qanastek/EMEA-V3 huggingface dataset:
Gelatin
Ġelatina
Black ink comprising: black iron oxide (E172) shellac anhydrous ethanol – see leaflet for further information propylene glycol isopropyl alcohol butanol concentrated ammonia solution potassium hydroxide
Inka sewda li fiha: iron oxide iswed (E172) shellac anhydrous ethanol – ara l- fuljett għal aktar tagħrif propylene glycol isopropyl alcohol butanol soluzzjoni konċentrata ta ’ l- ammonia potassium hydroxide.
Store in a refrigerator (2ºC - 8ºC).
Aħżen fi friġġ (2°C – 8°C).
Keep the blister card in the outer carton in order to protect from light.
Żomm il- karta blister fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
6.5 Nature and contents of container
36 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
White polyvinyl chloride / polychlorotrifluoroethylene blister sealed with aluminium / Polyethylenterephtalate (PET) / paper foil lidding.
Blister abjad magħmul minn polyvinyl chloride / polychlorotrifluoroethylene siġillat b’ għatu ta ’ aluminium foil/ Polyethylenterephtalate (PET).
The blisters are sealed with a peel-push child resistant opening feature.
Il- blisters huma ssiġillati b’ karatteristika biex tinfetaħ li hija qaxxar- imbotta u reżistenti għal ftuħ mit - tfal.
34 Each blister card contains 10 capsules.
Kull karta blister fiha 10 kapsuli.
HYCAMTIN capsules should not be opened or crushed.
Il- kapsuli HYCAMTIN m’ għandomx jinfetħu jew jitfarrku.
12/ 11/ 1996 Date of latest renewal:
12/ 11/ 1996 Data ta ’ l- aħħar tiġdid:
HYCAMTIN 1 mg hard capsules
HYCAMTIN 1 mg kapsuli iebsin
Each capsule contains topotecan hydrochloride equivalent to 1 mg of topotecan.
Kull kapsula fiha topotecan hydrochloride ekwivalenti għal 1 mg ta ’ topotecan.
The capsules are opaque pink and imprinted with ‘ HYCAMTIN’ and ‘ 1 mg’.
Il- kapsuli huma roża trasparenti u mmarkati b ’ ‘ HYCAMTIN ’ u ‘ 1 mg ’.
Therapy with HYCAMTIN capsules should only be prescribed and therapy supervised by a physician experienced in the use of chemotherapeutic agents.
Il- kapsuli HYCAMTIN għandom jiġu preskritti u t- terapija għandha tiġi segwita biss minn tabib li għandu esperjenza fl- użu ta ’ sustanzi kimoterapewtiċi.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/ l, a platelet count of ≥ 100 x 109/ l and a haemoglobin level of ≥ 9 g/ dl (after transfusion if necessary)...
Qabel ma jingħata l- ewwel kors ta ’ topotecan, il- pazjent irid ikollu linja bażi ta ’ l- għadd ta ’ newtrofili ta ’ ≥ 1. 5 x 109/ l, għadd ta ’ plejtlits ta ’ ≥ 100 x 109/ l u livell ta ’ emoglobina ta ’ ≥ 9g/ dl (jekk hemm bżonn wara trażfusjoni).
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/ l, the platelet count is ≥ 100 x 109/ l, and the haemoglobin level is ≥ 9 g/ dl.
Dożi sussegwenti Topotecan m’ għandux jerġa ’ jiġi amministrat ħlief jekk l- għadd tan- newtrofili jkun ≥ 1 x 109/ l, l - għadd ta ’ plejtlits ikun ≥ 100 x 109/ l, u l- livell ta ’ l- emoglobina jkun ≥ 9 g/ dl (wara trasfużjoni, jekk ikun hemm bżonn).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/ l) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.4 mg/ m2/ day to 36 1.9 mg/ m2/ day (or subsequently down to 1.5 mg/ m2/ day if necessary).
Jekk it- tnaqqis fid- doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l- għadd ta ’ nutrofili < 0. 5 x 109/ l) għal 7 t’ ijiem jew iktar, jew newtropenja qawwija bid- deni jew infezzjoni, jew li kellhom il- kura sospiża minħabba newtropenja, id- doża għandha titnaqqas b’ 0. 4 mg / m2/ ġurnata 38 għal 1. 9 mg/ m2/ ġurnata (jew sussegwentement imnaqqsa għal 1. 5 mg/ m2/ ġurnata jekk ikun hemm bżonn).
Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
Id- dożi għandhom jitnaqqsu bl- istess mod jekk l- għadd ta ’ plejtlits jaqa ’ taħt 25 x 109/ l.
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/ or colony stimulating factors.
Fatturi ta ’ riskju bażi jinkludu fil- passat ILD, fibrożi pulmonari, kanċer tal - 39 pulmun, espożizzjoni toraċika għal radjazzjoni u l- użu ta ’ mediċini pnewmotossiċi u/ jew fatturi li jistimulaw kolonji.
37 cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Il- pazjenti għandhom ikunu sorveljati għal sintomi pulmonari li jindikaw mard ta ’ l- interstizju tal- pulmun (e. ż. sogħla, deni, qtigħ ta 'nifs u/ jew nuqqas ta' ossiġenu), u topotecan għandu jitwaqqaf jekk tkun ikkonfermata dijanjożi ġdida ta ’ ILD.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2-2.5-fold of control.
40 Cyclosporin A (inibitur ta ’ ABCB1, ABCC1 [MRP- 1], u CYP3A4) meta ngħata flimkien ma ’ topotecan mill- ħalq wassal għal żjieda fl- AUC ta ’ topotecan ta ’ bejn wieħed u ieħor darbtejn sa darbtejn u nofs aktar mill- kontroll.
38 In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Meta topotecan jiġi użat ma ’ prodotti kimoterapewtiċi oħra, jista ’ jkun hemm bżonn li titnaqqas id - doża ta ’ kull prodott mediċinali biex ittejjeb it- tollerabilità tagħhom.
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, can not be excluded.
Madankollu, bħal prodotti mediċinali ċitotossiċi oħra topotecan huwa ġenotossiku w effetti fuq il- fertilità, inkluż fuq il- fertilità tar- raġel, ma jistgħux jiġu esklużi.
39 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/ possibly related to oral topotecan therapy.
Il- frekwenzi assoċjati ma ’ l- effetti avversi ematoloġiċi u dawk mhux ematoloġiċi elenkati hawn taħt huma dawk ta ’ effetti avversi ikkunsidrati li għandhom / jista ’ jkollhom x’ jaqsmu mat- terapija ta ’ topotecan mill- ħalq.
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports and not known (cannot be estimated from the available data).
Il- frekwenzi huma definiti bħala: komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10); mhux 41 komuni (> 1/ 1, 000, < 1/ 100); rari (> 1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000) inklużi rapporti iżolati u mhux magħrufa (ma jistgħux jiġu stabbiliti mit- tagħrif eżistenti).
40 Safety data are presented based on an integrated data set of 682 patients with relapsed lung cancer administered 2536 courses of oral topotecan monotherapy (275 patients with relapsed SCLC and 407 with relapsed non-SCLC).
It- tagħrif ta ’ sigurtà ppreżentat huwa bbażat fuq tagħrif integrat minn 682 pazjent b’ kanċer tal- pulmun li reġa ’ tfaċċa li ħadu 2536 kors ta ’ topotecan mill- ħalq bħala monoterapija (275 pazjent b’ SCLC li reġa ’ tfaċċa u 407 b’ non- SCLC li reġa ’ tfaċċa).
Haematological Neutropenia:
Ematoloġiċi Newtropenja:
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
42 deni f’ 17%, 2% u 4% tal- pazjenti rispettivament.
Therapeutic interventions associated with non-haematological effects included anti emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
L- intervent terapewtiku assoċjat ma ’ effetti mhux ematoloġiċi kien jinkludi mediċini kontra r- rimettar, li ngħataw lil 47% tal- pazjenti f' 38% tal- korsijiet u mediċini kontra d- dijareja, li ngħataw lil 15% tal - pazjenti f' 6% tal- korsijiet.
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork.
L- attività ta ’ topotecan kontra tumuri tikkonsisti fl- inibizzjoni ta ’ topoisomerase- I, li hija enżima partikolarment involuta fir- replikazzjoni ta ’ DNA waqt li jneħħi l- istrejn tat- tidwir ta ’ qabel il- moving replication fork.
Relapsed SCLC A phase III trial (study 478) compared oral topotecan plus Best Supportive Care [BSC] [n=71] with BSC alone [n=70] in patients who had relapsed following first line therapy [median time to progression [TTP] from first-line therapy:
43 SCLC li reġa ’ feġġ Prova klinika tal- fażi III qabblet topotecan flimkien ma ’ l- Aħjar Kura ta ’ Appoġġ [BSC] [n=71] ma ’ BSC waħdu [n=70] f’ pazjenti li l- kanċer tagħhom reġa ’ feġġ wara t- terapija ewlenija [żmien medju għall- progressjoni [TTP] mit- terapija ewlenija:
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy.
Sar studju tal- fażi 2 (Studju 065) u studju tal- fażi 3 (Studju 396) biex l- effikaċja ta ’ topotecan mill - ħalq kontra topotecan mogħti ġol- vina tiġi evalwata f’ pazjenti li l- kanċer tagħhom reġa ’ feġġ ≥ 90 jum wara li spiċċaw kors wieħed ta ’ kemoterapija qabel ma bdew it- trattament (ara Tabella 1).
42 Paediatrics Safety and effectiveness of oral topotecan in paediatric patients have not been established.
Pedjatrija Is- sigurtà u l- effikaċja ta ’ topotecan mill- ħalq f’ pazjenti pedjatriċi ma ġewx stabbiliti.
Administration of oral cyclosporine A (15 mg/ kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0- and 2.5-fold respectively (see section 4.5).
Meta cyclosporine A (15 mg/ kg), inibitur tal- ġarriera ABCB1 (P- gp) u ABCC1 (MRP- 1) kif ukoll inibitur tal- enżema tal- metaboliżmu CYP3A4, jingħata mill- ħalq fi żmien 4 sigħat wara topotecan mill- ħalq, l- AUC0- 24h, normalizzat skond id- doża, ta 'topotecan lactone u topotecan totali żdiedet għal bejn wieħed u ieħor 2. 0 u 2. 5- darba, rispettivament (ara sezzjoni 4. 5).
43 Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Minnħabba l- mod ta ’ kif jaħdem, topotecan huwa ġenotossiku għal ċelluli mammiferi (ċelluli tal - limfoma tal- ġrieden u limfoċiti tal- bnedmin) in vitro u ċelluli tal- mudullun tal- ġrieden in vivo.
In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
45 F’ studji dwar it- tossiċita riprodduttiva fil- firien, ma kien hemm l- ebda effett fuq il- fertilità tal- firien nisa jew irġiel; madankollu, fin- nisa ġew osservati super- ovulation u żjieda żgħira f’ telf tal- fetu qabel ma jeħel mal- ħajt tal- ġuf.
Hydrogenated vegetable oil, Glyceryl monostearate
Hydrogenated vegetable oil, Glyceryl monostearate
Gelatin, Titanium dioxide (E171), red iron oxide (E172)
Ġelatina, Titanium dioxide (E171), Iron oxide aħmar (E172)
Black ink comprising: black iron oxide (E172) shellac anhydrous ethanol – see leaflet for further information, propylene glycol isopropyl alcohol butanol concentrated ammonia solution potassium hydroxide
Inka sewda li fiha: iron oxide iswed (E172) shellac anhydrous ethanol – ara l- fuljett għal aktar tagħrif propylene glycol isopropyl alcohol butanol soluzzjoni konċentrata ta ’ l- ammonia potassium hydroxide.
44 6.5 Nature and contents of container
46 6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Each blister card contains 10 capsules.
Kull karta blister fiha 10 kapsuli.
45 ANNEX II
47 ANNESS II
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release GlaxoSmithKline Manufacturing S. p. A.
Isem u indirizz tal- manifattur reponsabbli għall- ħruġ tal- lott GlaxoSmithKline Manufacturing S. p. A.
Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma Italy
Strada Provinciale Asolana 90 43056 San Polo di Torrile Parma L- Italja
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETIV TAL- PRODOTT MEDIĊINALI
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 05 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 05 preżentata fit- Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ posta u tiffunzjona qabel ma l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 01 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan dwar il- Maniġġjar ta ’ Riskju L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil- Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 01 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP) preżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat - Tqegħid fis- Suq u fl- aġġornamenti sussegwenti tal- RMP mifthema mas- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport Perjodikament Aġġornat dwar Sigurtà (PSUR) li jmiss, skond ir- regolament tas- CHMP dwar Sistemi għal- Maniġġjar ta ’ Riskji għal- prodotti mediċinali għall- użu fil- bniedem.
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.
Fuq talba ta ’ l- EMEA.
47 ANNEX III
49 ANNESS III
OUTER CARTON 1 x 1 mg vial 5x 1 mg vial
KARTUNA TA ’ BARRA Fjala 1 x 1mg 5 Fjali x 1mg
HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
HYCAMTIN 1 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni topotecan
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet).
L- ammont totali tas- sustanza attiva fil- fjala jipprovdi 1 mg kull ml tas- sustanza attiva meta jiġi rikostitwit skond ir- rakkomandazzjonijiet (ara Fuljett ta ’ Tagħrif).
tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
For intravenous use.
Għal użu għal ġol- vini.
Reconstitute before use.
Irrikostitwixxi qabel l- użu.
Keep the vial in the outer carton in order to protect from light.
Żomm il- fjala fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
WARNING:
AVVIŻ:
Cytotoxic agents, special handling instructions (see Package Leaflet).
Prodotti ċitotossiċi, struzzjonijiet speċjali għal manniġġar (ara l- Fuljett ta ’ Tagħrif).
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
L - affarijiet kollha li ntużaw biex ingħatat il- mediċina jew għat- tindif ta ’ wara (u dawn jinkludu l - ingwanti) għandhom jitpoġġew f’ boroż speċjali li wara jiġu maħruqa f’ temperaturi għolja.
Liquid waste may be flushed with large amounts of water.
Skart likwidu jista ’ jiġi mormi u għandu jintefa ħafna ilma fuqu.
EU/ 1/ 96/ 027/ 005 1 x 1 mg vial EU/ 1/ 96/ 027/ 004 5 x 1 mg vials
EU/ 1/ 96/ 027/ 005 fjala 1 x 1mg EU/ 1/ 96/ 027/ 004 5 fjali x 1mg
51 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
53 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- Ż- ŻGĦAR EWLENIN
VIAL
FJALA
HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan IV use
HYCAMTIN 1 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni topotecan Użu IV
1 mg vial
Fjala ta ’ 1 mg
OUTER CARTON 1 x 4 mg vial 5 x 4 mg vial
KARTUNA TA ’ BARRA Fjala 1 x 4mg 5 Fjali x 4mg
HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
HYCAMTIN 4 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni topotecan
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet).
L- ammont totali tas- sustanza attiva fil- fjala jipprovdi 1 mg / ml tas- sustanza attiva meta jiġi rikostitwit skond ir- rakkomandazzjonijiet (ara Fuljett ta ’ Tagħrif).
tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
Tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
1 x 4 mg 5 x 4 mg
1 x 4 mg 5 x 4mg
EU/ 1/ 96/ 027/ 003 1 x 4 mg vial EU/ 1/ 96/ 027/ 001 5 x 4 mg vials
EU/ 1/ 96/ 027/ 003 fjala 1 x 4 mg EU/ 1/ 96/ 027/ 001 5 fjali x 4 mg
HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan IV use
HYCAMTIN 4 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni topotecan Użu IV
4 mg vial
Fjala ta ’ 4 mg
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HYCAMTIN 0.25 mg hard capsules topotecan
HYCAMTIN 0. 25 mg kapsuli iebsin topotecan
Oral use.
Jittieħed mill- ħalq
HYCAMTIN capsules should not be broken or crushed.
Il- kapsuli HYCAMTIN m’ għandomx jinqasmu jew jitfarrku.
Cytotoxic agent, special handling instructions (see Package Leaflet)
Prodott ċitotossiku, struzzjonijiet speċjali għal manniġġar (ara l- Fuljett ta ’ Tagħrif).
hycamtin 0.25 mg
hycamtin 0. 25 mg
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
59 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI BLISTERS
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN JINGĦATA
NAME OF MARKETING AUTHORISATION HOLDER
ISEM TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
58 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
60 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
HYCAMTIN 1 mg hard capsules topotecan
HYCAMTIN 1 mg kapsuli iebsin topotecan
59 10.
61 10.
60 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
62 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI BLISTERS
61 B.
63 B.
62 Package leaflet:
64 Fuljett ta ’ tagħrif:
Information for the user
Informazzjoni għal min jagħmel użu minnu
Hycamtin 1 mg
Hycamtin 1mg
Hycamtin 4 mg
Hycamtin 4mg
powder for concentrate for solution for infusion topotecan
trab għall- konċentrat għal soluzzjoni għall- infużjoni topotecan
You may need to read it again. • If you have any further questions, ask your doctor. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jista jkollok bżonn terġa taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħoġbok għid lit- tabib tiegħek.
What Hycamtin is and what it is used for 2.
X’ inhu Hycamtin u għalxiex jintuża 2.
Before you are given Hycamtin 3.
Qabel ma ’ tingħata Hycamtin 3.
How to use Hycamtin 4.
Kif għandek tuża Hycamtin 4.
How to store Hycamtin 6.
Kif taħżen Hycamtin 6.
What Hycamtin is and what it is used for
X’ inhu Hycamtin u għalxiex jintuża
Hycamtin helps to destroy tumours.
Hycamtin jgħin biex jeqred it- tumuri.
A doctor or a nurse will give you the medicine as an infusion into a vein (a drip) in hospital.
Tabib jew infermier jgħatik il- mediċina bħala infużjoni ġol - vina (dripp) fl- isptar.
Hycamtin is used to treat: • ovarian cancer or small cell lung cancer that has come back after chemotherapy • advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Hycamtin jintuża biex jikkura: • kanċer ta ’ l- ovarji jew kanċer taċ- ċelluli ż- żgħar tal- pulmun li reġa ’ tfaċċa mill- ġdid wara l - kimoterapija • kanċer taċ- ċerviċi avanzat jekk trattament kirurġiku jew radjuterapija m’ humiex possibbli.
When treating cervical cancer, Hycamtin is combined with another drug called cisplatin.
Fit - trattament tal- kanċer taċ- ċerviċi, Hycamtin jingħata ma ’ mediċina oħra jisimha cisplatin.
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
It- tabib tiegħek jiddeċiedi flimkien miegħek jekk terapija b’ Hycamtin hijiex aħjar milli iżjed trattament bil- kimoterapija li ħadt fil- bidu.
Before you are given Hycamtin
Qabel ma 'tingħata Hycamtin
You should not receive Hycamtin: • if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Hycamtin. • if you are breast feeding • if your blood cell counts are too low.
M’ għandekx tirċievi Hycamtin: − jekk inti allerġiku/ a (għandek sensittivita ’ eċċessiva) għal topotecan jew għal xi wieħed mill - ingredjenti l- oħra ta ’ Hycamtin. − jekk inti qed tredda ’ − jekk l- għadd taċ- ċelluli tad- demm tiegħek huma baxxi wisq.
Your doctor will tell you, based on the results of your last blood test. → Tell your doctor if any of these applies to you.
It- tabib tiegħek jgħidlek, skond ir- riżultati ta ’ l- aħħar test tad- demm. → Għid lit- tabib tiegħek jekk xi wahda minn dawn tapplika għalik.
Take special care with Hycamtin Your doctor needs to know before you are given this medicine: • if you have any kidney or liver problems.
It- tabib tiegħek għandu bżonn ikun jaf qabel ma inti tingħata din il- mediċina: • jekk għandek problemi fil- kliewi jew fil- fwied.
Your dose of Hycamtin may need to be adjusted. • if you are pregnant or plan to become pregnant • if you plan to father a child Hycamtin may harm a baby conceived before, during or soon after treatment.
Id- doża tieghek ta ’ Hycamtin jista ’ jkun ikollha bżonn tinbidel. • jekk inti tqila jew qed taħseb biex toħroġ tqila • jekk qed tippjana li ssir missier Hycamtin jista ’ jagħmel ħsara lit- tarbija jekk il- mara toħroġ tqila qabel, waqt jew ftit wara t - trattament.
You should use an effective method of contraception.
Għandek tuża metodu effettiv ta ’ kontraċezzjoni.
Ask your doctor for advice. → Tell your doctor if any of these applies to you.
65 → Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
63 Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including any herbal products or medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew dan l- aħħar ħadt kwalunkwe mediċini oħra li jinkludu prodotti jew mediċini tal- ħxejjex li inti akkwistajt mingħajr riċetta.
Remember to tell your doctor if you start to take any other medicines while you ’ re on Hycamtin.
Ftakar għid lit- tabib tiegħek jekk tibda tieħu kwalunkwe mediċina oħra waqt li tkun qed tirċievi Hycamtin.
Using Hycamtin with food and drink There is no known interaction between Hycamtin and alcohol.
Meta tieħu Hycamtin ma ’ l- ikel u max- xorb M’ hemm l- ebda interazzjoni magħrufa bejn Hycamtin u l- alkoħol.
However, you should check with your doctor whether drinking alcohol is advisable for you.
Iżda trid tikkonsulta mat- tabib tiegħek jekk tistax tixrob l- alkoħol waqt il- kura.
Pregnancy and breast feeding Hycamtin is not recommended for pregnant women.
Tqala u treddigħ Hycamtin mhux rakkomandat għan- nisa tqal.
It may harm the baby if conceived before, during or soon after treatment.
Jista ’ jagħmel ħsara lit- tarbija jekk il- mara toħroġ tqila qabel, waqt jew ftit wara t- trattament.
You should use an effective method of contraception.
Għandek tuża metodu effettv ta ’ kontraċezzjoni.
Ask your doctor for advice.
Staqsi lit- tabib tiegħek għal parir.
Do not try and become pregnant/ father a child until a doctor advises you it is safe to do so.
Tipprovax toħroġ tqila/ issir missier sakemm mat- tabib jgħidlek li m’ hemmx periklu.
Male patients who may wish to father a child, should ask their doctor for family planning advice or treatment.
Pazjent raġel li jixtieq isir missier, għandu jitlob parir lit- tabib dwar l- ippjanar tal- familja jew dwar trattament meħtieġ.
If pregnancy occurs during treatment, tell your doctor immediately.
Jekk il- mara toħroġ tqila waqt it- trattament, għid lit- tabib tiegħek immedjatament.
Do not breast-feed if you are being treated with Hycamtin.
Treddax jekk qed tkun ikkurata b’ Hycamtin.
Do not restart breast-feeding until the doctor tells you it is safe to do so.
Terġax tibda tredda ’ qabel ma ’ t- tabib jgħidlek li huwa sikur li tagħmel dan.
Driving and using machines Hycamtin can make people feel tired.
Sewqan u tħaddim ta ’ magni Hycamtin jista ’ jġiegħel persuni jħossuhom għajjenin.
If you feel tired or weak, do not drive and do not use machines.
Jekk tħossok għajjien/ a jew debboli issuqx u tħaddimx magni.
How Hycamtin is used
Kif jintuża Hycamtin
The dose of Hycamtin you are given will be worked out by your doctor, based on: • your body size (surface area measured in squaremetres) • the results of blood tests carried out before treatment • the disease being treated.
Id- doża ta ’ Hycamtin li ser tingħata tinħadem mit- tabib tiegħek, skond: • id- daqs ta ’ ġismek (erja tas- superfiċje imkejla f’ metri kwadri) • ir- riżultati tat- testijiet tad- demm li saru qabel bdiet il- kura • il- marda li qed tiġi kkurata.
The usual dose • For ovarian and small cell lung cancer:
Id- doża li s- soltu tingħata • Għall- kanċer ta ’ l- ovarji u taċ- ċelluli ż- żgħar tal- pulmun:
1.5 mg per squaremetres of body surface area per day. • For cervical cancer:
1. 5mg kull metru kwadru ta ’ l- erja tas- superfiċje tal- ġisem kuljum. • Għall- kanċer taċ- ċerviċi:
0.75 mg per squaremetres of body surface area per day.
0. 75mg kull metru kwadru ta ’ l- erja tas- superfiċje tal- ġisem kuljum.
When treating cervical cancer, Hycamtin is combined with another medicine, called cisplatin.
Meta tikkura kanċer taċ- ċerviċi, Hycamtin jingħata ma ’ mediċina oħra, imsejħa cisplatin.
Your doctor will advise you about the correct dose of cisplatin.
It- tabib tiegħek jgħidlek dwar id- doża korretta ta ’ cisplatin.
It is usually dripped into your arm over about 30 minutes.
Kif jingħata Hycamtin Tabib jew infermier itik id- doża adattata ta ’ HYCAMTIN bħala infużjoni (dripp). Ġeneralment jitħalla jqattar għal ġod- driegħ fuq medda ta ’ 30 minuta.
• For ovarian and small cell lung cancer, you will have treatment once a day for 5 days. • For cervical cancer, you will have treatment once a day for 3 days.
• Għall- kanċer ta ’ l- ovarji u taċ- ċelluli ż- żgħar tal- pulmun, inti tingħata trattament darba kuljum għal ħamest ijiem. • Għall- kanċer taċ- ċerviċi, inti tingħata trattament darba kuljum għal tlett ijiem.
This pattern of treatments will normally be repeated every three weeks, for all cancers.
Dan il- mudell ta ’ kura normalment jiġi ripetut kull tlett ġimgħat għall kanċers kollha.
The treatment may vary, depending on the results of your regular blood tests.
Il- kura tista ’ tvarja, skond ir- riżulati tat- testijiet tad- demm li inti tieħu regolarment.
Stopping treatment Your doctor will decide when to stop the treatment.
66 Twaqqif tal- kura It- tabib tieghek jiddeċiedi meta jwaqqaf il- kura.
Like all medicines, Hycamtin can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Hycamtin jista ’ jikkawża effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Serious side effects: tell your doctor These very common side effects may affect more than 1 in 10 people treated with Hycamtin. • Signs of infections:
Effetti sekondarji serji: għid lit- tabib tiegħek Dawn l- effetti sekondarji komuni ħafna jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 ikkurati b’ Hycamtin.
Hycamtin may reduce the number of white blood cells and lower your resistance to infection.
Hycamtin jista ’ jnaqqas in- numru ta ’ ċelluli bojod fid- demm u jbaxxilek ir- reżisenza ghal infezzjonijiet.
This can even be life threatening.
Dan jista ’ jkun ta ’ periklu għal- ħajja.
Signs include:
Sinjali jinkludu:
- serious deterioration of your general condition
deni deterjorament serju tal- kundizzjoni ġenerali tiegħek sintomi lokali bħal ġriżmejk jaħarquk jew problemi bl- awrina (per eżempju, tħoss ħruq meta tgħaddi l- awrina, li tista ’ tkun infezzjoni fl- awrina)
- local symptoms such as sore throat or urinary problems (for example, a burning
• xi kultant uġigħ ta ’ żaqq qawwi, dijareja (rarament bid- demm) u deni jistgħu jkunu sinjali ta ’ infjammazzjoni tal- musrana (kolite).
sensation when urinating, which may be a urinary infection) • occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis)
Dan l- effett sekondarju rari jista ’ jaffettwa minn 1 sa 1000 persuna ikkurati b’ Hycamtin
This rare side effect may affect up to 1 in 1000 people treated with Hycamtin). • Lung inflammation (interstitial lung disease):
Infjammazzjoni tal- pulmun (mard ta ’ l- interstizju tal- pulmun):
Signs include:
Inti l- aktar f' riskju jekk diġa għandek mard tal- pulmun, kelli kura b' raġġi lill- pulmun tiegħek, jew qabel tkun ħadt mediċini li kkawżawlek ħsara fil- pulmun.
- difficulty in breathing
Jinkludu sinjali bħal: - diffikulta ’ biex tieħu nifs - sogħla - deni
→ Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
→ Għid lit- tabib tiegħek immedjatament jekk ikollok kwalunkwe sintomi ta ’ dawn il - kundizzjonijiet, għaliex jista ’ jkun hemm bżonn li tmur l- isptar.
Very common side effects These may affect more than 1 in 10 people treated with Hycamtin • Feeling generally weak and tired (temporary anaemia).
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw aktar minn persuna waħda minn kull 10 ikkurati b’ Hycamtin • Tħossok ġeneralment debboli u għejjien/ a (anemija temporanja).
In some cases you may need a blood transfusion. • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
F’ ċerti każi jista ’ jkun ikollok bżonn trasfużjoni tad- demm. • Tbenġil jew fsada mhux tas- soltu, ikkawżat minn tnaqqis fin- numru ta ’ ċelluli tat- tgħaqqid tad- demm fid- demm.
This can lead to severe bleeding from relatively small injuries such as a small cut.
Dan jista ’ jwassal għal fsada serja minn ġrieħi relattivament ż- żgħar bħal qatgħa żgħira.
Rarely, it can lead to more severe bleeding (haemorrhage).
Rarament, dan jista ’ jwassal għal fsada aktar serja (emorraġija).
Talk to your doctor for advice on how to minimize the risk of bleeding. • Weight loss and loss of appetite (anorexia); tiredness; weakness; feeling unwell. • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation • Inflammation and ulcers of the mouth tongue or gums • High body temperature (fever) • Hair loss.
Kellem lit - tabib tiegħek għal parir dwar kif tnaqqas ir- riskju ta ’ fsada. • Tnaqqis fil- piż u nuqqas t’ aptit (anoressija); għeja; debbulizza, u ma ’ tħossokx f’ sikktek • Tħoss dardir (nawseja); rimettar; dijarea; uġigħ fl- istonku; stitikezza • Infjammazzjoni u ulċeri fil- ħalq, fl- ilsien jew fil- ħanek • Temperatura tal- ġisem għolja (deni) • Telf ta ’ xagħar. → Għid lit- tabib tiegħek jekk kwalunkwe waħda minn dawn issir problema.
Common side effects These may affect up to 1 in 10 people treated with Hycamtin • Allergic or hypersensitivity reactions (including rash) • Yellow skin • Itching sensation • Muscle pain
Effetti sekondarji komuni Dawn jistghu jaffettwaw sa persuna wahda minn kull 10 persuni kkurati b’ Hycamtin • Reazzjonijiet allerġiċi jew ta ’ sensittività eċċessiva (inkluż raxx) • Ġilda safra • Sensazzjoni ta’ tekil • Uġigħ fil- muskoli 67 → Għid lit- tabib jekk kwalunkwe waħda minn dawn issir problema
Rare side effects These may affect up to 1 in 1000 people treated with Hycamtin. • Severe allergic or anaphylactic reactions • Swelling caused by fluid build up (angioedema) • Mild pain and inflammation at the site of injection • Itchy rash (or hives).
Effetti sekondarji rari Dawm jistgħu jaffettwaw sa persuna waħda minn kull 1000 ikkurati b’ Hycamtin. • Reazzjonijiet allerġiċi jew anafilattici serji • Nefħa kkawzata minn akkumulazzjoni ta ’ fluwidu (anġjoedema) • Uġigħ ħafif u infjammazzjoni fis- sit ta ’ l- injezzjoni • Raxx li jġegħlek tħokk (jew ħorriqija)
If you are being treated for cervical cancer, you may get side effects from the other medicine 65 (cisplatin) that you will be given along with Hycamtin.
Jekk inti qegħda tiġi kkurata għall- kanċer taċ- ċerviċi, inti jista ’ jkun ikollok effetti sekondarji mill - mediċina l- oħra (cisplatin) li inti se tingħata flimkien ma Hycamtin.
Those effects are described in the cisplatin patient information.
Dawk l- effetti huna deskritti fit - tagħrif għall- pazjent ta ’ cisplatin.
If you get side effects → Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet,
Jekk ikollok effetti sekondarji → Għid lit- tabib jew lill- ispiżjar tiegħek jekk xi wieħed minn dawn l- effetti sekondarji isiru severi jew ituk il- problemi, jew jekk tinnota xi effetti sekondarji m’ humiex imsemmija f’ dan il- fuljett,.
How to store Hycamtin
Kif taħżen Hycamtin,
Keep out of the reach and sight of children.
Żomm il- prodott fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Hycamtin after the expiry date which is stated on the carton.
Tużax Hycamtin wara d- data ta ’ skadenza li hemm fuq il- kartuna.
Further information
Aktar tagħrif,
What Hycamtin contains
X’ fih Hycamtin:
• The active substance is topotecan.
- Is- sustanza attiva hija topotecan.
Each vial contains topotecan hydrochloride equivalent to 1 mg or 4 mg of topotecan. • The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.
- L- ingredjenti l- oħra huma: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) u
What Hycamtin looks like and contents of the pack
Id- Dehra ta ’ Hycamtin u l- kontenut tal- pakkett
Hycamtin comes as a powder for concentrate for solution for intravenous infusion.
Hycamtin jiġi bħala trab għall- konċentrat għal soluzzjoni għall- infużjoni għal ġol- vini.
It is available in packs containing either 1 or 5 vials; each vial contains 1 mg or 4 mg of topotecan.
Din il- mediċina tiġi f’ pakketti li fihom fjala waħda jew inkella ħames fjali; kull fjala fiha 1 mg jew 4 mg ta ’ topotecan.
The powder needs to be reconstituted and diluted before infusion.
Qabel l- infużjoni t- trab irid jiġi rikostitwit u dilwit.
The powder in the vial provides 1 mg per ml of active substance when reconstituted as recommended.
It- trab fil- fjala jipprovdi 1 mg għal kull ml ta ’ sustanza attiva meta jiġi rikostitwit kif issuġġerit.
Marketing Authorisation Holder:
Detentur ta ’ l- Awtrizzazzjoni għat- tqegħid fis- Suq:
GlaxoSmithKline Manufacturing S. p. A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italy.
GlaxoSmithKline Manufacturing S. p. A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, L- Italja.
66 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
68 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżerntant lokali tad- Detentur ta ’ l- Awtroizzazzjoni għat- tqegħid fis- Suq:
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This leaflet was last approved on
Dan il- fuljett kien approvat l- aħħar:
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
Information for the health care professional only
Informazzjoni għal professjonisti fil- qasam mediku biss
Instructions on how to reconstitute, store and dispose of Hycamtin
Struzzjonijiet dwar kif tirrikostitwixxi, taħżen u tiddisponi minn Hycamtin
Reconstitution Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Rikostituzzjoni Hycamtin 1 mg trab għal konċentrat għal soluzzjoni għall- infużjoni irid jiġi rikostituwit ma 1. 1 ml ta ’ ilma għal injezzjonijiet biex jipprovdi 1 mg ta ’ topotecan għal kull ml.
Hycamtin 4 mg powder for concentrate for solution for infusion should be reconstituted with 4 ml of water for injections to provide 1 mg per ml of topotecan.
Hycamtin 4 mg trab għal konċentrat għal soluzzjoni għall- infużjoni irid jiġi rikostituwit ma 4 ml ta ’ ilma għal injezzjonijiet biex jipprovdi 1 mg ta ’ topotecan għal kull ml.
Further dilution is required.
Iktar dilwizzjoni hija meħtieġa.
The appropriate volume of the reconstituted solution should be diluted with either 0.9% w/ v sodium chloride intravenous infusion or 5% w/ v glucose intravenous infusion, to a final concentration of between 25 and 50 microgram per ml.
Il- volum addattat tas- soluzzjoni rikostitwita għandu jiġi dilwit jew b’ 0. 9% w/ v sodium chloride li huwa wżat għal infużjoni ġol- vini jew b’ 5% w/ v glucose bħala infużjoni ġol- vini biex ikun hemm konċentrazzjoni finali ta ’ bejn 25 u 50 mikrogrammi kull ml.
Storage of the prepared solution The product should be used immediately after it is prepared for infusion.
Ħażna tas- soluzzjoni lesta Il- prodott għandu jintuża minnufih wara li jiġi ppreparat għall- infużjoni.
If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).
Jekk it- taħlita tkun magħmula taħt kundizzjonijiet asettiċi stretti, l- infużjoni ta ’ Hycamtin tista ’ titlesta fi żmien 12- il siegħa f’ temperatura tal- kamra (jew 24 siegħa jekk tkun maħżuna f’ temperatura ta ’ bejn 2- 8oC).
68 • Pregnant staff should be excluded from working with this medicinal product. • Staff handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves. • All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. • Liquid waste may be flushed with large amounts of water. • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Maniġġar u rimi Għandhom jiġu addotati l- proċeduri normali għal maniġġar u rimi ta ’ prodotti mediċinali ta ’ kontra t - tumuri: • Il- ħaddiema jridu jiġu mħarrġa kif jippreparaw il- prodott medicinali. • Ħaddiema nisa li jkunu tqal m’ għandhomx jithallew jaħdmu b’ dan il- prodott il- mediċinali. • Il- ħaddiema li jkunu qed jippreparaw dan il- prodott mediċinali għandhom jilbsu ilbies protettiv li jinkludi l- ilbies ta ’ maskra, nuċċali biex iħares l- għajnejn u ngwanti. • L- affarijiet kollha li ntużaw għall- għoti tal- mediċina jew għat- tindif ta ’ wara (u dawn jinkludu l - ingwanti) għandhom jitpoġġew f’ boroż speċjali li wara jiġu maħruqa b’ temperaturi għolja. • Skart likwidu jista ’ jiġi mormi u għandu jintefa ħafna ilma fuqu. • Kuntatt aċċidentali mal- ġilda jew mal- għajnejn għandu jiġi trattat immedjatament b’ ammonti kbar ta ’ ilma.
69 Package leaflet:
70 Fuljett ta ’ tagħrif:
Hycamtin 0.25 mg
Hycamtin 0. 25 mg
hard capsules topotecan
kapsuli iebsin topotecan
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you.
Jista jkollok bżonn terġa taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew l- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
It may harm them, even if their symptoms seem to be the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anke jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħoġbok għid lit- tabib jew l- ispiżjar tiegħek.
Before you take Hycamtin 3.
Qabel ma ’ tieħu Hycamtin 3.
How to take Hycamtin 4.
Kif għandek tieħu Hycamtin 4.
Hycamtin is used to treat: • small cell lung cancer that has come back after chemotherapy.
Hycamtin jintuża biex jikkura: • kanċer taċ- ċelluli ż- żgħar tal- pulmun li reġa ’ tfaċċa mill- ġdid wara l- kimoterapija
Your doctor will decide with you whether a Hycamtin therapy is better than further treatment with your initial chemotherapy.
It- tabib tiegħek jiddeċiedi flimkien miegħek jekk terapija b’ Hycamtin hijiex aħjar milli iżjed trattament bil- kimoterapija li ħadt fil- bidu.
Before you take Hycamtin
Qabel ma ’ tingħata Hycamtin
Do not take Hycamtin: • if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Hycamtin. • if you are breast feeding. • if your blood cell counts are too low.
Tieħux Hycamtin: • jekk inti allerġiku/ a (għandek sensittivita ’ eċċessiva) għal topotecan jew għal xi wieħed mill - ingredjenti l- oħra ta ’ Hycamtin. • jekk inti qed tredda ’ • jekk l- għadd taċ- ċelluli tad- demm tiegħek huma baxxi wisq.
Your doctor will tell you, based on the results of your last blood test. → Tell your doctor if any of these applies to you.
It- tabib tiegħek jgħidlek, skond ir - riżultati ta ’ l- aħħar test tad- demm. → Għid lit- tabib tiegħek jekk xi wahda minn dawn tapplika għalik.
Take special care with Hycamtin Your doctor needs to know before you are given this medicine: • if you have any kidney or liver problems.
Oqgħod attent ħafna b’ Hycamtin It- tabib tiegħek għandu bżonn ikun jaf qabel ma inti tingħata din il- mediċina: • jekk għandek problemi fil- kliewi jew fil- fwied.
You should use 70 an effective method of contraception.
Għandek tuża metodu effettiv ta ’ kontraċezzjoni.
Ask your doctor for advice. → Tell your doctor if any of these applies to you.
71 → Għid lit- tabib tiegħek jekk xi waħda minn dawn tapplika għalik.
Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including any herbal products or medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu jew dan l- aħħar ħadt kwalunkwe mediċini oħra li jinkludu prodotti jew mediċini tal- ħxejjex li inti akkwistajt mingħajr riċetta.
There may be a higher than usual chance of you getting side effects if you are also being treated with cyclosporin A.
Jista ’ jkun hemm ċans akbar minn normal li jkollok effetti sekondarji jekk qed tirċievi wkoll trattament b’ cyclosporin A.
You will be monitored closely while you are taking these two medicines.
Tiġi segwit mill- qrib waqt li qed tieħu dan iż- żewġ mediċini.
Remember to tell your doctor if you start to take any other medicines while you are on Hycamtin.
Ftakar għid lit- tabib tiegħek jekk tibda tieħu kwalunkwe mediċina oħra waqt li tkun qed tirċievi Hycamtin.
Taking Hycamtin with food and drink There is no known interaction between Hycamtin and alcohol.
Meta tieħu Hycamtin ma ’ l- ikel u max- xorb M’ hemm l- ebda interazzjoni magħrufa bejn Hycamtin u l- alkoħol.
However, you should check with your doctor whether drinking alcohol is advisable for you.
Iżda trid tikkonsulta mat- tabib tiegħek jekk tistax tixrob l- alkoħol.
Hycamtin capsules may be taken with or without food.
Il- kapsuli Hycamtin jistgħu jittieħdu ma ’ l- ikel jew mhux ma ’ l- ikel.
The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
Il- kapsula( i) għandha tinbela sħiħa u wieħed m’ għandux jomodha, jfarrakha jew jaqsamha.
Pregnancy and breast-feeding Hycamtin is not recommended for pregnant women.
Tqala u treddigħ Hycamtin mhux rakkomandat għan- nisa tqal.
It may harm the baby if conceived before, during or after the treatment.
Jista ’ jagħmel ħsara lit- tarbija jekk il- mara toħroġ tqila qabel, waqt jew ftit wara t- trattament.
If you feel tired or weak do not drive and do not use machines.
Jekk tħossok għajjien/ a jew debboli issuqx u tħaddimx magni.
Important information about some of the ingredients of Hycamtin This medicinal product contains a trace amount of ethanol (alcohol).
Informazzjoni importanti fuq xi wħud mill- ingredjenti ta ’ Hycamtin Dan il- prodott mediċinali fih xi traċċi ta ’ etanol (alkoħol).
How to take Hycamtin
Kif jintuża Hycamtin
Always take Hycamtin exactly as your doctor has told you.
Dejjem għandek tieħu Hycamtin skond il- parir tat- tabib.
You should always check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
The dose (and number of capsules) of Hycamtin you are given will be worked out by your doctor based on: • your body size (surface area measured in square metres) • the results of blood tests carried out before treatment • the disease being treated.
Id- doża (u numru ta ’ kapsuli) ta ’ Hycamtin li ser tingħata tinħadem mit- tabib tiegħek, skond: • id- daqs ta ’ ġismek (erja tas- superfiċje imkejla f’ metri kwadri) • ir- riżultati tat- testijiet tad- demm li saru qabel bdiet il- kura • il- marda li qed tiġi kkurata.
The prescribed number of capsules should be swallowed whole, once a day for 5 days.
Il- kapsuli, skond in- numru preskritt, għandhom jinbelgħu sħaħ, darba kuljum għal ħamest ijiem.