qanastek/EMEA-V3 huggingface dataset:
OUTER CARTON AND BOTTLE LABEL FOR TABLETS
KARTUNA TA ’ BARRA U TIKKETTA TAL- FLIXKUN GĦALL- PILLOLI
AMMONAPS 500 mg tablets sodium phenylbutyrate
AMMONAPS 500 mg pilloli sodium phenylbutyrate
Each tablet contains 500 mg of sodium phenylbutyrate.
Kull pillola fiha 500 mg ta ’ sodium phenylbutyrate
Contains sodium, see package leaflet for further information.
Fih sodium, ara l- fuljett ta ’ tagħrif għal aktar informazzjoni.
250 tablets 500 tablets
250 pillola 500 pillola
EXP {month/ year}
JIS{ xahar/ sena}
EU/ 1/ 99/ 120/ 001 250 tablets EU/ 1/ 99/ 120/ 002 500 tablets
EU/ 1/ 99/ 120/ 001 250 pillola EU/ 1/ 99/ 120/ 002 500 pillola
Ammonaps 500 mg [outer packaging only]
Ammonaps 500 mg [ippakkjar ta ’ barra biss]
21 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
21 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OUTER CARTON AND BOTTLE LABEL FOR GRANULES
KAXXA TAL- KARTUN TA ’ BARRA U TIKKETTA TAL- FLIXKUN GĦALL- GRANULI
AMMONAPS 940 mg/ g granules. sodium phenylbutyrate
AMMONAPS 940 mg/ g granijiet sodium phenylbutyrate
1 g of granules contains 940 mg of sodium phenylbutyrate
1 g ta ’ granijiet fihom 940 mg ta ’ sodium phenylbutyrate
266 g granules 532 g granules
266 g granijiet 532 g granijiet
[the below is for immediate packaging only] AMMONAPS granules can be stored for a single period of 3 months at a temperature not above 25°C, after which the product must be discarded.
[dan t’ hawn taħt hu għall- pakkett ewlieni biss] Il- granuli AMMONAPS jistgħu jinħażnu għal perjodu wieħed ta ’ 3 xhur f’ temperatura ta ’ mhux iktar minn 25°C, u wara dan iż- żmien, il- prodott għandu jintrema.
Date removed from refrigerator: _______________
Data meta tneħħa mill- friġġ: _______________
EU/ 1/ 99/ 120/ 003 266 g granules EU/ 1/ 99/ 120/ 004 532 g granules
EU/ 1/ 99/ 120/ 003 266 g granuli EU/ 1/ 99/ 120/ 004 532 g granuli
[Justification for not including Braille accepted]
[Il- ġustifikazzjoni biex ma ’ jkunx inkluż il- Braille hija aċċettata]
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li
please tell your doctor or pharmacist.
m´humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What AMMONAPS is and what it is used for 2.
X’ inhu AMMONAPS u għalxiex jintuża 2.
Before you take AMMONAPS 3.
Qabel ma tieħu AMMONAPS 3.
How to take AMMONAPS 4.
Kif għandek tieħu AMMONAPS 4.
How to store AMMONAPS 6.
Kif taħżen AMMONAPS 6.
WHAT AMMONAPS IS AND WHAT IT IS USED FOR
X’ INHU AMMONAPS U GĦALXIEX JINTUŻA
AMMONAPS is prescribed to patients with urea cycle disorders.
AMMONAPS jingħata bir- riċetta lil pazjenti bi problemi fiċ- ċiklu ta ’ l- urea.
Patients with these rare disorders lack certain liver enzymes and are therefore unable to eliminate nitrogen waste, which builds up in the body after eating protein.
Il- pazjenti b’ dawn il - problemi rari jbatu minn nuqqas ta ’ ċerti enżimi tal- fwied u għalhekk mhumiex kapaċi jneħħu nitrogen żejjed mill- ġisem, li jifforma fil- ġisem wara li jittieħdu l- proteini.
Nitrogen waste, in the form of ammonia, is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
L- ammont żejjed ta ’ nitrogen jinsab fil- forma ta ’ ammonia, li hi tossika b’ mod speċjali fuq il- moħħ u twassal, f’ każi serji, li l- pazjent ma jibqax daqstant konxju u għal koma.
AMMONAPS helps the body to eliminate nitrogen waste.
AMMONAPS jgħin lill- ġisem biex ineħħi nitrogen eċċessiv.
BEFORE YOU TAKE AMMONAPS
QABEL MA TIEĦU AMMONAPS
Do not take AMMONAPS
Tiħux AMMONAPS
- if you are pregnant.
- jekk inti tqila.
- if you are allergic (hypersensitive) to sodium phenylbutyrate or any of the other ingredients of
- jekk inti allerġiku/ a( tbagħti minn sensittività eċċessiva) għal phenylbutyrate jew sustanzi oħra
AMMONAPS.
ta ’ AMMONAPS.
Take special care with AMMONAPS
Oqgħod attent ħafna b’ AMMONAPS
- if you have difficulty swallowing.
- jekk għandek diffikultà biex tibla ’.
AMMONAPS tablets can get stuck in the esophagus and
Il- pilloli AMMONAPS jistgħu jeħlu fl- esofagu u jikkawżaw
cause ulcers.
ulċeri.
If you have difficulty swallowing it is recommended to use AMMONAPS granules instead.
Jekk għandek diffikultà biex tibla ’, hu rakkomandat li tuża l- granuli AMMONAPS minflok il- pilloli.
- if you suffer from heart failure, decreased kidney function or other diseases where retention of
- jekk inti tbati minn kollass tal- qalb, minn tnaqqis fil- funzjoni tal- kliewi jew mard ieħor fejn iż -
the sodium salt contained in AMMONAPS may make your condition worse.
żamma tal- melħ tas- sodium li hemm f’ AMMONAPS, tista ’ taggrava l- kundizzjoni tiegħek.
- if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body
- jekk għandek problemi fit- funzjoni tal- kliewi jew tal- fwied, minħabba li AMMONAPS jiġi
through the kidney and liver.
mneħħi mill- ġisem mill- kliewi u mill- fwied.
- when given to small children, since they may not be able to swallow the tablets and may choke.
- Meta jingħata lit- tfal iż- żgħar, għaliex jista ’ ma jirnexxilhomx jibilgħu l- pilloli u jistgħu jifgaw.
It is recommended to use AMMONAPS granules instead.
Hu rakkomandat li minflok jintużaw granijiet ta ’ AMMONAPS.
AMMONAPS must be combined with a protein limited diet, designed especially for you by the doctor and the dietician.
AMMONAPS għandu jittieħed flimkien ma ’ dieta limitata li hi maħduma apposta għalik mit- tabib jew minn espert tad- dieta.
You must follow this diet carefully.
Int għandek issegwi din id- dieta sew.
AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.
AMMONAPS ma jevitax kompletament l- okkorrenza ta ’ eċċess akut ta ’ ammonia fid- demm u mhuwiex adattat biex jikkura din il- kundizzjoni, li hi emerġenza medika.
25 If you require laboratory tests, it is important to remind your doctor that you take AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
25 Jekk ikollok bżonn ta ’ testijiet tal- laboratorju, hu importanti li tfakkar it- tabib tiegħek li int tieħu AMMONAPS, għax is- sodium phenylbutyrate jista ’ jinfluwenza ċerti riżultati tat- testijiet tal - laboratorju.
It is especially important to tell your doctor if you are taking medicines containing valproic acid, haloperidol, corticosteroids or probenicid, since these medicines may change the effect of AMMONAPS and you will therefore need more frequent blood controls.
B’ mod speċjali hu importanti li tgħid lit- tabib tiegħek jekk qed tieħu mediċini oħra li fihom valproic acid, haloperidol, kortikosterojdi jew probenicid, għax dawn il- mediċini jistgħu jibdlu l- effett ta ’ AMMONAPS u għalhekk, inti ser ikollok bżonn ta ’ testijiet tad- demm iktar frekwenti.
If you are uncertain if your medicines contain these substances, you should check with your doctor or pharmacist.
Jekk m’ intix ċert/ a jekk il- mediċini tiegħek fihomx dawn is- sustanzi, għandek tiċċekkja mat- tabib jew ma ’ l- ispiżjar tiegħek.
Pregnancy and breast-feeding Do not use AMMONAPS if you are pregnant, since this medicine could harm your unborn baby.
Tqala u Treddigħ Tużax AMMONAPS jekk inti tqila, għax din il- mediċina tista ’ tagħmel ħsara lit- tarbija mhux imwielda tiegħek.
If you are a woman who could get pregnant during treatment with AMMONAPS, you must use reliable contraception.
Jekk inti mara li tista ’ toħroġ tqila matul il- kura b’ AMMONAPS, għandek tuża metodu effettiv ta ’ kontraċezzjoni.
Do not use AMMONAPS if you are breast-feeding, since this medicine could pass into the breast-milk and harm your baby.
Tużax AMMONAPS jekk tkun qed tredda ’, għax din il- mediċina tista ’ tgħaddi fil- ħalib tas- sider u tagħmel ħsara lit- tarbija tiegħek.
Important information about some of the ingredients of AMMONAPS Each AMMONAPS tablet contains 62 mg of sodium.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ AMMONAPS Kull pillola ta ’ AMMONAPS fiha 62 mg ta ’ sodium.
To be taken into consideration by patients on a sodium controlled diet.
Dan għandu jkun ikkunsidrat minn pazjenti li qegħdin fuq dieta kkontrollata tas- sodium.
HOW TO TAKE AMMONAPS
KIF GĦANDEK TIEĦU AMMONAPS
Always take AMMONAPS exactly as your doctor has told you.
Dejjem għandek tieħu AMMONAPS skond il- parir tat- tabib.
Remember that AMMONAPS must be taken with the special protein reduced diet.
Ftakar li AMMONAPS irid jittieħed mad- dieta speċjali tal- proteini mnaqqsa.
The daily dose of AMMONAPS will be calculated from your protein tolerance, diet and body weight or body surface.
Id- doża ta ’ kuljum ta ’ AMMONAPS tinħadem fuq it- tolleranza tiegħek għall- proteini, id- dieta u l- piż tal- ġisem jew is- superfiċje tal- ġisem.
You will therefore need regular blood tests to determine the correct daily dose.
Għalhekk, int ser ikollok bżonn ta ’ eżamijiet regolari tad- demm biex tkun determinata d- doża korretta ta ’ kuljum.
You should take AMMONAPS by mouth in equally divided doses with each meal.
Int għandek tieħu AMMONAPS minn ħalqek u tqassam id- doża b’ mod ugwali ma ’ kull ikla.
You should take AMMONAPS with a large volume of water.
Għandek tieħu AMMONAPS ma ’ ammont kbir ta ’ ilma.
AMMONAPS tablets should not be given to children who are not able to swallow tablets.
Il- pilloli AMMONAPS m’ għandhomx jingħataw lit- tfal li mhumiex kapaċi jibilgħu l- pilloli.
It is recommended that AMMONAPS granules are used instead.
Hu rakkomandat li jintużaw il- granijiet ta ’ AMMONAPS minflok.
You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Ser ikollok bżonn tieħu l- kura u ssegwi dieta matul ħajtek kollha, ħlief jekk ikollok trapjant tal- fwied li jkun irnexxa.
If you take more AMMONAPS than you should Patients who have taken very high doses of AMMONAPS experienced sleepiness, tiredness, light- headedness and less frequently confusion, headache, taste disturbances, decrease in hearing, disorientation, impaired memory and worsening of existing neurological conditions.
26 Jekk tieħu AMMONAPS aktar milli suppost Pazjenti li ħadu dożi qawwija ħafna ta ’ AMMONAPS kellhom ngħas, għeja, sturdament, u b’ mod inqas frekwenti, konfużjoni, uġigħ ta ’ ras, disturbi fit- togħma, tnaqqis fis- sens tas- smigħ, diżorjentament, indeboliment tal- memorja u aggravament ta ’ kundizzjonijiet newroloġiċi eżistenti.
If you experience any of these symptoms, you should immediately contact your doctor or the nearest hospital emergency department for supportive treatment.
Jekk inti jkollok kwalunkwe minn dawn is- sintomi, għandek tikkuntattja lit- tabib tiegħek jew l- eqreb dipartiment ta ’ l- emerġenza ta ’ l- isptar immedjatament għal kura ta ’ sapport.
26 If you forget to take AMMONAPS You should take a dose as soon as possible with your next meal.
Jekk tinsa tieħu AMMONAPS Għandek tieħu doża kemm jista ’ jkum malajr l- ewwel darba li tiekol.
Make sure that there are at least 3 hours between two doses.
Dejjem kun ċert li hemm ta ’ l - inqas tliet (3) siegħat bejn żewġ dożi.
Like all medicines, AMMONAPS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, AMMONAPS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Very common side effects (likely to occur in more than 1 out of 10 persons): irregular menstrual periods and cessation of menstrual periods.
Effetti sekondarji komuni ħafna (li x’ aktarx li ser iseħħu f’ iktar minn 1 f’ kull 10 pazjenti): mestrwazzjoni irregolari u l- waqfien tal- mestrwazzjoni.
If you are sexually active and your period stops altogether, do not assume that this is caused by AMMONAPS.
Jekk inti sesswalment attiva u l- mestrwazzjoni tiegħek tieqaf għal kollox, tassumix li dan kien ikkawżat minn AMMONAPS.
If this occurs, please discuss it with your doctor, as the absence of your period may be caused by pregnancy (see Pregnancy and breast-feeding section above).
Jekk dan sseħħ, jekk jogħġbok iddiskutih mat- tabib tiegħek, għax l- assenza tal- mestrwazzjoni tiegħek tista ’ tkun ikkawżata minn tqala (ara s- sezzjoni Tqala u treddigħ hawn fuq).
Common side effects (likely to occur in more than 1 out of 100 persons and less than 1 out of 10 persons): changes in number of blood cells (red cells, white cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), taste disturbances, pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, weight gain and altered laboratory test values.
Effetti sekondarji komuni (li x’ aktarx li ser iseħħu f’ iktar minn 1 f’ kull 100 persuna u f’ inqas minn 1 f’ kull 10 persuni): tibdil fin- numru ta ’ ċelluli ħomor tad- demm (ċelluli ħomor, ċelluli bojod u plejtlets), nuqqas t’ aptit, dipressjoni, irritabilità, uġigħ ta ’ ras, ħass ħażin, żamma ta ’ fluwidu (nefħa), disturbi fit- togħma, uġigħ ta ’ żaqq, rimettar, dardir, stitikezza, riħa fil- ġilda, raxx, funzjoni anormali tal- kliewi, żieda fil- piż u valuri mibdula tat- testijiet tal- laboratorju.
Uncommon side effects (likely to occur in more than 1 out of 1,000 persons and less than 1 out of 100 persons): deficiency in red blood cells due to bone marrow depression, bruising, altered heart rhythm, rectal bleeding, stomach irritation, stomach ulcer, inflammation of the pancreas.
Effetti sekondarji mhux komuni (li x’ aktarx li ser iseħħu f’ iktar minn 1 f’ kull 1, 000 persuna u f’ inqas minn 1 f’ kull 100 persuna): nuqqas ta ’ ċelluli ħomor tad- demm minħabba dipressjoni ta ’ l- għadma tal - mudullun, tbenġil, rittmu mibdul tat- taħbit tal- qalb, ħruġ ta ’ demm mir- rektum, irritazzjoni fl- istonku, ulċera fl- istonku, infjammazzjoni tal- pankreas.
If any of the side effects get 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.
If persistent vomiting occurs, you should contact your doctor immediately.
Jekk iseħħ rimettar persistenti, għandek tikkuntattja lit- tabib tiegħek immedjatament.
HOW TO STORE AMMONAPS
KIF TAĦŻEN AMMONAPS
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal..
Do not use AMMONAPS after the expiry date which is stated on the carton and the bottle label after “ EXP”.
Tużax AMMONAPS wara d- data ta ’ skadenza li tidher fuq il- kaxxa tal- kartun u fuq it- tikketta tal - flixkun wara “ JIS ”.
Medicines should not be disposed of via wastewater or household waste.
27 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What AMMONAPS contains
X’ fih AMMONAPS
- The active substance is sodium phenylbutyrate.
- Is- sustanza attiva hi sodium phenylbutyrate.
Each tablet of AMMONAPS contains 500 mg
Kull pillola AMMONAPS fiha 500 mg ta ’ sodium
of sodium phenylbutyrate.
phenylbutyrate.
- The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal
- Is- sustanzi l- oħra huma microcrystalline cellulose, magnesium stearate u colloidal anhydrous
anhydrous silica.
silica.
27 What AMMONAPS looks like and contents of the pack AMMONAPS tablets are off-white, oval and embossed with “ UCY 500”.
Id- Dehra ta ’ AMMONAPS u d- daqs tal- pakkett Il- pilloli AMMONAPS huma bojod jagħtu fil- griż, ovali u bl- ittri “ UCY 500 ” imnaqqxa fuqhom.
The tablets are packaged in plastic bottles with child-resistant caps.
Il- pilloli huma ppakkjati fi fliexken tal- plastik b’ għatjien li huma reżistenti ghat- tfal.
Each bottle contains 250 or 500 tablets.
Kull flixkun fih 250 jew 500 pillola.
Marketing Authorisation Holder Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm Sweden
Swedish Orphan International AB Drottninggatan 98 SE- 111 60 Stockholm L- Isvezja
Manufacturer Bioglan AB Borrgatan 31 SE-211 24 Malmö Sweden
Manifattur Bioglan AB Borrgatan 31 SE- 211 24 Malmö L- Isvezja
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 Ewropea dwar il - mediċini (EMEA) http: // www. emea. europa. eu /.
AMMONAPS 940 mg/ g granules sodium phenylbutyrate
Ammonaps 940 mg/ g granuli sodium phenylbutyrate
It may harm them, even
TAGĦTIHIEX lil persuni oħra. Tista ’ tagħmlilhom il- ħsara,
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m´humiex
- if you are allergic (hypersensitive) to sodium phenylbutyrate or any of the other ingredients of
- jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal phenylbutyrate jew sustanzi oħra
- if you have decreased kidney or liver function, since AMMONAPS is eliminated from the body
- - jekk għandek problemi fit- funzjoni tal- kliewi jew tal- fwied, minħabba li AMMONAPS jiġi
AMMONAPS must be combined with a protein limited diet, designed especially for you by the doctor and the dietician.
AMMONAPS għandu jittieħed flimkien ma ’ dieta limitata ta ’ proteini li hi maħduma apposta għalik mit- tabib jew minn espert tad- dieta.
If you require laboratory tests, it is important to remind your doctor that you take AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
Jekk ikollok bżonn ta ’ testijiet tal- laboratorju, hu importanti li tfakkar it- tabib tiegħek li int tieħu AMMONAPS, għax is- sodium phenylbutyrate jista ’ jinfluwenza ċerti riżultati tat- testijiet tal - laboratorju.
29 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
29 Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Important information about some of the ingredients of AMMONAPS One small spoon of AMMONAPS granules contains 118 mg of sodium.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ AMMONAPS Kuċċarina żgħira ta ’ granuli ta ’ AMMONAPS fiha 118 mg ta ’ sodium.
One medium sized spoon of AMMONAPS granules contains 360 mg of sodium.
Kuċċarina ta ’ daqs medju ta ’ granuli ta ’ AMMONAPS fiha 360 mg ta ’ sodium.
One large spoon of AMMONAPS granules contains 1066 mg of sodium.
Kuċċarina kbira ta ’ granuli ta ’ AMMONAPS fiha 1066 mg ta ’ sodium.
You should take AMMONAPS in equally divided doses by mouth, through a gastrostomy (tube through the abdomen to the stomach) or through a nasogastric tube (tube through the nose to the stomach).
Int għandek tieħu AMMONAPS minn ħalqek u tqassam id- doża b’ mod permezz ta ’ gastrostomy (tubu fl- istonku li jgħaddi mill- addome) jew mit- tubu nażogastriku (tubu fl- istonku mill- imnieħer).
You should take AMMONAPS with each meal or feeding.
Għandek tieħu AMMONAPS ma ’ kull ikla.
In small children this can be 4 to 6 times per day.
Fi tfal żgħar dan jista ’ jkun 4 sa 6 darbiet kuljum.
To measure the dose: • Shake the bottle lightly before opening • Use the correct spoon:
Biex tkejjel id- doża: • Ċaqlaq il- flixkun bil- mod qabel tiftħu • Użu l- kuċċarina korretta:
0.95 g = small spoon, 2.9 g = medium sized spoon and 8.6 g = large spoon • Take a heaped spoonful of granules out of the bottle • Pass a flat surface, e. g. the back of a knife blade, over the top of the spoon to remove the excess of granules • The granules left in the spoon are one spoonful • Take the correct number of spoonful granules from the bottle
0. 95 g = kuċċarina żgħira, 2. 9 g = kuċċarina ta ’ daqs medju, u 8. 6 g = kuċċarina kbira • Ħu kuċċarina imburġata ta ’ granuli minn ġol- flixkun • Għaddi wiċċ lixx, eż. in- naħa ta ’ wara ta ’ xafra ta ’ sikkina, fuq il- wiċċ tal- kuċċarina biex tneħħi l- granuli żejda. • Il- granuli li jibqa ’ fil- kuċċarina huma kuċċarina waħda mimlija. • Ħu n- numru korrett ta ’ kuċċarini mimlijin bil- granuli mill- flixkun
30 When taken by mouth:
30 Meta teħodhom f’ ħalqek:
Mix the measured dose with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas) and take it immediately after mixing.
Ħallat id- doża mkejla ma ’ ikel solidu (bħal patata mgħaffġa jew sauce tat- tuffieħ) jew ikel likiwdu (bħall- ilma, meraq tat- tuffieħ, meraq tal- larinġ jew ikel tat- trabi li ma jkunx fih proteini) u ħudu eżatt kif tħawwad.
Patients with a gastrostomy or nasogastric tube:
Pazjenti b’ gastrostomy jew tubu nażogastriku:
Mix the granules with water until there are no dry granules left (stirring the solution helps to dissolve the granules). When the granules are dissolved in water you get a milky white liquid.
Ħallat il- granuli ma ’ l- ilma sakemm ma jibqax granuli xotti iktar (li tħawwad is- soluzzjoni jgħin biex il- granuli jinħallu).
Take the solution immediately after mixing.
Meta l- granuli jinħallu fl- ilma, tikseb likwidu abjad qisu ħalib.
If you take more AMMONAPS than you should Patients who have taken very high doses of AMMONAPS experienced sleepiness, tiredness, light- headedness and less frequently confusion, headache, taste disturbances, decrease in hearing, disorientation, impaired memory and worsening of existing neurological conditions.
Jekk tieħu AMMONAPS aktar milli suppost Pazjenti li ħadu dożi qawwija ħafna ta ’ AMMONAPS kellhom ngħas, għeja, sturdament, u b’ mod inqas frekwenti, konfużjoni, uġigħ ta ’ ras, disturbi fit- togħma, tnaqqis fis- sens tas- smigħ, diżorjentament, indeboliment tal- memorja u aggravament ta ’ kundizzjonijiet newroloġiċi eżistenti.
If you forget to take AMMONAPS You should take a dose as soon as possible with your next meal.
Jekk tinsa tieħu AMMONAPS Għandek tieħu doża kemm jista ’ jkun malajr ma ’ l- ikla li jmiss tiegħek.
Make sure that there are at least 3 hours between two doses.
Aċċerta ruħek li jkun hemm mill- inqas 3 sigħat bejn żewġ dożi.
If any of the side effects get 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.
Store in a refrigerator (2°C – 8°C).
Aħżen fi- frigg (2°C – 8°C).
AMMONAPS granules can be removed from the refrigerator for one single period of maximum 3 months and stored at a temperature not above 25°C, after which the product must be discarded.
Il- granijiet AMMONAPS jistgħu jitneħħew mill- friġġ għal perjodu wieħed sa massimu ta ’ 3 xhur u jinħażnu f’ temperatura ta ’ mhux iktar minn 25°C, u wara dan, il- prodott għandu jintrema.
Do not forget to mark the date on the bottle, when removed from the refrigerator.
Tinsiex tikteb fuq il- flixkun id- data ta ’ meta neħħejtu minn ġol- friġġ.
1 g of AMMONAPS granules contains 940 mg
1 g ta ’ granuli ta ’ AMMONAPS fih 940 mg ta ’
of sodium phenylbutyrate.
sodium phenylbutyrate.
- The other ingredients are calcium stearate and colloidal anhydrous silica.
- Is- sustanzi l- oħra huma calcium stearate u colloidal anhydrous silica.
What AMMONAPS looks like and contents of the pack AMMONAPS granules are off-white.
Il- granuli AMMONAPS huma ta ’ kulur abjad jagħti fil- griż.
The granules are packaged in plastic bottles with child-resistant caps.
Il- granuli huma ppakkjati fi fliexken tal- plastik b’ għatjien li huma reżistenti ghat- tfal.
Each bottle contains 266 g or 532 g of granules.
Kull flixkun fih 266 g jew 532 g ta ’ granuli.
Three spoons (one small, one medium and one large) are included to measure your daily dose.
Tliet kuċċarina (waħda żgħira, waħda ta ’ daqs medju u waħda kbira) huma inklużi biex tkun tista ’ tkejjel id- doża tiegħek ta ’ kuljum.
What is Angiox?
X’ inhu Angiox?
Angiox is a white powder that is made up into a solution for injection or infusion (drip into a vein).
Angiox hu trab abjad li jinħall biex jifforma soluzzjoni għall- injezzjoni jew l- infużjoni (dripp f’ vina).
It contains the active substance bivalirudin.
Fih is- sustanza attiva bivalirudin.
What is Angiox used for?
Għal xiex jintuża Angiox?
Angiox is used to treat adults with ‘ acute coronary syndromes’ (ACS, reduced blood flow to the heart), such as unstable angina (a type of chest pain that varies in severity) or myocardial infarction (heart attack) without ‘ ST segment elevation’ (an abnormal reading on the electrocardiogram or ECG).
Angiox jintuża biex jittratta adulti b ’ ‘ sindromi koronarji akuti ’ (ACS- acute coronary syndromes, tnaqqis fil- fluss tad- demm lejn il- qalb), bħall- anġina instabbli (tip ta ’ uġigħ fis- sider li jvarja fis - severità) jew attakk tal- qalb mingħajr ‘ elevazzjoni tas- segment ST ’ (qari mhux normali fl - elettrokardjogramma jew ECG).
It is used together with aspirin and clopidogrel (medicines that help to prevent blood clots) in patients who are about to undergo treatment for their ACS, such as using medicines, undergoing angioplasty or having a heart bypass operation.
Jintuża flimkien ma ’ l- aspirina u clopidogrel (mediċini li jgħinu fil - prevenzjoni ta ’ l- emboli (tagħqid tad- demm) f’ pazjenti li jkunu se jingħataw trattament għall- ACS, bħall- użu ta ’ mediċini, l- anġoplastika (angioplasty) jew operazzjoni tal- bajpass.
Angioplasty or ‘ percutaneous coronary intervention’ (PCI) is an operation to unblock the heart’ s blood vessels.
L- anġoplastika jew ‘ intervent koronarju minn ġol- ġilda ’ (PCI - ‘ percutameous coronary intervention ’) hija operazzjoni li tiżblokka l- arterji u l- vini tal- qalb.
Angiox is also used to prevent blood clots in patients who are going to have PCI.
Angiox jintuża wkoll biex jipprevjeni l- emboli f’ pazjenti li tkun se ssirilhom PCI.
How is Angiox used?
Kif jintuża Angiox?
Angiox is intended to be given intravenously (into a vein).
Angiox huwa magħmul biex jingħata fil- vina.
It should be given by a doctor who has experience in the emergency care of patients with heart problems or in carrying out procedures on the heart.
Għandu jingħata minn tabib bl- esperjenza fil- kura ta ’ emerġenza ta ’ pazjenti bi problemi tal- qalb jew fil- proċeduri fuq il- qalb.
The dose of Angiox and duration of treatment depend on why it is being used.
Id- doża ta ’ Angiox u kemm idum it- trattament jiddependu mir- raġuni għaliex ikun qed jintuża.
The first dose is given by injection, and is followed immediately by an infusion.
L - ewwel doża tingħata b’ injezzjoni, u tiġi segwita immedjatament minn infużjoni.
For ACS, the duration of the infusion depends on how the ACS is to be treated: it can last for a maximum of 72 hours in patients to be treated with medicines.
Għall- ACS, kemm iddum l- infużjoni jiddependi minn kif tkun qed tiġi ttrattata l- ACS: tista ’ ddum massimu ta ’ 72 siegħa f’ pazjenti li jkunu qed jiġu ttrattati b’ mediċini.
When used to prevent blood clots in patients undergoing PCI, a higher dose of Angiox is used, and the infusion may be continued for up to four hours after the procedure.
Meta jintuża biex jipprevjeni l- emboli f’ pazjenti li jkun se jsirilhom PCI, tintuża doża ikbar ta ’ Angiox, u l- infużjoni tista ’ titkompla sa massimu ta ’ erba ’ sigħat wara l- proċedura.
The infusion doses need to be reduced in patients with kidney problems who are undergoing PCI.
Id- dożi ta ’ l- infużjoni jkunu jridu jitnaqqsu f’ pazjenti bi problemi bil- kliewi li tkun se ssirilhom PCI.
Angiox should not be used in patients with severe kidney problems.
Angiox m’ għandux jintuża f’ pazjenti bi problemi severi tal- kliewi.
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Għal iktar tagħrif, ara s- Sommarju tal- Karatteristiċi tal- Prodott (li huwa wkoll parti mill- EPAR).
How does Angiox work?
Kif jaħdem Angiox?
Blood clotting can be a problem when blood flow is disturbed in any way.
L- għaqid tad- demm jista ’ jkun problema meta l- fluss tad- demm jiġi mfixkel b’ xi mod.
Angiox is an anticoagulant: it prevents the blood from coagulating (clotting).
Angiox hu antikoagulant: jipprevjeni d- demm milli jagħqad (clotting).
The active substance in Angiox, bivalirudin, is a synthetic substance derived from hirudin, the anticoagulant substance produced by leeches.
Is- sustanza attiva f’ Angiox, bivalirudin, hija sustanza sintetika derivata mill- hirudin, l- antikoagulant prodott mis- sangisugi mediċinali.
Thrombin is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Jimblokka speċifikament waħda mis- sustanzi li għandha x’ taqsam mal- proċess ta ’ tagħqid tad- demm 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised for non-commercial or commercial purposes, provided the EMEA is acknowledged central to the processes involved in blood clotting.
(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 2008 Reproduction and/ or distribution of this document is authorised for non- commercial or commercial purposes, provided the EMEA is acknowledged magħrufa bħala trombina. It- trombina huwa ċentrali għall- proċessi involuti fit- tagħqid tad- demm.
By using Angiox during ACS or PCI, the risk of a blood clot forming is greatly reduced.
Bl - użu ta ’ Angiox waqt l- ACS jew PCI, ir- riskju tal- formazzjoni ta ’ emboli jitnaqqas ħafna.
This can help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack and can improve the effectiveness of PCI.
Dan jista ’ jgħin sabiex tinżamm iċ- ċirkolazzjoni tad- demm lejn il- qalb f’ pazjenti bl- anġina jew f’ dawk li jkollhom attakk tal- qalb u jista ’ jtejjeb l- effikaċja tal- PCI.
How has Angiox been studied?
Kif ġie studjat Angiox?
Angiox has been studied in over 20,000 patients.
Angiox ġie studjat f’ iktar minn 20, 000 pazjent.
For the treatment of ACS, the main study involved almost 14,000 patients and compared the effectiveness of Angiox, taken alone or with a glycoprotein IIb/ IIIa inhibitor (GPI, another type of medicine that helps to prevent blood clots), with the standard treatment combination of heparin (another anticoagulant) and a GPI.
Għat- trattament ta ’ l- ACS, l- istudju ewlieni li fih ħadu sehem kważi 14, 000 pazjent u qabbel l- effikaċja ta ’ Angiox, meħud waħdu jew ma ’ inibitur tal - gliċoproetina IIb/ IIIa (GPI, tip ieħor ta ’ mediċina li tgħin fil- prevenzjoni ta ’ emboli tad- demm), mal - kombinazzjoni tat- trattament standard li tikkonsisti minn eparina (antikoagulant ieħor) u GPI.
All of the patients also received aspirin, with or without clopidogrel.
Il - pazjenti kollha ngħataw ukoll l- aspirina, ma ’ jew mingħajr clopidogrel.
The effectiveness of Angiox in PCI has been studied in over 6,000 patients.
L- effikaċja ta ’ Angiox f’ PCI ġiet studjata f’ iktar minn 6, 000 pazjent.
Angiox was compared with heparin.
Angiox tqabbel ma ’ l- eparina.
During the PCI, patients often had a stent inserted (a short tube that remains in the artery to stop it closing), and they also received other medicines that help to prevent blood clots, such as abciximab and aspirin.
Waqt il- PCI, il- pazjenti ħafna drabi kellhom stent (tubu qasir li jibqa ’ fl- arterja biex ma jħallihiex tingħalaq) infilzata, u ngħataw ukoll mediċini oħra li jgħinu fil- prevenzjoni ta ’ emboli, bħall - abciximab u l- aspirina.
For all of the studies, there were four main measures: rates of death, heart attack, urgent revascularisation (restoring blood flow to the heart) and major bleeding.
Għall- istudji kollha, kien hemm erba ’ miżuri ewlenin: ir- rati tal- mewt, l- attakk tal- qalb, il - vaskularizzazzjoni mill- ġdid urġenti (il- fluss tad- demm lejn il- qalb jerġa ’ għan- normal) u l- ħruġ tad - demm maġġuri.
What benefit has Angiox shown during the studies?
X’ inhu l- benefiċċju ta ’ Angiox li ntwera f’ dawn l- istudji?
Angiox was as effective as the comparator treatments.
Angiox kien effettiv daqs it- trattament tat- tqabbil.
When used to treat ACS, Angiox, taken with or without a GPI, was as effective as the standard treatment in preventing the overall number of new events (deaths, heart attacks or revascularisations) after 30 days and after a year.
Meta jintuża fit- trattament ta ’ l- ACS, Angiox, meħud ma ’ jew mingħajr GPI, kien effettiv daqs it- trattament standard fil- prevenzjoni tan- numru globali ta ’ episodji ġodda (imwiet, attakki tal- qalb jew vaskularizzazzjonijiet mill- ġdid) wara 30 jum u wara sena.
Angiox was most effective in patients who also took aspirin and clopidogrel.
Angiox kien l- iktar effettiv f’ pazjenti li kienu qed jieħdu wkoll l- aspirina u clopidogrel.
Patients receiving Angiox without GPI also had a lower rate of bleeding after 30 days and after a year.
Il - pazjenti li jieħdu Angiox mingħajr GPI ukoll wassal għal rata iktar baxxa ta ’ ħruġ ta ’ demm wara 30 jum u wara sena.
In patients undergoing PCI, Angiox was as effective as heparin in all measures, except major bleeding, for which it was significantly better than heparin.
F’ pazjenti li tkun se ssirilhom PCI, Angiox kien effettiv daqs l- eparina fil- miżuri kollha, ħlief fil- ħruġ ta ’ demm maġġuri, li għalihom kien ferm aħjar mill- eparina.
What is the risk associated with Angiox?
X’ inhu r- riskju assoċjat ma ’ Angiox?
The most common side effect with Angiox (seen in more than 1 patient in 10) is minor bleeding.
L- iktar effett sekondarju komuni ma ’ Angiox (li deher f’ iktar minn pazjent wieħed minn kull 10) huwa l- ħruġ ħafif tad- demm.
For the full list of all side effects reported with Angiox, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrappurtati ma ’ Angiox, ara l - Fuljett ta ’ Tagħrif.
Angiox should not be used in people who may be hypersensitive (allergic) to bivalirudin, other hirudins, or any of the other ingredients.
Angiox m’ għandux jingħata lil persuni allerġiċi għal bivalirudin, hirudins oħra, jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in patients who have had recent bleeding, who have severe high blood pressure or severe kidney problems, or a heart infection.
Lanqas ma għandu jintuża minn pazjenti li riċentament ikun ħarġilhom ammont sinifikanti ta ’ demm, li jkollhom pressjoni għolja ħafna jew infezzjoni fil- qalb.
Why has Angiox been approved?
Għaliex ġie approvat Angiox?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Angiox is an acceptable substitute for heparin in the treatment of ACS and during PCI.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li Angiox huwa sostitut aċċettabbli għall- eparina fit- trattament ta ’ l- ACS u waqt il- PCI.
The Committee concluded that Angiox’ s benefits are greater than its risks for the treatment of adult patients with ACS planned for urgent or early intervention, with aspirin and clopidogrel, and as an anticoagulant in patients undergoing PCI.
Il- Kumitat ikkonkluda li l - benefiċċji ta ’ Angiox huma ikbar mir- riskji tiegħu fit- trattament ta ’ pazjenti adulti bl- ACS ippjanati għal interventi urġenti jew bikrija, bl- aspirina jew bil- clopidogrel, u bħala antikoagulant f’ pazjenti li tkun se ssirilhom PCI.
The Committee recommended that Angiox be given marketing authorisation.
Il- Kumitat irrakkomanda li Angiox jingħata l- awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Angiox:
Tagħrif ieħor dwar Angiox:
The European Commission granted a marketing authorisation valid throughout the European Union for Angiox to The Medicines Company UK Ltd on 20 September 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Angiox lil The Medicines Company UK Ltd fl- 20 ta ’ Settembru 2004.
The full EPAR for Angiox is available here.
L- EPAR sħiħ għal Angiox huwa disponibbli minn hawnhekk.
This summary was last updated in 01-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi:
EU number
Numru ta ’ l- UE
Powder for concentrate for solution for injection or infusion
Trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni
Vial (glass)
kunjett (ħġieġ)
Angiox 250 mg powder for concentrate for solution for injection or infusion
Angiox 250 mg trab għal konċentrat għal soluzzjoni għal injezzjoni jew għal infużjoni
Each vial contains 250 mg bivalirudin.
Kull kunjett fih 250 mg bivalirudin.
After reconstitution 1 ml contains 50 mg bivalirudin.
Wara rikostituzzjoni 1 ml ikun fih 50 mg bivalirudin.
After dilution 1 ml contains 5 mg bivalirudin.
Wara dilwizzjoni 1 ml ikun fih 5 mg bivalirudin.
Powder for concentrate for solution for injection or infusion.
Trab għal konċentrat għal soluzzjoni għal injezzjoni jew għal infużjoni.
White to off-white lyophilised powder
Trab abjad għal abjad jagħti fil- griż lajofilizzat
For the treatment of adult patients with acute coronary syndromes (unstable angina/ non-ST segment elevation myocardial infarction (UA/ NSTEMI)) planned for urgent or early intervention.
Għat- trattament ta ’ pazjenti adulti b’ xi sindromi koronarji akuti (anġina mhux stabbli/ infart mijokardijaku ta ’ elevazzjoni segmentali mhux ST (UA/ NSTEMI)) ippjanati għal intervent urġenti jew bikri.
Angiox should be administered with aspirin and clopidogrel.
Angiox għandu jingħata ma ’ aspirina u clopidogrel.
An anticoagulant in patients undergoing percutaneous coronary intervention (PCI).
Antikoagulant f’ pazjenti sottoposti għal intervent koronarju perkutanju (PCI – percutaneous coronary intervention).
Angiox is intended for intravenous (IV) use.
Angiox huwa maħsub għal użu għal ġol- vini (IV).
Angiox should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures.
Angiox għandu jiġi amministrat minn tabib b’ esperjenza jew f‘ kura koronarja akuta jew fi proċeduri ta ’ intervent koronarju.
Adults/ Elderly
Adulti/ Anzjani
Acute coronary syndromes (ACS)
Sindromi koronarji akuti (ACS)
The recommended starting dose of Angiox for patients with ACS is an intravenous bolus of 0.1 mg/ kg followed by an infusion of 0.25 mg/ kg/ h.
Id- doża tal- bidu rakkomandata ta ’ Angiox għal pazjenti b’ ACS hija bolus li jingħata ġol- vini ta ’ 0. 1 mg/ kg segwit b’ infużjoni ta ’ 0. 25 mg/ kg/ h.
Patients who are to be medically managed may continue the infusion of 0.25 mg/ kg/ h for up to 72 hours.
Pazjenti li għandhom jiġu ġestiti medicament jistgħu jibqgħu jieħdu l- infużjoni ta ’ 0. 25 mg/ kg/ h sa 72 siegħa.
If the patient proceeds to PCI, an additional bolus of 0.5 mg/ kg should be administered and the infusion increased to 1.75 mg/ kg/ h for the duration of the procedure.
Jekk il- pazjent jipproċedi għal PCI, għandu jingħata bolus addizzjonali ta ’ 0. 5 mg/ kg u l- infużjoni għandha tiżdied għal 1. 75 mg/ kg/ h għal sakemm iddum il- proċedura.
Following PCI, the reduced infusion dose of 0.25 mg/ kg/ h may be resumed for 4 to 12 hours as clinically necessary.
Wara PCI, id- doża ta ’ infużjoni mnaqqsa ta ’ 0. 25 mg/ kg/ h tista ’ titkompla skond kif ikun klinikament meħtieġ.
For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the IV infusion of bivalirudin should be continued until the time of surgery.
Ftit qabel il- kirurġija,
Just prior to surgery, a 0.5mg/ kg bolus dose should be administered followed by a 1.75mg/ kg/ h infusion for the duration of the surgery.
2 għandha tingħata doża bolus ta ’ 0. 5mg/ kg segwita minn infużjoni 1. 75mg/ kg/ h għal kemm iddum il - kirurġija.
2 For patients who proceed to CABG surgery on pump, the IV infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin.
Għal pazjenti li jipproċedu għal kirurġija CABG tat- tip on pump, l- infużjoni IV ta ’ bivalirudin għandha titkompla sa siegħa qabel il- kirurġija u wara, l- infużjoni għandha titwaqqaf u l - pazjent għandu jiġi ttrattat b’ eparina mhux frazzjonata.
The recommended dose of Angiox for patients undergoing PCI is an intravenous bolus of 0.75 mg/ kg body weight followed immediately by an intravenous infusion at a rate of 1.75 mg/ kg body weight/ hour for at least the duration of the procedure.
Id- doża rakkomandata ta ’ Angiox għal pazjenti li jkunu qed jagħmlu PCI hija bolus fil- vini ta ’ 0. 75 mg/ kg ta ’ piż tal- ġisem segwit immedjatament minn infużjoni fil- vini b’ rata ta ’ 1. 75 mg/ kg ta ’ piż tal - ġisem fis- siegħa għal mill- anqas it- tul tal- proċedura.
The infusion may be continued for up to 4 hours post-PCI as clinically warranted.
L- infużjoni tista ’ titkompla sa 4 sigħat wara l- PCI kif klinikament meħtieġ.
The safety and efficacy of a bolus only dose of Angiox has not been evaluated and is not recommended even if a short PCI procedure is planned.
Is- sigurtà u l- effikaċja ta ’ doża bolus biss ta ’ Angiox għadhom ma ġewx evalwati u mhumiex rakkomandati anki jekk tkun ippjanata proċedura PCI qasira.
No dose adjustment is necessary provided renal functions are normal.
M’ hemmx bżonn ta ’ aġġustament fid- doża sakemm il- funzjonijiet tal- kliewi jkunu normali.
In the presence of renal insufficiency the infusion dose/ rate should be adjusted.
Fil - preżenza ta ’ insuffiċjenza tal- kliewi, ir- rata/ doża ta ’ l- infużjoni għandha tiġi aġġustata.
Caution should be exercised in the elderly due to age-related decrease in renal function.
Għandha tintuża kawtela fl- anzjani minħabba t- tnaqqis relatat ma ’ l- età fil- funzjoni tal- kliewi.
The activated clotting time (ACT) may be used to assess bivalirudin activity.
Il- ħin attivat tal- koagulazzjoni tad- demm (ACT) jista ’ jintuża biex tiġi evalwata l- attività ta ’ bivalirudin.
ACT values 5 minutes after bivalirudin bolus average 365 +/ - 100 seconds.
Il- medja tal- valuri ta ’ l- ACT 5 minuti wara bolus ta ’ bivalirudin hija ta ’ 365 + / - 100 sekonda.
If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/ kg should be administered.
Jekk l- ACT ta ’ 5 minuti jkun anqas minn 225 sekonda, għandha tingħata t- tieni doża bolus ta ’ 0. 3 mg/ kg.
In order to reduce the potential for low ACT values, the reconstituted and diluted product should be thoroughly mixed prior to administration and the bolus dose administered by a rapid intravenous push.
Sabiex jitnaqqas il- potenzjal għal valuri baxxi ta ’ ACT, il- prodott rikostitwit u dilwit għandu jiġi mħallat sewwa qabel ma jingħata u d- doża bolus tingħata permezz ta ’ push rapidu fil- vini.
Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75mg/ kg infusion dose is properly administered.
Ladarba l - valur ta ’ l- ACT ikun akbar minn 225 sekonda, ma jkunx meħtieġ monitoraġġ aktar bil- kundizzjoni li d- doża ta ’ l- infużjoni ta ’ 1. 75 mg/ kg tingħata sewwa.
The arterial sheath can be removed 2 hours after discontinuation of the bivalirudin infusion without further ACT monitoring.
L- għant ta ’ l- arterja tista ’ titneħħa sagħtejn wara t- twaqqif ta ’ l- infużjoni ta ’ bivalirudin mingħajr aktar monitoraġġ ta ’ l- ACT.
Renal insufficiency
Insuffiċjenza tal- kliewi
The ACS dose (0.1mg/ kg bolus/ 0.25mg/ kg/ h infusion) should not be adjusted for patients with renal insufficiency.
Id- doża ta ’ ACS (0. 1mg/ kg bolus/ 0. 25mg/ kg/ h infużjoni) ma għandhiex tiġi aġġustata għal pazjenti b’ insuffiċjenza tal- kliewi.
Patients with moderate renal impairment (GFR 30-59ml/ min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/ kg/ h.
Pazjenti b’ insuffiċjenza renali moderata (GFR 30- 59ml/ min) li jkunu qed jagħmlu PCI (sew jekk qed jiġu ikkurati bi bivalirudin għal ACS jew le) għandhom jirċievu rata ta ’ infużjoni aktar baxxa ta ’ 1. 4 mg/ kg/ h.
The bolus dose should not be changed from the posology described under ACS or PCI above.
Id- doża tal- bolus m’ għandhiex tinbidel mill- pożoloġija deskritta hawn fuq taħt ACS jew PCI.
During PCI, monitoring of clotting time such as the ACT is recommended in patients with renal insufficiency.
Matul PCI, il- monitoraġġ tal- ħin biex jagħqad id- demm bħall- ACT huwa rrakkomandat f’ pazjenti b’ insuffiċjenza renali.
The ACT should be checked at 5 minutes post bolus dose.
L- ACT għandu jiġi ċċekkjat 5 minuti wara d- doża bolus.
If the ACT is less than 225 seconds, a second bolus dose of 0.3 mg/ kg should be administered and the ACT re-checked 5 minutes after the administration of the second bolus dose.
Jekk l- ACT ikun anqas minn 225 sekonda, għandha tingħata t- tieni doża bolus ta ’ 0. 3 mg/ kg u l- ACT jiġi ċċekkjat mill- ġdid 5 minuti wara l- għoti ta ’ din it- tieni doża bolus.
In patients with moderate renal impairment included in a pivotal phase III PCI study (REPLACE-2) ACT values assessed 5 minutes after bivalirudin bolus averaged 366 +/ - 89 seconds with no dose adjustment.
Fil- pazjenti b’ indeboliment moderat tal- kliewi inklużi fl- istudju PCI pivitali ta ’ fażi III (REPLACE- 2), il- valuri ACT 5 minuti wara bolus ta ’ bivalirudin kellhom medja ta ’ 366 + / - 89 sekonda mingħajr aġġustament tad- doża.
At the end of the PCI procedure, the ACT values averaged 355 +/ - 81seconds in these patients.
Fit- tmiem tal- proċedura ta ’ PCI, il- medja tal- valuri ACT f’ dawn il- pazjenti kienet ta ’ 355 + / - 81 sekonda.
Angiox is contraindicated in patients with severe renal insufficiency (GFR < 30ml/ min) and also in dialysis-dependent patients (see section 4.3).
3 Angiox huwa kontra- indikat f’ pazjenti b’ insuffiċjenza severa tal- kliewi (GFR < 30ml/ min) kif ukoll f’ pazjenti dipendenti fuq id- dijalisi (ara sezzjoni 4. 3).
3 Hepatic impairment
Indeboliment tal- fwied
No dose adjustment is needed.
M’ hemmx bżonn ta ’ aġġustament fid- doża.
Pharmacokinetic studies indicate that hepatic metabolism of bivalirudin is limited, therefore the safety and efficacy of bivalirudin have not been specifically studied in patients with hepatic impairment.
Studji farmakokinetiċi jindikaw li l- metaboliżmu epatiku ta ’ bivalirudin huwa limitat, għalhekk is- sigurtà u l- effikaċja ta ’ bivalirudin ma ġewx studjati speċifikament f’ pazjenti b’ indeboliment tal- fwied.
There is no relevant indication for use of Angiox in children or adolescents.
M’ hemm ebda indikazzjoni relevanti għall- użu ta ’ Angiox fi tfal jew adoloxxenti.
Use with low molecular weight and unfractionated heparin
Uża b’ piż molekulari baxx u eparina mhux frazzjonata
Patients can be started on Angiox 30 minutes after discontinuation of unfractionated heparin given intravenously, or 8 hours after discontinuation of low molecular weight heparin given subcutaneously.
Il- pazjenti jistgħu jinbdew fuq Angiox 30 minuta wara t- twaqqif ta ’ eparina mhux frazzjonata mogħtija ġol- vina, jew 8 sigħat wara t- twaqqif ta ’ eparina b’ piż molekulari baxx mogħtija taħt il- ġilda.
Use with GPIIb/ IIIa inhibitors
Użu ma ’ inibituri ta ’ GPIIb/ IIIa
Angiox can be used in conjunction with a GPIIb/ IIIa inhibitor.
Angiox jista ’ jintuża flimkien ma ’ inibitur ta ’ GPIIb/ IIIa.
Refer to section 5.1 for further information regarding the use of bivalirudin with or without a GPIIb/ IIIa inhibitor.
Għal aktar informazzjoni dwar l- użu ta ’ bivalirudin bi jew mingħajr inibitur GPIIb/ IIIa, irreferi għal sezzjoni 5. 1.
Angiox is contraindicated in patients with:
Angiox huwa kontra- indikat f’ pazjenti bi:
• a known hypersensitivity to the active substance or to any of the excipients, or to hirudins • active bleeding or increased risk of bleeding because of haemostasis disorders and/ or irreversible coagulation disorders • severe uncontrolled hypertension and subacute bacterial endocarditis • severe renal impairment (GFR < 30ml/ min) and in dialysis-dependent patients.
• sensittività eċċessiva magħrufa għas- sustanza attiva jew għal xi sustanzi mhux attivi fil- prodott, jew għall- hirudins • fsada attiva jew riskju akbar ta ’ fsada minħabba disturbi ta ’ emostasi u/ jew disturbi ta ’ koagulazzjoni irriversibbli • pressjoni għolja severa mhux ikkontrollata u endokardite batterika subakuta • indeboliment sever tal- kliewi (GFR < 30ml/ min) u f’ pazjenti dipendenti fuq id- dijalisi
Angiox is not intended for intramuscular use.
Angiox mhuwiex maħsub għal użu ġol- muskoli.
Do not administer intramuscularly.
Tagħtix ġol- muskoli.
Haemorrhage:
Emorraġija: