natgillin/translations-raw huggingface dataset:
Available pharmacokinetic data preclude conclusions regarding the relationship between plasma levels of total/ free doxorubicin and its influence on the efficacy/ safety of Myocet.
Na osnovi farmakokinetičnih podatkov, ki so na voljo, ni možno izpeljati sklepov o odnosu med plazemsko koncentracijo skupnega/ prostega doksorubicina v plazmi in njenim vplivom na učinkovitost/ varnost Myoceta.
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.
Očistek skupnega doksorubicina je bil 5, 1 ± 4, 8 l/ h, volumen porazdelitve v stanju dinamičnega ravnovesja (Vd) pa 56, 6 ± 61, 5 l, medtem ko je bil očistek pri običajnem doksorubicinu 46, 7 ± 9, 6 l/ h, Vd pa 1. 451 ± 258 l.
The major circulating metabolite of doxorubicin, doxorubicinol, is formed via aldo-keto-reductase.
Glavni presnovek doksorubicina v krvnem obtoku, doksorubicinol, se tvori z aldo- keto- reduktazo.
The peak levels of doxorubicinol occur in the plasma later with Myocet than with conventional doxorubicin.
Pri Myocetu so najvišje plazemske koncentracije doksorubicinola dosežene kasneje kot pri običajnem doksorubicinu.
The pharmacokinetics of Myocet have not been specifically studied in patients with renal insufficiency.
Pri bolnicah z zmanjšanim delovanjem jeter ali ledvic farmakokinetike Myoceta niso posebej raziskovali.
Doxorubicin is known to be eliminated in large part by the liver.
Doksorubicin se v veliki meri izloča skozi jetra.
A dose reduction of Myocet has been shown to be appropriate in patients with impaired hepatic function (see section 4.2 for dosage recommendations).
Pri bolnicah z okvarjenim delovanjem jeter se je zmanjšanje odmerka Myoceta izkazalo za ustrezno (glejte tudi poglavje 4. 2 za priporočene odmerke).
Substances that inhibit P-glycoprotein (P-Gp) have been shown to alter the disposition of doxorubicin and doxorubicinol (see also section 4.5).
Za snovi, ki zavirajo delovanje P- glikoproteina (P- Gp), so dokazali, da spremenijo razpoložljivost doksorubicina in doksorubicinola (glejte tudi poglavje 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.
Študij genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja niso opravili, vendar je za doksorubicin znano, da je mutagen in karcinogen ter da lahko vpliva na sposobnost razmnoževanja.
Myocet doxorubicin HCl • lactose
Myocet doksorubicinijev klorid • laktoza
Myocet liposomes • egg phosphatidylcholine • cholesterol • citric acid • sodium hydroxide • water for injections
Liposomi Myocet • jajčni fosfatidilholin • holesterol • citronska kislina • natrijev hidroksid • voda za injekcije
Myocet buffer • sodium carbonate • water for injections
Pufer Myocet • natrijev karbonat • voda za injekcije
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.
Kemična in fizikalna stabilnost med uporabo, po rekonstituciji, sta bili dokazani do 8 ur pri temperaturi 25 °C in do 5 dni pri temperaturi med 2 ° in 8 °C.
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.
Ne shranjujte dlje kot 24 ur pri temperaturi med 2 ° in 8 °C, razen če rekonstitucija in redčenje nista bila opravljena v nadzorovanih in preverjeno aseptičnih pogojih.
Store in a refrigerator (2ºC – 8ºC).
Shranjujte v hladilniku (2 °C - 8 °C).
Myocet is available in cartons containing 2 sets of the three constituents.
Myocet je na voljo v škatlah, ki vsebujejo 2 kompleta treh sestavin.
Sodium chloride for injection 0.9%, needed to dissolve doxorubicin HCl, is not provided in the package.
Natrijev klorid 9 mg/ ml (0, 9%) raztopine za injiciranje, potrebne za razredčenje doksorubicinijevega klorida, ni v ovojnini.
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 doksorubicinijev klorid Steklene viale vrste I, ki vsebujejo 50 mg liofiliziranega praška doksorubicinijevega klorida, zaprte s sivimi zamaški iz butilne gume in oranžnimi aluminijastimi tesnili flip- off.
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 Myocet Viale vrste I iz kremenčevega stekla, ki vsebujejo najmanj 1, 9 ml liposomov, zaprte s sivimi zamaški, prevlečenimi s silikonom, in zelenimi aluminijastimi tesnili flip- off.
Myocet buffer Glass vials containing not less than 3 ml of buffer, sealed with siliconised grey stopper and blue aluminium flip-off seals.
Pufer Myocet Steklene viale, ki vsebujejo vsaj 3 ml pufra, zaprte s sivimi zamaški, prevlečenimi s silikonom, in modrimi aluminijastimi tesnili flip- off.
6.6 Special precautions for disposal and other handling
10 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Preparation of Myocet ASEPTIC TECHNIQUE MUST BE STRICTLY OBSERVED THROUGHOUT HANDLING OF MYOCET SINCE NO PRESERVATIVE IS PRESENT.
Priprava Myoceta Med ROKOVANJEM Z MYOCETOM SE MORATE STROGO DRŽATI ASEPTIČNIH TEHNIK, KER ZDRAVILO NE VSEBUJE KONZERVANSOV.
Caution should be exercised in the handling and preparation of Myocet.
Pri rokovanju z Myocetom in njegovi pripravi morate biti previdni.
The use of gloves is required
Uporaba rokavic je nujna.
Step 1.
1. korak:
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.
Priprava Lahko uporabite enega od dveh načinov ogrevanja: grelec Techne DB- 3 Dri Block ali vodno kopel: • vključite grelec Techne DB- 3 Dri Block in nastavite temperaturo na 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).
Nastavitev temperature preverite na termometrih na vsakem od grelnih blokov. • Če uporabljate vodno kopel, jo vključite in pustite, da se temperatura ustali na 58 °C (55- 60 °C).
(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)).
(Čeprav sta nastavitvi temperature na vodni kopeli in grelnem bloku različni, je temperatura vsebine vial v istem območju (55- 60 °C)).
Remove the carton of Myocet constituents from the refrigerator.
Vzemite škatlo s sestavinami Myoceta iz hladilnika.
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.
Rekonstitucija doksorubicinijevega klorida • Vzemite 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansov (ni na voljo v kompletu) in injicirajte v vsako od vial Myocet doksorubicinijevega klorida, namenjeno pripravi. • Dobro pretresite v obrnjenem položaju, da se doksorubicin povsem raztopi.
Step 3.
3. korak:
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).
Termometer naj bo pri tem nastavljen na temperaturo 75- 76 °C.
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
Temperatura na termometru naj bo 55 - 60 °C. • Med ogrevanjem nadaljujte s 4. korakom.
Adjust Ph of liposomes • Withdraw 1.9 ml of Myocet liposomes.
Injicirajte v vialo s pufrom Myocet in tako uravnajte pH • vrednost liposomov.
Inject into Myocet buffer vial to adjust the Ph of liposomes.
Tlak se lahko poveča in morda ga boste morali sprostiti.
Pressure build-up may require venting. • Shake well.
Dobro pretresite. •
Step 5.
5. korak:
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.
V doksorubicin dodajte liposome z uravnano vrednostjo pH Z brizgo zajemite celotno vsebino liposomov z uravnano vrednostjo pH iz viale s pufrom Myocet. • Vzemite vialo z rekonstituiranim Myocet doksorubicinijevim kloridom iz vodne kopeli ali suhega • grelca.
Then IMMEDIATELY (within 2 minutes) inject Ph-adjusted liposomes into vial of heated reconstituted Myocet doxorubicin HCl.
Nato NEMUDOMA (v največ 2 minutah) injicirajte liposome z uravnano vrednostjo pH v vialo z ogretim, rekonstituiranim Myocet doksorubicinijevim kloridom.
Remove venting device. • SHAKE VIGOROUSLY. • WAIT FOR A MINIMUM OF 10 MINUTES BEFORE USING, KEEPING THE MEDICINE AT ROOM TEMPERATURE.
PRI TEM NAJ BO ZDRAVILO NA SOBNI • TEMPERATURI.
10 The Techne DB-3 Dri Block Heater is fully validated for use in the constitution of Myocet.
Grelec Techne DB- 3 Dri Block je v celoti validiran za uporabo pri konstituciji Myoceta.
Three inserts, each with two 43.7mm openings per insert must be used.
Uporabiti morate tri vstavke, vsakega z dvema 43, 7- milimetrskima odprtinama.
To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Za ustrezen nadzor temperature je priporočena uporaba 35- milimetrskega termometra za vodo.
The resulting reconstituted preparation of Myocet contains 50 mg of doxorubicin HCl/ 25 ml of liposomal dispersion (2 mg/ ml).
Končni rekonstituirani pripravek Myoceta vsebuje 50 mg doksorubicinijevega klorida/ 25 ml liposomske disperzije (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.
11 Po rekonstituciji morate končni izdelek dodatno razredčiti v natrijevem kloridu 9 mg/ ml (0, 9%) raztopini za injiciranje ali v glukozi 50 mg/ ml raztopini za injiciranje na končno prostornino 40 ml do 120 ml na 50 mg rekonstituiranega Myoceta, tako da dobite končno koncentracijo 0, 4 do 1, 2 mg/ ml doksorubicina.
Once constituted, the liposomal dispersion for infusion containing liposome-encapsulated doxorubicin should be a red orange opaque homogeneous dispersion.
Liposomska disperzija za infundiranje, ki vsebuje doksorubicin, enkapsuliran v liposomih, mora biti po konstituciji rdeče- oranžna neprosojna homogena disperzija.
All parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Vse parenteralne raztopine morate pred uporabo vizualno pregledati in preveriti, ali so v njih delci in ali je raztopina razbarvana.
Procedure for proper disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Postopek za ustrezno odlaganje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort France
Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort Francija
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca (izdelovalcev) zdravila, odgovornega (odgovornih) za sproščanje serije
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 Velika Britanija
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) Španija
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• POGOJI ALI OMEJITVE GLEDE NAČINA IZDAJANJA IN UPORABE ZDRAVILA, KI VELJAJO ZA IMETNIKA DOVOLJENJA ZA PROMET
Medicinal product subject to restricted medical prescription (See Annex I:
Zdravilo se izda le na zdravniški recept (glej Dodatek I:
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Imetnik tega dovoljenja za promet mora s to odločbo obvestiti Evropsko komisijo o načrtih za promet z zdravilom, ki je dobilo dovoljenje.
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.
Po obnovitvi dovoljenja za promet bo imetnik dovoljenja za promet vložil letna Periodična poročila o posodobitvi varnosti (PSUR) dokler ne bo nadaljnih napotkov od CHMP.
14 A.
14 DODATEK III
15 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
Carton containing 2 sets of 3 vials
Pakiranje vsebuje 2 kompleta 3 vial
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Liposomal doxorubicin
Myocet 50 mg prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje liposomski doksorubicin
50 mg doxorubicin HCl
50 mg doksorubicinijevega klorida
Myocet doxorubicin HCl lactose
Myocet doksorubicinijev klorid laktoza
Myocet liposomes egg phosphatidylcholine, cholesterol, citric acid, sodium hydroxide, water for injections
Liposomi Myocet jajčni fosfatidilholin, holesterol, citronska kislina, natrijev hidroksid, voda za injekcije
2 sets each containing:
2 kompleta, vsak vsebuje:
1 vial Myocet doxorubicin HCl 1 vial Myocet liposomes 1 vial Myocet buffer
1 vialo Myocet doksorubicinijevega klorida 1 vialo liposomov Myocet 1 vialo pufra Myocet
EXP MM/ YYYY
{MM/ LLLL}
LOT XXXX
Serija XXXX
17 PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING
18 PODATKI NA VMESNI OVOJNINI
1 vial Myocet doxorubicin HCl 1 vial Myocet liposomes 1 vial Myocet buffer
1 viala Myocet doksorubicinijevega klorida 1 viala liposomov Myocet 1 viala pufra Myocet
MYOCET DOXORUBICIN HCL VIAL
VIALA Z MYOCET DOKSORUBICINIJEVIM KLORIDOM
Myocet doxorubicin HCl I. V. use
Myocet doksorubicinijev klorid i. v. uporaba
20 STICKER/ TEAR OFF SECTION OF LABEL FOR RELABELLING THE MYOCET DOXORUBICIN HCL VIAL CONTAINING RECONSTITUTED FINISHED CONCENTRATE FOR DISPERSION FOR INFUSION
21 NALEPKA/ DEL NALEPKE, KI GA ODTRGATE ZA PONOVNO OZNAČEVANJE VIALE Z MYOCET DOKSORUBICINIJEVIM KLORIDOM, KI VSEBUJE REKONSTITUIRAN, DOKONČEN KONCENTRAT ZA DISPERZIJO ZA INFUNDIRANJE
Myocet 50 mg concentrate for dispersion for infusion Liposomal doxorubicin
Myocet, 50 mg, koncentrat za disperzijo za infundiranje liposomski doksorubicin
Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Datum priprave: ______________ Čas priprave _______________ Pripravil: __________________
21 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
22 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Myocet liposomes
Liposomi Myocet
MYOCET BUFFER
PUFER MYOCET
Myocet 50 mg powder and pre-admixtures for concentrate for liposomal dispersion for infusion Doxorubicin HCl
Myocet 50 mg prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje Doksorubicinijev klorid
Read all of this leaflet carefully, before you start using this medicine.
Pred začetkom jemanja natančno preberite navodilo!
- If you have any further questions, ask your doctor or your hospital pharmacist.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom v bolnišnici.
2.
Kaj je zdravilo Myocet in za kaj ga uporabljamo 2.
3.
Kaj morate vedeti, preden boste uporabili zdravilo Myocet 3.
4.
Kako uporabljati zdravilo Myocet 4.
6.
Shranjevanje zdravila Myocet 6.
WHAT MYOCET IS AND WHAT IS IT USED FOR
KAJ JE MYOCET IN ZA KAJ GA UPORABLJAMO
Myocet consists of a powder and pre-admixtures for concentrate for liposomal dispersion for infusion and is supplied as a three-vial system:
Myocet sestavljajo prašek in dodatki za koncentrat za liposomsko disperzijo za infundiranje in je na voljo v obliki sistema treh vial:
Myocet doxorubicin HCl, Myocet liposomes and Myocet buffer.
Myocet doksorubicinijev klorid, liposomi Myocet in pufer Myocet.
The active substance is presented as a lyophilised powder for single-use.
Zdravilna učinkovina je v obliki liofiliziranega praška za enkratno uporabo.
Once the content of the vials has been mixed together the resulting liposomal dispersion is orange-red and opaque.
Ko je vsebina vial zmešana skupaj, je liposomska disperzija oranžno- rdeča in neprozorna.
Myocet is a preparation of the anti-tumour agent doxorubicin, which is encased in microscopic fat particles known as liposomes.
Myocet je pripravek protitumorske učinkovine doksorubicina, enkapsuliranega v mikroskopsko majhne maščobne delce, imenovane liposomi.
Doxorubicin belongs to a group of anti-tumour medicines called anthracyclines.
Doksorubicin sodi v skupino protitumorskih zdravil, imenovanih antraciklini.
It damages the tumour cells.
Ti poškodujejo tumorsko celico.
Myocet, in combination with cyclophosphamide, is used for the first-line treatment of metastatic breast cancer in women.
Myocet se v kombinaciji s ciklofosfamidom uporablja za prvo zdravljenje metastaznega raka dojke pri ženskah.
BEFORE YOU USE MYOCET
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO 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.
Povejte zdravniku, če: • ste alergični na doksorubicin ali katerokoli sestavino Myoceta. • ste noseči, mislite, da bi lahko bili noseči, ali dojite. • ste v preteklosti imeli srčno- žilno bolezen (na primer srčni napad, srčno odpoved ali dalj časa trajajoči zvišan krvni tlak) • imate težave z jetri.
Do not use Myocet if: • you are allergic to doxorubicin or any of the ingredients contained in Myocet.
Ne uporabljajte zdravila Myocet, če: • ste alergični na doksorubicin ali katerokoli sestavino Myoceta.
Take special care with Myocet.
Bodite posebno pozorni pri uporabi zdravila Myocet.
Doxorubicin may cause blood disorders and heart problems; therefore careful monitoring will be performed.
Doksorubicin lahko povzroči bolezni krvi in težave s srcem, zato vas bodo pozorno nadzirali.
25 Doxorubicin is an irritant and special care should be taken when administering the infusion of Myocet.
26 Doksorubicin je dražljivec, zato morate biti pri infundiranju Myoceta posebno previdni.
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.
Če na mestu infundiranja Myocet uhaja na kožo ali okolna tkiva, je treba infundiranje takoj prekiniti in na prizadeto mesto za 30 minut položiti led.
Subsequently, the Myocet infusion will be started in another vein.
Zatem boste začeli z novim infundiranjem Myoceta v drugo veno.
Myocet may cause infusion-related side effects, such as flushing, fever, chills, headaches and back pain.
Myocet lahko povzroči neželene učinke, povezane z infundiranjem, kot so rdečica, vročina, mrzlica, glavoboli in bolečine v hrbtu.
These can be avoided by increasing the length of time the infusion is given over.
Izogniti se jim je mogoče tako, da podaljšamo čas infundiranja.
Using Myocet with food and drink.
Uporaba zdravila Myocet s hrano in pijačo:
There are no known interactions with food and drink.
Ni znanih interakcij s hrano in pijačo.
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.
Nosečnost in dojenje Preden prejmete to zdravilo, povejte zdravniku, če ste noseči, mislite, da bi lahko bili noseči, ali dojite.
Myocet can not be used in pregnancy and women receiving Myocet should not breast-feed.
Myoceta ne smete uporabljati med nosečnostjo in ženske, ki ga prejemajo, ne smejo dojiti.
Women of childbearing potential should use an effective contraceptive during and up to 6 months after treatment with Myocet.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem z Myocetom in do 6 mesecev po njem.
If you feel dizzy or are unsure of yourself do not drive or operate machinery.
Če se vam vrti v glavi ali niste gotovi vase, ne vozite ali upravljajte strojev.
Myocet may interact with substances that are known to interact with doxorubicin.
Myocet lahko medsebojno učinkuje s snovmi, za katere je znano, da medsebojno učinkujejo z doksorubicinom.
Such substances include cyclosporin, phenobarbital, streptozocin, phenytoin, warfarin.
Med take snovi sodijo ciklosporin, fenobarbital, streptozocin, fenitoin in varfarin.
HOW TO USE MYOCET
KAKO UPORABLJATI MYOCET
The dose of Myocet will be calculated according to the surface area of your body.
Odmerek Myoceta bodo izračunali glede na površino vašega telesa.
When Myocet is administered in combination with cyclophosphamide the generally recommended dose is 60-75 mg/ m2.
Pri uporabi Myoceta v kombinaciji s ciklofosfamidom je splošni priporočeni odmerek 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.
Lahko se tudi odloči, da vam zmanjša odmerek.
Myocet is administered by a health care professional as an intravenous infusion, after reconstitution of the individual vials and dilution.
Po rekonstituciji posameznih vial in redčenju, Myocet daje strokovni zdravstveni delavec v obliki intravenske infuzije.
The infusion will be carried out one day every 3 weeks.
Infuzijo boste prejeli enkrat na 3 tedne.
The number of infusions will depend on the circumstances of your disease or response to the medicine.
Število infuzij bo odvisno od okoliščin vaše bolezni in odziva na zdravilo.
Repeated treatment courses with Myocet are possible.
Možno je, da bodo ponovili več krogov zdravljenja z Myocetom.
Treatment usually lasts for approximately 3-6 months.
Zdravljenje ponavadi traja približno 3- 6 mesecev.
Like all medicines, Myocet can have side effects.
Kot vsa zdravila ima lahko tudi Myocet neželene učinke.
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.
Najpogostejši neželeni učinki so bolezni krvi, pri čemer zmanjšane ravni krvnih celic lahko povzročijo: • zmanjšano odpornost proti okužbam ali vročini, • boleča usta ali razjede grla in ust, • povečana možnost modric, • utrujenost, pomankanje energije, omotičnost..
Your doctor will monitor your blood regularly for these effects and will decide if specific treatment is required.
Zdravnik bo redno pregledoval vašo kri, da bi odkril takšne učinke in se bo odločil ali je potrebno posebno zdravljenje.
26 Other very common side effects may include: • diarrhoea, vomiting and feeling sick, • hair loss.
27 Drugi pogosti neželeni učinki so lahko: • diareja, bruhanje in slabost, • izguba las.