qanastek/EMEA-V3 huggingface dataset:
Solvent vial: ethanol 95%, water for injections.
Kunjett ta ’ TAXOTERE: polysorbate 80 Kunjett ta ’ solvent: ethanol 95% fl- ilma għall- injezzjonijiet
Each blister pack of TAXOTERE 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 ’ TAXOTERE 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni fiha: • kunjett b’ doża waħda ta ’ konċentrat, • kunjett b’ doża waħda ta ’ solvent.
Intravenous use
Użu għal ġol- vini.
79 8.
79 8.
80 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ TAXOTERE 20 mg
80 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXIJEW FUQ IL- FOLJI KONĊENTRAT u SOLVENT TAXOTERE 20 mg
TAXOTERE concentrate
TAXOTERE konċentrat
SOLVENT for TAXOTERE
SOLVENT għal TAXOTERE
VIAL/ TAXOTERE 20 mg
KUNJETT / TAXOTERE 20 mg
TAXOTERE 20 mg concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 20 mg konċentrat għal soluzzjoni għall- infużjoni docetaxel Użu għal ġol- vini
82 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
82 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ SOLVENT FOR TAXOTERE 20 mg
KUNJETT/ SOLVENT GĦAT- TAXOTERE 20 mg
SOLVENT for TAXOTERE 20 mg
SOLVENT għal TAXOTERE 20 mg
83 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ TAXOTERE 80 mg
83 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT KAXXA TAL_ KARTUN/ TAXOTERE 80 mg
1 vial of TAXOTERE 80 mg concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ ml) Fill:
Kunjett wieħed ta ’ TAXOTERE 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 TAXOTERE 13% (w/ w) ethanol 95% in water for injections Fill:
94. 4 mg/ 2. 36 ml Fjala waħda ta ’ solvent għal TAXOTERE 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet Volum attwali:
Solvent vial: ethanol 95%, water for injections.
Kunjett ta ’ TAXOTERE: polysorbate 80 Kunjett ta ’ solvent: ethanol 95%, ilma għall- injezzjonijiet
Each blister pack of TAXOTERE 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 ’ TAXOTERE 80 mg konċentrat u solvent għal soluzzjoni għall- infużjoni fiha: • kunjett b’ doża waħda ta ’ konċentrat, • kunjett b’ doża waħda ta ’ solvent
84 8.
84 8.
85 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CONCENTRATE and SOLVENT/ TAXOTERE 80 mg
85 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI KONĊENTRAT u SOLVENT TAXOTERE 80 mg
VIAL/ TAXOTERE 80 mg
KUNJETT/ TAXOTERE 80 mg
TAXOTERE 80 mg concentrate for solution for infusion docetaxel intravenous use
TAXOTERE 80 mg konċentrat għal soluzzjoni għall- infużjoni docetaxel Użu għal ġol- vini
87 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
87 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL/ SOLVENT FOR TAXOTERE 80 mg
KUNJETT/ SOLVENT GĦAL TAXOTERE 80 mg
SOLVENT for TAXOTERE 80 mg
SOLVENT għal - TAXOTERE 80 mg
89 PACKAGE LEAFLET:
89 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER TAXOTERE 20 mg concentrate and solvent for solution for infusion docetaxel
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU TAXOTERE 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
What TAXOTERE is and what it is used for 2.
X’ inhu TAXOTERE u għalxiex jintuża 2.
Before you use TAXOTERE 3.
Qabel ma tieħu TAXOTERE 3.
How to use TAXOTERE 4.
Kif għandek tuża TAXOTERE 4.
How to store TAXOTERE 6.
Kif taħżen TAXOTERE 6.
WHAT TAXOTERE IS AND WHAT IT IS USED FOR
X’ INHU TAXOTERE U GĦALXIEX JINTUŻA
The name of this medicine is TAXOTERE.
L- isem ta ’ din il- mediċina huwa TAXOTERE.
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.
TAXOTERE 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:
TAXOTERE 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, TAXOTERE jista ’ jingħata jew waħdu jew flimkien ma ’ doxorubicin jew trastuzumab jew capecitabine. − Għat- trattament ta ’ kanċer bikri tas- sider b’ involviment tal- glandoli limfatiċi, TAXOTERE jista ’ jingħata flimkien ma ’ doxorubicin u cyclophosphamide. − Għat- trattament tal- kanċer tal- pulmun, TAXOTERE jista ’ jingħata jew waħdu jew flimkien ma cisplatin. − Għat- trattament ta ’ kanċer tal- prostata, TAXOTERE jingħata flimkien ma ’ prednisone jew prednisolone. − Għat- trattament ta ’ kanċer metastatiku ta ’ l- istonku, TAXOTERE jingħata flimkien ma ’ cisplatin u 5- fluorouracil. − Għat- trattament ta ’ kanċer tar- ras u l- għonq, TAXOTERE jingħata flimkien ma ’ cisplatin u 5 - fluorouracil.
BEFORE YOU USE TAXOTERE
QABEL MA TUŻA TAXOTERE
You must not be given TAXOTERE if
M’ għandux jingħatalek TAXOTERE jekk:
• you are allergic (hypersensitive) to docetaxel or any of the other ingredients of TAXOTERE. • 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 ’ TAXOTERE. • in- numru taċ- ċelluli bojod fid- demm huwa baxx wisq. • għandek mard serju tal- fwied. • inti tqila b’ tarbija jew qegħda tredda ’.
Take special care with TAXOTERE
90 Oqgħod attent ħafna b’ TAXOTERE:
In case of white blood cells disturbances, you may experience associated fever or infections.
Qabel kull darba li tibda l- kura b ’ TAXOTERE ikollok tagħmel testijiet tad- demm biex tiċċekja jekk għandekx biżejjed ċelluli fid- demm u funzjoni adegwata tal- fwied biex tkun tista ’ tieħu TAXOTERE. Fil- każ li jkun hemm abnormalitajiet fiċ- ċelluli bojod tad- demm, jista ’ jkollok id- deni jew infezzjonijiet assoċjati magħhom.
90 You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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 TAXOTERE 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 ’ TAXOTERE, speċjalment reazzjonijiet allerġiċi u żamm ta ’ fluwidu (nefħa ta ’ l- idejn, saqajn, riġlejn jew żieda fil- piż).
This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Dan għaliex TAXOTERE 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:
TAXOTERE must NOT be administered if you are pregnant or if you are planning to become pregnant.
TAXOTERE 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 TAXOTERE is no longer administered to you.
Trid tieħu l- miżuri kontraċettivi adegwati waqt il- kura u għal mhux inqas minn tliet xhur wara li TAXOTERE jitwaqqaf.
You must NOT breast-feed while you are treated with TAXOTERE.
MA TISTAX tredda ’ waqt li qed tieħu l- kura b ’ TAXOTERE.
There is no reason why you cannot drive between courses of TAXOTERE except if you feel dizzy or are unsure of yourself.
M’ hemm ebda raġuni għaliex ma tistax issuq bejn kors u ieħor ta ’ TAXOTERE sakemm ma tħossokx sturdut/ sturduta jew m’ intix żgur/ żgura.
HOW TO USE TAXOTERE
KIF GĦANDEK TUŻA TAXOTERE
TAXOTERE will be administered to you by a healthcare professional.
TAXOTERE sejjer jingħatalek minn professjonist fil- qasam tas- saħħa.
TAXOTERE will be given by infusion into one of your veins.
TAXOTERE sejjer jingħatalek permezz t’ infużjoni f’ waħda mill- vini tiegħek.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
91 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 TAXOTERE. 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, TAXOTERE can cause side effects, although not everybody gets them.
Bħal kull mediċini oħra kontra l- kanċer, TAXOTERE jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most commonly reported adverse reactions of TAXOTERE 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 ’ TAXOTERE 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 TAXOTERE may be increased when TAXOTERE is given in combination with other chemotherapeutic agents.
Is- severità ta ’ dawn il- ġrajjiet avversi ta ’ TAXOTERE jistgħu jiżdiedu meta TAXOTERE jingħata flimkien ma ’ sustanzi kimoterapewtiċi oħra.
During the infusion at the hospital the following allergic reactions (experienced in more than 1 person in 10) may occur: • flushing, skin reactions, itching • chest tightness; difficulty in breathing • fever or chills • back pain • low blood pressure.
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.
More severe reactions may occur.
Reazzjonijiet aktar severi jistgħu jiġru.
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of drugs that are received:
Bejn infużjoni u oħra ta ’ TAXOTERE 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 • 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
(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, • taqlib ta ’ l- istonku inklużi t- tqalligħ, rimettar u d- dijarrea, stitikezza, • uġigħ addominali,
92 • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
92 • 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. • emboli
HOW TO STORE TAXOTERE
KIF TAĦŻEN TAXOTERE
TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax TAXOTERE wara d- data ta ’ skadenza li tidher fuq il- kartuna, folja tal- pakkett u kunjetti.
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 TAXOTERE concentrate vial contains
X’ fih il- kunjett ta ’ TAXOTERE konċentrat:
What solvent vial contains 13% (w/ w) ethanol 95% in water for injections.
13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet
What TAXOTERE looks like and contents of the pack TAXOTERE 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
TAXOTERE 20 mg konċentrat għal soluzzjoni għall- infuzjoni hija soluzzjoni ċara, magħquda, safra għal safra tagħti fil- kannella.
93 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 ’ konċentratu • kunjett b’ doża waħda ta ’ solvent.
Marketing Authorisation Holder Aventis Pharma S. A.
Aventis- Pharma S. A.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
94 Österreich Eesti sanofi- aventis GmbH sanofi- aventis Estonia OÜ Tel: +43 1 80 185 – 0 Tel: +372 627 34 88
95 The following information is intended for medical or healthcare professionals only:
95 L- informazzjoni li ġejja hija intenzjonata biss għall- persuni professjonali tal- mediċina jew tal - kura tas- saħħa.
PREPARATION GUIDE FOR USE WITH TAXOTERE 20 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
GWIDA TA ’ TAGĦRIF FUQ IL- PREPARAZZJONI GHALL- UŻU B’ TAXOTERE 20 mg KONĊENTRAT BIEX ISSIR IT- TAĦLITA LIKWIDA GĦALL- INFUŻJONI BIS- SOLVENT TA ’ TAXOTERE
It is important that you read the entire contents of this procedure prior to the preparation of either the TAXOTERE premix solution or the TAXOTERE infusion solution
Huwa importanti li taqra l- kontenut sħiħ ta ’ din il- proċedura qabel ma tipprepara jew is- soluzzjoni inizjali tal- bidu ta ’ TAXOTERE jew l- infużjoni ta ’ TAXOTERE.
TAXOTERE 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.
TAXOTERE 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 TAXOTERE is a 13% w/ w solution of ethanol 95% in water for injections.
Is- solvent ta ’ TAXOTERE huwa taħlita ta ’ 13% (w/ w) ethanol 95% fl- ilma għall- injezzjonijiet.
TAXOTERE is supplied as single-dose vials.
TAXOTERE jigi bħala kunjett li ghandu doża waħda.
Each box contains one TAXOTERE vial (20 mg) and one corresponding solvent for TAXOTERE vial in a blister pack.
Kull kaxxa fiha kunjett wieħed ta ’ TAXOTERE ta ’ 20 mg u kunjett wieħed ta ’ solvent korrispondenti għal TAXOTERE, f’ pakketti bil- fojl.
TAXOTERE vials should be stored between 2 °C and 25 °C and protected from light.
Il- kunjetti ta ’ TAXOTERE għandhom jinħażnu bejn 2 °C u 25 °C u jkunu protetti mid- dawl.
TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax TAXOTERE wara d- data ta ’ skadenza li tidher fuk il- kartuna, il- folja tal- pakkett u l- kunjetti.
2.1 TAXOTERE 20 mg vial
2. 1 Kunjett ta ’ TAXOTERE 20 mg
• The TAXOTERE 20 mg vial is a 7 ml clear glass vial with a green flip-off cap.
• Il- kunjett ta ’ TAXOTERE ta ’ 20 mg huwa wieħed ta ’ 7 ml magħmul minn ħġieġ ċar b’ tapp aħdar li jinfetaħ billi tgħollih.
• The TAXOTERE 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Il- kunjett ta ’ TAXOTERE ta ’ 20 mg fih soluzzjoni ta ’ docetaxel fil- polysorbate 80 b’ konċentrazzjoni ta ’ 40 mg/ ml.
• Each TAXOTERE 20 mg vial contains 0.5 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Kull kunjett ta ’ TAXOTERE 20 mg fih 0. 5 ml ta ’ soluzzjoni ta ’ docetaxel, b’ konċentrazzjoni ta ’ 40 mg/ ml fil- polysorbate 80 (volum attwali:
This volume has been established during the development of TAXOTERE 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 ’ TAXOTERE 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 TAXOTERE 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 ’ TAXOTERE, 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 TAXOTERE 20 mg vial
2. 2 Solvent għall- kunjett ta ’ TAXOTERE 20 mg:
• The solvent for TAXOTERE 20 mg vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
• Is- solvent għal TAXOTERE 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 TAXOTERE composition is a 13% w/ w solution of ethanol 95% in water for injections.
• Is- solvent għal TAXOTERE hu magħmul minn 13% (w/ w) ethanol 95% fl- ilma għall - injezzjonijiet.
• Each solvent for TAXOTERE 20 mg vial contains 1.98 ml.
96 • Kull kunjett tas- solvent, li tmur ma ’ kunjett ta ’ TAXOTERE 20 mg, fiha 1. 98 ml.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dan il- volum huwa aġġustat biex jikkomplementa l- volum ta ’ TAXOTERE 20 mg fil- kunjett tiegħu. Iż- żieda tal- kontenut sħiħ tas- solvent mill- kunjett, għall- kontenut tal- kunjett ta ’ TAXOTERE 20 mg, jiżgura konċentrazzjoni tas- soluzzjoni inizjali ta ’ 10 mg/ ml ta ’ docetaxel.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Jekk konċentrat ta ’ TAXOTERE, 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 TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Jekk konċentrat ta ’ TAXOTERE, jew is- soluzzjoni inizjali tal- infużjoni jew l- infużjoni innifisha tiġi f’ kuntatt mal- mukoża, aħsel immedjatament u sew bl- ilma.
4.1 Preparation of the TAXOTERE premix solution (10 mg docetaxel/ ml)
4. 1 Preparazzjoni ta ’ TAXOTERE, soluzzjoni inizjali (10 mg docetaxel/ ml)
4.1.1 If the vials are stored under refrigeration, allow the required number of TAXOTERE 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 ’ TAXOTERE 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 TAXOTERE vial by partially inverting the vial.
4. 1. 2 Uża siringa b’ labra mwaħħla magħha u tella ’ l- kontenut sħiħ tas- solvent ta ’ TAXOTERE, 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 TAXOTERE vial.
4. 1. 3 Injetta il- kontenut sħiħ tas- siringa fil- kunjett korrispondenti ta ’ TAXOTERE.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
4. 1. 4 Neħħi s- siringa u l- labra u ħawwad b’ idejk billi ddawwar repetutament il- kunjett għal mhux anqas minn 45 sekonda.
97 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).
97 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).
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.
4.2.4 The TAXOTERE 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 ’ TAXOTERE 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, TAXOTERE 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.
99 PACKAGE LEAFLET:
99 FULJETT TA ’ TAGĦRIF:
INFORMATION FOR THE USER TAXOTERE 80 mg concentrate and solvent for solution for infusion docetaxel
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU TAXOTERE 80 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
You must not be given TAXOTERE if
M’ jistax jingħatalek TAXOTERE jekk:
Take special care with TAXOTERE
100 Oqgħod attent ħafna b’ TAXOTERE:
Before each treatment with TAXOTERE, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive TAXOTERE.
Qabel kull darba li tibda l- kura b ’ TAXOTERE ikollok tagħmel testijiet tad- demm biex tiċċekja jekk għandekx biżejjed ċelluli fid- demm u funzjoni adegwata tal- fwied biex tkun tista ’ tieħu TAXOTERE.
In case of white blood cells disturbances, you may experience associated fever or infections.
Fil- każ li jkun hemm abnormalitajiet fiċ- ċelluli bojod tad- demm, jista ’ jkollok id- deni jew infezzjonijiet assoċjati magħhom.
100 You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE 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 TAXOTERE 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 ’ TAXOTERE, speċjalment reazzjonijiet allerġiċi u żamm ta ’ fluwidu (nefħa ta ’ l- idejn, saqajn, riġlejn jew żieda fil- piż).
This is because TAXOTERE or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Dan għaliex TAXOTERE jew il- mediċina l- oħra jistgħu ma jaħdmux tajjeb daqs dak mistenni u jista ’ jkun aktar probabbli li tiżviluppa xi effetti sekondarji.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to TAXOTERE.
101 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 TAXOTERE. 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.
102 • swelling of the hands, feet, legs • tiredness; or flu-like symptoms • weight gain or loss.
102 • 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.
TAXOTERE should not be used after the expiry date shown on the carton, blister pack and vials.
Tużax TAXOTERE wara d- data ta ’ skadenza li tidher fuq il- kartuna, il- folja tal- pakkett u l- kunjetti.
What TAXOTERE looks like and contents of the pack TAXOTERE 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution.
TAXOTERE 80 mg konċentrat għal soluzzjoni għall- infuzjoni hija soluzzjoni ċara, magħquda, safra għal safra tagħti fil- kannella.
103 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 ’ TAXOTERE 80 mg konċentrat għal soluzzjoni għall- infuzjoni u, • kunjett b’ doża waħda ta ’ solvent ta ’ TAXOTERE.
Eesti sanofi-aventis Estonia OÜ Tel: +372 627 34 88
104 Österreich Eesti sanofi- aventis GmbH sanofi- aventis Estonia OÜ Tel: +43 1 80 185 – 0 Tel: +372 627 34 88
105 The following information is intended for medical or healthcare professionals only:
105 L- informazzjoni li ġejja hija intenzjonata biss għall- persuni professjonali tal- mediċina jew tal - kura tas- saħħa.
PREPARATION GUIDE FOR USE WITH TAXOTERE 80 MG CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
GWIDA TA ’ TAGĦRIF FUQ IL- PREPARAZZJONI GHALL- UŻU B’ TAXOTERE 80 mg KONĊENTRAT BIEX ISSIR IT- TAĦLITA LIKWIDA GĦALL- INFUŻJONI BIS- SOLVENT TA ’ TAXOTERE
TAXOTERE 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.
TAXOTERE 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 TAXOTERE vial (80 mg) and one corresponding solvent for TAXOTERE vial in a blister pack.
Kull kaxxa fiha kunjett wieħed ta ’ TAXOTERE ta ’ 80 mg u kunjett wieħed ta ’ solvent korrispondenti għal TAXOTERE, f’ pakketti bil- fojl.
2.1 TAXOTERE 80 mg vial
2. 1 Kunjett ta ’ TAXOTERE 80 mg
• The TAXOTERE 80 mg vial is a 15 ml clear glass vial with a red flip-off cap.
• Il- kunjett ta ’ TAXOTERE ta ’ 80 mg huwa wieħed ta ’ 7 ml magħmul minn ħġieġ ċar b’ tapp aħdar li jinfetaħ billi tgħollih.
• The TAXOTERE 80 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ ml.
• Il- kunjett ta ’ TAXOTERE ta ’ 80 mg fih soluzzjoni ta ’ docetaxel fil- polysorbate 80 b’ konċentrazzjoni ta ’ 40 mg/ ml.
• Each TAXOTERE 80 mg vial contains 2.0 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
• Kull kunjett ta ’ TAXOTERE 80 mg fih 2. 0 ml ta ’ soluzzjoni ta ’ docetaxel, b’ konċentrazzjoni ta ’ 40 mg/ ml fil- polysorbate 80 (volum attwali:
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 80 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 ’ TAXOTERE, ikun hemm ammont minimu li jista ’ jittella ’ ta ’ 8 ml, li għandu 10 mg/ ml docetaxel, li jikkorrispondi għall- ammont indikat fuq it- tabella ta ’ 80 mg kull fjala.
2.2 Solvent for TAXOTERE 80 mg vial
2. 2 Solvent għall- kunjett ta ’ TAXOTERE 80 mg:
• The solvent for TAXOTERE 80 mg vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
• Is- solvent għal TAXOTERE 80 mg huwa f’ kunjett tal- ħġieġ ċar ta ’ 15 ml u li għandu tapp trasparenti u mingħajr kulur, li jinfetaħ billi tgħollih.
106 3.
106 • Kull kunjett tas- solvent, li tmur ma ’ kunjett ta ’ TAXOTERE 80 mg, fiha 7. 33 ml.
4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
107 4. 1. 4 Neħħi s- siringa u l- labra u ħawwad b’ idejk billi ddawwar repetutament il- kunjett għal mhux anqas minn 45 sekonda.
107 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).
What is Tekturna?
X' inhu Tekturna?
Tekturna is a medicine containing the active substance aliskiren.
Tekturna hu mediċina li fiha s- sustanza attiva aliskiren.
What is Tekturna used for?
Għal x' hiex jintuża Tekturna?
Tekturna is used to treat essential hypertension (high blood pressure). ‘ Essential ’ means that no specific cause for the hypertension can be found.
Tekturna jintuża fit- trattament tal- pressjoni għolja essenzjali. ‘ Essenzjali 'tfisser li ma tkunx tista' tinstab kawża speċifika għall- pressjoni għolja.
How is Tekturna used?
Kif jintuża Tekturna?
The recommended dose of Tekturna is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Id- doża rrakkomandatata ta 'Tekturna hi 150 mg darba kuljum, jew waħedha jew flimkien ma' mediċini oħra għall- pressjoni għolja.
The dose may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Id- doża tista 'tiżdied għal 300 mg darba kuljum fil- pazjenti li l- pressjoni tagħhom ma tkunx tista' tiġi kkontrollata adegwatament.
Tekturna is not recommended for children, due to a lack of information on safety and effectiveness in this group.
Tekturna mhux rakkomandat għat- tfal, minħabba nuqqas ta 'tagħrif dwar is- sigurtà u l- effikaċja f' dan il- grupp.
How does Tekturna work?
Kif jaħdem Tekturna?
The active substance in Tekturna, aliskiren, is a renin inhibitor.
Is- sustanza attiva f' Tekturna, aliskiren, hi inibitur tar- renin.
How has Tekturna been studied?
Kif ġie studjat Tekturna?
The effects of Tekturna were first tested in experimental models before being studied in humans.
L- effetti ta 'Tekturna għall- ewwel ġew ittestjati f' mudeli esperimentali qabel ma ġew studjati fil - bnedmin.
Tekturna was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Tekturna ġie studjat f' 14- il studju ewlieni li fihom ħadu sehem iktar minn 10, 000 pazjent bi pressjoni għolja essenzjali.
In five of the studies, the effects of Tekturna taken alone were compared with those of placebo (a dummy treatment).
F' ħamsa mill - istudji, l- effetti ta 'Tekturna meħud waħdu tqabblu ma' dawk ta 'plaċebo (trattament finta).
Tekturna, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Tekturna, meħud waħdu jew flimkien ma 'mediċini oħra, tqabbel ma' mediċini oħra għall- pressjoni għolja.
Combination studies looked at Tekturna used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
L - istudji kombinatorji ħarsu lejn l- effett ta 'Tekturna użat flimkien ma' inibitur ta 'enzim li jikkonverti l - angiotensin (ramipril), ma' sustanza li timblokka r- riċettur ta 'l- angiotensin (valsartan), ma' beta - 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
What benefit has Tekturna shown during the studies?
X' inhu l- benefiċċju ta 'Tekturna li ntwera f' dawn l- istudji?
Tekturna on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Tekturna waħdu kien iktar effettiv mill- plaċebo u kien effettiv daqs it- trattamenti komparattivi fit - tnaqqis tal- pressjoni.
When the results of the five studies comparing Tekturna taken alone with placebo were looked at together, patients aged under 65 had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Tekturna, from an average of 99.4 mmHg at the start of the study.
Meta r- riżultati tal- ħames studji li qabblu Tekturna meħud waħdu ma 'plaċebo ġew studjati flimkien, il- pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil- pressjoni dijastolika ta' 9. 0 mmHg wara tmien ġimgħat jieħdu 150 mg Tekturna, minn medja ta '99. 4 mmHg fil - bidu tat- trattament.
Larger falls were seen in patients aged 65 or over and those taking higher doses of Tekturna.
Fil- pazjenti li kellhom 65 sena jew iktar u f' dawk li kienu qed jieħdu dożi ogħla ta 'Tekturna kien hemm tnaqqis ikbar fil- pressjoni.
Tekturna also reduced blood pressure in patients with diabetes, patients who were overweight, and those who were over 65 years of age.
Tekturna ġab ukoll tnaqqis fil- pressjoni fil - pazjenti bid- dijabete, pazjenti b' piż eċċessiv, u f' dawk li kellhom iktar minn 65 sena.
The studies also showed that Tekturna, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with those produced by these medicines taken without Tekturna.
L- istudji wrew ukoll li Tekturna, meta meħud flimkien ma 'mediċini oħra (speċjalment hydrochlorothiazide), jista' jwassal għal iktar tnaqqis fil- pressjoni meta mqabbel mat- tnaqqis fil - pressjoni kkawżat minn dawn il- mediċini meħuda mingħajr Tekturna.
What is the risk associated with Tekturna?
X' inhu r- riskju assoċjat ma 'Tekturna?
The most common side effect with Tekturna (seen in between 1 and 10 patients in 100) is diarrhoea.
L- iktar effett sekondarju komuni ta 'Tekturna (li deher f' bejn pazjent wieħed u 10 minn kull 100) hi d - dijarea.
For the full list of all side effects reported with Tekturna, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti sekondarji rrappurtati ma' Tekturna, ara l- Fuljett ta 'Tagħrif.
Tekturna should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Tekturna m' għandux jintuża minn persuni li huma sensittivi żżejjed (allerġiċi) għal aliskiren jew għal xi sustanza oħra tiegħu.
Why has Tekturna been approved?
Għaliex ġie approvat Tekturna?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Tekturna are greater than its risks for the treatment of essential hypertension.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Tekturna fit- trattament tal- pressjoni għolja essenzjali huma ikbar mir- riskji tiegħu.
The Committee recommended that Tekturna be given marketing authorisation.
Il- Kumitat irrakkomanda li Tekturna jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tekturna:
Tagħrif ieħor dwar Tekturna:
The European Commission granted a marketing authorisation valid throughout the European Union for Tekturna to Novartis Europharm Limited on 22 August 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Tekturna lil Novartis Europharm Limited fl- 22 ta 'Awwissu ta' l- 2007.
The full EPAR for Tekturna can be found here.
L- EPAR sħiħ għal Tekturna jinsab hawn.
Tekturna 150 mg film-coated tablets
Tekturna 150 mg pilloli miksijin b’ rita
The recommended dose of Tekturna is 150 mg once daily.
Id- doża irrikkmandata ta ’ Tekturna hija 150 mg darba kuljum.
Tekturna may be used alone or in combination with other antihypertensive agents (see sections 4.4 and 5.1).
Tekturna jista ’ jintuża waħdu jew ma ’ aġenti oħra li jbaxxu l- pressjoni (ara sezzjonijiet 4. 4 u 5. 1).
Tekturna should be taken with a light meal once a day, preferably at the same time each day.
Tekturna għandu jittieħed ma ’ ikla ħafifa darba kuljum, l- aħjar fl- istess ħin tal- ġurnata kuljum.
Grapefruit juice should not be taken together with Tekturna.
Il - meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Tekturna.
Paediatric patients (below 18 years) Tekturna is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy (see section 5.2).
Pazjenti tfal (taħt it- 18- il sena) Tekturna mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja (ara sezzjoni 5. 2).
In the event of severe and persistent diarrhoea, Tekturna therapy should be stopped.
F’ każ ta ’ dijarea severa u persistenti, it- terapija b’ Tekturna għandha titwaqqaf.
Sodium and/ or volume depleted patients In patients with marked volume- and/ or salt-depletion (e. g. those receiving high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Tekturna.
Pazjenti li għandhom nuqqas ta ’ sodium u/ jew volum F’ pazjenti li jkollhom nuqqas serju ta ’ volum u/ jew melħ (eż dawk li qed jingħataw dożi għoljin ta ’ dijuretiċi) jista ’ jkun hemm sintomi ta ’ pressjoni baxxa wara li tibda l- kura b’ Tekturna.
This condition should be corrected prior to administration of Tekturna, or the treatment should start under close medical supervision.
Din il - kundizzjoni għandha tiġi korretta qabel ma jingħata Tekturna, jew il- kura għandha tinbeda taħt superviżjoni medika stretta.
Renal impairment In clinical studies Tekturna has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μ mol/ l or 1.70 mg/ dl in women and ≥ 177 μ mol/ l or 2.00 mg/ dl in men and/ or estimated glomerular filtration rate (GFR) < 30 ml/ min), history of dialysis, nephrotic syndrome or renovascular hypertension.
Indeboliment renali Fil- provi kliniċi, Tekturna ma ġiex investigat f’ pazjenti li għandhom il- pressjoni għolja u li jbatu minn indeboliment renali sever (krejatinina fis- serum ≥ 150 μmol/ l jew 1. 70 mg/ dl fin- nisa u ≥ 177 μmol/ l jew 2. 00 mg/ dl fl- irġiel u/ jew rata ta ’ filtrazzjoni fil- glomeruli (GFR) stmata < 30 ml/ min), li kellhom dijalisi fil- passat, sindrome nefrotika jew pressjoni għolja renovaskulari.
Caution should be exercised in hypertensive patients with severe renal impairment due to the lack of safety information for Tekturna.
Għandu jkun hemm kawtela f’ pazjenti bil- pressjoni għolja b’ indeboliment renali sever minħabba n- nuqqas ta ’ tagħrif dwar is - sigurtà li hemm għal Tekturna.
Renal artery stenosis No data are available on the use of Tekturna in patients with unilateral or bilateral renal artery stenosis, or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Tekturna f’ pazjenti bi stenożi ta ’ l- arterja renali unilaterali jew bilaterali, jew fi stenożi f’ kilwa waħda.
Tekturna has no known clinically relevant interactions with medicinal products commonly used to treat hypertension or diabetes.
Tekturna mhux magħruf li jagħmel interazzjonijiet li għandhom rilevanza klinika ma ’ prodotti mediċinali li jintużaw għall- kura ta ’ pressjoni għolja jew dijabete.
Co-administration of aliskiren with either valsartan (↓ 28%), metformin (↓ 28%), amlodipine (↑ 29%) or cimetidine (↑ 19%) resulted in between 20% and 30% change in Cmax or AUC of Tekturna.
Meta aliskiren jingħata ma ’ valsartan (↓28%), metformin (↓28%), amlodipine (↑29%) jew cimetidine (↑19%) is- Cmax jew AUC ta ’ Tekturna inbidlu b’ bejn 20% u 30%.
When administered with atorvastatin, steady-state Tekturna AUC and Cmax increased by 50%.
Meta ngħata ma ’ atorvastatin, l - AUC u Cmax fi stat fiss ta ’ Tekturna żdiedu b’ 50%.
Co- administration of Tekturna had no significant impact on atorvastatin, valsartan, metformin or amlodipine pharmacokinetics.
Meta Tekturna ingħata ma ’ atorvastatin, valsartan, metformin jew amlodipine dan ma kellux impatt sinifikanti fuq il- farmakokinetika tagħhom.
As a result no dose adjustment for Tekturna or these co-administered medicinal products is necessary.
Għalhekk, m’ hemmx bżonn ta ’ aġġustar tad- doża għal Tekturna jew ta ’ dawn il- prodotti mediċinali li jingħataw miegħu.
Digoxin bioavailability may be slightly decreased by Tekturna.
3 Il- biodisponibilità ta ’ digoxin tista ’ titnaqqas xi ftit b’ Tekturna.
3 Preliminary data suggest that irbesartan may decrease Tekturna AUC and Cmax.
Tagħrif preliminari jindika li irbesartan jista ’ jnaqqas xi ftit l- AUC u s- Cmax ta ’ Tekturna.
In experimental animals, it has been shown that P-gp is a major determinant of Tekturna bioavailability.
F’ annimali esperimentali, intwera li P- gp jiddetermina bil- kbir il- biodisponibilità ta ’ Tekturna.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Tekturna.
John’ s wort, rifampicin) għalhekk jistgħu jnaqqsu l- biodisponibilità ta ’ Tekturna.
John’ s wort, rifampicin) might therefore decrease the bioavailability of Tekturna.
John’ s Wort, rifampicin) għalhekk jistgħu jnaqqsu l- bijodisponibilità ta ’ Tekturna.
4 potassium or other substances that may increase serum potassium levels (e. g. heparin) may lead to increases in serum potassium.
4 Potassium u dijuretiċi li ma jħallux il- potassium jintilef Minn esperjenza b’ sustanzi oħrajn li jeffettwaw is- sistema renin- angiotensin, l- użu ta ’ dijuretiċi li ma jħallux il- potassium jintilef, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium jew sustanzi oħra li jistgħu jżidu l- livelli ta ’ potassium fis- serum (eż heparin) jistgħu jwasslu għal żidied tal- potassium fis- serum.
Grapefruit juice should not be taken together with Tekturna.
Il- meraq tal- grejpfrut m’ għandux jittieħed flimkien ma ’ Tekturna.
Warfarin The effects of Tekturna on warfarin pharmacokinetics have not been evaluated.
Warfarin L- effetti ta ’ Tekturna fuq il- farmakokinetika ta ’ warfarin ma kienux evalwati.
Food intake Meals with a high fat content have been shown to reduce the absorption of Tekturna substantially.
It- teħid ta ’ l- ikel Ikliet b’ kontenut ta ’ xaħam għoli ntwerew li jnaqqsu l- assorbiment ta ’ Tekturna b’ mod sostanzjali.
Tekturna was not teratogenic in rats or rabbits (see section 5.3).
Tekturna ma kienx teratoġeniku fi frien jew fniek (ara sezzjoni 5. 3).
As for any medicine that acts directly on the RAS, Tekturna should not be used during the first trimester of pregnancy or in women planning to become pregnant and is contraindicated during the second and third trimesters (see section 4.3).
Bħal kull mediċina oħra li taħdem direttament fuq ir - RAS, Tekturna m’ għandux jintuża waqt l- ewwel trimestru tat- tqala jew f’ nisa li qed jippjanaw biex joħorġu tqal u huwa kontraindikat waqt it- tieni u t- tielet trimestri (ara sezzjoni 4. 3).
If pregnancy is detected during therapy, Tekturna should be discontinued accordingly.
Jekk jinsab li hemm tqala waqt it- terapija, Tekturna għandu jitwaqqaf kemm jista ’ jkun malajr kif ikun xieraq.
Tekturna was secreted in the milk of lactating rats.
Tekturna għadda fil- ħalib ta ’ firien li kienu qed ireddgħu.
Tekturna has negligible influence on the ability to drive and use machines.
Tekturna ftit li xejn għandu influwenza fuq il- ħila biex issuq u tħaddem magni.
Tekturna has been evaluated for safety in more than 7,800 patients, including over 2,300 treated for over 6 months, and more than 1,200 for over 1 year.
Tekturna ġie evalwat għas- sigurtà f’ aktar minn 7, 800 pazjent, li kienu jinkludu aktar minn 2, 300 li ingħataw kura għal aktar minn 6 xhur, u aktar minn 1, 200 għal aktar minn sena.
Treatment with Tekturna resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Kura b’ Tekturna wasslet għal inċidenza globali ta ’ reazzjonijiet avversi simili għal plaċebo sa ’ 300 mg.