qanastek/EMEA-V3 huggingface dataset:
Do not remove the pre-filled pen while the injection is being given.
Tneħħix il- pinna mimlija għal- lest waqt li tkun qiegħda tingħata l- injezzjoni.
You will see a yellow indicator move into the windows during the injection.
Waqt li tkun qiegħda tingħata l- injezzjoni, fit- twieqi ta ’ l- injezzjoni, inti tibda tara sinjal isfar jiċċaqlaq.
The injection is complete when the yellow indicator stops moving.
L- injezzjoni tkun kompleta meta s- sinjal l- isfar jieqaf jiċċaqlaq.
Lift the pre-filled pen straight up from the injection site.
Tella ’ l- pinna mimlija għal- lest mill- post ta ’ l- injezzjoni.
The white needle sleeve will move down over the needle and lock into place over the needle tip.
Il- biċċa l- bajda li tgħatti l- labra tinżel fuq il- labra u tissakkar f’ postha, fuq il- ponta tal- labra.
Do not try to touch the needle.
Tippruvax tmiss il- labra.
The white needle sleeve is there to protect you from touching the needle.
Il- biċċa l- bajda li tgħatti l- labra qiegħda hemm biex tipproteġik milli tmiss il- labra.
You may notice a spot of blood at the injection site.
Jista ’ jkun li inti tinnota taqtira demm fil- post ta ’ l- injezzjoni.
You can press a cotton ball or a piece of gauze over the injection site for 10 seconds.
Tista ’ tagħfas ballun tat- tajjar jew garża fuq il- post ta ’ l- injezzjoni għal 10 sekondi.
Use a plaster if you want to.
Togħrokx il- post ta ’ l- injezzjoni.
186 Throwing away supplies
Biex tarmi l- affarijiet li użajt
• Do not put either of the caps back on the pre-filled pen. • Put used pre-filled pen immediately into the special container as instructed by your doctor, nurse or pharmacist. • Keep this container out of the reach and sight of children. • Never put the pre-filled pens that you have used into your normal household rubbish bin. • Only use each pre-filled pen for one injection.
Uża l- pinna mimlija għal- lest għal injezzjoni waħda biss.
If you use more Humira than you should:
194 Jekk tuża Humira aktar milli suppost
If you accidentally inject Humira more frequently than told to by your doctor, you should call your doctor and tell him/her that you have taken more.
Jekk inti aċċidentalment tinjetta Humira aktar frekwentament milli ordnalek it- tabib tiegħek, inti għandek iċċempel lit- tabib tiegħek u tgħidlu li ħadt aktar milli suppost.
Always take the outer carton or the pre-filled pen of medicine with you, even if it is empty.
Dejjem ħu miegħek il- kartuna ta ’ barra jew il- kunjett tal- mediċina, anke jekk ikunu vojta.
Tell your doctor immediately if you notice any of the following: • Severe r ash, hives or other signs of allergic reaction; • Swollen face, hands, feet; • Trouble breathing, swallowing; • Shortness of breath with exertion or upon lying down or swelling of the feet; • Signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
Raxx sever, urtikarja jew sinjali oħra ta ’ reazzjoni allerġika; • Nefħa fil- wiċċ, fl- idejn u fis- saqajn; • Diffikultà biex tieħu n- nifs, biex tibla ’; • Qtugħ ta ’ nifs meta tagħmel l- eżeċizzju jew meta timtedd jew nefħa fis- saqajn; • Sinjali u sintomi li għandhom x’ jaqsmu ma’ disturbi tad- demm bħal deni persistenti, tbenġil, • ħruġ ta ’ demm, tkun pallidu.
Tell your doctor as soon as possible if you notice any of the following: • Signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination; • Feeling weak or tired; • Coughing; • Tingling; • Numbness; • Double vision; • Arm or leg weakness • A bump or open sore that doesn't heal
Sinjali ta ’ infezzjoni bħal deni, tħossok marid, feriti, problemi tas- snien, ħruq waqt għamil ta ’ l - • awrina; Tħossok dgħajjef jew għajjien; • Sogħla; • • Tnemnim; Tirżiħ; • • Tara doppju; Dgħufija fl- idejn jew fir- riġlejn; • Nefħa jew ferita miftuħa li ma tfiqlekx. •
Common (in more than 1 in 100 patients but less than 1 in 10 patients): • lower respiratory tract infections (such as bronchitis, pneumonia);
Komuni (f’ aktar minn pazjent 1 minn 100 izda inqas minn pazjent 1 minn 10): infezzjonijiet fin- naħa t’ isfel tas- sistema respiratorja (bħal bronkite, pnewmonja); • infezzjonijiet fin- naħa ta ’ fuq tas- sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni fis - • sinus); infezzjonijiet virali (bħal influenza, infafet kiesħa, ħruq ta ’ Sant’ Antnin); • infezzjonijiet batterjoloġiċi (li jinkludu infezzjonijiet fis- sistema urinarja); • • infezzjonijiet tal- fungu; sturdament, vertigo, uġigħ ta ’ ras, disturbi fis- sensazzjoni; •
187 • upper respiratory tract infections (including cold, runny nose, sinus infection); • viral infections (including influenza, cold blisters and shingles) • bacterial infections (including urinary tract infection); • fungal infection; • dizziness, vertigo, headache, sensation disorders; • cough, sore throat; • nausea, diarrhoea, abdominal pain, mouth inflamation and ulcers; • elevated liver enzymes; • rash, itching; • musculoskeletal pain; • fever, fatigue.
195 sogħla, uġigħ fil- griżmejn; • nawseja, dijarea, uġigħ addominali, infjammazzjoni w ulċeri fil- ħalq; • żieda fl- enżimi tal- fwied; • raxx, ħakk; • uġigħ muskoskeletrali; • deni, għeja kbira. •
Uncommon (in more than 1 in 1000 patients but less than 1 in 100patients): • serious infections (including tuberculosis, histoplasmosis and sepsis [blood poisoning]), joint infection; • skin infections, skin warts, superficial fungal infections; • anaemia, low white blood cell and platelet counts, lymphopaenia (low immune cell counts); • swelling of the lymph nodes; • systemic lupus erythematosus; • allergic reactions, (including seasonal and medicines allergy); • increased lipid and uric acidvalues, appetite disorders; • anxiety, depression, feeling sleepy and difficulty sleeping, shaking; • taste disturbances; • vision disturbances, eye inflammation or infection; • ear discomfort; • sensation of heart beatingirregularly, high blood pressure, flushing; • asthma, shortness of breath, hoarseness; • abdominal symptoms (such as vomiting, constipation), rectal bleeding; • skin disorders (such as psoriasis, eczema or infections)itchy rash, slow wound healing, bruising, hair loss; • muscle weakness; • urinary disturbances (such as blood in urine, increased urinary frequency); • increased menstrual bleeding; • flu-like symptoms, chest pain, swelling of the feet; • accidental injury, impaired healing.
Mhux komuni (f’ aktar minn pazjent 1 minn 1000 izda inqas minn pazjent 1 minn 100) infezzjonijiet serji (li jinkludu tuberkulożi, ħistoplażmożi u fil- pene [avvelenament tad- demm]), • infezzjoni fil- ġogi; infezzjonijiet u felul fil- ġilda; infezzjonijiet superfiċjali tal- fungu; • anemija, għadd baxx taċ- ċelluli bojod u pjastrini fid- demm; limfopenja (għadd baxx taċ- ċelluli • ta ’ l- immunita ’); nefħa fin- nodi limfatiċi; • • systemic lupus erythematosus; reazzjonijiet allerġiċi (li jinkludu dawk staġonali kif ukoll allerġija għal mediċini); • żieda fil- valuri tal- lipidi u aċtu uriku, disturbi fl- aptit; • ansjetà, depressjoni, tħossok bi ngħas u diffikultà biex torqod, rogħoda; • • disturbi fit- togħma disturbi tal- vista, infjammazzjoni jew infezzjoni fl- għajnejn; • • skonfort fil- widnejn; sensazzjoni ta ’ taħbit irregolari tal- qalb, pressjoni għolja tad- demm; fwawar; • ażżma, qtugħ ta ’ nifs, vuċi ħarxa; • sintomi addominali (bħal rimettar, stitikezza), ħruġ ta ’ demm mir- rektum; • disturbi fil- ġilda (bħal psorjasi, ekżema jew infezzjonijiet), raxx li jqabbdek il- ħakk, dewmien • biex ifiqu l- feriti, tbenġil, taqa ’ ix- xagħar; dgħufija tal- muskoli; • dirstubi fis- sistema urinarja (bħal demm fl- awrina, tagħmel l- awrina aktar frekwentament); • żieda fil- ħruġ ta ’ demm tal- mestrwazzjoni; • sintomi li jixbħu lil dawk ta ’ l- influwenza, uġigħ fis- sider, nefħa fis- saqajn. • korriment aċċidentali, fejqan jieħu iżjed fit- tul •
Rare (in more than 1 in 10,000 patients but less than 1 in 1000 patients) • high pressure within the eyes, inflammation of the colored part of the eye, extensive inflammation of the eye; • skin cancer, cancer, cancer that affects the lymph system, malignant melanoma; • thyroid disorders; • protein in urine; • reduction in blood platelets which increases risk of bleeding or bruising, reduction in blood cells which can cause weakness, bruising or make infections more likely; • chest pain, heart stops pumping, blockages in the arteries of the heart, fluid around the heart that can cause severe chest pain, heart problems that can cause shortness of breath or ankle swelling, sensation of heart beating rapidly; • hearing loss, buzzing; • inflammation of the pancreas which causes severe pain in the abdomen and back, inflammation that causes abdominal pain and diarrhea, blockages of the intestine that cause nausea and vomiting, inflammation that causes pain on swallowing, indigestion, inflammation of the stomach which causes pain in the abdomen, nausea and vomiting; • extensive injury to the liver, abdominal symptoms (such as vomiting, indigestion, constipation), excess fat in the liver which can cause abdominal discomfort, fatigue and feeling unwell, stones in the gallbladder that can cause sever pain and fever, blood test shows changes in the way the liver is working;
Rari (f’ aktar minn pazjent 1 minn 10, 000 izda inqas minn pazjent 1 minn 1000) pressjoni għolja fl- għajnejn, infjammazzjoni tal- parti kkulurita tal- għajn, infjammazzjoni • estensiva tal- għajn; kanċer tal- ġilda, kanċer, kanċer li jaffetwa is- sistema limfatika, melanoma malinna; • • distrubi fit- tirojde; • proteina fl- awrina; nuqqas tal- pjastrini fid- demm li jżid ir- riskju ta ’ ħruġ ta ’ demm jew tbenġil, nuqqas taċ- ċelluli • fid- demm li jista jikkawża dgħufija, tbenġil, jew iżid iċ- ċans ta ’ infezzjonijiet; uġigħ fis- sider, il- qalb tieqaf tħabbat, imblukkar fl- arterji tal- qalb, ilma mad- dawra tal- qalb li • jista jwassal għal uġigħ qawwi fis- sider, problemi fil qalb li jistgħu iwasslu għal qtugħ ta ’ nifs jew nefħa fl- aksa, sensazzjoni ta ’ taħbit mgħaġġel tal- qalb; telf ta’ smiegħ, żanżin fil- widnejn • infjammazzjoni tal- frixa li tista tikkawża uġigħ qawwi fiż- żaqq u fid- dahar, infjammazzjoni li • tikkawża uġigħ ta ’ żaqq u dijarea, imblukkar tal- intestini li jikkawżaw dardir u rimettar, infjammazzjoni li tikkawża uġigħ meta tibla, indiġessjoni, infjammazzjoni tal- istonku li tikkawża uġigħ ta ’ żaqq dardir u rimettar; ħsara estensiva fil- fwied, sintomi addominali (bħal rimettar, indiġessjoni, stitikezza), xaħam • żejjed fil- fwied li jista jwassal għal skumdita ’ addominali, għejja u telqa tal- ġisem mingħajr l - ebda sinjali ta ’ mard, ġebel fil- marrara li jistgħu jikkawżaw uġigħ qawwi u deni, testijiet tad - demm li juru bdil fis sistema ta kif jaħdem il- fwied; infjammazzjoni li tikkawża deni, raxx fil- ġilda u wġigħ fil- ġogi; • infjammazzjoni tal- musrana l- kbira li tikkawża deni, wġigħ addominali, bugħawwieg, stitikezza; • distruzzjoni ta ’ tessuti interni u tal- ġilda ikkawżati minn infezzjoni; •
188 • inflammation that causes fever, skin rash, joint pain; • inflammation of the large intestine that causes fever, abdominal pain and cramping, constipation; • skin and deep tissue destruction caused by infection; • high blood level of calcium that is usually without symptoms but could cause abdominal pain, depression, weakness and kidney stones, low blood calcium that can cause tingling in the fingers and toes and muscle cramping; • abnormal muscle breakdown which can lead to kidney problems; • swelling in the back of the throat, fluid around the lungs that may cause shortness of breath, pain upon taking a deep breath; • inflammation of abdominal fat causing painful skin nodules; • a sac in the wall of a major artery, blockage of a heart valve usually without symptoms but may cause shortness of breath with exercise, chest pain and fainting, inflammation and clot of a vein, blockage of a blood vessel, sensation of heart beating rapidly; • multiple sclerosis; facial muscle weakness or paralysis.
196 livelli għoljin ta ’ kalċju fid- demm li ġeneralment ikunu mingħajr sintomi iżda jistgħu jikkawzaw • wġigħ addominali, dipressjoni, dgħufija u ġebel fil- kliewi, livelli baxxi ta ’ kalċju fid- demm li jikkawżaw tnemnim fis- swaba tal- idejn u tas- saqajn u bugħawwieg fil- muskoli Tifrik tal- muskolu addominali li jista jwassal għal problemi fil- kliewi; • Nefħa fuq wara tal- gerżuma, ilma madwar il- pulmun li jista jwassal għal qtugħ ta ’ nifs, uġigħ • meta tieħu nifs fil- fond; Infjammazzjoni tax- xaħam addominali li tikkawza għoqiedi ta ’ wġiegħ fil- ġilda; • Borża fil- ħajt ta ’ arterja principali, imblukkar ta ’ valv tal- qalb li ġeneralment ikunu mingħajr • sintomi iżda jistgħu jikkawzaw qtugħ ta ’ nifs meta tagħmel eżerċizzju, uġigħ fis- sider u ħass ħażin, infjammazzjoni u demm magħqud fil- vini, imblukkar ta ’ vini jew arterji, sensazzjoni ta ’ taħbit mgħaġġel tal- qalb; Sklerozi multipla; Dgħufija fil- muskoli tal- wiċċ jew paralisi. • • Sindromu ta ’ Guillain- Barré, (debbolizza fil- muskoli, sensazzjonijiet mhux tas- soltu, tnemnim fl- idejn u fil- parti ta ’ fuq tal- ġisem); • Perforazzjoni tal- intestini. hepatosplenic T- cell lymphoma •
Do not use the Humira pre-filled pen after the expiry date stated on the label/blister/carton after EXP:.
Tużax il- pinna mimlija għal- lest ta ’ Humira wara d- data ta ’ skadenza li tidher fuq it- tikketta/ il- folja/ il - pakkett wara JIS:
Keep the pre-filled pen in the outer carton.
Żomm il- pinna mimlija għal- lest fil- kartuna ta ’ barrai.
HUMIRA 40 mg solution for injection does not contain preservatives; therefore, any unused product or waste material should be disposed of in accordance with local requirements
Humira 40 mg soluzzjoni għall- injezzjoni ma għandux preservanti; għalhekk kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Is- sustanzi l- oħra huma mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide u ilma għall- injezzjoni.
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodju (23 mg) f’ kull doża ta ’ 0. 8ml, jiġifieri jista jitqies bħala li ma fihx sodju.
What the Humira pre-filled pen looks like and contents of the pack
Id- Dehra ta ’ Humira u l- kontenuti tal- pakkett:
The Humira pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Humira.
Il- pinna ta ’ Humira mimlija għal- lest hijia pinna ta ’ kulur griż u kulur l- għanbaqra, li tintuża darba biss, li fiha siringa tal- ħġieġ b’ Humira.
There are two caps – one is grey and labelled ‘1’ and the other is plum and labelled ‘2’.
Hemm żewġ għotjin – wieħed griż u mmarkat ‘ 1 ’ u l- ieħor kulur l- għanbaqra u mmarkat ‘ 2 ’.
189 There is a window on each side of the pen through which you can see the Humira solution inside the syringe.
Hemm tieqa fuq kull ġenb tal- pinna, li minnha tista ’ tara s - soluzzjoni Humira ta’ ġos- siringa.
The Humira pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens.
197 Il- pinna ta ’ Humira mimlija għal- lest tista ’ tinxtara f’ pakketti ta ’ 1, 2, 4 jew 6 pinen mimlijin għal- lest.
Not all pack sizes may be marketed.
Kull pinna mimlija għal- lest tiġi b’ kuxxinett wieħed bl- alkoħol magħha.
Humira is also available as a vial or pre-filled syringe.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali. Humira jista ’ tinxtara ukoll bħala kunjett jew siringa mimlija għal- lest.
For any information about this medicine, 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:
Eesti Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Läti Tel: + 371 67605580
198 Österreich Eesti Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Läti Tel: + 371 67605580
Postępu 18A PL-02-676 Warszawa Tel.: + 48 22 606-10-50
Polska Abbott Laboratories Poland Sp. z o. o. ul. Postępu 18A PL- 02- 676 Warszawa Tel.: + 48 22 606- 10- 50
Latvija Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Tel: + 371 67605580
199 Latvija Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Tel: + 371 67605580
Lietuva Abbott Laboratories Baltics Vienības 87h LV-1004 Rīga Latvija Tel: + 371 67605580
Lietuva Abbott Laboratories Baltics Vienības 87h LV- 1004 Rīga Latvia Tel: + 371 67605580
This leaflet was last approved in {MM/YYYY}
Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}
192
200
What is Hycamtin?
X' inhu Hycamtin?
Hycamtin is a medicine that contains the active substance topotecan.
Hycamtin hu mediċina li fiha s- sustanza attiva topotecan.
It is available as a powder to be made up into a solution for infusion (drip into a vein) and as capsules (white:
Huwa disponibbli fi trab li jitħallat biex jifforma soluzzjoni għall- infużjoni (drip fil- vina) u f' kapsuli (bojod:
1 mg).
0. 25 mg; roża 1 mg).
What is Hycamtin used for?
Għal xiex jintuża Hycamtin?
Hycamtin is an anticancer medicine.
Hycamtin hu mediċina għal kontra l- kanċer.
It is used on its own to treat patients with: • metastatic cancer of the ovary (when the cancer has spread to other parts of the body).
Jintuża waħdu fit- trattament ta 'pazjenti bi: • kanċer metastatiku fl- ovarji (meta l- kanċer ikun infirex għal partijiet oħra tal- ġisem).
It is used after at least one other treatment has failed; • small cell lung cancer, when the cancer has relapsed (come back).
Jintuża wara li jkun falla ta 'l- anqas trattament ieħor; • kanċer tal- pulmun fiċ- ċelluli żgħar, meta l- kanċer ikun reċidiv (reġa' tfaċċa).
It is used when giving the original treatment again is not recommended.
Jintuża meta ma jkunx rakkomandat li jerġa 'jingħata t- trattament oriġinali.
It is also used together with cisplatin (another anticancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Jintuża wkoll flimkien maċ- ċisplatin (mediċina oħra kontra l- kanċer) biex jittratta nisa b' kanċer fiċ - ċerviċi (l- għonq ta 'l- utru), meta l- kanċer jkun reġa' tfaċċa wara r- radjuterapija, jew meta l- marda tkun fi stadju avvanzat (stadju IVB: il- kanċer jkun infirex 'l hinn miċ- ċerviċi).
How is Hycamtin used?
Kif jintuża Hycamtin?
Treatment with Hycamtin should only be given under the supervision of a doctor experienced in the use of chemotherapy.
It- trattament b' Hycamtin għandu jingħata biss taħt is- supeviżjoni ta 'tabib li jkollu esperjenza fl- użu tal- kemjoterapija.
Infusions should be carried out in a specialised cancer ward.
L- infużjonijiet għandhom isiru fi swali onkoloġiċi speċjalizzati.
The patient ’ s blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels.
Il- livelli ta 'ċelluli bojod tad- demm, platelets u emoglobina għandhom jiġu ċċekkjati qabel it- trattament biex ikun żgurat li dawn ikunu ogħla mil- livelli minimi definiti.
The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low.
Jista 'jkun hemm bżonn li jiġu aġġustati d- dożi jew li jingħataw mediċini oħra lill- pazjenti, meta l- livell ta' ċelluli bojod fid- demm jibqa 'baxx ħafna.
The dose of Hycamtin to be used depends on the type of cancer that it is being used to treat and the patient’ s weight and height.
Id- doża ta 'Hycamtin li għandha tintuża tiddependi mit- tip ta' kanċer li d- doża qiegħda tintuża għat - trattament kif ukoll mill- piż u t- tul tal- pazjent.
When Hycamtin is used on its own for ovarian cancer, it is given by intravenous infusion over 30 minutes.
Meta Hycamtin jintuża waħdu għall- kanċer fl- ovarji, jingħata permezz ta 'infużjoni intravenuża fi żmien 30 minuta.
For lung cancer, Hycamtin can be given as an infusion or, for adults, as capsules.
Għall- kanċer tal- pulmun, Hycamtin jista 'jingħata bħala infużjoni jew, f' każ ta' adulti, f' kapsuli.
For both ovarian and lung cancer, Hycamtin is given every day for five days with a three-week interval between the start of each course.
Kemm għall- kanċer ta 'l- ovarji kemm għal dak tal- pulmun, Hycamtin jingħata kuljum għal ħamest ijiem b' waqfa ta' tliet ġimgħat bejn il- bidu ta 'kull kors.
Treatment may continue until the disease gets worse.
It- trattament jista 'jitkompla sa meta l- marda taggrava.
When used with cisplatin in ovarian cancer, Hycamtin is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1).
Meta jintuża ma 'ċisplatin fil- kanċer ta' l- ovarji, Hycamtin jingħata f' forma ta 'infużjoni fl- ewwel, it - tieni u t- tielet jum (u ċ- ċisplatin jingħata fl- ewwel jum).
This is repeated every 21 days for six courses or until the disease gets worse.
Dan jiġi repetut kull 21 jum għal sitt korsijiet jew sakemm taggrava l- marda.
For full details, see the Summary of Product Characteristics, also part of the EPAR.
Għad- dettalji kollha, ara s- Sommarju tal- Karatteristiċi tal- Prodott, ukoll parti mill- EPAR.
How does Hycamtin work?
Kif jaħdem Hycamtin?
The active substance in Hycamtin, topotecan, is an anticancer medicine that belongs to the group ‘ topoisomerase inhibitors’.
Is- sustanza attiva f' Hycamtin, topotecan, hija mediċina ta 'kontra l- kanċer li tagħmel parti mill- grupp ta' 'inibituri ta' topoisomerażi '.
It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Din timblokka enzim, it- topoisomerażi I, li għandu x' jaqsam mal - moltiplikazzjoni tad- DNA.
When the enzyme is blocked, the DNA strands break.
Meta l- enzim jiġi mblukkat, is- slejtiet tad- DNA jinkisru.
This prevents the cancer cells from dividing and they eventually die.
Dan ma jħallix liċ- ċelluli tal- kanċer jimmoltiplikaw u eventwalment dawn imutu.
Hycamtin also affects non-cancer cells, which causes side effects.
Hycamtin jolqot ukoll iċ- ċelluli li mhumiex bil- kanċer, li jwassal għal effetti sekondarji.
How has Hycamtin been studied?
Kif ġie studjat Hycamtin?
Hycamtin as an infusion has been studied in more than 480 women with ovarian cancer who had failed one treatment with platinum-containing anticancer medicines.
Hycamtin fil- forma ta 'infużjoni ġie studjat f' iktar minn 480 mara b' kanċer fl- ovarji li kien fallielhom trattament wieħed b' mediċini ta' kontra l- kanċer miksija bil- platinu.
Three studies were ‘ open ’, meaning that the medicine was not compared to any other treatment and the patients knew that they were receiving Hycamtin.
It- tliet studji kienu 'miftuħin', jiġifieri l- mediċina ma tqabblitx ma 'trattament ieħor u l- pazjenti kienu jafu li qegħdin jirċievu Hycamtin.
The fourth study involved 226 women, and compared Hycamtin with paclitaxel (another anticancer medicine).
Fir- raba 'studju ħadu sehem 226 mara, u dan qabbel Hycamtin ma' paclitaxel (mediċina oħra ta 'kontra l- kanċer).
The main measure of effectiveness was the number of patients whose tumours responded to treatment.
Il- mezz ewlieni tal- kejl ta 'l- effikaċja kien l- għadd ta' pazjenti b' tumuri li rrispondew għat- trattament.
Hycamtin has also been studied in three main studies in 656 patients with relapsed small cell lung cancer.
Hycamtin ġie studjat ukoll fi tliet studji ewlenin li fihom ħadu sehem 656 pazjent b' kanċer tal- pulmun taċ- ċelluli żgħar reċidiv.
One study compared Hycamtin capsules with symptom control alone and another compared Hycamtin as an infusion with cyclophosphamide, doxorubicin and vincristine (a standard combination of chemotherapy).
Studju minnhom qabbel Hycamtin f' forma ta 'kapsuli bil- kontroll tas- sintomi biss u l- ieħor qabbel Hycamtin fil- forma ta' infużjoni maċ- ċiklofosfamide, doxorubiċina (doxorubicin) u vinkristina (vincristine) (kombinazzjoni standard ta 'kemjoterapija).
The third study compared Hycamtin given as an infusion and as capsules.
It- tielet studju qabbel Hycamtin mogħti fil- forma ta 'infużjoni u ta' kapsuli.
The effectiveness was measured by looking at survival or response rates.
L- effikaċja tkejlet b' ħarsa lejn ir- rati ta 'sopravivenza u r - rati ta' rispons.
Hycamtin as an infusion has been studied in 293 women with advanced cervical cancer, where the effectiveness of a combination of Hycamtin and cisplatin was compared with that of cisplatin alone.
Hycamtin fil- forma ta 'infużjoni ġie studjat f' 293 mara b' kanċer avvanzat fiċ- ċerviċi, fejn l- effikaċja tal- kombinazzjoni ta' Hycamtin u ċisplatin tqabblet ma 'dik taċ- ċisplatin waħdu.
The effectiveness was measured by looking at overall survival.
L- effikaċja tkejlet b' ħarsa lejn is- sopravivenza globali.
What benefit has Hycamtin shown during the studies?
X' inhu l- benefiċċju ta 'Hycamtin li ntwera f' dawn l- istudji?
In ovarian cancer, the studies showed the effectiveness of Hycamtin, with an overall response rate of about 16%.
Fil- kanċer fl- ovarji, l- istudji wrew l- effikaċja ta 'Hycamtin, b' rata ta' rispons globali ta 'madwar 16%.
In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).
Fl- istudju ewlieni, 21% tal- pazjenti li kienu ngħataw Hycamtin (23 minn 112) irrispondew għat - trattament, meta mqabbla ma '14% tal- pazjenti li ngħataw paclitaxel (16 minn 114).
In lung cancer, looking at the results obtained in all three studies, the response rate was 20% (480 patients received Hycamtin).
Fil- kanċer tal- pulmun, ħarsa lejn ir- riżultati miksuba mit- tliet studji kollha, ir- rata ta 'rispons kienet ta' 20% (480 pazjent li kienu ngħataw Hycamtin).
Compared to symptom control alone, Hycamtin prolonged survival by 12 weeks.
Meta mqabbel mal- kontroll tas- sintomi biss, Hycamtin tawwal is- sopravivenza bi 12- il ġimgħa.
It was as effective as the standard combination chemotherapy.
Kellu effett daqs il- kombinazzjoni ta 'trattament standard tal - kemjoterapija.
Hycamtin given as capsules was as effective as Hycamtin given as an infusion.
Hycamtin mogħti f' forma ta 'kapsuli kellu effett daqs Hycamtin mogħti f' forma ta' infużjoni.
In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.
Fil- kanċer taċ- ċerviċi, il- pazjenti li kienu qed jingħataw il- kombinazjoni ta 'Hycamtin u ċisplatin għexu medja ta' 9. 4 xhur iktar, meta mqabbla ma '6. 5 xhur għall- pazjenti li jkunu ngħataw ċisplatin waħdu.
What is the risk associated with Hycamtin?
X' inhu r- riskju assoċjat ma 'Hycamtin?
The most common side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia (too few of the white blood cells that fight infection), febrile neutropenia (neutropenia that causes fever), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain, mucositis (mouth sores), alopecia (hair loss), anorexia (loss of appetite, which may be severe), pyrexia (fever), asthenia (weakness) and fatigue (tiredness).
L- iktar effetti sekondarji komuni ma 'Hycamtin (li dehru f' iktar minn pazjent wieħed minn kull 10) huma n- newtropenija (ftit wisq ċelluli bojod biex jikkumbattu l- infezzjoni), newtropenija assoċjata mad- deni (newtropenija li tikkawża deni), tromboċitopenija (għadd baxx ta' platelets), anemija (għadd baxx ta 'ċelluli ħomor tad- demm), lewkopenija (għadd baxx ta' ċelluli bojod tad- demm), nawżea (dardir), remettar u dijarrea (dawn kollha jistgħu jkunu gravi), stitikezza, użigħ addominali (ta 'żaqq), mukożite (infjammazzjonijiet fil- ħalq), alopeċja (telf ta' xagħar), anoressija (telf ta 'aptit, li jista' jkun gravi), piressija (deni), astenija (debbolizza) u għejja.
Neutropenia as a side-effect of Hycamtin can lead to neutropenic colitis (inflammation of the bowel), causing severe abdominal pain, fever and possibly diarrhoea, and which may need hospital treatment.
In- newtropenija bħala effett sekondarju ta 'Hycamtin tista' twassal għal kolite newtropenika (infjammazzjoni tal- musrana), u tikkawża wġigħ ta 'żaqq qawwi, deni u possibbilment dijarrea, u li jista' jwassal għal li l- pazjent jiddaħħal l- isptar.
For the full list of all side effects reported with Hycamtin, see the Package Leaflet.
Għal - lista sħiħa ta 'l- effetti sekondarji kollha rrappurtati ma' Hycamtin, ara l- Fuljett ta 'Tagħrif.
Hycamtin should not be used in people who may be severely hypersensitive (allergic) to topotecan or any of the other ingredients.
Hycamtin m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal topotecan jew xi ingredjenti oħra.
It should not be used in patients who are breast-feeding, or in patients who have severe bone marrow depression (low white blood cell and platelet counts) before treatment.
M' għandux jintuża minn pazjenti tqal jew li jkunu qed ireddgħu, jew f' pazjenti li jkollhom depressjoni tal- mudullun gravi (għadd baxx ta 'ċelluli bojod u platelets) qabel it- trattament.
Why has Hycamtin been approved?
Għaliex ġie approvat Hycamtin?
The Committee recommended that Hycamtin be given marketing authorisation.
Il- Kumitat għall- prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta 'Hycamtin huma ikbar mir- riskji tiegħu meta użat għat- trattament tal- karċinoma metastatika ta' l- ovarji jew kanċer tal- pulmun taċ- ċelluli żgħar reċidiv kif ukoll għat- trattament tal- kanċer taċ- ċerviċi
2/ 3 Other information about Hycamtin:
2/ 3 (flimkien ma 'ċisplatin).
The European Commission granted a marketing authorisation valid throughout the European Union for Hycamtin to SmithKline Beecham on 12 November 1996.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Hycamtin lil SmithKline Beecham fit- 12 ta 'Novembru 1996.
The marketing authorisation was renewed on 12 November 2001 and on 12 November 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fit- 12 ta 'Novembru 2001 u fit- 12 ta' Novembru 2006.
The full EPAR for Hycamtin is available here.
L- EPAR sħiħ għal Hycamtin jista 'jiġi kkonsultat hawn.
Powder for concentrate for solution for infusion
Trab għall- konċentrat għal soluzzjoni għall- infużjoni
Intravenous use
Għal użu għal ġol- vini
vial (glass)
fjala (tal- ħġieġ)
5 vials (17 ml)
5 fjali (17 ml)
1 vial (17 ml)
Fjala 1 (17 ml)
5 vials
5 fjali
1 vial
Fjala 1
Capsule, hard
Kapsula, iebsa
10 capsules
10 kapsuli
HYCAMTIN 1 mg powder for concentrate for solution for infusion
HYCAMTIN 1 mg trab għall- konċentrat għal soluzzjoni għall- infużjoni.
Each vial contains 1 mg topotecan (as hydrochloride), with a 10% overage of fill.
Kull fjala fiha 1 mg topotecan bħala (hydrochloride), b’ 10% żejjed.
Light yellow to greenish powder.
Trab isfar ċar fl- aħdar.
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy. patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Monoterapija b’ topotecan hija indikata għall- kura ta ’: pazjenti li jbatu minn karċinoma metastatika ta ’ l- ovarji meta ma tkunx ħadmet it- terapija ewlenija jew terapija sussegwenti. pazjenti b’ kanċer taċ- ċelluli ż- żgħar tal- pulmun [SCLC] li reġa ’ tfaċċa u li għalihom trattament mill- ġdid bit- terapija ewlenija m’ huwiex ikkunsidrat xieraq (ara sezzjoni 5. 1).
Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
Topotecan flimkien ma ’ cisplatin huwa indikat għall- pazjenti b’ karinoma taċ- ċerviċi li reġgħet feġġet wara radjuterapija u għall- dawk il- pazjenti bil- marda fl- Istadju IVB.
Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Pazjenti li qabel kellhom esponiment għal- cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament biż- żewġ mediċini flimkien (ara sezzjoni 5. 1).
The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Topotecan irid jintuża biss f’ dipartimenti speċjalizzati fl- għoti ta ’ kimoterapija ċitotossika u jista ’ jingħata biss taħt l- osservazzjoni ta ’ speċjalista li għandu esperjenza fl- użu ta ’ kimoterapija (ara sezzjoni 6. 6).
When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Meta jintuża flimkien ma ’ cisplatin, l- informazzjoni kompleta ta ’ kif jiġi preskritt cisplatin għandha tiġi kkonsultata.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/ l, a platelet count of ≥ 100 x 109/ l and a haemoglobin level of ≥ 9 g/ dl (after transfusion if necessary).
Qabel ma jingħata l- ewwel kors ta ’ topotecan, il- pazjent irid ikollu linja bażi ta ’ l- għadd ta ’ nutrofili ta ’ ≥ 1. 5 x 109/ l, għadd ta ’ plejtlits ta ’ ≥ 100 x 109/ l u livell ta ’ emoglobina ta ’ ≥ 9g/ dl (jekk hemm bżonn wara trażfusjoni).
Topotecan must be reconstituted and further diluted before use (see section 6.6).
Topotecan irid jiġi rikostitwit u imbagħad dilwit aktar qabel l- użu (ara sezzjoni 6. 6).
Ovarian and Small Cell Lung Carcinoma
Karċinoma ta ’ l- Ovarji u taċ- Ċelluli ż- Żgħar tal- Pulmun
Initial dose The recommended dose of topotecan is 1.5 mg/ m2 body surface area/ day administered by intravenous infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course.
Doża inizjali Id- doża ta ’ topotecan rakkomandata hija ta ’ 1. 5 mg/ m2 tal- erja tas- superfiċje tal- ġisem kuljum.
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Id- doża trid tingħata b’ infużjoni fil- vina għal 30 minuta kuljum għal ħames ġranet konsekuttivi b’ intervall ta ’ 3 ġimgħat bejn il- bidu ta ’ kull kors.
2 Subsequent doses Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/ l, the platelet count is ≥ 100 x 109/ l, and the haemoglobin level is ≥ 9 g/ dl (after transfusion if necessary).
Jekk jiġi ttollerat mill- ġisem, il- kura tista ’ tkompla sakemm il - marda tmur għall- aħjar (ara sezzjonijiet 4. 8 u 5. 1) 2 Dożi sussegwenti Topotecan m’ għandux jerġa ’ jiġi amministrat ħlief jekk l- għadd tan- newtrofili jkun ≥ 1 x 109/ l, l - għadd ta ’ plejtlits ikun ≥ 100 x 109/ l, u l- livell ta ’ l- emoglobina jkun ≥ 9 g/ dl (wara trasfużjoni, jekk ikun hemm bżonn).
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e. g.
Il- prattika ta ’ onkoloġija standard għall- immaniġġjar ta ’ newtropenija hija jew li tamministra topotecan ma ’ mediċini oħra (e. ż.
G-CSF) or to dose reduce to maintain neutrophil counts.
G- CSF) jew li tnaqqas id- doża biex iżżomm il- livelli ta ’ newtrofili.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/ l) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/ m2/ day to 1.25 mg/ m2/ day (or subsequently down to 1.0 mg/ m2/ day if necessary).
Jekk it- tnaqqis fid- doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l- għadd ta ’ newtrofili < 0. 5 x 109/ l) għal 7 ijiem jew iktar, jew newtropenja qawwija bid- deni jew infezzjoni, jew li kellhom il- kura sospiża minħabba newtropenja, id- doża għandha titnaqqas b’ 0. 25mg/ m2/ jum għal 1. 25 mg/ m2/ ġurnata (jew sussegwentement imnaqqsa għal 1. 0 mg/ m2/ ġurnata jekk ikun hemm bżonn).
Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
Id- dożi jridu jitnaqsu wkoll jekk in- numru ta ’ plejtlits jaqa ’ taħt 25 x 109/ l.
In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/ m2 and a further dose reduction was required to manage adverse effects.
Fl- istudji kliniċi li saru, topotecan ma baqax jingħata jekk d- doża tnaqqset għal 1. 0 mg/ m2 u kien hemm il- bżonn ta ’ aktar tnaqqis fid- doża biex jiġu ikkontrollati l- effetti avversi.
Cervical Carcinoma
Karċinoma ċervikali
Initial dose The recommended dose of topotecan is 0.75 mg/ m2/ day administered as 30 minute intravenous infusion daily on days 1, 2 and 3.
Doża inizjali Id- doża rakkommandata ta ’ topotecan hija ta ’ 0. 75 mg/ m2/ ġurnata amministrata bħala infużjoni ġol - vina għal 30 minuta kuljum fil- ġranet 1, 2 u 3.
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/ m2/ day and following the topotecan dose.
Cisplatin huwa amministrat bħala infużjoni ġol- vina fil - ġurnata 1 f’ doża ta ’ 50 mg/ m2/ ġurnata u wara tingħata d- doża ta ’ topotecan.
This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Din l- iskeda ta ’ trattament hija ripetuta kull 21 ġurnata għall- 6 korsijiet jew sakemm il- marda tmur għall- aħjar.
Subsequent doses Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 109/ l, the platelet count is more than or equal to 100 x 109/ l, and the haemoglobin level is more than or equal to 9g/ dl (after transfusion if necessary).
Dożi sussegwenti Topotecan m’ għandux jerġa ’ jiġi amministrat ħlief jekk l- għadd tan- newtrofili jkun aktar minn jew 1 x 109/ l, l- għadd ta ’ plejtlits ikun aktar minn jew 100 x 109/ l, u l- livell ta ’ l- emoglobina jkun aktar minn jew 9 g/ dl (wara trasfużjoni, jekk ikun hemm bżonn).
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 109/ l) for 7 days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/ m2/ day for subsequent courses (or subsequently down to 0.45 mg/ m2/ day if necessary).
Jekk it- tnaqqis fid- doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l- għadd tan - newtrofils anqas minn 0. 5 x 109/ l) għal 7 ijiem jew aktar, jew newtropenja qawwija assoċċjata ma ’ deni jew infezzjoni jew li t- trattament kien ittardjat minħabba newtropenja, id- doża għandha titnaqqsilhom b’ 20% għal 0. 60 mg/ m2 / ġurnata għall- korsijiet sussegwenti (jew sussegwement titnaqqas għal 0. 45mg/ m2/ jum jekk ikun hemm bżonn).
Doses should be similarly reduced if the platelet count falls below 25 x 109/ l.
Id- dożi għandhom jitnaqqsu bl- istess mod jekk il- għadd tal- plejtlits jinżel f’ livell anqas minn 25 x 109/ l..
Dosage in renally impaired patients Monotherapy (Ovarian and Small cell lung carcinoma) Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/ min.
Id- doża f’ pazjenti b’ indeboliment renali Monoterapija (Karċinoma ta ’ l- Ovarji u taċ- Ċelluli ż- Żgħar tal- pulmun) M’ hemmx biżżejjed informazzjoni biex ikun hemm rakkomandazzjonijiet għal pazjenti li għandhom tneħħija tal- krejatinina ta ’ < 20 ml/ min.
Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Il- ftit informazzjoni li teżisiti tindika li d- doża trid titnaqqas f’ pazjenti li jbatu minn indeboliment tal- kliewi moderat.
The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/ min is 0.75 mg/ m2 / day for 5 consecutive days.
Id- doża ta ’ topotecan rakkomandata f ’ monoterapija f’ pazjenti b’ karċinoma ta ’ l- ovarji jew taċ- ċelluli ż- żgħar tal- pulmun u li għandhom tneħħija tal- krejatinina ta ’ bejn l- 20 u d- 39 ml/ min hija ta ’ 0. 75 mg/ m2 / ġurnata għal ħamest ijiem konsekuttivi.
Combination therapy (Cervical carcinoma) In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/ dL.
Jekk waqt it- terapija
If, during topotecan/ cisplatin combination therapy serum creatinine exceeds 1.5 mg/ dL, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/ continuation.
3 b’ topotecan flimkien ma ’ cisplatin il- krejatinina tas- serum taqbeż il- 1. 5mg/ dL, huwa rakkommandat li tiġi kkonsultata l- informazzjoni kompleta ta ’ kif jiġi preskritt cisplatin għall- parir dwar tnaqqis jew tkomplija tad- doża.
If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Jekk cisplatin jitwaqqaf, m’ hemmx tagħrif biżżejjed dwar it- tkomplija ta ’ topotecan bħala monoterapija f’ pazjenti b’ kanċer ċervikali.
3 Paediatrics The experience in children is limited, therefore no recommendation for treatment of paediatric patients with HYCAMTIN can be given (see sections 5.1 and 5.2).
Pedjatrija L- esperjenza fit- tfal hija limitata u għalhekk ma tista ’ tingħata l- ebda rakkommandazzjoni għat - trattment ta ’ pazjenti pedjatriċi b’ HYCAMTIN (ara sezzjonijiet 5. 1 u 5. 2).
4.3 Contraindications
HYCAMTIN huwa kontra- indikat f’ pazjenti li
HYCAMTIN is contraindicated in patients who − have a history of severe hypersensitivity to the active substance or to any of the excipients − are breast feeding (see section 4.6) − already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/ l and/ or a platelet count of < 100 x 109/ l.
linja bażi ta ’ newtrofili ta ’ < 1. 5 x 109/ l u/ jew għadd ta ’ plejtlits ta ’ < 100 x 109/ l.
Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
It- tossiċità ematoloġika hija relatata mad- doża, u spiss għandu jsir eżami sħiħ ta ’ l- għadd taċ- ċelluli tad- demm li jinkludi l- plejtlits (ara sezzjoni 4. 2).
As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Bħal prodotti mediċinali ċitotossiċi oħra, topotecan jista ’ jikkawża suppressjoni serja tal- mudullun ta ’ l- għadam.
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Suppressjoni tal- mudullun ta ’ l- għadam li twassal għal- sepsis u mewt minħabba sepsis ġew irrappurtati f’ pazjenti trattati b’ topotecan (ara sezzjoni 4. 8).
Topotecan-induced neutropenia can cause neutropenic colitis.
Newtropenja kkawżata minn Topotecan tista twassal għal kolite tan- newtropenja.
Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Fi provi kliniċi b’ topotecan, ġew irrappurtati każijiet ta ’ mewt minħabba l- kolite tan- newtropenja.
In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
F’ pazjenti li jkollhom deni, newtropenja, u tip t' uġigħ ta ’ żaqq kompatibbli, għandha tiġi kkunsidrata l- possibilità ta ’ kolite tan- newtropenja.
Topotecan has been associated with reports of interstitial lung disease, some of which have been fatal (see section 4.8).
Topotecan ġie assoċċjat ma ’ rapporti ta ’ mard ta 'l- interstizju tal- pulmun, fejn ftit minnhom kienu fatali (ara sezzjoni 4. 8).
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic drugs and/ or colony stimulating factors.
Fatturi ta ’ riskju bażi jinkludu fil- passat ILD, fibrożi pulmonari, kanċer tal - pulmun, espożizzjoni toraċika għal radjazzjoni u l- użu ta ’ mediċini pnewmotossiċi u/ jew fatturi li jistimulaw kolonji.
Patients should be monitored for pulmonary symptoms indicative of interstitial lung disease (e. g. cough, fever, dyspnoea and/ or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed.
Il- pazjenti għandhom ikunu sorveljati għal sintomi pulmonari li jindikaw mard ta ’ l- interstizju tal- pulmun (e. ż. sogħla, deni, qtigħ ta 'nifs u/ jew nuqqas ta' ossiġenu), u topotecan għandu jitwaqqaf jekk tkun ikkonfermata dijanjożi ġdida ta ’ ILD.
Topotecan and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Topotecan u topotecan flimkien ma cisplatin huma assoċjati b’ mod komuni ma ’ tromboċitopenja klinikamnet rilevanti.
This should be taken into account, e. g. in case patients at increased risk of tumour bleeds are considered for therapy.
Din għandha tiġi kkunsidrata e. ż. f’ każ li pazjenti li għandhom riskju ogħla ta ’ fsada minn tumuri jiġu kkunsidrati għal terapija.
As expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Kif inhu mistenni, pazjenti li għandhom stat ta ’ saħħa ħażina (PS > 1) għandhom rata ta ’ rispons aktar baxxa u inċidenza ogħla ta ’ kumplikazzjonijiet bħal- deni, infezzjoni u sepsis (ara sezzjoni 4. 8).
Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3.
Stima preċiża ta ’ l- istat ta ’ saħħa tal- persuna fiż- żmien li fih tingħata t- terapija huwa importanti biex tiżgura li l- pazjenti ma ddeterjorawx sa l- istat ta ’ saħħa 3.
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/ min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/ dl) due to cirrhosis.
M’ hemmx biżżejjed esperjenza dwar l- użu ta ’ topotecan f’ pazjenti li għandhom indeboliment serju tal - kliewi (tneħħija tal- krejatinina < 20 ml/ min) jew li jbatu minn indeboliment serju tal- fwied (bilirubin fis- serum ≥ 10 mg/ dl) minħabba ċirrożi.
Topotecan is not recommended to be used in these patient groups.
L- użu ta ’ topotecan f’ dawn il- pazjenti mhuwiex issuġġerit.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/ dl) were given 1.5 mg/ m2 for five days every three weeks.
Numru żgħir ta ’ pazjenti b’ indeboliment tal- fwied (bilirubin fis- serum bejn 1. 5 u 10 mg/ dl) ingħataw doża ta ’ 1. 5 mg/ m2 għal ħamest ijiem kull tlett ġimgħat.
A reduction in topotecan clearance was observed however there are insufficient data available to make a dose recommendation for this patient group.
Tnaqqis fit- tneħħija ta ’ topotecan ġiet osservata, madanakollu m’ hemmx biżżejjed informazzjoni biex ikun hemm rakkomandazzjoni ta ’ doża f’ dan il- grupp ta ’ pazjenti.
4.5 Interaction with other medicinal products and other forms of interaction
4 4. 5 Prodotti mediċinali oħra li ma ’ jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
No in vivo human pharmacokinetic interaction studies have been performed.
Ma sarux studji ta ’ interazzjoni farmakokinetiċi umani in vivo.
Topotecan does not inhibit human P450 enzymes (see section 5.2).
Topotecan ma jinibixxix l- enżimi umani P450 (ara sezzjoni 5. 2).
In a population study, the co- 4 administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Fi studju li sar fuq pazjenti, il- ko - amministrazzjoni ta ’ granisetron, ondansetron, morphine jew kortikosterojdi ma jidhirx li kellhom effetti sinifikant fuq il- farmakokinetika ta ’ topotecan totali (fil- forma attiva jew inattiva).
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Meta topotecan jiġi użat ma ’ prodotti kimoterapewtiċi oħra, jista ’ jkun hemm bżonn li titnaqqas id - doża ta ’ kull waħda minn dawn il- kuri biex tittejjeb it- tollerabilità tagħhom kollha.