qanastek/EMEA-V3 huggingface dataset:
Furthermore, no metabolites have been observed in plasma following administration of radiolabeled drug to humans based on total radiolabel and microbiologically active concentrations.
Minbarra hekk, ma nstabux metaboli fil- plażma wara li ngħataw mediċini radjutikkettati lill- bnedmin bbażati fuq l- ammont totali radjutikkettat u konċentrazzjonijiet mikrobijoloġikament attivi.
Of the four minor metabolites detected in urine, two are Phase I oxidative metabolites present in low concentrations.
Mill- erba ’ metaboli minuri li nstabu fl- awrina, tnejn huma metaboli ossidati ta ’ Fażi I li nstabu f’ konċentrazzjonijiet baxxi.
Elimination Daptomycin is excreted primarily by the kidneys.
Eliminazzjoni Daptomycin jitneħħa l- aktar permezz tal- kliewi.
Concomitant administration of probenecid and daptomycin has no effect on daptomycin pharmacokinetics in humans suggesting minimal to no active tubular secretion of daptomycin.
Meta jingħataw probenecid flimkien ma ’ daptomycin, ma jkunx hemm effett fuq il- farmakonkinetiċi ta ’ daptomycin fil- bnedmin, li tindika li hemm ftit li xejn jew l- ebda sekrezzjoni tubulari attiva ta ’ daptomycin.
10 Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/ h/ kg and its renal clearance is 4 to 7 ml/ h/ kg.
Wara li jingħata minn ġol- vina, it- tneħħija ta ’ daptomycin mill- plażma hija madwar 7 sa 9 ml/ h/ kg u t - tneħħija mill- kliewi hija 4 sa 7 ml/ h/ kg.
In a mass balance study using radiolabelled material, 78% of the administered dose was recovered from the urine based on total radioactivity, whilst urinary recovery of unchanged daptomycin was approximately 50% of the dose.
Fi studju ta ’ mass balance b’ materjal radjutikkettat, 78% tad- doża mogħtija kienet irkuprata mill - awrina bbażata fuq ir- radjuattività totali, filwaqt li l- ammont ta ’ daptomycin mhux mibdul irkuprat mill- awrina kien madwar 50% tad- doża.
About 5% of the administered radiolabel was excreted in the faeces.
Madwar 5% tad- doża radjutikkettata ħarġet ma ’ l- ippurgar.
Elderly No dose adjustment is necessary based on age alone.
Anzjani M’ hemmx bżonn li tiġi aġġustata d- doża fuq bażi ta ’ l- età biss.
However, renal function should be assessed and the dose should be reduced if there is evidence of severe renal insufficiency.
Madankollu għandha titqies il- funzjoni renali u d- doża titnaqqas jekk ikun hemm evidenza ta ’ insuffiċjenza renali severa.
Children and adolescents (< 18 years of age) Pharmacokinetic profiles were obtained following single intravenous administration of daptomycin 4 mg/ kg in paediatric patients with proven or suspected Gram-positive infection, divided into three age groups (2-6 years, 7-11 years and 12-17 years).
10 Tfal u adolexxenti (età < 18- il sena) Il- profili farmakoketiċi kienu inkisbu wara għotja waħda ta ’ 4 mg/ kg daptomycin ġol- vina f’ pazjenti pedjatriċi b’ infezzjoni Gram- pożittiva li tkun ġiet ippruvata jew suspettata, maqsumin fi tlett gruppi ta ’ etajiet (2- 6 snin, 7- 11- il sena u 12- 17- il sena).
The pharmacokinetics of daptomycin following a single 4 mg/ kg dose in adolescents aged 12-17 years are generally similar to those of healthy adult subjects with normal renal function with trends towards lower AUC and Cmax in adolescents.
Il- farmakokinetika ta ’ daptomycin wara doża waħda ta ’ 4 mg/ kg f’ adolexxenti ta ’ etajiet bejn it- 12- 17- il sena huma b’ mod ġenerali simili għal dawk f’ individwi adulti b’ saħħithom b’ funzjoni renali normali b’ tendenzi għal AUC u Cmax aktar baxxi f’ adolexxenti.
In the younger age groups (2-6 years and 7-11 years), exposure (Cmax and AUC) and elimination half-life for the same mg/ kg dose were reduced compared with adolescents.
Fil- gruppi ta ’ etajiet aktar żgħar (2- 6 snin u 7 - 11- il sena), l- esponiment (Cmax u AUC) u l- half- life tat- tneħħija għall- istess doża b’ mg/ kg kienu anqas meta mqabbla ma ’ l- adolexxenti.
Obesity Relative to non-obese subjects daptomycin systemic exposure measured by AUC is increased by about 28% in moderately obese subjects (Body Mass Index of 25-40 kg/ m2) and by 42% in extremely obese subjects (Body Mass Index of > 40 kg/ m2).
Obeżità Imqabbla ma ’ individwi mhux obeżi, l- esponiment sistemiku ta ’ daptomycin imkejjel mill- AUC jiżdied b’ madwar 28% f’ individwi obeżi b’ mod moderat (Indiċi tal- Piż tal- Ġisem ta ’ 25- 45 kg/ m2) u b’ 42% f’ individwi obeżi b’ mod esaġerat (Indiċi tal- Piż tal- Ġisem ta ’ > 40 kg/ m2).
However, no dose adjustment is considered to be necessary based on obesity alone.
Madankollu, mhux meqjus li jkun neċessarju li tiġi adattata d- doża fuq bażi ta ’ l- obeżità biss.
Gender No clinically significant gender-related differences in daptomycin pharmacokinetics have been observed.
Sess Ma dehrux differenzi klinikament sinifikanti fil- farmakokinetiċi ta ’ daptomycin relatati mas- sess.
Renal insufficiency Following administration of a single 4 mg/ kg or 6 mg/ kg dose of daptomycin to subjects with various degrees of renal insufficiency, daptomycin clearance (CL) was reduced and systemic exposure (AUC) was increased.
Insuffiċjenza renali Wara li ingħatat doża waħda ta ’ 4 mg/ kg jew 6 mg/ kg daptomycin lill- individwi li kellhom gradi varji ta ’ insuffiċjenza renali, it- tneħħija ta ’ daptomycin (CL) naqset u l- espożizzjoni sistemika (AUC) żdiedet.
In subjects with severe renal insufficiency (CLcr < 30 ml/ min) and end-stage renal disease, exposure (AUC) and elimination half life were increased between 2-3-fold relative to healthy subjects.
F’ individwi li kellhom insuffiċjenza renali severa (CLcr < 30 ml/ min) u mard renali fl- aħħar stadju, l- espożizzjoni (AUC) u half life ta ’ l- eliminazzjoni żdiedu b’ 2- 3 darbiet meta mqabbla ma ’ individwi b’ saħħithom.
See section 4.2 regarding the need for dose adjustment.
Ara sezzjoni 4. 2 dwar il- bżonn li tiġi aġġustata d- doża.
Hepatic insufficiency The pharmacokinetics of daptomycin is not altered in subjects with moderate hepatic insufficiency (Child-Pugh B classification of hepatic insufficiency) compared with healthy volunteers matched for gender, age and weight following a single 4 mg/ kg dose.
Insuffiċjenza epatika Il- farmakokinetiċi ta ’ daptomycin ma jinbidlux f’ individwi b’ insuffiċjenza epatika moderata (klassifika ta ’ insuffiċjenza epatika Child- Pugh B) meta mqabbla ma ’ voluntiera b’ saħħithom ippariġġati skond is- sess, l- età u l- piż tal- ġisem wara doża waħda ta ’ 4 mg/ kg.
No dosage adjustment is necessary when administering daptomycin in patients with moderate hepatic insufficiency.
M’ hemmx bżonn ta ’ aġġustament tad- doża meta daptomycin jingħata lill- pazjenti b’ insuffiċjenza epatika moderata.
The pharmacokinetics of daptomycin in patients with severe hepatic insufficiency (Child-Pugh C classification) have not been evaluated.
Il - farmakokinetiċi ta ’ daptomycin f’ pazjenti b’ insuffiċjenza epatika severa (klassifika Child- Pugh C) ma kienux evalwati.
In studies of clinically-relevant duration (14-28 days), daptomycin administration was associated with minimal to mild degenerative/ regenerative changes in skeletal muscle in the rat and dog.
Fi studju li dam sejjer tul ta ’ żmien li huwa klinikament rilevanti (14- 28 ġurnata), l- għoti ta ’ daptomycin kien assoċjat ma ’ tibdil diġenerattiv/ riġenerattiv minimu fil- muskoli skeletrali tal- far u tal - kelb.
Microscopic changes in skeletal muscle were minimal (approximately 0.05% of myofibres affected) and at the higher doses were accompanied by elevations in CPK.
Tibdil mikroskopiku fil- muskoli skeletali kienu minimi (madwar 0. 05% fil- mijofibri affettwati) u b’ dożi ogħla seħħew flimkien ma ’ żiediet fis- CPK.
No fibrosis or rhabdomyolysis was observed.
L- ebda fibrożi jew rabdomajelożi ma dehru.
Depending on the study duration, all muscle effects, including microscopic changes, were fully reversible within 1-3 months following cessation of dosing.
Skond kemm dam l- istudju, l- effetti kollha fuq il- muskoli, inklużi bidliet mikroskopiċi, reġgħu lura għal kollox fi żmien 1- 3 xhur wara li waqfu d- dożi.
No functional or pathological changes in smooth or cardiac muscle were observed.
L- ebda bidliet fil- funzjoni jew patoloġiċi fil- muskoli lixxi jew kardijaċi ma dehru.
11 The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/ kg for patients with normal renal function.
L- aktar livell baxx fejn deher effett (LOEL) għal mijopatija fil- firien u klieb seħħet b’ livelli ta ’ esponiment ta ’ 0. 8 sa 2. 3- il darba tal- livelli terapewtiċi fil- bniedem b’ 6 mg/ kg għall- pazjenti b’ funzjoni renali normali.
A study in dogs demonstrated that skeletal myopathy was reduced upon once daily administration as compared to fractionated dosing at same total daily dose, suggesting that myopathic effects in animals were primarily related to time between doses.
Studju fil- klieb wera li mijopatija skeletrali kienet imnaqqsa bl- għotja ta ’ darba kuljum meta mqabbla ma ’ dożi frazzjonati bl- istess doża totali kuljum, li tindika li effetti mijopatiċi fl- annimali kienu l- aktar relatati mal- ħin bejn id- dożi.
Effects on peripheral nerves were observed at higher doses than those associated with skeletal muscle effects in adult rats and dogs, and were primarily related to plasma Cmax.
Effetti fuq nervituri periferali dehru b’ dożi ogħla minn dawk assoċjati ma ’ effetti fil- muskoli skeletrali fil- firien u klieb adulti, u kienu l- aktar relatati mas- Cmax fil- plażma.
Peripheral nerve changes were characterised by minimal to slight axonal degeneration and were frequently accompanied by functional changes.
Tibdil fin- nervituri periferali kienu karatterizzati b’ deġenerazzjoni ta ’ l- axon minima għal ħafifa u ħafna drabi akkumpanjata b’ tibdil fil - funzjoni.
Reversal of both the microscopic and functional effects was complete within 6 months post-dose.
Kemm l- effetti mikroskopiċi kif ukoll dawk tal- funzjoni reġgħu lura għal kollox fi żmien 6 xhur wara d- doża.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 6 mg/ kg once daily in patients with normal renal function.
Il- marġini ta ’ sigurtà għall- effetti periferali fuq in- nervituri fil- firien u klieb huma 8 - u 6- darbiet aktar rispettivament ibbażati fuq tqabbil tal- figuri ta ’ Cmax fil- Livell fejn Ma jkunx 11 Jidher Effett (NOEL) bis- Cmax jinkiseb b’ dożi ta ’ 6 mg/ kg darba kuljum f’ pazjenti b’ funzjoni renali normali.
In contrast to adult dogs, juvenile dogs appeared to be more sensitive to peripheral nerve lesions as compared to skeletal myopathy.
B’ kuntrast ma ’ klieb adulti, klieb ta ’ età żgħira dehru li kienu aktar sensittivi għal selħiet tan- nervituri periferali meta imqabbla ma ’ majopatija skeletrali.
Juvenile dogs developed peripheral and spinal nerve lesions at doses lower than those associated with skeletal muscle toxicity.
Klieb ta ’ età żgħira żviluppaw selħiet tan- nervituri periferali u ta ’ l- ispina b’ dożi aktar baxxi minn dawk assoċjati ma ’ tossiċità fil- muskoli skeletrali.
Reproductive toxicity testing showed no evidence of effects on fertility, embryofetal, or postnatal development.
Testijiet dwar it- tossiċità fuq is- sistema riproduttiva ma wriet l- ebda evidenza ta effetti fuq il- fertilità, fuq l- embriju/ fetu, jew fuq l- iżvilupp wara t- twelid.
However, daptomycin can cross the placenta in pregnant rats (see section 5.2).
Madankollu, daptomycin jista ’ jaqsam il- plaċenta fil- firien waqt it- tqala (ara sezzjoni 5. 2).
Excretion of daptomycin into milk of lactating animals has not been studied.
L- eskrezzjoni ta ’ daptomycin fil- ħalib ta ’ annimali li jkunu qed ireddgħu ma kienetx studjata.
Long-term carcinogenicity studies in rodents were not conducted.
Ma sarux studji fit- tul li juru hemmx effett karċinoġeniku f’ annimali gerriema.
Daptomycin was not mutagenic or clastogenic in a battery of in vivo and in vitro genotoxicity tests.
Daptomycin ma kienx mutaġeniku jew klastoġeniku f’ serje ta ’ testijiet dwar l- effett tossiku fuq il- ġeni li saru in vivo u in vitro.
Sodium hydroxide.
Sodium hydroxide
Cubicin is not physically or chemically compatible with glucose-containing solutions.
Cubicin m’ huwiex kompatibbli fiżikament jew kimikament ma ’ soluzzjonijiet li fihom glucose.
After reconstitution:
Wara li jitħallat:
Chemical and physical in-use stability of the reconstituted solution in the vial has been demonstrated for 12 hours at 25°C and up to 48 hours at 2°C - 8°C.
L- istabbiltà kimika u fiżika waqt l- użu tas- soluzzjoni mħallta fil- kunjett intweriet għal 12- il siegħa f’ 25°C u sa 48 siegħa f’ 2°C - 8°C.
Chemical and physical stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours at 2°C - 8°C.
L- istabbiltà kimika u fiżika tas- soluzzjoni dilwita fil- boroż ta ’ l- infużjoni hija stabbilita bħala 12- il siegħa f’ 25°C jew 24 siegħa f’ 2°C - 8°C.
The combined storage time (reconstituted solution in vial and diluted solution in infusion bag; see section 6.6) at 25°C should not exceed 12 hours (or 24 at 2°C - 8°C).
Il- ħin tal - ħażna kombinat (soluzzjoni mħallta fil- kunjett u soluzzjoni dilwita fil- borża ta ’ l- infużjoni, ara sezzjoni 6. 6) f’ 25°C m’ għandux jaqbeż it- 12- il siegħa (jew 24 f’ 2°C - 8°C).
From a microbiological point of view the product should be used immediately.
Mil- lat mikrobijoloġiku, dan il- prodott għandu jintuża mill- ewwel.
If not used immediately, in-use storage times are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8°C, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax mill- ewwel, il - ħinijiet tal- ħażna waqt l- użu huma r- responsabbiltà ta ’ min qed jużah u normalment ma jkunux aktar minn 24 siegħa f’ 2°C - 8°C, sakemm r- rikostituzzjoni/ dilwazzjoni ma tkunx saret f’ post kontrollat b’ kundizzjonijiet asettiċi validati.
12 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Store in a refrigerator at 2°C - 8°C.
Aħzen fi friġġ f’ temperatura ta ’ 2°C - 8°C.
For storage conditions of the reconstituted diluted medicinal product see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit dilwit, ara sezzjoni 6. 3.
Single use 10 ml type 1 clear glass vials with type 1 rubber stoppers and aluminium closures with yellow plastic flip off caps.
Kunjetti li jintużaw darba ta ’ 10 ml tal- ħġieġ tat- tip 1 b’ tappijiet tal- gomma tat- tip 1 u siġilli ta ’ l - Aluminium b’ għotjien tal- plastik sofor li tiftaħhom b’ daqqa ta ’ saba ’.
6.6 Special precautions for disposal and other handling
12 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
A 50 mg/ ml concentration is obtained by reconstituting with 7 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, or water for injections.
Konċentrazzjoni ta ’ 50 mg/ ml tinkiseb meta titħallat ma ’ 7 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni, jew ilma għall- injezzjonijiet.
Aseptic technique should be used to reconstitute lyophilised Cubicin.
Meta jitħallat Cubicin lajofilizzat, għandha tintuża teknika asettika.
The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper.
L- għatu tal- polypropylene li tiftħu b’ daqqa ta ’ saba ’ għandu jitneħħa sabiex jikxef il- partijiet tan- nofs tat- tapp tal- gomma.
7 ml of either sodium chloride 9 mg/ ml solution for injection or water for injections should be slowly injected through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
7 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml jew ilma għall- injezzjonijiet għandhom jiġu injettati bil- mod min- nofs tat- tapp tal- gomma fil- kunjett billi timmira l- labra lejn il- ġenb tal- kunjett.
The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
Il- kunjett għandu jiddawar bil- mod sabiex ikun żgurat li- prodott kollu jixxarrab u imbagħad jitħalla joqgħod għal 10 minuti.
Finally the vial should be gently rotated/ swirled for a few minutes as needed to obtain a clear reconstituted solution.
Fl- aħħar, il- kunjett għandu jiddawwar/ jitbandal b’ mod ċirkolari bil- mod għal ftit minuti skond kemm ikun hemm bżonn sabiex tinkiseb taħlita ta ’ soluzzjoni ċara.
Vigorous shaking/ agitation should be avoided to prevent foaming of the product.
Evita li tħallat/ tħawwad bil- qawwi biex tevita li l- prodott itella ’ r- rawgħa.
Reconstitution is typically complete within 15 minutes.
Bħala regola, il- proċess ta ’ rikostituzzjoni jkun lest fi 15- il minuta.
The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected for the absence of particulates prior to use.
Is- soluzzjoni rikostitwita għandha tiġi iċcekkjata bir- reqqa biex ikun żgurat li l- prodott ikun inħall u miflija sabiex ikun aċċertat li m’ hemmx xi frak qabel l- użu.
Reconstituted solutions of Cubicin range in colour from pale yellow to light brown.
Is- soluzzjoniet rikostitwiti ta ’ Cubicin ivarjaw fuq medda ta ’ kuluri minn isfar ċar għall- kannella ċar.
The reconstituted solution should then be diluted with sodium chloride intravenous infusion (typical volume 50 ml) and infused over 30 minutes as directed in section 4.2.
Is- soluzzjoni rikostitwita wara għandha tiġi dilwita b’ infużjoni għal ġol- vina ta ’ sodium chloride (bħala regola volum ta ’ 50 ml) u l- infużjoni mogħtija fuq medda ta ’ 30 minuta kif spjegat f’ sezzjoni 4. 2.
The following have been shown to be compatible when added to Cubicin containing infusion solutions: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin and lidocaine.
Dawn li ġejjin intwerew li kienu kompatibbli meta miżjuda ma ’ soluzzjonijiet ta ’ l- infużjoni li kien fihom Cubicin: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin u lidocaine.
Cubicin vials are for single-use only.
Il- kunjetti ta ’ Cubicin huma għal użu ta ’ darba biss.
19 January 2006
19 Jannar 2006
Cubicin 500 mg powder for concentrate for solution for infusion
Cubicin 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni
Each vial contains 500 mg daptomycin.
Kull kunjett fih 500 mg daptomycin.
One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ ml (0.9%) solution or water for injections.
Millilitru wieħed jipprovdi 50 mg daptomycin wara li jkun imħallat ma ’ 10 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni jew ilma għall- injezzjonijiet.
15 Due to limited clinical experience (see table and footnotes below) Cubicin should only be used in patients with any degree of renal insufficiency (Cr Cl < 80 ml/ min) when it is considered that the expected clinical benefit outweighs the potential risk.
14 Minħabba esperjenza klinika limitata (ara t- tabella u n- noti f’ qiegħ it- tabella hawn taħt) Cubicin għandu jintuża biss f’ pazjenti bi kwalunkwe grad ta ’ insuffiċjenza renali (Cr Cl < 80 ml/ min) meta jkun ikkunsidrat li l- benefiċċju kliniku mistenni ikun akbar mir- riskju li jista ’ jkun hemm.
The response to treatment and renal function should be closely monitored in all patients with some degree of renal insufficiency) (see also sections 4.4 and 5.2).
Ir- respons għat- trattament u l- funzjoni renali għandhom ikunu segwiti mill- qrib fil- pazjenti kollha li għandhom xi grad ta ’ insuffiċjenza renali (ara wkoll sezzjonijiet 4. 4 u 5. 2).
16 4.3 Contraindications
15 4. 3 Kontra- indikazzjonijiet
In addition, dose regimens for daptomycin that might be appropriate for the treatment of enterococcal infections, with or without bacteraemia, have not been identified.
Minbarra hekk, il- kors tad- dożi għal daptomycin li jistgħu jgħoddu għall- kura ta ’ infezzjonijiet b’ enterokokki, bil- batterimja jew mingħajrha, ma ġewx identifikati.
17 Peripheral Neuropathy Patients who develop signs or symptoms that might represent a peripheral neuropathy during therapy with Cubicin should be investigated and consideration should be given to discontinuation of daptomycin (see sections 4.8 and 5.3).
16 Newropatija periferali Pazjenti li jkollhom sinjali jew sintomi li jistgħu jindikaw newropatija periferali waqt it- terapija bi Cubicin għandhom jiġu eżaminati u għandu jiġi kkonsidrat li jitwaqqaf daptomycin (ara sezzjonijiet 4. 8 u 5. 3).
NSAIDs and COX-2 inhibitors).
17 Daptomycin jitneħħa l- aktar b’ filtrazzjoni renali u għalhekk il- livelli fil- plażma jistgħu jiżdiedu meta jingħata flimkien ma ’ mediċini li jnaqqsu l- filtrazzjoni renali (eż NSAID’ s u inibituri ta ’ COX- 2).
19 Infections and Infestations Common:
18 Infezzjonijiet u infestazzjonijiet Komuni:
Renal insufficiency, including renal impairment and renal failure
Insuffiċjenza renali, inklużi indeboliment renali u insuffiċjenza renali
20 Post-Marketing Adverse reactions that have been reported Post-Marketing that are not listed above are:
Wara t- tqegħid fis- suq Reazzjonijiet avversi li kienu rappurtati wara t- tqegħid fis- suq li mhux imniżżla hawn fuq huma:
Immune system disorders Hypersensitivity, manifested by isolated spontaneous reports including, but not limited to; pulmonary eosinophilia, vesicobullous rash with mucous membrane involvement and sensation of oropharyngeal swelling.
19 Disturbi fis- sistema immuni Sensittività eċċessiva, li dehret f’ rapporti iżolati spontanji li jinkludu, iżda mhux limitati għall -; eżinofilja pulmonari, raxx b’ imsiemer bil- materja li jieħu wkoll fil- membrani mukożi u sensazzjoni ta ’ nefħa orofarinġali.
21 Mechanisms of resistance Strains with decreased susceptibility to daptomycin have been reported especially during the treatment of patients with difficult-to-treat infections and/ or following administration for prolonged periods.
Mekkaniżmi ta ’ reżistenza Razez b’ suxxettibilità mnaqqsa għal daptomycin kienu rrappurtati l- aktar waqt kura ta ’ pazjenti b’ infezzjonijiet li huma diffiċli- biex- tikkurhom u/ jew wara amministrazzjoni għal perijodi twal.
The mechanism of resistance to daptomycin has not yet been identified.
20 assocata ma ’ l- għażla ta ’ l- organiżmi b’ suxxettibilità mnaqqsa jew reżistenza batuta għal daptomycin waqt it- terapija.
22 Differences in Population
Popolazzjoni Popolazzjoni ITT (intenzjoni li tiġi kkurata)
Among these failures six patients treated with Cubicin and one patient treated with vancomycin were infected with Staphylococcus aureus that developed increasing MICs of daptomycin on or following therapy (see “ Mechanisms of resistance” above).
Fost 21 dawn il- fallimenti sitt pazjenti kkurati bi Cubicin u pazjent wieħed ikkurat b’ vancomycin kienu infettati bi Staphlococcus aureus li żviluppa żieda fl- MIC’ s ta ’ daptomycin waqt jew wara t- terapija (ara “ Mekkaniżmi ta ’ reżistenza ” hawn fuq).
23 Following intravenous administration, plasma clearance of daptomycin is approximately 7 to 9 ml/ h/ kg and its renal clearance is 4 to 7 ml/ h/ kg.
Wara li jingħata minn ġol- vina, it- tneħħija ta ’ daptomycin mill- plażma hija madwar 7 sa 9 ml/ h/ kg u t - tneħħija mill- kliewi hija 4 sa 7 ml/ h/ kg.
Children and adolescents (< 18 years of age) Pharmacokinetic profiles were obtained following single intravenous administration of daptomycin 4 mg/ kg in paediatric patients with proven or suspected Gram-positive infection, divided into three age groups (2-6 years, 7-11 years and 12-17 years).
22 Tfal u adolexxenti (età < 18- il sena) Il- profili farmakoketiċi kienu inkisbu wara għotja waħda ta ’ 4 mg/ kg daptomycin ġol- vina f’ pazjenti pedjatriċi b’ infezzjoni Gram- pożittiva li tkun ġiet ippruvata jew suspettata, maqsumin fi tlett gruppi ta ’ etajiet (2- 6 snin, 7- 11- il sena u 12- 17- il sena).
24 The lowest observable effect level (LOEL) for myopathy in rats and dogs occurred at exposure levels of 0.8 to 2.3-fold the human therapeutic levels at 6 mg/ kg for patients with normal renal function.
L- aktar livell baxx fejn deher effett (LOEL) għal mijopatija fil- firien u klieb seħħet b’ livelli ta ’ esponiment ta ’ 0. 8 sa 2. 3- il darba tal- livelli terapewtiċi fil- bniedem b’ 6 mg/ kg għall- pazjenti b’ funzjoni renali normali.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 6 mg/ kg once daily in patients with normal renal function.
Il- marġini ta ’ sigurtà għall- effetti periferali fuq in- nervituri fil- firien u klieb huma 8 - u 6- darbiet aktar rispettivament ibbażati fuq tqabbil tal- figuri ta ’ Cmax fil- Livell fejn Ma jkunx 23 Jidher Effett (NOEL) bis- Cmax jinkiseb b’ dożi ta ’ 6 mg/ kg darba kuljum f’ pazjenti b’ funzjoni renali normali.
25 For storage conditions of the reconstituted diluted medicinal product see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna tal- prodott mediċinali rikonstitwit dilwit, ara sezzjoni 6. 3.
Single use 10 ml type 1 clear glass vials with type 1 rubber stoppers and aluminium closures with blue plastic flip off caps.
Kunjetti li jintużaw darba ta ’ 10 ml tal- ħġieġ tat- tip 1 b’ tappijiet tal- gomma tat- tip 1 u siġilli ta ’ l - Aluminium b’ għotjien tal- plastik ċelesti li tiftaħhom b’ daqqa ta ’ saba ’.
6.6 Special precautions for disposal and other handling
24 6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
A 50 mg/ ml concentration is obtained by reconstituting with 10 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, or water for injections.
Konċentrazzjoni ta ’ 50 mg/ ml tinkiseb meta titħallat ma ’ 10 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni għall- injezzjoni, jew ilma għall- injezzjonijiet.
10 ml of either sodium chloride 9 mg/ ml solution for injection or water for injections should be slowly injected through the centre of the rubber stopper into the vial pointing the needle towards the wall of the vial.
10 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride 9 mg/ ml jew ilma għall- injezzjonijiet għandhom jiġu injettati bil- mod min- nofs tat- tapp tal- gomma fil- kunjett billi timmira l- labra lejn il- ġenb tal- kunjett.
27 ANNEX II
25 ANNESS II
28 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in the amended version dated 4th December 06 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Il- MAH għandhu jiżgura li s- sistema ta ’ farmakoviġilanza kif spjegata fil- verżjoni amendata bid- data ta ’ l- 4 ta ’ Diċembru 06 ippreżentata f’ Module 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat - tqegħid fis- Suq, qiegħda fis- seħħ u qed tiffunzjona qabel ma ’ l- prodott ikun fis- suq u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.1 dated 18th July 07 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan ta ’ l- Immaniġġar tar- Riskju Il- MAH jintrabat li jagħmel l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali kif iddettaljat fil - Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 2. 1 bid- data tat- 18 ta ’ Lulju 07 tal- Pjan għall - Immaniġġar tar- Riskju (RMP) ippreżentat f’ Module 1. 8. 2. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti ta ’ l- RMP bi qbil ma ’ CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linji Gwida ta ’ CHMP dwar is- Sistemi ta ’ l- Immaniġġar tar- Riskju għall- prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jiġi sottomess fl- istess ħin mar- Rapport Perjodiku Aġġornat ta ’ Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Flimkien ma dan, għandu jiġi sottomess RMP aġġornat • Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- iSpeċifikazzjonijiet ta ’ Sigurtà, il - Pjan ta ’ Farmakoviġilanza jew l- attivitajiet tat- tnaqqis tar- riskju kurrenti • Fi żmien 60 ġurnata minn meta jintlaħaq pass importanti (ta ’ farmakoviġilanza jew tnaqqis tar - riskju) • Meta dan jiġi mitlub mill- EMEA
29 ANNEX III
27 ANNESS III
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Cubicin 350 mg powder for concentrate for solution for infusion daptomycin
Cubicin 350 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni daptomycin
Sodium hydroxide
Sodium hydroxide
Read the package leaflet before use for directions on reconstitution.
Aqra l- fuljett ta ’ tagħrif qabel l- użu għall- istruzzjonijiet dwar kif issir it- taħlita.
EXP Read the leaflet for the shelf life of the reconstituted product
JIS Sabiex tkun taf kemm idum tajjeb il- prodott imħallat, aqra l- fuljett ta tagħrif.
Store in a refrigerator
Aħżen fi friġġ.
Dispose of in accordance with local requirements
Armi hekk kif jitolbu l- liġijiet lokali.
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
31 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL
KUNJETT
For intravenous use
Użu għal ġol- vini
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
32 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Cubicin 500 mg powder for concentrate for solution for infusion daptomycin
Cubicin 500 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni daptomycin
36 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
34 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
INFORMATION FOR THE USER
36 FULJETT TA ’ TAGĦRIF:
- If you have any further questions, ask your doctor, nurse or pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib, infermier jew lill- ispiżjar tiegħek.
please tell your doctor, nurse or pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, infermier jew lill- ispiżjar tiegħek.
What Cubicin is and what it is used for 2.
X’ inhu Cubicin u għalxiex jintuża 2.
Before you are given Cubicin 3.
Qabel ma tingħata Cubicin 3.
How Cubicin is given 4.
Kif jingħatalek Cubicin 4.
How to store Cubicin 6.
Kif taħżen Cubicin 6.
WHAT CUBICIN IS AND WHAT IT IS USED FOR
X’ INHU CUBICIN U GĦALXIEX JINTUŻA
The active substance in Cubicin powder for concentrate for solution for infusion is daptomycin.
Is- sustanza attiva fi Cubicin trab għall- konċentrat għal soluzzjoni għall- infużjoni hija daptomycin.
Daptomycin is an antibiotic that can stop the growth of certain bacteria.
Daptomycin huwa antibijotiku li jista ’ jwaqqaf it- tkattir ta ’ ċerti batteri.
Cubicin is used in adults to treat infections of the skin and the tissues below the skin.
Cubicin jintuża fl- adulti biex jikkura infezzjonijiet tal- ġilda, u t- tessuti taħt il- ġilda.
It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphyloccocus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection.
Jintuża wkoll f’ adulti biex jikkura infezzjonijiet fit- tessuti li jiksu l- parti ta ’ ġewwa tal- qalb (inklużi l- valvuli tal- qalb) li huma kkawżati minn batterju imsejjaħ Staphylococcus aureus u biex ifejjaq infezzjonijiet fid- demm ikkawżati mill- istess batterju meta jkun assoċjat ma ’ infezzjoni tal- ġilda jew tal- qalb.
Depending on the type of infection(s) that you have, your doctor may also prescribe other antibiotics while you are receiving treatment with Cubicin.
Skond it- tip ta ’ infezzjoni( jiet) li għandek, it- tabib tiegħek jista ’ jordnalek ukoll antibijotiċi oħrajn waqt li tkun qed tirċievi l- kura bi Cubicin.
BEFORE YOU ARE GIVEN CUBICIN
QABEL MA TINGĦATA CUCIBIN
You should not be given Cubicin If you are allergic (hypersensitive) to daptomycin or to sodium hydroxide.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal daptomycin jew għal sodium
If this applies to you, tell your doctor or nurse.
Jekk dan jgħodd għalik, għid lit- tabib jew infermier tiegħek.
If you think you may be allergic, ask your doctor or nurse for advice.
Jekk taħseb li tista ’ tkun allerġiku, staqsi lit- tabib jew infermier tiegħek għall- parir.
Take special care with Cubicin
Oqgħod attent ħafna bi Cubicin
- If you have, or have previously had kidney problems.
- Jekk għandek, jew xi darba kellek, problemi tal- kliewi.
Your doctor may need to change the dose
It- tabib tiegħek jista ’ jkollu bżonn
of Cubicin (see section 3 of this leaflet).
jibdillek id- doża ta ’ Cubicin (ara sezzjoni 3 ta ’ dan il- fuljett).
- Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle
- Kultant, pazjenti li jkunu qed jirċievu Cubicin jistgħu jiżviluppaw tenerezza jew uġigħ fil -
weakness (see section 4 of this leaflet for more information).
muskoli jew dgħjufija fil- muskoli (ara sezzjoni 4 ta ’ dan il- fuljett għal aktar tagħrif).
If this happens tell your doctor.
Jekk jiġri hekk għid lit- tabib tiegħek.
Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin.
It- tabib tiegħek se jaċċerta ruħu li jsirlek test tad- demm u jagħtik parir dwar jekk għandekx tkompli tirċievi Cubicin.
The symptoms generally go away within a few days of stopping Cubicin.
Is- sintomi normalment jgħaddu fi ftit ġranet minn meta twaqqaf Cubicin.
- If you are very overweight.
- Jekk il- piż ta ’ ġismek huwa ħafna aktar milli suppost.
There is a possibility that your blood levels of Cubicin could be
Hemm possibiltà li l- livelli ta ’ Cubicin
higher than those found in persons of average weight and you may need careful monitoring in case of side effects.
fid- demm tiegħek ikunu ogħla minn dawk li jinkisbu f’ persuni ta ’ piż medju u jista ’ jkollok bżonn monitoraġġ b’ attenzjoni f’ każ ta ’ effetti sekondarji.
If any of these applies to you, tell your doctor or nurse before you are given Cubicin.
Jekk xi wieħed minn dawn is- sintomi japplika għalik, għid lit- tabib jew infermier tiegħek qabel tingħata Cubicin.
39 Tell your doctor if you develop any of the following symptoms:
37 Għid lit- tabib tiegħek jekk tiżviluppa xi wieħed mis- sintomi li ġejjin:
- Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with
- Kwalunkwe tingiż jew tnemnim ta ’ l- idejn jew saqajn, telf ta ’ sensazzjoni jew difikultajiet bil -
movements.
movimenti mhux normali.
If this happens, tell your doctor who will decide whether you should continue the treatment.
Jekk jiġri hekk, għid lit- tabib tiegħek li jiddeċiedi jekk għandekx tkompli l- kura.
- Diarrhoea, especially if you notice blood.
- Dijarrea, l- aktar jekk tara xi dmija.
- Cubicin may interfere with laboratory tests that measure how well your blood is clotting.
- Cubicin jista ’ jxekkel it- testijiet tal- laboratorju li jkejlu kemm qed jagħqad tajjeb id- demm.
The
Ir -
results can suggest poor blood clotting when, in fact, there is no problem.
riżultati jistgħu jindikaw li t- tagħqid tad- demm huwa batut meta, fil- fatt, ma jkunx hemm problema.
Therefore it is important that your doctor takes into account that you are receiving Cubicin.
Għalhekk huwa importanti li t- tabib jikkonsidra l- fatt li qed tirċievi Cubicin.
Please inform your doctor that you are on treatment with Cubicin.
Jekk jogħġbok għarraf lit- tabib tiegħek li qed tieħu Cubicin.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.
It- tabib tiegħek se jgħamillek testijiet tad- demm biex jeżaminalek is- saħħa tal- muskoli tiegħek qabel tibda l- kura u ta ’ spiss waqt il- kura bi Cubicin.
Use in children The use of Cubicin in children has not been studied and is therefore not recommended.
L- użu fit- tfal L- użu ta ’ Cubicin fit- tfal ma ġiex studjat u għalhekk mhux irrikkmandat.
Use in elderly People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Użu fl- anzjani Nies li għandhom ’ l fuq minn 65 sena jistgħu jingħataw l- istess doża bħal ta ’ l- adulti, bil- kundizzjoni li l- kliewi tagħhom ikunu qed jaħdmu tajjeb.
Taking other medicines Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib, infermier jew spiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
It is particularly important that you mention the following:
Huwa important b’ mod partikolari li ssemmi dan li ġej:
- Medicines called statins or fibrates (to lower cholesterol) or ciclosporin.
- Mediċini magħrufin bħala statins jew fibrati (biex ibaxxu l- kolesterol) jew ciclosporin.
It is possible that the
Huwa
risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin.
possibli li jkun hemm riskju akbar ta ’ effetti sekondarji li jeffettwaw il- muskoli meta xi wieħed minn dawn il- mediċini (u oħrajn li jistgħu jaffettwaw il- muskoli) jittieħdu waqt kura bi Cubicin.
Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.
It- tabib jista ’ jiddeċidi li ma jagħtikx Cubicin jew li jwaqqaflek il- mediċina l- oħra għal ftit żmien.
- Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2
- Mediċini kontra l- uġigħ magħrufin bħala mediċini mhux sterojdi kontra l- infjammazzjoni
inhibitors (e. g. celecoxib).
(NSAIDs) jew inibituri tal- COX- 2 (eż celecoxib).
These could interfere with the effects of Cubicin in the kidney.
Dawn jistgħu jinterferixxu ma ’ l- effetti ta ’ Cubicin fil- kliewi.
Pregnancy and breast-feeding Cubicin is not usually given to pregnant women.
Tqala u Treddigħ Cubicin normalment ma jingħatax lin- nisa waqt it- tqala.
Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.
Għid lit- tabib tiegħek jekk ħriġt tqila, taħseb li tista ’ tkun ħriġt tqila, jew jekk qed tippjana li toħroġ tqila.
Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.
M’ għandekx tredda ’ jekk qed tirċievi Cubicin għaliex jista ’ joħroġ fil- ħalib ta ’ sidrek u jaffettwa lit - tarbija.
Driving and using machines Cubicin has no known effects on the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni L- effetti ta ’ Cubicin dwar il- ħila biex issuq jew tħaddem magni. mhux magħrufa.
HOW CUBICIN IS GIVEN
KIF JINGĦATALEK CUBICIN
Cubicin will usually be given to you by a doctor or a nurse.
Cubicin normalment jingħatalek minn tabib jew infermier.
The dose will depend on how much you weigh and the type of infection being treated.
Id- doża li tingħatalek tiddependi fuq il- piż ta ’ ġismek u t- tip ta ’ infezzjoni li qed tiġi kkurata.
The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection.
Id- doża tas- soltu għall- adulti hija ta ’ 4 mg għal kull kilogramma (kg) tal- piż tal- ġisem darba kuljum għall - infezzjonijiet tal- ġilda jew 6 mg għal kull kg piż tal- ġisem darba kuljum għal infezzjoni fil- qalb jew infezzjoni fid- demm assoċjata ma ’ infezzjoni fil- ġilda jew fil- qalb.
The same dose is recommended in people aged over 65 years provided their kidneys are working well.
Din id- doża tingħatalek direttament fid- demm (ġo vina) fuq perijodu ta ’ madwar 30 minuta. L- istess doża hija irrikkmandata f’ persuni li għandhom ’ l fuq minn 65 sena bil- kundizzjoni li l- kliewi tagħhom ikunu qed jaħdmu sew.
If your kidneys do not work well, you may receive Cubicin less often, e. g. once every other day.
38 Jekk il- kliewi tiegħek mhux qed jaħdmu tajjeb, tista ’ tirċievi Cubicin anqas ta ’ spiss, eż. darba kull jumejn.
If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.
Jekk qed tirċievi d- dijalisi, u d- doża ta ’ Cubicin li jmiss taqa ’ fil- jum li jmissek id- dijalisi, normalment tingħata Cubicin wara s- sessjoni tad- dijalisi.
40 A course of treatment usually lasts for 1 to 2 weeks for skin infections.
Kors ta ’ kura normalment idum minn ġimgħa sa ġimgħatejn għal infezzjonijiet tal- ġilda.
For blood or heart infections and skin infections your doctor will decide how long you should be treated.
Għal infezzjonijiet fid- demm jew fil- qalb u fil- ġilda t- tabib tiegħek jiddeċiedi kemm għandek iddum tirċievi l- kura.
Like all medicines, Cubicin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Cubicin jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Some side effects are very rare (reported in less than 1 in 10,000 patients given Cubicin) A hypersensitivity reaction (serious allergic reaction including anaphylaxis) has been reported, in some cases during the infusion.
Xi effetti sekondarji huma rari ħafna (irrappurtati f’ anqas minn 1 f’ kull 10, 000 pazjent li jingħata Cubicin) Reazzjoni ta ’ sensittività eċċessiva (reazzjoni allerġika serja inkluża anafilassi) kienet irrappurtata, f’ xi każijiet waqt l- infużjoni.
This serious allergic reaction needs immediate medical attention.
Din ir- reazzjoni allerġika teħtieġ attenzjoni medika immedjata.
Tell your doctor or nurse straight away if you experience any of the following symptoms:
Għid lit - tabib tiegħek jew infermier mill- ewwel jekk tħoss xi wieħed mis- sintomi li ġejjin:
- Chest pain or tightness
- Uġigħ jew għafis f’ sidrek
- Rash with blistering, sometimes affecting the mouth and genitals
- Raxx bi bżieżaq, kultant jaffettwaw il- ħalq jew il- ġenitali
- Swelling around throat
- Nefħa mad- dawra ta ’ griżmejk
- Rapid or weak pulse
- Polz mgħaġġel jew dgħajjef
- Wheezing
- Tħarħir
- Fever
- Deni
- Shivering or trembling
- Tkexkix jew tregħid
- Hot flushes
- Fwawar ta ’ sħana
- Dizziness
- Sturdament
- Fainting
- Ħass ħażin
- Metallic taste
- Togħma ta ’ metall
Tell your doctor if you experience unexplained muscle pain, tenderness, or weakness.
Għid lit- tabib tiegħek jekk tħoss xi uġigħ mingħajr spjegazzjoni, tenerezza jew dgħjufija fil- muskoli.
In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
F’ każijiet rari ħafna (irrappurtati f’ anqas minn 1 minn kull 10, 000 pazjent) problemi tal- muskoli jistgħu jkunu serji, inkluż it- therrija tal- muskoli (rabdomajelożi) li tista ’ twassal għal ħsara fil- kliewi.
Cubicin may also cause other side effects:
Cubicin jista ’ jikkawża effetti sekondarji oħrajn:
Some side effects are common (reported in more than 1 in 100 patients given Cubicin)
Xi effetti ekondarji huma komuni (irrappurtati f’ aktar minn 1 minn kull 100 pazjent li jingħataw Cubicin)
- Fungal infections such as thrush,
- Infezzjonijiet tal- moffa bħal traxx,
- Headache,
- Uġigħ ta ’ ras,
- Diarrhoea, felling sick (nausea) or being sick (vomiting),
- Dijarrea, tħossok ma tiflaħx (dardir) jew tkun ma tiflaħx (rimettar),
- Skin rash,
- Raxx tal- ġilda,
- Pain, itchiness or redness at the site of infusion,
- Uġigħ, ħakk jew ħmura fis- sit mnejn tingħata l- injezzjoni,
- Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
- Testijiet tad- demm li juru li għandek livelli ogħla ta ’ enzimi tal- fwied jew creatine
Some side effects are uncommon (reported in more than 1 in 1,000 but less than 1 in 100 patients given Cubicin)
Xi effetti sekondarji mhumiex komuni (irrappurtati f’ aktar minn 1 minn kull 1, 000 iżda anqas minn 1 minn kull 100 pazjent li jingħataw Cubicin)
- Urinary tract infection,
- Infezzjoni tal- passaġġ awrinarju,
- Blood disorders (e. g increased number of small blood particles called platelets, which may
- Disturbi tad- demm (eż żieda fin- numru ta ’ partiċelli żgħar tad- demm, imsejħa plejtlits, li jistgħu
increase the tendency for blood clotting, decreased number of red blood cells, known as anaemia, or higher levels of certain types of white blood cells),
jżidu t- tendenza tad- demm biex jagħqad, tnaqqis fin- numru ta ’ ċelluli ħomor tad- demm, magħrufa bħala anemija, jew livelli ogħla ta ’ ċerti tipi ta ’ ċelluli bojod tad- demm),
- Decreased appetite,
- Tnaqqis fl- aptit,
- Dizziness, anxiety, difficulty in sleeping, tingling or numbness of the hands or feet, taste
- Sturdament, ansjetà, tbati biex torqod, tingiż jew tnemnim ta ’ l- idejn jew saqajn, disturbi fit -
disturbance,
togħma,
- Changes in heart rhythm, flushes, high or low blood pressure,
- Tibdil fir- ritmu tal- qalb, fwawar, il- pressjoni togħla jew titbaxxa,
- Constipation, abdominal pain, indigestion, inflammation of the tongue,
- Stitikezza, uġigħ addominali, indiġestjoni, infjammazzjoni ta ’ l- ilsien,
- Yellowing of the skin and eyes,
- Il- ġilda u l- għajnejn jisfaru,
- Itchy rash of skin,
- Raxx tal- ġilda bil- ħakk,
- Muscle pain or weakness, joint pain,
- Uġigħ fil- muskoli jew dgħjufija, uġigħ fil- ġogi,
- kidney problems,
- Problemi fil- kliewi,
- Inflammation and irritation of the vagina,
- Infjammazzjoni jew irritazzjoni fil- vaġina,
- General pain or weakness, fever, tiredness,
- Uġigħ ġenerali jew dgħjufija, deni jew għeja,
- Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactic
- Test tad- demm juri żiediet fil- livelli ta ’ zokkor fid- demm, krejatinina fis- serum, mijoglobina,
dehydrogenase (LDH), or imbalance of salts.
jew lactic dehydrogenase (LDH), jew taqlib fl- ekwilibriju ta ’ l- imluħa.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib, lill- infermier jew lill- ispiżjar tiegħek.
HOW TO STORE CUBICIN
KIF TAĦŻEN CUBICIN
Your doctor, nurse or pharmacist knows how to store Cubicin properly.
It- tabib, l- infermier jew l- ispiżjar tiegħek jafu kif Cubicin jinħażen b’ mod xieraq.
What Cubicin contains
X’ fih Cubicin
- The active substance is daptomycin.
- Is- sustanza attiva hi daptomycin.
- The other ingredient is sodium hydroxide.
- Is- sustanza l- oħra hi sodium hydroxide.
What Cubicin looks like and contents of the pack Cubicin is supplied as a pale yellow to light brown powder in a glass vial.
Id- Dehra ta ’ Cubicin u l- kontenuti tal- pakkett Cubicin jiġi bħala trab isfar ċar għal kannella ċar f’ kunjett tal- ħġieġ.
It is mixed with a solvent to form a liquid before it is administered.
Jitħallat ma ’ solvent biex jifforma likwidu qabel jingħata.
Cubicin is available in packs containing 1 vial.
Cubicin jiġi f’ pakketti li jkun fihom kunjett 1.
Manufacturer Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Manifattur Novartis Pharmaceuticals UK Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Č eská republika Novartis s. r. o.
40 Česká republika Novartis s. r. o.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
43 INFORMATION FOR THE HEALTHCARE PROFESSIONALS
41 TAGĦRIF GĦALL- PROFESSJONISTI FIL- KURA TAS- SAĦĦA
Please refer to the Summary of Product Characteristics before prescribing.
Jekk jogħġbok irreferi għas- Sommarju tal- Karatteristiċi tal- Prodott qabel tikteb riċetta għalih.