natgillin/translations-raw huggingface dataset:
There was a significant improvement in the primary endpoint of time to progression (TTP) for patients treated with combination therapy of Caelyx plus bortezomib compared to patients treated with bortezomib monotherapy as indicated by a risk reduction (RR) of 35% (95% CI; 21-47%), p < 0.0001, based on 407 TTP events.
Opazno je bilo bistveno izboljšanje kar zadeva primarni končni rezultat, ki je bil čas do napredovanja bolezni (TTP) pri bolnikih, ki so bili zdravljeni s kombinirano terapijo z zdravilom Caelyx in bortezomibom, v primerjavi s tistimi, ki so prejemali bortezomib v monoterapiji; to so ugotovili na podlagi zmanjšanja tveganja (RR) za 35% (95% interval zaupanja IZ; od 21 do 47%), p < 0, 0001 na osnovi 407 TTP dogodkov.
The median TTP was 6.9 months for the bortezomib monotherapy patients compared with 8.9 months for the Caelyx plus bortezomib combination therapy patients.
Pri bolnikih, ki so prejemali monoterapijo z bortezomibom, je znašala mediana vrednost TTP 6, 9 mesecev, pri tistih, ki so prejemali kombinirano terapijo z zdravilom Caelyx in bortezomibom pa je bila 8, 9 mesecev.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%), p < 0.0001.
Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45% (95% IZ; od 29 do 57%), p < 0, 0001.
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the Caelyx plus
Mediana vrednost TTP je znašala 6, 5 mesecev pri bolnikih, ki so prejemali monoterapijo z bortezomibom, v primerjavi z vrednostjo 9, 3 mesece pri tistih, ki so prejemali kombinirano terapijo z zdravilom Caelyx in bortezomibom.
Caelyx is a long-circulating pegylated liposomal formulation of doxorubicin hydrochloride.
Caelyx je pegiliran liposomski pripravek doksorubicinijevega klorida, ki v krvnem obtoku ostane dolgo časa.
Pegylated liposomes are small enough (average diameter of approximately 100 nm) to pass intact (extravasate) through defective blood vessels supplying tumours.
Znake
Evidence of penetration of pegylated liposomes from blood vessels and their entry and accumulation in tumours has been seen in mice with C-26 colon carcinoma tumours and in transgenic mice with KS-like lesions.
20 prodiranja pegiliranih liposomov iz krvnih žil in njihovega vstopa ter kopičenja v tumorjih so opažali pri miših s karcinomskimi tumorji kolona C- 26 in pri transgenskih miših z lezijami, podobnimi Kaposijevemu sarkomu.
Over the dose range of 10 mg/ m2 – 60 mg/ m2 Caelyx displayed non-linear pharmacokinetics.
V manjših odmerkih (10 do 20 mg/ m2) ima Caelyx linearno farmakokinetiko, v odmernem območju od 10 do 60 mg/ m2 pa je njegova farmakokinetika nelinearna.
700 to 1,100 l/ m2) and a rapid elimination clearance (24 to 73 l/ h/ m2).
Standardni doksorubicinijev klorid se izdatno porazdeli po tkivih (volumen porazdelitve: od 700 do 1. 100 l/ m2) in ima hiter eliminacijski očistek (24 to 73 l/ uro/ m2).
Population pharmacokinetics The pharmacokinetics of Caelyx was evaluated in 120 patients from 10 different clinical trials using the population pharmacokinetic approach.
Populacijska farmakokinetika Farmakokinetiko zdravila Caelyx so ovrednotili po načelih populacijske farmakokinetike pri 120 bolnikih iz 10 različnih kliničnih raziskav.
The pharmacokinetics of Caelyx over the dose range of 10 mg/ m2 to 60 mg/ m2 was best described by a two compartment non-linear model with zero order input and Michaelis-Menten elimination.
Farmakokinetiko zdravila Caelyx v odmernem območju od 10 do 60 mg/ m2 najbolje opiše dvoprostorni nelinearni model z vnosom ničelnega reda in Michaelis - Mentenovim izločanjem.
The mean intrinsic clearance of Caelyx was 0.030 l/ h/ m2 (range 0.008 to 0.152 l/ h/ m2) and the mean central volume of distribution was 1.93 l/ m2 (range 0.96 – 3.85 l/ m2) approximating the plasma volume.
Srednja vrednost intrinzičnega očistka zdravila Caelyx je 0, 030 l/ uro/ m2 (razpon od 0, 008 do 0, 152 l/ uro/ m2), srednja vrednost osrednjega volumna porazdelitve pa 1, 93 l/ m2 (razpon od 0, 96 do 3, 85 l/ m2), kar se približuje volumnu plazme.
The apparent half-life ranged from 24 – 231 hours, with a mean of 73.9 hours.
Navidezni razpolovni čas je od 24 do 231 ur, srednja vrednost pa je 73, 9 ur.
Breast cancer patients The pharmacokinetics of Caelyx determined in 18 patients with breast carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Bolnice z rakom dojk Farmakokinetika zdravila Caelyx, ugotovljena pri 18 bolnicah z rakom dojk, je bila podobna farmakokinetiki pri večji populaciji 120 bolnikov z različnimi vrstami raka.
The mean intrinsic clearance was 0.016 l/ h/ m2 (range 0.008 - 0.027 l/ h/ m2), the mean central volume of distribution was 1.46 l/ m2 (range 1.10 - 1.64 l/ m2).
Srednja vrednost intrinzičnega očistka je bila 0, 016 l/ uro/ m2 (razpon od 0, 008 do 0, 027 l/ uro/ m2), srednja vrednost osrednjega volumna porazdelitve pa 1, 46 l/ m2 (razpon od 1, 10 do 1, 64 l/ m2).
The mean apparent half-life was 71.5 hours (range 45.2 - 98.5 hours).
Srednja vrednost navideznega razpolovnega časa je bila 71, 5 ur (razpon od 45, 2 do 98, 5 ur).
Ovarian cancer patients The pharmacokinetics of Caelyx determined in 11 patients with ovarian carcinoma were similar to the pharmacokinetics determined in the larger population of 120 patients with various cancers.
Bolnice z rakom jajčnikov Farmakokinetika zdravila Caelyx, ugotovljena pri 11 bolnicah z rakom jajčnikov, je bila podobna farmakokinetiki pri večji populaciji 120 bolnikov z različnimi vrstami raka.
The mean intrinsic clearance was 0.021 l/ h/ m2 (range 0.009 – 0.041 l/ h/ m2), the mean central volume of distribution was 1.95 l/ m2 (range 1.67 – 2.40 l/ m2).
Srednja vrednost intrinzičnega očistka je bila 0, 021 l/ uro/ m2 (razpon od 0, 009 do 0, 041 l/ uro/ m2), srednja vrednost osrednjega volumna porazdelitve pa 1, 95 l/ m2 (razpon od 1, 67 do 2, 40 l/ m2).
The mean apparent half-life was 75.0 hours (range 36.1 – 125 hours).
Srednja vrednost navideznega razpolovnega časa je bila 75, 0 ur (razpon od 36, 1 do 125 ur).
22 AIDS-KS patients The plasma pharmacokinetics of Caelyx were evaluated in 23 patients with KS who received single doses of 20 mg/ m2 administered by a 30-minute infusion.
Bolniki, ki imajo z aidsom povezan Kaposijev sarkom Plazemsko farmakokinetiko zdravila Caelyx so ovrednotili pri 23 bolnikih s Kaposijevim sarkomom, ki so prejeli po en odmerek 20 mg/ m2 v 30- minutni infuziji.
The pharmacokinetic parameters of Caelyx (primarily representing pegylated liposomal doxorubicin hydrochloride and low levels of unencapsulated doxorubicin hydrochloride) observed after the 20 mg/ m2 doses are presented in Table 8.
Farmakokinetični parametri zdravila Caelyx (v prvi vrsti za pegiliran liposomski doksorubicinijev klorid in majhno koncentracijo neinkapsuliranega doksorubicinijevega klorida), ugotovljeni po odmerku 20 mg/ m2, so prikazani v preglednici 8.
Pharmacokinetic Parameters in Caelyx-Treated AIDS-KS
Farmakokinetični parametri zdravila Caelyx pri bolnikih s Kaposijevim sarkomom, povezanim z aidsom
Mean + Standard Error
Srednja vrednost ± standardna napaka
20
20 mg/ m2 (n=23) Parameter
Maximum Plasma Concentration* (µg/ ml)
21 Največja koncentracija v plazmi * (μg/ ml)
Plasma Clearance (l/ h/ m2) Volume of Distribution (l/ m2) AUC (µg/ ml⋅ h) λ 1 half-life (hours) λ 2 half-life (hours) *Measured at the end of a 30-minute infusion
Plazemski očistek (l/ h/ m2) Volumen porazdelitve (l/ m2) AUC (μg/ ml· h) λ1 razpolovni čas (h) λ2 razpolovni čas (h) * izmerjeno na koncu 30- minutne infuzije
Dermal toxicity:
Dermalna toksičnost:
Similar dermal lesions, which are described as palmar-plantar erythrodysesthesia were also observed in patients after long-term intravenous infusion (see section 4.8).
Podobne kožne lezije, ki jih opisujejo kot palmo- plantarno eritrodizestezijo, so opažali tudi pri bolnikih po dolgotrajnih intravenskih infuzijah (glejte poglavje 4. 8).
Anaphylactoid response:
Anafilaktoidni odziv:
Local toxicity:
Lokalna toksičnost:
Subcutaneous tolerance studies indicate that Caelyx, as against standard doxorubicin hydrochloride, causes slighter local irritation or damage to the tissue after a possible extravasation.
Raziskave subkutane tolerance za zdravilo kažejo, da Caelyx v primerjavi s standardnim doksorubicinijevim kloridom po morebitni ekstravazaciji povzroči manj lokalnega draženja oz. poškodbe tkiva.
Mutagenicity and carcinogenicity:
Mutagenost in kancerogenost:
23 Reproductive toxicity:
Reprodukcijska toksičnost:
Caelyx resulted in mild to moderate ovarian and testicular atrophy in mice after a single dose of 36 mg/ kg.
Caelyx je pri miših po enkratnem odmerku 36 mg/ kg povzročil blago do zmerno atrofijo jajčnikov in mod.
Decreased testicular weights and hypospermia were present in rats after repeat doses ≥ 0.25 mg/ kg/ day and diffuse degeneration of the seminiferous tubules and a marked decrease in spermatogenesis were observed in dogs after repeat doses of 1 mg/ kg/ day (see section 4.6).
Pri podganah sta se po večkratnih odmerkih ≥ 0, 25 mg/ kg/ dan pojavili zmanjšana teža mod in hipospermija, pri psih pa so po večkratnih odmerkih 1 mg/ kg/ dan ugotavljali difuzno degeneracijo semenskih kanalov in izrazito zmanjšanje spermatogeneze (glejte poglavje 4. 6).
Nephrotoxicity:
Nefrotoksičnost:
PHARMACEUTICAL PARTICULARS
FARMACEVTSKI PODATKI 22 6. 1 Seznam pomožnih snovi
α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ω -methoxypoly(oxyethylen)- 40 sodium salt (MPEG-DSPE) fully hydrogenated soy phosphatidylcholine (HSPC) cholesterol ammonium sulphate sucrose histidine water for injections hydrochloric acid sodium hydroxide
α - (2 - [1, 2- distearoil- sn- glicero( 3) fosfooksi] etilkarbamoil) - ω- metoksipoli( oksietilen) - 40 natrijeva sol (MPEG- DSPE) popolnoma hidrogeniran sojin fosfatidilholin (HSPC) holesterol amonijev sulfat saharoza histidin voda za injekcije klorovodikova kislina natrijev hidroksid
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
- Zdravilo je med uporabo kemično in fizikalno stabilno 24 ur pri temperaturi 2 °C do 8 °C.
If not used
Če se ne uporabi takoj, čas
immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C.
in pogoje shranjevanja pred uporabo z lastno odgovornostjo določi uporabnik na lastno odgovornost, vendar ne sme presegati 24 ur pri temperaturi 2 °C do 8 °C.
Determine the dose of Caelyx to be administered (based upon the recommended dose and the patient’ s body surface area).
Določite odmerek zdravila Caelyx, ki ga mora bolnik prejeti (glede na priporočeni odmerek in bolnikovo telesno površino).
The appropriate dose of Caelyx must be diluted in 5% (50 mg/ ml) glucose solution for infusion prior to administration.
Ustrezni odmerek zdravila Caelyx morate pred dajanjem razredčiti v 5% (50 mg/ ml) raztopini
For doses < 90 mg, dilute Caelyx in 250 ml, and for doses ≥ 90 mg, dilute Caelyx in 500 ml.
Za odmerke < 90 mg Caelyx razredčite v 250 ml, za odmerke ≥ 90 mg pa v 500 ml.
This can be infused over 60 or 90 minutes as detailed in 4.2.
Odmerek lahko infundirate v 60 ali 90 minutah, kakor je podrobno opisano v poglavju 4. 2.
The use of any diluent other than 5% (50 mg/ ml) glucose solution for infusion, or the presence of any bacteriostatic agent such as benzyl alcohol may cause precipitation of Caelyx.
Uporaba kateregakoli drugega vehikla kot 5% (50 mg/ ml) raztopine glukoze za infundiranje oz. prisotnost kakršnegakoli bakteriostatika, npr. benzil alkohola, lahko povzroči obarjanje zdravila Caelyx.
It is recommended that the Caelyx infusion line be connected through the side port of an intravenous infusion of 5% (50 mg/ ml) glucose.
Priporočljivo je, da je infuzijska linija za Caelyx prek stranskega nastavka priključena na intravensko infuzijo 5% (50 mg/ ml) glukoze.
SP Europe Rue de Stalle 73 B – 1180 Bruxelles Belgium
SP Europe Rue de Stalle 73 B - 1180 Bruxelles Belgija
Date of first authorization:
Datum pridobitve dovoljenja:
19 May 2006
21. junij 1996 Datum zadnjega podaljšanja dovoljenja: may 19, 2006
25 ANNEX II
24 DODATEK II
SP Labo N. V., Industriepark 30, 2220, Heist-op-den-Berg, Belgium
SP Labo N. V., Industriepark 30, 2220, Heist- op- den- Berg, Belgija
Pharmacovigilance system The MAH must ensure that the system of Pharmacovigilance, as described in version dated June 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the Market.
Ta sistem mora delovati, še preden pride zdravilo na trg in ves čas ko je na trgu.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version dated 01 June 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt upravljanja s tveganji Imetnik dovoljenja za promet se zavezuje, da bo opravil študije in dodatne farmakovigilančne dejavnosti, ki so podrobneje navedene v Načrtu izvajanja farmakovigilance, kot je bilo dogovorjeno v verziji Načrta upravljanja s tveganji z dne 1. junija 2007 (RMP), ki je bila podana v Modulu 1. 8. 2.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s Smernico CHMP o sistemih upravljanja s tveganji za zdravila, namenjena za uporabo v humani medicini, je treba posodobljen RMP predložiti ob istem času kot naslednje Periodično poročilo o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba predložiti posodobljen RMP: • če imetnik dovoljenja za promet prejme nove podatke, ki bi lahko vplivali na sedanjo specifikacijo varnosti zdravila, Načrt izvajanja farmakovigilance ali dejavnosti za zmanjšanje tveganj na najmanjšo možno mero, • v roku 60 dni od doseganja pomembnega mejnika (glede farmakovigilance ali zmanjševanja tveganj), • na zahtevo agencije EMEA.
LABELLING
28 PODATKI NA ZUNANJI OVOJNINI
CAELYX CARTON 20 mg/ 10 ml – 1 vial CAELYX CARTON 20 mg/ 10 ml – 10 vials
CAELYX ŠKATLA 20 mg/ 10 ml – 1 viala CAELYX ŠKATLA 20 mg/ 10 ml – 10 vial
Caelyx 2 mg/ ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Caelyx 2 mg/ ml koncentrat za raztopino za infundiranje pegilirani liposomski doksorubicinijev klorid
Excipients: α -(2-[1,2-distearoyl-sn-glycero(3)phosphooxy]ethylcarbamoyl)-ϖ - methoxypoly(oxyethylen)-40 sodium salt, fully hydrogenated soy phosphatidylcholine, cholesterol, ammonium sulphate, sucrose, histidine, water for injections, hydrochloric acid and sodium hydroxide.
Pomožne snovi: α - (2 - [1, 2- distearoil- sn- glicero( 3) fosfooksi] etilkarbamoil) - ω- metoksipoli( oksietilen) - 40 natrijeva sol, popolnoma hidrogeniran sojin fosfatidilholin, holesterol, amonijev sulfat, saharoza, histidin, voda za injekcije, klorovodikova kislina, natrijev hidroksid.
1 vial 10 vials 20 mg/ 10 ml
1 viala 10 vial 20 mg/ 10 ml
Intravenous use, following dilution in 5% (50 mg/ ml) glucose solution for infusion.
Intravenska uporaba po razredčenju s 5% (50 mg/ ml) raztopino glukoze za infundiranje.
Caelyx should be handled and disposed of in a manner consistent with that of other cytotoxic medicinal products.
Za ravnanje z zdravilom Caelyx in odstranjevanje ostankov zdravila veljajo enaka pravila kot za druga citotoksična zdravila.
EU/ 1/ 96/ 011/ 001 (1 vial) EU/ 1/ 96/ 011/ 002 (10 vials)
EU/ 1/ 96/ 011/ 001 (1 viala) EU/ 1/ 96/ 011/ 002 (10 vial)
CAELYX CARTON 50 mg/ 25 ml – 1 vial CAELYX CARTON 50 mg/ 25 ml – 10 vials
CAELYX ŠKATLA 50 mg/ 25 ml – 1 viala CAELYX ŠKATLA 50 mg/ 25 ml – 10 vial
1 vial 10 vials 50 mg/ 25 ml
1 viala 10 vial 50 mg/ 25 ml
EU/ 1/ 96/ 011/ 003 (1 vial) EU/ 1/ 96/ 011/ 004 (10 vials)
EU/ 1/ 96/ 011/ 003 (1 viala) EU/ 1/ 96/ 011/ 004 (10 vial)
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
32 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CAELYX LABEL 20 mg/ 10 ml
CAELYX NALEPKA 20mg/ 10ml
34 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
33 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
CAELYX LABEL 50 mg/ 25 ml
CAELYX NALEPKA 50 mg/ 25ml
PACKAGE LEAFLET
35 NAVODILO ZA UPORABO
Caelyx 2 mg/ ml concentrate for solution for infusion Pegylated liposomal doxorubicin hydrochloride
Caelyx 2 mg/ ml, koncentrat za raztopino za infundiranje pegilirani liposomski doksorubicinijev klorid
What Caelyx is and what it is used for 2.
Kaj je zdravilo Caelyx in za kaj ga uporabljamo 2.
Before you use Caelyx 3.
Kaj morate vedeti, preden boste uporabili zdravilo Caelyx 3.
How to use Caelyx 4.
Kako uporabljati zdravilo Caelyx 4.
Possible side effects 5 How to store Caelyx 6.
Shranjevanje zdravila Caelyx 6.
WHAT CAELYX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO CAELYX IN ZA KAJ GA UPORABLJAMO
Caelyx is used to treat cancer of the breast in patients at risk for heart problems.
Caelyx uporabljamo za zdravljenje raka dojk pri bolnicah, ogroženih zaradi težav s srcem.
Caelyx is also used to treat cancer of the ovary.
Caelyx se uporablja tudi za zdravljenje raka jajčnikov.
It is used to kill cancer cells, shrink the size of the tumour, delay the growth of the tumour, and extend your survival.
Zdravilo služi za uničevanje rakavih celic, zmanjšanje velikosti tumorja in upočasnitev njegove rasti ter podaljšanje preživetja bolnice.
Caelyx is also used in combination with another medicine, bortezomib, to treat multiple myeloma, a cancer of the blood in patients who have received at least 1 prior therapy.
Zdravilo Caelyx uporabljamo tudi v kombinaciji z drugim zdravilom, bortezomibom, za zdravljenje multiplega mieloma, vrste krvnega raka pri bolnikih, ki so že prejeli najmanj 1 predhodno terapijo.
Caelyx is also used to produce an improvement in your Kaposi’ s sarcoma including flattening, lightening and even shrinkage of the cancer.
Caelyx se uporablja tudi za izboljšanje stanja pri Kaposijevem sarkomu, vključno s sploščenjem rakavih poškodb, njihovo posvetlitvijo in celo zmanjšanjem velikosti.
Other symptoms of Kaposi’ s sarcoma, such as swelling around the tumour, may also improve or disappear.
Tudi drugi simptomi Kaposijevega sarkoma, npr. otekanje okrog tumorja, se lahko izboljšajo ali izginejo.
Caelyx contains a medicine which is able to interact with cells in such a way as to selectively kill cancer cells.
Caelyx vsebuje zdravilo, ki deluje tako, da selektivno uničuje rakave celice.
BEFORE YOU USE CAELYX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO CAELYX
Do not use Caelyx
Ne uporabljajte zdravila Caelyx
- if you are allergic (hypersensitive) to doxorubicin hydrochloride or any of the other ingredients
- če ste alergični na (preobčutljivi za) doksorubicinijev klorid ali katerokoli sestavino zdravila
of Caelyx.
Caelyx, Če prejemate zdravilo Caelyx ne smete dojiti.
Take special care with Caelyx
Bodite posebno pozorni pri uporabi zdravila Caelyx
- if you are receiving any treatment for heart disease or liver disease;
- če prejemate kakršnakoli zdravila za srčno ali jetrno bolezen;
- if you are diabetic, because Caelyx contains sugar which may require an adjustment to the
- če imate sladkorno bolezen, saj Caelyx vsebuje sladkor, zaradi česar vam bo lahko treba
treatment of your diabetes;
prilagoditi zdravljenje sladkorne bolezni;
- if you have Kaposi’ s sarcoma and have had your spleen removed.
- če imate Kaposijev sarkom in so vam odstranili vranico.
Taking other medicines Please tell your doctor or pharmacist
Jemanje drugih zdravil Obvestite svojega zdravnika ali farmacevta
- if you are taking or have recently taken any other medicines, including medicines obtained
- če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
- about any other cancer treatments you are on or have been taking, as particular care needs to be
- o vsakem drugem zdravilo proti raku, ki ga jemljete ali ste ga jemali, saj je pri jemanju zdravil,
taken with treatments which reduce the number of white blood cells, as this may cause further reduction in the number of white blood cells.
ki zmanjšajo število levkocitov, potrebna posebna previdnost, ker lahko ta zdravila dodatno zmanjšajo število levkocitov.
Avoid becoming pregnant while you or your partner are taking Caelyx and in the six months following discontinuation of Caelyx treatment.
Pazite, da ne zanosite v času, ko vi ali vaš partner prejemate Caelyx, in še šest mesecev po prekinitvi zdravljenja z njim.
Because doxorubicin hydrochloride may be harmful to nursing infants, women must discontinue breast-feeding before starting treatment with Caelyx.
Ker lahko doksorubicinijev klorid škoduje dojenčku, mora ženska nehati dojiti še pred začetkom zdravljenja z zdravilom Caelyx.
Health experts recommend that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Zdravstveni strokovnjaki priporočajo, naj ženske, okužene s HIV, v nobenem primeru ne dojijo, da se prepreči prenos virusa na otroka.
HOW TO USE CAELYX
KAKO UPORABLJATI ZDRAVILO CAELYX
It must not be used interchangeably with other formulations of doxorubicin hydrochloride.
Caelyx je edinstven pripravek in ga ne smemo prosto zamenjevati z drugimi pripravki doksorubicinijevega klorida.
Depending on the dose and indication, this may take from 30 minutes to more than one hour (i. e., 90 minutes).
90 minut).
If you are being treated for multiple myeloma, and have already received at least 1 prior therapy, Caelyx will be administered at a dose of 30 mg per square metre of your body surface area (based on your height and weight) as a 1 hour intravenous infusion on Day 4 of the bortezomib 3 week regimen immediately after the bortezomib infusion.
Če se zdravite zaradi multiplega mieloma in ste že prejeli najmanj 1 predhodno terapijo, vam bodo zdravilo Caelyx dali v odmerku 30 mg na kvadratni meter telesne površine (ta pa je odvisna od vaše telesne višine in mase) v obliki enourne intravenske infuzije na 4. dan 3- tedenske sheme zdravljenja z bortezomibom, in sicer takoj po infuziji bortezomiba.
If you are being treated for Kaposi’ sarcoma, Caelyx will be administered at a dose of 20 mg per square metre of your body surface area (based on your height and weight).
Če se zdravite zaradi Kaposijevega sarkoma, boste zdravilo Caelyx prejeli v odmerku 20 mg na kvadratni meter vaše telesne površine (izračunane na podlagi vaše telesne višine in mase).
The dose is repeated every 2 to 3 weeks for 2 - 3 months, then as often as necessary to maintain an improvement in your condition.
Odmerek je treba ponavljati na vsaka 2 do 3 tedne skupaj 2 do 3 mesece, potem pa tako pogosto, kot je treba, da se ohrani izboljšanje vašega stanja.
If you use more Caelyx than you should Acute overdosing worsens side effects like sores in the mouth or decreases the number of white blood cells and platelets in the blood.
Če ste uporabili večji odmerek zdravila Caelyx, kot bi smeli Akutni prevelik odmerek zdravila poslabša neželene učinke zdravila, npr. razjede v ustih, ali zmanjša število levkocitov in trombocitov v krvi.
Like all medicines, Caelyx can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Caelyx neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.