qanastek/EMEA-V3 huggingface dataset:
Table 3 Antitumour efficacy summary for combination and single-agent studies
Tabella 3 Studji fil- qosor fuq l- effikaċja anti- tumorali b’ sustanzi waħdedhom jew flimkien
Tumour response rate Relative Risk
Rata fir- rispons tumorali
(0.78-1.31)
(0. 78- 1. 31)
(0.83-1.72)
(0. 83- 1. 72)
(0.64-1.56)
(0. 64- 1. 56)
Median PFS (months)a Risk Ratio
Medjan PFS (xhur) a Riskju Proporzjonali
1.03
1. 03
0.87
0. 87
(0.80-1.34)
(0. 80- 1. 34)
(1.06-2.20)
(1. 06- 2. 20)
(0.66-1.16)
(0. 66- 1. 16)
PFS, progression-free survival; Dox, doxorubicin; Epi, epirubicin; Relative Risk, comparator taken as reference; Risk Ratio, Myocet taken as reference a Secondary endpoint
PFS, – sopravivenza mingħajr progressjoni; Dox, doxorubicin; Epi, epirubicin; Riskju Relattiv, komparatur meħud bħala referenza; Riskju Proporzjonali, Myocet meħud bħala referenza a Punt ta ’ referenza terminali sekondarju
The plasma pharmacokinetics for total doxorubicin in patients receiving Myocet shows a high degree of inter-patient variability.
Il- farmakokinetiċita tal- plażma għal doxorubicin totali f’ pazjenti fuq Myocet juru grad għoli ta ’ varjabilità bejn pazjenti.
In general however, the plasma levels of total doxorubicin are substantially higher with Myocet than with conventional doxorubicin, while the data indicate that peak plasma levels of free (not liposome-encapsulated) doxorubicin are lower with Myocet than with conventional doxorubicin.
B’ mod ġenerali madankollu, il- livelli totali ta ’ doxorubicin fil- plażma huma sostanzjalment ogħla b ’ Myocet milli b’ doxorubicin konvenzjonali, filwaqt li l- informazzjoni tindika li l- livelli l- aktar għolja ta ’ doxorubicin liberu (mhux enkapsulat f ’ liposomi) fil- plażma huma anqas b’ Myocet milli f doxorubicin konvenzjonali.
Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/ free doxorubicin and its influence on the efficacy/ safety of Myocet.
Informazzjoni farmakokinetika disponibbli tipprekludi li jsiru konklużjonijiet rigward ir- relazzjoni bejn livelli totali/ doxorubicin liberu fil- plażma u l - influwenza tiegħu fuq l- effikaċja / sigurtà ta ’ Myocet.
The clearance of total doxorubicin was 5.1 ± 4.8 l/ h and the volume of distribution at steady state (Vd) was 56.6 ± 61.5 l whereas after conventional doxorubicin, clearance and Vd were 46.7 ± 9.6 l/ h and 1,451 ± 258 l, respectively.
Għal doxorubicin konvenzjonali r- rata ta ’ tneħħija u Vd kienet ta ’ 46. 7 ± 9. 6 l/ h u 1, 451 ± 258 l rispettivament.
The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase.
Il - metabolit ewlieni li jiċċirkola ta ’ doxorubicin, doxorubicinol, huwa ffurmat permezz ta ’ aldo- keto - reductase.
The peak levels of doxorubicinol occur in the plasma later with Myocet than with conventional doxorubicin.
L- ogħla livelli fil- plażma ta ’ doxorubicinol jseħħu aktar tard ma’ Myocet milli ma’ doxorubicin konvenzjonali.
The pharmacokinetics of Myocet have not been specifically studied in patients with renal insufficiency.
Il- farmakokinetiċita ta ’ Myocet għadhom ma ġewx studjati b’ mod speċifiku f’ pazjenti b’ insuffiċjenza renali jew epatika.
Doxorubicin is known to be eliminated in large part by the liver.
Huwa magħruf li doxorubicin huwa eliminat prinċipalment mill- fwied.
A dose reduction of Myocet has been shown to be appropriate in patients with impaired hepatic function (see section 4.2 for dosage recommendations).
It- tnaqqis fid- doża ta ’ Myocet f’ pazjenti li għandhom indeboliment ħepatiku deher li kien xieraq (ara sezzjoni 4. 2 għar- rakkomandazzjonijiet fuq id- doża
Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
Sustanzi li jimpedixxu P- glycoprotein (P- Gp) intwerew li jibdlu t- tqassim ta ’ doxorubicin u doxorubicinol (ara wkoll sezzjoni 4. 5).
Studies of genotoxicity, carcinogenicity and reproductive toxicity of Myocet have not been performed but doxorubicin is known to be both mutagenic and carcinogenic and may cause toxicity to reproduction.
Ma sarux studji fuq l- effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva ta ’ Myocet iżda huwa magħruf li doxorubicin huwa kemm mutaġeniku u karċinoġeniku u jista ’ jikkaġuna tossiċità għal riproduzzjoni.
Myocet doxorubicin HCl • lactose
Myocet doxorubicin HCl • lactose
Myocet liposomes • egg phosphatidylcholine • cholesterol • citric acid • sodium hydroxide • water for injections
Liposomi ta ’ Myocet • egg phosphatidylcholine • cholesterol • citric acid • sodium hydroxide • ilma għall- injezzjoni
Myocet buffer • sodium carbonate • water for injections
Baffer ta ’ Myocet • sodium carbonate • ilma għall- injezzjoni
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk msemmija f’ sezzjoni 6. 6.
Chemical and physical in-use stability after reconstitution has been demonstrated for up to 8 hours at 25°C, and for up to 5 days at 2°C – 8ο C.
9 Kien hemm stabbilità kimika u fiżika waqt l- użu wara rikostituzzjoni sa 8 sigħat f’ temperatura ta ’ 25°C, u sa 5 t’ ijiem f’ temperaturi ta ’ bejn 2°C – 8οC.
From a microbiological point of view, the product should be used immediately.
Jekk ma jintużax minnufih, min juża l - prodott għandu jieħu responsabbiltà tal- ħinijiet tal- ħażna u l- kundizzjonijiet ta ’ qabel ma jintuża dan il- prodott.
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 2ο C – 8ο C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Dawn m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ temperaturi ta ’ 2οC – 8οC, kemm- il darba l- prodott ikun ġie rikostitwit u dilwit f’ post ikkontrollat u validat għal kundizzjonijiet asettiċi.
Store in a refrigerator (2ºC – 8ºC).
Aħżen fi friġġ (2°C – 8οC).
Myocet is available in cartons containing 2 sets of the three constituents.
Myocet huwa disponibbli f’ kartuni li fihom 2 settijiet ta ’ tlett kostitwenti.
Sodium chloride for injection 0.9%, needed to dissolve doxorubicin HCl, is not provided in the package.
Sodium chloride, 0. 9%, għall- injezzjoni, meħtieġ biex iħoll doxorubicin HCl, m’ huwiex provdut fil- pakkett.
Myocet doxorubicin HCl Type I glass vials containing 50 mg of doxorubicin HCl lyophilised powder, sealed with grey butyl rubber stoppers and orange flip-off aluminium seals.
Myocet doxorubicin HCl Fjali tal- ħġieġ ta ’ Tip I li fihom 50 mg ta ’ trab lajofilizzat ta ’ doxorubicin HCl, issiġillat b’ tappijiet tal - lastku griż tal- butyl u siġilli ta ’ l- aluminju oranġju li jinqalgħu b’ daqqa ta ’ saba ’.
9 Myocet liposomes Type I flint glass tubing vials containing not less than 1.9 ml of liposomes, sealed with siliconised grey stopper and green flip-off aluminium seals.
Liposomi ta ’ Myocet Fjali tubulari tal- ħġieġ ta ’ Tip I ta ’ żnied li ma fihomx inqas minn 1. 9 ml ta ’ liposomi, issiġillati b’ tappijiet griżi silikonizzati u b’ siġill aħdar ta ’ l- aluminju li jinqalgħu b’ daqqa ta ’ saba ’.
Myocet buffer Glass vials containing not less than 3 ml of buffer, sealed with siliconised grey stopper and blue aluminium flip-off seals.
Baffer ta ’ Myocet Fjali tal- ħgieġ li fihom mhux inqas minn 3 ml ta ’ baffer, issiġillati b’ tapp griz silikonizzat b’ siġilli ta ’ l- aluminju blu li jinqalgħu b’ daqqa ta ’ saba ’.
Preparation of Myocet ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF MYOCET SINCE NO PRESERVATIVE IS PRESENT.
Preparazzjoni ta ’ Myocet TEKNIKA ASETTIKA GĦANDHA TIĠI OSSERVATA WAQT LI MYOCET QED JIĠI MANIĠĠJAT BILLI M’ HEMMX PRESERVATTIV PREŻENTI.
Caution should be exercised in the handling and preparation of Myocet.
Għandu jkun hemm attenzjoni waqt l- imaniggjar u preparazzjoni ta ’ Myocet.
The use of gloves is required
Ingwanti huma meħtieġa
Step 1.
1 Stadju.
Set up Two alternative heating methods can be used: a Techne DB-3 Dri Block heater or a water bath: • Turn on the Techne DB-3 Dri Block heater and set the controller to 75-76°C.
Ħijter Techne DB- 3 Dri Block jew f’ banjumarija: • Ixgħel il- ħijter Techne DB- 3 Dri Block u qiegħed l- kontrollur fuq 75- 76°C.
Verify the temperature set point by checking the thermometer(s) on each heat block insert. • If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55-60°C).
Ivverifika l- livell tat - temperatura billi tiċċekja t- termometru (/ i) fuq kull blokka tas- sħana mdaħħla. • Jekk tuża banjumarija, ixgħel il- banjumarija u ħallih jilħaq ekwilibriju f’ 58°C (55- 60°C).
Verify the temperature set point by checking the thermometer.
Iċċekja l- livell tat- temperatura billi tiċċekja t- termometru.
(Please note that whilst the control settings on the water bath and heat block are set to different levels the temperature of the vial contents are in the same range (55-60°C)).
(Jekk jogħġbok innota li waqt li l- pożizzjonijiet tal- kontrolli tal- banjumarija u l- blokka tas- sħana qegħdin fuq livelli differenti, it- temperatura tal- kontenut tal- fjali tinsab fl- istess firxa (55- 60°C)).
Remove the carton of Myocet constituents from the refrigerator.
Neħħi l- kartuna li fiha l- kostitwenti ta ’ Myocet minn ġol- friġġ.
Step 2.
2 Stadju.
Reconstitute doxorubicin HCl • Withdraw 20 ml sodium chloride for injection (0.9%), preservative free, (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation. • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
Irrikostwixxi doxorubicin HCl • Iġbed 20 ml ta ’ (0. 9%) sodium chloride għall- injezzjoni, mingħajr preservattiv, (mhux provdut fil - pakkett), u injetta f’ kull Myocet doxorubicin HCl, intiż għal preparazzjoni. • Ħallat sew fil- pożizzjoni maqluba sabiex tiżgura li doxorubicin jinħall kollu.
Step 3.
10 3 Stadju.
Heat in water bath or dry heat block • Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75-76°C) for 10 minutes (not to exceed 15 minutes).
Saħħan f’ banjumarija jew f’ blokka ta ’ sħana xotta • Saħħan il- fjala ta ’ Myocet doxorubicin HCl rikostitwit f ’ ħijter Techne DB- 3 Dri Block bit - termometru fil- blokk jaqra (75- 76°C) għal 10 minuti (m’ għandhiex taqbez 15- il minuta).
If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55-60°C for 10 minutes (not to exceed 15 minutes). • While heating proceed to step 4
Jekk tuża l - banjumarija saħħan il- fjala ta ’ Myocet doxorubicin HCl bit- temperatura fuq 55- 60°C għal 10 minuti (m’ għandhiex taqbeż 15- il minuta). • Waqt li qed issaħħan ipproċedi għal stadju 4
Step 4.
4 Stadju.
Adjust Ph of liposomes • Withdraw 1.9 ml of Myocet liposomes.
Irranġa l- pH ta ’ liposomi • Iġbed 1. 9 ml ta ’ liposomi ta ’ Myocet.
Inject into Myocet buffer vial to adjust the Ph of liposomes.
Injetta fil- fjala tal- baffer ta ’ Myocet sabiex tirranġa l- pH ta ’ liposomi.
Pressure build-up may require venting. • Shake well.
Il- pressjoni li tinġema ’ għandha mnejn ikollha bżonn l- arja. • Ħallat sew.
Step 5.
5 Stadju.
Add Ph-adjusted liposomes to doxorubicin • Using syringe, withdraw the entire vial contents of Ph-adjusted liposomes from the Myocet buffer vial. • Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block.
Żid il- liposomi rranġati għal pH għal doxorubicin • B’ siringa, iġbed il- kontenut kollu ta ’ liposomi rranġati għal pH li jinsabu fil- fjala mill- fjala ta ’ baffer ta ’ Myocet. • Neħħi l- fjala ta ’ Myocet doxorubicin HCl rikonstitwit mill- banjumarija jew il- blokka tas- sħana niexfa.
SHAKE VIGOROUSLY.
ĦALLAT B’ MOD QAWWI.
Carefully insert a pressure-venting device equipped with a hydrophobic filter.
B’ attenzjoni daħħal tagħmir ta ’ l- arja li permezz tiegħu tista ’ tbaxxi l- pressjoni u li hu mgħammar b’ filtru idrofobiku.
Then IMMEDIATELY (within 2 minutes) inject Ph-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl.
Imbagħad MINNUFIH (fi żmien 2 minuti) injetta l- liposomi aġġustati għal pH fil- fjala ta ’ Myocet doxorubicin HCl rikonstitwit u msaħħan.
Remove venting device. • SHAKE VIGOROUSLY. • WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
Neħħi t- tagħmir ta’ l- arja. • ĦALLAT B’ MOD QAWWI. • STENNA MINIMU TA ’ 10 MINUTI QABEL MA TUŻA L- MEDIĊINA, ŻOMM IL - MEDICINA FIT- TEMPERATURA TAL- KAMRA.
10 The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.
Il- ħijter Techne DB- 3 Dri Block huwa validat b’ mod sħiħ sabiex jintuża biex jiġi konstitwit Myocet.
Three inserts, each with two 43.7mm openings per insert must be used.
Tlett daħliet, kull waħda b’ żewġ fethiet ta ’ 43. 7mm għal kull daħla għandhom jintużaw.
To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Sabiex jiġi żgurat li jkun hemm kontroll tajjeb tat- temperatura termometru ta ’ immersjoni ta ’ 35 mm huwa rakkomandat.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/ 25 ml of liposomal dispersion (2 mg/ ml).
Il- preparazzjoni rikostitwita ta ’ Myocet li tirriżulta ikun fiha 50 mg ta ’ doxorubicin HCl/ 25 ml ta ’ tixrid liposomali (2 mg/ ml).
After reconstitution the finished product must be further diluted in 0.9% (w/ v) sodium chloride for injection, or 5% (w/ v) glucose for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet so that a final concentration of 0.4 to 1.2 mg/ ml doxorubicin is obtained.
Wara li jiġi rikostitwit, il- prodott finali għandu jiġi dilwit aktar fi 0. 9% (w/ v) sodium chloride għall - injezzjoni, jew 5% (w/ v) glucose għall- injezzjoni sa volum aħħari ta ’ 40 ml sa 120 ml kull 50 mg ta ’ Myocet rikonstitwit sabiex il- konċentrazzjoni finali ta ’ doxorubicin tkun ta ’ bejn 0. 4 sa 1. 2 mg/ ml.
Once constituted, the liposomal dispersion for infusion containing liposome-encapsulated doxorubicin should be a red orange opaque homogeneous dispersion.
La darba jkun konstitwit, it- tixrid liposomali għall- infużjoni li fih doxorubicin enkapsulat fil- liposoma għandu jkun ta ’ tixrid omoġenju opak ta ’ lewn ħamrani- oranġjo.
All parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Kull soluzzjoni parenterali għandha tiġi spezzjonata viżwalment għal frak żgħir u tibdil fil- kulur qabel ma tingħata.
Do not use the preparation if foreign particulate matter is present.
Il- preparazzjoni m’ għandhiex tintuża jekk ikun hemm fiha frak barrani.
Procedure for proper disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Proċedura għar- rimi Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema b’ mod konformi mal- liġijiet lokali.
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort France
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort Franza
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park, Llanishan, Cardiff, Wales CF14 5RA United Kingdom
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park, Llanishan, Cardiff, Wales CF14 5RA Ir- Renju Unit
GP-Pharm Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spain
GP- Pharm Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spanja
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (ara Anness 1:
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jagħti tagħrif lill- Kummissjoni Ewropea dwar il- pjanijiet tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
Following the renewal of the Marketing Authorisation, the Marketing Authorisation Holder will submit annual Periodic Safety Update Reports (PSURs) unless otherwise requested by the CHMP.
Wara t- tiġdid ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq, id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq se jissottometti r- Rapporti Perjodiċi Aġġornati dwar is- Sigurtà (PSUR) sakemm ma jiġix mitlub mod ieħor mis- CHMP.
Carton containing 2 sets of 3 vials
16 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA Kartuna li jkun fiha 2 settijiet ta ’ 3 fjali
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Liposomal doxorubicin
Myocet 50 mg trab u sustanzi imħalltin lesti għal konċentrat għat- tixrid liposomali għall- infużjoni Liposomal doxorubicin
Myocet doxorubicin HCl lactose
Myocet doxorubicin HCl lactose
Myocet liposomes egg phosphatidylcholine, cholesterol, citric acid, sodium hydroxide, water for injections
Liposomi ta ’ Myocet egg phosphatidylcholine, cholesterol, citric acid, sodium hydroxide, ilma għall- injezzjoni
Myocet buffer sodium carbonate, water for injections
Baffer ta ’ Myocet sodium carbonate, ilma għall- injezzjoni
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Trab u sustanzi imħalltin lesti għal konċentrat għat- tixrid liposomali għall- infużjoni
Carton contents:
Kontenut tal- kaxxa:
2 sets each containing:
2 settijiet li kull wieħed fih:
1 vial Myocet doxorubicin HCl 1 vial Myocet liposomes 1 vial Myocet buffer
Fjala ta ’ baffer Myocet
For intravenous use after reconstitution and dilution.
Għal użu ġol- vini wara li jiġi rikostitwit u dilwit.
Cytotoxic.
Citotossiku.
17 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
18 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT INTERMEDJARJU
Powder and pre-admixtures for concentrate for liposomal dispersion for infusion
Trab u sustanzi ta ’ qabel ma jsir it- taħlit għal konċentrat għat- tixrid liposomali għall- infużjoni
Carton contents:
Kontenut tal- kartuna:
1 vial Myocet doxorubicin HCl 1 vial Myocet liposomes 1 vial Myocet buffer
Fjala ta ’ Myocet doxorubicin HCl Fjala ta ’ liposomi Myocet Fjala ta ’ baffer Myocet
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
EXP MM/ YYYY
19 EXP XX/ SSSS
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
Any unused product or waste materials should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
11 ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MYOCET DOXORUBICIN HCL VIAL
FJALA MYOCET DOXORUBICIN HCL
Myocet doxorubicin HCl I. V. use
Myocet doxorubicin HCl Użu I. V.
20 STICKER/ TEAR OFF SECTION OF LABEL FOR RELABELLING THE MYOCET DOXORUBICIN HCL VIAL CONTAINING RECONSTITUTED FINISHED CONCENTRATE FOR DISPERSION FOR INFUSION
21 STIKER/ BIĊĊA MIT- TABELLA LI TINQATA GĦAL TIKKETTJAR MILL- ĠDID TAL - FJALA TA ’ MYOCET DOXORUBICIN HCL LI FIHA IL- KONĊENTRAT RIKOSTITWIT LEST GĦAT- TIXRID GĦALL- INFUŻJONI
Myocet 50 mg concentrate for dispersion for infusion Liposomal doxorubicin
Myocet 50 mg konċentrat għat- tixrid għall- infużjoni Liposomal doxorubicin
Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Data ta ’ Preparazzjoni: ______________ Ħin ta ’ Preparazzjoni: ______________ Ippreparat Minn: __________________
MYOCET LIPOSOMES
LIPOSOMI TA ’ MYOCET
Myocet liposomes
Liposomi ta ’ Myocet
1.9 ml
1. 9 ml
MYOCET BUFFER
BAFFER TA ’ MYOCET
Myocet buffer
Baffer ta ’ Myocet
24 PACKAGE LEAFLET:
24 B. FULJETT TA ’ TAGĦRIF
INFORMATION FOR THE USER
25 FULJETT TA ’ TAGĦRIF:
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Doxorubicin HCl
Myocet 50 mg trab u taħlita ta ’ qabel għal konċentrat għat- tixrid liposomali għall- infużjoni Doxorubicin HCl
Read all of this leaflet carefully, before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
- If you have any further questions, ask your doctor or your hospital pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lis- ispiżjar ta ’ l- isptar tiegħek.
In this leaflet:
F' dn il- fuljett:
What Myocet is and what is it used for.
X' inhu Myocet u għalxiex jintuża.
Before you use Myocet.
Qabel ma ’ tuża Myocet.
How to use Myocet.
Kif għandek tuża Myocet.
How to store Myocet.
Kif taħżen Myocet.
WHAT MYOCET IS AND WHAT IS IT USED FOR
X’ INHU MYOCET U GĦALXIEX JINTUŻA
Myocet consists of a powder and pre-admixtures for concentrate for liposomal dispersion for infusion and is supplied as a three-vial system:
Hu provdut bħala sistema ta 'tlett fjali:
Myocet doxorubicin HCl, Myocet liposomes and Myocet buffer.
Myocet doxorubicin HCl, liposomi ta ’ Myocet u baffer ta ’ Myocet.
The active substance is presented as a lyophilised powder for single-use.
Is- sustanza attiva hija preżenti bħala trab lajofilizzat li jintuża darba biss.
Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.
Meta l- kontenut tal- fjali jiġi mħallat flimkien, it- tixrid liposomali li jirriżulta huwa ta ’ lewn oranġjo - ħamrani u opak.
Myocet is available in cartons containing 2 sets of the three constituents.
Myocet huwa disponibbli f’ kaxex li fihom 2 settijiet tat- tlett kostitwenti.
Myocet is a preparation of the anti-tumour agent doxorubicin, which is encased in microscopic fat particles known as liposomes.
Myocet huwa preparazzjoni tas- sustanza kontra t- tumuri, doxorubicin, enkapsulat f’ partiċelli mikroskopi tax- xaħam magħrufa bħala liposomi.
Doxorubicin belongs to a group of anti-tumour medicines called anthracyclines.
Doxorubicin jagħmel parti minn grupp ta ’ mediċini li jaħdmu kontra t- tumur imsejħa anthracyclines.
It damages the tumour cells.
Hu jagħmel ħsara liċ- ċelluli tat- tumur.
Myocet, in combination with cyclophosphamide, is used for the first-line treatment of metastatic breast cancer in women.
Myocet, flimkien ma ’ cyclophosphamide, jiġi użat bħala l- ewwel difiża tal- kanċer tas- sider fl- istadju metastatiku fin- nisa.
BEFORE YOU USE MYOCET
QABEL MA TUŻA MYOCET
You should tell your doctor if: • you are allergic to doxorubicin or any of the ingredients contained in Myocet. • you are pregnant, or think you may be pregnant, or are breast-feeding. • you have a history of cardiovascular disease (for example heart attacks, heart failure or long- standing high blood pressure) • you have problems with your liver.
Għandek tgħid lit- tabib tiegħek jekk: • int allerġiku/ a għal doxorubicin jew xi sustanzi oħra ta ’ Myocet. • int tqila, jew taħseb li int tqila jew qed tredda ’. • int għandek storja ta 'mard kardjovaskulari (per eżempju attakki tal- qalb, insuffiċjenza kardijaka jew pressjoni għolja ta' demm għal żmien twil) • jekk għandek problemi fil- fwied.
Do not use Myocet if: • you are allergic to doxorubicin or any of the ingredients contained in Myocet.
Tużax Myocet jekk: • inti allerġiku/ a għal doxorubicin jew xi sustanzi oħra ta ’ Myocet.
Take special care with Myocet.
26 Oqgħod attent ħafna b’ Myocet.
Doxorubicin may cause blood disorders and heart problems; therefore careful monitoring will be performed.
Doxorubicin jista ’ jikkaġuna problemi fid- demm u problemi fil- qalb; għalhekk għandu jkun hemm monitoraġġ b’ attenzjoni.
25 Doxorubicin is an irritant and special care should be taken when administering the infusion of Myocet.
Doxorubicin huwa irritant u attenzjoni speċjali trid tingħata waqt l- għoti ta ’ l- infużjoni ta ’ Myocet.
If Myocet leaks from the infusion site into the skin and surrounding tissues, the infusion must be stopped immediately and ice applied to the affected area for 30 minutes.
Għandu jiġi applikat silġ fiż- żona affetwata għal nofs siegħa.
Subsequently, the Myocet infusion will be started in another vein.
Sussegwentement, l - infużjoni ta ’ Myocet trid tinbeda ġo vina oħra.
Myocet may cause infusion-related side effects, such as flushing, fever, chills, headaches and back pain.
Myocet jista ’ jikkaġuna effetti oħrajn relatati ma ’ l- infużjoni, bħal ħmura, deni, tregħid, uġigħ ta ’ ras u uġigħ fid- dahar.
These can be avoided by increasing the length of time the infusion is given over.
Dawn jistgħu jiġu evitati billi jiġi miżjud il- ħin li fih tingħata l- infużjoni.
Using Myocet with food and drink.
Meta tuża Myocet ma ’ l- ikel u max- xorb.
There are no known interactions with food and drink.
M' hemm l- ebda effetti magħrufa ma ’ l- ikel u x- xorb.
Pregnancy and breast-feeding Tell your doctor of pharmacist if you are pregnant, think you may be pregnant or are breast-feeding, before you receive treatment with this medicine.
Tqala u treddigħ Għid lit- tabib jew spiżjar tiegħek jekk int tqila, taħseb li int tqila jew qed tredda ’, qabel ma tieħu kura b' din il- mediċina.
Myocet can not be used in pregnancy and women receiving Myocet should not breast-feed.
Myocet m' għandux jintuża waqt it- tqala u nisa fuq Myocet m' għandhomx jreddgħu.
Women of childbearing potential should use an effective contraceptive during and up to 6 months after treatment with Myocet.
Nisa li jistgħu joħorġu tqal għandhom jużaw kontraċettiv effettiv waqt u sa 6 xhur wara kura b’ Myocet.
Myocet has been reported to cause dizziness.
Kien hemm rapporti li Myocet jikkaġuna sturdamenti.
If you feel dizzy or are unsure of yourself do not drive or operate machinery.
Jekk tħossok sturdut jew m' intiex żgur minnek nnifsek m' għandekx issuq jew tħaddem magni.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Myocet may interact with substances that are known to interact with doxorubicin.
Myocet għandu mnejn ikollu interazzjoni ma ’ sustanzi li hu magħruf li jkollhom interazzjoni ma ’ doxorubicin.
Such substances include cyclosporin, phenobarbital, streptozocin, phenytoin, warfarin.
Dawn is- sustanzi jinkludu cyclosporin, phenobarbital, streptozocin, phenytoin, warfarin.
HOW TO USE MYOCET
KIF GĦANDEK TUŻA MYOCET
The dose of Myocet will be calculated according to the surface area of your body.
Id- doża ta ’ Myocet ser tiġi kkalkulata skond l- erja tas- superfiċje tal- ġisem tiegħek.
When Myocet is administered in combination with cyclophosphamide the generally recommended dose is 60-75 mg/ m2.
Meta Myocet jiġi mogħti flimkien ma ’ cyclophosphamide id- doża rakkomandata hija ġeneralment ta ’ 60- 75 mg/ m2.
Your doctor will work out exactly how much you need based on your individual circumstances and may choose to lower the dose.
It - tabib tiegħek ser jikkalkula kemm eżattament għandek bżonn u jista ’ jagħżel li jnaqqas id- doża tiegħek skond iċ- ċirkostanzi individwali tiegħek.
Myocet is administered by a health care professional as an intravenous infusion, after reconstitution of the individual vials and dilution.
Myocet jiġi mogħti minn professjonist fil- kura tas- saħħa bħala infużjoni ġol- vina, wara rikostituzzjoni mill- fjali individwali u wara li jiġi dilwit.
The infusion will be carried out one day every 3 weeks.
L- infużjoni ssir darba kull 3 ġimgħat.
The number of infusions will depend on the circumstances of your disease or response to the medicine.
In- numru ta ’ infużjonijiet ser jiddependu miċ- ċirkostanzi tal- marda tiegħek jew ir- rispons għall - mediċina.
Repeated treatment courses with Myocet are possible.
Korsijiet ta ’ kura ripetut b’ Myocet huma possibbli.
Treatment usually lasts for approximately 3-6 months.
Kura ġeneralment iddum għal madwar 3- 6 xhur.
Like all medicines, Myocet can have side effects.
Bħal kull mediċina oħra, Myocet jista ’ jkollu effetti sekondarji.
The very common side effects are blood disorders, where reduced levels of certain blood cells may cause: • reduced resistance to infection or fever, • sore mouth or throat and mouth ulcers, • increased bruising, • tiredness, lack of energy, feeling dizzy.
L- aktar effetti komuni huma mard fid- demm fejn livelli livelli mnaqqsa ta ’ ċertu ċelloli tad- demm jistgħu jikkawżaw: • tnaqqis għar- reżistenza għall- infezzjonijiet jew id- deni, • uġigħ fil- ħalq jew fil- griżmejn u ulċeri fil- ħalq,
Your doctor will monitor your blood regularly for these effects and will decide if specific treatment is required.
It- tabib tiegħek ser jissorvelja d- demm tiegħek b’ mod regolari għal dawn l- effetti u jiddeċiedi jekk ikollokx bżonn xi kura speċifika.
26 Other very common side effects may include: • diarrhoea, vomiting and feeling sick, • hair loss.
Effetti oħra komuni ħafna jistgħu jinkludu: • dijarrea, remettar u tħossok ma tiflaħx, • telf tax- xagħar
Other less common side effects may include: • shortness of breath and swollen ankles because of heart failure, irregular heart beat, low potassium level in the blood (which may be noticed as weakness and cramps), • breathing difficulties, cough, chest pains and fainting, coughing blood, • swelling and reddening and blistering of the skin around the injection site, • stomach pains from an open sore on the lining of the stomach, also called gastric ulcer and pain and swelling of the food pipe, • fever and chills (covers pneumonitis, plus breathing difficulties and cough), muscle weakness and aches, • yellowing of the skin and/ or eyes, also called jaundice, • change in frequency of urination, painful urination and blood in the urine, • constipation, feeling thirsty and loss of appetite, • skin problems including itchiness of the skin, tender, swollen areas around hair roots and nail disorders, • abnormal manner of walking, • speech difficulties, • back pain, • nose bleeds, • agitation, • sleepiness or drowsiness but sometimes insomnia.
Effetti oħra komuni jistgħu jinkludu • nuqqas ta ’ nifs u għakiesi minfuħa minħabba insuffiċjenza kardijaka, taħbit irregolari tal - qalb, livell baxx tal- potassa fid- demm (li jista ’ jkun innotat bħala debolezza jew bugħawiġijiet), • diffikultajiet fit- teħid tan- nifs, sogħla, uġigħ fis- sider u ħass ħażin, sogħla bid- demm, • nefħa u ħmura u nuffat fuq il- ġilda madwar is- sit ta ’ l- injezzjoni, • uġigħ fl- istonku minn ġerħa miftuħa fir- rita ta ’ l- istonku, magħrufa wkoll bħala ulċera ta ’ l - istonku u nefħa fl- apparat ta ’ l- ikel, • deni u sirdat (ikopri l- pnewmonite, flimkien ma ’ diffikutajiet fit- teħid tan- nifs u s- sogħla), debolezza mil- muskoli u uġigħ, • sfurija fil- ġilda u/ jew l- għajnejn, li tissejjaħ ukoll suffejra, • bidla kemm ta ’ spiss tgħaddi awrina, awrina bl- uġigħ u demm fl- awrina, • stitikezza, tħossok bil- għatx u nuqqas ta ’ aptit, • problemi fil- ġilda li jinkludi l- ħakk, postijiet teneri u minfuħa madwar l- għeruq tax- xagħar u problemi fid- dwiefer, • mod anormali fil- mixi, • diffikultajiet kif titkellem, • uġihħ fid- dahar, • jinfaraġ l- imnieħer, • aġitazzjoni, • ngħas, jew ħedla imma xi kultant nuqqas ta ’ irqadt.
During the infusion at the hospital, you may have an allergic reaction and notice any of the following:
Waqt l- infużjoni fl- isptar jista ’ jkollok reazzjoni allerġika u tinduna f’ xi waħda minn dawn:
light-headedness, tiredness, headache, back pain, flushing.
mejt, għejja, uġigħ ta ’ ras, uġigħ fid- dahar, ħmurija.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE MYOCET
KIF TAĦŻEN MYOCET
Store in a refrigerator (2ºC – 8ºC).
Aħżen fi friġġ (2°C - 8°C).
From a microbiological point of view, the product should be used immediately.
Mil- lat mikrobijoloġiku dan il- prodott għandu jintuża minnufih.
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 2οC – 8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax minnufih, il- ħin ta ’ żamma fil- ħażna u l- kundizzjonijiet huwa responsabbli għalih l- utent u m’ għandux ikun aktar minn 24 siegħa f’ temperatura ta ’ 2οC – 8οC, sakemm ir- rikostituzzjoni tiegħu jew id- dilwazzjoni ma sarx f’ post ikontrollat u asettiku vvalidat.
Do not use after the expiry date stated on the label and carton.
28 Tużax Myocet wara d- data ta ’ skadenza li tidher fuq it- tabella u l- kartuna.
Do not use Myocet if you notice that it shows evidence of discoloration, precipitation or any other particulate matter.
Tużax Myocet jekk tinnota li hemm evidenza ta ’ tibdil fil- kulur, preċipitazzjoni jew xi fdal ieħor.
Myocet 50 mg powder and pre -admixtures for concentrate for liposomal dispersion for infusion Liposomal doxorubicin
X’ fih Myocet Myocet 50 mg trab u taħlita ta ’ qabel għal konċentrat għat- tixrid lipsomali għall- infużjoni Liposomal doxorubicin
- The active substance is doxorubicin HCl, 50 mg.
- Is- sustanza attiva hi doxorubicin HCl, 50 mg.
- The other ingredients are lactose (Myocet doxorubicin HCl vial), egg phosphatidylcholine,
- Is- sustanzi l- oħra huma lactose (kunjett ta ’ Myocet doxorubicin HCl), egg phosphatidylcholine,
cholesterol, citric acid and sodium hydroxide and water for injections (Myocet liposomes vial), and sodium carbonate and water for injections (Myocet buffer vial).
kolesterol, citric acid u sodium hydroxide u ilma għall- injezzjonijiet (kunjett ta ’ Myocet b’ liposomi), u sodium carbonate u ilma għall- injezzjonijiet (kunjett tal- baffer ta 'Myocet).
The marketing authorisation holder is:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq huwa:
The Manufacturer is:
Il- Manifattur huwa:
St Mary’s Pharmaceutical Unit Quadrant Centre Cardiff Business Park Llanishan Cardiff Wales CF14 5RA United Kingdom.
St Mary’ s Pharmaceutical Unit Quadrant Centre Cardiff Business Park Llanishan Cardiff Wales CF14 5RA Ir- Renju Unit.
This leaflet was last approved on:...
Dan il- fuljett kien approvat l- aħħar f ’:...
28 The following information is intended for healthcare professionals only:
29 L- informazzjoni li ġejja hija intiża għal professjonisti fil- kura tas- saħħa biss:
PREPARATION GUIDE
GWIDA GĦALL- PREPARAZZJONI
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Liposomal doxorubicin
Myocet 50 mg trab u taħlita ta ’ qabel għal konċentrat għat- tixrid lipsomali għall- infużjoni Liposomal doxorubicin
It is important you read the entire contents of this guide prior to the preparation of this medicinal product.
Huwa importanti li taqra l- kontenut kollu ta ’ din il- gwida qabel ma dan il- prodott mediċinali jiġi ppreparat.
(1) Myocet doxorubicin HCl, (2) Myocet liposomes, and (3) Myocet buffer.
Myocet huwa provdut f’ sistema ta ’ tlett fjali (1) Myocet doxorubicin HCl, (2) Liposomi ta ’ Myocet, u (3) Baffer ta ’ Myocet.
In addition to these three components, 0.9% (w/v) sodium chloride for injection will also be required for the reconstitution of the doxorubicin HCl.
Barra minn dawn it- tlett komponenti, ikun hemm bżonn ta ’ 0. 9% (w/ v) sodium chloride għall- injezzjoni għar- rikostituzzjoni ta ’ doxorubicin HCl.
Myocet must be reconstituted prior to administration.
Myocet għandu jiġi rikostitwit qabel ma jingħata.
RECOMMENDATIONS FOR SAFE HANDLING
RAKKOMANDAZZJONIJIET GĦAL MANIĠĠAR MINGĦAJR PERIKLU
The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted, namely:
Il- proċeduri normali għal maniġġar u rimi kif suppost ta ’ prodotti mediċinali li jaħdmu kontra t- tumur għandhom jiġu adottati.
• • •
Dawn jinkludu:
Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.
• L- impjegati għandhom jiġu mħarrġa kif jirrikostitwixxu prodott mediċinali. • Nisa tqal għandhom jiġu esklużi milli jaħdmu fuq il- prodott mediċinali. • L- impjegati li jaħdmu fuq il- prodott mediċinali waqt ir- rikostituzzjoni tiegħu għandhom jilbsu lbies protettiv li jinkludu maskri, goggles u ingwanti. • Kull ħaġa li tintuża waqt l- għoti jew tindif, li jinkludu ingwanti, għandhom jitqegħdu f' borża tar - rimi ta ’ riskju għoli għall- inċinerazzjoni f' temperatura għolja.
Liquid waste may be flushed with large amounts of water.
Skart likwidu jista ’ jiġi fflaxxjat b' ammonti kbar ta ’ ilma. • Kuntatt aċċidentali mal- ġilda jew l- għajnejn għandu jiġi kkurat b’ ammonti kbar ta ’ ilma.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
PREPARAZZJONI GĦALL- GĦOTI ĠOL- VINA
Aseptic technique must be strictly observed throughout handling of Myocet since no preservative is present.
Teknika asettika għandha tiġi wżata b’ mod strett waqt li Myocet ikun qed jiġi maniġġjat billi m’ hemmx preservattiv preżenti.
3.1 Preparation of Myocet
3. 1 Preparazzjoni ta ’ Myocet
Step 1.
Stadju.
Set up Two alternative heating methods can be used: a Techne DB-3 Dri Block heater or a water bath: • Turn on the Techne DB-3 Dri Block heater and set the controller to 75-76°C.
Ħijter Techne DB- 3 Dri Block jew f’ banjumarija: • Ixgħel il- ħijter Techne DB- 3 Dri Block u qiegħed il- kontrollur fuq 75- 76°C.
Verify the temperature set point by checking the thermometer(s) on each heat block insert. • If using a water bath, turn on the water bath and allow it to equilibrate at 58°C (55-60°C).
Ivverifika l- livell tat - temperatura billi tiċċekja t- termometru (/ i) fuq kull blokka ta ’ sħana mdaħħla. • Jekk tuża banjumarija, ixgħel il- banjumarija u ħallih jilħaq ekwilibriju f ’ 58°C (55- 60°C).
Remove the carton of Myocet constituents from the refrigerator.
Neħħi l- kaxxa li fiha l- kostitwenti ta ’ Myocet minn ġol- friġġ.
29 Step 2.
2 Stadju.
Reconstitute doxorubicin HCl • Withdraw 20 ml sodium chloride for injection (0.9%), preservative free, (not provided in the package), and inject into each Myocet doxorubicin HCl, intended for preparation. • Shake well in the inverted position to ensure doxorubicin is fully dissolved.
30 • Iġbed 20 ml ta ’ (0. 9%) sodium chloride għall- injezzjoni, mingħajr preservattiv, (mhux provdut fil - pakkett), u injetta f’ kull Myocet doxorubicin HCl, intiż għal preparazzjoni. • Ħallat sew fil- pożizzjoni maqluba sabiex tiżgura li doxorubicin jinħall kollu.
Step 3.
3 Stadju.
Heat in water bath or dry heat block • Heat the reconstituted Myocet doxorubicin HCl vial in the Techne DB-3 Dri Block heater with the thermometer in the block reading (75-76°C) for 10 minutes (not to exceed 15 minutes). • If using the water bath heat the Myocet doxorubicin HCl vial with the thermometer temperature reading 55-60°C for 10 minutes (not to exceed 15 minutes). • While heating proceed to step 4
Saħħan f’ banjumarija jew f’ blokka ta ’ sħana xotta • Saħħan il- fjala ta ’ Myocet doxorubicin HCl rikonstitwit f’ ħijter Techne DB- 3 Dri Block bit - termometru fil- blokk taqra (75- 76°C) għal 10 minuti (m’ għandhiex taqbeż 15- il minuta). • Jekk tuża l- banjumarija saħħan il- fjala ta’ Myocet doxorubicin HCl bit- temperatura tat- termometru fuq 55- 60°C għal 10 minuti (m’ għandhiex taqbeż 15- il minuta). • Waqt li qed issaħħan ipproċedi għal stadju 4
Adjust pH of liposomes • Withdraw 1.9 ml of Myocet liposomes.
Aġġusta l- pH ta ’ liposomi • Iġbed 1. 9 ml ta ’ liposomi ta ’ Myocet.
Inject into Myocet buffer vial to adjust the pH of liposomes.
Injetta fil- fjala tal- baffer ta ’ Myocet sabiex taġġusta l- pH ta ’ liposomi.
Step 5.
Stadju 5.
Add pH-adjusted liposomes to doxorubicin • Using a syringe, withdraw the entire vial contents of pH-adjusted liposomes from the Myocet buffer vial. • Remove the reconstituted Myocet doxorubicin HCl vial from the water bath or dry heat block.
Żid il- liposomi bil- pH irrangat għal doxorubicin • B’ siringa, iġbed il- kontenut kollu ta ’ liposomi bil- pH irranġat mill- fjala ta ’ baffer ta ’ Myocet. • Neħħi l- fjala ta ’ Myocet doxorubicin HCl rikostitwit mill- banjumarija jew il- blokka tas- sħana niexfa.
Then IMMEDIATELY (within 2 minutes) inject pH-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl.
Imbagħad MINNUFIH (fi żmien 2 minuti) injetta l- liposomi bil- pH irranġat fil fjala ta ’ Myocet doxorubicin HCl rikostitwit u msaħħan.
Remove venting device. • SHAKE VIGOROUSLY. • WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
Neħħi t- tagħmir ta l- arja. • ĦALLAT B’ MOD QAWWI. • STENNA MINIMU TA ’ 10 MINUTI QABEL MA TUŻA L- MEDIĊINA FIT- TEMPERATURA TAL- KAMRA.
The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.
Il- Ħijter Techne DB- 3 Dri Block huwa validat b’ mod sħiħ sabiex jintuża biex jiġi kostitwit Myocet.
To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Sabiex jiġi żgurat li jkun hemm kontroll tajjeb tat- temperatura, termometru ta ’ immersjoni ta ’ 35 mm huwa rakkomandat.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/25 ml of concentrate for liposomal dispersion for infusion (2 mg/ml).
Il- preparazzjoni rikostitwita ta ’ Myocet li tirriżulta ikun fiha 50 mg ta ’ doxorubicin HCl/ 25 ml ta ’ konċentrat għal tixrid liposomali għall- infuzjoni (2 mg/ ml).
After reconstitution the finished product must be further diluted in 0.9% (w/v) sodium chloride for injection, or 5% (w/v) glucose for injection to a final volume of 40 ml to 120 ml per 50 mg reconstituted Myocet so that a final concentration of 0.4 to 1.2 mg/ml doxorubicin is obtained.
Wara li jiġi rikostitwit, il- prodott finali għandu jiġi dilwit aktar b’ 0. 9% (w/ v) sodium chloride għall - injezzjonijiet, jew 5% (w/ v) glucose għall- injezzjoni sa volum fl- aħħar ta ’ 40 ml sa 120 ml kull 50 mg ta ’ Myocet rikostitwit sabiex il- konċentrazzjoni finali ta ’ doxorubicin tkun ta ’ bejn 0. 4 sa 1. 2 mg/ ml.
Once constituted, the liposomal dispersion for infusion containing liposome encapsulated doxorubicin should be a red orange opaque homogeneous dispersion.
La darba jkun kostitwit, it- tixrid liposomali għall- infużjoni li fih doxorubicin enkapsulat fil- liposoma għandu jkun ta ’ tixrid omoġenju opak ta ’ lewn ħamrani- oranġjo.
All parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Il- prodotti mediċinali parenterali kollha għandhom jiġu spezzjonati għal frak żgħir u telf fil- kulur qabel ma jingħataw.
Do not use the preparation if foreign particulate matter is present.
It- taħlita m’ għandhiex tintuża jekk ikun hemm frak barrani fiha.
It has been demonstrated that once reconstituted Myocet has a chemical and physical in-use stability at room temperature for up to 8 hours or in a refrigerator (2-8οC) for up to 5 days.
Ġie ippruvat li hekk kif Myocet ikun rikostitwit, dan ikollu stabilità kimika u fiżika waqt l- użu fit - temperatura tal- kamra sa 8 sigħat jew fil- friġġ (2- 8° C) sa ħamest ijiem.
From a microbiological point of view, the product should be used immediately.
Jekk ma jintużax immedjatament, min juża l- prodott għandu jieħu responsabbiltà tal- ħinijiet tal- ħażna u l- kundizzjonijiet ta ’ qabel jintuża dan il- prodott.
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 -8οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Dawn m’ għandhomx ikunu ta ’ aktar minn 24 siegħa f’ temperaturi ta ’ 2οC – 8οC, ħlief meta l- prodott ikun ġie rikostitwit u dilwit f’ post ikkontrollat u validat għal kundizzjonijiet asettiċi.
Myocet should be administered by intravenous infusion over a period of 1 hour.
Myocet għandu jingħata permezz ta ’ infużjoni minn ġol- vina fuq firxa ta ’ siegħa.
Myocet must not be administered by the intramuscular or subcutaneous route or as a bolus injection.
Myocet m’ għandux jingħata minn ġol- muskolu jew minn b’ rotta subkutanja jew bħala injezzjoni bolus
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk tixtieq aktar informazzjoni relatata mar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (parti wkoll mill- EPAR).
What is Myozyme?
X’ inhu Myozyme?
Myozyme is a powder to be made up into a solution for infusion (drip into a vein).
Myozyme huwa trab li jitħallat f’ soluzzjoni għall- infużjoni (dripp ġol- vina).
It contains the active substance alglucosidase alfa.
Huwa fih is- sustanza attiva alglukosidażi alfa (alglucosidase alfa).
What is Myozyme used for?
Għal xiex jintuża Myozyme?
Myozyme is used to treat patients who have Pompe disease, a rare inherited disorder.
Myozyme jintuża biex fit- trattament pazjenti li għandhom il- marda ta ’ Pompe, disturb rari li jintiret.
Patients with Pompe disease do not have enough of an enzyme called alpha-glucosidase.
Fil- pazjenti li jbatu minn din il- marda jiġi osservat in- nuqqas ta ’ enzima msejħa alfa- glukosidażi (alpha- glucosidase).
This enzyme normally converts glycogen (a carbohydrate) into glucose.
Din l- enzima normalment tikkonverti l- glikoġenu (glycogen, karboidrat) fi glukożju.
If the enzyme is not present, glycogen builds up in certain tissues, particularly the heart and muscle, including the diaphragm (the main breathing muscle under the lungs).
Jekk l- enzima mhijiex preżenti, il- glikoġenu jakkumula f’ ċerti tessuti, b’ mod partikolari fil - qalb u fil- muskoli, inkluż fid- dijaframma (il- muskolu tat- teħid tan- nifs ewlieni taħt il- pulmuni).
The progressive build-up of glycogen causes a wide range of signs and symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
L - akkumulu progressiv ta ’ glikoġenu tikkawża firxa wiesgħa ta ’ sinjali u sintomi, inklużi tkabbir tal - qalb, diffikultajiet fit- teħid tan- nifs u dgħufija tal- muskoli).
The disease can appear at birth but also later in life.
Il- marda tista ’ tidher mat- twelid iżda wkoll iktar tard fil- ħajja.
For this late-onset form of the disease, the benefits of Myozyme have not been proven.
Il- benefiċċji ta ’ Myozyme mhumiex magħrufin għal din il- forma ta ’ marda li tibda tard.
Because the number of patients with Pompe disease is low, the disease is considered ‘ rare’, and Myozyme was designated as an ‘ orphan medicine ’ (a medicine used in rare diseases) on 14 February 2001.
Minħabba li n- numru ta ’ pazjenti bil- marda ta ’ Pompe huwa wieħed baxx, il- marda hija kkunsidrata ‘ rari ’, u fl- 14 ta ’ Frar 2001, Myozyme kien ikkwalifikat bħala ‘ mediċina orfni ’ (mediċina li tintuża f’ mard rari).
How is Myozyme used?
Kif jintuża Myozyme?
Myozyme treatment should be supervised by a doctor who has experience in the management of patients with Pompe disease or other inherited diseases of the same type.
It- terapija b’ Myozyme għandha tkun sorveljata minn tabib li għandu esperjenza fit- trattament ta ’ pazjenti bil- marda ta ’ Pompe jew xi mard ieħor li jintiret tal- istess tip.
Myozyme is used as an infusion of 20 mg per kilogram body weight given once every two weeks.
Myozyme jintuża bħala infużjoni ta ’ 20 mg għal kull kilogramma ta ’ piż tal- ġisem mogħtija darba kull ġimagħtejn.
The starting infusion rate should be 1 mg/ kg per hour, which should be gradually increased by 2 mg/ kg/ hr every 30 minutes until the maximum rate of 7 mg/ kg/ hr is reached.
Ir- rata inizjali tal- infużjoni hija 1 mg/ kg kull siegħa, li għandha tiżdied gradwalment b’ 2 mg/ kg/ siegħa kull 30 minuta sakemm tintlaħaq rata massima ta ’ 7 mg/ kg/ siegħa.
Myozyme may be given to children, adolescents, adults or elderly patients.
Myozyme jista ’ jingħata lit- tfal, adolexxenti, adulti jew anzjani.
How does Myozyme work?
Kif jaħdem Myozyme?
Myozyme is an enzyme replacement therapy.
Myozyme huwa terapija enzimatika sostituttiva.
Enzyme replacement therapy provides patients with the enzyme they are lacking.
It- terapija enzimatika sostituttiva tipprovdi l- pazjenti bl- enzima li jkollhom nuqqas tagħha.