qanastek/EMEA-V3 huggingface dataset:
Neoclarityn oral lyophilisate is packed in unit dose blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, and 100 doses of oral lyophilisate.
Neoclarityn lajofiliżejt li jittieħed mill- ħalq huwa pakkjat f’ folji b’ doża individwali ġo pakketti ta ’ 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, u 100 doża.
Ísland Hörgatún 2 IS-210 Garðabær Sími: + 354 535 70 00
81 82 Ísland Hörgatún 2 IS- 210 Garðabær Sími: + 354 535 70 00
81 PACKAGE LEAFLET:
83 FULJETT TA ’ TAGĦRIF:
What Neoclarityn orodispersible tablet is and what it is used for 2.
X’ inhi Neoclarityn pillola li tinħall fil- ħalq u għalxiex jintuża 2.
Before you take Neoclarityn orodispersible tablet 3.
Qabel ma tieħu Neoclarityn pillola li tinħall fil- ħalq 3.
How to take Neoclarityn orodispersible tablet 4.
Kif għandek tieħu Neoclarityn pillola li tinħall fil- ħalq 4.
How to store orodispersible tablet 6.
Kif taħżen Neoclarityn pillola li tinħall fil- ħalq 6.
WHAT NEOCLARITYN ORODISPERSIBLE TABLET IS AND WHAT IT IS USED FOR
X’ INHI NEOCLARITYN PILLOLA LI TINAĦALL FIL- ĦALQ U GĦALXIEX JINTUŻA
Neoclarityn orodispersible tablet is an antiallergy medicine that does not make you drowsy.
Neoclarityn pillola li tinħall fil- ħalq hija mediċina kontra l- allerġiji li ma traqdekx.
Neoclarityn orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites).
Neoclarityn pillola li tinħall fil- ħalq ittaffi s- sintomi assoċjati ma ’ rajnajtis allerġiku (infjammazzjoni tal- passaġġi fl- imnieħer ikkawżata minn allerġija, per eżempju hay fever jew allerġija għad- dust mites).
Neoclarityn orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn pillola li tinħall fil- ħalq tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal- ġilda ikkawżata minn allerġija).
BEFORE YOU TAKE NEOCLARITYN ORODISPERSIBLE TABLET
QABEL MA TIEĦU NEOCLARITYN PILLOLA LI TINĦALL FIL- ĦALQ
Do not take Neoclarityn orodispersible tablet:
Tieħux Neoclarityn pillola li tinħall fil- ħalq
- if you are allergic (hypersensitive) to desloratadine, or any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal desloratadine, jew sustanzi oħra ta ’
Neoclarityn orodispersible tablet, or to loratadine.
Neoclarityn pillola li tinħall fil- ħalq, jew għal loratadine.
Neoclarityn 2.5 mg orodispersible tablet is indicated for adults and children (6 years of age and older).
Neoclarityn 2. 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 6 snin ‘ l fuq).
Take special care with Neoclarityn orodispersible tablet
Oqgħod attent ħafna b’ Neoclarityn pillola li tinħall fil- ħalq
Taking Neoclarityn orodispersible tablet with food and drink
Meta tieħu mediċini oħra M’ hemmx tgħarif dwar interazzjonijiet ta ’ Neoclarityn ma ’ mediċini oħra.
82 Neoclarityn orodispersible tablet does not need to be taken with water or liquid.
84 Meta tieħu Neoclarityn pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Neoclarityn pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Additionally, Neoclarityn orodispersible tablet may be taken with or without a meal.
Minbarra hekk, Neoclarityn pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby taking Neoclarityn is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Neoclarityn mhux irrakkomandat.
Important information about some of the ingredients of Neoclarityn orodispersible tablet This product contains aspartame.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Neoclarityn pillola li tinħall fil- ħalq Dan il- prodott fih aspartame.
HOW TO TAKE NEOCLARITYN ORODISPERSIBLE TABLET
KIF GĦANDEK TIEĦU NEOCLARITYN PILLOLA LI TINĦALL FIL- HALQ
Children 6 to 11 years of age: take one 2.5 mg Neoclarityn orodispersible tablet once a day.
Tfal ta ’ 6 sa 11- il sena: ħu pillola 2. 5 mg Neoclarityn li tinħall fil- ħalq ta ’ darba kuljum.
Adults and adolescents (12 years of age and older): take two 2.5 mg Neoclarityn orodispersible tablets once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Neoclarityn pillola li tinħall fil- ħalq darba kuljum.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Neoclarityn orodispersible tablets.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu l- pilloli Neoclarityn li jinħallu fil- ħalq.
If you take more Neoclarityn orodispersible tablet than you should Take Neoclarityn orodispersible tablet only as prescribed for you.
Jekk tieħu Neoclarityn pillola li tinħall fil- ħalq aktar milli suppost Ħu l- pillola Neoclarityn li tinħall fil- ħalq biss kif ordnawlek.
However, if you take more Neoclarityn orodispersible tablet than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar pillola Neoclarityn li tinħall fil- ħalq milli suppost, għamel kuntatt mat- tabib jew l- spiżjar tiegħek.
If you forget to take Neoclarityn orodispersible tablet If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule.
Jekk tinsa tieħu Neoclarityn pillola li tinħall fil- ħalq Jekk tinsa tieħu id- doża fil- ħin, ħudha malli tiftakar, imbagħad erġa ’ lura għall- iskeda regolari tiegħek.
Like all medicines, Neoclarityn can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Neoclarityn jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
However, fatigue, dry mouth and headache
Madankollu, għejja, ħalq xott u uġigħ ta ’ ras kienu rappurtati b’ mod aktar frekwenti minn dawk li jkun
83 were reported more often than with a dummy tablet.
85 hemm b’ pillola finta.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n - nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
HOW TO STORE NEOCLARITYN ORODISPERSIBLE TABLET
KIF TAĦŻEN NEOCLARITYN PILLOLA LI TINĦALL FIL- ĦALQ
Do not use Neoclarityn orodispersible tablet after the expiry date which is stated on the carton and blister.
Tużax Neoclarityn pillola li tinħall fil- ħalq wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il - folja.
Tell your pharmacist if you notice any change in the appearance of Neoclarityn orodispersible tablet.
Għid lill- ispiżjar tiegħek jekk tara xi tibdil fid- dehra ta ’ Neoclarityn pillola li tinħall fil- ħalq.
What Neoclarityn orodispersible tablet contains
X’ fih Neoclarityn pillola li tinħall fil- ħalq:
What Neoclarityn orodispersible tablet looks like and contents of the pack
Id- Dehra ta ’ Neoclarityn pillola li tinħall fil- ħalq u l- kontenuti tal- pakkett
Neoclarityn 2.5 mg orodispersible tablet is light red, speckled, and round with “ K” branded on one side.
Neoclarityn 2. 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ K ” fuq naħa.
Neoclarityn orodispersible tablet is packed in unit dose blisters in packs of 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet.
Neoclarityn pillola li tinħall fil- ħalq qegħda ppakkjata f’ dożi b’ waħdiet f’ pakketti ta ’ 5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 u 100 doża ta ’ pilloli li jinħallu fil- ħalq.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
86 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
Κύπρος Οδός Αγίου Νικολάου, 8 CY-1055 Λευκωσία Τηλ: +357-22 757188
Κύπρος Οδός Αγίου Νικολάου, 8 CY- 1055 Λευκωσία
86 PACKAGE LEAFLET:
88 FULJETT TA ’ TAGĦRIF:
Neoclarityn 5 mg orodispersible tablets desloratadine
Neoclarityn 5 mg pilloli li jinħallu fil- ħalq desloratadine
How to store Neoclarityn orodispersible tablet 6.
Kif taħżen Neoclarityn pillola li tinħall fil- ħalq 6.
Do not take Neoclarityn orodispersible tablet
Tieħux Neoclarityn pillola li tinħall fil- ħalq
Neoclarityn 5 mg orodispersible tablet is indicated for adults and adolescents (12 years of age and older).
Neoclarityn 5 mg pillola li tinħall fil- ħalq tintuża għall- adulti u tfal (minn 12 snin ‘ l fuq).
Taking other medicines There are no known interactions of Neoclarityn with other medicines.
89 M’ hemmx tgħarif dwar interazzjonijiet ta ’ Neoclarityn ma ’ mediċini oħra.
Taking Neoclarityn orodispersible tablet with food and drink 87 Neoclarityn orodispersible tablet does not need to be taken with water or liquid.
Meta tieħu Neoclarityn pillola li tinħall fil- ħalq ma ’ l- ikel u max- xorb Neoclarityn pillola li tinħall fil- ħalq m’ għandhiex bżonn tittieħed ma ’ l- ilma jew x likwidu.
Water or other liquid is not needed to swallow the dose.
Neoclarityn pillola li tinħall fil- ħalq tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
Adults and adolescents (12 years of age and older): take one 5 mg Neoclarityn orodispersible tablet once a day.
Adulti u adolexxenti (12- il sena ‘ l fuq): ħu pillola waħda ta ’ 5 mg Neoclarityn pillola li tinħall fil- ħalq darba kuljum.
88 During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n - nifs, affann, ħakk, ħbiebes u nefħa) u raxx kienu rrappurtati rari ħafna.
Neoclarityn 5 mg orodispersible tablet is light red, speckled, and round with “ A” branded on one side.
Neoclarityn 5 mg pillola li tinħall fil- ħalq hija ħamra ċara, ittikjata, u tonda immarkata b ’ “ A ” fuq naħa.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
91 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
91 PACKAGE LEAFLET:
93 FULJETT TA ’ TAGĦRIF:
What Neoclarityn is and what it is used for 2.
X’ inhi Neoclarityn u għalxiex jintuża 2.
Neoclarityn oral solution is an antiallergy medicine that does not make you drowsy.
Neoclarityn soluzzjoni orali hija mediċina kontra l- allerġiji li ma traqdekx.
Neoclarityn oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites). These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.
Dawn is- sintomi jinkludu għatis, imnieħer inixxi jew ħakk fl- imnieħer, ħakk fis- saqaf tal- ħalq u ħakk, ħmura jew dmugħ fl- għajnejn.
Neoclarityn oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy).
Neoclarityn soluzzjoni orali tintuża wkoll biex ittaffi s- sintomi assoċjati ma ’ urtikarja (kundizzjoni tal - ġilda ikkawżata minn allerġija).
of Neoclarityn.
sustanzi oħra ta ’ Neoclarityn.
Neoclarityn oral solution is indicated for children 1 through 11 years of age, adolescents (12 years of age and older), and adults, including the elderly.
Neoclarityn soluzzjoni orali tintuża fi tfal minn sena sa 11- il sena, adolexxenti (minn 12- il sena ’ l fuq), u adulti, inklużi l- anzjani.
92 Taking Neoclarityn with food and drink Neoclarityn may be taken with or without a meal.
94 Meta tieħu Neoclarityn ma ’ l- ikel u max- xorb Neoclarityn jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
If you are pregnant or nursing a baby, taking Neoclarityn oral solution is not recommended.
Jekk ħriġt tqila jew qed tredda tarbija, l- użu ta ’ Neoclarityn soluzzjoni orali mhux irrakkomandat.
Important information about some of the ingredients of Neoclarityn Neoclarityn oral solution contains sorbitol.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Neoclarityn Neoclarityn soluzzjoni orali fiha sorbitol.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Neoclarityn oral solution.
Dwar it- tul tal- kura, it- tabib tiegħek ser jikkonsidra x’ tip ta ’ rajnajtis allerġiku qed tbati minnu u jiddetermina għal kemm għandek iddum tieħu s- soluzzjoni orali Neoclarityn.
If you take more Neoclarityn than you should Take Neoclarityn oral solution only as it is prescribed for you.
Jekk tieħu Neoclarityn aktar milli suppost Ħu Neoclarityn soluzzjoni orali biss kif ordnawlek.
However, if you take more Neoclarityn oral solution than you were told to, contact your doctor or pharmacist.
Madankollu, jekk tieħu aktar Neoclarityn soluzzjoni orali milli suppost, għamel kuntatt mat- tabib jew l- ispiżjar tiegħek.
Like all medicines, Neoclarityn oral solution can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Neoclarityn soluzzjoni orali jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
In most children and adults, side effects with Neoclarityn were about the same as with a dummy solution or tablet.
Fil- parti l- kbira tat- tfal u adulti, l- effetti sekondarji b’ Neoclarityn kienu rrapurtati kważi daqs kieku ħadu soluzzjoni jew pillola finta.
During the marketing of Neoclarityn, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) and rash have been reported very rarely.
Meta Neoclarityn tqiegħed fuq is- suq, każijiet ta ’ reazzjonijiet allerġiċi qawwija (tbatija biex tieħu n - nifs, affann, ħakk, ħbiebes u nefħa), u raxx kienu rrappurtati rari ħafna.
Neoclarityn oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap.
Neoclarityn soluzzjoni orali, jiġi fi fliexken ta ’ daqsijiet ta ’ 30, 50, 60, 100, 120, 150, 225 u 300 ml magħluqin b’ għatu tal- plastik mhux faċli biex jiftħuh it- tfal.
94 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is NeoRecormon?
X’ inhu NeoRecormon?
NeoRecormon is a white powder and solvent in a vial, which is made up into a solution for injection.
NeoRecormon huwa trab abjad u solvent f’ kunjett, li huwa magħmul f’ soluzzjoni għal injezzjoni.
NeoRecormon is also available in a cartridge and a pre-filled syringe.
NeoRecormon huwa disponibbli wkoll fi skartoċċ u f’ siringa mimlija għal- lest.
NeoRecormon exists in various strengths, from 1000 IU/ ml to 60,000 IU/ ml (see the Package Leaflet for full details).
NeoRecormon jiġi f’ qawwiet differenti, minn 1000 IU/ ml għal 60, 000 IU/ ml (ara l- Fuljett ta ’ Tagħrif għal dettalji sħaħ).
NeoRecormon contains the active ingredient epoetin beta.
NeoRecormon fih is- sustanza attiva epoetin beta.
What is NeoRecormon used for?
Għal x’ hiex jintuża NeoRecormon?
NeoRecormon is used for the prevention or treatment of anaemia (fewer than normal red blood cells in the blood) of various causes.
NeoRecormon jintuża għall- prevenzjoni jew kura ta ’ anemija (għadd inqas min- normal ta ’ ċelloli ħomor tad- demm fid- demm) ta ’ kawżi differenti.
It may be used in babies, children, and adults depending on the cause of the anaemia: • Treating anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin • Preventing anaemia in premature babies • Treating anaemia in adult patients with cancer who are receiving chemotherapy (the medicines used for the treatment of cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
Jista ’ jintuża fi trabi, tfal, u adulti jiddependi mill - kawża ta ’ l- anemija għal: • Kura ta ’ anemija kkawżata minn ħsara fil- kliewi fuq perjodu ta ’ żmien twil, meta l- ġisem ma jipproduċix biżżejjed ormon naturali erythropoietin • Prevenzjoni ta ’ anemija fi trabi prematuri • Kura ta ’ anemija f’ pazjenti adulti b’ kanċer li qegħdin jirċievu kemjoterapija (il- mediċini wżati għat- trattament tal- kanċer), meta l- kemjoterapija tipprevjeni l- mudullun milli jipproduċi biżżejjed ċelloli tad- demm.
It can also be used in patients who are going to have an operation and donate their own blood before surgery (autologous blood transfusion) to increase the amount of blood that can be taken.
Jista ’ jintuża wkoll f’ pazjenti li se jagħmlu operazzjoni u jagħtu demmhom stess qabel kirurġija (trasfużjoni tad- demm awtologa) sabiex iżidu l- ammont ta ’ demm li jista ’ jittieħed.
Please see the Package Leaflet for full details.
Jekk jogħġbok ara l- Fuljett ta ’ Tagħrif għad- dettalji sħaħ.
How is NeoRecormon used?
Kif jintuża NeoRecormon?
NeoRecormon can be given intravenously (injected into a vein) or subcutaneously (injected under the skin).
NeoRecormon jista ’ jingħata ġol- vini (injettat f’ vina) jew taħt il- ġilda (injettat taħt il- ġilda).
A doctor who has experience in the care of patients with the types of anaemia NeoRecormon should start treatment with NeoRecormon.
Tabib li jkollu esperjenza fil- kura ta ’ pazjenti bit- tipi ta ’ anemija NeoRecormon għandu jibda t- trattament b’ NeoRecormon.
The doses and dosage schedules (how often NeoRecormon is injected, and for how long) vary depending on why NeoRecormon is used, and are adjusted according to the response.
Id- dożi u l- iskedi tad- dożi (kemm għandu jiġi injettat spiss NeoRecormon, u għal kemm żmien) ivarjaw u dan jiddependi fuq ir- raġuni l- għala jintuża NeoRecormon, u dawn jiġu aġġustati skond ir- reazzjoni.
How does NeoRecormon work?
Kif jaħdem NeoRecormon?
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow.
Ormon imsejjaħ erythropoietin jistimula l- produzzjoni ta ’ ċelloli tad- demm ħomor mill- mudullun.
Epoetin beta, the active ingredient of NeoRecormon, is a copy of the erythropoietin found in the body.
Epoetin beta, is- sustanza attiva ta ’ NeoRecormon, hija kopja tal- erythropoietin li hemm fil- ġisem.
Epoetin beta is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce it.
Epoetin beta huwa prodott b’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad- DNA ’: huwa magħmul minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha possibbli tipproduċih.
In patients receiving chemotherapy 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
F’ pazjenti li 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged or in patients with long-term kidney failure and other conditions, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged jkunu qegħdin jirċievu kemjoterapija jew f’ pazjenti b’ indeboliment fit- tul tal- kliewi u kundizzjonijiet oħrajn, l- anemija tista ’ tiġi kkawżata minn nuqqas ta ’ erythropoietin, jew mill- ġisem li ma jirrispondix biżżejjed għall- erythropoietin li huwa għandu b’ mod naturali.
NeoRecormon works by stimulating production of red blood cells in the same way as erythropoietin.
NeoRecormon jaħdem billi jistimula l - produzzjoni taċ- ċelloli tad- demm ħomor bl- istess mod ta ’ erythropoietin.
How has NeoRecormon been studied?
Kif ġie studjat NeoRecormon?
The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic kidney failure (1663 patients, including some comparative studies against placebo [dummy treatment]), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison to no treatment), and in cancer patients (1204 patients with different types of cancer, comparison with placebo).
L- effikaċja ta ’ NeoRecormon biex jittratta jew jipprevjeni anemija ġiet studjata f’ bosta studji inkluż anemija f’ indeboliment kroniku tal- kliewi (1663 pazjenti, inkluż xi studji komparattivi kontra plaċebo [trattament finta]), trasfużjoni awtologa tad- demm (419- il pazjent, tqabbil ma ’ plaċebo), anemija fi trabi prematuri (177 tarbija, tqabbil ma ’ ebda trattament), u f’ pazjenti b’ kanċer (1204 pazjenti b’ tipi differenti ta ’ kanċer, tqabbil ma ’ plaċebo).
The main measure of effectiveness in most clinical studies was whether NeoRecormon increased the red blood cells in the blood (by measuring haemoglobin levels, the protein found in red blood cells that carries oxygen around the body, or the volume of red cells), or reduced the need for blood transfusion.
Il- miżura prinċipali ta ’ l- effikaċja f’ ħafna mill- istudji kliniċi kienet jekk NeoRecormon żiedx iċ- ċelloli tad- demm ħomor fid- demm (billi sar kejl tal- livelli tal- ħemoglobina, il- proteina li tinstab fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġenu madwar il- ġisem, jew il- volum ta ’ ċelloli ħomor), jew jekk naqqasx il- ħtieġa għal trasfużjoni tad- demm.
What benefit has NeoRecormon shown during the studies?
X’ benefiċċji wera NeoRecormon matul l- istudji?
NeoRecormon was significantly more effective than placebo (dummy treatment) at increasing haemoglobin levels in patients with various types of anaemia, including those with kidney disease.
NeoRecormon kien ferm iktar effettiv minn plaċebo (trattament finta) fiż- żieda tal- livelli ta ’ ħemoglobina f’ pazjenti b’ tipi varji ta ’ anemija, inkluż dawk b’ mard tal- fwied.
It increases the amount of blood that can be taken from patients before surgery for autologous blood transfusion.
Iżid l- ammont ta ’ demm li jista ’ jittieħed minn pazjenti qabel kirurġija għal trasfużjoni tad- demm awtologa.
It reduces the need for transfusion in premature babies and in cancer patients receiving chemotherapy.
Inaqqas il- ħtieġa għal trasfużjoni fi trabi prematuri u f’ pazjenti b’ kanċer li jirċievu kemjoterapija.
What is the risk associated with NeoRecormon?
X’ inhu r- riskju assoċjat ma ’ NeoRecormon?
Most side effects occur in patients with chronic renal failure or cancer.
Ħafna mill- effetti sekondarji jseħħu f’ pazjenti b’ indeboliment tal- fwied kroniku jew b’ kanċer.
The most common side effects are an increase in blood pressure or the worsening of an existing headache or hypertension (high blood pressure).
L- aktar effetti sekondarji komuni huma żjieda fil- pressjoni tad- demm jew aggravar ta ’ uġigħ ta ’ ras eżistenti jew pressjoni tad- demm għolja.
For the full description of the side effects reported with NeoRecormon, please see the Package Leaflet.
Għal deskrizzjoni sħiħa ta ’ l- effetti sekondarji rrapportati b’ NeoRecormon, jekk jogħġbok ara l- Fuljett ta ’ Tagħrif.
NeoRecormon should not be used in people who may be hypersensitive (allergic) to epoetin beta or any of the other ingredients, and in patients who have poorly controlled high blood pressure.
NeoRecormon ma għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal epoetin beta jew għal xi sustanza oħra tiegħu, u f’ pazjenti li għandhom pressjoni tad- demm li ma tantx hija kkontrollata tajjeb.
Why has NeoRecormon been approved?
Għaliex ġie approvat NeoRecormon?
The Committee for Medicinal products for Human Use (CHMP) decided that NeoRecormon’ s benefits are greater than its risks to patients to treat and prevent various types of anaemia.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ NeoRecormon jisbqu r- riskji tiegħu għal pazjenti sabiex jittrattaw u jipprevjenu tipi varji ta ’ anemija.
They recommended that NeoRecormon be given marketing authorisation.
Jirrikmanda li NeoRecormon jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about NeoRecormon:
Tagħrif ieħor dwar NeoRecormon:
The European Commission granted a marketing authorisation valid throughout the European Union, for NeoRecormon to Roche Registration Limited on 17 July 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal NeoRecormon lil Roche Registration Limited fis- 17 ta ’ Lulju 1997.
The Marketing Authorisation was renewed on 17 July 2002.
L- Awtorizzazzjoni għat - Tqegħid Fis- Suq ġiet imġedda fis- 17 ta ’ Lulju 2002.
The full EPAR for NeoRecormon is available here.
L- EPAR sħiħ għal NeoRecormon huwa disponibbli minn hawnhekk.
This summary was last updated in 1-2006
Dan is- sommarju ġie aġġornat l- aħħar f1- 2006
EU/ 1/ 97/ 031/ 019
Numru ta ’ l- EU EU/ 1/ 97/ 031/ 019
NeoRecormon
Isem inventat NeoRecormon
50000 IU
Qawwa 50000 IU
Powder and solvent for solution for injection
Għamla Farmaċewtika Trab u solvent għal soluzzjoni għall- injezzjoni
Subcutaneous or intravenous use
Mnejn jingħata Użu għal taħt il - ġilda jew għal ġol- vini
powder: multidose vial (glass); solvent: ampoule (glass)
Il- pakkett trab: kunjett b’ ħafna dożi (ħġieġ); solvent: ampulla (ħġieġ)
solvent:
Kontenut solvent:
Solution 5000 IU/ ml)
10 ml (Soluzzjoni rikostitwita 5000 IU/ ml)
1 vial + 1 ampoule
Daqs tal- pakkett kunjett + ampulla
Subcutaneous or intravenous use
Użu għal taħt il - ġilda jew għal ġol- vini
powder: multidose vial (glass); solvent: ampoule (glass)
trab: kunjett b’ ħafna dożi (ħġieġ); solvent: ampulla (ħġieġ)
Solution 20000 IU/ ml)
5 ml (Soluzzjoni rikostitwita 20000 IU/ ml)
1 vial + 1 ampoule
kunjett + ampulla
powder and solvent: two- chamber cartridge (glass)
trab u solvent: skartoċċ b’ żewġ kompartimenti (ħġieġ)
Solution 10000 IU/ ml)
1 ml (Soluzzjoni rikostitwita 10000 IU/ ml)
1 cartridge
skartoċċ
3 cartridges
3 skrataċ
Solution 20000 IU/ ml)
1 ml (Soluzzjoni rikostitwita 20000 IU/ ml)
0.3 ml (1667 IU/ ml)
0. 3 ml (1667 IU/ ml)
1 pre-filled syringe
siringa mimlija għal- lest
6 pre-filled syringes
6 siringi mimlija għal- lest
0.3 ml (3333 IU/ ml)
0. 3 ml (3333 IU/ ml)
EU/ 1/ 97/ 031/ 028
1/ 3 EU/ 1/ 97/ 031/ 028
0.3 ml (6667 IU/ ml)
0. 3 ml (6667 IU/ ml)
EU/ 1/ 97/ 031/ 039
2/ 3 EU/ 1/ 97/ 031/ 039
Solution 60000 IU/ ml)
1 ml (Soluzzjoni rikostitwita 60000 IU/ ml)
1 ml (reconst solution 60000 IU/ ml)
1 ml (Soluzzjoni rikostitwita 60000 IU/ ml)
NeoRecormon Multidose 50,000 IU Lyophilisate and solvent for solution for injection (5000 IU/ ml)
NeoRecormon Multidose 50, 000 IU Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni (5000 IU/ ml)
One vial contains 50,000 international units (IU) corresponding to 415 micrograms epoetin beta* (recombinant human erythropoietin).
Kunjett wieħed fih 50, 000 unita internazzjonali (IU) li jikkorrispondu għal 415 mikrogrammi epoetin beta * (eritropoetin rikombinanti uman).
One ampoule contains 10 ml solvent (water for injections with benzyl alcohol and benzalkonium chloride as preservatives).
Ampulla waħda fiha 10 ml solvent (ilma għall- injezzjonijiet bl- alkoħol benżiliku u klorur tal - benżalkonju bħala preservattivi).
One ml of reconstituted solution contains 5000 IU epoetin beta.
Kull 1 ml ta ’ soluzzjoni rikostitwita fiha 5000 IU epoetin beta.
* produced in Chinese Hamster Ovary cells (CHO) by recombinant DNA technology
* prodott minn ċelluli tal- Ovarju tal- Ħamster Ċiniż (CHO) permezz ta ’ teknoloġija rikombinanti tad - DNA.
Phenylalanine (up to 5.0 mg/ vial) Sodium (less than 1 mmol per dose) Benzyl alcohol (up to 40 mg per multidose solvent ampoule)
Phenylalanine (sa 5. 0 mg/ kunjett) Sodju (inqas minn 1 mmol kull doża) Benzyl alcohol (sa 40 mg kull ampulla multidose bis- solvent)
Lyophilisate and solvent for solution for injection.
Lajofiliżat u solvent għal soluzzjoni għall- injezzjoni.
White lyophilisate and clear, colourless solvent.
Lajofiliżat abjad u solvent ċar u bla kulur.
- Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and
- Kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza kronika tal- kliewi (CRF) f’ pazjenti
paediatric patients.
adulti u pedjatriċi.
- Treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving
- Kura ta ’ anemija sintomatika f’ pazjenti adulti b’ tumuri malinni mhux mijelojdi li qed jirċievu
chemotherapy.
kimoterapija.
- Increasing the yield of autologous blood from patients in a pre-donation programme.
- Għal żjieda fl- ammont ta ’ demm li jagħmel il- pazjent innifsu fi programm qabel ma jibda jagħti
Its use in this indication must be balanced against the reported increased risk of thromboembolic events.
L- użu tiegħu f’ dan il- każ għandu jkun meqjus skond iż- żjieda fir- riskju rrappurtat ta ’ avvenimenti tromboembolitiċi.
Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/ dl [6.21 - 8.07 mmol/ l], no iron deficiency) if blood conserving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Il- kura għandha tingħata biss lil pazjenti b’ anemija moderata (Hb 10 - 13 g/ dl [6. 21 - 8. 07 mmol/ l], mingħajr defiċenza ta ’ ħadid) jekk ma jkunx hemm proċeduri biex jippreservaw id- demm jew jekk dawn il- proċeduri ma jkunux tajbin biżżejjed meta trid issir operazzjoni maġġura, mhux urġenti li jkollha bżonn ammonti kbar ta ’ demm (4 unitajiet jew iżjed għan- nisa jew 5 unitajiet jew iżjed għall- irġiel).
Therapy with NeoRecormon should be initiated by physicians experienced in the above mentioned indications.
It- terapija b’ NeoRecormon għandha tinbeda minn tobba li għandhom esperjenza fl- indikazzjonijiet imsemmijin hawn fuq.
As anaphylactoid reactions were observed in isolated cases, it is recommended that the first dose be administered under medical supervision.
Minħabba li kien hemm reazzjonijiet anafilattiċi f’ każi iżolati, huwa rakkomandat li l- ewwel doża tingħata taħt sorveljanza medika.
This multidose preparation can be used for several patients.
Din id- doża multipla tista ’ tintuża għal ħafna pazjenti.
To avoid the risk of cross-infection always follow aseptic techniques and use disposable sterile syringes and needles for each administration.
Sabiex jiġi evitat it- tixrid ta ’ infezzjonijiet fost il- pazjenti, dejjem żomm mat- teknika assettika u uża siringi u labar sterili li jistg] u jintremu għal kull injezzjoni.
Please check that only one vial of NeoRecormon Multidose is in use (i. e. reconstituted) at any one time.
Dejjem ara li hemm fjala waħda ta ’ NeoRecomon (Doża Multipla) qed tintuża (jiġifieri rikostitwit) f’ kull ħin.
The reconstituted product is a colourless, clear to slightly opalescent solution.
2 Il- prodott rikostitwit huwa soluzzjoni bla kulur, ċara għal kemmxejn tkanġi.
For instructions on reconstitution of the product before administration, see section 6.6.
Għal struzzjonijiet dwar ir- rikostituzzjoni tal- prodott qabel l- għotja, ara sezzjoni 6. 6.
2 Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients:
Kura ta ’ anemija sintomatika f’ pazjenti adulti u pedjatriċi b’ insuffiċjenza kronika tal- kliewi:
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient ’ s clinical course and condition is necessary.
Is- sintomi u r- riżultat ta ’ l- anemija jistgħu jvarjaw bl- età, sess u effett globali tal- marda; valutazzjoni ta ’ tabib tal- progressjoni u l- kundizzjoni klinika tal- pazjent individwali hija neċessarja.
NeoRecormon should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
NeoRecormon għandu jingħata minn taħt il- ġilda jew minn ġol- vini sabiex iżid l- emoglobina sa mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
2 minutes, e. g. in haemodialysis patients via the arterio-venous fistula at the end of dialysis.
F’ każ ta ’ amministrazzjoni ġol- vini, s- soluzzjoni għandha tingħata fuq medda ta ’ madwar 2 minuti, e. ż. f’ pazjenti b’ dijalisi tad- demm għandha tingħatalhom mill- fistula arterjo- venuża fl- aħħar tad- dijalisi.
Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Minħabba varjabilità bejn il- pazjenti, xi kultant jistgħu jiġu osservati valuri ndividwali ta ’ l - emoglobina għall- pazjent aktar jew inqas mil- livell mixtieq ta ’ emoglobina.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/ dl (6.2 mmol/ l) to 12 g/ dl (7.5 mmol/ l).
Varjabilità ta ’ l - emoglobina għandha tiġi rranġata permezz ta ’ mmaniġġjar tad- doża, b’ kunsiderazzjoni għall- firxa mmirata ta ’ l- emoglobina ta ’ 10 g/ dl (6. 2 mmol/ l) sa 12 g/ dl (7. 5 mmol/ l).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ l - emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għall- aġġustament xieraq tad- doża għal meta jiġu osservati valuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l) hija deskritta hawn taħt.
A rise in haemoglobin of greater than 2 g/ dl (1.25 mmol/ l) over a four week period should be avoided.
Żjieda fl- emoglobina ta ’ aktar minn 2 g/ dl (1. 25 mmol/ l) fuq perjodu ta ’ erba ’ ġimgħat għandha tiġi evitata.
If the rate of rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in one month or if the haemoglobin level is increasing and approaching 12 g/ dl (7.45 mmol/ l), the dose is to be reduced by approximately 25%.
Jekk ir- rata ta ’ żjieda ta ’ emoglobina hija ikbar minn 2 g/ dl (1. 25 mmol/ l) f’ xahar wieħed, jew jekk il- livell ta ’ l- emoglobina qed jiżdied u jqarreb 12 g/ dl (7. 45 mmol/ l), id- doża għandha titnaqqas b’ madwar 25%.
If the haemoglobin level continues to increase, therapy should be interrupted until the hemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Jekk il- livell ta ’ l- emoglobina jibqa jiżdied, it- terapija għandha titwaqqaf sakemm il- livell ta ’ l- emoglobina jibda jonqos, u f’ dan il- każ it- terapija għandha terġa tinbeda b’ doża ta ’ madwar 25% inqas mid- doża mogħtija qabel.
Patients should be monitored closely to ensure that the lowest approved dose of NeoRecormon is used to provide adequate control of the symptoms of anaemia.
Il- pazjenti għandhom jiġu sorveljati mill- viċin sabiex jiġi assigurat li tiġi wżata l- inqas doża approvata ta ’ NeoRecormon biex jiġi pprovdut kontoll adegwat tas- sintomi ta ’ l- anemija.
In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the weekly increase in Hb and the target Hb should be determined individually taking into account the clinical picture.
Jekk ikun hemm pressjoni għolja jew mard kardjovaskulari, ċerebrovaskulari jew mard fil- vini u fl - arterji periferali, iż- żjieda tal- ġimgħa fl- Hb u l- Hb li għandu jintlaħaq għandhom jiġu determinati ndividwalment, b’ kunsiderazzjoni għar- riżultati kliniċi.
Treatment with NeoRecormon is divided into two stages.
Kura b’ NeoRecormon hija maqsuma f’ żewġ stadji:
Correction phase
Fażi ta ’ korrezzjoni
- Subcutaneous administration:
- Amministrazzjoni minn taħt il- ġilda:
- The initial dosage is 3 x 20 IU/ kg body weight per week.
- Id- doża tal- bidu hi 3 × 20 IU/ kg piż tal- ġisem fil- ġimgħa.
The dosage may be increased every 4
Id- dożaġġ jista ’ jiġi miżjud kull 4
weeks by 3 x 20 IU/ kg and week if the increase of Hb is not adequate (< 0.25 g/ dl per week).
ġimgħat b’ 3 × 20 IU/ kg u ġimgħa jekk iż- zieda fl- Hb ma tkunx biżżejjed (< 0. 25 g/ dl kull ġimgħa)
- The weekly dose can also be divided into daily doses.
- Id- doża ta ’ kull ġimgħa tista ’ wkoll tinqasam f’ dożi ta ’ kuljum.
- Intravenous administration:
- Amministrazzjoni għal ġol- vini:
The initial dosage is 3 x 40 IU/ kg per week.
Id- doża tal- bidu hi 3 × 40 IU/ kg fil- ġimgħa.
The dosage may be raised after 4 weeks to 80 IU/ kg three times per week - and by further increments of 20 IU/ kg if needed, three times per week, at monthly intervals.
Id- dożaġġ jista ’ jiġi miżjud wara 4 ġimgħat għal 80 IU/ kg – tliet darbiet fil- ġimgħa – u jekk ikun hemm bżonn, b’ żidiet oħra ta ’ 20 IU/ kg tliet darbiet fil- ġimgħa, b’ xahar bejn żjieda u oħra.
For both routes of administration, the maximum dose should not exceed 720 IU/ kg per week.
Għaż- żewġ modi ta ’ amministrazzjoni, l- ogħla doża m’ għandhiex taqbeż 720 IU/ kg fil- ġimgħa.
Maintenance phase To maintain an Hb of between 10 and 12 g/ dl, the dosage is initially reduced to half of the previously administered amount.
Fażi ta ’ manteniment Biex l- Hb jinżamm bejn 10 u 12 g/ dl, fil- bidu id- dożaġġ jitnaqqas sa nofs l- ammont li kien qed jingħata qabel.
Subsequently, the dose is adjusted at intervals of one or two weeks individually for the patient (maintenance dose).
Wara, id- doża tiġi aġġustata f’ intervalli ta ’ ġimgħa jew ġimgħatejn għall- pazjent individwali (doża ta ’ manteniment).
In the case of subcutaneous administration, the weekly dose can be given as one injection per week or in divided doses three or seven times per week.
Meta jingħata minn taħt il- ġilda, id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda fil - ġimgħa jew maqsuma f’ dożi, tlieta jew seba ’ darbiet fil- ġimgħa.
Patients who are stable on a once weekly dosing regimen may be switched to once every two weeks administration.
Pazjenti li huma stabbli fuq dożaġġ ta ’ darba fil- ġimgħa jistgħu jinqalbu għall- amministrazzjoni ta ’ darba kull ġimgħatejn.
In this case dose increases may be necessary.
F’ dan il- każ, jista ’ jkun hemm bżonn żidiet fid- doża.
Results of clinical studies in children have shown that, on average, the younger the patients, the higher the NeoRecormon doses required.
3 Riżultati kliniċi fit- tfal urew li, ġeneralment iktar ma jkunu żgħar il- pazjenti iktar ikun hemm bżonn ta ’ dożi ta ’ NeoRecormon għoljin.
Nevertheless, the recommended dosing schedule should be followed as the individual response cannot be predicted.
Madankollu, l- iskeda tad- dożaġġ rakkomandata għandha tkun segwita, minħabba li r- rispons individwali ma jistax jitbassar.
3 Treatment with NeoRecormon is normally a long-term therapy.
Kura b’ NeoRecormon normalment hija terapija fit- tul.
It can, however, be interrupted, if necessary, at any time.
Minkejja dan, jekk hemm bżonn, tista ’ titwaqqaf f’ kull waqt.
Data on the once weekly dosing schedule are based on clinical studies with a treatment duration of 24 weeks.
Tagħrif dwar l- iskeda ta ’ dożaġġ ta ’ darba fil- ġimgħa huwa bbażat fuq studji kliniċi b’ kura li damet 24 ġimgħa.
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients:
Kura ta ’ anemija sintomatika indotta mill- kimoterapija f’ pazjenti bil- ċanċer:
NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e. g. haemoglobin concentration ≤ 10g/ dl (6.2 mmol/ l)).
NeoRecormon għandu jingħata minn taħt il- ġilda lill- pazjenti b’ anemija (e. ż. konċentrazzjoni ta ’ l - emoglobina ≤ 10g/ dl (6. 2 mmol/ l)).
The weekly dose can be given as one injection per week or in divided doses 3 to 7 times per week.
Id- doża ta ’ kull ġimgħa tista ’ tingħata bħala injezzjoni waħda kull ġimgħa jew f’ dożi mqassmin bejn 3 u 7 darbiet fil- ġimgħa.
The recommended initial dose is 30,000 IU per week (corresponding to approximately 450 IU/ kg body weight per week, based on an average weighted patient).
Id- doża tal- bidu rakkomandata hi 30, 000 IU kull ġimgħa (tikkorrispondi għal madwar 450 IU/ kg piż tal- ġisem kull ġimgħa, bbażata fuq pazjent ta ’ piż medju).
A sustained haemoglobin level of greater than 12 g/ dl (7.5 mmol/ l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/ dl (7.5 mmol/ l) are observed are described below.
Livell sostnut ta ’ l - emoglobina ta ’ aktar minn 12 g/ dl (7. 5 mmol/ l) għandu jiġi evitat; gwida għall- aġġustament xieraq tad- doża għal meta jiġu osservati valuri ta ’ l- emoglobina li jaqbżu 12 g/ dl (7. 5 mmol/ l) hija deskritta isfel.
If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/ dl (0.62 mmol/ l), the current dose should be continued.
Jekk wara 4 ġimgħat ta ’ terapija il- valur tal- emoglobina żdied b’ mill- inqas 1 g/ dl (0. 62 mmol/ l), id - doża li tkun qed tingħata għandha titkompla.
If the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), a doubling of the weekly dose should be considered.
Jekk il- valur tal- emoglobina ma żdiedx b’ mill- inqas 1 g/ dl (0. 62 mmol/ l), wieħed għandu jikkunsida li jirdoppja d- doża ta ’ kull ġimgħa.
If, after 8 weeks of therapy, the haemoglobin value has not increased by at least 1 g/ dl (0.62 mmol/ l), response is unlikely and treatment should be discontinued.
Jekk wara 8 ġimgħat ta ’ terapija il- valur ta ’ emoglobina ma żdiedx b’ mill- inqas 1 g/ dl (0. 62 mmol/ l), hemm probabbilta ’ li l- pazjent mhux se jirrispondi u l- kura għandha titwaqqaf.
The therapy should be continued up to 4 weeks after the end of chemotherapy.
It- terapija għandha titkompla sa 4 ġimgħat wara t- tmiem tal- kemoterapija.
The maximum dose should not exceed 60,000 IU per week.
L- ogħla doża m’ għandhiex taqbeż 60, 000 IU kull ġimgħa.
Once the therapeutic objective for an individual patient has been achieved, the dose should be reduced by 25 to 50% in order to maintain haemoglobin at that level.
La darba l- mira terapewtika għall- pazjent individwali ġiet milħuqa, d- doża għandha titnaqqas b’ 25 sa 50% biex b’ hekk l- emoglobina tinżamm f’ dak il- livell.
Appropriate dose titration should be considered.
Għandha tiġi kkunsidrata titrazzjoni xierqa tad- doża.
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), the dose should be reduced by approximately 25 to 50%.
Jekk l- emoglobina taqbeż 12 g/ dl (7. 5 mmol/ l), id- doża għandha titnaqqas b’ madwar 25 sa 50%.
Treatment with NeoRecormon should be temporarily discontinued if haemoglobin levels exceed 13 g/ dl (8.1 mmol/ l).
Kura b’ NeoRecormon għandha titwaqqaf temporanjament jekk il- livelli ta ’ l- emoglobina jaqbżu 13 g/ dl (8. 1 mmol/ l).
Therapy should be reinitiated at approximately 25% lower than the previous dose after haemoglobin levels fall to 12 g/ dl (7.5 mmol/ l) or below.
Wara li l- livelli ta ’ l- emoglobina jonqsu għal 12 g/ dl (7. 5 mmol/ l) jew inqas, it- terapija għandha terġa tinbeda b’ doża ta ’ madwar 25% inqas mid- doża mogħtija qabel.
If the rise in haemoglobin is greater than 2 g/ dl (1.3 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
Jekk iż- żjieda fl- emoglobina tkun aktar minn 2 g/ dl (> 1. 3 mmol/ l) f’ 4 ġimgħat, id- doża għandha titnaqqas b’ 25 sa 50%.
Treatment for increasing the amount of autologous blood:
4 Kura biex jiżdied id- demm li jagħmel il- pazjent innifsu:
2 minutes or subcutaneously.
Is- soluzzjoni irrikostitwita tingħata ġol- vini fuq medda ta ’ madwar 2 minuti jew taħt il- ġilda.
NeoRecormon is administered twice weekly over 4 weeks.
NeoRecormon tingħata darbtejn fil- ġimgħa fuq medda ta ’ 4 ġimgħat.
PCV ≥ 33%, NeoRecormon is administered at the end of blood donation.
F’ dawk id- drabi fejn il- PCV tal - pazjent jippermetti d- donazzjoni tad- demm, jiġifieri PCV ≥ 33%, NeoRecormon jingħata fl- aħħar tad- donazzjoni.
During the entire treatment period, a PCV of 48% should not be exceeded.
Tul il- perjodu kollu tal- kura, PCV ta ’ 48% m’ għandux jinqabeż.
The dosage must be determined by the surgical team individually for each patient as a function of the required amount of pre-donated blood and the endogenous red cell reserve:
Id- dożaġġ għandu jkun iddeterminat għal kull pazjent individwali mill- iskwadra kirurġika bħala funzjoni ta ’ l- ammont meħtieġ ta ’ demm mogħti minn qabel u r- riserva ta ’ ċelluli ħomor endoġeni:
The required amount of pre-donated blood depends on the anticipated blood loss, use of blood conserving procedures and the physical condition of the patient.
L- ammont meħtieġ ta ’ demm mogħti minn qabel jiddependi fuq l- ammont ta ’ demm maħsub li se jintilef, użu ta ’ proċeduri għal preservazzjoni tad- demm, u l- kundizzjoni fiżika tal- pazjent.
4 This amount should be that quantity which is expected to be sufficient to avoid homologous blood transfusions.
Dan l- ammont għandu jkun dik il- kwantita` li hija mistennija li tkun biżżejjed biex tiġi evitata trasfużjoni ta ’ demm omologa.
The required amount of pre-donated blood is expressed in units whereby one unit in the nomogram is equivalent to 180 ml red cells.
L- ammont meħtieġ ta ’ demm mogħti minn qabel hu espress f’ unitajiet fejn unità waħda fin - nomogramma hija ekwivalenti għal 180 ml ċelluli ħomor.
The ability to donate blood depends predominantly on the patient's blood volume and baseline PCV.
Il- kapaċita` li jingħata d- demm tiddependi l- iktar fuq il- volum tad- demm tal- pazjent u l- PCV fil- linja bażi.
Both variables determine the endogenous red cell reserve, which can be calculated according to the following formula.
Iż- żewġ varjabbli jiddeterminaw ir- riserva ta ’ ċelluli ħomor endoġena, li tista ’ tiġi kkalkolata skond din il- formula:
Endogenous red cell reserve = blood volume [ml] x (PCV - 33) ÷ 100
Riserva ta ’ ċelluli ħomor endoġeni = volum tad- demm [ml] × (PCV - 33) ÷ 100 Nisa: volum tad- demm [ml] = 41 [ml/ kg] × piż tal- ġisem [kg] + 1200 [ml] Irġiel: volum tad- demm [ml] = 44 [ml/ kg] × piż tal- ġisem [kg] + 1600 [ml] (piż tal- ġisem ≥ 45 kg)
Women:
/ k g. c:
Men:
4 Ü/ k
blood volume [ml] = 41 [ml/ kg] x body weight [kg] + 1200 [ml] blood volume [ml] = 44 [ml/ kg] x body weight [kg] + 1600 [ml]
tti
(body weight ≥ 45 kg)
00 / kg
The indication for NeoRecormon treatment and, if given, the single dose should be determined from the required amount of pre-donated blood and the endogenous red cell reserve according to the following graphs.
i
Female patients
4 TÜ ie e
Male patients
2 ux j
Required amount of pre-donated blood [units]
i. v 00 jitt i. v: 2 x
Required amount of pre-donated blood [units]
M
Endogenous red cell reserve [ml]
Riserva ta ’ ċelluli ħomor endoġeni [ml]
The single dose thus determined is administered twice weekly over 4 weeks.
Id- doża waħdanija ddeterminata b’ dan il- mod tingħata darbtejn fil- ġimgħa fuq medda ta ’ 4 ġimgħat.
The maximum dose should not exceed 1600 IU/ kg body weight per week for intravenous or 1200 IU/ kg per week for subcutaneous administration.
L- ogħla doża m’ għandhiex tkun iktar minn 1600 IU/ kg piż tal- ġisem kull ġimgħa għall - amministrazzjoni ġol- vini jew 1200 IU/ kg kull ġimgħa għall- amministrazzjoni minn taħt il- ġilda.
4.3 Contraindications
5 4. 3 Kontra- indikazzjonijiet
Hypersensitivity to the active substance or any of the excipients.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi.
Poorly controlled hypertension.
Pressjoni għolja mhux kontrollata tajjeb.
In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Meta ikun qed jingħata għall - “ kura biex jiżdied id- demm li jagħmel il- pazjent innifsu ”: infart mijokardjali jew puplesija fix- xahar ta ’ qabel il- kura, angina pectoris mhux stabbli, riskju akbar ta ’ deep venous thrombosis bħal storja ta ’ mard tromboemboliku fil- vini.