qanastek/EMEA-V3 huggingface dataset:
If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once. • Very rarely people experienced flu-like symptoms, especially when they just started treatment.
Kellem lit- tabib tiegħek minnufih jekk ikollok tisfir mhux tas- soltu jew diffikultà fin- nifs; ilsienek, wiċċek jew griżmejk minfuħin, jew nefħa madwar is- sit ta ’ l- injezzjoni; jekk tħossok ħażin jew sturdut jew jekk tikkollassa. • Rari ħafna kien hemm persuni li esperjenzaw sintomi li jixbħu lil dawk ta ’ l- influwenza, speċjalment meta jkunu għadhom kemm bdew it- trattament.
These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Dawn jinkludu deni, rogħda, uġigħ ta ’ ras, uġigħ fir- riġlejn, uġigħ fl- għadam u/ jew tħossok ma tiflaħx b’ mod ġenerali.
These reactions were usually mild to moderate and went away within a few hours or days.
Dawn ir- reazzjonijiet ġeneralment kienu ħfief għal moderati u marru wara ftit sigħat jew ġranet.
273 Additional side effects in people with chronic kidney disease (renal anaemia) • Increase in blood pressure, worsening of existing high blood pressure and headache are the most common side effects.
Effetti sekondarji oħra f’ persuni b’ marda kronika fil- kliewi (anemija renali) • L- aktar effetti sekondarji komuni huma żjieda fil- pressjoni tad- demm, pressjoni tad- demm għolja li tmur għall- agħar u uġigħ ta ’ ras.
Your doctor will regularly check your blood pressure, particularly at the beginning of therapy.
It- tabib tiegħek se jiċċekkja l- pressjoni tad- demm tiegħek regolarment, speċjalment fil- bidu tal- kura.
Your doctor may treat the high blood pressure with drugs or temporarily interrupt your NeoRecormon therapy. • Call a doctor at once if you get headaches, especially sudden, stabbing, migraine-like headaches, confusion, speech disturbance, unsteady walking, fits or convulsions.
It- tabib tiegħek jista ’ jikkura l- pressjoni tad - demm għolja permezz ta ’ mediċinali jew billli jinterrompi temporanjament it- terapija b’ NeoRecormon. • Kellem tabib immedjatament jekk ikollok uġigħ ta ’ ras, speċjalment uġigħ ta ’ ras f’ daqqa, li ttektek u li tixbaħ lill- emigranja, konfużjoni, disturbi fil- kliem, mixi mhux stabbli, aċċessjoni jew konvulżjoni.
These may be signs of severely elevated blood pressure (hypertensive crisis), even if your blood pressure is usually normal or low.
Dawn jistgħu jkunu sinjali ta ’ pressjoni tad- demm elevata b’ mod sever (kriżi ipertensiva), anki jekk il- pressjoni tad- demm tiegħek normalment tkun normali jew baxxa.
It needs to be treated at once. • If you have low blood pressure or shunt complications you may be at risk of shunt thrombosis (a blood clot in the vessel used for connection to the dialysis system). • Very rarely, patients have had rising levels of potassium or phosphates in the blood.
Din għandha tiġi kkurata mill- ewwel. • Jekk ikollok pressjoni tad- demm baxxa jew kumplikazzjonijiet tax- shunt tista ’ tkun f’ riskju ta ’ trombożi tax- shunt (tgħaqqid tad- demm ġol- vina jew arterja użata għall- konnessjoni mas- sistema tad- dijalisi). • Rari ħafna kien hemm pazjenti li kellhom żjieda fil- livelli ta ’ potassju jew tal- fosfati fid - demm.
This can be treated by your doctor. • Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon.
Dan jista ’ jiġi kkurat mit- tabib tiegħek. • Aplasija pura taċ- ċelloli l- ħomor (PRCA) ikkawżata minn antikorpi newtrallizzanti kienet osservata waqt terapija b’ eritropoetin, inkluż każijiet iżolati waqt kura b’ NeoRecormon.
PRCA means that the body stopped or reduced the production of red blood cells.
PRCA jfisser li l- ġisem jieqaf jew inaqqas il- produzzjoni taċ- ċelluli l- ħomor tad- demm.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
Din tikkawża anemija severa, li s- sintomi tagħha jinkludu għejja mhux tas- soltu u nuqqas ta ’ enerġija.
If your body produces neutralising antibodies, your doctor will discontinue therapy with NeoRecormon, and determine the best course of action to treat your anaemia.
Jekk ġismek jipproduċi antikorpi newtralizzanti, it- tabib tiegħek se jwaqqaf il- kura b’ NeoRecormon u jiddetermina l- aħjar azzjoni biex tkun ikkurata l- anemija tiegħek.
Additional side effects in adults receiving chemotherapy for cancer • Increase in blood pressure and headache may occasionally occur.
Aktar effetti mhux mixtieqa f’ adulti li qed jirċievu kimoterapija għall- kanċer • Kultant jistgħu jseħħu żjieda fil- pressjoni tad- demm u uġigħ ta ’ ras.
Your doctor may treat the high blood pressure with drugs. • An increase in the occurrence of blood clots has been observed.
It- tabib tiegħek jista ’ jikkura l- pressjoni għolja tad- demm b’ mediċini. • Kienet osservata żjieda fl- okkorrenza ta ’ tgħaqqid tad- demm.
Additional side effects in people donating their own blood before surgery • A slight increase in the occurrence of blood clots has been observed.
Effetti sekondarji oħra f’ persuni li jagħtu d- demm tagħhom qabel kirurġija • Kienet osservata żjieda żgħira fl- okkorrenza ta ’ tgħaqqid tad- demm.
HOW TO STORE NEORECORMON
KIF TAĦŻEN NEORECORMON
• Keep out of the reach and sight of children. • Do not use NeoRecormon after the expiry date which is stated on the pack. • Store in a refrigerator (2°C – 8°C). • The vial can be removed from the refrigerator and left at room temperature for a single period of maximum 5 days (but not above 25°C). • The reconstituted solution may be stored for 1 month in a refrigerator at 2°C – 8°C. • Keep the container in the outer carton in order to protect from light. • Medicines should not be disposed of via wastewater or household waste.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax NeoRecormon wara d- data ta ’ skadenza li tidher fuq il- pakkett. • Aħżen fi friġġ (2°C – 8°C). • Il- kunjett jista ’ jitneħħa mill- friġġ u jista ’ jitħalla f’ temperatura tal- kamra għal perjodu wieħed ta ’ mhux aktar minn 5 ijiem (iżda mhux f’ aktar minn 25°C). • Is- soluzzjoni rikostitwita għandu jinżam għal xagħar fi friġġ f’ temperatura ta ’ bejn 2°C – 8°C. • Żomm il - kontenitur fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
What NeoRecormon contains
X’ fih NeoRecormon
- The active substance is epoetin beta.
- Is- sustanza attiva hi epoetin beta.
One vial contains either 50,000 IU or 100,000 IU
Kunjett wieħed fih 50, 000 IU jew 100, 000 IU (unitajiet
(international units) epoetin beta.
internazzjonali) epoetin beta.
- The other ingredients are urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate,
- Is- sustanzi l- oħra huma urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate,
disodium hydrogen phospate, calcium chloride, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
disodium hydrogen phospate, calcium chloride, glycine, L- Leucine, L- Isoleucine, L- Threonine, L- Glutamic acid, u L- Phenylalanine.
- The solvent contains benzyl alcohol and benzalkonium chloride as preservatives in 10 ml (for
- Is- solvent fih benzyl alcohol u benzalkonium chloride bħala preservattivi f’ 10 ml (għal
the NeoRecormon Multidose 50,000 IU) or 5 ml (for the NeoRecormon Multidose 100,000 IU) water for injections.
NeoRecormon Multidose 50, 000 IU) jew f’ 5 ml (għal NeoRecormon Multidose 100, 000 IU) ilma għall- injezzjonijiet.
What NeoRecormon looks like and contents of the pack
Id- Dehra ta ’ NeoRecormon u l- kontenuti tal- pakkett
White lyophilisate and clear, colourless solvent
Lajofiliżat abjad u solvent ċar u bla kulur.
NeoRecormon Multidose is provided as a lyophilisate vial and solvent ampoule for solution for injection.
NeoRecormon Multidose huwa pprovdut bħala kunjett ta ’ lajofiliżat u ampulla b’ solvent għal soluzjoni għall- injezzjoni.
Manufacturer Roche Diagnostics GmbH Sandhofer Str.
Il- Manifattur Roche Diagnostics GmbH Sandhofer Str.
116 68305 Mannheim Germany
116 68305 Mannheim Il- Ġermanja
Norge Roche Norge AS Tlf: +47 - 22 78 90 00
Norge Deutschland Roche Norge AS Roche Pharma AG Tlf: +47 - 22 78 90 00 Tel: +49 (0) 7624 140
275 Ελλάδα Roche (Hellas) A.E.
E.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
276 PACKAGE LEAFLET:
281 FULJETT TA ’ TAGĦRIF:
NeoRecormon 10,000 IU NeoRecormon 20,000 IU NeoRecormon 60,000 IU Lyophilisate and solvent for solution for injection in cartridge Epoetin beta
NeoRecormon 10, 000 IU NeoRecormon 20, 000 IU NeoRecormon 60, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni fi skartoċċ Epoetin beta
please tell your doctor of pharmacist.
imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
NeoRecormon cartridge is a two-chamber cartridge containing white lyophilisate and solvent.
Skortoċċ NeoRecormon huwa skartoċċ b’ żewġ kompartimenti li fih lajofiliżat abjad u solvent.
After dissolving, NeoRecormon is injected under the skin (subcutaneously).
Wara li jinħall, NeoRecormon jiġi injettat taħt il- ġilda (subkutanju) jew ġo vina (ġol- vini).
Do not use NeoRecormon: • if you are allergic (hypersensitive) to epoetin beta or any of the other ingredients of NeoRecormon or benzoic acid, a metabolite of benzyl alcohol • if you have blood pressure problems that cannot be controlled • if you are donating your own blood before surgery, and:
Tużax NeoRecormon: • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- epoetin beta jew sustanzi oħra ta ’ NeoRecormon jew għal benzoic acid, metabolit ta ’ benzyl alkoħol. • jekk għandek problemi bil- pressjoni tad- demm li ma jistgħux jiġu kkontrollati; • jekk qed tagħti d- demm tiegħek qabel kirurġija, u:
you had a heart attack or stroke in the month before your treatment you have unstable angina pectoris – new or increasing chest pain you are at risk of blood clots in the veins (deep venous thrombosis) – for example, if you have had clots before.
kellek attakk jew puplesija fix- xahar ta ’ qabel il- kura għandek anġina pektoris mhux stabbli – uġigħ fis- sider ġdid jew li qed iżid tinsab f’ riskju ta ’ ta ’ formazzjoni ta ’ demm magħqud fil- vini (trombożi fil- vini l - fondi) – per eżempju, jekk kellek tgħaqqid fid- demm qabel.
277 • in infants or young children up to 3 years, since NeoRecormon in cartridge contains benzyl alcohol as a preservative If any of these apply to you, or might apply, tell your doctor at once.
Jekk xi waħda minn dawn tapplika għalik, jew tista ’ tapplika għalik, għarraf lit- tabib tiegħek immedjatament.
Take special care with NeoRecormon: • if your anaemia does not improve with epoetin treatment • if you are low in certain B vitamins (folic acid or vitamin B12) • if you have very high levels of aluminium in your blood • if your blood platelet count is high • if you have chronic liver disease • if you have epilepsy • if you have developed anti-erythropoietin antibodies and pure red cell aplasia (reduced or stopped production of red blood cells) during prior exposure to any erythropoietic substance.
Oqgħod attent ħafna b’ NeoRecormon: • jekk l- anemija li għandek ma titjiebx bil- kura b’ epoetin • jekk għandek livelli baxxi ta ’ ċerti vitamini B (folic acid jew vitamina B12) • jekk għandek livelli għoljin ħafna ta ’ aluminju fid- demm • jekk l- għadd ta ’ plejtlits fid- demm tiegħek huwa għoli • jekk għandek mard kroniku tal- fwied • jekk għandek epilessija • jekk żviluppajt antikorpi kontra l- eritropoetin u aplasia pura taċ- ċelluli l - ħomor (produzzjoni taċ- ċelluli l- ħomor tad- demm imnaqqsa jew imwaqqfa) waqt esposizzjoni preċedenti għal xi sustanza eritropoetika.
Your doctor may do regular blood tests to check: • your potassium level.
It- tabib tiegħek jista ’ jwettaq testijiet tad- demm regolari sabiex jiċċekkja: • il- livell ta ’ potassju tiegħek.
If you have high or rising potassium levels your doctor may reconsider your treatment • your blood platelet count.
Jekk għandek livell ta ’ potassju għoli jew li qed jiżdied it- tabib tiegħek jista ’ jerġa jikkonsidra l- kura tiegħek • l- għadd ta ’ plejtlits tiegħek.
278 Pregnancy and breast-feeding There is not much experience with NeoRecormon in pregnant women or women who are breast- feeding.
283 Tqala u treddiegħ M’ hemmx wisq esperjenza ta ’ NeoRecormon f’ nisa tqal jew f’ nisa li jkunu qed ireddgħu.
Driving and using machines No effects on ability to drive or use machines have been observed.
Sewqan u tħaddim ta ’ magni Ma ġew osservati l- ebda effetti fuq il- ħila ta ’ sewqan u l- użu ta’ magni.
Important information about some of the ingredients of NeoRecormon This medicine contains phenylalanine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ NeoRecormon Din il- mediċina fiha phenylalanine.
NeoRecormon is almost sodium-free.
Neo- Recormon huwa kważi bla sodju.
NeoRecormon injections can then be given by a trained nurse, doctor or other professional.
Imbagħad injezzjonijiet ta ’ NeoRecormon jistgħu jingħataw minn infermiera mħarrġa, tobba jew professjonisti oħrajn.
Once you have been shown how, you can also inject the solution yourself.
La darba tiġi muri kif, tista ’ wkoll tinjetta ’ s- soluzzjoni inti stess,
NeoRecormon cartridge should only be used with Reco-Pen.
Skartoċċ NeoRecormon għandu jintuża biss ma ’ Reco- Pen.
Instructions for use First wash your hands!
Istruzzjonijiet għall- użu L- ewwel aħsel idejk!
Remove one cartridge from the pack,
Neħħi skartoċċ wieħed mill- pakkett.
Remove a needle from the pack and fix it securely on the Reco-Pen,
Neħħi labra mill- pakkett u waħħalha sewwa ma ’ Reco- Pen.
Insert the cartridge into the Reco-Pen,
Daħħal l- iskartoċċ fir- Reco- Pen.
Press the cartridge to dissolve the lyophilisate in the solvent Check the solution in the cartridge:
Għafas l- iskartoċċ biex tiddissolvi l- lajofiliżat fis- solvent Iċċekkja s- soluzzjoni fl- iskartoċċ:
is it clear? is it colourless? is it free of particles? answer is NO to any question, do not administer the injection.
hija ċara? hija bla kulur? hija ħielsa minn frak?
Dispose of it and start again with a different cartridge.
Armiha u ibda mill- ġdid bi skartoċċ differenti.
If you answer yes to all three, remove the cap from the Reco-Pen and go to step 5.
Jekk it- tweġiba għat- tliet mistoqsijiet hija iva, neħħi l- għatu minn Reco- Pen u mur għall- punt 5.
Do this by lightly tapping on the upper half of the Reco-Pen.
Neħħi l- arja mill- iskartoċċ u l- labra. Għamel dan billi ttektek bil- mod fuq in- nofs ta ’ fuq ta ’ Reco- Pen.
This will cause any air bubbles to rise to the top.
Dan iwassal biex xi bżieżaq ta ’ l- arja jitilgħu ’ il fuq.
Then hold the Reco-Pen vertically and the needle upwards, and gently push the plunger upwards.
Imbagħad żomm ir- Reco- Pen b’ mod vertikali u l- labra ’ il fuq, u bil- mod imbotta l- planġer ’ il fuq.
Keep pushing the plunger until the amount of NeoRecormon in the Reco-Pen is as prescribed.
Kompli imbotta l - planġer ’ il fuq sakemm l- ammont ta ’ NeoRecormon fir- Reco- Pen huwa kif preskritt.
Clean the skin at the injection site using an alcohol wipe.
Naddaf il- ġilda fil- lok ta ’ l- injezzjoni permezz ta ’ mselħa bl- alkoħol.
Form a skin fold by pinching the skin between thumb and forefinger.
Ifforma tinja fil- ġilda billi toqros il- ġilda bejn subgħajk il- kbir u l- werrej.
Holding the Reco-Pen near the needle, insert the needle into the skin fold with a quick, firm action.
Int u żżomm ir- Reco- Pen viċin il- labra, daħħal il- labra fit- tinja fil- ġilda b’ moviment ħafif u sod.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Oħroġ il- labra malajr u agħmel pressjoni fuq is - sit ta ’ l- injezzjoni b’ biċċa xotta u sterili.
NeoRecormon dosing The dose of NeoRecormon depends on your dise ase condition, the way the injection is given (under the skin) and your body weight.
284 Doża ta ’ NeoRecormon Id- doża ta ’ NeoRecormon tiddependi mill- kundizzjoni tal- marda, mill- mod kif tingħata l- injezzjoni (taħt il- ġilda) u mill- piż tal- ġisem tiegħek.
Your doctor will work out the right dose for you.
It- tabib tiegħek se jikkalkula id- doża t- tajba għalik.
279 • Symptomatic anaemia caused by chronic kidney disease
• Anemija sintomatika kkawżata minn marda kronika tal- fwied
Treatment with NeoRecormon is divided into two stages:
It- trattament b’ NeoRecormon huwa maqsum f’ żewġ stadji:
a) Correcting the anaemia The initial dose is 20 IU per injection for every 1 kg of your body weight, given three times per week.
a) Korrezzjoni ta ’ l- anemija Id- doża tal- bidu hija ta ’ 20 IU kull injezzjoni għal kull 1 kg tal- piż ta ’ ġismek, mogħtija tliet darbiet fil- ġimgħa.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week.
Wara 4 ġimgħat, it- tabib iwettaq xi testijiet u, jekk ir- respons għall- kura mhux suffiċjenti, id- doża tista ’ tiżdied għal 40 IU/ kg kull injezzjoni, mogħtija tliet darbiet fil- ġimgħa.
The doctor may continue to increase your dose at monthly intervals if necessary.
Jekk ikun neċessarju t - tabib jista ’ jkompli jżid id- doża tiegħek f’ intervalli ta ’ xahar.
The maximum dose should not exceed 720 IU for every 1 kg of your body weight per week.
Id- doża massima m’ għandhiex tkun ta ’ aktar minn 720 IU għal kull 1 kg tal- piż ta ’ ġismek fil- ġimgħa.
Every one or two weeks, the doctor may adjust your dose to find your individual maintenance dose.
Kull ġimgħa jew ġimagħtejn, it- tabib jista ’ jaġġusta d- doża tiegħek sabiex isib id- doża ta ’ manutenzjoni individwali għalik.
Your doctor will take regular blood samples.
It- tabib tiegħek għandu jieħu kampjuni tad- demm b’ mod regolari.
He or she may raise or lower your dose, or interrupt your treatment according to the test results.
Huwa jista ’ jżidlek jew inaqqaslek id- doża, jew jinterrompi l - kura skond ir- riżultati tat- testijiet.
• People donating their own blood before surgery
• Persuni li jagħtu d- demm tagħhom qabel il- kirurġija
The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.
Id- doża ta ’ NeoRecormon tiddependi mill- kundizzjoni tiegħek, mil- livelli ta ’ ċelluli l- ħomor tad - demm u mill- ammont ta ’ demm li se jingħata qabel il- kirurġija.
The dose worked out by your doctor will be given twice per week for 4 weeks.
Id- doża kkalkulatamit- tabib tingħata darbtejn fil- ġimgħa għal 4 ġimgħat.
When you donate blood, NeoRecormon will be given to you at the end of a donation session.
Meta tagħti d- demm, NeoRecormon jingħatalek fl- aħħar tas- sessjoni ta ’ donazzjoni.
The maximum dose should not exceed •1200 IU for every 1 kg of your body weight per week.
285 Id- doża massima m’ għandhiex taqbeż 1200 IU għal kull 1 kg tal- piż ta ’ ġismek kull ġimgħa.
Even at very high blood levels, no symptoms of poisoning have been observed.
Anki b’ livelli għoljin ħafna fid- demm, ma ġew osservati l- ebda sintomi ta ’ ivveleniment.
280 If you forget to take NeoRecormon If you have missed an injection, or injected too little, talk to your doctor.
Jekk tinsa tieħu NeoRecormon Jekk qbiżt injezzjoni, jew injettajt ftit wisq, kellem lit- tabib tiegħek.
If you have any further questions on the use of this product, as your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, NeoRecormon can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra NeoRecormon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects which can affect any patient • Most people get lower levels of iron in their blood.
Effetti sekondarji li jistgħu jaffetwaw lil kull pazjent Ħafna persuni jkollhom livelli ta ’ ħadid fid- demm tagħhom aktar baxx.
Almost all patients have to be treated with iron supplements during their NeoRecormon therapy. • Rarely, allergies or skin reactions, such as rash or hives, itching or reactions around the injection site have occurred. • Very rarely a severe form of allergic reaction has occurred, especially just after an injection.
Kważi l- pazjenti • kollha jkollhom jiġu kkurati b’ supplimenti ta ’ ħadid waqt it- terapija b’ NeoRecormon. • Rari dehru allerġiji jew reazzjonijiet tal- ġilda, bħal raxx jew urtikarja, ħakk jew reazzjonijiet madwar is- sit ta ’ l- injezzjoni. • Rari ħafna dehret forma severa ta ’ reazzjoni allerġika, speċjalment eżatt wara l- injezzjoni.
Additional side effects in people with chronic kidney disease (renal anaemia) • Increase in blood pressure, worsening of existing high blood pressure and headache are the most common side effects.
Effetti sekondarji oħra f’ persuni b’ marda kronika fil- kliewi (anemija renali) • L- aktar effetti sekondarji komuni huma żjieda fil- pressjoni tad- demm, pressjoni tad- demm għolja li tmur għall- agħar u uġigħ ta ’ ras.
PRCA means that the body stopped or reduced the production of red blood cells.
PRCA jfisser li l- ġisem jieqaf jew inaqqas il- produzzjoni taċ- ċelluli tad- demm ħomor.
This causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy.
286 Din tikkawża anemija severa, li s- sintomi tagħha jinkludu għejja mhux tas- soltu u nuqqas ta ’ enerġija.
• Keep out of the reach and sight of children. • Do not use NeoRecormon after the expiry date which is stated on the pack. • Keep the cartridge in the outer carton, in order to protect from light. • Store in a refrigerator (2°C – 8°C). • The cartridge not yet inserted into the Reco-Pen can be removed from the refrigerator and left at room temperature for a single period of maximum 5 days (but not above 25°C). • After insertion into the Reco-Pen the cooling chain may only be interrupted for injecting the product. • The dissolved solution may be stored for 1 month in a refrigerator at 2°C – 8°C. • Medicines should not be disposed of via wastewater or household waste.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax NeoRecormon wara d- data ta ’ skadenza li tidher fuq il- pakkett. • Żomm l- iskartoċċ fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl. • Aħżen fi friġġ (2°C – 8°C). • L- iskartoċċ li għadu ma ddaħħalx fir- Reco Pen jista ’ jitneħħa mill- friġġ u jista ’ jitħalla f’ temperatura tal- kamra għal perjodu wieħed ta ’ mhux aktar minn 5 ijiem (iżda mhux f’ aktar minn 25°C). • Wara li jiddaħħal fir- Reco- Pen, it- tkessiħ jista ’ jiġi interrott biss għall- injezzjoni tal- prodott. • Is- soluzzjoni mdewba tista ’ tinżam għal xagħar fi friġġ f’ temperatura ta ’ bejn 2°C – 8°C. • Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
One cartridge contains either 10,000 IU, 20,000 IU or
Skartoċċ wieħed fih 10, 000 IU, 20, 000 IU jew 60, 000 IU
60,000 IU (international units) epoetin beta.
(unitajiet internazzjonali) epoetin beta.
- The solvent contains benzyl alcohol and benzalkonium chloride as preservatives in 1 ml water
- Is- solvent fih benzyl alcohol u benzalkonium chloride bħala preservattivi f’ 1 ml ilma għall -
for injections.
injezzjonijiet.
Pack size of 1, or 3.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Not all pack sizes may be marketed.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Marketing Authorisation Holder Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
287 Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Ir- RenjuUnit
282 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Slovenská republika Roche Slovensko, s.r.o.
288 Slovenská republika Ísland Roche Slovensko, s. r. o.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA): http: // www. emea. europa. eu /.
284 PACKAGE LEAFLET:
289 FULJETT TA ’ TAGĦRIF:
NeoRecormon 500 IU NeoRecormon 1,000 IU NeoRecormon 2,000 IU NeoRecormon 3,000 IU NeoRecormon 4,000 IU NeoRecormon 5,000 IU NeoRecormon 6,000 IU NeoRecormon 10,000 IU NeoRecormon 20,000 IU NeoRecormon 30,000 IU Solution for injection in pre -filled syringe Epoetin beta
NeoRecormon 500 IU NeoRecormon 1, 000 IU NeoRecormon 2, 000 IU NeoRecormon 3, 000 IU NeoRecormon 4, 000 IU NeoRecormon 5, 000 IU NeoRecormon 6, 000 IU NeoRecormon 10, 000 IU NeoRecormon 20, 000 IU NeoRecormon 30, 000 IU Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest Epoetin beta
may harm them, even if their symptoms are the same as yours.
il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
NeoRecormon is a clear, colourless solution for injection under the skin (subcutaneously) or into a vein (intravenously).
NeoRecormon huwa soluzzjoni ċara u bla kulur għall- injezzjoni taħt il- ġilda (użu għal taħt il- ġilda) jew ġo vina (użu għal ġol- vini).
Epoetin beta is produced by a specialised genetic technology and works in exactly the same way as the natural hormone erythropoietin.
Epoetin beta huwa magħmul minn teknoloġija ġenetika speċjalizzata u jaħdem bl - istess mod eżatt bħall- ormon naturali, eritropoetin.
NeoRecormon injections are used for:
Injezzjonijiet NeoRecormon jintużaw għal:
• Treating symptomatic anaemia caused by chronic kidney disease (renal anaemia) in patients on dialysis, or not yet on dialysis. • Preventing anaemia in premature infants (weighing 750 to 1500 g and born at less than 34 weeks). • Treating anaemia with related symptoms in adult cancer patients receiving chemotherapy • Treating people donating their own blood before surgery.
• Kura ta ’ anemija sintomatika kkawżata minn mard kroniku tal- kliewi (anemija renali) f’ pazjenti fuq id- dijalisi, jew li għad mhux fuq id- dijalisi. • Prevenzjoni jew kura ta ’ anemija fi trabi prematuri (b’ piż bejn 750 u 1500 g u li twieldu qabel l- 34 ġimgħa). • Kura ta ’ anemija b’ sintomi relatati f’ pazjenti adulti bil- kanċer li qed jirċievu kimoterapija. • Kura ta ’ persuni li jagħtu d- demm tagħhom qabel kirurġija.
Do not use NeoRecormon: • if you are allergic (hypersensitive) to epoetin beta or any of the other ingredients of NeoRecormon • if you have blood pressure problems that cannot be controlled • if you are donating your own blood before surgery, and:
Tużax NeoRecormon: • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- epoetin beta jew sustanzi oħra ta ’ NeoRecormon • jekk għandek problemi bil- pressjoni tad- demm li ma jistgħux jiġu kkontrollati; • jekk qed tagħti d- demm tiegħek qabel il- kirurġija, u:
If any of these apply to you, or might apply, tell your doctor at once.
Jekk xi waħda minn dawn tapplika għalik, għarraf lit- tabib tiegħek immedjatament.
If you are donating your own blood before surgery, your doctor will need to: • check that you are capable of giving blood, especially if you weigh less than 50 kg • check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) • make sure that only 12% of your blood will be donated at once.
291 • jara li għandek livell suffiċjenti ta ’ ċelluli l- ħomor tad- demm (emoglobina ta ’ mill- inqas 11 g/ dl) • jiżgura li ma jingħatax aktar minn 12% tad- demm tiegħek f’ daqqa.
286 Do not misuse NeoRecormon Misuse of NeoRecormon by healthy people may lead to an increase in blood cells and consequently thicken the blood.
Tużax NeoRecormon ħażin L- użu ħażin ta ’ NeoRecormon minn persuni b’ saħħithom jista ’ jwassal għal żjieda fiċ- ċelluli tad - demm u bħala konsegwenza jħaxxen id- demm.
Important information about some of the ingredients of NeoRecormon This medicine contains phenylalanine.
Informazzjoni importanti dwar xi uħud mis- sustanzi ta ’ NeoRecormon Din il- mediċina fiha phenylalanine.
Once you have been shown how, you can also inject the solution yourself.
Ladarba tiġi muri kif, anke inti tkun tista ’ tinjetta s- soluzzjoni waħdek.
The NeoRecormon pre-filled syringe is ready for use.
Is- siringa mimlija għal- lest b’ NeoRecormon hija lesta għall- użu.
Each syringe should be used for a single injection only.
Kull siringa għandha tintuża għall - injezzjoni waħda biss.
Do not mix NeoRecormon with other injections or infusion solutions.
Tħallatx NeoRecormon ma ’ injezzjonijiet jew soluzzjonijiet għall- infużjoni oħra.
1 Remove one syringe from the pack.
Neħħi siringa waħda mill- pakkett.
Check the liquid in the syringe:
Iċċekkja li l- likwidu fis- siringa:
is it clear? is it colourless? is it free of particles? answer is NO to any question, do not administer the injection.
huwa ċar? huwa mingħajr kulur? huwa ħieles minn frak?
Dispose of it and start again with a different syringe.
Armiha u erġa ’ ibda b’ siringa differenti.
If you answer yes to all three, remove the cap from the syringe and go to step 2.
Jekk ir- risposta hija iva għat- tlieta li huma, neħħi l- għatu mis- siringa u mur għal punt 2.
2 Remove a needle from the pack, fix it securely on to the syringe and remove the protective cap from the needle.
2 Neħħi l- labra mill- pakkett, waħħalha b’ mod sikur mas- siringa u neħħi l- għatu prottettiv mill- labra.
Do this by lightly tapping on the upper half of the syringe.
Neħħi l- arja mis- siringa u mil- labra.
Then hold the syringe vertically and the needle upwards, and gently push the plunger upwards.
292 vertikali u l- labra ’ il fuq, u bil- mod imbotta l- planġer ’ il fuq.
Keep pushing the plunger until the amount of NeoRecormon in the syringe is as prescribed.
Ibqa ’ mbotta l- planġer sakemm l- ammont ta ’ NeoRecormon fis- siringa ikun dak preskritt.
4 Clean the skin at the injection site using an alcohol wipe.
4 Naddaf il- ġilda fis- sit ta ’ l- injezzjoni permezz ta ’ mselħa bl- alkoħol.
287 5 Holding the syringe near the needle, insert the needle into the skin fold with a quick, firm action.
5 Waqt li żżomm is- siringa minn qrib il- labra, daħħal il- labra fit- tinja fil- ġilda b’ moviment ħafif u sod.
Withdraw the needle quickly and apply pressure over the injection site with a dry, sterile pad.
Oħroġ l- labra malajr u agħmel pressjoni fuq is- sit ta ’ l- injezzjoni b’ biċċa sterili u xotta.
Your doctor will work out the right dose for you.
Doża ta ’ NeoRecormon Id- doża ta ’ NeoRecormon tiddependi mill- kundizzjoni tal- marda, mill- mod kif tingħata l- injezzjoni (taħt il- ġilda jew ġo vina) u mill- piż tal- ġisem tiegħek.
• Symptom atic anaemia caused by chronic kidney disease
It- tabib tiegħek se jikkalkula id- doża t- tajba għalik. • Anemija sintomatika kkawżata minn marda kronika tal- fwied
If the solution is given into your vein it should be injected over about 2 minutes, eg people on haemodialysis will receive the injection via the arterio-venous fistula at the end of dialysis.
Jekk is- soluzzjoni tingħata ġo vina din għandha tiġi injettata fuq medda ta ’ madwar 2 minuti, eż. pazjenti fuq emodijalisi se jingħataw l - injezzjoni mill- fistula arterjo- venuża fl- aħħar tad- dijalisi.
People who are not on haemodialysis will usually have injections under the skin.
Pazjenti mhux fuq emodijalisi, normalment jingħataw injezzjonijiet taħt il- ġilda.
a) Correcting the anaemia The initial dose for injections under the skin is 20 IU per injection for every 1 kg of your body weight, given three times per week.
It- trattament b’ NeoRecormon huwa maqsum f’ żewġ stadji: a) Korrezzjoni ta ’ l- anemija Id- doża tal- bidu għall- injezzjoni taħt il- ġilda hija ta ’ 20 IU kull injezzjoni għal kull 1 kg tal- piż ta ’ ġismek, mogħtija tliet darbiet fil- ġimgħa.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 40 IU/kg per injection, given three times per week.
Wara 4 ġimgħat, it- tabib iwettaq xi testijiet u, jekk ir- respons għall- kura mhux suffiċjenti, id- doża tista ’ tiżdied għal 40 IU/ kg f’ kull injezzjoni, mogħtija tliet darbiet fil- ġimgħa.
The initial dose for injections into veins is 40 IU per injection for every 1 kg of your body weight, given three times per week.
Id- doża tal- bidu għall- injezzjonijiet ġol- vini hija ta ’ 40 IU kull injezzjoni għal kull 1 kg tal- piż tal - ġisem tiegħek, mogħtija tliet darbiet kull ġimgħa.
After 4 weeks, the doctor will do tests and, if the treatment response is not sufficient, your dose may be raised to 80 IU/kg per injection, given three times per week.
Wara 4 ġimgħat, it- tabib se jagħmel testijiet u, jekk ir- rispons għall- kura mhux suffiċjenti, id- doża tista ’ tiżdied għal 80 IU/ kg kull injezzjoni, mogħtija tliet darbiet fil- ġimgħa.
The doctor may continue to increase your dose at monthly intervals if necessary.
It- tabib jista ’ jkompli jżid id- doża f’ intervalli ta ’ xahar, jekk ikun hemm bżonn.
• Anaemia in premature infants
• Anemija fi trabi prematuri
Injections are given under the skin.
L- injezzjonijiet huma mogħtija taħt il- ġilda.
The initial dose is 250 IU per injection for every 1 kg the infant weighs, three times a week.
Id- doża tal- bidu hija 250 IU kull injezzjoni għal kull 1 kg li tiżen it- tarbija, tliet darbiet fil- ġimgħa.
Treatment with NeoRecormon should start as early as possible, preferably by day 3 of the infant’s life.
293 Kura b’ NeoRecormon għandha tinbeda kmieni kemm jista ’ jkun, preferibilment mat- tielet ġurnata tal - ħajja tat- tarbija.
Premature infants who have been transfused before the start of treatment with NeoRecormon are not likely to benefit as much as untransfused infants.
kura b’ NeoRecormon x’ aktarx li ma jibbenefikawx daqs trabi li ma ġewx mogħtija trasfużjoni.
The treatment should last for 6 weeks.
Il- kura għandha ddum għal 6 ġimgħat.
288 • Adults with symptomatic anaemia receiving chemotherapy for cancer
• Adulti b’ anemija sintomatika li qed jingħataw kimoterapija għall- kanċer
This may be given as one injection per week, or in divided doses as 3 to 7 injections per week.
Din tista ’ tingħata bħala injezzjoni waħda kull ġimgħa, jew tinqasam f’ dożi bħala 3 sa 7 injezzjonijiet kull ġimgħa.
Your doctor will take regular blood samples.
It- tabib tiegħek se jieħu kampjuni tad- demm b’ mod regolari.
The therapy should be continued for up to 4 weeks after the end of chemotherapy.
It- terapija għandha titkompla għal mhux aktar minn 4 ġimgħat wara t- tmiem tal- kemoterapija.
Injections are given into a vein over 2 minutes, or under the skin.
L- injezzjonijiet jingħataw ġol- vina fuq medda ta ’ żewġ minuti, jew taħt il- ġilda.
The dose of NeoRecormon depends on your condition, red blood cell levels and how much blood will be donated before surgery.
Id- doża ta ’ NeoRecormon tiddependi mill- kundizzjoni tiegħek, mil- livelli ta ’ ċelluli ħomor tad - demm u mill- ammont ta ’ demm li se jingħata qabel il- kirurġija.
The maximum dose should not exceed • for injections into veins:
Id- doża massima m’ għandhiex taqbeż • għall- injezzjonijiet ġol- vini:
1600 IU for every 1 kg of your body weight per week • for injections under the skin:
1600 IU għal kull 1 kg tal- piż ta ’ ġismek kull ġimgħa • għall- injezzjonijiet taħt il- ġilda:
POSSIBLE SIDE EFFECTS
EFFETTI SEKONDARJI LI JISTA ’ JKOLLU Bħal kull mediċina oħra NeoRecormon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Like all medicines, NeoRecormon can cause side effects, although not everybody gets them.
Effetti sekondarji li jistgħu jaffetwaw lil kull pazjent
Side effects which can affect any patient • Most people get lower levels of iron in their blood.
294 • Ħafna persuni jkollhom livelli ta ’ ħadid fid- demm tagħhom aktar baxx.
If you get unusual wheezing or difficulty breathing; swollen tongue, face or throat, or swelling around the injection site; if you feel lightheaded or faint or if you collapse, call your doctor at once.
Kellem lit- tabib tiegħek minnufih jekk ikollok tisfir mhux tas- soltu jew diffikultà fin- nifs; ilsienek, wiċċek jew griżmejk minfuħin, jew nefħa madwar is- sit ta ’ l- injezzjoni; jekk tħossok ħażin jew sturdut jew jekk tikkollassa. • Rari ħafna kien hemm persuni li esperjenzaw sintomi li jixbħu lil dawk ta ’ l- influwenza, speċjalment meta jkunu għadhom kemm bdew it- trattament.
289 • Very rarely people experienced flu-like symptoms, especially when they just started treatment.
Dawn jinkludu deni, rogħda, uġigħ ta ’ ras, uġigħ fir- riġlejn, uġigħ fl- għadam u/ jew tħossok ma tiflaħx b’ mod ġenerali.
These include fever, chills, headaches, pain in the limbs, bone pain and/or feeling generally unwell.
Dawn ir- reazzjonijiet ġeneralment kienu ħfief għal moderati u marru wara ftit sigħat jew ġranet.
This can be treated by your doctor. • Pure red cell aplasia (PRCA) caused by neutralising antibodies has been observed during erythropoietin therapy, including in isolated cases during therapy with NeoRecormon.
Dan jista ’ jiġi kkurat mit- tabib tiegħek. • Aplasija pura taċ- ċelloli l- ħomor (PRCA) ikkawżata minn antikorpi newtrallizzanti kienet osservata waqt terapija bl- eritropoetin, inkluż każijiet iżolati waqt kura b’ NeoRecormon.
• Keep out of the reach and sight of children. • Do not use NeoRecormon after the expiry date which is stated on the pack. • Keep the pre-filled syringe in the outer carton, in order to protect from light. • Store in a refrigerator (2°C – 8°C). • The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C). • Medicines should not be disposed of via wastewater or household waste.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal. • Tużax NeoRecormon wara d- data ta ’ skadenza li tidher fuq il- pakkett. • Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl. • Aħżen fi friġġ (2°C – 8°C). • Is- siringa tista ’ titneħħa mill- friġġ u tista ’ titħalla f’ temperatura tal- kamra għal perjodu wieħed ta ’ mhux aktar minn 3 ijiem (iżda mhux f’ aktar minn 25°C).
One pre-filled syringe contains either 500, 1,000, 2,000,
Siringa mimlija għal- lest fiha 500, 1, 000, 2, 000, 3, 000, 4, 000,
3,000, 4,000, 5,000, 6,000, 10,000, 20,000 or 30,000 IU (international units) epoetin beta in 0.3 ml or 0.6 ml water for injections.
5, 000, 6, 000, 10, 000, 20, 000 jew 30, 000 IU (unitajiet internazzjonali) epoetin beta f’ 0. 3 ml jew 0. 6 ml ilma għall- injezzjonijiet.
- The other ingredients are urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate
- Is- sustanzi l- oħra huma urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate
dihydrate, disodium phospate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine.
dihydrate, disodium phospate dodecahydrate, calcium chloride dihydrate, glycine, L- Leucine, L - Isoleucine, L- Threonine, L- Glutamic acid, u L- Phenylalanine.
NeoRecormon is provided as a solution for injection in 1, 4 or 6 pre-filled syringes with 1, 4 or 6 needles.
NeoRecormon huwa pprovdut bħala soluzzjoni għall- injezzjoni f’ 1, 4 jew 6 siringi mimlija għal- lest b’ 1, 4 jew 6 labriet.
Pack size of 1, 4 or 6.
Daqs tal- pakkett ta ’ 1, 4 jew 6.
България Рош България ЕООД Тел: +359 2 818 44 44
Magyarország България Рош България ЕООД Тел: +359 2 818 44 44
Nederland Roche Nederland B.V.
296 Nederland Danmark Roche Nederland B. V.
Norge Roche Norge AS Tlf: +47 - 22 78 90 00
Norge Deutschland Roche Norge AS Tlf: +47 - 22 78 90 00 Roche Pharma AG Tel: +49 (0) 7624 140
Eesti Roche Eesti OÜ Tel: + 372 - 6 177 380
Eesti Österreich Roche Austria GmbH Tel: +43 (0) 1 27739 Roche Eesti OÜ Tel: + 372 - 6 177 380
Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
Polska Roche Polska Sp. z o. o.
Ελλάδα Roche (Hellas) A.E.
Roche (Hellas) A.. E.
España Roche Farma S.A.
Roche Farma S. A.
Portugal Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Tel: +351 - 21 425 70 00
This leaflet was last approved in
297 Dan il- fuljett kien approvat l- aħħar f ’
What is NeoSpect?
X’ inhu NeoSpect?
NeoSpect is a kit for preparing a radiolabelled medicine.
NeoSpect huwa kitt għall- preparazzjoni ta ’ mediċina radjutikkettjata.
NeoSpect includes a white powder for solution for injection, which contains the active substance depreotide.
NeoSpect jinkludi trab abjad għat- taħlil għal injezzjoni, li fih is- sustanza attiva depreotide.
What is NeoSpect used for?
Għal xiex jintuża NeoSpect?
NeoSpect is not used on its own, but it must be radiolabelled before use.
NeoSpect ma jintużax waħdu, iżda jrid ikun radjutikkettjat qabel jintuża.
Radiolabelling is a technique where a substance is tagged (labelled) with a radioactive compound.
Radjutikkettjar hija teknika fejn sustanza hija miżjuda (imlaqqma) b’ taħlita radjuattiva.
NeoSpect is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
NeoSpect huwa radjutikkettjat billi jitħallat ma ’ soluzzjoni ta ’ technetium radjuattiv (99mTc).
The radiolabelled medicine is for diagnostic use.
Il- mediċina radjutikkettjata tintuża għal skopijiet dijanjostiċi.
NeoSpect is used in patients who have a single pulmonary nodule (a small, round lesion in the lungs) detected by a chest X-ray or computerised tomography (CT) scan to see if the nodule is malignant (cancerous).
NeoSpect jintuża fuq pazjenti li għandhom nefħa pulmonari (ferita tonda żgħira, fil- pulmuni) osservata permezz ta ’ X- ray tas- sider jew permezz ta ’ sken temografiku kompjuterizzat (CT) sabiex jaraw jekk in- nefħa hijiex malinna (kanċeruża).
How is NeoSpect used?
Kif jintuża NeoSpect?
NeoSpect is only handled and given by specialised personnel who have experience in the safe handling of radioactive material.
NeoSpect huwa immaniġġjat u jingħata biss minn personal speċjalizzat li għandu esperjenza fl - immaniġġjar bla periklu ta ’ materjal radjuattiv.
Once made up into a radiolabelled solution, NeoSpect is given by intravenous injection (into a vein), and a scan is taken two to four hours after the injection.
Malli jkun magħmul f’ soluzzjoni radjutikkettjata, NeoSpect jingħata permezz ta ’ injezzjoni ġol- vini (ġo vina), u jittieħed sken bejn sagħtejn u erba ’ sigħat wara l- injezzjoni.
It should not usually be used on more than one occasion in any one patient.
Normalment m’ għandux jintuża f’ iktar minn okkażjoni waħda fuq l- istess pazjent.
How does NeoSpect work?
Kif jaħdem NeoSpect?
The active substance in NeoSpect, depreotide, is a somatostatin analogue.
Is- sustanza attiva f’ NeoSpect, depreotide, hija analoga għal somatostatin.
This means that it acts like somatostatin, and binds to the same receptors as somatostatin in the body.
Dan ifisser li taġixxi bħal somatostatin, u tingħaqad ma ’ l- istess receptors fil- ġisem bħal somatostatin.
These receptors are found in large numbers on some malignant tumours such as lung tumours.
Dawn ir- receptors jinsabu fi kwantità fuq tumuri malinni bħal tumuri fil- pulmun.
When NeoSpect is radiolabelled, the radioactive element technetium-99m (99mTc) is attached to depreotide.
Meta NeoSpect jiġi radjutikkettjat, l - element radjuattiv technetium- 99m (99mTc) jingħaqad ma ’ depreotide.
As depreotide binds to the receptors, it carries the radioactivity with it, and this can be detected using special imaging equipment, such as scintigraphy or single photon emission computed tomography (SPECT).
Billi depreotide jingħaqad mar - receptors, din iġġorr ir- radjuattività magħha u din tista ’ tiġi nnutata billi jintuża apparat speċjali għall - imaging bħal sintigrafija jew tomografija komputata ta ’ emissjoni ta ’ foton waħda (scintigraphy jew single photon emission computed tomography) (SPECT).
If the solitary pulmonary nodule is labelled with NeoSpect, it is likely to be malignant.
Jekk in- nefħa pulmonari solitarja tiġi ttiketatta b’ NeoSpect, il- probabbiltà hija li din tkun malinna.
If it is not, then it is likely to be benign (non-malignant).
Jekk le, allura l- probabbiltà hi li din tkun beninna (mhux malinna).
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NeoSpect ġie studjat f’ żewġ proċessi prinċipali li involvew 258 pazjent suspetatti b’ kanċer fil- pulmun.
The main measure of effectiveness was the accuracy of diagnosing a malignant tumour (positive) or a benign tumour (negative).
Il- kejl ewlieni ta ’ l- effikaċja kienet il- preċiżjoni tad- dijanjożi ta ’ tumur malinn (pożittiv) jew tumur beninn (negattiv).
What benefit has NeoSpect shown during the studies?
X’ kienu l- benefiċċji ta ’ NeoSpect nnutati waqt l- istudji?
The result of the NeoSpect scan was in agreement with the result obtained by histology in between 80 and 90% of the cases.
Ir- riżultat ta ’ NeoSpect scan kien jaqbel mar- riżultat miksub mill- istoloġija f’ madwar 80 u 90% tal - każi.
Adding a NeoSpect scan to a CT scan increased the specificity of the scan, making it easier for the doctor to identify a nodule as malignant.
Iż- żieda ta ’ NeoSpect scan ma ’ ma ’ CT scan żdiedet l- ispeċifiċità ta ’ l- isken, u dan jagħmilha eħfef għat- tabib sabiex jidentifika nefħa bħala waħda malinna.
What is the risk associated with NeoSpect?
X’ inhu r- riskju assoċjat ma ’ NeoSpect?
Side effects with NeoSpect are uncommon, but the most common (seen in between 1 and 10 patients in 1000) are headache, nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, dizziness, flushing and fatigue (tiredness).
L- effetti sekondarji f’ NeoSpect m’ humiex komuni, iżda l- aktar komuni (innutati f’ bejn 1 u 10 pazjenti minn 1000) huma uġigħ ta ’ ras, nawsja (tħossok ma tiflaħx), rimettar, dijarea, uġigħ addominali (żaqq), sturdament, fawra u għeja kbira (għeja).
NeoSpect should not be used in people who may be hypersensitive (allergic) to depreotide, sodium pertechnetate or any of the other ingredients.
NeoSpect m’ għandux jintuża fuq nies li huma sensittivi żżejjed (allerġiċi) għal depreotide, sodium pertechnetate jew għal xi sustanza oħra tiegħu.
NeoSpect should not be used in women who are pregnant or breast-feeding.
NeoSpect m’ għandux jintuża fuq nisa tqal jew li qed ireddgħu.
Why has NeoSpect been approved?
Għalfejn ġie approvat NeoSpect?
The Committee for Medicinal products for Human Use (CHMP) decided that NeoSpect’ s benefits are greater than its risks for the scintigraphic imaging of suspected malignant lung tumours in the lung after initial detection, in combination with CT scan or chest X-ray, in patients with solitary pulmonary nodules.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ NeoSpect huma akbar mir- riskji tiegħu bħala scintigraphic imaging ta ’ tumuri malinni fil- pulmun wara s- sejba inizjali, flimkien ma ’ CT scan jew X- ray tas- sider, f’ pazjenti b’ nefħiet pulmonari solitarji.
The Committee recommended that NeoSpect be given marketing authorisation.
Il- Kumitat irrakkomanda li NeoSpect jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about NeoSpect:
Tagħrif ieħor dwar NeoSpect:
The European Commission granted a marketing authorisation valid throughout the European Union for NeoSpect on 29 November 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Neospect fid- 29 ta ’ Novembru 2000.
The marketing authorisation was renewed on 29 November 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fid- 29 ta ’ Novembru 2005.
The marketing authorisation holder is CIS bio international.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa CIS bio international.
The full EPAR for NeoSpect is available here.
L- EPAR sħiħ għal NeoSpect jista ’ jinkiseb minn hawnhekk.
EU Numbers
Numru ta ’ l- EU
Strength
Qawwa 47 mikrogramma
Pharmaceutical Form
Għamla farmaċewtika Sett għall- preparazzjoni
47 micrograms
radjufarmaċewtika
Vial (glass)
Kunjett (tazza)
EU/ 1/ 00/ 154/ 002
Sett għall- preparazzjoni 47 mikrogramma EU/ 1/ 00/ 154/ 002
NeoSpect 47 micrograms, kit for radiopharmaceutical preparation.
NeoSpect 47 mikrogramma, sett għall- preparazzjoni radjufarmaċewtika.
Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate.
Kull fjala fiha 47 mikrogramma ta 'depreotide bħala depreotide trifluoroacetate.