qanastek/EMEA-V3 huggingface dataset:
The vaccine works by causing the body to produce its own protection (antibodies) against the disease.
Il- vaċċin jaħdem billi jġiegħel lill- ġisem stess jipproduċi protezzjoni (antikorpi) kontra l- marda.
MPL is included in this vaccine as an adjuvant and aluminium phosphate as an adsorbent.
MPL huwa inkluż f’ dan il- vaċċin bħala awżiljarju u l- aluminium phosphate bħala adsorbent.
These substances are included in Fendrix to accelerate, improve and prolong the protective effect of the vaccine.
Dawn is- sustanzi huma inklużi f’ Fendrix biex iħaffu, itejjbu u jtawwlu l- effett protettiv tal - vaċċin.
Hepatitis B disease is caused by the hepatitis B virus.
Il- marda ta ’ l- epatite B hija kkawżata mill- virus ta ’ l- epatite B.
It causes the liver to become swollen (inflamed).
Huwa jikkawża nefħa fil- fwied (infjammazzjoni).
The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
Il- virus jinsab fil- likwidi tal- ġisem bħad- demm, is- semen, it- tisfija tal- vaġina, jew il- bżieq tal- persuni infettati.
Symptoms may not be seen for 6 weeks to 6 months after infection.
Is- sintomi jistgħu ma jidhrux minn 6 ġimgħat sa 6 xhur wara l- infezzjoni.
Sometimes people who have been infected do not look or feel ill.
Xi kultant persuni li jkunu nfettati ma jidhrux jew ma jħossuhomx morda.
Others have mild flu-like symptoms, but some people can become very ill.
Oħrajn ikollhom sintomi ħfief bħal ta ’ l- influwenza, iżda xi wħud jistgħu jkunu morda ħafna.
They may be extremely tired, and have dark urine, pale faces, yellowish skin and/ or eyes (jaundice), and other symptoms possibly requiring hospitalisation.
Huma jkunu għajjenin ħafna, ikollhom l- awrina skura, wiċċhom bla kulur, il- ġilda u/ jew l- abjad ta ’ l- għajnejn sofor (suffejra) u sintomi oħra li għalihom jista ’ jkollhom bżonn jittieħdu l- isptar.
Most adults fully recover from the disease.
Il- biċċa l- kbira tal- persuni adulti jfiequ kompletament mill- marda.
But some people, who may not even have had symptoms can remain infected.
Iżda xi wħud, li jista ’ jkun lanqas biss kellhom sintomi, jistgħu jibqgħu infettati.
They are called hepatitis B virus carriers.
Dawn jissejjħu ġarriera tal- virus ta ’ l- epatite B.
Hepatitis B virus carriers can infect others throughout their lives.
Ġarriera tal- virus ta ’ l- epatite B jistgħu jinfettaw persuni oħra matul ħajjithom kollha.
Hepatitis B virus carriers are at risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.
Ġarriera ta ’ l - epatite B għandhom ukoll ir- riskju ta ’ mard serju fil- fwied, bħaċ- ċirrożi (merk fil- fwied) u kanċer tal - fwied.
As with all vaccines, Fendrix cannot completely prevent infections with hepatitis B virus, even after you have received the complete primary course of four doses.
Bħal f’ kull vaċċin ieħor, Fendrix ma jistax jilqgħa kompletament kontra infezzjonijiet bil- virus ta ’ l - epatite B anke wara li inti tkun ħadt il- kors primarju kollu ta ’ erba ’ dożi.
Also, if you have already been infected with hepatitis B virus prior to receiving Fendrix, but you are not yet feeling unwell, Fendrix may not be able to prevent you from becoming ill.
Anke jekk inti kont diġa ’ infettat bil- virus ta ’ l- epatite B qabel ma ’ ħadt Fendrix, iżda għadek m’ intix qed tħossok ma tiflaħx, Fendrix jista ’ jkun li ma jilqgħalekx milli timrad.
Fendrix can only help to protect you against infection with hepatitis B virus.
Fendrix jista ’ jipproteġik biss kontra l- infezzjoni mill- virus ta ’ l- epatite B.
It cannot protect you against other infections that can affect the liver and that can cause symptoms similar to those of hepatitis B virus infection.
Huwa ma jistax jipproteġik minn infezzjonijiet oħra li jistgħu jaffettwaw il- fwied u jikkawżaw sintomi bħal dawk ta ’ infezzjoni bil- virus ta ’ l- epatite B.
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B virus infection.
Huwa mistenni li tilqim b ’ Fendrix jista ’ jilqgħa wkoll kontra l- epatite D minħabba li l- epatite D (ikkawżata mill- aġent delta) ma tiġrix fin- nuqqas ta ’ infezzjoni bl- epatite B.
Vaccination is the best way to protect against this disease.
18 It- tilqim huwa l- aħjar mod kif tilqgħa kontra din il- marda.
None of the components in the vaccine are infectious.
L- ebda komponent tal- vaċċin ma huwa Infettiv.
BEFORE YOU RECEIVE FENDRIX
QABEL MA TIEĦU FENDRIX
Fendrix should not be given:
Fendrix m’ għandux jingħata:
• if you have previously had any allergic reaction to Fendrix, or any ingredient contained in this vaccine.
• jekk inti fil- passat kellek xi allerġija għall- Fendrix jew sustanzi oħra li fih dan il- vaċċin.
The active substances and other ingredients in Fendrix are listed at the end of the leaflet.
Is - sustanzi attivi u l- ingredjenti l- oħra li jinstabu f’ Fendrix, huma mniżżlin fl- aħħar ta ’ dan il - fuljett.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue; • if you have previously had an allergic reaction to any vaccine against hepatitis B disease; • if you have a severe infection with a high temperature.
Is- sinjali ta ’ xi allerġija jistgħu jinkludu, raxx fil- ġilda bil- ħakk, qtugħ ta ’ nifs, u nefħa fil- wiċċ jew fl- ilsien; • jekk inti fil- passat kellek xi allerġija għal kwalunkwe vaċċin kontra l- epatite B; • jekk inti għandek infezzjoni qawwija b’ deni għoli.
In these cases, the vaccination will be postponed until you have recovered.
F’ dawn il- każijiet it- tilqim b’ Fendrix ikun pospost sakemm tkun irkuprajt.
A minor infection such as a cold should not be a problem, but talk to your doctor first.
Xi infezzjoni ħafifa bħal xi riħ m’ għandiex tkun problema iżda qabel ikkonsulta mat- tabib.
Take special care with Fendrix Tell your doctor if you have any known allergies.
Oqgħod attent ħafna b’ Fendrix Għid lit- tabib tiegħek jekk taf li għandek xi allergiji.
Tell your doctor if you have experienced any health problems after previous administration of a vaccine.
Għid lit- tabib tiegħek jekk fil- passat esperjenzajt xi problemi ta ’ saħħa wara l- amministrazjoni ta ’ vaċċin.
Taking other medicines Tell your doctor if you have recently had or expect to shortly have any other vaccinations.
Meta tieħu mediċini oħra Għid lit- tabib tiegħek jekk dan l- aħħar ħadt jew wasalt biex tieħu kwalunkwe tilqim ieħor.
An interval of at least 2 to 3 weeks between Fendrix and any other vaccine is recommended.
Huwa rrakkomandat li intervall ta ’ bejn ta ’ lanqas 2 u 3 ġimgħat għandu jitħalla bejn Fendrix u kwalunkwe tilqima oħra.
If Fendrix is to be given at the same time as specific hepatitis B immunoglobulins, these should be given at different injection sites.
Jekk Fendrix għandu jingħata flimkien ma ’ immunoglobulini speċifiċi kontra l- epatite B, dawn għandhom jingħataw f’ siti ta ’ injezzjoni differenti.
Your doctor will be able to advise you .”
It- tabib tiegħek ikun jista ’ jgħatik parir.
Pregnancy and breast-feeding Tell your doctor if you are or think you may be pregnant.
Tqala u Treddigħ Għid lit- tabib tiegħek jekk inti tqila jew taħseb li inti tqila.
Driving and using machines Take special care while driving and using machines as Fendrix may give you headache or make you feel tired.
Sewqan u tħaddim ta ’ magni Oqogħod attent waqt li ssuq jew tħaddem xi magni għaliex Fendrix jista ’ jgħammillek uġigħ ta ’ ras jew iġgħalek tħossok għajjien.
HOW FENDRIX IS GIVEN
KIF JINGĦATA FENDRIX
If you are a patient with renal insufficiency, you will receive a total of four injections.
Jekk inti pazjent b’ insuffiċjenza tal- kliewi, inti se tirċievi total ta ’ erba ’ injezzjonijiet.
These will be given within a time period of 6 months.
Dawn se jiġu mogħtija f’ perjodu ta ’ 6 xhur.
Each injection is given on a separate visit.
Kull injezzjoni tingħata waqt żjara separata.
The first dose will be given on an agreed date with your doctor and the remaining three doses will be given one month, two months, and six months after the first dose.
L- ewwel doża tiġi mogħtija fid- data miftiehma mat- tabib tiegħek u t- tlett dożi li jibqa ’ jiġu mogħtija xahar, xahrejn u sitt xhur wara l- ewwel doża.
First dose:
L- ewwel doża:
Second dose:
It- tieni doża:
Third dose:
It- tielet doża:
Fourth dose:
Ir- raba doża:
at an elected date 1 month later 2 months after the first dose 6 months after the first dose
f’ data magħżula xahar wara xahrejn wara l- ewwel doża 6 xhur wara l- ewwel doża
Once you have received the first injection of Fendrix, the subsequent injections need to be of the same vaccine.
Ladarba tkun irċievejt l- ewwel injezzjoni ta ’ Fendrix, l- injezzjonijiet li jmiss iridu jkunu ta ’ l- istess vaċċin.
The doctor or nurse will inform you when you should come back for the subsequent injections.
It- tabib jew l- infermier jinfurmak dwar meta għandek terġa ’ tmur għall- injezzjonijiet li jmiss.
Your doctor will advise you on the possible need for extra doses, and future booster doses.
19 It- tabib jinfurmak dwar iżjed dożi jekk ikun hemm bżonn, u dwar dożi ta ’ rinforz fil- futur.
Fendrix can be used as a booster dose after a primary vaccination course with either a commercial recombinant hepatitis B vaccine or Fendrix.
Fendrix tista ’ tingħata bħala doża ta ’ rinforz wara li l- kors ta ’ tilqim primarju ikun sar kemm b’ vaċċin rikombinanati ta ’ l- epatite B li jinsab fis- suq kif ukoll b’ Fendrix.
19 If you miss a scheduled injection, talk to your doctor and arrange another visit.
Jekk tfalli xi injezzjoni skedata, kellem lit- tabib tiegħek u agħmel appuntament ieħor.
Make sure you finish the complete vaccination course of four injections.
Kun żgur li tispiċċa l- kors kollu ta ’ erba ’ tilqimiet.
If not, you may not be fully protected against the disease.
Jekk le, int tista ’ ma tkunx protett kontra din il - marda.
The doctor or nurse will give Fendrix as an injection into the muscle, usually in your upper arm.
It- tabib jew l- infermier jagħtik Fendrix bħala injezzjoni fil- muskolu ġeneralment fin- naħa ta ’ fuq ta ’ driegħek.
They will take care that Fendrix is not given into a blood vessel and into the skin.
Huma se jieħdu ħsieb li l- vaċċin ma jingħatax fil- vina jew fil- ġilda.
Like all medicines, Fendrix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Fendrix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd..
Side effects that occurred during a clinical trial with Fendrix in pre-haemodialysis and haemodialysis patients were as follows:
Effetti sekondarji li dehru waqt prova klinika b’ Fendrix fil- pazjenti ta ’ qabel id- dialisi tad- demm u ta’ waqt id- dialisi tad- demm kienu kif ġej:
♦ Very common (more than 1 per 10 doses of vaccine): • Pain or discomfort at the injection site • Fatigue • Headache
♦ Komuni ħafna (aktar minn każ 1 minn kull 10 dożi ta ’ vaċċin): • Uġigħ jew skonfort fis- sit ta ’ l- injezzjoni. • Għeja • Uġigħ ta ’ ras
♦ Common (less than 1 per 10 but more than 1 per 100 doses of vaccine): • Redness, swelling at the injection site • Fever • Stomach and digestive complaints
♦ Komuni (anqas minn każ 1 minn kull 10 iżda aktar minn każ 1 minn kull 100 doża ta’ vaċċin): • Ħmura u nefħa fis- sit ta ’ l- injezzjoni • Deni • Sintomi fl- istonku jew diġestivi
♦ Uncommon (less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • Chills • Other injection site reaction • Red raised skin rash
♦ Mhux komuni (anqas minn każ 1 minn kull 100 iżda aktar minn każ 1 minn kull 1000 doża ta ’ vaċċin): • Tkexkix ta ’ bard • Reazzjoni oħra fis- sit ta ’ l- injezzjoni • Raxx aħmar u mqabbeż fil- ġilda
Healthy subjects were also included in clinical studies.
Suġġetti f’ saħħithom kienu wkoll inklużi fl- istudji kliniċi.
Side effects observed with Fendrix were generally comparable to those seen in pre-haemodialysis and haemodialysis patients.
L- effetti mhux mixtieqa li ġew osservati b’ Fendrix kienu bejn wiehed u ieħor bhal dawk li dehru fil - pazjenti ta ’ qabel id- dialisi tad- demm u fil- pazjenti ta ’ waqt id- dialisi tad- demm.
In addition, the following effects were rarely observed:
Magħhom ġew innutati rarament dawn l- effetti li ġejjin:
♦ Rare (less than 1 per 1,000 but more than 1 per 10,000 doses of vaccine): • Allergy, unusual tiredness, hot flushes, • Dizziness • Thirst • Back pain, swelling of the tendons • Nervousness • Viral infection
♦ Rari (anqas minn każ 1 kull 1, 000 iżda aktar minn każ 1 minn kull 10, 000 doża ta ’ vaċċin): • Allerġija, għeja mhux tas- soltu, fwawar • Sturdament • Għatx • Uġigħ fid- dahar, nefħa fit- tendini • Nervożiżmu • Infezzjoni virali
If these events continue or become severe, tell your doctor.
Jekk dawn l- effetti jkomplu jew isiru gravi, għid lit- tabib tiegħek.
Allergic reactions, including anaphylactoid reactions, may occur very rarely (less than 1 per 10,000 doses of vaccine).
Reazzjonijiet allerġiċi, inkluż reażzjonijiet anafilattiċi, jistgħu jiġru anqas rari (anqas minn każ 1 minn kull 10, 000 doża tal- vaċċin).
These may be local or widespread rashes that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Dan jista ’ jkun raxx lokalizzat jew mifrux li jista ’ jkun bil- ħakk jew bl - infafet, nefħa fl- għajnejn u l- wiċċ, tbatija biex tieħu n- nifs jew tibla ’ u pressjoni taqa ’ f’ daqqa u tintilef minn sensik.
Such reactions may occur before leaving the doctor’s surgery.
Reazzjonijiet bħal dawn jistgħu jiġru qabel ma titlaq mill- klinika tat- tabib.
However, you should seek immediate treatment in any event.
Madanakollu xorta waħda għandek tfittex għajnuna medika immedjatament f’ kull każ.
Additional side effects that have been reported very rarely (less than 1 per 10,000 doses of vaccine) in the days or weeks after vaccination with hepatitis B vaccines, include fits, faints, disease of the nerves of the eye, multiple sclerosis, loss of sensation in, or of the ability to move some parts of the body, severe headache with stiff neck, disruption of the normal brain functions.
20 Effetti oħra mhux mixtieqa li ġew irrappurtati rari ħafna (anqas minn każ 1minn kull 10, 000 doża tal - vaċċin) fil- ġranet jew fil- ġimgħat ta ’ wara t- tilqim bil- vaċċini ta ’ l- epatite B, jinkludu aċċessjonijiet, ħass ħażinijat, mard fin- nervituri ta ’ l- għajnejn, sklerożi multipla, nuqqas ta ’ sensazzjoni, jew ta ’ l - abbilità li ċċaqlaq xi partijiet mill- ġisem, uġigħ ta ras qawwi b’ ebusija fl- għonq tfixkil fil- funzjoni normali tal- moħħ.
20 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE FENDRIX
KIF TAĦŻEN FENDRIX
Do not use Fendrix after the expiry date which is stated on the carton.
Tużax Fendrix wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Freezing destroys the vaccine.
L- iffriżar jeqred il- vaċċin.
What Fendrix contains
X’ fih Fendrix:
The active substance contained in 1 dose (0.5 ml) of Fendrix is:
Is- sustanza attiva f’ doża waħda (0. 5 ml) ta ’ Fendrix hi:
Hepatitis B surface antigen 1, 2, 3 1 adjuvanted by AS04C containing:
L- antiġenu ta ’ barra ta ’ l- epatite B1, 2, 3 1 supplimentat minn AS04C li fih:
- 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
- 3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2 adsorbit fuq aluminium phosphate (total ta ’ 0. 5 milligrammi Al3+) 3
The other ingredients in the vaccine are: sodium chloride, water for injections.
manifatturat f’ ċelloli tal- ħmira (Saccharomyces cerevisiae) permezz tat- teknoloġija rekombinanti tad - DNA
What Fendrix looks like and contents of the pack
Sustanzi oħra fil- vaċċin jinkludu: sodium chloride, ilma għall- injezzjoni
Suspension for injection in prefilled syringe.
Id- Dehra ta ’ Fendrix u l- kontenut tal- pakkett:
Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Fendrix huwa suspensjoni bajda qisa ħalib, preżentata ġo siringa tal- ħġieġ mimlija għal- lest (0. 5 ml).
Fendrix is available in packs of 1 with or without separate needle and in pack size of 10 without needles.
Fendrix jinsab f’ pakkett ta ’ 1 b’ labra separata jew mingħajra u f’ pakkett ta ’ 10 mingħajr labar.
Marketing Authorisation Holder and Manufacturer:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur
Rue de l’Institut 89 B-1330 Rixensart Belgium
21 GlaxoSmithKline Biologicals s. a Rue de l’ Institut 89 B- 1330 Rixensart Il- Belġju
For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq.
Eesti GlaxoSmithKline - Eesti OÜ Tel: +372 667 6900 estonia@gsk.com
Eesti GlaxoSmithKline - Eesti OÜ
Tel: + 43 1 970 75-0 at.info@gsk.com
Tel: +372 667 6900 estonia@ gsk. com
Tηλ: + 30 210 68 82 100
Tel: + 43 1 970 75- 0 at. info@ gsk. com
Tel.: + 48 (22) 576 9000
Tel.: + 48 (22) 576 9000 Tηλ: + 30 210 68 82 100
This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - mediċini (EMEA): http: // www. emea. europa. eu /.
The following information is intended for medical or healthcare professionals only:
It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- mediċina jew fil- qasam tas- saħħa:
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
Waqt li jkun maħżun, jista ’ jifforma depożitu fin u abjad b’ saff likwidu ċar u bla kulur fil- wiċċ.
Before administration, the vaccine should be well shaken to obtain a slightly opaque, white suspension.
Qabel ma jingħata, il- vaċċin għandu jiġi mħawwad sew sabiex tinkiseb suspensjoni bajda u ftit opaka.
The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance.
Il- vaċċin għandu jiġi mifli sewwa għal xi frak u/ jew xi tibdil fl- apparenza fiżika kemm qabel kif ukoll wara li jiġi mħawwad.
The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Il- vaċċin m’ għandux jintuża f’ każ li jkun hemm xi bidla fl- apparenza tal- vaċċin.
Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.
Fendrix m’ għandux jingħata lill- suġġetti li kellhom ipersensittivittà għas- sustanza attiva jew għall - kwalunkwe addittiv.
Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.
Fendrix m’ għandux jingħata lill- suġġetti li kellhom ipersensittivittà wara li ngħataw vaċċini ta ’ l- epatite B fil- passat.
Fendrix should not be given to subjects suffering from acute severe febrile illness.
23 Fendrix m’ għandux jingħata lill- suġġetti li qed isofru minn mard akut b’ deni qawwi.
The presence of a minor infection such as a cold, is not a contraindication for immunisation.
Il- preżenza ta ’ infezzjoni ħafifa bħal riħ, m’ hijiex kontra- indikazzjoni għat- tilqim.
Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.
Minħabba li l- amministrazzjoni ġol- muskolu gluteali tista ’ twassal għal rispons imnaqqas tal- vaċċin, din ir - rotta għandha tiġi evitata.
Fendrix should under no circumstances be administered intradermally or intravenously.
Fendrix m’ għandha qatt tingħata minn taħt il- ġilda jew fil- vina.
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster
Minħabba li l- pazjenti ta ’ qabel id- dialisi tad- demm u ta ’ waqt id- dialisi tad- demm ikunu partikolarment esposti għall- HBV u għandhom riskju akbar li jiġu infettati b’ mod kroniku, għanda tiġi kkunsidrata attitudni ta ’ prekawzjoni jiġifieri li tingħata doża ta ’ rinforz biex tiżgura livell ta ’ antikorp protettiv kif mfisser fir- rakkomandazzjonijiet u l- gwidi nazzjonali.
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Jekk teħtieġ iktar tagħrif dwar il- kundizzjoni medika jew it- trattament tiegħek, aqra l- Fuljett ta 'Tagħrif (li hu wkoll parti mill- EPAR) jew kellem lit- tabib jew spiżjar tiegħek Jekk trid aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR).
What is Ferriprox?
X’ inhu Ferriprox?
Ferriprox is a medicine containing the active substance deferiprone.
Ferriprox hu mediċina li fiha s- sustanza attiva deferiprone.
It is available as white, capsule- shaped tablets (500 mg) and as an oral solution (100 mg/ ml).
Tiġi bħala pilloli bojod b’ forma ta ’ kapsuli (500 mg) u bħala soluzzjoni orali (100 mg/ ml).
What is Ferriprox used for?
Għal xiex jintuża Ferriprox?
Ferriprox is used to treat iron overload (an excess of iron in the body) in patients with thalassaemia major (an inherited disease where patients are unable to make enough haemoglobin, the protein found in red blood cells that carries oxygen around the body).
Ferriprox jintuża għat- trattament ta ’ l- eċċess tal- ħadid fil- ġisem f’ pazjenti b’ talassemija maġġuri (marda tintiret fejn il- pazjenti ma jkunux kapaċi jagħmlu biżżejjed emoglobina, il- proteina fiċ- ċelloli tad- demm ħomor li ġġorr l- ossiġnu madwar il- ġisem).
Ferriprox is used when deferoxamine (another medicine used to treat iron overload) cannot be used.
Ferriprox jintuża meta ma jkunx jista ’ jintuża deferoxamine (mediċina oħra użata fit- trattament ta ’ l- akkumulazzjoni eċċessiva tal- ħadid.
How is Ferriprox used?
Kif jaħdem Ferriprox?
Ferriprox treatment should be started and maintained by a doctor who has experience in the treatment of patients with thalassaemia.
It- trattament b’ Ferriprox għandu jinbeda u jiġi mantnut minn tabib li jkollu esperjenza fit- trattament ta ’ pazjenti b’ talassemija.
The total daily dose of Ferriprox is 75 -100 mg per kilogram body weight given in three separate doses per day.
Id- doża totali kuljum ta ’ Ferriprox hi 75 - 100 mg għal kull kilogramma li jiżen il- pazjent fi tliet dożi separati kuljum.
If tablets are used, the number of tablets for each dose is adjusted to the nearest half tablet.
Jekk jintużaw il- pilloli, l- għadd ta ’ pilloli għal kull doża jiġi aġġustat għall- eqreb nofs pillola.
If the oral solution is used, the dose is adjusted to the nearest 2.5 ml.
Jekk tintuża s- soluzzjoni orali, id- doża tiġi aġġustata sa l- eqreb 2. 5 ml.
For example, a 70 kg patient will take three and a half tablets or 17.5 ml three times a day.
Ngħidu aħna, pazjent li jiżen 70 kg ikollu jieħu tliet pilloli u nofs jew 17. 5 ml tliet darbiet kuljum.
Doses above 100 mg/ kg per day are not recommended because of an potentially increased risk of side effects.
Id- dożi ta ’ iktar minn 100 mg/ kg kuljum mhux rakkomandati minħabba żieda potenzjali fir - riskju ta ’ l- effetti sekondarji.
Patients taking Ferriprox, or their carers, must be given a reminder card that reminds the patient how to take the medicine safely.
Il- pazjenti li jkunu qed jieħdu Ferriprox, jew min ikun qed jieħu ħsiebhom, għandhom jingħataw kard li tfakkar lill- pazjent kif jieħu l- mediċina b’ mod sigur.
How does Ferriprox work?
Kif jaħdem Ferriprox?
Patients with thalassaemia major need frequent blood transfusions.
Il- pazjenti b’ talassemija maġġuri jkollhom bżonn trasfużjonijiet tad- demm frekwenti.
When patients receive repeated transfusions, the transfused red cells bring iron.
Meta l- pazjenti jieħdu trasfużjonijiet ripetuti, iċ- ċelloli tad- demm ħomor trasfużi jġibu l- ħadid.
However, the body does not have a natural way of removing excess iron, so it builds up.
Iżda l- ġisem m’ għandux metodu naturali li bih jista ’ jneħħi l- ħadid żejjed, u għalhekk dan jakkumula.
Over time, the excess iron can damage important organs such as the heart or liver.
Matul iż - żmien, il- ħadid żejjed jista ’ jagħmel ħsara f’ organi importanti bħall- qalb u l- fwied.
The active substance in Ferriprox, deferiprone, is an ‘ iron chelator’.
Is- sustanza attiva f ’ Ferriprox, deferiprone, hu ‘ chelator tal- ħadid ’.
It binds to iron in the body to form a compound (a ‘ chelate’) that can be excreted by the body, mainly in the urine, and to a lesser extent in the faeces (stools).
Jeħel mal- ħadid fil- ġisem u jifforma kompost (‘ chelate ’) li jista ’ jitneħħa mill- ġisem, l- aktar fl- awrina, u f’ ammonti iżgħar fl- ippurgar.
This helps to correct the iron overload and prevent damage due to excess iron.
Dan jgħin biex ikun ikkoreġut l- eċċess tal- ħadid u jipprevjeni l- ħsara kkawżata mill- eċċess tal- ħadid.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged deferoxamine (the standard treatment to remove iron) in 71 patients over two years.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġie studjat Ferriprox?
The study was an ‘ open label’ study, meaning that the doctor and patients knew which medicine they were using, because Ferriprox is given by mouth, whereas deferoxamine is given by subcutaneous infusion (a very slow injection under the skin) overnight.
L- istudju kien wieħed ‘ b’ tikketta miftuħa ’, jiġifieri t- tabib u l- pazjenti kienu jafu liema mediċina kienu qed jużaw, għax Ferriprox jingħata oralment, waqt li deferoxamine jingħata b’ infużjoni taħt il- ġilda matul lejl.
A later study compared treatment alternating Ferriprox and deferoxamine (five days ’ Ferriprox plus two days ’ deferoxamine each week) with continuous treatment with deferoxamine on its own, in 60 patients over 12 months.
Iktar tard sar studju li qabbel trattament li jalterna Ferriprox u deferoxamine (ħamest ijiem Ferriprox flimkien ma ’ jumejn deferoxamine kull ġimgħa) mat- trattament kontinwu b’ deferoxamine waħdu f’ 60 pazjent matul 12- il xahar.
In all studies, effectiveness was measured by looking at the levels of ferritin in the blood before and during treatment.
Fl- istudji kollha, l- effettività tkejlet billi ġew ikkunsidrati l- livelli ta ’ ferretin fid- demm qabel u waqt it- trattament.
Ferritin is a protein that stores iron in the body.
Ferritin hu proteina li taħżen il- ħadid fil- ġisem.
The serum ferritin level (the amount of ferritin in the blood) is indicative of the amount of iron stored in the body.
Il- livell ta ’ ferretin fis- serum (l- ammont ta ’ ferretin fid- demm) juri l- ammont ta ’ ħadid merfugħ fil- ġisem.
What benefit has Ferriprox shown during the studies?
X’ inhu l- benefiċċju ta ’ Ferriprox li ntwera f’ dawn l- istudji?
In the initial comparative study, the mean serum ferritin levels were not significantly different in the two treatment groups, but average iron concentration in the liver of Ferriprox-treated patients seemed to increase more than in deferoxamine-treated patients.
Fl- ewwel studju komparattiv, ma kienx hemm differenza sinjifikanti fil- livelli medji ta ’ ferretin fis - serum fiż- żewġ gruppi ta ’ trattament, iżda l- konċentrazzjoni medja tal- ħadid fil- fwied ta ’ pazjenti ttrattati b’ Ferriprox deher jiżdied iktar milli fil- pazjenti ttrattati b’ deferoxamine.
In the alternating treatment study, the treatment schedule combining Ferriprox for five days with deferoxamine for two days reduced ferritin levels to the same extent as deferoxamine taken on its own.
Fl- istudju bit - trattament jalterna, l- iskeda tat- trattament li tikkombina Ferriprox għal ħamest ijiem ma ’ deferoxamine għal jumejn naqqset il- livelli ta ’ ferretin daqs meta ttieħed deferoxamine waħdu.
However, the number of patients in the study was not sufficient to prove that such a schedule is as effective as deferoxamine taken on its own.
Madankollu, l- għadd ta ’ pazjenti fl- istudju ma kienx biżżejjed biex ikun ippruvat li skeda bħal din kienet effettiva daqs deferoxamine meħud waħdu.
What is the risk associated with Ferriprox?
X’ inhuma r- riskji assoċjati ma ’ Ferriprox?
The most common side effects with Ferriprox (seen in more than 1 patient in 10) are reddish/ brown urine (showing that iron is being excreted), nausea (feeling sick), abdominal (tummy) pain and vomiting.
L- iktar effetti sekondarji komuni ma ’ Ferriprox (li dehru f’ iktar minn pazjent wieħed minn kull għaxra) huma awrina ħamranija fil- kannella (li turi li l- ħadid ikun qed jinħareġ mill- ġisem), dardir, uġigħ ta ’ żaqq u remettar.
An uncommon but serious side effect is agranulocytosis (very low levels of a type of white blood cell).
Effett sekondarju mhux komuni iżda serju hu l- agranulocytosis (livelli baxxi ħafna ta ’ tip ta ’ ċelloli tad- demm bojod).
Ferriprox should not be used in people who may be hypersensitive (allergic) to deferiprone or any of the other ingredients.
Ferriprox m’ għandux jintuża minn persuni li jistgħu jkunu allerġiċi għal deferiprone jew għal xi sustanzi oħra tiegħu.
Ferriprox should not be used in people who have had neutropenia (low levels of a type of white blood cell) repeatedly or agranulocytosis.
Ferriprox m’ għandux jintuża minn minn ikollu n- newtropenja (livelli baxxi ta ’ tip ta ’ ċelloli tad- demm bojod) ripetutament jew agranulocytosis.
Ferriprox should also not be used with medicines that might cause neutropenia or agranulocytosis.
Ferriprox m’ għandux jintuża ma ’ mediċini li jistgħu jikkawżaw newtropenja jew agranulocytosis.
Ferriprox should not be used in women who are pregnant or breast-feeding.
Ferriprox m’ għandux jintuża minn nisa tqal jew li jkunu qed ireddgħu.
Why has Ferriprox been approved?
Għaliex ġie approvat Ferriprox?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ferriprox’ s benefits are greater than its risks for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Ferriprox huma ikbar mir- riskji tiegħu meta użat għat- trattament ta ’ eċċess ta ’ ħadid fil- pazjenti b’ talassemija maġġuri meta t- terapija b’ deferoxamine tkun kontraindikata jew ma tkunx biżżejjed.
They recommended that Ferriprox be given marketing authorisation.
Irrakkomandaw li Ferriprox jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Ferriprox was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Ferriprox oriġinarjament ġie awtorizzat għal ‘ Ċirkostanzi ta ’ Eċċezzjoni ’, għax, billi l- marda hi rari, it- tagħrif disponibbli fi żmien l- approvazzjoni kien wieħed limitat.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 12 April 2002.
Billi l- kumpanija pprovdiet it - tagħrif addizzjonali mitlub, iċ - ‘ Ċirkostanzi ta ’ Eċċezzjonali ’ ntemmu fit- 12 ta ’ April ta ’ l- 2002.
Other information about Ferriprox:
Tagħrif ieħor dwar Ferriprox:
The European Commission granted a marketing authorisation valid throughout the European Union for Ferriprox on 25 August 1999.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Ferriprox valida għall- Unjoni Ewropea kollha fil- 25 t’ Awissu 1999.
The marketing authorisation was renewed on 25 August 2004.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fil- 25 ta ’ Awissu 2004.
The marketing authorisation holder is Apotex Europe B. V.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq huwa Apotex Europe B. V.
The full EPAR for Ferriprox is available here.
L- EPAR sħiħ għal Ferripox huwa disponibbli minn hawn.
EU Number EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
Numru ta ’ l- EU EU/ 1/ 99/ 108/ 001 EU/ 1/ 99/ 108/ 002 EU/ 1/ 99/ 108/ 003
Invented name Ferriprox Ferriprox Ferriprox
Isem inventat Ferriprox Ferriprox Ferriprox
Strength 500 mg 100 mg/ ml 100 mg/ ml
Qawwa 500 mg 100 mg/ ml 100 mg/ ml
Pharmaceutical Form Film-coated tablet Oral solution Oral solution
Għamla farmaċewtika Pilloli miksija b’ rita Soluzzjoni orali Soluzzjoni orali
Route of Administration Oral use Oral use Oral use
Mnejn jingħata Jittieħed mill- ħalq Jittieħed mill- ħalq Jittieħed mill- ħalq
Packaging bottle (HDPE) bottle (PET) bottle (PET)
Il- pakkett flixkun (HDPE) flixkun (PET) flixkun (PET)
Content 100 tablets 250 ml 500 ml
Kontenut 100 pillola 250 ml 500 ml
Package size 1 bottle 1 bottle 1 bottle
Daqs tal- pakkett 1 flixkun 1 flixkun 1 flixkun
Ferriprox 500 mg film-coated tablets
Ferriprox ta ’ 500 mg pilloli miksija b’ rita
Each tablet contains 500 mg deferiprone.
Kull pillola fiha 500 mg ta ’ deferiprone
White to off-white, capsule-shaped, film-coated tablets imprinted “ APO” bisect “ 500” on one side, plain on the other.
Pilloli miksija b’ rita, b’ forma ta ’ kapsula, ta ’ lewn abjad jew abjad jagħti fil- griż, li għandhom stampat fuqhom “ APO ” b’ qasma fin- nofs u “ 500 ” fuq naħa waħda, u xejn fuq in- naħa l- oħra.
The tablet is scored.
Il- pillola għandha ferq.
The tablet can be divided into equal halves.
Il- pillola tista ’ tinqasam min- nofs.
Ferriprox is indicated for the treatment of iron overload in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.
Ferriprox hu indikat għall- kura ta ’ livelli eċċessivi ta ’ ħadid f’ pazjenti li għandhom talessimja maġġura meta t- terapija b’ deferoxamine hi kontra- indikata jew inadegwata.
Deferiprone therapy should be initiated and maintained by a physician experienced in the treatment of patients with thalassaemia.
It- terapija b’ deferiprone trid tinbeda u titkompla minn tabib li għandu esperjenza fil- kura ta ’ pazjenti bit- talessimja.
Deferiprone is usually given as 25 mg/ kg body weight, orally, three times a day for a total daily dose of 75 mg/ kg body weight.
Deferiprone ġeneralment jingħata bħala 25 mg/ kg piż korporali, mill- ħalq, tliet darbiet kuljum għal doża aħħarija ta ’ kuljum ta ’ 75 mg/ kg piż korporali.
Dosage per kilogram body weight should be calculated to the nearest half tablet.
Id- dożaġġ għal kull kilogramm ta ’ piż tal- ġisem għandu jiġi kkalkulat sa l- eqreb nofs pillola.
See table below for recommended doses for body weights at 10 kg increments.
Ara t- tabella t’ hawn taħt għal dożi rakkomandati skond piżijiet tal- ġisem li jikbru b’ 10 kg kull darba.
Doses above 100 mg/ kg/ day are not recommended because of the potentially increased risk of adverse reactions; chronic administration of more than 2.5 times the maximum recommended dose has been associated with neurological disorders (see sections 4.4, 4.8, and 4.9).
Dożi ta ’ aktar minn 100 mg/ kg/ kuljum mhumiex irrakkomandati minħabba l- potenzjal ta ’ żjieda fir - riskju ta ’ reazzjonijiet avversi; l- għoti kroniku tad- doża massima rrakkomandata kien assoċjat ma ’ disturbi newroloġiċi (ara sezzjonijiet 4. 4, 4. 8, u 4. 9).
There are limited data available on the use of deferiprone in children between 6 and 10 years of age, and no data on deferiprone use in children under 6 years of age.
Hemm biss informazzjoni limitata disponibbli fuq l- użu ta ’ deferiprone fi tfal ta ’ bejn is- 6 u l- 10 snin, u m’ hemm l- ebda informazzjoni dwar deferiprone għal tfal ta ’ taħt is- 6 snin.
Due to the serious nature of agranulocytosis, that can occur with the use of deferiprone, special monitoring is required for all patients.
Minħabba n- natura serja ta ’ l- agranuloċitosi li tista ’ sseħħ bl- użu ta ’ deferiprone, monitoraġġ speċjali hu meħtieġ għall- pazjenti kollha.
Caution must be used when the patients ’ absolute neutrophil count (ANC) is low, as well as when treating patients with renal insufficiency or hepatic dysfunction.
Trid tingħata attenzjoni meta l- kownt assolut tan- newtrofili (absolute neutrophil count - ANC) ikun baxx, kif ukoll meta jkunu qed jiġu kkurati pazjenti b’ insuffiċjenza renali jew b’ disfunzjoni tal- fwied (ara sezzjoni 4. 4).
(see section 4.4).
Tabella tad- dożi
2 Dose table
2 Piż tal- Ġisem
To obtain a dose of about 75 mg/ kg/ day, use the number of tablets suggested in the following table for the body weight of the patient.
Doża Totali ta ’ Kuljum Doża
Sample body weights at 10 kg increments are listed.
Numru ta ’ Pilloli
Body weight
(tliet darbiet/ kuljum)
Total daily dose
darbiet/ kuljum)
Dose
20
Number of tablets
500 500
(kg) 20 30 40 50 60 70 80 90
1. 0
(three times/ day) 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5
2. 0 2. 5 3. 0 3. 5 4. 0 4. 5
Contraindications
4. 3 Kontra- indikazzjonijiet
History of recurrent episodes of neutropenia.
Passat ta ’ episodji rikorrenti ta ’ newtropenja.
History of agranulocytosis.
Passat ta ’ agranuloċitosi.
Pregnancy or breast-feeding (see section 4.6).
Tqala jew treddigħ (ara sezzjoni 4. 6).
Due to the unknown mechanism of deferiprone-induced neutropenia, patients must not take medicinal products known to be associated with neutropenia or those that can cause agranulocytosis (see section 4.5).
Minħabba l- mekkaniżmu mhux magħruf dwar newtropenja sensitizzata minn deferiprone, pazjenti m’ għandhomx jieħdu prodotti mediċinali magħrufa li huma assoċjati ma ’ newtropenja jew dawk li jistgħu jikkawżaw agranuloċitosi (ara sezzjoni 4. 5).
Neutropenia/ Agranulocytosis Deferiprone has been shown to cause neutropenia, including agranulocytosis.
Newtropenja/ Agranuloċitosi Intwera li deferiprone jikkawża n- newtropenja, inkluża l- agranuloċitosi.
The patient ’ s neutrophil count should be monitored every week.
Il- kownt tan- newtrofili tal- pazjent għandu jkun immonitorjat kull ġimgħa.
In clinical trials, weekly monitoring of the neutrophil count has been effective in identifying cases of neutropenia and agranulocytosis.
Fi provi kliniċi, l- immonitorjar ta ’ kull ġimgħa tan- newtrofili kien effettiv fl- identifikazzjoni ta ’ każijiet ta ’ newtropenja u agranuloċitosi.
Neutropenia and agranulocytosis resolved once therapy was withdrawn.
In- newtropenja u l- agranuloċitosi fiequ ġaladarba t- terapija twaqqfet.
If the patient develops an infection while on deferiprone, therapy should be interrupted and the neutrophil count monitored more frequently.
Jekk il- pazjent jiżviluppa xi infezzjoni meta jkun qed jieħu deferiprone, it- terapija għandha titwaqqaf u l- kownt tan- newtrofili għandu jiġi osservat aktar ta ’ spiss.
Patients should be advised to report immediately to their physician any symptoms indicative of infection such as fever, sore throat and flu-like symptoms.
Il- pazjenti għandhom jingħataw parir biex jirrappurtaw immedjatament lit- tabib tagħhom kwalunkwe sintomi li jistgħu jindikaw xi infezzjoni bħal deni, uġigħ fil- griżmejn u sintomi bħal dawk ta ’ l- influwenza.
Suggested management of cases of neutropenia is outlined below.
L- immaniġġjar issuġġerit ta ’ każijiet ta ’ newtropenja hu elenkat fil- qosor hawn taħt.
It is recommended that such a management protocol be in place prior to initiating any patient on deferiprone treatment.
Hu rrakkomandat li dan il- protokoll ta ’ immaniġġjar ikun disponibbli qabel ma tinbeda l- kura b’ deferiprone fuq xi pazjent.
Treatment with deferiprone should not be initiated if the patient is neutropenic.
Il- kura b’ deferiprone m’ għandhiex tinbeda jekk il- pazjent hu newtropeniku.
The risk of agranulocytosis and neutropenia is higher, if the baseline absolute neutrophil count (ANC) is less than 1.5x109/ l.
Ir- riskju ta ’ agranuloċitosi u ta ’ newtropenija hu ogħla, jekk il- kownt ta ’ l- ANC fil- linja bażi jkun inqas minn 1. 5x109/ l.
In the event of neutropenia:
F’ każ ta ’ newtropenja:
Instruct the patient to immediately discontinue deferiprone and all other medicinal products with a potential to cause neutropenia.
Ordna ’ l- pazjent sabiex iwaqqaf minnufih it- teħid ta ’ deferiprone u l- prodotti mediċinali l- oħra kollha li potenzjalment jistgħu jikkaġunaw newtropenja.
The patient should be advised to limit contact with other individuals in order to reduce the risk of infection.
Il- pazjent għandu jingħata parir biex inaqqas il - kuntatt ma ’ individwi oħrajn biex inaqqas ir- riskju ta ’ infezzjoni.
Obtain a complete blood cell (CBC) count, with a white blood cell (WBC) count, corrected for the presence of nucleated red blood cells, a neutrophil count, and a platelet count immediately upon diagnosing the event and then repeat daily.
Ikseb il- kownt sħiħ taċ- ċelluli tad - demm (complete blood cell - CBC), flimkien ma ’ l- kownt taċ- ċelluli bojod tad- demm (white blood cell
It is recommended that following recovery from neutropenia, weekly CBC, WBC, neutrophil and platelet counts continue to
Hu rakkomandat li wara l- irkupru min- newtropenja, kull ġimgħa jinkiseb l- għadd tas - CBC, tal- WBC, tan- newtrofili u tal- plejtlits, u dan għandu jibqa ’ jinkiseb kull ġimgħa għal tliet
3 be obtained for three consecutive weeks, to ensure that the patient recovers fully.
3 ġimgħat konsekuttivi, biex jiġi żgurat li l- pazjent jirkupra kompletament.
Should any evidence of infection develop concurrently with the neutropenia, the appropriate cultures and diagnostic procedures should be performed and an appropriate therapeutic regimen instituted.
Jekk ikun hemm xi evidenza li xi infezzjoni qed tiżviluppa fl- istess ħin man- newtropenja, il- kulturi adattati u l- proċeduri dijanjostiċi għandhom jitwettqu, u jinbeda kors adattat ta ’ antibijotiċi.
In the event of severe neutropenia or agranulocytosis:
F’ każ ta ’ newtropenja jew agranuloċitosi severa:
Follow the guidelines above and administer appropriate therapy such as granulocyte colony stimulating factor, beginning the same day that the event is identified; administer daily until the condition resolves.
Segwi l- linji gwida t’ hawn fuq u agħti t- terapija adattata, bħal fattur li jistimula l- kolonja tal - granuloċiti, li għandhom jinbdew fl- istess jum li l- każ jiġi identifikat; agħti kuljum sakemm il - kundizzjoni tfieq.
Provide protective isolation and if clinically indicated, admit patient to the hospital.
Ipprovdi iżolament protettiv u jekk klinikament indikat, daħħal il- pazjent l- isptar.
Limited information is available regarding rechallenge.
Informazzjoni limitata hi disponibbli dwar ir- riċalinġ.
Therefore, in the event of neutropenia, rechallenge is not recommended.
Għalhekk fil- każ ta ’ newtropenja, ir- riċalinġ mhux rakkomandat.
In the event of agranulocytosis, a rechallenge is contraindicated.
F’ każ ta ’ agranuloċitosi, ir- riċalinġhu kontra- indikat.
Carcinogenicity/ mutagenicity/ effects on fertility In view of the genotoxicity results, a carcinogenic potential of deferiprone cannot be excluded (see section 5.3).
Karċinoġeneċità/ mutaġeniċità/ effetti fuq il- fertilità Minħabba r- riżultati tal- ġenotossiċità, il- potenzjal karċinoġeniku ta ’ deferiprone ma jistax jiġi eskluż (ara sezzjoni 5. 3).
No animal studies to evaluate the potential effects of deferiprone on fertility have been reported.
Ma kienu rrappurtati l- ebda studji fuq l- annimali biex jevalwaw l- effetti potenzjali ta ’ deferiprone fuq il- fertilità.
Serum ferritin concentration/ plasma Zn2+ concentration It is recommended that serum ferritin concentrations, or other indicators of body iron load, be monitored every two to three months to assess the long-term effectiveness of the chelation regimen in controlling the body iron load.
Konċentrazzjoni tal- ferritin fis- serum/ konċentrazzjoni Zn2+ fil- plażma Hu rakkomandat li l- konċentrazzjonijiet tal- ferritin fis- serum, jew indikaturi oħrajn tal- livell tal- ħadid fil- ġisem ikunu mmonitorjati kull xahrejn jew tlieta biex tkun evelawata l- effettività tal- kelazzjoni fil - kontroll tal- livelli tal- ħadid fil- ġisem.
Interruption of therapy with deferiprone should be considered if serum ferritin measurements fall below 500 μ g/ l.
Il- waqfien tat- terapija b’ deferiprone għandu jiġi kkunsidrat jekk il- kejl tal- ferritin fis- serum jaqa ’ taħt il- 500 μg/ l.
Monitoring of plasma Zn2+ concentration, and supplementation in case of a deficiency, is recommended.
Il- monitoraġġ tal- konċentrazzjoni taż- Zn2+ fil- plażma, u li jingħata suppliment f’ każ ta ’ defiċjenza, huma rakkomandati.
HIV positive or other immune compromised patients No data are available on the use of deferiprone in HIV positive or in other immune compromised patients.
Pazjenti li huma pożittivi għall- HIV jew pazjenti oħrajn li huma kompromessi immunoloġikament M’ hemm l- ebda informazzjoni disponibbli dwar l- użu ta ’ deferiprone f’ pazjenti li huma pozittivi għall- HIV jew pazjenti oħrajn li huma kompromessi immunoloġikament.
Given that deferiprone can be associated with neutropenia and agranulocytosis, therapy in immune compromised patients should not be initiated unless potential benefits outweigh potential risks.
Minħabba li deferiprone jista ’ jkun assoċjat ma ’ newtropenja u agranuloċitosi, it- terapija f’ pazjenti li huma kompromessi immunoloġikament m’ għandhiex tinbeda ħlief jekk il- benefiċċji potenzjali ma jegħlbux ir- riskji potenzjali.
Renal or hepatic impairment and liver fibrosis There are no data available on the use of deferiprone in patients with renal or hepatic impairment.
Indeboliment renali jew epatiku u fibrożi tal- fwied M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ deferiprone f’ pazjenti li għandhom indeboliment tal- kliewi jew fil- fwied.
Since deferiprone is eliminated mainly via the kidneys, there may be an increased risk of complications in patients with impaired renal function.
Billi deferiprone jitneħħa primarjament mill- kliewi, jista ’ jkun hemm riskju ogħla ta ’ kumplikazzjonijiet f’ pazjenti li għandhom indeboliment fil- funzjoni renali.
Similarly, as deferiprone is metabolised in the liver, caution must be exercised in patients with hepatic dysfunction.
Bl- istess mod, billi deferiprone hu metabolat fil- fwied, għandha tingħata attenzjoni f’ pazjenti b’ disfunzjoni epatika.
Renal and hepatic function should be monitored in this patient population during deferiprone therapy.
Il - funzjoni renali u epatika għandha tkun immonitorjata f’ din il- popolazzjoni ta ’ pazjenti matul it- terapija b’ deperiprone.
If there is a persistent increase in serum alanine aminotransferase (ALT), interruption of deferiprone therapy should be considered.
Jekk ikun hemm żjieda persistenti fil- livelli ta ’ serum alanine aminotransferase (ALT), l- interruzzjoni tat- terapija b’ deferiprone għandha tkun ikkunsidrata.
In thalassaemia patients there is an association between liver fibrosis and iron overload and/ or hepatitis C.
F’ pazjenti li għandhom it- talessimja, hemm rabta bejn il- fibrożi tal- fwied u l- livelli eċċessivi ta ’ ħadid u/ jew epatite Ċ.
Special care must be taken to ensure that iron chelation in patients with hepatitis C is optimal.
Attenzjoni speċjali trid tingħata biex ikun żgurat li l- kelazzjoni tal- ħadid f’ pazjenti bl - epatite Ċ hi mill- aħjar.
In these patients careful monitoring of liver histology is recommended.
F’ dawn il- pazjenti, l- immonitorjar bl- attenzjoni ta ’ l- istoloġija tal- fwied hu rakkomandat.
Discoloration of urine Patients should be informed that their urine may show a reddish/ brown discoloration due to the excretion of the iron-deferiprone complex.
Tibdil fil- kulur ta ’ l- awrina Il- pazjenti għandhom ikunu infurmati li l- awrina tagħhom tista ’ tibdel il- kulur għal- lewn ħamrani/ kannella minħabba t- tneħħija tal- kumpless kimiku tal- ħadid- deferiprone.
Chronic overdose and neurological disorders Neurological disorders have been observed in children treated with 2.5 to 3 times the recommended dose for several years.
Disturbi kroniċi ta ’ doża eċċessiva u newroloġiċi Disturbi newroloġiċi kienu osservati fi tfal ikkurati bi 2. 5 sa 3 darbiet tad- doża rakkomandata għal diversi snin.
Prescribers are reminded that the use of doses above 100 mg/ kg/ day are not recommended (see sections 4.2, 4.8 and 4.9).
Dawk li jagħtu r- riċetta għandhom jiġu mfakkra li l- użu ta ’ dożi ta ’ aktar minn 100 mg/ kg/ jum mhuwiex rakkomandati (ara sezzjonijiet 4. 2, 4. 8 u 4. 9).