qanastek/EMEA-V3 huggingface dataset:
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ ml docetaxel is not exceeded.
72 Jekk hija meħtieġa doża akbar minn 200 mg ta ’ docetaxel, uża volum t’ infużjoni akbar biex tiżgura li ma teċċedix il- konċentrazzjoni ta ’ 0. 74 mg/ ml ta ’ docetaxel.
73 ANNEX II
73 ANNESS II
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GHALL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall- ħrug tal- lott
Aventis Pharma Dagenham Rainham Road South Dagenham, Essex RM10 7XS United Kingdom
Aventis Pharma Dagenham, Rainham Road South, Dagenham, Essex RM10 7XS, Renju Unit
• CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
Medicinal product subject to restricted medical prescription (see Annex I:
Prodott mediċinali jingħata b’ riċetta ristretta tat- tabib (Ara Anness I:
Summary of Product Characteristics, section 4.2)
Sommarju tal- Karatteristiċi tal- Prodott, sezzjoni 4. 2)
• CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Not applicable.
Ma jgħoddx f ’ dan il- każ.
The PSUR cycle of Docetaxel Winthrop is aligned with the cross-referred product, TAXOTERE, until otherwise specified.
Iċ- ċiklu tal- PSUR ta ’ Docetaxel Winthrop huwa allinjat ma ’ l- prodott ta ’ referenza, TAXOTERE, sakemm ma jiġix speċifikat b ’ xort ’ oħra.
75 ANNEX III
75 ANNESS III
77 PARTICULARS TO APPEAR ON OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ Docetaxel Winthrop 20 mg
77 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT KAXXA TAL- KARTUN/ Docetaxel Winthrop 20 mg
Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion
Docetaxel Winthrop 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
1 vial of Docetaxel Winthrop 20 mg concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ ml) Fill:
Kunjett wieħed ta ’ Docetaxel Winthrop 20 mg konċentrat għal soluzzjoni għall- infużjoni 20 mg docetaxel f’ 0. 5 ml polysorbate 80 (40 mg/ ml) Volum attwali:
24.4 mg/ 0.61 ml 1 vial of solvent for Docetaxel Winthrop 13% (w/ w) ethanol 95% in water for injections Fill:
24. 4 mg/ 0. 61 ml Kunjett wieħed ta ’ solvent għal Docetaxel Winthrop 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet Volum attwali:
1.98 ml
1. 98 ml
Solvent vial: ethanol 95%, water for injections.
Kunjett ta ’ Docetaxel Winthrop: polysorbate 80 Kunjett ta ’ solvent: ethanol 95% fl- ilma għall- injezzjonijiet
Each blister pack of Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
Kull folja tal- pakkett ta ’ Docetaxel Winthrop 20 mg konċentrat u solvent għal soluzzjoni għall - infużjoni fiha: • kunjett b’ doża waħda ta ’ konċentrat, • kunjett b’ doża waħda ta ’ solvent.
See accompanying preparation guide.
It- taħlita likwida trid issir bil- volum sħiħ tas- solvent li hemm fil- kunjett Ara l- gwida ta ’ tagħrif fuq il- preparazzjoni.
To be administered under the supervision of a physician experienced in the use of cytotoxic agents
Jrid jingħata taħt is- superviżjoni ta ’ tabib speċjalizzat fl- użu tas- sustanzi ċitotossiċi.
Do not store above 25 °C or below 2 °C.
Taħżinx f’ temperatura ’ l fuq minn 25 °Ċ jew taħt 2 °Ċ.
Single-use vials - discard unused contents appropriately
Kunjetti li jintużaw darba biss – armi l- kontenut mhux użat kif adattat.
Aventis Pharma S. A., 20 avenue Raymond Aron, 92165 Antony Cedex, France
Aventis Pharma S. A., 20 avenue Raymond Aron, 92165 Antony Cedex, Franza
Justification for not including Braille accepted.
Il- ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata.
79 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ Docetaxel Winthrop 20 mg
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXIJEW FUQ IL- FOLJI KONĊENTRAT u SOLVENT Docetaxel Winthrop 20 mg
Docetaxel Winthrop concentrate
Docetaxel Winthrop konċentrat
SOLVENT for Docetaxel Winthrop
SOLVENT għal Docetaxel Winthrop
80 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ Docetaxel Winthrop 20 mg
KUNJETT / Docetaxel Winthrop 20 mg
Docetaxel Winthrop 20 mg concentrate for solution for infusion docetaxel intravenous use
Docetaxel Winthrop 20 mg konċentrat għal soluzzjoni għall- infużjoni
Read the package leaflet before use.
Aqra l- fuljett ta ’ ġol- kaxxa qabel tużah.
0.5 ml (Fill 0.61 ml)
0. 5 ml (volum attwali 0. 61 ml)
81 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
81 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ SOLVENT FOR Docetaxel Winthrop 20 mg
KUNJETT/ SOLVENT GĦAT- Docetaxel Winthrop 20 mg
SOLVENT for Docetaxel Winthrop 20 mg
SOLVENT għal Docetaxel Winthrop 20 mg
13% (w/ w) ethanol 95% in water for injections 1.5 ml (Fill 1.98 ml)
13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet 1. 5 ml (volum attwali 1. 98 ml)
82 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ Docetaxel Winthrop 80 mg
82 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT KAXXA TAL_ KARTUN/ Docetaxel Winthrop 80 mg
1 vial of Docetaxel Winthrop 80 mg concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ ml) Fill:
Kunjett wieħed ta ’ Docetaxel Winthrop 80 mg konċentrat għal soluzzjoni għall- infużjoni 80 mg docetaxel f’ 2 ml polysorbate 80 (40 mg/ ml) Volum attwali:
94.4 mg/ 2.36 ml 1 vial of solvent for Docetaxel Winthrop 13% (w/ w) ethanol 95% in water for injections Fill:
94. 4 mg/ 2. 36 ml Fjala waħda ta ’ solvent għal Docetaxel Winthrop 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet Volum attwali:
7.33 ml
7. 33 ml
Solvent vial: ethanol 95%, water for injections.
Kunjett ta ’ Docetaxel Winthrop: polysorbate 80 Kunjett ta ’ solvent: ethanol 95%, ilma għall- injezzjonijiet
Each blister pack of Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion contains: • one single-dose vial of concentrate, • one single-dose vial of solvent.
Kull folja tal- pakkett ta ’ Docetaxel Winthrop 80 mg konċentrat u solvent għal soluzzjoni għall - infużjoni fiha: • kunjett b’ doża waħda ta ’ konċentrat, • kunjett b’ doża waħda ta ’ solvent
Dilution required with the entire contents of the solvent vial.
ATTENZJONI: it- taħlita likwida trid issir bil- volum sħiħ tas- solvent li hemm fil- kunjett.
See accompanying preparation guide.
Ara il- gwida ta ’ tagħrif fuq il- preparazzjoni.
83 8.
83 8.
Do not store above 25 °C or below 2 °C.
Taħżinx f’ temperatura ’ l fuq minn 25°Ċ jew taħt 2°Ċ.
Batch:
Lot: -
Justification for not including Braille accepted.
Il- Ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata.
84 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ Docetaxel Winthrop 80 mg
84 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI KONĊENTRAT u SOLVENT/ Docetaxel Winthrop 80 mg
85 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ Docetaxel Winthrop 80 mg
KUNJETT/ Docetaxel Winthrop 80 mg
Docetaxel Winthrop 80 mg concentrate for solution for infusion docetaxel intravenous use
Docetaxel Winthrop 80 mg konċentrat għal soluzzjoni għall- infużjoni
2 ml (Fill 2.36 ml)
2 ml (volum attwali 2. 36 ml)
86 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
86 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ SOLVENT FOR Docetaxel Winthrop 80 mg
KUNJETT/ SOLVENT GĦAL Docetaxel Winthrop 80 mg
SOLVENT for Docetaxel Winthrop 80 mg
SOLVENT għal- Docetaxel Winthrop 80 mg
13% (w/ w) ethanol 95% in water for injections 6 ml (Fill 7.33 ml)
13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet ta ’ 6 ml 1. 5 ml (Volum attwali 7. 33 ml)
88 PACKAGE LEAFLET:
88 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion docetaxel
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Docetaxel Winthrop 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
- If you have any further questions, ask your doctor or your hospital pharmacist.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek fl- isptar.
- If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
please tell your doctor or hospital pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek fl- isptar.
In this leaflet:
F ’ dan il- fuljett:
What Docetaxel Winthrop is and what it is used for 2.
X’ inhu Docetaxel Winthrop u għalxiex jintuża 2.
Before you use Docetaxel Winthrop 3.
Qabel ma tieħu Docetaxel Winthrop 3.
How to use Docetaxel Winthrop 4.
Kif għandek tuża Docetaxel Winthrop 4.
Possible side-effects 5.
Effetti sekondarji li jista ’ jkollu 5.
How to store Docetaxel Winthrop 6.
Kif taħżen Docetaxel Winthrop 6.
WHAT Docetaxel Winthrop IS AND WHAT IT IS USED FOR
X’ INHU DOCETAXEL WINTHROP U GĦALXIEX JINTUŻA
The name of this medicine is Docetaxel Winthrop.
L- isem ta ’ din il- mediċina huwa Docetaxel Winthrop.
Its common name is docetaxel.
L- isem komuni tagħha huwa docetaxel.
Docetaxel is a substance derived from the needles of yew trees.
Id - docetaxel hija sustanza derivata mill- weraq, taħt għamla ta ’ labar, tas- siġar tat- tassu.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaxel jappartjeni għall- klassi ta ’ mediċini kontra l- kanċer li jissejħu taxoids.
Docetaxel Winthrop has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer:
Docetaxel Winthrop kien preskritt mit- tabib tiegħek għat- trattament tal- kanċer tas- sider, xi tipi speċjali ta ’ kanċer tal- pulmun (dak it- tip ta ’ kanċer tal- pulmun li mhux ikkaratteriżżat minn ċelluli żgħar), kanċer tal- prostata, kanċer ta ’ l- istonku jew kanċer tar- ras u ta ’ l- għonq: − Għat- trattament ta ’ kanċer avvanżat tas- sider, Docetaxel Winthrop jista ’ jingħata jew waħdu jew flimkien ma ’ doxorubicin jew trastuzumab jew capecitabine. − Għat- trattament ta ’ kanċer bikri tas- sider b’ involviment tal- glandoli limfatiċi, Docetaxel Winthrop jista ’ jingħata flimkien ma ’ doxorubicin u cyclophosphamide. − Għat- trattament tal- kanċer tal- pulmun, Docetaxel Winthrop jista ’ jingħata jew waħdu jew flimkien ma cisplatin. − Għat- trattament ta ’ kanċer tal- prostata, Docetaxel Winthrop jingħata flimkien ma ’ prednisone jew prednisolone. − Għat- trattament ta ’ kanċer metastatiku ta ’ l- istonku, Docetaxel Winthrop jingħata flimkien ma ’ cisplatin u 5- fluorouracil. − Għat- trattament ta ’ kanċer tar- ras u l- għonq, Docetaxel Winthrop jingħata flimkien ma ’ cisplatin u 5- fluorouracil.
with cisplatin and 5-fluorouracil.
QABEL MA TUŻA DOCETAXEL WINTHROP 2.
You must not be given Docetaxel Winthrop if
M’ għandux jingħatalek Docetaxel Winthrop jekk:
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Winthrop. • the number of white blood cells is too low. • you have a severe liver disease. • you are pregnant or breast feeding.
• jekk inti allerġiku/ a (tbati minn sensittivita ’ eċċessiva) għal docetaxel jew sustanzi oħra ta ’ Docetaxel Winthrop. • in- numru taċ- ċelluli bojod fid- demm huwa baxx wisq. • għandek mard serju tal- fwied. • inti tqila b’ tarbija jew qegħda tredda ’.
89 Take special care with Docetaxel Winthrop
89 Oqgħod attent ħafna b’ Docetaxel Winthrop:
In case of white blood cells disturbances, you may experience associated fever or infections.
Qabel kull darba li tibda l- kura b’ Docetaxel Winthrop ikollok tagħmel testijiet tad- demm biex tiċċekja jekk għandekx biżejjed ċelluli fid- demm u funzjoni adegwata tal- fwied biex tkun tista ’ tieħu Docetaxel Winthrop. Fil- każ li jkun hemm abnormalitajiet fiċ- ċelluli bojod tad- demm, jista ’ jkollok id - deni jew infezzjonijiet assoċjati magħhom.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Winthrop administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Winthrop in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Ser jgħidulek biex tieħu l- premedikazzjoni li tikkonsisti f’ corticosteroid orali bħal dexamethasone, jum qabel tieħu Docetaxel Winthrop u trid tkompli hekk għal jum wieħed jew jumejn wara, biex tnaqqas ir- riskju ta ’ xi effetti mhux mixtieqa li jista ’ jkollok wara l- infużjoni ta’ Docetaxel Winthrop, speċjalment reazzjonijiet allerġiċi u żamm ta ’ fluwidu (nefħa ta ’ l- idejn, saqajn, riġlejn jew żieda fil - piż).
During treatment, you may be given medication to maintain the number of your blood cells.
Waqt it- trattament, tista ’ tingħata xi mediċini biex jinżamm l- għadd taċ- ċelluli tad- demm tiegħek.
Taking other medicines
Meta tieħu mediċini oħra:
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Jekk joghġbok, għid lit- tabib jew lis- spiżjar fl- isptar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
This is because Docetaxel Winthrop or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Dan għaliex Docetaxel Winthrop jew il- mediċina l- oħra jistgħu ma jaħdmux tajjeb daqs dak mistenni u jista ’ jkun aktar probabbli li tiżviluppa xi effetti sekondarji
Pregnancy and breast-feeding
Tqala u treddigħ:
Docetaxel Winthrop must NOT be administered if you are pregnant or if you are planning to become pregnant.
Docetaxel Winthrop MA JISTAX jittieħed jekk inti tqila b’ tarbija jew qed tippjana biex toħroġ tqila.
You must take adequate contraceptive precautions during therapy and for at least three months after Docetaxel Winthrop is no longer administered to you.
Trid tieħu l- miżuri kontraċettivi adegwati waqt il- kura u għal mhux inqas minn tliet xhur wara li Docetaxel Winthrop jitwaqqaf.
If pregnancy occurs during your treatment, you must immediately inform your doctor.
Jekk toħroġ tqila waqt it- trattament, għandek tgħid lit- tabib tiegħek immedjatament.
You must NOT breast-feed while you are treated with Docetaxel Winthrop.
MA TISTAX tredda ’ waqt li qed tieħu l- kura b’ Docetaxel Winthrop.
If you are thinking of becoming pregnant or breastfeeding discuss it with your doctor first.
Jekk qed taħseb biex toħroġ tqila jew ser tredda ’, iddiskutija l- ewwel mat- tabib tiegħek.
Driving and using machines
Sewqan u tħaddim ta ’ magni:
There is no reason why you cannot drive between courses of Docetaxel Winthrop except if you feel dizzy or are unsure of yourself.
M’ hemm ebda raġuni għaliex ma tistax issuq bejn kors u ieħor ta ’ Docetaxel Winthrop sakemm ma tħossokx sturdut/ sturduta jew m’ intix żgur/ żgura.
HOW TO USE Docetaxel Winthrop
KIF GĦANDEK TUŻA DOCETAXEL WINTHROP
Docetaxel Winthrop will be administered to you by a healthcare professional.
Docetaxel Winthrop sejjer jingħatalek minn professjonist fil- qasam tas- saħħa.
Usual dosage
Dożaġġ normali
The dose will depend on your weight and your general condition.
Id- doża tiddependi fuq il- piż tiegħek u l- qagħda ġenerali li tinsab fiha.
Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
It- tabib tiegħek sejjer jikkalkula l- erja tas- superfiċi ta ’ ġismek f’ metri kwadri (m2) u b’ hekk ser ikun jista ’ jikkalkula d- doża li għandek tieħu.
Method and route of administration
Il- metodu u l- mod ta ’ kif jingħata
Docetaxel Winthrop will be given by infusion into one of your veins.
Docetaxel Winthrop sejjer jingħatalek permezz t’ infużjoni f’ waħda mill- vini tiegħek.
The infusion will last approximately one hour during which you will be in the hospital.
L- infużjoni iddum madwar siegħa u waqt din il- proċedura inti ser tkun l- isptar.
90 Frequency of administration
90 Kemm jingħata spiss
You should usually receive your infusion once every 3 weeks.
Għandek normalment tirċievi l- infużjoni tiegħek darba kull 3 ġimgħat.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Winthrop.
It- tabib tiegħek jista ’ jibdillek id- doża u l- frekwenza tad- dożi skond ir- riżultati tad- demm, il- qagħda ġenerali tiegħek u r- rispons għal Docetaxel Winthrop. Partikulament, jekk joghġbok, għid lit- tabib tiegħek jekk speċjalment tiżviluppa id- dijarea, selħiet fil- ħalq, sensazzjoni ta ’ tnemnim jew xi parti imtarrxa tal- ġisem jew deni u għidlu/ ghidilha bir- riżultati tat- testijiet tiegħek tad- demm.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/ him results of your blood tests.
B’ din l - informazzjoni tippermetti lilhu/ lilha biex jiddeċiedi/ tiddeċiedi jekk id- dożżaġġ għandu jiġi mnaqqas.
If you have any further questions on the use of this product, ask your doctor, or hospital pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek fl - isptar.
Like all other anticancer medicines, Docetaxel Winthrop can cause side effects, although not everybody gets them.
Bħal kull mediċini oħra kontra l- kanċer, Docetaxel Winthrop jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
It- tabib tiegħek sejjer jiddiskuti dawn miegħek u jispjegalek ir- riskju u l- benefiċji potenzjali tat - trattament.
The most commonly reported adverse reactions of Docetaxel Winthrop alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhea and tiredness.
Ir- reazzjonijiet avversi l- aktar komunement irrapportati ta ’ Docetaxel Winthrop waħdu huma: tnaqqis fl- għadd taċ- ċelluli ħomor u bojod tad- demm, alopeċja, tqalligħ, rimettar, selħiet tal- ħalq, dijarrea u għeja.
The severity of adverse events of Docetaxel Winthrop may be increased when Docetaxel Winthrop is given in combination with other chemotherapeutic agents.
Is- severità ta ’ dawn il- ġrajjiet avversi ta ’ Docetaxel Winthrop jistgħu jiżdiedu meta Docetaxel Winthrop jingħata flimkien ma ’ sustanzi kimoterapewtiċi oħra.
More severe reactions may occur.
Waqt l- infużjoni fl- isptar jistgħu jiġru dawn ir- reazzjonijiet allerġiċi (li jgħaddu minnhom aktar minn persuna waħda f’ kull 10): • fwawar, reazzjonijiet fil- ġilda, ħakk, • rass tas- sider, tbatija fin- nifs, • deni jew tkexkix tal- bard, • uġigħ fid- dahar, • pressjoni baxxa Reazzjonijiet aktar severi jistgħu jiġru.
The hospital staff will monitor your condition closely during treatment.
L- istaff ta ’ l- isptar jimmoniterjawlek il- kundizzjoni tiegħek mill- qrib waqt it- trattament.
Tell them immediately if you notice any of these effects.
Għidilhom immedjatament jekk tinduna b’ waħda minn dawn l- effetti.
Between infusions of Docetaxel Winthrop the following may occur, and the frequency may vary with the combinations of drugs that are received:
Bejn infużjoni u oħra ta ’ Docetaxel Winthrop jista ’ jkollu dawn l- effetti, li l- frekwenza tagħhom tvarja skond it- taħlita ta ’ mediċini li qed tieħu:
Very common (experienced in more than 1 in 10 patients): • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets • fever: if this happens you must tell your doctor immediately • allergic reactions as described above • loss of appetite (anorexia) • insomnia • feeling of numbness or pins and needles or pain in the joints of muscles • headache • alteration in sense of taste • inflammation of the eye or increased tearing of the eyes • swelling caused by faulty lymphatic drainage • shortness of breath • nasal drainage; inflammation of the throat and nose; cough
(li ssibhom f’ aktar minn 1 f ’ kull 10 pazjenti) • infezzjonijiet, tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm (anemija), jew dak taċ- ċelluli bojod (li huma importanti fit- taqbida kontra l- infezzjoni) u l- plejtlits, • deni: jekk dan jiżviluppalek għandek tgħid lit- tabib tiegħek immedjatament • reazzjonijiet allerġiċi kif deskritti hawn fuq • nuqqas t’ aptit (anoreskja) • Insonnja • sensazzjoni li xi parti imtarrxa ta ’ ġismek jew tnemnim, jew uġigh fil- ġogi jew muskoli • uġigħ ta ’ ras • tibdil fis- sens tat- tegħim • infjammazzjoni ta ’ l- għajn jew tidmigħ ta ’ l- għajnejn • nefħa dovuta għal difett fil- funzjoni tas- sistema limfatika • qtugħ ta ’ nifs
91 • bleeding from the nose • sores in the mouth • stomach upsets including nausea, vomiting and diarrhea, constipation • abdominal pain • indigestion • short term hair loss (in most cases normal hair growth should return) • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) • change in the color of your nails, which may detach • muscle aches and pains; back pain or bone pain • change or absence of menstrual period • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
91 • tnixxija ta ’ l- imnieħer; infjammazjoni tal- gerżuma u l- imnieħer; sogħla • tinfaraġ • selħiet fil- ħalq • taqlib ta ’ l- istonku inklużi t- tqalligħ, rimettar u d- dijarrea, stitikezza • uġigħ addominali • indiġistjoni • waqgħa temporanja tax- xagħar (fil- biċċa l- kbira tal- każijiet ix- xagħar għandu normalent jerġa ’ jikber) • ħmura u nefħa tal- pali t’ idejk jew il- qigħan ta’ saqajk li jistgħu jikkaġunaw li l- ġilda titqaxxar (din tista ’ tiġri ukoll fid- dirgħajn, il- wiċċ u l- ġisem) • bidla fil- kulur tad- dwiefer tieghek, li jistgħu jinqalgħu • uġigħ fil- muskoli, uġigħ tad- dahar u uġigħ fl- ghadam • bidla fil- mestrwazzjoni jew in- nuqqas tagħha • nefħa ta ’ l- idejn, saqajn u riġlejn • għejja jew tħossok qiesek bl- influwenza • żieda jew tnaqqis fil- piż
Common (experienced in less than 1 in 10 but more than 1 in 100 patients): • oral candidiasis • dehydration • dizziness • hearing impaired • decrease in blood pressure; irregular or rapid heart beat • heart failure • oesophagitis • dry mouth • difficulty or painful swallowing • haemorrhage • raised liver enzymes (hence the need for regular blood tests).
Komuni (li ssibhom f’ anqas minn 1 f’ kull 10 iżda iżjed minn 1 f’ kull 100 pazjent) • candidiasis orali • deidrazzjoni • sturdament • tnaqqis tas- smigħ • waqgħa tal- pressjoni tad- demm; polz irregolari jew il- qalb tħabbat mgħaġġla • insuffiċjenza tal- qalb • esofaġite • ħalq xott • diffikultà jew ugigħ meta tibla ’ • emoraġija • l- enżimi għoljin tal- fwied (għalhekk, meħtieġa it- testijiet regolari tad- demm)
Uncommon (experienced in more than 1 in 1,000 but less than 1 in 100 patients): • fainting • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling • inflammation of the colon, small intestine; intestinal perforation • blood clots.
(li ssibhom f’ aktar minn 1 f’ kull 1, 000 iżda anqas minn 1 f’ kull 100 pazjent) • ħass ħażin • fis- sit ta ’ l- injezzjoni reazzjonijiet fil- ġilda, flebite (infjammazzjoni tal- vina) few nefħa; infjammazzjoni tal- musrana l- kbira u tal- musrana z- zgħira, perforament ta ’ l- imsaren
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or hospital pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek fl- isptar.
HOW TO STORE Docetaxel Winthrop
KIF TAĦŻEN DOCETAXEL WINTHROP
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax Docetaxel Winthrop wara d- data ta ’ skadenza li tidher fuq il- kartuna, folja tal- pakkett u kunjetti.
The premix solution should be used immediately after preparation.
Is- soluzzjoni tal- bidu trid tintuża immedjatament wara li tkun ippreparata.
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
Madankollu, l- istabbiltà kimika u fiżika tas- soluzzjoni tal- bidu ntweriet li tibqa ’ tajba għal 8 sigħat meta tinżamm bejn 2° Ċ u t- 8° Ċ jew f’ temperatura ambjentali (taħt 25 °Ċ).
The infusion solution should be used within 4 hours at room temperature (below 25 °C).
L- infużjoni mħallta għall- użu trid tintuża fit- temperatura ambjentali fi żmien 4 sigħat (taħt 25 °Ċ).
What Docetaxel Winthrop concentrate vial contains
X’ fih il- kunjett ta ’ Docetaxel Winthrop konċentrat
- The active substance is docetaxel.
- Is- sustanza attiva hi docetaxel.
Each ml of docetaxel solution contains 40 mg of docetaxel
Kull ml tas- soluzzjoni ta ’ docetaxel fih 40 mg ta ’ docetaxel
anhydrous.
anidru.
One vial contains 20 mg docetaxel.
Kunjett wieħed fih 20 mg ta ’ docetaxel.
- The other ingredient is polysorbate 80.
- Is- sustanza l- oħra hi polysorbate 80.
What solvent vial contains 13% (w/ w) ethanol 95% in water for injections.
X’ fih il- kunjett ta ’ solvent 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet
What Docetaxel Winthrop looks like and contents of the pack Docetaxel Winthrop 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.
Id- Dehra tal- prodott u d- daqs tal- pakkett Docetaxel Winthrop 20 mg konċentrat għal soluzzjoni għall- infuzjoni hija soluzzjoni ċara, magħquda, safra għal safra tagħti fil- kannella.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Kull folja tal- pakkett fih: • kunjett b’ doża waħda ta ’ konċentrat u • kunjett b’ doża waħda ta ’ solvent.
Marketing Authorisation Holder Aventis Pharma S. A.
Id- Detentur ta ’ l- Awtorizzazzjoni ghat- Tqegħid fis- Suq Aventis- Pharma S. A.
20 avenue Raymond Aron 92165 Antony Cedex France
20 avenue Raymond Aron 92165 Antony Cedex Franza
Manufacturer Aventis Pharma, Dagenham Rainham Road South Dagenham Essex RM10 7XS United Kingdom
Aventis Pharma Dagenham Rainham Road South Dagenham Essex RM10 7XS Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
93 Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88
93 Österreich Eesti sanofi- aventis GmbH sanofi- aventis Estonia OÜ Tel: +43 1 80 185 – 0 Tel: +372 627 34 88
This leaflet was last approved in {MM/ YYYY}.
Dan il- fuljett kien approvat l- aħħar f ’ XX/ SSSS
94 The following information is intended for medical or healthcare professionals only:
94 L- informazzjoni li ġejja hija intenzjonata biss għall- persuni professjonali tal- mediċina jew tal - kura tas- saħħa.
PREPARATION GUIDE FOR USE WITH Docetaxel Winthrop 20 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR Docetaxel Winthrop
GWIDA TA ’ TAGĦRIF FUQ IL- PREPARAZZJONI GHALL- UŻU B’ Docetaxel Winthrop 20 mg KONĊENTRAT BIEX ISSIR IT- TAĦLITA LIKWIDA GĦALL- INFUŻJONI BIS - SOLVENT TA’ Docetaxel Winthrop
It is important that you read the entire contents of this procedure prior to the preparation of either the Docetaxel Winthrop premix solution or the Docetaxel Winthrop infusion solution
Huwa importanti li taqra l- kontenut sħiħ ta ’ din il- proċedura qabel ma tipprepara jew is- soluzzjoni inizjali tal- bidu ta ’ Docetaxel Winthrop jew l- infużjoni ta ’ Docetaxel Winthrop.
FORMULATION
FORMULAZZJONI
Docetaxel Winthrop 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ ml docetaxel (anhydrous) in polysorbate 80.
Docetaxel Winthrop 20 mg konċentrat għal soluzzjoni għall- infużjoni, hija taħlita ċara u magħquda, safra jew safra tagħti fil- kannella, u li għandha 40 mg/ ml ta ’ docetaxel (anidru) fil- polysorbate 80.
The solvent for Docetaxel Winthrop is a 13% w/ w solution of ethanol 95% in water for injections.
Is - solvent ta ’ Docetaxel Winthrop huwa taħlita ta ’ 13% (w/ w) ethanol 95% fl- ilma għall- injezzjonijiet.
PRESENTATION
PREżENTAZZJONI
Docetaxel Winthrop is supplied as single-dose vials.
Docetaxel Winthrop jigi bħala kunjett li ghandu doża waħda.
Each box contains one Docetaxel Winthrop vial (20 mg) and one corresponding solvent for Docetaxel Winthrop vial in a blister pack.
Kull kaxxa fiha kunjett wieħed ta ’ Docetaxel Winthrop ta ’ 20 mg u kunjett wieħed ta ’ solvent korrispondenti għal Docetaxel Winthrop, f’ pakketti bil- fojl.
Docetaxel Winthrop vials should be stored between 2 °C and 25 °C and protected from light.
Il- kunjetti ta ’ Docetaxel WinthropDocetaxel Winthrop għandhom jinħażnu bejn 2 °C u 25 °C u jkunu protetti mid- dawl.
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax Docetaxel Winthrop wara d- data ta ’ skadenza li tidher fuk il- kartuna, il- folja tal- pakkett u l - kunjetti.
2.1 Docetaxel Winthrop 20 mg vial
2. 1 Kunjett ta ’ Docetaxel Winthrop 20 mg
• The Docetaxel Winthrop 20 mg vial is a 7 ml clear glass vial with a green flip-off cap.
• Il- kunjett ta ’ Docetaxel Winthrop ta ’ 20 mg huwa wieħed ta ’ 7 ml magħmul minn ħġieġ ċar b’ tapp aħdar li jinfetaħ billi tgħollih.
• The Docetaxel Winthrop 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Il- kunjett ta ’ Docetaxel Winthrop ta ’ 20 mg fih soluzzjoni ta ’ docetaxel fil- polysorbate 80 b’ konċentrazzjoni ta ’ 40 mg/ ml.
• Each Docetaxel Winthrop 20 mg vial contains 0.5 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Kull kunjett ta ’ Docetaxel Winthrop 20 mg fih 0. 5 ml ta ’ soluzzjoni ta ’ docetaxel, b’ konċentrazzjoni ta ’ 40 mg/ ml fil- polysorbate 80 (volum attwali:
24.4 mg/ 0.61 ml).
24. 4 mg/ 0. 61 ml).
This volume has been established during the development of Docetaxel Winthrop to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Dan il - volum sar waqt l- iżvilupp ta ’ Docetaxel Winthrop biex ipatti għat- telf ta ’ parti mill- likwidu waqt il- preparazzjoni tas- soluzzjoni inizjali (ara sezzjoni 4) dovut għall- formazzjoni ta’ ragħwa, dak li jibqa ’ f’ kuntatt mal- ħġieġ tal- kunjettu l- ammont ċkejken li jibqa ’ fil- flixkun u li ma jkunx jista ’ jittella ’.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel Winthrop vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Din iż- żieda fil- volum tiżgura li, wara li ssir it- taħlita tal- kontenut sħiħ tal- kunjett tas - solvent mal- kontenut tal- kunjett ta’ Docetaxel Winthrop, ikun hemm ammont minimu li jista ’ jittella ’ ta ’ 2 ml, li għandu 10 mg/ ml docetaxel, li jikkorrispondi għall- ammont indikat fuq it - tabella ta ’ 20 mg kull fjala.
2.2 Solvent for Docetaxel Winthrop 20 mg vial
2. 2 Solvent għall- kunjett ta ’ Docetaxel Winthrop 20 mg:
• The solvent for Docetaxel Winthrop 20 mg vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
• Is- solvent għal Docetaxel Winthrop 20 mg huwa f’ kunjett tal- ħġieġ ċar ta ’ 7 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
• The solvent for Docetaxel Winthrop composition is a 13% w/ w solution of ethanol 95% in water for injections.
• Is- solvent għal Docetaxel Winthrop hu magħmul minn 13% (w/ w) ethanol 95% fl- ilma għall - injezzjonijiet.
• Each solvent for Docetaxel Winthrop 20 mg vial contains 1.98 ml.
95 • Kull kunjett tas- solvent, li tmur ma ’ kunjett ta ’ Docetaxel Winthrop 20 mg, fiha 1. 98 ml.
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 20 mg vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dan il - volum huwa aġġustat biex jikkomplementa l- volum ta ’ Docetaxel Winthrop 20 mg fil- kunjett tiegħu. Iż- żieda tal- kontenut sħiħ tas- solvent mill- kunjett, għall- kontenut tal- kunjett ta’ Docetaxel Winthrop 20 mg, jiżgura konċentrazzjoni tas- soluzzjoni inizjali ta ’ 10 mg/ ml ta ’ docetaxel.
RECOMMENDATIONS FOR THE SAFE HANDLING
RAKKOMANDAZZJONIJIET GĦALL- IMMANIĠĠAR BIL- GALBU
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Jekk konċentrat ta’ Docetaxel Winthrop, jew is- soluzzjoni inizjali ta ’ l- infużjoni jew l- infużjoni nnifisha tiġi f’ kuntatt mal- ġilda, aħsel immedjatament u sew bis- sapun u l- ilma.
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Jekk konċentrat ta’ Docetaxel Winthrop, jew is- soluzzjoni inizjali tal- infużjoni jew l- infużjoni innifisha tiġi f’ kuntatt mal- mukoża, aħsel immedjatament u sew bl- ilma.
PREPARATION FOR THE INTRAVENOUS ADMINISTRATION
PREPARAZZJONI TAL- PRODOTT GĦALL- GĦOTI ĠOL- VINA
4.1 Preparation of the Docetaxel Winthrop premix solution (10 mg docetaxel/ ml)
4. 1 Preparazzjoni ta ’ Docetaxel Winthrop, soluzzjoni inizjali (10 mg docetaxel/ ml)
4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Winthrop boxes to stand at room temperature (below 25 °C) for 5 minutes.
4. 1. 1 Jekk il- kunjetti kienu maħżuna fil- friġġ, ħalli n- numru ta ’ kaxex ta’ Docetaxel Winthrop li għandek bżonn f’ temperatura ambjentali (taħt 25 °Ċ) għal 5 minuti.
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Winthrop vial by partially inverting the vial.
4. 1. 2 Uża siringa b’ labra mwaħħla magħha u tella ’ l- kontenut sħiħ tas- solvent ta’ Docetaxel Winthrop, b’ mod asettiku, billi taqleb il- kunjett tas- solvent partjalment rasu ’ l isfel.
4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Winthrop vial.
4. 1. 3 Injetta il- kontenut sħiħ tas- siringa fil- kunjett korrispondenti ta ’ Docetaxel Winthrop.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
96 4. 1. 4 Neħħi s- siringa u l- labra u ħawwad b’ idejk billi ddawwar repetutament il- kunjett għal mhux anqas minn 45 sekonda.
96 4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25 °C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
4. 1. 5 Ħalli il- kunjett, li issa fih is- soluzzjoni inizjali, joqgħod għal 5 minuti f’ temperatura ambjentali (taħt 25 °Ċ) u ara li t- taħlita hija omoġenja u ċara (il- formazzjoni tar- ragħwa hija ħaġa normali u tista ’ tibqa ’ anke wara 5 minuti dovuta għall - preżenza tal- polysorbate 80 fil- formulazzjoni).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between + 2 °C and + 8 °C or at room temperature (below 25 °C).
Madankollu, l- istabbiltà kimika u fiżika tas- soluzzjoni inizjali ntweriet li ddum għal 8 sigħat meta tkun maħżuna bejn +2°Ċ jew +8°Ċ jew f’ temperatura ambjentali (taħt 25 °Ċ).
4.2 Preparation of the infusion solution
4. 2 Preparazzjoni ta ’ l- infużjoni
4.2.1 More than one premix vial may be necessary to obtain the required dose for the patient.
4. 2. 1 Jista ’ jagħti l- każ li jkollok tuża aktar minn kunjett wieħed għas- soluzzjoni inizjali mħallta biex tilħaq id- doża indikata għall- pazjent.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Ibażżat fuq id- doża meħtieġa preċiżament f’ milligrami għall pazjent,, tella ’ b’ mod asettiku, l- ammont meħtieġ ta ’ soluzzjoni inizjali, li fiha 10 mg/ ml ta ’ docetaxel, minn numru appropjat ta ’ kunjetti b’ użu ta ’ siringi immarkati, bil- labar f’ posthom.
For example, a dose of 140 mg docetaxel would require 14 ml docetaxel premix solution.
Biex nieħdu eżempju, doża ta ’ 140 mg ta ’ docetaxel tirrikjedi 14 ml ta ’ soluzzjoni inizjali ta ’ docetaxel.
4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
4. 2. 2 Injetta l- volum meħtieġ tas- soluzjoni inizjali f’ borża jew flixkun ta ’ l- infużjoni ta ’ 250 ml, li għandha/ għandu soluzzjoni ta ’ 5% glukosju jew 0. 9% kloridu tas- sodju.
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ ml docetaxel is not exceeded.
Jekk hija meħtieġa doża akbar minn 200 mg ta ’ docetaxel, uża volum t’ infużjoni akbar biex tiżgura li ma teċċedix il - konċentrazzjoni ta ’ 0. 74 mg/ ml ta ’ docetaxel.
4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
4. 2. 3 Ħawwad il- borża jew il- flixkun ta ’ l- infużjoni b’ idejk billi iċċaqlaqha/ iċċaqalqu minn naħa għall- oħra.
4.2.4 The Docetaxel Winthrop infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
4. 2. 4 Is- soluzzjoni għall- infużjoni ta ’ Docetaxel Winthrop għandha tintuża fi żmien 4 sigħat u għandha tingħata b’ mod asettiku bħala infużjoni fuq żmien ta ’ siegħa f’ temperatura ambjentali (taħt 25 °Ċ) u f’ dawl normali.
4.2.5 As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Soluzzjonijiet li jkollhom xi preċipitat jew frak żgħir għandhom jintremew.
DISPOSAL
RIMI
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Il- materjali kollha li ntużaw għas- soluzzjoni u għall- infużjoni għandhom jintremew kif jixraq skond il - proċeduri irrakkomandati.
98 PACKAGE LEAFLET:
98 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion docetaxel
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Docetaxel Winthrop 80 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
You must not be given Docetaxel Winthrop if
M’ jistax jingħatalek Docetaxel Winthrop jekk:
99 Take special care with Docetaxel Winthrop
99 Oqgħod attent ħafna b’ Docetaxel Winthrop:
Taking other medicines
Meta tieħu/ tuża mediċini oħra:
This is because Docetaxel Winthrop or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Dan għaliex Docetaxel Winthrop jew il- mediċina l- oħra jistgħu ma jaħdmux tajjeb daqs dak mistenni u jista ’ jkun aktar probabbli li tiżviluppa xi effetti sekondarji.
Frequency of administration
Kemm jingħata spiss
100 Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Winthrop.
100 It- tabib tiegħek jista ’ jibdillek id- doża u l- frekwenza tad- dożi skond ir- riżultati tad- demm, il- qagħda ġenerali tiegħek u r- rispons għal Docetaxel Winthrop. Partikulament, jekk joghġbok, għid lit- tabib tiegħek jekk speċjalment tiżviluppa id- dijarea, selħiet fil- ħalq, sensazzjoni ta ’ tnemnim jew xi parti imtarrxa tal- ġisem jew deni u għidlu/ ghidilha bir- riżultati tat- testijiet tiegħek tad- demm.
Very common (experienced in more than 1 in 10 patients): • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets • fever: if this happens you must tell your doctor immediately • allergic reactions as described above • loss of appetite (anorexia) • insomnia • feeling of numbness or pins and needles or pain in the joints of muscles • headache • alteration in sense of taste • inflammation of the eye or increased tearing of the eyes • swelling caused by faulty lymphatic drainage • shortness of breath • nasal drainage; inflammation of the throat and nose; cough • bleeding from the nose • sores in the mouth • stomach upsets including nausea, vomiting and diarrhea, constipation • abdominal pain
(li ssibhom f’ aktar minn 1 f ’ kull 10 pazjenti) • infezzjonijiet, tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm (anemija), jew dak taċ- ċelluli bojod (li huma importanti fit- taqbida kontra l- infezzjoni) u l- plejtlits, • deni: jekk dan jiżviluppalek għandek tgħid lit- tabib tiegħek immedjatament • reazzjonijiet allerġiċi kif deskritti hawn fuq • nuqqas t’ aptit (anoreskja) • Insonnja • sensazzjoni li xi parti imtarrxa ta ’ ġismek jew tnemnim, jew uġigh fil- ġogi jew muskoli • uġigħ ta ’ ras • tibdil fis- sens tat- tegħim • infjammazzjoni ta ’ l- għajn jew tidmigħ ta ’ l- għajnejn • nefħa dovuta għal difett fil- funzjoni tas- sistema limfatika • qtugħ ta ’ nifs • tnixxija ta ’ l- imnieħer; infjammazjoni tal- gerżuma u l- imnieħer; sogħla • tinfaraġ • selħiet fil- ħalq
101 • indigestion • short term hair loss (in most cases normal hair growth should return) • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body) • change in the color of your nails, which may detach • muscle aches and pains; back pain or bone pain • change or absence of menstrual period • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
101 • taqlib ta ’ l- istonku inklużi t- tqalligħ, rimettar u d- dijarrea, stitikezza • uġigħ addominali • indiġistjoni • waqgħa temporanja tax- xagħar (fil- biċċa l- kbira tal- każijiet ix- xagħar għandu normalent jerġa ’ jikber) • ħmura u nefħa tal- pali t’ idejk jew il- qigħan ta’ saqajk li jistgħu jikkaġunaw li l- ġilda titqaxxar (din tista ’ tiġri ukoll fid- dirgħajn, il- wiċċ u l- ġisem) • bidla fil- kulur tad- dwiefer tieghek, li jistgħu jinqalgħu • uġigħ fil- muskoli, uġigħ tad- dahar u uġigħ fl- ghadam • bidla fil- mestrwazzjoni jew in- nuqqas tagħha • nefħa ta ’ l- idejn, saqajn u riġlejn • għejja jew tħossok qiesek b ’ l- influwenza • żieda jew tnaqqis fil- piż
Uncommon (experienced in more than 1 in 1,000 but less than 1 in 100 patients): • fainting • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling • inflammation of the colon, small intestine; intestinal perforation • blood clots.
(li ssibhom f’ aktar minn 1 f’ kull 1, 000 iżda anqas minn 1 f’ kull 100 pazjent) • ħass ħażin • fis- sit ta ’ l- injezzjoni reazzjonijiet fil- ġilda, flebite (infjammazzjoni tal- vina) few nefħa; infjammazzjoni tal- musrana l- kbira u tal- musrana z- zgħira, perforament ta ’ l- imsaren • emboli
Docetaxel Winthrop should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax Docetaxel Winthrop wara d- data ta ’ skadenza li tidher fuq il- kartuna, il- folja tal- pakkett u l - kunjetti.
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
Madankollu, l- istabbiltà kimika u fiżika tas- soluzzjoni tal- bidu ntweriet li tibqa ’ tajba għal 8 sigħat meta tinżamm bejn 2 °Ċ u t- 8 °Ċ jew f’ temperatura ambjentali (taħt 25 °Ċ).
The infusion solution should be used within 4 hours at room temperature (below 25 °C).
L- infużjoni mħallta għall- użu trid tintuża fit- temperatura ambjentali (taħt 25 °Ċ). fi żmien 4 sigħat.
One vial contains 80 mg docetaxel.
Kunjett wieħed fih 80 mg ta ’ docetaxel.
What Docetaxel Winthrop looks like and contents of the pack Docetaxel Winthrop 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution.
Id- Dehra tal- prodott u d- daqs tal- pakkett Docetaxel Winthrop 80 mg konċentrat għal soluzzjoni għall- infuzjoni hija soluzzjoni ċara, magħquda, safra għal safra tagħti fil- kannella.
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Kull folja tal- pakkett fih: • kunjett b’ doża waħda ta ’ Docetaxel Winthrop 80mg konċentrat għal soluzzjoni għall- infuzjoni u • kunjett b’ doża waħda ta ’ solvent ta ’ Docetaxel Winthrop.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
103 Eesti Österreich sanofi-aventis Estonia OÜ Tel: +372 627 34 88
103 Österreich Eesti sanofi- aventis GmbH sanofi- aventis Estonia OÜ Tel: +43 1 80 185 – 0 Tel: +372 627 34 88
España sanofi-aventis, S. A.
España sanofi- aventis, S. A..
104 The following information is intended for medical or healthcare professionals only:
104 L- informazzjoni li ġejja hija intenzjonata biss għall- persuni professjonali tal- mediċina jew tal - kura tas- saħħa.
PREPARATION GUIDE FOR USE WITH Docetaxel Winthrop 80 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR Docetaxel Winthrop
GWIDA TA ’ TAGĦRIF FUQ IL- PREPARAZZJONI GHALL- UŻU B’ Docetaxel Winthrop 80 mg KONĊENTRAT BIEX ISSIR IT- TAĦLITA LIKWIDA GĦALL- INFUŻJONI BIS - SOLVENT TA’ Docetaxel Winthrop
Docetaxel Winthrop 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown- yellow solution containing 40 mg/ ml docetaxel (anhydrous) in polysorbate 80.
Docetaxel Winthrop 80 mg konċentrat għal soluzzjoni għall- infużjoni, hija taħlita ċara u magħquda, safra jew safra tagħti fil- kannella, u li għandha 40 mg/ ml ta ’ docetaxel (anidru) fil- polysorbate 80.
Each box contains one Docetaxel Winthrop vial (80 mg) and one corresponding solvent for Docetaxel Winthrop vial in a blister pack.
Kull kaxxa fiha kunjett wieħed ta ’ Docetaxel Winthrop ta ’ 80 mg u kunjett wieħed ta ’ solvent korrispondenti għal Docetaxel Winthrop, f’ pakketti bil- fojl.
Docetaxel Winthrop vials should be stored between 2 °C and 25 °C and protected from light.
Il- kunjetti ta ’ Docetaxel Winthrop Docetaxel Winthrop għandhom jinħażnu bejn 2 °C u 25 °C u jkunu protetti mid- dawl.
2.1 Docetaxel Winthrop 80 mg vial
2. 1 Kunjett ta ’ Docetaxel Winthrop 80 mg
• The Docetaxel Winthrop 80 mg vial is a 15 ml clear glass vial with a red flip-off cap.
• Il- kunjett ta ’ Docetaxel Winthrop ta ’ 80 mg huwa wieħed ta ’ 7 ml magħmul minn ħġieġ ċar b’ tapp aħdar li jinfetaħ billi tgħollih.
• The Docetaxel Winthrop 80 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Il- kunjett ta ’ Docetaxel Winthrop ta ’ 80 mg fih soluzzjoni ta ’ docetaxel fil- polysorbate 80 b’ konċentrazzjoni ta ’ 40 mg/ ml.
• Each Docetaxel Winthrop 80 mg vial contains 2.0 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Kull kunjett ta ’ Docetaxel Winthrop 80 mg fih 2. 0 ml ta ’ soluzzjoni ta ’ docetaxel, b’ konċentrazzjoni ta ’ 40 mg/ ml fil- polysorbate 80 (volum attwali:
94.4 mg/ 2.36 ml).
99. 4 mg/ 2. 36 ml).