qanastek/EMEA-V3 huggingface dataset:
• loss of appetite • feeling sick (nausea) • being sick (vomiting) • high temperature (fever) • pain in your stomach (abdomen) • yellowing of your skin or the whites of your eyes (jaundice) • dark-coloured urine • itching of your skin.
• nuqqas ta 'aptit • tħossok ma tiflaħx (imqalla') • tkun ma tiflaħx (taqla ') • temperatura għolja (deni) • uġigħ fl- istonku tiegħek (addomenu) • sfurija tal- ġilda tiegħek jew l- abjad ta' għajnejk (sufferja) • awrina ta 'kulur skur • ħakk fil- ġilda tiegħek.
If you notice any of these signs:
Jekk tinnota xi wieħed minn dawn is- sinjali:
→ Tell your doctor immediately.
Għid lit- tabib tiegħek mill- ewwel.
Taking other medicines Tell your doctor or pharmacist if you ’ re taking any other medicines, if you’ ve taken any recently, or if you start taking new ones – these include herbal medicines or other medicines you bought without a prescription.
Meta tieħu mediċini oħra Għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, jew jekk tibda tieħu xi ġodda - dawn jinkludu mediċini erbali jew mediċini oħra li tkun xtrajt mingħajr riċetta.
Pregnancy Volibris may harm unborn babies conceived before, during or soon after treatment.
Tqala Volibris jista 'jagħmel ħsara lil- trabi mhux imwielda li l- konċepiment tagħhom ikun sar qabel waqt jew ftit wara l- kura.
→ If it is possible you could become pregnant, use a reliable form of birth control (contraception) while you’ re taking Volibris.
Jekk hu possibli li tista 'toħroġ tqila, uża tip ta' kontroll tat- twelid ta 'min joqgħod fuqu (kontraċezzjoni) waqt li tkun qed tieħu Volibris.
Talk to your doctor about this.
Kellem lit- tabib tiegħek dwar dan.
→ Don’ t take Volibris if you are pregnant or planning to become pregnant.
Tieħux Volibris jekk inti tqila jew qed tippjana biex toħroġ tqila.
→ If you become pregnant or think that you may be pregnant while you’ re taking Volibris, see your doctor immediately.
→ Jekk toħroġ tqila jew taħseb li tista tkun tqila waqt li qed tieħu Volibris, ara lit- tabib tiegħek mill- ewwel.
If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking Volibris and regularly while you are taking Volibris.
Jekk inti mara li tista 'toħroġ tqila it- tabib tiegħek jistaqsik biex tagħmel test tat- tqala qabel ma tibda' tieħu Volibris u regolarment waqt li tkun qed tieħu Volibris.
If you are a man taking Volibris, it is possible that Volibris may lower your sperm count.
Jekk inti raġel li qed tieħu Volibris, huwa possibli li Volibris ibaxxilek l- għadd ta 'l- isperma tiegħek.
Talk to your doctor if you have any questions or concerns about this.
Kellem lit- tabib tiegħek jekk ikollok xi mistoqsijiet jew xi inċertezzi dwar dan.
45 Breast-feeding It is not known if Volibris is transferred to breast milk.
46 Treddigħ Mhuwiex magħruf jekk Volibris jgħaddix fil- ħalib tas- sider.
→ Don’ t breast feed while you're taking Volibris.
→ Treddgħax waqt li tkun qed tieħu Volibris.
Driving and using machines It is not known whether Volibris affects your ability to drive or use machines.
Sewqan u tħaddim ta ’ magni M' huwiex magħruf jekk Volibris jaffettwax il- ħila tiegħek biex issuq jew tħaddem magni.
However, it can cause side effects such as headaches (listed in Section 4), and the symptoms of your condition can also make you less fit to drive.
Madankollu, jista 'jikkawża effetti mhux mixtieqa bħal uġigħ ta' ras (imsemmija f' Sezzjoni 4), u s- sintomi tal- marda jistgħu wkoll inaqqsulek il- kapaċità li ssuq.
→ Don’ t drive or operate machines if you’ re feeling unwell.
Issuqx jew tħaddem magni jekk ma tħossokx tiflaħ.
Important information about some of the ingredients of Volibris Volibris tablets contain small amounts of a sugar called lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Volibris Il- pilloli ta 'Volibris fihom ammonti żgħar ta' zokkor li jissejjaħ lactose.
If you have an intolerance to lactose or any other sugars:
Jekk għandek xi ntolleranza għal lactose jew xi tip ta 'zokkor ieħor:
→ Contact your doctor before taking Volibris.
Ikkuntattja lit- tabib tiegħek qabel ma tieħu Volibris.
Volibris tablets contain a colouring called Allura red AC Aluminium Lake (E129) which can cause allergic reactions (see Section 4).
Il- pilloli ta 'Volibris fihom is- sustanza li tagħti l- kulur Allura red AC Aluminium Lake (E129), li tista ’ tikkawża reazzjonijiet allerġiċi (ara Sezzjoni 4).
HOW TO TAKE VOLIBRIS
KIF GĦANDEK TIEĦU VOLIBRIS
Check with your doctor or pharmacist if you ’ re not sure.
Dejjem għandek tieħu Volibris skond kif ikun qallek t- tabib tiegħek. Aċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
How much Volibris to take The usual dose of Volibris is one 5 mg tablet, once a day.
Kemm għandek tieħu Volibris Id- doża tas- soltu ta 'Volibris hija pillola waħda ta' 5 mg, darba kuljum.
Your doctor may decide to increase your dose to 10 mg, once a day.
It- tabib tiegħek jista 'jiddeċiedi li jżid id -' doża tiegħek għal 10 mg darba kuljum.
How to take Volibris It is best to take your tablet at the same time each day.
Kif għandek tieħu Volibris L- aħjar li tieħu il- pillola tiegħek fl- istess ħin kuljum.
Swallow the tablet whole, with a glass of water, do not chew or break the tablet.
Ibla 'il- pillola sħiħa ma' tazza ilma, tomgħodx jew tkisser il- pillola.
You can take Volibris with or without food.
Tista ’ tieħu Volibris ma ’ l- ikel jew fuq stonku vojt.
If you take more Volibris than you should If you accidentally take too much Volibris:
Jekk tieħu Volibris aktar milli suppost Jekk aċċidentalment tieħu ħafna Volibris:
→ Ask your doctor or pharmacist for advice.
→Staqsi lit- tabib jew lill- ispiżjar tiegħek għall- parir.
If you forget to take Volibris If you forget a dose of Volibris, just take the tablet as soon as you remember, then carry on as before.
Jekk tinsa tieħu Volibris Jekk tinsa tieħu doża ta 'Volibris, ħu il- pillola mill- ewwel kif tiftakar, u mbagħad kompli bħal qabel.
Don’ t take two doses at the same time to make up for a forgotten dose.
M’ għandekx tieħu żewġ dożi fl- istess ħin biex tpatti għal doża li tkun insejt tieħu.
Do n't stop taking Volibris without your doctor's advice.
Tieqafx tieħu Volibris mingħajr il- parir tat- tabib tiegħek.
Volibris is a treatment that you will need to keep on taking to control your PAH.
Volibris hija kura li jkollok bżonn tibqa 'tieħu biex tikkontrolla il- PAH tiegħek.
→ Don’ t stop taking Volibris unless you have agreed this with your doctor.
→Tieqafx tieħu Volibris sakemm ma tkunx iddeċidejt dan mat- tabib tiegħek.
Like all medicines, Volibris can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Volibris jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These may affect more than one in 10 people:
Dawn jistgħu jaffettwaw aktar minn 1 f' kull 10 minn nies:
• swelling (oedema), especially of the ankles and feet.
• nefħa (edema), speċjalment ta 'l- egħkiesi u s- saqajn.
If you notice this side effect, tell your doctor. • headache.
Jekk tinduna b’ dan l- effett sekondarju, kellem lit- tabib tiegħek. • uġigħ ta` ras.
These may affect up to one in 10 people:
Dawn jistgħu jaffettwaw sa 1 kull 10 minn nies:
• anaemia (a reduced number of red blood cells), which can cause tiredness, weakness, shortness of breath, and generally feeling unwell • a runny or blocked nose, congestion or pain in the sinuses • constipation • pain in your stomach (abdomen) • flushing (redness of the skin) • palpitations (fast or irregular heart beats).
• anemija (nuqqas ta 'ċelluli ħomor tad- demm), jista ’ jkollok għeja, debbolizza, qtugħ ta ’ nifs, jew ġeneralment ma tħossokx tajjeb • imnieħer imblukkat jew flissjoni, konġestjoni jew uġigħ fis- sinuses • stitikezza • uġigħ fl- istonku tiegħek (addomenu) • fawra (ħmura fil- ġilda) • palpitazzjonijiet (taħbit tal- qalb mgħaġġel jew irregolari).
These may affect up to one in 100 people:
Dawn jistgħu jaffettwaw sa 1 kull 100 minn nies:
• Allergic reactions.
• Reazzjonijiet allerġiċi.
You may notice a rash or itching and swelling (usually of the face, lips, tongue or throat), which may cause difficulty in breathing or swallowing.
Tista 'tinnota raxx jew ħakk jew nefħa (l- aktar fil- wiċċ, fix- xuftejn fl- ilsien jew fil- gerżuma), li tista' jikkawża diffikultà fin- nifs jew biex tibla '.
→ Tell your doctor straight away if you get these effects or if they happen suddenly after taking Volibris.
→Għid lit- tabib tiegħek mill- ewwel jekk ikollok dawn l- effetti jew jekk jiġru f' daqqa wara li tkun ħadt Volibris.
Some patients may have the following side effects:
Xi pazjenti jista 'jkollhom dawn l- effetti mhux mixtieqa:
• heart failure (associated with swelling/ fluid retention) • worsening shortness of breath shortly after starting Volibris.
• falliment tal- qalb (assoċċjat ma 'nefħa/ ritenzjoni ta' fluwidu) • qtigħ ta 'nifs li jmur għall- agħar ftit wara li jinbeda Volibris.
It is important to have regular blood tests, to check for anaemia and that your liver is working properly.
Huwa mportanti li tieħu testijiet regolari tad- demm biex tiċċekkja għal anemija u li l- fwied tiegħek qed jaħdem sew.
Make sure that you have also read the information in Section 2 under ‘ You will need regular blood tests’ and ‘ Signs that your liver is not working properly’.
Kun żgur li taqra wkoll l- informazzjoni f' Sezzjoni 2 taħt 'Ikollok bżonn testijiet regolari tad- demm' u 'Sinjali l- fwied tiegħek mhux qed jaħdem sew'.
HOW TO STORE VOLIBRIS
KIF TAĦŻEN VOLIBRIS
Do not use Volibris after the expiry date which is stated on pack and blister.
Tużax Volibris wara d- data ta ’ skadenza li tidher fuq pakkett u folja blister.
The expiry date means the last day of the month shown.
Id- data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
This medicine does not require any special storage conditions.
Dan il- prodott mediċinali m' għandux bżonn xi kundizzjonijiet speċjali għall- ħażna.
Medicines should not be disposed of in wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Ask your pharmacist how to dispose of medicines you no longer require.
Staqsi lill- ispiżjar dwar kif għandek tarmi mediċini li m’ għankekx bżonn.
What Volibris contains • The active substance is ambrisentan (5 mg or 10 mg).
X’ fih Volibris: • Is- sustanza attiva hija ambrisentan (5 mg jew 10 mg).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol/ polyethylene glycol 3350, lecithin (soya) (E322) and Allura red AC Aluminium Lake (E129).
• Is- sustanzi l- oħra huma: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stereate, polyvinyl alcohol, talc (E553b), titanium dioxide (E171), macrogol/ polyethylene glycol 3350, lecithin (soya) (E322) u Allura red AC Aluminium Lake (E129).
What Volibris looks like and contents of the pack Volibris 5 mg tablet is a pale pink, square, convex tablet engraved with ‘ GS ’ on one face and ‘ K2C’ on the other.
Il- pillola ta 'Volibris 5 mg hija roża ċar, kwadra, u konvessa b" GS' imbuzzata fuq naħa waħda u 'K2C' fuq in- naħa l- oħra.
Volibris 10 mg tablet is a deep pink, oval, convex tablet engraved with ‘ GS ’ on one face and ‘ KE3’ on the other.
Il- pillola ta 'Volibris 10 mg hija roża skur, ovali, u konvessa b" GS' imbuzzata fuq naħa waħda u 'KE3' fuq in- naħa l- oħra.
Volibris is supplied as 5 mg and 10 mg film-coated tablets in blister packs of 10 or 30 tablets.
Volibris issibu bħala pilloli ta '5 mg u 10 mg f' pakketti ta' folji ta '10 jew 30pillola miksijin b' rita.
Marketing Authorisation Holder Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Middlesex UB6 0NN Ir- Renju Unit
Manufacturer Glaxo Wellcome GmbH & Co.
Glaxo Wellcome GmbH & Co.
KG Bad Oldesloe Germany
KG Bad Oldesloe Il- Ġermanja
This leaflet was last approved in {MM/ YYYY}..
Dan il- fuljett kien approvat l- aħħar f ’ {MM/ YYYY}.
London, 21 June 2007 Doc.
Londra, 21 ta 'Ġunju 2007 Doc.
EMEA/ 287136/ 2008
EMEA/ 381427/ 2007
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for VORAXAZE
MISTOQSIJIET U TWEĠIBIET DWAR L- IRTIRAR TA 'L- APPLIKAZZJONI GĦAT - TQEGĦID FIS- SUQ għal VORAXAZE
International non-proprietary name (INN): glucarpidase
Denominazzjoni Komuni Internazzjonali (INN): glucarpidase
On 21 May 2007, Protherics PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Voraxaze, for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Fil- 21 ta 'Mejju 2007, Protherics PLC innotifikat uffiċjalment lill- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) li huma jixtiequ jirtiraw l- applikazzjoni tagħhom għal awtorizzazzjoni għat- tqegħid fis- suq għal Voraxaze, għat- trattament addizzjonali ta' pazjenti li qegħdin jesperjenzaw jew li huma f' riskju ta 'tossiċità b' methotrexate.
What is Voraxaze?
X' inhu Voraxaze?
Voraxaze is a powder to be made up into a solution for injection.
Voraxaze huwa trab li għandu jinġieb f' soluzzjoni għal injezzjoni.
It contains the active substance glucarpidase.
Fih is- sustanza attiva glucarpidase.
What was Voraxaze expected to be used for?
Għal x' hiex huwa mistenni li jintuża Voraxaze?
Voraxaze was to be used as an add-on treatment in patients already receiving a medicine, methotrexate, to prevent or treat the toxic effects of methotrexate.
Dan it- trattament jimpedixxi jew jittratta l- effetti tossiċi ta 'methotrexate.
Methotrexate is used to treat a number of diseases, including some types of cancer.
Methotrexate jintuża biex jittratta numru ta 'mard, inkluż tipi ta' kanċer.
Some cancer patients receive high doses, and, because of this, can experience toxic effects, such as damage to the kidneys, bone marrow suppression (leading to anaemia, an increased risk of infection and bleeding) and mucositis (an inflammation of the mucosa, the lining of organs such as the mouth, with soreness, redness and ulceration).
Xi pazjenti morda bil- kanċer jirċievu dożi għoljin, u minħabba f' hekk, jistgħu jesperjenzaw effetti tossiċi, bħal ħsara fil- kliewi, suppressjoni tal- mudullun ta 'l- għadam (li jwassal għal anemija, riskju miżjud ta' infezzjoni u fsada) u mukożite (infjammazzjoni tal- mukosa, ir- rita ta 'organi bħalma huwa l- ħalq, b' uġigħ, ħmura u ulċeri).
These toxic effects can be life-threatening.
Dawn l- effetti tossiċi jistgħu jkunu ta 'theddida għall- ħajja.
Another medicine, folinic acid, is often given after the methotrexate to help control the toxicities (‘ rescue’ treatment) but these may still develop despite the rescue treatment.
Mediċina oħra, aċidu foliniku, tingħata spiss wara methotrexate biex tgħin tikkontrolla t- tossiċitajiet (trattament ta '‘ salvataġġ ’), madankollu dawn xorta waħda jistgħu jiżviluppaw minkejja t- trattament ta' salvataġġ.
Voraxaze would have been used either as a treatment in patients who had developed such toxic effects, or as prevention in patients who were at risk of developing them, such as patients who have high levels of methotrexate in their blood, or those who have poorly functioning kidneys (when methotrexate may be eliminated more slowly).
Voraxaze kien sejjer jintuża jew bħala trattament f' pazjenti li żviluppaw effetti tossiċi bħal dawn, jew bħala prevenzjoni f' pazjenti li kienu f' riskju li jiżviluppawhom, bħal pazjenti li kellhom livelli għoljin ta 'methotrexate fid- demm tagħhom, jew pazjenti li l- kliewi tagħhom ma kienux qegħdin jaħdmu sew (meta methotrexate jista' jiġi eliminat aktar bil- mod).
Voraxaze was to be given to adults or children as a single injection if the level of methotrexate in the patient’ s blood was above a given ‘ threshold’ at certain times after administration of methotrexate.
Voraxaze kien sejjer jingħata lil adulti jew tfal bħala injezzjoni waħda jekk il- livell ta 'methotrexate fid- demm tal- pazjent ikun ogħla minn ċertu ‘ limitu ’ partikolari f' ċerti ħinijiet wara l- għoti ta' methotrexate.
Because the number of patients with this condition is low, it is considered ‘ rare’, and glucarpidase was designated an ‘ orphan medicine’ (a medicine used in rare diseases) on 3 February 2003.
Billi l- għadd ta 'pazjenti li jbatu minn din il- kundizzjoni huwa wieħed baxx, il- marda hi meqjusa' rari 'u glucarpidase ġie kklassifikat bħala' mediċina orfni '(mediċina użata fil- mardiet rari) fit- 3 ta' Frar 2003
How is Voraxaze expected to work?
Kif inhu mistenni li jaħdem Voraxaze?
The active substance in Voraxaze, glucarpidase, is a copy of the naturally-occurring enzyme carboxypeptidase G2.
Is- sustanza attiva f' Voraxaze, glucarpidase, hija kopja ta 'l- enzim li jseħħ b' mod naturali carboxypeptidase G2.
Carboxypeptidase G2 was originally found in a Pseudomonas bacterium.
Carboxypeptidase G2 oriġinarjament instab f' Pseudomonas bacterium.
It can break down methotrexate into substances that do not have any toxic effects.
Jista 'jitfarrak f' methotrexate f' sustanzi li ma għandhom ebda effett tossiku.
This helps the body eliminate excess methotrexate, and therefore reduces the potential for toxic effects.
Dan jgħin lill- ġisem jelimina l - methotrexate żejjed, u għalhekk inaqqas il- potenzjal għal effetti tossiċi.
The glucarpidase in Voraxaze is made by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA) that makes it able to produce it.
Glucarpidase f' Voraxaze jiġi prodott b' metodu magħruf bħala teknoloġija 'rikombinanti tad- DNA ’: huwa magħmul minn batterju li jkun irċieva ġene (DNA) li jagħmilha possibbli li jipproduċih.
The recombinant enzyme acts in the same way as the natural carboxypeptidase G2.
L - enzim rikombinanti jaġixxi bl- istess mod bħal carboxypeptidase G2 naturali.
(44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu © European Medicines Agency, 2007.
(44- 20) 74 18 84 00 Fax (44- 20) 75 23 71 29 E- mail: mail@ emea. eu. int http: // www. emea. eu. int © European Medicines Agency, 2007.
The studies in human involved a total of 222 patients in two main studies.
L- istudji fl- umani involvew total ta '222 pazjent f' żewġ studji prinċipali.
Voraxaze was not compared to another treatment.
Voraxaze ma tqabbilx ma 'trattament ieħor.
All patients received the medicine as part of a compassionate use programme: the doctor requested Voraxaze from the manufacturer as soon as they encountered a patient with methotrexate toxicities who could possibly benefit from the medicine.
Il- pazjenti kollha rċevew il- mediċina bħala parti minn programm ta 'użu ta' kompassjoni: it- tobba talbu Voraxaze mingħand il- fabbrikant malli ltaqgħu ma 'pazjent b' tossiċitajiet għal methotrexate li seta' jibbenefika mill- mediċina.
The main measure of effectiveness was the reduction in blood levels of methotrexate.
Il- miżura ewlenija ta 'l- effikażja kienet it- tnaqqis fil- livelli tad- demm ta' methotrexate.
The application was at day 180 when the company withdrew.
L- applikazzjoni kienet waslet f' jum 180 meta l- kumpanija rtirat.
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Wara li l- CHMP ivvaluta t- tweġibiet mill- kumpanija għal lista ta 'mistoqsijiet, kien għad fadal xi kwistjonijiet mhux solvuti pendenti.
The CHMP normally takes up to 210 days to evaluate a new application.
Il- CHMP normalment jieħu sa 210 jiem biex jivvaluta applikazzjoni ġdida.
Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Fuq il- bażi tar- reviżjoni tad- dokumentazzjoni inizjali, il- CHMP iħejji lista ta 'mistoqsijiet fil- jum 120, li tintbagħat lill - kumpanija.
Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Ladarba l- kumpanija tkun provdiet it- tweġibiet kollha għall- mistoqsijiet, il- CHMP jirrivedihom u jista ', qabel jagħti opinjoni, jsaqsi xi mistoqsijiet oħra fil- jum 180.
Following the CHMP’ s opinion, it usually takes around two months for the European Commission to grant a licence.
Wara l- opinjoni tal - CHMP, normalment ikun hemm bżonn ta 'madwar xahrejn biex il- Kummissjoni Ewropea tagħti l - liċenzja.
What was the recommendation of the CHMP at that time?
X' kienet ir- rakkomandazzjoni tas- CHMP f' dak iż- żmien?
Based on the review of the data and the company’ s response to the CHMP list of questions at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Voraxaze could not have been approved for the adjunctive treatment of patients experiencing or at risk of methotrexate toxicity.
Fuq il- bażi tar- reviżjoni tat- tagħrif u tat- tweġibiet għal- lista ta 'mistoqsijiet tal- CHMP fiż- żmien ta' l - irtirar, il- CHMP kellu xi tħassib u kien ta 'l- opinjoni proviżorja li Voraxaze ma setax jiġi approvat għat- trattament addizzjonali ta' pazjenti li kienu qegħdin jesperjenzaw jew li kienu f' riskju ta 'tossiċità b' methotrexate.
The main concerns of the CHMP were related to the manufacture of Voraxaze.
It- tħassib ewlieni tal- CHMP kellu x' jaqsam mal- fabbrikazzjoni ta 'Voraxaze.
The production of the medicine had moved from the factory that made the medicine used in the studies, to another factory that was to make the commercial product.
Il- produzzjoni tal - mediċina mxiet mill- fabbrika li għamlet il- mediċina wżata fl- istudji, għal fabbrika oħra li kellha tagħmel il- prodott kummerċjali.
The Committee had concerns that this move was not yet fully organised, especially with regards to the way the production would be controlled (validation), and that the consequences of the move on the product’ s purity were not been fully understood.
Il- Kumitat kien imħasseb li dan il- pass kien għadu mhux organizzat għal kollox, b' mod speċjali fir- rigward tal- mod li bih il- produzzjoni tkun se tiġi kkontrollata (validazzjoni), u li l- konsegwenzi tal- pass fuq il- purità tal- prodott ma ġewx mifhuma għal kollox.
The Committee also had some concern regarding the use of Voraxaze with folinic acid.
Il - Kumitat kellu xi tħassib ukoll fuq l- użu ta 'Voraxaze ma' l- aċidu foliniku.
Folinic acid can also be broken down in the body by Voraxaze, and further studies should be carried out to look at the consequences of this when managing patients with methotrexate toxicities.
L- aċidu foliniku jista 'jiġi assorbit ukoll mill- ġisem billi jitkisser minn Voraxaze, u għandhom jitwettqu aktar studji sabiex jiġu studjati l- konsegwezi ta' dan meta jiġu ġestiti pazjenti b' tossiċitajiet b' methotrexate.
The letter from the company notifying the EMEA of the withdrawal of the application is available here.
L- ittra mill- kumpanija li tgħarraf lill- EMEA dwar l- irtirar ta 'l- applikazzjoni tinstab hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with Voraxaze?
X' inhuma l- konsegwenzi ta 'l- irtirar għall- pazjenti li kienu qed jieħdu sehem fi studji kliniċi / programmi ta' użu ta 'kompassjoni b' Voraxaze?
The company informed the CHMP that there are no consequences for patients currently included in the clinical trials of Voraxaze.
Il- kumpanija għarrfet lill- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li kienu qed jieħdu sehem fl- istudji kliniċi ta 'Voraxaze.
The company also plans to continue their compassionate use programme.
Il- kumpanija qegħda tippjana wkoll li tkompli l- programm ta 'użu ta' kompassjoni tagħha.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi studju kliniku jew fi programm ta 'użu ta' kompassjoni u trid iżjed tagħrif dwar it- trattament tiegħek, ikkuntattja lit- tabib li qed jagħtihulek.
Wilzin 25 mg hard capsules
Wilzin 25 mg kapsuli iebsin
Each hard capsule contains 25 mg of zinc (corresponding to 83.92 mg of zinc acetate dihydrate).
Kull kapsula iebsa fiha 25 mg ta ’ zinc (li jikkorispondi għal 83. 92 mg ta ’ zinc acetate dihydrate).
Size 1 hard capsule with aqua blue opaque cap and body, imprinted "93-376”.
Kapsula iebsa opaka ta ’ daqs 1 ta 'lewn ikħal b' kappa ta' l- istess kulur, li fuqha hemm stampat "93 - 376 ”.
Treatment of Wilson’ s disease.
Trattament għal marda ta ’ Wilson.
Wilzin treatment should be initiated under the supervision of a physician experienced in the treatment of Wilson’ s disease (see section 4.4).
It- trattament b’ Wilzin għandu jiġi mibdi taħt is- sorveljanza ta ’ tabib li għandu esperjenza fit - trattament tal- marda ta ’ Wilson (ara sezzjoni 4. 4).
Wilzin is a life-long therapy.
It- terapija b' Wilzin tingħata għal għomrok.
There is no difference in dosage between symptomatic and presymptomatic patients.
M’ hemm l- ebda differenza fid- doża bejn pazjenti sintomatiċi u pazjenti li għad ma għandhomx sintomi.
Wilzin is available in hard capsules of 25 mg or 50 mg.
Wilzin hu disponibbli f’ kapsuli iebsin ta ’ 25 mg jew 50 mg.
• Adults:
Adulti:
The usual dosage is 50 mg 3 times daily with a maximum dose of 50 mg 5 times daily. • Children and adolescents:
Id- doża tas- soltu hija ta ’ 50 mg 3 darbiet kuljum b’ doża massima ta ’ 50mg 5 darbiet kuljum.
Data are very limited in children under 6 years but since the disease is fully penetrant, prophylactic treatment should be considered as early as possible.
It- tagħrif fit- tfal ta ’ taħt is- 6 snin huwa limitat ħafna iżda peress li l- marda hija penetranti bi sħiħ, trattament profilattiku għandu jiġi kkonsiderat mill- aktar fis possibbli.
The recommended dosage is as follows:
Id- doża rakkomandata hija kif ġejja:
- from 1 to 6 years:
- minn 1 sa 6 snin:
25 mg twice daily
25 mg darbtejn kuljum
- from 6 to 16 years if bodyweight under 57 kg:
- minn 6 sa 16- il sena jekk il- piż tal- ġisem jkun taħt il- 57 kg:
25 mg three times daily
25 mg tliet darbiet kuljum.
- from 16 years or if bodyweight above 57 kg:
- minn 16- il sena jew jekk il- piż tal- ġisem jkun ‘ il fuq minn 57 kg:
50 mg three times daily.
50 mg tliet darbiet
• Pregnant women:
Nisa tqal:
A dosage of 25 mg 3 times daily is usually effective but the dosage should be adjusted to copper levels (see section 4.4 and section 4.6).
Doża ta ’ 25mg 3 darbiet kuljum hija ġeneralment effettiva iżda d- doża għandha tiġi aġġustata mal- livelli ta 'copper (ara sezzjoni 4. 4 u sezzjoni 4. 6).
In all cases, dosage should be adjusted according to therapeutic monitoring (see section 4.4.).
Fil- każijiet kollha, id- dożaġġ għandu jiġi aġġustat skont il- monitoraġġ terapewtiku (ara sezzjoni 4. 4).
Wilzin must be taken on an empty stomach, at least 1 hour before or 2-3 hours after meals.
Wilzin għandu jittieħed fuq stonku vojt, ta ’ l- anqas siegħa qabel jew minn 2- 3 sigħat wara l- ikel.
In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid-morning, between breakfast and lunch.
F’ kaz ta ’ intolleranza gastrika, li ta ’ spiss iseħħ bid- doża ta ’ filgħodu, din id- doża tista ’ tiġi mdewwma sa nofs l- għodwa, bejn il- kolazzjon u l- ikla ta ’ nofsinhar.
It is also possible to take Wilzin with a little protein, such as meat (see section 4.5).
Huwa possibbli wkoll li Wilzin jittieħed ma ’ ftit proteina, bħal ma ’ huwa l- laħam (ara sezzjoni 4. 5).
In children who are unable to swallow capsules, these should be opened and their content suspended in a little water (possibly sugar or syrup flavoured water).
2 Fi tfal li mhumiex kapaċi jibilgħu l- kapsuli, dawn għandhom jiġu miftuħin u l- kontenut tagħhom jitħallat ma ’ ftit ilma (possibbilment ilma biz- zokkor jew ġulepp).
When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for 2 the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Meta pazjent jinqaleb minn fuq trattament kelanti għal terapija ta ’ manteniment b’ Wilzin, it- trattament kelanti għandu jinżamm u jingħata ma Wilzin għal 2- 3 ġimgħat għaliex dan huwa ż- żmien li t - trattament b' zinc jieħu biex jistimola induzzjoni massima ta ’ metallothionein u l- impediment totali ta ’ l- assorbiment ta 'copper.
The administration of the chelating treatment and Wilzin should be separated by at least 1 hour.
Bejn l- għoti tat- trattament kelanti u ta 'Wilzin għandha tgħaddi mill- inqas siegħa.
Zinc acetate dihydrate is not recommended for the initial therapy of symptomatic patients because of its slow onset of action.
Zinc acetate dihydrate mhuwiex rakkomandat għat- terapija inizjali f’ pazjenti sintomatiċi minħabba li l- azzjoni tiegħu tibda bil- mod.
Symptomatic patients must be initially treated with a chelating agent; once copper levels are below toxic thresholds and patients are clinically stable, maintenance treatment with Wilzin can be considered.
Pazjenti sintomatiċi jridu jiġu ttrattati fil- bidu permezz ta ’ mediċina kelanti; la darba l- livell ta 'copper jinżel taħt il- livell tossiku u l- pazjenti jkunu klinikament stabbli, trattament ta ’ manteniment b’ Wilzin jista ’ jiġi kkonsiderat.
Nevertheless, while awaiting zinc induced duodenal metallothionein production and consequential effective inhibition of copper absorption, zinc acetate dehydrate could be administered initially in symptomatic patients in combination with a chelating agent.
Madankollu, waqt l- istennija tal- produzzjoni ta 'metallothionein fid- duwodenu kawżata minn zinc u l - impediment effettiv ta ’ l- assorbiment ta' copper b' konsegwenza ta dan, zinc acetate dihydrate jista ’ jingħata inizjalment f’ pazjenti sintomatici flimkien ma ’ mediċina kelanti.
Although rare, clinical deterioration may occur at the beginning of the treatment, as has also been reported with chelating agents.
Għalkemm rari, deterjorament kliniku jista ’ jseħħ fil- bidu tat- trattament, kif ġie rrappurtat ukoll f' każ ta’ mediċini kelanti.
Whether this is related to mobilisation of copper stores or to natural history of the disease remains unclear.
Mhux ċar jekk dan għandux x’ jaqsam mal- mobilizzazzjoni tal- ħażniet ta 'copper jew ma ’ l- istorja naturali tal- marda.
A change of therapy is recommended in this situation.
Tibdil fit- terapija huwa rakkomandat f’ din is- sitwazzjoni.
Caution should be exercised when switching patients with portal hypertension from a chelating agent to Wilzin, when such patients are doing well and the treatment is tolerated.
Għandha tiġi eżerċitata l- kawtela meta pazjenti bi pressjoni għolja portali jinqalbu minn fuq prodotti kelanti għal fuq Wilzin, meta dawn il- pazjenti jkunu sejrin tajjeb u t- trattament huwa ttolerat.
Two patients of a series of 16 died from hepatic decompensation and advanced portal hypertension after being changed from penicillamine to zinc therapy.
Żewġ pazjenti minn 16- il pazjent mietu minn dekompensazzjoni tal- fwied u pressjoni għolja portali avvanzata wara li nqalbu minn fuq penicillamine għal fuq terapija b' zinc.
Therapeutic monitoring The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/ l (normal:
Monitoraġġ terapewtiku L- għan tat- trattament huwa li jżomm il- livell ta 'copper liberu fil- plażma (magħruf ukoll bħala non - ceruloplasmin copper fil- plażma) anqas minn 250 mikrogramma/ l (normali:
100-150 microgram/ l) and the urinary copper excretion below 125 microgram/ 24 h (normal: < 50 microgram/ 24 h).
100- 150 mikrogramma/ l) u tneħħija ta 'copper fl- awrina anqas minn 125 mikrogramma/ 24 siegħa (normali: < 50 mikrogramma/ 24 siegħa).
The non-ceruloplasmin plasma copper is calculated by subtracting the ceruloplasmin-bound copper from the total plasma copper, given that each milligram of ceruloplasmin contains 3 micrograms of copper.
Non- ceruloplasmin copper fil- plażma huwa kkalkulat billi jitnaqqas copper marbut ma ceruloplasmin mit- total ta 'copper fil- plażma, la kemm- il darba kull milligramma ta' ceruloplasmin fiha 3 mikrogrammi ta ’ copper.
The urinary excretion of copper is an accurate reflection of body loading with excess copper only when patients are not on chelation therapy.
L- eskrezzjoni ta 'copper fl- awrina hija riflessjoni preċiża tat- tagħbija tal- ġisem b’ ta' copper żejjed biss meta l- pazjenti ma jkunux fuq terapija ta ’ kelazzjoni.
Urinary copper levels are usually increased with chelation therapy such as penicillamine or trientine.
Il- livelli ta 'copper fl- awrina ġeneralment jogħlew b ’ terapija kelanti bħal ma hija b' penicillamine jew trientine.
The level of hepatic copper cannot be used to manage therapy since it does not differentiate between potentially toxic free copper and metallothionein bound copper.
Il- livell ta 'copper fil- fwied ma jistax jiġi użat biex timmaniġġa t- terapija peress li dan ma jiddistingwix bejn copper liberu li huwa potenzjalment tossiku u copper marbut ma ’ metallothionein.
In treated patients, assays of urinary and/ or plasma zinc may be a useful measure of treatment compliance.
F’ pazjenti ttrattati, l- analiżi ta 'zinc fl- awrina u/ jew fil- plażma jistgħu jkunu ta ’ kejl utli ta ’ konformità tat- trattament.
Values of urinary zinc above 2 mg/ 24 h and of plasma zinc above 1250 microgram/ l generally indicate adequate compliance.
Livelli ta 'zinc fl- awrina ‘ il fuq min 2mg/ 24 siegħa u ta ’ zinc fil- plażma ‘ il fuq minn 1250 mikrogrammi/ l ġeneralment jindikaw konformità adegwata.
Like with all anti-copper agents overtreatment carries the risk of copper deficiency, which is especially harmful for children and pregnant women since copper is required for proper growth and mental development.
Bħal f’ kull trattament b’ mediċini kontra copper, trattament eċċessiv iġor ir- riskju ta ’ defiċjenza ta 'copper, li hu speċjalment ta ’ ħsara għat- tfal u n- nisa tqal billi copper huwa meħtieġ għall- iżvilupp kif suppost u għall- iżvilupp mentali.
In these patient groups, urinary copper levels should be kept a little above the upper limit of normal or in the high normal range (i. e.
F’ dawn il- gruppi ta ’ pazjenti, il- livelli ta ’ copper fl- awrina għandhom jinżammu ftit ‘ il fuq mill- limitu ta ’ fuq tan- normal jew fil- medda normali għolja (i. e.
40 – 50 microgram/ 24 h).
40- 50 mikrogramma/ 24 siegħa).
Laboratory follow-up including haematological surveillance and lipoproteins determination should also be performed in order to detect early manifestations of copper deficiency, such as anaemia and/ or leukopenia resulting from bone marrow depression, and decrease in HDL cholesterol and HDL/ total cholesterol ratio.
3 Eżamijiet ta 'wara fil- laboratorju li jinkludu sorveljanza ematoloġika u kejl ta' lipoproteini għandhom isiru wkoll sabiex tiskopri manifestazzjonijiet bikrin ta ’ defiċjenza ta 'copper, bħal anemija u/ jew lewkopinja kkawżati minn depressjoni tal- mudullun, u tnaqqis fil- kolesterol HDL u l- proporzjon HDL/ kolesterol totali.
3 In case of gastric intolerance, often occurring with the morning dose, this dose may be delayed to mid- morning, between breakfast and lunch.
F’ kaz ta ’ intolleranza gastrika, li ta ’ spiss iseħħ bid- doża ta ’ filgħodu, din id- doża tista ’ tiġi mdewwma sa nofs l- għodwa, bejn il- kolazzjon u l- ikla ta ’ nofsinhar.
It is also possible to take Wilzin with a little protein, such as meat (see section 4.5).
Hu wkoll possibbli li Wilzin jittieħed ma ’ ftit proteina, bħal ma ’ huwa l- laħam (ara sezzjoni 4. 5).
Other anti-copper agents Pharmacodynamic studies were conducted in Wilson’ s disease patients on the combination of Wilzin (50 mg three times daily) with ascorbic acid (1 g once daily), penicillamine (250 mg four times daily), and trientine (250 mg four times daily).
Mediċini anti- copper oħrajn Studji farmakodinamiċi saru f’ pazjenti bil- marda ta’ Wilson b' terapija kombinata ta ’ Wilzin (50 mg tliet darbiet kuljum) ma ’ ascorbic acid (1g darba kuljum), penicillamine (250 mg erba ’ darbiet kuljum) u trientine (250 mg erba ’ darbiet kuljum).
They showed no significant overall effect on copper balance although mild interaction of zinc with chelators (penicillamine and trientine) could be detected with decreased faecal but increased urinary copper excretion as compared with zinc alone.
Ma wrew l- ebda effett totali sinifikattiv fuq il- bilanċ ta 'copper għalkemm interazzjoni ħafifa ta' zinc ma ’ kelaturi (penicillamine u trientene) setgħet tiġi osservata bi tnaqqis fl- ippurgar iżda b’ żieda fl- eskrezzjoni ta 'copper fl- awrina meta mqabbla ma zinc waħdu.
This is probably due to some extent of complexion of zinc by the chelator, thus reducing the effect of both active substances.
Dan probabilment huwa minħabba xi ammont ta 'rabta ta' ta 'zinc mal- kelaturi, li b’ hekk inaqqas l- effett taż- żewġ sustanzi attivi.
When switching a patient on chelating treatment to Wilzin for maintenance therapy, the chelating treatment should be maintained and co-administered for 2 to 3 weeks since this is the time it takes for the zinc treatment to induce maximum metallothionein induction and full blockade of copper absorption.
Meta pazjent ikun qed jinqaleb minn fuq trattament kelanti għal fuq Wilzin bħala terapija ta ’ manteniment, il- trattament kelanti għandu jitkompla u jingħata ma Wilzin għal 2- 3 gimgħat billi dan huwa ż- żmien li jieħu t- trattament b' zinc biex jikkawża induzzjoni massima ta 'metallothionein u impediment totali ta ’ l- assorbiment ta' copper.
Other medicinal products The absorption of zinc may be reduced by iron and calcium supplements, tetracyclines and phosphorus-containing compounds, while zinc may reduce the absorption of iron, tetracyclines, fluoroquinolones.
Prodotti mediċinali oħrajn L- assorbiment ta 'zinc jista ’ jiġi mnaqqas minn supplimenti ta' iron u ta 'calcium, tetracyclines u prodotti li fihom phosphorus, filwaqt li zinc jista ’ jnaqqas l- assorbiment ta ’ iron, tetracyclines u fluoroquinolones.
Food Studies of the co-administration of zinc with food performed in healthy volunteers showed that the absorption of zinc was significantly delayed by many foods (including bread, hard boiled eggs, coffee and milk).
Ikel Studji fuq l- għoti flimkien ta '- zinc ma ’ l- ikel ġo voluntiera b’ saħħithom urew li l- assorbiment ta' zinc kien imdewwem b' mod sinifikanti minn ħafna ikel (li jinkludi ħobż, bajd iebes mgħolli, kafe u ħalib).
Substances in food, especially phytates and fibres, bind zinc and prevent it from entering the intestinal cells.
Sustanzi fl- ikel, speċjalment phytates u fibri, jorbtu zinc u ma jħalluħx jidħol fiċ- ċelloli intestinali.
However, protein appears to interfere the least.
Madankollu, il- proteina tidher li hija l- anqas li ttellef.
Data on a limited number of exposed pregnancies in patients with Wilson’ s disease give no indication of harmful effects of zinc on embryo/ foetus and mother.
Tagħrif miġbur minn għadd ristrett ta ’ tqaliet esposti f’ pazjenti bil- marda ta ’ Wilson ma jagħtu l- ebda indikazzjoni ta ’ effetti ta ’ ħsara ta 'zinc fuq l- embriju/ fetu u l- omm.
Five miscarriages and 2 birth defects (microcephaly and correctable heart defect) were reported in 42 pregnancies.
Ħames korrimenti u 2 difetti tat - twelid (mikrokefalija u difett fil- qalb korregibbli) ġew irrapportati f’ 42 tqala.
Animal studies conducted with different zinc salts do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Studji fuq l- annimali li saru b’ ta 'zinc salts differenti ma jindikawx effetti ta ’ ħsara diretti jew indiretti fir- rigward ta ’ tqala, l- iżvilupp ta ’ l- embriju/ fetu, il- ħlas u l- iżvilupp ta ’ wara t- twelid (ara sezzjoni 5. 3).
It is extremely important that pregnant Wilson’ s disease patients continue their therapy during pregnancy.
Huwa importanti ħafna li pazjenti tqal bil- marda ta ’ Wilson ikomplu t- terapija tagħhom matul it- tqala.
Which treatment should be used, zinc or chelating agent should be decided by the physician.
Liema trattament għandu jintuża, zinc jew prodott kelanti għandu jiġi deċiż mit- tabib.
Dose adjustments to guarantee that the foetus will not become copper deficient must be done and close monitoring of the patient is mandatory (see section 4.4).
Aġġustamenti fid- doża biex jiżguraw li l- fetu ma jkollux nuqqas ta ’ copper għandhom jsiru w monitoraġġ mill- qrib tal- pazjenta huwa obbligatorju (ara sezzjoni 4. 4)
4 4.7 Effects on ability to drive and use machines
Zinc huwa eliminat fil- ħalib tas- sider ta ’ l- omm u jista ’ jkun hemm nuqqas ta 'copper ikkawżat minn zinc fit- tarbija li qed titredda.
Clinical experience of more than 1 000 patient-years with zinc (more than 500 with zinc acetate dihydrate) as well as post-marketing surveillance with zinc acetate dihydrate of more than 1 000 patient-years showed that the most common undesirable effect is gastric irritation.
Esperjenza klinika fuq aktar minn 1000 sena ta ’ pazjenti b' zinc (aktar minn 500 b’ zinc acetate dihydrate) kif ukoll sorveljanza ta ’ wara t- tqegħid fis- suq b’ zinc acetate dihydrate ta ’ aktar minn 1000 sena ta ’ pazjenti wriet li l- aktar effett mhux mixtieq komuni hija l- irritazzjoni gastrika.
This is usually worst with the first morning dose and disappears after the first days of treatment.
Din hija generalment l- agħar bl- ewwel doża ta ’ filgħodu u tisparixxi wara l- ewwel ġranet tat- trattament.
Delaying the first dose to mid-morning or taking the dose with a little protein may usually relieve the symptoms.
L - ittardjar ta ’ l- ewwel doża għal nofs l- għodwa jew li d- doża ttieħed ma ’ ftit proteina tista ’ ittaffi s - sintomi.
Reported adverse reactions are listed below, by system organ class and by frequency.
Effetti avversi rrapportati huma elenkati hawn taħt, skond il- klassi tas- sistema ta 'l- organi u l - frekwenza.
Frequencies are defined as: very common (> 1/ 10), common (> 1/ 100 ,< 1/10) and uncommon (> 1/1 ,000, < 1/100):
Il- frekwenzi huma mfissra bħala: komuni ħafna (> 1/ 10), komuni (> 1/ 100, < 1/ 10) u mhux komuni (> 1/ 1, 000, < 1/ 100):
Blood and lymphatic system disorders Gastrointestinal disorders Laboratory investigations
Mard gastrointestinali Investigazzjonijiet fil- laboratorju
uncommon: common: common:
komuni: komuni:
sideroblastic anaemia; leukopenia gastric irritation blood amylase, lipase and alkaline phosphatase increased
irritazzjoni gastrika blood amylase, lipase u alkaline phosphatase għoljin
Anaemia may be micro-, normo- or macrocytic and is often associated with leukopenia.
Anemija tista ’ tkun mikro -, normo - jew makroċitika u hija ta ’ spiss assoċjata ma ’ lewkopenja.
Bone marrow examination usually reveals characteristic "ringed sideroblasts" (i. e. developing red blood cells containing iron-engorged paranuclear mitochondria).
Eżami tal- mudullun ġeneralment juri l- karatteristiċi “ sideroblasti biċ- ċrieki ” (i. e. ċelloli tad- demm ħomor li qed jiżviluppaw li fihom mitokondrija paranuklejari mimlijin bil- ħadid).
They may be early manifestations of copper deficiency and may recover rapidly following reduction of zinc dosage.
Dawn jistgħu jkunu sinjali bikrin ta ’ nuqqas ta ’ copper u jistgħu jirkupraw malajr wara tnaqqis fid- doża ta 'zinc.
However, they must be distinguished from haemolytic anaemia which commonly occurs where there is elevated serum free copper in uncontrolled Wilson’ s disease.
Madankollu, għandhom jintgħarfu minn anemija emolitika li ta ’ spiss isseħħ fil- marda ta ’ Wilson li ma tkunx kontrollata, fejn ikun hemm livell għoli ta 'copper liberu fis- serum.
Elevations of serum alkaline phosphatase, amylase and lipase may occur after a few weeks of treatment, with levels usually returning to high normal within the first one or two years of treatment.
Żidiet ta ’ serum alkaline phosphatase, amylase u lipase jistgħu jseħħu wara ftit gimagħat ta ’ trattament, b’ livelli li ġeneralment jirritornaw lura għal- livelli normali għoljin matul l- ewwel sena jew tnejn ta ’ trattament.
Three cases of acute oral overdosage with zinc salts (sulphate or gluconate) have been reported in the literature.
Tliet każi ta ’ doża eċċessiva orali akuta b’ ta 'zinc salts (sulphate jew gluconate) ġew irraportati fil - letteratura medika.
Death occurred in a 35 year-old woman on the fifth day after ingestion of 6 g of zinc (40 times the proposed therapeutic dose) and was attributed to renal failure and haemorrhagic pancreatitis with hyperglycaemic coma.
Il- mewt seħħet f’ mara ta ’ 35 sena fil- ħames jum wara li ħadet 6 g zinc (40 darba d - doża terapewtika proposta) u kienet attribwita għal insuffiċjenza renali u l- infjammazzjoni emorraġika tal- frixa b’ koma ipergliċemika.
The same dose did not produce any symptoms except for vomiting in an adolescent who was treated by whole-bowel irrigation.
L- istess doża ma pproduċiet l- ebda sintomi ħlief rimettar f’ adolexxenti li kien ittratat permezz ta ’ irrigazzjoni tal- musrana kollha.
Another adolescent who ingested 4 g of zinc had serum zinc level of about 50 mg/ l 5 hours later and only experienced severe nausea, vomiting and dizziness.
Adolexxenti ieħor li bela ’ 4 g ta ’ zinc kellu l- livell ta 'zinc fis- serum ta ’ madwar 50mg/ l 5- il siegħa wara u sofra biss dardir qawwi, rimettar u sturdament.
Treatment of overdose should be with gastric lavage or induced emesis as quickly as possible to remove unabsorbed zinc.
Trattament ta ’ doża eċċessiva għandu jsir permezz ta ’ ħasil ta ’ l- istonku jew rimettar ipprovokat mill - aktar fis possibli biex jitneħħa zinc li jkun għadu ma giex assorbit.
Heavy metal chelation therapy should be considered if plasma zinc levels are markedly elevated (> 10 mg/ l).
Terapija ta ’ kelazzjoni b’ metalli tqal għandha tiġi kkunsidrata jekk il- livelli ta 'zinc fil- plażma jibqgħu għoljin ħafna (> 10mg/ l).
Pharmacotherapeutic group: various alimentary tract and metabolism product, ATC code:
Kategorija farmakoterapewtika: prodott ta 'partijiet varji ta' l- apparat alimentari u tal- metaboliżmu, Kodiċi ATC:
Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile.
Il- marda ta ’ Wilson (deġenerazzjoni epatolentikulari) hija difett metaboliku awtosomali reċessiv fl - eskrezzjoni ta 'copper ġol- bile.
Copper accumulation in the liver leads to hepatocellular injury and eventual cirrhosis.
L- akkumulazzjoni ta 'copper fil- fwied twassal għal ħsara epatoċellulari u eventwalment ċirrożi.
When the liver capacity of storing copper is exceeded copper is released into the blood and is taken up in extra hepatic sites, such as the brain, resulting in motor disorders and
Meta l- kapaċità tal- fwied li jaħżen copper tiġi maqbuża copper joħroģ fid - demm u ma jiģix assorbit mill- fwied imma minn postijiet oħra, bħall- moħħ, li jirriżulta f’ disturbi fil - moviment u manifestazzjonijiet psikjattriċi.
Patients may present clinically with predominantly hepatic, neurologic, or psychiatric symptoms.
Il- pazjenti jistgħu jidhru klinikament l- iktar b’ sintomi epatiċi, newroloġiċi jew psikjattriċi.
The active moiety in zinc acetate dihydrate is zinc cation, which blocks the intestinal absorption of copper from the diet and the reabsorption of endogenously secreted copper.
Il- frazzjoni attiva f’ zinc acetate dihydrate hija ta 'zinc ketajin, li timpedixxi l- assorbiment intestinali ta' copper mid- dieta u r- riassorbiment ta 'copper merħi mill- ġisem.
Zinc induces the production of metallothionein in the enterocyte, a protein that binds copper thereby preventing its transfer into the blood.
Zinc jqanqal il- produzzjoni ta ’ metallothionein fl- enteroċita, proteina li torbot copper magħha u b’ hekk ma tħallix it- trasferiment tiegħu għal ġod- demm.
The bound copper is then eliminated in the stool following desquamation of the intestinal cells.
Copper marbut jiġi mbagħad eliminat ma ’ l- ippugar wara deskwamazzjoni taċ - ċelloli intestinali.
Pharmacodynamic investigations of copper metabolism in patients with Wilson’ s disease included determinations of net copper balance and radiolabelled copper uptake.
Stħarriġ farmakodinamiku tal- metaboliżmu ta 'copper f’ pazjenti bil- marda Wilson kienu jinkludu l - miżura tal- bilanċ nett ta' copper u t- teħid ta 'copper radjutikkettat.