qanastek/EMEA-V3 huggingface dataset:
These include: • Vincristine, vinblastine and other vinca alkaloids (used to treat cancer) • Ciclosporin (used in transplant surgery) • Tacrolimus and sirolimus (used in transplant surgery) • Rifabutin (used to treat certain infections) • Medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given with ritonavir) and non nucleoside reverse transcriptase inhibitors (NNRTIs) • Midazolam, triazolam, alprazolam and some similar medicines called benzodiazepines (used as sedatives or muscle relaxants) • Diltiazem, verapamil, nifedipine, nisoldipine and some of the other medicines called calcium channel blockers (used to treat high blood pressure) • Digoxin (used to treat heart failure) • Sulfonylureas such as glipizide (used to treat high blood sugar).
Dawn jinkludu: • Vincristine, vinblastine u alkalojdi vinka oħrajn (jintużaw għall- kura tal- kanċer) • Ciclosporin (jintuża meta issir kirurġija ta ’ trapjant) • Tacrolimus u sirolimus (jintużaw meta issir kirurġija ta ’ trapjant) • Rifabutin (jintuża għall- kura ta ’ ċerti infezzjonijiet) • Mediċini li jintużaw għall- kura ta ’ HIV li jissejħu impedituri protease (jinkludu lopinavir u atazanavir, li jingħataw ma ’ ritonavir) u impedituri mhux nuklejosidi ta ’ reverse transcriptase (NNRTIs) • Midazolam, triazolam, alprazolam u mediċini simili li jissejħu benżodijażepini (jintużaw bħala sedattivi jew rilassanti tal- muskoli) • Diltiazem, verapamil, nifedipine, nisoldipine u xi ftit mill- mediċini l- oħrajn li jissejħu imblukkaturi tal- kanali ta ’ calcium (jintużaw għal kura ta ’ pressjoni tad- demm għolja) • Digoxin (jintuża għal kura ta ’ insuffiċjenza tal- qalb) • Sulfonylureas bħal glipizide (jintużaw għal kura ta ’ zokkor għoli fid- demm).
Taking Noxafil with food and drink Each dose of Noxafil should be taken with food or a nutritional supplement if you are unable to tolerate food to enhance the oral absorption.
Meta tieħu Noxafil ma ’ l- ikel u max- xorb Kull doża ta ’ Noxafil għandha tittieħed ma ’ l- ikel jew ma ’ suppliment nutrizzjonali jekk ma tistax iżżomm ikel li jgħin biex ikun hemm assorbiment orali aħjar.
See section 3 of this leaflet for more information on how to take the suspension.
Ara sezzjoni 3 ta ’ dan il- fuljett għal aktar tagħrif fuq kif għandek tieħu s- suspensjoni.
Pregnancy and breast-feeding Tell your doctor if you are or think you are pregnant before you start to take Noxafil.
Tqala u treddigħ Għid lit- tabib tiegħek jekk int jew taħseb li jista ’ jkun li ħriġt tqila qabel ma tibda tieħu Noxafil.
Do not use Noxafil during pregnancy unless you are told by your doctor.
Tużax Noxafil waqt it- tqala sakemm ma jkunx qallek it- tabib tiegħek.
You should use effective contraception while you are taking Noxafil if you are a woman who could become pregnant.
Għandek tuża kontraċezzjoni effettiva meta tkun qed tieħu Noxafil jekk int mara li tista ’ toħroġ tqila.
Contact your doctor immediately if you become pregnant while being treated with Noxafil.
Għamel kuntatt mat- tabib teigħek mill - ewwel jekk toħroġ tqila waqt li tkun fuq kura b’ Noxafil.
Do not breast-feed while being treated with Noxafil.
M’ għandekx tredda ’ meta tkun qed tingħata kura b’ Noxafil.
Driving and using machines There is no information on the effect of Noxafil on the ability to drive and use machines.
Sewqan u tħaddim ta ’ magni M’ hemmx tagħrif dwar l- effett ta ’ Noxafil fuq il- ħila biex issuq u tħaddem magni.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery such as sleepiness or blurred vision.
Jekk jogħġbok għarraf lit- tabib tiegħek jekk tħoss xi effetti li jistgħu jikkawżawlek problemi biex issuq jew l- użu ta ’ magni oħrajn bħal ngħas jew vista mċajpra.
Important information about some of the ingredients of Noxafil Noxafil contains approximately 1.75 g of glucose per 5 ml of suspension.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Noxafil Noxafil fih madwar 1. 75 g ta ’ glucose għal kull 5 ml ta ’ suspensjoni.
You should not take this medicine if you have a condition called glucose-galactose malabsorption and should take note of this amount of glucose if you need to watch your sugar intake for any reason.
M’ għandekx tieħu din il - mediċina jekk għandek kondizzjoni li tissejjaħ malassorbiment tal- glucose- galactose u għandek iżżomm nota ta ’ dan l- ammont ta ’ glucose jekk għal xi raġuni għandek toqgħod attent għall- ammont ta ’ zokkor li tieħu.
HOW TO TAKE NOXAFIL
KIF GĦANDEK TIEĦU NOXAFIL
Noxafil must only be used as directed by your doctor.
Noxafil għandu jintuża biss kif jindikalek it- tabib tiegħek.
Your doctor will monitor your response and condition to determine how long Noxafil needs to be given and whether any change is needed to your daily dose.
It- tabib tiegħek ser jeżamina r- rispons u l - kundizzjoni sabiex jiddeċidi kemm għandu jdum jingħata Noxafil u jekk ikunx hemm bżonn ta ’ xi tibdil fid- doża ta ’ kuljum.
28 Indication Treatment of refractory Fungal Infections
28 Indikazzjoni Kura ta ’ Infezzjonijiet Refrattorji tal- Fungu
Dose Take 400 mg (two 5 ml spoonfuls) of the suspension twice a day with food or with a nutritional supplement if you are unable to tolerate food.
Doża Ħu 400 mg (żewġ kuċċarini ta ’ 5 ml) tas- suspensjoni darbtejn kuljum ma ’ l- ikel jew ma ’ suppliment nutrizzjonali jekk ma tistax iżżomm ikel.
If you are not able to take food or nutritional supplement, your doctor will tell you to take 200 mg (one 5 ml spoonful) four times a day.
Jekk ma tistax tiekol jew tieħu suppliment nutrizzjonali, it- tabib tiegħek ser jgħidlek biex tieħu 200 mg (kuċċarina waħda ta ’ 5 ml) erba ’ darbiet kuljum.
Initial treatment of Thrush
Kura tal- bidu ta ’ Traxx
On the first day of treatment take 200 mg (one 5 ml spoonful) once.
Fl- ewwel jum ta ’ kura ħu 200 mg (kuċċarina waħda ta ’ 5 ml) darba.
After the first day, take 100 mg (2.5 ml) once a day with food or nutritional supplement if you are unable to tolerate food.
Wara l- ewwel jum, ħu 100 mg (2. 5 ml) darba kuljum ma ’ l- ikel jew ma ’ supplliment nutrizzjonali jekk ma tistax iżżomm ikel.
Prevention of serious Fungal Infections
Biex tevita Infezzjonijiet serji tal- Fungu
Take 200 mg (one 5 ml spoonful) three times a day with food or nutritional supplement if you are unable to tolerate food.
Ħu 200 mg (kuċċarina waħda ta ’ 5 ml) tliet darbiet kuljum ma ’ l- ikel jew ma ’ suppliment nutrizzjonali jekk ma tistax iżomm ikel.
If you take more Noxafil than you If you are concerned that you may immediately.
Jekk tieħu Noxafil aktar milli suppost Jekk qed tinkwieta li ħadt iżżejjed, għamel kuntatt mat- tabib tiegħek jew ma professjonist fil- kura tas - saħħa mill- ewwel.
If you forget to take Noxafil If you have missed a dose, take it as soon as you remember and then carry on as before.
Jekk tinsa tieħu Noxafil Jekk qbiżt doża, ħudha malli tiftakar u imbagħad kompli bħal qabel.
However, if it is almost time for your next dose, take your dose when it is due.
Iżda jekk ikun kważi wasal il- ħin tad- doża li jmissek, ħudha meta suppost.
Like all medicines, Noxafil can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Noxafil jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Common side effects (occurring in at least 1 in 100 patients) are:
Effetti sekondarji komuni (jseħħu mill- anqas f’ 1 minn kull 100 pazjent) huma:
Headache, dizziness, numbness or tingling Sleepiness Nausea (feeling or being sick), loss of appetite, stomach pain, diarrhoea, upset stomach, vomiting, wind, dry mouth Abnormal liver function tests Rash Weakness, tiredness A decrease in white blood cells (that can increase the risk of infections) Fever Abnormal levels of salts in the blood.
Uġigħ ta ’ ras, sturdament, tnemnim jew tingiż Ngħas Tqallih (tħossok jew tkun ma tiflaħx), titlef l- aptit, uġigħ fl- istonku, dijarea, taqlib ta ’ l- istonku, rimettar, gass, ħalq xott Testijiet tal- fwied anormali Raxx Debbulizza, għeja Tnaqqis taċ- ċelluli bojod tad- demm (li jista ’ jżid ir- riskju għall- infezzjonijiet) Deni Livelli anormali ta ’ mlielaħ fid- demm.
Uncommon side effects (occurring in at least 1 in 1,000 patients) are:
Effetti sekondarji mhux komuni (jseħħu mill- anqas f’ 1 minn kull 1, 000 pazjent) huma:
Anaemia, low numbers of cells called platelets that help the blood to clot, low numbers of some types of white blood cells, enlargement of lymph glands Allergic reaction High blood levels of glucose Disturbances in feeling or moving, tremor, fits Heart rhythm problems including very fast heartbeat (palpitations), abnormal findings on heart tests (like ECGs that show heart rhythm) High or low blood pressure Inflammation of the pancreas Inflammation of liver, liver damage, jaundice (yellow colour of the skin or the eyes) Problems with kidney function, failure of the kidneys Menstrual disorder Blurred vision Hair loss, itching Mouth ulcers 29 Shivering, generally feeling unwell or weak Scattered body pain, including in muscles and joints, back pain Fluid retention, altered medicine levels.
Anemija, numru baxx ta ’ ċelluli li jissejħu plejlets li jgħinu d- demm biex jagħqad, numri baxxi ta ’ ċerti tipi ta ’ ċelluli bojod tad- demm, tkabbir tal- glandoli tal- limf Reazzjoni allerġika Livelli għoljin ta ’ glucose Disturbi ta ’ kif tħoss jew tiċċaqlaq, tregħid, aċċesjonijiet Problemi tar- ritmu tal- qalb inkluż taħbit mgħaġġel ħafna (palpitazzjonijiet), sejbiet anormali tat - testijiet tal- qalb (bħall- ECGs li juru r- ritmu tal- qalb) Pressjoni għolja jew baxxa Infjammazzjoni tal- pankrejas Infjammazzjoni tal- fwied, fil- fwied, suffejra (kulur isfar tal- ġilda jew ta ’ l- għajnejn) Problemi fil- funzjoni tal- kliewi, insuffiċjenza tal- kliewi Disturbi menstruwali Vista mċajpra Jaqa x- xagħar, ħakk Ulċeri fil- ħalq 29 Tirtod, tħossok ma tiflaħx b’ mod ġenerali jew dgħajjef Uġigħ mifrux mal- ġisem, inkluż fil- muskoli u l- ġogi, uġigħ fid- dahar Ritenzjoni ta ’ fluwidi, tibdil fil- livelli ta ’ mediċini.
Rare side effects (occurring in at least 1 in 10,000 patients) are:
Effetti sekondarji rari (jseħħu mill anqas f’ 1 minn kull 10, 000 pazjent) huma:
Pneumonia and other lung damage Low numbers of all blood cells, blood clotting disorder, bleeding Severe allergic reactions, including widespread blistering rash and skin peeling Poor functioning of the adrenal gland Altered brain function, fainting Sudden behaviour changes, problems with thinking or speech Pain, weakness, numbness, or tingling in the arm or leg Depression Double vision, a blind or dark spot in the visual field Hearing problems Heart failure or heart attack, heart rhythm disorders Stroke, blood clots in brain, limbs or lungs Bleeding into the gut Inflammation or failure of the liver, rarely leading to death Enlargement of both the liver and spleen, liver tenderness Blistering rash, large purple discolourations on the skin caused by bleeding underneath the skin Inflammation of the kidneys Breast pain Swelling of the face or tongue.
Pulmonite jew ħsara oħra fil- pulmun Numri baxxi taċ- ċelluli kollha tad- demm, disturbi fit- tgħaqid tad- demm, fsada Reazzjonijiet allerġiċi severi, inkluż raxx bil- bżieżaq mal- ġisem kollu u titqaxxar il- ġilda Il- glandola adrenali ma taħdimx tajjeb Il- moħħ jibda jiffunzjona differenti, ħass ħażin Tibdil f’ daqqa ta ’ l- imġieba, tbati biex taħseb jew biex titkellem Uġigħ, debbulizza, tnemnim, jew tingiz fid- driegħ jew fir- riġlejn Dipressjoni Tara doppju, titlef id- dawl f’ roqgħa tal- kamp viżiv jew tara roqgħa skura Problemi tas- smigħ Insuffiċjenza tal- qalb jew attakk tal- qalb, disturbi fir- ritmu tal- qalb Puplesija, demm magħqud fil- moħħ, riġlejn jew pulmun Fsada fil- musrana Infjammazzjoni jew insuffiċjenza tal- fwied, li f’ każijiet rari wasslet għall- mewt Tkabbir kemm tal- fwied kif ukoll tal- milsa, tenerezza tal- fwied Raxx bi bżiezaq, dbabar kbar vjola fuq il- ġilda li jiġu kkawżati minn fsada taħt il- ġilda Infjammazzjoni tal- kliewi Uġigħ fis- sider Nefħa tal- wiċċ jew ta ’ l- ilsien.
HOW TO STORE NOXAFIL
KIF TAĦŻEN NOXAFIL
Do not freeze.
Tgħamlux fil- friża.
Do not use Noxafil after the expiry date which is stated on the label.
Tużax Noxafil wara d- data ta ’ skadenza li tidher fuq it- tikketta.
If you have any suspension left in a bottle more than four weeks after it was first opened, you should not use this medicine.
Jekk jibqalek xi suspensjoni fil- flixkun wara aktar minn erba ’ ġimgħat minn meta tkun ftaħtu l- ewwel darba, m’ għandekx tuża din il- mediċina.
Please return the bottle containing any left over suspension to your pharmacist.
Jekk jogħġbok ħu lura l- flixkun b’ dak li jkun baqa ’ mis - suspensjoni lill- ispiżjar tiegħek.
What Noxafil contains
X’ fih Noxafil
- The active substance in Noxafil oral suspension is posaconazole.
- Is- sustanza attiva fis- suspensjoni orali ta’ Noxafil hija posaconazole.
Each millilitre of oral
Kull millilitru
suspension contains 40 milligrams of posaconazole.
ta’ suspensjoni orali fih 40 milligramma ta ’ posaconazole.
- The other ingredients in the suspension are polysorbate 80, simeticone, sodium benzoate
- Is- sustanzi l- oħra huma polysorbate 80, simeticone, sodium benzoate (E211), sodium citrate
(E211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E171), artificial cherry flavour containing benzyl alcohol and propylene glycol, and purified water.
dihydrate, citric acid monohydrate, glycerol, xanthan gum, glucose likwidu, titanium dioxide (E171), togħma artifiċjali taċ- ċirasa li fiha benzyl alcohol u propylene glycol, u ilma purifikat.
30 What Noxafil looks like and contents of the pack
30 Id- Dehra ta ’ Noxafil u l- kontenuti tal- pakkett
Noxafil is a white, cherry flavoured, 105 ml oral suspension packaged in amber glass bottles.
Noxafil huwa suspensjoni bajda, b’ togħma taċ- ċirasa, 105 ml ta ’ suspensjoni orali impakkettati fi fliexken tal- ħġieġ kannella jagħtu fl- oranġjo.
A measuring spoon is provided with each bottle for measuring 2.5 and 5 ml doses of the oral suspension.
Hemm ukoll kuċċarina għal kejl ma ’ kull flixkun biex tkejjel dożi ta ’ 2. 5 u 5 ml ta’ suspensjoni orali.
SP Europe Rue de Stalle, 73 B-1180 Bruxelles Belgium
Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq SP Europe Rue de Stalle, 73 B- 1180 Bruxelles Il- Belġju
SP S.A.
Manifattur SP S. A.
2, rue Louis Pasteur F-14200 Hérouville St Clair France
2, rue Louis Pasteur F- 14200 Hérouville St Clair Franza
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States must ensure that all conditions with regard to the safe and effective use of the medicinal products described below are implemented:
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet kollha fir- rigward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt huma mplimentati:
The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following: • Educational material • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq se jiftiehem ma ’ l- Awtoritajiet Kompetenti Nazzjonali dwar id- dettalji ta ’ programm edukattiv, u għandu jimplimenta programm bħal dan b’ mod nazzjonali biex jiżgura li qabel jiġi preskritt Nplate it- tobba kollha jkollhom pakkett ta ’ informazzjoni għall- professjonisti fil- qasam tas- saħħa li fih dan li ġej: • Materjal edukkattiv • Sommarju tal- Karatteristiċi tal- Prodott (SPC) u Fuljett ta ’ Tagħrif u Tikketta
Key elements to be included in the educational material
Punti prinċipali li għandhom ikunu nkużi fil- materjal edukkattiv
• Posology • Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients. • The documents will discuss the following identified and potential risks:
• Pożoloġija • Obligazzjonijiet tal- professjonist fil- qasam tas- saħħa rigward il- preskrizzjoni ta ’ romiplostim u l- ħtieġa li jiġu pprovduti pariri komprensivi lill- pazjenti dwar ir- riskji u l- benefiċċji. • Id- dokumenti se jiddiskutu ir- riskji identifikati u potenzjali li ġejjin:
The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
L- inċidenza ta ’ tromboċitopenija fil- provi kliniċi u ċ- ċans li terġa sseħħ wara li titwaqqaf il- kura.
Advice on management of patients upon cessation of romiplostim.
Parir dwar l- immaniġġjar ta ’ pazjenti wara li jitwaqqaf romiplostim.
Background information on reticulin in the bone marrow.
Informazzjoni eżistenti dwar reticulin fil- mudullun ta ’ l- għadam.
Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Rati eżistenti ta ’ reticulin fil- mudullun ta ’ l- għadam f’ pazjenti b’ ITP u l- inċidenza osservata u l - mekkaniżmu ta ’ azzjoni potenzjali ta ’ depożizzjoni ta ’ reticulin bħala rispons għal romiplostim.
Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Twissija li, waqt li m’ hemm l- ebda data disponibbli, depożizzjoni ta ’ reticulin bħala rispons għal romiplostim tista ’ twassal għal fibrosi tal- mudullun ta ’ l - għadam.
Advice on when further investigations and a bone marrow biopsy might be appropriate.
Parir dwar meta jistgħu jkunu xierqa aktar investigazzjonijiet u bijopsija tal - mudullun ta ’ l- għadam.
The incidence in clinical trials of thrombotic / thromboembolic complications.
L- inċidenza ta ’ kumplikazzjonijiet trombotiċi / tromboemboliċi fil- provi kliniċi.
Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Parir biex jiġu segwiti l- linji gwida dwar l- aġġustament fid- doża biex ikun evitat għadd ta ’ plejtlits ’ l fuq mill- firxa normali.
The incidence of neutralising antibodies to romiplostim in clinical trials.
L- inċidenza ta ’ antikorpi newtralizzanti għal romiplostim fil- provi kliniċi.
The implications of romiplostim-neutralising antibodies cross-reacting with endogenous thrombopoietin (TPO).
L - implikazzjonijiet jekk antikorpi newtralizzanti għal romiplostim jirreaġixxu ma ’ trombopoetin endoġenu (TPO).
Antibody testing available upon request of physician, contact details for this antibody testing.
Ittestjar għall- antikorpi huwa disponibbli fuq talba tat - tabib, dettalji ta ’ kuntatt għal dan l- ittestjar għall- antikorpi.
Romiplostim may induce the progression of existing haematological malignancies and myelodysplastic syndrome (MDS).
Romiplostim jista ’ jikkawża l- progressjoni ta ’ tumuri malinni ematoloġiċi eżistenti u tas - sindromè mijelodisplastika (MDS).
Therefore, it should not be used in these indications outside the context of a clinical trial.
Għalhekk m’ għandux jintuża f’ dawn l - indikazzjonijiet jekk mhux fi prova klinika.
Data from clinical trials in MDS on the incidence of blast cell increases and progression to AML.
Data minn provi kliniċi b’ MDS dwar l - inċidenza ta ’ żjieda ta ’ ċelluli blastiċi u progressjoni għal AML.
Reiteration that the risk-benefit for the treatment of thrombocytopenia in non ITP patient populations has not been established.
Twissija mill- ġdid li ma kienux stabbiliti r- riskji u l- benefiċċji għall- kura ta ’ tromboċitopenija f’ popolazzjonijiet ta ’ pazjenti li m’ għandhomx ITP.
Clarification that risk-benefit for the treatment of paediatric ITP has not been established.
Għandu jkun iċċarat li ma kienux stabbiliti r- riskji u l- benefiċċji tal- kura ta ’ ITP fit- tfal.
The incidence of medication errors in clinical trials.
L- inċidenza ta ’ żbalji fil- medikazzjoni fil- provi kliniċi.
Provision of dosing calculator to simplify the calculation of the correct dose and guide in correct reconstitution and administration.
Għandha tiġi pprovduta kalkulatriċi tad- dożaġġ biex il- kejl tad- doża t- tajba tkun eħfef, u gwida dwar rikostituzzjoni u għoti tajbin.
What is Nplate?
X’ inhu Nplate?
Nplate is a powder that is made up into a solution for injection.
Nplate huwa trab li jitħallat biex isir soluzzjoni għall- injezzjoni.
It contains the active substance romiplostim.
Huwa fih is- sustanza attiva romiplostim.
What is Nplate used for?
Għalxiex jintuża Nplate?
Nplate is used in adults with long-term immune thrombocytopenic purpura (ITP), a disease in which the patient’ s immune system destroys the platelets (components in the blood that help it to clot).
Nplate jintuża fl- adulti b’ purpura tromboċitopenika immuni (ITP) fuq żmien twil, marda fejn is - sistema immuni tal- pazjent teqred il- pjastrini (komponenti fid- demm li jgħinuh jagħqad).
Patients with ITP have low platelet counts and are at risk of bleeding.
Pazjenti b’ ITP għandhom għadd baxxi ta ’ pjastrini u huma fil- periklu ta ’ fsada.
Nplate is used in patients who have already been treated with medicines such as corticosteroids or immunoglobulins and who have had their spleen removed, if these treatments have not worked.
Nplate jintuża f’ pazjenti li diġà ġew ittrattati b’ mediċini bħalma huma kortikosterojdi jew immunoglobulini u li tneħħitilhom il- milsa, jekk dawn it- trattamenti ma ħadmux.
It can also be considered for use in patients who have been treated for ITP who have a spleen and cannot have surgery.
Jista ’ wkoll ikun ikkunsidrat għall- użu f’ pazjenti li ġew ikkurati għall- ITP li għandhom milsa u ma tistax issirilhom il - kirurġija.
The spleen is an organ that is involved in the destruction of platelets.
Il- milsa hija organu li huwa involut fil- qerda tal- pjastrini.
Because the number of patients with ITP is low, the disease is considered ‘ rare’, and Nplate was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 27 May 2005.
Minħabba li n- numru ta ’ pazjenti li għandhom ITP huwa wieħed baxx, dan il- mard huwa kkunsidrat bħala ‘ rari ’, u fis- 27 ta ’ Mejju 2005, Nplate ġie denominat bħala ‘ mediċina orfni ’ (mediċina li tintuża f’ mard rari).
How is Nplate used?
Kif jintuża Nplate?
Treatment with Nplate should be supervised by a doctor who has experience in treating blood diseases.
It- trattament b’ Nplate għandu jkun sorveljat minn tabib li għandu esperjenza fil- kura ta ’ mard tad - demm.
Nplate is given once a week as an injection under the skin.
Nplate jingħata darba fil- ġimgħa bħala injezzjoni taħt il- ġilda.
The starting dose depends on the patient’ s weight, and is then adjusted every week to maintain platelet counts at target levels.
Id- doża tal- bidu tiddependi fuq il- piż tal- pazjent, imbagħad hija aġġustata kull ġimgħa biex iżżomm l- għadd tal- pjastrini fil- livelli fil- mira.
Treatment can be interrupted if platelet counts become too high.
It- trattament jista ’ jiġi interrott jekk l- għadd tal- pjastrini jsir għoli wisq.
Treatment with Nplate should be stopped after four weeks of treatment with the maximum dose of Nplate if the platelet count does not reach levels that are high enough to reduce the risk of bleeding.
It- trattament b’ Nplate għandu jitwaqqaf wara erba ’ ġimgħat ta ’ trattament b’ doża massima ta ’ Nplate jekk l- għadd tal- pjastrini ma jilħaqx livelli li huma għoljin biżżejjed biex inaqqsu l- periklu ta ’ fsada.
Nplate should be used with caution in patients who have problems with their liver or kidneys because it has not been formally studied in this group.
Nplate għandu jintuża bil- kawtela f’ pazjenti li għandhom problemi bil- fwied jew kliewi tagħhom minħabba li ma ġiex studjat formalment f’ dan il- grupp.
How does Nplate work?
Kif jaħdem Nplate?
The active substance in Nplate, romiplostim, is a medicine that stimulates the production of platelets.
Is- sustanza attiva f’ Nplate, romiplostim, hija mediċina li tistimula l- produzzjoni tal- pjastrini.
In the body, a hormone called ‘ thrombopoietin ’ stimulates the production of platelets in the bone marrow.
Fil - ġisem, ormon imsejjaħ ‘ trombopoietin ’ jistimula l- produzzjoni ta ’ pjastrini fil- mudullun.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Romiplostim huwa proteina li ‘ tfasslet ’ (‘ engineered ’ - iddisinjata speċifikament) sabiex tkun tista ’ taqbad ma u 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. attach to and stimulate the same receptors as thrombopoietin.
Reproduction is authorised provided the source is acknowledged. tistimula l- istess riċetturi bħal trombopoietin.
By mimicking the action of thrombopoietin, romiplostim stimulates the production of platelets, increasing blood platelet counts.
Billi jimita l- azzjoni ta ’ trombopoietin, romiplostim jistimula l- produzzjoni tal- pjastrini, u jżid l- għadd tal- pjastrini.
Romiplostim is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce romiplostim.
Huwa magħmul minn batterju li jkun irċieva ġene (DNA), li jagħmlu kapaċi jipproduċi romiplostim.
How has Nplate been studied?
Kif ġie studjat Nplate?
The effects of Nplate were first tested in experimental models before being studied in humans.
L- effetti ta ’ Nplate għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Nplate has been compared with placebo (a dummy treatment) in two main studies involving adults with long-term ITP.
Nplate tqabbel ma ’ plaċebo (trattament finta) f’ żewġ studji ewlenin li jinvolvu adulti b’ ITP fuq perjodu ta ’ żmien twil.
The first study involved 63 patients whose spleens had been removed but whose disease was still not controlled.
L- ewwel studju nvolva 63 pazjent li l- milsa tagħhom kienet tneħħiet iżda li l - marda tagħhom ma kinitx ikkontrollata.
The second study involved 62 patients who still had their spleens and who had been treated for ITP in the past.
It- tieni studju involva 62 pazjent li kien għad kellhom il- milsa tagħhom u kienu ttrattati għall- ITP fil- passat.
In both studies, the main measure of effectiveness was the number of patients who had a lasting response to treatment.
Fiż- żewġ studji, il- miżura ewlenija tal- effikaċja kienet in- numru ta ’ pazjenti li kellhom rispons li dam għat- trattament.
This was classified as the patient ’ s platelet counts being above 50 million per millilitre for at least six of the last eight weeks of the 24-week treatment period, without the need for any other medicines for ITP.
Din kienet ikklassifikata bħala li l- għadd tal- pjastrini tal- pazjenti aktar minn 50 miljun kull millilitru għal mill- inqas tmien ġimgħat mill- perijodu ta ’ trattament ta ’ 24 ġimgħa, mingħajr il - ħtieġa ta ’ xi mediċini oħrajn għall- ITP.
Platelet counts below 30 million per millilitre are considered to put ITP patients at risk of bleeding, while normal counts are between 150 and 400 million per millilitre.
L- għadd tal- pjastrini inqas minn 30 miljun kull millilitru huwa kkunsidrat li jpoġġi lil pazjenti b’ ITP f’ periklu ta ’ fsada, waqt li għadd normali huwa bejn 150 u 400 miljun kull millilitru.
What benefit has Nplate shown during the studies?
Liema benefiċċju wera Nplate waqt l- istudji mwettqa?
Nplate was more effective than placebo at increasing blood platelet counts.
Nplate kien iktar efikaċi minn plaċebo fiż- żieda tal- għadd tal- pjastrini.
In the study of patients whose spleen had been removed, 38% of the patients had a lasting response to treatment with Nplate (16 out of 42), compared with none of the 21 patients receiving placebo.
Fl- istudju ta ’ pazjenti li l- milsa tagħhom kienet tneħħiet, 38% tal- pazjenti kellhom reazzjoni li ddum għat- trattament b’ Nplate (16 minn 42), meta mqabblin ma ’ xejn mill- 21 pazjent li kienu qed jirċievu plaċebo.
In the study of patients with a spleen, 61% of the patients had a lasting response to treatment with Nplate (25 out of 41), compared with 5% of the patients receiving placebo (1 out of 21).
Fl- istudju ta ’ pazjenti b’ milsa, 61% tal- pazjenti kellhom reazzjoni li ddum għat- trattament b’ Nplate (25 minn 41), meta mqabblin ma ’ 5% tal- pazjenti li rċievew plaċebo (1 minn 21).
What is the risk associated with Nplate?
X’ inhu r- riskju assoċjat ma ’ Nplate?
The most common side effect with Nplate (seen in more than 1 patient in 10) is headache.
L- iktar effett sekondarju komuni b’ Nplate (li deher f' iktar minn pazjent 1 minn kull 10) huwa uġigħ ta ’ ras.
For the full list of all side effects reported with Nplate, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Nplate, ara l- Fuljett ta ’ Tagħrif.
Nplate should not be used in people who may be hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Nplate m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal romiplostim, għal xi sustanza oħra tiegħu, jew għall- proteini prodotti minn Escherichia coli (batterju).
Why has Nplate been approved?
Għaliex ġie approvat Nplate?
The Committee for Medicinal Products for Human Use (CHMP) noted that the effectiveness of Nplate had been shown in patients whose spleens had been removed, as well as in patients who still had their spleens.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) innota li intweriet l- effikaċja ta ’ Nplate f’ pazjenti li tneħħietilhom il- milsa, kif ukoll f’ pazjenti li kien għad kellhom il- milsa tagħhom.
However, because removal of the spleen is a potential cure for ITP, the Committee concluded that Nplate should only be used in these patients with a spleen if they are not able to undergo surgery.
Madankollu, minħabba li t- tneħħija tal- milsa hija kura potenzjali għall- ITP, il- Kumitat ikkonkluda li Nplate għandu jintuża biss f’ dawn il- pazjenti b’ milsa jekk dawn il- pazjenti ma tkunx tista ’ ssirilhom kirurġija.
Therefore, the CHMP decided that Nplate’ s benefits are greater than its risks for adult chronic immune (idiopathic) thrombocytopenic purpura splenectomised patients who are refractory to other treatments, and that it may be considered as second-line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Għaldaqstant, is- CHMP iddeċieda li l- benefiċċji ta ’ Nplate huma ikbar mir - riskji tiegħu għall- pazjenti adulti li tneħħitilhom il- milsa b’ purpura tromboċitopenika (idjopatika) immuni kronika, u li jista ’ jiġi kkunsidrat bħala trattamernt tat- tieni linja f’ pazjenti adulti li ma tneħħitilhomx il- milsa fejn il- kirurġija hija kontraindikata.
The Committee recommended that Nplate be given marketing authorisation.
Il- Kumitat irrakkomanda li Nplate jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Nplate?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur ta ’ Nplate?
The company that makes Nplate will provide educational packs for doctors in each Member State.
Il- Kumpanija li tipproduċi Nplate se tipprovdi pakketti edukattivi għat- tobba f’ kull Stat Membru.
The packs will include information on the safety and effectiveness of Nplate.
Il - pakketti se jinkludu informazzjoni dwar is- sigurtà u l- effikaċja ta ’ Nplate.
They will also remind doctors how to use the medicine and to discuss the benefits and risks of Nplate with patients.
Huma se jfakkru wkoll lit - tobba kif jużaw il- mediċina u jiddiskutu l- benefiċċji u r- riskji ta ’ Nplate mal- pazjenti.
Doctors will also receive a ‘ dosing calculator’ to help them calculate the volumes of Nplate that need to be injected.
It- tobba se jirċievu wkoll ‘ kalkulatur tad- doża ’ biex jgħinhom jikkalkulaw il- volumi ta ’ Nplate li jeħtieġu jiġu injettati.
These volumes can sometimes be very small.
Dawn il- volumi xi kultant jistgħu jkunu żgħar ħafna.
Other information about Nplate:
Informazzjoni oħra dwar Nplate:
The European Commission granted a marketing authorisation valid throughout the European Union for Nplate to Amgen Europe B. V. on 04 February 2009.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Nplate lil Amgen Europe B. V. fil- 04 ta ’ Frar 2009.
The summary of opinion of the Committee for Orphan Medicinal Products for Nplate is available here.
Is- sommarju ta ’ opinjoni tal- Kumitat għall- Prodotti Mediċinali Orfni għal Nplate huwa disponibbli hawn.
The full EPAR for Nplate can be found here.
L- EPAR sħiħ għal Nplate jista ’ jiġi kkonsultat hawn.
EMEA Number
Numru ta ’ l- EU
Nplate 250 micrograms powder for solution for injection
Nplate 250 mikrogramma trab għal soluzzjoni għall- injezzjoni
Each vial contains 250 µg of romiplostim.
Kull kunjett fih 250 µg ta ’ romiplostim.
After reconstitution, a deliverable volume of 0.5 ml solution contains 250 µg of romiplostim (500 µg/ ml).
Wara r- rikostituzzjoni, volum li jista ’ jingħata ta ’ 0. 5 ml ta ’ soluzzjoni fih 250 µg ta ’ romiplostim (500 µg/ ml).
An additional overfill is included in each vial to ensure that 250 µg of romiplostim can be delivered.
Spazju żejjed li jista ’ jintela huwa inkluż f’ kull kunjett sabiex jiġi żgurat li tista ’ tingħata 250 µg ta ’ romiplostim.
Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).
Romiplostim huwa prodott minn teknolġija tat- tfassil tad- DNA f’ Escherichia coli (E. coli).
This powder is white.
Dan it- trab huwa abjad.
Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e. g. corticosteroids, immunoglobulins).
Nplate huwa indikat għall- pazjenti adulti b’ purpura tromboċitopenika immuni (idjopatika) (ITP) kronika li tneħħitilhom il- milsa u li ma rrispondewx għal kura oħra (e. ż. kortikosterojdi, immunoglobulini).
Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.
Nplate jista ’ jiġi meqjus bħala kura sekondarja għall- pazjenti adulti li ma tneħħitilhomx il- milsa fejn kirurġija hija kontra- indikata.
Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.
Il- kura għandha tibqa ’ taħt is- sorveljanza ta ’ tabib li għandu esperjenza fil- kura ta ’ mard ematoloġiku.
Nplate should be administered once weekly as a subcutaneous injection.
Nplate għandu jingħata darba fil- ġimgħa bħala injezzjoni taħt il- ġilda.
The initial dose of romiplostim is 1 µg/ kg based on actual body weight.
Id- doża tal- bidu ta ’ romiplostim hija 1 µg/ kg ibbażata fuq il- piż attwali tal- ġisem.
Dose calculation
Kalkulazzjoni tad- doża
Initial or subsequent once weekly dose:
Doża tal- bidu jew sussegwenti ta ’ darba fil- ġimgħa:
Weight* in kg x Dose in µg/ kg = Individual patient dose in µg
Piż * f’ kg x Doża f’ µg/ kg = Doża ndividwali tal- pazjent f’ µg
Volume to administer:
2 Volum li għandu jingħata:
Dose in µg x 1 ml 500 µg = Amount to inject in ml
ml 500 µg
75 kg patient is initiated at 1 µg/ kg of romiplostim.
ta ’ 75 kg jinbeda
The individual patient dose = 75 kg x 1 µg = 75 µg The corresponding amount of Nplate solution to inject = 75 µg x 1 ml = 0.15 ml 500 µg
Id- doża ndividwali tal- pazjent = 75 kg x 1 µg = 75 µg L- ammont li jikkorrispondi ta ’ soluzzjoni ta ’ Nplate li għandu jiġi njettat =
2 *Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim.
* Meta tiġi kkalkulata d- doża ta ’ romiplostim, għandu dejjem jiġi wżat il- piż attwali tal- pazjent fil- bidu tal- kura.
Future dose adjustments are based on changes in platelet counts only and made in 1 µg increments (see Table below).
Aktar aġġustamenti fid- doża huma bbażati fuq bidliet fl- għadd tal- plejtlits biss u jsiru fi żjidiet ta ’ 1 µg (ara t- Tabella taħt).
Dose adjustments
Aġġustamenti fid- doża
A subject’ s actual body weight at initiation of therapy should be used to calculate dose.
Fil- bidu tal- kura, il- piż attwali tal- pazjent għandu jiġi wżat biex tikkalkula d- doża.
The once weekly dose of romiplostim should be increased by increments of 1 μ g/ kg until the patient achieves a platelet count ≥ 50 x 109/ l.
Id- doża ta ’ darba fil- ġimgħa ta ’ romiplostim għandha tiġi miżjuda b’ żjidiet ta ’ 1 μg/ kg sakemm il- pazjent jilħaq għadd ta ’ plejtlits ta ’ ≥ 50 x 109/ l.
Platelet counts should be assessed weekly until a stable platelet count (≥ 50 x 109/ l for at least 4 weeks without dose adjustment) has been achieved.
L- għadd tal- plejtlits għandu jiġi stmat kull ġimgħa sakemm jintlaħaq għadd stabbli ta ’ plejtlits (≥ 50 x 109/ l għal mill- inqas 4 ġimgħat mingħajr aġġustament fid- doża).
Platelet counts should be assessed monthly thereafter.
L - għadd tal- plejtlits għandu jkompli jiġi stmat kull xahar.
Do not exceed a maximum once weekly dose of 10 μ g/ kg.
Taqbiżx id- doża massima ta ’ 10 μg/ kg darba fil- ġimgħa.
Adjust the dose as follows:
Aġġusta d- doża kif ġej:
Platelet count Action (x 109/ l )< 50 Increase once weekly dose by 1 μg/kg > 200 for two Decrease once weekly dose by 1 μg/kg consecutive weeks Do not administer, continue to assess the platelet count weekly > 400 After the platelet count has fallen to < 200 x 109/l, resume dosing with once weekly dose reduced by 1 μg/kg
Għadd tal- plejtlits X’ għandek tagħmel (x 109/ l) < 50 Żid id- doża ta ’ darba fil- ġimgħa b’ 1 μg/ kg > 200 għal ġimagħtejn wara xulxin > 400
A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors (see section 4.4, loss of response to romiplostim).
Jekk fil- firxa ta ’ dożaġġ irrakkomandata ma jkunx hemm rispons, jew ir- rispons ma jinżammx, wieħed għandu jipprova jagħraf il- fatturi li qed jikkawżaw dan (ara sezzjoni 4. 4, telf ta ’ rispons għal romiplostim).
Method of administration
Metodu kif jingħata
After reconstitution of the powder, Nplate solution for injection is administered subcutaneously.
Wara r- rikostituzzjoni tat- trab, Nplate soluzzjoni għall- injezzjoni jingħata taħt il- ġilda.
The injection volume may be very small.
Il- volum ta ’ injezzjoni jista ’ jkun żgħir ħafna.
A syringe with graduations of 0.01 ml should be used.
Għandha tintuża siringa b’ marki tal- kejl ta ’ 0. 01 ml.
For instructions on reconstitution of Nplate, see section 6.6.
Għall- istruzzjonijiet dwar ir- rikostituzzjoni ta ’ Nplate, ara sezzjoni 6. 6.
Treatment discontinuation
Waqfien tal- kura
Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 μ g/ kg.
Kura b’ romiplostim għandha titwaqqaf jekk l- għadd tal- plejtlits ma jiżdiedx għal- livell suffiċjenti biex jevita fsada ta ’ importanza klinika wara erba ’ ġimgħat ta ’ terapija b’ romiplostim bl- għola doża ta ’ kull ġimgħa ta ’ 10 μg/ kg.
Patients should be clinically evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician.
Il- pazjenti għandhom jiġu vvalutati perjodikament b’ mod kliniku u l- kontinwazzjoni tal- kura għandha tiġi deċiża fuq bażi ndividwali mit- tabib li qed jikkura.
The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).
Id- dehra mill- ġdid ta ’ tromboċitopenija hija probabbli mal- waqfien tal- kura (ara sezzjoni 4. 4).
Elderly patients (≥ 65 years)
3 Pazjenti anzjani (≥ 65 sena)
No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
Ma kienet osservata l- ebda differenza globali fis- sigurtà jew l- effikaċja f’ pazjenti b’ età ta ’ < 65 u ≥ 65 sena (ara sezzjoni 5. 1).
Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.
Għalkemm ibbażat fuq dan it- tagħrif l- ebda aġġustament fil- kors ta ’ dożaġġ ma huwa meħtieġ għall- pazjenti aktar anzjani, attenzjoni hija rrakkomandata peress li s’ issa hemm biss numru żgħir ta ’ pazjenti anzjani inklużi fil- provi kliniċi.
3 Children and adolescents (< 18 years)
Tfal u adoloxxenti (< 18- il sena)
Nplate is not recommended for use in children below age 18 due to insufficient data on safety or efficacy.
Nplate mhux irrakkomandat għall- użu fit- tfal taħt 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà jew l- effikaċja.
No dose advice in this population can be provided.
Ma jistax jingħata parir dwar id- doża f’ din il - popolazzjoni.
No formal clinical studies have been conducted in these patient populations.
Ma sarux studji kliniċi formali f’ dawn il- popolazzjonijiet ta ’ pazjenti.
Nplate should be used with caution in these populations.
Nplate għandu jintuża b’ attenzjoni f’ dawn il- popolazzjonijiet.
Hypersensitivity to the active substance, to any of the excipients or to E. coli derived proteins.
Sensittività eċċessiva għas- sustanza attiva, għal xi sustanzi mhux attivi jew għall- proteini ġejjin minn E. coli.
The following special warnings and precautions have been actually observed or are potential class effects based on the pharmacological mechanism of action of thrombopoietin (TPO) receptor stimulators.
It- twissijiet u l- prekawzjonijiet speċjali li ġejjin kienu osservati attwalment jew huma effetti potenzjali tal- klassi bbażati fuq il- mekkaniżmu farmakoloġiku ta ’ azzjoni ta ’ stimulaturi tar- riċetturi ta ’ thrombopoietin (TPO).
Reoccurrence of thrombocytopenia and bleeding after cessation of treatment
Dehra mill- ġdid ta ’ tromboċitopenija u fsada wara l- waqfien tal- kura.
Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim.
Tromboċitopenija x’ aktarx li terġa sseħħ mal- waqfien tal- kura b’ romiplostim.
There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Hemm riskju miżjud ta ’ fsada jekk kura b’ romiplostim titwaqqaf fil- preżenza ta ’ sustanzi kontra l- koagulazzjoni tad- demm jew kontra l- plejtlits.
Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim.
Mal- waqfien tal- kura b’ romiplostim, il- pazjenti għandhom jiġu sorveljati mill- viċin għal tnaqqis fl- għadd ta ’ plejtlits u għandhom jiġu mmaniġġjati b’ mod mediku biex tiġi evitata fsada.
It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines.
Huwa rrakkomandat li, jekk titwaqqaf il- kura b’ romiplostim, terġa tinbeda kura ta ’ ITP skond il- linji ġwida tal- kura kurrenti.
Additional medical management may include cessation of anticoagulant and/ or antiplatelet therapy, reversal of anticoagulation, or platelet support.
Immaniġġjar mediku ieħor jista ’ jinkludi waqfien ta ’ sustanzi kontra l - koagulazzjoni tad- demm u/ jew terapija kontra l- plejtlits, taqlib ta ’ l- antikoagulazzjoni, jew support bi plejtlits.
Increased bone marrow reticulin
Żjieda fir- reticulin tal- mudullun tal- għadam
Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
Żjieda fir- reticulin tal- mudullun tal- għadam huwa maħsub li hija riżultat ta ’ l- istimulazzjoni tar - riċettur ta ’ TPO li twassal għal żjieda fin- numru ta ’ magakarjoċiti fil- mudullun tal- għadam li wara jista ’ jeħles ċitokini.
Increased reticulin may be suggested by morphological changes in the peripheral blood cells and can be detected through bone marrow biopsy.
Żjieda fir- reticulin tista ’ tkun issuġġerita minn bidliet morfoloġiċi fiċ- ċelluli periferali tad- demm u tista ’ tinstab permezz ta ’ bijopsija tal- mudullun tal- għadam.
Therefore, examinations for cellular morphological abnormalities using peripheral blood smear and complete blood count (CBC) prior to and during treatment with romiplostim are recommended.
Għalhekk qabel u waqt kura b’ romiplostim huma rrakkomandati eżaminazzjonijiet għall- anormalitajiet fil- morfoloġija taċ- ċelluli bl- użu ta ’ smear tad- demm periferali u għadd komplet tad- demm (CBC).
See Section 4.8 for information on the increases of reticulin observed in romiplostim clinical trials.
Ara Sezzjoni 4. 8 għall- informazzjoni dwar żjidiet fir- reticulin osservati fi provi kliniċi ta ’ romiplostim.
If a loss of efficacy and abnormal peripheral blood smear is observed in patients, administration of romiplostim should be discontinued, a physical examination should be performed, and a bone marrow biopsy with appropriate staining for reticulin should be considered.
Jekk fil- pazjenti jkunu osservati telf ta ’ l- effikaċja u smear tad- demm periferali mhux normali, l- għoti ta ’ romiplostim għandu jitwaqqaf, għandha ssir eżaminazzjoni fiżika, u għandha tiġi kkunsidrata bijopsija tal- mudullun tal- għadam bi staining xieraq għal reticulin.
If available, comparison to a prior bone marrow biopsy should be made.
Jekk disponibbli, din għandha titqabbel ma ’ bijopsija tal- mudullun tal- għadam ta ’ qabel.
If efficacy is maintained and abnormal peripheral blood smear is observed in patients, the physician should follow appropriate clinical judgment, including consideration of a bone marrow biopsy, and the risk-benefit of romiplostim and alternative ITP treatment options should be re-assessed.
Jekk fil- pazjenti l- effikaċja tibqa ’ u tkun osservata smear tad- demm periferali mhux normali, it- tabib għandu jsegwi l- ġudizzju kliniku xieraq, inkluż konsiderazzjoni ta ’ bijopsija tal- mudullun tal- għadam, u għandhom jerġgħu jiġu stmati r- riskju u l- benefiċċju ta ’ romiplostim u l- għażla ta ’ kura alternattiva ta ’ ITP.
Thrombotic/ thromboembolic complications
4 Komplikazzjonijiet trombotiċi/ tromboemboliċi
Platelet counts above the normal range present a theoretical risk for thrombotic/ thromboembolic complications.
Għadd ta ’ plejtlits ’ l fuq mill- firxa nomali jfisser riskju teoretiku għall- komplikazzjonijiet trombotiċi/ tromboemboliċi.
The incidence of thrombotic/ thromboembolic events observed in clinical trials was similar between romiplostim and placebo, and an association between these events and elevated platelet counts was not observed.
L- inċidenza ta ’ avvenimenti trombotiċi/ tromboemboliċi osservata fi provi kliniċi kienet simili bejn romiplostim u plaċebo, u assoċjazzjoni bejn dawn l- avvenimenti u għadd ta ’ plejtlits għoli ma kienetx osservata.
Dose adjustment guidelines should be followed (see section 4.2).
Għandhom jiġu segwiti linji gwida dwar l- aġġustament tad- doża (ara sezzjoni 4. 2).
4 Progression of existing haematopoietic malignancies or Myelodysplastic Syndromes (MDS)
Progressjoni ta ’ tumuri malinni ematopojetiċi eżistenti jew Sindromi Mijelodisplastiċi (MDS)
TPO receptor stimulators are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation, and platelet production.
Stimulaturi tar- riċettur ta ’ TPO huma fatturi tat- tkabbir li jwasslu għall- espansjoni taċ- ċellula proġenitura trombopoetika, divrenzjar, u għall- produzzjoni ta ’ plejtlits.
The TPO receptor is predominantly expressed on the surface of cells of the myeloid lineage.
Ir- riċettur ta ’ TPO huwa preżenti primarjament fuq il- wiċċ ta ’ ċelluli ta ’ nisel mijelojd.
For TPO receptor stimulators there is a theoretical concern that they may stimulate the progression of existing haematopoietic malignancies or MDS.
Għal stimulaturi tar- riċettur ta ’ TPO hemm tħassib teoretiku li huma jistgħu jistimulaw żvilupp ta ’ tumuri malinni ematopoetiċi eżistenti jew ta ’ MDS.
Romiplostim should not be used for the treatment of thrombocytopenia due to MDS or any other cause of thrombocytopenia other than ITP outside of clinical trials.
Jekk mhux waqt provi kliniċi, romiplostim m’ għandux jintuża għall- kura ta ’ tromboċitopenija kkawżata minn MDS jew xi kawża oħra ta ’ tromboċitopenija minbarra ITP.