor will decide how many days ’ treatment you need.
It- tabib tiegħek ser jiddeċiedi kemm il- jum ta ’ kura teħtieġ.
For prevention of surgical site infections following surgery of the colon or rectum, the recommended dose of INVANZ is 1 g administered as a single intravenous dose 1 hour before surgery.
Għal prevenzjoni ta ’ infezzjonijiet fis- sit ta ’ l- operazzjoni wara operazzjoni tal- kolon jew tar- rektum, id- doża rakkomandata ta ’ INVANZ hi ta ’ 1g mogħtija bħala doża waħda fil- vina siegħa qabel l - operazzjoni.
It is very important that you continue to receive INVANZ for as long as your doctor prescribes it.
Hu importanti ħafna li tkompli tieħu INVANZ għaż- żmien li t- tabib jagħtik ir- riċetta għalih.
If you take more INVANZ than you should
26 Jekk tieħu INVANZ aktar milli suppost għandek
26 If you are concerned that you may have been given too much INVANZ, contact your doctor or another healthcare professional immediately.
Jekk qed tinkwieta li stajt ingħatajt wisq INVANZ, ikkuntattja minnufih lit- tabib tiegħek jew professjonista mediku ieħor.
If you forget to take INVANZ
Jekk tinsa tieħu INVANZ
If you are concerned that you may have missed a dose, contact your doctor or another healthcare professional immediately.
Jekk qed tinkwieta li setgħet inqabżet xi doża ta 'INVANZ, ikkuntattja minnufih lit- tabib tiegħek jew professjonista mediku ieħor.
Like all medicines, INVANZ can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, INVANZ jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Adults 18 years of age and older:
Adulti minn 18 il- sena ’ l fuq:
The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are: • Headache • Diarrhoea, nausea, vomiting • Rash, itching • Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site).
L- iktar effetti sekondarji komuni (iktar minn 1 f’ kull 100 pazjent u inqas minn 1 minn kull 10 pazjenti) huma: • Uġigħ ta 'ras • Dijarea, dardir, rimettar • Raxx, ħakk • Problemi bil- vina li fiha qed tingħata l- mediċina (inklużi infjammazzjoni, formazzjoni ta' boċċa, nefħa fis- sit ta 'l- injezzjoni, tnixxija ta' fluwidu fit- tessut u l- ġilda ta 'madwar is- sit ta' l - injezzjoni).
Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are: • Dizziness, sleepiness, sleeplessness, confusion, seizure • Low blood pressure, slow heart rate • Shortness of breath, sore throat • Constipation, yeast infection of the mouth, antibiotic-associated diarrhoea, acid regurgitation, dry mouth, indigestion, loss of appetite • Skin redness • Vaginal discharge and irritation • Abdominal pain, fatigue, fungal infection, fever, oedema/ swelling, chest pain, abnormal taste.
Effetti sekondarji inqas komuni (iktar minn 1 f’ kull 1, 000 pazjent u inqas minn 1 minn kull 100 pazjent) huma: • Sturdament, ngħas, nuqqas ta 'rqad, konfużjoni, puplesija • Pressjoni tad- demm baxxa, nuqqas fir- rata li tħabbat il- qalb • Qtugħ ta ’ nifs, uġigħ fil- ġriżmejn • Stitikezza, infezzjoni ta ’ fungu fil- ħalq, dijarea assoċjata ma' antibijotiċi, rigurġitazzjoni ta ’ l - aċidu, ħalq xott, indiġestjoni, nuqqas ta 'aptit • Ħmura fil- ġilda • Tnixxija mill- vaġina u irritazzjoni fil- vaġina • Uġigħ fiż- żaqq, għeja, infezzjoni fungali, deni, edema/ nefħa, uġigħ fis- sider, togħma mhux tas - soltu.
Side effects reported rarely (more than 1 in 10,000 patients and less than 1 in 1,000 patients) are: • Decrease in white blood cells, decrease in blood platelet count • Low blood sugar • Agitation, anxiety, depression, tremor • Irregular heart rate, increased blood pressure, bleeding, fast heart rate • Nasal congestion, cough, bleeding from the nose, pneumonia, abnormal breathing sounds, wheezing • Inflammation of the gall bladder, difficulty in swallowing, faecal incontinence, jaundice, liver disorder • Inflammation of the skin, fungal infection of the skin, skin peeling, infection of the wound after an operation • Muscle cramp, shoulder pain • Urinary tract infection, kidney impairment • Miscarriage, genital bleeding • Allergy, feeling unwell, pelvic peritonitis, changes to the white part of the eye, fainting.
Effetti sekondarji rrappurtati rarament (iktar minn 1 f’ kull 10, 000 pazjent u inqas minn 1 minn kull 1, 000 pazjent) huma: • Tnaqqis ta 'ċelluli bojod tad- demm, tnaqqis fl- għadd tal- plejtlets • Livell baxx taz- zokkor fid- demm • Aġitazzjoni, ansjetà, dipressjoni, rogħda • Taħbit irregolari tal- qalb, żieda fil- pressjoni tad- demm, ħruġ tad- demm, taħbit mgħaġġel tal - qalb • Imnieħer miżdud, sogħla, tinfaġar, pnewmonja, ħsejjes mhux tas- soltu fin- nifs, tħarħir • Infjammazzjoni tal- bużżieqa tal- marrara, diffikultà biex tibla', inkontinenza ta ’ l- ippurgar, suffejra, mard fil- fwied • Infjammazzjoni tal- ġilda, infezzjoni fungali tal- ġilda, ġilda titqaxxar, infezzjoni tal- ferita wara operazzjoni • Bugħawwieġ tal- muskoli u uġigħ fl- ispalla • Infezzjoni fil- passaġġ ta 'l- awrina, ħsara fil- kliewi • Korriment, ħruġ ta ’ demm mill- partijiet ġenitali • Allerġija, ma tħossokx tajjeb, peritonite pelvika, bidliet fil- parti l- bajda ta ’ l- għajn, tintilef minn sensik.
27 Children and adolescents (3 months to 17 years of age):
27 Tfal u adolexxenti (minn 3 xhur sa 17- il sena):
The most common (more than 1 in 100 patients and less than 1 in 10 patients) side effects are: • Diarrhoea • Diaper rash • Pain at the infusion site
L- iktar effetti sekondarji komuni (iktar minn 1 f’ kull 100 pazjent u inqas minn 1 minn kull 10 pazjenti) huma: • Dijarea • Raxx ikkawżat mill- ħrieqi • Uġigħ fis- sit ta ’ l- infużjoni
Less common (more than 1 in 1,000 patients and less than 1 in 100 patients) side effects are: • Headache • Hot flush, high blood pressure, red or purple, flat, pinhead spots under the skin • Discoloured faeces, black tar-like faeces • Skin redness, skin rash • Burning, itching, redness and warmth at infusion site, redness at injection site • Increase in platelet count,
Effetti sekondarji inqas komuni (iktar minn 1 f’ kull 1, 000 pazjent u inqas minn 1 minn kull 100 pazjent) huma: • Uġigħ ta ’ ras • Fwawar, pressjoni tad- demm għolja, tikek żgħar u ċatti ħomor jew vjola taħt il- ġilda • Tibdil fil- kulur ta ’ l- ippurgar, ippurgar iswed qisu qatran • Ħmura tal- ġilda, raxx tal- ġilda • Ħruq, ħakk, ħmura u sħana fis- sit ta ’ l- infużjoni, ħmura fis- sit ta ’ l- infużjoni • Żieda fl- għadd tal- plejtlets,
There have also been reports of changes in some laboratory blood tests
Kien hemm ukoll rapporti ta 'bidliet f' xi testijiet tad- demm tal- laboratorju.
Since the drug has been marketed, severe allergic reactions (anaphylaxis), hallucinations, and altered mental status have been reported very rarely.
Minn meta l- mediċina tpoġġiet fuq is- suq, ġew irrappurtati b’ mod rari ħafna reazzjonijiet allerġiċi severi (anafilassi), alluċinazzjonijiet u tibdil fl- istatus mentali.
The first signs of a severe allergic reaction may include swelling of the face and/ or throat.
L- ewwel sinjali ta ’ reazzjoni allerġika severa jistgħu jinkludu nefħa tal- wiċċ u/ jew tal- gerżuma.
If these symptoms occur you must inform your doctor or nurse immediately.
Jekk iseħħu dawn is- sintomi għandek tgħarraf minnufih lit- tabib jew lin- ners tiegħek.
HOW TO STORE INVANZ
KIF TAĦŻEN INVANZ?
Do not use INVANZ after the expiry date which is stated on the container.
Ma għandekx tuża INVANZ wara d- data li jiskadi u li tidher fuq ir- reċipjent.
The first 2 numbers indicate the month; the next 4 numbers indicate the year.
L- ewwel 2 numri jindikaw ix- xahar; l- 4 numri li jmiss jindikaw is- sena.
Do not store above 25°C
Taħżinx f’ temperatura ’ l fuq minn 25°C.
FURTHER INFORMATION
X’ fih INVANZ
What INVANZ contains The active ingredient of INVANZ is ertapenem 1g.
Is- sustanza ativa ta ’ INVANZ hi ertapenem 1g.
The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
Is- sustanzi l- oħra huma: sodium bicarbonate (E500) and sodium hydroxide (E524).
What INVANZ looks like and contents of the pack INVANZ is a sterile, white to off-white, freeze-dried powder.
Id- dehra tal- prodott u d- daqs tal- pakkett INVANZ hu trab sterilizzat iffriżat- imnixxef, ta ’ kulur minn abjad għal abjad jagħti fil- griż.
Solutions of INVANZ range from colourless to pale yellow.
Soluzzjonijiet ta ’ INVANZ ivarjaw minn bla kulur sa isfar ċar.
Variations of colour within this range do not affect potency.
Varjazzjonijiet tal- kulur f’ din il- firxa ma jaffettwawx il- qawwa.
Not all pack sizes may be marketed.
INVANZ 1g trab għal konċentrat għas- soluzzjoni għall- infużjoni hu fornut f’ pakketti ta ’ kunjett 1 jew 10 kunjetti.
Manufacturer Laboratoires Merck Sharp & Dohme – Chibret Route de Marsat - Riom F-63963 Clermont-Ferrand Cedex 9 France
Mhux id- daqsijiet tal- pakketti kollha jistgħu jkunu għall- bejgħ.
28
28 Id- Detentur ta 'l- awtorizzazzjoni għat - tqegħid fis- suq:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Slovenija Merck Sharp & Dohme, inovativna zdravila d. o. o.
29 Slovenija Ireland Merck Sharp & Dohme, inovativna zdravila Merck Sharp and Dohme Ireland (Human Health) Limited d. o. o.
Ι talia Merck Sharp & Dohme (Italia) S. p. A.
Suomi/ Finland Ιtalia MSD Finland Oy Merck Sharp & Dohme (Italia) S. p. A.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. --------------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA) http: // www. emea. eu. int / --------------------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions of how to reconstitute and dilute INVANZ:
Struzzjonijiet dwar kif tittikostitwixxi u tiddilwixxi INVANZ:
Adult and adolescents (13 to 17 years of age):
Adults and adolescents (13 to 17 years of age):
Reconstitute the contents of a 1 g vial of INVANZ with 10 ml of water for injection or sodium chloride 9 mg/ ml (0.9%) solution to yield a reconstituted solution of approximately 100 mg/ ml.
Il- kontenut ta 'kunjett ta' 1g ta 'INVANZ għandhom jiġu rikostitwiti ma' 10ml ta 'ilma għall - injezzjoni jew ma' 9mg/ ml (0. 9%) ta 'soluzzjoni ta ’ sodium chloride biex jagħmlu soluzzjoni rikostitwita ta' bejn wieħed u ieħor 100mg/ ml.
For a 1 g dose, immediately transfer contents of the reconstituted vial to a 50 ml bag of sodium chloride 9 mg/ ml (0.9%) solution; or For a 50 ml vial of diluent:
Għal doża ta '1g, ittrasferixxi minnufih il- kontenut tal- kunjett rikostitwit f' borża tal- 50ml ta' 9mg/ ml (0. 9%) ta 'soluzzjoni ta ’ sodium chloride, jew
30 Children (3 months to 12 years of age):
Tfal (minn 3 xhur sa 12- il sena):
Reconstitute the contents of a 1 g vial of INVANZ with 10 ml of water for injection or sodium chloride 9 mg/ ml (0.9%) solution to yield a reconstituted solution of approximately 100 mg/ ml.
Irrikostitwixxi l- kontenut ta 'kunjett ta' 1g ta 'INVANZ ma' 10ml ta 'ilma għall- injezzjoni jew soluzzjoni ta' 9mg/ ml (0. 9%) ta 'sodium chloride biex toħloq soluzzjoni rikostitwita ta' madwar 100mg/ ml.
2.
Ħawwad sew biex jinħall (Ara sezzjoni 6. 4.) 2.
Infuse over a period of 30 minutes
L- infużjoni għandha ddum 30 minuta.
The reconstituted solution should be diluted in sodium chloride 9 mg/ ml (0.9%) solution immediately after preparation.
Is- soluzzjoni rikostitwita għandha tiġi dilwita f’ soluzzjoni ta ’ 9mg/ ml (0. 9%) ta ’ sodium chloride dritt wara l- preparazzjoni.
Diluted solutions should be used immediately.
Soluzzjonijiet dilwiti għandhom jintużaw minnufih.
If not used immediately, in use storage times are the responsibility of the user.
Jekk ma jintużawx minnufih, iż- żmien tal- ħażna waqt l- użu hu r- responsabbiltà ta ’ l- utent.
Diluted solutions (approximately 20 mg/ ml ertapenem) are physically and chemically stable for 6 hours at room temperature (25°C) or for 24 hours at 2 to 8°C (in a refrigerator).
Soluzzjonijiet dilwiti (madwar 20mg/ ml ta ’ ertapenem) huma fiżikament u kimikament stabbli għal 6 sigħat fit- temperatura tal- kamra (25°C) jew għal 24 siegħa f’ minn 2 sa 8°C (fil- friġġ).
Solutions should be used within 4 hours of their removal from the refrigerator.
Is- soluzzjonijiet għadhom jintużaw fi żmien 4 sigħat minn meta jinħarġu mill- friġġ.
Do not freeze the reconstituted solutions.
Tiffriżax is- soluzzjonijiet rikostitwiti.
The reconstituted solutions should be inspected visually for particulate matter and discolouration prior to administration, whenever the container permits.
Is- soluzzjonijiet rikostitwiti għandhom jiġu eżaminati viżwalment għal frak jew għal tibdil fil- kulur qabel ma jingħataw, kull meta jippermetti l- kontenitur.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew lill- ispiżjar tiegħek Jekk tixtieq aktar informazzjoni abbażi tar- rakkomandazzjonijiet tas- CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Invega?
X' inhu Invega?
Invega is a medicine that contains the active substance paliperidone.
Invega hu mediċina li fiha s- sustanza attiva paliperidone.
It is available as prolonged- release tablets (orange-brown:
Jiġi bħala pilloli b' rilaxx prolongat (kannella- oranġjo:
3 mg; beige:
1. 5 mg; bojod; 3 mg: beige:
6 mg; pink:
6 mg; roża:
9 mg; yellow:
9 mg; sofor:
12 mg). ‘ Prolonged release ’ means that paliperidone is released slowly from the tablet over a few hours.
Rilaxx prolongat ifisser li paliperidone idum ftit sigħat biex jiġi rilaxxat mill- pillola.
What is Invega used for?
Għal xiex jintuża Invega?
Invega is used to treat schizophrenia, a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Invega jintuża fit- trattament tal- iskiżofrenija, marda mentali li għandha għadd ta 'sintomi, inkluż taħdit u ħsieb diżorganizzat, alluċinazzjonijiet (jiġifieri d- dehra u s- smigħ ta' oġġetti li ma jkunux hemm), suspetti u delużjonijiet (ħsibijiet żbaljati).
How is Invega used?
Kif jintuża Invega?
The recommended starting dose of Invega is 6 mg once a day, taken in the morning.
Id- doża rakkomandata ta 'Invega hi 6 mg darba kuljum, meħuda filgħodu.
The tablet should be swallowed whole with a drink.
Il- pillola trid tinbela sħiħa ma 'xi xarba.
Invega should be taken either without food or with breakfast, but patients should not switch between taking the medicine with food on one day and without food on another.
Invega għandu jittieħed jew waħdu jew mal- kolazzjoni, iżda l- pazjenti m' għandhomx jieħdu l- mediċina daqqa mal- ikel u daqqa waħidha.
The dose of Invega can be altered after assessment of symptoms, to a final dose of between 3 and 12 mg once a day.
Id- doża ta 'Invega tista' tigo varjata wara valutazzjoni tas- sintomi, għal doża finali ta 'bejn 3 u 12- il mg darba kuljum.
It should be used with caution in patients who have severe problems with their liver.
M' għandux jintuża minn pazjenti li jkollhom problemi serji fil- fwied.
Patients with mild or moderate kidney problems, including some elderly patients, should start with a lower dose of Invega, but it is not recommended for patients with severe kidney problems.
Il- pazjenti li jkollhom problemi fil- kliewi ħfief jew moderati, inkluż xi pazjenti anzjani, għandhom jibdew b' doża baxxa ta 'Invega, iżda Invega mhux rakkomandat għal pazjenti bi problemi severi fil- kliewi.
Invega has not been studied in patients under 18 years of age.
Invega ma ġiex studjat f' pazjenti ta 'inqas minn 18- il sena.
How does Invega work?
Kif jaħdem Invega?
The active substance in Invega, paliperidone, is an antipsychotic medicine.
Is- sustanza attiva f' Invega, paliperidone, hija mediċina antipsikotika.
It is known as an ‘ atypical’ antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Hija magħrufa bħala antipsikotiku 'atipiku' minħabba li hija differenti minn mediċini antipsikotiċi li ilhom disponibbli mis - snin ħamsin.
Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Paliperidone hu prodott tat- tkissir (metabolit) attiv ta 'risperidone, mediċina antipsikotika oħra li ilha tintuża fit- trattament tal- iskiżofrenija sa mis- snin disgħin.
In the brain, it attaches to several different receptors on the surface of nerve cells.
Fil- moħħ, jeħel ma 'diversi riċetturi varji fuq is- superfiċje taċ- ċelloli tan- nervituri.
This disrupts signals transmitted between brain cells by ‘ neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Dan ifixkel is- sinjali trasmessi bejn iċ- ċelloli tal- moħħ permezz tan - 'newrotrasmettituri', kimiċi li jippermettu liċ- ċelloli tan- nervituri jikkomunikaw ma 'xulxin.
Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin), which are involved in schizophrenia.
Paliperidone jaġixxi bl- imblukkar tar- riċetturi għad- dopamina u għal 5- hydroxytryptamine (imsejjaħ ukoll serotonin), newrotrasmettituri involuti fl- iskiżofrenija.
By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms.
Bl- imblukkar ta 'dawn ir - riċetturi, paliperidone jgħin fin- normalizzazzjoni tal- attività tal- moħħ u jnaqqas is- sintomi.
How has Invega been studied?
Kif ġie studjat Invega?
The effects of Invega were first tested in experimental models before being studied in humans.
L- effetti ta 'Invega għall- ewwel ġew ittestjati fuq mudelli esperimentali qabel ma ġew studjati fil - bniedem.
Invega has been studied in three main short-term studies involving 1,692 adults with schizophrenia.
L- effettività ta 'Invega ġiet studjata fi tliet studji ewlenin, li fihom ħadu sehem 1, 692 adult infettati bl - iskiżofrenija.
In all three studies, doses of Invega between 3 and 15 mg a day were compared with placebo (a dummy treatment) and with olanzapine (another antipsychotic medicine).
Fit- tliet studji, Invega, f' dożi ta 'bejn 3 u 15- il mg kuljum, tqabbel ma' plaċebo (trattament finta) u ma 'olanzapine (mediċina oħra antipsikotika).
The main measure of effectiveness was the change in the patients ’ symptoms using a standard scale for schizophrenia after six weeks.
Il- mezz ewlieni tal- kejl tal- effettività kien it- tibdil fis- sintomi tal- pazjent bl- użu ta 'skala standard għall- iskiżofrenija wara sitt ġimgħat.