qanastek/EMEA-V3 huggingface dataset:
The relevance of the hepatocarcinogenic potential of micafungin for the human therapeutic use is not known.
Ir - rilevanza tal- potenzjal epatokarċinoġeniku ta ’ micafungin għall- użu terapewtiku fil- bniedem għadu mhux magħruf.
The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
It- tossikoloġija ta ’ micafungin wara dożi intravenużi ripetuti fil- firien u/ jew fil- klieb wriet risponsi avversi fil- fwied, passaġġ urinarju, ċelluli tad- demm ħomor, u l- organi ta ’ riproduzzjoni tar- raġel.
The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
Il - livelli ta ’ espożizzjoni li fihom ma seħħux dawn l- effetti (NOAEL) kienu fl- istess tal- livelli jew inqas ta ’ espożizzjoni klinika.
Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Konsegwentement, risponsi avversi bħal dawn huma mistennija li jseħħu waqt l- użu kliniku b’ micafungin.
In standard safety pharmacology tests, cardiovascular and histamine releasing effects of micafungin were evident and appeared to be time above threshold dependent.
F’ testijiet standard ta ’ sigurtà farmakoloġika, effetti kardjovaskulari u ta ’ rilaxx ta ’ l- istamina minħabba micafungin kienu evidenti f’ dożi għolja u dehru li kienu dipendenti fuq il- ħin ’ il fuq mil - limitu.
Prolongation of infusion time reducing the plasma concentration peak appeared to reduce these effects.
Il- prolungament tal- ħin ta ’ l- infużjoni li jnaqqas l- akbar konċentrazzjoni fil- plażma deher li jnaqqas dawn l- effetti.
In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
Fi studji ripetuti tat- tossiċità tad- doża fil- firien sinjali ta ’ epatotossiċità kienu jikkonsistu minn żieda fil- livelli ta ’ enzimi tal- fwied u bidliet deġenerattivi ta ’ l- epatoċiti li kienu akkumpanjati minn sinjali ta ’ riġenerazzjoni kumpensatorja Fil- kelb, l- effett fuq il- fwied kien jikkonsisti f’ żieda fil- piż u ipertrofija ċentrilobulari, mingħajr ma ġiet osservata ebda bidla deġenrattiva ta ’ epatoċiti.
In rats, vacuolation of the renal pelvic epithelium as well as vacuolation and thickening (hyperplasia) of the bladder epithelium were observed in 26-week repeat dose studies.
Fit- tieni studju
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
12 li dam sejjer 26 ġimgħa, iperplasija ta ’ ċelloli transizzjonali fil- bużżieqa ta ’ l- awrina seħħet b’ inċidenza ferm aktar baxxa.
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Il- perijodu ta ’ dożaġġ ta ’ micafungin f’ dawn l- istudji fuq il- firien (6 xhur) jaqbeż il- perijodu ta ’ dożi ta ’ micafungin fil- pazjenti (ara sezzjoni 5. 1).
Micafungin haemolysed rabbit blood in vitro.
Micafungin emolizza d- demm tal- fenek f’ testijiet in vitro.
In rats, signs of haemolytic anaemia were observed after repeated bolus injection of micafungin.
Fil- firien, ġew osservati sinjali ta ’ anemija emolitika wara injezzjonijiet ripetuti ta ’ bolus ta ’ micafungin.
In repeat dose studies in dogs, haemolytic anaemia was not observed.
Fi studji b’ dożi ripetuti fil- klieb, ma ġietx osservata anemija emolitika.
In reproductive and developmental toxicity studies, reduced birth weight of the pups was noted.
Fi studji dwar it- tossiċità riproduttiva u ta ’ l- iżvilupp, ġie nnotat li kien hemm tnaqqis bil- piż tat - twelid tal- frieħ.
One abortion occurred in rabbits at 32 mg/kg/day.
Abort wieħed seħħ fil- fniek meta ngħata 32 mg/ kg/ kuljum.
Male rats treated intravenously for 9 weeks showed vacuolation of the epididymal ductal epithelial cells, increased epididymis weights and reduced number of sperm cells (by 15%), however, in studies of 13 and 26 weeks duration these changes did not occur.
Firien irġiel ittrattati fil - vini għal 9 ġimgħat urew vakulazzjoni taċ- ċelloli epiteljali tal- kanal epididimali, piż akbar ta ’ l - epididimi u tnaqqis fl- għadd ta ’ ċelluli ta ’ l- isperma (bi 15%), madankollu fi studji li damu sejrin għal 13 u 26 ġimgħa dawn il- bidliet ma seħħux.
In adult dogs, atrophy of seminiferous tubules with vacuolation of the seminiferous epithelium and decreased sperm in the epididymides were noted after prolonged treatment (39 weeks) but not after 13 weeks of treatment.
Fil- klieb adulti, atrofija tat- tubi seminiferi b’ vakulazzjoni ta ’ l- epitilu seminiferu u anqas sperma fl- epididimidi ġew innotati wara trattament fit- tul (39 ġimgħa), imma mhux wara 13- il ġimgħa ta ’ trattament.
In juvenile dogs, 39 weeks treatment did not induce lesions in the testis and epididymides in a dose dependent manner at the end of treatment but after a treatment free period of 13 weeks a dose dependent increase in these lesions were noted in the treated recovery groups.
Fi klieb żgħar, 39 ġimgħa ta ’ trattament ma wassalx għal leżjonijiet fit- testikoli u l- epididimide f’ manjiera dipendenti mid- doża fi tmiem it- trattament imma wara perijodu ta ’ 13- il ġimgħa mingħajr trattament ġie nnotat li kien hemm żieda f’ dawn il- leżjonijiet fil- gruppi ta ’ rkupru trattati.
No impairment of male or female fertility was observed in the fertility and early embryonic development study in rats.
Ma ġie osservat l- ebda indeboliment għall- fertilità tar- raġel jew tal- mara fl- istudju dwar l- iżvilupp embrijoniku ta ’ firien.
Micafungin was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests, including an in vitro study on unscheduled DNA synthesis using rat hepatocytes.
Micafungin ma kienx mutaġeniku jew klastoġeniku meta kien evalwat f’ batterija standard ta ’ testijiet in vitro u in vivo li jinkludi studju in vitro fuq sintesi mhux skedata tad- DNA li uża epatoċiti ta ’ firien.
Lactose monohydrate Citric acid anhydrous (to adjust the pH) Sodium hydroxide (to adjust the pH)
Lactose monohydrate Citric acid anhydrous (għal aġġustament tal- pH) Sodium hydroxide (għal aġġustament tal- pH)
12 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jiġi mħallat jew jingħata b’ infużjoni ma ’ prodotti mediċinali oħra għajr dawk imsemmija f’ sezzjoni 6. 6.
Reconstituted concentrate in vial:
Konċentrat rikostitwit fil- kunjett:
Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25°C when reconstituted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Stabbiltà kimika u fiżika waqt l- użu kienet murija sa 48 siegħa f’ temperatura ta ’ 25°C meta rikostitwit b ’ soluzzjoni għall- infużjoni 9 mg/ ml (0. 9%) ta ’ sodium chloride jew soluzzjoni għall- infużjoni 50 mg/ ml (5%) ta ’ glucose.
Diluted infusion solution:
Soluzzjoni dilwita għal infużjoni:
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light when diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Stabbiltà kimika u fiżika waqt l- użu kienet murija għal 96 siegħa f’ temperatura ta ’ 25°C meta kienet protetta mid- dawl meta dilwita b’ soluzzjoni għall- infużjoni ta ’ sodium chloride 9 mg/ ml (0. 9%) jew soluzzjoni għall- infużjoni ta ’ glucose 50 mg/ ml (5%).
Mycamine contains no preservatives.
Mycamine ma fihx preservattivi.
From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Mil- lat mikrobijoloġiku, is- soluzzjonijiet rikostitwiti u dilwiti għandhom jintużaw immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.
Jekk ma jintużawx mill- ewwel, iż- żminijiet u l- kundizzjonijiet ta ’ ħażna effettivi qabel l- użu huma fir- responsabbiltà ta ’ l- utent u normalment ma jkunx aktar minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, sakemm ir- rikostituzzjoni u d- dilwizzjoni ma jkunux saru f’ kundizzjonijiet asettiċi kkontrollati u validati.
6.4 Special precautions for storage
13 6. 4 Prekawzjonijiet speċjali għall- ħażna
10 ml Type I glass vial with an isobutylene-isoprene (Teflon-laminated) rubber stopper and a flip-off cap.
Kunjett ta ’ 10 ml magħmul minn ħġieġ ta ’ Tip I b’ tapp tal- lastku isobutylene- isoprene (laminat bit - Teflon) u għatu li jinqala bis- suba ’.
The vial is wrapped with an UV-protective film.
Il- kunjett huwa miksi b’ pellikola li tilqa ’ kontra l- UV.
Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
Mycamine m’ għandux jiġi mħallat jew infuż ma ’ prodotti mediċinali oħra għajr dawk imsemmija hawn taħt.
Using aseptic techniques at room temperature, Mycamine is reconstituted and diluted as follows:
Billi jintużaw metodi asettiċi f’ temperatura tal- kamra, Mycamine jiġi rikostitwit u dilwit kif ġej:
The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
L- għatu tal- plastik irid jitneħħa mill- kunjett u t- tapp jiġi diżinfettat bl- alkoħol.
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
5 ml ta ’ soluzzjoni għall- infużjoni 9 mg/ ml (0. 9%) ta ’ sodium chloride jew soluzzjoni għall - infużjoni ta ’ glucose 50 mg/ ml (5%) (meħudin minn flixkun/ borża ta ’ 100 ml) għandhom jiġu injettati b’ mod asettiku u bil- mod mal- ġenb il- wiċċ ta ’ ġewwa.
Although the concentrate will foam, every effort should be made to minimise the amount of foam generated.
Għalkemm il- konċentrat ser jagħmel ir- ragħwa, għandu jsir kull sforz sabiex jitnaqqas l- ammont ta ’ ragħwa ġġenerat.
A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
Iridu jiġu rikostitwiti numru suffiċjenti ta ’ kunjetti ta ’ Mycamine sabiex tinkiseb id- doża meħtieġa f’ milligrammi (ara t- tabella taħt).
The vial should be rotated gently.
Il- kunjett għandu jiġi mdawwar bil- ġentilezza.
DO NOT SHAKE.
M’ GĦANDUX JIĠI MĦAWWAD.
The powder will dissolve completely.
It- trab għandu jinħall kompletament.
The concentrate should be used immediately.
Il- konċentrat għandu jintuża immedjatament.
The vial is for single use only.
Il- kunjett għandu jintuża darba biss.
The refore, please discard unused reconstituted concentrate immediately.
Għalhekk, jekk jogħġbok armi kull konċentrat rikostitwit mhux użat, immedjatament.
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Il- konċentrat rikostitwit kollu għandu jinġibed minn kull kunjett u jiġi rritornat fil- flixkun/ borża li minnu/ minnha ttieħed oriġinarjament.
The diluted infusion solution should be
Is- soluzzjoni għall- infużjoni dilwita għandha tintuża mill- ewwel.
Chemical and physical in-use stability has been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Stabbiltà kimika u fiżika waqt l- użu kienet murija għal 96 siegħa f’ temperatura ta ’ 25°C meta protett mid- dawl u dilwit kif deskritt hawn fuq.
The infusion bottle/ bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Il- flixkun/ borża ta ’ l- infużjoni għandhom jiġu maqluba b’ mod ġentili sabiex tixxerred is - soluzzjoni dilwita iżda MHUX imħawda sabiex tiġi evitata r- ragħwa.
Do not use if the solution is cloudy or has precipitated.
Tużax jekk is- soluzzjoni tkun imdardra jew ippreċipitat.
The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Il- flixkun/ borża ta ’ l- infużjoni bis- soluzzjoni għal infużjoni dilwita għandhom jiddaħħlu f’ borża opaka li tingħalaq sabiex jiġu protetti mid- dawl.
Preparation of the solution for infusion
Preparazzjoni tas- soluzzjoni għal infużjoni
Dose (mg)
Doża (mg)
Mycamine vial to be used (mg/vial)
Kunjett ta ’ Mycamine li jrid jintuża (mg/ kunjett)
Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Volum ta ’ (0. 9%) sodium chloride jew (5% glucose) li jrid jiġi magħdud f’ kull kunjett
Volume (concentration) of reconstituted powder
Volum (konċentrazzjoni ta ’ trab rikostitwit
Standard infusion (added up to 100 ml) Final concentration
Infużjoni standard (miżjuda sa 100 ml) Konċentrazzjoni finali
5 ml (10 mg/ml)
madwar 5 ml (10 mg/ ml)
0. 5 mg/ ml
0. 50 mg/ ml
5 ml (20 mg/ml)
madwar 5 ml
1.0 mg/ml
1. 0 mg/ ml
10 ml
madwar 10 ml madwar 10 ml
1. 5 mg/ ml
1. 5 mg/ ml 2. 0 mg/ ml
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.
Wara r- rikostituzzjoni u l- infużjoni, is- soluzzjoni għandha tingħata b’ infużjoni ġol- vina għal madwar siegħa.
Mycamine 100 mg powder for solution for infusion
Mycamine 100 mg trab għal soluzzjoni għall- infużjoni
Each vial contains 100 mg micafungin (as sodium).
Kull kunjett fih 100 mg micafungin (bħala sodium).
After reconstitution each ml contains 20 mg micafungin (as sodium).
Wara r- rikostituzzjoni kull ml fih 20 mg micafungin (bħala sodium).
For a full list of excipients, see section 6.1.
Kull kunjett ta ’ 100 mg fih 200 mg ta ’ lactose Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Għandha tingħata konsiderazzjoni għal gwida uffiċjali/ nazzjonali dwar l- użu xieraq ta ’ mediċini antifungali.
15 The dose regimen of Mycamine depends on the body weight of the patient as given in the following tables:
16 Ir- reġimen tad- doża ta ’ Mycamine jiddependi fuq il- piż tal- ġisem tal- pazjent kif mogħti fit- tabelli li ġejjin:
100 mg/day* 150 mg/day 50 mg/day
100 mg/ kuljum * 150 mg/ kuljum 50 mg/ kuljum persistenza ta- kulturi jew jekk
2 mg/kg/day* 3 mg/kg/day 1 mg/kg/day
2 mg/ kg/ kuljum * 3 mg/ kg/ kuljum 1 mg/ kg/ kuljum il- kundizzjoni
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
klinika ma titjibx, id- doża tista ’ tiżdied għal 200 mg/ kuljum f’ pazjenti li jiżnu > 40 kg jew 4 mg/ kuljum f’ pazjenti li jiżnu ≤ 40 kg.
100 mg/day* 50 mg/day
100 mg/ kuljum * 50 mg/ kuljum
2 mg/kg/day* 1 mg/kg/day
2 mg/ kg/ kuljum * 1 mg/ kg/ kuljum
*If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.
* Kemm- il darba r- rispons tal- pazjent ma jkunx adegwat, eż. persistenza tal- kulturi jew jekk il- kundizzjoni klinika ma titjiebx, id- doża tista ’ tiżdied għal 200 mg/ kuljum f’ pazjenti li jiżnu > 40 kg jew 4 mg/ kg/ kuljum f’ pazjenti li jiżnu ≤ 40 kg.
Gender/Race No dose adjustment is necessary based on gender or race (see section 5.2).
Ġeneru/ Razza M’ hemmx bżonn ta ’ aġġustament fid- doża bbażat fuq is- sess jew ir- razza (ara sezzjoni 5. 2).
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.
17 Wara r- rikostituzzjoni u d- dilwazzjoni, is- soluzzjoni għandha tingħata permezz ta ’ infużjoni ġol- vini għal madwar siegħa.
16 4.3 Contraindications
4. 3 Kontra- indikazzjonijiet
To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended.
Sabiex jiġi mnaqqas ir- riskju ta ’ riġenerazzjoni adattabbli u l- formazzjoni sussegwenti ta ’ tumur tal- fwied, it- twaqqif bikri f’ każ ta ’ livelli għolja u persistenti ta ’ ALT/ AST hu rakkomandat.
Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties.
It- trattament b’ micafungin għandu jitwettaq b’ analiżi reqqa fuq bażi ta ’ riskju/ benefiċċju, b’ mod partikolari fuq pazjenti li għandhom indeboliment sever fil- funzjoni tal- fwied jew mard kroniku tal- fwied li hu magħruf li jirrapreżenta kondizzjonijiet preneoplastiċi, bħal fibrożi avvanzata fil- fwied, ċirrosi, epatite virali, mard tal- fwied ta ’ trabi li għadhom jitwieldu jew difetti konġenitali ta ’ l- enzimi, jew li qed jirċievu terapiji konkomitanti li jinkludu karatteristiċi epatotossiċi u/ jew ġenotossiċi.
Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.
Pazjenti li jiżviluppaw evidenza klinika jew tal- laboratorju ta ’ emolisi waqt it- terapija b’ micafungin għandhom jiġi sorveljati mill- qrib jekk dawn il- kundizzjonijiet imorru għall- agħar u dawn għandhom jiġu evalwati biex jiġi stabbilit ir- riskju/ siwi dwar jekk it- terapija għandhiex titkompla.
Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
18 Micafungin għandu potenzjal baxx ta ’ interazzjoni ma ’ mediċini metabolizzati permezz ta ’ proċessi medjati minn CYP3A.
17 Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
L- esponiment (AUC) ta ’ itraconazole, sirolimus u nifedipine żdied kemmxejn fil- preżenza ta ’ micafungin (22%, 21% u 18% rispettivament).
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Deċiżjoni dwar jekk wieħed għandux ikompli/ iwaqqafx it- treddigħ jew ikompli/ iwaqqafx it- terapija b’ Mycamine għandha tittieħed billi wieħed iqis is- siwi tat- treddigħ lill- wild u s- siwi ta ’ terapija ta ’ Mycamine lill- omm.
The se patients had a wide variety of complex underlying conditions such as haematological malignancies and HIV-infection or were transplant recipients and/or treated in intensive care.
Dawn il- pazjenti kellhom varjetà wiesgħa ta ’ kundizzjonijiet bażiċi kumplessi bħal tumuri malinni ematoloġiċi u infezzjonijiet ta ’ l- HIV jew kienu reċipjenti ta ’ trapjanti u/ jew trattati fil- kura intensiva.
In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
19 Fit- tabella li ġejja, ir- reazzjonijiet avversi huma elenkati skond is- sistema tal- klassifika ta ’ l- organi u t - terminu preferut MedDRA.
18 System Organ
Disturbi tad -
hyperhidrosis
iperkalemija,
Metabolism and nutritional disorders
nutrizzjoni Disturbi psikjatriċi
hypokalaemia, hypomagnesaemia, hypocalcaemia
ipokalċimja
hyponatraemia, hyperkalaemia, hypophosphataemia, anorexia
ipofosfatemija, anoreksja nuqqas ta ’ irqad, ansjetà, konfużjoni
Psychiatric disorders
Disturbi fis- sistema nervuża Disturbi fil- qalb
insomnia, anxiety, confusion
uġigħ ta ’ ras
Nervous system disorders Cardiac disorders
Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali
headache
flebite
somnolence, tremor, dizziness, dysgeusia tachycardia, palpitations, bradycardia
pressjoni baxxa, pressjoni għolja, fwawar dispnea
Vascular disorders
Disturbi gastro - intestinali
phlebitis
20 Sistema
hypotension, hypertension, flushing
Mhux komuni
shock
Mhux
Respiratory, thoracic and mediastinal disorders
tal- Klassifika ta ’ l -
dyspnoea
< 1/ 1, 000
Gastrointestinal disorders
Disturbi fil- fwied
nausea, vomiting, diarrhoea, abdominal pain
żieda ta ’ alkaline
dyspepsia, constipation
insuffiċjenza epatika
Hepatobiliary disorders
u fil- marrara
blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal
phosphatase fid -
hepatic failure (see section 4.4), gamma- glutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis
(ara sezzjoni 4. 4),
hepatocellular damage including fatal cases (see section 4.4)
li tinkludi każijiet fatali (ara sezzjoni 4. 4)
rash
raxx
urticaria, pruritus, erythema
urtikarja, ħakk, eritema
19 System Organ
Disturbi fil- kliewi
Uncommon
żieda fil- kreatinina
Not known
indeboliment
≥ 1/100 to < 1/10
u fis- sistema
≥ 1/1,000 to < 1/100
tad- demm, żieda fl -
1/10,000 to < 1/1,000
renali (ara
(frequency cannot be
urinarja
Paediatric patients The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
21 Pazjenti pedjatriċi L- inċidenza ta ’ xi reazzjonijiet avversi (elenkati fit- tabella hawn isfel) kienu ogħla f’ pazjenti tfal milli f’ pazjenti adulti.
20 Renal and urinary disorders common
Disturbi fil- kliewi u fis- sistema urinarja komuni
Mechanism(s) of resistance As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
22 Għall- aġenti kollha ta ’ kontra l- mikrobi, ġew irrapportati każijiet ta ’ suxxetibilità mnaqqsa u każijiet ta ’ reżistenza inkroċjata ma ’ echinocandins oħrajn ma jistgħux jiġu esklużi.
21 Candida glabrata [0.007 - 0.12] Candida tropicalis [0.007 - 0.12] Candida krusei [0.015 - 0.12] Candida kefyr [0.03 - 0.06] Candida parapsilosis [0.12 - 2] Candida guilliermondii [0.5] Candida lusitaniae [0.12 - 0.25] Candida spp.
Speċijiet komunement suxxettibbli [Firxiet MIC fl- Ewropa, mcg/ ml] Candida albicans [0. 007- 0. 25] Candida glabrata [0. 007- 0. 12] Candida tropicalis [0. 007- 0. 12] Candida krusei [0. 015- 0. 12] Candida kefyr [0. 03- 0. 06] Candida parapsilosis [0. 12- 2] Candida guilliermondii [0. 5] Candida lusitaniae [0. 12- 0. 25] Candida spp.
Information from clinical studies Candidaemia and Invasive Candidiasis:
23 Tagħrif minn studji kliniċi Kandidemija u Kandidjasi invażiva:
Adult Patients
% Differenza [95% CI]
35 (72.9)
35 (72. 9)
38 (76.0)
38 (76. 0)
-2.7 [-17.3, 11.9] §
- 2. 7 [- 17. 3, 11. 9] §
2 2
< 2 sentejn
21 (80.8) 7 (70.0) 7 (100)
21 (80. 8)
24 (77.4) 6 (66.7) 4 (80)
24 (77. 4) 6 (66. 7)
Prophylaxis:
24 Profilassi:
23 In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
F’ ċirkulazzjoni sistemika, micafungin jeħel ħafna mal- proteini tal- plażma (> 99%), l- aktar ma ’ l - albumina.
Clearance was influenced by age, with mean values of clearance in younger children (2-11 years) being approximately 1.3 -fold greater than those in older children (12-17 years).
25 iżgħar (2- 11- il sena) ikunu madwar 1. 3 darbiet aktar minn dawk fi tfal akbar (12- 17 - il sena).
24 increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
Fiż - żewġ studji l- inċidenza/ l- għadd ogħla ta ’ tumuri epatoċellulari kienu osservati 18- il xahar u 20 xahar wara l- perijodu li fih ma sar l- ebda trattament fil- grupp li ngħata doża għolja ta ’ 32 mg/ kg/ kuljum kif ukoll fi grupp li ngħata doża iżgħar (għalkemm mhux statistikament sinifikanti).
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
26 li dam sejjer 26 ġimgħa, iperplasija ta ’ ċelloli transizzjonali fil- bużżieqa ta ’ l- awrina seħħet b’ inċidenza ferm aktar baxxa.
25 6.2 Incompatibilities
6. 2 Inkompatibilitajiet
6.4 Special precautions for storage
27 6. 4 Prekawzjonijiet speċjali għall- ħażna
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Il- konċentrat rikostitwit kollu għandu jinġibed minn kull kunjett u jiġi rritornat fil - flixkun/ borża li minnu/ minnha ttieħed oriġinarjament.
The diluted infusion solution should be used immediately.
Is- soluzzjoni għall- infużjoni dilwita għandha tintuża mill- ewwel.
The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Il- flixkun/ borża ta ’ l- infużjoni għandhom jiġu maqluba b’ mod ġentili sabiex tixxerred is - soluzzjoni dilwita iżda MHUX imħawda sabiex tiġi evitata r- ragħwa.
0.5 mg/ml
0. 50 mg/ ml
5 ml (20 mg/ml)
madwar 5 ml (20 mg/ ml)
10 ml
madwar 10 ml
1.5 mg/ml
1. 5 mg/ ml
2.0 mg/ml
2. 0 mg/ ml
27 ANNEX III
29 ANNESS III
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
50 mg micafungin (as sodium).
50 mg micafungin (bħala sodium).
After reconstitution each ml contains 10 mg of micafungin (as sodium).
Wara r- rikostituzzjoni kull ml fih 10 mg ta ’ micafungin (bħala sodium).
Lactose monohydrate, citric acid anhydrous and sodium hydroxide.
Lactose monohydrate, citric acid anhydrous u sodium hydroxide.
See the package leaflet for further information.
Aqra l- fuljett ta ’ tagħrif għal aktar informazzjoni.
For intravenous infusion after reconstitution and dilution.
Għal infużjoni ġol- vini wara rikostituzzjoni u dilwizzjoni.
Justification for not including Braille accepted.
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata.
Mycamine 50 mg powder for solution for infusion Micafungin Intravenous use.
Mycamine 50 mg trab għal soluzzjoni għall- infużjoni Micafungin Użu għal ġol- vini.
100 mg micafungin (as sodium).
100 mg micafungin (bħala sodium).
After reconstitution each ml contains 20 mg of micafungin (as sodium).
Wara r- rikostituzzjoni kull ml fih 20 mg ta ’ micafungin (bħala sodium).
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
36 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Mycamine 100 mg powder for solution for infusion Micafungin Intravenous use.
Mycamine 100 mg trab għal soluzzjoni għall- infużjoni Micafungin Użu għal ġol- vini.
Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder for solution for infusion Micafungin
Mycamine 50 mg trab għal soluzzjoni għall- infużjoni Mycamine 100 mg trab għal soluzzjoni għall- infużjoni Micafungin
What Mycamine is and what it is used for 2.
X’ inhu Mycamine u għalxiex jintuża 2.
Before you use Mycamine 3.
Qabel ma tuża Mycamine 3.
How to use Mycamine 4.
Kif għandek tuża Mycamine 4.
How to store Mycamine 6.
Kif taħżen Mycamine 6.
WHAT MYCAMINE IS AND WHAT IT IS USED FOR
X’ INHU MYCAMINE U GĦALXIEX JINTUŻA
Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Mycamine jissejjaħ mediċina antifungali peress li jintuża biex jittratta infezzjonijiet ikkaġunati minn ċelluli fungali.
Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida.
Mycamine jintuża biex jittratta infezzjonijiet fungali ikkawżati minn ċelluli fungali jew ċelluli tal- ħmira msejħa Candida.
Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Mycamine huwa effettiv biex jittratta infezzjonijiet sistemiċi (dawk li jkunu ppenetraw il- ġisem).
It interferes with the production of a part of the fungal cell wall.
Huwa jinterferixxi mal- produzzjoni ta ’ parti mir- riti taċ- ċelluli fungali.
An intact cell wall is necessary for the fungus to continue living and growing.
Rita taċ- ċellula intatta hija meħtieġa għal fungus biex tkompli tgħix u tiżviluppa.
Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.
Mycamine jikkaġuna difetti fir- riti taċ- ċelluli fungali, li ma jippermettux lil fungus ikompli jgħix u jikber.
Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
It- tabib tiegħek ordnalek Mycamine minħabba ċ- ċirkostanzi li ġejjin meta ma nstabx trattament antifungali ieħor xieraq (ara sezzjoni 2):
• To treat adults, adolescents and children who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body). • To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate. • To treat adults, adolescents and children who are at risk of developing a Candida fungal infection that may penetrate the body.
• Biex jiġu ttrattati adulti, adoloxxenti u tfal li għandhom infezzjoni fungali serja msejħa kandidjasi invażiva (infezzjoni li ppenetrat il- ġisem). • Biex jiġu ttrattati adulti u adoloxxenti ≥ 16 sena t’ eta li għandhom infezzjoni fungali fil- gerżuma (esofagu) meta jkun adattat trattament ġol- vina (intravenuż). • Biex jiġu ttrattati adulti, adoloxxenti u tfal li huma f’ riskju li jiżviluppaw infezzjoni fungali ta ’ Candida li tista ’ tippenetra l- ġisem.
BEFORE YOU USE MYCAMINE
QABEL MA TUŻA MYCAMINE
Do not use Mycamine
Tużax Mycamine
- if you are allergic (hypersensitive) to micafungin or any of the other ingredients of Mycamine.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal micafungin jew sustanzi oħra ta ’
Take special care with Mycamine In rats, long-term treatment with micafungin led to liver damage and subsequent liver tumours.
Oqgħod attent ħafna b’ Mycamine Fil- firien, trattament fuq perijodu ta ’ żmien twil b’ micafungin irriżulta fi ħsara għal- fwied u sussegwentemat għal tumuri fil- fwied.
The potential risk of developing liver tumours in humans is not known, and your doctor will assess the benefits and risks of Mycamine treatment before starting your medicine.
Il- potenzjal li jiżviluppaw tumuri fil- fwied fil- bniedem mhix magħrufa, u t- tabib tiegħek għandu janalizza s- siwi u r- riskju tat- trattatment b ’ Mycamine qabel tibda tieħu l- mediċina.
Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests.
39 insuffiċjenza tal- fwied jew epatite) jew kellek riżultati ta ’ testijiet anormali tal- funzjoni tal- fwied.
During treatment your liver functions will be monitored more closely.
Waqt it- trattament il- funzjoni tal- fwied tiegħek ser jiġi monitorat aktar mill- qrib.
- if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis
- jekk għandek anemija emolitika (anemija minħabba it- tkissir ta ’ ċelluli tad- demm ħomor) jew
(breakdown of red blood cells).
emolisi (tkissir ta ’ ċelluli tad- demm ħomor).
If this
- jekk għandek problemi bil- kliewi (eż. insuffiċjenza tal- kliewi u test anormali tal- funzjoni tal -
happens, your doctor may decide to monitor your kidney function more closely.
Jekk dan iseħħ, it- tabib tiegħek għandu mnejn jiddeċiedi li jimmonitorja l- funzjoni tal - kliewi aktar mill- qrib.
Using Mycamine with food and drink As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Meta tuża Mycamine ma ’ l- ikel u max- xorb Billi Mycamine jingħata fil- vini (ġo vina) ma huma meħtieġa l- ebda restrizzjonijiet fuq l- ikel jew ix - xorb.
Mycamine should not be used during pregnancy unless clearly necessary.
Mycamine m’ għandux jintuża waqt it- tqala jekk ma jkunx hemm bżonn ċar.
If you use Mycamine you should not breast-feed.
M’ għandekx tredda ’ jekk tuża Mycamine.
Driving and using machines There is no information on the effect of Mycamine on the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni M’ hemm ebda informazzjoni li tissuġġerixxi li Mycamine jaffettwa l- ħila ta ’ sewqan jew tħaddim ta ’ magni.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Jekk jogħġbok informa lit- tabib tiegħek jekk ikollok xi effetti li jikkaġunawlek problemi waqt is- sewqan jew waqt it- tħaddim ta ’ makkinarju ieħor.
Important information about some of the ingredients of Mycamine If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Mycamine Jekk it- tabib tiegħek qallek li għandek intolleranza għal ċertu tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO USE MYCAMINE
KIF GĦANDEK TUŻA MYCAMINE
Mycamine must be prepared and given to you by a doctor or another health care professional.
Mycamine għandu jiġi ppreparat u mogħti lilek minn tabib jew professjonist ieħor tal- kura tas- saħħa.
Mycamine should be administered once daily by slow intravenous (into a vein) infusion.
Mycamine għandu jingħata darba kuljum b’ infużjoni bil- mod ġol- vini.
Your doctor will determine how much Mycamine you will receive each day.
It- tabib tiegħek ser jistabbilixxi kemm ser tieħu Mycamine kuljum.
Use in adults, adolescents ≥ 16 years of age and elderly
Użu fl- adulti, adoloxxenti ≥ 16- il sena u anzjani
- The usual dose to treat an invasive Candida infection is 100 mg per day for patients weighing
- Id- doża li s- soltu tingħata biex tiġi ttrattata infezzjoni ta ’ Candida invażiva hija ta ’ 100 mg kuljum
40 kg or more and 2 mg/kg per day for patients weighing 40 kg or less.
għal pazjenti li jiżnu 40 kg jew aktar u 2 mg/ kg kuljum għal pazjenti li jiżnu 40 kg jew anqas.
- The dose to treat a Candida infection of the oesophagus is 150 mg for patients weighing more
- Id- doża biex tiġi ttrattata infezzjoni Candida ta ’ l- esofagu hija ta ’ 150 mg għal pazjenti li jiżnu
than 40 kg and 3 mg/kg per day for patients weighing 40 kg or less.
aktar minn 40 kg u 3 mg/ kg kuljum għal pazjenti li jiżnu 40 kg jew anqas.
- The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing
- Id- doża li s- soltu tingħata lill- adulti u t- tfal għall- prevenzjoni ta ’ infezzjonijiet invażivi ta ’
more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.
Candida hija 50 mg kuljum għal pazjenti li jiżnu aktar minn 40 kg u 1 mg/ kg kuljum għal pazjenti li jiżnu 40 kg jew anqas.
Use in children (including newborns) and adolescents < 16 years of age
Użu fi tfal (inkluż trabi li għadhom jitwieldu) u adoloxxenti < 16- il sena
- The usual dose to prevent invasive Candida infections is 50 mg per day for patients weighing
- Id- doża li s- soltu tingħata għall- prevenzjoni ta ’ infezzjonijiet invażivi ta ’ Candida hija 50 mg
more than 40 kg and 1 mg/kg per day for patients weighing 40 kg or less.
kuljum għal pazjenti li jiżnu aktar minn 40 kg u 1 mg/ kg kuljum għal pazjenti li jiżnu 40 kg jew inqas.
If you receive more Mycamine than you should Your doctor monitors your response and condition to determine what dose of Mycamine is needed.
40 It- tabib tiegħek jimmonitorja r- rispons u l- kundizzjoni tiegħek biex jistabbilixxi d- doża ta ’ Mycamine li għandek bżonn.
However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another health care professional immediately.
Madankollu, jekk inti inkwetat/ a li stajt ingħatajt iżżejjed Mycamine, kellem lit - tabib tiegħek jew lil professjonist ieħor tal- kura tas- saħħa immedjatament.
If you miss a dose of Mycamine Your doctor monitors your response and condition to determine what Mycamine treatment is needed.
Jekk tinsa tieħu Mycamine It- tabib tiegħek jimmonitorja r- rispons u l- kundizzjoni tiegħek biex jistabbilixxi xi trattament b’ Mycamine għandek bżonn.
However, if you are concerned that you may have missed a dose, speak to your doctor or another health care professional immediately.
Madankollu, jekk inti inkwetat/ a li stajt qbiżt doża, kellem lit- tabib tiegħek jew lil professjonist ieħor tal- kura tas- saħħa immedjatament.
38 Effects when treatment with Mycamine is stopped There are no known withdrawal symptoms.
Jekk tieqaf tieħu Mycamine M’ hemmx sintomi magħrufa tat- twaqqif tal- mediċina.
Like all medicines, Mycamine can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Mycamine jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The safety of Mycamine has been assessed in clinical trials.
Is- sigurtà ta ’ Mycamine ġiet analizzata fi provi kliniċi.
Patients in these trials were critically ill, had a wide variety of other medical conditions, and required many other medicines.
Pazjenti f’ dawn il- provi kienu morda serjament, kellhom varjetà ta ’ kundizzjonijiet mediċi oħra, u ħtieġu mediċini oħra.
Mycamine may cause the following side effects:
Mycamine jista ’ jikkawża l- effetti sekondarji li ġejjin:
Common (affects 1 to 10 users in 100)
Komuni (affettwati minn utent 1 sa 10 f’ 100)
- abnormal blood tests (decreased white blood cells [leucopenia; neutropenia]); decreased red blood
- riżultati anormali għat- testijiet tad- demm (tnaqqis fiċ- ċelluli l- bojod [lewkopenja; newtropenja]);
cells (anaemia)
tnaqqis fiċ- ċelluli ħomor tad- demm (anemija)
- decreased potassium in the blood (hypokalaemia); decreased magnesium in the blood
- tnaqqis ta ’ potassium fid- demm (ipokalemja); tnaqqis ta ’ magnesium fid- demm (ipomagnesemja);
(hypomagnesaemia); decreased calcium in the blood (hypocalcaemia)
tnaqqis ta ’ calcium fid- demm (ipokalċemja)
- inflammation of the vein wall (at injection-site)
- infjammazzjoni tar- rita tal- vina (fil- post ta ’ l- injezzjoni)
- nausea (feeling sick); vomiting (being sick); diarrhoea; abdominal pain
- dardir (tħossok ma tiflaħx); remettar (tħossok ma tiflaħx); dijarea, uġigħ addominali
- abnormal liver function tests (increased alkaline phosphatase; increased aspartate
- riżultati anormali ta ’ testijiet tal- funzjoni tal- fwied (żieda fl- alkaline phosphatase; żieda fl -
aminotransferase, increased alanine aminotransferase)
aspartate aminotransferase, żieda fl- alanine aminotransferase)
- increased bile pigment in the blood (hyperbilirubinaemia)
- żieda fil- pigment biljari fid- demm (iperbilirubinemja)
- rigors (shivering)
- rogħda (tertir)
Uncommon (affects 1 to 10 users in 1,000)
Mhux komuni (affettwati minn 1 sa 10 utenti f’ 1000)
- abnormal blood tests (decreased blood cells [pancytopenia]); decreased blood platelets
- riżultati anormali tat- testijiet tad- demm (tnaqqis fl- għadd ta ’ ċelluli [panċitopenja]); tnaqqis fl -
(thrombocytopenia); increases in a certain type of white blood cells called eosinophils; decreased albumin in the blood (hypoalbuminaemia)
ammont ta ’ plejtlets tad- demm (tromboċitopenja); żieda f’ ċerti tipi ta ’ ċelluli tad- demm bojod li jissejħu ejosinofili; tnaqqis fl- albumina fid- demm (ipoalbuminemija)
- allergic attack (anaphylactic reaction / anaphylactoid shock); hypersensitivity
- attakk allerġiku (reazzjoni anafilattika / xokk anafilattojdi); sensittività eċċessiva
- increased sweating
- żieada fl- ammont ta ’ għaraq
- decreased sodium in the blood (hyponatraemia); increased potassium in the blood
- tnaqqis tas- sodium fid- demm (iponatremja); żieda fil- potassium fid- demm (iperkalemja)
(hyperkalaemia); decreased phosphates in the blood (hypophosphataemia); anorexia (eating disorder)
- tnaqqis fl- ammont ta ’ fosfati fid- demm (ipofosfatemja); anoreksja (disturb marbut ma ’ l- ikel)
- insomnia (difficulty in sleeping); anxiety; confusion
- insomnija (ssibha diffiċli biex torqod); ansjetà; konfużjoni
- feeling lethargic (somnolence); trembling; dizziness; disturbed taste
- tħossok għajjien (ngħas); titriegħed, stordament; togħma disturbata
- increased heart rate; stronger heartbeat; irregular heartbeat
- rata mgħaġġla tal- qalb; taħbit tal- qalb aktar qawwi; taħbit tal- qalb irregolari
- high or low blood pressure; skin flushing
- pressjoni għolja jew baxxa; ħmura tal- ġilda
- indigestion; constipation
- indiġestjoni; stitikezza
- liver failure; increased liver enzymes (gamma-glutamyltransferase); jaundice (yellowing of the
- insuffiċjenza tal- fwied; żieda fl- enzimi tal- fwied (gamma- glutamyltransferase); suffejra (sfurija
skin or whites of the eyes caused by liver or blood problems); reduced bile reaching the intestine (cholestasis); enlarged liver; liver inflammation
tal- ġilda jew l- abjad ta ’ l- għajnejn ikkaġunati mill- fwied jew problemi tad- demm); inqas bila tilħaq l- imsaren (kolestasi); nefħa tal- fwied; infjammazzjoni tal- fwied
- itchy rash (urticaria); itching; skin flushing (erythema)
- raxx bil- ħakk (urtikarja); ħakk, il- ġilda tiħmar (eritema)
- abnormal kidney function tests (increased blood creatinine; increased urea in the blood);
- riżultati anormali għat- testijiet tal- funzjoni tal- kliewi (żieda tal- kreatinina fid- demm; żieda ta ’ urea
aggravated kidney failure
fid- demm); insuffiċjenza tal- kliewi aggravata
- increase in an enzyme called lactate dehydrogenase
- livelli ogħla ta ’ enzima imsejħa lactate dehydrogenase
- clotting in vein at injection-site; inflammation at injection-site; pain at injection-site; collection of
- emboli fil- vina fil- post ta ’ l- injezzjoni; infjammazzjoni fis- sit ta ’ l- injezzjoni; jinġabar il- fluwidu
fluid in your body
f’ ġismek
Rare (affects 1 to 10 users in 10,000)
Rari (affettwati minn 1 sa 10 utenti f’ 10, 000)
- anaemia due to breakdown of red blood cells (haemolytic anaemia), breakdown of red blood cells
- anemija minħabba it- tkissir ta ’ ċelluli tad- demm ħomor (anemija emolitika), tkissir ta ’ ċelluli
(haemolysis)
ħomor tad- demm (emolisi)
Not known (frequency cannot be estimated from the available data)
Mhux magħruf (frekwenza ma tistax tiġi stmata mit- tagħrif disponibbli)
- shock
- xokk
- damage to liver cells including death
- ħsara liċ- ċelluli tal- fwied li jinkludu mewt
- kidney problems; acute kidney failure
- problemi tal- kliewi; insuffiċjenza akuta tal- kliewi
The following reactions have been reported more often in paediatric patients than in adult patients:
Ir- reazzjonijiet li ġejjin ġew rapportati aktar ta ’ spiss f’ pazjenti tfal milli f’ pazjenti adulti:
Common (affects 1 to 10 users in 100)
Komuni (jaffettwaw 1 sa 10 utenti f’ 100)
- decreased blood platelets (thrombocytopenia)
- tnaqqis fl- ammont ta ’ plejtlets tad- demm (tromboċitopenija)
- increased heart rate (tachycardia)
- żieda fit- taħbit tal- qalb (takikardja)
- high or low blood pressure
- pressjoni għolja jew baxxa
- increased bile pigment in the blood (hyperbilirubinaemia); enlarged liver
- żieda fil- pigment tal- bile fid- demm (iperbilirubinemija); fwied minfuħ
- acute kidney failure; increased urea in the blood
- insuffiċjenza tal- kliewi akuta; żieda ta ’ l- urea fid- demm
HOW TO STORE MYCAMINE
KIF TAĦŻEN MYCAMINE
Do not use Mycamine after the expiry date which is stated on the vial and on the carton.
Tużax Mycamine wara d- data ta ’ skadenza li tidher fuq il- kunjett u fuq il- kartuna.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall- aħħar jum ta ’ dak ix- xahar.
The unopened vial does not require any special storage conditions.
Il- kunjett mhux miftuħ m’ għandux bżonn ħażna speċjali.
The reconstituted concentrate and the diluted infusion solution should be used immediately.
Il- konċentrat rikostitwit u s- soluzzjoni għall- infużjoni dilwita għandhom jintużaw immedjatament.
Do not use the diluted infusion solution if it is cloudy or precipitated.
Tużax is- soluzzjoni għal infużjoni dilwita jekk tkun imdardra jew preċipitata.
In order to protect the infusion bottle / bag containing the diluted infusion solution from light it should be inserted into a closable opaque bag.
Biex tipproteġi l- flixkun / borża ta ’ l- infużjoni bis- soluzzjoni għall- infużjoni dilwita mid- dawl, dan/ din għandhom jiddaħħlu f’ borża opaka li tingħalaq.
The vial is for single use only.
Il- kunjett huwa għall- użu darba biss.
Therefore, please discard unused reconstituted concentrate immediately.
Għalhekk, jekk jogħġbok armi kwalunkwe konċentrat rikostitwit mhux użat immedjatament.
Reconstituted Mycamine should be used immediately because it does not contain any preservatives to prevent bacterial contamination.
Mycamine rikostitwit għandu jintuża minnufih minħabba li ma fihx preservattivi sabiex jipprevjenu kontaminazzjoni batterjali.
Only a trained health care professional who has read the complete directions properly can prepare this medicine for use.
Professjonista tal- kura tas- saħħa mħarreġ biss li jkun qara l- istruzzjonijiet kollha sewwa jista ’ jħejji din il- mediċina għall- użu.
What Mycamine contains
X’ fih Mycamine
- The active substance is micafungin sodium.
- Is- sustanza attiva hi micafungin sodium.
1 vial contains 50 mg or 100 mg micafungin (as sodium).
Kunjett wieħed fih 50 mg jew 100 mg micafungin (bħala sodium).
- The other ingredients are lactose monohydrate, citric acid anhydrous and sodium hydroxide.
- Is- sustanzi l- oħra huma lactose monohydrate, citric acid anhydrous u sodium hydroxide.
What Mycamine looks like and contents of the pack
Id- dehra ta ’ Mycamine u l- kontenuti tal- pakkett
40 Mycamine 50 mg or 100 mg powder for solution for infusion is a white compact freeze-dried powder.
Mycamine 50 mg jew100 mg trab għal soluzzjoni għal infużjoni huwa trab abjad kompatt ixxottat bil - friża.
Mycamine is supplied in a box containing 1 vial.
Mycamine jiġi f’ kaxxa li fiha kunjett wieħed.
Marketing Authorisation Holder Astellas Pharma Europe B.V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Astellas Pharma Europe B. V.
Manufacturer Astellas Ireland Co., Ltd.
Manifattur Astellas Ireland Co., Ltd.
Killorglin, County Kerry Ireland
Killorglin, County Kerry L- Irlanda
43 The following information is intended for medical or healthcare professionals only:
45 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Five ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion (taken from a 100 ml bottle/bag) should be aseptically and slowly injected into each vial along the side of the inner wall.
5 ml ta ’ 9 mg/ ml (0. 9%) sodium chloride ta ’ soluzzjoni għall- infużjoni jew 50 mg/ ml (5%) soluzzjoni għall- infużjoni ta ’ glucose (meħudin minn flixkun/ borża ta ’ 100 ml) għandhom jiġu injettati b’ mod asettiku u bil- mod mal- ġenb tal- wiċċ ta ’ ġewwa.
Therefore, please discard unused reconstituted concentrate immediately.
Għalhekk, jekk jogħġbok armi kull konċentrat rikostitwit mhux użat, immedjatament.
The diluted infusion solution should be used immediately.
Is- soluzzjoni għal infużjoni dilwita għandha tintuża mill- ewwel.
Chemical and physical in-use stability have been demonstrated for 96 hours at 25°C when protected from light and diluted as described above.
Stabbiltà kimika u fiżika waqt l- użu kienet murija għal 96 siegħa f’ temperatura ta ’ 25°C meta protett mid- dawl u meta dilwit kif deskritt hawn fuq.
Volume (concentration) of reconstituted powder
Volum (konċentrazzjoni) ta ’ trab rikostitwit
1 x 100
Infużjoni standard (miżjuda sa 100 ml) Konċentrazzjoni finali
10 ml
madwar 5 ml (10 mg/ ml) madwar 5 ml (20 mg/ ml) madwar 10 ml madwar 10 ml
5 ml
0. 50 mg/ ml 1. 0 mg/ ml 1. 5 mg/ ml 2. 0 mg/ ml
Ref.
Londra, 20 ta ’ Marzu 2007 Dok.
EMEA/ 129723/ 2007
Ref EMEA/ 129723/ 2007
QUESTIONS AND ANSWERS ON RECOMMENDATION FOR THE REFUSAL OF THE MARKETING AUTHORISATION for MYCOGRAB
MISTOQSIJIET U TWEĠIBIET DWAR IR- RAKKOMANDAZZJONI GĦAR- RIFJUT TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ għal MYCOGRAB
International non-proprietary name (INN): efungumab
Denominazzjoni Komuni Internazzjonali (INN – International non- proprietary name): efungumab